# EDGAR Filing Document

**Accession Number:** 0001625297
**File Stem:** 0001628279-23-000069
**Filing Date:** 2023-3
**Character Count:** 2793409
**Document Hash:** 32ad17911255632e821439f67cb578ce
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001628279-23-000069.hdr.sgml**: 20230523

**ACCESSION NUMBER**: 0001628279-23-000069

**CONFORMED SUBMISSION TYPE**: DRS/A

**PUBLIC DOCUMENT COUNT**: 50

**FILED AS OF DATE**: 20230310

**DATE AS OF CHANGE**: 20230309

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** INDIVIOR PLC
- **CENTRAL INDEX KEY:** 0001625297
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** X0
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** DRS/A
- **SEC ACT:** 1933 Act
- **SEC FILE NUMBER:** 377-06470
- **FILM NUMBER:** 23720882

**BUSINESS ADDRESS:**
- **STREET 1:** 234 BATH ROAD
- **CITY:** SLOUGH, BERKSHIRE
- **STATE:** X0
- **ZIP:** SL1 4EE
- **BUSINESS PHONE:** 804-379-1090

**MAIL ADDRESS:**
- **STREET 1:** 234 BATH ROAD
- **CITY:** SLOUGH, BERKSHIRE
- **STATE:** X0
- **ZIP:** SL1 4EE

**Amendment No. 3 to Confidential Submission.**

**As submitted confidentially with the Securities and Exchange Commission on March 9, 2023.**

**This draft registration statement has not been publicly filed with the Securities and Exchange Commission and remains strictly confidential.**

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

**FORM 20-F/A**

☒ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☐ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended ___________.

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report __________

For the transition period from ______ to ______

Commission file number:

**Indivior PLC**

(Exact name of Registrant as specified in its charter and translation of Registrant's name into English)

England and Wales

(Jurisdiction of incorporation or organization)

234 Bath Road, Slough, Berks, SL1 4EE

United Kingdom

(Address of principal executive offices)

---

| | |
|:---|:---|
| Mark Crossley, Chief Executive Officer<br>Indivior PLC<br>10710 Midlothian Turnpike, Suite 125<br>North Chesterfield, Virginia 23235<br>(804) 379-1090; cosec@indivior.com | Copies to:<br>Michael Levitt<br>Freshfields Bruckhaus Deringer US LLP<br>601 Lexington Avenue, 31st Floor, New York, NY 10022<br>(212) 277-4000 |

---

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol** | **Name of each exchange on which registered** |
| Ordinary shares, $0.50 nominal value per share | INDV | Nasdaq Global Select Market |

---

Securities registered or to be registered pursuant to Section 12(g) of the Act: None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None

Indicate the number of outstanding shares of each of the issuer's classes of capital or common stock as of the close of the period covered by the annual report:

N/A

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes&nbsp;&nbsp;&nbsp;&nbsp; ☒ No

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. ☐ Yes&nbsp;&nbsp;&nbsp;&nbsp; ☐ No

Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☐ Yes&nbsp;&nbsp;&nbsp;&nbsp; ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☐ Yes&nbsp;&nbsp;&nbsp;&nbsp; ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of "large accelerated filer," "accelerated filer," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated Filer ☐ Non-accelerated filer ☒ <br> Emerging growth company ☒

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards<sup>†</sup> provided pursuant to Section 13(a) of the Exchange Act. ☐

† The term "new or revised financial accounting standard" refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the eﬀectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing: U.S. GAAP ☐

International Financial Reporting Standards as issued by the International Accounting Standards Board ☒ Other ☐

If "Other" has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.&nbsp;&nbsp;&nbsp;&nbsp; Item 17 ☐ Item 18 ☐

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☐

(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☐ No ☐

------

**TABLE OF CONTENTS**

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| | | |
|:---|:---|:---|
| | | **Page** |
| | [Glossary](#id39cb0e1a10249e1ab7b8f77d921d68a_4) | [2](#id39cb0e1a10249e1ab7b8f77d921d68a_4) |
| | [About this Registration Statement](#id39cb0e1a10249e1ab7b8f77d921d68a_157) | [5](#id39cb0e1a10249e1ab7b8f77d921d68a_157) |
| | [Cautionary Note Regarding Forward Looking Statements](#id39cb0e1a10249e1ab7b8f77d921d68a_173) | [6](#id39cb0e1a10249e1ab7b8f77d921d68a_173) |
| [PART I](#id39cb0e1a10249e1ab7b8f77d921d68a_189) | [PART I](#id39cb0e1a10249e1ab7b8f77d921d68a_189) | [PART I](#id39cb0e1a10249e1ab7b8f77d921d68a_189) |
| [Item 1](#id39cb0e1a10249e1ab7b8f77d921d68a_205) | [Identity of Directors, Senior Management and Advisers](#id39cb0e1a10249e1ab7b8f77d921d68a_205) | [8](#id39cb0e1a10249e1ab7b8f77d921d68a_205) |
| [Item 2](#id39cb0e1a10249e1ab7b8f77d921d68a_222) | [Offer Statistics and Expected Timetable](#id39cb0e1a10249e1ab7b8f77d921d68a_222) | [9](#id39cb0e1a10249e1ab7b8f77d921d68a_222) |
| [Item 3](#id39cb0e1a10249e1ab7b8f77d921d68a_238) | [Key Information](#id39cb0e1a10249e1ab7b8f77d921d68a_238) | [9](#id39cb0e1a10249e1ab7b8f77d921d68a_238) |
| [Item 4](#id39cb0e1a10249e1ab7b8f77d921d68a_7) | [Information on the Company](#id39cb0e1a10249e1ab7b8f77d921d68a_7) | [62](#id39cb0e1a10249e1ab7b8f77d921d68a_7) |
| [Item 4A](#id39cb0e1a10249e1ab7b8f77d921d68a_255) | [Unresolved Staff Comments](#id39cb0e1a10249e1ab7b8f77d921d68a_255) | [105](#id39cb0e1a10249e1ab7b8f77d921d68a_255) |
| [Item 5](#id39cb0e1a10249e1ab7b8f77d921d68a_269) | [Operating and Financial Review and Prospects](#id39cb0e1a10249e1ab7b8f77d921d68a_269) | [105](#id39cb0e1a10249e1ab7b8f77d921d68a_269) |
| [Item 6](#id39cb0e1a10249e1ab7b8f77d921d68a_283) | [Directors, Senior Management and Employees](#id39cb0e1a10249e1ab7b8f77d921d68a_283) | [129](#id39cb0e1a10249e1ab7b8f77d921d68a_283) |
| [Item 7](#id39cb0e1a10249e1ab7b8f77d921d68a_10) | [Major Shareholders and Related Party Transactions](#id39cb0e1a10249e1ab7b8f77d921d68a_10) | [155](#id39cb0e1a10249e1ab7b8f77d921d68a_10) |
| [Item 8](#id39cb0e1a10249e1ab7b8f77d921d68a_16) | [Financial Information](#id39cb0e1a10249e1ab7b8f77d921d68a_16) | [157](#id39cb0e1a10249e1ab7b8f77d921d68a_16) |
| [Item 9](#id39cb0e1a10249e1ab7b8f77d921d68a_301) | [The Offer and Listing](#id39cb0e1a10249e1ab7b8f77d921d68a_301) | [160](#id39cb0e1a10249e1ab7b8f77d921d68a_301) |
| [Item 10](#id39cb0e1a10249e1ab7b8f77d921d68a_2518) | [Additional Information](#id39cb0e1a10249e1ab7b8f77d921d68a_2518) | [161](#id39cb0e1a10249e1ab7b8f77d921d68a_2518) |
| [Item 11](#id39cb0e1a10249e1ab7b8f77d921d68a_329) | [Quantitative and Qualitative Disclosures About Market Risk](#id39cb0e1a10249e1ab7b8f77d921d68a_329) | [190](#id39cb0e1a10249e1ab7b8f77d921d68a_329) |
| [Item 12](#id39cb0e1a10249e1ab7b8f77d921d68a_343) | [Description of Securities Other than Equity Securities](#id39cb0e1a10249e1ab7b8f77d921d68a_343) | [190](#id39cb0e1a10249e1ab7b8f77d921d68a_343) |
| [PART II](#id39cb0e1a10249e1ab7b8f77d921d68a_371) | [PART II](#id39cb0e1a10249e1ab7b8f77d921d68a_371) | [PART II](#id39cb0e1a10249e1ab7b8f77d921d68a_371) |
| [Item 13](#id39cb0e1a10249e1ab7b8f77d921d68a_387) | [Defaults, Dividend Arrearages and Delinquencies](#id39cb0e1a10249e1ab7b8f77d921d68a_387) | [191](#id39cb0e1a10249e1ab7b8f77d921d68a_387) |
| [Item 14](#id39cb0e1a10249e1ab7b8f77d921d68a_403) | [Material Modifications to the Rights of Security Holders and Use of Proceeds](#id39cb0e1a10249e1ab7b8f77d921d68a_403) | [191](#id39cb0e1a10249e1ab7b8f77d921d68a_403) |
| [Item 15](#id39cb0e1a10249e1ab7b8f77d921d68a_417) | [Controls and Procedures](#id39cb0e1a10249e1ab7b8f77d921d68a_417) | [191](#id39cb0e1a10249e1ab7b8f77d921d68a_417) |
| [Item 16A](#id39cb0e1a10249e1ab7b8f77d921d68a_432) | [Audit Committee Financial Expert](#id39cb0e1a10249e1ab7b8f77d921d68a_432) | [191](#id39cb0e1a10249e1ab7b8f77d921d68a_432) |
| [Item 16B](#id39cb0e1a10249e1ab7b8f77d921d68a_446) | [Code of Ethics](#id39cb0e1a10249e1ab7b8f77d921d68a_446) | [191](#id39cb0e1a10249e1ab7b8f77d921d68a_446) |
| [Item 16C](#id39cb0e1a10249e1ab7b8f77d921d68a_460) | [Principal Accountant Fees and Services](#id39cb0e1a10249e1ab7b8f77d921d68a_460) | [191](#id39cb0e1a10249e1ab7b8f77d921d68a_460) |
| [Item 16D](#id39cb0e1a10249e1ab7b8f77d921d68a_474) | [Exemptions From the Listing Standards for Audit Committees](#id39cb0e1a10249e1ab7b8f77d921d68a_474) | [191](#id39cb0e1a10249e1ab7b8f77d921d68a_474) |
| [Item 16E](#id39cb0e1a10249e1ab7b8f77d921d68a_488) | [Purchases of Equity Securities by the Issuer and Affiliated Purchasers](#id39cb0e1a10249e1ab7b8f77d921d68a_488) | [191](#id39cb0e1a10249e1ab7b8f77d921d68a_488) |
| [Item 16F](#id39cb0e1a10249e1ab7b8f77d921d68a_502) | [Change in Registrant's Certifying Accountant](#id39cb0e1a10249e1ab7b8f77d921d68a_502) | [191](#id39cb0e1a10249e1ab7b8f77d921d68a_502) |
| [Item 16G](#id39cb0e1a10249e1ab7b8f77d921d68a_516) | [Corporate Governance](#id39cb0e1a10249e1ab7b8f77d921d68a_516) | [192](#id39cb0e1a10249e1ab7b8f77d921d68a_516) |
| [Item 16H](#id39cb0e1a10249e1ab7b8f77d921d68a_530) | [Mine Safety Disclosure](#id39cb0e1a10249e1ab7b8f77d921d68a_530) | [192](#id39cb0e1a10249e1ab7b8f77d921d68a_530) |
| [Item 16I](#id39cb0e1a10249e1ab7b8f77d921d68a_1941) | [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](#id39cb0e1a10249e1ab7b8f77d921d68a_1941) | [192](#id39cb0e1a10249e1ab7b8f77d921d68a_1941) |
| [PART III](#id39cb0e1a10249e1ab7b8f77d921d68a_544) | [PART III](#id39cb0e1a10249e1ab7b8f77d921d68a_544) | [PART III](#id39cb0e1a10249e1ab7b8f77d921d68a_544) |
| [Item 17](#id39cb0e1a10249e1ab7b8f77d921d68a_560) | [Financial Statements](#id39cb0e1a10249e1ab7b8f77d921d68a_560) | [F-](#id39cb0e1a10249e1ab7b8f77d921d68a_560)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_560) |
| [Item 18](#id39cb0e1a10249e1ab7b8f77d921d68a_578) | [Financial Statements](#id39cb0e1a10249e1ab7b8f77d921d68a_578) | [F-](#id39cb0e1a10249e1ab7b8f77d921d68a_578)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_578) |
| [Item 19](#id39cb0e1a10249e1ab7b8f77d921d68a_592) | [Exhibits](#id39cb0e1a10249e1ab7b8f77d921d68a_592) | [193](#id39cb0e1a10249e1ab7b8f77d921d68a_592) |
|  | [Signature](#id39cb0e1a10249e1ab7b8f77d921d68a_606) | [195](#id39cb0e1a10249e1ab7b8f77d921d68a_606) |

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i

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**GLOSSARY**

ACO means acute cannabinoid overdose.

ADS means American Depositary Shares ("ADS"), a method by which the Group's ordinary shares presently trade in the United States over-the-counter market. We intend to replace our ADSs with ordinary shares listed on the Nasdaq Global Select Market following the U.S. Listing. See "*<u>[Item](#id39cb0e1a10249e1ab7b8f77d921d68a_301)[9](#id39cb0e1a10249e1ab7b8f77d921d68a_301)</u>*."

ANDA means an additional new drug application filed with the FDA.

AUD means alcohol use disorder.

Aelis means Aelis Farma, a French company from whom we obtained an exclusive option for AEF0117, a synthetic CB1 specific signaling inhibitor designed to treat cannabis-related disorders.

ANDA Litigation means legal proceedings related to intellectual property matters involving Dr. Reddy's Laboratories S.A. and Dr. Reddy's Laboratories, Inc. and separately, Alvogen Pine Brook LLC and Alvogen Inc.

BMAT means buprenorphine-medically assisted treatment, the process to treat OUD patients treated with Buprenorphine (as opposed to methadone).

Companies Act mean the UK Companies Act 2006 as amended, and the regulations made thereunder, which is the principal legislation under which we operate, and under which our ordinary share capital has been created.

CHMP means the Committee for Medicinal Products for Human Use, which is the relevant scientific committee in most cases with which one files marketing authorization applications under the EMA.

CIA refers to the Corporate Integrity Agreement which Indivior Inc. entered into in July 2020 with HHS-OIG. The five-year CIA requires, among other things, that Indivior Inc. implement measures designed to ensure compliance with the statutes, regulations, and written directives of U.S. Medicare, U.S. Medicaid, and all other U.S. federal healthcare programs, as well as with the statutes, regulations, and written directives of the U.S. Food and Drug Administration.

CJS means criminal justice system.

CMS means the Centers for Medicare and Medicaid Services.

CMO means a contract manufacturing organization.

CNS means central nervous system.

Companies Act means the Companies Act 2006 (of the United Kingdom).

CREST means the system for the paperless settlement of trades in securities and the holding of uncertificated securities in accordance with the CREST Regulations operated by Euroclear UK and International Limited.

CRO means a contract research organization, a third-party that performs clinical research on our behalf.

CUD means cannabis use disorder.

DATA 2000 means the Drug Addiction and Treatment Act of 2000.

DEA means the United States Drug Enforcement Agency.

------

Demerger means the acquisition of the specialty pharmaceutical business unit of RB by Indivior PLC, which became effective on December 23, 2014.

Demerger Agreement refers to that certain agreement entered into on November 17, 2014 between Indivior PLC and RB, Reckitt Benckiser Healthcare (UK) Limited, RB Pharmaceuticals Limited and RBP Global Holdings Limited to effect the Demerger and to govern the relationship between RB and Indivior PLC following the Demerger.

DIs means depositary interests issued through CREST by Computershare Investor Services PLC representing a beneficial interest in an ordinary share.

DSM-IV means the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, which is the official manual of the American Psychiatric Association. Its purpose is to provide a framework for classifying disorders and defining diagnostic criteria for the disorders listed.

DOJ means the U.S. Department of Justice.

DTC means The Depository Trust Company.

Exchange Act means the U.S. Securities Exchange Act of 1934, as amended.

EMA means the European Medicines Agency.

FCP means our Fine Chemical Plant at which we manufacture the active pharmaceutical ingredients used in our buprenorphine products.

FFDCA means the Federal Food, Drug, and Cosmetic Act under which the FDA derives its authority to regulate pharmaceuticals.

FDA means the U.S. Food and Drug Administration.

FTC means the U.S. Federal Trade Commission.

FTC Order means that certain Stipulated Order for Permanent Injunction and Equitable Monetary Relief in the United States District Court for the Western District of Virginia, Abingdon, between the Federal Trade Commission and Indivior Inc. entered July 24, 2020. As part of the resolution with the FTC and as detailed in the text of the FTC Order, for a ten-year period Indivior Inc. is required to make specified disclosures to the FTC and is prohibited from certain conduct. See *"<u>[Item 10.](#id39cb0e1a10249e1ab7b8f77d921d68a_2560)</u> Additional Information—C. Material Contracts.*"

HCL means buprenorphine hydrochloride, the active pharmaceutical ingredient used in the formulation of SUBLOCADE long-acting injection, SUBOXONE Film, SUBUTEX Tablet, SUBOXONE Tablet, and BUPRENEX.

HCP means healthcare provider, and may refer to a physician, physician's assistant, or nurse, under appropriate circumstances.

HHS-OIG means the Health and Human Services Office of the Inspector General.

ICH means International Conference on Harmonization, which publishes guidelines by which clinical trials of medicinal products in the EU must be conducted.

IND means an investigative new drug application filed with the FDA.

Indivior Inc. is an indirect wholly-owned United States subsidiary of the Group and directly or through its subsidiaries the entity that commercializes our products and runs the Group's operations in the United States.

------

MAT means medication-assisted treatment.

"Merger" means the transactions contemplated by that certain Agreement and Plan of Merger dated as of November 13, 2022 among certain of our subsidiaries and Opiant Pharmaceuticals, Inc., a specialty pharmaceutical company developing medicines for addictions and drug overdose, pursuant to which Opiant would become our wholly-owned subsidiary (the "Merger").

MHRA means the UK Medicines and Healthcare products Regulatory Agency.

MOUD means medication for opioid use disorder, which is the use of medications, in combination with counseling and behavioral therapies, to provide a "whole-patient" approach to the treatment of substance use disorders. Medications used in MOUD are approved by the FDA and MOUD programs are clinically driven and tailored to meet each patient's needs.

OHS means Organized Health Systems, a type of HCP.

"Opiant" means Opiant Pharmaceuticals, Inc., a specialty pharmaceutical company developing medicines for addictions and drug overdose. We completed our acquisition of Opiant on March 2, 2023. For more information see *<u>[Item 4.A](#id39cb0e1a10249e1ab7b8f77d921d68a_1955)</u>.*History and Development of the Company - Acquisition of Opiant.

OUD means opioid use disorder.

RB means Reckitt Benckiser Group PLC.

RB Group means RB and its subsidiaries.

REMS means a risk evaluation and mitigation strategy. The FDA has the authority to require the manufacturer to provide a REMS that is intended to ensure that the benefits of a drug product (or class of drug products) outweigh the risks of harm.

Resolution Agreement refers to an agreement by and among Indivior PLC, Indivior Inc., the United States Attorney's Office for the Western District of Virginia, and the United States Department of Justice's Consumer Protection Branch made as of July 24, 2020 by which the Group settled with DOJ, the FTC, and U.S. state attorneys general the criminal and civil liability in connection with a multi-count indictment brought in April 2019 by a grand jury in the Western District of Virginia, a civil lawsuit joined by the DOJ in 2018, and an FTC investigation. See "*<u>[Item 10.](#i53364dc849204e3e9b3cefe3cf84be34_159574)</u>—C. Material Contracts—Resolution Agreement*" and "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements—<u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal Proceedings*" for more information.

SEC means the United States Securities and Exchange Commission.

Securities Act means the U.S. Securities Act of 1933, as amended.

U.S. Listing means the process of applying to have our ordinary shares listed on the Nasdaq Global Select Market under the symbol "INDV".

WHO means the World Health Organization.

------

**ABOUT THIS REGISTRATION STATEMENT**

As used herein, references to "we," "us," the "Company," "Indivior," "Indivior PLC," "Indivior Group" or the "Group," or similar terms in this Form 20-F mean Indivior PLC and, as the context requires, its consolidated subsidiaries.

Our consolidated financial statements appearing in this registration statement on Form 20-F are prepared in U.S. dollars and in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board ("IFRS").

In this registration statement, we present certain financial information and measures and certain operational data which are not calculated in accordance with IFRS, such as adjusted operating profit, adjusted earnings and adjusted basic earnings per share. A summary of the non-IFRS measures discussed in this registration statement, and of how we use such measures, is presented in "*<u>[Item 5.](#id39cb0e1a10249e1ab7b8f77d921d68a_269)</u> Operating and Financial Review and Prospects*," including cross-references to the sections of this registration statement in which these non-IFRS measures are reconciled to the most directly comparable measure calculated in accordance with IFRS.

This registration statement includes certain trademarks, service marks and trade names that we own or otherwise have the right to use, such as SUBLOCADE®, SUBUTEX PRO®, PERSERIS®, SUBOXONE® Film, SUBOXONE® Tablet, SUBUTEX® Tablet, BUPRENEX®, and INDIVIOR®, which are protected under applicable intellectual property laws and are our property. This registration statement also contains additional trademarks, trade names, and service marks belonging to other parties, which are the property of their respective owners. Solely for convenience, our trademarks, service marks and trade names referred to in this prospectus may appear without the® or <sup>™</sup> symbol, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights to these trademarks, service marks and trade names. We do not intend our use or display of other parties' trademarks, trade names, or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.

Statements made in this registration statement on Form 20-F concerning the contents of any contract, agreement or other document are summaries of such contracts, agreements or documents and are not intended to be complete; such descriptions are qualified in their entirety by reference to the full text of such contract, agreement or other document that may be filed as an exhibit to this registration statement, and you may read the document itself for a complete description of its terms. Such exhibits may contain representations and warranties by the parties thereto, which were made only for purposes of that agreement and as of specified dates; are subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosure schedules; may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts; and are subject to standards of materiality applicable to the contracting parties that may differ from those applicable to investors. Investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Group or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations, warranties and covenants may have changed after the date of any such agreement, which subsequent information may or may not be fully reflected in the Group's public disclosures.

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**CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS**

Certain statements contained in this registration statement, including those in "*<u>[Item 3.D](#id39cb0e1a10249e1ab7b8f77d921d68a_1981)[.](#id39cb0e1a10249e1ab7b8f77d921d68a_1981)</u> Risk Factors*," "*<u>[Item 4.B.](#id39cb0e1a10249e1ab7b8f77d921d68a_1950)</u> Business Overview*" and "*<u>[Item 5.](#id39cb0e1a10249e1ab7b8f77d921d68a_269)</u> Operating and Financial Review and Prospects*" constitute "forward-looking statements." In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "forecasts," "plans," "prepares," "anticipates," "expects," "intends," "may," "will" or "should" or, in each case, their negative or other variations or comparable terminology although these are not exclusive means of identifying such statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance or achievements or industry results to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

The forward-looking statements in this registration statement are made based upon our current expectations and beliefs concerning future events impacting us and therefore involve a number of known and unknown risks and uncertainties. Such forward-looking statements are based on numerous assumptions regarding our present and future business strategy and the environment in which we operate, which may prove to be inaccurate. These forward-looking statements are not guarantees of future performance and actual results may differ materially from those expressed or implied in these forward-looking statements.

In particular, our actual results, performance or achievements or industry results could be affected by, among other things:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our reliance on third parties to manufacture commercial supplies of most of our products, conduct our clinical trials and at times to collaborate on products in our pipeline;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our ability to comply with legal and regulatory settlements, healthcare laws and regulations, requirements imposed by regulatory agencies and payment and reporting obligations under government pricing programs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The substantial litigation and ongoing investigations to which we are or may become a party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Risks related to the manufacture and distribution of our products, some of which are controlled substances;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Market acceptance of our products as well as our ability to commercialize our products and compete with other market participants;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The uncertainties related to the development of new products, including through acquisitions, and the related regulatory approval process;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our dependence on a small number of significant customers;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our ability to retain key personnel or attract new personnel;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our dependence on third-party payors for the reimbursement of our products and the increasing focus on pricing and competition in our industry;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Unintended side effects caused by the clinical study or commercial use of our products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our use of hazardous materials in our manufacturing facilities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our import, manufacturing and distribution of controlled substances;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our ability to successfully execute acquisitions, partnerships, joint ventures, dispositions or other strategic acquisitions;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our ability to protect our intellectual property rights and the substantial cost of litigation or other proceedings related to intellectual property rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The risks related to product liability claims or product recalls;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The significant amount of laws and regulations that we are subject to, including due to the international nature of our business;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Macroeconomic trends and other global developments such as the COVID-19 pandemic;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The terms of our debt instruments, changes in our credit ratings and our ability to service our indebtedness and other obligations as they come due;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Changes in applicable tax rate or tax rules, regulations or interpretations and our ability to realize our deferred tax assets; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Such other factors as set out in "*<u>[Item 3.D.](#id39cb0e1a10249e1ab7b8f77d921d68a_1981)</u> Risk Factors*" and "*<u>[Item 5.](#id39cb0e1a10249e1ab7b8f77d921d68a_269)</u> Operating and Financial Review and Prospects*."

In light of these risks, uncertainties and assumptions, the forward-looking events described in this registration statement may not occur. Forward-looking statements contained in this registration statement apply only at the date of this registration statement. We undertake no obligation publicly to update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

We strongly recommended that you read the risk factors set out in "*<u>[Item 3.D.](#id39cb0e1a10249e1ab7b8f77d921d68a_1981)</u> Risk Factors*" of this registration statement for a more complete discussion of the factors that could affect our future performance and the industry in which we operate.

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**PART I**

**ITEM 1: IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS**

**A.Directors and Senior Management.**

***Directors***

The following table sets forth the names and positions of the members of our Board as of the date of this registration statement. Except as otherwise indicated, the business address of each of the directors is 234 Bath Road, Slough, Berkshire SL1 4EE, United Kingdom.

---

| | | | |
|:---|:---|:---|:---|
| **Name** | **Position** | **Director**<br>**Since** | **Term**<br>**Expires**<sup>(1)</sup> |
| Graham Hetherington | Chair | Nov. 2019 | Nov. 2023 |
| Mark Crossley | Chief Executive Officer<br>and Executive Director | Feb. 2017 | <sup>(2)</sup> |
| Ryan Preblick | Chief Financial Officer<br>and Executive Director | Nov. 2020 | <sup>(2)</sup> |
| Daniel J. Phelan | Senior Independent Director; <br>Designated Non-Executive Director<br>for Workforce Engagement | Nov. 2014 | Nov. 2023<sup>(3)</sup> |
| Peter Bains | Independent Non-Executive Director | Aug. 2019 | Jul. 2025 |
| Jerome Lande | Non-Executive Director | March 2021 | Dec. 2023 |
| Joanna Le Couilliard | Independent Non-Executive Director | March 2021 | Mar. 2024 |
| A. Thomas McLellan, Ph.D. | Independent Non-Executive Director | Nov. 2014 | Nov. 2023<sup>(4)</sup> |
| Lorna Parker | Independent Non-Executive Director | Nov. 2014 | Nov. 2023<sup>(5)</sup> |
| Barbara Ryan | Independent Non-Executive Director | June 2022 | Mar. 2024 |
| Mark Stejbach | Independent Non-Executive Director | March 2021 | Mar. 2024 |
| Juliet Thompson | Independent Non-Executive Director | March 2021 | Mar. 2024 |

---

______________

(1)The dates listed represent the end of the respective Director's term of office on the Board.

(2)Per their employment with the Group, Messrs. Crossley and Preblick serve at the request of the Board and may be removed at any time. Their business address is 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA, 23235, United States.

(3)Mr. Phelan will retire from the Board at September 30, 2023.

(4)Dr. McLellan will continue to serve as an independent non-executive director until a replacement has been appointed and a period of transition has been completed.

(5)Ms. Parker will retire from the Board at September 30, 2023.

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***Senior Management***

The following table sets forth the names and positions of the members of our Senior Management team as of the date of this registration statement. Except as otherwise indicated, the business address for each member of our Senior Management is 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA, 23235, United States.

---

| | |
|:---|:---|
| **Name** | **Position** |
| Mark Crossley | Chief Executive Officer |
| Ryan Preblick | Chief Financial Officer |
| Jeff Burris | Chief Legal Officer |
| Cindy Cetani | Chief Integrity and Compliance Officer |
| Nina DeLorenzo | Chief Global Impact Officer |
| Jon Fogle | Chief Human Resources Officer |
| Christian Heidbreder | Chief Scientific Officer |
| Kathryn Hudson <sup>(1)</sup> | Company Secretary |
| Vishal Kalia | Chief Strategy Officer |
| Richard Simkin | Chief Strategy and Commercial Officer |
| Hillel West <sup>(1)</sup> | Chief Manufacturing and Supply Officer |

---

____________

(1)Business address is 234 Bath Road, Slough, Berkshire SL1 4EE, United Kingdom.

**B.Advisers.**

Our external legal advisers are Freshfields Bruckhaus Deringer LLP, whose address is 100 Bishopsgate, London EC2P 2SR, United Kingdom, and Freshfields Bruckhaus Deringer U.S. LLP, whose address is 601 Lexington Avenue, 31st Floor, New York, NY 10022.

**C.Auditors.**

PricewaterhouseCoopers (U.K.) LLP has been our auditor for group statutory purposes since incorporation.

PricewaterhouseCoopers (U.S.) LLP has audited our financial statements for the periods ended December 31, 2022, 2021 and 2020. PricewaterhouseCoopers (U.S.) LLP is an independent registered public accounting firm, registered with the Public Company Accounting Oversight Board (United States). For more information on our auditors, see "*<u>[Item 10.G.](#id39cb0e1a10249e1ab7b8f77d921d68a_2540)</u> Statements by Experts*."

**ITEM 2: OFFER STATISTICS AND EXPECTED TIMETABLE**

Not applicable.

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**ITEM 3. KEY INFORMATION**

**B.Capitalization and Indebtedness**

The table below sets forth our capitalization and indebtedness as of December 31, 2022, to which no significant updates have occurred through the date of this filing. This table should be read in conjunction with "*<u>[Item 5.](#id39cb0e1a10249e1ab7b8f77d921d68a_269)</u> Operating and Financial Review and Prospects*," and the audited consolidated financial statements and the related notes thereto, which appear elsewhere in this registration statement.

---

| | |
|:---|:---|
| *(in millions)* | **December 31, 2022** |
| **Cash and cash equivalents**<sup>(1, 2)</sup>  | $**774** |
| **Current borrowings** |  |
| Bank loans  | 3 |
| **Total current debt**  | 3 |
| **Non-current borrowings**  |  |
| Bank loans | 237 |
| **Total non-current debt**  | 237 |
| **Total borrowings**<sup>(3)</sup> | **240** |
| **Equity** <sup>(45)</sup> |  |
| Share capital | 68 |
| Share premium | 8 |
| Capital redemption reserve | 6 |
| Other reserves | (1295) |
| Foreign currency translation reserve | (39) |
| Retained earnings | 1303 |
| **Total equity**  | **51** |
| **Total capitalization**  | $**291** |

---

______________

(1)Cash and cash equivalents at December 31, 2021 was $1,102 million.

(2)In March 2023, the Group completed the acquisition of Opiant Pharmaceuticals for $146 million. For a description of the acquisition, see the Audited Consolidated Financial Statements, <u>[Note 27](#id39cb0e1a10249e1ab7b8f77d921d68a_2672)</u>, *Post Balance Sheet Subsequent Events.*

(3)Total borrowings reflects the principal amount drawn on our term loan ($246 million and $249 million at December 31, 2022 and 2021, respectively), net of unamortized debt issuance costs ($6 million and $7 million at December 31, 2022 and 2021, respectively). For a description of the term loan, see "Item 5. Liquidity and Capital Resources - Contractual Obligations."

(4)In October 2022, the Group completed a share consolidation. For a description of the share consolidation, see the Audited Consolidated Financial Statements, <u>[Note 23](#id39cb0e1a10249e1ab7b8f77d921d68a_1524)</u>, *Share Capital*.

(5)In February 2023, the Group completed its second share repurchase program. For a description of the share repurchase program, see the Audited Consolidated Financial Statements, <u>[Note 27](#id39cb0e1a10249e1ab7b8f77d921d68a_2672)</u>, *Post Balance Sheet Subsequent Events.*

**C.Reasons for the Offer and Use of Proceeds**

Not applicable.

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**D.Risk Factors**

You should carefully consider the risks described below, together with all of the other information in this registration statement on Form 20-F. The risks and uncertainties below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we believe to be immaterial may also adversely affect our business. If any of the following risks occur, our business, financial condition, and results of operations could be seriously harmed and you could lose all or part of your investment. This registration statement also contains forward-looking statements that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including the risks described below and elsewhere in this registration statement.

**<u>Summary of Risk Factors</u>**

We are subject to a variety of risks and uncertainties which could have a material adverse effect on our business, financial condition, and results of operations. The summary below is not exhaustive and is qualified by reference to the full set of risk factors set forth in this "Risk Factors" section.

<u>Risks Related to our Business</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We rely on third parties to manufacture commercial supplies of most of our products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Compliance with legal and regulatory settlements requires significant resources and, if we fail to comply, we could be subject to penalties or excluded from government healthcare programs.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are subject to substantial litigation and ongoing investigations and information requests.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are subject to additional risks because we import, manufacture, and distribute controlled substances.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are subject to risks related to the manufacture of our products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We receive substantial revenue from a small number of key proprietary products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We depend on

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to commercialize our products and acceptance of our products by physicians, patients, and healthcare payors.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Several factors affect the rate at which our revenues may grow.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We operate in a highly competitive industry.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We rely on some third parties for our pharmaceutical pipeline and our commercial product sales.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Clinical trials for the development of products may be unsuccessful.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We rely on third parties to conduct our clinical trials.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Failure to retain key personnel or attract new personnel could have an adverse effect on us.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We depend on third-party payors for reimbursement for our products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The clinical study or commercial use of our products may cause unintended side effects.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We use hazardous materials in our manufacturing facilities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may fail to develop or acquire other new products or compounds.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Acquisitions, partnerships, joint ventures, dispositions, and other business combinations or strategic transactions involve several inherent risks.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may be subject to adverse public opinion.

<u>Risks Related to Intellectual Property</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may fail to obtain and maintain patents and protect other proprietary rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may incur substantial costs as a result of litigation or other proceedings related to intellectual property rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may not be able to protect our intellectual property rights throughout the world.

<u>Risks Related to Regulatory or Legal Matters</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The regulatory approval process is expensive, time-consuming, and uncertain.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Regulatory agencies may impose limitations or post-approval requirements on our products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Guidelines published by professional societies, insurance carriers, physician groups, science foundations, and other organizations may affect the use of the Group's products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Product liability and product recalls could have a material adverse effect on us.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are subject to federal, state, local, and foreign healthcare laws and regulations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may inadvertently fail to comply with payment and reporting obligations under governmental pricing programs.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are subject to healthcare fraud and abuse, transparency, and false claims laws.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are subject to anti-corruption laws and regulations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The pharmaceutical industry faces government scrutiny regarding pricing and competition.

<u>Risks Related to our Financial Condition and Tax Matters</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are subject to macroeconomic trends in the markets where we operate.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The COVID-19 pandemic and governmental and societal responses thereto have adversely affected our business and may continue to do so.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our $250 million term loan contains covenants that could limit our ability to plan for or respond to changes in our business.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may not be able to generate sufficient cash to service all of our indebtedness and may be forced to take other actions to satisfy our obligations under our indebtedness, which may not be successful.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Changes in our credit ratings may reduce access to capital and increase borrowing costs.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our insurance coverage may not be adequate.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our effective tax rate may increase, and changes in tax rules and regulations, or interpretations thereof, may adversely affect our financial condition.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our deferred tax assets may not be realized.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• If a United States person is treated as owning at least 10% of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences.

<u>Risks Related to Our Ordinary Shares</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our ordinary shares are subject to market price volatility.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may in the future relocate our primary listing to the U.S., which could cause volatility in our share price and shareholder base.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The rights afforded to our shareholders are governed by English law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We may not pay dividends in the future.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Our business strategy may involve future transactions which may dilute existing shareholders' interests.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Securities or industry analysts may fail to publish research or may publish inaccurate or unfavorable research about our business.

<u>Risks Related to Information Security and Data Privacy</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are at risk for business interruptions or breaches of data security.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are required to maintain the privacy and security of personal information.

<u>Risks Related to Our International Status and Operations</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are subject to various risks related to the local and international nature of our business.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are exposed to risks related to currency exchange rates.

<u>Risks Related to Being a Publicly-Traded Company in the U.S.</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Corporate responsibility matters may impose additional costs and expose us to new risks.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are a foreign private issuer and may lose our foreign private issuer status in the future.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We expect to eventually change to U.S. generally accepted accounting principles.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are subject to risks related to changes in accounting standards, assumptions, and estimates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The obligations associated with being a public company in the U.S. are significant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We have not yet completed our evaluation of our internal control over financial reporting.

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**<u>Risks Related to our Group and Its Business</u>**

***We rely on third parties to manufacture, package, test, and distribute our products and their facilities and processes must meet stringent regulatory requirements.***

The Group relies almost exclusively on third parties, including contract manufacturing organizations, to manufacture, package, test, and distribute our products. The manufacturing of our products, which include oral solid dose tablet products, film products, and terminally sterilized and aseptically filled injectables, is subject to stringent global regulatory, quality, and safety standards, including current Good Manufacturing Practice ("cGMP"). Our recently developed products, including SUBOXONE Film, SUBLOCADE long-acting injectable, and PERSERIS long-acting injectable, are significantly more complicated to manufacture than tablet products. We have limited control over the performance of our third-party manufacturers and are currently dependent on our third-party contract manufacturing partners whom we manage via supply and quality agreements.

Similarly, the Group relies on a third-party logistics vendor and a network of specialty pharmacists and specialty distributors to fulfill orders and distribute our products worldwide. This process is complicated because most of our products contain controlled substances that require special handling, such as adherence to a risk evaluation and mitigation strategy ("REMS") protocol or import restrictions on controlled substances. See also, "*We are subject to additional risks because we import, manufacture, and distribute controlled substances."*

Our Fine Chemical Plant ("FCP") in Hull, UK manufactures the Buprenorphine HCl Active Pharmaceutical Ingredient ("API") used in our tablet and film drug products. This site also produces the intermediate Buprenorphine Base, which is purified by a third-party manufacturer and used in the manufacture of the SUBLOCADE (buprenorphine extended-release) injection drug product. All other APIs required for use in the manufacture of our commercial drug products are supplied by third-party manufacturers.

SUBOXONE (buprenorphine/naloxone) Film drug product is manufactured under a license and supply agreement with Aquestive Therapeutics (formerly known as MonoSol Rx). SUBLOCADE is manufactured under a supply agreement with Curia (formerly known as AMRI). We provide the buprenorphine API used in all of our products and procure from third-party suppliers the polymer and syringe assembly used in the manufacture of SUBLOCADE and PERSERIS, and the API used in PERSERIS as well as the other API used in SUBOXONE. PERSERIS is manufactured under a supply agreement with Curia, which manufactures the liquid syringe, and Patheon Pharmaceuticals, LLC, which manufactures the powder syringe containing risperidone API. Curia has a manufacturing facility located in Burlington, MA, and is developing additional capacity in Albuquerque, NM. Patheon has a manufacturing facility located in Greenville, NC. We also utilize a third party packager.

We or our third-party manufacturers may encounter difficulties in production, such as issues with production costs and yields, process controls, quality control, and quality assurance, including testing of stability, impurities and impurity levels, sterility, and other product specifications by validated test methods, compliance with strictly enforced global and regional regulations, and disruptions or delays caused by man-made or natural disasters, pandemics or epidemics, or other business interruptions, including, for example, the COVID-19 pandemic. In addition, manufacturing capacity for SUBLOCADE and PERSERIS is currently constrained. We have made investments in capacity improvements at the existing Curia facility, safety stock, and additional equipment and expect an additional manufacturing line to become available in 2023 which, once validated and given regulatory approval, should meet anticipated demand for the next few years. However, there can be no assurance that such efforts will be successful. If our third-party manufacturers fail to complete planned capacity expansions in a timely manner or at all, if such expansions are delayed or are not approved by the U.S. Food and Drug Administration ("FDA") or if we are unable to otherwise obtain adequate manufacturing capacity for SUBLOCADE and PERSERIS, we may suffer supply disruptions which would reduce growth in our net revenues and in turn have a material adverse effect on our business, financial condition, and results of operations.

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If we or any of our third-party manufacturers cannot successfully manufacture material that conforms to our specifications and the applicable regulatory authorities' strict regulatory requirements or pass regulatory inspection, we or our third-party manufacturers will not be able to ensure an adequate supply of products and/or secure or maintain regulatory approval for the manufacturing facilities. In addition, we have no direct control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or any other applicable regulatory authorities do not approve these facilities for the manufacture of our products or if they withdraw any such approval in the future, or if our suppliers or third-party manufacturers decide they no longer want to supply our primary active ingredients or manufacture our products, we may need to find alternative manufacturing facilities, which may significantly impact our ability to develop, obtain regulatory approval for or market our products. To the extent our manufacturing facility or that of any third-party manufacturers that we engage with respect to our products are different from those currently being used for commercial supply in the U.S., studies will have to be completed, and the FDA will need to approve such facilities prior to our sale of any product manufactured using these facilities. Any delay or interruption in our ability to meet commercial demand for our products, including any further potential disruption caused by the COVID-19 pandemic, will result in the loss of potential revenues and could adversely affect our ability to gain market acceptance for these products. In addition, any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trials, and, depending upon the period of delay, require us to commence new clinical trials at additional expense or terminate clinical trials completely, which in turn could have a material adverse effect on our business financial condition, and results of operations.

***Compliance with the terms and conditions of our Corporate Integrity Agreement, the Resolution Agreement with the U.S. Attorney's Office for the Western District of Virginia and the U.S. Department of Justice ("DOJ")'s Consumer Protection Branch, and the Stipulated Order for Permanent Injunction and Equitable Monetary Relief with the U.S Federal Trade Commission ("FTC") requires significant resources and management time and, if we fail to comply, we could be subject to criminal charges, penalties, or, under certain circumstances, excluded from government healthcare programs, which would materially adversely affect our business.***

Our Group operates on a global basis and the pharmaceutical industry is both highly competitive and highly regulated. Complying with all applicable laws and regulations, industry standards, and our Group's Code of Conduct are core to the Group's mission, culture, and practices. The Group has processes and procedures to identify, analyze and investigate any potential or actual violations of law, regulation, or policy and, if necessary, take appropriate remedial or corrective actions. Effective procedures and controls assist in ensuring that we provide reliable information and prevent and detect potential fraud. Failure to comply with applicable laws and regulations may subject the Group to civil, criminal, and administrative liability, including but not limited to the imposition of substantial monetary penalties, fines, damages and restructuring of the Group's operations through the imposition of compliance or integrity obligations, and have a potentially adverse impact on the Group's prospects, reputation, results of operations and financial condition.

In 2020, Indivior Inc. entered into a Corporate Integrity Agreement ("CIA") with the U.S. Department of Health and Human Services Office of the Inspector General ("HHS-OIG"). The CIA was part of the Group's resolution of federal criminal and civil charges related to its film and tablet products. In particular, an indictment and superseding indictment issued in the U.S. District Court for the Western District of Virginia in 2019 charged Indivior Inc. and Indivior PLC with health care fraud, mail fraud, wire fraud, and conspiracy to commit the same. The indictments generally alleged that the Company had falsely represented that SUBOXONE Film was safer and less susceptible to misuse, abuse, diversion, and inadvertent pediatric exposure than SUBOXONE and SUBUTEX Tablets, purportedly to delay approval of generic versions of SUBOXONE tablets and retain market share. The indictments were dismissed as part of a resolution agreement with the United States Department of Justice in which the Company did not admit to any wrongdoing, except that subsidiary Indivior Solutions, Inc. ("Solutions") pleaded guilty to a one-count felony information charging Solutions with making false statements to MassHealth (the

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administrator of Medicaid and the Children's Health Insurance Program (CHIP) in Massachusetts) in October 2012. The resolution agreement also settled civil claims alleging that the Company caused false claims to be submitted to government healthcare programs.

The CIA imposes significant compliance obligations on Indivior Inc.'s business and practices and requires Indivior Inc. to engage an Independent Review Organization and a Board Compliance Expert to assess Indivior Inc.'s compliance program and compliance with CIA requirements. The CIA also sets forth monetary penalties that may be imposed on a per-day basis for failure to comply with certain obligations in the CIA. The CIA also includes procedures under which Indivior Inc. must notify HHS-OIG of certain reportable events, and must notify HHS-OIG if it fails to meet the requirements under the CIA. The CIA requires the filing of annual reports describing steps Indivior Inc. has taken in implementing the terms of the CIA, certifications from certain employees that their department or functional area is compliant with certain laws and regulations, and a certification from the Compliance Officer and Chief Executive Officer that Indivior Inc. is in compliance with the CIA, to the best of their knowledge. The CIA also requires an annual resolution from the Nomination and Governance Committee of the Group's Board of Directors that it has reviewed the effectiveness of the Group's compliance program. In the event that HHS-OIG determines Indivior Inc. to be in material breach of certain requirements of the CIA, including, without limitation, repeated violations or any flagrant violation of the CIA, a failure by Indivior Inc. to report a reportable event and take corrective action, a failure to engage and use an independent review organization, among others, Indivior Inc. may be subject to exclusion from participation in the U.S. federal healthcare programs, which would have a severe impact on the Group's ability to comply with the financial covenants in the Group's $250 million term loan, maintain sufficient liquidity to fund its operations, pay off its debt in 2026, generate future revenue and would ultimately impact the Group's viability.

The FTC Stipulated Order contains specific notice and reporting requirements over a 10-year period related to certain activities, including product switching conduct, filing of a Citizen Petition, and receiving FDA approval or acquiring an entity or product that has FDA approval to be marketed in the U.S. The Group may be punished for contempt of court, including, but not limited to criminal contempt, if it fails to comply with any terms of the FTC Stipulated Order or Resolution Agreement.

The Resolution Agreement imposes several significant compliance obligations on the Group, separate from the CIA, including without limitation certain reporting obligations and the requirement that the Group's Chief Executive Officer (a) certifies on an annual basis that, to the best of their knowledge, after a reasonable inquiry, the Group was in compliance with the U.S. Federal Food, Drug and Cosmetic Act (and implementing regulations) and has not committed healthcare fraud, or (b) provides a certified list of all non-compliant activities and steps taken to remedy the activity. The Resolution Agreement also requires an annual resolution from the Group's Board of Directors that it has reviewed the effectiveness of the Group's Compliance Measures. A material breach of the Resolution Agreement could reinstate the indictment against the Group.

The Group's policies, procedures and protocols are designed to prevent and detect failures to comply with the terms of the CIA, the Resolution Agreement and the FTC Order; however, there can be no assurance that a relevant failure that bypasses established controls will be prevented or detected. Any failure to comply with such terms may subject the Group to criminal charges and penalties, or, under certain circumstances, could exclude the Group from U.S. government healthcare programs, which could have a material adverse effect on the Group's business, financial condition and results of operation.

For more information, see "*<u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>—Legal Proceedings—DOJ Resolution*" and "*<u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)[9](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)</u>—Provisions and Other Liabilities*" of "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements*" and "*<u>[Item 10.C.](#id39cb0e1a10249e1ab7b8f77d921d68a_2560)</u> Material Contracts*." We have filed copies of the Resolution Agreement, the CIA, and the FTC Order as Exhibits Nos. 4.3, 4.4, and 4.5, respectively, to this Registration Statement.

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***We are currently, in the past have been, and in the future may be, subject to substantial litigation and ongoing litigation that could cause us to incur significant legal expenses, divert management's attention, and result in harm to our business.***

We have been, are, and may in the future become, involved in various legal proceedings, regulatory proceedings and government enforcement actions. Such proceedings may include claims for, or the possibility of, damages or fines and penalties involving substantial amounts of money or other relief, including but not limited to civil or criminal fines and penalties. For example:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In 2019, the U.S. Attorney's Office for the Western District of Virginia brought an indictment, followed by a superseding indictment (the "2019 Indictment"), against the Group in connection with our marketing and promotional practices related to SUBOXONE Film and SUBOXONE and SUBUTEX Tablets. The indictments charged Indivior Inc. and Indivior PLC with health care fraud, mail fraud, wire fraud, and conspiracy to commit the same. They generally alleged that the Company had falsely represented that SUBOXONE film was safer and less susceptible to misuse, abuse, diverse, and inadvertent pediatric exposure than SUBOXONE tablets, purportedly to delay approval of generic versions of SUBOXONE tablets and retain market share. On July 24, 2020, as part of a global resolution with the U.S. Attorney's Office for the Western District of Virginia, the DOJ's Consumer Protection Branch, the FTC, and several U.S. state attorneys general ("Resolution Agreement"), a wholly-owned subsidiary of Indivior PLC pleaded guilty to a single count of making a false statement relating to healthcare matters in 2012. DOJ dismissed all charges in the indictment and the Group agreed to pay substantial fines totaling $600 million and agreed to substantial reporting and compliance obligations related to its U.S. operations, among other things.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In January 2021, the Group announced it had reached an agreement with Reckitt Benckiser Group plc ("RB") to resolve claims that RB issued in the Commercial Court in London in November 2020, seeking indemnity under the Demerger Agreement entered into on November 17, 2014 between RB and Indivior to effect the Demerger and to govern the relationship between the RB Group and the Indivior Group following the Demerger. Pursuant to the settlement, RB agreed to withdraw the $1.4 billion claim and to release Indivior from any claim for indemnity under the Demerger Agreement relating to the DOJ and FTC settlements which RB entered into in July 2019, as well as other claims for indemnity arising from those matters. Indivior agreed to pay RB a total of $50 million and also agreed to release RB from any claims to seek damages relating to Indivior's settlement with the DOJ and the FTC.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In January 2022, the United States District Court for the District of New Jersey approved the Group's Stipulation and Agreement of Settlement of a securities law class action brought in that court by holders of our Level 1 American Depository Receipts (ADRs) for approximately $2 million. This class action was filed in 2019 against Indivior PLC and a number of directors and officers for alleged violations of federal securities laws, including among other things Section 10(b) of the Exchange Act and Rule 10b-5. Plaintiffs' allegations in this class action lawsuit mirrored many of the allegations of the 2019 Indictment, including that the Group had falsely represented that SUBOXONE Film was safer and less susceptible to misuse, abuse, diverse, and inadvertent pediatric exposure than SUBOXONE and SUBUTEX Tablets, in order increase SUBOXONE Film revenues in the United States and delay generic competition. The Plaintiffs alleged that Indivior made these untrue statements of material facts or omitted material facts and employed devices, schemes and artifices to defraud and engaged in acts, practices and a course of business that operated as a fraud or deceit upon the class in order to inflate its stock price.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In July 2022, the Group settled antitrust, patent infringement, and wrongful injunction claims with the manufacturer of a generic buprenorphine/naloxone film drug product for approximately $72 million.

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We are also subject to several significant unresolved matters. For example,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Civil antitrust cases filed by a class of direct purchasers, a class of end payors, and 41 states and the District of Columbia have been consolidated in multi-district litigation pending in the U.S. District Court for the Eastern District of Pennsylvania, which is set for trial beginning September 18, 2023 (the "Antitrust MDL"). The parties are engaged in mediation which is being overseen by the trial court. In 2022, the Group recognized a provision of $290 million related to certain multidistrict antitrust class and state claims, but the Group cannot predict with any certainty how these matters will ultimately be resolved, or the costs or timing of such resolution. In particular, any final aggregate costs of these matters, whether resolved by settlement or trial, may be materially different from this provision. Separate antitrust cases filed by several insurance companies are pending in the Circuit Court for the County of Roanoke, Virginia. A trial on the Group's pleas in bar (affirmative defense of statute of limitations) related to this case in Roanoke, Virginia is set to begin on October 16, 2023, and trial on the merits is scheduled for July 15, 2024. Finally, Humana, Centene, and other insurance carriers filed antitrust cases in federal court in the Eastern District of Pennsylvania in 2020. The federal district court dismissed the case before it, and the Third Circuit Court of Appeals affirmed the dismissal. Humana separately had filed a Kentucky state court case which was stayed pending a decision in the federal court case, and remains stayed at this time. Centene also filed an action in the Circuit Court for the County of Roanoke, Virginia following the Third Circuit's decision.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Group has been named as a defendant in more than 400 civil lawsuits brought by state and various local governments, public health agencies and payors against manufacturers, distributors, and retailers of opioids alleging that they engaged in a longstanding practice to market opioids as safe and effective for the treatment of long-term chronic pain to increase the market for opioids and their own market share, as well as individuals alleging personal injury claims.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In September 2022, certain shareholders issued representative and multiparty claims against the Group in the High Court of Justice for the Business and Property Courts of England and Wales, King's Bench Division generally alleging that the Group violated the UK Financial Services and Markets Act 2000 ("FSMA 2000") by making false or misleading statements or material omissions in public disclosures, including the 2014 Demerger Prospectus, regarding an alleged product-hopping scheme regarding the switch from SUBOXONE Tablets to SUBOXONE Film.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• See also "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements—<u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal Proceedings*," especially at the captions "Antitrust Litigation and Consumer Protection" and "Civil Opioid Litigation" for information regarding additional matters that we believe may be significant to the Group as of the date of the filing of this registration statement.

The amount of time that is required to resolve legal or regulatory proceedings is unpredictable and any litigation or claims against us, even those without merit, may cause us to incur substantial costs, divert management's attention from the day-to-day operation of our business, and materially harm our stock price and reputation. In addition, we are obligated to indemnify and advance expenses to certain individuals and entities involved in certain of these and related proceedings. Any adverse judgment in or settlement of any pending or any future litigation could result in significant payments, fines and penalties that could have a material adverse effect on our business, results of operations, financial condition and reputation.

We are also subject to ongoing investigations and information requests. For example, in May 2018, Indivior Inc. received an informal request from the U.S. Attorney's Office ("USAO") for the Southern District of New York, seeking records relating to the SUBOXONE Film manufacturing process. Indivior Inc. is discussing with the USAO certain information and allegations that the government received regarding SUBOXONE Film. If, as a result of these or any future investigations, we are found or suspected to have violated any applicable laws and regulations, we may be subject to a variety of fines, penalties, related administrative sanctions, potential exclusion from government healthcare program reimbursement or civil

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and/or criminal prosecution, any of which could have a material adverse effect on our reputation, business, financial condition, and results of operations.

See "*<u>[Item 10.](#id39cb0e1a10249e1ab7b8f77d921d68a_2560)</u> Additional Information—Material Contracts*" and "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements—<u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal Proceedings*" for more information.

***We are subject to additional risks because we import, manufacture, and distribute controlled substances.***

Our key products for opioid use disorder, SUBLOCADE long-acting injectable extended-release injection, SUBOXONE Film sublingual film, and SUBOXONE Tablets and SUBUTEX Tablets sublingual tablets, contain the active ingredient buprenorphine and is a controlled substance under the Controlled Substance Act (CSA). Buprenorphine is a partial agonist opioid. While we market these products for the treatment of opioid use disorder, the use of any opioid is highly stigmatized. Many people who are non-prescribers may fail to distinguish between drugs of abuse and drugs intended for treatment. The lack of distinction between the types and mechanisms of opioids, like buprenorphine, which is a partial opioid agonist, is widely misunderstood. Compared to a full opioid agonist, buprenorphine has less maximal euphoric effect than a full agonist, and a ceiling on its ability to cause respiratory depression. These perceptions and misunderstandings may cause a variety of problems for the Group, including adverse publicity and cause some persons or entities to decline to do business with us. See for example, "*We may be subject to adverse public opinion," and* "*Failure to retain key personnel or attract new personnel could have an adverse effect on us.* 

Products designed to treat drug addiction, by their nature, face additional risks. Drug addiction is a difficult environment in which to market our products. Societally, there is a stigma that prevents many persons who suffer from OUD or other types of addiction from coming forward to receive treatment because of potential reputational damage, societal scrutiny, and other factors. Patients with OUD often suffer from other co-morbidities, including poor general health and mental health issues like schizophrenia, which may impact one's understanding of the disease or affect their ability to obtain treatment. Similarly, drug addiction can result in job loss or unemployment, indebtedness, and criminal problems including incarceration which may make it more difficult for someone to obtain treatment. Other challenges include the misuse, diversion, or abuse of our products.

Regulators may impose additional requirements because of the nature of our products. Buprenorphine and products containing buprenorphine are classified as Schedule III controlled substances in the U.S. by the Drug Enforcement Agency (DEA) and similarly restricted by law enforcement authorities in the rest of the world that are signatories to the WHO Single Convention on Narcotic Drugs (1961). In the U.S., SUBLOCADE is subject to a REMS which restricts the distribution of the product so that SUBLOCADE is dispensed directly to certified healthcare settings and pharmacies so that the product is only administered by a healthcare professional. This closed distribution system helps mitigate the risk related to the potential for misuse and diversion by the patient, since the product is not dispensed directly to the patient.

In addition, our products contain controlled substances as defined in the U.S. Controlled Substances Act ("CSA"). Controlled substances are subject to several requirements and restrictions under the CSA and implementing regulations, including certain registration, security, recordkeeping, reporting, import, export and other requirements administered by the United States Drug Enforcement Agency (the "DEA"). There are also similar laws and regulations in the other jurisdictions where we operate.

Individual states have also established controlled substance laws and regulations. Though state-controlled substance laws often mirror federal law, they may separately schedule our products or our product candidates as well. We or our partners may also be required to obtain separate state registrations, permits or licenses in order to be able to manufacture, distribute, administer or prescribe controlled substances for clinical trials or commercial sale, and a failure to meet applicable regulatory

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requirements could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising under federal law.

U.S facilities conducting research, manufacturing, distributing, importing or exporting, or dispensing controlled substances must be licensed and must comply with the security, control, recordkeeping and reporting obligations under the CSA, DEA regulations, and corresponding state requirements. In addition, the DEA and state regulatory bodies conduct periodic inspections of certain registered establishments that handle controlled substances. Obtaining and maintaining the necessary registrations and complying with regulatory obligations may result in the delay of the importation, manufacturing, distribution or clinical research of our commercial products and product candidates. Furthermore, a failure to comply with CSA, DEA or state regulations by us or any of our third-party manufacturers can result in regulatory action, which can lead to criminal or civil penalties, the refusal to renew necessary registrations or proceedings to restrict, suspend or revoke applicable registrations.

Further, the APIs in many of our products and product candidates are controlled substances that are subject to regulation in all of the countries in which we market our products The shipment of pharmaceutical products that contain controlled substances, including certain of our products and product candidates, require import and export licenses from relevant authorities. We may not be granted or, if granted, may not maintain, such licenses. Even if we maintain such licenses, shipments may be held up in transit, which could cause significant delays and may lead to product batches being stored outside required the temperature ranges. Inappropriate storage may damage the product shipment resulting in a partial or total loss of revenue from one or more shipments of our products and product candidates and necessary APIs. A partial or total loss of revenue from one or more such shipments could have a material adverse effect on our business, results of operations and financial condition.

Products containing opioids often require a risk evaluation and mitigation strategy (a "REMS") to mitigate potential risks which may be associated with the use of a product and to inform patients and prescribers of those risks. For example, the FDA requires a REMS for SUBLOCADE and SUBOXONE Film, and other products that we sell in the future may become subject to a REMS specific to the product or shared with other products in the same class of drug. The cost to implement the REMS may be high, which may in turn have a material adverse effect on our business, financial condition, and results of operations.

***We are subject to risks related to the manufacture and distribution of our products globally and must meet stringent current Good Manufacturing Practices.***

All facilities and manufacturing techniques used for the manufacture of our products must be operated in conformity with the mandatory manufacturing standards (often referred to as current good manufacturing practice (cGMP)) of the FDA, the UK Medicines and Healthcare products Regulatory Agency ("MHRA"), the Irish Health Products Regulatory Authority (HPRA), and other regulatory authorities. Manufacturing facilities are subject to periodic unannounced inspections by the FDA, MHRA, HPRA, and other regulatory authorities. Failure to comply with applicable legal and regulatory requirements, and with the manufacturing details filed as part of our marketing authorization, subjects our manufacturing facilities or the facilities of our third-party manufacturers to possible legal or regulatory action, such as inspectional observations (e.g., Form FDA 483 notices), warning letters, suspension of manufacturing, product seizure, withdrawal of the product from the market, administrative, civil and criminal penalties, among other enforcement remedies. Therefore, such enforcement actions may adversely affect our ability to manufacture, or our third-party suppliers' ability to supply, finished products.

Also, the manufacturing and distribution of our products globally are highly exacting and complex, due in part to strict regulatory and manufacturing requirements. Problems may arise during manufacturing and distribution for a variety of reasons, including but not limited to equipment malfunction, failure to follow specific protocols and procedures, testing nonconformities (e.g. sterility failure), failure to follow and provide oversight in cGMP, defective raw materials, product theft or diversion within our legal chain of

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custody, restricted supply of raw materials or components due to geopolitical disruption or pandemic, and environmental factors.

Our manufacturing facilities, and those owned by third-party CMOs, also maintain high direct and indirect labor costs due to the complexity of manufacturing processes, often requiring specialized personnel. As such labor costs are largely fixed, we are unable to offset such costs if we experience any interruptions or delays in the manufacturing process, product or regulatory approval delays or product suspensions or recalls. In addition, any significant personnel shortages at our manufacturing facilities, whether temporary or prolonged, including due to the COVID-19 pandemic and related mandates, testing protocols or restrictions or shortages related to the labor market more broadly, may cause significant interruptions to our manufacturing facilities and to our supply of products. While some of these costs may be borne directly by third-party CMOs, we may also incur costs for additional safety stock and supplies, repairs, capital expenditures for improvements, even if not required to do so contractually, or indirectly for lost sales. Please refer to Item 4.B.6 - Manufacturing, for more information.

We have either a single or dual source of supply for the raw materials, product components, and drug products used in most of our marketed products, drug product candidates under development, and their respective APIs (including buprenorphine). Single sourcing puts us at risk of a potential interruption to supply in the event of manufacturing, quality or compliance difficulties.

In the event of any supply chain disruption or product quality issues, our suppliers or third-party manufacturers may not have contingency plans in place that enable them to continue to supply or manufacture our products within contractual deadlines or at all. If any of our suppliers or third-party manufacturers fails or refuses to supply us for any reason, it would take a significant amount of time and expense to implement and execute the necessary technology and design transfer to, and to qualify, a new supplier or manufacturer, as applicable. Often, as a general guide, this transfer time averages 36 months and is based on several factors. The FDA and similar international or national regulatory bodies must approve our filings which identify the manufacturers of the active and inactive pharmaceutical ingredients and certain packaging materials used in our products. If there are delays in qualifying new suppliers or facilities or a new supplier is unable to meet FDA's or similar international regulatory body's requirements for approval, there could be a shortage of the affected products for the marketplace or for use in clinical studies, or both, which could negatively impact our anticipated revenues and could potentially cause us to breach contractual obligations with customers or to violate local laws requiring us to deliver the product to those in need. Any delay in supplying, or any failure or refusal to supply, products to, or delays in manufacturing by, our suppliers, or any catastrophe or natural or man-made disaster affecting such third-party manufacturing facilities or suppliers, could result in our inability to meet current and future state commercial demands for our products, which in turn could materially adversely affect our business, prospects, results of operations and financial condition. The Group's supply monitoring and contingency planning processes include proactive management of inventories throughout the supply-to-patient delivery process and initiatives to identify and qualify alternative sites and/or suppliers. Despite these mitigating measures, if major delays, interruptions, or quality events occur at those contracted suppliers, contracted manufacturers, or packaging organizations, the delivery of products to our patients could be significantly disrupted, which could materially adversely affect the sales of our products and accompanying revenues. Further, any interruption in supply could result in delays in meeting our contractual obligations and could damage our relationships with our licensees, including the loss of manufacturing and supply rights and/or revenues.

***We receive substantial revenue from our key proprietary products and our success depends on our ability to successfully commercialize such products.***

Sales of our proprietary products comprise an increasingly significant portion of our revenues. We developed SUBOXONE Film and SUBLOCADE for the treatment of OUD, and PERSERIS for the treatment of schizophrenia. Our success depends in large part on our ability to continue to successfully manufacture and commercialize such products in the complex markets into which they are sold. A number of our products, such as SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets, are subject to

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substantial competition from generics and revenues from these products are declining, which increases the importance of SUBLOCADE. Further, we agreed in the Resolution Agreement to no longer employ a sales force to promote or sell SUBOXONE Film in the U.S. Any significant negative developments relating to these products could have a material adverse effect on our revenues from these products and, in turn, on our business, financial condition, cash flows and results of operations and the market price of our ordinary shares.

In addition, the biotechnology and biopharmaceutical industries are characterized by rapidly advancing technologies. Our future success will depend in part on our ability to maintain a competitive position. If we fail to stay at the forefront of technological change to create and develop product candidates, we may be unable to compete effectively. Our competitors or technological change may render limit the commercial value of our products or product candidates by advances in existing technological approaches or the development of new or different approaches, potentially eliminating the advantages of our proprietary products and product candidates.

***Our ability to generate revenues from our products is subject to attaining significant market acceptance among physicians, other qualified HCPs, patients, specialty distributors, and healthcare payors and our ability to successfully develop and execute commercialization strategies for each of our products. Failure to do so would adversely impact our financial condition and prospects.***

A substantial majority of our resources are focused on the commercialization of our current products. Our current products, and other products or product candidates that we may develop or acquire, may not attain market acceptance among physicians and other HCPs to administer our products, patients, specialty distributor, healthcare payors or the medical community. Some of our products, in particular SUBLOCADE and PERSERIS, have not been on the market for an extended period of time, which subjects us to numerous risks as we attempt to increase our market share. If any of our commercial strategies are unsuccessful or we fail to successfully modify our strategies over time due to changing market conditions, our ability to increase market share for our products, grow revenues and sustain profitability will be harmed.

We believe that the degree of market acceptance and our ability to generate revenues from our products will depend on several factors, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the timing of market introduction of our products as well as competitive products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to manufacture in sufficient quantities in compliance with requirements of regulatory agencies and at acceptable quality and pricing levels in order to meet commercial demand and where applicable demand for samples;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to secure formulary approvals for products at a substantial number of targeted hospitals and OHSs and CJSs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to implement and maintain agreements with wholesalers and distributors on commercially reasonable terms, and their performance, over which we have limited control;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to receive adequate levels of coverage and reimbursement for products from commercial health plans and government health programs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our ability to train, deploy and support a qualified field-facing team which includes a sales force, a managed care team, account teams that target Organized Health Systems ("OHSs") and criminal justice systems (CJS), as well as a channel team;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• market demand for our products through our marketing and sales activities and other arrangements established for their promotion;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the efficacy and safety of our products;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• potential or perceived advantages or disadvantages of our products over alternative treatments, including the cost of treatment and relative convenience and ease of administration;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the prevalence of the disease or condition for which the product is approved and the projected growth of the markets in which our products compete;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the effect of current and future healthcare laws and legislation and regulation controlling the conditions of treatment and the distribution of the products for OUD treatments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the extent to which physicians diagnose and treat the conditions that our products are approved to treat, physicians' willingness to prescribe the product, and our ability to educate physicians with respect to new products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the prevalence and severity of any side effects;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the price of our products, both in absolute terms and relative to alternative treatments;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• impact of past and limitation of future product price increases;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the extent to which physicians and patients delay visits or writing or filling prescriptions for our products and the extent to which operations of healthcare facilities, including infusion centers, are reduced;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• product labeling or product insert requirements of the FDA, or other regulatory authorities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the nature of any post-approval risk management plans mandated by regulatory authorities; see "*We are subject to additional risks because we import, manufacture, and distribute controlled substances,*" and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• acceptance by patients, physicians and applicable specialists.

Any factors preventing or limiting the market acceptance or commercialization of our products could have a material adverse effect on their sales and hence our business, results of operations and financial condition.

***Our revenues may decrease or grow at a slower than expected rate due to many factors.***

We cannot be assured that our products will be, or will continue to be, accepted in the U.S. or markets outside the U.S. or that we will be able to maintain or increase sales of our products. Factors that may cause revenues from our products to grow at a slower than expected rate, decrease or cease altogether, include, among others:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the perception of physicians and other members of the healthcare community as to our products' safety and efficacy relative to that of competing products and the willingness or ability of physicians and other members of the healthcare community to prescribe, dispense and/or administer, and patients to use, our products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• unfavorable publicity concerning us, our products, similar classes of drugs or the industry generally;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the cost-effectiveness of our products, the impact of price changes in the market, and the reimbursement policies of government and third-party payors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the cost and availability of raw materials necessary for the manufacture of our products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the successful manufacture of our products on a timely and cost-effective basis;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the size of the markets for our products, and patient and physician satisfaction with our products;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• significant changes in the competitive landscape for our products, including any approval of generic versions of our products or other branded products that may compete with our products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• adverse event information relating to our products or to similar classes of drugs;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• changes to the product labels of our products, or of products within the same drug classes, to add significant warnings or restrictions on use;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• our continued ability to engage third parties to package and/or distribute our products on acceptable terms;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• regulatory developments and actions related to the manufacture, commercialization or continued use of our products, including FDA actions such as the issuance of a REMS or warning letter, or conduct of an audit by the FDA or another regulatory authority in which a manufacturing or quality deficiency is identified;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the extent and effectiveness of the sales, marketing and distribution support for our products, including our licensees' decisions as to the timing and volume of product orders and shipments, the timing of product launches, and product pricing and discounting;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• disputes with our licensees relating to the use of our technology in, and marketing and sale of, products from which we received, or are currently receiving, manufacturing and/or royalty revenue, and the amounts to be paid with respect to such products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• exchange rate valuations and fluctuations;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• U.S. and global political changes and/or instability, and any related changes in applicable laws and regulations, that may impact resources and markets for our products; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the potential negative impact of current and future healthcare laws and legislation and regulation controlling the conditions of treatment and the distribution of the product including, with respect to OUD treatments, new governmental or regulatory guidelines or policies limiting the prescription of opioids to patients.

***We operate in a highly competitive industry, which includes companies with greater resources, including larger R&D and sales organizations, and more experience working with large and diverse product portfolios, than us. The approval and launch of generic or branded products that compete with SUBLOCADE, SUBOXONE Film, SUBOXONE Tablet, and SUBUTEX Tablet could have a material adverse effect on our business, prospects, results of operations and financial condition.***

The manufacture and sale of pharmaceuticals are highly competitive. Our competitors may have substantially greater financial, operational and human resources than we do. Companies with more extensive resources and larger research and development expenditures have a greater ability to fund clinical trials and other development work necessary for regulatory applications. There is also a risk that our competitors may launch competing products before we are able to complete all of the regulatory milestones required to launch our own product. Competitors may also have a greater ability to offer higher rebates, discounts, chargebacks or other incentives to gain commercial advantage, and may be more successful than us in acquiring or licensing new products for development and commercialization.

Smaller or earlier-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. If any product that competes with one of our products or product candidates is approved, our sales of that product could decrease, the effect of which would be heightened by our product and geographic concentration, which could have an adverse impact on our business, prospects, results of operations and financial condition.

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In addition, many pharmaceutical companies are able to deploy more personnel to market and sell their products than us. Each of our sales representatives is responsible for a territory of significant size. The continued growth of our current products and the launch of any future products may require the expansion of our sales force and sales support organization internationally and we may need to commit significant additional funds, management and other resources to the growth of our field organization. We may not be able to achieve any such necessary growth in a timely or cost-effective manner or at all or realize a positive return on our investment. Likewise, if our R&D organization is not appropriately sized to effectively develop our current pipeline and future pipeline projects, the commercial net present value of our current pipeline and any future pipeline projects may be diminished. This in turn could materially and adversely affect our business prospects, results of operations, and financial position. Critically, investment in a novel asset pipeline is required to ensure the sustainability of Indivior through the launch of new medicines as our existing products face increasing competition through generics and alternatives.

The pharmaceutical and biotechnology industries are also characterized by continuous product development and technological change. Our products could, therefore, be rendered obsolete or uneconomic through the development of new products with unique advantages (including, e.g., new chemical entities that may be safer, more effective or more convenient than our products) or by technological advances in manufacturing or production by our competitors. In particular, several of our branded products face competition from generic products in key markets as well as competition from alternative products to treatments. Among other things, competition could continue to require us to increase further the level of rebates and other offsets to gross revenues, particularly in our U.S. operations, and could impact potential volume growth of any particular product, which could reduce our net revenues and therefore our results of operations in future periods.

*Branded Products*

The introduction of branded products that compete with our products may lead to a loss of sales of our products and/or a decrease in the price at which our products can be sold. For example, SUBLOCADE is patent protected in the U.S., Australia, Canada, Ireland, UK, France, Germany, Italy, Spain, Denmark, Finland, Norway, the Netherlands, Switzerland, and Sweden, Israel, Japan, Mexico and New Zealand. However, Camurus, in partnership with Braeburn Pharmaceuticals, Inc., has sought FDA approval of its long-acting injectable buprenorphine product which would compete with SUBLOCADE in the U.S. Additionally, we expect that Braeburn may eventually seek approval in Canada. This product is already well established in Norway, Sweden, Finland Australia, and is available in additional countries. We expect it to be available in the U.S. eventually. Any of the foregoing competitive developments could have a material adverse effect on our business, prospects, results of operations and financial condition. Among other things, developments of this nature have in the past, and could in the future, require the Group to increase further the level of rebates and other offsets to gross revenues, particularly in its U.S. operations, as well as impact potential volume growth of any affected products, which, in turn, could reduce net revenues and, therefore, its results in future periods.

*Generic Products*

The introduction of generic products typically leads to a loss of sales of the branded product and/or a decrease in the price at which branded products can be sold, particularly when there is more than one generic product available in the market. In addition, legislation enacted in the U.S. allows for the dispensing of generic products and, in some instances, the dispensing of generic products rather than branded products may be required (in the absence of specific instructions from the prescribing physician). Our SUBOXONE Film product already faces three generic competitors in the U.S., and a fourth competitor received approval for its product in May 2022 but has not yet launched. We have seen our market share of SUBOXONE Film decline from approximately 80% when launched, to 53% due to generic tablets and branded competition. More recently, upon entry of generic competition, our market share has fallen to approximately 19% today, and we expect further declines if another competing product becomes available. Additionally, we no longer promote SUBOXONE Film in the U.S. and no longer market our SUBUTEX Tablets in the U.S. See also "<u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>—Legal Proceedings—DOJ Resolution" of

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"*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements*." We generally face generic competition globally for these products. For a detailed discussion of the competition that we face with respect to our current marketed products, technology platforms and product indications, please see the section entitled "Competition" in "*<u>[Item 4.B.](#id39cb0e1a10249e1ab7b8f77d921d68a_1950)</u> – Business Overview*" in this registration statement. If we are unable to compete successfully in this highly competitive industry, our business, financial condition, cash flows and results of operations could be materially adversely affected.

***Some of our pharmaceutical pipeline and our commercial product sales rely on collaborations with third parties, which may adversely affect the development and sale of our products.***

We depend on alliances with other companies, including pharmaceutical and biotechnology companies, vendors and service providers, for the development of a portion of the products in our pharmaceutical pipeline and for the commercialization and sales of certain of our commercial products. For example, we have collaborations with third parties under which we share development rights, obligations and costs and/or commercial rights and obligations. See "*<u>[Item 4.](#id39cb0e1a10249e1ab7b8f77d921d68a_2018)</u> Information on the Company—Long-Term Pipeline*."

Our agreements with development partners typically require substantial up-front investments, potential milestone or option payments, and royalties on net sales to the development partner. For example, through our agreements with multiple collaboration partners, we have aggregate potential financial obligations of up to $273 million upon the completion of all development milestones and additional potential financial obligations of an aggregate of $606 million if all sales milestones are met. Development milestone generally are payable upon the attainment of certain milestones towards and including the approval of a new product and by definition would be triggered if at all prior to the sale of such products; sales milestones are payable upon the attainment of specified commercial sales levels. See also Item 10.C, "Material Contracts," for additional details regarding these collaboration agreements.

Similarly, we have potential obligations of up to $68 million in connection with a Contingent Value Agreement entered into in connection with the acquisition of Opiant Pharmaceuticals related to the future sales of a product which is currently being developed; these payments would be triggered upon the commercial sale of OPTN003 reaching certain levels. In the event that we meet these milestones it would offset some of our future revenues from the Opiant OPTN003 product. See also Item 4A, History of the Company - Acquisition of Opiant Pharmaceuticals.

Also, failures by these parties to meet their contractual, regulatory, or other obligations to us or any disruption in the relationships between us and these third parties, could have a material adverse effect on our pharmaceutical pipeline and business. In addition, our collaborative relationships for R&D and/or commercialization and sales often extend for many years and have given, and may in the future give, rise to disputes regarding the relative rights, obligations and revenues of us and our collaboration partners, including the ownership or prosecution of intellectual property and associated rights and obligations. This could result in the loss of intellectual property rights or protection, delay the development and sale of potential pharmaceutical products, affect the effective sale and delivery of our commercialized products and lead to lengthy and expensive litigation, administrative proceedings or arbitration.

Also, there is a trend in the specialty pharmaceutical industry of seeking to "outsource" drug development by acquiring companies with promising drug candidates. We face substantial competition from historically innovative companies, as well as companies with greater financial resources than us, for such acquisition targets.

***Clinical trials for the development of products, including our key pipeline products, may be unsuccessful and our product candidates may not receive authorization for manufacture and sale.***

Before obtaining regulatory approvals for the commercial sale of each product under development, we must demonstrate, through pre-clinical, clinical and other studies, that the product is safe and effective for the claimed use or uses, and also demonstrate that the product is of appropriate quality. No assurance

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can be provided that a clinical study will demonstrate that a particular product candidate safely provided hypothesized benefits.

Also, the development process takes many years and can be very expensive. The number and duration of pre-clinical studies and clinical trials that are required vary depending on the product candidate, the indication being evaluated, the trial results and the regulations applicable to the particular product candidate. Such clinical and other studies can be delayed or halted for a variety of reasons, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• challenges in identifying clinical development pathways, including appropriate clinical trial protocol design, particularly where there is no regulatory precedent;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• delays or failures in obtaining regulatory authorization to commence a trial because of safety concerns of regulators relating to our product candidates or similar product candidates of our competitors or failure to follow regulatory guidelines;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• delays or failures in obtaining clinical materials and sufficient quantities of the product candidate for use in trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• delays or failures in reaching an agreement on acceptable terms with prospective study sites;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• delays or failures in obtaining approval of our clinical trial protocol from an institutional review board or ethics committees to conduct a clinical trial at a prospective study site;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• delays in identifying, recruiting, or enrolling patients to participate in a clinical trial;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• failure of clinical investigators to comply with FDA and other regulatory agencies' good clinical practice ("GCP") requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• unforeseen safety issues, including negative results from ongoing pre-clinical studies and adverse events associated with product candidates;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• inability to monitor patients adequately during or after treatment;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• difficulty monitoring multiple study sites;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• failure of our third-party research organizations or clinical investigators to satisfactorily perform their contractual duties, comply with regulations or meet expected deadlines;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• disagreements with collaborative partners on the planning and execution of product development; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• insufficient funds to complete the trials.

AEF0117(Synthetic CB1 Specific Signaling Inhibitor) is currently undergoing a Phase 2b study, and INDV-2000 (Selective Orexin-1 Receptor Antagonist) has completed a Phase 1 Single Ascending Dose (SAD) study and a Multiple Ascending Dose study began in September 2022. However, the results from early clinical trials may not be predictive of results obtained in later and larger clinical trials, and therefore these product candidates may fail to show the desired safety and efficacy in later clinical trials despite having progressed successfully through initial clinical testing. In that case, the FDA or the equivalent regulatory authority in jurisdictions outside the U.S. may determine our data are not sufficiently compelling to warrant marketing approval and may require us to engage in additional clinical trials or provide further analysis which may be costly and time-consuming and substantially delay the receipt of such regulatory approval (which may delay the launch of any potential product).

Additionally, INDV-1000 (Selective GABAb Positive Allosteric Modulator) is in the pre-clinical stage.

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For example, regulatory approval to conduct clinical studies for one of our non-opioid OUD treatments was delayed due to a clinical hold originating with FDA's concerns related to a third-party's product, rather than our own product.

Many companies in the pharmaceutical industry have suffered significant setbacks in drug development and there can be no guarantee that FDA approval will ultimately be obtained for any given product.

Further, the COVID-19 pandemic has caused certain delays in the execution of our internal and third-party clinical and/or chemistry, manufacturing and controls (CMC) studies such as patient enrollments in clinical trials and CMC operations. If these effects become more severe, we could experience more significant disruptions to our clinical development programs.

Even if the clinical trials of any product under development were to be completed, they may not demonstrate the quality, safety and efficacy required to result in an approvable or marketable product which would delay or prevent regulatory approval of the product. In addition, regulatory authorities in Europe, the U.S., and other countries may require additional studies, which could result in increased costs and significant development delays, or termination of a project if it would no longer be economically viable.

***We rely on third parties to conduct our clinical trials, and if they do not properly and successfully perform their legal and regulatory obligations, as well as their contractual obligations to us, we may not be able to obtain regulatory approvals for our product candidates within the timeframes currently envisaged, or at all and may be exposed to regulatory sanctions.***

We rely on contract research organizations and other third parties to assist in designing, managing, monitoring and otherwise carrying out our clinical trials, including with respect to site selection, contract negotiation and data management. We do not control these third parties and, as a result, may not be able to prevent delays, interruptions, or other issues with respect to the clinical trials conducted by such third parties. If we, contract research organizations, other third parties assisting us or our study sites fail to comply with applicable GCP requirements, the clinical data generated in the relevant clinical trials may be deemed unreliable and the FDA or its non-U.S. counterparts may require us to perform additional clinical trials before approving our marketing applications.

In addition, clinical trials must be conducted with products manufactured, labeled and supplied under the FDA's and non-U.S. regulatory agencies' current good manufacturing practices ("cGMP") regulations and in strict compliance with local regulatory requirements (e.g., compliance with Investigational New Drug (IND) application in the U.S., Clinical Trial Application (CTA) in Europe, etc.). Our failure, or the failure of third parties conducting clinical trials on our behalf, to comply with these regulations may require us to repeat or redesign clinical trials, which would delay the regulatory approval process or expose us to regulatory sanctions.

If our clinical trials do not meet regulatory requirements, or if the third parties conducting our clinical trials need to be replaced, our clinical trials may be extended, delayed, suspended or terminated. In addition, any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trials, and, depending upon the period of delay, require us to commence new clinical trials at additional expense or terminate clinical trials completely. If any of these events occur, we may not be able to obtain regulatory approval for our product candidates or succeed in our efforts to create approved line extensions for our existing products or generate additional useful clinical data in support of these products, which would adversely affect our business, prospects, results of operations and financial condition.

 ***Failure to retain key personnel or attract new personnel could have an adverse effect on us.***

We rely upon several key executives and employees who have an in-depth and long-term understanding of the industry and the disease space and our technologies, products, programs,

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collaborative relationships and strategic goals. Key personnel includes experienced employees with specific expertise and the ability to compliantly interact with healthcare providers, key opinion leaders, and key decision makers across the healthcare industry.

In particular, we must compete with other pharmaceutical and life sciences companies to recruit, hire, train and retain sales and marketing personnel as well as research and development personnel. Competition for such personnel in the pharmaceutical and biotechnology industries is intense, and there can be no assurance that we will be able to recruit or retain such personnel. If our sales force and sales organization are not appropriately sized to promote any current or potential future products adequately, the commercial potential of our current products and any future products may be diminished. The inability to recruit, hire, train and retain research and development personnel could negatively affect our ability to formulate and develop new products.

We do not carry "key person" insurance. The loss of the services of any of our key executives or employees could delay or prevent the successful completion of some of our vital activities. Any employee may terminate his or her employment at any time without notice or with only short notice and without cause or good reason. The resulting loss of institutional knowledge may have a material adverse effect on our operations and future growth.

The current industry-wide challenging labor environment may have a potential negative impact on the Group's attrition rate and its ability to recruit for certain key positions in some geographies. We have attempted to mitigate this by establishing various tools, including development, performance management and reward programs, to develop, retain, and recruit key personnel, but there can be no assurance that we will be successful.

As a result of the above factors, any failure to retain key personnel or attract new personnel could have a material adverse effect on our business, prospects, results of operations and financial condition.

***Revenues generated by sales of our products depend on the availability from third-party payors for reimbursement for our products and the extent of cost-sharing arrangements for patients (e.g., patient co-payment, co-insurance, deductible obligations) and cost-control measures imposed, and any reductions in payment rate or reimbursement or increases in our or in patients' financial obligation to payors could result in decreased sales of our products and/or decreased revenues.***

In both U.S. and non-U.S. markets, sales of our products depend, in part, on the availability of reimbursement from third-party payors such as state and federal governments, including Medicare and Medicaid in the U.S. and similar programs in other countries, managed care providers and private insurance plans. Deterioration in the timeliness, certainty and amount of reimbursement for our products, the existence of barriers to coverage of our products, increases in our financial obligation to payors, including government payors, limitations by healthcare providers on how much, or under what circumstances, they will prescribe or administer our products or unwillingness by patients to pay any required co-payments, or deductible amounts, could reduce the use of, and revenues generated from, our products and could have a material adverse effect on our business, financial condition, cash flows and results of operations.

For example, when generic versions of a product are available, payors may impose access restrictions on the branded product, such as requiring prior authorization, imposing high patient co-pays, or precluding coverage altogether. In some cases, similar restrictions might apply when a therapeutic alternative is available. In addition, when a new product is approved, the availability of government and private reimbursement, any applicable coverage restrictions and the amount of reimbursement are all uncertain. The prices for certain of our products, when commercialized, may be high compared to other pharmaceutical products. As a result, we may encounter difficulty in obtaining satisfactory pricing and reimbursement for our new products. The failure to obtain and maintain pricing and reimbursement at satisfactory levels for our products may adversely affect our results of operations and prospects.

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In the U.S., federal and state legislatures, health agencies and third-party payors continue to focus on containing the cost of healthcare, including by comparing the effectiveness, benefits and costs of similar treatments. Any adverse findings for our products may reduce the extent of reimbursement for our products. Economic pressure on state budgets may also result in states increasingly seeking to limit coverage or payment for drugs, including but not limited to price control initiatives, discounts and other pricing-related actions. Over the past several years, several states have enacted drug pricing transparency laws that require companies to report on drug price increases and justify how drug prices were set, and we expect additional state or federal drug pricing initiatives to be proposed and enacted in the future. In addition, state Medicaid programs are increasingly requesting that manufacturers pay supplemental rebates and require prior authorization by the state program for use of any drug. Managed care organizations continue to seek price discounts and, in some cases, impose restrictions on the coverage of particular drugs. Government efforts to reduce Medicaid expenses may lead to increased use of managed care organizations by Medicaid programs, which may in turn result in managed care organizations influencing prescription decisions for a larger segment of the population and a corresponding constraint on prices and reimbursement for our products. Further, on August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, or IRA, which, among other things, requires the HHS Secretary to negotiate, with respect to Medicare units and subject to a specified cap, the price of a set number of certain high-spend drugs and biologicals per year starting in 2026, penalizes manufacturers of certain Medicare Parts B and D drugs for price increases above inflation, and makes several changes to the Medicare Part D benefit, including a limit on annual out-of-pocket costs, and a change in manufacturer liability under the program that could negatively affect us. Congress continues to examine various policy proposals that may result in pressure on the prices of prescription drugs in government health programs.

In addition, the outcome or settlement of litigation could impact the practices of healthcare providers and patients, and the policies and practices of third-party payors, including Medicare, Medicaid, managed care providers and private insurance plans. For example, the Group has been named as a defendant in a federal multi-district opioid litigation. One or more defendants in the litigation have offered large volumes of products that would compete with OPNT0003 if it is approved by the FDA and launched and which compete with our film products free of charge to state plaintiffs as settlement compensation, which, if agreed to and approved, could negatively impact the sales of our products and potential products. The litigation and negative media attention may cause wholesalers to refrain from purchasing buprenorphine products from us, and may cause other business partners to decline to do business with us, which in turn could materially and adversely affect our business and financial condition.

In Europe and many other countries, government-sponsored healthcare systems are the primary payors for healthcare expenditures, including payment for drugs. We expect that these countries will continue to act to reduce expenditure on drugs, including mandatory price reductions, patient access restrictions, suspensions of price increases, increased mandatory discounts or rebates, preference for generic products, reduction in the amount of reimbursement and greater importation of drugs from lower-cost countries. Any such cost-control measures would likely reduce our revenues. In addition, certain countries set prices by reference to the prices in other countries where our products are marketed. Thus, the inability to secure adequate prices in a particular country may not only limit the marketing of products within that country, but may also adversely affect the ability to obtain acceptable prices in other markets.

There can be no assurance that our products will obtain favorable reimbursement status in any country. The failure to obtain and maintain reimbursement, or an adequate level of reimbursement, for our products may have a material adverse effect on our business, prospects, results of operations and financial condition.

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***The clinical study or commercial use of our products may cause unintended side effects or adverse reactions, or incidents of misuse may occur, which could adversely affect our products, business and share price.***

The administration of drugs to humans carries the inherent risk of product liability claims whether or not the drugs are actually the cause of an injury. Our products may cause, or may be perceived to have caused, injury or dangerous drug interactions or may produce undesirable or unintended side effects, and we may not learn about or understand those effects until the products have been administered to study participants or patients for a prolonged period of time. Additionally, incidents of product misuse may occur. We cannot be certain that the clinical or commercial use of our products will not produce undesirable or unintended side effects that have not been evident in the use of, or in clinical trials conducted for, such products to date.

These events, among others, could result in product recalls or additional regulatory controls (including additional regulatory scrutiny, a risk evaluation and mitigation strategy ("REMS") and requirements for additional labeling) or product liability claims. Our product liability insurance coverage may be inadequate to satisfy liabilities that arise, we may be unable to obtain adequate coverage at an acceptable cost or at all or our insurer may disclaim coverage as to a future claim. This could prevent or limit the development or commercialization of our products. In addition, the reporting of adverse safety events involving our products, including instances of product misuse, and public rumors about such events could cause our product sales or share price to decline or experience periods of volatility. These types of events could have a material adverse effect on our business, financial condition, cash flows and results of operations.

***We use hazardous materials in our manufacturing facilities, and any claims relating to the improper handling, storage, release or disposal of these materials could be time-consuming and expensive.***

Our operations are subject to complex and increasingly stringent environmental, health and safety laws and regulations in the countries where we operate and, in particular, in the U.K. and U.S. where we have manufacturing and R&D facilities. The costs of compliance with environmental, health and safety laws and regulations are significant. If an accident or contamination involving pollutants or hazardous substances occurs, an injured party could seek to hold us liable for any damages that result, and any liability could exceed the limits or fall outside the coverage of our insurance. We may not be able to maintain insurance with sufficient coverage on acceptable terms, or at all. Costs, damages and/or fines may result from the presence, investigation and remediation of such contamination at properties currently or formerly owned, leased or operated by us or at off-site locations, including where we have arranged for the disposal of hazardous substances or waste. In addition, we may be subject to third-party claims, including for natural resource damages, personal injury and property damage, in connection with such contamination. We have developed and implemented a proprietary risk mitigation program to preemptively identify and address environmental, health, safety and security risks; however, there can be no assurance that a violation of current or future environmental, health or safety laws or regulations will not occur. Any violations, even if inadvertent or accidental, or the cost of compliance with any resulting order, fine or liability that may be imposed, could materially adversely affect our business, financial condition, cash flows and results of operations.

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***If we fail to develop or acquire other new products or compounds for development, our business, prospects, results of operations and financial condition could be materially adversely affected.***

A key element of our long-term strategy is to develop or acquire and commercialize a portfolio of other products or product candidates in addition to our current products, through business or product acquisitions. Because we dedicate only a small portion of our own resources towards proprietary drug discovery, the success of this strategy depends in large part upon the combination of our regulatory, development and commercial capabilities and expertise and our ability to identify, select and acquire approved or clinically enabled product candidates for therapeutic indications that complement or augment our current products, or that otherwise fit into our development or strategic plans on terms that are acceptable to us. For example,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In June 2021, we acquired an exclusive option for AEF0117, a synthetic CB1-specific signaling inhibitor designed to treat cannabis-related disorders from the French company Aelis Farma.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are developing INDV-2000 (Selective Orexin-1 Receptor Antagonist), a non-opioid treatment for moderate to severe opioid use disorder, in collaboration with C4X Discovery.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• We are developing INDV-1000 (Selective GABAb Positive Allosteric Modulator) for the treatment of alcohol use disorder in collaboration with ADDEX therapeutics.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• On March 2, 2023, the Company completed its acquisition of Opiant Pharmaceuticals, Inc., a Delaware corporation ("Opiant"). Opiant is a specialty pharmaceutical company developing medicines for addictions and drug overdose. Opiant contributed to the development of NARCAN® (naloxone HCI) Nasal Spray ("NARCAN®"), a treatment to reverse opioid overdose which was approved by the FDA in November 2015. In addition to OPNT003, which is an investigation opioid overdose reversal treatment, Opiant's longer term pipeline includes medicines in development for alcohol use disorder and acute cannabinoid overdose.

See "*<u>[Item 4.B.](#id39cb0e1a10249e1ab7b8f77d921d68a_2018)</u> Business Overview—Long Term Pipeline*," for more information.

Identifying, selecting and acquiring promising products or product candidates requires substantial technical, financial and human resources expertise. Efforts to do so may not result in the actual acquisition or license of a particular product or product candidate, potentially resulting in a diversion of our Management's time and the expenditure of our resources with no resulting benefit. In addition, we face substantial competition from historically innovative companies, as well as companies with greater financial resources than us, for such acquisition targets. If we are unable to identify, select and acquire suitable products or product candidates from third parties or acquire businesses at valuations and on other terms acceptable to us, or if we are unable to raise the capital required to acquire businesses or new products, our business and prospects will be limited.

In addition, any growth through business development will depend upon us identifying and obtaining product candidates, our ability to develop those product candidates and the availability of funding to acquire, complete the development of, obtain regulatory approval for and commercialize these product candidates. We may not be able to successfully manage the risks or other anticipated and unanticipated problems in connection with an acquisition or in-licensing, and may not be able to realize the anticipated benefits of any acquisition or in-licensing for a variety of reasons, including the possibility that a product candidate proves not to be safe or effective in later clinical trials, a product fails to reach its forecast commercial potential or the integration of a product or product candidate gives rise to unforeseen difficulties and expenditures. It is common for multiple products and product candidates to be evaluated for the same indication by multiple parties at the same time, and we cannot predict whether our products' forecasted commercial potential will come to fruition. Any failure in identifying and managing these risks and uncertainties effectively would have a material adverse effect on our business, prospects, results of operations and financial condition.

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Moreover, any product candidate we acquire may require additional, time-consuming development or regulatory efforts prior to commercial sale or prior to expansion into other indications, including pre-clinical studies if applicable, and extensive clinical testing and approval by the FDA and applicable foreign regulatory authorities. All product candidates are prone to the risk of failure that is inherent in pharmaceutical product development, including the possibility that the product candidate will not be shown to be sufficiently safe and/or effective for approval by regulatory authorities. In addition, we cannot assure that any such products that are approved will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace or be more effective or desired than other commercially available alternatives. Any failure in identifying and managing these risks and uncertainties effectively would have a material adverse effect on our business, prospects, results of operations and financial condition.

***Acquisitions, partnerships, joint ventures, dispositions, and other business combinations or strategic transactions involve several inherent risks, any of which could result in the benefits anticipated not being realized and could have an adverse effect on our business, financial condition, and results of operations.***

Acquisitions are an important part of our growth model and we regularly consider and enter into strategic transactions, including mergers, acquisitions, investments and other growth, market and geographic expansion strategies, with the expectation that these transactions will result in increases in sales, cost savings, synergies and various other benefits. For example, in March 2023 we acquired Opiant Pharmaceuticals in exchange for $146 million in cash and potential future payments of up to $68 million upon the completion of certain sales milestones pursuant to a contingent value rights agreement. *See Item 4.A. - History and Development of the Company - Acquisition of Opiant Pharmaceuticals.*

In the future, our ability to acquire additional companies or products synergistic with our current businesses may be limited by antitrust regulators who may be particularly vigilant in our markets because we serve at-risk populations and because we already market several products in the space.

We may fail to realize anticipated benefits from such transactions or partnerships, or any future ones, we may be exposed to additional liabilities or compliance violations of any acquired business or joint venture and we may be exposed to litigation in connection with any transaction. Furthermore, we may have trouble identifying suitable acquisition targets in the future. Our ability to deliver the expected benefits from any strategic transactions is subject to numerous uncertainties and risks, including our acquisition assumptions; our ability to integrate personnel, labor models, financial, supply chain and logistics, IT and other systems successfully; disruption of our ongoing business and diversion of management time; the need to hire additional Management and other critical personnel; and increasing the scope, geographic diversity and complexity of our operations.

In addition, the integration of acquired businesses may create complexity in our financial systems and internal controls and make them more difficult to manage or cause us to fail to meet our financial reporting obligations. Any impairment of goodwill or other assets acquired in a strategic transaction or charges to earnings associated with any strategic transaction as well as any failure by the acquired business to produce the expected margins or cash flows, may materially reduce our profitability. Furthermore, we may finance these strategic transactions by incurring additional debt or raising equity, which could increase leverage or impact our ability to access capital in the future.

***We may be subject to adverse public opinion.***

The pharmaceutical industry is frequently subject to adverse publicity on many topics, including product recalls and research and discovery methods, as well as political controversy over pharmaceutical pricing, and the impact of novel techniques and therapies on humans, animals, and the environment, among others. We manufacture and market buprenorphine-based medications for the treatment of moderate-to-severe opioid use disorder Buprenorphine, a synthetic opioid, can cause death if used improperly and is inherently prone to the health and safety risks arising from their misuse and diversion.

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Negative publicity about us or our products, or about the industry as a whole, may adversely affect our corporate reputation, which could impact our operations, impair our ability to gain market acceptance for our products or lead to government intervention, which in turn could have an adverse impact on our business, prospects, results of operations and financial condition.

For example, our recent settlement with the DOJ created substantial adverse publicity and may have made it more difficult for some to distinguish our company, which works to address the opioid crisis, from those companies that created or exacerbated the opioid crisis. See *"<u>[Item 4](#id39cb0e1a10249e1ab7b8f77d921d68a_1955)</u>: Information on the Company—History and Development of the Company."* In announcing the settlement, the DOJ made a point to note that our medicines are opioids:

Suboxone is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment for opioid-use disorder. Suboxone contains buprenorphine, a powerful opioid. "Combatting the opioid crisis is a Department of Justice priority," said Principal Deputy Associate Attorney General Claire M. Murray. "Today's announced resolution and related actions hold accountable entities and individuals that unlawfully marketed opioid-addiction products."

This adverse publicity may reduce the willingness of third parties to do business with us, including credit providers and other investors, technology licensors, advocacy organizations, or potential employees, and may harm our ability to engage with policymakers on public policy issues critical to our business. For instance, in recent years, some state and federal officials were unwilling to meet with us to discuss policy issues while we were under government investigation, as were some third party groups.

**<u>Risks Related to Intellectual Property</u>**

***Failure to obtain and maintain patents and protect other proprietary rights, including in-licenses of such rights from third parties, may adversely affect us.***

Our success depends, in large part, on our ability to obtain and maintain patent and other intellectual property protection, particularly for our drug, compound, product, delivery, formulation and methods of treatment technologies and associated manufacturing processes in relation to both our products and our product candidates. The process of obtaining patents can be lengthy and expensive. We own, or license in, several patent rights in the U.S. and other countries covering certain products and have also developed brand names and trademarks for other products. We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary technologies and future products are covered by valid and enforceable patents or are effectively maintained as trade secrets or confidential information within the Group. Our existing patents, and any future patents we obtain, may not be sufficiently broad to prevent others from using our technologies or from developing competing products and technologies. If third parties disclose or misappropriate our proprietary rights, it may materially and adversely impact our business, prospects, results of operations and financial condition. Moreover, our ability to obtain and enforce patents and other proprietary rights is critical to our business strategy and success.

The patent positions of many pharmaceutical and life sciences companies are highly uncertain and involve complex legal and factual questions. In some cases, the legal principles that apply to these cases may be changing or unresolved. As a result, the validity and enforceability of our patents cannot be predicted with certainty. In addition, we cannot guarantee that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• we were the first to make the inventions covered by each of our issued patents and pending patent applications;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• we were the first to file patent applications for these inventions;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• patents will be granted in connection with any of our currently pending or future applications;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• other companies will not independently develop similar or alternative technologies or duplicate any of our technologies by inventing around our claims;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• a third-party will not challenge our proprietary rights, and if challenged that a court will hold that our patents are valid and enforceable;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• any patents issued to us or our collaboration partners will cover our products as ultimately developed, or provide us with any competitive advantages, or will not be challenged by third parties;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• we will develop additional proprietary technologies that are patentable; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the patents of others will not have an adverse effect on our business.

We also rely on trade secrets and other unpatented confidential information to maintain our competitive position but there can be no assurance that others may not independently develop the same or similar products or technologies, and may also obtain patents and other intellectual property protection for them. We have sought to protect trade secrets and confidential information, in some cases through the provisions of confidentiality and non-use agreements with our employees, consultants, advisers and partners. Nevertheless, it may not always be possible to prevent the disclosure of our trade secrets and other confidential information and for us to obtain an adequate remedy in the event of unauthorized disclosure or use of such information. In addition, if our employees, consultants or partners develop inventions or processes independently that may be applicable to our products or technologies under development, such inventions and processes will not necessarily become our property, but may remain the property of those persons or their employers or the persons may be entitled to compensation in respect of those inventions. Protracted and costly litigation could be necessary to enforce and determine the scope of our proprietary rights.

We have entered into several collaborative arrangements for the development and commercialization of products including Aquestive in relation to SUBOXONE Film and more recently Aelis Farma for the development of a potential product to treat cannabis use disorder. In connection with such arrangements, we have shared certain of our proprietary knowledge with our partners and it may not be possible or practical to prevent our partners from developing similar or functionally equivalent products. Any disputes between us and such partners may threaten our ability to continue using such proprietary knowledge and, in turn, could impact our ability to market our products. We have also engaged in collaborations, sponsored research agreements and other arrangements with academic researchers and institutions, some of which have received and may receive funding from government agencies. Although we have sought to retain ownership of all intellectual property rights pertaining to inventions that may result from such collaborations, there can be no assurance that governments, institutions, researchers or other third parties will not also attempt to claim certain rights to such inventions.

If we fail to obtain and maintain sufficient intellectual property protection for our current and future products and technologies and if third parties disclose or misappropriate our proprietary rights, our ability to successfully and fully exploit these products and technologies could be adversely affected, which in turn would adversely affect our business, prospects, results of operation and financial condition.

***We may incur substantial costs as a result of litigation or other proceedings relating to patents and other intellectual property rights, and we may be unable to protect our rights to, or commercialize our products.***

Litigation and other similar proceedings, such as *inter partes* reviews in the U.S. (which are initiated by third parties to challenge the validity of a patent) relating to infringement, validity or misappropriation of patent and other intellectual property rights in the pharmaceutical and life sciences industry are common. We may receive notifications of challenges to the validity of our patents or alleged infringement of patents owned by third parties. We have historically incurred, and expect that we will continue to incur, significant costs in connection with the ANDA proceedings relating to SUBOXONE Film in the U.S. If we choose to

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go to court to prevent a third party from infringing our patents, our licensed patents or our partners' patents (where we have the right to do so), that allegedly infringing third-party has the right to ask the court to rule that these patents are invalid and/or should not be enforced against that third-party.

For example, certain subsidiaries of the Group filed actions alleging that Alvogen Pine Brook LLC and Alvogen Inc. infringe U.S. Patent Nos. 9,687,454 (the "'454 Patent") and 9,931,305 (the '305 Patent"). The parties have stipulated to noninfringement of the '305 Patent under the court's claim construction, but the Group retained its rights to appeal the construction and pursue its infringement claims pending appeal. The Group's infringement claims concerning the '454 Patent remain pending, but Alvogen has challenged the validity of the asserted claims. Separately, other third parties may allege that patents on our other products or product candidates are not valid. These lawsuits are expensive, costing several million dollars per year, and time-consuming, even if we are ultimately successful in stopping the infringement of these patents. In addition, there is a risk that a court will decide that these patents are not valid or not infringed and that we do not have the right to prevent the other party from using the patented subject matter. There can be no assurance that these, or other litigation that we may file in the future, will be successful in preventing the infringement of our patents, that we will be able to successfully defend the validity of our patents, that any such litigation will be cost-effective, or that the litigation will have a satisfactory result for us. In addition, such litigation diverts the attention of Management and development personnel. Failure to stop infringement of our patents or an unsatisfactory result in litigation would adversely affect our business and results of operations. Additionally, when enforcing such patents, we also risk further liability as a result of counterclaims. For example, we became subject to counterclaims from Dr. Reddy's Laboratories for wrongful injunction related to the enforcement of particular claims of one of our patents, which we recently settled, and from Alvogen for alleged for antitrust violations related to our contracts with payors, although we have asked the court to grant summary judgment on such claims. See "<u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal Proceedings" of "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements.*"

A third-party may claim that we or our manufacturing or commercialization partners are using inventions covered by the third-party's patent rights, or that we or such partners are infringing, misappropriating or otherwise violating other intellectual property rights, and may go to court to stop us from engaging in our ordinary course operations and activities, including manufacturing or selling our products. There is a risk that a court could decide that we or our partners are infringing, misappropriating or otherwise violating third-party patents or other intellectual property rights, which could have a material adverse effect on our business and results of operations. In addition, such litigation diverts the attention of Management and development personnel.

We may initiate or defend legal proceedings relating to our patents alongside a collaborator or third-party with an interest or right in the relevant patents. In this scenario, our strategy for asserting or defending our rights might be impacted by that of our co-claimant or co-defendant which, in turn, may have an adverse impact on our existing commercial relationship.

In the pharmaceutical and life sciences industry, like other industries, it is not always clear to industry participants, including the Group, which patents cover various types of products or methods. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform. If we are sued for patent infringement, we would need to demonstrate that our products or methods do not infringe the patent claims of the relevant patent and/or that the patent claims are invalid or unenforceable, which we may not be able to do, and which could in turn result in our being required to pay substantial sums. These sums potentially include damages, legal fees, and increased damages if we are found to have infringed such rights willfully. Further, if a patent infringement suit is brought against us, our research, development, manufacturing, or sales activities relating to the product or product candidate that is the subject of the suit may be delayed, materially affected, or terminated by the grant of an injunction against us.

We cannot be certain that others have not filed patent applications for inventions covered by our licensors' or our issued patents or pending applications, or that we or our licensors were the first inventors. Our competitors may have filed, and may in the future file, patent applications covering subject

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matter similar to those of the Group. Any such patent application may have priority over our or our licensors' patents or applications and could further require us to obtain rights to patent rights covering such subject matter. For example, in June 2016, a third-party's patent application resulted in an issued patent that contains claims that could relate to SUBOXONE Film. In the U.S., if another party has filed a patent application on inventions similar to those of the Group, we may have to participate in an interference proceeding declared by the USPTO to determine the priority of invention in the U.S. The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our U.S. patent position with respect to such inventions. Patent interferences are limited or unavailable for applications filed after March 16, 2013.

As a result of patent infringement claims, or in order to avoid potential infringement claims, we or our collaborators may choose to seek, or be required to seek, a license from the third-party, which would be likely to include a requirement to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if a license can be obtained on acceptable terms, the rights may be non-exclusive, which would potentially give our competitors access to the same intellectual property rights. If we are unable to enter into a license on acceptable terms, we, or our collaborators, could be prevented from commercializing one or more of our product candidates, or forced to modify such product candidates, or cease some aspect of our business operations, which could adversely affect our business, prospects, results of operations or financial condition.

The cost to us of any patent litigation or other proceedings, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of complex patent and other intellectual property litigation more effectively than we can because they have substantially greater resources than the Group. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue its operations.

Any of the foregoing could have a material adverse effect on our business, prospects, results of operations and financial condition.

***We may not be able to protect our intellectual property rights throughout the world which could have an adverse effect on its business, results of operations and financial condition.***

Filing, prosecuting and defending patents relating to all of our product candidates and technologies throughout the world would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products, and further, may export otherwise infringing products to territories where we have patent protection but where enforcement is more difficult. These products may compete with our future products in jurisdictions where we do not have any issued patents and our patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for us to stop infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert efforts and attention from other aspects of our business, which could adversely affect our operations and financial condition. Moreover, our patent rights can be challenged in post-grant or *inter partes* review. For example, our patents for SUBLOCADE were challenged in the EU patent office under two separate European opposition proceedings. However, both of those proceedings have been dismissed.

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**<u>Risks Related to Regulatory or Legal Matters</u>**

***The regulatory approval process is expensive, time-consuming, and uncertain and may prevent us or our partners from obtaining approvals for the commercialization of some or all of our product candidates. Further, the FDA or other regulatory agencies may not agree with our regulatory approval strategies or components of our filings for our products and may not approve, or may delay the approval of, our products.***

The research, development, testing, manufacturing, approval, labeling, advertising and promotion, distribution and import and export of pharmaceutical products are subject to extensive regulation, and regulations differ from country to country. We must obtain government approvals before marketing or selling our products. Approval in one jurisdiction does not ensure approval in other jurisdictions. The regulatory approval process is lengthy, expensive and uncertain, and we may be unable to obtain approval for our product candidates. The FDA in the U.S., and comparable regulatory agencies in other jurisdictions, impose substantial and rigorous requirements for the development, manufacture and commercialization of products, the satisfaction of which can take a significant number of years and can vary substantially based upon the type, complexity and novelty of the product.

For example, in the U.S., the process for obtaining marketing approval for a drug or biologic product candidate generally includes (a) conducting preclinical laboratory and animal testing and submitting the results to FDA in an investigational new drug application (IND) requesting approval to test the product candidate in human clinical trials; (b) conducting adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate in the desired indication; (c) submitting an NDA, biologics license application (BLA), or supplemental NDA/BLA, as appropriate and (d) completing inspections by FDA of the facilities where the product candidate is manufactured, analyzed and stored to demonstrate compliance with cGMP, and any requested FDA audits of the clinical trial sites that generated the data supporting the application.

In addition, regulation is not static, and regulatory agencies, including the FDA, evolve in their staff, interpretations and practices and may impose more stringent requirements than currently in effect, which may adversely affect our plans for product development, approval, manufacture and/or commercialization. The approval procedure and the time required to obtain approval also vary among countries. Regulatory agencies may have varying interpretations of the same data, and approval by one regulatory agency does not ensure approval by regulatory agencies in other jurisdictions. In addition, the ultimate decision by the FDA or other regulatory agencies regarding drug approval may not be consistent with prior communications due to the evolution of new information or changes in clinical practice during the development and registration processes.

The product approval process can last many years, be very costly and still be unsuccessful. For example, the development of SUBLOCADE from concept to commercial launch took approximately 8 years. Regulatory approval by the FDA or other regulatory agencies can be delayed, limited or not granted at all. A product may fail to demonstrate safety and efficacy for each target indication in accordance with applicable regulatory agencies' standards for many reasons, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• data from preclinical testing and clinical trials may be interpreted by applicable regulatory agencies in ways different from how we or our licensees interpret it;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• regulatory agencies may not agree with our or our licensees' regulatory approval strategies, plans for accelerated development timelines, components of our or our licensees' filings such as clinical trial designs, conduct and methodologies, or the sufficiency of our or our licensees' submitted data to meet their requirements for product approval;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• regulatory agencies might not approve our or our licensees' manufacturing processes or facilities, or those of the contract research organizations ("CROs) and contract manufacturing organizations who conduct research or manufacturing work on our or our licensees' behalf;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• failure by our clinical investigational sites and the records kept at such sites, including any clinical trial data, to be in compliance with the FDA's good clinical practices (GCP), or other applicable legislation governing GCP, or to pass FDA, European Medicines Agency or other relevant regulatory agency's inspections of clinical trials;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• regulatory agencies may change their requirements for approval or post-approval marketing; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• adverse medical events during the trials could lead to requirements that trials be repeated or extended, or that a program be terminated or placed on clinical hold, even if other studies or trials relating to the program are successful.

In addition, disruptions at the FDA and other regulatory agencies that are unrelated to our company or our products, including those relating to the COVID-19 pandemic or other political or economic conditions, could cause delays to the regulatory approval process for our products. In June 2020, the FDA noted that it was continuing to ensure timely review of applications for medical products during the COVID-19 pandemic in line with its user fee performance goals; however, if a prolonged U.S. government shutdown occurs as a result of political or economic conditions or if the COVID-19 pandemic increases in severity or impact, the FDA's ability to timely review and process regulatory submissions could be significantly impacted.

Further, any adverse events or other data generated during the course of clinical trials of our product candidates and/or our currently marketed products could result in action by FDA or an equivalent regulatory authority. Such safety findings may restrict our ability to sell or adversely affect the commercialization of currently marketed products. Specifically, clinical trial safety data could result in FDA requiring changes to the clinical development program, labeling, including additional warnings or additional boxed warnings, or requiring us to take other actions that could have an adverse effect on patient and prescriber acceptance of our products. See also "*We are subject to ongoing obligations and continued regulatory review by the FDA and equivalent foreign regulatory agencies, and we may be subject to penalties and litigation and large incremental expenses if we fail to comply with regulatory requirements or experience problems with our products*."

Any failure to obtain, or delay in obtaining, regulatory approval for our products will prevent or delay their commercialization and could have a material adverse effect on our business, financial condition, cash flows and results of operations. In addition, any failure to obtain, or delay in obtaining, approval for our products could have a material impact on our shareholders' confidence in the strength of our development capabilities and/or our ability to generate significant revenue from our development program and could result in a significant decline in our share price. Further, even product candidates that receive regulatory approval may face additional regulatory hurdles or otherwise be unable to achieve expected market acceptance. See "*The FDA, the DEA, or other regulatory agencies may impose limitations or post-approval requirements on approvals for our products*" and "*Our ability to generate revenues from our products is subject to attaining significant market acceptance among physicians, patients, and healthcare payors.*"

***The FDA, the DEA, or other regulatory agencies may impose limitations or post-approval requirements on approvals for our products.***

Even if regulatory approval to market a product is granted by the FDA or other regulatory agencies, the approved label for the product may not be consistent with our initial expectations or commercial plans. For example, the FDA or other regulatory agencies may impose limitations on the clinical data that may be included in the label for the product or the indicated uses for which, or the manner in which, the product may be marketed, or may impose additional post-approval requirements. Our business could be materially adversely affected if we do not complete these post-approval requirements and, as a result, the FDA or other regulatory agencies require us to change the label for such product, or if such post-approval requirements significantly restrict the marketing, sale or use of such product.

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We may be required to include, as part of an NDA, a proposed risk evaluation and mitigation strategy ("REMS") whose goal is to mitigate potential risks that may be associated with the use of a product and to inform patients and prescribers of those risks. We may also be required to include a plan for communication with healthcare providers, restrictions on a drug's distribution, or a medication guide to provide information to consumers about the drug's risks and benefits. For example, the FDA requires separate REMS for SUBLOCADE and SUBOXONE Film. Other products that we sell in the future may become subject to a REMS specific to the product or shared with other products in the same class of drug. Depending on the nature of the REMS, the cost to implement the REMS may be high and the impact to the business may be significant. For example, we were required to conduct seven post-marketing requirement studies and three post-marketing commitment studies in connection with the approval of SUBLOCADE.

In the EU or UK, we may be required to adopt a risk management plan and our products could be subject to specific risk minimization measures, such as restrictions on prescription or supply, the conduct of post-marketing safety or efficacy studies, or the distribution of patient and/or prescriber educational materials.

In addition, post-marketing obligations in the form of further clinical trials may be imposed to further expand on the evaluation of the risk/benefit profile of the product relative to any potential safety concerns. These trials typically occur after approval and according to pre-specified timelines set by regulatory authorities. Depending on the nature of the post-marketing commitment, trial completion can be a lengthy process. Failure to comply with any of these requirements may potentially lead to suspension of the marketing authorization for the product and other penalties. The costs and other consequences of non-compliance with any of the post- approval obligations described above could have an adverse impact on its business, prospects, results of operations and financial condition.

Further, if a product for which we obtain regulatory approval is a controlled substance or has been shown to have a drug abuse liability, it will not become commercially available until after the DEA (or other applicable regulatory authority) provides its final schedule designation for the product, and may take longer and may be more restrictive than we expect or may change after its initial designation. In addition, a final designation that is more restrictive than we expect could adversely affect our ability to commercialize such product and could materially adversely affect our business, financial condition, cash flows and results of operations.

In addition, legislation and regulatory policies relating to post-approval requirements and restrictions on promotional activities for pharmaceutical products, or FDA, DEA or other regulatory agency regulations, guidance or interpretations with respect to such legislation or regulatory policy, may change, that may impact the development and commercialization of our products.

***We are subject to ongoing obligations and continued regulatory inspection by the FDA and equivalent foreign regulatory agencies, and we may be subject to penalties and litigation and large incremental expenses if we fail to comply with regulatory requirements or experience problems with our products.***

FDA and other regulatory authorities periodically inspect manufacturing facilities and the sponsor's and manufacturer's records to assess compliance with cGMP. Evidence of non-compliance with the statutory and regulatory requirements may result in suspension of manufacturing, product seizure, withdrawal of the product from the market, administrative, civil and criminal penalties, among other enforcement remedies both in the U.S. and abroad. See "*We are subject to risks related to the manufacture and distribution of our products globally."*

Additionally, FDA and other regulatory authorities track information on side effects and adverse events reported during clinical studies and after marketing approval. We are required to file periodic safety update reports with the authorities concerning adverse events. If, upon review, an authority determines that any events and/or reports indicate a trend or signal, they can require a change in a

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product label, restrict sales and marketing, require post-approval safety studies, require a labor-intensive collection of data regarding the risks and benefits of marketed products and ongoing assessments of those risks and benefits, and/or require other actions. Such safety findings could potentially lead to the withdrawal or suspension of the product from the market. FDA also periodically inspects our records related to safety reporting. Following such inspections, FDA may issue non-compliance notices on FDA Form 483 and warning letters that could cause us to modify certain activities. An FDA Form 483 notice, if issued, can list conditions FDA investigators believe may have violated relevant FDA standards. Failure to adequately and promptly correct the observations can result in a warning letter or other regulatory enforcement action.

FDA also regulates advertising and promotional activities for products in the U.S., requiring advertising, promotional materials and labeling to be truthful and not misleading, and products to be marketed only for their approved indications and in accordance with the provisions of the approved label. FDA actively investigates allegations of pre-approval and off-label promotion in order to enforce regulations prohibiting these types of activities. FDA routinely issues informal and more formal communications such as untitled letters or warning letters regarding companies' activities.

The manufacture, quality control, labeling, packaging, safety surveillance, adverse event reporting, storage, advertising, promotion and record-keeping for products are subject to extensive and ongoing regulatory requirements which are becoming increasingly stringent. If we become aware of previously unknown problems or potential new safety risks associated with any of our products, a regulatory agency may impose restrictions on our products, our contract manufacturers or on us. If we, our products and product candidates, or the manufacturing facilities for its products and product candidates, fail to comply with applicable regulatory requirements, regulatory agencies have wide-ranging powers of enforcement, including the power to impose monetary penalties. In such instances, we could experience a significant drop in the sales of the affected products, our product revenues and reputation in the marketplace may suffer, and it could become the target of lawsuits, each of which could have a material adverse effect on our business, prospects, results of operations and financial condition.

The regulations, policies or guidance of regulatory agencies may change and new or additional statutes or government regulations may be enacted that could prevent or delay regulatory approval of our product candidates or further restrict or regulate post-approval activities.

As a result of the breadth of these laws and regulations and the lack of definitive legal guidance in certain areas, it is possible that some of our business activities could be subject to challenge. Such challenges, irrespective of the underlying merit or the ultimate outcome of the matter, could have a material adverse effect on our business, prospects, reputation, results of operations and financial condition. Similarly, if we are unable to achieve and maintain regulatory compliance, we will not be permitted to market our drugs, which would materially adversely affect our business, results of operations and financial condition.

***Guidelines published by professional societies, insurance carriers, physician groups, science foundations, and other organizations may affect the use of the Group's products.***

Government agencies promulgate regulations and guidelines directly applicable to us and to our products. In addition, professional societies, practice management groups, insurance carriers, physicians' groups, private health and science foundations and organizations involved in various diseases also publish guidelines and recommendations to healthcare providers, administrators and payers, as well as patient communities. Recommendations by government agencies or other groups and organizations may relate to such matters as usage, dosage, route of administration and use of related therapies. In the U.S., for example, a growing number of organizations are providing assessments of the value and pricing of biopharmaceutical products, and even organizations whose guidelines have historically been focused on clinical matters have begun to incorporate analyses of the cost effectiveness of various treatments into their treatment guidelines and recommendations. In addition, value assessments may come from private organizations that publish their findings and offer recommendations relating to the reimbursement of

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products by government and private payers. Some companies and payers have announced pricing and payment decisions based in part on the assessments of private organizations. In addition, government health technology assessment organizations in many countries make reimbursement recommendations to payers in their jurisdictions based on the clinical effectiveness, cost-effectiveness and service effects of new, emerging and existing medicines and treatments. Such recommendations have included and may in the future include reimbursement for certain of our products for a narrower indication than was approved by applicable regulatory agencies or may include recommending against reimbursement entirely. Such recommendations or guidelines may affect our reputation, and any recommendations or guidelines that result in decreased use, dosage or reimbursement of our products could have a material adverse effect on our product sales, business and results of operations. In addition, the perception that such recommendations or guidelines will result in decreased use and dosage of our products could adversely affect the market price of our ordinary shares.

***Product liability and product recalls could have a material adverse effect on us.***

The testing, manufacturing, marketing and sale of pharmaceutical products entail a risk of product liability claims, product recalls, litigation and associated adverse publicity. Unanticipated side effects of, or manufacturing defects in, our products could exacerbate a patient's condition or could result in serious injury or impairments or even death. This could result in product liability claims and/or recalls of one or more of our products. In many countries, including in EU member states and the UK, national laws provide for strict (no-fault) liability.

Product liability claims may be brought by individuals seeking relief for themselves, or by or on behalf of groups seeking to represent a class of injured patients. Further, third-party payors, either individually or as a putative class or group action, may bring actions seeking to recover monies spent on products. The risk of product liability claims may also increase if we are subject to regulatory action by the FDA, the European Medicines Agency (the "EMA"), the UK Medicines and Health products Regulatory Agency ("MHRA"), or other competent authorities, or following a product recall. The cost of defending such claims is expensive even when the claims are without merit. A successful product liability claim against us could require us to pay a substantial monetary award. Moreover, an adverse judgment in a product liability suit, even if insured or eventually overturned on appeal, could generate substantial negative publicity about our products and business and inhibit or prevent the commercialization of other products.

Moreover, although we carry product liability insurance, current coverage may not be adequate. Further, product liability insurance is difficult to obtain and may not be available in the future on acceptable terms or at all. Product recalls may be issued at our discretion or at the discretion of our suppliers, government agencies and other entities that have regulatory authority over pharmaceutical sales. Any recall of our products could materially adversely affect our business by rendering us unable to sell that product for some time and by adversely affecting our reputation. In addition, product liability claims, product complaints or product quality issues reported by us (or others) to authorities as required by local regulations could result in an investigation (conducted by the FDA, the EMA, or the competent authorities of EU member states or other national authorities) into the safety or efficacy of our products, our manufacturing processes and facilities, or our marketing programs. An investigation could potentially lead to a recall of our products or more serious enforcement actions including seizure, injunction or criminal charges, proposed changes to the indications for which they may be used or suspension or withdrawal of approval. The Group has no insurance coverage for product recalls. Any of the foregoing could have a material adverse effect on our business, prospects, results of operations and financial condition. Further, product liability insurance may not be available for many claims relating to our opioid drug products due to contractual exclusions in our insurance policies.

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***We are subject to federal, state and foreign healthcare laws and regulations and implementation or changes to such healthcare laws and regulations could adversely affect our business and results of operations.***

We are subject to extensive federal, state and foreign healthcare regulation. The healthcare system is highly regulated in the U.S., the EU, the UK and other countries where we operate and, as a pharmaceutical company that participates in government-regulated healthcare programs, we are subject to complex laws and regulations. Violation of the healthcare laws that we are subject to, or any other federal, state or foreign regulations, may subject us to significant administrative, civil and/or criminal penalties, damages, disgorgement, fines, exclusion, imprisonment, additional reporting requirements, and/or oversight from federal or other healthcare programs that could require the restructuring of our operations. Any of these could have a material adverse effect on our business and financial results. Any action against us for violation of these laws, even if we ultimately are successful in our defense, will cause us to incur significant legal expenses and divert our Management's attention away from the operation of our business.

The U.S. and some foreign jurisdictions are considering or have enacted several legislative and regulatory proposals that change the healthcare system in ways that could impact profitability. In the U.S. and abroad there is significant interest in implementing regulations and legislation with the stated goals of containing healthcare costs, improving quality, and/or expanding access. The pharmaceutical industry has been a focus of these efforts and has been significantly affected by major legislative initiatives, particularly in the U.S.

For example, the Affordable Care Act substantially changed the way healthcare is financed by both governmental and private insurers, and continues to significantly impact the U.S. pharmaceutical industry. Congress has enacted laws that modified certain provisions of the Affordable Care Act such as removing penalties, starting January 1, 2019, for not complying with the Affordable Care Act's individual mandate to carry health insurance. It is unclear how any future modifications to the Affordable Care Act or its implementing regulations, judicial challenges related to the Affordable Care Act, or other future healthcare reforms will affect our business.

In addition, drug pricing by pharmaceutical companies in the U.S. has come under increased scrutiny. Specifically, there have been state and U.S. congressional inquiries into pricing practices by pharmaceutical companies. For example, Congress launched an inquiry into pharmacy benefit managers and their practices which are believed by some to have led to consolidation, lack of transparency, and spread pricing. U.S. policymakers have also studied the impact rebates (i.e., the return of part of the purchase price of a prescription drug in exchange for favorable formulary placement) may play in driving up overall drug prices. Significant developments that may adversely affect pricing in the U.S. include drug pricing and Medicare reforms by Congress, regulatory changes to Medicare Part B (physician-administered drugs) and Medicare Part D (prescription drug benefit), additional changes relating to the Affordable Care Act, and trends in the practices of managed care groups and institutional and governmental purchasers.

The pharmaceutical industry faces uncertainty regarding the continuation of current drug pricing policy. For example, on November 20, 2020, HHS finalized the "rebate rule" by publishing regulations removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Medicare Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. Legislation has delayed the implementation of the rebate rule until January 1, 2032.

Congress and the Biden Administration continue to seek new legislative and/or administrative measures to control drug costs. On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law which, among other things, requires the HHS Secretary to negotiate, with respect to Medicare units and subject to a specified cap, the price of a set number of certain high Medicare spend

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drugs and biologicals per year starting in 2026, penalizes manufacturers of certain Medicare Parts B and D drugs for price increases above inflation, and makes several changes to the Medicare Part D benefit, including a limit on annual out-of-pocket drug costs starting at $2,000 in 2025, a $35 monthly cap on insulin payments, and a change in manufacturer liability under the program that could negatively affect us. Congress continues to examine various policy proposals that may result in pressure on the prices of prescription drugs in government health programs.

Governments across the world continue to consider and take action to lower drug prices. In the U.S., there is bi-partisan support for drug pricing reforms at both federal and state levels, which include potential legislative and regulatory actions to encourage the import of drugs, to price drugs according to a defined international pricing reference, to encourage more competition, and to undertake other initiatives. These, together with federal and state government fiscal constraints resulting from the COVID-19 pandemic which constrain public benefit health programs, pose direct and indirect downward pressure risk on drug prices. The Group continues to monitor potential legislative and regulatory changes and their impacts, advocating for the Group's products based on scientific studies and patient-centered outcomes. However, certain potential legislative and regulatory drug pricing changes could have an adverse impact on the Group's financial performance and results in the future.

In Europe, legislators, policymakers, and healthcare insurance funds continue to propose and implement cost-containing measures to keep healthcare costs down, due in part to the attention being paid to healthcare cost containment in Europe. Certain of these changes could impose limitations on the prices we will be able to charge for our products and any approved product candidates or the amounts of reimbursement available for these products from governmental agencies or third-party payers, which may increase the tax obligations on pharmaceutical companies such as ours, or may facilitate the introduction of generic competition with respect to our products.

With the intent of lowering prescription drug prices in the U.S., federal and state governments in the U.S. have enacted and continue to consider additional legislation and regulation applying international reference pricing to prescription drugs, otherwise limiting the pricing of prescription drugs, and authorizing the importation of drugs from countries outside the U.S. Such measures could have a material effect on our business, results of operations and financial condition, though importation programs as of October 2022 exclude controlled substances.

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our current products and/or those for which we may receive regulatory approval in the future.

***Failure to comply with payment and reporting obligations under the Medicaid Drug Rebate program or other governmental pricing programs in the U.S. could result in additional reimbursement requirements, penalties, sanctions and fines.***

In the U.S., we participate in the Medicaid Drug Rebate and Medicare Part D programs and, by virtue of such participation, are also required by federal law to participate in the 340B Program and Federal Supply Schedule pricing program. These programs require us to pay certain rebates based on pricing data, such as (among others) average manufacturer price and best price, reported by us to the various federal agencies administering the programs.

Pricing and rebate calculations vary among products and programs. The calculations are complex and the calculation methodology is often subject to interpretation by us, governmental or regulatory agencies and the courts. If we become aware that our reporting for a prior period was incorrect or has changed as a result of the recalculation of the pricing data, we are obliged to resubmit the corrected data. Such restatements and recalculations can increase our costs for complying with the laws and regulations governing the various programs. Any corrections to our rebate calculations could result in either additional or reduced rebate liability for past periods, depending on the nature of the correction. Price recalculations may also affect the ceiling price at which we are required to offer our products to certain covered

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healthcare entities, such as safety-net providers under the 340B Program, as well as the prices under which our products are made available to federal government purchasers such as the U.S. Department of Veterans Affairs and the Department of Defense under the Veterans Health Care Act of 1992, as amended ("VHCA").

We are liable for errors associated with our submission of pricing data. In addition to retroactive rebates and the potential for 340B Program and VHCA refunds, if we are found to have knowingly submitted any false price or product information to the government, we may be liable for civil monetary penalties. Any failure to submit data on a timely basis could result in a civil monetary penalty for each day the information is late beyond the due date. In the case of the Medicaid Drug Rebate program, such failure could also be grounds for CMS to terminate our Medicaid drug rebate agreement, pursuant to which we participate in the Medicaid program. In the event that CMS terminates our rebate agreement, no federal payments would be available under Medicaid or Medicare Part B for our covered outpatient drugs. As another example, we can be subjected to civil monetary penalties under, or termination from, the 340B Program if we knowingly and intentionally overcharge covered entities.

CMS and HHS-OIG have previously indicated that they intend to pursue more aggressively companies that fail to report pricing data to the government in a timely manner. Governmental agencies may also make changes in program interpretations or requirements or conditions of participation, some of which may have implications for amounts that we previously estimated or paid. There can be no assurance CMS or any other government agency will find that our submissions are complete and correct.

Any of the foregoing could have a material adverse effect on our business, prospects, results of operations and financial condition.

***We are subject, directly or indirectly, to a variety of U.S. and international laws and regulations related to fraud and abuse and transparency. Enforcement actions under such laws have increased in recent years. If we fail to comply, or have not fully complied, with such laws, we could face substantial penalties.***

In the U.S., we are subject directly, or indirectly through our customers and other third parties, to various federal, state and local fraud and abuse and transparency laws. Our sales, marketing, patient support and medical activities may be subject to scrutiny under these laws. The U.S. federal healthcare program Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving anything of value to induce (or in return for) the referral of business, including the purchase, recommendation or prescription of a particular drug reimbursable under Medicare, Medicaid or other federally financed healthcare programs. The statute has been interpreted to apply to arrangements between pharmaceutical companies on one hand and patients, prescribers, purchasers and formulary managers on the other. Although there are several statutory exemptions and regulatory safe harbors protecting certain common manufacturer business arrangements and activities from prosecution and administrative sanction, the exemptions and safe harbors are drawn narrowly and are subject to regulatory revision or changes in interpretation by the DOJ and HHS-OIG. Practices or arrangements that involve remuneration may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Violations of the federal Anti-Kickback Statute may be established without providing specific intent to violate the statute, and may be punishable by civil, criminal, and administrative fines and penalties, damages, imprisonment, and/or exclusion from participation in federal healthcare programs.

The federal civil False Claims Act prohibits, among other things, any person from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of federal funds, or knowingly making, or causing to be made, a false statement to get a false claim paid. A claim resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim. The False Claims Act also permits a private individual acting as a "whistleblower" to bring actions on behalf of themselves and the federal government alleging violations of the statute and to share in any monetary recovery. Violations of the False Claims Act may result in significant financial penalties (including

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mandatory penalties on a per claim or statement basis), treble damages and exclusion from participation in federal healthcare programs.

Pharmaceutical companies are subject to other federal false claims and statements laws, some of which extend to non-government health benefit programs. For example, the healthcare fraud provisions under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, or HIPAA, impose criminal liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third party payors, or falsifying or covering up a material fact or making any materially false or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Violations of HIPAA fraud provisions may result in criminal, civil and administrative penalties, fines and damages, including exclusion from participation in federal healthcare programs.

The majority of individual states also have statutes or regulations similar to the federal anti-kickback law and the False Claims Act, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor. Other states restrict whether and when pharmaceutical companies may provide meals to healthcare professionals or engage in other marketing-related activities, and certain states and cities require the identification or licensing of sales representatives.

The Physician Payment Sunshine Act requires tracking of payments and transfers of value to physicians and teaching hospitals and ownership interests held by physicians and their families, and reporting to the federal government and public disclosure of these data. Beginning in 2022, reporting is also required of information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives. A number of states now require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products and to report gifts and payments to healthcare providers in the states. Government agencies and private entities may inquire about our marketing practices or pursue other enforcement activities based on the disclosures in those public reports.

We are further subject in a similar manner to federal and state data privacy and security laws, such as HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and state breach reporting requirements. Collectively, these laws may affect, among other things, our current and proposed research, sales, marketing and educational programs, as well as other possible relationships with customers, pharmacies, physicians, payers, and patients. We are subject to similar data privacy and security laws in Europe, including the EU General Data Protection Regulation (2016/679), or GDPR, under which fines of up to €20.0 million or up to 4% of the annual global revenue of the infringer, whichever is greater, could be imposed for significant non-compliance. We are also subject to *qui tam*, or whistleblower lawsuits, under the False Claims Act. Compliance with these laws, including the development of a comprehensive compliance program, is difficult, costly and time-consuming.

Because of the breadth and evolving interpretations and requirements of these laws, the narrowness of available statutory and regulatory exemptions, and the wide array of U.S. and international authorities with overlapping regulatory jurisdiction, it is possible that some of our business activities could be subject to challenge under one or more of such laws. For example, pharmaceutical manufacturer co-pay programs, including pharmaceutical manufacturer donations to patient assistance programs offered by charitable foundations, are the subject of ongoing litigation, enforcement actions and settlements (involving other manufacturers and to which we are not a party) and evolving interpretations of applicable regulatory requirements and certain state laws, and any change in the regulatory or enforcement environment regarding such programs could impact our ability to offer such programs. Any action against us alleging violation of these laws, whether brought by law enforcement, regulatory agencies or private *qui tam* actions brought by individual whistleblowers in the name of the government, could cause us to incur significant legal expenses and divert our Management's attention from the operation of our business, even if we successfully defend against those actions. If any enforcement actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could

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have an impact on our business, including the imposition of significant civil, criminal and administrative sanctions, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, imprisonment, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

***Failure to comply with anti-corruption laws and regulations, anti-money laundering laws and regulations, and/or economic sanctions could result in us becoming subject to fines or penalties.***

We are subject to various federal and foreign laws and regulations regarding anti-corruption, anti-money laundering, and economic sanctions. These include the U.K. Bribery Act of 2010 and the U.S. Foreign Corrupt Practices Act of 1977, as amended, which prohibits, among other things, payments, offers, or promises made for the purpose of improperly influencing any act or decision of a foreign official. The nature of our business means that we engage in significant interactions with foreign officials. We are also subject to economic sanctions and export controls rules and regulations imposed by, amongst others, the U.S. Department of the Treasury's Office of Foreign Assets Control, the U.S. Department of Commerce, other agencies of the U.S. government, HM Treasury and other agencies of the UK government, the European Union, and the United Nations. Any expansion, broadened or changed interpretation, variation or addition to these rules and regulations could impose significant compliance costs on us.

We have mechanisms in place to procure compliance with applicable anti-corruption, anti-money laundering, and economic sanctions rules and regulations, and applicable self-regulatory industry codes by region that the Group has committed to follow. However, there can be no assurance that our policies and procedures will be followed at all times or will effectively detect and/or prevent violations of applicable compliance regimes by our employees, consultants, sub-contractors, agents and partners. As a result, in the event of non-compliance, we could be subject to legal proceedings, fines and/or civil or criminal penalties, the disgorgement of profits, damage to our reputation and resulting loss of revenue and profits, which could have a material adverse impact on our business, financial conditions and operations.

***The pharmaceutical sector is facing increased government scrutiny from competition and pricing authorities around the world, and any failure to comply, may expose us to significant damages and commercial restrictions that can materially and adversely affect our business.***

We are required to comply with competition laws in the territories where we do business around the world. Compliance with these laws has been the subject of increasing focus and activity by regulatory authorities (and private plaintiffs, where they have enforcement rights under the law), both in the U.S. and Europe, in recent years. Violations of such laws may have a material adverse effect on our reputation, business, financial condition, and results of operations. Our company has faced and may in the future face investigations and/or legal proceedings alleging that actions purportedly taken by our company violated such laws. For example, we are a party to civil claims brought by state officials and private plaintiffs alleging that we violated U.S. federal and/or state antitrust and consumer protection laws. See <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u> "Legal Proceedings—Intellectual Property Related Matters – Antitrust Litigation and Consumer Protection" included in "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements - Audited Consolidated Financial Statements*." We may face additional claims from state officials and private plaintiffs in the future, and any such claims could materially and adversely affect our business. Also, on July 24, 2020, we entered into a Stipulated Order for Permanent Injunction and Equitable Monetary Relief in the U.S. District Court for the Western District of Virginia, Abingdon Division, with the FTC. As part of the resolution with the FTC, for a ten-year period Indivior Inc. is required to make specified disclosures to the FTC and is prohibited from certain conduct. See "*<u>[Item 10.](#id39cb0e1a10249e1ab7b8f77d921d68a_2560)</u> Additional Information—C. Material Contracts*."

Companies operating in the pharmaceutical industry also face challenges to the validity or enforceability of listed patents and frequently agree to settlements of patent litigation. Regulatory authorities in the U.S. and Europe, including the FTC and the European Commission, increasingly

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scrutinize patent settlements. Additionally, competition law authorities may send formal or informal requests for information about particular settlement agreements, and there is a risk that governmental authorities, customers, other downstream purchasers or others may commence actions alleging violations of antitrust laws based on our settlement agreements.

The U.S. Congress and certain state legislatures in the U.S. have also passed, or proposed passing, legislation that could adversely impact the ability to settle patent litigation. For example, the State of California has enacted legislation that prohibits, with certain exceptions and safe harbors, various types of patent litigation settlements, and imposes substantial monetary penalties on companies and individuals who do not comply.

Following calls in recent years from policymakers and other stakeholders in many countries for governmental intervention to address the high prices of certain pharmaceutical products, we may become, from time to time, subject to governmental investigations, claims or other legal or regulatory actions regarding our pricing and/or other alleged exclusionary practices. It is not possible to predict the ultimate outcome of any such investigations, claims or proceedings or what other investigations or lawsuits or regulatory responses may result from such assertions, which could have a material adverse effect on our reputation, business, financial condition, and results of operations.

**<u>Risks Related to our Financial Condition and Tax Matters</u>**

***Weakness in the economy, market trends, uncertainty and other conditions in the markets in which we operate, particularly in the U.S., may adversely affect the profitability and financial stability of our customers, and could negatively impact our sales growth and results of operations.***

Our financial performance depends in part on general economic conditions in the geographic markets in which we operate, particularly in the U.S. where we generated 81% of our revenue from continuing operations in fiscal 2022. Further, as a global business, we are also subject to changes in economic conditions and cost inflation, interest rates, capital markets, foreign exchange rates, political conditions, and tax policies. For example, in 2022, the U.S. has seen price inflation at its highest levels in 40 years. In the U.K., and Europe, energy prices are at record highs and shortages are possible. The global supply chain has continued to experience significant challenges disrupting all industries. The Ukraine/Russia war compounded supply chain troubles caused by the COVID-19 pandemic which include: shortages of materials and labor; unprecedented demand for goods and services; constricted logistics capacity; and raising commodity and energy prices. The Group has noted lead time extension, constricted capacity and minor disruption in some supply components. Numerous industries have suffered from supply chain disruptions or labor shortages, that may affect us in unexpected ways. If major delays or shortages occur, the delivery of products to our patients could be disrupted and impact the short-term Group's financial performance. Any of these geopolitical or macroeconomic trends may have an adverse effect on our profitability, ability to generate revenue or fund operations, and ability to raise capital, which in turn could have a material adverse effect on our business, financial condition, and results of operations.

***The COVID-19 pandemic and governmental and societal responses thereto have adversely affected our business, results of operations, and financial condition, and the continuation of the pandemic or the outbreak of other health epidemics could further harm our business, results of operations, and financial condition.***

The COVID-19 pandemic remains dynamic and continues to have a significant impact on the global healthcare delivery system. Many healthcare systems have had to restructure operations to prioritize caring for COVID-19 patients and limit or cease other activities. The severe burden on healthcare systems caused by this pandemic has impaired the ability to diagnose and treat patients with non-COVID-19 related conditions and impaired the ability of many clinical research sites to start new studies, enroll new patients and monitor patients in clinical trials. Health care provider offices and institutions have experienced workforce disruption, including the inability to hire staff and challenges maintaining

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appropriate staffing. The lack of access to healthcare providers has caused, and may continue to cause, delays in appropriate diagnosis, treatment and ongoing care for some patients, which could subsequently impact prescribing and use of our products. The evolving effects of the COVID-19 pandemic and government measures taken in response have had a significant impact, both direct and indirect, on businesses and commerce, as significant reductions in business related activities have occurred, supply chains have been disrupted, and manufacturing and clinical development activities have been curtailed or suspended.

Many governments, including in the U.S., UK, and Canada, imposed stringent restrictions to seek to mitigate, or slow, the spread of COVID-19, including restrictions on international and local travel, public gatherings and participation in business meetings, as well as closures of workplaces, schools, and other public sites, and are continuing to encourage "social distancing." Although many of these restrictions have been lifted, some of these restrictions remain and, due to the unpredictability of the COVID-19 pandemic, including variants, it is possible that some or all of these measures could be reinstated. Moreover, the COVID-19 pandemic has significantly affected the global economy, including due to the restrictive measures adopted to prevent its spread, as well as various government stimulus programs. Both the severity and duration of the COVID-19 pandemic, as well as the future impact on the economy and potential government stimulus programs, are unknown.

The COVID-19 pandemic, and possible future variants or other pandemics, may continue to negatively affect us in a variety of ways, including restrictions on access to HCPs by our sales force, disruptions to the supply of our products to patients if we experience either a significant absence of our employees and/or employees at our contract manufacturing organizations, vendors and service providers due to infection and/or government containment measures, and/or capacity issues at our airfreight and road logistics providers. In addition, the COVID-19 pandemic continues to result in overall fewer patient visits to healthcare provider offices for non-COVID-19 reasons or essential treatments, as patients become unable or unwilling to make visits due to overburdened healthcare systems, safety concerns, quarantines and other travel restrictions, or elect to have remote consultations with their providers. This trend has also impaired our ability to enroll new patients in clinical trials and the development of real-world evidence for our existing products that are used for regulatory submissions and to supplement our label. Any of the above factors could have a material adverse effect on our business, financial condition, and results of operations.

 ***Our term loan contains certain covenants that could limit our ability to plan for or respond to changes in our business.***

The Group has a $250 million term loan provided for under a credit agreement, most recently amended and restated as of April 27, 2022, by and among certain subsidiaries of Indivior PLC and the other parties thereto. The credit agreement includes a minimum liquidity requirement of the larger of $100 million or 50% of the outstanding loan balance as well as several restrictive covenants that, among other things, and subject to certain exceptions and baskets, limit our ability and/or our subsidiaries' ability to:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• incur or assume liens or additional debt or provide guarantees in respect of obligations of other persons;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• pay dividends or distributions or redeem or repurchase capital stock;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• prepay, redeem or repurchase or amend or modify the terms of certain debt;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• make loans, investments, acquisitions (including certain acquisitions of exclusive licenses) and capital expenditures;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• enter into agreements that restrict distributions from our subsidiaries;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• enter into transactions with affiliates;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• sell, transfer or exclusively license certain assets, including material intellectual property, and capital stock of our subsidiaries;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• consolidate or merge with or into, or sell substantially all of our assets to, another person;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• engage in new material lines of business; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• amend or modify our organizational documents.

Our failure to comply with the terms of our Term Loan could lead to an event of default under the term loan that could result in an acceleration where all amounts outstanding under the term loan would become immediately due and payable. In addition, any default or acceleration under the term loan could lead to an event of default and acceleration under other debt instruments that contain cross-default or cross-acceleration provisions. We can provide no assurance that our assets and the assets of our subsidiaries would be sufficient to repay in full any of those. In addition, if we are unable to repay those amounts, our creditors could proceed against any collateral granted to them to secure repayment of those amounts.

Further, there can be no assurance that we will be able to refinance our existing term loan at maturity, or obtain other or additional financing on attractive terms. In fact, our involvement in the opioid industry has in the past, and may in the future, limit the number of business partners willing to lend to us. See *"<u>[Item 3.](#i56ef77e8a843490995b8285e91603860_4022092)</u> Key Information—D. Risk Factors—We may be subject to adverse public opinion."*

***We may not be able to generate sufficient cash to service all of our indebtedness and may be forced to take other actions to satisfy our obligations under our indebtedness.***

We have a $250 million term loan and more than $500 million of other obligations. See Item 5.B. - Liquidity and Capital Resources - Contractual Obligations, <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1487)[17](#id39cb0e1a10249e1ab7b8f77d921d68a_1487)</u> "Financial Liabilities—Borrowings," and <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)[9](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)</u> "Provisions and Other Liabilities" included in *"<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u>* Financial Statements - Audited Consolidated Financial Statements." Additionally, at December 31, 2022 we had an additional $546 million of contractual liabilities due over the next five years, mostly related to the settlement of prior litigation. See "*<u>[Item 5.](#iaf701403a2a44bfd822eebd888f635b9_149177)</u> Operating and Financial Review and Prospects—B Liquidity and Capital Resources—Contractual Obligations*." Further, the Group has substantial unresolved litigation and in 2022, recognized a provision for $290 million related to certain multidistrict antitrust class and state claims, See <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal Proceedings, which represents an estimate of potential, future liability.

Our ability to make scheduled payments on our indebtedness or our other obligations or to refinance our indebtedness depends on our financial condition and operating performance and our ability to generate cash, which is subject to prevailing economic, industry and competitive conditions and to certain financial, business and other factors discussed in these "Risk Factors", many of which are beyond our control. Our term loan will mature in 2026. See "*<u>[Item 5.](#iaf701403a2a44bfd822eebd888f635b9_151132)</u> Operating and Financial Review and Prospects—B Liquidity and Capital Resources—Borrowings—The Term Loan*." At the maturity of our term loan and any other debt which we incur, if we do not have sufficient cash flows from operations and other capital resources to pay our debt obligations, or to fund our other liquidity needs, or if we are otherwise restricted from doing so due to corporate, tax or contractual limitations, we may be required to refinance our indebtedness. If we are unable to refinance all or a portion of our indebtedness or obtain such refinancing on terms acceptable to us, we may be forced to reduce or delay our business activities or capital expenditures, sell assets or raise additional debt or equity financing in amounts that could be substantial. The type, timing and terms of any future financing will depend on our cash needs and the prevailing conditions in the financial markets. We can provide no assurance that we will be able to accomplish any of these measures in a timely manner or on commercially reasonable terms, if at all.

Our ability to restructure or refinance our debt will depend in part on our financial condition at such time. Any refinancing of our debt could be at higher interest rates than our current debt and may require us to comply with more onerous covenants, which could further restrict our business operations. The terms of existing or future debt instruments may restrict us from adopting some of these alternatives.

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Furthermore, we may be unable to find alternative financing, and even if we could obtain alternative financing, it might not be on terms that are favorable or acceptable to us. If we are not able to refinance our debt, obtain additional financing or sell assets on commercially reasonable terms or at all, we may not be able to satisfy our debt obligations. In that event, borrowings under other debt agreements or instruments that contain cross-default or cross-acceleration provisions may become payable on demand, and we may not have sufficient funds to repay all our debts, including the term loan.

If our cash flows and capital resources are insufficient to fund payments of interest or principal on our outstanding debt or our obligations, we could face substantial liquidity problems and might be required to reduce or delay capital expenditures, sell assets or business operations, seek additional capital or restructure or refinance our term loan. We cannot ensure that we would be able to take any of these actions, that these actions would be successful and permit us to meet our scheduled obligations or that these actions would be permitted under the terms of existing or future debt agreements, including the agreement governing our term loan. In addition, any failure to make payments of interest and principal on our outstanding term loan on a timely basis would likely result in a reduction of our credit rating, which could harm our ability to incur additional indebtedness.

***Changes in our credit ratings and outlook may reduce access to capital and increase borrowing costs.***

The Group's credit ratings are based on several factors, including our financial strength, business prospects (including markets in which we complete, number of products with commercial sales, market share of our products, level of competition, remaining patent life of products being sold commercially, R&D pipeline and stage of those assets), and factors outside of our control, such as conditions affecting our industry generally, the market's perception of our environmental, social and governance actions and prospects, or the introduction of new rating practices and methodologies. A re-emergence or further outbreak of a pandemic could negatively impact our credit ratings and thereby adversely affect our access to capital and cost of capital. We cannot provide assurances that our current credit ratings will remain in effect or that the ratings will not be lowered, suspended or withdrawn entirely by the rating agencies. If credit rating agencies lower, suspend or withdraw the ratings, the market price or marketability of our securities may be adversely affected. Pressure on the credit ratings could also arise from higher shareholder payouts or larger acquisitions than we have currently planned that result in increased leverage, or in a deterioration in the credit metrics used by the rating agencies to assess creditworthiness. In addition, any change in ratings could make it more difficult for the Group to raise capital on acceptable terms, impact the ability to obtain adequate financing and result in higher interest costs on future financings.

***Our insurance coverage may not be adequate.***

Our business exposes us to potential product liability and professional indemnity claims and other risks which are inherent in the research, pre-clinical and clinical evaluation, manufacturing, sales and marketing and use of pharmaceutical products. We have public liability (general liability) and product liability insurance. However, product liability insurance may be unavailable for many claims involving our opioid drug products due to contractual exclusions in our insurance policies. Additionally, we have directors' and officers' insurance for direct claims, but are not able to obtain coverage for indemnification or for securities law claims against the Group and are self-insured for such matters. (However, we are in the process of renewing our coverage and have received indicative interest from commercial insurance markets and may in the future purchase such coverage. We also have insurance covering property damage and business interruption, third-party named suppliers, marine and cargo, directors' and officers' liability, clinical trials, automobile (fleet vehicles), employers' liability, and personal accident and travel.

While we believe the insurance coverage currently in place is generally appropriate for a business of our current size, nature and financial position, there is no certainty that coverage limits and indemnity provisions will be adequate to cover all potential claims that could arise against us in the conduct of our business nor that claims will arise from insurable risks. In addition, there are areas where insurance

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coverage, while potentially available, would carry premiums that are not commercially reasonable and/or may be difficult to obtain or maintain on commercially reasonable terms. Product liability insurance, particularly for buprenorphine products, is difficult to obtain and may not be available in the future on acceptable terms or at all. A successful claim or claims against us in excess of or outside the ambit of our insurance coverage may have a material adverse effect on our business, prospects, results of operations and financial condition.

***Our effective tax rate may increase, and changes in tax rules and regulations, or interpretations thereof, may adversely affect our financial condition.***

As a global biopharmaceutical company, we are subject to taxation in several different jurisdictions. As a result, our effective tax rate is derived from a combination of applicable tax rates in the various places where we operate. In preparing our financial statements, we estimate the amount of tax that will become payable in each of these places. Our effective tax rate may fluctuate depending on several factors, including, but not limited to, the distribution of our profits or losses between the jurisdictions where we operate and differences in the interpretation of tax laws. In addition, the tax laws of any jurisdiction in which we operate may change in the future, which could impact our effective tax rate. Tax authorities in the jurisdictions in which we operate may audit us. If we are unsuccessful in defending any tax positions adopted in our submitted tax returns, we may be required to pay taxes for prior periods, interest, fines or penalties, and may be obligated to pay increased taxes in the future, any of which could have a material adverse effect on our business, financial condition, cash flows and results of operations.

Our effective tax rates could be affected by numerous factors, such as changes in tax laws, regulations, administrative practices, principles and interpretations, the mix and level of earnings in a given taxing jurisdiction or our ownership or capital structures. Any current or future proposed changes to the tax rules that apply to corporations could materially affect our tax obligations and effective tax rate. In addition, the Organisation for Economic Co-operation and Development (OECD) has achieved widespread political agreement to work towards the implementation of a global minimum tax. As a result, it is possible that the Group's consolidated effective tax rate will increase in the short term. It is difficult to predict whether and when tax law changes will be enacted that would have a material adverse effect on our business, financial condition, results of operations and cash flows.

The application of tax law is subject to interpretation and is subject to audit by taxing authorities. Additionally, administrative guidance can be incomplete or vary from legislative intent, and therefore the application of the tax law is uncertain. While we believe the positions taken by the Group comply with relevant tax laws and regulations, taxing authorities could interpret our application of certain laws and regulations differently. Future tax controversy matters may result in previously unrecorded tax expenses, higher future tax expenses or the assessment of interest and penalties.

***Our deferred tax assets may not be realized.***

At December 31, 2022, 2021 and 2022, we had $219 million, $105 million and $75 million of deferred tax assets, respectively, consisting of $91 million, $81 million and $51 million of net deferred tax assets in the U.S, and $87 million, $11 million and $7 million of net deferred tax assets in the UK, respectively. It is possible that some or all of such deferred tax assets will not be realized, especially if we incur losses in either the U.S. or the UK in the future. Losses may arise from unforeseen operating events, or the occurrence of significant excess tax benefits arising from the vesting of restricted stock units. Unless we are able to generate sufficient taxable income in the future, a substantial reduction in the carrying value of either our U.S. or UK deferred tax assets may be required, which would materially increase our expenses in the period the reduction is recognized and materially adversely affect our business, financial condition, and results of operations.

US tax laws limit deductibility of compensation for certain management roles. At December 31, 2022 the Group carried approximately $12 million of deferred tax assets that are not expected to be realized

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once the U.S. listing is complete. Approximately three-quarters of this amount will be charged to equity and one quarter will be presented as a tax charge to book expense in the period the listing takes place.

***If a U.S. person is treated as owning at least 10% of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences.***

If a U.S. person is treated as owning (directly, indirectly, or constructively) at least 10% of the value or voting power of our ordinary shares, such person may be treated as a "United States shareholder" with respect to each "controlled foreign corporation" in our group. Because our group includes one or more U.S. subsidiaries, certain of our non-U.S. subsidiaries could be treated as controlled foreign corporations (regardless of whether or not we are treated as a controlled foreign corporation). A United States shareholder of a controlled foreign corporation may be required to report annually and include in its U.S. taxable income its pro rata share of "Subpart F income," "global intangible low-taxed income," and investments in U.S. property by controlled foreign corporations, regardless of whether we make any distributions. An individual that is a United States shareholder with respect to a controlled foreign corporation generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a U.S. corporation that is a United States shareholder with respect to a controlled foreign corporation. Failure to comply with these reporting and tax paying obligations may subject a United States shareholder to significant monetary penalties and may prevent the statute of limitations from starting with respect to such shareholder's U.S. federal income tax return for the year for which reporting was due. We cannot provide any assurances that we will assist investors in determining whether any of our non-U.S. subsidiaries is treated as a controlled foreign corporation or whether any investor is treated as a United States shareholder with respect to any such controlled foreign corporation or furnish to any United States shareholders information that may be necessary to comply with the aforementioned reporting and tax paying obligations. A United States investor should consult its advisors regarding the potential application of these rules to an investment in our ordinary shares.

**<u>Risks Related to Our Ordinary Shares</u>**

***Our ordinary shares are subject to market price volatility and the market price may decline disproportionately in response to developments that are unrelated to our operating performance.***

The market price of our ordinary shares has been, and may in the future be, volatile and subject to wide fluctuations as a result of a variety of factors including, but not limited to general economic conditions, developments with our pending litigation, period to period variations in operating results or changes in revenue or profit estimates by us, market and industry participants, and/or financial analysts. The market price could also be adversely affected by developments unrelated to our operating performance, such as the operating and share price performance of other companies that investors may consider comparable to us, speculation about us in the press and/or the investment community, unfavorable press, strategic actions by competitors (including acquisitions and restructurings, new competing products, and new generic products), changes in market conditions, regulatory changes and broader market volatility and movements. Any or all of these factors could result in material fluctuations in the price of our ordinary shares, which could lead to investors getting back less than they invested or a total loss of their investment.

***We may in the future relocate our primary listing to the U.S., which could cause volatility in our share price and shareholder base.***

We currently maintain a premium listing on the London Stock Exchange (the "LSE") and are a member of the FTSE 250 index of listed companies. Upon the effectiveness of this registration statement, we intend to also list on the Nasdaq Global Select Market (the "Nasdaq").

We do not have any current plans to change our primary listing but may do so in the future if and when appropriate. Such a change would require approval by a special resolution of a majority of not less than 75% of the votes attaching to Indivior PLC's shares voted on the resolution (whether in person or by proxy) at a General Meeting. However, if we were ever to change our primary listing from the LSE:

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• we would no longer be eligible to be a member of the FTSE 250 and other indices.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• we would not necessarily be eligible for inclusion in certain U.S. indices in the near term until we achieve certain trading volume thresholds on the Nasdaq, among other requirements, and moreover, we cannot guarantee that once eligible, we will be included in any index in the U.S.

If we were to change our primary listing to the U.S., then certain institutional holders of our ordinary shares may no longer be permitted to hold our ordinary shares (pursuant to their internal investment mandate, for example, relating to FTSE 250 status and LSE premium listing status), and certain similarly situated U.S. investors may not immediately be able to invest in our ordinary shares (pursuant to their investment mandates, for example, due to our lack of inclusion in U.S.-centric indices). Any such mismatch between supply and demand could cause the price of our ordinary shares to become more volatile and could impact our ability to meet certain criteria for inclusion on U.S. indices.

***The rights afforded to our shareholders are governed by English law. Not all rights available to shareholders under U.S. law will be available to holders of our ordinary shares.***

The rights of holders of our ordinary shares are governed by English law and our articles of association (the "Articles"), that may not provide the level of legal certainty and transparency afforded by incorporation in a U.S. state.

Indivior PLC is organized under the laws of England and Wales. The United Kingdom (of which England is a part) is not a member state of the European Union. Further, there can be no assurance that English law will not change in the future or that it will serve to protect investors in a similar fashion afforded under corporate law principles in the U.S., which could adversely affect the rights of investors.

Rights afforded to shareholders under English law differ in certain respects from the rights of shareholders in typical U.S. companies. In particular, English law currently significantly limits the circumstances in which the shareholders of English companies may bring derivative actions (i.e., legal actions brought by a shareholder on behalf of a company against a third-party). Under English law, in most cases, only Indivior PLC may be the proper plaintiff for the purposes of maintaining proceedings in respect of wrongful acts committed against it and, generally, neither an individual shareholder, nor any group of shareholders, has any right of action in such circumstances. In addition, English law does not afford appraisal rights to dissenting shareholders in the form typically available to shareholders in a U.S. company.

It may not be possible for shareholders outside the UK to enforce any judgments in civil or commercial matters or any judgments in securities laws of countries other than the UK against some or all of the directors or executive officers of Indivior PLC who are resident in the UK or countries other than those in which judgment is made.

For more information, see "*<u>[Item 10.](#i1ad3a9ca197f4e2a8446cfabdce44c91_125958)</u> Additional Information—Differences in Corporate Law between England and the State of Delaware.*"

***We may not pay dividends in the future. Our ability to pay dividends or make other returns of capital in the future depends, among other things, on our financial performance.***

There can be no guarantee that our historical performance will be repeated in the future, particularly given the competitive nature of the industry in which we operate, and our revenue, profit and cash flow may significantly underperform market expectations. If our cash flow underperforms market expectations, then our capacity to pay a dividend or make other returns of capital (including, without limitation, share repurchases) may be negatively impacted. Any decision to declare and pay dividends or to make other returns of capital will be made at the discretion of the Board and will depend on, among other things, applicable law, regulation, restrictions (if any) on the payment of dividends and/or capital returns in our financing arrangements, our financial position, retained earnings/profits, working capital requirements,

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finance costs, general economic conditions and other factors that the Board deems significant from time to time.

We last paid a dividend on our ordinary shares in 2016. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future, including due to limitations that are currently imposed by our credit agreement. Any return to shareholders likely will therefore be limited to the increase in the price of our ordinary shares, if any. Similarly, while we announced a $100 million share repurchase program on July 28, 2021, and an additional $100 million share repurchase program on April 8, 2022, any future repurchase of shares is subject to the discretion of our Board and will depend on similar factors as those that affect decisions to pay dividends. There can be no assurance that the Group will repurchase any additional shares beyond the programs already announced.

***Our business strategy may involve future transactions that may harm the market price of our ordinary shares or require us to seek additional funds, and such funding may not be available on commercially favorable terms or at all and may cause dilution to our existing shareholders. The issuance of additional ordinary shares in connection with future acquisitions, any share incentive or share option plan, or otherwise, may dilute all other shareholdings.***

In order to achieve our business strategy, we regularly review potential transactions related to technologies, products or product rights, and businesses that are complementary to our business, including mergers and acquisitions, licenses and collaborations, and development and supply, commercialization or co-promotion arrangements, among others. We may choose to enter into one or more of these or other transactions at any time, that may cause substantial fluctuations in the market price of our ordinary shares. Moreover, depending upon the nature of any transaction, we may experience a charge to earnings, which could also materially adversely affect our results of operations and could harm the market price of our ordinary shares.

In order to finance such transactions, we may require additional funds, and we may seek such funds through various sources, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets, monetization of royalty streams or other financing methods or structures. In particular, we may, for these and other purposes, issue additional equity or convertible equity securities which would cause our shareholders to suffer dilution to their percentage ownership of the Group, or the market price of our ordinary shares may be adversely affected. The source, timing and availability of any financings will depend on global economic conditions, credit and financial market conditions, interest rates and other factors. If we issue additional equity securities or securities convertible into equity securities, our shareholders will suffer dilution of their investment, and it may adversely affect the market price of our ordinary shares.

In addition, the Companies Act 2006 (of England and Wales) provides that the directors of an England and Wales public limited company may only allot shares (or grant rights to subscribe for or convertible into shares) with the prior authorization of the company's shareholders, such authorization stating the maximum amount of shares that may be allotted under such authorization and specify the date on which such authorization will expire, being not more than five years, each as specified in the articles of association or relevant shareholder resolution. Furthermore, subject to certain limited exceptions, the Companies Act 2006 generally provides that the shareholders of a company have statutory pre-emption rights when new shares in such company are allotted and issued for cash. However, it is possible for such statutory pre-emption right to be disapplied by either the articles of association of the company, or by shareholders passing a special resolution at a general meeting, being a resolution passed by at least 75% of the votes cast. Such a disapplication of statutory pre-emption rights may not be for more than five years from the date of adoption of the articles of association, if the disapplication is contained in the articles of association, or from the date of the special resolution, if the disapplication is by a special resolution. On May 5, 2022, our shareholders authorized our Board to allot additional shares and disapply pre-emption rights in respect of certain additional share issuances, in each case applying until the earlier of (i) the close of business on June 30, 2023; or (ii) the conclusion of Indivior PLC's annual general

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meeting to be held in 2023. If we are unable to obtain renewal of these existing authorities from our shareholders, or are otherwise limited by the terms of new share issuance and/or disapplication of statutory preemption rights authorities approved by our shareholders, our ability to issue additional shares to effect or to fund acquisition or other transaction opportunities, or to otherwise raise capital, could be adversely affected.

In addition, future investors or lenders may demand, and may be granted, rights superior to those of existing shareholders. If we issue additional debt securities, our existing debt service obligations will increase further. If we are unable to generate sufficient cash to meet these obligations and need to use existing cash or liquidate investments in order to fund our debt service obligations or to repay our debt, we may be forced to curtail our operations. We cannot be certain that additional financing will be available from any of these sources when needed or, if available, will be on acceptable terms. If we fail to obtain additional capital when we need it, we may not be able to execute our business strategy successfully and may have to give up rights to our product platforms, and/or products, or grant licenses on terms that may not be favorable to us.

***If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.***

The trading market for our ordinary shares will depend in part on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who cover us downgrade our rating, lower our price target, or publish inaccurate or unfavorable research about our business, our share price could decline. If one or more of these analysts cease coverage of our company or fail to publish reports on our company regularly, demand for our ordinary shares could decrease, which might cause our share price and trading volume to decline.

**<u>Risks Related to Information Security and Data Privacy</u>**

***Business interruptions or breaches of data security could disrupt our product sales and delay the development of our product candidates.***

We are increasingly dependent on information technology systems and infrastructure, including mobile technologies, to operate our business. In the ordinary course of our business, we collect, store and transmit confidential information, including intellectual property, proprietary business information and personal information. It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. While we have implemented processes to collect, store, and transmit such information in a secure manner, there can be no assurance that any measures we take will prevent potential cyber-attacks or security breaches that could adversely affect the confidentiality and integrity of such confidential information.

We also use a number of third-party vendors who have or could have access to our confidential information. The size and complexity of our information technology systems, and those of third-party vendors with whom we contract, make such systems potentially vulnerable to breakdown, malicious intrusion, security breaches, ransomware, and other cyber-attacks, all of which would be costly to remedy. In addition, the use of mobile devices or cloud-based systems that access confidential information increases the risk of data security breaches, which could lead to the loss of confidential information, trade secrets or other proprietary information. Failures of or disruptions to our systems or the systems of third parties on whom we rely, particularly if prolonged, could result in breaches of data security and/or a loss of key data which would adversely affect our reputation, business and results of operations. While we have implemented security measures to protect our data security and information technology systems, such measures may not prevent the adverse effect of such events.

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***We are required to maintain the privacy and security of personal information in compliance with privacy and data protection regulations worldwide. Failure to meet the requirements could result in fines, penalties, or private actions, harm our business and damage our reputation with customers, suppliers, and associates.***

We rely on systems, networks, products, and services, some of which are managed by third-party service providers to protect our information. Increased information security threats, more sophisticated cyber-attacks and a growing base of diversified threat actors continually pose a risk to all systems and data.

Additionally, we collect, store, and process personal information relating to many stakeholders, including our customers, suppliers, and associates. This information is increasingly subject to a variety of U.S. and international laws and regulations, such as the General Data Protection Regulation, as enacted in the European Union, the Data Protection Act in the UK, Canada's Personal Information Protection and Electronic Documents Act, the California Consumer Privacy Act, Virginia's Consumer Data Protection Act, the Colorado Privacy Act, the Connecticut Data Privacy Act, the Utah Consumer Privacy Act, and other emerging privacy and cybersecurity laws internationally, at the federal level in the U.S., and across various U.S. states, that may carry significant potential penalties for noncompliance.

The FTC also sets expectations for failing to take appropriate steps to keep consumers' personal information secure or failing to provide a level of security commensurate to promises made to individuals about the security of their personal information (such as in a privacy notice) may constitute unfair or deceptive acts or practices in violation of Section 5(a) of the Federal Trade Commission Act ("FTC Act"). The FTC expects a company's data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health information is considered sensitive data that merits stronger safeguards. With respect to privacy, the FTC also sets expectations that companies honor the privacy promises made to individuals about how a company handles consumers' personal information; any failure to honor promises, such as the statements made in a privacy policy or on a website, may also constitute unfair or deceptive acts or practices in violation of the FTC Act. While we do not intend to engage in unfair or deceptive acts or practices, the FTC has the power to enforce promises as it interprets them, and events that we cannot fully control, such as data breaches, may result in FTC enforcement. Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.

These data privacy and data protection laws and regulations are typically intended to protect the privacy of personal information that is collected, processed, transmitted, and stored in or from the governing jurisdiction. In many cases, these laws apply not only to third-party transactions, but also to transfers of information between a company and its subsidiaries. While we have invested and continue to invest significant resources to comply with data privacy regulations, many of these regulations are new, complex, and subject to interpretation. Noncompliance with these laws could result in negative publicity, damage to our reputation, penalties, or significant legal liability. We could be adversely affected if legislation or regulations are revised or extended to require changes in our business practices or if governing jurisdictions interpret or implement their legislation or regulations in ways that negatively affect our business. The landscape of federal and state laws regulating personal information is constantly evolving, and compliance with these laws requires a flexible privacy framework and substantial resources, and compliance efforts will likely be an increasing and substantial cost in the future.

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**<u>Risks Related to Our International Status and Operations</u>**

***We are subject to various risks related to the local and international nature of our business, including domestic and foreign laws, regulations, and standards. Failure to comply with such laws and regulations or the occurrence of unforeseen developments such as litigation could adversely affect our business.***

Our business operates in several countries including the U.S., UK, Canada, France, Germany, Italy, and Australia and our products are available in 39 countries worldwide. As a result, we are subject to specific risks of conducting business in different jurisdictions across these countries and other parts of the world. Our business is subject to a wide array of domestic and international laws, regulations and standards in jurisdictions where we operate, including advertising and marketing regulations, anti-bribery and corruption/money laundering laws, anti-competition regulations, data protection (including payment card industry data security standards) and cybersecurity requirements (including protection of information and incident responses), environmental protection laws, foreign exchange controls and cash repatriation restrictions, government business regulations applicable to us as a government contractor or supplier selling to governmental agencies, import and export requirements, intellectual property laws, labor laws, product compliance laws, supplier regulations regarding the sources of supplies or products, tax laws, zoning laws, unclaimed property laws and laws as well as regulations and standards applicable to other commercial matters. In particular, occupational health and safety or consumer product safety regulation may require that we take appropriate corrective action, including but not limited to product recall, in respect of products that we have distributed. Managing a product recall or other corrective action can be expensive and can divert the attention of Management and other personnel for significant time periods. Moreover, we are also subject to audits and inquiries by government agencies in the normal course of business.

Failure to comply with any of these laws, regulations and standards could result in civil, criminal, monetary and non-monetary penalties as well as potential damage to the Group's reputation. Changes in these laws, regulations and standards, or in their interpretation, could increase the cost of doing business, including, among other factors, as a result of increased investments in technology and the development of new operational processes. Furthermore, while we have implemented policies and procedures designed to facilitate compliance with these laws, regulations, and standards, and applicable self-regulatory industry codes by region that the Group has committed to follow, but there can be no assurance that neither we nor our associates, contractors or agents will not violate such laws inadvertently, regulations and standards or our policies. Any product recall or other corrective action may negatively affect customer confidence in the relevant Group member's products and the Group itself, regardless of whether it is successfully implemented. Any such failure to comply or violation could individually or in the aggregate materially adversely affect our business, financial condition, results of operations and cash flows.

***We are exposed to risks related to currency exchange rates.***

We are incorporated in England and Wales but present our financial statements in U.S. dollars. Based on the country where sales originate, we derived 81%, 76% and 70% of our net revenues from the U.S. in 2022, 2021, and 2020, respectively. We also conduct business in the U.K., Europe and Australia, among other places. As a result, our agreements with customers not based in the U.S. often involve payments denominated in currencies other than U.S. dollars, which creates foreign currency translation risk. Our operating results are therefore subject to currency fluctuations in translating revenues and costs from those foreign currencies to U.S. dollars. Additionally, if in the future we expand our sales and operations into new markets, different currencies could expose us to additional currency translation risks. These risks increase with the strengthening of the U.S. dollar.

We currently do not actively, hedge exchange rate fluctuations, although we attempt to balance large non-U.S. dollar liabilities with a similarly sized assets in the same currency. To the extent that we do not hedge our exposure to foreign currency exchange rate fluctuations, or to the extent that such hedging is

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structured ineffectively or does not offset our exposure to exchange rate fluctuations, our business, financial condition, and results of operations could be materially adversely affected.

Exchange rate fluctuations between local currencies and the U.S. dollar also create risk in other ways, including but not limited to: (i) increasing the U.S. dollar cost of non-U.S. research and development expenses and the cost of sourced product components outside the U.S. (in the case of a weakening of the U.S. dollar); (ii) decreasing the value of our revenues denominated in other currencies (in the case of a strengthening of the U.S. dollar); (iii) distorting the value of non-U.S. dollar transactions and cash deposits; and (iv) affecting commercial pricing and profit margins of our products. These effects can have an adverse impact on our results of operations and financial condition and may also make it more difficult for investors to understand the relative strengths or weaknesses of our underlying business on a period-over-period comparative basis.

**<u>Risks Related to Being a Publicly-Traded Company in the U.S.</u>**

***Corporate responsibility, specifically related to environmental, social and governance ("ESG") matters, may impose additional costs and expose us to new risks.***

Comprehensive public ESG (Environmental, Social, Governance) and sustainability reporting is becoming more broadly expected by investors, shareholders and third parties and in many cases becoming mandatory. Certain organizations, including those that provide corporate governance and other corporate risk information to investors and shareholders have developed, and others may in the future develop, scores and ratings to evaluate companies and investment funds based upon ESG or "sustainability" metrics. Moreover, the standards by which ESG matters are measured are developing and evolving, and certain areas are subject to assumptions that could change over time.

Many investment funds focus on positive ESG business practices and sustainability scores when making investments and may consider a company's ESG or sustainability scores as a factor in making an investment decision. In addition, investors, particularly institutional investors, can use these scores to benchmark companies against their peers and if a company is perceived as lagging, may make voting decisions, or take other actions, to hold these corporations and their boards of directors accountable. Board diversity, social issues such as the U.K.'s Equality, Diversity and Inclusion (EDI) factors, and sustainability are ESG topics that are receiving heightened attention from investors, shareholders, lawmakers and listing exchanges, as are claims of corporate greenwashing related to ESG and sustainability communications. Ongoing focus on corporate responsibility matters by investors and other parties as described above may impose additional costs or expose us to new risks.

From time to time, we may announce certain initiatives, including goals, regarding our focus areas, which include environmental matters, responsible sourcing, promoting access to medicines, social investments, and diversity and inclusion. We may face reputational damage in the event our corporate responsibility initiatives or objectives do not meet the standards expected by our investors, shareholders, lawmakers, listing exchanges or other constituencies, if we are unable to achieve an acceptable ESG or sustainability rating from third-party rating services, if we fail or are perceived to have failed in the achievement of our initiatives or goals whether due to changes in our business or otherwise or if we fail to accurately report our progress on such initiatives and goals. A low ESG or sustainability rating by a third-party rating service could also result in the exclusion of our ordinary shares from consideration by certain investors who may elect to invest with our competitors instead.

Any of the above factors could have a material adverse effect on our reputation, business, financial condition, and results of operations. While we monitor a broad range of ESG issues, there can be no certainty that we will manage such issues successfully, or that we will successfully meet the expectations of investors, employees, consumers and other stakeholders.

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***We are a foreign private issuer. Should we no longer qualify as a foreign private issuer in the future, we may incur significant additional expenses. Also, as a foreign private issuer, we are not subject to SEC proxy rules but are subject to Exchange Act reporting obligations that, to some extent, are more lenient and less frequent than those of a domestic U.S. issuer. As a foreign private issuer, we are permitted to follow certain home country corporate governance practices in lieu of certain requirements applicable to domestic U.S. issuers. This may afford less protection to holders of our ordinary shares.***

On June 30, 2022, not more than 50% of our ordinary shares were held by shareholders resident in the U.S. Therefore, we qualify as a "foreign private issuer" (within the meaning of Rule 405 of the Securities Act, as amended (the "Securities Act") and Rule 3b-4 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). We are thus exempt from certain provisions of the Exchange Act that are applicable to U.S. public companies, including: (i) the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act, (ii) the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time and (iii) the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form 8-K, upon the occurrence of specified significant events. Foreign private issuers are required to file their annual report on Form 20-F within 120 days after the end of each fiscal year, while U.S. domestic issuers that are non-accelerated filers are required to file their annual report on Form 10-K within 90 days after the end of each fiscal year. Foreign private issuers are also exempt from Regulation Fair Disclosure, aimed at preventing issuers from making selective disclosures of material information.

In addition, as a foreign private issuer whose shares will be listed on Nasdaq, we are permitted to follow certain home country corporate governance practices in lieu of certain Nasdaq requirements. As a company incorporated in the U.K. and which has a primary listing on the main market of the London Stock Exchange, we may follow our home country's practice with respect to, among other things, the Nasdaq rules requiring shareholders to approve equity compensation plans and material revisions thereto. Unlike the requirements of the Nasdaq, the corporate governance practice and requirements in the UK generally do not require us to obtain shareholder approval for equity compensation plans and material revisions thereto, except under certain restricted circumstances. As a result of the above, shareholders may not have the same protections afforded to shareholders of companies that are not foreign private issuers.

The determination of foreign private issuer status is made annually on the last business day of an issuer's most recently completed second financial quarter. We will also test foreign private issuer status within 30 days before the effectiveness of this registration statement. Accordingly, we will next make a determination with respect to our foreign private issuer status on June 30, 2023.

There is a risk that we could lose our foreign private issuer status if, for example, more than 50% of our issued ordinary share capital is held by U.S. residents. If we lose our foreign private issuer status, we would become subject to the extensive periodic and ongoing disclosure and reporting requirements under the U.S. securities laws that apply to domestic issuers, including preparing consolidated financial statements in accordance with U.S. generally accepted accounting principles (U.S. GAAP, in addition to those prepared in accordance with IFRS as required by the listing rules made by the UK Listing Authority under the UK Financial Services and Markets Act 2000 (as set out in the UK Financial Conduct Authority's Handbook of Rules and Guidance), as amended (the "Listing Rules")), and preparing quarterly financial statements. We would also be subject to the proxy statement requirements under Section 14 of the Exchange Act, and our officers, directors and principal shareholders would be subject to the reporting and "short-swing" profit recovery provisions of Section 16 of the Exchange Act. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer will be significantly greater than the costs incurred as a foreign private issuer. If we are required to report as a domestic issuer, we may incur additional expenses which could have an adverse effect on our results of operations.

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***We will change the financial reporting standards that we apply to our financial statements from IFRS to U.S. generally accepted accounting principles, or "U.S. GAAP" should we no longer qualify as a foreign private issuer ("FPI"), and may voluntarily do so sooner and, as a result, some of our financial data may not be easily comparable to historical financial results.***

Should we lose FPI status, SEC rules will require us to transition from IFRS to U.S. GAAP and we will report our financial statements under U.S. GAAP for periods following our loss of FPI status. We may elect to do so sooner. In connection with this transition, we have invested significant resources and time to convert historical financial statements prepared under IFRS from prior fiscal years into U.S. GAAP financial statements. We have incurred, and expect that we may further incur, significant additional legal, accounting and other expenses in connection with this transition, that may negatively impact our results of operations.

There have been and there may in the future be certain significant differences between U.S. GAAP and IFRS, including differences related to intangible assets, capitalized development costs, acquired in-process research and development costs, lease accounting, and income tax. As a result, our financial information and reported earnings for future periods within a fiscal year or any interim period could be significantly different if they are prepared in accordance with U.S. GAAP. Consequently, if we begin reporting in U.S. GAAP, you may not be able to meaningfully compare our financial statements under U.S. GAAP with our historical financial statements under IFRS.

***Changes in accounting standards and subjective assumptions, estimates and judgments by Management related to complex accounting matters, could significantly affect our financial results or financial condition.***

Accounting standards, including both IFRS and U.S. GAAP, and related accounting pronouncements, implementation guidelines and interpretations with regard to a wide range of matters that are relevant to our business, such as revenue recognition, asset impairment, inventories, lease obligations, self-insurance, tax matters, pensions and litigation, and impairment of goodwill and other intangible assets are complex and involve many subjective assumptions, estimates and judgments. See, for example, "*<u>[Item 5.](#id39cb0e1a10249e1ab7b8f77d921d68a_2388)</u> Operating and Financial Review and Prospects—Critical Accounting Estimates*." Further, these estimates may be more sensitive, particularly regarding assumptions pertaining to the difference between gross revenue and net revenue, than in other industries. Changes in accounting standards or their interpretation or changes in underlying assumptions and estimates or judgments could significantly change our reported or expected financial performance or financial condition.

***The obligations associated with being a public company in the U.S. require significant resources and Management attention, and changing laws, regulations and standards are creating uncertainty for U.S. public companies.***

As a public company in the U.S., we will incur legal, accounting and other expenses that we did not previously incur. We will become subject to the reporting requirements of the Exchange Act and the Sarbanes-Oxley Act of 2002 ("Sarbanes-Oxley Act"), the listing requirements of Nasdaq, and other applicable securities rules and regulations. The Exchange Act requires that we file annual and other reports with respect to our business, financial condition, and results of operations. The Sarbanes-Oxley Act requires, among other things, that we establish and maintain effective internal controls over financial reporting. Furthermore, the establishment and the maintenance of the corporate infrastructure demanded of a U.S. public company may, in certain circumstances, divert Management's attention from implementing our growth strategy, which could prevent us from improving our business, financial condition, and results of operations. We have made, and will continue to make, enhancements to our internal controls and procedures for financial reporting and accounting systems in order to meet our reporting obligations as a public company in the U.S. However, the measures we take may not be sufficient to satisfy these obligations. In addition, compliance with these rules and regulations has increased our legal and financial compliance costs and has made some activities more time-consuming

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and costly. These additional obligations may have a material adverse impact on our business, financial condition, results of operations and cash flow.

In addition, changing laws, regulations and standards relating to corporate governance, ESG matters, and public disclosure are creating uncertainty for public companies in the U.S., increasing legal and financial compliance costs and making some activities more time-consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We have invested, and expect to continue to invest, resources to comply with evolving laws, regulations and standards, and this investment may result in increased operating expenses and a diversion of Management's time and attention from revenue-generating activities to compliance activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us and our business, financial condition, results of operations and cash flow could be adversely affected.

***We have not yet completed our evaluation of our internal control over financial reporting in compliance with Section 404 of the Sarbanes-Oxley Act. If we fail to maintain an effective system of internal control over financial reporting ("ICFR"), or if we identify a material weakness, we may not be able to accurately report our financial results or prevent fraud and, as a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our ordinary shares and may cause other increases in operating costs.***

We will be required to comply with the internal control evaluation and certification requirements of Section 404 of the Sarbanes-Oxley Act by the end of our 2024 fiscal year. We have not yet completed our evaluation as to whether our current ICFR meets the requirements of Section 404. We may not be compliant and may not be able to meet the Section 404 requirements in a timely manner. If it is determined that we are not in compliance with Section 404, we may be required to implement new internal control procedures and re-evaluate our financial reporting. We may also experience higher than anticipated operating expenses during the implementation of these changes and thereafter, should we need to hire additional qualified personnel to help us become compliant with Section 404. If we fail, for any reason, to implement these changes effectively or efficiently, such failure could harm our reputation, operations, financial reporting or financial results and could result in our conclusion that our ICFR is not effective.

If we identify a material weakness in our ICFR, our ability to meet our reporting obligations and the trading price of our ordinary shares could be negatively affected. A material weakness is a deficiency, or a combination of deficiencies, in ICFR, such that a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Accordingly, a material weakness increases the risk that the financial information we report contains material errors. Any system of internal controls, however well-designed and operated, is based in part on certain assumptions and can provide only reasonable, not absolute, assurances that the objectives of the system are met. If we cannot conclude that we have effective internal control over our financial reporting, investors could lose confidence in the reliability of our financial statements, which could lead to a decline in the trading price of our ordinary shares. Failure to comply with reporting requirements could also subject us to sanctions and/or investigations by Nasdaq or the SEC or other regulatory authorities.

If we fail to develop and maintain an effective system of ICFR, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our ordinary shares.

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Effective ICFR is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us, as and when required, conducted in connection with Section 404 of the Sarbanes-Oxley Act, or ("Section 404"), or any subsequent testing by our independent registered public accounting firm, as and when required, may reveal deficiencies in our ICFR that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our ordinary shares.

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**ITEM 4: INFORMATION ON THE COMPANY**

**A.History and Development of the Company**

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders ("SUD") and serious mental illnesses. Through our acquisition of Opiant Pharmaceuticals, we intend to enter the opioid overdose reversal market as well. As a pioneer in developing evidence-based treatments for opioid use disorder ("OUD"), our vision is that the millions of people across the globe suffering from substance use disorders and serious mental illness will have access to evidence-based treatment to change lives. As a leader in addiction, Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease.

Building on its portfolio of leading OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder, and co-morbidities, including schizophrenia.

Headquartered in the U.S. in Richmond, VA, Indivior employs more than 900 individuals globally and its portfolio of products is available in 39 countries worldwide.

Our core products include the following approved treatments:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• SUBLOCADE (buprenorphine extended-release) monthly injection;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• SUBOXONE Film (buprenorphine and naloxone sublingual film);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• SUBOXONE Tablet (buprenorphine and naloxone sublingual tablets); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• SUBUTEX Tablet (buprenorphine sublingual tablets),

all of which are treatments for OUD, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• PERSERIS (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults in the U.S.

Product availability varies across the 39 countries in which Indivior treatments are available, including in terms of dosage form, strength and indication.

The Group operates in the United States and in other selected areas of the World, such as much of Europe, Canada, Australia and through distribution partners in other parts of the World. Our core geographic market (based on the country where the sale originates) is the U.S., which accounted for 81%, 76%, and 71% of net revenues in the years ended December 31, 2022, 2021, 2020, respectively.

Our business was initially developed and managed as a separate division of Reckitt Benckiser Group PLC ("RB" and, together with its subsidiaries, the "RB Group"), a public limited company incorporated under the laws of England and Wales. Indivior PLC was incorporated on September 26, 2014 for the purpose of acquiring the specialty pharmaceutical business unit from RB (the "Demerger"). Following the Demerger, which became effective on December 23, 2014, Indivior PLC has operated as a standalone business.

The treatment of OUD as a therapeutic area emerged in the early 1920s. The U.S. government's efforts to address OUD through supply regulation and control, and to address public health concerns through scientific innovation, influenced a gradual shift in research interest towards developing a treatment for opioid dependence or OUD, as the disorder is presently known.

In 1966, RB led the breakthrough discovery of buprenorphine and developed, in partnership with the U.S. National Institute on Drug Abuse ("NIDA"), buprenorphine for the treatment of opioid dependence. SUBUTEX Tablet (buprenorphine sublingual tablet) was our first approved product specifically indicated

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for the treatment of opioid dependence. SUBUTEX Tablet was launched in the French market in February 1996 by Schering-Plough, which licensed the global marketing rights to the buprenorphine products from RB Group. Shortly thereafter, SUBUTEX Tablet was approved in additional EU countries. SUBOXONE Tablet (buprenorphine/naloxone) sublingual tablet was approved across the EU by the EMA in September 2006.

The enactment of the Drug Addiction and Treatment Act of 2000 ("DATA 2000") was a significant development in the history of addiction treatment in the U.S. Previously, treatment options for opioid dependence were limited: abstinence-based programs that have a high rate of relapse, and methadone clinics (the only medication-assisted treatment option). These clinics provide daily dosing and are unpopular with opioid-dependent individuals owing to inconvenience and the significant societal stigma associated with a full opioid receptor agonist. (A full opioid receptor agonist binds tightly to the opioid receptors and undergoes significant change to produce maximal opioid effect; examples of full agonists in addition to methadone include codeine, fentanyl, heroin, hydrocodone, morphine, and oxycodone.) As a result, many opioid-dependent individuals remained untreated.

Under DATA 2000, office-based physicians who had completed appropriate training were able to obtain a federal waiver to treat a limited number of opioid-dependent patients with medications specifically approved by the FDA for the treatment of opioid dependence, and to prescribe and/or dispense these medications in their office-based settings. By permitting treatment for opioid dependence in the privacy of physicians' offices with take home doses, DATA 2000 was significant in creating access to treatment and beginning to medicalize the condition like other chronic diseases.

On December 29, 2022 Congress enacted the Mainstreaming Addiction Treatment Act (MAT Act) which eliminated the requirement for a health care practitioner (HCP) to apply for a separate waiver through the Drug Enforcement Administration (DEA) to dispense certain treatments (including buprenorphine) for maintenance or detoxification of patients with OUD. Indivior believes the elimination of these requirements as part of this legislation will help to normalize the chronic brain disease of addiction and expand access to evidence-based buprenorphine treatment. The Group supports efforts to encourage more HCPs to provide BMAT.

*Launch of SUBUTEX Tablets, SUBOXONE Tablets, and SUBOXONE Film in the U.S.*

We launched SUBUTEX Tablet (buprenorphine) and SUBOXONE Tablet (buprenorphine/naloxone) in the U.S. in 2003, following FDA approval in October 2002.

Subsequently, in August 2010, the FDA approved SUBOXONE Film (buprenorphine/naloxone) sublingual film, which dissolves quicker than SUBUTEX and SUBOXONE Tablets.

In the U.S. we discontinued the distribution of SUBUTEX Tablets in 2011 and SUBOXONE Tablets in 2013 as generics for these products had and were entering the market.

Our SUBOXONE Film product already faces three generic competitors in the U.S., and a fourth competitor received approval for its product in May 2022 but has not yet launched. We are aware of one competitor that has received FDA approval but is unable to enter the market until 2024, and another with an application pending before the FDA. Despite the launches of these generic formulations of tablets and film and branded competition, SUBOXONE Film has maintained a meaningful share of the buprenorphine-based opioid dependence treatment market (by mg volume) of approximately 19%.

In 2020, the Group's U.S. sales force ceased promoting SUBOXONE Film as part of the Resolution Agreement with the Department of Justice ("DOJ"), discussed below, and ceased all detailing of the product in that year, though it remains available for sale.

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*Launch of SUBLOCADE in U.S.*

SUBLOCADE (buprenorphine extended-release) injection for subcutaneous use was approved by the FDA in 2018 and launched in 2019.

Even with the availability of oral products for the treatment of OUD, SUBLOCADE became the largest product by net revenue for the Group by the second quarter of 2022.

*Launch of Perseris in U.S.*

In 2019, we launched PERSERIS in the U.S. PERSERIS is the first once-monthly subcutaneous extended-release injectable suspension of risperidone, indicated for the treatment of schizophrenia in adults.

*Agreements with DOJ, FTC and OIG-HHS*

In 2020 the Group and certain of its subsidiaries reached agreements with the DOJ, the U.S. Federal Trade Commission ("FTC"), the U.S. Attorney's Office for the Western District of Virginia, and U.S. state attorneys general to resolve criminal and civil liability in connection with an indictment brought in 2019 by a grand jury in the Western District of Virginia, a civil lawsuit joined by the Justice Department in 2018, and an FTC investigation related to alleged charges of healthcare fraud, wire fraud, mail fraud, and conspiracy in connection with marketing and promotional practices related to SUBOXONE Film, and SUBOXONE Tablet. As part of the agreement with the DOJ ("Resolution Agreement"), a wholly-owned subsidiary of Indivior PLC pleaded guilty to a single count of making a false statement relating to healthcare matters in 2012 in violation of 18 U.S.C. Section 1035 related to SUBOXONE Film, and was excluded from participating in government healthcare programs. The exclusion did not pertain to the rest of the Group and did not limit access to our medications for patients in the U.S. Under the terms of the agreements, DOJ dismissed all charges in the 2019 indictment and the Group agreed to make payments to federal and state authorities totaling $600 million (plus applicable interest of 1.25% on a portion of that total amount), of which $200 million has been paid. This indictment followed a federal criminal grand jury investigation that began in 2013. As part of the resolution, the Group and Indivior Inc. also agreed to significant compliance and reporting obligations under the Resolution Agreement with DOJ and a stipulated injunction with the FTC, and Indivior Inc. agreed to a Corporate Integrity Agreement ("CIA") with the Office of Inspector General of the U.S. Department of Health and Human Services ("HHS-OIG"). See (i) "*<u>[Item 3.D.](#i56ef77e8a843490995b8285e91603860_4022085)</u> Risk Factors—*"*Compliance with the terms and conditions of our Corporate Integrity Agreement, the Resolution Agreement with the U.S. Attorney's Office for the Western District of Virginia and the U.S. Department of Justice's Consumer Protection Branch, and the Stipulated Order for Permanent Injunction and Equitable Monetary Relief with the FTC, requires significant resources and Management time and, if we fail to comply, we could be subject to criminal charges, penalties, or, under certain circumstances, excluded from government healthcare programs, which would materially adversely affect our business,*" (ii) *"<u>[Item 18](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u>. Financial Statements—Audited Consolidated Financial Statements—<u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>—Legal Proceedings—DOJ Resolution,"* (iii) "*<u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)[19](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)</u>—Provisions and Other Liabilities,*" and "*<u>[Item 10.C.](#id39cb0e1a10249e1ab7b8f77d921d68a_2560)</u> Material Contracts.*" We have filed copies of the Resolution Agreement, the Corporate Integrity Agreement, and the Stipulated Order for Permanent Injunction and Equitable Monetary Relief between FTC and Indivior Inc. as Exhibits Nos. 4.3, 4.4, and 4.5, respectively, to this Registration Statement. We have and continue to comply with our reporting obligations under each of the agreements and to make investments in our Global Integrity & Compliance Program to promote compliance and drive continuous learning and evolution of an effective compliance program.

*Outside the U.S.*

In Europe, generic versions of the SUBUTEX Tablets have been available since 2010 and SUBOXONE Tablets since 2018. Despite a strong competition, our group's total oral BMAT market share (by mg volume) remained significant currently at 49% in 2022, 50% in 2021, and 54% in 2020. In Canada, our SUBOXONE Tablets product faces two generic competitors. We have seen our market share (by mg volume) of SUBOXONE Tablets eroding overtime, currently at 23% in 2022. In addition, we face

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competition from branded oral buprenorphine-based tablets and historically well-established methadone oral formulations.

We currently distribute SUBLOCADE (called SUBUTEX Prolonged Release in Europe) in Canada, Australia, Sweden and Finland and have special "named patient" programs in Israel, UAE, Qatar and New Zealand. Germany, Italy, Denmark, New Zealand, and Switzerland have approved SUBLOCADE (under the name SUBUTEX Prolonged Release) and we are exploring commercial launch in those countries in the near future. We expect our distributor to launch Perseris in Canada in the second half of 2023.

We distribute SUBOXONE Film in Denmark, Finland, Germany, Italy, Norway, U.K., Sweden, Australia, Canada, Israel, and Malaysia.

We distribute SUBOXONE Tablets in 37 countries in addition to the U.S. including Europe, the U.K., Canada, and Australia, and SUBUTEX Tablets in 18 countries worldwide, primarily in Europe, including France, United Kingdom, Germany, and Italy.

In July 2021, the Group sold the assets of its TEMGESIC franchise (buprenorphine) outside of North America. The Group has certain transition obligations to the purchaser which are expected to be completed over a period of twenty-four months from the date of sale for which the Group is being separately compensated.

**Indivior Global Integrity & Compliance Program**

Indivior has developed and maintained a compliance function and program dating back to before the Demerger from RB Group. It has undergone continuous improvement and enhancement of its capabilities since then, including:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• utilizing external consultants to evaluate and assist with evolution of its Global Integrity & Compliance Program;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• accelerated the build out of its updated Integrity & Compliance team structure, including hiring additional credentialed personnel; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• hired an executive committee level Chief Integrity and Compliance Officer in 2018 who reports directly to the CEO and the Board.

This team now includes more than 20 professionals who have established and support implementation of the defined and communicated "Indivior Global Integrity & Compliance Program Framework" which is based on the elements of an effective compliance program as defined by governing authorities. Our Integrity & Compliance team assesses risk and assists in meeting the obligations under the CIA, the Resolution Agreement, and the FTC Order. It is responsible for administering our Code of Conduct and related healthcare compliance policies, procedures and guidance with integrated controls. In addition, it works to ensure an appropriate tone at the top, develops various integrity and ethics initiatives, including business-led risk monitoring, educates on and integrates relevant risks to help support strong risk monitoring, conducts risk assessments and mitigation, and is responsible for administering the Group's Global Integrity & Compliance Program, together with the executive committee who are the members of the Indivior Compliance Committee.

*Development Pipeline* 

In addition to our commercially available products we have a pipeline of new drug candidates for the treatment of cannabis use disorder ("CUD"), opioid use disorder ("OUD"), and alcohol use disorder ("AUD"). We also acquired pipeline assets as part of our acquisition of Opiant Pharmaceuticals, discussed below.

Our capital expenditures for 2022, 2021, and 2020 were $6 million, $4 million, and $6 million, respectively. These capital expenditures, were primarily for equipment used in the manufacture of our

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products, and were made primarily in the U.S. and U.K. The Group funded these expenditures from its existing cash balances.

Purchase of intangible assets for 2022, 2021, and 2020 were $1 million, $30 million, and $nil, respectively. In 2021, the intangible assets purchase of $30 million reflects a payment made to Aelis Farma for an exclusive option and license agreement to develop its leading compound (AEF0117) targeting cannabis use disorder. This molecule currently is in late-stage phase 2b clinical development in the U.S. The Group funded this asset purchase from its existing cash balances.

*Acquisition of Opiant Pharmaceuticals*

On March 2, 2023, the Company completed its acquisition of Opiant Pharmaceuticals, Inc., a Delaware corporation ("Opiant"). Previously, on November 13, 2022, the Company, Indivior Inc., a Delaware corporation and wholly-owned subsidiary of the Company, and Olive Acquisition Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Indivior Inc. ("Merger Sub"), and Opiant Pharmaceuticals, Inc., a Delaware corporation ("Opiant") entered into an Agreement and Plan of Merger (the "Merger Agreement").

Opiant is a specialty pharmaceutical company developing medicines for addictions and drug overdose. Opiant contributed to the development of NARCAN® (naloxone HCI) Nasal Spray ("NARCAN®"), a treatment to reverse opioid overdose which was approved by the FDA in November 2015. Opiant's longer term pipeline includes medicines in development for alcohol use disorder and acute cannabinoid overdose.

Opiant's lead development product is OPNT003 - Nasal Nalmefene for opioid overdose reversal, was developed in response to the need for stronger, longer-acting formulations of antagonists to counteract the very high potency synthetic opioids that are now claiming thousands of lives each year. Opiant is pursuing a 505(b)(2) development path for OPNT003 and submitted a new drug application with the FDA for the drug and intranasal delivery device combination on November 22, 2022. On January 19, 2023, Opiant announced that the FDA granted OPNT003 a Priority Review designation and had been given a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2023, accelerating the review time from ten months to six months from the date of filing. Further, the U.S. Patent and Trademark Office has issued Patent No. 11,458,091 with formulation and method of use claims around OPNT003 which expires in 2038. We have full commercial rights to OPNT003.

*Merger Agreement*

Pursuant to the Merger Agreement, each issued and outstanding share of Opiant's common stock (an "Opiant Share"), except as provided in the Merger Agreement, was converted into the right to receive (i) $20 per share, net to the holder thereof in cash, without interest thereon for approximate total equity value of $146 million (the "Cash Amount"), plus (ii) one contingent value right (each, a "CVR"), which will represent the right to receive contingent payments of up to $8 per share, net to the holder thereof in cash, without interest thereon, in the aggregate (the "Milestone Payments"), upon the achievement of specified milestones pursuant to the terms of the Contingent Value Rights Agreement as further described under the heading "—CVR Agreement" below, with a maximum amount payable should OPNT003 achieve all milestones of approximately an additional $68 million in the aggregate (the Cash Amount plus one CVR, the "Merger Consideration").

In addition, at the Effective Time, each Opiant equity-based award was canceled in exchange for the Cash Amount (less the exercise price in the case of any stock option) plus one CVR, in each case, multiplied by the number of Opiant Shares underlying such award. In the case of any such award subject to performance-based vesting conditions, the number of Opiant Shares underlying the award will generally be determined based on actual performance for any performance periods that have been completed as of the Effective Time but for the avoidance of doubt treating certain milestones as unachieved and certain as achieved if the deadline for achievement has not passed. Notwithstanding the foregoing, any stock option with an exercise price that is greater than the Cash Amount will instead be

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canceled in exchange for the right to receive cash payments in an amount equal to (1) the excess, if any, of (a) the total amount of the Milestone Payments actually payable in connection with a CVR pursuant to the terms of the CVR Agreement minus (b) the amount by which such exercise price exceeds the Cash Amount multiplied by (2) the number of Opiant Shares underlying such award.

*CVR Agreement*

In connection with the Merger, Indivior Inc. and a rights agent to be selected by Indivior Inc. and Opiant entered into the CVR Agreement governing the terms of the CVRs to be issued pursuant to the Merger. The holders of CVRs will not be permitted to transfer CVRs (subject to certain limited exceptions).

Each CVR represents the obligation of Indivior Inc. to pay the following Milestone Payments, in cash, without interest thereon and less any applicable withholding taxes, payable as specified upon the achievement of the following milestones (each, a "Milestone"):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• During the period beginning with the first commercial sale of OPTN003 (provided that if the first commercial sale occurs less than 45 days prior to the end of a calendar quarter, then the period beginning with the first day of the first calendar quarter immediately following the quarter in which the first commercial sale occurred) and ending on the seventh anniversary of the beginning of such period:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ $2.00 per CVR, upon the first achievement in any four consecutive calendar quarters of worldwide Net Sales (as defined in the CVR Agreement) with respect to OPTN003 exceeding $225,000,000;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ $2.00 per CVR, upon the first achievement in any four consecutive calendar quarters of worldwide Net Sales (as defined in the CVR Agreement) with respect to OPTN003 exceeding $300,000,000;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ $2.00 per CVR, upon the first achievement in any four consecutive calendar quarters of worldwide Net Sales (as defined in the CVR Agreement) with respect to OPTN003 exceeding $325,000,000; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• During the period beginning with the first commercial sale of OPTN003 (provided that if the first commercial sale occurs less than 45 days prior to the end of a calendar quarter, then the period beginning with the first day of the first calendar quarter immediately following the quarter in which the first commercial sale occurred) and ending on the third anniversary of the beginning of such period, $2.00 per CVR, upon the achievement of worldwide Net Sales (as defined in the CVR Agreement) with respect to OPTN003 exceeding $250,000,000.

We estimate total potential payments to be up to an additional $68 million over a period of up to 7 years from the date of the first commercial sales of OPTN003. Until the earlier of (a) the 7<sup>th</sup> anniversary of the closing of the merger and (b) the achievement of U.S. commercial launch, Indivior Inc., shall, and shall cause its affiliates to, use their commercially reasonable efforts to develop and seek FDA approval for OPNT003 and following receipt of approval to achieve U.S. commercial launch. However, there is no requirement that Indivior Inc. or its affiliates undertake any level of efforts, or employ any level of resources, to develop, market or commercialize certain of Opiant's products after U.S. commercial launch. Additionally, neither Indivior Inc. nor its affiliates are required to conduct or commit to conduct, any additional clinical, safety or efficacy studies in connection with obtaining regulatory approvals of OPNT003. The CVR Agreement has been filed as Exhibit 4.21 to this Registration Statement.

*Other Information*

The Group's legal name is Indivior PLC. Indivior PLC is a public limited company incorporated under the laws of England and Wales that was incorporated on September 26, 2014. The principal legislation under which the Group operates is the Companies Act. The registered office address of Indivior PLC is:

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234 Bath Road, Slough, Berkshire, United Kingdom, SL1 4EE and its telephone number is +1 (804) 379-1090. The Group's website is https://www.indivior.com/.

Our ordinary shares are listed on the premium listing segment of the Official List of the UK Financial Conduct Authority (the "Official List") and traded on the Main Market of the London Stock Exchange under the ticker symbol "INDV." We are filing this registration statement on Form 20-F in anticipation of the dual listing of our ordinary shares on Nasdaq Global Select Market under the ticker symbol "INDV."

There has been no public takeover offer as of the date of this registration statement by third parties in respect of the Group's shares or by the Group in respect of other companies' shares which have occurred during the last and current financial year, other than in respect of acquisitions by the Group in the ordinary course pursuant to its business strategy.

Upon the effectiveness of this registration statement, the Group will become subject to the information requirements of the Exchange Act, except that as a foreign private issuer, the Group will not be subject to the proxy rules or the short-swing profit disclosure rules of the Exchange Act. In accordance with these statutory requirements, the Group will file or furnish reports and other information with the SEC. The SEC maintains an Internet website that contains reports and other information about issuers that file electronically with the SEC. The address of that website is www.sec.gov.

We make our electronic filings with the SEC available at no cost on the Group's Investor Relations website, <u>www.Indivior.com/en/Investors</u>, as soon as reasonably practicable after we file such material with, or furnish it to, the SEC.

**B.Business Overview** 

**1. Industry overview**

***Substance use and its impact***

According to the United Nations Office on Drugs and Crime World Drug Report 2022, an estimated 269 million people worldwide had used drugs at least once in the previous year, representing nearly 1 in every 19 people.

People who use drugs regularly are likely to experience negative health consequences. They are also more at risk of contracting infectious diseases such as HIV and hepatitis C, and to experience overdose and suffer from premature death. Furthermore, an association exists between SUD and co-occurring or comorbid mental health disorders (for example, depression, anxiety or psychosis). There is also an association between SUD and socioeconomic disadvantage, low educational attainment, increased difficulty in finding and remaining in employment, and financial instability and poverty.

Globally, drug use killed almost half a million people in 2019, while SUD resulted in 18 million years of healthy life lost, mostly due to opioids.

The threat SUD poses to global health has long been recognized, and as such strengthening the prevention and treatment is included in the United Nation's Sustainable Development Goals for 2030.

Overdose deaths continue to climb in the United States. According to the U.S. Center for Disease Control & Prevention (CDC), more than 107,477 people are predicted to have died from drug overdose in the 12-month period ending August 2022, with 73,102 of these deaths attributed to opioids. The majority of opioid-related overdose deaths in the U.S. are the result of synthetic opioids (mainly fentanyl and illicit fentanyl analogs) that are more potent than heroin and that can unexpectedly cause respiratory depression by being ingested as a substitute for heroin or with drugs such as prescription opioids, cocaine, methamphetamine or nonopioids with sedative or hypnotic properties (e.g., benzodiazepines, gabapentin, and xylazine).

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During the COVID-19 pandemic, signs that health harms caused by drug use have increased, taking different forms across countries. The U.S. has experienced a marked increase in drug overdoses. According to the latest provisional data released by the U.S. Centers for Disease Control (CDC), more than 103,000 people reportedly died from a drug overdose in the 12-month period ending April 2022, and 69,000 of these deaths resulted from illicit opioids, like fentanyl. This reflects an increase of 34% over the period ending April 2021.

***Substance use disorder ("SUD"): the disease***

Substance Use Disorder ("SUD") has been described as a "medical disorder that affects the brain and changes behavior." Various substances may be involved including alcohol, illicit drugs, prescription medications, and even some over-the-counter medicines.

The National Institute on Drug Abuse ("NIDA"), the Substance Abuse and Mental Health Services Administration ("SAMHSA") "and the National Institutes of Health ("NIH") all describe SUD as a long-term and relapsing condition characterized by the individual compulsively seeking and using drugs despite adverse consequences.

Since SUD is marked by periods of recovery and symptom recurrence, or relapse, it resembles other chronic diseases like hypertension and type-2 diabetes. These diseases are lifelong conditions that require continual effort to manage. Symptoms will likely return during periods where treatment compliance is low or absent, and symptoms will likely diminish when compliance to treatment begins again in earnest.

In 2020, 40.3 million people aged 12 and older globally had a SUD, and 28.3 million persons had an alcohol use disorder, representing the largest population of people suffering from SUD.

There is no single cause of SUD; people begin using substances for many reasons and one person's path to addiction may look drastically different from that of another. The prevailing view is that no one thing can predict someone's risk of developing a SUD—rather, the interaction of the person's unique biology and environment both influence how the drug will impact a person's susceptibility to becoming addicted.

***Opioid use disorder ("OUD")***

Opioids are a major concern in many countries because of the severe health consequences associated with their use, including non-fatal and fatal overdose.

OUD is a growing global public health crisis which still carries the "disease stigma" in many countries. OUD can be perceived as a moral failing and sign of personal weakness rather than a chronic and relapsing disease affecting the brain that can be managed and respond to treatment. As a consequence, we believe coherent action to deal with sufferers and addiction is generally lacking.

According to the United Nation's World Drug Report 2022, approximately 61.3 million people used opioids for non-medical purposes in 2020, corresponding to 1.2% of the global population, and the number of users worldwide has nearly doubled over the past decade. In the U.S., in 2020, an estimated 9.5 million people used opioids non-medically in the past year. Of these, more than 900,000 used heroin.

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In addition, the number of deaths from opioid overdose in the U.S. continues to increase, and the rate of increase may have accelerated since the beginning of the pandemic.

![picture110032022a.jpg](picture110032022a.jpg)

The majority of opioid-related overdose deaths in the U.S. are now the result of fentanyl being ingested as a substitute for heroin or with drugs such as cocaine and methamphetamine that had been adulterated, or "cut," with the opioid. Fentanyl is 30 to 50 times more potent than heroin and can unexpectedly cause respiratory depression. Individuals may not be aware that they have been exposed to fentanyl-laced drugs including heroin, prescription opioids, or psychostimulants.

Against the context of the concerning and dramatic rise in deaths from opioid overdose, Indivior is doing more to understand the interaction between fentanyl and buprenorphine. According to a peer-reviewed study conducted by the University of Leiden in Leiden, Netherlands and completed in 2019, sustained high-plasma concentrations of buprenorphine (similar to those provided by SUBLOCADE at steady-state) significantly reduced fentanyl-induced respiratory depression in opioid-tolerant participants.

The European market is smaller than the U.S. market with an estimated 1 million opioid-dependent individuals, the majority of whom are heroin users. The European market is relatively mature with numbers of patients in treatment being largely stable over the last five years. There are currently approximately 514,000 patients in treatment, but there is also an emerging patient population of opioid analgesic-dependent patients who are currently under-diagnosed. Initial estimates, which we believe are conservative, suggest that in 2017 there were potentially approximately 2 million individuals dependent on prescription opioid analgesics in the United Kingdom, France, Germany, Spain, Italy, Sweden, Finland, Canada, Israel, and Australia.

According to the Australian Institute of Health and Welfare, approximately 48,000 patients are treated annually for opioid dependence in Australia. There is increasing awareness among healthcare providers in Australia of the misuse of opioid analgesics and the need for treatment. Recent policy changes to address this concern in Australia include re-classifying products containing Codeine® so that they must be dispensed by a pharmacist rather than over the counter.

Similarly, according to the Canadian Centre on Substance Use and Addiction, approximately 9.6% of Canadian adults who used opioid medications, or 351,000 persons, reported problematic use, and approximately 153,000 are in treatment according to data from IQVIA. Outside of the U.S., Canada, and Australia, approximately 269 million people aged 15 to 64 suffer from drug use disorders or drug dependence, according to the UNODC. Treatment services are generally very underdeveloped (with the exception of Australia and New Zealand), the key challenge being to convince governments to treat addiction as a chronic medical disease rather than a social disorder.

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***Treatment for Opioid Use Disorder***

Medication for opioid use disorder ("MOUD") is the use of medications, in combination with counseling and behavioral therapies, to provide a "whole-patient" approach to the treatment of substance use disorders. Medications used in MOUD are approved by the FDA and MOUD programs are clinically driven and tailored to meet each patient's needs.

Research shows that a combination of medication and psychosocial support can successfully treat these disorders, and for some people struggling with addiction, MOUD can help sustain recovery. MOUD is also used to prevent or reduce opioid overdose.

MOUD is primarily used for the treatment of addiction to opioids such as heroin and prescription pain relievers that contain opiates. The prescribed medication operates to normalize brain chemistry, block the euphoric effects of alcohol and opioids, relieve physiological cravings, and normalize body functions without the negative and euphoric effects of the substance. MOUD has been shown to be more effective than medication or counseling alone in treating OUD.

A common misconception about MOUD is that some of the medicines used simply substitute one drug for another. However, these medications may restore healthy brain function, which leads to improvements in behaviors associated with addiction. Longer-term use of these medications is associated with improved outcomes.

Treatment methods in the EU differ from the U.S. While U.S. patients can obtain a 30-day prescription and self-administer treatment, such as SUBOXONE Film, prescribed by a treating physician, supervised dosing in the EU requires a daily visit to the clinic for many patients. Methadone and generics are also generally more broadly available as social funding puts pressure on prices, and treatment is more highly regulated. However, the harm reduction mindset is now changing towards recovery and the EU has begun to recognize the need to implement treatment systems that allow patients to return to a more normal lifestyle.

***Treatment access***

Despite the prevalence of SUD, including opioid misuse, and the existence of effective treatments, including medication for opioid use disorder, most people who need treatment do not seek or receive it. Figures show that only 20% of people with OUD in the U.S. are being treated for it.

People in urgent need of treatment are often unaware of their treatment options, have limited access to treatment and counseling, or simply do not seek it out because they are afraid of being stigmatized. In addition, there are numerous legal restrictions for pharmacological treatment, and inadequate training of clinicians which further limits access.

***Focus on the Criminal Justice System***

In the U.S., a substantial share of persons suffering from OUD cycle repeatedly through the criminal justice system, with the rate of individuals suffering from OUD in jails and prisons estimated at one in six. Further, persons exiting the criminal justice system have been shown to be 40 times more likely to suffer from opioid overdose than persons in the general population.

While as recently as 2019 medication-assisted treatment ("MAT") was rarely available to patients in criminal justice settings, treatment is increasingly available. The shift has been spurred by research findings and pronouncements from industry and professional medical societies that MAT in correctional settings saves lives, which in turn has shaped changes in law and policy. Treatment for OUD in correction settings has been shown to reduce overdose deaths by 75%, reduce recidivism by 32%, and reduce transmission of HIV and hepatitis. Congress is considering legislation authorizing Medicaid coverage of persons in correctional settings up to 30 days pre-release. The DOJ issued guidance in April 2022 underscoring the rights of persons with OUD to treatment under the Americans with Disabilities Act,

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including in correctional settings. States have begun to expand treatment availability in criminal justice settings. For example, the state of New York enacted landmark legislation in 2021 mandating MAT be made available to patients with OUD in the state's prisons and jails.

***Other industry areas***

In addition to opioid dependence treatments, we have a pipeline of new drug candidates for the treatment of cannabis use disorder ("CUD") and alcohol use disorder ("AUD"), as well as new drug candidates for opioid overdose reversal, alcohol use disorder, and acute cannabinoid overdose, "See "Long-term pipeline products," below.

***Cannabis Use Disorder***

Worldwide, an estimated 209 million individuals used cannabis in 2020, corresponding to more than 4.0% of the global population aged 15–64, According to the United Nation's World Drug Report 2022. The annual prevalence of the use of cannabis remains highest in North America (14.5%), the subregion of Australia and New Zealand (12.1%), and West and Central Africa (9.4%). In the last decade, the number of cannabis users worldwide has increased by nearly 18%.

In 2021, more than 49.6 million people aged 12 or older in the U.S. used cannabis in the prior year according to Substance Abuse and Mental Health Services Administration. According to the same source, cannabis was the most popular illicit drug used in the U.S. by a wide margin.

The most recent Global Burden of Disease study published by The Lancet, which included 195 countries over the 1990-2016 period estimated that 22.1 million people met the diagnostic criteria for CUD (289.7 cases per 100,000 people). Cannabis is the most commonly used substance of abuse in the U.S. after alcohol and tobacco. Nearly 50 million people used marijuana in the U.S. in 2020 and 14.2 million people in the U.S. had a CUD during the same period.

Cannabis remains the most widely used drug worldwide. The increase in cannabis users goes in parallel with a long-term trend of increase of THC (tetrahydrocannabinol, the principal psychoactive ingredient) concentrations in seized cannabis in Europe and the U.S. In the states that have legalized cannabis in the U.S. (cannabis is legal for adult's recreational use in 19 states and Washington, D.C. and for medical use in 38 states and Washington, D.C.), there has been a diversification of cannabis products, different methods of use and changes in the potency of THC content in the available products.

A common assumption about the risk for CUD among users is that it is rare. However, recent U.S. data suggests that 3 out of 10 cannabis users eventually developed CUD (as defined in the DSM-IV). The risk of progression from cannabis use to CUD also increases with frequency of use. In the U.S., adults with CUD, on average, use cannabis 6.2 out of 10 days over a year. About 1 in 19 (9.7%) non-dependent weekly cannabis users progressed to dependence within a year.

***Alcohol Use Disorder***

Harmful use of alcohol contributed to approximately 30 million deaths worldwide in 2016, according to the WHO.

An estimated 5.1% of the global burden of disease is attributable to alcohol consumption. Alcohol is also associated with significant societal costs, including those related to violence, child neglect and abuse, and absenteeism in the workplace. Therapeutic approaches, including pharmacotherapy, play a pivotal role in treating patients with alcohol use disorders but are commonly underutilized.

According to the United Nations, in 2020, approximately 108 million people suffered from alcohol use disorder.

According to data from the WHO, worldwide, an estimated 2.3 million individuals used alcohol in 2016, corresponding to 42.9% of the global population aged 15 and older. Approximately 13.9% of

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persons aged 15 and older in the U.S. suffer from alcohol use disorder*.* More than 60% of persons with AUD self-report that their alcohol consumption increased since the beginning of the COVID-19 pandemic, while less than 13% report that their alcohol consumption has decreased.

***Schizophrenia***

Schizophrenia is a mental disorder characterized by continuous or relapsing episodes of psychosis, an abnormal condition of the mind that results in difficulties determining what is real and what is not real. Major symptoms include hallucinations (typically hearing voices), delusions, and disorganized thinking. Other symptoms include social withdrawal, decreased emotional expression, and apathy.

Schizophrenia affects an estimated 2.1 million people in the U.S., according to the National Institute of Mental Health. Adherence is a major problem leading to relapse and often hospitalization. Between 20-40% of schizophrenia patients attempt suicide, between 5-13% actually die of suicide, and 41.7% of patients who suffer from schizophrenia have a substance use disorder comorbidity. Schizophrenia is responsible for an annual $62 billion in direct healthcare costs in the U.S., according to the Schizophrenia & Psychosis Action Alliance.

The patient journey for someone with schizophrenia is not easy. The symptoms of schizophrenia itself can impair a person's ability to understand or perceive their own illness, which is one key reason why people with schizophrenia stop taking their medication.

Epidemiological and clinical studies have shown that psychiatric disorders like schizophrenia, but also including borderline and antisocial personality disorders, bipolar, depression and anxiety disorders are highly co-morbid with substance use disorders, a condition referred to as "dual" or "co-occurring" disorders. The presence of co-occurring conditions increases severity and complicates recovery from addiction, and a natural outgrowth of increased severity is to recognize a multidisciplinary and holistic approach to the treatment of patients suffering from substance use disorders.

Schizophrenia requires ongoing treatment to manage symptoms and prevent relapse. Treatments include antipsychotic medications and supportive psychosocial treatment. Anti-psychotic medicines have a large and established market with an estimated 70 million prescriptions and over $20 billion in U.S. gross sales in the recent 12 months ending October 2022, according to data from IQVIA and Symphony Healthcare. Long-acting injectable ("LAI") antipsychotics were prescribed more than 2.1 million times and make up annual sales of approximately $8.1 billion in gross sales in the U.S., and are growing robustly at a compound annual growth rate of approximately 14% over the past five years, according to the same sources. Treatment of schizophrenia drives a majority of LAI prescriptions, and risperidone is one of the most commonly used antipsychotic used to treat schizophrenia.

We began marketing PERSERIS, (risperidone) extended-release injectable suspension in the U.S. in 2019, and expect to begin selling in Canada through a distributor in the second half of 2023. This product is an extended-release monthly formulation of risperidone, one of the most widely prescribed drug for the treatment of schizophrenia, according to data from Symphony Healthcare.

***Opioid Overdose Reversal***

The Group plans to enter the opioid overdose reversal market with its acquisition of Opiant Pharmaceuticals, which it completed on March 2, 2023.

There is a large and growing addressable market for opioid overdose reversal agents driven by sales into community-based and first responder institutions, as well as directly to patients via pharmacies. The current addressable market is substantial, to ensure an opioid overdose reversal agent is available for all first responders, including fire departments, emergency medical services, federal law enforcement, local law enforcement, and other community groups. The co-prescribing of opioid overdose reversal agents alongside prescription opioids has also driven growth. It is estimated that only five percent of patients at higher risk of an opioid overdose have a naloxone prescription. Currently there are only thirteen states

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that have some form of mandatory co-prescription legislation in place; however, several states are considering co-prescribing legislation in the near future.

Synthetic opioids such as fentanyl and its derivatives are particularly dangerous because of a long half-life of seven to ten hours that may require continuous monitoring of overdose victims and repeated dosing with naloxone to initially resuscitate a patient and to prevent relapse. A long-acting opioid overdose reversal drug may reduce this burden.

The Group, through its wholly-owned subsidiary Opiant Pharmaceuticals, is developing OPNT003 (nasal nalmefene) for opioid overdose reversal. Refer to "Long-Term Pipeline," below.

**Products of the Indivior Group**

Our core marketed products are described below:

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| | | | | |
|:---|:---|:---|:---|:---|
| **Product** | **Active**<br>**Ingredients** | **Delivery**<br>**Method** | **Main**<br>**Markets** | **2022 Global**<br>**Net Sales**<br>*(in millions)* |
| *<u>Opioid Use Disorder</u>* |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;**Long-Acting Injectable**  |  |  |  | $408.0 |
| SUBLOCADE and SUBUTEX PRO extended-release Injectable | Buprenorphine | Extended-release injectable suspension | U.S., Australia, Canada, Israel, Finland, and Sweden.<br>Approved in Germany, Italy, Denmark, New Zealand. |  |
| &nbsp;&nbsp;&nbsp;&nbsp;**Sublingual** |  |  |  | $465.0 |
| SUBOXONE Film | Buprenorphine and Naloxone | Sublingual film that adheres under the tongue or on the inside of the cheek for direct absorption into the bloodstream | U.S., Canada, all 27 EU Member States (plus UK, Iceland, Norway, Sweden, Finland, Denmark, and Lichtenstein), Australia, New Zealand, Qatar, UAE, and Malaysia |  |
| SUBUTEX Tablet | Buprenorphine | Sublingual tablet that is placed under the tongue to dissolve | 18 countries worldwide, primarily in Europe, including France, United Kingdom, Germany, and Italy |  |
| SUBOXONE Tablet | Buprenorphine and Naloxone | Sublingual tablet that is placed under the tongue to dissolve | 37 countries worldwide |  |
| *<u>Schizophrenia</u>* |  |  |  |  |
| PERSERIS extended-release Injectable | Risperidone | Extended-release injectable suspension | U.S. | $28.0 |

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***SUBLOCADE Long-acting injectable (buprenorphine) extended-release injection***

As the first long-acting buprenorphine-based injectable approved by the U.S. Food and Drug Administration ("FDA") for the treatment of moderate to severe OUD, SUBLOCADE is a highly differentiated treatment. Our RECOVER extension study, which was a 24-month observational study of individuals who participated in the Phase 3 SUBLOCADE study, assessed life changes in patients with OUD who received SUBLOCADE as part of a randomized clinical efficacy study. It has shown that SUBLOCADE may translate into (1) increased abstinence from illicit opioids compared to placebo; (2)

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improved patient-reported quality-of-life outcomes (such as health status, employment and insurance status, and healthcare resource utilization); and (3) improved recovery post-treatment. Administration of monthly subcutaneous injections of SUBLOCADE also eliminates the risk of missing daily doses that might result in subtherapeutic plasma levels (see below), potentially leading to relapse to opioid-seeking and opioid-taking behaviors. Finally, because SUBLOCADE may only be administered by a healthcare practitioner via a closed distribution system whereby the patient never has access to the drug, it is expected to reduce the potential for diversion or misuse.

The logic that underpins this technology lies in a deep understanding of the relationship between buprenorphine plasma levels, whole-brain mu-opioid receptor occupancy (MOR) in the brain, and the key clinical pharmacodynamic effects of withdrawal suppression and opioid blockade. Clinical studies confirmed that the minimum threshold plasma concentration of buprenorphine needed to effectively block the subjective drug-liking effects of a full opioid agonist such as hydromorphone is 2 ng/mL, which translated into at least 70% MOR occupancy in the brain for the entire 1-month period. These unique pharmacokinetic and pharmacodynamic properties of SUBLOCADE also translated into clinical efficacy and safety and better patient outcomes.

The expected benefits of these levels of receptor occupancy/opioid blockade are that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Patients would likely experience substantially reduced levels of cravings associated with addiction;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Patients should receive no gratification from abuse of opioids;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Levels of adherence and compliance with treatment should be significantly improved because it is administered once monthly and late administration of up to 14 days is not expected to affect clinical efficacy;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• It is designed to protect patients right from the start of treatment, through every day of the month, including moments of vulnerability;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• For physicians, there should be positive clinical and patient outcomes using this technology;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• For physicians and wider society, there should be reduced levels of potential diversion and abuse compared to sublingual buprenorphine—once injected, the buprenorphine cannot easily be extracted and diverted; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• For payors, the benefit should come in reduced costs from higher compliance, better clinical outcomes and reduced abuse and diversion.

We currently distribute SUBLOCADE in the U.S., Australia, Canada, and Israel. Germany, Italy, Sweden, Finland, Denmark, New Zealand, and Switzerland have also approved and we are making plans for commercial launch in those countries. We market SUBLOCADE under the name SUBUTEX PRO in Europe.

***SUBOXONE Film (buprenorphine and naloxone) sublingual film***

SUBOXONE Film was initially launched in the U.S. in 2010 and is currently sold in the U.S. and more than 30 other countries. It is one of only four products currently approved by the FDA for the treatment of opioid dependence pursuant to DATA 2000 in both the induction and maintenance phases of treatment (although several are approved for "treatment of opioid dependence"). SUBOXONE Film was developed as an alternative to the sublingual tablet.

SUBOXONE Film was developed through an exclusive agreement with Aquestive (formerly known as Monosol), utilizing its proprietary technology, to deliver SUBOXONE Film in a fast-dissolving sublingual film.

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SUBOXONE Film containing 2mg buprenorphine and 0.5mg naloxone, and 8mg buprenorphine and 2mg naloxone, was first approved for the maintenance treatment of opioid dependence in the U.S. in August 2010, in Australia in December 2010 and in Malaysia in July 2013. Additional dosage strengths of SUBOXONE Film containing 4mg buprenorphine and 1mg naloxone, and 12mg buprenorphine and 3mg naloxone, were subsequently approved in the U.S. in August 2012 and in Australia in May 2014. SUBOXONE Film was also approved in the U.S. in April 2014 for use in the induction phase of buprenorphine-based treatment of opioid dependence. In addition, on September 22, 2021 the FDA approved the buccal route of administration for SUBOXONE Sublingual Film. Patients may now choose either under-the-tongue (sublingual) or against the cheek (buccal) administration.

The Group's U.S. sales force ceased promoting SUBOXONE Film as required by the Resolution Agreement with the DOJ and ceased all detailing of the product in that year, though it remains available for sale. For more information, see "<u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>—Legal Proceedings—DOJ Resolution" and "<u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)[19](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)</u>—Provisions and Other Liabilities" of "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements*" and "*<u>[Item 10.C.](#id39cb0e1a10249e1ab7b8f77d921d68a_2560)</u> Material Contracts*."

Historically, SUBOXONE Film was our highest revenue product, and it together with other oral buprenorphine products remain significant sources of revenue for us.

***SUBOXONE Tablet (buprenorphine and naloxone) sublingual tablet***

SUBOXONE Tablet is a fixed-dose combination of buprenorphine and naloxone in the ratio of four parts buprenorphine to one part naloxone. SUBOXONE Tablet was designed to discourage intravenous abuse of the tablet formulation in patients dependent on full opioid agonists (e.g., heroin and morphine). Naloxone is a potent antagonist at opioid receptors.

SUBOXONE Tablet containing 2mg buprenorphine and 0.5mg naloxone, and 8mg buprenorphine and 2mg naloxone, was approved in the U.S. by the FDA in October 2002 as an orphan drug for maintenance treatment of opioid dependence.

SUBOXONE Tablet is approved in 37 countries worldwide. We discontinued distribution of SUBOXONE Tablet in the U.S. market in March 2013.

***SUBUTEX Tablet (buprenorphine) sublingual tablet***

SUBUTEX Tablet containing 0.4mg, 2mg, and 8mg buprenorphine was first approved for the treatment of opioid dependence in France in July 1995 and was launched in the French market in February 1996. 2mg and 8mg tablets were subsequently approved in the U.S. and launched in April 2003, but were discontinued from sale in the U.S. market in September 2011. We currently distribute SUBUTEX tablets in 18 mostly European countries, but not in the U.S.

***PERSERIS Long-acting injectable (risperidone) extended-release injection***

PERSERIS (risperidone extended-release) is a novel sustained-release formulation of risperidone administered once every 28 days for the treatment of schizophrenia. PERSERIS consists of a two-syringe system, whose contents are mixed immediately prior to administration. One syringe contains the delivery system, and the other contains the sterile drug substance risperidone.

We received FDA approval for PERSERIS in 90mg and 120mg doses in 2018 and launched PERSERIS in the U.S. in 2019. In addition, PERSERIS was approved in Canada through our exclusive partnership with a Canadian distributor in November, 2020. We expect our Canadian distributor to begin distributing PERSERIS in Canada in the second half of 2023.

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**Competition**

We operate in a highly competitive industry. While we seek patent and trademark protection where appropriate, several of our branded products face competition from generic products in key markets as well as competition from alternative products and treatments.

For example, SUBLOCADE is patent protected in the U.S., Australia, Canada, UK, Ireland, France, Germany, Italy, Spain, Denmark, Finland, Norway, the Netherlands, Switzerland, and Sweden, Israel, Japan, Mexico and New Zealand. However, Camurus, in partnership with Braeburn, has sought FDA approval of its long-acting injectable buprenorphine product in the U.S. and, based on their efforts to date, we expect their product to become available for sale in the U.S. Outside the U.S., this product enjoys first mover advantage in all countries except Canada. It is well established in the Nordics (Norway, Sweden, Finland, and Denmark) and Australia, and available in other parts of Europe.

Our SUBOXONE Film product already faces three generic competitors in the U.S., and a fourth competitor received approval for its product in May 2022 but has not yet launched. We are aware of one competitor that has received FDA approval but is unable to enter the market until 2024, and another with an application pending before the FDA. We have seen our market shares of film decline from greater than 50% in 2018 to slightly less than 19%, and expect further declines if other competing products become available or if existing participants choose to disrupt the market in line with industry analogs. We no longer promote SUBOXONE Film in the U.S. as discussed above.

In contrast, no generic competition is present in Australia. In Europe and Canada, we have recently launched SUBOXONE Film and it enjoys patent protection until 2030.

Our SUBOXONE Film and SUBOXONE and SUBUTEX Tablets face generic competition in most markets. In Europe, generic versions of the SUBUTEX Tablets have been available since 2010 and SUBOXONE Tablets since 2018. In addition, we face competition from branded oral buprenorphine-based tablets and historically well-established methadone oral formulations. Despite a strong competition, our group's total oral BMAT market share (by mg volume) remained significant at currently at 49% in 2022, 50% in 2021, and 54% in 2020. In Canada, our SUBOXONE Tablets product faces two generic competitors. We have seen our market share (by mg volume) of SUBOXONE Tablets eroding overtime, currently at 23% in 2022. Further, our SUBOXONE Film and SUBOXONE and SUBUTEX Tablets face competition from branded oral buprenorphine-based tablets and historically well-established methadone oral formulations.

In Canada, our SUBOXONE Tablets product faces two generic competitors. We have seen our market share (by mg volume) of SUBOXONE Tablets eroding overtime, currently at 23% in 2022.

We launched our PERSERIS long acting injectable for the treatment of schizophrenia in the U.S. in February 2019. While it enjoys patent protection, PERSERIS faces competition from other long-acting injectables, including existing products from competitors such as Johnson and Johnson, Otsuka, and Alkermes, as well as potential future entrants, in addition to a heavily genericized oral market.

The introduction of generic or branded products that compete with the Group's products or heightened competition amongst existing participants could impact both the market share of the Indivior Group's products and pricing and, therefore, adversely impact its results of operations. The introduction of generic products typically leads to a loss of sales of a branded product and/or a decrease in the price at which branded products can be sold. In addition, legislation enacted in the U.S. and several EU countries allows for, and in a few instances in the absence of specific instructions from the prescribing physician, mandates the dispensing of generic products rather than branded products where a generic version is available.

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**Research and Development** 

We invest in research and development to create innovative medications and services that address the needs of patients with the complex chronic condition of SUD. These efforts include the development of new medications that are designed to minimize diversion and misuse, increase compliance with treatment, support public health, improve patient outcomes and expand access to treatment for areas of SUD where no pharmacotherapy is currently available.

Chronic addictive behaviors are characterized by compulsive drug and alcohol use, loss of control over drug-seeking and drug-taking, and an intense drive to take the drug at the expense of other behaviors, with little regard for subsequent consequences. From a psychiatric perspective, SUD has aspects of both impulse control disorders and compulsive disorders. In addictive and compulsive disorders, which have prominent motivational drivers, dysfunction in the brain's cortical regions significantly affects cognitive regulatory processes such that the individual fails to inhibit self-defeating urges or desires appropriately. This failure to resist repetitive, maladaptive behaviors is a key clinical feature of SUD, and aspects of decision-making are compromised either directly (i.e., a dysfunctional inhibitory system) or indirectly (i.e., a dysfunctional reward system).

Indivior has a long history of supporting the SUD treatment community: it discovered buprenorphine in 1966 and has been involved in manufacturing and supplying buprenorphine to patients as a treatment for OUD. Indivior has built a portfolio of treatments for OUD and a pipeline of new molecules to address other chronic conditions and co-occurring disorders of SUD. Indivior launched the first buprenorphine-based medication for the treatment of OUD in France in 1996. The Group's medications are now available in 39 countries and include buprenorphine sublingual tablets (SUBUTEX), buprenorphine and naloxone sublingual tablets (SUBOXONE), buprenorphine and naloxone sublingual film (SUBOXONE Film), and the first FDA-approved once-monthly injectable buprenorphine formulation (SUBLOCADE). All along, Indivior has invested in education programs on evidence-based treatment models that have helped change modern addiction medicine and transform the perception of SUD from a global human crisis to a chronic disease that should be recognized and treated. Indivior also launched the first FDA-approved once-monthly injectable risperidone formulation (PERSERIS) for the treatment of schizophrenia.

Our research and development team is led by our Chief Scientific Officer, Dr. Christian Heidbreder, a leading authority on the development of SUD treatments, and consists of approximately 100 persons distributed across the following sub-functions:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Global Chemistry, Manufacturing, and Controls ("CMC")** includes capabilities spanning formulation development, analytical development, chemical development, process development, and technology transfer. Indivior CMC facilities based in Hull (United Kingdom) and Fort Collins (Colorado, USA) are equipped with cutting-edge technologies including pilot plant storage, formulation laboratories, analytical laboratories, chemistry laboratories, stability chambers, office spaces, and support spaces. These facilities are also built to environmental and energy-saving standards, including the installation of a solar panel farm to increase use of renewable energy.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Global Medicines Development** encompasses all required functions to support clinical and nonclinical development, from early to late stage clinical development including pivotal Phase 3 trials and post-marketing commitment and requirement studies: (1) medical, scientific writing, publications and communication; (2) clinical development and operations; (3) data and statistical sciences; (4) clinical pharmacology and nonclinical sciences; (5) epidemiology, health economics and outcomes research; (6) clinical, medical and safety compliance, and (7) drug discovery and translational medicine.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Global Regulatory Affairs** focuses on (1) regulatory strategy; (2) regulatory CMC and compliance; (3) regulatory operations; (4) global labeling and advertisement/promotion; and (5) local regulatory affairs.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **R&D Strategy and Business Operations** enhances organizational coordination, and value-based decision-making for the research and development pipeline, through resource planning, optimization of systems, processes, and support of portfolio governance.

Our research and development function endeavors to conduct all clinical trials (Phase I through Phase IV) in partnership with Clinical Research Organizations. During Phase II and Phase III of clinical trials, because the formulation of the medication must be finalized and the scalability of production proven, we engage contractors with the relevant capabilities. During the various phases of clinical trials, the number of participants in, and consequently the expenses related to, the project increases significantly. Please refer to "*<u>[Item 5](#id39cb0e1a10249e1ab7b8f77d921d68a_269)</u>. Operating and Financial Review and Prospects*" for further details of research and development expenses during the financial periods included in this registration statement.

***Long term pipeline***

Our research and development activities are focused on building on our leadership position in the treatment of SUD. Through three active collaborations, we are investing to advance research into molecules that address cannabis use disorder ("CUD"), opioid use disorder ("OUD") and alcohol use disorder ("AUD"). In addition, with the recent acquisition of Opiant Pharmaceuticals, our pipeline now includes new drug candidates for opioid overdose reversal, alcohol use disorder, and acute cannabinoid overdose. However, our long-term pipeline reflects only potential products, and any product would require completion of clinical trials to demonstrate safety and efficacy, and approval by the FDA. See Item 3.C Risk Factors - "*Clinical trials for the development of products, including our key pipeline products, may be unsuccessful and our product candidates may not receive authorization for manufacture and sale."*

*Cannabis Use Disorder, AEF0117 Synthetic CB1 Specific Signaling Inhibitor*

Our most advanced program is part of the strategic collaboration we formed with French company Aelis Farma ("Aelis") in June 2021. This collaboration gives Indivior an exclusive option for AEF0117 designed to treat CUD. Aelis Farma is currently conducting Phase 2B clinical trials of AEF0117 in treatment-seeking subjects with moderate to severe CUD. The trial is randomized, double-blind, placebo-controlled, prospective, multicenter study conducted in the US and aims to enroll 330 treatment-seeking adult volunteers with a cannabis use of 5 days or more per week who meet diagnostic standards for moderate to severe CUD. The primary efficacy end point is the response to treatment defined as one day or less of cannabis use per week from week 5 to week 12. Other CMC, nonclinical toxicology, and clinical work-streams are progressing as planned. During the option period, Aelis is fully in charge of clinical and nonclinical development activities.

Upon completion of a successful Phase 2B trial, Indivior will have the opportunity to exercise the option for $100 million in exchange for an exclusive global license to develop, make and commercialize the AEF0017 and would assume responsibility and costs for all future development, regulatory, commercial, and manufacturing activities. Upon commercialization, we would also pay to Aelis Farma a tiered royalty on net sales generally ranging from mid to high teens.

The U.S. patents for AEF0017 expire in 2033 and 2039, and the former patent might be extended until 2038. AEF0117, if approved, would address the growing need for treatments targeting CUD. There are no FDA-approved medications for CUD. We believe AEF0117 is the most advanced new chemical entity under investigation and, if and when approved for use by the FDA, represents a unique opportunity to address a growing public health need.

*Opioid Use Disorder, INDV-2000 Selective Orexin-1 Receptor Antagonist*

We are developing INDV-2000 (Selective Orexin-1 Receptor Antagonist), a treatment for moderate to severe OUD, in collaboration with C4X Discovery. INDV-2000 is a non-opioid treatment, which may differentiate it in the market.

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A Phase 1, Single Ascending Dose study was completed and indicated that INDV-2000 was well tolerated with no drug-related severe or serious adverse events and demonstrated good pharmacokinetics in healthy volunteers. Additional clinical trials will be required to further demonstrate safety and efficacy prior to submission to the FDA for approval. Conducted at Altasciences in Overland Park, Kansas, it included a double-blind, placebo-controlled, randomized, single ascending dose study of 8 subjects with INDV-2000 administered in fasting condition, and an open, cross-over, food interaction, single-dose study with INDV-2000 administered once under both fasting conditions and non-fasting conditions.

A Multiple Ascending Dose study began in September 2022.

Our rights to INDV-2000 are structured as an exclusive worldwide license. Upon commercialization, we would also pay to C4X Discovery a single digit, flat royalty on net sales.

The U.S. patents for INDV-2000 expire in 2037.

*Alcohol Use Disorder, INDV-1000 Selective GABAb Positive Allosteric Modulator*

INDV-1000 (Selective GABAb Positive Allosteric Modulator), for the treatment of AUD, is being developed in collaboration with ADDEX Therapeutics, and is in the pre-clinical development phase. Two lead molecules and potential back-ups have been identified and the two lead molecules are being synthesized and progressed to maximum tolerated dose and dose range finding animal studies.

Our rights to INDV-1000 are structured as an exclusive worldwide license. Upon commercialization, we would pay to ADDEX a tiered royalty on net sales generally ranging from single digits to low teens.

*OPNT003 - Nasal Nalmefene for Opioid Overdose Reversal*

In 2017, National Institute of Health ("NIH") leadership called for the development of stronger, longer-acting formulations of antagonists to counteract the very high potency synthetic opioids that are now claiming thousands of lives each year. Through our wholly-owned subsidiary, Opiant Pharmaceuticals, we are pursuing a 505(b)(2) development path for OPNT003 and submitted a new drug application with the FDA for the drug and intranasal delivery device combination on November 22, 2022. On January 19, 2023, the FDA granted OPNT003 a Priority Review designation and a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2023, accelerating the review time from ten months to six months from the date of filing. Nalmefene for injection was previously approved by the FDA for treating suspected or confirmed opioid overdose. The 505(b)(2) pathway allows companies to rely in part on the FDA's findings of safety and efficacy for a previously approved product and to supplement these findings with a more limited set of their own studies to satisfy FDA requirements, as opposed to conducting the full array of preclinical and clinical studies that would typically be required.

The U.S. Patent and Trademark Office (USPTO) had issued Patent No. 11,458,091 includes claims covering combinations of nalmefene and Intravail® in a nasal formulation which expires in 2038.

*OPNT002 - Nasal Naltrexone for Alcohol Use Disorder ("AUD")*

Alcohol triggers the release of naturally occurring endorphins, which then bind to the opioid receptors in the brain, leading to dopamine release in the brain's reward center. Naltrexone is thought to reduce heavy drinking through the blockade of these opioid receptors, which results in dampening of alcohol-induced dopamine release and reward. Naltrexone is currently approved by the FDA for the treatment of AUD as a tablet and depot injection. However, in contrast to current naltrexone formulations OPNT002 will be taken nasally on an "as needed" basis, in anticipation of drinking or once drinking has started in order to reduce alcohol intake. We anticipate that the ability to take naltrexone on an as-needed basis could improve patient compliance and enable a patient to regain control of their drinking, especially in situations where heavy drinking is otherwise habitual. Furthermore, we expect patients to have high rates of adherence, because they will not be required to abstain and potentially go through detoxification and

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withdrawal prior to initiating OPNT002 therapy, unlike the typical situation with existing medicines for AUD.

Phase 1 clinical data have shown rapid nasal absorption of OPNT002, which supports its suitability for use on an as needed basis, as high levels of naltrexone can be delivered within minutes, which is likely to be very important during a period of craving. The FDA has also provided feedback on the proposed 505(b)(2) development plan, which is based on a harm reduction primary endpoint rather than a primary endpoint based on abstinence.

In October of 2019, a dose ranging study confirming the suitability of our OPNT002 formulation of AUD was completed.

In January 2022, the first patient was dosed in a double blind, placebo-controlled Phase 2 study of OPNT002 in 300 patients with AUD. The trial will determine whether OPNT002 reduces heavy drinking as measured by a change in the World Health Organization ("WHO") drinking risk levels. The total trial duration per patient is 20 weeks with top line data anticipated to follow in Q2 2024. The primary end point will be measured by the proportion of patients showing an improvement in World Health Organization (WHO) Risk Levels of Alcohol Consumption consisting of a 2-level reduction from baseline to end of treatment.

*OPNT004 - Drinabant Injection for Acute Cannabinoid Overdose ("ACO")*

In December 2018, an exclusive global licensing agreement was signed with Sanofi for the development and commercialization of drinabant for the treatment of acute cannabinoid overdose ("ACO"). Drinabant is a selective, high affinity cannabinoid CB-1 receptor antagonist that is being developed as an injectable for administration in an emergency department setting. In a proof of principle study that Sanofi completed with 36 patients, oral drinabant blocked both subjective and objective psychological effects of inhaled delta9-tetrahydrocannabinol ("THC"). Sanofi also generated extensive safety data in Phase 1 and 2 studies with more than 700 subject for up to 24 weeks.

ACO is most frequently linked to the ingestion of "edibles" containing large quantities of THC and the abuse of synthetic cannabinoids (often referred to as "K2" and "Spice") that are more potent and yet cheaper than cannabis. Edibles, sold as candies, brownies, and cookies, pose particular risks for children who can consume these by accident. Based on 2014 rates from the National Emergency Department sample and United States Census Bureau figures, we estimate that ACO resulted in more than one million emergency department visits in the United States in 2016. With an increasing number of states legalizing cannabis for personal and recreational use, ACO rates are expected to rise. Features of ACO produced by edibles and synthetic cannabinoids can include psychosis, panic and anxiety, feelings of paranoia, agitation, hallucinations, nausea, vomiting and cardiac arrhythmias. These symptoms often require emergency medical attention and can take hours to days to resolve. There are currently no FDA approved treatments for ACO.

In January 2020, a Letter of Intent was signed with the National Center for Advancing Translational Sciences ("NCATS") to collaborate on the development of OPNT004. NCATS is one of 27 divisions and centers of the NIH. This collaboration, carried out under a Cooperative Research and Development Agreement provides development research for certain pre-clinical activities and studies to support our planned filing of an Investigational New Drug ("IND") application for OPNT004. Activities carried out under this agreement have resulted in the development of formulations which may be suitable for parental administration of OPNT004. These formulations are currently being tested for stability, with pre-clinical toxicology studies.

The United States Patent and Trademark Office (USPTO) issued Patent No. 11,471,437 entitled "Compositions and methods for treating cannabinoid hyperemesis syndrome with a cannabinoid receptor antagonist" for OPNT004. This patent covers OPNT004 as a method of treatment for CHS using drinabant administered as a parenteral formulation and expires in 2040.

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**Manufacturing**

***Raw Materials***

***Active Pharmaceutical Ingredients ("API")***

The Group sources a large portion of its active pharmaceutical ingredients from its own manufacturing facilities. The API used in our buprenorphine products are manufactured at our Fine Chemical Plant ("FCP") located in Hull, United Kingdom. The FCP manufactures the buprenorphine hydrochloride ("HCl") and the buprenorphine base active pharmaceutical ingredients (''buprenorphine'') used in the formulation of SUBLOCADE long-acting injection, SUBOXONE Film, SUBUTEX Tablet, SUBOXONE Tablet, and BUPRENEX. The FCP has the capacity to produce all of our current buprenorphine HCl requirements with approximately 25% demonstrated capacity remaining. A third-party manufacturer performs an additional purification step for the crystallized buprenorphine base that we use to make SUBLOCADE (sold under the name SUBUTEX PRO outside the U.S.). We believe there are adequate supplies of the raw materials used to manufacture buprenorphine, and the ingredient is readily available from other suppliers (although it would require significant time to qualify and obtain regulatory approval to change suppliers).

We procure the naloxone HCl active pharmaceutical ingredient mainly from two suppliers for both SUBOXONE Tablet and SUBOXONE Film, although the ingredient is readily available from other suppliers (although it would require significant time to qualify and obtain regulatory approval to change suppliers).

Buprenorphine and products containing buprenorphine are classified as Schedule III controlled narcotics in the U.S. and require permits for import and export. An annual importation assessment value for buprenorphine and products containing buprenorphine is set by each importing country through the International Narcotics Control Board (the "INCB"). Once the assessment value has been reached for a given country, no additional import permits may be issued unless proper justification for an assessment value increase is provided to the respective country's governing body, which reports to the INCB. While this process has not impacted product supply to our patients in the past, it presents a manufacturing and product supply risk that must be monitored and managed closely.

We procure risperidone active pharmaceutical ingredient mainly from a single supplier for PERSERIS, although the ingredient is readily available from other suppliers (although it would require significant time to qualify and obtain regulatory approval to change suppliers).

***SUBLOCADE***

SUBLOCADE (buprenorphine extended-release) injection for subcutaneous use is manufactured under an agreement with Curia (formerly known as AMRI). We provide the buprenorphine base, polymer and syringe assembly used in the manufacture of SUBLOCADE.

Curia has a manufacturing facility located in Burlington, MA and is developing additional capacity in Albuquerque, NM. Manufacture of all SUBLOCADE output for the U.S. market and the rest of the world is approved at the Burlington facility and U.S. market manufacturing approval is planned for Albuquerque.

We rely on third parties to fill syringes with the API and polymer, to package the products, and to perform quality assurance and quality testing.

Current manufacturing capacity for SUBLOCADE is currently single sourced and would not be adequate for our peak net revenue assumptions. However, we have made investments in additional equipment and expect the additional manufacturing line at Curia's Albuquerque site to be approved for the U.S. in the second half of 2023. We believe that, once validated and approved, the additional manufacturing line should meet anticipated demand for net revenue in the medium term. In addition, we are evaluating alternate options to secure the supply of SUBLOCADE for the long term and for business

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continuity reasons. See "*<u>[Item 3.D.](#i56ef77e8a843490995b8285e91603860_4022087)</u>—Risk Factors—We rely on third parties to manufacture commercial supplies of most of our products, whose facilities and processes must meet stringent regulatory requirements."*

***SUBOXONE Film***

SUBOXONE Film is manufactured under an exclusive license and supply agreement with Aquestive Therapeutics (formerly known as MonoSol RX). Under the terms of the agreement, Aquestive is the exclusive global manufacturer and primary packager of SUBOXONE Film and is prohibited from developing any other film product containing buprenorphine without our written consent. We provide both the buprenorphine HCl and the naloxone HCl used in the manufacture of SUBOXONE Film.

Aquestive has two manufacturing facilities located in Portage, Indiana. Manufacture and primary packaging of all SUBOXONE Film output for most markets is now approved at both facilities.

***SUBOXONE and SUBUTEX Tablets***

We contract with Reckitt Benckiser Group PLC ("RB") to manufacture SUBOXONE and SUBUTEX Tablets. We provide both buprenorphine HCl and naloxone HCl used in the manufacture of SUBOXONE and SUBUTEX Tablets. RB manufactures and performs the packaging of all SUBOXONE and SUBUTEX tablets globally at its facility in Hull, United Kingdom.

***PERSERIS***

PERSERIS has two components. Syringe A, also known as the liquid syringe, contains the delivery system and is manufactured under a supply agreement with Curia. Syringe B, also known as the powder syringe, which contains risperidone active pharmaceutical ingredient and is manufactured under a supply agreement with Patheon Pharmaceuticals, LLC ("Patheon"). The finished product is later terminally sterilized after packaging into cartons. We provide the API, polymer and syringe assembly used in the manufacture of Syringe A and Syringe B, respectively. Contents in Syringe A and Syringe B are mixed before administering to the patient. We rely on third parties to fill syringes with the API and polymer, to package the products, to perform site quality assurance testing, and terminally sterilize the products. Patheon has a manufacturing facility located in Greenville, North Carolina and Curia has a manufacturing facility located in Burlington, Massachusetts.

Current manufacturing capacity for PERSERIS is currently single sourced. However, we plan to transfer production of SUBLOCADE to Curia's Albuquerque site, and when complete this will make available sufficient capacity to manufacture PERSERIS at peak expected volumes. As noted above, we have made investments in additional equipment and expect the additional manufacturing line at Curia's Albuquerque site to be approved in the second half of 2023. See "*<u>[Item 3.D.](#i56ef77e8a843490995b8285e91603860_4022087)</u>—Risk Factors—We rely on third parties to manufacture commercial supplies of most of our products, whose facilities and processes must meet stringent regulatory requirements."* 

***Other Products***

We contract with the RB Group to manufacture TEMGESIC and BUPRENEX. We provide the API used in the manufacture of this product. The RB Group manufactures and performs the packaging of all TEMGESIC and BUPRENEX globally at its facility in Hull, United Kingdom. We sold the TEMGESIC product line globally in 2021 (other than North America) but continue to supply TEMGESIC to the purchaser of that business.

***Additional Manufacturing and Distributions Processes***

We outsource to third parties certain aspects of the manufacturing and distribution process, including: (i) packaging our products with tamper evident pouches or child resistant components, in cardboard cartons, (ii) terminally sterilizing products that are not able to be manufactured under aseptic conditions, and (iii) securely storing products, fulfilling orders, and providing other customer service functions.

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**Sales, Marketing and Distribution**

Our sales, marketing, and distribution processes for our products begin with a focus on the patient. Our products are intended for patients who suffer from OUD or schizophrenia, two highly stigmatized diseases. These patients are found not just in private physician offices, but also in emergency rooms, hospitals, addiction or rehabilitation centers, organized health systems ("OHSs") and, frequently, as part of their journey with addiction, as incarcerated individuals in the criminal justice system. Accordingly, we focus our sales and marketing efforts not just on physicians in private practice but also to healthcare providers situated in these diverse treatment environments.

Our sales, marketing, and distribution efforts vary by market.

*United States*

We derive approximately 81% of our net revenues, and an even larger portion of our profitability, from the U.S. market. Unlike many markets in the rest of the world, the U.S. market is not a single payor market. Instead, our activities are directed at a patchwork of federal and state agencies, organized health systems, criminal justice systems, and healthcare providers who provide treatment and assistance for patients suffering from OUD and schizophrenia.

*Payors and Reimbursement*

We have dedicated professionals responsible for obtaining access and eliminating barriers to care at the national, regional and state payor level, including every state Medicaid program. We have coverage from approximately 90% of payors, including almost all commercial insurance payors, and the Veterans' Administration, the Department of Defense, and the Bureau of Indian Affairs.

A significant portion of our customers are reimbursed through the Medicaid plans of states and the District of Columbia, primarily because most individuals suffering from OUD are not employed or do not have employer-based health coverage.

*Organized Health Systems ("OHS").* 

Many patients who use our products are found at OHSs, such as hospitals and managed care organizations. OHS are an important channel for our products because they have the resources and administration to appropriately handle controlled substances that are prescribed, delivered, and stored, and are equipped to administer the requirements applicable to our products, including REMS. Our OHS Access Team and Key Account Team call on key decision makers at OHSs to expand access to our products. Our goal is to ensure access to our products by establishing treatment protocols (both medical and logistical), removing barriers to access, gaining formulary access where needed, and ensuring that protocols are in place to ensure compliance with applicable DEA, state, and local requirements regarding the storage of controlled substances. As part of this process, the sales team focuses on effectively communicating the scientific rationale and the benefits of our products, appropriately balanced with safety information, and the OHS Access Director Team and medical team focus on potentially better adherence, increased continuity of care, and overall cost and resource optimization in the total treatment plan.

*Criminal Justice Systems ("CJS").* 

We also have dedicated teams for customers in the CJS, including various types of prisons, such as states' departments of corrections, county jails, and federal prisons, along with specialty treatment courts. A specialty treatment court is a court with expertise in substance abuse disorders which may offer alternative and deferred prosecution arrangements for appropriate persons.

For prisons, our dedicated teams attempt to increase access to our products, overcome logistical barriers to care, and promote particular products, but do not call on HCPs behind the walls of the prisons.

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For specialty treatment courts, our Criminal Justice Access Directors educate judges, prosecutors, social workers, and patients about the benefits of our products. The patient is ultimately referred to a HCP, either in a private office or federally qualified health center, where the decision to use a BMAT, such as SUBLOCADE, is the patient's decision with the assistance of his or her HCP. At these referral sites and locations, our sales personnel coordinate with the HCPs and their staff to ensure understanding of the scientific rationale and the benefits of our products, appropriately balanced with safety information.

*Commercialization Activities*

Our commercial activities in the U.S. are currently focused on SUBLOCADE long-acting injectable, and PERSERIS long-acting injectable. We do not promote SUBOXONE Film in the U.S. Our sales organization in the U.S. comprises approximately 275 trained and experienced pharmaceutical professionals, which we call Clinical Specialists who are managed by Area Sales Managers. Clinical Specialists act as a vital link between the various stakeholders within the addiction community, including key opinion leaders, counselors, treatment advocates, pharmacists, nurses and healthcare providers in specialized treatment centers. We believe that our clear focus on patient needs helps deepen customer relationships which then allows the team the time to engage in clinical and logistical discussions that dramatically improve patient access to treatment with SUBLOCADE and PERSERIS.

Our Clinical Specialists are supported by dedicated and experienced professionals in our managed care group who create access to treatment for patients by partnering with U.S. commercial payors and federal, state, and local governmental payors.

*Marketing*

Our marketing efforts are focused on reaching the sufferers of the diseases that our products treat and the HCPs who treat them. In each of our markets, our commercial activities are supported by strategic planning, business analytics and measurement, and quarterly territory plans, ensuring that each market and sales territory is effectively resourced to maximize market access, and to increase appropriate use of our products.

In the U.S., our marketing team is responsible for claims development as well as developing marketing and sales materials, product websites, conference presentations and presence, and media plans which are reviewed by our Promotions Review Committee (PRC) consisting of medical, regulatory, and legal team members to assess compliance with rules and regulations as appropriate. We also provide reimbursement support for our U.S. markets. In addition, we have established strong marketing expertise in increasing disease state and treatment awareness, embedded in various platforms including grassroots, digital and traditional media. We employ third party vendors, such as advertising agencies, market research firms and suppliers of marketing and other sales support-related services, to assist with our commercial activities.

The challenges that we face in the sales process for our products include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• understanding of the science that underpins the SUBLOCADE and PERSERIS value propositions,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• considerations related to buprenorphine being a controlled substance that is subject to regulation in the countries where our products are marketed,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• SUBLOCADE having been approved by the FDA with a REMS,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• SUBLOCADE requiring secure, refrigerated storage and the requirement that SUBLOCADE and PERSERIS be administered by an HCP.

To assist our sales and marketing efforts, we invest in data infrastructure and related professionals to derive insights from our data. These insights allow us to prioritize our marketing efforts, identify obstacles and barriers to treatment, and suggest new approaches.

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*Distribution*

We distribute our products in 39 countries. Based on the country where sales originate, we derived 81%, 76% and 70% of our net revenues from the United States in 2022, 2021 and 2020, respectively.

The distribution of our buprenorphine products is more complicated than other specialty pharmaceutical products because buprenorphine is regulated in the U.S. as a Schedule III drug by the FDA, and similarly restricted by law enforcement authorities in the rest of the world. Additionally, certain products, like SUBLOCADE, utilize a restricted delivery network. Additionally, to ensure proper administration, SUBLOCADE and PERSERIS may only be administered by a HCP, and are not dispensed to the patient directly. To ensure that our products are available to HCPs and patients, we utilize specialty distributors and a network of several hundred specialty pharmacies that are equipped to adhere to these special requirements.

In contrast, SUBOXONE Film may be dispensed directly to a patient by a pharmacy with an appropriate DEA license. Accordingly, a substantial portion of our sales are to pharmaceutical wholesalers, specialty pharmacies, and distributors who, in turn, sell our products to pharmacies, hospitals, and other customers, including federal and state entities.

Our three largest customers (who are wholesale pharmaceutical companies in the U.S.) accounted for 55%, 57%, and 57% of global net revenues in 2022, 2021 and 2020. Our largest customer accounted for 22%, 21%, and 19% of our net revenues in 2022, 2021, and 2020. These customers are our primary purchases of SUBOXONE Film in the U.S., and as sales of SUBLOCADE grow, which is sold mostly through specialty pharmacists and specialty distributors, the relative importance of these three largest customers declines.

*Logistics*

We use central third-party logistics and warehouses that comply with applicable local regulations for storage and distribution of our products into the supply chain. Our third-party logistics provider specializes in integrated operations that include warehousing and transportation services that can be scaled and customized to our needs based on market conditions and the demands and delivery service requirements for our medicines and materials. Their services eliminate the need to build dedicated internal infrastructures that would be difficult to scale without significant capital investment. Our third-party logistics provider warehouses all medicines in controlled FDA-registered facilities in the U.S., or which meet applicable requirements outside the U.S. Orders are prepared and shipped through an order entry system to ensure adequate supply and delivery of our medicines.

**Rest of the World**

Our commercial activities are currently focused on SUBLOCADE long-acting injectable (also called SUBUTEX PRO), SUBUTEX Tablet, SUBOXONE Tablet and SUBOXONE Film. Depending on the size and demands of the relevant markets, dedicated teams of clinical liaisons, health policy liaisons, or a combination of both, work to accelerate access to treatment for patients.

In Canada and in approved markets in Europe and Australia, we have a field force of sales specialists. In markets where these products either are not approved or are unable to be promoted under local regulation, we have medical affairs personnel responsible for responding to medical information requests and for providing information consistent with local treatment protocols with respect to such products. In certain European markets, we have a sales team and a team of medical science liaisons supporting our rolling launches of SUBLOCADE AND SUBOXONE Film.

Outside the U.S. and Europe, we directly market SUBLOCADE, SUBOXONE Film, and SUBOXONE Tablets in in Canada and SUBLOCADE, SUBOXONE Film, and SUBUTEX Tablets in Australia. We also utilize distributors in certain markets outside the U.S. where we do not market our products directly.

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We distribute our products internationally using contracted third-party distribution services.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In North America, we utilize 2 distribution partners, one in the U.S. and one in Canada.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In Europe, we use 2 distribution hubs, one in the UK and one in France, and 13 pre-wholesalers that sell our product on consignment. Additionally, we have 12 distribution partners across Europe.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Outside North America and Europe we have 3 pre-wholesalers that sell our product on consignment, and nine distributor customers across 12 countries.

**Other Activities**

*Advocacy, Education, and Patient Support Programs*

We collaborate with patient organizations, stakeholders and policymakers to achieve our vision that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorder of addiction. Our advocacy agenda focuses on policy to expand access, advance equity, and increase focus on the CJS.

We believe that our educational and engagement efforts helped to expand the availability of treatment options beyond the clinical setting in the U.S., leading to patients today having the flexibility to receive appropriate treatment in the privacy of a physician's office.

We are also focusing on access to medically assisted treatment in correctional settings to ensure that resources are focused where challenges are greatest.

Equity in treatment is an issue for several reasons such as due to patients in the CJS being outside the insurance system and ineligible by federal law for Medicaid benefits. We work on initiatives to increase patients' access to medical care while incarcerated as well as access to care and coverage as they transition into communities. We also advocate to make Medicaid available as broadly as possible, and to eliminate barriers to care, including prior authorizations, step edits, and deductibles.

We also have various programs to help patients access and afford our products. For example, we sponsor a commercial co-pay assistance program that helps patients meet co-payment obligations imposed by their commercial insurance.

Additionally, we sponsor an insurance reimbursement hub to facilitate the dispensing of our products that HCPs and pharmacies may access via telephone to confirm coverage and level of benefits. We also provide patient access specialists to problem solve access issues, coverage, and coding (after a product has been ordered).

There has been enhanced scrutiny of company-sponsored patient assistance programs, both from government enforcement and payors.

*Medical Affairs* 

Our Medical Affairs Team, which supports HCPs and health administrators and includes Medical Science Liaisons and Medical Outcomes Value Liaisons responsible for responding to unsolicited off-label questions, clarifying data related to our products, working with study investigators, and developing and delivering real world evidence regarding the usage and potential benefits or risks of a medical product derived from an analysis of real-world data.

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**Intellectual Property**

We own or license several patents and patent rights in the U.S. and other countries covering or relating to certain of the products and pipeline products mentioned above, and have created brand names and also registered trademarks where appropriate for our products. Generally, and where possible, we rely upon patent protection to ensure market exclusivity for the life of the patent. We consider the overall protection of our patents, trademarks and license rights to be of material value and take actions to protect these rights from infringement or misuse where appropriate.

The majority of an innovative product's commercial value is usually realized during the period in which the product has market exclusivity. In the branded pharmaceutical industry, an innovator's product's market exclusivity is generally determined by two forms of protection: patent rights held by the innovator company; and any regulatory forms of exclusivity to which the innovator is entitled. In the U.S. and some other countries, when market exclusivity expires and generic versions of a product are approved and marketed, there are often very substantial and rapid declines in the branded product's sales. The rate of this decline varies by country and by therapeutic category; however, following patent expiration, branded products often continue to have some market viability based either upon the goodwill generated by the product name, which typically benefits from trademark protection, or upon the difficulties associated with replicating the product formulation or bioavailability.

Patents are a key determinant of market exclusivity for most branded pharmaceuticals as they can provide the innovator with the right to exclude others from practicing an invention related to the product. Patents may cover, among other things, the active ingredient(s), various uses of a drug product, pharmaceutical formulations, drug delivery mechanisms, the manufacture of products and processes for the manufacture of products, and intermediate compounds useful in the manufacture of products. Protection for aspects of individual products extends for varying periods in accordance with the expiry dates of patents in the various countries. The protection afforded, which may also vary from country to country, depends upon the type of patent, its scope of coverage and the availability of meaningful legal remedies in the country. However, patents and other forms of protection can never protect us from all forms of competition, such as from similar products or from alternatives. See, for example, "*<u>[Item 4.B.](#id39cb0e1a10249e1ab7b8f77d921d68a_2050)</u> Business Overview—3. Competition*."

Many developed countries provide certain non-patent incentives for the development of pharmaceuticals. For example, the U.S., EU and Japan each provides for a minimum period of time after the approval of certain new drugs during which the regulatory agency may not rely upon the innovator's data to approve a competitor's generic copy. Regulatory exclusivity is also available in certain markets as incentives for research on new indications, orphan drugs (drugs that demonstrate promise for the diagnosis or treatment of rare diseases or conditions) and medicines that may be useful in treating pediatric patients. Regulatory exclusivity is independent of any patent rights and can be particularly important when a drug lacks broad patent protection. However, most regulatory forms of exclusivity do not prevent a second innovative competitor from gaining regulatory approval prior to the expiration of regulatory exclusivity when the second innovative competitor has conducted its own safety and efficacy studies on its drug, even when that drug is identical to that marketed by the first innovator.

We estimate the likely market exclusivity period for each of our branded products on a case-by-case basis. It is not possible to predict with certainty the length of market exclusivity for any of our branded products because of the complex interaction between patent and regulatory forms of exclusivity, the relative success or lack thereof of potential competitors' experience in product development and inherent uncertainties concerning patent litigation. There can be no assurance that a particular product will enjoy market exclusivity for the full period of time that we currently estimate or that the exclusivity will be limited to the estimate.

We also rely on trade secrets, know-how and inventions, which are not protected by patents and try to protect this information by entering into confidentiality agreements with parties that have access to it, such

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as our corporate partners, collaborators, licensees, employees and consultants. We also license or assign certain intellectual property rights to third parties.

The Group (generally Indivior UK Limited) also owns, or licenses, patent rights (i.e. granted patents or pending applications) in certain key jurisdictions in respect to our products and pipeline products. The patent rights listed below are those which are critical to our products:

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| | | | |
|:---|:---|:---|:---|
| **Number** | **Geographic**<br>**Scope** | **Expiry** | **Description** |
| ***SUBLOCADE*** | | | |
| U.S. 8,921,387<br>U.S. 8,975,270<br>U.S. 9,272,044<br>U.S. 9,498,432<br>U.S. 9,782,402<br>U.S. 9,827,241<br>U.S. 10,198,218<br>U.S. 10,558,394<br>U.S. 10,592,168<br>U.S. 10,646,484<br>U.S. 11,000,520<br>(and foreign equivalents) | U.S., Europe, United Kingdom, Australia, Canada, Israel, Mexico, and New Zealand | 2031 - 2038 | Commercial Buprenorphine<br>Depot Method and Formulation |
| ***PERSERIS*** |  |  |  |
| U.S. 9,180,197<br>U.S. 9,186,413<br>U.S. 9,597,402<br>U.S. 10,010,612<br>U.S. 10,058,554<br>U.S. 10,376,590<br>U.S. 10,406,160<br>U.S. 11,013,809<br>U.S. 11,110,093<br>U.S. 11,478,407<br>U.S. 16/041,170 (pending application) <br>(and foreign equivalents) | U.S., Europe, United Kingdom, Australia, Canada, Israel, Mexico, and New Zealand | 2026 - 2038 | Commercial Risperidone Depot and Method |
| ***SUBOXONE Film*** |  |  |  |
| 8,603,514<br>9,687,454<br>11,135,216<br>(and foreign equivalents) | U.S., Australia, New Zealand, Europe,<br>United Kingdom  | 2024 - 2029 | Formulation |

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**Regulatory Overview**

Our activities are subject to a rigorous regulatory framework on a local and international level that conditions and affects our activities. The process of obtaining regulatory approvals and the subsequent compliance with applicable laws, regulations and other requirements require the expenditure of substantial time and financial resources. The following is a summary of the regulatory landscape applicable to our business and the reimbursement schemes applicable to its products in the key markets in which we operate.

**United States**

***Overview***

Pharmaceutical companies operate in a highly regulated environment. In the U.S., we must comply with laws, regulations and other requirements promulgated by numerous federal and state authorities, including the FDA and other agencies and divisions of the Department of Health and Human Services, the Drug Enforcement Agency ("DEA"), and other agencies of the DOJ, the Consumer Product Safety Commission, the Environmental Protection Agency, the U.S. Bureau of Customs and Border Protection (the "CBP"), and state agencies such as boards of pharmacy. Applicable legal requirements govern to varying degrees the research, development, manufacturing, commercialization and sale of our prescription pharmaceutical products, including pre-clinical and clinical testing, approval, production, labeling, sale, distribution, import, export, post-market surveillance, advertising, dissemination of information and promotion. Failure to comply with applicable legal requirements can result in product recalls, seizures, injunctions, refusal to approve or withdrawal of approval of product applications, monetary fines or criminal prosecution.

***Food and Drug Administration***

The FDA's authority to regulate pharmaceuticals comes primarily from the Federal Food, Drug, and Cosmetic Act ("FFDCA"). In addition to reviewing new drug applications ("NDAs") for branded drugs and additional new drug applications ("ANDAs") for generic drugs, the FDA has the authority to ensure that pharmaceuticals introduced into interstate commerce are neither "adulterated" nor "misbranded." Adulterated means that the product or its manufacture does not comply with FDA quality and related standards. A drug is adulterated if, among other things: it is prepared under unsanitary conditions such that it may have been contaminated or may cause injury to patients, (ii) its manufacture does not comply with cGMP, (iii) it does not comply with an official compendium, (iv) its strength, purity or quality differs from that which it purports to possess, or (v) if it is manufactured, processed or held in a facility which refuses FDA inspection. Misbranded means, among other things, that the labeling of, or advertising or promotional materials for, the product contains false or misleading information, fails to conform to the FDA approval for the drug, or fails to include required information about risks.

In order to market and sell a new drug product in the U.S., a drug manufacturer must file with the FDA an NDA that shows the safety and effectiveness of the new drug. In order to market and sell a generic version of an already-approved drug product, a drug manufacturer must file an ANDA that shows that the generic version is, with narrow exceptions, the same active ingredient, dosage form, strength and route of administration as a previously approved reference product, and "bioequivalent" to that reference product, meaning that it is absorbed at the same rate and to the same extent as the reference product. The FDA classifies certain generic drugs as "therapeutically equivalent," meaning that they are expected to have the same clinical effect and safety as the branded drug product. Alternatively, a manufacturer may submit an NDA under FFDCA section 505(b)(2) for a drug product that has some differences from an already-approved drug product, but that relies in whole or in part on the findings of safety and/or effectiveness of a previously approved reference product, or on medical literature. A section 505(b)(2) NDA must demonstrate that the proposed product is safe and effective notwithstanding the differences from the approved drug product.

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*Research, Development and NDA process*

The path leading to FDA approval of an NDA for a new drug begins when the drug product is merely a chemical formulation in the laboratory. In general, the process involves the following steps:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)completion of formulation, laboratory and animal testing in accordance with good laboratory practices ("GLP"), which characterizes the drug product from a pre-clinical perspective and provides preliminary evidence that the drug product is safe to test in human beings;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)filing with the FDA an Investigational New Drug Application ("IND") which once effective will permit the conduct of clinical trials (testing in human beings under adequate and well-controlled conditions) in the U.S.;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)designing and conducting clinical trials to show the safety and efficacy of the drug product in accordance with good clinical practice ("GCP") and other requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)submitting the NDA for FDA review, which generally must include data from at least two well-controlled clinical trials demonstrating safety and effectiveness, as well as characterization of the drug product and a description of the manufacturing process, controls and facilities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v)satisfactory completion of FDA pre-approval inspections regarding the conduct of the clinical trials and manufacturing at the designated facility or facilities in accordance with current Good Manufacturing Practices ("cGMP");

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vi)if applicable, completion of a FDA Advisory Committee meeting in which the FDA requests views and recommendations from outside experts in evaluating the NDA;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vii)final FDA approval of the full prescribing information, labeling and packaging of the drug product; and

&nbsp;&nbsp;&nbsp;&nbsp;(viii)in some cases, commitments to meet post-approval requirements, including ongoing monitoring and reporting of adverse events related to the drug product, implementation of a Risk Evaluation and Mitigation Strategy ("REMS") program, if applicable, and conduct of any agreed post-marketing requirement or post-marketing commitment studies.

Clinical trials are typically conducted in four sequential phases, although they may overlap. The four phases are as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)Phase I trials are typically small (fewer than 100 study subjects and often involving healthy volunteers) and are primarily designed to determine the pharmacokinetics and toxicity of the drug product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)Phase II trials usually involve 100 to 300 participants and are designed to determine whether the drug product produces any clinically significant effects in patients with the intended disease or condition and to provide further information about safety and dosing. If the results of these trials show promise, then larger Phase III trials may be conducted.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)Phase III trials are often multi-institution studies that involve a large number of participants and are designed to show efficacy and safety in the intended treatment population. Phase III (and some Phase II) trials are designed to be pivotal trials. The goal of a pivotal trial is to establish the safety and efficacy of a drug product with sufficient robustness for purposes of regulatory approval.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)Phase IV studies are conducted following approval. In some cases, the FDA requires post marketing requirement studies or post marketing commitment studies after the NDA has been approved. Such post-marketing clinical studies or surveillance programs are intended to obtain more information about the risks of harm, benefits and optimal use of the drug product by

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evaluating the results of the drug product in a larger number of patients. The FDA may require post-approval studies either at the time of approval or, if it becomes aware of new safety information, after approval.

A drug manufacturer may conduct clinical trials either in the U.S. or outside the U.S., but in all cases must comply with GCP and must ensure that there is: (i) a legally effective informed consent process when enrolling participants; (ii) an independent review by an Institutional Review Board or ethics committee to minimize and manage the risks of harm to participants; and (iii) ongoing monitoring and reporting of adverse events related to the drug product.

In addition, under the Pediatric Research Equity Act 2003 ("PREA") as amended, all NDAs must include assessments on a drug in pediatric patients unless the applicant receives a waiver or deferral. A drug sponsor may also seek to conduct a clinical trial of a drug product on pediatric patients based on a written request from the FDA in order to obtain a form of marketing exclusivity as permitted under the Best Pharmaceuticals for Children Act 2002, as amended. Under PREA, FDA may require post-approval studies assess the safety and effectiveness of the indication in pediatric patients.

The path leading to FDA approval of a section 505(b)(2) NDA for a drug product that has differences from an already-approved product is somewhat shorter. In a section 505(b)(2) NDA, the drug sponsor relies, in whole or in part, on investigations to which the sponsor does not have a right of reference to establish that its proposed product is safe and effective. For example, a section 505(b)(2) NDA may rely on published literature or on the FDA's prior finding of safety and effectiveness of another company's product. Section 505(b)(2) NDAs are typically used for new products with differences from previously approved products such as in dosage forms, dosage strengths, route of administration or indication and where, therefore, an ANDA may not be used. New clinical trial data may also be needed to establish that the proposed product is safe and effective given its differences.

Under the U.S. Prescription Drug User Fee Act 1992, as amended, the FDA has the authority to collect fees from drug manufacturers who submit NDAs and section 505(b)(2) NDAs for review and approval. For U.S. fiscal year 2023, the user fee rate has been set at $3,242,026 for an NDA and $1,621,013 for an NDA not requiring clinical data, generally certain section 505(b)(2) NDAs.

*ANDA process*

The path leading to FDA approval of an ANDA is very different from that of an NDA. By statute, the drug manufacturer does not complete pre-clinical studies and safety and efficacy clinical trials, and instead focuses on a showing of sameness and bioequivalence to a previously approved Reference Listed Drug ("RLD"), typically a branded drug approved under an NDA. Sameness means, with limited exceptions, the same active ingredient or ingredients, dosage form, strength, route of administration and labeling. Bioequivalence is generally established by studies that involve comparing the absorption rate and concentration levels of a generic drug in the human body to that of the RLD. In the event that the generic drug behaves in the same manner in the human body as the RLD, the two drug products are considered bioequivalent. The FDA considers a generic drug therapeutically equivalent, and therefore the drug is generally substitutable under state pharmacy dispensing law, where it is shown to be the same as and bioequivalent to the RLD. Legislation enacted in most states in the U.S. allows or, in some instances mandates, that a pharmacist dispense an available generic drug that has been rated therapeutically equivalent when filling a prescription for a branded product, in the absence of specific contrary instructions from the prescribing physician. ANDA filings must include information on manufacturing processes, controls and facilities comparable to an NDA.

In 2010, Congress passed into law the Generic Drug User Fee Act to address the FDA's backlog, which at the time was over 2,000 ANDA filings. This legislation granted the FDA authority to collect, for the first time, user fees from generic drug manufacturers who submit ANDA filings for review and approval, and the fees collected help the FDA fund the drug approval process. For U.S. fiscal year 2022, the user fee rate is set at $225,712 for an ANDA. The FDA will also collect from generic drug manufacturers a

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separate fee where they reference a so-called Drug Master File for a contract manufacturer, and separate annual manufacturing facility fees for API and finished drug products.

Aside from the backlog described above, the timing of FDA approval of ANDA filings depends on other factors, including whether an ANDA holder has challenged any listed patents to the reference listed drug (the "RLD") and whether the RLD is entitled to one or more periods of non-patent data or marketing exclusivity under the FFDCA, as discussed elsewhere in this section.

*Patent and non-patent exclusivity periods*

A sponsor of an NDA is required to identify in its application any patent that claims the drug or a use of the drug subject to the application. Upon NDA approval, the FDA lists these patents in a publication referred to as the Orange Book. Any person that files a section 505(b)(2) NDA that relies upon reference to an approved NDA for which the patents are listed, or an ANDA to secure approval of a generic version of the previously approved drug, must make a certification in respect of listed patents. If the ANDA or section 505(b)(2) NDA applicant certifies that there are no listed patents or that the listed patents have expired, the FDA may approve the application immediately. If the applicant certifies that the patents have not expired, the FDA may only approve the application upon expiry of the patents. Alternatively, the applicant may certify that the listed patents are invalid, unenforceable and/or not infringed by the proposed drug. The applicant must give notice to the holder of the NDA for the RLD and the patent holder (if different) of the bases upon which the patents are challenged. If the NDA holder or patent owner sues the applicant for infringement within 45 days, the FDA may not approve the ANDA or section 505(b)(2) NDA until the earliest of: (i) 30-months after receipt of the notice by the holder of the NDA for the RLD; entry of a district court of appellate court judgment holding the patent invalid, unenforceable or not infringed; such other time as the court may order; or (iv) the expiry of the patent. If an infringement suit is not initiated within 45 days of notice to the NDA holder, the FDA may approve the application immediately.

A key motivation for ANDA applicants to challenge patents is the 180-day market exclusivity period ("generic exclusivity") granted to the developer of a generic version of a product that is the first to submit an ANDA with a Paragraph IV certification. For a variety of reasons, there are situations in which a company may not be able to take advantage of an award of generic exclusivity. The determination of when generic exclusivity begins and ends is complicated, and is subject to several forfeiture provisions.

The holder of the NDA for the RLD may also be entitled to certain non-patent exclusivity during which the FDA cannot accept for filing or approve an application for a competing generic product or section 505(b)(2) NDA product. Generally, if the RLD is a new chemical entity, the FDA may not accept for filing any application that references the innovator's NDA for five years from the approval of the innovator's NDA. However, this five-year period is shortened to four years where an applicant's ANDA includes a Paragraph IV certification, and the 30-month stay on FDA approval is lengthened accordingly. In other cases, where the innovator has provided certain clinical study information essential for approval, the FDA may accept for filing, but may not approve, an ANDA or section 505(b)(2) application that references the corresponding aspect of the innovator's NDA for a period of three years from the approval of the innovator's NDA. Certain additional periods of exclusivity may be available, such as orphan exclusivity if the RLD is indicated for use in a rare disease or condition, or pediatric exclusivity if the RLD is studied for pediatric patients based on a written request from the FDA.

*Risk Evaluation and Mitigation Strategies ("REMS")*

The FDA has the authority to require the manufacturer to provide a REMS that is intended to ensure that the benefits of a drug product (or class of drug products) outweigh the risks of harm. The FDA may require that a REMS include elements to assure safe use to mitigate a specific serious risk of harm, such as requiring that prescribers have particular training or experience or that the drug product is dispensed in certain healthcare settings. The FDA has the authority to impose civil penalties on or take other enforcement action against any drug manufacturer who fails properly to implement an approved REMS. Separately, there are prohibitions on a drug manufacturer using an approved REMS to delay generic

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competition. The FDA has been active in instituting class-wide and product-specific REMS for opioid drug products.

The FDA requires a REMS for SUBOXONE Film and for SUBLOCADE Injection. SUBOXONE Film is part of the Buprenorphine Transmucosal Products for Opioid Dependence ("BTOD") shared REMS program, the goals of which are to: 1) mitigate the risks of accidental overdose, misuse, and abuse, and 2) inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products The goal of the SUBLOCADE REMS program is to mitigate the risk of serious harm or death that could result from intravenous self-administration by ensuring healthcare settings and pharmacies are certified and only provide SUBLOCADE directly to a healthcare provider for administration by a healthcare provider to the patient.

Other products for which the Group secures NDA approval in the U.S. in the future may become subject to a REMS specific to the product or shared with other products in the same class of drug, if FDA determines that additional steps beyond labeling are required to help ensure the benefits of the medication outweighs its risks.

*Quality assurance requirements*

The FDA enforces requirements to ensure that the methods used in, and the facilities and controls used for, the manufacture, processing, packaging and holding of drugs conform to cGMP. The cGMP requirements that the FDA enforces are comprehensive and cover all aspects of manufacturing operations, from receipt of raw materials to finished product distribution, and are designed to ensure that the finished products meet all the required identity, strength, quality and purity characteristics. Ensuring compliance requires a continuous commitment of time, money and effort in all operational areas.

The FDA conducts pre-approval and post-approval inspections of facilities engaged in the development, manufacture, processing, packaging, testing and holding of the drugs subject to NDAs and ANDA filings. Prior to approval, if the FDA concludes that the facilities to be used do not or did not meet cGMP, it will not approve the application. Corrective actions to remedy the deficiencies must be performed and are usually verified in a subsequent inspection.

The FDA also conducts periodic post-approval inspections of drug manufacturing facilities to assess their cGMP status. Adverse inspections can lead to FDA inspection observations, warning letters, seizure, recalls, injunctions, and shutdown of facilities. In addition, where products or components for manufacturing are being imported into the U.S., the FDA may issue an import alert to prevent shipments into the country. In addition, if the FDA concludes that a company is not in compliance with cGMP requirements, sanctions may be imposed that include preventing that company from receiving the necessary licenses to export its products, preventing further approvals for applications involving the facility or facilities and issue and classifying that company as an "unacceptable supplier," thereby disqualifying that company from selling products to governmental agencies.

*Reporting requirements*

Pharmaceutical manufacturers are subject to adverse event reporting requirements during clinical trials and following approval, with expedited reporting for certain serious adverse events and periodic reporting for other adverse events. To comply with these requirements, manufacturers must have robust procedures for surveillance, receipt, evaluation and reporting of adverse events. Manufacturers must also submit annual reports to FDA for each approved product, and field alert reports where there is a quality or labeling issue with a product already distributed to the market.

*Labeling and marketing*

For all pharmaceuticals sold in the U.S., the FDA and other regulatory and law enforcement bodies also regulate sales and marketing to ensure that drug product claims made by manufacturers are not false, misleading or otherwise improper. Manufacturers are required to file copies of all product-specific

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promotional materials with the FDA's Office of Prescription Drug Promotion at the time of their first use. Failure to implement a robust internal company review process and to comply with FDA requirements regarding labeling and promotion increases the risk of enforcement action by the FDA, the DOJ, or the states.

In addition, the FDA has the authority to require labeling changes after approval of a drug if it becomes aware of new safety information.

***Import and export requirements***

To import pharmaceuticals into the U.S., the importer must file an entry notice and bond with the Customs and Board Protection ("CBP"). All drugs are subject to FDA examination before release by the CBP. Any article that appears to be in violation of the federal Food, Drug and Cosmetic Act ("FFDCA") may be refused admission and a notice of detention and hearing may be issued. If the FDA ultimately refuses admission, the CBP may issue a notice for redelivery and assess liquidated damages for up to three times the value of the drugs.

Products for export from the U.S. are subject to foreign countries' import requirements and the exporting requirements of the FDA. For example, international sales of drugs manufactured in the U.S. that are not approved by the FDA for use in the U.S. are subject to FDA export requirements. FDA will provide a certificate of pharmaceutical product ("eCPP") directly to a requesting country to provide assurance that the product has been approved for export from the U.S. and that the manufacturing facilities are in compliance with cGMP. To obtain this certificate, the drug manufacturer must apply to the FDA.

***Drug Enforcement Administration***

The U.S. Drug Enforcement Agency ("DEA") is the federal agency in the U.S. responsible for enforcement of the Controlled Substances Act ("CSA"). The CSA classifies drugs and other substances based on identified potential for dependence and abuse. Schedule I controlled substances are those with a high abuse potential and have no currently accepted medical use; thus they cannot be lawfully marketed or sold. Schedule II/IIN substances have a high potential for abuse which may lead to severe psychological or physical dependence. Many narcotics and stimulants are Schedule II controlled substances. Schedule III/IIN substances have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. Examples of Schedule III substances are products containing not more than 90 milligrams of Codeine® per dosage (Tylenol® with Codeine®) and buprenorphine, the active ingredient in SUBLOCADE and SUBOXONE. Consequently, the manufacture, storage, distribution and sale of these substances are all highly regulated.

DEA regulations make it extremely difficult for a manufacturer in the U.S. to import finished dosage forms of controlled substances manufactured outside the U.S., particularly for Schedule II controlled substances and narcotics in other Schedules. These rules reflect a broader enforcement approach by the DEA to regulate the manufacture, distribution and dispensing of legally-produced controlled substances. Accordingly, drug manufacturers who market and sell finished dosage forms of controlled substances in the U.S. often manufacture or have them manufactured in the U.S.

The DEA also requires drug manufacturers to design and implement a system that identifies suspicious orders of controlled substances, such as those of unusual size, those that deviate substantially from a normal pattern and those of unusual frequency, prior to completion of the sale. A compliant suspicious order monitoring system includes well-defined due diligence, "know your customer" efforts and order monitoring.

To meet its responsibilities, the DEA conducts periodic inspections of registered establishments that handle controlled substances. Annual registration is required for any facility that manufactures, tests, distributes, dispenses, imports or exports any controlled substance. The facilities must have the security,

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control and accounting mechanisms required by the DEA to prevent loss and diversion. Failure to maintain compliance, particularly as manifested in loss or diversion, can result in regulatory action. The DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations. In certain circumstances, violations could lead to criminal proceedings.

Individual states also regulate controlled substances, and manufacturers, distributors and third-party active pharmaceutical ingredient suppliers and manufacturers, are subject to such regulation by several states with respect to the manufacture and distribution of these products.

***Government benefit programs***

Statutory and regulatory requirements for Medicaid, Medicare, Tricare (the uniformed services healthcare program for active duty service members, active duty family members, National Guard and Reserve members and their family members, retirees and retiree family members, survivors, and certain former spouses worldwide) and other government healthcare programs govern provider reimbursement levels for government beneficiaries, including requiring that pharmaceutical companies pay rebates to individual states based on Medicaid utilization of the manufacturer's products. The federal and state governments may continue to enact measures in the future aimed at containing or reducing payment levels for prescription pharmaceuticals paid for in whole or in part with government funds.

From time to time, legislative or regulatory changes are made to government healthcare programs that impact our business. For example, the Medicare Prescription Drug Improvement and Modernization Act 2003 created a new out-patient prescription drug coverage program for people with Medicare through a new system of private market drug benefit plans. This law provides an out-patient prescription drug benefit to seniors and individuals with disabilities in the Medicare program ("Medicare Part D").

Further, on August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, or IRA, which, among other things, requires the U.S. Department of Health and Human Services Secretary to negotiate, with respect to Medicare units and subject to a specified cap, the price of a set number of certain high Medicare spend drugs and biologicals per year starting in 2026, penalizes manufacturers of certain Medicare Parts B and D drugs for price increases above inflation, and makes several changes to the Medicare Part D benefit, including a limit on annual out-of-pocket costs, and a change in manufacturer liability under the program. Congress continues to examine various policy proposals that may result in pressure on the prices of prescription drugs in the government health programs.

In addition, the Patient Protection and Affordable Care Act ("Affordable Care Act") has changed the way healthcare services are delivered and financed by both government and private insurers in the U.S. The overall impact of the Affordable Care Act reflects several uncertainties; the impact to our business is largely attributable to changes in the Medicare Part D coverage gap, the imposition of an annual fee on branded prescription pharmaceutical manufacturers and increased rebates payable to state Medicaid programs. There are several other provisions in the legislation that collectively have additional impact, including originator average manufacturer price for new formulations and the expansion of the ceiling prices under section 340B of the Public Health Services Act, as amended, (the "340B Program") to new entities.

Further, federal policy makers have taken and are expected to continue to try to take steps toward expanding healthcare coverage beyond the Affordable Care Act, which could have ramifications for the pharmaceutical industry. Additional legislative changes, regulatory changes, or guidance could be adopted, which may impact marketing approvals and reimbursement for our products. For example, there has been increasing legislative, regulatory, and enforcement interest in the U.S. with respect to drug pricing practices. There have been several inquiries by the U.S. Congress and proposed and enacted federal and state legislation and regulatory initiatives designed to, among other things, bring more transparency to product pricing, evaluate the relationship between pricing and manufacturer patient programs, and reform government healthcare program reimbursement methodologies for drug products.

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***Healthcare fraud and abuse laws; Privacy***

We are subject to various federal, state and local laws targeting fraud and abuse in the healthcare industry. For example, in the U.S., there are federal and state anti-kickback laws that prohibit the payment or receipt of kickbacks, bribes or other remuneration intended to induce the purchase or recommendation of healthcare products and services covered by government healthcare programs or reward past purchases or recommendations. In addition, the federal False Claims Act prohibits presenting or causing to be presented a false claim for payment by a federal healthcare program, and this law has been interpreted to include claims caused by improper drug manufacturer product promotion or the payment of kickbacks. Under the so-called Sunshine Act and related provisions of the Affordable Care Act, we must report to the federal government information on payments and transfers of value made to physicians and certain healthcare institutions, and also on drug samples distributed. In addition, if we receive protected patient health information, it may be subject to federal or state privacy laws. Violations of these laws can lead to civil and criminal penalties, including fines, imprisonment and exclusion from participation in federal healthcare programs. These laws apply to hospitals, physicians and other potential purchasers of our products and are potentially applicable to us as both a manufacturer and a supplier of products reimbursed by federal healthcare programs. In addition, some states in the U.S. have enacted compliance and reporting requirements that apply to drug manufacturers.

We must comply with the FCPA worldwide and similar anti-bribery laws in non-U.S. jurisdictions such as the U.K. Bribery Act of 2010, which generally prohibit companies and their intermediaries from making improper payments to non-U.S. officials for the purpose of obtaining or retaining business. Because of the predominance of government-sponsored healthcare systems around the world, most of our customer relationships outside the U.S. are with governmental entities and are therefore subject to such anti-bribery laws. See also, *"<u>[Item 3.D.](#i56ef77e8a843490995b8285e91603860_4022086)</u> Risk Factors—We are subject, directly or indirectly, to a variety of U.S. and international laws and regulations related to fraud and abuse and transparency. Enforcement actions under such laws have increased in recent years. If we fail to comply, or have not fully complied, with such laws, we could face substantial penalties."*

**European Union and UK**

***Overview***

In the EU and UK, medicinal products are subject to extensive pre- and post-marketing regulation by regulatory authorities at both the EU and national levels. Additional rules also apply at the national level relating specifically to controlled substances.

Following a referendum in 2016, the UK formally left the EU on January 31, 2020 and the transition period, during which EU laws continued to apply to the UK, expired on December 31, 2020.

A significant proportion of the regulatory framework in the UK applicable to medicinal products is currently derived from European Union Directives and Regulations, and since January 1, 2021, the EU laws which have been transposed into UK law through secondary legislation continue to be applicable in the UK as retained EU law, although any new EU law developments have ceased to apply in the UK from that date. The divergence between the UK and the EU regimes increases as time passes, including for example, with respect to EU law developments to which the UK is not subject, such as the Clinical Trials Regulation. There have been no new significant legislative enactments in the UK since its exit from the EU with respect to medicinal products which would materially deviate the UK's overall regulatory position from the EU law at the time the UK exited the EU. However, there are important procedural and other differences, such as the requirement to obtain a UK-specific marketing authorization, for example.

There are several ongoing UK government consultations relevant to medicinal products, most notably with respect to clinical trials and the future regulatory landscape in the UK is uncertain. In addition, a draft bill has recently been published by the UK government (the so-called "Brexit Freedoms Bill"), which would, if passed, mean among other things that retained EU law would cease to apply. However, that bill is at a very early stage, is subject to change and has already been subject to fierce political opposition,

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The position in Northern Ireland differs in certain respects from that of the rest of the United Kingdom (England, Scotland and Wales) as Northern Ireland has chosen to retain some EU rules following the UK's departure from the EU.

***Clinical trials and marketing approval***

Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations and the International Council for Harmonization ("ICH") guidelines on GCP. Prior to commencing a clinical trial, the sponsor must obtain a clinical trial authorization from the competent authority and a positive opinion from an independent ethics committee. The application for a clinical trial authorization must include, among other things, a copy of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the medicinal product under investigation.

Under the EU Regulation on Clinical Trials (Regulation (EU) 536/2014) which came into force as of January 31, 2022, and replaces the existing Directive 2001/20/EC, a centralized procedure is in place where the sponsor submits the application for a clinical trial through an EU portal. The application is then evaluated and approved or rejected by the respective member state where the trial is to take place. If more than one member state is concerned, the application will be reviewed in a coordinated process with one member state acting as "reporting" member state. Any subsequent substantial changes to the trial protocol or other information submitted with the clinical trial applications must be approved by the member states concerned. The EU Regulation on Clinical Trials provides for certain transitional rules for clinical trials applied for before it came into effect and gives sponsors a choice as to whether to apply the previous rules until January 31, 2023.

The UK regulatory framework in relation to clinical trials is derived from secondary national UK legislation implementing the EU Directive 2001/20/EC. The UK is not subject to the new EU Regulation on Clinical Trials and the details of the future regulation of clinical trials in the UK are as yet uncertain. There was a government consultation in January 2022 and the outcome is yet to be published.

After completion of the required clinical testing, a drug manufacturer must obtain a marketing authorization in line with Regulation EC 726/2004 (and as transposed into national laws) before it may place its medicinal product on the market in the EU. There are various application procedures available depending on the type of product involved. The centralized procedure gives rise to marketing authorizations that are valid throughout the EU and, by extension (after national implementing decisions), in Norway, Iceland and Liechtenstein, which, together with the EU member states, comprise the EEA. Applicants file marketing authorization applications with the EMA where they are reviewed by a relevant scientific committee, in most cases the Committee for Medicinal Products for Human Use ("CHMP"). The EMA forwards CHMP opinions to the European Commission, which uses them as the basis for deciding whether to grant a marketing authorization. The centralized procedure is compulsory for medicinal products that (i) are derived from biotechnology processes; (ii) contain a new active substance (not yet approved on November 20, 2005) indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative disorders, viral diseases or autoimmune diseases and other immune dysfunctions; (iii) are orphan medicinal products; or (iv) are advanced therapy medicinal products, such as gene or cell therapy medicines.

For those medicinal products for which the centralized procedure is not available, the applicant must submit marketing authorization applications to the national medicines regulators through one of three procedures: (i) a national procedure, which results in a marketing authorization in a single EU member state; (ii) the decentralized procedure, in which applications are submitted simultaneously in two or more EU member states; and (iii) the mutual recognition procedure, which must be used if the product has already been authorized in at least one other EU member state, and in which the EU member states are required to grant an authorization recognizing the existing authorization in the other EU member state, unless they identify a serious risk to public health. A national procedure is only possible for one-member state; as soon as an application is submitted in a second member state the mutual recognition or

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decentralized procedure will be triggered. Marketing authorizations granted under a national procedure are also initially valid for five years but can be renewed indefinitely.

Marketing authorization applications for generic medicinal products do not need to include the results of pre-clinical and clinical trials but can instead refer to the data included in the marketing authorization of a reference product for which regulatory data exclusivity has expired. If a marketing authorization is granted for a medicinal product containing a new active substance, that product benefits from eight years of data exclusivity during which generic marketing authorization applications referring to the data of that product may not be accepted by the regulatory authorities, and a further two years of market exclusivity during which such generic products may not be placed on the market. The two-year period may be extended to three years if during the first eight years a new therapeutic indication with significant clinical benefit over existing therapies is approved.

In the UK, the EU centralized procedure described above no longer applies and a separate application will be required to the UK Medicines and Healthcare products Regulatory Agency ("MHRA") for a UK marketing authorization. The MHRA may consider marketing authorizations approved in EEA member states through decentralized or mutual recognition procedures, which may accelerate the process of granting a marketing authorization in the UK.

In the EU, companies developing a new medicinal product must agree to a Paediatric Investigation Plan ("PIP") with the EMA and must conduct pediatric clinical trials in accordance with that PIP unless a waiver applies, for example because the relevant disease or condition occurs only in adults. The marketing authorization application for the product must include the results of pediatric clinical trials conducted in accordance with the PIP, unless a waiver applies, or a deferral has been granted, in which case the pediatric clinical trials must be completed at a later date. Products that are granted a marketing authorization on the basis of the pediatric clinical trials conducted in accordance with the PIP are eligible for a six-month extension of the protection under a supplementary protection certificate (if any is in effect at the time of approval). This pediatric reward is subject to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted. In the UK, after January 1, 2021, PIP applications were required to be submitted separately to the MHRA though EU PIPs agreed prior to that date were adopted as UK PIPs as at that date. The UK MHRA PIP application system mirrors the EU system and the MHRA has said it will continue to follow the EU guidelines on such applications. The MHRA will take account of whether an EU PIP is already granted when deciding whether to grant a UK PIP. The MHRA strongly encourages parallel submission to EMA and MHRA.

***Pharmacovigilance and risk management***

The holders of a marketing authorization are subject to extensive pharmacovigilance and risk management obligations under Directive 2001/83/EC and Regulation EC 726/2004.

According to EMA, pharmacovigilance "is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem." In the EU and the UK, the holders of a marketing authorization must establish and maintain a pharmacovigilance system with the overall aim to monitor and ensure the safety of a medicinal product and appoint an individual qualified person for pharmacovigilance who is responsible for oversight of that system. They are also required to establish and maintain a pharmacovigilance system master file detailing the pharmacovigilance system. On request, the system master file must be made available to the competent authorities for inspection. In the UK, if the qualified person does not reside or operate in the UK, there will need to be a national pharmacovigilance contact person who does reside or operate in the UK. Key pharmacovigilance obligations include the recording of suspected serious adverse reactions to the medicinal product in and outside the EU and promptly reporting them through the centralized EudraVigilance database. In addition, the holders of a marketing authorization are required to submit periodic safety update reports ("PSURs").

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All new marketing authorization applications must include an RMP describing the risk management system that the holder of the marketing authorization will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the marketing authorization. Such risk-minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs or the conduct of additional clinical trials or post-authorization safety studies.

***Promotional restrictions***

In the EU and UK, all advertising and promotional activities for the product must be consistent with the approved summary of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines is also prohibited. Although general requirements for advertising and promotion of medicinal products are established under EU and UK legislation, the details are governed by national regulations and can differ from one country to another.

***Manufacturing and importing***

Medicinal products may only be manufactured in the EU, or imported into the EU from another country, by the holder of a manufacturing authorization. The manufacturer or importer must comply with the EU GMP and have a qualified person who is responsible for certifying that each batch of product placed on the market in a member state has been manufactured in accordance with the laws in force in that member state and in accordance with the requirements of the marketing authorization. If a medicinal product is imported from outside the EU, each batch of product has to undergo a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorization. Manufacturing facilities are subject to periodic inspections by the competent authorities for compliance with EU GMP and may, if products are produced for another market, also be subject to inspections under the GMP requirements applicable in that market. The position in the UK is broadly equivalent, save that a UK specific manufacturer's license is required from the MHRA (in addition to the UK marketing authorization), which also requires compliance with EU GMP. For the purposes of EU legislation, the UK is now classified as a "third country."

The manufacture, import, export, storage, distribution and sale of controlled substances are subject to additional regulation at the national level in the EU and UK. In many EU member states, the regulatory authority responsible for medicinal products is also responsible for controlled substances. In the UK and in certain EU member states, responsibility is split and in the UK the Home Office is responsible for controlled substances while the MHRA is responsible for medicinal products. Generally, any company manufacturing or distributing a medicinal product containing a controlled substance in the EU or UK will need to hold a controlled substances license from the competent national authority and will be subject to specific record-keeping and security obligations. Separate import or export certificates are required for each shipment into or out of the country.

***Pricing and reimbursement***

Pricing and reimbursement remain mostly within the discretion of the respective member state. However, the member states must at least comply with the Transparency Directive (Directive 89/105/EEC), which primarily provides procedural obligations. Governments influence the price of medicinal products in the EU and the UK through pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to patients. Some member states operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these member states may require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available therapies. Other countries allow companies to fix their own prices for medicinal products but monitor and control company profits. Such differences in national pricing regimes may create price differentials across Europe. The downward pressure on healthcare costs in general,

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particularly prescription medicines, has become intense. As a result, barriers to entry of new products are becoming increasingly high and patients are unlikely to use a drug product that is not reimbursed by their government.

In addition, in most European countries, physicians are encouraged or even required to prescribe generic rather than branded products and many governments also advocate generic substitution by requiring or permitting pharmacists to substitute a different company's generic version of the branded drug product that was originally prescribed.

**Rest of the world**

***Current markets***

After the U.S. and Europe, our largest markets are Canada and Australia, where we market our products pursuant to standards set by Health Canada and the Therapeutic Goods Administration, respectively. We also market our products in certain other developed countries. The laws, guidelines and standards promulgated by the relevant regulatory authorities that regulate the development, testing, manufacturing, marketing and selling of pharmaceuticals in each of these jurisdictions are broadly similar to those in the U.S. and Europe, although the precise requirements may vary from country to country.

We also market our products in various emerging markets, where regulatory review and oversight processes continue to evolve. At present, such countries typically require prior regulatory approval or marketing authorization from large, developed markets (such as the U.S.) before they will initiate or complete their review. Some countries also require the applicant to conduct local clinical trials as a condition of marketing authorization. Many emerging markets continue to implement measures to control drug product prices, such as implementing direct price controls or advocating the prescribing and use of generic drugs.

**Environmental**

Our Fine Chemical Plant manufactures the buprenorphine hydrochloride ("HCl") active pharmaceutical ingredient used in the formulation of SUBLOCADE long-acting injection, SUBOXONE Film, SUBUTEX Tablet, SUBOXONE Tablet, and BUPRENEX. The FCP utilizes caustic materials as part of the manufacturing process, as well as a thermal reaction; however, these aspects of the process are tightly controlled and, we believe, represent low risk to the surrounding environment.

Our operations, like those of other pharmaceutical companies, involve the use of substances regulated under environmental laws, primarily in manufacturing processes and, as such, we are subject to numerous federal, state, local and non-U.S. environmental protection and health and safety laws and regulations. Certain environmental laws can impose strict liability (that is, liability imposed without regard to fault) and joint and several liability on current or previous owners of real property and current or previous owners or operators of facilities for the costs of investigation, removal or remediation of hazardous substances or materials at such properties or at properties at which parties have disposed of hazardous substances. These agencies may require that we reimburse the government for costs incurred at these sites or otherwise pay for the cost of investigation and clean-up of these sites, including compensation for damage to natural resources. Environmental laws are complex, frequently amended and have generally become more stringent over time.

**Human Capital**

Our goal is to be an employer of choice and provide a fair, equitable, and conducive working environment free from discrimination and harassment. Indivior regards its employees as fundamental to its long-term success and provides a variety of training, development, and communication programs to ensure its business activities are always conducted in line with its guiding principles and stakeholder expectations.

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At Indivior, we value our distinctive culture and believe it is a key source of sustainable competitive advantage. We believe diversity and inclusion in its broadest sense supports innovation, continuous improvement of quality, and increased speed and efficiency in meeting the various needs of patients, customers and stakeholders.

Our Diversity and Inclusion Policy, which applies to the Board and our workforce, reflects our beliefs and values. Supporting and promoting the diversity of our people is an important priority for the Group, and we have focused on developing an inclusive culture that values all employees regardless of their age, disability, gender, race, sexual orientation or other protected characteristics. We achieve this through an ongoing focus on creating an environment that allows our talented people to prosper and a framework of policies and practices that promote equal opportunities in all areas of employment.

Our 50-person Culture & Inclusion Champions network is well established and has helped us to implement many initiatives aimed at strengthening our diversity and inclusion practices and building on our culture. We also conduct an annual survey of employees to monitor engagement levels and act on feedback received through this process. At the end of 2022, we were awarded the Great Place To Work Certification for all countries entered: Australia, Canada, France, Germany, Italy, Sweden, the United Kingdom, and the United States.

The table below sets forth the average monthly number of persons employed by the Group, including Directors, by business function during the years indicated.

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| | | | |
|:---|:---|:---|:---|
| **Business function** | **2022** | **2021** | **2020** |
| Operations | 675 | 573 | 567 |
| Management | 178 | 164 | 168 |
| Research and development | 75 | 65 | 84 |
| Average number of employees | 928 | 802 | 819 |

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At December 31, 2022, the Group employed 953 people worldwide. Of these, 657 were located in the United States, 264 were located in Europe, the Middle East, Africa, or Canada, and 32 were located in Australia.

Certain of our employees are represented by unions or works councils. We believe that we have a good relationship with our employees and with the unions and works councils that represent certain employees.

We strive to promote diversity, inclusion and equal opportunity across the organization. Women or minorities hold a third (4 of 12) of the seats on our Board of Directors. As of December 31, 2022, 52% of our employees were women. Additionally, 28% of senior managers (including members of our Executive Committee who are not directors of Indivior PLC and directors of each subsidiary company) were women.

***Addressing the COVID-19 pandemic***

In response to COVID-19, the Group established an agile cross-functional response structure and implemented several mitigation and contingency actions to help maintain the functioning of operations across the organization, supply of all products to our patients, and the welfare of our employees. The Group continuously monitors the potential impact on the health and well-being of our employees, as well as the workforce of our key third parties, which ultimately may impact our operations, and ensures our mitigation and contingency actions are as appropriate and effective as possible.

During 2022, Indivior continued to maintain many of the measures it put in place in 2020 for the health, welfare and safety of its employees during the COVID-19 pandemic. These measures were tailored to the specific circumstances of each workforce group and site, such as, for example, workers at the FCP in Hull in the United Kingdom or sales force representatives working in communities across the

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U.S. In 2020, the FCP also put in place a comprehensive risk management process tailored to current circumstances and prevailing UK government regulations that is still in operation.

Indivior's management team is mindful of its employees' expectations following the working environment changes and experiences that resulted from the global COVID-19 pandemic. Indivior continues to promote flexible ways of working including a new collaboration model where eligible employees work three core days within the working week in office and the remaining two days can be remote. Given the shift to a remote working environment started in 2020, the Group continues to closely monitor cybersecurity threats and the overall operating effectiveness of the monitoring and control activities.

See "*<u>[Item 3.D](#id39cb0e1a10249e1ab7b8f77d921d68a_1981)</u>, Risk Factors*", "*Risks Related to our Financial Condition and Tax Matters—The COVID-19 pandemic and governmental and societal responses thereto have adversely affected our business, results of operations and financial condition, and the continuation of the pandemic or the outbreak of other health epidemics could harm our business, results of operations, and financial condition.*"

**Corporate Governance**

We provide information with respect to our Board of Directors, Executive Officers and corporate governance policies and principles on our Investor Relations website, <u>www.Indivior.com/en/Investors</u><u>.</u> Specifically, the Group makes available on its Investor Relations website, under the heading *"Governance & Responsibility"* (i) its codes of conduct or ethics for the Board, senior financial officers, and employees, and (ii) the terms of reference (committee charters) of the Group's board committees. If the Group makes changes in, or provides waivers from, the provisions of any of its codes of ethics that the SEC requires it to disclose, the Group intends to disclose these events in the "*Governance & Responsibility*" section of its Investor Relations website.

**C.Organizational Structure**

Indivior PLC is the ultimate holding company of the Group. The following table sets out details of the Group's significant subsidiaries as of December 31, 2022:

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| | | |
|:---|:---|:---|
| **Name** | **Country of** <br>**incorporation or registration** | **Proportion of** <br>**Ownership Interest** |
| RBP Global Holdings Limited | England and Wales | 100% |
| Indivior UK Limited | England and Wales | 100% |
| Indivior Europe Limited | Ireland | 100% |
| Indivior Inc. | U.S. | 100% |
| Indivior Treatment Services, Inc. | U.S. | 100% |
| Indivior Pty Ltd | Australia | 100% |
| Indivior Finance Sarl | Luxembourg | 100% |

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**D.Property, Plant and Equipment**

The following table contains information regarding existing or planned material tangible fixed assets owned or leased by the Group.

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| | | | |
|:---|:---|:---|:---|
| **Location** | **Tenure** | **Principal use** | **Size** |
| Richmond, Virginia | Lease | Office space | 72,602 square feet |
| Hull, England | Owned<sup>(1)</sup> | Office space, research facility and manufacturing facility | 70,808 square feet |
| Fort Collins, Colorado | Lease | Office space and <br>research facility | 41,600 square feet |
| Slough, England | Lease | Office space | 20,912 square feet |
| Santa Monica, California | Lease | Office space | 7,863 square feet |

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(1)The Hull, England property is leased for 150 years and accounted for as owned.

**ITEM 4A: UNRESOLVED STAFF COMMENTS**

None.

**ITEM 5: OPERATING AND FINANCIAL REVIEW AND PROSPECTS**

The following discussion of our financial condition and results of operations should be read in conjunction with the audited consolidated financial statements as of December 31, 2022, 2021 and 2020 and for each of the three years ended December 31, 2022 (the "Consolidated Annual Financial Statements"). The historical financial information has been included in "*<u>[Item 18](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u>. Financial Statements*." The following discussion should also be read in conjunction with other information relating to our business contained in this registration statement, including "*<u>[Item 3.](#id39cb0e1a10249e1ab7b8f77d921d68a_1981)[D](#id39cb0e1a10249e1ab7b8f77d921d68a_1981)</u>. Risk Factors*."

The Historical Financial Information has been prepared in accordance with IFRS as issued by the International Accounting Standards Board.

The following discussion includes forward-looking statements that reflect our plans, estimates and beliefs and involves risks and uncertainties. Our actual results could differ materially from those discussed in these statements. Factors that could cause or contribute to these differences include, but are not limited to, those discussed below and elsewhere in this registration statement, particularly in "*<u>[Item 3.D.](#id39cb0e1a10249e1ab7b8f77d921d68a_1981)</u> Risk Factors*."

References below to "2022", "2021," and "2020" are for the financial years ending December 31, 2022, December 31, 2021, and December 31, 2020, respectively.

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**A.Operating Results**

The following table summarizes our key measures of financial condition and results of operations for the periods under review:

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| | | | | | |
|:---|:---|:---|:---|:---|:---|
| | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** |
|<br>*(in millions, except per share data)* | **2022** | **2021** | **2020** | **% Change 2022-2021** | **% Change 2021-2020** |
| Net revenues | $901 | $791 | $647 | 14% | 22% |
| Operating (loss)/profit<sup>(1)</sup> | $(85) | $213 | $(156) | NM | NM |
| Adjusted operating profit<sup>(3)</sup> | $212 | $187 | $88 | 13% | 113% |
| Net (loss)/income<sup>(1)</sup> | $(53) | $205 | $(148) | NM | NM |
| Adjusted net income<sup>(3)</sup> | $169 | $140 | $59 | 21% | 137% |
| (Loss)/earnings per share - basic<sup>(1)(2)</sup> | $(0.38) | $1.41 | $1.01 | NM | NM |
| Adjusted earnings per share - basic<sup>(1)(2)</sup>  | $1.22 | $0.96 | $0.40 | 27% | 140% |

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(1)Reflects a provision of $290 million for multidistrict antitrust class and state claims.

(2)On October 10, 2022, Indivior PLC completed a 5:1 share consolidation. The Company's basic and diluted weighted average number of shares outstanding, basic (loss)/earnings per share, and diluted (loss)/earnings per share reflect the share consolidation for all periods presented. See<u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1524)[23](#id39cb0e1a10249e1ab7b8f77d921d68a_1524)</u> for further discussion.

(3)Adjusted Basis excludes the impact of the items. See "*<u>[Item 5](#i8b2234b53cbb4eeca331cabc1953ffe2_600095)</u>*. Operating and Financial Review and Prospects — Exceptional Items and Adjusted Results" for a discussion of the items excluded from our adjusted results and "*<u>[Item 5](#i8b2234b53cbb4eeca331cabc1953ffe2_600107)</u>*. Operating and Financial Review and Prospects — Non-IFRS Measures" for the definition of adjusted operating profit, adjusted net income, adjusted earnings per share, a reconciliation of this metric to a reported IFRS measure for the periods presented and an explanation of why we believe this metric provides useful information to investors regarding our financial condition and results of operations. Adjusted results are not a substitute for, or superior to, reported results presented in accordance with International Financial Reporting Standards.

(4)NM - Not meaningful.

For the periods under review, the Group operated as one business segment, which is predominantly the development, manufacture, and sale of buprenorphine-based prescription drugs for the treatment of opioid dependence and related disorders. Substantially all our net revenues for such periods were derived from sales of SUBLOCADE and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE tablet). SUBLOCADE accounted for 45% of our net revenues in 2022 (2021: 31%, 2020: 20%). Other buprenorphine-based sublingual products accounted for 52% of our net revenues in 2022 (2021: 67%, 2020: 78%). In the U.S. market for buprenorphine-based treatments for opioid dependence, SUBOXONE Film had an average market share of approximately 19% in 2022 (2021: 22%, 2020: 21%).

The U.S. market is the largest contributor to our net revenues. The following table sets out a breakdown of net revenue as between the U.S. and the rest of the world.

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| | | | | | |
|:---|:---|:---|:---|:---|:---|
| | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** |
|<br>*(in millions)* | **2022** | **2021** | **2020** | **2022-2021 % Change** | **2021-2020 % Change** |
| United States | 731 | 603 | 456 | 21% | 32% |
| Rest of world (including United Kingdom) | 170 | 188 | 191 | (10)% | (2)% |
| **Total Indivior Group net revenue**  | $**901** | $**791** | $**647** | **14%** | **30%** |

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**Key factors affecting operating results**

***Market growth***

Our net revenues are impacted by the overall growth of the markets where we operate. Market growth is impacted by increased treatment penetration, which is a function of patient awareness and desire to seek treatment, as well as the number of certified physicians available to deliver treatment. Competitive pressures can drive pricing and can also influence decisions of third-party payors regarding inclusion of products on their list of approved drugs covered by insurance. To increase access to treatment for patients, we engage with government agencies, key opinion leaders in addiction and healthcare professionals to bring patient outcomes to the forefront of decision making. Additionally, we engage in non-branded marketing to increase awareness for patients and families impacted by addiction on a country-by-country basis as allowed by local regulations.

In 2022, the U.S. BMAT market grew in mid-single digits. The Group continues to expect long-term US market growth to be sustained in the mid- to high-single digit percentage range due to increased overall public awareness of the opioid epidemic and approved treatments, together with regulatory and legislative actions that have expanded OUD treatment funding and treatment capacity.

The December 29, 2022 enactment of the Consolidated Appropriations Act, 2023 (P.L. 117-328), including the Mainstreaming Addiction Treatment Act (MAT Act), eliminated the requirement for health care practitioners (HCP) to apply for a separate waiver through the Drug Enforcement Administration (DEA) to dispense certain treatments for maintenance or detoxification of patients with OUD, including buprenorphine. Historically, HCPs treating patients with OUD with buprenorphine had to undertake special additional registration, meet training requirements that did not apply to any other medicine class, and limit the number of patients they could treat. Indivior believes the elimination of these requirements as part of this legislation will help to normalize the chronic disease of addiction and expand access to evidence-based buprenorphine treatment. The Group supports efforts to encourage more HCPs to provide BMAT as a treatment option.

***Competition***

We operate in a highly-competitive industry. While we seek patent and trademark protection where appropriate, several of our branded products face competition from generic products in key markets as well as competition from alternative products to treatments. The introduction of generic or branded products that compete with the Group's products could impact the market share of the Group's products and pricing and adversely impact its results. The introduction of generic products typically leads to a loss of sales of a branded product and/or a decrease in the price at which branded products can be sold. Additionally, legislation enacted in the U.S. allows for, and in a few instances in the absence of specific instructions from the prescribing physician mandates, the dispensing of generic products rather than branded products where a generic version is available.

SUBLOCADE is patent protected in the U.S., Australia, Canada, UK, Ireland, France, Germany, Italy, Spain, Denmark, Finland, Norway, the Netherlands, Switzerland, Sweden, Israel, Japan, Mexico and New Zealand. However, Camurus, in partnership with Braeburn, has sought FDA approval of its long-acting injectable buprenorphine product. This product is already well established the Nordics (Norway, Sweden, Finland, and Denmark) and Australia, and available in other parts of Europe. Based on the efforts to date by this competitor in the U.S., we expect their product to become available for sale in the U.S. eventually.

In the U.S. market for buprenorphine-based treatments for opioid dependence, SUBOXONE Film had an average market share of approximately 19% in 2022 and 22% in 2021, and 21% in 2020.

Our SUBOXONE Film product already faces three generic competitors in the U.S., and a fourth competitor received approval for its product in May 2022 but has not yet launched. We understand that a fifth competitor has been approved to enter the market beginning in 2024. We have seen our market shares of SUBOXONE Film decline from greater than 50% in 2018 to 19% in 2022, and expect further

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declines if another competing product becomes available. Additionally, we no longer promote SUBOXONE Film in the U.S. In contrast, no generic competition is present in Australia. In Europe and Canada, we have recently launched SUBOXONE Film and it enjoys patent protection until 2030.

Our SUBOXONE and SUBUTEX Tablets face generic competition in most markets. In the EU, generic versions of the SUBUTEX Tablet have been available since 2010 but our branded SUBUTEX Tablet currently maintains a market share of approximately 50.7% (by mg volume) of the mono-buprenorphine market giving the Group a total market share (mono-buprenorphine and buprenorphine/naloxone) of approximately 55.7%. Further our SUBOXONE and SUBUTEX Tablets face competition from branded oral buprenorphine-based tablets and historically well-established methadone oral formulations.

We launched our PERSERIS long acting injectable for the treatment of schizophrenia in the U.S. in February 2019. While it enjoys patent protection, it faces competition from other long-acting injectables marketed by Johnson and Johnson and Otsuka, as well generic competition from oral risperidone formulations. We also anticipate the eventual approval of another branded long-acting injectable containing risperidone from and an additional competitor, but expect that it will be limited to maintenance treatment of patients already controlled on oral risperidone.

***Distribution channels***

In the United States, we have distribution agreements with the three largest wholesalers, which accounted for 55% of our global net revenue in 2022 (2021 and 2020: 57%). These wholesalers, in turn, distribute our products through various channels including the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Commercial managed care.* This category comprises insurance programs intended to reduce the cost of providing health benefits and improve the quality of care to their members. One of the most common forms of managed care is the use of a panel or network of healthcare providers that provide care to enrollees. Also within commercial managed care is the Medicare Part D Program, a social insurance program administered by the U.S. government.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Medicaid*. Medicaid is a jointly funded, Federal-State health insurance program that covers children, the aged, blind, and/or disabled and other people who are eligible to receive federally assisted income maintenance payments, including prescription drugs. We are obligated to offer "Best Price" under Medicaid, being the lowest price at which the manufacturer sells a drug to any purchaser in any pricing structure (inclusive of discounts and rebates).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Federal.* This channel encompasses the provision of outpatient drugs to federal government purchasers, including the U.S. Department of Veterans Affairs and the Department of Defense, or under the 340B Program. Pricing discounts are provided separately for drugs provided under these schemes.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *Pharmacy.* This channel covers end customers paying cash directly at the pharmacy. Often, we provide discount coupons to customers where cash is used for payment.

In the rest of the world, distribution channels differ by country. For example, in France, we engage with different wholesalers, hospitals, pharmacies and individuals, while in Australia, we engage with a single pre-wholesaler that negotiates the import and onward distribution of the products across the country.

***Pricing***

We offer various types of price reductions for our products, particularly in the U.S., which are reflected in net revenue. In the U.S., we primarily offer:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• ***Medicaid, federal and commercial managed care rebates.*** These are rebates granted to Medicaid, U.S. federal agencies and commercial managed care providers that purchase products from us. The level of these rebates varies by channel and product. Patients covered by

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commercial insurance often benefit from coupons to reduce any out-of-pocket payments they would otherwise be required to make.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• ***Fees under distribution agreements.*** Wholesalers, specialty pharmacies and specialty distributors of the Group's products are generally offered various forms of consideration, including allowances/discounts, service fees and prompt payment discounts, for distributing the products. Wholesaler and specialty distributor allowances and service fees arise from contractual agreements and are estimated as a percentage of the price at which the Group sells product to them. In addition, customers are offered a prompt pay discount for payment within a specified contractual period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• ***Chargebacks.*** Discounts that occur when contracted indirect customers purchase directly from wholesalers and specialty distributors. Contracted customers generally purchase a product at its contracted price. The wholesaler or specialty distributor, in turn, then generally charges back to the Group the difference between the wholesale acquisition cost and the contracted price paid to the wholesaler or specialty distributor by the customer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• ***Returns.*** Returns are generally made if the product is damaged, defective, or otherwise cannot be used by the customer. In the United States, the Group typically permit returns six months prior to and up to twelve months after the product expiration date. Outside the United States, returns are only allowed in certain countries on a limited basis.

In Europe, changes to government policy or practices could adversely affect the level of reimbursement through government schemes. In the United States, proposals by legislators at both federal and state levels, regulators, and third-party payors continue to emerge with the aim of keeping healthcare costs down while expanding healthcare benefits. Similarly, in Europe, legislators, policymakers and healthcare insurance funds continue to propose and implement cost-containing measures to keep healthcare costs down, due in part to the attention being paid to healthcare cost containment and other austerity measures in Europe. Certain of these changes could impose limitations on the prices that the Group will be able to charge for its products and any approved product candidates. Further, an increasing number of EU member states and other foreign countries use prices for products established in other countries as "reference prices" to help determine the price of the product in their own territory. Consequently, a downward trend in prices of products in some countries could contribute to similar downward trends elsewhere.

***Legal proceedings***

The Group's operations are subject to a wide range of laws and regulations. Perceived or actual non-compliance with these applicable laws and regulations can result in investigations or proceedings leading to civil or criminal sanctions, fines and/or damages. The Group is also a party to several civil lawsuits, including ongoing litigation in the federal False Claims Act allegations, the ANDA Litigation, multidistrict antitrust class and state claims and civil opioid litigation.

We have made provisions for matters that the Group has assessed to be probable of loss. See <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u> under "False Claims Act Allegations," "Intellectual property related matters," and "Multidistrict antitrust class and state claims**"** for a discussion of matters in which liabilities or provisions have been recognized.

The Group has assessed all other legal and other matters to be <u>not</u> probable based upon current facts and circumstances, including any potential impact the DOJ resolution could have on these matters. Where liabilities related to these matters are determined to be possible, they represent contingent liabilities for which liabilities or provisions have been recognized, <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1505)[20](#id39cb0e1a10249e1ab7b8f77d921d68a_1505)</u> sets out the contingent liabilities for legal and other disputes for which the Group has assessed as contingent liabilities. Where we believe that it is possible to reasonably estimate a range for the contingent liability this has been disclosed.

The Group has settled several regulatory and litigation matters since 2020 requiring contractual payments to be made in future periods. See "*<u>[Item 5](#iaf701403a2a44bfd822eebd888f635b9_149177)[.](#iaf701403a2a44bfd822eebd888f635b9_149177)</u> Liquidity and Capital Resources—Contractual* 

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*Obligations*" for payments to be made related to the settlement of litigation matters, the Group's Term Loan and contractual lease liabilities.

For further discussion regarding legal proceeding risk, see *"Notes to the Consolidated Financial Statements* <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1505)[20](#id39cb0e1a10249e1ab7b8f77d921d68a_1505)</u>*Contingent liabilities* and <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>*Legal Proceedings*, and "*<u>[Item 3.D](#id39cb0e1a10249e1ab7b8f77d921d68a_1981)</u>.—Risk Factors*."

**Key income statement items**

***Net revenue***

Net revenue is generated from sales of pharmaceutical products (i.e. gross revenues), net of rebates, discounts and returns. We estimate and recognize returns, discounts, incentives and rebates in the period in which we recognize the underlying sales, as a reduction of gross revenues.

***Cost of sales***

Cost of sales includes all costs directly related to bringing products to their final selling destination. It includes purchasing and receiving costs, direct and indirect costs to manufacture products, including materials, labor and overhead expenses necessary to acquire and convert purchased materials and supplies into finished goods. Cost of sales also includes royalties on certain licensed products, inspection costs, depreciation, amortization of intangible assets for marketed products, freight charges and costs to operate equipment.

***Selling, general and administrative expenses***

Selling, general and administrative expenses comprise personnel costs (primarily, the field sales force), as well as marketing expenses, consulting services, depreciation of fixed assets, travel and other selling and distribution related expenses, corporate overheads and other administrative expenses. Selling, general and administrative expenses also include expenses relating to recognition or release of legal provisions.

***Research and development expenses***

Research and development expenses comprise internal research costs and external costs of human and animal trials, and corresponding equipment required. Research and development expenditure is expensed as incurred prior to filing for regulatory approval, as the Group has determined that filing for regulatory approval is the earliest point at which a project's successful outcome can become probable.

***Net finance expense***

Net finance expenses are the finance costs of borrowings and legal settlements recognized in the income statement over the term of those borrowings and related legal settlement payment periods.

***Taxation***

Tax charges represent the aggregate amount included in the determination of profit or loss for the year in respect of current tax and deferred tax. Current tax is the amount of income taxes payable (recoverable) in respect of the taxable profit/(loss) for a year. Deferred tax represents the amounts of income taxes payable/(recoverable) in future periods in respect of taxable (deductible) temporary differences and unused tax losses.

**Results of operations**

The discussion below references certain non-IFRS measures, including adjusted gross profit, adjusted gross margin, adjusted selling, general and administrative expenses, adjusted other operating income, adjusted operating profit, adjusted net finance expense and adjusted net income. These measures are not a substitute for, or superior to, reported results presented in accordance with IFRS. In addition, certain of these non-IFRS measures are adjusted results. Where significant expenses or income

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that do not reflect the Group's ongoing operations are incurred during the year, these items are disclosed as exceptional items (non-recurring and/or non-operating adjustments). These items are excluded from adjusted results consistent with our internal reporting.

See also "*<u>[Item 5](#i8b2234b53cbb4eeca331cabc1953ffe2_600095)</u>. Operating and Financial Review and Prospects — Exceptional Items and Adjusted Results*" for a discussion of the exceptional items excluded from our adjusted results and "*<u>[Item 5](#i8b2234b53cbb4eeca331cabc1953ffe2_600107)</u>. Operating and Financial Review and Prospects — Non-IFRS Measures*" for the definition of adjusted operating profit, adjusted net income, adjusted earnings per share, a reconciliation of this metric to a reported IFRS measure for the periods presented and an explanation of why we believe this metric provides useful information to investors regarding our financial condition and results of operations.

The results of operations that follow reflect the historical periods under review and should not be taken as indicative of future performance.

***Comparison of the years ended December 31, 2022 and December 31, 2021***

.

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| | | | |
|:---|:---|:---|:---|
| | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** |
|<br>*(in millions)* | **2022** | **2021** | **% Change** |
| **Net revenues**  | $**901** | $**791** | **14%** |
| Cost of sales | (159) | (127) | 25% |
| **Gross profit**  | **742** | **664** | **12%** |
| Selling, general and administrative expenses | (763) | (431) | 77% |
| Research and development expenses | (72) | (52) | 38% |
| Net other operating income | 8 | 32 | N/A |
| **Operating (loss)/profit**  | **(85)** | **213** | **(140)%** |
| Net finance expense | (29) | (23) | 26% |
| **(Loss)/profit before taxation**  | **(95)** | **190** | **(150)%** |
| Income tax benefit | 42 | 15 | 180% |
| **Net (loss)/income**  | $**(53)** | $**205** | **(126)%** |

---

***Net revenues.*** Substantially all our net revenues for such periods were derived from sales of SUBLOCADE, PERSERIS and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet). SUBLOCADE accounted for 45% of our net revenues in 2022 (2021: 31%). PERSERIS accounted for 3% of our net revenues in 2022 (2021: 2%) and other buprenorphine-based sublingual products accounted for 52% of our net revenues in 2022 (2021: 67%). The increase in net revenues for such periods were attributable to an increase in products sold across all major product lines. Price changes were insignificant to our net revenues.

On a disaggregated basis, the Group's net revenue by major product line:

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| | | | |
|:---|:---|:---|:---|
| | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** |
|<br>*(in millions)* | **2022** | **2021** | **% Change** |
| SUBLOCADE | 408 | 244 | 40% |
| PERSERIS | 28 | 17 | 65% |
| Sublingual (SUBOXONE)/Other | 465 | 530 | (12)% |
| **Total Indivior Group net revenue**  | $**901** | $**791** | **14%** |

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Total net revenues increased by $110 million, or 14%, to $901 million in 2022 from $791 million in 2021. The increase was primarily driven by higher net revenues from SUBLOCADE, which increased by $164 million or 14% from 2021, due to continued growth in the BMAT market and by our relatively stable

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market share for SUBOXONE Film in the U.S. Strong year-over-year SUBLOCADE net revenue growth was due to volume growth in the Organized Health Systems channel and increased new patient enrollments. SUBOXONE Film share averaged 20% (2021: 20%) and exited 2022 at 19% (2021 exit share: 22%). In 2022, total net revenues from PERSERIS was $28 million, representing a 65% increase from 2021.

The U.S. market is the largest contributor to our net revenues. Sales rebates, discounts and returns and other offsets to gross revenues are reflected in net revenues. The following table sets out a breakdown of net revenue as between the U.S. and the rest of the world.

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| | | | |
|:---|:---|:---|:---|
| | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** |
|<br>*(in millions)* | **2022** | **2021** | **% Change** |
| United States | 731 | 603 | 21% |
| Rest of world (including United Kingdom) | 170 | 188 | (10)% |
| **Total Indivior Group net revenue**  | $**901** | $**791** | **14%** |

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In 2022, U.S. net revenue increased by 21% to $731 million as compared to $603 million in 2021, primarily due to strong growth in net revenue attributable to SUBLOCADE over the same period, the market share resilience of SUBOXONE Film and the underlying BMAT market growth.

In 2022, net revenue attributable to the rest of the world (including the United Kingdom) decreased 10% at actual exchange rates to $170 million from $188 million in 2021. In 2022, positive contributions from product launches in new markets (SUBLOCADE / SUBUTEX Prolonged Release and SUBOXONE Film) were more than offset by unfavorable foreign currency translation and ongoing competitive pressure on legacy tablet products. In 2022, SUBLOCADE / SUBUTEX® Prolonged Release net revenue in ROW was $27 million (at actual exchange rates), respectively. Net revenue at a constant exchange rate is an alternative performance measure used by Management to evaluate underlying performance of the business and is calculated by applying the 2021 exchange rate to net revenue in the currency of the foreign entity. Please refer the *Non-IFRS Measures* section below for further discussion.

We estimate provisions for rebates, discounts and returns based on contractual arrangements with customers or terms of the regulations and/or agreements applicable for transactions with healthcare authorities, and in some cases on assumptions about the attainment of targeted volumes. We recognize returns, discounts, incentives and rebates in the period in which we recognize the underlying sales, as a reduction of gross revenues and as current liabilities on our consolidated balance sheets under trade and other payables. The outstanding amounts are affected by changes in gross sales, the provision for net product sales deductions and timing of payments/credits. Estimates, assumptions and judgements applied to determine the provision for rebates, discounts and returns are set out in "*<u>[Item 18](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u>. Financial Statements—*<u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1372)</u> *"Basis of Preparation.*"

The following table provides a summary of activities with respect to provisions for rebates, discounts and returns for the years ended December 31, 2022 and 2021:

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| | | |
|:---|:---|:---|
| **Provision for rebates, discounts and returns** *(in millions)* | **2022** | **2021** |
| **Opening balance at beginning of period**  | (436) | (396) |
| Provision related to sales made in: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Current period | (1090) | (1003) |
| &nbsp;&nbsp;&nbsp;&nbsp;Prior period | 14 | 24 |
| Payments | 1084 | 939 |
| **Closing balance at beginning of period**  | $(428) | $(436) |

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The provision for rebates, discounts and returns decreased to $428 million as of December 31, 2022 from $436 million as of December 31, 2021 primarily due to the timing of rebate payments.

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The provision for rebates, discounts and returns increased from $396 million as of December 31, 2020 to $436 million as of December 31, 2021 primarily due to a year-over-year decrease in net revenue and timing of rebate payments.

***Cost of sales***. Cost of sales increased by $32 million, or 25%, to $159 million in 2022 from $127 million in 2021 due to higher sales volumes in the U.S and inflation.

Gross margin, which we define as gross profit divided by revenue, was 82% in 2022 as compared to 84% in 2021. We define adjusted gross margin as adjusted gross profit divided by net revenue and we define adjusted gross profit as gross profit excluding exceptional items. Gross margin declined slightly as expected in 2022, reflecting a higher mix of less profitable government channels for SUBOXONE film in the US and some cost impacts from inflation.

***Selling, general and administrative expenses***. Selling, general and administrative expenses increased by $332 million, or 77%, to $763 million in 2022 from $431 million in 2021. In 2022, selling, general and administrative expenses included exceptional items of $296 million for litigation provisions primarily related to the antitrust litigation and consumer protection claims. The increase in expenses also included $6 million and $2 million, respectively, of exceptional legal and consulting costs incurred in preparation for the planned additional listing of Indivior shares on a US exchange. Exceptional costs of $6 million was included in 2021 due to a non-cash adjustment to the provision for ANDA litigation offset by release of provisions.

Adjusted selling, general and administrative expenses, which we define as selling, general and administrative expenses excluding exceptional items, increased to $461 million in 2022 from $425 million in 2021. This increase primarily reflects sales and marketing investments to grow the Group's long-acting injectable products, SUBLOCADE and PERSERIS, along with cost inflation.

***Research and development expenses***. Research and development expenses increased by $20 million, or 38%, to $72 million in 2022 from $52 million in 2021. The increases over the year-ago periods reflect higher R&D activity for SUBLOCADE studies (safety and efficacy and Post Marketing Requirement (PMR) studies), process validation testing related to LAI capacity expansion and continued early-stage asset development.

***Net other operating income***. Net other operating income was $8 million in 2022 and $32 million in 2021. In 2022, net other operating income included a fair value gain on equity investments and the net proceeds received from the out-licensing of nasal naloxone opioid overdose patents and a Directors' & Officers' insurance claim settlement that were recorded as exceptional other operating income. Net other operating income in 2021 included $32 million, respectively, of net exceptional benefits primarily due to the net proceeds received from the sale of the legacy TEMGESIC®/ BUPREX® / BUPREXX® (buprenorphine) franchise outside of North America and a Directors' & Officers' insurance claim settlement.

Adjusted other operating income, which we define as other operating income excluding exceptional items was $3 million in 2022 (2021: nil).

***Operating (loss)/profit.*** Operating loss in 2022 was $85 million as compared to an operating profit of $213 million in 2021. In 2022, net exceptional costs of $297 million are included compared to the net exceptional benefit of $26 million in FY 2021. On an adjusted basis, 2022 adjusted operating profit increased 13% to $212 million (2021: $187 million). The loss in 2022 on a reported basis primarily reflected the exceptional litigation provision. The increase in 2022 on an adjusted basis reflected strong net revenue growth partially offset by higher operating expenses, mainly related to increased sales and marketing investments to grow the Group's long-acting injectable technologies, SUBLOCADE and PERSERIS, and higher R&D expenses.

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***Net finance expense.*** Net finance expenses decreased by $13 million, or 57%, to $10 million in 2022 from $23 million in 2021. The reduction in net finance expense reflected higher interest income earned on the Group's investments and rising interest rates.

Adjusted net finance expense, which we define as net finance expense excluding exceptional items was $22 million in 2021.There were no adjustments to net finance expense in 2022.

***Taxation***. Income tax benefit in 2022 was $42 million, reflecting an effective tax rate of 44% on the Group's profits for 2022 as compared with an income tax benefit of $15 million in 2021, reflecting an effective tax rate of -8% on the Group's profits for 2021. In 2022 adjusted tax expense was $33 million, excluding the $75 million tax benefit on exceptional items, an effective tax rate of 16%. In 2021, adjusted tax expense amounted to $25 million, excluding the $40 million tax benefit on exceptional items, an effective tax rate of 15%.

***Net income***. Net income decreased by $258 million, representing a net loss of $53 million in 2022 compared to a net profit of $205 million in 2021 which primarily reflects the exceptional litigation provision.

Adjusted net income, which comprises net income excluding exceptional items described above, was $169 million in 2022 compared to $140 million in 2021. The increase in net income on an adjusted basis primarily reflects higher net revenue partially offset by the increase in operating expense, primarily SG&A investments behind SUBLOCADE and PERSERIS.

***Comparison of the years ended December 31, 2021 and December 31, 2020***

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| | | | |
|:---|:---|:---|:---|
| | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** |
|<br>*(in millions)* | **2021** | **2020** | **% Change** |
| **Net revenues**  | $**791** | $**647** | **22%** |
| Cost of sales | (127) | (97) | 31% |
| **Gross profit**  | **664** | **550** | **21%** |
| Selling, general and administrative expenses | (431) | (666) | (35)% |
| Research and development expenses | (52) | (40) | 30% |
| Net other operating income | 32 |  | N/A |
| **Operating profit/(loss)**  | **213** | **(156)** | **(237)%** |
| Net finance expense | (23) | (17) | 35% |
| **Profit/(loss) before taxation**  | **190** | **(173)** | **(210)%** |
| Income tax benefit | 15 | 25 | (40)% |
| **Net income/(loss)**  | $**205** | $**(148)** | **(239)%** |

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***Net revenues.*** Substantially all our net revenues for such periods were derived from sales of SUBLOCADE, PERSERIS and other buprenorphine-based sublingual products (including SUBOXONE Film and SUBOXONE Tablet). SUBLOCADE accounted for 31% of our net revenues in 2021 (2020: 20%). PERSERIS accounted for 2% of our net revenues in 2021 and 2020 and other buprenorphine-based sublingual products accounted for 67% of our net revenues in 2021 (2020: 78%). The increase in net revenues for such periods were attributable to an increase in products sold across all major product lines. Price changes were insignificant to our net revenues.

On a disaggregated basis, the Group's net revenue by major product line:

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| | | | |
|:---|:---|:---|:---|
| | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** |
|<br>*(in millions)* | **2021** | **2020** | **% Change** |
| SUBLOCADE | 244 | 130 | 88% |
| PERSERIS | 17 | 14 | 21% |

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| | | | |
|:---|:---|:---|:---|
| Sublingual (SUBOXONE)/Other | 530 | 503 | 5% |
| **Total Indivior Group net revenue**  | $**791** | $**647** | **22%** |

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Total net revenues increased by $144 million, or 22%, to $791 million in 2021 from $647 million in 2020. The increase was primarily driven by higher net revenues from SUBLOCADE, which increased by $114 million or 88% from 2020, due to continued growth in the BMAT market and by our relatively stable market share for SUBOXONE Film in the U.S. Strong year-over-year SUBLOCADE net revenue growth was due to volume growth in the Organized Health Systems channel and increased new patient enrollments. SUBOXONE Film share averaged 20% (2020: 21%) and exited 2021 at 22% (2020 exit share: 21%). In 2021, total net revenues from PERSERIS was $17 million, representing a 21% increase from 2020.

The U.S. market is the largest contributor to our net revenues. Sales rebates, discounts and returns and other offsets to gross revenues are reflected in net revenues. The following table sets out a breakdown of net revenue as between the U.S. and the rest of the world.

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| | | | |
|:---|:---|:---|:---|
| | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** | **For the years ended<br>December 31,** |
|<br>*(in millions)* | **2021** | **2020** | **% Change** |
| United States | 603 | 456 | 32% |
| Rest of world (including United Kingdom) | 188 | 191 | (2)% |
| **Total Indivior Group net revenue**  | $**791** | $**647** | **22%** |

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In 2021, U.S. net revenue increased by 32% to $603 million as compared to $456 million in 2020, primarily due to strong growth in net revenue attributable to SUBLOCADE over the same period, the market share resilience of SUBOXONE Film and the underlying BMAT market growth.

In 2021, net revenue attributable to the rest of the world (including the United Kingdom) decreased 2% at actual exchange rates to $188 million from $191 million in 2020. The decrease in net revenue was mainly due to ongoing competitive pressure and austerity measures in the legacy tablet business in western Europe, and the disposal of the legacy TEMGESIC/ BUPREX/ BUPREXX franchise, which led to a $5 million decrease in net revenue for 2021. The decrease in net revenue was partially offset by net revenue from new products, including net revenue of $16 million attributable to SUBLOCADE and favorable foreign currency translation benefits.

The following table provides a summary of activities with respect to provisions for rebates, discounts and returns for the years ended December 31, 2021 and 2020:

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| | | |
|:---|:---|:---|
| **Provision for rebates, discounts and returns** *(in millions)* | **2021** | **2020** |
| **Opening balance at beginning of period**  | (396) | (460) |
| Provision related to sales made in: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Current period | (1003) | (898) |
| &nbsp;&nbsp;&nbsp;&nbsp;Prior period | 24 | 16 |
| Payments | 939 | 946 |
| **Closing balance at beginning of period**  | $(436) | $(396) |

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The provision for rebates, discounts and returns decreased from $460 million as of December 31, 2019 to $396 million as of December 31, 2020 primarily due to a year-over-year decrease in net revenue and timing of rebate payments.

The provision for rebates, discounts and returns increased from $396 million as of December 31, 2020 to $436 million as of December 31, 2021 primarily due to a year-over-year increase in net revenue and timing of rebate payments.

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***Cost of sales***. Cost of sales increased by $30 million, or 31%, to $127 million in 2021 from $97 million in 2020 due to higher sales volumes in the U.S.

Gross margin, which we define as gross profit divided by revenue, was 84% in 2021 as compared to 85% in 2020. We define adjusted gross margin as adjusted gross profit divided by net revenue and we define adjusted gross profit as gross profit excluding exceptional items. Adjusted gross margin was 84% in 2021 as compared to 86% in 2020. Adjusted gross margin in 2020 included exceptional items related to changes in inventory provision estimates due to the adverse impact of the COVID-19 pandemic on our business. These changes in inventory provision estimates have been considered exceptional as they are one-off and do not reflect the underlying performance of our business. The decrease in gross margin and adjusted gross margin primarily reflects the continued relative strength of SUBOXONE Film in the U.S., particularly in less profitable government channels.

***Selling, general and administrative expenses***. Selling, general and administrative expenses decreased by $235 million, or 35%, to $431 million in 2021 from $666 million in 2020 primarily due to selling, general and administrative expenses in 2020 including costs of $239 million related to the resolution of litigation matters.

Adjusted selling, general and administrative expenses, which we define as selling, general and administrative expenses excluding exceptional items, decreased slightly to $424 million in 2021 from $427 million in 2020. The decline largely reflects one-time costs related to the U.S. direct-to-consumer advertising campaign for SUBLOCADE in 2020 and lower legal fees and expenses related to the DOJ matter in 2021, which was settled in the third quarter of 2020 with our entry into the Resolution Agreement. The decrease was partially offset by sales and marketing investments to grow the Group's long-acting injectable technologies, SUBLOCADE and PERSERIS in 2021.

***Research and development expenses***. Research and development expenses increased by $12 million, or 30%, to $52 million in 2021 from $40 million in 2020. The increase reflects planned higher research and development activity, as certain projects and post-market studies that were suspended in 2020 due to the COVID-19 pandemic were resumed in 2021 as well as strategic pipeline and production capacity investments in 2021.

***Net other operating income***. Other operating income was $32 million in 2021 and $nil in 2020, primarily attributable to net proceeds received from the disposal of the legacy TEMGESIC/ BUPREX / BUPREXX (buprenorphine) franchise outside of North America (+$19 million), net proceeds received from the out-licensing of nasal naloxone opioid overdose patents (+$1 million) and a directors and officers insurance claim settlement (+$12 million received in the fourth quarter of 2021).

Adjusted other operating income, which we define as other operating income excluding exceptional items was $nil in 2021.

***Operating profit/(loss).*** Operating profit in 2021 was $213 million as compared to an operating loss of $156 million in 2020. Adjusted operating profit, which comprises operating profit excluding the exceptional items described above, was $187 million in 2021 as compared to $88 million in 2020. The increase in adjusted operating profit was primarily driven by strong net revenue growth.

***Net finance expense.*** Net finance expenses increased by $6 million, or 35%, to $23 million in 2021 from $17 million in 2020. The increase primarily reflects lower interest income on the Group's cash balance due to lower short-term interest rates 2021 as compared to 2020 and higher expense primarily related to interest on the Group's outstanding DOJ settlement amount.

Adjusted net finance expense, which we define was net finance expense excluding exceptional items was $22 million in 2021. There were no adjustments to net finance expense in 2020.

***Taxation***. Income tax benefit in 2021 was $15 million, reflecting an effective tax rate of -8% on the Group's profits for 2021 as compared with an income tax benefit of $25 million in 2020, reflecting an

------

effective tax rate of 14% on the Group's profits for 2020. Income tax benefit in 2021 included a one-time tax benefit of $40 million and income tax benefit in 2021 included tax on exceptional items of $37 million. Excluding these exceptional items, the Group's effective tax rate was 15% in 2021 as compared to 17% in 2020.

***Net income***. Net income increased to $205 million in 2021, representing an increase of $353 million, from a $148 million loss in 2020.

Adjusted net income, which comprises net income excluding the exceptional items described above, was $140 million in 2021 as compared to $59 million in 2020. The increase in adjusted net income was primarily driven by higher operating profit, partially offset by higher tax and net finance expenses.

**Exceptional Items and Adjusted Results**

Where significant expenses or income that do not reflect the Group's ongoing operations are incurred during the year, these items are recorded as exceptional items. Exceptional items are excluded from adjusted results consistent with our internal reporting. Adjusted results are not a substitute for, or superior to, reported results presented in accordance with IFRS. Management performs a quantitative and qualitative assessment to determine if an item should be considered for exceptional treatment.

The COVID-19 pandemic had an adverse impact on the Group in 2020, primarily driven by a decrease in patient enrollments during the onset of the initial outbreak. In 2020, the Group announced cost-saving actions to protect the financial and operational flexibility of the Group. Consistent with the Group's existing policies, the restructuring charges due to the COVID-19 pandemic were considered non-recurring and therefore classified as exceptional. Additionally, the Group revised estimates used in inventory provision calculations for SUBLOCADE and PERSERIS which led to an overall increase in inventory needing to be provided for. Provisions were based on expiration dating and sales forecasts associated with SUBLOCADE and PERSERIS inventory in line with the Group policy. The change in inventory provision due to the COVID-19 pandemic was considered a one-off transaction in 2020 and therefore recorded as exceptional. No exceptional items were recorded in 2021 specifically due to the impact of the COVID-19 pandemic.

In 2021, after the restructuring program concluded, a remaining provision was released which resulted in an exceptional benefit of $1 million. In 2021, upon conclusion of expert discovery, the Group increased the provision for intellectual property-related matters - ANDA litigation to $73 million resulting in an exceptional charge for $24 million (refer to <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal Proceedings in the Audited Consolidated Financial Statements). Debt refinancing costs in 2021 consist of advisory and legal fees incurred related to the Group's debt refinancing. These costs are included in SG&A. Additionally, in 2021 the Group wrote off $1 million of unamortized deferred financing costs due to extinguishment and settlement of the previous term loan. These costs are included within finance expense. In 2021, the Group received net proceeds from the disposal of the TEMGESIC / BUPREX / BUPREXX (buprenorphine) analgesic franchise outside of North America to Eumedica Pharmaceuticals AG for $19 million. The Group also received proceeds from the out-licensing of nasal naloxone opioid overdose patents for $1 million.

In 2022, the Group recognized a provision for $290 million related to certain multidistrict antitrust class and state claims (refer to <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal Proceedings in the Audited Consolidated Financial Statements). A provision of $6 million was recognized to settle a dispute over reimbursement of legal expenses with a supplier. In 2021, negotiation with DOJ-related plaintiffs led to a change in the Group's provision for DOJ-related matters which resulted in a provision release of $18 million. Additionally, the Group recognized $6 million of exceptional consulting costs in preparation for an additional listing of Indivior shares on a major US exchange. The Group recognized $5 million exceptional other income related to Directors' and Officers' insurance reimbursement claims. Exceptional tax benefits recorded in 2022 relate mainly to the impact of the re-measurement of certain deferred tax assets.

------

The table below sets out exceptional items recorded in each period:

---

| | | | |
|:---|:---|:---|:---|
| | **For the year ended<br>December 31,** | **For the year ended<br>December 31,** | **For the year ended<br>December 31,** |
| | **2022** | **2021** | **2020** |
|<br>*(in millions)* | | | |
| **Exceptional items within cost of sales**  |  |  |  |
| Cost of sales<sup>(1)</sup> |  |  | (5) |
| **Total exceptional items within cost of sales**  | **—** | **—** | **(5)** |
| **Exceptional items within selling, general and administrative expenses**  |  |  |  |
| Restructuring costs<sup>(2)</sup> |  | 1 | (11) |
| Legal expenses/provision<sup>(3)</sup> | (296) | 18 | (228) |
| ANDA litigation<sup>(4)</sup> | 0 | (24) |  |
| Debt refinancing<sup>(5)</sup> |  | (1) |  |
| US listing costs<sup>(6)</sup> | (6) |  |  |
| **Total exceptional items within selling, general and administrative expenses**  | $**(302)** | $**(6)** | $**(239)** |
| **Exceptional items within net other operating income**  |  |  |  |
| Net proceeds from the sale of intangible assets<sup>(7)</sup> |  | 20 |  |
| Insurance reimbursement<sup>(8)</sup> | 5 | 12 |  |
| **Total exceptional items within other operating income**  | $**5** | $**32** | $**—** |
| **Exceptional items within net finance expense**  |  |  |  |
| Finance expense<sup>(5)</sup>  |  | (1) |  |
| **Total exceptional items within finance expense**  | $**—** | $**(1)** | $**—** |
| **Total exceptional items before taxes**  | $**(297)** | $**25** | $**(244)** |
| **Exceptional items within taxation**  |  |  |  |
| Tax on exceptional items | 57 | (3) | 37 |
| Exceptional tax item<sup>(9)</sup> | 18 | 43 |  |
| **Total exceptional items within taxation**  | $**75** | $**40** | $**37** |
| **Total exceptional items**  | $**(222)** | $**65** | $**(207)** |

---

________________

(1)For 2020, relates to changes in inventory provision estimates due to the adverse impact of the COVID-19 pandemic on our business.

(2)For 2020, relates to cost-saving actions taken by the Group in response to challenges posed by the COVID19 pandemic in 2020. In 2021 the restructuring program concluded and the remaining provision was released which resulted in an exceptional benefit of $1 million.

(3)In 2021, negotiation with DOJ-related plaintiffs led to a change in the Group's provision for DOJ-related matters which resulted in a provision release of $18 million. In 2020, relates to net settlement expenses for DOJ-related matters ($178 million) and RB ($50 million). In 2022, the Group recognized a provision of $290 million related to certain multidistrict antitrust class and state claims (refer to <u>[No](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[te](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal proceedings for further discussions) and $6 million to settle a dispute over reimbursement of legal costs with a supplier.

(4)In 2021, upon conclusion of expert discovery, the Group increased the provision for ANDA Litigation, to $73 million, resulting in an exceptional charge for $24 million.

(5)For 2021, relates to advisory and legal fees incurred related to the Group's debt refinancing, which are included in selling, general and administrative expenses. In 2021, the Group wrote off $1 million of unamortized deferred financing costs due to the extinguishment and settlement of the previous term loan. These costs are included within finance expense.

(6)In 2022, the Group recognized $6 million of exceptional consulting costs in preparation for a potential additional listing of Indivior shares on a major U.S. exchange.

------

(7)For 2021, relates to the net gain on disposal received from the sale of the disposal of the legacy TEMGESIC/ BUPREX / BUPREXX (buprenorphine) franchise outside of North America to Eumedica Pharmaceuticals AG for $19 million and the proceeds received from the out-licensing of nasal naloxone opioid overdose patents for $1 million.

(8)In 2022 and 2021, the Group recognized $5 million and $12 million, respectively of exceptional other income related to a directors' and officers' insurance reimbursement claim.

(9)Exceptional tax benefits recorded in 2022 relate mainly to the impact of the re-measurement of certain deferred tax assets. See <u>[Note 7](#id39cb0e1a10249e1ab7b8f77d921d68a_1427)</u> Tax for a further discussion. For 2021, relates to the approval of tax credits by the Internal Revenue Service in relation to development credits for SUBLOCADE claimed for 2014 to 2017 and the tax impact of settlement costs incurred with RB which were recorded in the prior year.

**Non-IFRS Measures**

In considering the financial performance of the business, Management analyzes the primary financial performance measures of adjusted operating profit, adjusted net income and adjusted basic earnings per share. Adjusted operating profit, adjusted net income and adjusted basic earnings per share are not measures defined by IFRS and are not a substitute for, or superior to, reported results presented in accordance with IFRS.

We believe adjusted operating profit, adjusted net income and adjusted basic earnings per share, as defined below, are useful to investors as they exclude items which do not impact our day-to-day operations and which Management in many cases does not directly control or influence. Similar concepts of adjusted operating profit and adjusted earnings are frequently used by securities analysts, investors and other interested parties in their evaluation of our company and in comparison to other companies, many of which present an adjusted operating profit or earnings-related performance measure when reporting their results.

Adjusted operating profit, adjusted net income and adjusted basic earnings per share have limitations as analytical tools. They are not recognized terms under IFRS and therefore do not purport to be an alternative to operating profit as a measure of operating performance. Adjusted operating profit, adjusted net income and adjusted basic earnings per share are not necessarily comparable to similarly titled measures used by other companies. As a result, you should not consider these performance measures in isolation from, or as a substitute analysis for, our results of operations.

In September 2022, the Group's shareholders approved a 5-for-1 share consolidation. On October 10th, 2022, the Group completed this share consolidation. Shareholders received 1 new Ordinary share with a nominal value of $0.50 each for every 5 previously existing Ordinary shares which had a nominal value of $0.10 cents each. The Group's basic and diluted weighted average number of shares outstanding, basic (loss)/earnings per share, diluted (loss)/earnings per share and adjusted basic earnings per share reflect the share consolidation for all periods presented.

Presented below are adjusted operating profit, adjusted net income and adjusted basic earnings per share for the historical periods presented along with a reconciliation of these metrics to a reported IFRS measure:

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**Adjusted basic earnings/(loss) per share reconciliation:**

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| | | | |
|:---|:---|:---|:---|
| | **For the years ended December 31,** | **For the years ended December 31,** | **For the years ended December 31,** |
|<br>**Earnings Per Share** | **2022** | **2021** | **2020** |
| **Reported basic (loss)/earnings per share - IFRS**  | $**(0.38)** | $**1.41** | $**(1.01)** |
| Adjustments to cost of sales<sup>(1)</sup> | $— | $— | $0.03 |
| Adjustments to selling, general and administrative expenses<sup>(2)</sup> | $2.20 | $0.04 | $1.63 |
| Adjustments to other operating income<sup>(3)</sup> | $(0.04) | $(0.22) | $— |
| Adjustments to finance expense<sup>(4)</sup> | $— | $0.01 | $— |
| Tax on exceptional items | $(0.43) | $0.02 | $(0.25) |
| Tax adjustments<sup>(5)</sup> | $(0.13) | $(0.30) | $— |
| **Adjusted basic earnings per share - Non IFRS**  | $**1.22** | $**0.96** | $**0.40** |

---

________________

(1)For 2020, relates to changes in inventory provision estimates due to the adverse impact of the COVID-19 pandemic on our business.

(2)In 2022, the Group recognized $6 million and of exceptional consulting costs in preparation for a potential additional listing of Indivior shares on a major U.S. exchange. In 2022, the Group recognized a provision for $290 million related to certain multidistrict antitrust class and state claims (Refer to <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal Proceedings for further discussion) and $6 million to settle a dispute over reimbursement of legal costs with a supplier. In 2021 negotiation with DOJ-related plaintiffs led to a change in the Group's provision for DOJ-related matters which resulted in a provision release of $18 million and upon conclusion of expert discovery, the Group increased the provision for ANDA Litigation, to $73 million, resulting in an exceptional charge for $24 million. In YTD 2021 the Group incurred an exceptional charge of $1 million related to advisory and legal fees incurred related to the Group's debt refinancing. In 2021, an exceptional benefit of $1 million related to the release of remaining provisions related to a restructuring program that concluded in 2021 initially put in place in 2020 in response to challenges posed by the COVID-19 pandemic. In 2020, adjustments related to costs of the restructuring program and net settlement expenses for DOJ-related matters ($178 million) and RB ($50 million).

(3)In 2022, the Group recognized $5 million of exceptional other income related to a directors' and officers' insurance reimbursement claim. In YTD 2021, exceptional benefit recorded relates to the net gain on disposal received from the sale of the disposal of the legacy TEMGESIC/ BUPREX / BUPREXX (buprenorphine) franchise outside of North America to Eumedica Pharmaceuticals AG for $19 million and the proceeds received from the out-licensing of nasal naloxone opioid overdose patents for $1 million. In 2021, adjustments also relate to $12 million of exceptional other income related to a directors' and officers' insurance reimbursement claim.

(4)In 2021, the Group wrote-off $1 million of unamortized deferred financing costs due to extinguishment and settlement of the previous term loan.

(5)Exceptional tax benefits recorded in 2022 relate mainly to the impact of the re-measurement of certain deferred tax assets. See <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1427)[7](#id39cb0e1a10249e1ab7b8f77d921d68a_1427)</u>, Tax for a further discussion. For 2021, relates to the approval of tax credits by the Internal Revenue Service in relation to development credits for SUBLOCADE claimed for 2014 to 2017 and the tax impact of settlement costs incurred with RB which were recorded in the prior year.

**Adjusted Summarized Results - Non IFRS**

---

| | | | |
|:---|:---|:---|:---|
| | **For the years ended December 31,** | **For the years ended December 31,** | **For the years ended December 31,** |
|<br>*(in millions, except per share data)* | **2022** | **2021** | **2020** |
| Adjusted operating profit - Non IFRS | $212 | $187 | $88 |
| Adjusted net income - Non IFRS | $169 | $140 | $59 |
| Adjusted basic earnings per share - Non IFRS | $1.22 | $0.96 | $0.40 |

---

**Adjusted gross margin reconciliation:**

---

| | | | |
|:---|:---|:---|:---|
| | **For the years ended December 31,** | **For the years ended December 31,** | **For the years ended December 31,** |
|<br>*(in millions)* | **2022** | **2021** | **2020** |
| **Gross margin- IFRS**  | $**742** | $**664** | $**550** |
| Adjustments to cost of sales<sup>(1)</sup> |  |  | 5 |
| **Adjusted gross margin - Non IFRS**  | $**742** | $**664** | $**555** |

---

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_____________

(1)For 2020, relates to changes in inventory provision estimates due to the adverse impact of the COVID-19 pandemic on our business.

**Adjusted operating profit/(loss) reconciliation:**

---

| | | | |
|:---|:---|:---|:---|
| | **For the years ended December 31,** | **For the years ended December 31,** | **For the years ended December 31,** |
|<br>*(in millions)* | **2022** | **2021** | **2020** |
| **Operating (loss)/profit - IFRS**  | $**(85)** | $**213** | $**(156)** |
| Adjustments to cost of sales<sup>(1)</sup> |  |  | 5 |
| Adjustments to selling, general and administrative expenses<sup>(2)</sup> | 302 | 6 | 239 |
| Adjustments to other operating income<sup>(3)</sup> | (5) | (32) |  |
| **Adjusted operating profit - Non IFRS**  | $**212** | $**187** | $**88** |

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_____________

(1)For 2020, relates to changes in inventory provision estimates due to the adverse impact of the COVID-19 pandemic on our business.

(2)In 2022, the Group recognized $6 million and of exceptional consulting costs in preparation for a potential additional listing of Indivior shares on a major U.S. exchange. In 2022, the Group recognized a provision for $290 million related to certain multidistrict antitrust class and state claims (Refer to <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal Proceedings for further discussion) and $6 million to settle a dispute over reimbursement of legal costs with a supplier. In 2021 negotiation with DOJ-related plaintiffs led to a change in the Group's provision for DOJ-related matters which resulted in a provision release of $18 million and upon conclusion of expert discovery, the Group increased the provision for ANDA Litigation, to $73 million, resulting in an exceptional charge for $24 million. In 2021 the Group incurred an exceptional charge of $1 million related to advisory and legal fees incurred related to the Group's debt refinancing. As defined by Management, "exceptional" items are significant expenses or income that do not reflect the Group's ongoing operations and are excluded from adjusted results consistent with internal reporting. In 2021, an exceptional benefit of $1 million related to the release of remaining provisions related to a restructuring program that concluded in 2021 initially put in place in 2020 in response to challenges posed by the COVID-19 pandemic. In 2020, adjustments related to costs of the restructuring program and net settlement expenses for DOJ-related matters ($178 million) and RB ($50 million).

(3)In 2022, the Group recognized $5 million of exceptional other income related to a directors' and officers' insurance reimbursement claim. In 2021, exceptional benefit recorded relates to the net gain on disposal received from the sale of the disposal of the legacy TEMGESIC/ BUPREX / BUPREXX (buprenorphine) franchise outside of North America to Eumedica Pharmaceuticals AG for $19 million and the proceeds received from the out-licensing of nasal naloxone opioid overdose patents for $1 million. In 2021, adjustments also relate to $12 million of exceptional other income related to a directors' and officers' insurance reimbursement claim.

**Adjusted net income reconciliation:**

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| | | | |
|:---|:---|:---|:---|
| | **For the years ended December 31,** | **For the years ended December 31,** | **For the years ended December 31,** |
|<br>*(in millions)* | **2022** | **2021** | **2020** |
| **Net (loss)/income for the period - IFRS**  | $**(53)** | $**205** | $**(148)** |
| Adjustments to costs of sales<sup>(1)</sup> |  |  | 5 |
| Adjustments to selling, general and administrative expenses<sup>(2)</sup> | 302 | 6 | 239 |
| Adjustments to other operating income<sup>(3)</sup> | (5) | (32) |  |
| Adjustments to finance expense<sup>(4)</sup> |  | 1 |  |
| Tax on exceptional items | (57) | 3 | (37) |
| Tax adjustments<sup>(5)</sup> | (18) | (43) |  |
| **Adjusted net income - Non IFRS**  | $**169** | $**140** | $**59** |

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________________

(1)For 2020, relates to changes in inventory provision estimates due to the adverse impact of the COVID-19 pandemic on our business.

(2)In 2022, the Group recognized $6 million and of exceptional consulting costs in preparation for a potential additional listing of Indivior shares on a major U.S. exchange. In 2022, the Group recognized a provision for $290 million related to certain multidistrict antitrust class and state claims (Refer to <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal Proceedings for further discussion) and $6 million to settle a dispute over reimbursement of legal costs with a supplier. In 2021 negotiation with DOJ-related plaintiffs led to a change in the Group's provision for DOJ-related matters which resulted in a provision release of $18 million and upon conclusion of expert discovery, the Group increased the provision for ANDA Litigation, to $73 million, resulting in an exceptional charge for $24 million. In YTD 2021 the Group incurred an exceptional charge of $1 million related to advisory and legal fees incurred

------

related to the Group's debt refinancing. In FY 2021, an exceptional benefit of $1 million related to the release of remaining provisions related to a restructuring program that concluded in 2021 initially put in place in 2020 in response to challenges posed by the COVID-19 pandemic. In 2020, adjustments related to costs of the restructuring program and net settlement expenses for DOJ-related matters ($178 million) and RB ($50 million).

(3)In 2022, the Group recognized $5 million of exceptional other income related to a directors' and officers' insurance reimbursement claim. In 2021, exceptional benefit recorded relates to the net gain on disposal received from the sale of the disposal of the legacy TEMGESIC/ BUPREX / BUPREXX (buprenorphine) franchise outside of North America to Eumedica Pharmaceuticals AG for $19 million and the proceeds received from the out-licensing of nasal naloxone opioid overdose patents for $1 million. In 2021, adjustments also relate to $12 million of exceptional other income related to a directors' and officers' insurance reimbursement claim.

(4)In Q3 2021, the Group wrote-off $1 million of unamortized deferred financing costs due to extinguishment and settlement of the previous term loan.

(5)Exceptional tax benefits recorded in 2022 relate mainly to the impact of the re-measurement of certain deferred tax assets. See <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1427)[7](#id39cb0e1a10249e1ab7b8f77d921d68a_1427)</u>, Tax for a further discussion. For 2021, relates to the approval of tax credits by the Internal Revenue Service in relation to development credits for SUBLOCADE claimed for 2014 to 2017 and the tax impact of settlement costs incurred with RB which were recorded in the prior year.

**B.Liquidity and Capital Resources**

***Overview***

The Group funds its operating costs, investments in organic growth of the business, research and development, and corporate expenses from cash flows generated by operations and borrowings from banks and other financial institutions. Indivior PLC is a holding company with no direct source of operating income. It is therefore dependent on its capital-raising abilities and dividend payments from its subsidiaries. The ability of companies within the Group to pay dividends and Indivior PLC's ability to receive distributions from its investments in other entities are subject to restrictions, including, but not limited to, the covenants in our $250 million term loan and the existence of sufficient distributable reserves.

Based on our current and anticipated levels of operations, and the condition in our markets and industry, we believe our cash on hand and cash flows from operations will enable us to meet our working capital, capital expenditures and debt service and other funding requirements for the foreseeable future. However, our liquidity is subject to certain contractual obligations, discussed below, and contingent liabilities. See <u>[I](#i56ef77e8a843490995b8285e91603860_4100253)</u>*<u>[tem 3.D](#i56ef77e8a843490995b8285e91603860_4100253)</u>* - Risk Factors, "*We are currently, in the past have been, and in the future may be, subject to substantial litigation and ongoing litigation that could cause us to incur significant legal expenses, divert management's attention, and result in harm to our business."*

As of December 31, 2022, the Group's gross borrowings under its Term Loan were $246 million, and the Group had $991 million of gross liquidity (comprising readily available cash of $774 million and investments of $217 million). The Group has contractual obligations of $792 million mainly comprised of obligations under its Term Loan and undiscounted legal settlement payments and lease liabilities. See "*<u>[Item](#iaf701403a2a44bfd822eebd888f635b9_149177)[5](#iaf701403a2a44bfd822eebd888f635b9_149177)[.](#iaf701403a2a44bfd822eebd888f635b9_149177)</u> Liquidity and Capital Resources—Contractual Obligations*."

In April 2022, the Group completed an amendment to its existing term loan which provides the Group greater flexibility in the use of cash being generated and changes the variable interest rate base from USD LIBOR to USD SOFR plus a credit spread adjustment of 26 bps. As part of the modification, the Group incurred $1 million of issuance costs, banking fees and legal fees which are deemed to be incremental and directly attributable to the amendment. Accordingly, the Group capitalized these costs, which were netted against the total amount borrowed and are amortized over the maturity period using the effective interest method.

***Borrowings***

See "*<u>[Item 3.B](#id39cb0e1a10249e1ab7b8f77d921d68a_1991)</u>. Capitalization and Indebtedness*" for details relating to our capitalization and indebtedness as at the dates indicated therein.

------

The table below sets out the current and non-current portion obligation of the Term Loan as presented in the balance sheet as of December 31, 2022 and December 31 2021:

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| | | |
|:---|:---|:---|
| **Term loan** *(in millions)* | **2022** | **2021** |
| Term loan – current | (3) | (3) |
| Term loan – non-current | (237) | (239) |
| **Total term loan**  | $**(240)** | $**(242)** |

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________________

\*Total term loan borrowings reflect the principal amount drawn net of debt issuance costs of $6 million (2021: $7 million)

*The Term Loan*

Certain subsidiaries of Indivior PLC entered into a New York law-governed credit agreement, originally dated as of December 19, 2014, as amended and restated from time to time, most recently by that certain Fourth Amendment dated as of April 27, 2022 with Morgan Stanley Senior Funding, Inc., Morgan Stanley Bank, N.A., and Deutsche Bank AG New York Branch as lenders (the "Credit Agreement"). The Credit Agreement provides for a $250 million term loan (the "Term Loan"). Certain subsidiaries of Indivior PLC, including Indivior Finance S.àr.l., Indivior Finance (2014) LLC, Indivior SMTM LLC, RBP Global Holdings Limited, and Indivior Global Holdings Limited, are borrowers under the Credit Agreement, and their obligations are guaranteed by the other borrowers and certain other subsidiaries of Indivior PLC. Such guarantees, and the obligations of the borrowers, are secured by substantially all the assets of the borrowers and the guarantors, including a pledge of all of the equity interests of the Borrowers and guarantors and, subject to certain customary exceptions, certain other potential subsidiaries.

The Term Loan has a 1% annual amortization feature with a quarterly payment of $0.625 million, with the remainder of the principal amount of the term loans outstanding on June 30, 2026 to be paid on such date. Interest on the Term Loan is payable on a "Term SOFR Rate" or (other than in the case of loans denominated in currencies other than U.S. dollars) at the "Alternate Base Rate," plus in each case, a different, applicable margin (see below). The Term SOFR Rate is the published rate, as adjusted to include the agreed credit spread adjustment to account for the recent phase out of the floating rate in the Original Credit Agreement, which was the London Interbank Offered Rate, or "LIBOR" but subject to a floor of 0.75% per annum. The Alternate Base Rate is the rate per annum equal to the highest of (i) the Federal Funds Effective Rate in effect on such day plus 0.50%, (ii) the Adjusted Term SOFR Rate (calculated based upon an interest period of one month) plus 1.00% and (iii) the "Prime Rate," which is a rate announced publicly by the Administrative Agent as its prime rate. Solely with respect to U.S. dollar denominated term loans, the Alternate Base Rate shall not be less than 1.75%. The Term Loan margin shall be either 5.25% in respect of a Term SOFR Rate loan or (solely with respect to U.S. dollar denominated term loans) 4.25% in respect of an Alternate Base Rate loan. The average interest rate during 2022 was 7.22%. The interest rate was 9.06% as of December 31, 2022.

The Credit Agreement includes an accordion feature such that a minimum of $75 million of additional incremental loans are permitted plus additional further incremental loans up to amounts based on various leverage ratios and subject to various conditions, including as to the absence of certain events of default, accuracy of certain representations and warranties, intercreditor relations, maturity, weighted average life to maturity, prepayments, interest rate margins, borrower identity, guarantors and security and other terms and conditions (including, without limitation, an "MFN" provision providing that the interest rate applicable to any incremental facility or loan must be not more than 50 basis points above the corresponding interest rate applicable to the Term Loan). The Term Loan allows for additional borrowing capacity which is available per management's discretion provided that (i) certain debt/EBITDA relationships are maintained, (ii) Term Loan lenders retain priority status with regards to collateral, and (iii) Term Loan lenders receive interest at the higher of the Term Loan interest rate or incremental borrowing rate. However, the is no commitment by any Lender to make any additional incremental loans.

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The Term Loan is subject to mandatory prepayment in respect of (i) certain non-ordinary course asset dispositions, exchanges or transfers, (ii) proceeds received under any casualty insurance policy or as a result of the taking of assets of any of the borrowers or their restricted subsidiaries pursuant to a condemnation or similar event, in each case above a threshold of $10 million per fiscal year and subject to certain re-investment rights and (iii) the proceeds of certain debt issuances. The Indivior Borrowers are also required, in certain circumstances, to make certain prepayments of Excess Cash Flow (as defined in the Credit Agreement) of the borrowers and their restricted subsidiaries for the fiscal year then ended. The borrower representative under the Credit Agreement has the option to reduce the amount to be paid by the aggregate amounts that have been otherwise prepaid at the option of the Indivior Borrowers or retired and cancelled as a result of certain assignments. The percentage of Excess Cash Flow to be paid is calculated as to 50% of an aggregate principal amount of Excess Cash Flow in the event the Total Leverage Ratio of Net Debt to Consolidated Adjusted EBITDA (each as defined in the Credit Agreement) is in excess of 1.00x. The Excess Cash Flow sweep steps down to (i) 0.25% if Total Leverage Ratio is less than or equal to 1.00x but greater than 0.50x and (ii) 0% if Total Leverage Ratio is less than or equal to 0.50x and the sweep only applies to amounts in excess of $1 million.

Under the Credit Agreement, the borrowers make representations and warranties as well as affirmative covenants and are subject to negative covenants customary for facilities of this nature, including a limitation on disposal of assets, a limitation on mergers and acquisitions and other fundamental changes, limitations on share buybacks and redemptions, dividends and other "restricted payments," a limitation on further negative pledges, a limitation on indebtedness, a limitation on prepayments and redemptions of certain indebtedness, a limitation on subsidiary distributions, a limitation on liens, sale and lease-back transactions and investments, a restriction on changes to any material line of business (including the business of the restricted subsidiaries of the borrowers), restrictions on modifying the terms of certain debt and general restrictions on the organizational documents and fiscal year of the borrowers. These negative covenants are subject to various carve-outs, grace periods and qualifications and, in some instances, are also applicable to the restricted subsidiaries of the borrowers.

The Credit Agreement contains a minimum liquidity covenant requiring that the borrowers and their restricted subsidiaries not allow liquidity to be less than the greater of $100 million or 50% of the aggregate amount of loans outstanding on the last day of each fiscal quarter with respect to the period of four consecutive fiscal quarters then most recently ended for which financial statements have been delivered (or are required to have been delivered) under the terms of the Credit Agreement.

The Credit Agreement contains customary events of default including non-payment of principal, interest, fees or any other amounts when due, breach of certain covenants or representations, cross event of default and cross acceleration, insolvency and insolvency events, material monetary judgments, pension defaults, material invalidity of guarantees or security, ranking and change of control. In the event of an event of default under the Credit Agreement (and at any time thereafter during the continuance of such event of default) the administrative agent under the Credit Agreement may, and at the request of the lenders shall, terminate the debt facilities and/or demand repayment in full of any borrowings outstanding under the debt facilities, together with accrued interest thereon and all fees and other accrued obligations of the borrowers.

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***Cash flow***

The following table summarizes the principal components of our cash flows for the periods under review:

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| | | | |
|:---|:---|:---|:---|
| | **For the years ended December 31,** | **For the years ended December 31,** | **For the years ended December 31,** |
|<br>*(in millions)* | **2022** | **2021** | **2020** |
| Net cash (outflow)/inflow from operating activities | (4) | 353 | (193) |
| Net cash outflow from investing activities | (223) | (14) | (4) |
| Net cash used in financing activities | (100) | (94) | (10) |
| Exchange difference on cash and cash equivalents | (1) | (1) | 5 |
| &nbsp;&nbsp;&nbsp;&nbsp;**Net (decrease)/increase in and cash equivalents**  | $**(328)** | $**244** | $**(202)** |

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*Net cash provided by operating activities*

The net cash outflow from operating activities was $4 million in 2022, a decrease of $357 million, compared to the net cash inflow of $353 million in 2021. This reflects the changes in cash generated from operations and higher interest paid on the Group's term loan facility, interest paid on settlement payments and income taxes paid in 2022 versus income tax refunds received in 2021.

Net cash provided by operating activities was $353 million in 2021, an increase of $546 million, or 27%, compared to a $193 million use of cash in 2020. The increase was a result of mainly strong 2021 operating profit, timing of government payables, surety bond refund and an exceptional tax refund from the IRS, which was offset by taxes paid, interest paid, and transaction costs paid related to the Group's debt refinancing. Net cash outflow from operating activities was $193 million in 2020, which reflects the impact of legal settlement expenses incurred and payments made related to the net settlement expenses for DOJ related matters and RB and timing of payments of made on government rebates payables. Legal settlement expenses incurred were one-time in nature and did not occur in 2021.

*Net cash used in investing activities*

Net cash used in investing activities was $223 million in 2022, an increase of $209 million, compared to net cash used of $14 million in 2021. This reflects the net investment in a portfolio of investment grade debt and treasury securities. See <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1463)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1463)[2](#id39cb0e1a10249e1ab7b8f77d921d68a_1463)</u> for further discussion on investments.

Net cash used in investing activities increased from $4 million in 2020 to $14 million in 2021, which reflects a $30 million payment made to Aelis Farma for an exclusive option and license agreement to develop its leading compound (AEF0117) targeting cannabis use disorders, partially offset by proceeds received from the sale of the legacy TEMGESIC / BUPREX / BUPREXX (buprenorphine) franchise outside of North America.

*Net cash used in financing activities*

Net cash used in financing activities increased by $6 million, to $100 million in 2022 from $94 million in 2021. This is primarily a reflection of an increase in payments made for the Group's share repurchase program.

Net cash used in financing activities increased by $84 million, from $10 million in 2020 to $94 million in 2021 which reflects payments made for the Group's share repurchase program and principal lease payments which were partially offset by the gross proceeds received upon refinancing of the Group's term loan.

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***Capital Expenditure***

The Group's capital expenditures were $4 million from 2020 through 2022. These capital expenditures, were primarily for equipment used in the manufacture of our products, and were made primarily in the U.K. The Group funded these expenditures from its existing cash balances.

Purchase of intangible assets for 2022, 2021 and 2020 were $nil, $30 million, and $1 million, respectively. In 2021, the intangible assets purchase of $30 million reflects a payment made to Aelis Farma for an exclusive option and license agreement to develop its leading compound (AEF0117) targeting cannabis use disorders. This molecule is in late-stage phase 2b clinical development in the U.S. The Group funded this asset purchase from its existing cash balances.

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| | | | |
|:---|:---|:---|:---|
| | **For the years ended December 31,** | **For the years ended December 31,** | **For the years ended December 31,** |
| **Capital Expenditures**<br>*(in millions)* | **2022** | **2021** | **2020** |
| Purchases of property, plant and equipment | 6 | 4 | 4 |
| Purchases of intangible assets | 1 | 30 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;**Total**  | $**7** | $**34** | $**4** |

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***Contractual Obligations***

The table below sets forth the Group's anticipated contractual cash flows including bank borrowings, legal settlement payments and lease liabilities on an undiscounted basis as of December 31, 2022:

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| | | | | |
|:---|:---|:---|:---|:---|
| | **Total** | **1 year or less** | **2-5 years** | **More than <br>5 years** |
|<br>*(in millions)* | **As at December 31, 2022** | **As at December 31, 2022** | **As at December 31, 2022** | **As at December 31, 2022** |
| Borrowings | 246 | 3 | 243 |  |
| DOJ Resolution | 450 | 50 | 400 |  |
| RB Settlement | 32 | 8 | 24 |  |
| Lease liabilities | 42 | 10 | 27 | 5 |
| ANDA Settlement | 22 | 10 | 12 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;**Total**  | $**792** | $**81** | $**706** | $**5** |

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***CVR Agreement***

In connection with the pending acquisition of Opiant, a subsidiary of Indivior has agreed to issue Contingent Value Rights to the stockholders of Opiant at the closing of the Merger. Each CVR represents the obligation of Indivior Inc. to pay the following Milestone Payments, in cash, without interest thereon and less any applicable withholding taxes, payable as specified upon the achievement of the following milestones (each, a "Milestone"):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• During the period beginning with the first commercial sale of OPTN003 (provided that if the first commercial sale occurs less than 45 days prior to the end of a calendar quarter, then the period beginning with the first day of the first calendar quarter immediately following the quarter in which the first commercial sale occurred) and ending on the seventh anniversary of the beginning of such period:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ $2.00 per CVR, upon the first achievement in any four consecutive calendar quarters of worldwide Net Sales (as defined in the CVR Agreement) with respect to certain of Opiant's products exceeding $225,000,000 (the "200M Annual Net Sales Milestone");

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ $2.00 per CVR, upon the first achievement in any four consecutive calendar quarters of worldwide Net Sales (as defined in the CVR Agreement) with respect to certain of Opiant's products exceeding $300,000,000;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;◦ $2.00 per CVR, upon the first achievement in any four consecutive calendar quarters of worldwide Net Sales (as defined in the CVR Agreement) with respect to certain of Opiant's products exceeding $325,000,000; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• During the period beginning with the first commercial sale of OPTN003 (provided that if the first commercial sale occurs less than 45 days prior to the end of a calendar quarter, then the period beginning with the first day of the first calendar quarter immediately following the quarter in which the first commercial sale occurred) and ending on the third anniversary of the beginning of such period, $2.00 per CVR, upon the achievement of worldwide Net Sales (as defined in the CVR Agreement) with respect to certain of Opiant's products exceeding $250,000,000.

We estimate total potential payments to be up to an additional $68 million over a period of up to 7 years from the date of the first commercial sales of a new Opiant product. Until the earlier of (a) the 7<sup>th</sup> anniversary of the closing of the merger and (b) the achievement of U.S. commercial launch, Indivior Inc., shall and shall cause its affiliates to use their commercially reasonable efforts to develop and seek FDA approval for OPNT003 and following receipt of approval to achieve U.S. commercial launch. However, there is no requirement that Indivior Inc. or its affiliates undertake any level of efforts, or employ any level of resources, to develop, market or commercialize certain of Opiant's products after U.S. commercial launch. Additionally, neither Indivior Inc. nor its affiliates are required to conduct or commit to conduct, any additional clinical, safety or efficacy studies in connection with obtaining regulatory approvals of OPNT003. The CVR Agreement has been filed as Exhibit 4.21 to this Registration Statement.

**C.Research and Development Expenses, Patents and Licenses, etc.**

See "*<u>[Item 4.B.](#id39cb0e1a10249e1ab7b8f77d921d68a_2061)</u>—Intellectual Property*," "*<u>[Item 4.B.](#id39cb0e1a10249e1ab7b8f77d921d68a_2000)</u>—Research and Development*," and "*<u>[Item 5.](#id39cb0e1a10249e1ab7b8f77d921d68a_269)</u> Operating and Financial Review and Prospects*

**D.Trend Information**

For a discussion of trend information, see "*<u>[Item 5](#i8b2234b53cbb4eeca331cabc1953ffe2_600129)[.](#i8b2234b53cbb4eeca331cabc1953ffe2_600129)[A](#i8b2234b53cbb4eeca331cabc1953ffe2_600129)</u>.— Operating Results—Key factors affecting results of operations*."

**E.Critical Accounting Estimates**

The consolidated financial statements are prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB"). The preparation of the financial statements requires Management to make certain estimates and assumptions, either at the balance sheet date or during the year, which affect the reported amounts of revenues, expenses, assets, liabilities and contingent amounts. Our most significant accounting estimates, set out in <u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1372)</u> "Basis of Preparation" included in "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements*," include a description of the estimates, assumptions and judgements applied in the preparation of the consolidated financial statements of the Group.

Given the uncertainties inherent in our business activities, we must make certain estimates and assumptions that require difficult, subjective and complex judgments. These estimates are based on the Group's knowledge of the amount, events, or actions considering history and expectations of future outcomes. Estimates and underlying assumptions are reviewed on an ongoing basis. Because of uncertainties inherent in such judgments, actual outcomes and results may differ from our assumptions and estimates, which could materially affect the Group's consolidated financial statements. Application of the following accounting policies requires certain assumptions and estimates that have the potential for the most significant impact on our consolidated financial statements. Management believes that the estimation uncertainties included within each policy could be material to the results of operations or cash flows in a given period. Revisions to the following estimates are recognized prospectively.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Accruals for rebates, discounts and returns

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Litigation and IP related claims

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Impairment of intangible assets

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**ITEM 6: DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES**

**A.Directors and Senior Management**

The following table sets forth the names and positions of the members of our Board as of the date of this registration statement. Except as otherwise indicated, the business address of each of the directors is 234 Bath Road, Slough, Berkshire SL1 4EE, United Kingdom.

There are no familial relationships between any director, executive officer, or person nominated or chosen by the Group to become a director or executive officer.

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| | | | |
|:---|:---|:---|:---|
| **Name** | **Position** | **Director**<br>**Since** | **Term**<br>**Expires**<sup>(1)</sup> |
| Graham Hetherington | Chair | Nov. 2019 | Nov. 2023 |
| Mark Crossley | Chief Executive Officer<br>and Executive Director | Feb. 2017 | <sup>(2)</sup> |
| Ryan Preblick | Chief Financial Officer<br>and Executive Director | Nov. 2020 | <sup>(2)</sup> |
| Daniel J. Phelan | Senior Independent Director; <br>Designated Non-Executive Director<br>for Workforce Engagement | Nov. 2014 | Nov. 2023<sup>(3)</sup> |
| Peter Bains | Independent Non-Executive Director | Aug. 2019 | Jul. 2025 |
| Jerome Lande | Non-Executive Director | Mar. 2021 | Dec. 2023 |
| Joanna Le Couilliard | Independent Non-Executive Director | Mar. 2021 | Mar. 2024 |
| Dr. A. Thomas McLellan, Ph.D. | Independent Non-Executive Director | Nov. 2014 | Nov. 2023<sup>(4)</sup> |
| Lorna Parker | Independent Non-Executive Director | Nov. 2014 | Nov. 2023<sup>(5)</sup> |
| Barbara Ryan | Independent Non-Executive Director | Jun. 2022 | Jun. 2025 |
| Mark Stejbach | Independent Non-Executive Director | Mar. 2021 | Mar. 2024 |
| Juliet Thompson | Independent Non-Executive Director | Mar. 2021 | Mar. 2024 |

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________________

(1)The dates listed represent the end of the respective Director's term of office on the Board.

(2)Per their employment with the Group, Messrs. Crossley and Preblick serve at the request of the Board and may be removed at any time. Their business address is 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA, 23235, United States.

(3)Mr. Phelan will retire from the Board at September 30, 2023.

(4)Dr. McLellan will continue to serve as an independent non-executive director until a replacement has been appointed and a period of transition has been completed.

(5)Ms. Parker will retire from the Board at September 30, 2023.

**Graham Hetherington**, age 64, has served as Chair of the Board since November 2020 and as a non-executive director since November 2019. Mr. Hetherington brings substantial financial and industry experience to the Board having served as the Chief Financial Officer of two FTSE 100 companies. He has a wide knowledge of international financial management and planning, including M&A and audit and risk management, coupled with an in-depth understanding of the U.S. market. Mr. Hetherington was previously Chief Financial Officer of Shire PLC, a global pharmaceutical company, from 2008 until 2014, Chief Financial Officer of Bacardi and Company between 2007-08 and Chief Financial Officer of Allied Domecq plc from 1999 to 2005. Mr. Hetherington was chair of the Audit Committee of BTG plc, a global healthcare company, from 2016 to 2019 and senior independent director of BTG plc from 2017 to 2019. Mr. Hetherington is a Fellow of the Chartered Institute of Management Accountants.

**Mark Crossley**, age 53, has been Chief Executive Officer since June 2020. He joined the Group in 2012 as the Global Finance Director with responsibilities for finance, information systems and procurement. He was appointed Chief Strategy Officer in October 2014. Mr. Crossley was appointed to the Board in February 2017 and served as Chief Financial Officer from 2017 to 2019. He was appointed Chief Financial and Operations Officer in July 2019, with oversight of the finance, information technology,

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manufacturing, supply, quality and procurement functions. Prior to joining Indivior, Mr. Crossley spent 13 years at Procter & Gamble in various finance leadership roles including Corporate Portfolio, Strategic and Business Planning (Female Beauty), as well as multiple roles in Corporate Treasury and its Baby Care division. He also enjoyed an eight-year career with various operational and staff assignments in the U.S. Coast Guard. Mr. Crossley graduated from the U.S. Coast Guard Academy with a BS in Management and Economics and received an MBA from Boston College.

**Ryan Preblick**, age 47, was appointed Chief Financial Officer and executive director in November 2020, having served as Interim Chief Financial Officer since June 2020. Mr. Preblick has been in a financial leadership capacity since joining Indivior in 2012. Prior to his appointment as Interim Chief Financial Officer in June 2020, Mr. Preblick was Senior Vice President, Global Finance and Commercial Operations. This included overseeing all key financial management, analysis and reporting elements of the Group's global business. Prior to that, he was Vice President, U.S. Finance with responsibility overseeing all financial aspects of the U.S. business, the Group's largest business, including management, planning, analysis and reporting, government pricing and managed care contracting operations. Mr. Preblick joined Indivior as U.S. Commercial Controller in 2012. Mr. Preblick began his career in corporate finance at Honeywell International and then spent twelve years at Altria Company (including Phillip Morris USA) in finance leadership roles of increasing responsibility working with Treasury, Financial Planning & Analysis, Market Analytics, Supply Chain and Brand Decision Support. Mr. Preblick holds a BS in Finance from Penn State University and an MBA from the University of Richmond.

**Daniel J. Phelan**, age 73, has served as an independent non-executive director since November 2014. Mr. Phelan retired from GlaxoSmithKline plc in December 2012 after 31 years, during which time he was an adviser to three chief executives and a member of the Corporate Executive Team. Prior to his retirement, he was Chief of Staff with global responsibility for Corporate Strategy and Development, Human Resources, Information Technology, Real Estate and Facilities, Environmental, Health and Safety, and Security. Before that, he was Senior Vice-President, Human Resources for fourteen years. Mr. Phelan previously served from 2006 to 2022 as a member of the board of directors of TE Connectivity Ltd. (NYSE: TEL) (formerly Tyco Electronics Ltd.), was a member of the Health Care and Life Sciences Advisory Board of Computer Sciences Corporation from 2013 to 2015 and served on the Advisory Board of RiseSmart, Inc. from 2012 to 2016. He was also a member of the Board of Trustees of Rutgers University from 2013 to 2017. Mr. Phelan is a graduate of Rutgers College and holds a Master's degree from The Ohio State University and a Law degree from Rutgers University School of Law. He is admitted to practice law in New Jersey and Pennsylvania. Mr. Phelan previously served as an officer on active duty and in the reserves of the U.S. Army Medical Service Corps. He has published on CEO succession planning and onboarding and public sector collective bargaining. Mr. Phelan will retire from the Board on September 30, 2023.

**Peter Bains**, age 65, has served as an independent non-executive director since August 2019. He currently serves as Chief Business Officer of MiNA Therapeutics Limited, a private company focused on the development of RNA activation therapeutics. Mr. Bains is Non-Executive Chair of ILC Therapeutics, a private UK-based biotechnology company and pioneer in the discovery and development of hybrid interferon drugs, and a non-executive director of both Apterna Limited and Biocon Limited. Mr. Bains has over three decades of experience in the biotech and pharmaceutical industry, including a 23-year career at GlaxoSmithKline, where he held numerous senior operational and strategic roles. He also served as the Chief Executive Officer of Sosei Group Corporation, a Tokyo-listed biotech company, from 2010 to 2018, and as the Chief Executive Officer of Syngene International, which he successfully took public on the Mumbai Exchange, from 2010 to 2016. Mr. Bains previously served as a member of the board of directors of Mereo BioPharma Group plc (NASDAQ: MREO), a public biopharmaceutical company focused on innovative therapeutics in both oncology and rare diseases, from 2015 to 2021. Mr. Bains has a BSc Combined (Honours) in Physiology/Zoology from Sheffield University.

**Jerome Lande**, age 47, has served as a non-executive director since March 2021. Mr. Lande has over 20 years of experience as a professional investor, including substantial investing in medical device, pharmaceutical and healthcare services companies. He currently serves as Head of Special Situations

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investments at Scopia Capital Management. Mr. Lande co-founded Coppersmith Capital Management, where he was managing partner and portfolio manager until it combined with Scopia in 2016. Prior to co-founding Coppersmith, Mr. Lande was a partner of MCM Capital Management, LLC, the general partner of MMI Investments, LP, a small-cap investment fund founded in 1996 to employ private equity investing methodologies in public equities, and where Mr. Lande oversaw research, trading, and activism from 1998 to 2011. During that time, he was also associated with MCM's private equity investments wherein he was directly involved with corporate development as well as equity growth. Mr. Lande is a member of the board of directors and of the compensation committee and chair of the strategy committee of CONMED Corporation (NYSE: CNMD), a public global medical technology company. Mr. Lande is also a member of the board of directors and of the audit/finance committee of Itron, Inc. (NASDAQ: ITRI), a public global technology company that offers products and services on energy and water resource management. He previously served as a member of the board of directors of Forest City Realty Trust, Inc. (NYSE: FCE/A), a public national real estate company. Mr. Lande holds a B.A. from Cornell University.

Mr. Lande became a non-executive director in connection with the Relationship Agreement between the Group and Scopia.

**Joanna Le Couilliard**, age 59, has served as an independent non-executive director since March 2021. Ms. Le Couilliard is a healthcare industry veteran with 25 years of healthcare management experience gained in Europe, the U.S. and Asia. Much of her career has been in pharmaceuticals at GlaxoSmithKline where, amongst other roles, she headed the U.S. vaccines business and Asia Pacific Pharmaceuticals business and led a program to modernize the commercial model. Ms. Le Couilliard was previously Chief Operating Officer at the BMI group of private hospitals in the UK. She currently serves as a non-executive director and chair of the Audit and Risk Committee at Niox Group PLC (previously Circassia Group plc), as a non-executive director and chair of the Remuneration Committee at Alliance Pharma plc, and as a non-executive director at the Italian-listed pharmaceutical company Recordati S.p.A., where she is also chair of the Remuneration and Nominations Committee. Ms. Le Couilliard has previously served as a non-executive director at Frimley Park NHS Foundation Trust in the UK, at Cello Health PLC and at the Duke NUS Medical School in Singapore. Ms. Le Couilliard is a Chartered Accountant holding an ACA from the Association of Chartered Accountants and holds a Masters in Natural Sciences from the University of Cambridge. Ms. Le Couilliard will become Chair of the Remuneration Committee with effect from October 1, 2023.

**Dr. A. Thomas McLellan, Ph.D.**, age 74, has served as an independent non-executive director since November 2014. He has been a career researcher for over 40 years with the Treatment Research Institute (which he co-founded in 1992) and the University of Pennsylvania. In his career, Dr. McLellan has published over 650 articles and chapters on addiction research. He has received several awards including Life Achievement Awards from the American, Swedish, Italian and British Societies of Addiction Medicine and from the American Public Health Association in 2010. Between 2009 and 2011, Dr. McLellan was unanimously confirmed by the U.S. Senate to serve as Deputy Director of the White House Office of National Drug Control Policy, where he was one of the principal authors of the President's National Drug Control Strategy. Dr. McLellan holds a BA from Colgate University and his MS and PhD from Bryn Mawr College. He received postgraduate training in psychology at The University of Oxford. Dr. McLellan will continue to serve as an independent non-executive director until a replacement has been appointed and a period of transition has been completed.

**Lorna Parker**, age 64, has served as an independent non-executive director since November 2014 and was Chair of the Nominations and Governance Committee from 2016 to 2020. She has over 26 years of executive search, management assessment and board consulting experience, and UK-listed company experience and provides strong leadership on governance matters including succession planning. Ms. Parker is currently an advisory partner at Manchester Square Partners, where she conducts board effectiveness reviews for FTSE 100 companies. She is also currently a supervisory board member of PAI Partners SAS, a trustee of the Royal Horticultural Society, and a trustee of the National Opera Studio. Previously, Ms. Parker served as a Senior Advisor at CVC Capital Partners from 2016 to 2021, director of Future Academies from 2014 to 2017, and Senior Advisor at BC Partners from 2008 to 2016. She was a

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partner from 1989 to 2008 at Spencer Stuart, where she led the private equity practice across Europe and the legal search practice group. Ms. Parker has an MA in Economics from Cambridge University and an MBA from Stanford Business School, where she was a Harkness Fellow. Ms. Parker will retire from the Board on September 30, 2023.

**Barbara Ryan**, age 63, has served as an independent non-executive director since June 2022. Ms. Ryan was a Wall Street sell-side research analyst covering the U.S. Large Cap Pharmaceutical Industry for more than 30 years before founding Barbara Ryan Advisors, a capital markets and communications firm, in 2012. She has deep experience in equity and debt financings, M&A, valuation, SEC reporting, financial analysis and corporate strategy across a broad range of life sciences companies. Ms. Ryan is also the Founder of Fabulous Pharma Females, a non-profit organization whose mission is to advance women in the biopharma industry. She is a Senior Advisor at Ernst & Young and is currently a non-executive director of INVO Bioscience, Inc. (NASDAQ: INVO), serving as a member of the Audit, Compensation, and Nominating and Governance Committees, and MiNK Therapeutics, Inc. (NASDAQ: INKT), serving as the chair of the Audit Committee and as a member of the Compensation Committee.

**Mark Stejbach,** age 59, has served as an independent non-executive director since March 2021. Mr. Stejbach has over 35 years of experience in biotech and pharmaceuticals, including senior roles in a broad range of commercial functions including marketing, sales, economic affairs, managed care and finance. Mr. Stejbach most recently served as Senior Vice President and Chief Commercial Officer at Alkermes, plc, a publicly traded global biopharmaceutical company, where he was responsible for building sales of Vivitrol from approximately $40 million to approximately $300 million. Prior to his role at Alkermes, Mr. Stejbach served as the Chief Commercial Officer at Tengion, Inc. from 2008 to 2012, and previously held senior positions at Merck and Biogen. He served as a non-executive director on the board of Flexion Therapeutics, Inc. (NASDAQ: FLXN) from 2016 until its acquisition in 2021. Flexion marketed a "buy-and-bill" long-acting injectable for the treatment of osteoarthritis. He also previously served as Senior Commercial Advisor to EIP Pharma Inc., a private company advancing CNS-focused therapeutics to benefit patients with neurodegenerative diseases. Mr. Stejbach holds an MBA from the Wharton School, University of Pennsylvania and a BS in mathematics from Virginia Tech.

**Juliet Thompson**, age 56, has served as an independent non-executive director since March 2021, and has been appointed as Senior Independent Director with effect from October 1, 2023. Ms. Thompson has over 30 years of finance, banking and board experience with significant focus in the healthcare sector. Ms. Thompson is a proven FTSE 250 audit chair and a former investment banker who has spent her career advising pharmaceutical companies. She played a leading role in setting up Code Securities, which was acquired by Nomura (becoming Nomura Code) but remained independent. At Nomura Code, Ms. Thompson advised companies in the healthcare and clean tech sectors on their financing and strategic options. She worked on over 50 transactions including IPO's, secondary offerings, private placements and M&A. As Nomura Code was devolved, she joined Stifel with a team from Nomura Code to head up the life sciences and clean tech teams where she advised CEOs and CFOs in the healthcare sector. Since retiring, Ms. Thompson has built a diverse portfolio; she currently chairs the Audit Committees of Novacyt S.A., OrganOx Limited and ANGLE plc. She previously served on the board of GI Dynamics, Inc., a Boston-based medical device company developing products for patients with type 2 diabetes and obesity. Ms. Thompson holds a BSc in Economics from the University of Bristol and is a Chartered Accountant holding an ACA from the Association of Chartered Certified Accountants.

**Agreement with Significant Shareholder**

The Group entered into an agreement titled Relationship Agreement with Scopia Capital Management LP ("Scopia") on March 24, 2021 (as further amended on July 7, 2022 and March [ ], 2023, the "Relationship Agreement"). In recognition of Scopia's ownership of approximately 16.9% of the Group's shares as at March 24, 2021, the Group agreed to appoint Jerome Lande as a Representative Director.

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Scopia agreed to certain standstill provisions (for example to vote on ordinary course resolutions in accordance with the Board's recommendation).

The parties amended and restated the Relationship Agreement on July 7, 2022 and March [ ], 2023] and further agreed that Scopia would not exercise voting rights in excess of 10% of the outstanding shares. The Relationship Agreement, as amended and restated, is filed as Exhibit 4.2 to this Registration Statement.

The Relationship Agreement, as amended, terminates upon the earlier of (i) December 31, 2023, (ii) the date on which Scopia publicly discloses that it has ceased to hold directly or indirectly at least five per cent of the issued share capital of the Group, or (iii) in certain circumstances, and only in the event that Mr. Lande has resigned from the Board, a specified date to be calculated with reference to the date of the 2023 AGM.

**Senior Management**

The following table sets forth the names and positions of the members of our Senior Management team as of the date of this registration statement. Except as otherwise indicated, the business address for each member of our Senior Management is 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA, 23235, United States.

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| | |
|:---|:---|
| **Name** | **Position** |
| Mark Crossley | Chief Executive Officer |
| Ryan Preblick | Chief Financial Officer |
| Jeff Burris | Chief Legal Officer |
| Cindy Cetani | Chief Integrity and Compliance Officer |
| Nina DeLorenzo | Chief Global Impact Officer |
| Jon Fogle | Chief Human Resources Officer |
| Christian Heidbreder | Chief Scientific Officer |
| Kathryn Hudson <sup>(1)</sup> | Company Secretary |
| Vishal Kalia | Chief Strategy Officer |
| Richard Simkin | Chief Strategy and Commercial Officer |
| Hillel West <sup>(1)</sup> | Chief Manufacturing and Supply Officer |

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________________

(1)The business address for Ms. Hudson and Mr. West is 234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom.

**Mark Crossley—**Chief Executive Officer. See biography at page <u>[129](#idc487f193c0946909335a938c59d9598_267941)</u>.

**Ryan Preblick—**Chief Financial Officer. See biography at page <u>[130](#idc487f193c0946909335a938c59d9598_268063)</u>.

**Jeff Burris**, age 51, was appointed Chief Legal Officer in December 2021. He brings 25 years of extensive legal, life sciences and public company experience to Indivior, including over 14 years as the head of the legal function at various life sciences companies. Mr. Burris joined Indivior from Arbor Pharmaceuticals where he was Vice President, General Counsel, Chief Compliance Officer and Secretary from October 2018 to October 2021. Prior to that he was Vice President, General Counsel, Chief Compliance Officer and Secretary at Alimera Sciences, a publicly traded pharmaceutical company, from April 2015 to September 2018 and Vice President, General Counsel and Chief Compliance Officer at CryoLife, a publicly traded biotechnology company, from February 2008 to August 2014. Jeff started his career in the corporate law group at Arnall Golden Gregory LLP focused on mergers, acquisitions, divestitures, contracting and licensing work. He then moved in-house to Waste Management, where he was Senior Counsel focused primarily on acquisitions and divestitures of Waste Management's Southern Group. Mr. Burris holds a BA in History and Economics from the University of Tennessee and a JD from The University of Chicago Law School.

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**Cindy Cetani**, age 58, was appointed as Chief Integrity & Compliance Officer for Indivior in October 2018. Ms. Cetani brings to Indivior 35 years of U.S. and global leadership predominantly in the pharmaceutical industry, with a diversity of cross-industry experience spanning life and health insurance. Ms. Cetani joined Indivior in 2018 from Novartis Pharmaceuticals Corp. (Novartis) where she served as Head of Compliance Operations, Group Integrity and Compliance at the Novartis headquarters in Basel, Switzerland. Prior to that role, she served as Chief Compliance Officer and U.S. Country Compliance Head and was responsible for administration of Novartis' U.S. compliance program and negotiation, implementation of, and compliance with Novartis' 5-year Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General, and was a member of the executive committee and global and international compliance leadership teams. Before joining Novartis in 2003, Ms. Cetani was Director of Operations, Managed Markets at Pharmacia, led Advertising Compliance for Prudential Healthcare, and held various managerial roles at U.S. life insurance and mutual benefit life insurance companies. Ms. Cetani is a Licensed Professional of Ethics and Compliance, and holds a BS, Commerce, Finance – Magna Cum Laude from Rider College.

**Nina DeLorenzo**, age 50, was appointed Chief Global Impact Officer in May 2022. She brings over 25 years of public affairs, communications, policy, and government affairs experience to Indivior. Immediately prior to joining Indivior, Ms. DeLorenzo was Senior Vice President of Global Communications and Public Affairs for Emergent BioSolutions from March 2020 to May 2022 where she led all aspects of corporate communications and was also responsible for citizenship, philanthropy, and third-party alliance building. Ms. DeLorenzo's previous experience also includes overseeing operations and engagement for a global organization of 450 external affairs professionals at Sanofi in Paris; leading international government affairs and other public policy functions at AbbVie; and in various senior government and public affairs roles at Pfizer Inc., Schering-Plough Corp. (now Merck), and the Pharmaceutical Research and Manufacturers of America (PhRMA). Prior to starting her career path in the pharmaceutical industry, Ms. DeLorenzo served in the administration of President George W. Bush, working in the White House Coalition Information Center at the outset of the war on terror; served in the Bureau of International Information Programs at the U.S. Department of State; and also worked in the U.S. Senate and on political campaigns. Ms. DeLorenzo obtained her BA in government and international relations from the University of Notre Dame and her master's degree in international relations from the University of Chicago.

**Jon Fogle**, age 52, was appointed Chief Human Resources Officer for the Group in October 2014. Prior to joining Indivior, Mr. Fogle worked at Reckitt Benckiser Pharmaceuticals (RBP), having joined RBP as Human Resources Director for the U.S. in 2007. In 2010, he was promoted to Global Human Resources Director, and, under his leadership, RBP grew from just over 200 employees in three countries to more than 900 employees in 11 countries. Working with the entire leadership team, Mr. Fogle fostered a strong commitment to developing both Indivior's culture and talent. Prior to joining RBP, he was Senior Vice President of Human Resources, North America for Capmark Finance (formerly GMAC Commercial Mortgage). Mr. Fogle holds a BS in psychology from Ursinus College and is a Society for Human Resource Management (SHRM) Senior Certified Professional.

**Dr. Christian Heidbreder,** age 60, has served as Chief Scientific Officer since December 2014. Dr. Heidbreder combines 30 years of experience in the neurosciences spanning the academic, governmental, and industrial sectors across Europe and the US. He has authored and co-authored over 450 peer-reviewed scientific publications, reviews, and published conference proceedings with more than 10,000 citations. For ten years prior to crossing into industry, Dr. Heidbreder made a mark in the halls of Academia at the University of Louvain in Belgium, at the National Institute on Drug Abuse in Baltimore, and at the Swiss Federal Institute of Technology in Zürich. For the last 20 years, Dr. Heidbreder held positions of increasing responsibility at SmithKline-Beecham's Neuroscience Department in the UK, GSK's R&D Centre of Excellence for Drug Discovery in Psychiatry in Italy, Altria's Health Sciences Department in the US, and Reckitt Benckiser Pharmaceuticals (RBP) in the US and the UK. Following the demerger of the Pharmaceuticals component of RBP in December 2014, Dr. Heidbreder joined Indivior as Chief Scientific Officer to provide strategic global leadership for worldwide R&D and Medical Affairs

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operations and drive the development of new pharmacotherapies in the area of addiction and related co-morbidities. Dr. Heidbreder holds BA, MA, and PhD degrees from the University of Louvain and is an Affiliate Professor in the Department of Pharmacology & Toxicology of the Virginia Commonwealth University School of Medicine and a Governance Fellow of the National Association of Corporate Directors. Dr. Heidbreder also served as a member of the National Advisory Council on Drug Abuse from 2018 to 2022 and has been a member of the National Institutes of Health Helping to End Addiction Long-term Multi-Disciplinary Working Group since 2018.

**Kathryn Hudson**, age 48, has served as Company Secretary since June 2015. Ms. Hudson is a Chartered Secretary who has over twenty years of experience working for UK-listed companies. Prior to joining Indivior, she was Company Secretary of Kingfisher plc, a constituent of the FTSE 100 and one of Europe's largest retailers, Deputy Company Secretary of Burberry Group plc, the FTSE 100 global luxury goods group, and Deputy Company Secretary of ICAP PLC, a FTSE 100 Interdealer Broker. Ms. Hudson is a fellow of the Chartered Governance Institute.

**Vishal Kalia,** age 42, was appointed Chief Strategy Officer in March 2023. He began his career with Indivior in 2016 as Head of Marketing and New Product Launch, followed by Head of Business Unit for Addiction Sciences leading the successful launch of SUBLOCADE, followed by SVP Responsible for Treatment Access (Channel, Managed Care), Organized Health Systems, Criminal Justice System, Patient Support Programs, Customer Marketing, and Business Strategy. Prior to joining Indivior, Vishal worked at global companies like Reckitt Benckiser and Nestle in a number of global and regional roles, leading global category development, launching several breakthrough innovation, lifecycle management, award winning brand communications, and global success models. Vishal graduated from DAW University with a Bachelors of Commerce and Accountancy and a Masters of International Marketing Management from Leeds University.

**Richard Simkin**, age 52, has served as Chief Commercial Officer since January 2015. He began his career with Reckitt Benckiser plc (formerly Reckitt & Colman plc) (RBP) in 1987 and held various roles in operations, sales and marketing with increasing responsibility. Prior to his role with RBP, Mr. Simkin held the position of Global Category Director for one of the core categories within the Reckitt Benckiser Group (RBG) where he was responsible for driving strategy and new product development. He also held a number of general manager positions within the RBG, including as General Manager, Portugal beginning in 2008. In 2012, Mr. Simkin was appointed President, North America of Reckitt Benckiser Pharmaceuticals Inc. (RBPI) and moved to the U.S. where he led the U.S. and Canadian teams in introducing market competition and preparing pre-launch activities related to RBPI's product pipeline. Mr. Simkin holds an MBA from the University of Lincoln (formerly the University of Lincolnshire and Humberside).

**Hillel West**, age 55, was appointed Chief Manufacturing and Supply Officer in February 2020. Mr. West has more than 25 years of experience in operations management, strategy and business development across the U.S., Europe, Asia-Pacific and emerging markets. He joined Indivior from Teva Pharmaceuticals where he held roles of increasing responsibility over his 14-year tenure including Head of Specialty Medicines Supply, Head of Global Supply Chain and Operations Strategy, and Vice President – Integration and Separation Management. Previously, he was a senior director at PwC Management Consulting for 9 years in New York, Israel and the Czech Republic, partnering with a number of U.S. Fortune 500 CPG, Food and Pharma manufacturers leading engagements in supply chain strategy, organizational and process transformation. Mr. West holds a Bachelor of Chemical Engineering (Hons) from Monash University, Australia and an MBA from Columbia University.

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**B.Compensation**

**Total Compensation for the Chair and Non-Executive Directors**

The table below sets out the total remuneration received by the Chair and the Non-Executive Directors for the year ended December 31, 2022.

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| | |
|:---|:---|
| | **2022**<sup>(1)</sup> |
| | **'000** |
| Graham Hetherington | £275.0 |
| Peter Bains | £85.0 |
| Jerome Lande <sup>(2)</sup> | $101.7 |
| Joanna Le Couilliard | £75.0 |
| A. Thomas McLellan | $110.0 |
| Lorna Parker | £75.0 |
| Daniel J. Phelan | $153.4 |
| Barbara Ryan <sup>(3)</sup> | $58.3 |
| Mark Stejbach | $110.0 |
| Juliet Thompson | £85.0 |

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__________________

(1)The amounts include fees and benefits. Fees are paid in their local currency. Since 2016, a fixed exchange rate (GB£1:U.S.$1.4434) has been applied to translate UK amounts into U.S. dollars, effectively setting fees at that time, on both a UK and U.S. basis. Benefits comprise the estimated grossed-up cost of providing professional support for the completion of UK tax returns for U.S. tax residents; these costs were translated to U.S. dollars using the average exchange rate for the last quarter of the 2022 financial year (GB£1:U.S.$1.1717).

(2)Jerome Lande stood down as a member of the Audit Committee with effect from April 25, 2022; his fees were adjusted accordingly.

(3)Barbara Ryan was appointed as a Non-Executive Director on June 1, 2022 and was appointed as a member of the Audit and Science & Policy Committees on July 27, 2022. The fee shown for 2022 is from the date of her appointment to December 31, 2022. As Mr. Ryan was appointed after the end of the 2021-2022 tax year, she did not incur a UK tax liability and did not need support to file a UK tax return.

**Compensation of Executive Directors and Senior Managers**

The table below sets forth the remuneration of the Executive Directors and Senior Managers for the financial year ended December 31, 2022.

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| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| | **Mark Crossley**<br> **$'000** | | **Ryan Preblick** <br>**$'000** | | **All Other** <br>**Senior Managers Combined**<br>**$'000** | |
| **<u>Fixed Pay</u>** | | | | | | |
| Base Salary | 806.0 |  | 499.2 |  | 3496.0 |  |
| Taxable Benefits <sup>(1)</sup> | 60.6 |  | 59.0 |  | 417.6 |  |
| Retirement Benefits <sup>(2)</sup> | 25.9 |  | 25.9 |  | 312.6 |  |
| **Total Fixed Pay**  | 892.5 |  | 584.1 |  | 4226.2 |  |
| **<u>Variable Pay</u>** |  |  |  |  |  |  |
| Annual Incentive Plan (AIP) <sup>(3)</sup> | 608.5 |  | 376.9 |  | 2917.7 |  |
| Long Term Incentive Plan (LTIP) | 8585.0 | <sup>(4)</sup> | 1283.2 | <sup>(5)</sup> | 25238.0 | <sup>(6)</sup> |
| **<u>Total Variable Pay</u>**  | 9193.5 |  | 1660.1 |  | 28155.7 |  |
| **Total Pay**  | 10086.0 |  | 2244.2 |  | 32381.9 |  |

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_____________

(1)Taxable benefits consist primarily of healthcare, car allowance, life and disability insurance and professional support for the completion of U.S. and UK tax returns. Taxable benefits included a car allowance ($19,500) and premiums for medical coverage ($18,800 for Mark Crossley and $29,000 for Ryan Preblick).

(2)Executive Directors and Senior Managers may receive contributions into a defined contribution plan, a cash allowance, pension benefits in the form of company profit-sharing or matching contributions into the U.S. qualified 401(k) plan or a combination thereof. Mark Crossley and Ryan Preblick received profit-sharing contributions of $12,200 (4% of base salary) and matching contributions of $13,700 (75% on elected deferrals up to 4.5% of base salary) to their 401(k) plan accounts.

(3)The maximum Annual Incentive Plan ("AIP") opportunity for the Chief Executive Officer is 200% of his base salary. The maximum AIP opportunity for the Chief Financial Officer is 120% of his base salary. The maximum AIP opportunity for our Senior Managers ranges from 90% to 140% of their base salary. For our Executive Directors, the AIP is paid 75% in cash, with the remaining 25% deferred into conditional shares for two years under the Group's Deferred Bonus Plan. See "Deferred Bonus Plan 2018 ("DBP")", beginning on page <u>[146](#i1a2713faf9704411929513c96c60156d_294238)</u>. For Senior Managers, the AIP is paid in cash. For fiscal year 2022, the Remuneration Committee set performance targets in the context of the business plan for 2022 and taking account of external forecasts. These targets were set by reference to the key strategic drivers for the business: global net revenues for SUBLOCADE and U.S. net revenues for PERSERIS, weighted 80%/20% respectively. For threshold performance 12.5% of the maximum bonus would be paid, for target performance 50% of the maximum bonus would be paid, and 100% of the maximum bonus would be paid for the delivery of performance significantly above both internal and external expectations. Achievement of the performance targets is calculated on a straight-line basis between threshold and target, and between target and maximum. Overall performance resulted in a formulaic payout of 75.5% of maximum.

(4)The LTIP awards granted to Mark Crossley in March and November 2020 will vest on March 9, 2023 and will then be subject to a two-year post-vesting holding period and will be released in March 2025. The value of the awards has been estimated based on the number of shares expected to vest (443,118) at the three-month average share price of Indivior shares for the last quarter of the 2022 financial year (1653.5p) and converted to U.S. dollars using the average GBP/U.S.$ exchange rate over the same period (GB£1:U.S.$1.1717). The proportion of the value disclosed in the single figure attributable to share price growth is 84.6%.

(5)The LTIP awards granted to Ryan Preblick in March 2020 will vest on March 9, 2023. The value of the award has been estimated based on the number of shares expected to vest (66,233) at the three-month average share price of Indivior shares for the last quarter of the 2022 financial year (1653.5p) and converted to U.S. dollars using the average GBP/U.S.$ exchange rate over the same period (GB£1:U.S.$1.1717). Mr. Preblick was not an Executive Director when the awards were granted to him and consequently the awards are not subject to a two-year post-vesting holding period. The proportion of the value disclosed in the single figure attributable to share price growth is 83.9%.

(6)The value of the awards has been estimated based on the number of shares expected to vest (1,302,672) at the three-month average share price of Indivior shares for the last quarter of the 2022 financial year (1653.5p) and converted to U.S. dollars using the average GBP/U.S.$ exchange rate over the same period (GB£1:U.S.$1.1717).

**Annual Incentive Plan ("AIP")**

In addition to base salary, an annual bonus opportunity exists for all employees, including the Executive Directors and Senior Managers. The maximum AIP opportunity for the Chief Executive Officer is 200% of his base salary. The maximum AIP opportunity for the Chief Financial Officer is 120% of his base salary. The maximum AIP opportunity for our Senior Managers ranges from 90% to 140% of their base salary. For our Executive Directors (the Chief Executive Officer and Chief Financial Officer), the AIP is paid 75% in cash, with the remaining 25% deferred into conditional shares for two years under the Group's Deferred Bonus Plan. See "The Deferred Bonus Plan 2018 ("DBP")", beginning on page <u>[146](#i1a2713faf9704411929513c96c60156d_294238)</u>. For Senior Managers, the AIP is paid in cash.

Performance measures under the AIP are designed to align to the key strategic drivers for the year ahead and are developed alongside the Group's annual financial plans. The Remuneration Committee has discretion to adjust the formulaic bonus outcomes both upward and downward (including to zero) to ensure alignment of pay with the underlying performance of the Group, e.g. in the event performance is impacted by unforeseen circumstances outside Management control.

For the 2022 financial year, the Remuneration Committee set performance targets in the context of the business plan for 2022 and taking account of external forecasts. These targets were set by reference to the key strategic drivers for the business: global net revenues for SUBLOCADE and U.S. net revenues for PERSERIS, weighted 80%/20% respectively. For threshold performance 12.5% of the maximum bonus would be paid, for target performance 50% of the maximum bonus would be paid, and 100% of the maximum bonus would be paid for the delivery of exceptional performance significantly above both internal and external expectations. Achievement of the performance targets is calculated on a straight-line basis between threshold and target, and between target and maximum. Overall performance resulted in a formulaic payout of 75.5% of maximum.

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In line with our Remuneration Policy, 25% of the 2022 bonus payable under the AIP to the Executive Directors was automatically deferred into conditional shares under the DBP. The deferred conditional share awards vest after two years subject to continued employment as well as malus provisions.

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| | | | | | |
|:---|:---|:---|:---|:---|:---|
| | **Date of Grant** | **Number of shares under award** | **Closing share price at date of grant** | **Aggregate fair market value as of the date of grant** <sup>(1)</sup><br>**$'000** | **Vesting Date** |
| Mark Crossley | Mar. 15, 2022 | 19215 | 1,349p | 342.9 | Mar. 15, 2024 |
| Ryan Preblick | Mar. 15, 2022 | 7140 | 1,349p | 127.4 | Mar. 15, 2024 |

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__________

(1)The market value used to determine the number of shares subject to awards was 1,370p, being the average mid-market closing price of Indivior shares on the business day immediately preceding the date of grant.

**Indivior PLC Long-Term Incentive Plan ("LTIP")**

On March 1, 2022, the Chief Executive Officer and Chief Financial Officer were granted conditional awards over shares with a value equal to 400% of their base salary, being the maximum cap under the 2021 Remuneration Policy.

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| | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| | **Date of Grant** | **Number of shares under award at maximum** | **Closing Share Price at date of grant** | **Aggregate fair market value as of the date of grant**<br>**$'000** | **Performance period** | **Vesting date** | **Release Date** | |
| Mark Crossley | Mar. 1, 2022 | 175699<sup>(1)</sup> | 1403.0p | 3224.0 | Jan. 2022 – Dec. 2024 | Mar. 1, 2025 | Mar. 1, 2027 | <sup>(2)</sup> |
| Ryan Preblick | Mar. 1, 2022 | 108820<sup>(1)</sup> | 1403.0p | 1996.8 | Jan. 2022 – Dec. 2024 | Mar. 1, 2025 | Mar. 1, 2027 | <sup>(2)</sup> |
| All Other Senior Managers Combined | <sup>(3)</sup> | 704538<sup>(4)</sup> | <sup>(5)</sup> | 13000.2 | Jan. 2022 – Dec. 2024 | Mar. 1, 2025 | Mar. 1, 2025 |  |

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______________

(1)The market value used to determine the number of shares subject to awards was 1370.6p, being the average mid-market closing price of Indivior shares on the five business days immediately preceding the date of grant on March 1, 2022.

(2)Awards granted to the Executive Directors under the LTIP are subject to a two-year post-vesting holding period and are then released to the Executive Director.

(3)634,901 shares were granted on March 1, 2022 to those senior managers existing as of that date, and 69,637 shares were granted on August 3, 2022 to a senior manager hired after the March 1, 2022 grant.

(4)The market value used to determine the number of shares subject to awards was 1370.6p and 1587.2p, being the average mid-market closing price of Indivior shares on the five business days immediately preceding the dates of grant on March 1, 2022 and August 3, 2022, respectively.

(5)The closing share price was 1403.0p and 1634.0p at the dates of the March 1, 2022 and August 3, 2022 grants, respectively.

(6)Conditional awards include the right to receive an amount equal in value to any dividends payable on the number of vested shares between the date of grant and the release date.

**Indivior Share Plans**

We have established the following plans, the key terms of which are summarized below.

***The Indivior Long-Term Incentive Plan (the "LTIP")***

The LTIP was adopted by the Board on November 5, 2014 and was amended by the Remuneration Committee on November 16, 2016, November 14, 2018 and February 14, 2023.

*Administration of the LTIP*

The LTIP is administered by the Remuneration Committee or, in the case of awards not being made to directors, such other committee as authorized by the Group (the "LTIP Committee").

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*Eligibility*

The LTIP Committee may select any employee of the Group, including any Executive Director, to participate in the LTIP.

*Awards*

Awards may be granted over ordinary shares and will normally take one of three forms:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• a conditional award, which is a right to receive ordinary shares on vesting;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• an option to acquire ordinary shares at a price set by reference to their market value at the grant date; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• an option to acquire ordinary shares for no cost or a nominal amount.

Awards may be satisfied by the issue of new ordinary shares, the transfer of ordinary shares held in treasury or by paying an equivalent amount in cash.

Awards are personal to the participant and may not be transferred except on death. No payment is required for the grant of an award.

*Timing*

Awards may only be granted within 42 days following: the announcement of the Group's results for any period; the removal of any restrictions imposed on the Group which have previously prevented an award from being granted; any date on which changes to legislation or regulations affecting share plans are announced or made; or at any other time if the LTIP Committee considers that exceptional circumstances exist. No awards may be granted under the LTIP after November 5, 2024.

*Individual limit*

Under the 2021 Remuneration Policy, the maximum annual award that may be made to any individual in respect of any financial year will be the lower of 300,000 ordinary shares or 400% of base salary.

*Plan limits*

The LTIP is subject to the limit that on any date, the aggregate nominal amount of ordinary shares that may be allocated under the LTIP may not, when added to the nominal amount of ordinary shares allocated in the previous 10 years under all employee share plans of the Group, exceed 10% of the then equity share capital of the Group.

For these purposes, ordinary shares are treated as allocated when they are issued or transferred in satisfaction (directly or indirectly) of a person's right under an award. No account will be taken of (i) ordinary shares acquired for a price equal to their market value at or about the date of acquisition and whose cost is borne by the employee; or (ii) an award to the extent to which the LTIP Committee considers that it will be satisfied by the transfer of existing ordinary shares other than treasury shares.

*Performance conditions*

Each award may, or in the case of Executive Directors of the Group must, be subject to one or more performance conditions, at least one of which must be linked to the performance of the Group, which will determine whether and to what extent the participant will receive ordinary shares. Performance conditions are normally measured over a period of three years. For Executive Directors the performance conditions are measured on one occasion only; there is no re-testing.

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The LTIP Committee may waive or change performance conditions if events happen as a result of which the LTIP Committee reasonably considers it appropriate to make the change, provided that any changed performance conditions will not be materially easier or more difficult to satisfy.

*Vesting of awards*

Awards will normally only vest in accordance with the performance conditions at the end of the performance period or, if later, three years after the date of grant. Awards granted to the Executive Directors under the LTIP are subject to a two-year post-vesting holding period and are then released to the Executive Director.

Each award may, to the extent that it vests, be adjusted by the LTIP Committee to include the dividends payable on the vested shares during the period starting with the date the award is granted and ending with the date on which the award vests or the option is exercised. The adjustment will be made, as the LTIP Committee may decide, either by paying an amount equal to the dividends in cash or by paying that amount in ordinary shares. Dividend equivalents will be paid to any relevant participant as soon as practicable after entitlement to the ordinary shares under the award or, in the case of an option, after exercise.

In the case of conditional awards, the ordinary shares are issued or transferred to the participant as soon as reasonably practicable upon vesting while in the case of options, the award becomes exercisable on vesting and may be exercised during the exercise period specified at the time of grant.

Alternatively, the LTIP Committee may decide to satisfy awards on vesting by a cash payment.

The LTIP includes a clawback provision under which the LTIP Committee may reduce and/or recover awards. Awards may be adjusted subsequent to their exercise if, before the later of (i) the second anniversary of the date a conditional award vests or an option becomes exercisable, as applicable, and (ii) the fifth anniversary of the award date the LTIP Committee determines in its absolute discretion that there was a material misstatement of the Group's results for any of the financial years during a performance period, there was serious misconduct by the participant, or at any time from the award date (or the start of the performance period, if earlier) there was serious reputational damage to any member of the Group.

*Termination of employment*

If a participant ceases to be employed within the Group for any reason other than misconduct, he is entitled to retain any awards which have vested.

If a participant ceases to be employed within the Group, his unvested awards lapse unless he leaves for a permitted reason. A permitted reason is death, injury, ill-health, disability, redundancy, retirement with his employer's agreement, the sale of the company or business in which the participant works and such other reason as the LTIP Committee may decide.

Where a participant leaves for a permitted reason and the award is subject to a performance condition, the award will vest after the end of the performance period and be released on the normal release date. Alternatively, the LTIP Committee may decide that the extent to which the award will vest will be measured in accordance with a determination of the performance conditions and other conditions at the end of the financial year in which the cessation of employment occurs. The award will also be reduced pro rata to reflect the period from the date of cessation of employment until the date of the end of the performance period as a proportion of the performance period, unless the LTIP Committee decides otherwise.

In the case of death, the performance conditions will not apply and the award will vest and be released on the date of death, but the award will be reduced on a time pro-rated basis. If the award is not subject to performance conditions, the award will vest on the normal vesting date unless the LTIP

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Committee decides otherwise. Options that have already vested, or which vest following termination of employment, may be exercised within the 12 months following their release.

*Change of control*

Special rules apply in the event of a change of control, including a change of control resulting from a scheme of arrangement or a takeover.

Unless the LTIP Committee decides otherwise, awards will vest (if at all) on the date of the change of control, but only to the extent that any performance conditions have been satisfied at that date as determined by the LTIP Committee and the extent to which the award vests shall be reduced pro rata to reflect the period from the date of the event until the date of the end of the performance period as a proportion of the performance period.

In the event of a change of control, participants may or the LTIP Committee may require that participants surrender their awards in return for substitute awards over shares in the acquiring company or another company. The LTIP Committee may allow awards to vest on a similar basis in the event of a demerger or other corporate events.

*Listing*

So long as the ordinary shares are listed on the Official List and traded on the London Stock Exchange, the Group will apply for any new ordinary shares issued under the LTIP to be admitted to the Official List and for permission to trade in those ordinary shares. Ordinary shares issued under the LTIP will rank equally in all respects with existing ordinary shares except for any rights attaching to the ordinary shares by reference to a record date prior to the date of allotment.

*Variation of Capital*

On any variation of the Group's share capital, or in the event of a demerger, special dividend or other circumstances which the LTIP Committee considers appropriate, the LTIP Committee may adjust the number or class of ordinary shares or securities comprised in an option or conditional award and, in the case of an option, the option price.

*Benefits non-pensionable*

Benefits under the LTIP will not form part of a participant's remuneration for pension purposes.

*Amendments*

The LTIP Committee may, without the approval of the Group, amend the LTIP through any minor changes to benefit the administration of the LTIP, to comply with or take account of the provisions of any proposed or existing legislation or changes to any applicable legislation, or to obtain or maintain favorable tax, exchange control or regulatory treatment for participants or for any company in the Group.

Except as described above, no amendment which is to the advantage of existing or future participants may be made, without the prior approval of the Group in general meeting, to those provisions dealing with eligibility, limitations on the number of ordinary shares which may be issued under the plan, or the rights of a participant in the event of a capitalization issue, rights issue or open offer, sub-division or consolidation of shares or reduction of capital or any other variation of capital of the Group.

*HM Revenue and Customs in the United Kingdom ("HMRC") registered options*

The LTIP allows options to be granted in satisfaction of the conditions of Schedule 4 of the Income Tax (Earnings and Pensions Act) 2003, as amended (the "ITEPA").

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*U.S. Participants*

The LTIP contains a part to ensure that options granted to and held by US participants have an exercise price that is at least fair market value, and that conditional awards granted to and held by such U.S. participants either meet the requirements of the short-term deferral exemption to Section 409A of the United States Internal Revenue Code 1986, as amended, or are compliant therewith.

*Canadian Participants*

The LTIP contains a part to ensure that an award made to a participant who is subject to taxation under the laws of Canada is not taxed as a "Salary Deferral Arrangement". All awards subject thereto are administered and interpreted in a manner which complies with such intent.

***The Indivior Savings-Related Share Option Plan (the "Sharesave Plan")***

The Sharesave Plan was adopted by the Board on November 5, 2014 and amended by the Remuneration Committee on May 16, 2017 and February 14, 2023.

*Administration*

The Sharesave Plan is administered, in accordance with its rules, by the Board or a duly authorized committee thereof.

*Eligibility*

All employees (including directors working 25 hours or more per week) who have a qualifying period (if any) of continuous service (commencing not earlier than five years prior to the Date of Grant) as the Directors may in their absolute discretion and from time to time determine of continuous service with the Group, or any subsidiary nominated to join in the Sharesave Plan, and who receive general earnings to which section 15 of the Income Tax (Earnings and Pensions) Act 2003 applies are eligible to participate. The Board may invite other employees of the Group to participate.

*Options*

Options will entitle the holder to acquire ordinary shares. Options will be personal to the participant and may not be transferred. No payment will be required for the grant of an option. No options will be granted under the Sharesave Plan after 30 November 2024.

*Timing*

Invitations to participate will normally be issued within 30 days (or 42 days if applications are scaled down) following: the announcement of the Group's results for any period or its issue of any prospectus, listing particulars or other document containing equivalent information relating to the ordinary shares; a day on which an announcement is made of a new prospectus for certified SAYE (Save As You Earn) savings arrangements (within the meaning of section 703(1) of the Income Tax (Trading and Other Income) Act 2005) for the purposes of Schedule 3 to the Income Tax (Earnings and Pensions) Act 2003; a day on which an announcement is made of amendments to be made to the Income Tax (Earnings and Pensions) Act 2003 (so far as those changes affect savings-related share option plans approved by HMRC) or a day on which any such amendments come into force; the date of any general meeting of the Group's shareholders; or at any other time if the Board determines that the circumstances are sufficiently exceptional to justify the grant of an option. No awards may be granted under the Sharesave Plan after November 30, 2024.

*Exercise price*

The price payable per ordinary share on exercise of an option granted under the Sharesave Plan may not be less than an amount equal to 80% of the market value of an ordinary share (or such other

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percentage as shall from time to time be specified in paragraph 28(1)(b) of Schedule 3 of the Income Tax (Earnings and Pensions) Act 2003) or, if greater, and ordinary shares are to be acquired by subscription, the nominal value of an ordinary share.

*Individual limit*

Each eligible employee will be given the opportunity to apply for an option, the total exercise price of which does not exceed the aggregate of the monthly contributions made and any bonus due under the Sharesave contract to be entered into as a condition of the grant of the option. The aggregate maximum monthly contribution payable by an employee under all Sharesave contracts linked to the options granted under the Sharesave Plan may not exceed such sum as may from time to time be permitted by statute and approved by the directors.

*Plan limits*

On any date, the aggregate nominal amount of new ordinary shares in respect of which options may be granted may not exceed 10% of the nominal amount of the equity share capital of the Group, less the total nominal amount of any new ordinary shares allocated in the previous 10 years under all employee share plans of the Group.

For these purposes, allocation means the issue of new ordinary shares or the transfer of treasury shares in satisfaction (directly or indirectly) of a person's rights under an award. No account will be taken of ordinary shares acquired by an employee where the ordinary shares are acquired for a price equal to their market value at or about the date of acquisition and the cost of those ordinary shares is borne by the employee. No account will be taken of an award if and to the extent to which the Board considers that it will be satisfied by the transfer of existing ordinary shares other than treasury shares. Any ordinary shares allocated, or remaining to be allocated, to the trustee of any trust which were used, or which are to be used, to satisfy awards granted under an employee share plan must be treated as having been allocated, or as remaining to be allocated, in respect of those awards unless the ordinary shares were acquired by the trustee pursuant to a rights issue or other opportunity offered to the trustee in respect of ordinary shares other than ordinary shares previously allocated to it. Where an award is granted in consideration of the release by the holder of an award previously granted to such holder under an employee share plan, then the earlier award is ignored and the later award is deemed to have been granted at the same time as the earlier award.

*Exercise of options*

Options will normally be exercisable in whole or in part during the period of six months starting on the bonus date. The bonus date is the date on which the bonus under the related Sharesave contract is payable. In normal circumstances this will be the third or fifth anniversary of the starting date of the Sharesave contract and will depend upon the election made by the participant at the time of grant.

Whenever an option is exercised, it may only be exercised with monies not exceeding the amount of the aggregate monthly contributions made and any bonus due under the related Sharesave contract.

*Termination of employment*

If the participant dies, his personal representatives may exercise his options in the 12 months following his death or, if earlier, the bonus date. If a participant ceases to be employed within the Group for a permitted reason, the participant may exercise his options in the six months following the termination of his employment. A permitted reason is injury, disability, redundancy, retirement, the transfer or sale outside the Group of the company or business in which the participant works or, in the case of any option which the participant has held for at least three years, where the employee does not return after maternity leave or ceases employment not by reason of dismissal for misconduct. If a participant ceases to be employed for any other reason, his option will lapse.

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For these purposes, a participant will not be treated as ceasing to be employed within the Group for so long as he remains employed by a company which is an associated company of the Group.

*Change of control*

The exercise of options will also be permitted in the event of a change in control, a reorganization, a court-sanctioned compromise or arrangement applicable to or affecting all of the ordinary shares, a takeover offer or a voluntary winding up of the Group. In the event of a change in control of the Group, participants may surrender their options in return for substitute options over shares in the acquiring company.

*Listing*

Application will be made for admission to the Official List of new ordinary shares issued under the Sharesave Plan and for permission to trade in those ordinary shares. Ordinary shares issued on the exercise of options will rank equally in all respects with existing ordinary shares except for rights attaching to ordinary shares by reference to a record date prior to the date of allotment.

*Variation of Capital*

If there is a variation in the share capital of the Group, the Board may adjust options in such manner as it determines to be appropriate.

*Benefits non-pensionable*

Benefits under the Sharesave Plan will not form part of a participant's remuneration for pension purposes.

*Amendments*

If and for so long as the ordinary shares are admitted to the Official List of the London Stock Exchange, no amendment which is to the advantage of employees or participants may be made to those provisions dealing with eligibility, individual or Sharesave Plan limits, the basis for entitlement to and the terms of the ordinary shares or the adjustment of options without the prior approval of the Group in general meeting, except for minor amendments to benefit the administration of the Sharesave Plan, to take account of a change in legislation or to obtain or maintain favorable tax, exchange control or regulatory treatment for participants or eligible employees or for a member of the Group. Subject to the foregoing, the Board may amend the Sharesave Plan in any respect.

***The Indivior PLC U.S. Employee Stock Purchase Plan (the "ESPP")***

The ESPP was approved by shareholders at the Annual General Meeting of the Group held on May 12, 2016 and amended by resolution of the Board on September 24, 2020 and by resolution of the Remuneration Committee on February 14, 2023. It is the intent of the Group to have the ESPP qualify as an "employee stock purchase plan" under Section 423 of the U.S. Internal Revenue Code of 1986, including any amendments or replacements of such section.

*Administration*

The ESPP is administrated by our Board or a duly authorized committee thereof.

*Eligibility*

All individuals who are eligible employees of the Group or participating subsidiaries are eligible to participate in the ESPP. An employee is ineligible if (i) upon enrollment in the ESPP, they would own directly or indirectly an aggregate of 5% or more of the total combined voting power or value of the Group or a subsidiary's shares; (ii) they work 20 hours a week or less; or (iii) they work for five months or less of the calendar year.

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*Options*

Under the ESPP, participants are granted options to purchase ordinary shares from the Group. As of each enrollment date, each participant is automatically granted an option to purchase a number of ordinary shares representing their savings but subject to a maximum number of ordinary shares with a market value at the date of grant of $10,000. Options may either be options to subscribe for newly-issued ordinary shares or for existing ordinary shares purchased in the market. The rights of the participant shall not be transferable. No option shall be granted under the ESPP after the date as of which the ESPP is terminated by the Board in accordance with the termination provisions or, in any event after, the tenth anniversary of the ESPP's approval by the Group's shareholders.

*Timing*

Participation in the ESPP is voluntary. Eligible employees who meet the specified requirements are able to enroll in the ESPP on the first day of each six-month period commencing with the first regular payroll period on or after each successive January 1 or July 1 (each an "Accumulation Period"). Any eligible employee may consent to enrollment in the ESPP by completing and signing an enrollment form (which authorizes the payroll deductions).

*Exercise Price*

The exercise price shall be eighty-five percent (85%) of the lower of (i) the fair market value of an ordinary share on the enrollment date on which the option is granted; or (ii) the fair market value of an ordinary share on the purchase date but, in the case of newly issued ordinary shares, not lower than the par value of an ordinary share. The Board may establish a different purchase price, though it may not be less than (i) the purchase price set forth above and (ii) in the case of newly issued ordinary shares, than the par value per ordinary share. Also, in such case, the Board must determine such different purchase price at least thirty (30) days prior to the Accumulation Period for which it is applicable.

*Payroll Deductions*

To participate in the ESPP, eligible employees must elect and authorize to have deductions made from their pay on each payday during the Accumulation Period to which the enrollment form relates. Each participant designates a percentage of their base earnings to be deducted. The minimum deduction is one percent (1%) and the maximum is ten percent (10%), of base earnings per Accumulation Period.

*Plan limits*

The ESPP will be subject to the limit that on any date, the aggregate number of new ordinary shares which may be issued (or treasury shares transferred) under the ESPP may not, when added to the number of new ordinary shares allocated in the previous 10 years under all employee share plans of the Group, exceed 10% of the equity share capital of the Group in issue at that time.

*Exercise of awards*

An award will normally be deemed to have been exercised on the specific trading day during an Accumulation Period on which ordinary shares are purchased under the ESPP. For each Accumulation Period, the purchase date is the last trading day occurring in such Accumulation Period. Whenever an award is exercised it will be for the number of ordinary shares (including partial or fractional shares) which the funds accumulated in their account at such purchase date will purchase at the applicable purchase price.

*Termination of employment*

Participation in the ESPP terminates immediately when a participant ceases to be employed with the Group or a participating subsidiary for any reason whatsoever, including but not limited to termination of employment, whether voluntary or involuntary, or on account of death, disability or retirement, or if the

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participating subsidiary employing the participant ceases to be a participating subsidiary. As soon as administratively practicable after termination, the Group shall pay the participant or legal representative all amounts accumulated in the participant's account.

*Change of Control*

A participant's accumulated savings at the relevant date will be used to exercise their options under the ESPP in the event of a change of control, takeover offer, scheme of arrangement or winding up of the Group.

*Listing*

Application will be made for admission to the Official List of any new ordinary shares issued under the ESPP and for permission to trade in those ordinary shares. Ordinary shares issued on the exercise of options will rank equally in all respects with existing ordinary shares except for rights attaching to ordinary shares by reference to a record date prior to the date of allotment.

*Variation of Capital*

In the event of any reorganization, recapitalization, stock split, stock dividend, combination of shares, merger, consolidation, acquisition of property or shares, separation, asset spin-off, stock rights offering, liquidation or other similar change in the capital structure of the Group, the Board shall make such adjustment, if any, as it deems appropriate in the number, kind and purchase price of the ordinary shares available for purchase under the ESPP. In the event of liquidation of the Group, each option to purchase ordinary shares shall terminate but the participant holding such an option shall have the right to exercise their option prior to such termination.

*Benefits non-pensionable*

Benefits under the ESPP do not form part of a participant's remuneration for pension purposes.

*Amendments*

The Board may amend or modify the ESPP at any time, provided that no amendment that would amend to the advantage of participants (i) the definition of eligible employees entitled to participate in the ESPP, (ii) the maximum number of ordinary shares reserved for sale and issuance under the ESPP, (iii) the number, kind and purchase price of the ordinary shares available for purchase in order to permit the enlargement of a participant's rights under the ESPP, (iv) the maximum fair market value option amount that a participant may be granted in a calendar year under the ESPP, or (v) the requirements of any securities exchange on which the ordinary shares are traded unless in each case it has been authorized by shareholders of the Group in a general meeting. The committee authorized to administer the ESPP may, without such approval, make minor amendments to benefit the administration of the ESPP, to take account of a change in legislation or to obtain or maintain favorable tax, exchange control or regulatory treatment for participants in the ESPP or for the Group or for members of its Group. Subject to the preceding paragraph, the committee authorized to administer the ESPP shall have the power to amend the ESPP and perform such acts as it deems necessary to promote the best interests of the Group.

***The Deferred Bonus Plan 2018 ("DBP")***

In line with our Remuneration Policy, the DBP requires the Executive Directors to defer 25% of their annual bonus in the form of ordinary shares or ADRs of the Group for a period of time. The DBP was adopted by the Board on July 19, 2018 and subsequently amended on November 19, 2018 and February 14, 2023. The DBP only applies to the Executive Directors (the Chief Executive Officer and Chief Financial Officer). The DBP is intended to comply with section 409A of the U.S. Internal Revenue Code of 1986.

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*Administration of the DBP*

The DBP is administered, in accordance with its rules, by the Remuneration Committee or another duly authorized committee of the Board (the "DBP Committee").

*Eligibility*

The DBP Committee may grant an award under the DBP to any employee (including an Executive Director) who was a participant in any annual bonus plan operated by the Group during the financial year immediately preceding the proposed date of grant as a means of deferring part of that employee's annual bonus into ordinary shares or ADRs of the Group.

*Awards*

Awards may be granted in the form of (i) options to acquire ordinary shares or ADRs of the Group, (ii) conditional share awards or (iii) phantom shares awards, in each case as the DBP Committee may determine in its absolute discretion. Prior to granting an award, the DBP Committee shall determine the amount of ordinary shares, ADRs or notional shares subject to an award where the market value of such ordinary shares, ADRs or notional shares, as applicable, shall not exceed 25% (or such other percentage as the DBP Committee may determine) of the individual's annual bonus.

*Timing*

Awards may only be granted within 42 days commencing on the day immediately after the announcement of the Group's results for any period or the day on which the DBP Committee considers that exceptional circumstances exist which justify the grant of awards.

*Vesting of awards*

Awards will typically vest after a period of two years from the date of grant or such other period or periods as the DBP Committee considers appropriate. Ordinary shares or ADRs transferred under the DBP will rank equally in all respects with existing ordinary shares or ADRs, as applicable, then in issue except for any rights attaching to such ordinary shares or ADRs, as applicable, by reference to a record date before the date of such transfer.

The DBP includes a clawback provision under which the DBP Committee may reduce awards, recover awards or make certain other adjustments to awards if (and in respect of vested awards only, before the second anniversary of such award's vesting date) the DBP Committee determines in its absolute discretion that there was a material misstatement of the Group's results for any financial year before an award was granted, there was serious misconduct by the participant, or at any time during or after any financial year before an award was granted there was serious reputational damage to any member of the Group.

*Termination of employment*

If, prior to an award vesting, a participant ceases to be employed within the Group due to voluntary resignation, misconduct or the Group becomes aware of facts or circumstances that would have entitled it to dismiss the participant for misconduct, such participant's unvested awards shall lapse. If, prior to an award vesting, a participant ceases to be employed within the Group for any other reason, then such participant's unvested award shall continue subject to the rules of DBP.

*Change of control*

Special rules apply in the event of a change of control, including a change of control resulting from a scheme of arrangement pursuant to the Companies Act or a takeover. Unless the DBP Committee decides otherwise, awards will vest on the date of the relevant event.

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The DBP Committee may determine that participants may surrender their awards in return for substitute awards over shares in the acquiring company or another company. The DBP Committee may allow awards to vest on a similar basis in the event of a voluntary winding-up of the Group.

*Dividends*

Subject to the determination of the DBP Committee, participants shall be entitled on the vesting of any award either (a) to be paid a cash amount equal to the dividend that the participant would have accrued had the participant held the number of ordinary shares or ADRs, as applicable, under the award from the date of grant until the vesting date or (b) to receive an additional number of ordinary shares or ADRs, as applicable, that could have been acquired with the amount of cash dividends payable on the ordinary shares or ADRs, as applicable, under the award.

*Variation of Capital*

On any variation of the Group's share capital, such as a rights issue, super dividend, demerger, dividend in specie or any capitalization issue or other similar event, awards may be adjusted in such manner as the DBP Committee considers appropriate. If any such event, in the opinion of the DBP Committee, would materially affect the value of an award, the DBP Committee may permit awards to vest on or prior to the date of such event.

*Amendments*

The DBP Committee may amend the DBP from time to time. However, except for minor amendments to benefit the administration of the DBP, to take account of changes in law, tax or regulatory treatment or to take account of local laws where participants are situated, no amendment that would adversely and materially affect the existing rights of a participant may be made unless with the written consent of the participant or a majority of the participants affected by the amendment.

***Indivior PLC Employee Benefit Trust***

In 2016, we established an employee benefit trust with an independent trustee, based in Jersey, Channel Islands, to purchase and hold shares in Indivior to be used to satisfy awards and/or options granted to eligible employees under our share plans established from time to time. Shares purchased in the market, held in trust and subsequently used to satisfy awards and/or options granted under the Group's share plans, do not count towards the limits under the plans.

The trustee has waived its rights to receive dividends on any shares that it holds. As at February 21, 2023, the employee benefit trust held 231,969 ordinary shares, which represent 0.17% of the Group's issued share capital as at February 21, 2023.

**Indivior Inc. Profit Sharing and 401(k) Plan (the "401(k) Plan")**

The 401(k) Plan is a defined contribution plan and is intended to be a qualified retirement plan under the U.S. Internal Revenue Code of 1986. The purpose of the 401(k) Plan is to enable eligible employees to save for retirement. As well as retirement benefits, the 401(k) Plan provides certain benefits in the event of death, disability, or other termination of employment. The 401(k) Plan is for the exclusive benefit of eligible employees and their beneficiaries.

Eligible employees may elect to defer a percentage of their eligible compensation into the 401(k) Plan, and the Group will match 75% of the first 6% of an eligible employee's contributions. Additionally, the Group automatically contributes an amount equal to 4% of an eligible employee's eligible compensation to the employee's 401(k) Plan, representing a profit sharing contribution.

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**Indivior Inc. Deferred Compensation Plan ("DCP")** 

We maintain a Deferred Compensation Plan ("DCP") that provides a select group of Management and other highly compensated employees in the U.S., including Executive Directors and Senior Managers, as determined by the committee administering the DCP, with an opportunity to defer the receipt of portions of their compensation. The DCP is intended to comply with section 409A of the U.S. Internal Revenue Code of 1986. The DCP allows highly compensated employees who are unable, due to limits that the Internal Revenue Service ("IRS") imposes on 401(k) plans, to save a proportionate amount of their eligible compensation for retirement within the 401(k) Plan, to defer compensation in excess of IRS limits.

Under our DCP, for each financial year, participants may elect to defer up to 75% of their base salary and up to 100% of their bonus. Employees hired before January 1, 2011 are eligible for a Group match on 401(k) deferrals in excess of the annual IRS limit up to 4.5% of eligible compensation. Amounts contributed to the DCP are invested in one or more investment options as elected by a participant or absent such election, the committee administering the DCP. Participants can elect to have the benefits associated with compensation deferred in a financial year paid on June 1 of a year at least two financial years after the financial year in which such compensation was deferred. Otherwise, and subject to certain exceptions, benefits under the DCP are paid in a lump sum or in a fixed amount annually over a period not to exceed 10 years starting 60 days (or for certain employees, six months) after termination of employment of the participant.

**Deeds of Indemnity**

The Company also entered into a deed poll of indemnity (the "Deed Poll") on November 5, 2014 for the benefit of the officers, directors, company secretary or any position equivalent to any of the foregoing ("Beneficiaries") of the Company or any body corporate that is a group undertaking of the Company ("Group Company"). Under the Deed Poll, the Company undertakes to indemnify each Beneficiary against any and all liability suffered or incurred by that Beneficiary in respect of that Beneficiary's acts or omissions while, or in the course of acting or purporting to act as, an officer of any Group Company or which otherwise arises by virtue of that Beneficiary holding or having held such position, in each case, to the extent arising out of or in connection with, directly or indirectly, any investigation, demand, claim, action or proceeding brought or threatened against that Beneficiary or any other person in any jurisdiction.

The Deed Poll do not extend to any liability incurred by the Beneficiary (1) to pay a fine imposed in criminal proceedings, (2) to pay a sum payable to a regulatory authority by way of a penalty in respect of non-compliance with any requirement of a regulatory nature, (3) in defending any criminal proceedings in which he is convicted, (4) in defending civil proceedings brought by the Company, in which judgment is given against him, or (5) in connection with an application for relief in which the court refuses to grant him relief. The Deed Poll also do not apply to the extent that the Beneficiary has been indemnified or reimbursed by any other insurance, where there has been gross negligence, fraud or willful default by the Beneficiary or where the Beneficiary has improperly derived a personal benefit or profit.

The Company may advance such funds to a Beneficiary as the Company, in its reasonable discretion, considers appropriate for the Beneficiary to meet expenditures incurred in defending any criminal or civil proceedings in connection with any alleged negligence, default, breach of duty or breach of trust by the Beneficiary or in defending himself in an investigation by a regulatory authority or against action proposed to be taken by a regulatory authority in connection with any alleged negligence, default, breach of duty or breach of trust by the Beneficiary.

The Deed Poll also provide that the Company will use reasonable endeavors to purchase and maintain insurance cover for directors and officers liabilities on reasonable commercial terms in respect of

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each Beneficiary for so long as the Beneficiary is a director or employee of any Group Company and for at least six years thereafter.

**Malus and Clawback**

The Remuneration Committee has the discretion to scale back or cancel LTIP awards, extend the performance period or defer the exercise period prior to the satisfaction of awards or after the end of any relevant holding period in the event that results are materially misstated for part of the performance period applicable to an award, an individual's conduct has amounted to gross misconduct or, in respect of awards made after the adoption of the 2018 Remuneration Policy, in the event of serious reputational damage to Indivior. Where LTIP awards have vested, the Committee has the discretion to "claw back" awards or reduce amounts of other payments due to the individual up to the fifth anniversary of the grant of awards in the circumstances described above.

***Executive Financial Recoupment Program***

As part of Indivior Inc.'s Corporate Integrity Agreement with the Office of the Inspector General of the U.S. Department of Health and Human Services, an Executive Financial Recoupment Program was implemented (the "Recoupment Program"). Under the terms of the Recoupment Program, up to two years of performance pay may be put at risk of forfeiture and/or recoupment for certain US-based executives (which includes both serving Executive Directors).

Forfeiture and/or recoupment may be applied in the event that it is determined that there has been a "Triggering Event"; a Triggering Event includes significant misconduct (violation of law or regulation or a significant violation of an Indivior policy) related to covered activities, or, significant misconduct related to covered activities by subordinate employees in the business unit for which the relevant executive had responsibility that is not an isolated incident and which the relevant executive knew or should have known was occurring.

Forfeiture and/or recoupment under the Recoupment Program may be applied to awards granted after November 20, 2020 and will cease to apply to awards on July 24, 2025 or the date on which Indivior Inc.'s obligations under the Corporate Integrity Agreement expire (if later).

**C.Board Practices**

As a foreign private issuer, we are permitted to follow certain home country corporate governance practices instead of those otherwise required under Nasdaq's rules for domestic U.S. issuers, provided that we disclose which requirements we are not following and describe the equivalent home country requirement. However, notwithstanding our ability to follow the corporate governance practices of our home country, the United Kingdom, in most cases we have elected to adhere to the corporate governance rules of Nasdaq applicable to U.S. domestic registrants that are not "controlled" companies. The corporate governance practices that we follow in lieu of Nasdaq's corporate governance rules are as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In lieu of the requirement to comply with Rule 5605(e)(1), which requires that director nominees must be selected, or recommended for the board's selection, by either independent directors constituting a majority of the board's independent directors in a vote in which only independent directors participate or a nominations committee comprised solely of independent directors, our Nomination and Governance Committee (which is responsible for director nominations) consists of six directors, one of whom we do not consider to be an independent non-executive director for the purposes of the 2018 UK Corporate Governance Code and as a result, might not be considered independent under the Nasdaq rules. The 2018 UK Corporate Governance Code, which sets out standards of good practice (as opposed to mandatory requirements) for companies with a UK Premium Listing (such as Indivior) on, *inter alia*, board and board committee composition, provides that the board of such companies should establish a

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nominations committee to lead the process for appointments and that the majority of the members of the nominations committee should be independent non-executive directors.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• In lieu of the requirement to comply with Rule 5620, which requires that a company is required to specify in its bylaws that for any meeting of the holders of common stock, a quorum shall not be less than 33 1/3% of the outstanding shares of the company's common voting stock, our articles of association specify that the quorum for a general meeting of shareholders shall be at least two people who are entitled to vote (who can be shareholders who are personally present or proxies for shareholders or a combination of both). Under English law, subject to the provisions of a company's articles of association, two shareholders present at a meeting (in person or by proxy) shall constitute a quorum.

**Board of Directors**

The Board is committed to the highest standards of corporate governance and maintaining a sound framework for the control and management of the business. The Board is responsible for leading and controlling the Group and has overall authority for the management and conduct of our business and our strategy and development. The Board is also responsible for ensuring the maintenance of a sound system of internal control and risk management (including financial, operational and compliance controls, and for reviewing the overall effectiveness of systems in place) and for the approval of any changes to the capital, corporate and/or management structure of the Group. At the date of this registration statement, the Board comprises 12 members: the Chair, nine Non-Executive Directors, and two Executive Directors. Daniel J. Phelan is the Group's Senior Independent Director. Juliet Thompson has been appointed as Senior Independent Director with effect from October 1, 2023.

**Committees of the Board**

Our Board has established an Audit Committee, a Remuneration Committee, a Nomination and Governance Committee and a Science and Policy Committee. Each of the Board's committees have Terms of Reference which are reviewed annually and approved by the Board.

***Audit Committee***

The Audit Committee has responsibility for, among other things, monitoring the financial integrity of the financial statements of the Group along with PwC our external auditors in that process. It focuses in particular on compliance with accounting policies and ensuring that an effective system of internal financial controls is maintained. The ultimate responsibility for reviewing and approving the annual report and accounts and other interim financial reports remains with the Board. The Audit Committee shall meet not less than four times a year to coincide with key dates in the Group's financial reporting cycle. The Audit Committee also meet on an ad hoc basis when necessary.

The responsibilities of the Audit Committee set out in its Terms of Reference cover external audit, internal audit, financial and narrative reporting, internal controls and risk management and the systems and procedures for detecting fraud. The Terms of Reference also set out the authority of the Audit Committee to carry out its responsibilities.

SEC rules and regulations and the Nasdaq listing standards require that the Audit Committee comprises at least three members who are all independent and possess requisite financial literacy and includes one member who qualifies as an "audit committee financial expert." The members of the Audit Committee are Juliet Thompson, Joanna Le Couilliard, Mark Stejbach and Barbara Ryan. Juliet Thompson is the Chair of the Audit Committee. Our Board has determined that each member is independent within the of SEC rules and regulations and the Nasdaq listing standards and possesses the required level of financial literacy as required by Nasdaq. Our Board has determined that Ms. Thompson and Ms. Le Couilliard both qualify as an "audit committee financial expert" as defined in the SEC rules and satisfies the financial sophistication requirement of Nasdaq.

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***Remuneration Committee***

The Remuneration Committee is responsible for determining the specific remuneration packages for the Chair, the Executive Directors and members of Senior Management. It is also responsible for determining general remuneration policy and monitoring workforce remuneration arrangements. The Remuneration Committee shall meet not less than quarterly.

The responsibilities of the Remuneration Committee set out in its Terms of Reference cover setting levels of remuneration and determination and monitoring of the remuneration policy, approval of the design of, and determining targets for, performance-related pay schemes and approval of the design and implementation of all long-term incentive arrangements. The Terms of Reference also set out the reporting responsibilities and the authority of the Remuneration Committee to carry out its responsibilities.

The members of the Remuneration Committee are Daniel J. Phelan, Graham Hetherington, Joanna Le Couilliard, Lorna Parker and Peter Bains each of whom is an Independent Non-Executive Director. Mr. Phelan is the Chair of the Remuneration Committee. Joanna Le Couilliard has been appointed as Chair of the Remuneration Committee with effect from October 1, 2023. Our Board has determined that each member is independent under the Nasdaq listing standards.

***Nomination and Governance Committee***

The Nomination and Governance Committee is responsible for considering and making recommendations to the Board in respect of appointments to the Board and the Board's committees. It is also responsible for keeping the structure, size and composition of the Board under regular review, and for making recommendations to the Board with regard to any necessary changes. The Nomination and Governance Committee's Terms of Reference cover succession planning, taking into account the skills and expertise that will be needed on the Board in the future. The Nomination and Governance Committee meets no less than quarterly. The Nomination and Governance Committee also has responsibility for oversight of the Group's Global Integrity & Compliance Program.

The members of the Nomination and Governance Committee are Graham Hetherington, Juliet Thompson, A. Thomas McLellan, Lorna Parker, Jerome Lande and Daniel J. Phelan. Graham Hetherington is the Chair of the Nomination and Governance Committee. Our Board has determined that each member of the Nomination and Governance Committee, other than Mr. Lande, is independent under the Nasdaq listing standards.

***Science and Policy Committee***

The Science and Policy Committee is responsible for providing assurance to the Board regarding the quality, competitiveness and integrity of the Group's research and development activities. It is responsible for reviewing the approaches adopted in respect of the Group's chosen therapy area of addiction and its co-morbidities, reviewing the scientific technology and research and development capabilities deployed within the business, assessing the decision-making processes for research and development projects, reviewing benchmarking against industry and scientific best practices and reviewing relevant and important bioethical issues and assisting in the formulation of appropriate policies in relation to such issues. Additionally, it is also the responsibility of the Science and Policy Committee to evaluate emerging issues and trends in science and policy matters including the potential impact of wider government policy that may affect the Group's overall business strategy.

The members of the Science and Policy Committee are Peter Bains, Barbara Ryan, Mark Stejbach and A. Thomas McLellan, Ph.D. The Science and Policy Committee is chaired by Peter Bains.

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**Code of Conduct and Ethical Guidelines**

Our Board has adopted a Code of Conduct and a Supplemental Code of Ethics for Senior Financial Officers that describes our commitment to, and requirements in connection with, ethical issues relevant to business practices and conduct.

**Indemnification of Directors and Senior Managers**

Each of the Directors and Senior Managers has the benefit of indemnity insurance maintained by the Group on their behalf indemnifying them against liabilities they may potentially incur to third parties as a result of their office as director or senior manager.

**Service Contracts with Directors and Senior Managers** 

*Chair and Non-Executive Directors' letters of appointment*

The terms of service of the Chair and the Non-Executive Directors are contained in letters of appointment. In accordance with the 2018 UK Corporate Governance Code, the Chair and Non-Executive Directors are appointed subject to re-appointment by shareholders at the Group's next AGM following their appointment and re-appointment at each subsequent AGM. The Group may terminate the appointment of the Chair and the Non-Executive Directors upon one month's written notice, and they are not otherwise entitled to receive compensation for loss of office.

*Executive Directors' service agreements*

The Executive Directors have service agreements that set out the contract between them and the Group. Messrs. Crossley and Preblick each have agreements that entitle them to 12 months base salary and a pro rata amount of their annual incentive in the event the Group terminates their employment without cause, or they terminate their employment for Good Reason (as defined in the agreements). A change in control alone does not constitute good reason. The Group is obligated to pay their base salary for one month if their employment terminates due to their death.

*Other Senior Managers*

The members of our Executive Committee, other than Messrs. Crossley and Preblick, have service agreements that set out the contract between them and the Group. The agreements with each member of the Executive Committee, other than the Executive Directors, generally provide for severance of 12 months' base salary following the termination of employment, plus a pro rata portion of the annual bonus the executive would have received for the year of termination, and in the case of termination of employment on or within 12 months following the date of a change of control and such termination is by the Group without Cause or by the Executive for Good Reason (as defined in the agreement), in which case severance is 24 months' base salary (12 months for the Executive Directors). An executive is also entitled to a pro rata portion of the annual bonus if their employment terminates as a result of their death or disability.

**D.Employees**

The information at "*<u>[Item 4.](#id39cb0e1a10249e1ab7b8f77d921d68a_2095)</u>—INFORMATION ON THE COMPANY—B. Business Overview Background—Human Capital*," is incorporated herein by reference.

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**E.Share Ownership**

The information at "*<u>[Item 7.](#id39cb0e1a10249e1ab7b8f77d921d68a_10)</u> Major Shareholders and Related Party Transactions*," is incorporated herein by reference.

In addition, the following executives hold options over shares in Indivior PLC as follows:

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| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| **Executive** | **Share Plan** | **Security** | **Total Purchase Price** | **Per Share Exercise Price** | **Vesting<br>Date** | **Expiry<br>Date** | **Number<br>of Shares** |
| Mark Crossley | LTIP <sup>(1)</sup> | ordinary shares | n/a | £5.55 | 5/11/2016 | 12/28/2024 | 42123 |
| Christian Heidbreder | LTIP <sup>(1)</sup> | ordinary shares | n/a | £5.55 | 5/11/2016 | 12/28/2024 | 63185 |
| Kathryn Hudson | Sharesave <sup>(2)</sup> | ordinary shares | n/a | £1.70 | 3/1/2023 | 8/31/2023 | 5294 |
| Kathryn Hudson | Sharesave <sup>(2)</sup> | ordinary shares | n/a | £4.80 | 3/1/2024 | 8/31/2024 | 1875 |
| Kathryn Hudson | Sharesave <sup>(2)</sup> | ordinary shares | n/a | £13.40 | 3/1/2026 | 8/31/2026 | 671 |
| Hillel West | Sharesave <sup>(2)</sup> | ordinary shares | n/a | £4.80 | 3/11/2024 | 8/31/2024 | 2250 |
| Hillel West | Sharesave <sup>(2)</sup> | ordinary shares | n/a | £4.80 | 3/11/2026 | 8/31/2026 | 2500 |

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______________

(1)Reflects market-value options held by the executives granted under the rules of the Indivior Long-Term Inventive Plan in December 2014 (on demerger).

(2)Reflects options granted senior managers under the rules of the Indivior UK Savings-Related Share Option Plan, which is a tax qualified plan available to all UK-based employees. Eligible employees may enter into a savings contract, saving up to £500 per month, with the opportunity to buy shares at 20% discount to market value at the time of invitation upon completion of the savings period.

**F.&nbsp;&nbsp;&nbsp;&nbsp;Disclosure of Registrant's Action to Recover Erroneously Awarded Compensation**

Not applicable.

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**ITEM 7: MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS**

**A.Major Shareholders**

As of February 28, 2023, approximately 59.6 million shares were held in the United States by 80 shareholders of record, comprising approximately 43.82% of our issued share capital.

The table below sets forth information with respect to the beneficial ownership of our ordinary shares, based on notifications made by such shareholders under the UK Financial Conduct Authority's Disclosure and Transparency Rules as of February 21, 2023 by:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• each of our directors, executive officers and senior managers individually and as a group; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• each person, or group of affiliated persons, who is known by us to own beneficially more than 3% of our ordinary shares.

Beneficial ownership is determined in accordance with the rules and regulations of the SEC. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, we have included shares that the person has the right to acquire within 60 days, including through the exercise of any option, warrant or other right or the conversion of any other security. These shares, however, are not included in the computation of the percentage ownership of any other person.

All ordinary shares have the same voting rights.

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| | | | |
|:---|:---|:---|:---|
| **NAME AND ADDRESS OF BENEFICIAL OWNER** | **NUMBER OF SHARES BENEFICIALLY OWNED** | | **TOTAL PERCENTAGE**<sup>(1)</sup> |
| **Major Shareholders:** | | | |
| &nbsp;&nbsp;&nbsp;&nbsp;Scopia Capital Management LP<sup>(2)</sup> | 12267363 |  | 9.00% |
| &nbsp;&nbsp;&nbsp;&nbsp;Morgan Stanley & Co. International plc<sup>(3)</sup> | 8211300 |  | 6.02% |
| &nbsp;&nbsp;&nbsp;&nbsp;Two Seas Capital LP (formerly Kairos Capital Management LP)<sup>(4)</sup> | 7511808 |  | 5.51% |
| &nbsp;&nbsp;&nbsp;&nbsp;J.P. Morgan Securities plc<sup>(5)</sup> | 7299350 |  | 5.36% |
| &nbsp;&nbsp;&nbsp;&nbsp;BlackRock, Inc.<sup>(6)</sup> | 6932391 |  | 5.09% |
| **Directors**<sup>(7)</sup> |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Graham Hetherington | 15844 |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Mark Crossley<sup>(8)</sup> | 132155 | <sup>(11)</sup> | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Ryan Preblick<sup>(8)</sup> | 28105 |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Daniel J. Phelan | 12063 |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Peter Bains | 10800 |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Jerome Lande | 63 |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Joanna Le Couilliard | 0 |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Dr. A. Thomas McLellan | 1509 |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Lorna Parker | 5173 |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Barbara Ryan | 0 |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Mark Stejbach | 8284 |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Juliet Thompson | 0 |  | \* |
| **Senior Management**<sup>(9)</sup> |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Jeff Burris | \* |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Cindy Cetani | \* |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Nina DeLorenzo | \* |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Jon Fogle | \* |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Dr. Christian Heidbreder | \* |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Kathryn Hudson<sup>(10)</sup> | \* |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Vishal Kalia | \* |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Richard Simkin | \* |  | \* |
| &nbsp;&nbsp;&nbsp;&nbsp;Hillel West<sup>(10)</sup> | \* |  | \* |
| **All Directors and Senior Managers as a Group**  | 581979 | <sup>(11) (12)</sup> | \* |

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________________

\*Represents beneficial ownership of less than one percent of our outstanding ordinary shares.

(1)Based on 136,291,476 ordinary shares outstanding as of January 31, 2023, which comprise our entire issued and outstanding share capital as of that date.

(2)The business address for Scopia Capital Management LP is 152 West 57th Street, 33rd Floor, New York, NY 10019, United States. Based on the Group's review of a Schedule 13D filed by Scopia Capital Management LP on October 28, 2022, Matthew Sirovich and Jeremy Mindich share voting and investment control of shares held by Scopia Capital Management LP.

(3)The business address for Morgan Stanley & Co. International plc is 25 Cabot Square, Canary Wharf, London, E14 4QA, United Kingdom. Based on the Group's review of Form SBSE-A filed by Morgan Stanley & Co. International plc on February 15, 2023, Morgan Stanley Investments (UK) has voting and investment control of shares held by Morgan Stanley & Co. International plc.

(4)The business address for Two Seas Capital LP (formerly Kairos Capital Management LP) is 32 Elm Place, 3rd Floor, Rye, NY 10580, United States. Based on the Group's review of a Schedule 13G filed by Two Seas Capital LP on February 13, 2023, Sina Toussi has voting and investment control of shares held by Two Seas Capital LP.

(5)The business address for J.P. Morgan Securities plc is 25 Bank Street, Canary Wharf, London, E14 5JP, United Kingdom. Based on the Group's review of an Annual Report filed with Companies House (UK) by J.P. Morgan Securities plc on May 3, 2022, J.P. Morgan Capital Holdings Limited has voting and investment control of shares held by J.P. Morgan Securities plc.

(6)The business address for BlackRock, Inc. is 55 East 52nd Street, New York, NY 10055, United States. Based on the Group's review of a Schedule 13D filed by BlackRock, Inc. on February 9, 2023, the Directors and Executive Officers of BlackRock, Inc. have voting and investment control of shares held by BlackRock, Inc.

(7)Except as otherwise indicated, the business address for each of our Directors is 234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom.

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(8)The business address for Mr. Crossley and Mr. Preblick is 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA 23235, United States.

(9)Except as otherwise indicated, the business address for each member of our Senior Management is 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA 23235, United States.

(10)The business address for Ms. Hudson and Mr. West is 234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom.

(11)This amount includes 42,123 shares which Mr. Crossley has the right to acquire within 60 days by option or other agreement.

(12)This amount includes 63,185 shares which Senior Management has the right to acquire within 60 days by option or other agreement.

Changes in the percentage ownership by major shareholders are set out below. The information in the table below is based on the notifications made by such shareholders as of the dates indicated under the UK Financial Conduct Authority's Disclosure and Transparency Rules.

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| | | | |
|:---|:---|:---|:---|
| | **December 31, 2020** | **December 31, 2021** | **December 31, 2022** |
| Scopia Capital Management LP | 15.51% | 13.52% | 8.98% |
| Morgan Stanley & Co. International plc | —% | —% | 7.02% |
| Two Seas Capital LP (formerly Kairos Capital Management LP) | 5.13% | 5.13% | 5.13% |
| J.P. Morgan Securities plc | —% | —% | 5.35% |
| BlackRock, Inc. | —% | —% | —% |

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**B.Related Party Transactions**

The Group entered into an agreement titled Relationship Agreement with Scopia Capital Management LP ("Scopia") on March 24, 2021 (as further amended on July 7, 2022 and March [ ], 2023, the "Relationship Agreement"). In recognition of Scopia's ownership of approximately 16.9% of the Group's shares as at March 24, 2021, the Group agreed to appoint Jerome Lande as a Representative Director. Scopia agreed to certain standstill provisions (for example to vote on ordinary course resolutions in accordance with the Board's recommendation).

The parties amended and restated the Relationship Agreement on July 7, 2022 and March [ ], 2023] and further agreed that Scopia would not exercise voting rights in excess of 10% of the outstanding shares. The Relationship Agreement, as amended and restated, is filed as Exhibit 4.2 to this Registration Statement.

The Relationship Agreement, as amended, terminates upon the earlier of (i) December 31, 2023, (ii) the date on which Scopia publicly discloses that it has ceased to hold directly or indirectly at least five per cent of the issued share capital of the Group, or (iii) in certain circumstances, and only in the event that Mr. Lande has resigned from the Board, a specified date to be calculated with reference to the date of the 2023 AGM.

**C.Interests of Experts and Counsel**

Not applicable.

**ITEM 8: FINANCIAL INFORMATION**

**A.Consolidated Statements and Other Financial Information**

See "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements*" for a list of all financial statements filed as part of this registration statement.

**<u>Share Consolidation</u>**

In September 2022, the Group's shareholders approved an additional listing in the U.S. Additionally, to fulfill U.S. exchange requirements for share price minimums and norms, the Group's shareholders also approved a 5-for-1 share consolidation. On October 10th, 2022, the Group completed this share consolidation. Shareholders received 1 new ordinary share with a nominal value of $0.50 each for every 5

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previously existing ordinary shares which had a nominal value of $0.10 cents each. All share and per share information of the Group, including basic and diluted weighted average number of shares outstanding, basic (loss)/ earnings per share, diluted (loss)/earnings per share and adjusted basic earnings per share reflect the share consolidation for all periods presented.

**<u>Share Repurchase Program</u>**

In July 2021, the Group commenced an irrevocable share repurchase program for an aggregate purchase price up to no more than $100 million or 73,462,098 of ordinary shares. In December 2021, the program concluded with the Group repurchasing 33,507,433 of the Group's ordinary shares over the duration of the program for an aggregate nominal value of $3m ($0.10 per share). In addition, 256,055 ordinary shares purchased as part of the share repurchase program at $0.10 each were canceled in January 2022. These shares are included in the total number of share capital outstanding as at December 31, 2021.

In May 2022, the Group commenced a second share repurchase program for an aggregate purchase price up to no more than $100 million or 39,698,610 of ordinary shares (equivalent shares post consolidation: 7,939,722), which is expected to end no later than March 31, 2023. During the year, prior to the share consolidation, the Group repurchased and cancelled 17,815,033 of the Company's ordinary shares for an aggregate nominal value of $2 million ($0.10 per share), including the 256,055 ordinary shares purchased as part of the Group's share repurchase program executed in 2021 and cancelled in January 2022. Subsequent to the share consolidation, the Group repurchased and cancelled 1,280,914 of the Company's ordinary shares for an aggregate nominal value of $1 million ($0.50 per share).

All ordinary shares repurchased under share repurchase programs were cancelled resulting in a transfer of the aggregate nominal value to a capital redemption reserve. The total cost of the share repurchase program was $90 million consisting of $89 million (2021: $100 million; 2020: $nil) paid for the repurchase of shares and $1 million (2021: $1 million; 2020: $nil) of directly attributable transaction costs paid, which include advisory fees and stamp duties. A net repurchase amount of $9 million has been recorded as a financial liability and reduction in retained earnings which represents the amount to be spent under the program up to February 16, 2023, the period closed for modification or termination of the program. Total purchases under the share repurchase program will be made out of distributable profits.

**<u>Corporate Debt and Equity Investments</u>**

In 2022, the Group purchased ordinary shares of a listed company and invested in a portfolio of investment-grade debt securities and has therefore adopted new accounting policies as disclosed below:

Investments comprise holdings in equity and debt securities. Investments in equity securities held for trading or for which the Group has not elected to recognize fair value gains and losses through other comprehensive income are initially recorded and subsequently measured at fair value through profit or loss. Investments in debt securities are initially recorded at fair value plus or minus directly attributable transaction costs and remeasured on the basis of the Group's business model and the contractual cash flow characteristics. Interest income from debt securities is included in finance income using the effective interest method.

**Legal Proceedings**

Except as disclosed in this paragraph, or in <u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u> "Legal Proceedings" included in "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements*," (which is incorporated by reference herein), there are no governmental, legal or arbitration proceedings (including any such proceedings which are pending or threatened of which the Group is aware), which may have, or have had during the 12 months prior to the date of this registration statement, a significant effect on the Group's and/or our

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financial position or profitability. In addition to the proceedings set out in this section, the Group is involved in other legal proceedings and claims in the ordinary course of business.

**B.Significant Changes**

For information on any significant changes that may have occurred since the date of our annual financial statements, see "*<u>[Item 5.](#id39cb0e1a10249e1ab7b8f77d921d68a_269)</u> Operating and Financial Review and Prospects*."

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**ITEM 9: THE OFFER AND LISTING**

**A.Offering and Listing Details**

Our only issued and outstanding shares are our ordinary shares of $0.50 each. We have no other outstanding class of equity securities. Our issued and outstanding ordinary shares are fully paid. Our ordinary shares are in certificated and uncertificated form.

The principal trading market for the Group's ordinary shares is the London Stock Exchange, where the Group's ordinary shares are traded under the symbol "INDV."

We are in the process of applying to have our ordinary shares listed on the Nasdaq Global Select Market under the symbol "INDV" (the "U.S. Listing"). We make no representation that such application will be approved or that our ordinary shares will trade on such market either now or at any time in the future.

The Group's ordinary shares are also listed and trade in the form of American Depositary Shares ("ADSs") in the United States over-the-counter market under the symbol "INVVY."

We intend to replace our ADSs with ordinary shares listed on the Nasdaq Global Select Market following the U.S. Listing. On August 4, 2022, we entered into a Letter Agreement with the ADS Depositary and Computershare Trust Company N.A. (the "Transfer Agent") to create a mechanism to effectively exchange ADSs for ordinary shares listed on Nasdaq. On the day immediately prior to our U.S. listing, the Transfer Agent will (a) cancel the ADS Depositary's entitlement to all of its certificated Indivior ordinary shares, (2) credit the ADS holders with those Indivior ordinary shares, which will be held in book-entry form, and (3) cancel all outstanding ADSs. We provided JPMorgan Chase Bank N.A., in its capacity as ADS Depositary, notice on October 3, 2022 of the termination of the ADS program effective upon the earlier of the effectiveness of the listing of our ordinary shares on the Nasdaq Global Select Market or nine months from the date of notice. As a result, upon effectiveness of this Registration Statement and the U.S. Listing, our ADS program will no longer exist and those ADSs will have been converted to Indivior ordinary shares listed on the Nasdaq Global Select Market.

Our ordinary shares are currently traded on the London Stock Exchange's main market for listed securities and such trades are settled through the CREST system in the United Kingdom. Upon completion of the U.S. Listing, our ordinary shares will also be eligible to be traded on the Nasdaq Global Select Market and such trades will be settled through the DTC system in the United States.

At the effective time of our U.S. Listing, all of our ordinary shares (other than those held by our affiliates) held in uncertificated form within the CREST system will be transferred to and deposited with DTC. In order to enable holders of uncertificated ordinary shares to continue to transfer and settle their interests through CREST after the effective time of our U.S. Listing in the manner in which they did prior to such time, such shareholders will receive depositary interests operated by Computershare Investor Services PLC through CREST representing ordinary shares ("DIs") on a one for one basis. Accordingly, after the effective time of our U.S. Listing, holders of uncertificated ordinary shares (other than our affiliates) will instead be able to transfer and settle their interests in ordinary shares in CREST accounts in the form of DIs.

At the effective time of our U.S. Listing, all of our ordinary shares (other than those held by our affiliates) held in certificated form will also be transferred to and deposited with DTC. Holders of ordinary shares in certificated form in certain permitted jurisdictions, which comprise Argentina, Botswana, Brazil, Chile, Gibraltar, Guernsey, Guinea, Hong Kong, Indonesia, Isle of Man, Jersey, Mexico, Namibia, Paraguay, Peru, South Africa, South Korea, Switzerland, Taiwan and the United Kingdom (the "Permitted Jurisdictions"), will automatically be enrolled in a corporate sponsored nominee facility where Computershare Company Nominees Limited will hold DIs as nominee for such holders. Holders of ordinary shares in certificated form outside the Permitted Jurisdictions will, for 180 calendar days, have the option to (i) transfer their ordinary shares to a bank, broker or nominee who is a participant in DTC or CREST or (ii) have their ordinary shares sold in the market at the holder's expense for the best price

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reasonably obtainable on their behalf; or (iii) have their ordinary shares delivered to them in certificated form. Following expiry of the 180-calendar day period, such holders will be issued a certificate in respect of their ordinary shares and will be the registered or record holder of such ordinary shares.

At the effective time of our U.S. Listing, all of our ordinary shares held by affiliates will automatically be transferred to GTU Ops Inc. (as nominee for Computershare Trust Company N.A.), and Computershare Trust Company N.A. (as depositary for the affiliate shareholders) will issue depositary receipts to the affiliate shareholders in respect of their ordinary shares on a one for one basis.

For additional details regarding our ordinary shares, see "*<u>[Item 10](#id39cb0e1a10249e1ab7b8f77d921d68a_2531)</u>. — Additional Information—A. Share Capital*."

**ITEM 10. ADDITIONAL INFORMATION**

**A.Share Capital**

As of January 31, 2022, the issued and fully paid share capital of Indivior was as follows:

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| | | |
|:---|:---|:---|
| **Class of share** | **Issued and fully paid shares** | **Amount $** |
| Ordinary shares, $0.50 nominal value per share | 136291476 | 68145738 |

---

The Group has one class of ordinary share which carries no rights to fixed income. Each share carries the right to one vote at general meetings of the Group. The ordinary shares are listed on the Official List and traded on the London Stock Exchange. As of January 31, 2023, the Group had 136,291,476 ordinary shares in issue, each with a nominal value of $0.50 per share.

The Group does not hold any shares in Treasury. There are no restrictions on the voting rights attaching to the Group's ordinary shares or the transfer of securities in the Group. No person holds securities of the Company which carry special voting rights with regard to control of the Company. The Group is not aware of any agreements between holders of securities that may result in restrictions on the transfer of securities or on voting rights.

For reconciliation of the number of shares outstanding at the beginning and end of the year, see <u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1524)[3](#id39cb0e1a10249e1ab7b8f77d921d68a_1524)</u>, "Share Capital" included in "*<u>[Item 18](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u>. Financial Statements – Audited Consolidated Financial Statements*." For a description of share-based options outstanding, see<u>[Note 8](#id39cb0e1a10249e1ab7b8f77d921d68a_1433)</u> "Earnings/(Loss) Per Share," and <u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1536)[5](#id39cb0e1a10249e1ab7b8f77d921d68a_1536)</u> "Share-Based Plans" included in "*<u>[Item 18](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u>. Financial Statements – Audited Consolidated Financial Statements*."

***History of share capital***

On September 26, 2014 (being the date of the Group's incorporation) two ordinary shares of $2.00 each in the capital of the Group were issued and were fully paid up in cash.

On January 21, 2015, the High Court of Justice made an Order confirming the reduction of the Group's share capital which was referred to in the prospectus published by the Group on November 17, 2014 (pages 188 to 189). Following registration of the Order of the High Court with Companies House, the capital reduction became effective on January 21, 2015. The nominal value of each ordinary share in the Group accordingly reduced from $2.00 to $0.10.

On October 10, 2022 the Group implemented a share consolidation pursuant to which every five existing ordinary shares were consolidated into one new ordinary share. The nominal value of an ordinary shares accordingly increased to $0.50. The ISIN for the new ordinary shares is GB00BN4HT335.

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The following table highlights increases in the share capital of the Group since January 1, 2020:

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| | | |
|:---|:---|:---|
| **Date** | **No. of Shares<br>(Post-Consolidation)** | **Share issued pursuant to:** |
| January 6, 2020 | 185777.0 | U.S. Employee Stock Purchase Plan |
| July 2, 2020 | 209733.4 | U.S. Employee Stock Purchase Plan |
| January 5, 2021 | 82304.8 | U.S. Employee Stock Purchase Plan |
| July 5, 2021 | 83578.4 | U.S. Employee Stock Purchase Plan |
| January 4, 2022 | 51043.6 | U.S. Employee Stock Purchase Plan |
| July 4, 2022 | 68905.2 | U.S. Employee Stock Purchase Plan |
| February 9, 2021 | 6740.4 | UK Sharesave Plan |
| June 29, 2021 | 9411.6 | UK Sharesave Plan |
| August 25, 2021 | 3750.0 | UK Sharesave Plan |
| August 31, 2021 | 750.0 | UK Sharesave Plan |
| Sept. 28, 2021 | 5588.2 | UK Sharesave Plan |
| February 18, 2020 | 138345.6 | Indivior Long-Term Incentive Plan |
| April 7, 2020 | 5568.2 | Indivior Long-Term Incentive Plan |
| Sept. 23, 2020 | 3940.4 | Indivior Long-Term Incentive Plan |
| December 4, 2020 | 26193.8 | Indivior Long-Term Incentive Plan |
| January 12, 2021 | 1401.0 | Indivior Long-Term Incentive Plan |
| March 4, 2021 | 106919.4 | Indivior Long-Term Incentive Plan |
| June 17, 2021 | 34287.8 | Indivior Long-Term Incentive Plan |
| August 20, 2021 | 1503.4 | Indivior Long-Term Incentive Plan |
| October 14, 2021 | 3580.2 | Indivior Long-Term Incentive Plan |
| Nov. 2, 2021 | 122766.8 | Indivior Long-Term Incentive Plan |
| March 1, 2022 | 771639.2 | Indivior Long-Term Incentive Plan |
| July 4, 2022 | 68905.0 | U.S. Employee Stock Purchase Plan |
| January 4, 2023 | 47044.0 | U.S. Employee Stock Purchase Plan |

---

***Share Repurchases and Canceled***

On July 30, 2021, the Group commenced an irrevocable share repurchase program for an aggregate purchase price up to no more than $100 million of ordinary shares. On December 23, 2021, the program concluded with the Group having repurchased 6,752,697.6 shares (adjusted for the October 2022 share consolidation) of the Group's ordinary shares over the duration of the program.

On May 3, 2022, the Group commenced a second share repurchase program for an aggregate purchase price up to no more than $100 million of ordinary shares, which is expected to end no later than March 31, 2023.

------

The following table highlights decreases in the share capital of the Group since January 1, 2020:

---

| | | |
|:---|:---|:---|
| **Date** | **No. of Shares<br>(Post-Consolidation)** | **Action** |
| July 2021 | 45379.4 | Purchases of Shares for cancellation |
| August 2021 | 1129334.0 | Purchases of Shares for cancellation |
| September 2021 | 1171704.0 | Purchases of Shares for cancellation |
| October 2021 | 886879.4 | Purchases of Shares for cancellation |
| November 2021 | 2086297.4 | Purchases of Shares for cancellation |
| December 2021 | 1598140.2 | Purchases of Shares for cancellation |
| January 2022 | 51211.0 | Purchases of Shares for cancellation |
| February 2022 | 0.0 | Purchases of Shares for cancellation |
| March 2022 | 0.0 | Purchases of Shares for cancellation |
| April 2022 | 0.0 | Purchases of Shares for cancellation |
| May 2022 | 789121.8 | Purchases of Shares for cancellation |
| June 2022 | 906355.4 | Purchases of Shares for cancellation |
| July 2022 | 708104.2 | Purchases of Shares for cancellation |
| August 2022 | 822101.6 | Purchases of Shares for cancellation |
| September 2022 | 841392.4 | Purchases of Shares for cancellation |
| October 2022 | 591337.0 | Purchases of Shares for cancellation |
| November 2022 | 354621.0 | Purchases of Shares for cancellation |
| December 2022 | 304956.0 | Purchases of Shares for cancellation |
| January 2023 | 236563.0 | Purchases of Shares for cancellation |
| February 2023\* | 199154.0 | Purchases of Shares for cancellation |

---

_____________

\*reflects purchases from Feb. 1, 2023 through Feb. 21, 2022.

**Information about the Ordinary Shares**

***Rights attached to the ordinary shares***

Each ordinary share ranks equally in all respects with each other ordinary share and has the same rights and restrictions as each other ordinary share. The ordinary shares rank *pari passu* with respect to all dividends or other distributions made, paid or declared by the Group. Further details of the rights attached to the ordinary shares in relation to dividends, attendance and voting at general meetings, entitlements on a winding-up of the Group and transferability of shares are set out in "*<u>[Item 10.B.](#id39cb0e1a10249e1ab7b8f77d921d68a_2526)</u> Memorandum and Articles of Association*."

***Description of the type and class of securities***

The ordinary shares have a nominal value of $0.50 each and the Group has one class of ordinary shares, the rights to which are detailed in the Articles, a summary of which is set out in "*<u>[Item 10.B.](#id39cb0e1a10249e1ab7b8f77d921d68a_2526)</u> Memorandum and Articles of Association*."

Except as described in this registration statement, the ordinary shares are credited as fully paid and free from all liens, equities, encumbrances and other interests. As described in "*<u>[Item 5.A.](#id39cb0e1a10249e1ab7b8f77d921d68a_2330)</u>—The Term Facility and Revolving Credit Facility*," there is a fixed charge covering all of our ordinary shares. The ordinary shares rank in full for all dividends and distributions on ordinary shares of the Group declared, made or paid after their issue.

------

The ordinary shares are in registered form and are capable of being held in uncertificated form. No temporary documents of title have been or will be issued in respect of the ordinary shares. As of February 20, 2022, the Group held no treasury shares. No ordinary shares have been issued other than fully paid.

***Rights attached to the ordinary shares***

Each ordinary share ranks equally in all respects with each other ordinary share and has the same rights (including voting and dividend rights and rights on a return of capital) and restrictions as each other ordinary share, as set out in the Articles.

Subject to the provisions of the Companies Act, any equity securities issued by the Group for cash must first be offered to shareholders in proportion to their holdings of ordinary shares. The Companies Act and the Listing Rules allow for the disapplication of pre-emption rights which may be waived by a special resolution of the shareholders, either generally or specifically, for a maximum period not exceeding five years.

Except in relation to dividends which have been declared and rights on a liquidation of the Group, the shareholders have no rights to share in the profits of the Group.

The ordinary shares are not redeemable. However, the Group may purchase or contract to purchase any of the ordinary shares on or off-market, subject to the Companies Act and the requirements of the Listing Rules. The Group may purchase ordinary shares only out of distributable reserves or the proceeds of a new issue of shares made to fund the repurchase.

Further details of the rights attached to the ordinary shares in relation to dividends, attendance and voting at general meetings, entitlements on a winding-up of the Group and transferability of shares are set out in "*<u>[Item 10.B.](#id39cb0e1a10249e1ab7b8f77d921d68a_2526)</u>—Memorandum of Association.*"

***Description of restrictions on free transferability***

The ordinary shares are freely transferable and there are no restrictions on transfer in the United Kingdom.

The Group may, under the Companies Act, send out statutory notices to those persons whom it knows or has reasonable cause to believe have an interest in its shares, asking for details of those who have an interest and the extent of their interest in a particular holding of shares. When a person receives a statutory notice and fails to provide any information required by the notice within the time specified in it, the Group can apply to the court for an order directing, among other things, that any transfer of shares which are the subject of the statutory notice is void.

**B.Memorandum and Articles of Association**

***Unrestricted objects***

The objects of the Group are unrestricted.

***Limited liability***

The liability of the Group's members is limited to the amount, if any, unpaid on the shares in the Group held by them.

***Change of name***

The Articles allow the Group to change its name by resolution of the Board. This is in addition to the Group's statutory ability to change its name by special resolution under the Companies Act.

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***Share rights***

Subject to any rights attached to existing shares, shares may be issued with such rights and restrictions as the Group may by ordinary resolution decide, or (if there is no such resolution or so far as it does not make specific provision) as the Board may decide (as long as there is no conflict with any resolution passed by the shareholders). Such rights and restrictions shall apply as if they were set out in the Articles. Redeemable shares may be issued, subject to any rights attached to existing shares. The Board may determine the terms and conditions and the manner of redemption of any redeemable share so issued. Such terms and conditions shall apply to the relevant shares as if they were set out in the Articles. Subject to the Articles, any resolution passed by the shareholders and other shareholders' rights, the Board may decide how to deal with any shares in the Group.

***Voting rights***

Members will be entitled to vote at a general meeting or class meeting whether on a show of hands or a poll, as provided in the Companies Act. The Companies Act provides that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• on a show of hands every member present in person has one vote and every proxy present who has been duly appointed by one or more members will have one vote, except that a proxy has one vote for and one vote against if the proxy has been duly appointed by more than one member and the proxy has been instructed by one or more members to vote for and by one or more other members to vote against. For this purpose the Articles provide that, where a proxy is given discretion as to how to vote on a show of hands, this will be treated as an instruction by the relevant member to vote in the way that the proxy decides to exercise that discretion; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• on a poll every member has one vote per share held by him and he may vote in person or by one or more proxies. Where he appoints more than one proxy, the proxies appointed by him taken together shall not have more extensive voting rights than he could exercise in person.

This is subject to any special terms as to voting which are given to any shares or on which shares are held.

In the case of joint holders of a share the vote of the senior who tenders a vote, whether in person or by proxy, shall be accepted to the exclusion of the votes of the other joint holders and, for this purpose, seniority shall be determined by the order in which the names stand in the register in respect of the joint holding.

***Restrictions***

No member shall be entitled to vote at any general meeting or class meeting in respect of any share held by him if any call or other sum then payable by him in respect of that share remains unpaid or if a member has been served with a restriction notice (as defined in the Articles) after failure to provide the Group with information concerning interests in those shares required to be provided under the Companies Act.

***Dividends and other distributions***

The Group may by ordinary resolution from time to time declare dividends not exceeding the amount recommended by the Board. Subject to the Companies Act, the Board may pay interim dividends, and also any fixed rate dividend, whenever the financial position of the Group, in the opinion of the Board, justifies its payment. If the Board acts in good faith, it is not liable to holders of shares with preferred or *pari passu* rights for losses arising from the payment of interim or fixed dividends on other shares.

The Board may withhold payment of all or any part of any dividends or other monies payable in respect of the Group's shares from a person with a 0.25% or greater holding, in number or nominal value, of the shares of the Group or of any class of such shares (in each case, calculated exclusive of any shares held as treasury shares) (in this paragraph, a "0.25% interest") if such a person has been served

------

with a restriction notice (as defined in the Articles) after failure to provide the Group with information concerning interests in those shares required to be provided under the Companies Act.

Except insofar as the rights attaching to, or the terms of issue of, any share otherwise provide, all dividends shall be apportioned and paid pro rata according to the amounts paid up on the share during any portion of the period in respect of which the dividend is paid. Except as set out above, dividends may be declared or paid in any currency.

The Board may if authorized by an ordinary resolution of the Group offer ordinary shareholders (excluding any member holding shares as treasury shares) in respect of any dividend the right to elect to receive ordinary shares by way of scrip dividend instead of cash.

Any dividend unclaimed after a period of 12 years from the date when it was declared or became due for payment shall be forfeited and revert to the Group.

The Group may stop sending cheques, warrants or similar financial instruments in payment of dividends by post in respect of any shares or may cease to employ any other means of payment, including payment by means of a relevant system, for dividends if either (i) at least two consecutive payments have remained uncashed or are returned undelivered or that means of payment has failed or (ii) one payment remains uncashed or is returned undelivered or that means of payment has failed and reasonable enquiries have failed to establish any new postal address or account of the holder. The Group may resume sending dividend cheques, warrants or similar financial instruments or employing that means of payment if the holder requests such resumption in writing.

***Variation of rights***

Subject to the Companies Act, rights attached to any class of shares may be varied with the written consent of the holders of not less than three-fourths in nominal value of the issued shares of that class (calculated excluding any shares held as treasury shares), or with the sanction of a special resolution passed at a separate general meeting of the holders of those shares. At every such separate general meeting (except an adjourned meeting) the quorum shall be two persons holding or representing by proxy not less than one-third in nominal value of the issued shares of the class (calculated excluding any shares held as treasury shares) or by the purchase or redemption by the Group of any of its own shares.

The rights conferred upon the holders of any shares shall not, unless otherwise expressly provided in the rights attaching to those shares, be deemed to be varied by the creation or issue of further shares ranking *pari passu* with them.

***Transfer of shares***

The shares are in registered form. Any shares in the Group may be held in uncertificated form and, subject to the Articles, title to uncertificated shares may be transferred by means of a relevant system. Provisions of the Articles do not apply to any uncertificated shares to the extent that such provisions are inconsistent with the holding of shares in uncertificated form, with the transfer of shares by means of a relevant system, with any provision of the legislation and rules relating to uncertificated shares or with the Group doing anything by means of a relevant system.

Subject to the Articles, any member may transfer all or any of his certificated shares by an instrument of transfer in any usual form or in any other form which the Board may approve. The instrument of transfer must be signed by or on behalf of the transferor and (in the case of a partly paid share) the transferee.

The transferor of a share is deemed to remain the holder until the transferee's name is entered in the register.

------

The Board can decline to register any transfer of any share which is not a fully paid share. The Board may also decline to register a transfer of a certificated share unless the instrument of transfer:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• is duly stamped or certified or otherwise shown to the satisfaction of the Board to be exempt from stamp duty and is accompanied by the relevant share certificate and such other evidence of the right to transfer as the Board may reasonably require;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• is in respect of only one class of share; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• if to joint transferees, is in favor of not more than four such transferees.

Registration of a transfer of an uncertificated share may be refused in the circumstances set out in the uncertificated securities rules (as defined in the Articles) and where, in the case of a transfer to joint holders, the number of joint holders to whom the uncertificated share is to be transferred exceeds four.

The Board may decline to register a transfer of any of the Group's certificated shares by a person with a 0.25% interest if such a person has been served with a restriction notice (as defined in the Articles) after failure to provide the Group with information concerning interests in those shares required to be provided under the Companies Act, unless the transfer is shown to the Board to be pursuant to an arm's length sale (as defined in the Articles).

***Sub-division of share capital***

Any resolution authorizing the Group to sub-divide any of its shares may determine that, as between the shares resulting from the sub-division, any of them may have a preference, advantage or deferred or other right or be subject to any restriction as compared with the others.

***General meetings***

The Articles rely on the Companies Act provisions dealing with the calling of general meetings. Under the Companies Act an annual general meeting must be called by notice of at least 21 days. The Group is a "traded company" for the purposes of the Companies Act and as such will be required to give at least 21 days' notice of any other general meeting unless a special resolution reducing the period to not less than 14 days has been passed at the immediately preceding annual general meeting or at a general meeting held since that annual general meeting or, pending the Group's first annual general meeting, at any general meeting.

Notice of a general meeting must be given in hard copy form, in electronic form, or by means of a website and must be sent to every member and every director. It must state the time and date and the place of the meeting and the general nature of the business to be dealt with at the meeting. As the Group is a traded company, the notice must also state the website address where information about the meeting can be found in advance of the meeting, the voting record time, the procedures for attending and voting at the meeting, details of any forms for appointing a proxy, procedures for voting in advance (if any are offered), and the right of members to ask questions at the meeting. In addition, a notice calling an annual general meeting must state that the meeting is an annual general meeting.

Each director shall be entitled to attend and speak at any general meeting. The chairman of the meeting may invite any person to attend and speak at any general meeting where he considers that this will assist in the deliberations of the meeting.

***Directors***

*Number of Directors*

The Directors shall be not less than two and not more than 15 in number (disregarding alternate directors). The Group may by ordinary resolution vary the minimum and/or maximum number of Directors.

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*Directors' shareholding qualification*

A Director shall not be required to hold any shares in the Group.

*Appointment of Directors*

Directors may be appointed by the Group by ordinary resolution or by the Board. A Director appointed by the Board holds office only until the next following annual general meeting of the Group and is then eligible for reappointment.

The Board or any committee authorized by the Board may from time to time appoint one or more Directors to hold any employment or executive office for such period and on such terms as they may determine and may also revoke or terminate any such appointment.

*Retirement of Directors*

At every annual general meeting of the Group any Director who has been appointed by the Board since the last annual general meeting, or who held office at the time of the two preceding annual general meetings and who did not retire at either of them, or who has held office with the Group, other than employment or executive office, for a continuous period of nine years or more at the date of the meeting, shall retire from office and may offer himself for reappointment by the members.

*Removal of Directors by special resolution*

The Group may by special resolution remove any Director before the expiration of his period of office.

*Vacation of office*

The office of a Director shall be vacated if:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• he resigns or offers to resign and the Board resolves to accept such offer;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• he is removed by notice given by all the other Directors and all the other Directors are not less than three in number;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• he is or has been suffering from mental or physical ill health and the Board resolves that his office be vacated;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• he is absent without the permission of the Board from meetings of the Board (whether or not an alternate Director appointed by him attends) for six consecutive months and the Board resolves that his office is vacated;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• he becomes bankrupt or compounds with his creditors generally;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• he is prohibited by a law from being a Director;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• he ceases to be a Director by virtue of the Companies Act; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• he is removed from office pursuant to the Group's Articles.

If the office of a Director is vacated for any reason, he must cease to be a member of any committee or sub-committee of the Board.

*Alternate Director*

Any Director may appoint any person to be his alternate and may at his discretion remove such an alternate Director. If the alternate Director is not already a Director, the appointment, unless previously approved by the Board, shall have effect only upon and subject to being so approved.

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*Proceedings of the Board*

Subject to the provisions of the Articles, the Board may meet for the dispatch of business, adjourn and otherwise regulate its meetings as it thinks fit. The quorum necessary for the transaction of the business of the Board may be fixed by the Board and, unless so fixed at any other number, shall be two. A meeting of the Board at which a quorum is present shall be competent to exercise all the powers, authorities and discretions vested in or exercisable by the Board.

The Board may appoint a Director to be the chairman or a deputy chairman and may at any time remove him from that office. Questions arising at any meeting of the Board shall be determined by a majority of votes. In the case of an equality of votes the chairman of the meeting shall have a second or casting vote.

All or any of the members of the Board may participate in a meeting of the Board by means of a conference telephone or any communication equipment which allows all persons participating in the meeting to speak to and hear each other. A person so participating shall be deemed to be present at the meeting and shall be entitled to vote and to be counted in the quorum.

The Board may delegate any of its powers, authorities and discretions (with power to sub-delegate) to any committee, consisting of such person or persons as it thinks fit, provided that the majority of persons on any committee or sub-committee must be Directors. The meetings and proceedings of any committee consisting of two or more members shall be governed by the provisions contained in the Articles for regulating the meetings and proceedings of the Board so far as the same are applicable and are not superseded by any regulations imposed by the Board.

*Remuneration of Directors*

Each of the Directors shall be paid a fee at such rate as may from time to time be determined by the Board, but the aggregate of all such fees so paid to the Directors shall not exceed £1,500,000 per annum or such higher amount as may from time to time be decided by ordinary resolution of the Group. Any Director who is appointed to any executive office shall be entitled to receive such remuneration (whether by way of salary, commission, participation in profits or otherwise) as the Board or any committee authorized by the Board may decide, either in addition to or in lieu of his remuneration as a Director. In addition, any Director who performs services which in the opinion of the Board or any committee authorized by the Board go beyond the ordinary duties of a Director may be paid such extra remuneration as the Board or any committee authorized by the Board may determine. Each Director may be paid his reasonable travelling, hotel and incidental expenses of attending and returning from meetings of the Board, or committees of the Board or of the Group or any other meeting which as a Director he is entitled to attend, and shall be paid all other costs and expenses properly and reasonably incurred by him in the conduct of the Group's business or in the discharge of his duties as a Director. The Group may also fund a Director's or former Director's expenditure and that of a Director or former Director of any holding company of the Group for the purposes permitted under the Companies Act and may do anything to enable a Director or former Director or a Director or former Director of any holding company of the Group to avoid incurring such expenditure as provided in the Companies Act.

*Pensions and gratuities for Directors*

The Board or any committee authorized by the Board may exercise the powers of the Group to provide benefits either by the payment of gratuities or pensions or by insurance or in any other manner for any Director or former Director or his relations, dependents or persons connected to him, but no benefits (except those provided for by the Articles) may be granted to or in respect of a Director or former Director who has not been employed by or held an executive office or place of profit with the Group or any of its subsidiary undertakings or their respective predecessors in business without the approval of an ordinary resolution of the Group.

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*Directors' interests*

The Board may, subject to the provisions of the Articles, authorize any matter which would otherwise involve a Director breaching his duty under the Companies Act to avoid conflicts of interest. Where the Board gives authority in relation to a conflict of interest or where any of the situations described in (i) to (v) below applies in relation to a Director, the Board may (a) require the relevant Director to be excluded from the receipt of information, the participation in discussion and/or the making of decisions related to the conflict of interest or situation; (b) impose upon the relevant Director such other terms for the purpose of dealing with the conflict of interest or situation as it may determine; and (c) may provide that the relevant Director will not be obliged to disclose information obtained otherwise than through his position as a Director of the Group and that is confidential to a third party or to use or apply the information in relation to the Group's affairs, where to do so would amount to a breach of that confidence. The Board may revoke or vary such authority at any time.

Subject to the provisions of the Companies Act, and provided he has declared the nature and extent of his interest to the Board as required by the Companies Act, a Director may:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)be party to, or otherwise interested in, any contract with the Group or in which the Group has a direct or indirect interest;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)hold any other office or place of profit with the Group (except that of auditor) in conjunction with his office of Director for such period and upon such terms, including remuneration, as the Board may decide;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)act by himself or through a firm with which he is associated in a professional capacity for the Group or any other company in which the Group may be interested (otherwise than as auditor);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)be or become a Director or other officer of, or employed by or a party to a transaction or arrangement with, or otherwise be interested in any holding company or subsidiary company of the Group or any other company in which the Group may be interested; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v)be or become a Director of any other company in which the Group does not have an interest and which cannot reasonably be regarded as giving rise to a conflict of interest at the time of his appointment as a Director of that other company.

A Director shall not, by reason of his office be liable to account to the Group or its members for any benefit realized by reason of having an interest permitted as described above or by reason of having a conflict of interest authorized by the Board and no contract shall be liable to be avoided on the grounds of a Director having any such interest.

*Restrictions on voting*

No Director may vote on or be counted in the quorum in relation to any resolution of the Board concerning his own appointment, or the settlement or variation of the terms or the termination of his own appointment, as the holder of any office or place of profit with the Group or any other company in which the Group is interested save to the extent permitted specifically in the Articles.

Subject to certain exceptions set out in the Articles, no Director may vote on, or be counted in a quorum in relation to, any resolution of the Board in respect of any contract in which he has an interest and, if he does so, his vote shall not be counted.

Subject to the Companies Act, the Group may by ordinary resolution suspend or relax to any extent the provisions relating to Directors' interests or the restrictions on voting or ratify any transaction not duly authorized by reason of a contravention of such provisions.

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*Borrowing and other powers*

Subject to the Articles and any directions given by the Group by special resolution, the business of the Group will be managed by the Board who may exercise all the powers of the Group, whether relating to the management of the business of the Group or not. In particular, the Board may exercise all the powers of the Group to borrow money, to guarantee, to indemnify, to mortgage or charge any of its undertaking, property, assets (present and future) and uncalled capital and to issue debentures and other securities and to give security for any debt, liability or obligation of the Group or of any third party. The Board must restrict the borrowings of the Group and exercise all voting and other rights or powers of control exercisable by the Group in relation to its subsidiary undertakings so as to secure that, save with the previous sanction of an ordinary resolution, no money shall be borrowed if the aggregate principal amount outstanding of all borrowings (as defined in the Articles) by the Indivior Group (exclusive of borrowings within the Indivior Group) then exceeds, or would as a result of such borrowing exceed, an amount equal to three times the adjusted capital and reserves (as defined in the Articles).

*Indemnity of Directors*

To the extent permitted by the Companies Act, the Group may indemnify any Director or former Director of the Group or any associated company against any liability and may purchase and maintain for any Director or former Director of the Group or any associated company insurance against any liability.

*Methods of service and communications with Shareholders*

Any notice, document (including a share certificate) or other information may be sent or supplied to any Shareholder by the Group personally, by post, by means of a relevant system, by sending or supplying it in electronic form to an address notified by the Shareholder to the Group for that purpose, where appropriate, by means of a website and notifying the Shareholder of its availability, or by any other means authorized in writing by the Shareholder. For joint shareholders, any notice, document (including a share certificate) or other information may be sent or supplied to any one of the joint holders and will be treated as having been sent or supplied to all the joint holders.

*The United Kingdom City Code on Takeovers and Mergers*

The United Kingdom City Code on takeovers and mergers (the "City Code") applies to the Group. Under the City Code, if an acquisition of an interest in the Group's ordinary shares were to increase the aggregate holding of an acquirer and its "concert parties" to an interest in the Group's ordinary shares carrying 30% or more of the voting rights in the Group, the acquirer and, depending upon the circumstance, its concert parties, would be required (except with the consent of the UK Takeover Panel) to make an offer in cash (or accompanied by a cash alternative) for the outstanding ordinary shares in the Group at a price not less than the highest price paid for any interest in the Group's ordinary shares by the acquirer or its concert parties during the 12 months prior to the announcement of the offer. A similar obligation to make such a mandatory offer would also arise on the acquisition of the Group's ordinary shares by a person (together with its concert parties) interested in the Group's ordinary shares carrying between 30% and 50% of the voting rights in the Group if the effect of such acquisition were to increase the percentage of shares carrying voting rights in which he or she is interested.

**Differences in Corporate Law between England and the State of Delaware**

As a public limited company incorporated under the laws of England and Wales, the rights of our shareholders are governed by applicable English law, including the Companies Act, and not by the law of any U.S. state. As a result, our directors and shareholders are subject to different responsibilities, rights and privileges than are applicable to directors and shareholders of U.S. corporations. We have set out below a summary of the differences between the provisions of the Companies Act applicable to us and the Delaware General Corporation Law relating to shareholders' rights and protections. This summary is not intended to be a complete discussion of the respective rights and it is qualified in its entirety by reference to English law, Delaware law and our Articles of Association. Before investing, you should

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consult your legal advisor regarding the impact of English corporate law on your specific circumstances and reasons for investing. The summary below does not include a description of rights or obligations under the U.S. federal securities laws or stock market listing requirements. You are also urged to carefully read the relevant provisions of the Delaware General Corporation Law and the Companies Act for a more complete understanding of the differences between Delaware and English law.

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| | | |
|:---|:---|:---|
| | **Delaware** | **England** |
| ***Number of Directors*** | Under Delaware law, a corporation must have at least one director and the number of directors shall be fixed by or in the manner provided in the bylaws, unless specified in the certificate of incorporation. | Under the Companies Act, a public limited company must have at least two directors and the number of directors may be fixed by or in the manner provided in a company's articles of association. |
| ***Removal of Directors*** | Under Delaware law, directors may be removed from office, with or without cause, by a majority shareholder vote, except (a) in the case of a corporation whose board is classified, shareholders may effect such removal only for cause, unless otherwise provided in the certificate of incorporation, and (b) in the case of a corporation having cumulative voting, if less than the entire board is to be removed, no director may be removed without cause if the votes cast against his or her removal would be sufficient to elect him or her if then cumulatively voted at an election of the entire board of directors, or, if there are classes of directors, at an election of the class of directors of which he or she is a part. | Under the Companies Act, shareholders may remove a director without cause by an ordinary resolution (which is passed by a simple majority of those voting in person or by proxy at a general meeting) irrespective of any provisions of any service contract the director has with the company, provided that 28 clear days' notice of the resolution is given to the company and certain other procedural requirements under the Companies Act are followed (such as allowing the director to make representations against his or her removal at the meeting and/or in writing). |
| ***Vacancies on the Board of Directors*** | Under Delaware law, vacancies and newly created directorships may be filled by a majority of the directors then in office (even though less than a quorum) or by a sole remaining director unless otherwise provided in the certificate of incorporation or bylaws of the corporation. | Under English law, the procedure by which directors (other than a company's initial directors) are appointed is generally set out in a company's articles of association, provided that where two or more persons are appointed as directors of a public limited company by resolution of the shareholders, resolutions appointing each director must be voted on individually unless a resolution of the shareholders that such resolutions do not have to be voted on individually is first agreed to by the meeting without any vote being given against it. |
| ***Annual General Meeting*** | Under Delaware law, the annual meeting of shareholders shall be held at such place, on such date and at such time as may be designated from time to time by the board of directors or as provided in the certificate of incorporation or by the bylaws. | Under the Companies Act, a public limited company must hold an annual general meeting each year. This meeting must be held within six months beginning with the day following the company's accounting reference date. |
| ***General Meeting*** | Under Delaware law, special meetings of the shareholders may be called by the board of directors or by such person or persons as may be authorized by the certificate of incorporation or by the bylaws. | Under the Companies Act, a general meeting of the shareholders of a public limited company may be called by the directors. Shareholders holding at least 5% of the paid-up capital (excluding any paid-up capital held as treasury shares) of the company carrying voting rights at general meetings can also require the directors to call a general meeting. |

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| | | |
|:---|:---|:---|
| | **Delaware** | **England** |
| ***Notice of General Meetings*** | Under Delaware law, written notice of any meeting of the shareholders must be given to each shareholder entitled to vote at the meeting not less than ten nor more than 60 days before the date of the meeting and shall specify the place, date, hour and purpose or purposes of the meeting. | The Companies Act provides that a general meeting (other than an adjourned meeting) must be called by notice of: <br>• in the case of an annual general meeting, at least 21 days; and <br>• in any other case, at least 14 days. <br>The company's articles of association may provide for a longer period of notice and, in addition, certain matters (such as the removal of directors or auditors) require special notice, which is 28 clear days' notice. The shareholders of a company may in all cases consent to a shorter notice period, the proportion of shareholders' consent required being 100% of those entitled to attend and vote in the case of an annual general meeting and, in the case of any other general meeting, a majority in number of the members having a right to attend and vote at the meeting, being a majority who together hold not less than 95% in nominal value of the shares giving a right to attend and vote at the meeting. |
| ***Quorum*** | The certificate of incorporation or bylaws may specify the number of shares, the holders of which shall be present or represented by proxy at any meeting in order to constitute a quorum, but in no event shall a quorum consist of less than 1/3 of the shares entitled to vote at the meeting. In the absence of such specification in the certificate of incorporation or bylaws, a majority of the shares entitled to vote, present in person or represented by proxy, shall constitute a quorum at a meeting of shareholders. | Subject to the provisions of a company's articles of association, the Companies Act provides that two shareholders present at a meeting (in person or by proxy) shall constitute a quorum. |
| ***Proxies*** | Under Delaware law, at any meeting of shareholders, a shareholder may designate another person to act for such shareholder by proxy, but no such proxy shall be voted or acted upon after three years from its date, unless the proxy provides for a longer period. | Under the Companies Act, at any meeting of shareholders, a shareholder may designate another person to attend, speak and vote at the meeting on their behalf by proxy (or, in the case of a shareholder which is a corporate body, may appoint a corporate representative). |

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| | | |
|:---|:---|:---|
| | **Delaware** | **England** |
| ***Issue of New Shares*** | Under Delaware law, if the company's certificate of incorporation so provides, the directors have the power to issue additional stock for consideration consisting of cash, any tangible or intangible property, or any benefit to the company or any combination thereof. | Under the Companies Act, the directors of a company must not exercise any power to allot shares or grant rights to subscribe for, or to convert any security into, shares unless they are authorized to do so by the company's articles of association or by an ordinary resolution of the shareholders.<br>Any authorization given must state the maximum amount of shares that may be allotted under it and specify the date on which it will expire, which must be not more than five years from the date the authorization was given. The authority can be renewed by a further resolution of the shareholders. |
| ***Preemptive Rights*** | Under Delaware law, unless otherwise provided in a corporation's certificate of incorporation, a stockholder does not, by operation of law, possess preemptive rights to subscribe to additional issuances of the corporation's stock. | Under the Companies Act, "equity securities" (being (i) shares in the company other than shares that, with respect to dividends and capital, carry a right to participate only up to a specified amount in a distribution ("ordinary shares") or (ii) rights to subscribe for, or to convert securities into, ordinary shares) proposed to be allotted for cash must be offered first to the existing equity shareholders in the company in proportion to the respective nominal value of their holdings, unless an exception applies or a special resolution to the contrary has been passed by shareholders in a general meeting or the articles of association provide otherwise in each case in accordance with the provisions of the Companies Act. |

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| | | |
|:---|:---|:---|
| | **Delaware** | **England** |
| ***Liability of Directors and Officers*** | Under Delaware law, a corporation's certificate of incorporation may include a provision eliminating or limiting the personal liability of a director to the corporation and its shareholders for monetary damages arising from a breach of fiduciary duty as a director. However, no provision can limit the liability of a director for:<br>• any breach of the director's duty of loyalty to the corporation or its shareholders; <br>• acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law; <br>• willful or negligent payment of unlawful dividends or stock purchases or redemptions; or <br>• any transaction from which the director derives an improper personal benefit. | Under the Companies Act, any provision (whether contained in a company's articles of association or any contract or otherwise) that purports to exempt a director of a company (to any extent) from any liability that would otherwise attach to him in connection with any negligence, default, breach of duty or breach of trust in relation to the company is void. <br>Any provision by which a company directly or indirectly provides an indemnity (to any extent) for a director of the company or of an associated company against any liability attaching to him in connection with any negligence, default, breach of duty or breach of trust in relation to the company of which he or she is a director is also void except as permitted by the Companies Act, which provides exceptions for the company to: (i) purchase and maintain insurance against such liability; (ii) provide a "qualifying third party indemnity" (being an indemnity against liability incurred by the director to a person other than the company or an associated company, which must not cover fines imposed in criminal proceedings, penalties imposed by regulatory bodies arising out of non-compliance with regulatory requirements, the defense costs of criminal proceedings where the director is found guilty, the defense costs of civil proceedings successfully brought against the director by the company or an associated company, or the costs of unsuccessful applications by the director for certain reliefs); and (iii) provide a "qualifying pension scheme indemnity" (being an indemnity against liability incurred in connection with the company's activities as trustee of an occupational pension plan). |

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| | | |
|:---|:---|:---|
| | **Delaware** | **England** |
| ***Voting Rights*** | Delaware law provides that, unless otherwise provided in the certificate of incorporation, each shareholder of record is entitled to one vote for each share of capital stock held by such shareholder. | Under English law, unless a poll is demanded by the shareholders of a company or is required by the Chairman of the meeting or the company's articles of association, shareholders shall vote on all resolutions on a show of hands.<br>Under the Companies Act, a poll may be demanded by: (i) not fewer than five shareholders having the right to vote on the resolution; (ii) any shareholder(s) representing at least 10% of the total voting rights of all the shareholders having the right to vote on the resolution (excluding any voting rights attached to treasury shares); or (iii) any shareholder (s) holding shares in the company conferring a right to vote on the resolution being shares on which an aggregate sum has been paid up equal to not less than 10% of the total sum paid up on all the shares conferring that right. A company's articles of association may provide more extensive rights for shareholders to call a poll.<br>Under English law, an ordinary resolution is passed on a show of hands if it is approved by a simple majority (more than 50%) of the votes cast by shareholders present (in person or by proxy) and entitled to vote. If a poll is demanded, an ordinary resolution is passed if it is approved by holders representing a simple majority of the total voting rights of shareholders present (in person or by proxy) who (being entitled to vote) vote on the resolution. Special resolutions require the affirmative vote of not less than 75% of the votes cast by shareholders present and entitled to do so (in person or by proxy) at the meeting. |

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| | | |
|:---|:---|:---|
| | **Delaware** | **England** |
| ***Variation of Class Rights*** | Under Delaware law, the holders of the outstanding shares of a class shall be entitled to vote as a class upon a proposed amendment, whether or not entitled to vote thereon by the certificate of incorporation, if the amendment would increase or decrease the aggregate number of authorized shares of such class, increase or decrease the par value of the shares of such class, or alter or change the powers, preferences or special rights of the shares of such class so as to affect them adversely. | The Companies Act provides that rights attached to a class of shares may only be varied or abrogated in accordance with provision in the company's articles for the variation or abrogation of those rights or, where the company's articles contain no such provision, if the holders of shares of that class consent to the variation or abrogation. Consent for these purposes means: <br>• consent in writing from the holders of at least 75% in nominal value of the issued shares of that class (excluding any shares held as treasury shares); or <br>• a special resolution passed at a separate meeting of the holders of that class sanctioning the variation. <br>The Companies Act provides that the quorum for a class meeting is not less than two persons holding or representing by proxy at least one-third of the nominal value of the issued shares of that class (excluding any shares held as treasury shares). Following a variation of class rights, shareholders who amount to not less than 15% of the shareholders of the class in question who did not approve the variation may apply to court to have the variation cancelled. Any application must be made within 21 days of the variation. The court may cancel the variation if it is satisfied having regard to all the circumstances of the case that the variation would unfairly prejudice the shareholders of the class represented by the applicant. |

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| | | |
|:---|:---|:---|
| | **Delaware** | **England** |
| ***Shareholder Vote on Certain Transactions*** | Generally, under Delaware law, unless the certificate of incorporation provides for the vote of a larger portion of the stock, completion of a merger, consolidation, sale, lease or exchange of all or substantially all of a corporation's assets or dissolution requires: <br>• the approval of the board of directors; and <br>• approval by the vote of the holders of a majority of the outstanding stock or, if the certificate of incorporation provides for more or less than one vote per share, a majority of the votes of the outstanding stock of a corporation entitled to vote on the matter.<br>Under Delaware law, a contract or transaction between the company and one or more of its directors or officers, or between the company and any other organization in which one or more of its directors or officers, are directors or officers, or have a financial interest, shall not be void solely for this reason, or solely because the director or officer participates in the meeting of the board which authorizes the contract or transaction, or solely because any such director's or officer's votes are counted for such purpose, if: <br>• the material facts as to the director's or officer's relationship or interest and as to the contract or transaction are disclosed or are known to the board, and the board in good faith authorizes the contract or transaction by the affirmative votes of a majority of the disinterested directors, even though the disinterested directors be less than a quorum;<br>• the material facts as to the director's or officer's relationship or interest and as to the contract or transaction are disclosed or are known to the shareholders entitled to vote thereon, and the contract or transaction is specifically approved in good faith by vote of the shareholders; or <br>• the contract or transaction is fair as to the corporation as of the time it is authorized, approved or ratified, by the board of directors, a committee or the shareholders. | The Companies Act provides for schemes of arrangement, which are arrangements or compromises between a company and any class of shareholders or creditors that may be used in certain types of reconstructions, amalgamations, capital reorganizations or takeovers. These arrangements require: <br>• the approval at a shareholders' or creditors' meeting convened by order of the court, of a majority in number of shareholders or creditors representing 75% in value of the capital held by, or debt owed to, the class of shareholders or creditors, or class thereof present and voting, either in person or by proxy; and<br>• the approval of the court. <br>Once approved, sanctioned and effective, all shareholders or creditors of the relevant class and the company are bound by the terms of the scheme.<br>In addition, the Companies Act provides for restructuring plans, which may be used by a company only for the purpose of reducing or mitigating the effects of financial difficulties it is encountering that may affect its ability to carry on business as a going concern. These plans are similar to schemes of arrangement, but: the only shareholder or creditor approval required is that of shareholders or creditors representing 75% in value of the capital held by, or debt owed to, the members present and voting of one class of shareholders or creditors that would have a genuine economic interest in the company if the plan were not approved; and if that approval is obtained, members of any other class of shareholders or creditors will be bound by the restructuring plan if they will not as a result be worse off than if the plan were not approved and the court grants its approval.<br>The Companies Act also contains certain provisions relating to transactions between a director and the company, including transactions involving the acquisition of substantial non-cash assets from a director (or person connected with a director) or the sale of substantial noncash assets to a director (or person connected with a director), and loans, quasi-loans and credit transactions between a company and a director or certain connected persons of directors. If such transactions meet certain thresholds set out within the Companies Act the approval of shareholders by ordinary resolution will be required. |

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| | | |
|:---|:---|:---|
| | **Delaware** | **England** |
| ***Standard of Conduct for Directors*** | Delaware law does not contain specific provisions setting forth the standard of conduct of a director. The scope of the fiduciary duties of directors is generally determined by the courts of the State of Delaware. In general, directors have a duty to act without self-interest, on a well-informed basis and in a manner they reasonably believe to be in the best interest of the shareholders. Directors of a Delaware corporation owe fiduciary duties of care and loyalty to the corporation and to its shareholders. The duty of care generally requires that a director act in good faith, with the care that an ordinarily prudent person would exercise under similar circumstances. Under this duty, a director must inform himself or herself of all material information reasonably available regarding a significant transaction. The duty of loyalty requires that a director act in a manner he or she reasonably believes to be in the best interests of the corporation. The director must not use his or her corporate position for personal gain or advantage. In addition, under Delaware law, when the board of directors of a Delaware corporation approves the sale or break-up of a corporation, the board of directors may, in certain circumstances, have a duty to obtain the highest value reasonably available to the shareholders. | Under English law, a director owes various statutory and fiduciary duties to the company, including: <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• to act in the way he or she considers, in good faith, would be most likely to promote the success of the company for the benefit of its shareholders as a whole; <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• to avoid a situation in which he or she has, or can have, a direct or indirect interest that conflicts, or possibly may conflict, with the interests of the company; <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• to act in accordance with the company's constitution and only exercise his or her powers for the purposes for which they are conferred; <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• to exercise independent judgment; <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• to exercise reasonable care, skill and diligence; <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• not to accept benefits from a third party conferred by reason of his or her being a director or doing (or not doing) anything as a director; and <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• to declare any interest that he or she has, whether directly or indirectly, in a proposed or existing transaction or arrangement with the company. |
| ***Shareholder Suits*** | Under Delaware law, a shareholder may initiate a derivative action to enforce a right of a corporation if the corporation fails to enforce the right itself. The complaint must: <br>• state that the plaintiff was a shareholder at the time of the transaction of which the plaintiff complains or that the plaintiff's shares thereafter devolved on the plaintiff by operation of law;<br>• allege with particularity the efforts made by the plaintiff to obtain the action the plaintiff desires from the directors and the reasons for the plaintiff's failure to obtain the action; or <br>• state the reasons for not making the effort. Additionally, the plaintiff must remain a shareholder through the duration of the derivative suit. | Under English law, generally, the company, rather than its shareholders, is the proper claimant in an action in respect of a wrong done to the company or where there is an irregularity in the company's internal management. Notwithstanding this general position, the Companies Act provides that (i) a court may allow a shareholder to bring a derivative claim (that is, an action in respect of and on behalf of the company) in respect of a cause of action arising from a director's negligence, default, breach of duty or breach of trust, subject to complying with the procedural requirements under the Companies Act and (ii) a shareholder may bring a claim for a court order where the company's affairs have been or are being conducted in a manner that is unfairly prejudicial to some or all of its shareholders. |

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**C.Material Contracts**

Our material contracts include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>The Fourth Amendment (and Restatement of) Credit Agreement</u>,* dated as of April 26, 2022 among Indivior Finance S.àr.l., Indivior Finance (2014) LLC, Indivior SMTM LLC, RBP Global Holdings Limited, Indivior Global Holdings Limited, and certain other Loan Parties, and Morgan Stanley Senior Funding, Inc., Morgan Stanley Bank, N.A., and Deutsche Bank AG New York Branch. For a description of this contract, see "*<u>[Item 5.](#id39cb0e1a10249e1ab7b8f77d921d68a_2345)</u> Operating and Financial Review and Prospects—B Liquidity and Capital Resources.*"

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Second Amended and Restated Relationship Agreement with Scopia Capital Management LP</u>* dated as of [&nbsp;&nbsp;&nbsp;&nbsp; ]. For a description of this contract, see "*<u>[Item 6.](#id39cb0e1a10249e1ab7b8f77d921d68a_2430)</u> Directors, Senior Management and Employees—A. Directors and Senior Management*."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Agreements with JPMorgan regarding American Depositar</u><u>y Shares</u>*. Deposit Agreement dated as of December 23, 2014 between Indivior PLC, JPMorgan Chase Bank, N.A., as Depositary and Owners and Holders from time to time of the American Depositary Receipts issued thereunder, including the Form of American Depositary Receipt; Notice of Termination dated October 3, 2022 related to that certain Deposit Agreement dated as of December 23, 2014 between Indivior PLC, JPMorgan Chase Bank, N.A.; Letter Agreement dated August 4, 2022 related to that certain Deposit Agreement dated as of December 23, 2014 between Indivior PLC, JPMorgan Chase Bank, N.A. For a description of our agreements with JPMorgan, see "*<u>[Item 9.](#id39cb0e1a10249e1ab7b8f77d921d68a_301)</u> The Offer and Listing—A. Offering and Listing Details*."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•*<u>Resolution Agreement</u>*. On July 24, 2020, Indivior Inc. settled with the DOJ, FTC, and U.S. state attorneys general the criminal and civil liability in connection with a multi-count indictment brought in April 2019 by a grand jury in the Western District of Virginia, a civil lawsuit joined by the DOJ in 2018, and an FTC investigation related to alleged charges of healthcare fraud, wire fraud, mail fraud, conspiracy in connection with marketing and promotion practices, pediatric safety claims, and over-prescribing of SUBOXONE Film and/or SUBOXONE Tablet by certain physicians. A wholly-owned subsidiary of Indivior PLC pleaded guilty to a single count of making a false statement relating to healthcare matters in 2012 in violation of 18 U.S.C. Section 1035. Indivior agreed to make payments to federal and state authorities totaling $600 million (plus applicable interest of 1.25% on a portion of that total amount), of which $200 million has been paid, and agreed to a stipulated injunction with the FTC, specific compliance measures with the DOJ, and entered into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services. Interest accrues on certain portions of the resolution which will be paid together with the annual installment payments. Under the terms of the Resolution Agreement, Indivior Inc. has agreed to compliance terms regarding its sales and marketing practices. The Resolution Agreement contains certain requirements, such as reporting obligations and that the Group's CEO (a) certify on an annual basis that, to the best of the CEO's knowledge, after a reasonable inquiry, Indivior Inc. was in compliance with the Federal Food, Drug and Cosmetic Act and implementing regulations governing the manufacture, marketing, sale, promotion, and distribution of Indivior products in the U.S. and has not committed healthcare fraud, or (b) provide a certified list of all non-compliant activity and steps taken to remedy the activity. Indivior Inc. is subject to contempt prosecution if it fails to comply with any terms of the Resolution Agreement. See also, "*<u>[Item 3](#i56ef77e8a843490995b8285e91603860_4022085)</u>. Key Information—D. Risk Factors*—*'Compliance with the terms and conditions of our Corporate Integrity Agreement, the Resolution Agreement with the United States Attorney's Office for the Western District of Virginia and Consumer Protection Branch, and the Stipulated Order for Permanent Injunction and Equitable Monetary Relief with the FTC, requires significant resources and management time and, if we fail to comply, we could be subject to penalties or, under certain circumstances, excluded from government healthcare programs, which would materially adversely affect our business.*'"

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Stipulated Order for Permanent Injunction and Equitable Monetary Relief</u>* in the U.S. District Court for the Western District of Virginia, Abingdon, between the FTC and Indivior Inc. entered July 24, 2020. As part of the resolution with the FTC and as detailed in the text of the stipulated order, for a ten-year period Indivior Inc. is required to make and provide specified disclosures and notifications to the FTC, including, among other items, regular written reports on Indivior Inc.'s compliance with the stipulated order and any proposed changes to Indivior Inc.'s corporate structure, and is prohibited from certain conduct related to, among other items, the filing of a New Drug Application for a Follow-on Drug Product with the United States Food and Drug Administration (FDA), the filing of a Citizen Petition with the FDA, or bringing a new drug product to market in the United States. Indivior Inc. also agreed to make a payment of $10 million to the FTC. See also, "*<u>[Item 3.](#i56ef77e8a843490995b8285e91603860_4022085)</u> Key Information—D. Risk Factors*—*'Compliance with the terms and conditions of our Corporate Integrity Agreement, the Resolution Agreement with the United States Attorney's Office for the Western District of Virginia and Consumer Protection Branch, and the Stipulated Order for Permanent Injunction and Equitable Monetary Relief with the FTC, requires significant resources and management time and, if we fail to comply, we could be subject to criminal chargers, penalties, or, under certain circumstances, excluded from government healthcare programs, which would materially adversely affect our business.'"*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Corporate Integrity Agreement between the Officer of Inspector General of the Department of Health and Human Services and Indivior Inc</u>*. made as of July 24, 2020. In addition to the Resolution Agreement, Indivior Inc. entered into a five-year CIA with the HHS-OIG. The five-year CIA requires, among other things, that Indivior Inc. implement measures designed to ensure compliance with the statutes, regulations, and written directives of U.S. Medicare, U.S. Medicaid, and all other U.S. Federal healthcare programs, as well as with the statutes, regulations, and written directives of the U.S. Food and Drug Administration. Furthermore, Indivior Inc. is subject to additional periodic reporting and monitoring requirements related to the CIA. In addition, the CIA requires reviews by an independent review organization who will submit audit findings to HHS-OIG and a review by a Board Compliance Expert, who will prepare two compliance assessment reports in the first and third reporting periods of the CIA and compliance-related certifications from Indivior Inc.'s executives and Board members, and the implementation of a risk assessment and mitigation process. The CIA sets forth specified monetary penalties that may be imposed on a per day basis for failure to comply with the obligations specified in the CIA. The CIA also includes specific procedures under which Indivior Inc. must notify HHS-OIG if it fails to meet the requirements under the CIA. In the event that HHS-OIG determines Indivior Inc. to be in material breach of certain requirements of the CIA (including, repeated violations or any flagrant obligations under the CIA, a failure by Indivior Inc. to report a reportable event and/or take corrective action, a failure to engage and use an independent review organization, a failure to respond to certain requests from HHS-OIG), Indivior Inc. may be subject to exclusion from participation in the U.S. federal healthcare programs, which would have a severe impact on Indivior Inc.'s ability to comply with the financial covenants in Indivior Inc.'s debt facility, maintain sufficient liquidity to fund its operations, pay off its debt, generate future revenue and ultimately impact Indivior Inc.'s viability. See also, "*<u>[Item 3](#i56ef77e8a843490995b8285e91603860_4022085)</u>. Key Information—D. Risk Factors*—*'Compliance with the terms and conditions of our Corporate Integrity Agreement, the Resolution Agreement with the United States Attorney's Office for the Western District of Virginia and Consumer Protection Branch, and the Stipulated Order for Permanent Injunction and Equitable Monetary Relief with the FTC, requires significant resources and management time and, if we fail to comply, we could be subject to criminal charges, penalties or, under certain circumstances, excluded from government healthcare programs, which would materially adversely affect our business.'"*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Lease of Land and Buildings at Dansom Lane, Hull HU8 7DS</u>*, by and between Reckitt Benckiser Healthcare (UK) Limited and RB Pharmaceuticals Limited, dated December 1, 2014. Under the terms of the lease, the Group has an exclusive right of use of the subject property for a 150-year term beginning on December 1, 2014. The lease is subject to certain affirmative and restrictive

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covenants usual to such contracts, including, among other items, limitations on the ability of the parties to sublet, assign, or sell the subject premises.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Certain incentive compensation, employee benefit, and related agreements may be considered to be material contracts</u>*, including (i) the Indivior PLC Annual Incentive Plan, (ii) the Indivior PLC Long-Term Incentive Plan, (iii) the trust deed in respect of the Indivior PLC Employee Benefits Trust, (iv) the Indivior PLC Savings-Related Share Option Plan, (v) the Indivior PLC U.S. Employee Stock Purchase Plan, (vi) the Indivior PLC Deferred Compensation Plan, and (vii) the Indivior Global Stock Profit Plan. For descriptions of these agreements, see "*<u>[Item 6.](#id39cb0e1a10249e1ab7b8f77d921d68a_2425)</u> Directors, Senior Management and Employees—B. Compensation*."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Copacker Supply Agreement</u>* by and between Reckitt Benckiser Healthcare (UK) Limited and Indivior UK Limited (f/k/a RB Pharmaceuticals Limited), originally made December 23, 2014, as amended March 29, 2019. Under the terms of the agreement, Reckitt Benckiser Healthcare (UK) Limited serves as the exclusive manufacturer and supplier of certain products and services, including SUBUTEX tablets, SUBOXONE Tablets, and TEMGESIC injectables and sublingual tablets, for a ten-year term beginning January 1, 2019. The agreement terminates January 1, 2029 although it requires the parties to discuss an extension.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Commercial Exploitation Agreement</u>* by and between Aquestive Therapeutics (f/k/a MonoSol Rx, LLC) and Indivior Inc. (f/k/a Reckitt Benckiser Pharmaceuticals Inc.), dated August 15, 2008, as amended August 19, 2009, November 13, 2009, March 30, 2010, October 13, 2010, December 15, 2010, December 9, 2011, December 1, 2012, October 14, 2013 (by Addendum A), July 30, 2014 (by Addendum B), January 12, 2017, November 25, 2019, December 29, 2020, and March 2, 2023. Under the terms of the agreement, Aquestive Therapeutics has granted certain exclusive rights to the Group, including an exclusive license under Aquestive patents to use and sell SUBOXONE sublingual film, and the Group has granted certain exclusive rights to Aquestive, including an exclusive right to manufacture SUBOXONE sublingual film. The parties agreed to an additional extension for three (3) years through August 16, 2026 after which the agreement renews annually unless a party provides notice to the other party at least one year prior to termination.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Master Manufacturing Services Agreement</u>* between Patheon Manufacturing Services LLC and Indivior UK Limited made April 6, 2018. Under the terms of the agreement, Patheon has been engaged by the Group to supply the component of our SUBLOCADE and PERSERIS products for a term ending December 31, 2027.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Master Development and Supply Agreement</u>* by and between Curia Massachusetts, Inc. and Indivior UK Limited made January 1, 2022. Under the terms of the agreement, the Group has engaged Curia to manufacture and supply components of our SUBLOCADE and PERSERIS products and to provide related development services for a five-year term beginning January 1, 2022. The agreement terminates January 1, 2027 but may be extended by mutual agreement of the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Packaging and Supply Agreement</u>* between Sharp Corporation and Indivior UK Limited made September 7, 2017, as last amended May 9, 2021. Under the terms of the agreement, Sharp serves as the exclusive packager and supplier for our products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Master Collaboration Agreement</u>* between Indivior UK Limited and Aelis Farma SAS made June 3, 2021. For a description of this contract, see "*<u>[Item 4.](#id39cb0e1a10249e1ab7b8f77d921d68a_2018)</u> Information on the Company—B Business Overview, Long-term pipeline*."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Agreement and Plan of Merger</u>* among Indivior PLC, Indivior Inc., Olive Acquisition Sub, Inc., and Opiant Pharmaceuticals, Inc. dated as of November 13, 2022. For a description of this contract, see "*<u>[Item 4.](#ibac0b59918a44a3ea9d781549c209552_211861)</u> Information on the Company—A. History and Development of the Company—Acquisition of Opiant—Merger Agreement*."

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>Contingent Value Rights Agreement</u>* dated as of March 2, 2023 between Indivior, Inc., Computershare Inc. and Computershare Trust Company, N.A. For a description of this agreement, see "*<u>[Item 4.](#ibac0b59918a44a3ea9d781549c209552_211862)</u> Information on the Company—A. History and Development of the Company—Acquisition of Opiant—CVR Agreement*."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>License Agreement by and among Indivior UK Limited and Aelis Farma dated June 3, 2021</u>*<u>. This</u> agreement gives the Group an option for $100 million in exchange for an exclusive global license to develop, make and commercialize AEF0017. The option becomes exercisable upon completion of a successful Phase 2B. The Group made an up-front payment of $30 million to Aelis, and upon exercise the Group would assume responsibility and costs for all future development, regulatory, commercial, and manufacturing activities. Upon commercialization, we would also pay to Aelis Farma a tiered royalty on net sales generally ranging from mid to high teens. We may make additional development milestone payments of up to $90 million and potential sales milestones of up to $235 million. Separately, we also invested $11 million in Aelis common stock in February 2022.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>License Agreement</u> by and among Indivior UK Limited and C4X Discovery Limited dated March 28, 2021.* This agreement gives the Group an exclusive global license to develop, make and commercialize INDV-2000. The Group made an up-front payment of $10 million to C4X. Upon commercialization, we would also pay to C4X a single-digit flat royalty on net sales. We may make additional development milestone payments of up to $40 million and potential sales milestones of up to $150 million.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• *<u>License Agreement by and among Indivior UK Limited and Addex Pharma S.A. dated January 2, 2021</u>.* This agreement gives the Group an exclusive global license to develop, make and commercialize INDV-1000. The Group made an up-front payment of $5 million to Addex. Upon commercialization, we would also pay to Addex a tiered royalty on net sales generally ranging from single digit to low teens. We may make additional development milestone payments of up to $145 million and potential sales milestones of up to $185 million.

**D.Exchange Controls**

Other than certain economic sanctions which may be in place from time to time, there are currently no UK laws, decrees or regulations restricting the import or export of capital or affecting the remittance of dividends or other payment to holders of ordinary shares who are non-residents of the United Kingdom. Similarly, other than certain economic sanctions which may be in force from time to time, there are no limitations relating only to nonresidents of the United Kingdom under English law or Indivior's articles of association on the right to be a holder of, and to vote in respect of, the ordinary shares.

**E.Taxation**

**Taxation in the United States**

The following discussion is a general summary based on present law of certain U.S. federal income tax considerations relevant to U.S. Holders (as defined below) of the ownership and disposition of ordinary shares. This discussion is not a complete description of all tax considerations that may be relevant to a U.S. Holder of ordinary shares; it is not a substitute for tax advice. It applies only to U.S. Holders that hold ordinary shares as capital assets and use the U.S. dollar as their functional currency. In addition, it does not describe all of the U.S. federal income tax considerations that may be relevant to a U.S. Holder in light of a U.S. Holder's particular circumstances, including U.S. Holders subject to special rules, such as banks or other financial institutions, insurance companies, tax-exempt entities, dealers, traders in securities that elect to mark-to-market, regulated investment companies, real estate investment trusts, partnerships and other pass-through entities (including S-corporations), U.S. expatriates, persons liable for the alternative minimum tax, persons that directly, indirectly or constructively, own 5% or more of the total combined voting power of the Group's voting stock or of the total value of the Group's equity interests, investors that hold ordinary shares in connection with a permanent establishment or fixed base

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outside the United States, or investors that hold ordinary shares as part of a hedge, straddle, conversion, constructive sale or other integrated financial transaction. This summary also does not address U.S. federal taxes other than the income tax (such as estate or gift taxes) or U.S. state and local, or non-U.S. tax laws or considerations.

As used in this section, "U.S. Holder" means a beneficial owner of ordinary shares that is, for U.S. federal income tax purposes: (i) a citizen or individual resident of the United States, (ii) a corporation, or other entity taxable as a corporation, created or organized in or under the laws of the United States, any state thereof or the District of Columbia, (iii) a trust subject to the control of one or more U.S. persons and the primary supervision of a U.S. court; or (iv) an estate the income of which is subject to U.S. federal income taxation regardless of its source.

The U.S. federal income tax treatment of a partner in a partnership (or other entity or arrangement treated as a partnership for U.S. federal income tax purposes) that holds ordinary shares generally will depend on the status of the partner and the activities of the partnership. Partnerships that hold ordinary shares should consult their own tax advisors regarding the specific U.S. federal income tax consequences to their partners of the partnership's ownership and disposition of ordinary shares.

***Dividends***

Subject to the discussion below under "– *Passive Foreign Investment Company Rules*," the gross amount of any distribution of cash or property (other than certain pro rata distributions of ordinary stock) with respect to ordinary shares will be included in a U.S. Holder's gross income as ordinary income from foreign sources when actually or constructively received. Dividends will not be eligible for the dividends-received deduction generally available to U.S. corporations. Dividends received by eligible non-corporate U.S. Holders that satisfy a minimum holding period and certain other requirements generally will be taxed at the preferential rate applicable to qualified dividend income if the Group qualifies for the benefits of the income tax treaty between the United States and the United Kingdom and the Group is not a passive foreign investment company (a "PFIC") as to the U.S. Holder in the year of distribution or the preceding year.

Dividends paid in a currency other than U.S. dollars will be included in income in a U.S. dollar amount based on the exchange rate in effect on the date of receipt, whether or not the currency is converted into U.S. dollars at that time. A U.S. Holder's tax basis in the non-U.S. currency will equal the U.S. dollar amount included in income. Any gain or loss realized on a subsequent conversion or other disposition of the non-U.S. currency for a different U.S. dollar amount generally will be U.S. source ordinary income or loss. If dividends paid in a currency other than U.S. dollars are converted into U.S. dollars on the day they are received, the U.S. Holder generally will not be required to recognize foreign currency gain or loss in respect of the dividend income.

Dividends received by certain non-corporate U.S. Holders generally will be includible in "net investment income" for purposes of the Medicare contribution tax.

***Dispositions***

Subject to the discussion below under "– *Passive Foreign Investment Company Rules*," a U.S. Holder generally will recognize capital gain or loss on the sale or other disposition of ordinary shares in an amount equal to the difference between the U.S. dollar value of the amount realized and the U.S. Holder's adjusted tax basis in the disposed ordinary shares. Any gain or loss generally will be treated as arising from U.S. sources and will be long-term capital gain or loss if the U.S. Holder's holding period exceeds one year. Deductions for capital loss are subject to significant limitations.

A U.S. Holder that receives a currency other than U.S. dollars on the sale or other disposition of ordinary shares will realize an amount equal to the U.S. dollar value of the currency received at the spot rate on the date of sale or other disposition (or, if the ordinary shares are traded on an "established securities market" at the time of disposition, in the case of cash basis and electing accrual basis U.S.

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Holders, the settlement date). A U.S. Holder that does not determine the amount realized using the spot rate on the settlement date will recognize foreign currency gain or loss if the U.S. dollar value of the currency received at the spot rate on the settlement date differs from the amount realized. A U.S. Holder will have a tax basis in the currency received equal to its U.S. dollar value at the spot rate on the settlement date. Any foreign currency gain or loss realized on the settlement date or on a subsequent conversion of the non-U.S. currency for a different U.S. dollar amount generally will be U.S. source ordinary income or loss.

Capital gains from the sale or other disposition of ordinary shares received by certain non-corporate U.S. Holders generally will be includible in "net investment income" for purposes of the Medicare contribution tax.

***Passive Foreign Investment Company Rules***

Based on the composition of the Group's current gross assets and income and the manner in which the Group expects to operate its business in future years, the Group believes that it should not be classified as a PFIC for U.S. federal income tax purposes for the Group's current taxable year and does not expect to be so classified in the foreseeable future. In general, a non-U.S. corporation will be a PFIC for any taxable year in which, taking into account a pro rata portion of the income and assets of 25% or more owned subsidiaries, either (i) 75% or more of its gross income is passive income, or (ii) 50% or more of the average quarterly value of its assets are assets that produce, or are held for the production of, passive income or which do not produce income. For this purpose, passive income generally includes, among other things and subject to various exceptions, interest, dividends, rents, royalties and gains from the disposition of assets that produce passive income. Whether the Group is a PFIC is a factual determination made annually, and the Group's status could change depending among other things upon changes in the composition and relative value of its gross receipts and assets. Because the market value of the Group's assets (including for this purpose goodwill) may be measured in large part by the market price of the ordinary shares, which is likely to fluctuate, no assurance can be given that the Group will not be a PFIC in the current year or in any future taxable year.

If the Group were a PFIC for any taxable year in which a U.S. Holder holds ordinary shares, such U.S. Holder would be subject to additional taxes on any excess distributions and any gain realized from the sale or other taxable disposition of ordinary shares (including certain pledges) regardless of whether the Group continues to be a PFIC. A U.S. Holder will have an excess distribution to the extent that distributions on ordinary shares during a taxable year exceed 125% of the average amount received during the three preceding taxable years (or, if shorter, the U.S. Holder's holding period). To compute the tax on excess distributions or any gain, (i) the excess distribution or gain is allocated ratably over the U.S. Holder's holding period, (ii) the amount allocated to the current taxable year and any year before the Group became a PFIC is taxed as ordinary income in the current year and (iii) the amount allocated to other taxable years is taxed at the highest applicable marginal rate in effect for each year and an interest charge is imposed to recover the deemed benefit from the deferred payment of the tax attributable to each year.

A U.S. Holder may be able to avoid some of the adverse impacts of the PFIC rules described above by electing to mark ordinary shares to market annually. The election is available only if the ordinary shares are considered "marketable stock," which generally includes stock that is regularly traded in more than de minimis quantities on a qualifying exchange (which includes Nasdaq). If a U.S. Holder makes the mark-to-market election, any gain from marking Shares to market or from disposing of them would be ordinary income. Any loss from marking ordinary shares to market would be recognized only to the extent of unreversed gains previously included in income. Loss from marking ordinary shares to market would be ordinary, but loss on disposing of them would be capital loss except to the extent of mark-to-market gains previously included in income. No assurance can be given that the ordinary shares will be traded in sufficient frequency and quantity to be considered "marketable stock." A valid mark-to-market election cannot be revoked without the consent of the IRS unless the ordinary shares cease to be marketable stock.

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U.S. Holders should consult their own tax advisors concerning the Group's possible PFIC status and the consequences to them if the Group were classified as a PFIC for any taxable year.

***Information Reporting and Backup Withholding***

Dividends on and proceeds from the sale or other disposition of ordinary shares may be reported to the IRS unless the holder is a corporation or otherwise establishes a basis for exemption. Backup withholding tax may apply to amounts subject to reporting. Any amount withheld may be credited against the holder's U.S. federal income tax liability subject to certain rules and limitations. U.S. Holders should consult with their own tax advisers regarding the application of the U.S. information reporting and backup withholding rules.

Certain non-corporate U.S. Holders are required to report information with respect to ordinary shares not held through an account with a domestic financial institution to the IRS. U.S. Holders that fail to report required information could become subject to substantial penalties. Prospective investors are encouraged to consult with their own tax advisors about these and any other reporting obligations arising from their investment in ordinary shares.

**THE DISCUSSION ABOVE IS A GENERAL SUMMARY. IT DOES NOT COVER ALL TAX MATTERS THAT MAY BE OF IMPORTANCE TO A PARTICULAR U.S. HOLDER. EACH U.S. HOLDER OF ORDINARY SHARES IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES TO IT OF OWNING AND DISPOSING OF ORDINARY SHARES IN LIGHT OF THE U.S. HOLDER'S OWN CIRCUMSTANCES.**

**Taxation in the United Kingdom**

The following statements are intended only as a general guide to certain UK tax considerations and do not purport to be a complete analysis of all potential UK tax consequences of acquiring, holding or disposing of the ordinary shares. They are based on current UK law and what is understood to be the current practice of HM Revenue and Customs ("HMRC") as at the date of this registration statement, both of which may change, possibly with retroactive effect. They apply only to shareholders who are resident, and in the case of individuals domiciled, for tax purposes in (and only in) the UK (except insofar as express reference is made to the treatment of non-UK residents), who hold their ordinary shares as an investment (other than where a tax exemption applies, for example where the ordinary shares are held in an individual savings account or pension arrangement) and who are the absolute beneficial owner of both the ordinary shares and any dividends paid on them. The tax position of certain categories of shareholders who are subject to special rules is not considered (except insofar as express reference is made to the treatment of exempt shareholders) and it should be noted that they may incur liabilities to UK tax on a different basis to that described below. This includes persons acquiring their ordinary shares in connection with employment, dealers in securities, insurance companies, collective investment schemes, charities, exempt pension funds, and temporary non-residents and non-residents carrying on a trade, profession or vocation in the UK.

**The statements summarize the current position and are intended as a general guide only. Shareholders who are in any doubt as to their tax position or who may be subject to tax in a jurisdiction other than the UK are strongly recommended to consult their own professional advisers.**

***Income from Ordinary Shares***

Indivior is not required to withhold UK tax when paying a dividend. Liability to tax on dividends will depend upon the individual circumstances of a shareholder.

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*UK Resident Individual Shareholders*

Under current UK tax rules specific rates of tax apply to dividend income. These include (i) a nil rate of tax (the "dividend allowance") for the first £2,000 of non-exempt dividend income in any tax year (reducing to £1,000 from April 6, 2023 and to £500 from April 6, 2024), and (ii) different rates of tax for dividend income that exceeds the dividend allowance. No tax credit attaches to dividend income. For these purposes "dividend income" includes UK and non-UK source dividends and certain other distributions in respect of shares.

An individual shareholder who is resident for tax purposes in the United Kingdom and who receives a dividend from Indivior will not be liable to UK tax on the dividend to the extent that (taking account of any other non-exempt dividend income received by the shareholder in the same tax year) that dividend falls within the dividend allowance.

To the extent that (taking account of any other non-exempt dividend income received by the shareholder in the same tax year) the dividend exceeds the dividend allowance, it will be subject to income tax at 8.75% to the extent that it falls below the threshold for higher rate income tax. To the extent that (taking account of other non-exempt dividend income received by the shareholder in the same tax year) it falls above the threshold for higher rate income tax then the dividend will be taxed at 33.75% to the extent that it is within the higher rate band, or 39.35% to the extent that it is within the additional rate band. For the purposes of determining which of the taxable bands dividend income falls into, dividend income is treated as the highest part of a shareholder's income. In addition, dividends within the dividend allowance which would (if there was no dividend allowance) have fallen within the basic or higher rate bands will use up those bands respectively for the purposes of determining whether the threshold for higher rate or additional rate income tax is exceeded.

*UK Resident Corporate Shareholders*

It is likely that most dividends paid on the ordinary shares to UK resident corporate shareholders would fall within one or more of the classes of dividend qualifying for exemption from corporation tax. However, it should be noted that the exemptions are not comprehensive and are also subject to anti-avoidance rules.

*UK Resident Exempt Shareholders*

UK resident shareholders who are not liable to UK tax on dividends, including exempt pension funds and charities, are not entitled to any tax credit in respect of dividends paid by the Group.

*Non-UK Resident Shareholders*

No tax credit will attach to any dividend paid by Indivior. A shareholder resident outside the UK may also be subject to non-UK taxation on dividend income under local law. A shareholder who is resident outside the UK for tax purposes should consult his or her own tax adviser concerning his or her tax position on dividends received from the Group.

***Disposal of Shares***

*UK Resident Shareholders*

A disposal or deemed disposal of ordinary shares by a shareholder who is resident in the UK for tax purposes may, depending upon the shareholder's circumstances and subject to any available exemption or relief (such as the annual exempt amount for individuals), give rise to a chargeable gain or an allowable loss for the purposes of UK taxation of capital gains.

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*Non-UK Resident Shareholders*

Shareholders who are not resident in the UK will not generally be subject to UK taxation of capital gains on the disposal or deemed disposal of ordinary shares unless they are carrying on a trade, profession or vocation in the UK through a branch or agency (or, in the case of a corporate shareholder, a permanent establishment) in connection with which the ordinary shares are used, held or acquired. Non-UK tax resident shareholders may be subject to non-UK taxation on any gain under local law.

An individual shareholder who has been resident for tax purposes in the UK but who ceases to be so resident or becomes treated as resident outside the UK for the purposes of a double tax treaty for a period of five years or less and who disposes of all or part of his or her ordinary shares during that period may be liable to capital gains tax on his or her return to the UK, subject to any available exemptions or reliefs.

***Stamp Duty and Stamp Duty Reserve Tax***

No UK stamp duty will be payable in respect of transfers of the ordinary shares, provided that no written instrument of transfer is entered into (which should not be necessary, while the ordinary shares are held within the DTC clearance system).

While the ordinary shares are held within the DTC clearance system (and provided the DTC satisfies various conditions specified in UK legislation), agreements to transfer such shares should not be subject to stamp duty reserve tax ("SDRT"). The Group has received HMRC clearance confirming that agreements to transfer ordinary shares which are held by way of DIs which will represent ordinary shares held within the DTC clearance system (see "*<u>[Item 9.](#id39cb0e1a10249e1ab7b8f77d921d68a_301)</u> The Offer and Listing—A. Offer and Listing Details,"* for a description of the DIs) will not be subject to UK SDRT.

Transfers of, or agreements to transfer, ordinary shares from the DTC clearance system into another clearance system (or into a depositary receipt system) should not, provided that the other clearance system or depositary receipt system satisfies various conditions specified in UK legislation, be subject to UK stamp duty or SDRT.

In the event that ordinary shares are not held in the DTC clearance system (or such ordinary shares have left the DTC clearance system, other than into another clearance system or depositary receipt system), and are to be subsequently transferred (or transferred back) into the DTC clearance system, such ordinary shares will not be transferred (or transferred back) into the DTC clearance system until the transferor of the ordinary shares has first transferred the ordinary shares to a depositary specified by us so that stamp duty (and/or SDRT) may be collected and paid to HMRC in connection with such transfer to the depositary. We have put in place arrangements such that prior to being transferred (or transferred back) into the DTC clearance system, ordinary shares must be transferred to GTU Ops Inc. (as depositary nominee for Computershare Trust Company N.A. (acting in its capacity as depositary)) or to such other relevant depositary and depositary nominee entities within the Computershare group as may be specified by Computershare. Before effecting the transfer of the ordinary shares to the relevant depositary nominee (as nominee for the relevant depositary), for onward transfer into the DTC clearance system, the transferor will be required to provide Computershare Trust Company N.A. (acting in its capacity as transfer agent) (the "Transfer Agent") with the funds necessary to settle any stamp duty (and/or SDRT) in respect of such transfer of ordinary shares, which would generally be charged at the rate of 1.5% of the value of the ordinary shares. Once the Transfer Agent has been provided with the necessary funds, all stamp tax obligations have been complied with by the relevant transferor and/or the Transfer Agent and the transfer of the ordinary shares from the transferor to the relevant depositary nominee (as nominee for the relevant depositary) has been effected, the relevant depositary will then issue depositary receipts in respect of the ordinary shares on a one for one basis. On instruction by, or on behalf of, the relevant transferor, the relevant depositary will then cancel the depositary receipts representing the ordinary shares and instruct the relevant depositary nominee to transfer the ordinary shares into the DTC clearance system.

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If the ordinary shares were transferred by way of written instrument, then UK stamp duty at the rate of 0.5% (rounded up to the next multiple of £5) of the amount or value of the consideration given would generally be payable on the written instrument transferring the ordinary shares. Other than in the circumstances described above for ordinary shares held in (or transferred to) the DTC clearance system (including ordinary shares that are held by way of DIs), a charge to SDRT will also arise on an unconditional agreement to transfer shares (at the rate of 0.5% of the amount or value of the consideration payable). However, if within six years of the date of the agreement becoming unconditional an instrument of transfer is executed pursuant to the agreement, and stamp duty is paid on that instrument, any SDRT already paid will be refunded (generally, but not necessarily, with interest) provided that a claim for repayment is made, and any outstanding liability to SDRT will be cancelled. The liability to pay stamp duty or SDRT is generally satisfied by the purchaser or transferee. An exemption from stamp duty is available on an instrument transferring shares where the amount or value of the consideration is £1,000 or less, and it is certified on the instrument that the transaction effected by the instrument does not form part of a larger transaction or series of transactions for which the aggregate consideration exceeds £1,000.

***Inheritance Tax***

Liability to UK inheritance tax may arise in respect of ordinary shares on the death of, or on a gift of ordinary shares by, an individual holder of such ordinary shares who is domiciled, or deemed to be domiciled, in the UK.

The ordinary shares, if held directly, rather than as DIs, will be assets situated in the UK for the purposes of UK inheritance tax. A gift of such assets by, or the death of, an individual holder of such assets may (subject to certain exemptions and reliefs) give rise to a liability to UK inheritance tax even if the holder is neither domiciled in the UK nor deemed to be domiciled there under certain rules relating to long residence or previous domicile.

Further, DIs may be treated as assets situated in the UK for the purposes of UK inheritance tax. Accordingly, the death of a holder of DIs or a gift of DIs by a holder may give rise to a liability to UK inheritance tax, even if the holder is neither domiciled nor deemed to be domiciled in the UK.

For inheritance tax purposes, a transfer of assets at less than full market value may be treated as a gift and particular rules apply to gifts where the donor reserves or retains some benefit. Special rules also apply to close companies and to trustees of settlements who hold ordinary shares, bringing them within the charge to inheritance tax. Shareholders should consult an appropriate tax adviser if they make a gift or transfer at less than full market value or if they intend to hold any ordinary shares or DIs through trust arrangements.

**F.Dividends and Paying Agents**

For a discussion of the declaration and payment of dividends on our ordinary shares, see "*<u>[Item 10.B.](#i1ad3a9ca197f4e2a8446cfabdce44c91_125959)</u>—Dividends and other distributions.*"

**G.Statement by Experts**

The financial statements of Indivior PLC as of December 31, 2022, 2021, and 2020, and for each of the three years in the period ended December 31, 2022 included in this registration statement on Form 20-F have been so included in reliance on the audit report of PricewaterhouseCoopers U.S. LLP, independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting. PricewaterhouseCoopers U.S. LLP is registered with the U.S. Public Company Accounting Oversight Board (PCOAB).

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**H.Documents on Display**

When this registration statement on Form 20-F becomes effective, we will be subject to the information reporting requirements of the Exchange Act applicable to foreign private issuers, and under those requirements will file reports with the SEC. Those other reports or other information and this registration statement may be inspected without charge and copied at the public reference facilities of the SEC located at 100 F Street, N.E., Washington, D.C. 20549. You may also obtain copies of the documents at prescribed rates by writing to the Public Reference Section of the SEC at 100 F Street, N.E., Washington, DC 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. The SEC also maintains a website at http://www.sec.gov from which certain filings may be accessed.

As a foreign private issuer, we will be exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders will be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we will not be required under the Exchange Act to file annual, quarterly and current reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, for so long as we are listed on a U.S. exchange and are registered with the SEC, we will file with the SEC, within 120 days after the end of each fiscal year, or such applicable time as required by the SEC, an annual report on Form 20-F containing financial statements audited by an independent registered public accounting firm, and will submit to the SEC, on a Form 6-K, all financial statements and other information required to be furnished on Form 6-K.

**I.Subsidiary Information**

Not applicable.

**ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK**

See "*<u>[Item 5.](#id39cb0e1a10249e1ab7b8f77d921d68a_2345)</u> Operating and Financial Review and Prospects—B. Liquidity and Capital Resources.*" In addition to the risks inherent in our operations, we are exposed to a variety of financial risks, such as market risk (including foreign currency exchange, cash flow and interest rate risk), credit risk and liquidity risk. Further information can be found under <u>[Note 1](#id39cb0e1a10249e1ab7b8f77d921d68a_1475)[5](#id39cb0e1a10249e1ab7b8f77d921d68a_1475)</u> "Financial Instruments and Risk Management" included in "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements.*"

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**b. Qualitative Information about Market Risk**

See "*<u>[Item 5.](#id39cb0e1a10249e1ab7b8f77d921d68a_2345)</u> Operating and Financial Review and Prospects—B. Liquidity and Capital Resources.*" In addition to the risks inherent in our operations, we are exposed to a variety of financial risks, such as market risk (including foreign currency exchange, cash flow and interest rate risk), credit risk and liquidity risk. Further information can be found under <u>[Note 15](#id39cb0e1a10249e1ab7b8f77d921d68a_1475)</u> "Financial Instruments and Risk Management" included in "*<u>[Item 18.](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u> Financial Statements—Audited Consolidated Financial Statements.*"

**ITEM 12: DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES**

**A.Debt Securities**

Not applicable.

**B.Warrants and Rights**

Not applicable.

**C.Other Securities**

Not applicable.

------

**D.American Depositary Shares**

Not applicable

**PART II**

**ITEM 13 DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES**

Not applicable.

**ITEM 14: MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS**

Not applicable.

**ITEM 15: CONTROLS AND PROCEDURES**

Not applicable.

**ITEM 16. [Reserved]** 

**ITEM 16A: AUDIT COMMITTEE FINANCIAL EXPERT**

Not applicable.

**ITEM 16B: CODE OF ETHICS**

Not applicable.

**ITEM 16C: PRINCIPAL ACCOUNTANT FEES AND SERVICES**

Not applicable.

**ITEM 16D: EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES**

Not applicable.

**ITEM 16E: PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS**

Not applicable.

------

**ITEM 16F: CHANGE IN REGISTRANTS CERTIFYING ACCOUNTANT**

The certifying accountant of the Group as of, and for, the fiscal years ended December 31, 2021 and 2020 was PricewaterhouseCoopers LLP (UK) ("***PwC UK***"). PwC UK will continue as the Group's certifying accountant under International Auditing Standards applicable for the United Kingdom for UK regulatory purposes and for purposes of our listing on the London Stock Exchange.

In connection with our contemplated dual listing on the Nasdaq Global Select Market, the Audit Committee approved the appointment of PricewaterhouseCoopers LLP (US) ("***PwC US***") as the Group's independent registered public accounting firm for the fiscal year ended December 31, 2022, effective September 28, 2022.

PwC-US participated in a portion of the audit of the Group's consolidated financial statements for the years ended December 31, 2021 and December 31, 2020. During the Group's two most recent years ended December 31, 2021 and December 31, 2020 and in the subsequent interim period through September 30 2022, other than in the normal course of the audit, the Group did not consult PwC US regarding either

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.the application of accounting principles to a specified transaction, either completed or proposed; or the type of audit opinion that might be rendered on the Group's financial statements; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b.any matter that was either the subject of a disagreement or a reportable event.

The audit reports of PwC UK on our consolidated financial statements as of and for the fiscal years ended December 31, 2021 and 2020 did not contain an adverse opinion or a disclaimer of opinion, nor were they qualified or modified as to uncertainty, audit scope or accounting principles.

During the fiscal years ended December 31, 2021 and 2020 and the subsequent interim period through September 30 2022, there were no disagreements between us and PwC UK on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure which, if not resolved to the satisfaction of PwC UK would have caused PwC UK to make reference to the subject matter of the disagreements in connection with its reports for such fiscal years; and there were no reportable events as defined in "*<u>[Item 16F](#id39cb0e1a10249e1ab7b8f77d921d68a_502)</u>. (a)(1)(v)"* of Form 20-F.

The Group provided PwC UK with a copy of this disclosure. PwC UK furnished the Group with a letter addressed to the U.S. SEC stating that it agreed with the statements made by the Group, which the Group files as Exhibit 16.1 to this registration statement.

**ITEM 16G: CORPORATE GOVERNANCE**

Not applicable.

**ITEM 16H: MINE SAFETY DISCLOSURE**

Not applicable.

**ITEM 16I: DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS**

Not applicable.

------

**PART III**

**ITEM 17: FINANCIAL STATEMENTS**

We have elected to furnish financial statements and related information specified in "*<u>[Item 18](#id39cb0e1a10249e1ab7b8f77d921d68a_578)</u>"*.

**ITEM 18: FINANCIAL STATEMENTS**

See the Financial Statements beginning on page F-1.

---

| | |
|:---|:---|
| **<u>[Audited Consolidated Financial Statements](#id39cb0e1a10249e1ab7b8f77d921d68a_1305)</u>**  | <u>[F-](#id39cb0e1a10249e1ab7b8f77d921d68a_1305)[2](#id39cb0e1a10249e1ab7b8f77d921d68a_1305)</u> |
| &nbsp;&nbsp;&nbsp;&nbsp;<u>[Report of Independent Registered Public Accounting Firm](#id39cb0e1a10249e1ab7b8f77d921d68a_1311)[(PCAOB ID 238)](#id39cb0e1a10249e1ab7b8f77d921d68a_1311)</u> | <u>[F-](#id39cb0e1a10249e1ab7b8f77d921d68a_1311)[2](#id39cb0e1a10249e1ab7b8f77d921d68a_1311)</u> |
| &nbsp;&nbsp;&nbsp;&nbsp;<u>[Consolidated Income Statements and Statements of Comprehensive Income](#id39cb0e1a10249e1ab7b8f77d921d68a_1318)[/(Loss)](#id39cb0e1a10249e1ab7b8f77d921d68a_1318)</u> | <u>[F-](#id39cb0e1a10249e1ab7b8f77d921d68a_1318)[3](#id39cb0e1a10249e1ab7b8f77d921d68a_1318)</u> |
| &nbsp;&nbsp;&nbsp;&nbsp;<u>[Consolidated Balance Sheets](#id39cb0e1a10249e1ab7b8f77d921d68a_1324)</u> | <u>[F-](#id39cb0e1a10249e1ab7b8f77d921d68a_1324)[4](#id39cb0e1a10249e1ab7b8f77d921d68a_1324)</u> |
| &nbsp;&nbsp;&nbsp;&nbsp;<u>[Consolidated Statements of Changes in Equity](#id39cb0e1a10249e1ab7b8f77d921d68a_1330)</u> | <u>[F-](#id39cb0e1a10249e1ab7b8f77d921d68a_1330)[5](#id39cb0e1a10249e1ab7b8f77d921d68a_1330)</u> |
| &nbsp;&nbsp;&nbsp;&nbsp;<u>[Consolidated Cash Flow Statements](#id39cb0e1a10249e1ab7b8f77d921d68a_1336)</u> | <u>[F-](#id39cb0e1a10249e1ab7b8f77d921d68a_1336)[7](#id39cb0e1a10249e1ab7b8f77d921d68a_1336)</u> |
| &nbsp;&nbsp;&nbsp;&nbsp;<u>[Notes to the Consolidated Financial Statements](#id39cb0e1a10249e1ab7b8f77d921d68a_1342)</u> | <u>[F-](#id39cb0e1a10249e1ab7b8f77d921d68a_1342)[8](#id39cb0e1a10249e1ab7b8f77d921d68a_1342)</u> |

---

------

**Report of Independent Registered Public Accounting Firm**

To the Board of Directors and Shareholders of Indivior PLC

***Opinion on the Financial Statements***

We have audited the accompanying consolidated balance sheets of Indivior PLC and its subsidiaries (the "Company") as of December 31, 2022, 2021 and 2020 and the related consolidated statements of income, comprehensive income/(loss), changes in equity and cash flow for the years then ended, including the related notes (collectively referred to as the "consolidated financial statements"). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022, 2021 and 2020, and the results of its operations and its cash flows for the years then ended in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

***Basis for Opinion***

These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB and in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

---

| |
|:---|
| /s/ PricewaterhouseCoopers LLP |
| Richmond, Virginia |
| March 9, 2023 |
| We have served as the Company's auditor since 2022. |

---

------

**Consolidated Income Statement**

---

| | | | | |
|:---|:---|:---|:---|:---|
| **For the year ended December 31** *(in millions, except per share data)* | **Notes** | **2022** | **2021** | **2020** |
| Net revenue  | 3 | $901 | $791 | $647 |
| Cost of sales |  | (159) | (127) | (97) |
| Gross profit  |  | 742 | 664 | 550 |
| Selling, general and administrative expenses  | 4 | (763) | (431) | (666) |
| Research and development expenses | 4 | (72) | (52) | (40) |
| Net other operating income | 4 | 8 | 32 | – |
| Operating (loss)/profit  |  | (85) | 213 | (156) |
| Finance income |  | 19 | 4 | 9 |
| Finance expense |  | (29) | (27) | (26) |
| Net finance expense  | 6 | (10) | (23) | (17) |
| (Loss)/profit before taxation  |  | (95) | 190 | (173) |
| Income tax benefit | 7 | 42 | 15 | 25 |
| Net (loss)/income  |  | $(53) | $205 | $(148) |
| (Loss)/earnings per ordinary share\*  |  |  |  |  |
| Basic (loss)/earnings per share | 8 | $(0.38) | $1.41 | $(1.01) |
| Diluted (loss)/earnings per share | 8 | $(0.38) | $1.35 | $(1.01) |

---

______________

\*Basic and diluted (loss)/earnings per share reflect the impact of the Company's share consolidation for all periods presented. Refer to <u>[Note 8](#id39cb0e1a10249e1ab7b8f77d921d68a_1433)</u> for further details.

**Consolidated Statement of Comprehensive (Loss)/Income**

---

| | | | |
|:---|:---|:---|:---|
| **For the year ended December 31** *(in millions)* | **2022** | **2021** | **2020** |
| Net (loss)/income | $(53) | $205 | $(148) |
| **Other comprehensive (loss)/income** |  |  |  |
| Items that may be reclassified to profit or loss in subsequent years: |  |  |  |
| Foreign currency translation adjustment, net | (19) | (7) | 10 |
| Other comprehensive (loss)/income | (19) | (7) | 10 |
| **Total comprehensive (loss)/income**  | $**(72)** | $**198** | $**(138)** |

---

The notes are an integral part of these Consolidated Financial Statements.

------

**Consolidated Balance Sheets**

---

| | | | | |
|:---|:---|:---|:---|:---|
| **As at December 31** *(in millions)* | **Notes** | **2022** | **2021** | **2020** |
| **Assets**  |  |  |  |  |
| **Non-current assets**  |  |  |  |  |
| Intangible assets | 9 | $70 | $82 | $62 |
| Property, plant and equipment | 10 | 54 | 58 | 60 |
| Right-of-use assets | 11 | 31 | 37 | 43 |
| Deferred tax assets | 7 | 219 | 105 | 75 |
| Investments | 12 | 98 |  |  |
| Other assets | 14 | 38 | 106 | 104 |
|  |  | 510 | 388 | 344 |
| **Current assets**  |  |  |  |  |
| Inventories | 13 | 114 | 95 | 93 |
| Trade receivables | 14 | 220 | 202 | 179 |
| Other assets | 14 | 27 | 32 | 50 |
| Current tax receivable | 7 | 5 | 13 | 7 |
| Investments | 12 | 119 |  |  |
| Cash and cash equivalents | 16 | 774 | 1102 | 858 |
|  |  | 1259 | 1444 | 1187 |
| **Total assets**  |  | $**1769** | $**1832** | $**1531** |
| **Liabilities**  |  |  |  |  |
| **Current liabilities**  |  |  |  |  |
| Borrowings | 17 | $(3) | $(3) | $(4) |
| Provisions | 19 | (303) | (5) | (38) |
| Other liabilities | 19 | (79) | (61) | (10) |
| Trade and other payables | 22 | (617) | (720) | (524) |
| Lease liabilities | 11 | (8) | (8) | (8) |
| Current tax liabilities | 7 | (9) | (7) | (15) |
|  |  | (1019) | (804) | (599) |
| **Non-current liabilities**  |  |  |  |  |
| Borrowings | 17 | (237) | (239) | (230) |
| Provisions | 19 | (5) | (76) | (51) |
| Other liabilities | 19 | (428) | (474) | (526) |
| Lease liabilities | 11 | (29) | (36) | (43) |
|  |  | (699) | (825) | (850) |
| **Total liabilities**  |  | **(1718)** | **(1629)** | **(1449)** |
| **Net assets**  |  | **51** | **203** | **82** |
| **Equity**  |  |  |  |  |
| **Capital and reserves**  |  |  |  |  |
| Share capital | 23 | $68 | $70 | $73 |
| Share premium |  | 8 | 7 | 6 |
| Capital redemption reserve | 24 | 6 | 3 | – |
| Other reserves | 24 | (1295) | (1295) | (1295) |
| Foreign currency translation reserve | 24 | (39) | (20) | (13) |
| Retained earnings |  | 1303 | 1438 | 1311 |
| **Total equity**  |  | $**51** | $**203** | $**82** |

---

The notes are an integral part of these Consolidated Financial Statements.

------

**Consolidated Statements of Changes in Equity**

---

| | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| *(in millions)* | **Notes** | **Share**<br>**capital** | **Share**<br> **premium** | **Capital redemption reserve**  | **Other** <br>**reserves** | **Foreign currency translation reserve** | **Retained**<br>**earnings** | **Total** <br>**equity** |
| **Balance at January 1, 2020**  |  | $**73** | $**5** | $**—** | $**(1295)** | $**(23)** | $**1449** | $**209** |
| **Comprehensive loss**  |  |  |  |  |  |  |  |  |
| Net loss |  |  |  |  |  |  | (148) | (148) |
| Other comprehensive income  |  |  |  |  |  | 10 |  | 10 |
| **Total comprehensive loss**  |  | **—** | **—** | **—** | **—** | **10** | **(148)** | **(138)** |
| **Transactions recognized directly in equity**  |  |  |  |  |  |  |  |  |
| Shares issued | 23 |  | 1 |  |  |  |  | 1 |
| Share-based plans | 25 |  |  |  |  |  | 8 | 8 |
| Taxation on share-based payments | 7 |  |  |  |  |  | 2 | 2 |
| **Total transactions recognized directly in equity**  |  | **—** | **1** | **—** | **—** | **—** | **10** | **11** |
| **Balance at December 31, 2020**  |  | $**73** | $**6** | $**—** | $**(1295)** | $**(13)** | $**1311** | $**82** |
| **Balance at January 1, 2021**  |  | $**73** | $**6** | $**—** | $**(1295)** | $**(13)** | $**1311** | $**82** |
| **Comprehensive income**  |  |  |  |  |  |  |  |  |
| Net income |  | **—** | **—** | **—** | **—** | **—** | 205 | 205 |
| Other comprehensive loss  |  | **—** | **—** | **—** | **—** | (7) | **—** | (7) |
| **Total comprehensive income**  |  | **—** | **—** | **—** | **—** | **(7)** | **205** | **198** |
| **Transactions recognized directly in equity**  |  |  |  |  |  |  |  |  |
| Shares issued | 23 |  | 1 |  |  |  |  | 1 |
| Shared repurchased and canceled | 23 | (3) |  | 3 |  |  | (101) | (101) |
| Share-based plans | 25 |  |  |  |  |  | 11 | 11 |
| Settlement of tax on equity awards |  |  |  |  |  |  | (1) | (1) |
| Taxation on share-based payments | 7 |  |  |  |  |  | 13 | 13 |
| **Total transactions recognized directly in equity**  |  |  |  |  |  |  |  |  |
| **Balance at December 31, 2021**  |  | $**(3)** | $**1** | $**3** | $**—** | $**—** | $**(78)** | $**(77)** |
| **Balance at January 1, 2022**  |  | $**70** | $**7** | $**3** | $**(1295)** | $**(20)** | $**1438** | $**203** |
| **Comprehensive loss** |  |  |  |  |  |  |  |  |

---

------

---

| | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| Net loss |  |  |  |  |  |  | (53) | (53) |
| Other comprehensive loss |  |  |  |  |  | (19) |  | (19) |
| **Total comprehensive loss**  |  | **—** | **—** | **—** | **—** | **(19)** | **(53)** | **(72)** |
| **Transactions recognized directly in equity**  |  |  |  |  |  |  |  |  |
| Shares issued | 23 | 1 | 1 |  |  |  |  | 2 |
| Shares repurchased and canceled | 23 | (3) |  | 3 |  |  | (90) | (90) |
| Transfer to share repurchase liability | 23 |  |  |  |  |  | (9) | (9) |
| Share-based plans | 25 |  |  |  |  |  | 16 | 16 |
| Settlement of tax on equity awards |  |  |  |  |  |  | (10) | (10) |
| Taxation on share-based plans | 7 |  |  |  |  |  | 11 | 11 |
| **Total transactions recognized directly in equity**  |  | **(2)** | **1** | **3** | **—** | **—** | **(82)** | **(80)** |
| **Balance at December 31, 2022**  |  | $**68** | $**8** | $**6** | $**(1295)** | $**(39)** | $**1303** | $**51** |

---

The notes are an integral part of these Consolidated Financial Statements.

------

**Consolidated Cash Flow Statement**

---

| | | | | |
|:---|:---|:---|:---|:---|
| **For the year ended December 31** *(in millions)* | **Notes** | **2022** | **2021** | **2020** |
| **Cash flows from operating activities**  |  |  |  |  |
| Operating (loss)/profit |  | $(85) | $213 | $(156) |
| Depreciation and amortization of property, plant and equipment and intangible assets | 9, 10 | 13 | 15 | 18 |
| Gain on disposal of intangible assets |  | (1) | (20) |  |
| Gain on disposal of right-of-use assets | 11 |  |  | (2) |
| Depreciation and impairment of right-of-use assets | 11 | 8 | 7 | 8 |
| Share-based payments | 25 | 16 | 11 | 8 |
| Settlement of tax on employee awards |  | (10) | (1) |  |
| Impact from foreign exchange movements |  | (3) | (3) | (5) |
| (Increase)/decrease in trade receivables |  | (21) | (25) | 15 |
| Decrease/(increase) in current and non-current other assets |  | 72 | 16 | (44) |
| Increase in inventories |  | (25) | (3) | (16) |
| (Decrease)/increase in trade and other payables |  | (98) | 201 | (103) |
| Increase/(decrease) in provisions and other liabilities<sup>(1)</sup> |  | 197 | (16) | 129 |
| **Cash generated from/(used in) operations**  |  | **63** | **395** | **(148)** |
| Interest paid |  | (24) | (18) | (20) |
| Interest received |  | 15 | 1 | 9 |
| Taxes paid |  | (57) | (17) | (34) |
| Transaction costs related to debt refinancing | 17 | (1) | (8) |  |
| **Net cash (outflow)/inflow from operating activities**  |  | $**(4)** | $**353** | $**(193)** |
| **Cash flows from investing activities** |  |  |  |  |
| Purchase of property, plant and equipment  | 10 | (5) | (4) | (4) |
| Purchase of investments | 12 | (245) |  |  |
| Maturity of investments | 12 | 27 |  |  |
| Purchase of intangible assets | 9 | (1) | (30) |  |
| Net proceeds from disposal of intangible assets | 9 | 1 | 20 |  |
| **Net cash outflow from investing activities**  |  | $**(223)** | $**(14)** | $**(4)** |
| **Cash flows from financing activities** |  |  |  |  |
| Proceeds from borrowings | 17 |  | 250 |  |
| Repayment of borrowings  | 17 | (3) | (236) | (4) |
| Principal elements of lease payments |  | (9) | (8) | (7) |
| Proceeds from the issuance of ordinary shares |  | 2 | 1 | 1 |
| Cash paid for the repurchase and cancellation of shares (including direct transaction costs) | 23 | (90) | (101) |  |
| **Net cash outflow from financing activities**  |  | $**(100)** | $**(94)** | $**(10)** |
| Exchange difference on cash and cash equivalents |  | (1) | (1) | 5 |
| **Net (decrease)/increase in cash and cash equivalents**  |  | (328) | 244 | (202) |
| Cash and cash equivalents at beginning of the period | 16 | 1102 | 858 | 1060 |
| **Cash and cash equivalents at end of the period**  |  | $**774** | $**1102** | $**858** |

---

__________________

(1)The 2022 increase in provisions and other liabilities primarily relates to the $290 million provision recognized related to certain multidistrict antitrust class and state claims (refer to <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal proceedings for further discussions), partially offset by payments for other settled matters. The 2020 increase in provisions and other liabilities primarily results from adjustment of the provision for DOJ and related matters, partially offset by the initial payment under the DOJ resolution.

The notes are an integral part of these Consolidated Financial Statements.

------

**NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS**

**1. GENERAL INFORMATION**

Indivior PLC (the "Company") and its subsidiaries (together, "Indivior" or the "Group") are predominantly engaged in the development, manufacture and sale of buprenorphine-based prescription drugs for the treatment of opioid dependence, and co-occurring disorders (the "Indivior Business").

The Group is a public limited company incorporated and domiciled in England, United Kingdom on September 26, 2014, and is the holding company for the Group. The address of the registered office and company number is 234 Bath Road, Slough, Berkshire, SL1 4EE, UK and 09237894, respectively.

Indivior PLC is the ultimate holding company of the Group. The following table sets out details of the Group's significant subsidiaries:

---

| | | |
|:---|:---|:---|
| **Name** | **Country of** <br>**incorporation or registration** | **Proportion of** <br>**Ownership Interest** |
| RBP Global Holdings Limited | England and Wales | 100% |
| Indivior UK Limited | England and Wales | 100% |
| Indivior Europe Limited | Ireland | 100% |
| Indivior Inc. | U.S. | 100% |
| Indivior Treatment Services, Inc. | U.S. | 100% |
| Indivior Pty Ltd | Australia | 100% |

---

The principal accounting policies adopted in the preparation of these financial statements are set out below. Unless otherwise stated, these policies have been consistently applied to all years presented.

**2. BASIS OF PREPARATION AND ACCOUNTING POLICIES**

The annual financial statements of the Group have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. The financial statements are presented in US dollars ($) and are prepared on a historical cost basis except where otherwise stated. As discussed in <u>[Note 8](#id39cb0e1a10249e1ab7b8f77d921d68a_1433)</u> and <u>[Note 23](#id39cb0e1a10249e1ab7b8f77d921d68a_1524)</u>, the Company effected a 5-for-1 share consolidation on October 10, 2022. Shareholders received 1 new ordinary share with a nominal value of $0.50 each for every 5 previously existing ordinary shares which had a nominal value of $0.10 each. The Company's basic and diluted weighted average number of shares outstanding, basic (loss)/earnings per share, and diluted (loss)/earnings per share reflect the share consolidation for all periods presented. The financial statements were approved by the Board of Directors on March 7, 2023.

**Going concern assessment**

The Directors have considered the Company's and the Group's financial plan, in particular with reference to the period through to June 2024.

The Directors have assessed the Group's ability to maintain sufficient liquidity to fund its operations, fulfill financial and compliance obligations as set out in <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)[19](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)</u>, and comply with the minimum liquidity covenant in the Group's debt facility for the period to June 2024 (the going concern period). A base case model was produced reflecting:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Board approved budgets for the period;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the proposed acquisition of Opiant Pharmaceuticals, Inc. which is expected to complete in Q1 2023; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• settlement of liabilities and provisions in line with contractual or expected terms.

------

The Directors also assessed a "severe but plausible" downside scenario which included the following key changes to the base case within the going concern period:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the risk that SUBLOCADE will not meet revenue growth expectations by modeling a 15% decline on forecasts;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• an accelerated decline in sublingual product sales including reversion to generic analogues for SUBOXONE Film in the US; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• stress testing of payments from ongoing legal proceedings.

Under both the base case and the downside scenario, sufficient liquidity exists and is generated by the business such that all operational and covenant requirements are met for the going concern period. The Directors believe the near-term litigation outcomes can be appropriately managed; should this not be the case, the Group would take the cases to trial where it believes it has a strong case that would not merit material additional payments in the going concern period. These risks were balanced against the Group's current and forecast liquidity position as well as other mitigating measures available to the Group. As a result of the analysis described above, the Directors reasonably expect the Group to have adequate resources to continue in operational existence for at least one year from the approval of these financial statements and therefore consider the going concern basis to be appropriate for the accounting and preparation of these financial statements.

**New accounting standards issued but not yet effective**

Certain new accounting standards, amendments to accounting standards and interpretations have been published that are not mandatory for December 31, 2022 reporting periods and have not been early adopted by the Group. These standards, amendments, or interpretations are not expected to have a material impact on the entity in the current or future reporting periods and on foreseeable future transactions.

**Adoption of new and revised standards**

There are no new accounting standards that are effective from January 1, 2022 that have had a material impact on the Company.

**Basis of consolidation**

The consolidated financial statements include the results of the Company and its subsidiaries. Subsidiaries are those investees, including structured entities, the Group controls because the Group (i) has power to direct the relevant activities of the investees that significantly affect their returns, (ii) has exposure, or rights, to variable returns from its involvement with the investees, and (iii) has the ability to use its power over the investees to affect its returns. Subsidiaries are consolidated from the date on which control is transferred to the Group (acquisition date) and are deconsolidated from the date on which control ceases. Intra-Group transactions, outstanding balances payable or receivable and unrealized income and expense on transactions between Group entities have been eliminated on consolidation. All subsidiaries have year ends which are co- terminous with the Company's. For IFRS reporting, subsidiaries' accounting policies are consistent with the policies adopted by the Group.

**Foreign currency translation**

The financial statements of each Group entity are measured using the currency of the primary economic environment in which the entity operates (the functional currency), which is generally the local currency with the exception of treasury and holding companies where the functional currency is the U.S. dollar. The Group's reporting currency is the U.S. dollar.

Foreign currency transactions are translated into the functional currency using exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the

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settlement of foreign currency transactions and from the remeasurement of monetary assets and liabilities denominated in foreign currencies are recognized within SG&A in the consolidated income statement.

The exchange rates used for the translation of currencies into U.S. dollars that have the most significant impact on the Group's results were:

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| | | | |
|:---|:---|:---|:---|
| | **2022** | **2021** | **2020** |
| GBP year-end exchange rate | 1.2083 | 1.3532 | 1.3651 |
| GBP average exchange rate | 1.2386 | 1.3763 | 1.2833 |
| EUR year-end exchange rate | 1.0698 | 1.1378 | 1.2226 |
| EUR average exchange rate | 1.0545 | 1.1840 | 1.1403 |

---

The financial statements of subsidiaries with different functional currencies are translated into U.S. dollars on the following basis:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Assets and liabilities at the year-end rate.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Profit and loss account items at the weighted average exchange rate for the year.

Exchange differences arising from translation of retained earnings and the net investment in foreign entities are recognized in the statement of comprehensive income on consolidation.

**Revenues**

Net revenue is generated from sales of pharmaceutical products, net of accruals for returns, discounts, incentives and rebates ("allowances"). Direct customers are often wholesalers and distributors of pharmaceutical products; indirect customers are often government-sponsored programs or commercial insurers with whom the Group has separate pricing and formulary agreements.

Net revenue is recognized when a contractual promise to a customer (performance obligation) has been fulfilled by transferring control over pharmaceutical products to the direct customer, substantially all of which is upon receipt of the products by the customer, and therefore all revenue is considered as "point in time". The amount of net revenue recognized is based on the consideration expected in exchange for pharmaceutical products, including reductions in revenue for rebates expected to be paid to indirect customers. The consideration Indivior receives may be fixed or variable. Variable consideration is only recognized when it is highly probable that a significant reversal will not occur. The Group has no material contracts with more than one performance obligation.

Management is required to determine the net transaction price in respect of each of its contracts with direct and indirect customers. In making such judgment, management assesses the impact of any variable consideration in the contract due to allowances. These are estimated and recognized in the period in which the underlying performance obligation is fulfilled as a reduction of net revenue.

The following are the Group's significant categories of allowances:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**• Government and commercial rebates** 

The Group records accruals for rebates for governmental programs as a reduction of sales when the product is sold into the distribution channel. The Group pays rebates to individual US states for all eligible units purchased under the Medicaid Drug Rebate Program in the United States (Medicaid) based on a "per unit rebate" calculation, which is based on the Group's average manufacturer prices and applicable supplemental agreements.

Management estimates expected unit sales under Medicaid and adjusts its rebate accrual based on actual unit, per unit rebate amounts and changes in trends in Medicaid utilization.

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Commercial rebates include amounts payable to payers and healthcare providers under contractual arrangements and may vary by product.

Government and commercial rebates are estimated using contracted rates, historical and &nbsp;&nbsp;&nbsp;&nbsp;estimated payer mix, historical utilization trends and payment processing time lag. Additionally, in developing estimates, management considers statutory rebate requirements, estimated patient mix, known market events or trends, channel inventory data obtained from third parties and other pertinent internal or external information. Management assesses and updates estimates each reporting period to reflect billing trends and other current information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**• Chargebacks**

Chargebacks relate to discounts that occur when contracted indirect customers purchase directly from wholesalers and specialty distributors at a contracted price. The wholesaler or specialty distributor, in turn, then generally charges back to the Group the difference between the wholesale acquisition cost and the contracted price paid to the wholesaler or specialty distributor by the customer.

Management estimates the accrual for these chargebacks based on historical and expected utilization of these programs.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**• Allowance for sales returns** 

Returns are generally made if the product is damaged, defective, or otherwise cannot be used by the customer. In the United States, the Group typically permit returns six months prior to and up to twelve months after the product expiration date. Outside the United States, returns are only allowed in certain countries on a limited basis.

Accruals for product returns are estimated based primarily on analysis of the Group's historical product return patterns, expected future returns, and contractual agreement terms. Estimated returns are accrued in the period the related revenue is recognized.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**• Sales discounts** 

Wholesalers, specialty pharmacies and specialty distributors of the Group's products are generally offered various forms of consideration, including discounts, service fees and prompt payment discounts, for distributing the products. Wholesaler and specialty distributor allowances and service fees arise from contractual agreements and are estimated as a percentage of the price at which the Group sells product to them. In addition, customers are offered a prompt pay discount for payment within a specified contractual period. Prompt pay discounts are classified as reductions of accounts receivables.

Management also takes account of factors such as levels of inventory in its various distribution channels, product expiry dates and information about potential entry of competing products into the market. In each case, the accruals made for allowances noted above are subject to continuous review and adjustment as appropriate, based on the most recent information available to management.

Adjustments to the accruals may be necessary based on actual utilization information submitted to the Group (in the case of accruals for rebates related to sales targets or contractual rebates), claims/invoices received (in the case of regulatory rebates and chargebacks) and actual return rates.

**Operating segments**

Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker (CODM). The CODM, who is responsible for allocating resources and assessing performance of the operating segments, has been identified as the Chief Executive Officer (CEO).

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**Cost of sales**

Cost of sales are recognized as the associated net revenue is recognized or when the asset no longer represents a probable future economic benefit. Cost of sales include manufacturing costs, movements in provisions for inventories, inventory write-offs, and depreciation and impairment charges in relation to manufacturing assets.

**Selling, general and administrative expenses**

Selling, general and administrative expenses comprise personnel costs, as well as marketing expenses, consulting services, depreciation of fixed assets, travel and other selling and distribution related expenses, corporate overheads, patent-related costs and other administrative expenses. Selling, general and administrative expenses also include expenses relating to recognition or release of legal provisions.

Expenses are recognized in respect of goods and services received when supplied in accordance with contractual terms. Marketing, promotional, and other selling expenses are charged to the consolidated income statement as incurred.

**Research and development**

Research and development expenses comprise internal and external research expenses. Internal R&D expenses include employee related expenses, occupancy costs, depreciation of corresponding equipment and other costs. External R&D expenses include cost related to clinical trials non-clinical activity, and laboratory services. Research expenditure is charged to the consolidated income statement in the year in which it is incurred.

Development expenditure is expensed as incurred, unless it meets the requirements of IAS 38 to be capitalized and then amortized over the useful life of the developed product, once commercialized.

The Group has determined that filing for regulatory approval is generally the earliest point at which internal development costs can be capitalized. However, judgment is exercised when assessing the point at which it is probable that the asset created will generate future economic benefits, which may not be until final regulatory approval for certain assets. All internal development expenditure incurred prior to filing for regulatory approval is therefore expensed as incurred.

**Net other operating income**

Net other operating income is credited to the consolidated income statement as earned.

**Finance income and expense**

Finance income represents interest earned on invested cash balances plus interest income from debt securities which is included in finance income using the effective interest method. Finance income on cash and cash equivalents and investments is recognized in the consolidated income statement in the period earned.

Finance costs of borrowings are recognized in the consolidated income statement over the term of those borrowings. Finance costs related to lease arrangements are recognized in the consolidated income statement over the lease period. Finance costs on significant legal matters are generally recognized in the income statement over the settlement payment period.

**Income tax**

Income tax for the year comprises current and deferred tax. Current tax is the expected tax payable on taxable income for the year, using tax rates enacted, or substantively enacted, at the balance sheet date, and any adjustment to tax payable in respect of previous years.

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Income tax is recognized in the consolidated income statement except to the extent that it relates to items recognized in other comprehensive income or directly in equity. In this case, the tax is also recognized in other comprehensive income or directly in equity, respectively.

Current tax for the current and prior periods is recognized as a liability to the extent that it has not yet been settled, and as an asset to the extent that the amounts already paid exceed the amount due.

Deferred tax is recognized on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the financial statements using the balance sheet approach. Deferred tax is not recorded if it arises from the initial recognition of an asset or liability in a transaction (other than a business combination) that affects neither accounting nor taxable profit or loss at that time. Deferred tax is determined using tax rates (and laws) that have been enacted or substantively enacted at the balance sheet date and apply when the deferred tax asset or liability is expected to reverse. They are revalued for changes in tax rates when new tax rates are substantively enacted.

**Intangible assets**

Intangible assets are carried at cost less accumulated amortization and impairment.

Payments made in respect of acquired distribution rights are capitalized when it is probable that the expected future economic benefits attributable to the asset will flow to the Group. The useful life of the acquired distribution rights is determined based on legal, regulatory, contractual, competitive, economic or other relevant factors. Acquired rights with finite lives are subsequently amortized using the straight-line method over their expected useful economic lives (see <u>[Note 9](#id39cb0e1a10249e1ab7b8f77d921d68a_1439)</u>).

Payments related to the acquisition of rights to products in development or marketed products are capitalized if it is probable that future economic benefits from the asset will flow to the Group. Probability of future economic benefit is assumed for all payments made for externally acquired products in development and therefore capitalized. Subsequent success-based milestone payments up to and including approval are capitalized when achieved. Products in development are not amortized as they are not yet in use but are assessed for impairment at the end of each reporting period. Once approved in their primary market, products in development are transferred to marketed products.

Marketed products are amortized over their useful economic life, which is generally estimated as the patent life within the product's primary market. Amortization of marketed products is recognized within cost of sales. All products are assessed for impairment indicators at the end of each reporting period and tested for impairment annually.

Acquired computer software licenses and related implementation costs are capitalized at cost. These costs are typically amortized on a straight-line basis, generally over a period of up to five years. For cloud-based software licenses, implementation costs are expensed as incurred and subscription costs are expensed ratably over the license period.

Gains and losses on the disposal of intangible assets are determined by comparing the asset's carrying value with any sale proceeds and are included in the consolidated income statement.

The carrying values of intangible assets are reviewed for impairment annually and/or when events or changes in circumstances indicate the carrying value may be impaired depending on the intangible asset type. If any such indication exists, the recoverable amount of the asset is estimated in order to determine the extent of impairment loss. Where it is not possible to estimate the recoverable amount of an individual asset, management estimates the recoverable amount of the cash-generating unit (CGU) to which it belongs.

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**Property, plant and equipment**

Property, plant and equipment are stated at historic cost less accumulated depreciation and impairment, with the exception of land, which is shown at cost less impairment. Cost includes expenditure that is directly attributable to the acquisition of the asset.

The cost of subsequent improvements and enhancements is included in the asset's carrying amount or recognized as a separate asset, as appropriate, only when it is probable that future economic benefits associated with the item will flow to the Group and the cost of the item can be reliably measured.

Except for freehold land and assets under construction, the cost of property, plant and equipment is depreciated on a straight-line basis over the expected useful life of the asset. For this purpose, expected lives are determined within the following limits:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• freehold buildings: not more than 20 years;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• plant and equipment: not more than 10 years;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• motor vehicles and computer equipment: not more than 4 years; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• leasehold improvements: up to the expected lease term.

Assets' residual values and useful lives are reviewed, and adjusted if necessary, at each balance sheet date. Property, plant and equipment are reviewed for impairment if events or changes in circumstances indicate that the carrying amount may not be appropriate. Freehold land is reviewed for impairment on an annual basis.

Gains and losses on the disposal of property, plant and equipment are determined by comparing the asset's carrying value with any sale proceeds and are included in the income statement.

**Leases and right-of-use asset** 

The Group leases various properties and equipment (including vehicles). Rental contracts are typically made for fixed periods of 3 to 10 years but may have termination or extension options. Management assesses whether it is reasonably certain to exercise the options at lease commencement and subsequently, if there is a change in circumstances within its control. Extension options (or periods after termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated). Such assessment involves management judgment and estimations based on information at the time the assessments are made.

As a lessee, management assesses whether a contract conveys the right to control use of an identified asset for a period in exchange for consideration, in which case it is classified as a lease. The Group recognizes a right-of-use asset (lease asset) and a corresponding liability at the lease commencement date, measured on a present value basis.

Leases with a term of 12 months or less (short-term leases) and low-value leases are not recognized on the balance sheet. For these short-term and low-value leases, the Group recognizes the lease payments as an operating expense on a straight-line basis over the term of the lease.

The Group's right-of-use assets are calculated based upon the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the amount of the initial measurement of the lease liability;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• any lease payments made to the lessor at or before the commencement date, less any lease incentives (e.g. rent abatements, tenant improvement allowances) received; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• any initial direct costs incurred by the Group.

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Right-of-use assets are amortized on a straight-line basis from the commencement date of the lease over the shorter of the lease term or useful life of the right-of-use asset. Right-of-use assets are assessed for impairment whenever there is an indication the carrying amount may not be recoverable, generally using cash flow projections for the cash-generating unit in which the right-of-use asset belongs.

Lease liabilities are initially measured at the present value of the lease payments to be made over the lease term using the discount rate for the lease at lease commencement. If the interest rate implicit in the lease can be determined, it will be used to measure the liability. If an interest rate is not implicit in the lease, the incremental borrowing rate for the respective loan type at the date of commencement will be used, which ranged from 3.9% to 7.9%. The incremental borrowing rate is determined by referencing the cost of borrowing in recent debt issuances for entities with comparable credit ratings, adjusted for the term of the lease and country of origin.

The Group remeasures the lease liability (and makes a corresponding adjustment to the related right-of-use asset) whenever the lease terms or expected payments under the lease change, or a modification occurs that is not accounted for as a separate lease. Lease payments are allocated between principal and finance cost. The finance cost is charged to profit or loss over the lease period to produce a constant periodic rate of interest on the remaining balance of the liability for each period. Principal elements of lease payments are recognized as cash flows from financing activities.

**Investments**

Investments comprise holdings in equity and debt securities. Investments in equity securities held for trading or for which the Group has not elected to recognize fair value gains and losses through other comprehensive income are initially recorded and subsequently measured at fair value through profit or loss (FVPL). Investments in debt securities are initially recorded at fair value plus or minus directly attributable transaction costs and remeasured on the basis of the Group's business model and the contractual cash flow characteristics.

The Group's investments in debt securities are held at amortized cost as the Group's intention is to hold these investments to maturity and collect contractual cash flows that are solely payments of principal and interest.

The Group applies an expected credit loss impairment model to financial instruments held at amortized cost. The recognition of a loss allowance is limited to 12-month expected credit losses unless credit risk increases significantly, which would require lifetime expected credit losses to be applied. When measuring expected credit losses, investments are grouped based on similar credit risk characteristics. Management uses judgment in selecting the inputs to the impairment model based on historical loss rates for similar instruments, current conditions, and forecasts of future economic conditions.

**Inventories**

Raw materials, stores and consumables, work in progress and finished goods are stated at the lower of cost or net realizable value. Cost comprises materials, direct labor and an appropriate portion of overhead expenses (based on normal operating capacity) required to get the inventory to its present location and condition. Inventory valuation is determined on a first in, first out basis. Selling expenses, product amortization, and certain other overhead expenses are excluded from product cost. Net realizable value is the estimated selling price less applicable selling expenses. Impairment of inventory is recognized in cost of sales.

**Trade receivables**

Trade receivables are initially recognized at their invoiced amounts less estimated adjustments for deductions such as cash discounts. Trade receivables consist of amounts due from customers, primarily wholesalers and distributors, for which there is no significant history of default. The credit risk of

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customers is assessed, taking into account their financial positions, past experiences and other relevant factors. Individual customer credit limits are imposed based on these factors.

Provisions for expected credit losses are established using an expected credit loss model (ECL). The provisions are based on a forward-looking ECL, which includes possible default events on the trade receivables over the entire holding period. These provisions represent the difference between the carrying amount in the consolidated balance sheet and the estimated collectible amount. Charges for ECL are recognized in the consolidated income statement within SG&A expenses.

**Cash and cash equivalents**

Cash and cash equivalents comprise cash in hand, current balances with banks and similar institutions, and highly liquid investments with original maturities of less than three months.

**Borrowings**

Interest-bearing borrowings are recognized initially at fair value less attributable transaction costs. Subsequent to initial recognition, interest-bearing borrowings are stated at amortized cost, with any difference between cost and redemption value being recognized within finance expense in the income statement over the year of the borrowings on an effective interest basis.

Borrowings are classified as a current liability unless the Group has an unconditional right to defer settlement of the liability for at least 12 months after the reporting date.

**Provisions and other liabilities**

Provisions are recognized when the Group has a present legal or constructive obligation as a result of past events, an outflow of resources to settle that obligation is more likely than not, and the amount can be reliably estimated. Provisions are measured at the present value of management's best estimate of the expenditure required to settle the present obligation at the reporting date. Provisions are reviewed regularly, and amounts updated where necessary to reflect the latest assumptions. The assessment of provisions can involve complex judgments about future events and can rely heavily on judgments and estimates. Given the inherent uncertainties related to these judgments and estimates, the actual outflows resulting from the realization of those risks could differ adversely and materially from management's assessments.

Other liabilities represent contractual obligations to third parties where the amount and timing of payments is fixed. Where other liabilities are not interest-bearing and the impact of discounting is significant, other liabilities are recorded at their present value, generally using a discount rate appropriate to the liability or approximating a market interest rate at the time the Group entered into the obligation.

**Trade and other payables**

Trade and other payables are recognized initially at fair value and, where applicable, subsequently measured at amortized cost using the effective interest method. Accrual balances are reviewed and adjusted in the light of actual experience of rebates, discounts or allowances given and returns made and any expected changes in arrangements. Future events could cause the assumptions on which the accruals are based to change, which could affect the future results of the Group. Please refer to the revenue policy accounting policy for further details on accruals for rebates, discounts and returns.

**Employee share-based plans**

The Group operates three equity-settled executive and employee share plans. For all grants of share options and awards, the fair value at the grant date is calculated using appropriate pricing models. The grant date fair value is recognized over the vesting period as an expense, with a corresponding increase in retained earnings.

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**Employee short-term obligations**

Liabilities for salaries and wages, including non-monetary benefits, vacation and accumulating sick leave expected to be settled within 12 months after the end of the period in which the employees render the related service, are recognized in respect of employees' services up to the end of the reporting period and are measured at the amounts expected to be paid when the liabilities are settled. The liability for vacation and accumulating sick leave is recognized in the provision for employee benefits. All other short-term employee benefits are included within trade and other payables.

**Pension commitments**

Some companies within the Group operate defined contribution and (funded and unfunded) defined benefit pension schemes. The cost of providing pensions to employees who are members of defined contribution schemes is charged to the income statement as contributions are made. The Group has no further payment obligations in respect of such schemes once the contributions have been paid.

**Post-retirement benefits other than pensions** 

Some companies within the Group provide post-retirement medical care to their retirees. The costs of providing these benefits are accrued over the period of employment and the liability recognized in the balance sheet is calculated using the projected unit credit method and is discounted to its present value and the fair value of any related asset is deducted.

**Accounting estimates and judgments** 

Management makes several estimates and assumptions regarding the future and significant judgments in applying the Group's accounting policies.

**Key estimates and assumptions**

Estimates and assumptions may affect the reported amount of assets and liabilities, disclosure of contingent assets and liabilities, and the reported amounts of revenues and expenses. These estimates are based on the Group's knowledge of the amount, events, or actions; however, actual results may ultimately differ from those estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to estimates are recognized prospectively. The key estimates and assumptions used in the financial statements are set out below.

**Accruals for returns, discounts, incentives and rebates**

The Group offers various types of reductions from list prices on its products. Products sold in the United States are covered by various programs (such as Medicare and Medicaid) under which products are sold at a discount. Rebates are granted to healthcare authorities, and under contractual arrangements with certain customers. Some wholesalers are entitled to chargeback incentives under specific contractual arrangements. Cash discounts may also be granted for prompt payment.

The discounts, incentives and rebates described above are estimated based on contractual arrangements with customers or terms of the relevant regulations and/or agreements applicable for transactions with healthcare authorities, and in some cases on assumptions about the attainment of targeted volumes. Several months may pass between the original estimate of rebates due and confirmation of the amount, which may increase the estimation risk. Please refer to the revenue accounting policy for further details.

Management also estimates the amount of product returns based on contractual sales terms and reliable historical data, adjusted for future expectations. The estimates are recognized in the period in which the underlying sales are recognized, as a reduction of sales revenue.

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During 2022, $14 million of revenue was recognized from performance obligations satisfied in prior years (2021: $24 million, 2020: $16 million), primarily relating to resolution of aged accruals for US government programs. The estimates for US governmental and commercial end-payor accruals are also reasonably expected to vary due to shifts between US governmental end-payor sales and US commercial end-payor sales. A 1 percentage point shift between these channels would impact the accrual by $4 million. Due to the number of variables contributing to the overall accruals for returns, discounts, incentives, and rebates, further meaningful sensitivity is not able to be provided. Accruals for returns, discounts, incentives, and rebates are disclosed in <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1517)[22](#id39cb0e1a10249e1ab7b8f77d921d68a_1517)</u> of the Group financial statements.

**Impairment of intangible assets**

In carrying out impairment reviews, specifically in relation to products in development, significant assumptions have been made. These include the probability of success in obtaining regulatory approvals, discount rates, and projected net revenues (based on future rate of market growth and market demand for the products acquired). As actual results differ and/or changes in expectations arise, impairment charges may be required which would have a material adverse impact on reported results and financial position. The cash flows used in the recoverable amount calculation for assets in development are inflation adjusted. Changes in the inflationary environment in 2022 did not have a significant impact on the recoverable amount calculations due to its effect on both projected cash inflows and outflows. See <u>[Note 9](#id39cb0e1a10249e1ab7b8f77d921d68a_1439)</u> to the Group financial statements for further details and sensitivity analysis.

**Provisions and IP-related claims**

Provisions, when made, are valued based on the management's best estimates considering all available information, external advice, and historical experience. The assessment of provisions can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions, including advice from counsel on the merits of the claim, the settlement or litigation strategy, amount and timing of potential payments, and discounting. As of December 31, 2022, the Group maintained a provision related to multidistrict antitrust class and state claims for $290 million (2021 and 2020: $nil), DOJ-related matters for $5 million (2021: $5 million; 2020: $32 million) and IP-related claims for $3 million (2021: $73 million; 2020: $47 million). These provisions are valued based on the management's best estimates considering available historical information and external advice. The multidistrict antitrust class and state claims provision represents management's estimate at this time of a potential aggregate settlement. However, management cannot predict with any certainty whether Indivior Inc. will reach a settlement with any of the Plaintiffs, and the final aggregate cost of these matters, whether resolved by settlement or trial, may be materially different. The provision for IP-related claims has been substantially transferred to other liabilities as a result of the settlement with DRL in 2022. The actual settlement was not materially different from the provision previously recorded. The provision for remaining IP-related claims continues to be management's best estimate, however, the final cost of settling or litigating this matter could be materially different. For more details, see <u>[Notes](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)[19](#id39cb0e1a10249e1ab7b8f77d921d68a_1499)</u> and <u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>to the Group financial statements.

**Critical judgments**

Management has made the following critical judgments in applying the Group's accounting policies that have the most significant effect on the amounts recognized in the Group financial statements:

**Ongoing litigation** 

The Group is involved in litigation, arbitration, and other legal proceedings. These proceedings typically are related to compliance and trade practices, commercial claims, product liability claims, intellectual property rights, and employment and wrongful discharge claims. For each claim or grouping of similar claims, management make's judgments regarding the relative merits and risks within the claims. These judgments inform the Group's defense strategies, whether a loss or settlement from the claims is probable and whether sufficient information exists to make a reliable estimate of the likely outcome of the claims. Provisions are recognized when the Group has a present legal or constructive obligation, an

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outflow of resource to settle the obligation is more likely than not, and the amount can be reliably estimated. Management has assessed as "contingent" matters that cannot be reliably estimated or are not considered probable at the current time. For more details of all the outstanding legal proceedings including those that have been deemed contingent, see <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u> to the Group financial statements.

Based on facts and circumstances at December 31, 2021, which did not indicate that a loss or settlement was probable, multidistrict antitrust class and state claims were treated as a contingent liability. Based on new developments, this judgment has now changed such that a provision has been recorded at December 31, 2022. Refer to <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u> to the Group financial statements for further details on the conditions that led to this change in judgment.

**3. SEGMENT INFORMATION**

The Group is engaged in a single business activity, which is predominantly the development, manufacture, and sale of buprenorphine-based prescription drugs for treatment of opioid dependence and related disorders. The CEO reviews disaggregated net revenue on a geographical and product basis and allocates resources on a functional basis between Commercial, Supply, Research and Development, and other Group functions. Financial results are reviewed on a consolidated basis for evaluating financial performance and allocating resources. Accordingly, the Group operates in a single reportable segment.

Revenues are attributed geographically based on the country where the sale originates. The following table represents net revenues and non-current assets, net of accumulated depreciation, amortization and impairment, by country. Non-current assets for this purpose consist of intangible assets, property, plant and equipment, right-of-use assets, investments, and other assets.

**Net revenue:**

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| | | | |
|:---|:---|:---|:---|
| **For the year ended December 31** *(in millions)* | **2022** | **2021** | **2020** |
| United States | 731 | 603 | 456 |
| Rest of World | 164 | 181 | 182 |
| United Kingdom | 6 | 7 | 9 |
| **Total**  | $**901** | $**791** | $**647** |

---

On a disaggregated basis, the Group's net revenue by major product line:

---

| | | | |
|:---|:---|:---|:---|
| **For the year ended December 31** *(in millions)* | **2022** | **2021** | **2020** |
| SUBLOCADE | 408 | 244 | 130 |
| PERSERIS | 28 | 17 | 14 |
| Sublingual/Other | 465 | 530 | 503 |
| **Total**  | $**901** | $**791** | $**647** |

---

**Significant customers**

Net revenues include amounts derived from significant customers that amount to 10% or more of the Group's revenues as net follows (in percentages of total net revenue):

---

| | | | |
|:---|:---|:---|:---|
| **Customer** | **2022%** | **2021%** | **2020%** |
| Customer A | 22% | 21% | 19% |
| Customer B | 16% | 18% | 17% |
| Customer C | 17% | 18% | 21% |

---

------

**Non-current assets:**

---

| | | | |
|:---|:---|:---|:---|
| **At December 31** *(in millions)* | **2022** | **2021** | **2020** |
| United States | 65 | 133 | 141 |
| United Kingdom | 223 | 145 | 122 |
| Rest of World | 3 | 5 | 6 |
| **Total**  | $**291** | $**283** | $**269** |

---

**4. OPERATING EXPENSES AND OTHER OPERATING INCOME**

The table below sets out selected operating costs and expense information.

---

| | | | | |
|:---|:---|:---|:---|:---|
| *(in millions)* | **Notes** | **2022** | **2021** | **2020** |
| **Research and development expenses**  |  | $**(72)** | $**(52)** | $**(40)** |
| Selling and marketing expenses |  | (218) | (192) | (202) |
| Administrative and general expenses |  | (545) | (239) | (464) |
| **Selling, general and administrative expenses**  |  | $**(763)** | $**(431)** | $**(666)** |
| Depreciation, amortization and impairment<sup>(1)</sup>  | 9, 10, 11 | $(13) | $(13) | $(17) |

---

__________________

(1)Depreciation and amortization expense is included in research and development and selling, general and administrative expenses. Additionally, depreciation and amortization expense in FY 2022 of $8 million (FY 2020 and 2021: $9 million) for ROU assets and intangibles is included within cost of sales.

**Net other operating income**

---

| | | | |
|:---|:---|:---|:---|
| **For the year ended December 31** *(in millions)* | **2022** | **2021** | **2020** |
| Net proceeds from the sale of intangible assets | 1 | 20 |  |
| Directors' and Officers' insurance reimbursements | 5 | 12 |  |
| Other income | 2 |  |  |
| Net other operating income | $**8** | $**32** | $**—** |

---

**5. EMPLOYEES**

**Details of employee costs**

**(a) Staff costs**

---

| | | | | |
|:---|:---|:---|:---|:---|
| *(in millions)* | **Note** | **2022** | **2021** | **2020** |
| The total employment costs, including Executive Directors, were: |  |  |  |  |
| Wages and salaries |  | (182) | (165) | (139) |
| Social security costs |  | (30) | (25) | (22) |
| Pension costs<sup>(1)</sup> |  | (12) | (6) | (9) |
| Share-based payments | 25 | (16) | (11) | (8) |
| Termination reversal/(costs) |  |  | 1 | (9) |
| **Total staff costs**  |  | $**(240)** | $**(206)** | $**(187)** |

---

__________________

(1)Pension costs predominately reflect contributions made towards the Group's defined contribution plans.

------

Key management is defined as the Executive Committee, a body of 10 employees (2021: 9 employees, 2020: 9 employees) including the CEO and the functional leads directly reporting the CEO plus all Non-Executive Directors. Compensation awarded to key management was, excluding Non-Executive Directors, was:

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Short-term employee benefits | (10) | (10) | (6) |
| Termination costs |  | (1) | (2) |
| Share-based payments | (10) | (7) | (5) |
| **Total compensation awarded** | $**(20)** | $**(18)** | $**(13)** |

---

**(b) Staff numbers**

The average monthly number of persons employed by the Group, including Directors, during the year was:

---

| | | | |
|:---|:---|:---|:---|
| | **2022** | **2021** | **2020** |
| Operations | 675 | 573 | 567 |
| Management | 178 | 164 | 168 |
| Research and development | 75 | 65 | 84 |
| **Average number of employees** | **928** | **802** | **819** |

---

**6. NET FINANCE EXPENSE**

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| **Finance income** |  |  |  |
| Interest income on cash and cash equivalents/investments | 18 | 1 | 7 |
| Other finance income | 1 | 3 | 2 |
| Total finance income | $19 | $4 | $9 |
| **Finance expense** |  |  |  |
| Interest expense on borrowings | (20) | (16) | (14) |
| Interest expense on lease liabilities | (2) | (2) | (3) |
| Interest expense on legal matters | (7) | (8) | (7) |
| Other finance expense |  | (1) | (2) |
| Total finance expense | $(29) | $(27) | $(26) |
| **Net finance expense**  | $**(10)** | $**(23)** | $**(17)** |

---

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**7. INCOME TAXES**

**Income tax benefi**t

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Current tax | (51) | (48) | (11) |
| Recognition of orphan drug credits earned in prior years |  | 43 |  |
| Other adjustments for prior year | (13) | 2 | 3 |
| **Total current tax**  | $**(64)** | $**(3)** | $**(8)** |
| Origination and reversal of temporary differences | 72 | 18 | 37 |
| Adjustments for changes in tax rates | 22 | (1) |  |
| Adjustments for prior year deferred tax | 12 | 1 | (4) |
| **Total deferred tax**  | $**106** | $**18** | $**33** |
| **Total income tax benefit**  | $**42** | $**15** | $**25** |

---

The standard rate of corporation tax in the UK was 19% for the year ended December 31, 2022 (2021 and 2020: 19%). The Group's losses for the year ended December 31, 2022, are taxed at an effective rate of 44% (2021: -8%; 2020: 14%).

The total tax benefit for the year reconciles to the accounting profit as follows:

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| (Loss)/profit before taxation | (95) | 190 | (173) |
| Tax at the notional UK corporation tax rate of 19% | (18) | 36 | (33) |
| Effects of: |  |  |  |
| Tax at rates other than the UK corporation tax rate | 5 | (1) | 5 |
| Impact of rate changes | (22) | 1 |  |
| Permanent differences | (3) | (4) | 7 |
| Benefit from innovation incentives | (3) |  |  |
| Recognition of orphan drug credits earned in prior years |  | (43) |  |
| Adjustments for prior year | (1) | (2) | 5 |
| Recognition of previously unrecognized tax benefit | (1) |  |  |
| Current year unrecognized deferred tax asset | 2 |  |  |
| Adjustments to amounts carried in respect of unresolved tax matters | (1) | (1) | (6) |
| Share awards |  |  | (2) |
| R&D tax credit | **—** | (1) | (1) |
| **Income tax benefit**  | $**(42)** | $**(15)** | $**(25)** |

---

The reported effective tax rate of 44% (2021: -8%; 2020:14%) was impacted by:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Permanent difference tax benefit of $3 million (2021: tax benefit of $4 million; 2020: tax expense of $7 million). Permanent differences arise due to differences between financial statement income and taxable income determination that will never reverse. Current year differences resulted from income not subject to tax, offset by business expenses not deductible.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The impact of rate change includes a $18 million tax benefit related to non-operating items (described in table below).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Prior year tax items related to the recognition of orphan drug credits.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Adjustments for prior year relate to tax accrual to return true ups of $1 million benefit (2021: $2 million, 2020: $5 million expense).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• The Group recognized $3 million (2021: $1 million, 2020: $1 million expense) tax benefit in relation to foreign currency translation adjustment recorded in the statement of other comprehensive (loss)/income.

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Income tax benefit | (42) | (15) | (25) |
| Tax on non-operating items | 57 | (3) | 37 |
| Non-operating tax items | 18 | 43 |  |
| **Income tax expense excluding non-operating items** | $**33** | $**25** | $**12** |

---

Management believes it has made adequate provision for the liabilities likely to arise from periods that are open and not yet agreed by tax authorities. The ultimate liability for such matters may vary from the amounts provided and is dependent upon the outcome of agreements with relevant tax authorities or litigation where appropriate. As a multinational Group, tax uncertainties remain in relation to Group financing, intercompany pricing, the location of taxable operations and the tax treatment of non-operating/non-recurring items. Management has concluded tax provisions made to be appropriate and does not believe a significant risk of material change to uncertain tax positions exists in the next 12 months.

**Factors affecting future tax charges**

As a Group with worldwide operations, Indivior is subject to several factors that may affect future tax charges, principally the levels and mix of profitability in different jurisdictions, transfer pricing regulations, tax rates imposed and tax regime reforms. The enacted United Kingdom Statutory Corporation Tax rate is 19% for the year ended December 31, 2022. In March 2021, the UK Chancellor announced an increase in the corporation tax rate from 19% to 25% with effect from April 2023. The increase to the corporation tax rate was enacted in June 2021.

The OECD published a framework for the introduction of a global minimum effective tax rate of 15%, applicable to large multinational groups. In July 2022, HM Treasury released draft legislation to implement these "Pillar Two" rules with effect from April 1, 2024, in the UK. Management is reviewing these draft rules to understand any potential impacts for when ultimately enacted.

**Tax assets and liabilities**

***Deferred taxes***

The Group recognizes deferred tax assets to the extent that sufficient future taxable profits are probable against which these future tax deductions can be utilized. At December 31, 2022, the Group's net deferred tax assets of $219 million includes $120 million (2021: $102 million, 2020: $59 million) in the US and $87 million (2021: $11 million, 2020: $7 million) in the UK. The US deferred tax asset of $120 million includes $25 million of share-based compensation (2021: $18 million, 2020: $5 million) and $4 million of profit in stock (2021 and 2020: $3 million). Management has assessed recoverability of deferred tax assets using Group-level budgets and forecasts consistent with those used for the assessment of asset impairments, particularly in relation to levels of future sales. These forecasts are therefore subject to similar uncertainties to those assessments as set out in Note 2, Going concern assessment. This exercise is reviewed each year and, to the extent required, an adjustment to the recognized deferred tax asset may be made. The Group made an overall loss in the current period, which is driven by costs and the deferred tax assets are expected to be used in full within the lifecycle of existing products. With the exception of specific assets that are not currently considered accessible (see unrecognized deferred tax assets below) and the anticipated future adjustment for non-deductibility of certain management compensation (see below), management has concluded full recognition of deferred tax assets to be

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appropriate and does not consider there a significant risk of a material change in their assessment in the next 12 months.

The composition of deferred tax assets is summarized in the table below.

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| | | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| **Deferred tax assets** *(in millions)* | **Unrealized profit in inventory** | **Inventory costs capitalized** | **Share-based payments** | **Short-term temporary differences** | **Long-term temporary differences** | **Litigation** | **Carry-forward losses** | **State taxes** | **Other** | **Total** |
| At January 1, 2020 | 12 | 4 | 2 | 19 | 1 |  |  | 5 | (3) | 40 |
| Credit to the income statement | 2 |  | 2 |  | 3 | 24 |  | 2 |  | 33 |
| Credit directly to equity |  |  | 2 |  |  |  |  |  |  | 2 |
| At January 1, 2021 | 14 | 4 | 6 | 19 | 4 | 24 |  | 7 | (3) | 75 |
| Credit to the income statement | (6) | 11 | 1 | 4 | 6 |  |  | 1 | 1 | 18 |
| Credit directly to equity |  |  | 13 |  |  |  |  |  |  | 13 |
| Exchange adjustments |  |  |  |  | (1) |  |  |  |  | (1) |
| At December 31, 2021 | 8 | 15 | 20 | 23 | 9 | 24 |  | 8 | (2) | 105 |
| (Charged)/credit to the income statement |  | 11 | 2 | (4) | (9) | 7 | 87 | 5 | 7 | 106 |
| Credit directly to equity |  |  | 9 |  |  |  |  |  |  | 9 |
| Exchange adjustments |  |  |  |  | (1) |  |  |  |  | (1) |
| **At December 31, 2022**  | $**8** | $**26** | $**31** | $**19** | $**(1)** | $**31** | $**87** | $**13** | $**5** | $**219** |

---

The Group has not recognized deferred tax assets in relation to certain losses and interest expense in the UK, as the likelihood of future economic benefit is not sufficiently assured.

Unrecognized deferred tax assets of $23 million (2021: $22 million, 2020: $17 million) consist of $12 million (2021: $14 million, 2020: $11 million) in respect of losses of earlier periods, $9 million (2021: $8 million, 2020: $6 million) in respect of interest expense, and foreign tax credit carry-forward of $2 million (2021 and 2020: nil). Both the losses and interest expense have an unlimited carry-forward period, and the foreign tax credits start to expire after nine years, or in 2031, if unused.

In September 2022, the Company's shareholders approved an additional listing in the US, which is expected to take place in spring 2023. Once listed in the US, US tax laws limit deductibility of compensation for certain management roles. The Group currently carries approximately $12 million of deferred tax assets that are not expected to be realized once the listing is complete. Approximately three-quarters of this amount will be charged to equity and one-quarter will be presented as a tax charge in the period the listing takes place, as a reversal of the original booking.

The tax (credit)/charge recognized other than within the consolidated income statement as follows:

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| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Other comprehensive income: |  |  |  |
| Current tax recorded in currency translation review | $(3) | $(1) | $1 |
| Equity: |  |  |  |
| Current taxation on share-based plans | $(2) | $— | $— |
| Deferred taxation on share-based plans | $(9) | $13 | $2 |

---

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***Other tax matters***

In 2022, the Group recognized a provision of $290 million related to certain multidistrict antitrust class and state claims. The resulting tax benefit of $68 million includes $12 million of rate change impact.

As disclosed in <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, the Group reached a settlement with Reckitt Benckiser in January 2021. Based on the strength of external advice received, an $8 million tax benefit from the settlement cost has been recognized in 2021 within tax items. Tax authorities may potentially challenge management's position.

The Group has undistributed earnings of $11 million (2021: $12 million, 2020: $10 million) which, if paid out as dividends, would be subject to tax in the hands of the recipient. An assessable temporary difference exists, but no deferred tax liability has been recognized as the Group is able to control the timing of distributions from this subsidiary and is not expected to distribute these profits in the foreseeable future. The potential deferred tax liability would be less than $1 million (2021 and 2020: less than $1 million).

**8. EARNINGS/(LOSS) PER SHARE**

In September 2022, the Group's shareholders approved a 5-for-1 share consolidation. On October 10th, 2022, the Group completed this share consolidation. Shareholders received 1 new Ordinary share with a nominal value of $0.50 each for every 5 previously existing Ordinary shares which had a nominal value of $0.10 cents each. All share and per share information of the Group, including basic and diluted weighted average number of shares outstanding, basic (loss)/earnings per share, and diluted (loss)/earnings per share reflect the share consolidation for all periods presented.

Presented below are the basic and diluted (loss)/earnings per share for 2022, 2021 and 2020:

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| | | | |
|:---|:---|:---|:---|
| | **2022** | **2021** | **2020** |
| Basic (loss)/earnings per share | $(0.38) | $1.41 | $(1.01) |
| Diluted (loss)/earnings per share | $(0.38) | $1.35 | $(1.01) |

---

**Basic**

Basic (loss)/earnings per share is calculated by dividing net (loss)/income for the year attributable to owners of the Group by the weighted average number of ordinary shares in issue during the year.

**Diluted**

Diluted (loss)/earnings per share is calculated by adjusting the weighted average number of ordinary shares outstanding to assume conversion of all dilutive potential ordinary shares. The Group has dilutive potential ordinary shares in the form of stock options and awards. These options and awards reflect the share consolidation for all periods presented, referred to above. The weighted average number of shares is adjusted for the number of shares granted to the extent performance conditions have been met at the balance sheet date and as determined using the treasury stock method.

The weighted average number of ordinary shares outstanding (on a basic basis) includes the favorable impact of 17,815,033 ordinary shares repurchased prior to the share consolidation in 2022 (equivalent post consolidation: 3,563,007), 1,280,914 ordinary shares repurchased after the share consolidation in 2022, and 33,507,433 ordinary shares repurchased through 2021 (equivalent post consolidation: 6,701,487). The weighted average number of ordinary shares outstanding for 2021 (on a

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basic basis) includes the favorable impact of the share repurchase program. Refer to <u>[Note 23](#id39cb0e1a10249e1ab7b8f77d921d68a_1524)</u> for further details.

Conditional awards of 7,839,441 (equivalent post consolidation approximately 1,568,000), 14,174,745 (equivalent post consolidation approximately 2,835,000) and 22,186,508 (equivalent post consolidation approximately 4,437,000) were granted under the Group's Long-Term Incentive Plan in 2022, 2021 and 2020, respectively.

---

| | | | |
|:---|:---|:---|:---|
| **Weighted average number of shares** *(in thousands)* | **2022** | **2021** | **2020** |
| On a basic basis | 139012 | 145660 | 146573 |
| Dilution for share awards and options | 6605 | 6280 | 4098 |
| On a diluted basis | **145617** | **151940** | **150671** |

---

**9. INTANGIBLE ASSETS**

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| *(in millions)* | **Acquired distribution rights** | **Products in development** | **Marketed products** | **Software** | **Total** |
| **Cost** |  |  |  |  |  |
| At January 1, 2022 | 220 | 66 | 57 | 39 | 382 |
| Additions |  | 1 |  |  | 1 |
| Exchange adjustments | (25) | (7) | (3) |  | (35) |
| **At December 31, 2022**  | $**195** | $**60** | $**54** | $**39** | $**348** |
| **Accumulated amortization and impairment** |  |  |  |  |  |
| At January 1, 2022 | 220 | 27 | 21 | 32 | 300 |
| Amortization charge |  |  | 5 | 2 | 7 |
| Exchange adjustments | (25) | (3) | (1) |  | (29) |
| **At December 31, 2022**  | $**195** | $**24** | $**25** | $**34** | $**278** |
| **Net book amount at December 31, 2022**  | $**—** | $**36** | $**29** | $**5** | $**70** |

---

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| | | | | | |
|:---|:---|:---|:---|:---|:---|
| *(in millions)* | **Acquired distribution rights** | **Products in development** | **Marketed products** | **Software** | **Total** |
| **Cost** |  |  |  |  |  |
| At January 1, 2021 | 235 | 37 | 57 | 39 | 368 |
| Additions |  | 30 |  |  | 30 |
| Disposal | (12) |  |  |  | (12) |
| Exchange adjustments | (3) | (1) |  |  | (4) |
| **At December 31, 2021**  | $**220** | $**66** | $**57** | $**39** | $**382** |
| **Accumulated amortization and impairment** |  |  |  |  |  |
| At January 1, 2021 | 235 | 27 | 15 | 29 | 306 |
| Amortization charge |  |  | 6 | 3 | 9 |
| Disposal | (12) |  |  |  | (12) |
| Exchange adjustments | (3) |  |  |  | (3) |
| **At December 31, 2021**  | $**220** | $**27** | $**21** | $**32** | $**300** |
| **Net book amount at December 31, 2021**  | $**—** | $**39** | $**36** | $**7** | $**82** |

---

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---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| *(in millions)* | **Acquired distribution rights** | **Products in development** | **Marketed products** | **Software** | **Total** |
| **Cost** |  |  |  |  |  |
| At January 1, 2020 | 228 | 36 | 56 | 39 | 359 |
| Exchange adjustments | 7 | 1 | 1 |  | 9 |
| **At December 31, 2020**  | $**235** | $**37** | $**57** | $**39** | $**368** |
| **Accumulated amortization and impairment** |  |  |  |  |  |
| At January 1, 2020 | 228 | 26 | 9 | 24 | 287 |
| Amortization charge |  |  | 6 | 5 | 11 |
| Exchange adjustments | 7 | 1 |  |  | 8 |
| **At December 31, 2020**  | $**235** | $**27** | $**15** | $**29** | $**306** |
| **Net book amount at December 31, 2020**  | $**—** | $**10** | $**42** | $**10** | $**62** |

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**Acquired distribution rights**

Acquired distribution rights have been fully amortized in all periods presented. In 2021, $19 million of net cash proceeds were received from the disposal of the TEMGESIC /BUPREX / BUPREXX (buprenorphine) analgesic franchise outside of North America to Eumedica Pharmaceuticals AG which had a nil carrying value. The remaining acquired distribution rights represent the ongoing sublingual tablet business in Europe which is still in use.

**Products in development**

Products in development are products in different stages of research and development which have not received regulatory approval. There were no new primary market product approvals in 2022.

In 2021 the Group entered a strategic collaboration with Aelis Farma that includes an exclusive option for the license of the global rights to AEF0117, a leading compound to treat cannabis-related disorders. Under the agreement, the Group paid $30 million to secure the option.

In 2021, $1 million of proceeds were received for the out-licensing of nasal naloxone opioid overdose patents to Adapt Pharmaceuticals (Emergent BioSolutions) which had a nil carrying value.

**Marketed products**

Marketed products include approved product rights for SUBLOCADE of $16 million (2021: 17 million; 2020: $18 million) and PERSERIS of $13 million (2021: $19 million; 2020: $24 million). In 2021, a new SUBLOCADE patent was approved in the United States extending the patent exclusivity period and amortization period from 2031 to 2035. Amortization expense of $5 million (2021: $6 million; 2020: $6 million) was recognized in cost of sales.

**Impairment of intangible assets**

An asset's recoverable amount is the higher of an asset's or CGU's fair value less costs of disposal or its value in use. In assessing value in use, its estimated future cash flows are discounted to their net present value using a pre-tax discount rate that reflects the current market assessments of the time value of money and the risks specific to the asset. No impairment was indicated when assessing the value in use of the Group's intangible assets, therefore fair value less costs of disposal was not assessed.

In carrying out impairment reviews of products in development, several significant assumptions have to be made. These include the probability of success in obtaining regulatory approvals, discount rates, and projected net revenues (based on future rate of market growth and market demand for the products acquired). These assumptions, covering periods through the expected patent life of the products and a reasonable period of generic competition thereafter, are based on past experience and management's

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expectations of market development. If actual results should differ, or changes in expectations arise, impairment charges may be required which would have a material adverse impact on reported results and financial position. Products in development of $36 million (2021: $39 million; 2020: $10 million) are subject to potential impairment in line with the aforementioned assumptions.

**Sensitivity analysis**

Management performed a sensitivity analysis by applying reasonable changes to key assumptions used in the recoverable amount calculations for its assets in development, assuming all other factors are kept constant. Consistent with other products in early stages of development, it is probable that these products in development could fail to obtain regulatory approvals. The probability of success is factored into the risk-adjusted calculation of the recoverable amounts; however, failure to reach commercialization would result in a full impairment of the assets.

For the INDV-2000 asset which is considered a separate CGU, with a carrying value of $9 million (2021 and 2020: $10 million), the key inputs and assumptions include the probability of success in obtaining regulatory approvals, discount rate, and market demand for the products. The Group determined that a reduction of peak market share by approximately 7% across weighted scenarios ranging 17% to 35% or an increase in the discount rate by approximately 3.4% to 18.0% would be required for the recoverable amount to be equal to the carrying amount. Given the risks inherent in pharmaceutical R&D and considering the current stage of development, the probability of regulatory approval is less than 25%; regulatory failure could result in a full impairment. Reasonable changes in any other individual assumption will not result in a material impairment charge.

For the AEF0117 asset which is considered a separate CGU, with a carrying value of $26 million (2021: $29 million), the key inputs and assumptions include the probability of success in obtaining regulatory approvals, discount rate, and projected net revenues. The Group determined that a reduction of projected net revenue by approximately 13% annually or an increase in the discount rate by approximately 2.0% to 16.6% would be required for the recoverable amount to be equal to the carrying amount. Given the risks inherent in pharmaceutical R&D and considering the current stage of development, the probability of regulatory approval is less than 25%; regulatory failure could result in a full impairment. Reasonable changes in any other individual assumption will not result in a material impairment charge.

**10. PROPERTY, PLANT AND EQUIPMENT**

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| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **Land and buildings** | **Plant and equipment** | **Total** |
| **Cost** |  |  |  |
| At January 1, 2022 | 55 | 77 | 132 |
| Additions |  | 6 | 6 |
| Disposals and asset write-offs | (1) |  | (1) |
| Exchange adjustment | (3) | (3) | (6) |
| **At December 31, 2022**  | $**51** | $**80** | $**131** |
| **Accumulated depreciation and impairment** |  |  |  |
| At January 1, 2022 | 21 | 53 | 74 |
| Charge for the year | 3 | 3 | 6 |
| Disposals and asset write-offs | (1) |  | (1) |
| Exchange adjustment |  | (2) | (2) |
| **At December 31, 2022**  | $**23** | $**54** | $**77** |
| **Net book amount at December 31, 2022**  | $**28** | $**26** | $**54** |

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| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **Land and buildings** | **Plant and equipment** | **Total** |
| **Cost** |  |  |  |
| At January 1, 2021 | 55 | 73 | 128 |
| Additions |  | 4 | 4 |
| Exchange adjustment |  |  |  |
| **At December 31, 2021**  | $**55** | $**77** | $**132** |
| **Accumulated depreciation and impairment** |  |  |  |
| At January 1, 2021 | 18 | 50 | 68 |
| Charge for the year | 3 | 3 | 6 |
| Exchange adjustment |  |  |  |
| **At December 31, 2021**  | $**21** | $**53** | $**74** |
| **Net book amount at December 31, 2021**  | $**34** | $**24** | $**58** |

---

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **Land and buildings** | **Plant and equipment** | **Total** |
| **Cost** |  |  |  |
| At January 1, 2020 | 54 | 66 | 120 |
| Additions |  | 6 | 6 |
| Exchange adjustment | 1 | 1 | 2 |
| **At December 31, 2020** | $**55** | $**73** | $**128** |
| **Accumulated depreciation and impairment** |  |  |  |
| At January 1, 2020 | 14 | 46 | 60 |
| Charge for the year | 4 | 3 | 7 |
| Exchange adjustment |  | 1 | 1 |
| **At December 31, 2020**  | $**18** | $**50** | $**68** |
| **Net book amount at December 31, 2020**  | $**37** | $**23** | $**60** |

---

Depreciation expense of $6 million (2021: $6 million; 2020: $7 million) is included in SG&A. Additions in the year relate primarily to PERSERIS syringe-filler equipment and other manufacturing equipment. Additions of $1 million (2021: $nil, 2020: $nil) had not yet been paid as of December 31, 2022.

**11. LEASES AND RIGHT-OF-USE ASSETS**

**Leases and right-of-use assets**

Potential future cash outflows of $21 million (2021 and 2020: $21 million) have not been included in the lease liability because it is not reasonably certain that the leases will be extended (or not terminated).

The following tables summarize movements of the right-of-use assets in 2022, 2021, and 2020:

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **Land and buildings** | **Plant and equipment** | **Total** |
| **Net book value** |  |  |  |
| **At January 1, 2022**  | **12** | **25** | **37** |
| Additions |  | 5 | 5 |
| Depreciation | (2) | (6) | (8) |
| Exchange adjustments | (1) | (2) | (3) |
| **At December 31, 2022**  | $**9** | $**22** | $**31** |

---

------

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **Land and buildings** | **Plant and equipment** | **Total** |
| **Net book value** |  |  |  |
| **At January 1, 2021**  | **14** | **29** | **43** |
| Additions |  | 2 | 2 |
| Depreciation | (2) | (5) | (7) |
| Exchange adjustments |  | (1) | (1) |
| **At December 31, 2021**  | $**12** | $**25** | $**37** |

---

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **Land and buildings** | **Plant and equipment** | **Total** |
| **Net book value** |  |  |  |
| **At January 1, 2020**  | **17** | **30** | **47** |
| Additions | 2 | 3 | 5 |
| Depreciation | (3) | (5) | (8) |
| Impairment | (2) |  | (2) |
| Exchange adjustments |  | 1 | 1 |
| **At December 31, 2020**  | $**14** | $**29** | $**43** |

---

Depreciation expense of $5 million (2021: $4 million; 2020: $5 million) is included in SG&A and $3 million (2021 and 2020: $3 million) in cost of sales within the income statement. Additions in the year relate primarily to vehicle leases and office space.

Lease liabilities at December 31, 2022 by maturity were as follows:

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Within one year | 10 | 10 | 10 |
| Later than one and less than five years | 27 | 29 | 31 |
| More than five years | 5 | 12 | 19 |
| Gross lease liabilities | 42 | 51 | 60 |
| Less: future interest on lease liabilities | (5) | (7) | (9) |
| **Net lease liabilities** | $**37** | $**44** | $**51** |

---

The net lease liabilities balance of $37 million (2021: $44 million; 2020: $51 million) is shown within current liabilities of $8 million (2021 and 2020: $8 million) and non-current liabilities of $29 million (2021: $36 million; 2020: $43 million).

Lease payments during the year were comprised of the following:

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Interest paid on lease liabilities | 2 | 2 | 3 |
| Payments of lease liabilities | 9 | 8 | 7 |
| **Total lease payments** | $**11** | $**10** | $**10** |

---

------

**12. INVESTMENTS**

---

| | | | |
|:---|:---|:---|:---|
| **Current and non-current investments** *(in millions)* | **Dec 31**<br>**2022** | **Dec 31**<br>**2021** | **Dec 31<br>2020** |
| Equity securities at FVPL | 10 |  |  |
| Debt securities held at amortized cost | 109 |  |  |
| **Total investments, current**  | $**119** | $**—** | $**—** |
| Debt securities held at amortized cost | 98 |  |  |
| **Total investments, non-current**  | $**98** | $**—** | $**—** |
| **Total**  | $**217** | $**—** | $**—** |

---

**Equity securities at FVPL**

In February 2022, the Group purchased ordinary shares of Aelis Farma. The shares were subject to a holding period of 365 days from the acquisition. The investment is classified as a current investment at December 31, 2022 as the holding period expires in less than 12 months. Fair value gain/(loss) recorded in 2022 was nominal and included within net other operating income.

**Debt securities held at amortized cost**

In 2022, the Group initiated purchases of investment-grade corporate debt and US Treasury securities. Also in 2022, the Group executed an agreement to fund insurance coverage. As part of this arrangement, the Company transferred $26 million to a separate cell of an insurance company. The Group controls the separate cell, an unincorporated entity, and receives benefit from its investment returns. As a result, the separate cell is deemed a structured entity and is consolidated by the Group. The $26 million was invested in debt securities which are classified as non-current as access to the funds is restricted for 24-months after the term of the insurance. All other debt securities held at amortized cost are also classified as non-current investments, except for those with maturities less than 12 months from the end of the reporting period, which are classified as current investments.

As of December 31, 2022, expected credit losses for the Group's investments held at amortized cost are deemed to be immaterial.

**Fair value hierarchy**

Fair value is the price that would be received to sell an asset or transfer a liability in an orderly transaction between market participants at the measurement date. The different levels have been defined as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Level 3: Unobservable inputs for the asset or liability

The Group's only financial instruments which are measured at fair value are equity securities at FVPL. The fair value of equity securities at FVPL is based on quoted market prices on the measurement date.

The following table categorizes the Group's financial assets measured at fair value by valuation methodology used in determining their fair value at December 31, 2022.

---

| | | | | |
|:---|:---|:---|:---|:---|
| **Financial assets at fair value** *(in millions)* | **Level 1** | **Level 2** | **Level 3** | **Total** |
| Equity securities at FVPL | 10 |  |  | 10 |

---

------

**13. INVENTORIES**

Inventory, net is comprised of:

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Raw materials, stores and consumables | 27 | 34 | 38 |
| Work in progress | 42 | 28 | 19 |
| Finished goods and goods held for resale | 45 | 33 | 36 |
| **Total inventories, net** | $**114** | $**95** | $**93** |

---

The cost of inventories recognized as an expense and included as cost of sales amounted to $159 million (2021: $127 million; 2020: $97 million). Cost of sales included inventory write-offs and losses of $7 million (2021: $12 million; 2020: $6 million). The inventory provision (reflected in the carrying amounts above) at December 31, 2022, was $8 million (2021: $13 million; 2020: $12 million).

**14. TRADE RECEIVABLES AND OTHER ASSETS**

The Group is not aware of any deterioration in the credit quality of its customers and considers the net receivables to be fully recoverable.

**Trade receivables**

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Trade receivables | 222 | 205 | 181 |
| Less: provision for ECL | (2) | (3) | (2) |
| **Trade receivables, net**  | $**220** | $**202** | $**179** |

---

The aging of past due trade receivables as of December 31 is as follows:

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Up to three months past due | 8 | 6 | 9 |
| Three to six months past due |  | 1 | 3 |
| Over six months past due | 4 | 6 | 2 |
|  | 12 | 13 | 14 |
| Not due and not impaired | 210 | 192 | 167 |
| Provision for impairment of receivables | (2) | (3) | (2) |
| **Trade receivables – net**  | $**220** | $**202** | $**179** |

---

As at December 31, 2022, a provision of $2 million (2021:$3 million; 2020: $2 million) was recorded against the trade receivables balance based on management's assessment of ECL. The assessment factors are discussed in <u>[Note 2.](#id39cb0e1a10249e1ab7b8f77d921d68a_1372)</u> The maximum exposure to credit risk at the year end is the carrying value of each class of receivable. The Group does not hold any collateral as security.

The Group's trade receivables are denominated in the following currencies:

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Sterling | 2 | 2 | 4 |
| Euro | 13 | 16 | 18 |
| U.S. dollar | 192 | 172 | 146 |
| Other currencies | 15 | 15 | 13 |
| **Total trade receivables**  | $**222** | $**205** | $**181** |

---

------

**Current and non-current other assets:**

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Current prepaid expenses | 14 | 18 | 17 |
| Other current assets | 13 | 14 | 33 |
| **Total other current assets**  | $**27** | $**32** | $**50** |
| Non-current prepaid expenses | 20 | 22 | 22 |
| Other non-current assets | 18 | 84 | 82 |
| **Total other non-current assets**  | $**38** | $**106** | $**104** |
| **Total other assets**  | $**65** | $**138** | $**154** |

---

Other current and non-current assets relate primarily to surety bond funding (see <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>). At December 31, 2022, remaining collateral provided to surety bond holders, inclusive of accrued interest, was $18 million (2021: $82 million; 2020: $108 million). During 2022 and 2021, the surety bond holders returned $64 million and $26 million, respectively, as a result of the settlement agreement with Dr. Reddy's Laboratories S.A. and Dr. Reddy's Laboratories, Inc. (together, "DRL") and acceptance by the Group's surety providers for a reduction in collateral held against to 50% of the total remaining bond amounts. The change in other non-current assets was primarily the result of the return of collateral.

Long-term prepaid expenses relate primarily to payments for contract manufacturing capacity.

------

**15. FINANCIAL INSTRUMENTS AND RISK MANAGEMENT**

The Group's financial assets and liabilities include investments, trade receivables, other assets, cash and cash equivalents, borrowings and trade and other payables as set out in Notes <u>[12](#id39cb0e1a10249e1ab7b8f77d921d68a_1463)</u>, <u>[14](#id39cb0e1a10249e1ab7b8f77d921d68a_1469)</u>, <u>[16](#id39cb0e1a10249e1ab7b8f77d921d68a_1481)</u>, <u>[17](#id39cb0e1a10249e1ab7b8f77d921d68a_1487)</u> and <u>[22](#id39cb0e1a10249e1ab7b8f77d921d68a_1517)</u>, respectively. The Group measures financial assets and liabilities at amortized cost, with the exception of investments in equity securities which are measured at fair value through profit or loss. Financial assets and liabilities are offset, and the net amount reported in the consolidated balance sheet when there is a legally enforceable right to offset and net settlement is intended. The carrying value (less impairment provision, where applicable) of current borrowings, cash and cash equivalents, trade receivables, other assets, trade accruals and trade payables is assumed to approximate fair value due to their short-term nature. At December 31, 2022, the carrying value of investments held at amortized cost was above the fair value by $3 million, due to rising interest rates. The fair value of investments held at amortized cost was calculated based on quoted market prices which would be classified as Level 1 in the fair value hierarchy in<u>[Note 12.](#id39cb0e1a10249e1ab7b8f77d921d68a_1463)</u>The non-current borrowing, which is presented at amortized cost, was trading at approximately 98% (2021: 99%; 2020: 98%) of par value.

Financial risk management of the Group is mainly exercised and monitored at Group level. The Group's financing and financial risk management activities are centralized to achieve benefits of scale and control with the goal of maximizing liquidity and mitigating operational and financial risks. Financial exposures of the Group are managed in a manner consistent with underlying business risks. Only those risks and flows generated by the underlying commercial operations are managed; speculative transactions are not undertaken.

**Foreign exchange risk management**

The Group operates internationally and is exposed to foreign exchange risk arising from various currency exposures. Foreign exchange risk arises from future commercial transactions, recognized assets and liabilities, and net investments in foreign operations. The Group's policy is to align the foreign currency assets and liabilities within its major subsidiaries in order to provide some protection against the remeasurement exposure on profits.

**Interest rate risk management**

The Group has interest-bearing assets and liabilities. The Group monitors interest income and expense rate exposure on a regular basis with an objective of minimizing net interest cost. The main interest rate risk arises from the Group's borrowings, which are discussed in <u>[Note 17](#id39cb0e1a10249e1ab7b8f77d921d68a_1487)</u>, due to the floating interest rate. This exposure is partially offset by the interest income generated on the Group's investments in debt securities with varying rates and maturities and cash and cash equivalents which are based on variable market interest rates. The majority of the Group's investments in debt securities are issued at fixed interest rates and changes in floating rates would not have a significant impact on interest rate risk.

**Liquidity risk management**

Liquidity risk is the risk that the Group is not able to settle or meet its obligations on time or at a reasonable price. The Group's policy is to ensure sufficient funding and facilities are in place to meet foreseeable liquidity requirements. The Group manages and monitors liquidity risk through regular reporting of current cash and borrowing balances and periodic review of short-, medium- and long-term cash forecasts, while considering the maturity of its borrowing facility. At December 31, 2022, Indivior had $3 million (2021: $3 million; 2020: $4 million) of borrowings repayable within one year and $774 million (2021: $1,102 million; 2020: $858 million) of cash and cash equivalents.

**Credit risk management**

The Group's exposure to credit risk arises from cash and cash equivalents, deposits with banks and financial institutions, investments in debt securities, trade receivables and other assets. Financial institution counterparties are subject to approval under the Group's counterparty risk policy and such

------

approval is limited to financial institutions with a BBB rating or above. The investments in debt securities are managed by an external third-party fund manager with instructions to maintain a portfolio rating of A or higher and an allocation to BBB at 25% or less of the total portfolio. The Group applies the credit ratings assigned by Standard and Poor's and Moody's when assessing expected credit losses and monitors these ratings for indications of credit deterioration. All the Group's corporate debt securities held at amortized cost are considered to be of low credit risk based on investment-grade credit ratings from Standard and Poor's or Moody's (BBB-/Baa3 or higher). The Group's U.S. Treasury securities have minimal default risk as they are guaranteed by the U.S. government.

Concentration of credit risk with respect to trade receivables in the U.S. is limited as the balances consist of amounts due from customers, primarily major wholesalers and distributors, for whom there is no significant history of default. Outside the U.S., no single customer accounts for a significant share of Group's trade receivables balance. In the U.S., in line with other pharmaceutical companies, the Group sells its products through a small number of wholesalers in addition to hospitals, pharmacies, physicians and other groups. Sales to the three largest wholesalers amounted to approximately 55% of the Group sales in 2022 (2021 and 2020: 57%). At December 31, 2022, the Group had trade receivables due from these three wholesalers totaling $131 million (2021: $142 million; 2020: $142 million). The Group is exposed to a concentration of credit risk in respect of these wholesalers such that, if one or more of them encounters financial difficulty, it could materially and adversely affect the Group's financial results. The Group's credit risk monitoring activities relating to these wholesalers include a review of their financial information and Standard & Poor's credit ratings, and establishment and periodic review of credit limits. However, the Group believes there is no further credit risk provision required in relation to these customers (see <u>[Note 14](#id39cb0e1a10249e1ab7b8f77d921d68a_1469)</u>).

**Capital risk management**

The Group considers capital to be net cash plus total reported equity. Net cash is calculated as cash and cash equivalents less total borrowings. Total borrowings reflect the outstanding principal amount of the term loan drawn before debt issuance costs of $6 million (2021: $7 million, 2020: $1 million) and do not include lease liabilities of $37 million (2021: $44 million; 2020: $51 million). Refer to <u>[Note 17](#id39cb0e1a10249e1ab7b8f77d921d68a_1487)</u> for further discussion on borrowings.

Total equity includes share capital, reserves and retained earnings as shown in the consolidated balance sheet.

---

| | | | | |
|:---|:---|:---|:---|:---|
| *(in millions)* | **Note** | **2022** | **2021** | **2020** |
| Net cash |  | 528 | 853 | 623 |
| Total equity |  | 51 | 203 | 82 |
|  |  | $**579** | $**1056** | $**705** |

---

The objectives for managing capital are to safeguard the Group's ability to continue as a going concern, in order to provide returns for shareholders and benefits for other stakeholders and to maintain an efficient capital structure to optimize the cost of capital.

The Group monitors net cash, which at year end amounted to net cash of $528 million (2021: $853 million; 2020: $623 million), to maintain an appropriate level of financial flexibility.

**16. CASH AND CASH EQUIVALENTS** 

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Cash and cash equivalents | $774 | $1102 | $858 |

---

There were no bank overdrafts at December 31, 2022, 2021, or 2020.

------

**17. FINANCIAL LIABILITIES - BORROWING**

In 2021, the Group completed a refinancing of its term loan, repaying in full the existing $235 million term loan and replacing it with a new term loan with a principal amount of $250 million. As a result of the debt refinancing, the Group incurred a collective charge of $2 million related to writing off unamortized deferred financing costs due to the extinguishment and settlement of previous term loan ($1 million) and advisory fees incurred in conjunction with the refinancing ($1 million). The Group capitalized $8 million of deferred financing and original issue discount costs related to the new term loan, which were netted against the total amount borrowed and are amortized over the maturity period using the effective interest method.

In 2022, the Group completed an amendment to its existing term loan which provides the Group greater flexibility in the use of cash being generated and changes the variable interest rate base from USD LIBOR to USD SOFR plus a credit spread adjustment of 26 bps. As part of the modification, the Group incurred $1 million of issuance costs, banking fees and legal fees which are deemed to be incremental and directly attributable to the amendment. Accordingly, the Group capitalized these costs, which were netted against the total amount borrowed and are amortized over the maturity period using the effective interest method.

---

| | | | |
|:---|:---|:---|:---|
| **Term loan** *(in millions)* | **2022** | **2021** | **2020** |
| Term loan – current | (3) | (3) | (4) |
| Term loan – non-current | (237) | (239) | (230) |
| **Total term loan**  | $**(240)** | $**(242)** | $**(234)** |

---

The terms of the loan in effect at December 31, 2022 are as follows:

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| | **Currency** | **Nominal interest margin** | **Maturity** | **Required annual payments** | **Minimum liquidity** |
| Term loan facility | USD | SOFR + 0.26% + 5.25% | 2026 | 1% | Larger of $100m or 50% of Loan Balance |

---

The term loan amounting to $246 million (2021: $249 million; 2020: $235 million) is secured against the assets of certain subsidiaries of the Group in the form of guarantees issued by respective subsidiaries.

Also included within the terms of the loan were:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Nominal interest margin is calculated as USD SOFR plus 0.26%, subject to a floor of 0.75%, plus a credit spread adjustment of 5.25%; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• There are no revolving credit commitments.

**Maturity of gross borrowings (including expected interest using the rate at the balance sheet date)**

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Within one year or on demand | 25 | 18 | 17 |
| Bank loans payable due: |  |  |  |
| Later than one and less than five years | 299 | 298 | 243 |
| More than five years |  |  |  |
| **Gross borrowings (including interest)** | $**324** | $**316** | $**260** |

---

------

**Analysis of changes in liabilities from financing activities**

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| *(in millions)* | **At January 1, 2022** | **Cash flows** | **Profit and loss** | **Additions** | **Reclassifications** | **Exchange adj.** | **At December 31, 2022** |
| Current borrowings | (3) | 3 |  |  | (3) |  | (3) |
| Non-current borrowings | (239) |  | (2) | 1 | 3 |  | (237) |
| Lease liabilities | (44) | 9 |  | (5) |  | 3 | (37) |
| Share repurchase |  | 90 |  | (99) |  |  | (9) |
| **Total**  | $**(286)** | $**102** | $**(2)** | $**(103)** | $**—** | $**3** | $**(286)** |

---

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| *(in millions)* | **At January 1, 2021** | **Cash flows** | **Profit and loss** | **Additions** | **Reclassifications** | **Exchange adj.** | **At December 31, 2021** |
| Current borrowings | (4) | 3 |  |  | (2) |  | (3) |
| Non-current borrowings | (230) | 233 | 2 | (242) | 2 |  | (239) |
| Lease liabilities | (51) | 8 |  | (2) |  | 1 | (44) |
| Share repurchase |  | 101 |  | (101) |  |  |  |
| **Total**  | $**(285)** | $**345** | $**2** | $**(345)** | $**—** | $**1** | $**(286)** |

---

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| *(in millions)* | **At January 1, 2020** | **Cash flows** | **Profit and loss** | **Additions** | **Reclassifications** | **Exchange adj.** | **At December 31, 2020** |
| Current borrowings | (4) | 4 |  |  | (4) |  | (4) |
| Non-current borrowings | (233) | (1) |  |  | 4 |  | (230) |
| Lease liabilities | (56) | 7 | 4 | (5) |  | (1) | (51) |
| **Total**  | $**(293)** | $**10** | $**4** | $**(5)** | $**—** | $**(1)** | $**(285)** |

---

**18. COMMITMENTS**

The Group has various purchase commitments for services and materials in the ordinary course of business. These commitments are generally entered into at current market prices and reflect normal business operations. As of December 31, 2022, the Group received invoices totaling $10 million for services to be provided in 2023.

In November 2022, the Company and Opiant Pharmaceuticals, Inc. (Opiant) announced that the companies have entered into a definitive agreement under which Indivior Inc. will acquire Opiant for an upfront consideration of $20.00 per share, in cash (approximately $146 million in aggregate), plus up to $8.00 per share in contingent value rights (CVRs) that may become payable in the event that certain net revenue milestones are achieved during the relevant seven-year period by OPNT003 after its approval and launch. See <u>[Note 2](#id39cb0e1a10249e1ab7b8f77d921d68a_2672)[7](#id39cb0e1a10249e1ab7b8f77d921d68a_2672)</u> for additional details of the Opiant acquisition which was effected after the reporting date.

As of December 31, 2022, the Group had no material PP&E or intangible asset commitments for future periods.

------

**19. PROVISIONS AND OTHER LIABILITIES**

The Group is involved in legal and intellectual property disputes as described in <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Legal proceedings.

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| **Provisions** *(in millions)* | **Multidistrict antitrust class and state claims** | **DOJ-related matters** | **IP-related matters** | **Restructuring costs** | **Other provisions** | **Total provisions** |
| **At January 1, 2020**  | **—** | **(438)** | **(45)** | **(2)** | **(3)** | $**(488)** |
| Charged to the income statement |  | (178) |  | (9) | (1) | (188) |
| Transfer to other liabilities |  | 586 |  |  |  | 586 |
| Interest and discounting |  | (2) | (2) |  |  | (4) |
| Utilized during the year/payments |  |  |  | 5 |  | 5 |
| **At December 31, 2020**  | $**—** | $**(32)** | $**(47)** | $**(6)** | $**(4)** | $**(89)** |
| Released/(charged) to income statement |  | 18 | (24) | 1 | 1 | (4) |
| Interest and discounting |  |  | (2) |  |  | (2) |
| Utilized during the year/payments |  | 9 |  | 5 |  | 14 |
| **At December 31, 2021**  | $**—** | $**(5)** | $**(73)** | $**—** | $**(3)** | $**(81)** |
| (Charged)/released to income statement | (290) |  |  |  | (7) | (297) |
| Transfer to other liabilities |  |  | 70 |  |  | 70 |
| **At December 31, 2022**  | $**(290)** | $**(5)** | $**(3)** | $**—** | $**(10)** | $**(308)** |
| **Provisions** |  |  |  |  |  |  |
| Current | (290) | (5) |  |  | (8) | (303) |
| Non-current |  |  | (3) |  | (2) | (5) |
| **At December 31, 2022**  | $**(290)** | $**(5)** | $**(3)** | $**—** | $**(10)** | $**(308)** |
| Current |  | (5) |  |  |  | (5) |
| Non-current |  |  | (73) |  | (3) | (76) |
| **At December 31, 2021**  | $**—** | $**(5)** | $**(73)** | $**—** | $**(3)** | $**(81)** |
| Current |  | (32) |  | (6) |  | (38) |
| Non-current |  |  | (47) |  | (4) | (51) |
| **At December 31, 2020**  | $**—** | $**(32)** | $**(47)** | $**(6)** | $**(4)** | $**(89)** |

---

**Multidistrict antitrust class and state claims**

In 2022, the Group recognized a provision of $290 million related to certain multidistrict antitrust class and state claims. The provision is management's estimate at this time of a potential aggregate settlement. However, management cannot predict with any certainty whether Indivior Inc. will reach a settlement with any of the Plaintiffs, and the final aggregate cost of these matters, whether resolved by settlement or trial, may be materially different. See<u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>, Antitrust litigation and consumer protection for further details. The effect of discounting is not material.

------

**DOJ-related matters**

The Group carries a provision of $5 million (2021: $5 million; 2020: $32 million) pertaining to all outstanding False Claims Act Allegations as discussed in <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>. These matters are expected to be settled within the next 12 months and are not expected to materially change.

**IP-related matters: ANDA litigation**

The Group carries provisions totaling $3 million (2021: $73 million; 2020: $47 million) for intellectual property-related matters outlined in<u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[2](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>. In 2021, upon conclusion of expert discovery, the Group increased the provision for intellectual property-related matters to $73 million, resulting in a charge of $24 million. In 2022, as a result of settlement with DRL, the provision has been substantially transferred to other liabilities. The Group does not expect the remaining matters to be settled within a year and therefore the provision is classified as non-current.

**Restructuring costs**

The restructuring provision related to cost-saving initiatives announced and implemented in 2020 which consisted of redundancy and related costs has been fully utilized as of December 31, 2021.

**Other provisions**

Other provisions totaling $10 million (2021: $3 million; 2020: $4 million) primarily represent general legal matters expected to be settled within the next 12 months and retirement benefit costs which are not expected to be settled within one year.

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**Other liabilities**

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| **Other liabilities** *(in millions)* | **DOJ Resolution** | **IP-related matters** | **RB indemnity settlement** | **Share repurchase** | **Other** | **Total other liabilities** |
| **At January 1, 2020**  |  |  |  |  |  |  |
| Charged to the income statement |  |  | (50) |  |  | (50) |
| Transfer from provisions | (586) |  |  |  |  | (586) |
| Interest and discounting | (3) |  |  |  |  | (3) |
| Utilized during the year/payments | 103 |  |  |  |  | 103 |
| **At December 31, 2020**  | $**(486)** | $**—** | $**(50)** | $**—** | $**—** | $**(536)** |
| Contract liabilities |  |  |  |  | (3) | (3) |
| Interest and discounting | (6) |  |  |  |  | (6) |
| Utilized during the year/payments |  |  | 10 |  |  | 10 |
| **At December 31, 2021**  | $**(492)** | $**—** | $**(40)** | $**—** | $**(3)** | $**(535)** |
| Transfer from provisions |  | (70) |  |  |  | (70) |
| Released to income statement |  |  | 2 |  |  | 2 |
| Share repurchase liability |  |  |  | (9) |  | (9) |
| Interest and discounting | (6) | (1) |  |  |  | (7) |
| Utilized during the year/payments | 54 | 50 | 8 |  |  | 112 |
| **At December 31, 2022**  | $**(444)** | $**(21)** | $**(30)** | $**(9)** | $**(3)** | $**(507)** |
| **Other liabilities** |  |  |  |  |  |  |
| Current | (52) | (10) | (8) | (9) |  | (79) |
| Non-current | (392) | (11) | (22) |  | (3) | (428) |
| **At December 31, 2022**  | $**(444)** | $**(21)** | $**(30)** | $**(9)** | $**(3)** | $**(507)** |
| Current | (53) |  | (8) |  |  | (61) |
| Non-current | (439) |  | (32) |  | (3) | (474) |
| **At December 31, 2021**  | $**(492)** | $**—** | $**(40)** | $**—** | $**(3)** | $**(535)** |
| Current |  |  | (10) |  |  | (10) |
| Non-current | (486) |  | (40) |  |  | (526) |
| **At December 31, 2020**  | $**(486)** | $**—** | $**(50)** | $**—** | $**—** | $**(536)** |

---

**DOJ resolution**

In July 2020, the Group settled criminal and civil liability with the DOJ, the U.S. Federal Trade Commission (FTC), and US state attorneys general in connection with a multi-count indictment brought in April 2019 by a grand jury in the Western District of Virginia, a civil lawsuit joined by the DOJ in 2018, and an FTC investigation. In November 2020, the first payment of $103 million (including interest) was made. In January 2022, an additional payment of $54 million (including interest) was made pursuant to the resolution agreement. Subsequently, five annual installments of $50 million plus interest will be due every January 15 from 2023 to 2027 with the final installment of $200 million due in December 2027. Interest accrues at 1.25% on certain portions of the resolution which will be paid together with the annual

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installment payments. For non-interest-bearing portions, the liability has been recorded at the net present value based on timing of the estimated payments and using a discount rate equal to the interest rate on the interest-bearing portions. In 2022, the Group recorded interest expense totaling $6 million (2021: $6 million; 2020: $3 million) related to this resolution. As of December 31, 2022, the Group carries other liabilities of $444 million (2021: $492 million; 2020: $486 million) related to the settlement agreement with the DOJ.

Under the terms of the resolution agreement with the DOJ, the Group has agreed to compliance terms regarding its sales and marketing practices. Compliance with these terms is subject to annual Board and CEO certifications submitted to the U.S. Attorney's Office. As part of the resolution with the FTC and as detailed in the text of the stipulated order, for a 10-year period Indivior Inc. is required to make specified disclosures to the FTC and is prohibited from certain conduct.

In addition to the resolution agreement, the Group entered into a five-year Corporate Integrity Agreement with the HHS Office of the Inspector General (HHS-OIG), pursuant to which the Group committed to promote compliance with laws and regulations and committed to the ongoing evolution of an effective compliance program, including written standards, training, reporting, and monitoring procedures. The Group is subject to reporting and monitoring requirements, including annual reports and compliance certifications from key management and the Board's Nominating & Governance Committee, which is submitted to HHS-OIG. In addition, the Group is subject to monitoring by an Independent Review Organization, which submits audit findings to HHS-OIG, and review by a Board Compliance Expert, who prepared a compliance assessment report in the first reporting period and will prepare a compliance assessment report in the third reporting period. To date, the Group reasonably believes it has met all of the requirements specified in these three agreements.

**IP-related matters**

The Group has other liabilities for intellectual property-related matters totaling $21 million (2021: $73 million previously classified as a provision; 2020: $47 million), which relates to a settlement of intellectual property litigation with DRL. In June 2022, the Group, entered into a settlement agreement with DRL resolving intellectual property litigation. Under the settlement agreement, the Group made a settlement payment to DRL in June 2022 with final payments due in 2023 and 2024. This liability has been recorded at the net present value, using a market interest rate at the time of the settlement determined to be 4.5%, considering the timing of payments and other factors. In 2022, the Group recorded $1 million of finance expense (2021: $2 million; 2020: $2 million) for time value of money on the liability.

**RB resolution**

In January 2021, the Group reached a settlement with RB to resolve claims which RB issued in the Commercial Court in London in November 2020, seeking indemnity under the 2014 Demerger Agreement between amongst others, RB and the Group (Demerger Agreement). Pursuant to the settlement, RB withdrew the US $1.4 billion claim and released the Group from any claim for indemnity under the Demerger Agreement relating to the DOJ and FTC settlements which RB entered into in July 2019, as well as other claims for indemnity arising from those matters. The Group agreed to pay RB a total of $50 million and has agreed to release RB from any claims to seek damages relating to its settlement with the DOJ and the FTC. The Group made an initial payment of $10 million in February 2021, followed by an installment payment of $8 million in January 2022. Subsequently, annual installment payments of $8 million will be due every January from 2023 to 2026. The Group carries a liability totaling $30 million (2021: $40 million) related to this settlement. This liability has been recorded at the net present value, using a market interest rate at the time of settlement determined to be 3.75%, considering the timing of payment and other factors.

**Share repurchase**

On May 3, 2022, the Group commenced a share repurchase program of up to $100 million. As of December 31, 2022, the Group recorded a liability for $9 million, which represents the amount to be spent

------

under the program up to February 16, 2023, the period closed for modification or termination of the program. This liability has been classified as current. Refer to <u>[Note 23](#id39cb0e1a10249e1ab7b8f77d921d68a_1524)</u> for further discussion.

**Other**

Other represents deferred revenue related to a supply agreement which is non-current as of December 31, 2022.

**20. CONTINGENT LIABILITIES**

The Group has assessed certain legal and other matters to be not probable based upon current facts and circumstances, including any potential impact the DOJ resolution could have on these matters. These represent contingent liabilities. Where liabilities related to these matters are determined to be possible, they represent contingent liabilities. Except for those matters discussed in <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u> under "Antitrust class and state claims", "False Claims Act allegations", and "Intellectual property-related matters", for which liabilities or provisions have been recognized, <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u> sets out the details for legal and other disputes for which the Group has assessed as contingent liabilities. Where the Group believes that it is possible to reasonably estimate a range for the contingent liability this has been disclosed.

**21. LEGAL PROCEEDINGS**

There are certain ongoing legal proceedings or threats of legal proceedings in which the Group is a party, but in which the Group believes the possibility of an adverse impact is remote and they are not discussed in this <u>[Note 21](#id39cb0e1a10249e1ab7b8f77d921d68a_1511)</u>.

**Antitrust litigation and consumer protection**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Multidistrict antitrust class and state claims**

Civil antitrust claims have been filed by (a) a class of direct purchasers, (b) a class of end payors, and (c) a group of states, now numbering 41, and the District of Columbia (collectively, the "Plaintiffs"). The Plaintiffs generally allege, among other things, that Reckitt Benckiser Pharmaceuticals, Inc. (now known as Indivior Inc.) violated US federal and/or state antitrust and consumer protection laws in attempting to delay generic entry of alternatives to SUBOXONE Tablets. Plaintiffs further allege that Indivior Inc. unlawfully acted to lower the market share of these products. These antitrust cases are pending in multidistrict litigation (the "Antitrust MDL") in federal court in the Eastern District of Pennsylvania. The court denied Indivior Inc.'s motion for summary judgment by order dated August 22, 2022. Trial is currently scheduled for September 18, 2023.

In late January 2023, Indivior Inc. participated in a mediation session related to the Antitrust MDL with the Plaintiffs, as well as plaintiffs in the *Carefirst* case discussed below under *Other Antitrust and Consumer Protection Claims*. The Plaintiffs and Indivior Inc. submitted initial monetary demands and offers prior to the mediation, and no subsequent monetary demands or offers have since been made. Additional mediation sessions may take place in the future.

The Group believes Indivior Inc. has meritorious defenses and will continue to vigorously defend itself in this matter. The Group has evaluated the current status of mediation, the strengths and weaknesses of the Plaintiffs' liability and damages claims, the Group's defenses, the inherent uncertainty of trial, the remaining legal issues to be resolved, and the benefits of certainty to the Group in resolving these claims and savings in legal fees and costs. The Group has determined that it is in the interests of its stakeholders to explore settlement of these matters. As a result, a provision of $290 million has been recognized by the Group, although any settlement could occur at a lower or higher amount. The provision is the Group's estimate at this time of a potential aggregate settlement in light of the above analysis. However, the Group cannot predict with any certainty whether Indivior Inc. will reach a settlement with any of the Plaintiffs, and the final aggregate cost of these matters, whether resolved by settlement or trial, may be materially different.

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If Indivior Inc. is found liable in a trial to any of the Plaintiffs and was unable to reduce the claimed damages of such Plaintiffs group or groups during such trial (or in any subsequent proceeding), which the Directors believe is beyond "severe but plausible" (and therefore remote) within the going concern period, then its financial position, results and future cash flows could be materially adversely affected. If the Group continues with mediation or other settlement discussions, it makes no guarantee as to whether any settlement can be reached and if so, what amounts, if any, it may agree to pay, or what amounts the Plaintiffs will demand.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Other antitrust and consumer protection claims**

In 2013, Reckitt Benckiser Pharmaceuticals, Inc. (now known as Indivior Inc.) received notice that it and other companies were defendants in a lawsuit initiated by writ in the Philadelphia County (Pennsylvania) Court of Common Pleas. See *Carefirst of Maryland, Inc. et al. v. Reckitt Benckiser Inc., et al.,* Case. No. 2875, December Term 2013. The plaintiffs include approximately 79 entities, most of which appear to be insurance companies or other providers of health benefits plans. The Carefirst Plaintiffs have not served a complaint, but they have indicated that their claims are related to those asserted in the Antitrust MDL. The Carefirst case remains pending.

In 2020, the Group was served with lawsuits filed by several insurance companies, some of whom are proceeding both on their own claims and through the assignment of claims from affiliated companies. Cases filed by (1) Humana Inc. and (2) Centene Corporation, Wellcare Healthcare Plans, Inc., New York Quality Healthcare Corp. (d/b/a Fidelis Care), and Health Net, LLC were pending in the Eastern District of Pennsylvania. The complaints were dismissed in July 2021. The plaintiffs filed Notices of Appeal in August 2021 to the United States Court of Appeals for the Third Circuit ("Third Circuit"). The Third Circuit affirmed the district court's dismissal by opinion and order dated December 15, 2022. Humana also filed a Complaint in state court in Kentucky on August 20, 2021 with substantially the same claims as were raised in the federal court case. See *Humana Inc. v. Indivior Inc.*, No. 21-CI-004833 (Ky. Cir. Ct.) (Jefferson Cnty). That case was stayed pending a decision by the Third Circuit, and remains stayed. Centene Corporation and the above-referenced related companies filed a complaint in the Circuit Court for the County of Roanoke, Virginia alleging similar claims on January 13, 2023 following the mandate from the Third Circuit affirming the district court's dismissal. See *Centene Corp. v. Indivior Inc.*, No. CL23000054-00 (Va. Cir. Ct.) (Roanoke Cnty).

Cases filed by (1) Blue Cross and Blue Shield of Massachusetts, Inc., Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc., (2) Health Care Service Corp., (3) Blue Cross and Blue Shield of Florida, Inc., Health Options, Inc., (4) BCBSM, Inc. (d/b/a Blue Cross and Blue Shield of Minnesota) and HMO Minnesota (d/b/a Blue Plus), (5) Molina Healthcare, Inc., and (6) Aetna Inc. are pending in the Circuit Court for the County of Roanoke, Virginia. See *Health Care Services Corp. v. Indivior Inc.*, No. CL20-1474 (Lead Case) (Va. Cir. Ct.) (Roanoke Cnty). These plaintiffs have asserted claims under federal and state RICO statutes, state antitrust statutes, state statutes prohibiting unfair and deceptive practices, state statutes prohibiting insurance fraud, and common law fraud, negligent misrepresentation, and unjust enrichment. In June 2021, defendants' motion to stay was denied and certain claims were dismissed without prejudice. The plaintiffs filed amended complaints, and the Group filed demurrers, seeking dismissal of some of the asserted claims. The court heard oral argument on the demurrers on September 1, 2022, and issued a letter opinion on October 14, 2022 sustaining in part and overruling in part the Group's demurrers. A jury trial on the Group's pleas in bar has been set for October 16-20, 2023. A jury trial on the merits has been set for July 15, 2024-August 8, 2024.

The Group is still in the process of evaluating the claims, believes it has meritorious defenses, and intends to defend itself. No estimate of the range of potential loss can be made at this time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Civil opioid litigation**

The Group has been named as a defendant in more than 400 civil lawsuits brought by state and local governments and public health agencies, among others, alleging that manufacturers, distributors, and

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retailers of opioids engaged in a longstanding practice to market opioids as safe and effective for the treatment of long-term chronic pain to increase the market for opioids and their own market shares for opioids, as well as individuals alleging personal injury claims. Most of these cases have been consolidated and are pending in a federal multi-district litigation ("the Opioid MDL") in the US District Court for the Northern District of Ohio. See *In re National Prescription Opiate Litigation*, MDL No. 2804 (N.D. Ohio); see also*, e.g., Winston County, Alabama v. AmerisourceBergen Drug Corp., et al.*, 6:22-cv-01394 (N.D. Ala.) (filed November 2022, not yet served, and not consolidated in Opioid MDL proceedings); *International Brotherhood of Electrical Workers Local 728 Family Healthcare Plan v. Allergan, PLC et al.*, Case ID: 190303872 (C.P. Phila. Cnty) (consolidated with Lead Case No. 2017-008095 in Delaware County and stayed). Litigation against the Group in the Opioid MDL is stayed. On December 12, 2022, the court set forth procedures requiring plaintiffs to show cause why the court should not dismiss cases in which plaintiffs have not submitted a plaintiff fact sheet or timely served the relevant defendants. Separately, motions to remand have been denied or withdrawn in more than 50 cases to which the Group is a party (among numerous other defendants). Motions to remand remain pending in additional cases to which the Group is a party.

The court in the Opioid MDL held a status conference on June 22, 2022, with county and municipality plaintiffs and certain manufacturer defendants (including the Group) and distributor defendants to discuss what information the parties needed to proceed, whether the parties would entertain settlement and whether there should be any bellwether trials from this subset of plaintiffs and defendants. During the status conference and at subsequent conferences, the court expressed its view that no additional bellwether trials should be needed for these cases, provided that the parties were progressing on a settlement track. The court held a status conference on January 25, 2023 concerning cases filed by school districts, hospitals, and third-party payors, followed by an additional status conference on February 24, 2023 regarding cases filed by hospitals and third-party payors. By order dated February 28, 2023, the court indicated that it will not select hospital cases for bellwether trials at this time, and set forth a process for selecting six bellwether third-party payor trials.

Separately, Indivior Inc. was named as a defendant in five individual complaints filed in West Virginia state court that have not been transferred to the MDL, and instead have been transferred to West Virginia's Mass Litigation Panel. See *In re Opioid Litigation*, No. 22-C-9000 NAS (W.V. Kanawha Cnty. Cir. Ct.) ("WV MLP Action"). Indivior Inc. moved to dismiss all five complaints on January 30, 2023. The plaintiffs in those cases separately have moved to strike the defendants' notices of non-party fault. Indivior's motions to dismiss, as well as the plaintiffs' motions to strike, remain pending. A hearing on motions to dismiss in the WV MLP Action, including Indivior Inc.'s motions, is set for March 24, 2023.

Given the status and preliminary stage of litigation in both the Opioid MDL and state courts, no estimate of possible loss in the opioid litigation can be made at this time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**False Claims Act allegations**

In August 2018, the United States District Court for the Western District of Virginia unsealed a declined *qui tam* complaint alleging causes of action under the Federal and state False Claims Acts against certain entities within the Group predicated on best price issues and claims of retaliation. See *United States ex rel. Miller v. Reckitt Benckiser Group PLC et al*., Case No. 1:15-cv-00017 (W.D. Va.). The suit also seeks reasonable attorneys' fees and costs. The Group filed a Motion to Dismiss in June 2021. The case was stayed for mediation in September 2021, but the parties did not reach agreement. In March 2022, Relator submitted a request for oral argument on the Motion to Dismiss. On July 21, 2022, the court entered an order staying the action and reserving a decision on the Group's Motion to Dismiss pending rehearing *en banc* by the US Court of Appeals for the Fourth Circuit in *US ex rel. Sheldon v. Allergan Sales, LLC.* On rehearing *en banc*, the Fourth Circuit affirmed the district court's opinion in US ex rel. Sheldon v. Allergan Sales, LLC by order dated September 23, 2022. The United States District Court for the Western District of Virginia has not yet ruled on the Group's Motion to Dismiss, and instead has further stayed the proceedings pending decisions by the Supreme Court of the United States in two cases

------

concerning the False Claims Act—*United States ex rel. Proctor v. Safeway, Inc*., and *United States ex rel. Schutte v. Supervalu, Inc.* 

In May 2018, Indivior Inc. received an informal request from the United States Attorney's Office ("USAO") for the Southern District of New York, seeking records relating to the SUBOXONE Film manufacturing process. The Group is discussing with the USAO certain information and allegations that the government received regarding SUBOXONE Film.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**UK shareholder claims**

On September 21, 2022, certain shareholders issued representative and multiparty claims against Indivior PLC in the High Court of Justice for the Business and Property Courts of England and Wales, King's Bench Division. On January 16, 2023, the representative served its Particular of Claims setting forth in more detail the claims against the Group, while the same law firm that represents the representative also sent its draft Particular of Claims for the multiparty action. The claims made in both the representative and multiparty actions generally allege that Indivior PLC violated the UK Financial Services and Markets Act 2000 ("FSMA 2000") by making false or misleading statements or material omissions in public disclosures, including the 2014 Demerger Prospectus, regarding an alleged product-hopping scheme regarding the switch from SUBOXONE® tablets to SUBOXONE® film. Indivior PLC filed an application to strike out the representative action on February 27, 2023. A hearing on the application to strike out has been scheduled for November 20-21, 2023.

The Group has begun its evaluation of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Intellectual property-related matters**

Various subsidiaries of the Group filed actions against Alvogen Pine Brook LLC and Alvogen Inc. (together, "Alvogen") in the United States District Court for the District of New Jersey (the "NJ District Court") alleging that Alvogen's generic buprenorphine/naloxone film product infringes US Patent Nos. 9,687,454 (the "454 Patent") and 9,931,305 (the "305 Patent") in 2017 and 2018, respectively. The cases were consolidated in May 2018. In January 2019, the NJ District Court granted Indivior a temporary restraining order ("TRO") to restrain the launch of Alvogen's generic buprenorphine/naloxone film product pending a trial on the merits of the '305 Patent, and the subsidiaries of the Group that were a party to the case were required to post a surety bond of $36 million. The parties entered into an agreement whereby Alvogen was enjoined from selling in the US its generic buprenorphine/naloxone film product unless and until the Court of Appeals for the Federal Circuit ("CAFC") issued a mandate vacating Indivior's separate preliminary injunction entered against Dr. Reddy's Laboratories, Inc. ("DRL") in a related case. The CAFC's mandate vacating Indivior's preliminary injunction as to DRL issued in February 2019, and Alvogen launched its generic product. Any sales in the US by Alvogen are on an "at-risk" basis, subject to the ongoing litigation against Alvogen in the NJ District Court. In November 2019, Alvogen filed an amended answer alleging various antitrust counterclaims. In January 2020, Indivior and Alvogen stipulated to noninfringement of the '305 Patent under the court's claim construction, but Indivior retained its rights to appeal the construction and pursue its infringement claims pending appeal. Indivior's infringement claims concerning the '454 Patent and Alvogen's antitrust counterclaims remain pending in the NJ District Court. In June 2022, the parties participated in court-ordered mediation. The parties did not reach settlement. Summary judgment motions have been fully briefed, and the court heard arguments on those motions on August 29, 2022. The NJ District Court has not yet ruled on those motions, and no trial date has been set.

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**22. TRADE AND OTHER PAYABLES**

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Provision for rebates, discounts and returns | (428) | (436) | (396) |
| Accounts payable | (36) | (137) | (20) |
| Accruals and other payables | (138) | (136) | (97) |
| Other tax and social security payable | (15) | (11) | (9) |
| Interest payable |  |  | (2) |
| **Trade and other payables**  | $**(617)** | $**(720)** | $**(524)** |

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The change in the year was primarily the result of the timing of settlement of trade payables.

The carrying amounts of total trade and other payables are denominated in the following currencies:

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| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Sterling | (45) | (36) | (25) |
| Euros | (12) | (10) | (14) |
| U.S. dollar | (540) | (658) | (473) |
| Other currencies | (20) | (16) | (12) |
| **Trade and other payables** | $**(617)** | $**(720)** | $**(524)** |

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**23. SHARE CAPITAL**

---

| | | | |
|:---|:---|:---|:---|
| **Issued and fully paid** *(in millions)* | **Equity ordinary shares** | **Nominal value paid per share $** | **Nominal value** |
| **At January 1, 2022**  | 702439638 | 0.10 | 70 |
| Ordinary shares issued | 4184940 | 0.10 | 1 |
| Shares repurchased and canceled | (17815033) | 0.10 | (2) |
| Share consolidation | (551047636) |  |  |
| Share repurchased and cancelled (post share consolidation) | (1280914) | 0.50 | (1) |
| **At December 31, 2022**  | **136480995** |  | **68** |

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---

| | | | |
|:---|:---|:---|:---|
| **Issued and fully paid** *(in millions)* | **Equity ordinary shares** | **Nominal value paid per share $** | **Nominal value** |
| **At January 1, 2021**  | 733635511 | 0.10 | 73 |
| Ordinary shares issued | 2311560 | 0.10 |  |
| Shares repurchased and canceled | (33507433) | 0.10 | (3) |
| **At December 31, 2021**  | **702439638** |  | **70** |

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---

| | | | |
|:---|:---|:---|:---|
| **Issued and fully paid** *(in millions)* | **Equity ordinary <br>shares** | **Nominal value paid per share $** | **Nominal value** |
| **At January 1, 2020**  | 730787719 | 0.10 | 73 |
| Ordinary shares issued | 2847792 | 0.10 |  |
| **At December 31, 2020**  | **733635511** |  | **73** |

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**Ordinary shares issued**

In 2022, prior to share consolidation, 4,184,940 ordinary shares at $0.10 each (2021: 2,311,560 and 2020: 2,847,792 at $0.10 each) were allotted to satisfy vesting/exercises under the Group's Long-Term Incentive Plan and the US Employee Stock Purchase Plan.

**Share consolidation**

In October 2022, the Company completed a share consolidation. Shareholders received 1 new ordinary share with a nominal value of $0.50 each for every 5 previously existing ordinary shares which had a nominal value of $0.10 each. As a result of the consolidation, as at October 10, 2022 the Company's issued share capital consisted of 137,761,909 ordinary shares at $0.50 each (equivalent shares pre-consolidation: 688,809,545).

**Shares repurchased and canceled**

In July 2021, the Group commenced an irrevocable share repurchase program for an aggregate purchase price up to no more than $100 million or 73,462,098 of ordinary shares. In December 2021, the program concluded with the Group repurchasing 33,507,433 of the Group's ordinary shares over the duration of the program for an aggregate nominal value of $3 million ($0.10 per share). In addition, 256,055 ordinary shares purchased as part of the share repurchase program at $0.10 each were canceled in January 2022. These shares are included in the total number of share capital outstanding as at December 31, 2021.

In May 2022, the Group commenced a second share repurchase program for an aggregate purchase price up to no more than $100 million or 39,698,610 of ordinary shares (equivalent shares post consolidation: 7,939,722), which is expected to end no later than March 31, 2023. During the year, prior to the share consolidation, the Group repurchased and cancelled 17,815,033 of the Company's ordinary shares for an aggregate nominal value of $2 million ($0.10 per share), including the 256,055 ordinary shares purchased as part of the Group's share repurchase program executed in 2021 and cancelled in January 2022. Subsequent to the share consolidation, the Group repurchased and cancelled 1,280,914 of the Company's ordinary shares for an aggregate nominal value of $1 million ($0.50 per share).

All ordinary shares repurchased during the year under share repurchase programs were cancelled (except for 16,793 shares that were canceled in January 2023) resulting in a transfer of the aggregate nominal value to a capital redemption reserve. The total cost of the share repurchase program was $90 million consisting of $89 million (2021: $100 million; 2020: $nil) paid for the repurchase of shares and $1 million (2021: $1 million; 2020: $nil) of directly attributable transaction costs paid, which include advisory fees and stamp duties. A net repurchase amount of $9 million has been recorded as a financial liability and reduction in retained earnings which represents the amount to be spent under the program up to February 16, 2023, the period closed for modification or termination of the program. Total purchases under the share repurchase program will be made out of distributable profits.

**24. OTHER EQUITY**

**Foreign currency translation** 

The foreign currency translation reserve contains the accumulated foreign exchange differences from the translation of the financial statements of the Group's foreign operations arising when the Group's entities are consolidated.

**Other reserves**

The other reserves balance relates to the Group formation in 2014. It represents the difference between the nominal value of the shares issued by the Group and the net investment in the Group by the former owner.

------

**Capital redemption reserve**

The capital redemption reserve was created for capital maintenance purposes as a result of the repurchase and cancellation of ordinary shares under the Group's share repurchase programs as required under the UK Companies Act.

**25. SHARE-BASED PLANS**

**Employee plans**

***Indivior Long-Term Incentive Plan (LTIP)***

In 2015, a share-based incentive plan was introduced for employees (including Executive Directors) of the Group. An award under the LTIP can take the form of a nil-cost option, a market value option, or a conditional award.

The Remuneration Committee may determine the vesting of awards is conditional upon the satisfaction of one or more performance conditions. Awards with performance conditions granted under the LTIP will normally have a performance period of at least three years. Awards granted to Executive Directors are subject to a further two-year post-vesting period.

The fair values of awards granted under the Long-Term Incentive Plans are calculated using a Monte Carlo simulation model. The key assumptions in the simulation model are share price of the Group, expected volatilities of the Group, risk-free rate, and dividend yield.

For all plans, the inputs to the option pricing models are reassessed for each grant. The following assumptions were used in calculating the fair value of options granted under the LTIP schemes.

---

| | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| **Award** | **Grant date** | **Performance period** | **Share price on grant date £** | **Volatility %**<sup>(1)</sup> | **Dividend yield %** | **Expected life in years** | **Risk-free interest rate**<sup>(2)</sup> | **Weighted average fair value** | **Exercisable Shares**<sup>(3)</sup> |
| 2019 | March 5, 2019 | 2019–21 | 1.08 | 73 | 0 | 3 | 0.82 | 0.77 |  |
| 2019 | March 5, 2019 | 2019–21 | 1.08 | 73 | 0 | 5 | 0.82 | 0.5 | 269674 |
| 2019 | August 8, 2019 | 2019–21 | 0.58 | 73 | 0 | 5 | 0.82 | 0.5 |  |
| 2020 | March 9, 2020 | 2020-22 | 0.45 | 110 | 0 | 3 | 0.10 | 0.41 | 2612726 |
| 2020 | March 9, 2020 | 2020-22 | 0.45 | 110 | 0 | 5 | 0.10 | 0.42 | 472721 |
| 2020 | November 6, 2020 | 2020-23 | 1.17 | 110 | 0 | 5 | 0.10 | 1.10 | 31596 |
| 2021 | March 1, 2021 | 2021-23 | 1.29 | 115 | 0 | 5 | 0.10 | 1.16 | 513665 |
| 2021 | March 1, 2021 | 2021-23 | 1.29 | 115 | 0 | 3 | 0.10 | 1.17 | 2040118 |
| 2022 | March 1, 2021 | 2022-24 | 2.81 | 64 | 0 | 5 | 0.90 | 2.23 | 284519 |
| 2022 | March 1, 2021 | 2022-24 | 2.81 | 64 | 0 | 3 | 0.90 | 2.41 | 1209650 |
| 2022 | August 3, 2022 | 2022-24 | 3.17 | 64 | 0 | 3 | 0.90 | 2.25 | 69637 |

---

______________

(1)The expected volatility is based on historical volatility over the period of time commensurate with the expected award term immediately prior to the date of grant.

(2)The risk-free interest rate reflects the continuous risk-free yield based on the UK Government interest rates as of the valuation date, based upon a maturity commensurate with the performance period.

(3)Reflects the impact of the 5:1 share consolidation completed in October 2022.

------

The maximum number of shares that could vest under the Group's LTIP was:

---

| | |
|:---|:---|
| *(in millions)* | **Total LTIP** |
| Outstanding at January 1, 2020 | 25 |
| Awarded | 22 |
| Vested/exercised | (1) |
| Forfeited | (12) |
| Outstanding at December 31, 2021 | $34 |
| Awarded | 14 |
| Vested/exercised | (1) |
| Forfeited | $(7) |
| Outstanding at December 31, 2021 | 40 |
| Awarded | 8 |
| Vested/exercised | (4) |
| Forfeited | (5) |
| Share consolidation | (31) |
| **Outstanding at December 31, 2022**  | $**8** |

---

For awards outstanding at year end, the weighted average remaining contractual life is 0.97 years (2021: 1.25 years; 2020: 1.56 years).

**Other employee plans**

The Group operates an HMRC-approved SAYE plan for UK employees and US Employee Stock Purchase Plan ("ESPP") for US employees. The amounts recognized for these plans are not material for disclosure.

**Charged to income statement**

The expense charged to the consolidated income statement for share-based payments is as follows:

---

| | | | |
|:---|:---|:---|:---|
| *(in millions)* | **2022** | **2021** | **2020** |
| Granted in current year | (7) | (6) | (3) |
| Granted in prior years | (9) | (7) | (10) |
| Unvested awards due to unmet performance conditions |  | 2 | 5 |
| **Total share-based expense for the year**  | $**(16)** | $**(11)** | $**(8)** |

---

**26. RELATED PARTIES**

In March 2021, the Group entered into a Relationship Agreement with its largest shareholder, Scopia Capital Management LP ("Scopia"). The Relationship Agreement provides for Scopia to have one representative director appointed to the Board and contains certain standstill, voting and governance terms. In July 2022, the Group announced that it has amended the existing Relationship Agreement with Scopia. Under the original terms, the Relationship Agreement terminated in the event that Scopia (and its affiliates) ceased to have interests in at least 10% of the Company's issued share capital. As announced on July 1, 2022, Scopia has sold interests in the Company representing 2.28% which has taken the total holding of Scopia (and its affiliates) to 9.71%, below this 10% threshold, and down from 16.9% at

------

origination of the agreement. The Group has agreed not to exercise its right to terminate the Relationship Agreement immediately, and instead has agreed:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• to continue with the agreement until the expiration of its original term of December 31, 2023, unless the Relationship Agreement is otherwise extended by mutual agreement or terminated earlier in accordance with its terms; and.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• the threshold for automatic termination will be amended, such that the Relationship Agreement will terminate in the event that Scopia (and its affiliates) cease to have interests in at least 5% of the Company's issued share capital (reduced from 10% under the original terms).

Key management compensation is disclosed in <u>[Note 5](#id39cb0e1a10249e1ab7b8f77d921d68a_1415)</u>.

The significant subsidiaries included in the consolidated financial statements at December 31, 2022 are disclosed in <u>[Note](#id39cb0e1a10249e1ab7b8f77d921d68a_1352)[1](#id39cb0e1a10249e1ab7b8f77d921d68a_1352)</u>.

**27. POST BALANCE SHEET SUBSEQUENT EVENTS**

**Acquisition of Opiant Pharmaceuticals, Inc.**

On March 2, 2023, the Group acquired all outstanding shares of Opiant Pharmaceuticals, Inc. (Opiant) for upfront consideration of $20.00 per share in cash (approximately $146 million in aggregate), plus up to $8.00 per share in CVRs. The Group will pay $2.00 per CVR for each of the following net revenue thresholds achieved by OPTN003, Opiant's lead asset, during any period of four consecutive quarters prior to the seventh anniversary of the US commercial launch: (i) $225 million, (ii) $300 million, and (iii) $325 million. The remaining (iv) $2.00 per CVR would be paid if OPNT003 achieves net revenue of $250 million during any period of four consecutive quarters prior to the third anniversary of the US commercial launch. The maximum amount payable by the Group should OPNT003 achieve all four CVRs would be approximately $68 million. The Group has funded the acquisition using internal resources.

The acquisition of Opiant extends Indivior's addiction treatment portfolio, primarily with the pipeline product OPNT003, nasal nalmefene, an opioid overdose treatment with clinically demonstrated characteristics well-suited to confront illicit synthetic opioids like fentanyl. The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for OPNT003 and it granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2023.

Due to the proximity of the acquisition to the approval date of the Group financial statements, the Group has not completed the initial accounting for the acquisition and hence disclosures related to the fair valuation of the assets and liabilities acquired and resultant goodwill (including the factors that make up the goodwill) and any contingent liabilities were not determinable by the approval date of the Group financial statements. The acquisition will be accounted for as a business combination using the acquisition method of accounting in accordance with IFRS 3 Business Combinations and consequently the assets acquired, and liabilities assumed will be recorded by the Group at fair value, with any excess of the purchase price over the fair value of the identifiable assets and liabilities being recognized as goodwill.

The accounting impact of this acquisition and the results of the operations for Opiant will be included in the Group's Consolidated Financial Statements for the first quarter of 2023.

**Share repurchase program**

In February 2023, the Company completed its second share repurchase program. In 2023, an additional 484,362 shares were repurchased and canceled at $0.50 each, bringing the total cost of the program to $101 million including directly attributable costs.

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**28. PARENT COMPANY INFORMATION** 

Cash dividends and/or share repurchase programs, if any, are made by Indivior PLC (the "Parent Company"). The Parent Company's primary source of income and cash flow is dividends and loans from its subsidiaries, which are restricted by our term loan (see <u>[Note 1](#id39cb0e1a10249e1ab7b8f77d921d68a_1487)[7](#id39cb0e1a10249e1ab7b8f77d921d68a_1487)</u>). The term loan allows the subsidiaries to pay cash dividends, transfer assets, and make loans to the Parent Company at an accumulating amount representing 50% consolidated net income, as defined in the term loan. The stand-alone condensed financial statements of the Parent Company are presented below in accordance with SEC regulations when such restrictions exist. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future.

**Parent Company Income Statements**

---

| | | | |
|:---|:---|:---|:---|
| **For the year ended December 31** *(in millions)* | **2022** | **2021\*** | **2020\*** |
| Administrative and general expenses | $(23) | $(17) | $(5) |
| Legal settlement |  |  | (50) |
| Other (loss)/ income | (12) | 12 |  |
| Dividends from subsidiaries | 152 | 109 |  |
| **Operating profit/(loss)**  | $**117** | $**104** | $**(55)** |
| Interest income | 1 |  |  |
| Profit/(loss) before taxation | 118 | 104 | (55) |
| Tax credit | 8 | 12 | 3 |
| **Net income/(loss)**  | $**126** | $**116** | $**(52)** |

---

____________

\*See below for details regarding the revision due to a prior period adjustment.

There were no items of other comprehensive income or loss for the years ended December 31, 2022, 2021 or 2020.

------

**Parent Company Balance Sheets**

---

| | | | |
|:---|:---|:---|:---|
| **As at December 31** *(in millions)* | **2022** | **2021\*** | **2020\*** |
| **Assets**  |  |  |  |
| **Non-current assets**  |  |  |  |
| Investments in subsidiaries | 1550 | 1508 | 1497 |
| Deferred tax assets | 12 |  | 5 |
|  | $**1562** | $**1508** | $**1502** |
| **Current assets**  |  |  |  |
| Amounts due from subsidiaries | 1 |  | 3 |
| Other assets | 4 | 9 | 3 |
| Cash and cash equivalents | 60 | 21 | 19 |
|  | 65 | 30 | 25 |
| **Total assets**  | $**1627** | $**1538** | $**1527** |
| **Liabilities** |  |  |  |
| **Current liabilities** |  |  |  |
| Trade and other payables | (21) | (9) | (10) |
| Amounts due to subsidiaries | (54) | (2) | (1) |
|  | (75) | (11) | (11) |
| **Non-current liabilities** |  |  |  |
| Other liabilities | (22) | (32) | (40) |
| **Total liabilities**  | $**(97)** | $**(43)** | $**(51)** |
| **Net assets**  | $**1530** | $**1495** | $**1476** |
| **Equity**  |  |  |  |
| Share capital | 68 | 70 | 73 |
| Share premium | 8 | 7 | 6 |
| Capital redemption reserve | 6 | 3 |  |
| Retained earnings | 1448 | 1415 | 1397 |
| **Total equity**  | $**1530** | $**1495** | $**1476** |

---

____________

\*See below for details regarding the revision due to a prior period adjustment.

------

**Parent Company Statements of Changes in Equity**

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| *(in millions)* | **Share**<br>**capital** | **Share**<br> **premium** | **Capital redemption reserve**  | **Retained earnings** | **Total equity** |
| **Balance at January 1, 2020, as reported**  | $**73** | $**5** | $**—** | $**1387** | $**1465** |
| Prior period adjustment\* |  |  |  | 52 | $52 |
| **At January 1, 2020, revised\***  | $**73** | $**5** | $**—** | $**1439** | $**1517** |
| **Comprehensive loss**  |  |  |  |  |  |
| Net loss for the financial year, revised\* |  |  |  | (52) | (52) |
| **Total comprehensive loss, revised\***  | $**—** | $**—** | $**—** | $**(52)** | $**(52)** |
| **Transactions with owners**  |  |  |  |  |  |
| Shares issued |  | 1 |  |  | 1 |
| Share-based payments |  |  |  | 8 | 8 |
| Taxation on share-based payments |  |  |  | 2 | 2 |
| **Total transactions recognized directly in equity** | $**—** | $**1** | $**—** | $**10** | $**11** |
| **Balance at December 31, 2020, revised\***  | $**73** | $**6** | $**—** | $**1397** | $**1476** |
| **Balance at January 1, 2021**  | $**73** | $**6** | $**—** | $**1397** | $**1476** |
| **Comprehensive income** |  |  |  |  |  |
| Net income for the financial year, revised\* |  |  |  | 116 | 116 |
| **Total comprehensive income**  | **—** | **—** | **—** | **116** | **116** |
| Transactions recognized directly in equity |  |  |  |  |  |
| Shares issued |  | 1 |  |  | 1 |
| Shares repurchased and cancelled | (3) |  | 3 | (101) | (101) |
| Share-based payments |  |  |  | 11 | 11 |
| Settlement of tax on equity awards |  |  |  | (1) | (1) |
| Taxation on share-based payments |  |  |  | (7) | (7) |
| **Total transactions recognized directly in equity** | $**(3)** | $**1** | $**3** | $**(98)** | $**(97)** |
| **Balance at December 31, 2021** | $**70** | $**7** | $**3** | $**1415** | $**1495** |
| **Balance at January 1, 2022**  | $**70** | $**7** | $**3** | $**1415** | $**1495** |
| **Comprehensive income** |  |  |  |  |  |
| Net income for the financial year |  |  |  | 126 | 126 |
| **Total comprehensive income**  | $**—** | $**—** | $**—** | $**126** | $**126** |
| **Transactions recognized directly in equity**  |  |  |  |  |  |
| Shares issued | 1 | 1 |  |  | 2 |
| Shares repurchased and cancelled | (3) |  | 3 | (90) | (90) |
| Transfer to share repurchase liability |  |  |  | (9) | (9) |
| Share-based payments |  |  |  | 16 | 16 |
| Settlement of tax on equity awards |  |  |  | (10) | (10) |
| **Total transactions recognized directly in equity**  | $**(2)** | $**1** | $**3** | $**(93)** | $**(91)** |
| **Balance at December 31, 2022**  | $**68** | $**8** | $**6** | $**1448** | $**1530** |

---

______________

\*See below for details regarding the revision due to a prior period adjustment.

------

**Parent Company Cash Flow Statements**

---

| | | | |
|:---|:---|:---|:---|
| **For the year ended December 31** *(in millions)* | **2022** | **2021\*** | **2020\*** |
| **Cash flows from operating activities:** |  |  |  |
| Operating profit/(loss) | 117 | 104 | (55) |
| Settlement of tax on employee awards | (10) | (1) |  |
| Impact from foreign exchange movements | (1) |  |  |
| Decrease/(increase) in other assets | 5 | (7) |  |
| (Increase)/decrease in amounts due from subsidiaries | (1) | 3 | 20 |
| (Decrease)/increase in trade and other payables | 3 | (1) | 10 |
| Increase in amounts due to subsidiaries | 49 | 1 | 1 |
| (Decrease)/Increase in other liabilities | (10) | (8) | 40 |
| **Cash generated from operations**  | $**152** | $**91** | $**16** |
| Interest received | 1 |  |  |
| Taxes refunded - Group relief |  | 11 | 2 |
| **Net cash inflow from operating activities**  | $**153** | $**102** | $**18** |
| **Net cash flows from investing activities**  |  |  |  |
| Investment in subsidiaries | (26) |  |  |
| **Net cash outflow from investing activities** | $**(26)** | $**—** | $**—** |
| **Cash flows from financing activities** |  |  |  |
| Proceeds from the issuance of ordinary shares | 2 | 1 | 1 |
| Shares repurchased and cancelled | (90) | (101) |  |
| **Net cash (outflow)/inflow from financing activities**  | $**(88)** | $**(100)** | $**1** |
| **Net increase in cash and cash equivalents**  | **39** | **2** | **19** |
| Cash and cash equivalents at beginning of the year | 21 | 19 |  |
| **Cash and cash equivalents at end of the year**  | $**60** | $**21** | $**19** |

---

______________

\*See below for details regarding the revision due to a prior period adjustment.

**Basis of preparation** 

The Parent Company financial statements have been prepared using the same accounting principles and policies as described in the notes to our consolidated financial statements except for the investment in the subsidiaries that are recognized and measured at cost. Any material contingencies, long-term obligations and guarantees have been separately disclosed in the accompanying consolidated financial statements.

------

**Prior Period Adjustment**

During the year ended December 31, 2022, the Company identified prior period errors in the parent company financial statements footnote related to the recognition of stock-based compensation expense. Accordingly, the Company revised the Parent Company financial statements footnote to increase net income by $11 million and $8 million in 2021 and 2020, respectively, and to increase investment in subsidiaries and retained earnings by $71 million and $60 million at December 31, 2021 and 2020, respectively. The Company evaluated the materiality of the adjustments to prior-period consolidated financial statements and concluded the effect of the adjustments were immaterial to all periods.

**Reconciliations of Parent Company financial information** 

---

| | | | |
|:---|:---|:---|:---|
| **As at December 31** *(in millions)* | **2022** | **2021\*** | **2020\*** |
| **Profit (loss) reconciliation** |  |  |  |
| Parent company profit/(loss) for the year | 126 | 116 | (52) |
| Additional profit/(loss) if subsidiaries had been accounted for using the equity method | (179) | 89 | (96) |
| **Consolidated (loss)/profit for the year**  | $**(53)** | $**205** | $**(148)** |
| **Equity reconciliation** |  |  |  |
| Parent company equity | 1530 | 1495 | 1476 |
| Adjustment to equity if subsidiaries had been accounted for using the equity method | (1479) | (1292) | (1394) |
| **Consolidated equity**  | $**51** | $**203** | $**82** |

---

______________

\*See above for details regarding the revised due to a prior period adjustment.

------

**ITEM 19: EXHIBITS**

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 1.1+  | Memorandum and Articles of Association of Indivior PLC (adopted by a special resolution on 30 October 2014, as amended by a special resolution on 23 December 2014 and on 30 September 2022). |
| 2.1 | Form of Share Certificate upon listing on the Nasdaq Stock Market |
| 4.1.1+  | Deposit Agreement dated as of December 23, 2014 between Indivior PLC, JPMorgan Chase Bank, N.A., as Depositary and Owners and Holders from time to time of the American Depositary Receipts issued thereunder, including the Form of American Depositary Receipt. |
| 4.1.2+  | Letter Agreement dated August 4, 2022 related to that certain Deposit Agreement dated as of December 23, 2014 between Indivior PLC, JPMorgan Chase Bank, N.A. |
| 4.1.3+  | Notice of Termination dated October 3, 2022 related to that certain Deposit Agreement dated as of December 23, 2014 between Indivior PLC, JPMorgan Chase Bank, N.A. |
| 4.2# | Second Amended and Restated Relationship Agreement with Scopia Capital Management LP dated as of March [ ], 2023. |
| 4.3+  | Resolution Agreement by and among Indivior PLC, Indivior Inc., the United States Attorney's Office for the Western District of Virginia, and the United States Department of Justice's Consumer Protection Branch made as of July 24, 2020. |
| 4.4+  | Corporate Integrity Agreement between the Officer of Inspector General of the Department of Health and Human Services and Indivior Inc. made as of July 24, 2020. |
| 4.5+  | Stipulated Order for Permanent Injunction and Equitable Monetary Relief in the United States District Court for the Western District of Virginia, Abingdon, between Federal Trade Commission and Indivior Inc. entered July 24, 2020. |
| 4.6+  | Fourth Amendment (and Restatement of) Credit Agreement, dated as of April 26, 2022 among Indivior Finance S.A.R.L., Indivior SMTM LLC, RBP Global Holdings Limited, and certain other Loan Parties, and Morgan Stanley Senior Funding, Inc. |
| 4.7+  | Lease of Land and Buildings at Damsom Lane, Hull HU8 7DS, by and between Reckitt Benckiser Healthcare (UK) Limited and RB Pharmaceuticals Limited, dated December 1, 2014. |
| 4.8\*+  | The Indivior Inc. Incentive Compensation Policy. |
| 4.9\*+  | Rules of the Indivior PLC Long-Term Incentive Plan. |
| 4.10\*+  | Trust Deed in respect of the Indivior PLC Employee Benefit Trust. |
| 4.11\*+  | The Indivior PLC Savings-Related Share Option Plan. |
| 4.12\*+  | The Indivior PLC U.S. Employee Stock Purchase Plan. |
| 4.13\*+  | Rules of the Indivior Group Deferred Bonus Plan. |
| 4.14.1† | Copacker Supply Agreement by and between Reckitt Benckiser Healthcare (UK) Limited and RB Pharmaceuticals Limited, dated December 23, 2014. |
| 4.14.2† | First Amendment to Copacker Supply Agreement Reckitt Benckiser Healthcare (UK) Limited and Indivior UK Limited, formerly known as RB Pharmaceuticals Limited, as amended and restated on March 29, 2019. |
| 4.15.1† | Commercial Exploitation Agreement by and between Aquestive Therapeutics (f/k/a MonoSol Rx, LLC and Reckitt Benckiser Pharmaceuticals Inc., dated August 15, 2008 (as amended on August 19, 2009, November 13, 2009, March 30, 2010, October 13, 2010, December 15, 2010, December 9, 2011, December 1, 2012, October 14, 2013 (by Addendum A), July 30, 2014 (by Addendum B), January 12, 2017, November 25, 2019, December 29, 2020, and March 2, 2023.) |
| 4.15.2† | Supplemental Agreement by and between MonoSol Rx, LLC and Indivior UK Limited, dated September 24, 2017. |
| 4.16.1† | Packaging and Supply Agreement between Indivior UK Limited and Sharp Corporation made September 7, 2017. |
| 4.16.2† | First Amendment to Packaging and Supply Agreement between Indivior UK Limited and Sharp Corporation made March 23, 2018. |

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------

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| | |
|:---|:---|
| 4.16.3 | Second Amendment to Packaging and Supply Agreement between Indivior UK Limited and Sharp Corporation made August 17, 2020. |
| 4.16.4† | Third Amendment to Packaging and Supply Agreement between Indivior UK Limited and Sharp Corporation made January 1, 2021. |
| 4.16.5 | Amendment No. 4 to Packaging and Supply Agreement between Indivior UK Limited and Sharp Corporation made May 9, 2021. |
| 4.17† | Master Development and Supply Agreement made January 1, 2022 by and between Curia Massachusetts, Inc. and Indivior UK Limited. |
| 4.18.1† | Master Manufacturing Services Agreement between Patheon Manufacturing Services LLC and Indivior UK Limited made April 6, 2018 (as amended on May 27, 2021). |
| 4.18.2† | Product Agreement between Patheon Manufacturing Services LLC and Indivior UK Limited made April 25, 2018 (as amended on January 1, 2019, March 1, 2019, and April 17, 2020). |
| 4.18.3† | Capital Expenditure and Equipment Agreement between Patheon Manufacturing Services LLC and Indivior UK Limited made June 30, 2019. |
| 4.19.1† | License Agreement between Indivior UK Limited and Aelis Farma made June 3, 2021. |
| 4.19.2† | Master Collaboration Agreement between Indivior UK Limited and Aelis Farma made August 3, 2021. |
| 4.19.3† | Letter Agreement regarding an Irrevocable Subscription Agreement and Irrevocable Lock-Up Commitment between Indivior UK Limited and Aelis Farma made January 6, 2022. |
| 4.20+  | Agreement and Plan of Merger between Indivior Inc., Olive Acquisition Sub, Inc. and Opiant Pharmaceuticals, Inc. dated as of November 13, 2022. |
| 4.21† | Contingent Value Rights Agreement dated as of March 2, 2023 between Indivior, Inc., Computershare Inc. and Computershare Trust Company, N.A. |
| 4.22† | License Agreement by and among Indivior UK Limited and C4X Discovery Limited dated March 28, 2021.  |
| 4.23† | License Agreement by and among Indivior UK Limited and Addex Pharma S.A. dated January 2, 2018. |
| 5.1# | Consent of PricewaterhouseCoopers LLP (US) |
| 5.2+  | Letter of PricewaterhouseCoopers LLP (UK) regarding change in certifying accountant. |
| 8.1 | Subsidiaries of the Registrant |

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__________________

†Confidential treatment requested as to certain portions, which portions have been omitted and filed separately with the Securities and Exchange Commission

\*Management Contract

+ &nbsp;&nbsp;&nbsp;&nbsp;Previously filed

#&nbsp;&nbsp;&nbsp;&nbsp;To be filed by amendment

The Merger Agreement is being included to provide investors with information regarding the terms of the Merger Agreement. It is not intended to provide any other factual information about the Company, Indivior Inc., Olive Acquisition Sub, Inc., Opiant or their respective subsidiaries or affiliates. The representations, warranties and covenants contained in the Merger Agreement were made only for purposes of that agreement and as of specific dates, were solely for the benefit of the parties to the Merger Agreement and may be subject to limitations agreed upon by the parties in connection with negotiating the terms of the Merger Agreement, including being qualified by confidential disclosures made by each party to the other for the purposes of allocating contractual risk between them that differ from those applicable to investors. In addition, certain representations and warranties may be subject to a contractual standard of materiality different from those generally applicable to investors and may have been used for the purpose of allocating risk between the parties rather than establishing matters as facts. Information concerning the subject matter of the representations, warranties and covenants may change after the date of the Merger Agreement, which subsequent information may or may not be fully reflected in public disclosures by Indivior PLC. or its affiliates or Opiant. Investors should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition of Indivior PLC, Indivior Inc., Olive Acquisition Sub, Inc., Opiant or any of their respective subsidiaries, affiliates or businesses.

------

**SIGNATURES**

The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this registration statement on its behalf.

---

| | |
|:---|:---|
| Indivior PLC | Indivior PLC |
| By: |  |
| Title: | &nbsp;&nbsp;&nbsp;Chief Financial Officer |

---

Date: [&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;], 2023

## Exhibit 2.1

**Exhibit 2.1**

![a21formofsharecertasof22001a.jpg](a21formofsharecertasof22001a.jpg)

THIS CERTIFIES THAT is the owner of CUSIP DATED COUNTERSIGNED AND REGISTERED: COMPUTERSHARE TRUST COMPANY, N.A. TRANSFER AGENT AND REGISTRAR, FULLY-PAID ORDINARY SHARES OF Indivior plc (hereinafter called the "Company") transferable in accordance with, and subject to, the Company's articles of association on the books of the Company in person or by duly authorized attorney upon surrender of this certificate properly endorsed. This certificate is not valid unless countersigned by the Transfer Agent and registered by the Registrar. Witness the facsimile signatures of its duly authorized officers. ORDINARY SHARES NOMINAL VALUE $0.50 ORDINARY SHARES Certificate Number Shares . INDIVIOR PLC INCORPORATED UNDER THE LAWS OF ENGLAND AND WALES WITH COMPANY NUMBER 09237894 FACSIMILE SIGNATURE TO COME FACSIMILE SIGNATURE TO COME Director Secretary By AUTHORIZED SIGNATURE SEE REVERSE FOR CERTAIN DEFINITIONS THIS CERTIFICATE IS TRANSFERABLE IN CITIES DESIGNATED BY THE TRANSFER AGENT, AVAILABLE ONLINE AT www.computershare.com ZQ\|CERT#\|COY\|CLS\|RGSTRY\|ACCT#\|TRANSTYPE\|RUN#\|TRANS# G4766E 11 6 DD-MMM-YYYY \* \* 0 0 0 0 0 0 \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* 0 0 0 0 0 0 \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* 0 0 0 0 0 0 \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* 0 0 0 0 0 0 \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* \* 0 0 0 0 0 0 \* \* \* \* \* \* \* \* \* \* \* \* \* \* \*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Alexander David Sample \*\*\*\* Mr. Sample \*\*\*\* Mr. Sample \*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\* \*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\* 000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*0 00000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*00 0000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000 000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*0000 00\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*00000 0\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000 \*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\* \*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\* Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*Shares\*\*\*\*000000\*\*S \* \*ZERO HUNDRED THOUSAND ZERO HUNDRED AND ZERO\*\* MR. SAMPLE & MRS SAMPLE & MR. A PLE & MRS. SAMPLE ZQ00000000 Certificate Num bers 1234567890/1234567890 1234567890/1234567890 1234567890/1234567890 1234567890/1234567890 1234567890/1234567890 1234567890/1234567890 Total Transaction Num /No. 123456 Denom . 123456 Total 1234567 MR A SAMPLE DESIGNATION (IF ANY) ADD 1 ADD 2 ADD 3 ADD 4 PO BOX 43004, Providence, RI 02940-3004 CUSIP XXXXXX XX X Holder ID XXXXXXXXXX Insurance Value 1,000,000.00 Num ber of Shares 123456 DTC 12345678 123456789012345

------

![a21formofsharecertasof22002a.jpg](a21formofsharecertasof22002a.jpg)

The IRS requires that the named transfer agent ("we") report the cost basis of certain shares or units acquired after January 1, 2011. If your shares or units are covered by the legislation, and you requested to sell or transfer the shares or units using a specific cost basis calculation method, then we have processed as you requested. If you did not specify a cost basis calculation method, then we have defaulted to the first in, first out (FIFO) method. Please consult your tax advisor if you need additional information about cost basis. If you do not keep in contact with the issuer or do not have any activity in your account for the time period specified by state law, your property may become subject to state unclaimed property laws and transferred to the appropriate state. . INDIVIOR PLC A FULL STATEMENT OF THE POWERS, DESIGNATIONS, PREFERENCES AND RELATIVE, PARTICIPATING, OPTIONAL OR OTHER SPECIAL RIGHTS OF EACH CLASS OF SHARES OF THE COMPANY OR SERIES THEREOF AND THE QUALIFICATIONS, LIMITATIONS OR RESTRICTIONS OF SUCH PREFERENCES AND/OR RIGHTS WILL BE FURNISHED BY THE COMPANY WITHOUT CHARGE TO ANY SHAREHOLDER WHO SO REQUESTS UPON APPLICATION TO THE TRANSFER AGENT NAMED ON THE FACE HEREOF OR TO THE OFFICE OF THE SECRETARY OF THE COMPANY. THE TRANSFER OF THESE SHARES REPRESENTED BY THIS CERTIFICATE REQUIRES THE COMPLETION OF A SPECIALIZED STOCK TRANSFER FORM AND MAY BE SUBJECT TO THE UNITED KINGDOM'S HM REVENUE AND CUSTOMS STAMP DUTY. PLEASE CONTACT THE TRANSFER AGENT FOR ADDITIONAL INFORMATION. For US purposes the following abbreviations, when used in the inscription on the face of this certificate, shall be construed as though they were written out in full according to applicable laws or regulations: TEN COM - as tenants in common UNIF GIFT MIN ACT -............................................Custodian................................................ (Cust) (Minor) TEN ENT - as tenants by the entireties under Uniform Gifts to Minors Act........................................................ (State) JT TEN - as joint tenants with right of survivorship UNIF TRF MIN ACT -............................................Custodian (until age................................) and not as tenants in common (Cust) ............................. under Uniform Transfers to Minors Act................... (Minor) (State) Additional abbreviations may also be used though not in the above list.

## Exhibit 4.14

**Exhibit 4.14.1**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

Dated 23 December 2014

**COPACKER SUPPLY AGREEMENT**

**BETWEEN**

**(1)&nbsp;&nbsp;&nbsp;&nbsp;RECKITT BENCKISER HEALTHCARE (UK) LIMITED**

**("Supplier")**

**AND**

**(2)&nbsp;&nbsp;&nbsp;&nbsp;RB PHARMACEUTICALS LIMITED**

**("Buyer")**

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**THIS AGREEMENT** is made on 23 December 2014

**BETWEEN:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;**Reckitt Benckiser Healthcare (UK) Limited** incorporated and registered in England and Wales with company number 261312 whose registered office is at 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom (**"Supplier"**),

**AND**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;**RB Pharmaceuticals Limited** incorporated and registered in England and Wales with company number 7183451 whose registered office is at 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom (**"Buyer"**).

**WHEREAS** the Buyer wishes to engage the Supplier to manufacture and supply the Products (as defined below) on the terms of this Agreement and the Supplier wishes to manufacture and supply the Products to the Buyer on the terms of this Agreement.

**IT IS AGREED** as follows:

1&nbsp;&nbsp;&nbsp;&nbsp;**DEFINITIONS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1&nbsp;&nbsp;&nbsp;&nbsp;In this Agreement the following definitions shall apply, unless the context requires otherwise.

**"Active Pharmaceutical Ingredient" or "API"** means, with respect to a Product, any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product.

**"Actual Order Volume"** has the meaning set out in paragraph 4 in Schedule One.

**"Affected Party"** has the meaning set out in clause 18.1.

**"Affiliate"** means in relation to a company, any entity Controlled by that company or any entity which Controls that company or any entity which is Controlled by another entity, which also Controls that company whether such Control is direct or indirect. **"Supplier's Affiliates"** and **"Buyer's Affiliates"** shall be construed accordingly in relation to the Supplier and the Buyer respectively.

**"Agreement"** means this agreement.

**"Amended Supply Agreement"** means the supply agreement between the parties dated 23 July 2012, as updated and amended from time to time.

**"API Specification"** has the meaning set out in Schedule Eleven.

**"Arising Product Intellectual Property Rights"** means such Intellectual Property Rights as are developed or created during the conduct of, and as a result of, the work undertaken under this Agreement and which relate exclusively to any Product (including without limitation its manufacture and/or use) (excluding, for the avoidance of doubt, any Existing Intellectual Property Rights).

**"Asset Purchase Agreement"** means the asset purchase agreement between the parties dated 23 May 2012.

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**"Assumed API Costs"** has the meaning set out in paragraph 1(2) in Schedule One.

**"Budget Order Volume"** has the meaning set out in paragraph 2 in Schedule One.

**"Business Continuity Plan"/**the **"BCP Plan"** has the meaning set out in clause 19.1.

**"Business Day"** means a day (other than a Saturday or Sunday) on which banks are open for business in London, UK.

**"Buyer lndemnitees"** has the meaning set out in clause 11.2.

**"CAPA"** means a corrective and preventative action taken pursuant to applicable quality procedures.

**"cGMP"** means all applicable standards for good manufacturing practices as promulgated under applicable laws, including (a) Directive 2001/83/EC, 2003/94/EC and any applicable guidance on good manufacturing practices adopted pursuant to Article 47 of Directive 2001/83/EC, in particular relevant guidance on good manufacturing practices contained in the Rules Governing Medicinal Products in the European Union, Volume IV Good Manufacturing Practice for Medicinal Products, the principles detailed in the ICH Q7A guidelines, and (b) U.S Good Manufacturing Practice regulations promulgated by the U S. Food and Drug Administration including 21 CFR Part 210 and 211, in each case as amended from time to time.

**"Certificate of Analysis"** means the certificate of analysis contemplated by the Technical Agreement.

**"Change Plan"** has the meaning set out in clause 8.6.

**"Change in Specification"** has the meaning set out in clause 8.8.1.1.

**"Commencement Date"** has the meaning set out in clause 2.3.

**"Confidential Information"** means

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(A)&nbsp;&nbsp;&nbsp;&nbsp;information concerning the existence of this Agreement and the fact that the Supplier is manufacturing the Products (as hereinafter defined) for the Buyer;

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(B)&nbsp;&nbsp;&nbsp;&nbsp;information related to Arising Product Intellectual Property Rights, Arising Supplier Intellectual Property Rights, Existing Intellectual Property Rights, the Specifications and Technical Manual (all as defined herein), know how, and data and information of a technical, operational, administrative, financial or business nature, whether oral or in some tangible form, such as in documents, papers, drawings, diagrams, discs, articles, samples, prototypes or otherwise, in each case that is disclosed (intentionally or unintentionally) by one party or their Affiliates to the other party or its Affiliates.

Without limiting the foregoing, the Confidential Information of the Buyer includes all Manufacturing IPR as defined in the Asset Purchase Agreement, the Specifications and the Technical Manual.

**"Control"** means, in relation to a company, the ability of a person to ensure that the activities and business of that company are conducted in accordance with the wishes of that person, and a person shall be deemed to have Control of a company if it possesses or is entitled to acquire 50% or more of the shares carrying votes exercisable at a general meeting (or its equivalent) of the particular company if such company is a corporation issuing voting shares or the right to receive the majority of the income of that company on any distribution by it of all of its income or the majority of its assets on a winding up **"Controlled"** shall be construed accordingly.

**"Delivery Point"** means the Buyer's specified point for delivery at either (i) [\*\*\*], or (ii) [\*\*\*], or (iii) such other UK delivery address as specified by the Buyer from time to time.

------

**"Demerger Agreement"** means the demerger agreement to be entered into between Reckitt Benckiser Group plc and lndivior plc on or around 17 November 2014.

**"Direct Manufacturing Costs"** means costs which are directly attributed to the manufacture of the Products, as set out in the **"direct costs"** section of the FOS.

**"EMA''** means the European Medicines Agency or any successor entity thereto.

**"Emergency Trigger Level"** means an OTIF performance level of 85 per cent.

**"Escalation Notice"** has the meaning set out in clause 20.1.

**"Excess Supply"** has the meaning set out in clause 5.4.

**"Existing Intellectual Property Rights"** means any Intellectual Property Rights owned by or licensed to the Buyer or the Supplier (as applicable) or their Affiliates (i) prior to the date of this Agreement or (ii) that is created or resulting during the term of this Agreement otherwise than under or pursuant to this Agreement (**"Supplier's Existing Intellectual Property Rights"** and **"Buyer's Existing Intellectual Property Rights"** shall be construed accordingly in relation to the Supplier and the Buyer respectively).

**"Existing Tooling"** means the Tooling which, as at the date of this Agreement, is owned by the Buyer, as indicated in Schedule Seven.

**"FCP Lease"** means the lease of the fine chemical plant, land and buildings on Dansom Lane, Hull, HUB 7DS dated on or around 1 December 2014 entered into by the parties.

**"FDA"** means the United States Food and Drug Administration and any successor agency thereto.

**"Force Majeure Event"** has the meaning set out in clause 18.1.

**"FOS"** means the factory operating statement as agreed between the parties from time to time each year (the initial version of which is set out at Appendix 1 to Schedule One).

**"ILCH"** means the Index of Labour Costs per Hour released by the Office for National Statistics.

**"Indirect Manufacturing Costs"** means costs which are indirectly attributed to the manufacture of the Products, as set out in the **"indirect costs"** section of the FOS.

**"Indirect Manufacturing Cost Product Allocation"** has the meaning set out in paragraph 2 in Schedule One.

**"Intellectual Property Rights"** means patents, applications for patents, utility models, applications for utility models, trade marks or applications for trade marks or trading names (whether or not registered or registrable), rights in know how (including trade secrets, technology, methods of manufacture and specifications), designs (registered or unregistered and including applications for registered designs), copyright (including rights in computer software), topography rights and other rights in semiconductor chips, rights in inventions, the right to claim damages for past infringements of any or all such rights and all rights having equivalent or similar effect wherever situated.

**"Key Performance Indicators" / "KPls"** means those target performance levels as set out in Schedule Five or otherwise agreed between the parties in writing from time to time.

**"Manufacturing Costs"** has the meaning set out in paragraph 1(1) in Schedule One.

**"Manufacturing Site"** means the Supplier's site of manufacture of Products as specified in the Supplier's manufacturing licence and controlled substance licence in respect of such Products.

**"Material OTIF Failure"** has the meaning set out in clause 14.3.2.

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**"Optional Restricted Period"** has the meaning set out in clause 3.6.1.2.

**"Order"** has the meaning set out in clause 5.1.1.

**"Order Requirements"** means each Order shall, for each SKU of Products, have a minimum order quantity of one (1) pallet, and be in multiples of whole pallets.

**"OTIF"** means, in relation to delivery of Products, on time in full.

**"Pallet Policy"** shall be construed in accordance with clause 5.7.

**"Plant Day"** shall have the meaning set out in the Demerger Agreement.

**"Premises"** has the meaning set out in the FCP Lease.

**"Price"** means the prices (described by reference to skus) specified in the price list attached to the FOS to be charged by the Supplier to the Buyer in respect of any Products supplied pursuant to this Agreement.

**"Proceeding"** means any judicial, administrative or adversarial proceeding (public or private), any action, claim, lawsuit, litigation, arbitration or mediation, any hearing, investigation, probe or inquiry by any governmental authority, or any other dispute, in each case initiated by a third party (including any governmental authority).

**"Products"** means those products listed in Schedule Two or as otherwise agreed by the parties in writing, together with such additional, improved, modified or replacement products as shall be agreed between the parties from time to time as are manufactured by the Supplier and for supply to the Buyer under this Agreement and wherever **"Products"** is referred to in this Agreement it shall refer to the relevant Products or all Products as the case may be, as listed in Schedule Two.

**"Product Field"** has the meaning set out in clause 13.7.

**"Product Forecast"** has the meaning set out in clause 5.1.

**"Protected Person"** has the meaning set out in clause 3.6.3.

**"Purchase Terms"** has the meaning set out in clause 6.6.

**"Raw Materials"** means, on a Product by Product basis, such raw materials and components as are used to manufacture such Product, including without limitation all packaging components but excluding API.

**"Raw Materials Manufacturing Cost"** means, with respect to a Product, the cost of all materials and components, excluding the API, which are directly used to manufacture and form an integral part of such Product.

**"Rectification Plan"** has the meaning set out in clause 14.3.2.2.

**"Restricted Period"** has the meaning set out in clause 3.6.1.1.

**"Restricted Person"** means

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(A)&nbsp;&nbsp;&nbsp;&nbsp;until any such time as Reckitt Benckiser Group plc becomes Controlled by a third party, each Supplier Affiliate, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(B)&nbsp;&nbsp;&nbsp;&nbsp;from and including the date (if any) on which Reckitt Benckiser Group plc becomes Controlled by a third party, the body corporate (if different to the Supplier) that operates the Manufacturing Site, or possesses or has access to any information within limb (B) of the

------

definition of Confidential Information with respect to the manufacture of one or more Products.

**"Services"** means those internal logistics and other services listed in Schedule Two or as otherwise agreed by the parties in writing in respect of each of the Products to be performed by the Supplier in respect of any of the Products as part of its obligations in supplying the relevant Products under this Agreement, including any Temporary Additional Services as required.

**"SOP"** means standard operating procedure.

**"Specifications"** means each of the specifications for the Products as listed in the relevant Technical Manual and in Schedule Four signed for the purposes of identification by each party, as amended from time to time, and in accordance with which the Supplier shall manufacture and supply the Products.

**"SKU"** means stock keeping unit.

**"Supplier lndemnitees"** has the meaning set out in clause 11.1.

**"Target OTIF Level"** means an OTIF performance level of 98.5 per cent.

**"Tax Authority"** means any authority responsible for the collection or management of any tax.

**"Technical Agreement"** means the Technical Agreement entered into between the parties on or about the date of this Agreement, as such agreement shall be amended from time to time.

**"Technical Manual"** means the manual in respect of each of the Products containing the technical information for manufacture of the Products which is supplied by the Buyer to the Supplier and signed for the purposes of identification by each party along with any and all manufacturing policies of the Buyer which may be provided by the Buyer or its Affiliates to the Supplier from time to time.

**"Technical Transfer"** means those activities required to be performed by the Supplier in order to transfer the manufacture of the Products to an alternative supplier and manufacture batches up to and including process validation as further set out in clause 14.

**"Temporary Additional Services"** means those services as are set out in Schedule Three.

**"Tooling"** has the meaning set out in clause 6.6.

**"Transferee"** has the meaning set out in clause 2.2.

**"VAT"** means

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(A)&nbsp;&nbsp;&nbsp;&nbsp;within the European Union, any tax imposed by any Member State in conformity with the Directive of the Council of the European Union on the common system of value added tax (2006/112/EC), and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(B)&nbsp;&nbsp;&nbsp;&nbsp;outside the European Union, any tax corresponding to, or substantially similar to, the common system of value added tax referred to in paragraph (A) of this definition.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2&nbsp;&nbsp;&nbsp;&nbsp;Unless otherwise indicated, references to clauses and schedules are references to clauses and schedules in this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.3&nbsp;&nbsp;&nbsp;&nbsp;For the purpose of this Agreement, references to **"manufacturing"** a Product includes, without limitation, manufacturing, processing, formulating, packaging, finishing, filling, labelling, holding and quality control testing of such a Product, and **"manufacture"** shall be construed accordingly.

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2&nbsp;&nbsp;&nbsp;&nbsp;**TERM**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1&nbsp;&nbsp;&nbsp;&nbsp;This Agreement shall be effective from the Commencement Date and, subject to applicable laws and the provisions of clause 15 (Termination), shall have effect until seven (7) years following the Commencement Date unless terminated by either party giving the other not less than thirty-six (36) months written notice, such termination not to take effect earlier than the sixth anniversary of the Commencement Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2&nbsp;&nbsp;&nbsp;&nbsp;If notice has been served under clause 2.1, at the request of the Buyer any time during the period of notice the Supplier shall promptly and efficiently undertake and complete a Technical Transfer in accordance with clause 14 to the Buyer or a third party identified by the Buyer (the Buyer or the third party (or both) being the **''Transferee"**) to enable the Transferee to establish and conduct cGMP manufacture of the Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3&nbsp;&nbsp;&nbsp;&nbsp;The parties agree that this Agreement shall commence immediately upon Plant Day (the **"Commencement Date"**).

3&nbsp;&nbsp;&nbsp;&nbsp;**SUPPLY OF PRODUCTS AND SERVICES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1&nbsp;&nbsp;&nbsp;&nbsp;During the term of this Agreement, and subject to the terms of this Agreement the Supplier shall, at the Manufacturing Site:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.1&nbsp;&nbsp;&nbsp;&nbsp;manufacture and supply the Buyer's requirements of the Products on an exclusive basis (save where such exclusivity is disapplied in accordance with the terms of this Agreement), and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.2&nbsp;&nbsp;&nbsp;&nbsp;supply or procure the supply of the Services.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3&nbsp;&nbsp;&nbsp;&nbsp;The Buyer shall supply the API to the Supplier for the sole purpose of manufacturing the Products. If the Buyer is unable to supply the API to the Supplier, the Buyer may in its discretion arrange for an alternative source of API to be supplied to the Supplier and in such event the Supplier shall use all reasonable endeavours to qualify such alternative source as promptly as practicable, at the Buyer's cost (as to expenses properly incurred). For the avoidance of doubt, the Supplier shall not be responsible for sourcing the API. The Supplier shall not be in breach of its obligations under this Agreement to manufacture Products to the extent such breach was caused by a failure of the Buyer's obligations to supply quantities of API in accordance with this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.4&nbsp;&nbsp;&nbsp;&nbsp;Unless and to the extent the Raw Materials are supplied by the Buyer to the Supplier as provided in this clause 3, the Supplier shall only obtain Raw Materials from sources approved in writing by the Buyer and shall ensure that such Raw Materials are of the requisite standard to comply with the Specification and any applicable laws, codes of practice and regulations, provided however the Buyer may at its sole discretion supply any Raw Materials required for the Products to the Supplier to be delivered to the Supplier's manufacturing plant as agreed between the parties hereto. The said Raw Materials will be solely used by the Supplier for the Products The Supplier shall incorporate the cost and agreed wastage level as charged by the Buyer with no further charge into the Price of the Products. The Buyer shall provide the Supplier with a Certificate of Analysis for all APls and any Raw Materials as may be supplied by the Buyer under this clause 3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.5&nbsp;&nbsp;&nbsp;&nbsp;Unless otherwise agreed with the Buyer in writing or set out in this Agreement, the Supplier shall operate on a full service basis (meaning that the Supplier shall be responsible for the purchase of all Raw Materials, except for Raw Materials provided by the Buyer (if any), and the supply of the Products in finished form to the Buyer). The Buyer shall only be invoiced for the Price of finished Products inclusive of such costs and expenses.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6&nbsp;&nbsp;&nbsp;&nbsp;Subject to clause 3.7, the Supplier (for itself and on behalf of each Restricted Person) covenants with the Buyer that it will not, without the prior written consent of the Buyer whether directly or indirectly

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and whether alone or in conjunction with or on behalf of any other person and whether as principal, shareholder, director, employee, agent, consultant, partner or otherwise:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.1&nbsp;&nbsp;&nbsp;&nbsp;during:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.1.1&nbsp;&nbsp;&nbsp;&nbsp;the term of this Agreement and the period of one (1) year thereafter (the **"Restricted Period"**); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.1.2&nbsp;&nbsp;&nbsp;&nbsp;at the Buyer's option (which it may exercise in its sole discretion), a further one (1) year period from the end of the Restricted Period (the **"Optional Restricted Period"**),

canvass, solicit or approach, or cause to be canvassed, solicited or approached, any person for orders or deal with or contract with any person, who at any time during such period is or was:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.1.2.1&nbsp;&nbsp;&nbsp;&nbsp;negotiating with the Buyer or any of its Affiliates for the supply by the Buyer or any of its Affiliates of one or more of the Products, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.1.2.2&nbsp;&nbsp;&nbsp;&nbsp;was an actual customer of the Buyer or any of its Affiliates for one or more of the Products,

where the above mentioned orders or contracts relate to products which are competitive with a Product supplied by the Supplier to the Buyer or any of its Affiliates at any time during such period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.2&nbsp;&nbsp;&nbsp;&nbsp;during:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.2.1&nbsp;&nbsp;&nbsp;&nbsp;the Restricted Period, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.2.2&nbsp;&nbsp;&nbsp;&nbsp;the Optional Restricted Period,

interfere, or seek to interfere, with the continuation of Raw Materials to the Buyer or any of its Affiliates from any supplier who has been supplying such Raw Materials to the Buyer or any of its Affiliates at any time during such period if such interference causes or would cause that supplier to cease supplying, or materially reduce its supply of those Raw Materials to the Buyer. For avoidance of doubt, if a third party supplier suffers a shortage of supply of Raw Materials which are used by the Supplier other than to manufacture any Products, then the Supplier's negotiation with or attempts to obtain a supply of Raw Materials from such third party supplier under the terms of the Supplier's agreed arrangements with such third party supplier shall not of itself constitute interference by the Supplier for the purpose of this clause.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.3&nbsp;&nbsp;&nbsp;&nbsp;during:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.3.1&nbsp;&nbsp;&nbsp;&nbsp;the Restricted Period, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.3.2&nbsp;&nbsp;&nbsp;&nbsp;the Optional Restricted Period,

solicit or entice, or endeavour to solicit or entice, away from the Buyer or its Affiliates, any person employed in a managerial, supervisory, technical or sales capacity by, or who is or who was a consultant to, the Buyer or its Affiliates (each a **"Protected Person"**) at any time during such period unless such person responds to a bona fide recruitment advertisement or general solicitation that is not targeted at Protected Persons;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.4&nbsp;&nbsp;&nbsp;&nbsp;subject to clause 3.6.6, during:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.4.1&nbsp;&nbsp;&nbsp;&nbsp;the Restricted Period; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.4.2&nbsp;&nbsp;&nbsp;&nbsp;the Optional Restricted Period,

engage in, or be concerned with, or interested in, any person that conducts a business competitive with all or a substantial part of the Products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.5&nbsp;&nbsp;&nbsp;&nbsp;subject to clause 3.6.6, during:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.5.1&nbsp;&nbsp;&nbsp;&nbsp;the Restricted Period, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.5.2&nbsp;&nbsp;&nbsp;&nbsp;the Optional Restricted Period,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(A)&nbsp;&nbsp;&nbsp;&nbsp;whether alone or with, or for the benefit of any other person, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(B)&nbsp;&nbsp;&nbsp;&nbsp;assist (including without limitation by way of granting a licence to or providing information to) any other person to,

research, develop, manufacture, market or sell in any manner any products that are competitive with, or could be competitive with, one or more of the Products that are manufactured by the Supplier or any Supplier Affiliate during such period, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6.6 &nbsp;&nbsp;&nbsp;&nbsp;during the term of this Agreement, unless expressly authorised by the Buyer in writing, for the purpose of commercial sale during the term of this Agreement supply (or directly or indirectly authorise the manufacture or supply of) the Products or any product which might reasonably be considered to compete with the Products to any person, firm or company other than the Buyer or an Affiliate of the Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7&nbsp;&nbsp;&nbsp;&nbsp;Clause 3.6 shall not apply to the extent that

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7.1.1&nbsp;&nbsp;&nbsp;&nbsp;the Supplier or any Restricted Person is the holder of securities in a company whose securities are listed on a recognised investment exchange (as defined in the Financial Services and Markets Acts 2000, as amended) and holds not more than five per cent (5%) of the votes which could normally be cast at a general meeting of that company, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7.1.2&nbsp;&nbsp;&nbsp;&nbsp;the Supplier or any Restricted Person acquires an interest in an entity which is directly or indirectly interested in carrying on any business which competes with the business of the Buyer as it was carried out at the date of this Agreement but the acquisition is not made with the sole or main purpose of acquiring a business which so competes.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8&nbsp;&nbsp;&nbsp;&nbsp;If the Buyer discontinues receiving a Product under this Agreement, then the reference in clause 3.6.1.1 to **"term of this Agreement"** shall be construed as a reference to the period commencing on the Commencement Date and ending on the date of delivery of the last order of the Product in question.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.9&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall (i) by the fifth day of each month, provide a written report to the Buyer on the Bollini usage/reconciliation in respect of the previous month to Fiege Logistics Italy (or any successor thereof), and (ii) each calendar quarter, provide a written report to the Buyer on the usage of sequential labels for Belgium to the Buyer's regulatory affairs director for Western Europe (or such other person nominated by the Buyer from time to time), which reporting in each case ((i) and (ii)) shall be in accordance with any applicable SOP of the Supplier.

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**4&nbsp;&nbsp;&nbsp;&nbsp;INSPECTION TESTING AND SAMPLES DURING MANUFACTURE**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1&nbsp;&nbsp;&nbsp;&nbsp;Pursuant to the terms of any legislative or contractual rights or otherwise, the Buyer may reject or revoke acceptance of any Products which are defective or which do not comply with the Specifications or the provisions of this Agreement, other than as a result of a breach of the Buyer of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2&nbsp;&nbsp;&nbsp;&nbsp;Subject to the last sentence of this clause 4.2, the Supplier shall supply the Buyer with such Health and Safety data sheets (MSDS) and other available information as shall detail the compliance of the Supplier with its manufacturing obligations under this Agreement and the condition necessary to ensure that the Products can be safely handled and used by Buyer's personnel and by any subsequent purchaser or user thereof, for such purpose as shall have been notified to the Supplier in writing. The Buyer shall supply the Supplier with the foregoing in respect of any API or any Raw Materials supplied by the Buyer (if any) to the Supplier under this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3&nbsp;&nbsp;&nbsp;&nbsp;**Buyer right of audit; records**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3.1&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall, if requested by the Buyer (a) upon reasonable prior notice, once per calendar year, (b) if the Buyer receives any notice from any regulatory authority of competent jurisdiction with respect to the manufacture or packaging of any Product, during the term of this Agreement and up to seven years after the last delivery of Products has been made by the Supplier to the Buyer, (c) in the event of a breach, or the Buyer's reasonable suspicion of a breach of clause 9.1 or (d) following implementation by the Supplier of a CAPA in response to a previous audit or incident give the Buyer or its authorised representatives access (such access to be limited to during normal working hours unless immediate access is required under local law) to the Supplier's premises (including without limitation the Manufacturing Site), Products, reference samples, manufacturing records and books (including without limitation records relating to manufacturing processes, work in progress, operating procedures, sampling records, testing and packaging procedures), in each case with respect to Products, for the purpose of auditing the Supplier's quality control and procedures with respect to Products (such audit to be at the Buyer's cost). The Supplier shall use reasonable endeavours to ensure that its employees, its Affiliates and their employees and its subcontractors cooperate with and provide reasonable assistance to the Buyer during such audit.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3.2&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall retain manufacturing records and books (as referred to in clause 4.3.1) for seven (7) years after the last delivery of Products under this Agreement or as otherwise required under local laws. Such records and books shall, in so far as they are applicable, be maintained in accordance with applicable law and regulation. At the end of that period the Supplier shall notify the Buyer in writing and offer to transfer the relevant records and books to the Buyer for retention at the Buyer's cost (as to reasonable expenses, properly incurred). If the Buyer does not notify the Supplier of its acceptance within two (2) months, then the Supplier can destroy such manufacturing records and books securely, in accordance with the Supplier's normal document retention and destruction procedures.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4&nbsp;&nbsp;&nbsp;&nbsp;**Supplier right of audit; records**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4.1&nbsp;&nbsp;&nbsp;&nbsp;The Buyer shall, if requested by the Supplier (a) upon reasonable prior notice, once per calendar year, (b) if the Supplier receives any notice from any regulatory authority of competent jurisdiction with respect to the manufacture of API under this Agreement, during the term of this Agreement and up to seven years after the last delivery of API has been made by the Buyer to the Supplier, (c) in the event of a breach, or the Supplier's reasonable suspicion of a breach of Schedule Eleven, or (d) following implementation by the Buyer of a CAPA in response to a previous audit or incident give the Supplier or its authorised representatives access (such access to be limited to during normal working hours unless immediate access is required under local law) to the Buyer's site of manufacture of API under this Agreement, reference samples, manufacturing records and books (including without limitation records relating to

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manufacturing processes, work in progress, operating procedures, sampling records, testing and packaging procedures), in each case with respect to API supplied by the Buyer to the Supplier under this Agreement, for the purpose of auditing the Buyer's quality control and procedures with respect to API (such audit to be at the Supplier's cost). The Buyer shall use reasonable endeavours to ensure that its employees, its Affiliates and their employees and its subcontractors cooperate with and provide reasonable assistance to the Supplier during such audit.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4.2&nbsp;&nbsp;&nbsp;&nbsp;The Buyer shall retain manufacturing records and books (as referred to in clause 4.4.1) with respect to API supplied under this Agreement for seven (7) years after the last delivery of such API under this Agreement or as otherwise required under local laws. Such records and books shall, in so far as they are applicable, be maintained in accordance with applicable law and regulation. At the end of that period the Buyer shall notify the Supplier in writing and offer to transfer the relevant records and books to the Supplier for retention at the Supplier's cost (as to reasonable expenses, properly incurred). If the Supplier does not notify the Buyer of its acceptance within two (2) months, then the Buyer can destroy such manufacturing records and books securely, In accordance with the Buyer's normal document retention and destruction procedures.

**5&nbsp;&nbsp;&nbsp;&nbsp;DELIVERY**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1&nbsp;&nbsp;&nbsp;&nbsp;Each week the Buyer may provide (or cause to be provided from its Affiliates) a rolling forecast of its requirements for the Products for the next twelve (12) months (a **"Product Forecast"**). The parties agree that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1.1&nbsp;&nbsp;&nbsp;&nbsp;the first eleven (11) weeks of such forecast, on a rolling basis, shall be binding and as such in submitting each Product Forecast the Buyer or any of its Affiliates will issue to the Supplier a purchase order (**"Order"**) for the Products to be delivered to the Buyer as provided in clause 5.2, which Order shall constitute a firm order for Products and shall be binding on the Supplier. If the Buyer does not provide a Product Forecast each week, the projections for the Buyer's requirements for the Products as set out in the most recent Product Forecast shall apply beyond the first eleven (11) weeks until such time as the Buyer provides the Supplier with a revised Product Forecast,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1.2&nbsp;&nbsp;&nbsp;&nbsp;the Supplier will also ensure that it will have on hand at its Manufacturing Site as of the date of receipt of each of the Buyer's forecasts, sufficient Raw Materials and other materials necessary to manufacture the Buyer's requirements for the Products as set out in the first sixteen (16) weeks of each such forecast, the parties agreeing that anything purchased by the Supplier against such sixteen (16) weeks forecast (or purchased pursuant to clause 6.4) and subsequently not used shall be at the Buyer's cost PROVIDED THAT this clause 5.1.2 shall not apply to the extent that the Buyer has agreed to supply to the Supplier any or all of the Raw Materials and the Buyer has failed to provide sixteen (16) weeks' stock of such Raw Materials, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1.3&nbsp;&nbsp;&nbsp;&nbsp;the Buyer shall ensure that, unless otherwise agreed with the Supplier, all Orders comply with the Order Requirements and the Buyer shall not order the same SKU of Products more than twice in any consecutive four (4) week period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.2&nbsp;&nbsp;&nbsp;&nbsp;Following receipt of an Order from the Buyer, the Supplier shall, at its own expense, deliver, or procure the delivery, of the Products DAP (lncoterms 2010) to the Delivery Point. In respect of all Orders, the Supplier shall deliver the Products to the Buyer at the time specified in the Order. With respect to given Products, delivery shall be effected on the last to occur of the following events: (i) such Products are physically delivered to the Delivery Point, (ii) such Products have been QP released in accordance with the Technical Agreement, or (iii) the Buyer has received a Certificate of Analysis from the Supplier confirming such Products meet the Specifications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3&nbsp;&nbsp;&nbsp;&nbsp;The Supplier represents and warrants that, unless otherwise agreed in writing with the Buyer, at the time of delivery all Products will have a minimum shelf life remaining of four months less than full

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shelf life, except in the case of an Order for Products the delivery of which has been deferred at the Buyer's request.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.4&nbsp;&nbsp;&nbsp;&nbsp;If the Supplier delivers to the Buyer a supply of the Products exceeding the amount specified in the applicable Order (the **"Excess Supply"**), the Buyer shall purchase such amount of the Excess Supply equal to the lower of:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.4.1&nbsp;&nbsp;&nbsp;&nbsp;one (1) additional pallet of the amount specified in the relevant Order, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.4.2&nbsp;&nbsp;&nbsp;&nbsp;ten per cent (10%) of the total Order,

For the avoidance of doubt, the Buyer shall not be obliged to purchase any amount of Product above the amounts specified in clauses 5.4.1 and 5.4.2 unless such purchase has been agreed in writing in advance between the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.5&nbsp;&nbsp;&nbsp;&nbsp;Following delivery, the Buyer shall have five (5) working days to examine each delivery of the Products and report any defects (including without limitation defects in quantity or obvious defects in quality identifiable from visible inspection of the pallet delivered) to the Supplier within such period. If no report is received by the Supplier within such period the Buyer will be deemed to have accepted such Products. The parties further agree that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.5.1&nbsp;&nbsp;&nbsp;&nbsp;If such a report is received by the Supplier, the Supplier shall notify the Buyer whether or not it agrees that the Products in question are defective within five (5) working days after receipt of such report (and if the Supplier fails to do so within such five (5) working day period, the Supplier shall be deemed to have agreed with the Buyer's determination that the Products in question are defective). If the Supplier does not agree with the Buyer that the Products in question are defective then the parties' respective heads of quality shall promptly meet (and in any event within ten (10) working days after the Supplier's receipt of the Buyer's report) to discuss and attempt to resolve the dispute. If the heads of quality have not resolved the dispute within fifteen (15) working days after the Supplier's receipt of the Buyer's report then a sample of the alleged defective Product shall be submitted for analysis to an independent laboratory (or other appropriate expert) to be agreed upon in good faith between the Buyer and the Supplier in writing. The decision of such laboratory (or expert) shall be final and binding on the parties and the corresponding expenses will be paid by the party found to be in error.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.5.2&nbsp;&nbsp;&nbsp;&nbsp;If the Supplier agrees with the Buyer that the Products are defective (or is deemed to have so agreed) or the laboratory or other expert determines that the Products are defective (and such defect is not as a result of the Buyer's breach of this Agreement), the Supplier shall, at the Buyer's option, either (a) if the Buyer has paid for the Products in question, reimburse the Buyer for the Price it paid for such Products or, if the Buyer has not paid for the Products in question, reimburse the Buyer's cost of the API used in such Products or (b) deliver replacement Products at no additional charge to the Buyer in substitution for the rejected Products and reimburse the Buyer's cost of the API used in such replacement Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.6&nbsp;&nbsp;&nbsp;&nbsp;The Supplier represents and warrants that it will have the capacity to fill the Buyer's requirements for the amount of Products set forth in any Order so long as such amount does not exceed 125% of the forecasted demand set forth in the immediately preceding Product Forecast. The Supplier shall provide the Buyer with capacity information, and complete a vulnerability analysis from time to time to demonstrate that the available capacity meets the Buyer's requirements. The Supplier shall promptly take action to address to the Buyer's reasonable satisfaction any capacity issues identified by the analysis.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.7&nbsp;&nbsp;&nbsp;&nbsp;If required by the Buyer, the Supplier shall make arrangements to meet the Buyer's **"Pallet Policy"** for shipment of Product to each specified location. A copy of the Policy is attached in Schedule Six.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.8&nbsp;&nbsp;&nbsp;&nbsp;For avoidance of doubt, the terms and conditions relating to Products, which were ordered prior to Plant Day in accordance with the Amended Supply Agreement but fall due for delivery during the term

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of this Agreement, will be governed (including as to cost) by the terms and conditions of this Agreement.

**6&nbsp;&nbsp;&nbsp;&nbsp;API, RAW MATERIALS AND TOOLING**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1&nbsp;&nbsp;&nbsp;&nbsp;The parties agree that the API and Raw Materials shall be sourced by the Supplier in accordance with this clause 6.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall collect the APls from the Buyer at the entrance to the Premises.

**Active Pharmaceutical Ingredients (API)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall only use API supplied by the Buyer (or by a third party approved in writing by the Buyer) in the manufacture of any Products and the parties agree:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.1&nbsp;&nbsp;&nbsp;&nbsp;the Supplier will order API from the Buyer according to the minimum batch quantity of [\*\*\*]kg of Buprenorphine and [\*\*\*]kg of Naloxone (or as otherwise agreed between the parties) which shall be delivered by the Buyer or the Buyer's nominee on a one (1) week lead time together with the APls' Certificate of Analysis,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.2 &nbsp;&nbsp;&nbsp;&nbsp;the Supplier will at all times retain appropriate stockholdings of API, being three (3) to six (6) months usage of each of Buprenorphine and Naloxone or as otherwise agreed following review twice a year, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.3&nbsp;&nbsp;&nbsp;&nbsp;notwithstanding the terms of any shipping document or any other delivery documents, the API is supplied by the Buyer on a consignment basis as set out in Schedule Eleven;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.3.1&nbsp;&nbsp;&nbsp;&nbsp;all risk in the API (including without limitation for any loss of or damage to the API) transfers to the Supplier at the point of delivery to the Supplier, the Supplier shall maintain and store the API in appropriate and secure conditions in accordance with applicable laws and shall fully insure the API for so long as it remains at the Supplier's risk; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.3.2&nbsp;&nbsp;&nbsp;&nbsp;legal title to the API shall remain with the Buyer after delivery to the Supplier pending use in the manufacture of the Products. Legal title in the API shall pass to the Supplier upon use in the manufacture of the Products and will be sold and charged to the Supplier in accordance with Schedule One and Schedule Eleven;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.4&nbsp;&nbsp;&nbsp;&nbsp;the Supplier shall monitor, account for all usage and wastage of the API and is responsible for filing of annual reports with relevant authorities detailing all storage and use of API within the Supplier's control and at the Supplier's risk, the Supplier will report such information to the Buyer on a monthly basis and co-ordinate the filing of such annual reports with the Buyer,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.5&nbsp;&nbsp;&nbsp;&nbsp;all API supplied by the Buyer will be solely used by the Supplier for the Products, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.6&nbsp;&nbsp;&nbsp;&nbsp;the Supplier shall ensure that all personnel involved in the manufacture of the Products are suitably trained for the handling of APls used in the Product.

**<u>Raw Materials</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall be responsible for the purchase of all Raw Materials (except for Raw Materials elected to be supplied by the Buyer) as required to meet the Orders. The Supplier shall only obtain Raw Materials from suppliers to the extent specified as authorised suppliers for the relevant material or component within the Technical Manual and the marketing authorisation or otherwise approved in writing by the Buyer. The Supplier shall ensure that such Raw Materials and other components are of the requisite standard to comply with the Specification.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5&nbsp;&nbsp;&nbsp;&nbsp;The parties agree that for any Raw Material which (i) is on a lead time from the Supplier of more than sixteen (16) weeks; or (ii) has a minimum order quantity in excess of the forecasted quantity of applicable Products in the forthcoming sixteen (16) weeks (including without limitation those materials specified in Schedule Nine); the Supplier shall liaise with the Buyer in respect of such purchase and prior to such purchase shall obtain confirmation from the Buyer that the Buyer will underwrite any write-off (if applicable) of unused Raw Materials, before purchasing such Raw Materials as detailed in Schedule Nine.

**<u>Tooling</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6&nbsp;&nbsp;&nbsp;&nbsp;To the extent that the Buyer is not already the owner thereof (as indicated in Schedule Seven), the Buyer may agree in its sole discretion to provide the Supplier with sufficient funds to cover the Supplier's purchase of the punch and die tooling (as described in Schedule Seven) required to support the capacity required for the anticipated supply of the Products, such tooling to be used solely for the production of the Products (being such tooling specified in Schedule Seven and hereinafter referred to as the **"Tooling"**). The purchase price for the Tooling, the amortisation formula and other commercial terms (**"Purchase Terms"**) in respect thereof are set out in Schedule Seven.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.7&nbsp;&nbsp;&nbsp;&nbsp;Upon the Buyer's achievement of the Purchase Terms with respect to each item of Tooling (other than Existing Tooling) such Tooling shall become the sole and exclusive property of the Buyer, and the Supplier shall take all such actions as the Buyer may reasonably request (including, without limitation, the execution and delivery to the Buyer of documents of title and other instruments) confirming the Buyer's exclusive right, title and interest therein. Notwithstanding the foregoing, the Supplier acknowledges and agrees that all designs, drawings, samples, prototypes and all Intellectual Property Rights related thereto, with respect to the Tooling and the Products are the exclusive property of the Buyer. From and after the date on which the Buyer achieves the Purchase Terms with respect to an item of Tooling, the Supplier shall mark such item conspicuously with a sign or sticker indicating that such item is the exclusive property of the Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.8 &nbsp;&nbsp;&nbsp;&nbsp;The Supplier acknowledges and agrees that the Buyer is the sole and exclusive owner of the Existing Tooling and the Supplier shall take all such actions as the Buyer may reasonably request (including, without limitation, the execution and delivery to the Buyer of documents of title and other instruments) confirming the Buyer's exclusive right, title and interest therein. The Supplier acknowledges and agrees that all designs, drawings, samples, prototypes and all Intellectual Property Rights related thereto, with respect to the Existing Tooling are the exclusive property of the Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.9&nbsp;&nbsp;&nbsp;&nbsp;Throughout the term of this Agreement, the Supplier, at its expense, shall maintain the Tooling in good working order and repair for at least five (5) years, shall not encumber or charge the Tooling in any manner whatsoever, shall procure insurance with an insurance company approved by the Buyer (such approval not to be unreasonably withheld) insuring the Tooling for its replacement value against all insurable risks, and shall use the Tooling exclusively for the production of the Products for the Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.10&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding anything contained in this Agreement to the contrary, the Supplier shall use reasonable endeavours to ensure that the Tooling shall have a working life of at least five (5) years from the date it was or is commissioned, the date of commissioning for Tooling existing at the date of this Agreement being set out in Schedule 7. The repair or replacement of any such Tooling that fails to achieve such capacity shall be at Supplier's sole cost and expense. The Supplier shall continue to provide routine maintenance on Tooling that has exceeded such life, provided, however, that if such a Tooling fails and the Supplier is unable to return it to service through the application of routine maintenance, any further costs of repair or replacement of such Tooling shall be at Buyer's sole cost and expense.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.11&nbsp;&nbsp;&nbsp;&nbsp;Where the Tooling is provided by the Buyer, ownership, title and interest in the Tooling shall at all times belong to the Buyer, and the Supplier shall throughout the term of this Agreement keep and maintain the sign and/or sticker on the Tooling indicating the sole ownership of the property of the Buyer.

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**7&nbsp;&nbsp;&nbsp;&nbsp;PRICE AND PAYMENT**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1&nbsp;&nbsp;&nbsp;&nbsp;The price for the Products shall be those set out in Schedule One and shall be fixed for the period up to and including 31 December 2016. The parties agree that the Price shall be subject to review thereafter every one year, and each such review shall commence following the Supplier's provision to the Buyer of the Supplier's proposed pricing for the forthcoming year by 31 July of the then current year. The first such review shall take place following the Supplier's first proposal for the year 2017 (to be made by 31 July 2016). The parties agree that the proposed pricing and review every one year (and any corresponding adjustment) will reflect the principles set out in Schedule One.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.2&nbsp;&nbsp;&nbsp;&nbsp;For the duration of this Agreement, the Supplier shall use its reasonable endeavours to be technically and commercially competitive taking into account the market for the supply of Raw Materials, and improvements in technology and the production of products similar to the Products. The Supplier will prepare an improvement plan and provide this to the Buyer before 31 July each year. Such improvement plan shall be discussed as part of the annual review set out in clause 7.1 above and the Supplier agrees to adhere to any improvement plan mutually agreed between the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3&nbsp;&nbsp;&nbsp;&nbsp;The Buyer shall pay the Price for Products delivered to it pursuant to clause 5 together with any other invoices submitted to it pursuant to this Agreement within 60 days of receipt by the Buyer from the Supplier of a valid VAT (or other applicable similar taxes) invoice therefor.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4&nbsp;&nbsp;&nbsp;&nbsp;On reasonable request of the Buyer from time to time, the Supplier shall supply:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4.1&nbsp;&nbsp;&nbsp;&nbsp;those of the Services listed in Schedule Two (if any) specified in the request and the Buyer shall reimburse the Supplier for such Services at cost without any mark up, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4.2&nbsp;&nbsp;&nbsp;&nbsp;the Temporary Additional Services pursuant to the provisions and charges as set out in Schedule Three, until the Buyer provides notice to the Supplier in accordance with Schedule Three to cease providing the Temporary Additional Services,

provided that such supply of Services shall be performed either (i) In relation to the provision of the Products or (ii) as reasonably required for the purposes of performing a Technical Transfer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.5&nbsp;&nbsp;&nbsp;&nbsp;The amounts payable by the Buyer to the Supplier in relation to the Services set out in this Agreement shall be subject to a price review at each anniversary of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.6&nbsp;&nbsp;&nbsp;&nbsp;The Buyer shall be entitled to set off against any amounts due to the Supplier hereunder any amounts due to it and any of its Affiliates from the Supplier under this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.7&nbsp;&nbsp;&nbsp;&nbsp;The parties acknowledge that the Price includes delivery to the Delivery Point and that in the event that the Buyer specifies an alternative Delivery Point, the variation in the Supplier's delivery cost (including any additional charges, or any cost reductions) shall be passed through (without mark-up or variation) to the Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.8&nbsp;&nbsp;&nbsp;&nbsp;Any amounts expressed to be payable under this Agreement by the Buyer to the Supplier shall be deemed to be exclusive of any VAT which is chargeable on any supply or supplies for which that amount (or any part thereof) is the whole or part of the consideration for VAT purposes.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9&nbsp;&nbsp;&nbsp;&nbsp;If anything done by the Supplier under this Agreement is a supply on which VAT is chargeable and the Supplier is required to account to the relevant Tax Authority for any VAT chargeable on that supply, then an amount equal to any VAT so chargeable shall be paid by the Buyer to the Supplier (in addition to, and at the same time as, any other consideration for that supply) and the Supplier shall provide the Buyer with a valid VAT invoice for that supply.

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**8&nbsp;&nbsp;&nbsp;&nbsp;SERVICE LEVELS, GOVERNANCE AND CHANGE CONTROL**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall meet the agreed Key Performance Indicators in its performance of the Services as set out in Schedule Five. All Key Performance Indicators except for OTIF are for monitoring purposes only.

**<u>Governance</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2&nbsp;&nbsp;&nbsp;&nbsp;The parties agree that appropriate representatives of each of the parties' operational team shall have a weekly telephone conference or meeting to discuss the operational issues under this agreement, including if applicable the provision of Product Forecasts and Orders.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3&nbsp;&nbsp;&nbsp;&nbsp;The parties further agree that they shall each appoint a relationship manager to be responsible for the management of arrangements and supply of Products under this Agreement. The parties acknowledge that their respective relationship managers are as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.1&nbsp;&nbsp;&nbsp;&nbsp;The Buyer's relationship manager is Purchasing Manager,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.2&nbsp;&nbsp;&nbsp;&nbsp;The Supplier's relationship manager is Site Director,

who shall meet (in person or telephone conference) on a monthly basis unless otherwise agreed by both parties to discuss the performance under, and any issues arising under, this Agreement, and shall include a review of performance against the KPls, and assess volume of API used and stored (so as to understand the Supplier's use of API as described in clause 6.3.4). Accordingly, the Supplier agrees to provide the Buyer's relationship manager in advance of each meeting a report showing the performance against the KPls over the previous month and over a rolling twelve (12) month period or, if shorter, the period from the Commencement Date to the end of the previous month.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4&nbsp;&nbsp;&nbsp;&nbsp;The parties further agree that approximately every three (3) months, and in any event four (4) times a year (unless otherwise agreed between the parties) they shall hold a joint steering group meeting comprised of the key stakeholders from each of the parties which shall include:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4.1&nbsp;&nbsp;&nbsp;&nbsp;for the Buyer, the Buyer's relationship manager and the Buyer's supply director (together with any other additional representative as nominated by the Buyer), and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4.2&nbsp;&nbsp;&nbsp;&nbsp;for the Supplier, the Supplier's relationship manager and the Supplier's SVP Health Supply (together with any other additional representative as nominated by the Supplier),

who shall meet to discuss the performance under, and any issues arising under, this Agreement, review of performance against the KPls, and discuss any strategic issues, including without limitation any expected variation in demand and/or capacity (if any).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.5&nbsp;&nbsp;&nbsp;&nbsp;The parties agree that the monthly meetings of the relationship managers shall be used to resolve where possible any issues or problems as they arise. However, the parties agree that in the event any problem or issue is not resolved between the relationship managers, either relationship manager shall escalate the matter by providing written notice to the other party as set out in clause 20.

**<u>Change Control and Change Management</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.6&nbsp;&nbsp;&nbsp;&nbsp;The parties acknowledge the regulatory requirements and associated timescales involved in making changes to the manufacture of the Products are significant and as such both parties agree that, upon becoming aware of any possible need or desire to make any changes, that party will provide the other with written notice of such possible change (including rationale, expected timings, risk assessment, price impact and any impact on business continuity). Upon receipt of such notice the parties will meet to discuss such proposed changes (each acting reasonably and in good faith). Any changes agreed between the parties shall be documented in writing via a change plan specifying timings, responsibilities of each of the parties and costs, and must be signed by both parties (**"Change Plan"**). The Supplier will not make any changes to the manufacture of the Products without a Change Plan

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signed by the Buyer PROVIDED THAT neither party shall be entitled to reject such Change Plan if such rejection would result in the other party being in breach of its obligations under any applicable laws or regulations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.7&nbsp;&nbsp;&nbsp;&nbsp;The Supplier and Buyer shall implement any Change Plan in accordance with its terms and the Supplier shall keep the Buyer informed of progress, and each party shall notify the other party in the event of any delays or changes to the Change Plan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.8&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding the above, the Supplier provides the following undertakings with respect to the manufacture and supply of the Products,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.8.1&nbsp;&nbsp;&nbsp;&nbsp;the Supplier undertakes to

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.8.1.1 &nbsp;&nbsp;&nbsp;&nbsp;provide a minimum of twenty four (24) months' written notice to the Buyer in the event that the Supplier wishes to (i) change or modify the manufacture of the Products according to the Specification which shall include a change to a production process or method (a **"Change in Specification"**) or (ii) or the Supplier wishes to change the site of manufacture of Products, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.8.1.2&nbsp;&nbsp;&nbsp;&nbsp;notify the Buyer as soon as reasonably practicable after the Supplier becomes aware of any changes in applicable law which are likely to affect the supply of the Products under this Agreement (including rationale, expected timings, risk assessment, price impact and any impact on business continuity),

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.8.2&nbsp;&nbsp;&nbsp;&nbsp;the Supplier undertakes that in the event of (i) a Change in Specification, (ii) a change in the site of manufacture of the Products, or (iii) when the Supplier becomes aware of any changes in applicable law which are likely to affect the supply of Products under this Agreement, it shall use its reasonable endeavours to procure sufficient Products, with the maximum possible shelf life, to meet the Buyer's Product Forecasts for the agreed transition period from the date of such notification or such other volume as the Buyer may agree with the Supplier;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.8.3&nbsp;&nbsp;&nbsp;&nbsp;the Supplier undertakes that in the event of a change in site of manufacture of Products, upon written notice from the Buyer the Supplier shall grant the Buyer, or the Buyer's representatives, reasonable access to the new site of manufacture as soon as reasonably practicable following receipt of such notice and at any time thereafter, and in any event prior to the change, in order to ensure that it meets all regulatory requirements under applicable law. Any approval by the Buyer of a new site of manufacture shall not relieve the Supplier of any obligations under this clause 8 or this Agreement; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.8.4&nbsp;&nbsp;&nbsp;&nbsp;the Supplier further undertakes that it shall reimburse any and all reasonable, documented and auditable direct and indirect costs incurred by the Buyer as a result of the Change in Specification or change in the site of manufacture of Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.9&nbsp;&nbsp;&nbsp;&nbsp;The parties agree that where the change is agreed as a result of a third party initiator (e.g. authorities or regulators making a change in requirements) the costs of complying with such change shall be borne by the party on whose activity is changed by such change in regulation (apportioned accordingly to the extent the change in regulation applies to each party), and the parties set out in Schedule Ten (10) an illustrative list of possible anticipated changes and the party bearing the costs (of both parties) for making such changes.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.10&nbsp;&nbsp;&nbsp;&nbsp;The Supplier agrees certain changes are included within the Price (and accordingly the Buyer shall not incur any additional charges in respect of such changes), including

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.10.1&nbsp;&nbsp;&nbsp;&nbsp;up to 400 artwork changes per year (or pro rata for any part thereof); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.10.2&nbsp;&nbsp;&nbsp;&nbsp;up to 400 person-hours of Supplier's time per year (or pro rata for any part thereof) in relation to any changes,

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each as more fully described in Schedule Ten.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.11&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall not raise any charges for any changes outside an agreed Change Plan, nor any other charges outside of those specified in this Agreement unless otherwise agreed in writing by the Buyer.

9**&nbsp;&nbsp;&nbsp;&nbsp;QUALITY AND RECALLS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall manufacture the Products and supply the Services strictly in accordance with

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.1&nbsp;&nbsp;&nbsp;&nbsp;the Specifications;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.2&nbsp;&nbsp;&nbsp;&nbsp;the Technical Manual;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.3&nbsp;&nbsp;&nbsp;&nbsp;the Technical Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.4&nbsp;&nbsp;&nbsp;&nbsp;cGMP;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.5&nbsp;&nbsp;&nbsp;&nbsp;all applicable licences, permits, registrations, authorisations, regulations and legislation in relation to controlled drugs or substances;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.6&nbsp;&nbsp;&nbsp;&nbsp;all other applicable laws and regulations; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.7 &nbsp;&nbsp;&nbsp;&nbsp;the terms of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2&nbsp;&nbsp;&nbsp;&nbsp;Prior to commencement of the manufacture of the Products the Supplier shall satisfy itself that the know-how contained in the Technical Manual (and any other information provided by the Buyer to the Supplier) is sufficient to enable it to efficiently perform its obligations under this Agreement. If the Supplier concludes that further information is necessary it shall notify the Buyer and obtain such information prior to the commencement of manufacture. If sufficient information has not been provided to the Supplier by the Buyer in respect of a particular SKU of Product, such particular SKU shall not be subject to Key Performance Indicators while such information has not been provided.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3&nbsp;&nbsp;&nbsp;&nbsp;If the Supplier shall become aware that any aspect of a Specification is liable to result in the manufacture of a defective Product which may lead to a liability being incurred, the Supplier shall, as soon as reasonably practicable, notify the Buyer in writing. The Supplier and the Buyer shall promptly meet to discuss and address the risk of manufacture of defective Product and if the Supplier can reasonably demonstrate that manufacture of Product in accordance with the specification would, or would likely, result in a defective product, the Supplier may, while the Supplier rectifies such risk, suspend its obligations to supply Product under this Agreement, without prejudice to any right or remedy of the Buyer, and provided that the Supplier uses all reasonable endeavours to rectify such risk as promptly as practicable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4&nbsp;&nbsp;&nbsp;&nbsp;Upon reasonable request by the Buyer the Supplier shall provide the production and quality records in respect of any or all of the Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.5&nbsp;&nbsp;&nbsp;&nbsp;The Supplier will provide the Buyer with Certificates of Analysis of all batches of the Products manufactured by it. Such certificates shall comply with, and be in the form set out in, the quality assurance requirements included in the Specifications and the Technical Manual. The Supplier shall not release the Products from its warehouse for sale until the Certificates of Analysis relating to such Products demonstrate that the Products meet the Specifications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.6&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall establish and maintain a batch-tracking system to enable it to identify and procure the recall (if necessary) of Products which may be affected in any way by manufacturing and production problems. The Supplier shall provide details to the Buyer of its batch-tracking system upon request to do so.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7&nbsp;&nbsp;&nbsp;&nbsp;The parties agree that, in relation to Product recalls:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7.1&nbsp;&nbsp;&nbsp;&nbsp;The Buyer shall be responsible for any recall of a Product. The Supplier shall cooperate with the Buyer in the event of any recall and provide such reasonable assistance in connection therewith as the Buyer may reasonably request.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7.2&nbsp;&nbsp;&nbsp;&nbsp;In the event the Buyer should be required or should voluntarily decide to initiate a recall, Product withdrawal, or field correction of any Product, the Buyer shall notify the Supplier and provide a copy of its recall letter. In conjunction with such recall, the Supplier shall provide reasonable assistance in any investigation reasonably required to determine the cause and extent of the problem causing the recall.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7.3&nbsp;&nbsp;&nbsp;&nbsp;In the event that the Supplier independently believes that a recall, Product withdrawal, or field correction of a Product may be necessary or appropriate, the Supplier shall notify the Buyer and reasonably cooperate with the Buyer concerning the necessity and nature of such action.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7.4&nbsp;&nbsp;&nbsp;&nbsp;All coordination of any recall or field correction activities involving a Product shall be handled by the Buyer whether or not such action was initiated by the Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7.5&nbsp;&nbsp;&nbsp;&nbsp;Subject to clause 9.7.7, in the event that any Product is recalled as a result of a the breach of this Agreement by or negligent or intentionally wrongful act of, the Supplier or its representatives (including without limitation the supply by the Supplier of Product that does not conform to the requirements of this clause 9), then the Supplier shall bear all of the costs and expenses of such recall, including, without limitation, expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product from customers and shipment of an equal amount of replacement Product to those same customers.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7.6&nbsp;&nbsp;&nbsp;&nbsp;Subject to clause 9.7.7, in the event that any Product is recalled for any other reason other than that specified in clause 9.7.5, then the Buyer shall bear all of the costs and expenses of such recall, including without limitation expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the costs of notifying customers and costs associated with shipment of recalled Product from customers and shipment of an equal amount of replacement Product to those same customers.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7.7&nbsp;&nbsp;&nbsp;&nbsp;To the extent that the reason for any recall of Products hereunder is in part caused by the Supplier and in part caused by the Buyer, then the costs and expenses shall be allocated in an equitable manner between the parties. For avoidance of doubt, neither party shall be liable for any indirect or consequential loss in relation to the Product recall.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7.8&nbsp;&nbsp;&nbsp;&nbsp;If the parties disagree on who shall bear the costs and expenses of a Product recall under this Clause 9.7, the parties shall use the dispute resolution process as set out in clause 20 to determine the allocation of such costs and expenses.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7.9&nbsp;&nbsp;&nbsp;&nbsp;The Buyer will inform the Supplier of any product manufacturing complaints they are aware of. The Supplier shall investigate the issues promptly and provide a written report to the Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7.10&nbsp;&nbsp;&nbsp;&nbsp;If the Supplier becomes aware of any Product complaints it will promptly notify the buyer and provide reasonable assistance in investigating such complaints.

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**10&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;WARRANTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1&nbsp;&nbsp;&nbsp;&nbsp;The Supplier hereby warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.1&nbsp;&nbsp;&nbsp;&nbsp;any Products manufactured pursuant to this Agreement shall comply with all provisions as to quality set out in clause 9 hereof;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.2&nbsp;&nbsp;&nbsp;&nbsp;it will not be negligent in the manufacture of the Products or in the supply of Services;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.3&nbsp;&nbsp;&nbsp;&nbsp;the Products manufactured pursuant to this Agreement will:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.3.1&nbsp;&nbsp;&nbsp;&nbsp;be free from all defects obvious on visual inspection of the Product,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.3.2&nbsp;&nbsp;&nbsp;&nbsp;be fit for their purpose and satisfactory quality,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.3.3&nbsp;&nbsp;&nbsp;&nbsp;comply with all applicable statutes and regulations relating to the Products,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.3.4&nbsp;&nbsp;&nbsp;&nbsp;conform in all respects with the Specifications and the Technical Manual;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.4&nbsp;&nbsp;&nbsp;&nbsp;any Services supplied by the Supplier or its subcontractors or agents will be supplied:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.4.1&nbsp;&nbsp;&nbsp;&nbsp;by appropriately qualified and trained personnel, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.4.2&nbsp;&nbsp;&nbsp;&nbsp;with reasonable care and diligence;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.5&nbsp;&nbsp;&nbsp;&nbsp;so far as the Supplier is aware the manufacture of the Products and the supply of the Services will not infringe any third party rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2&nbsp;&nbsp;&nbsp;&nbsp;The Supplier further warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2.1&nbsp;&nbsp;&nbsp;&nbsp;it will meet all Orders from the Buyer for the Product, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2.2&nbsp;&nbsp;&nbsp;&nbsp;it will supply the Products in accordance with Clause 5.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.3&nbsp;&nbsp;&nbsp;&nbsp;The Buyer warrants that any supply of APls provided by the Buyer to the Supplier in accordance with the terms of this Agreement shall comply with the API Specification.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4&nbsp;&nbsp;&nbsp;&nbsp;Each of the Supplier and the Buyer warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.1&nbsp;&nbsp;&nbsp;&nbsp;it is duly incorporated and organised and is validly existing under the laws of its jurisdiction of incorporation and has the corporate power and authority to own its assets and to conduct its businesses and to perform its obligations hereunder,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.2&nbsp;&nbsp;&nbsp;&nbsp;the execution and delivery of this Agreement by it and the completion by it of the obligations contemplated herein, do not and will not result in the breach of, or violate any term or provision of, its articles or by-laws,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.3&nbsp;&nbsp;&nbsp;&nbsp;it is not subject to any outstanding injunction, judgement or order of any governmental authority which would prevent or materially delay the transactions contemplated by this Agreement, there are no civil, criminal or administrative claims, actions, suits, demands, proceedings, hearings or investigations pending or, to the Supplier's knowledge, threatened at law, in equity or otherwise, in, before, or by, any governmental authority which (if successful) would prevent or materially delay the Supplier's compliance with the provisions of this Agreement,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.4&nbsp;&nbsp;&nbsp;&nbsp;no dissolution, winding up, bankruptcy, liquidation or similar proceeding has been commenced, or is pending or proposed, in respect of it,

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.5&nbsp;&nbsp;&nbsp;&nbsp;the execution and delivery of this Agreement and the completion of the obligations contemplated herein have been duly approved by appropriate persons within its organisation and this Agreement constitutes legal, valid and binding obligations of the Supplier enforceable against it in accordance with its terms, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.6&nbsp;&nbsp;&nbsp;&nbsp;it or its Affiliates has taken or will take all action as may be required or necessary to obtain and maintain, comply and keep current any governmental licences, permits, approvals and/or registrations that are necessary for the Supplier and/or its Affiliates to manufacture and/or supply the Products and Services and to carry out and perform its obligations under this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.5&nbsp;&nbsp;&nbsp;&nbsp;Without prejudice to any other remedy (and the Buyer's rights generally under this Agreement) if any Services are not supplied or performed in accordance with this Agreement, then the Buyer at its sole option shall be entitled to require the Supplier at Supplier's cost within such reasonable time as is required by the Buyer in writing to supply replacement Services conforming with this Agreement.

**11&nbsp;&nbsp;&nbsp;&nbsp;INDEMNITY**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1&nbsp;&nbsp;&nbsp;&nbsp;On the terms and subject to the conditions of this clause 11, the Buyer shall defend, indemnify and hold harmless the Supplier, its Affiliates and their respective officers, directors, employees and agents (collectively, **"Supplier lndemnitees"**), from and against any and all liabilities, damages, losses, costs, taxes, expenses (including reasonable legal fees and other expenses of litigation and arbitration), claims, demands, suits, penalties, judgments or administrative and judicial orders (collectively, **"Losses"**) relating to any Proceeding to the extent arising out of or resulting from (i) any negligent act or omission of the Buyer or its Affiliates, or any of their respective officers, directors, employees or agents in connection with the performance of this Agreement; or (ii) any breach by the Buyer or its Affiliates of any of its representations, warranties or obligations contained in this Agreement, in each case (i) and (ii), except for those Losses for which the Supplier has an obligation to indemnify a Buyer lndemnitee pursuant to clause 11.2, as to which Losses each party shall indemnify the other to the extent of their respective liability for such Losses.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2&nbsp;&nbsp;&nbsp;&nbsp;On the terms and subject to the conditions of this clause 11, the Supplier shall defend, indemnify and hold harmless the Buyer, its Affiliates, and their respective officers, directors, employees and agents (collectively, **"Buyer lndemnitees"**), from and against any and all Losses relating to any Proceeding to the extent arising out of or resulting from (i) any negligent act or omission of the Supplier, its Affiliates, its contract manufacturers or Raw Material suppliers (other than the Buyer), or any of their respective officers, directors, employees or agents in connection with the performance of this Agreement, or (ii) any breach by the Supplier or its Affiliates of any of its representations, warranties or obligations contained in this Agreement, in each case (i) and (ii), except for those Losses for which the Buyer has an obligation to indemnify a Supplier lndemnitee pursuant to clause 11.1, as to which Losses each party shall indemnify the other to the extent of their respective liability for such Losses.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3&nbsp;&nbsp;&nbsp;&nbsp;Each party shall take out and maintain in full force and effect sufficient insurance (which shall be no less than [\*\*\*] GBP (£[\*\*\*]) in respect of each and every claim or series of claims arising from the same incident) to cover such liabilities as it may incur by virtue of this Agreement or by reason of the manufacture and supply of the Products including, without limitation, in respect of product liability claims. The existence of such insurance shall not be construed as a limitation of the Supplier's liability hereunder and shall not affect the liability of the Buyer hereunder which shall be limited to payment for any Products which are the subject matter of any Orders and which have been supplied by the Supplier in accordance with the provisions of this Agreement. The Supplier shall ensure that the Buyer's interest is noted on such policy and, at the request of the Buyer, produce for inspection by the Buyer a valid certificate of insurance in respect of such insurance cover and the receipt for the then current premium.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.4&nbsp;&nbsp;&nbsp;&nbsp;Each party shall promptly notify the other of claims likely to be made by such party under the terms of this Agreement, and shall promptly exchange any relevant documents and records within its possession or control, save for any documents or records which are the subject of legal or professional privilege, for the purpose of investigating such claim. Each party shall consult the other party prior to making any settlement of a third party claim or action.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.5&nbsp;&nbsp;&nbsp;&nbsp;Nothing in clause 11 shall operate to limit or exclude any liability for death or personal injury caused by either party's (or their agent's or subcontractor's) act or omission or negligence or for fraud.

**12&nbsp;&nbsp;&nbsp;&nbsp;TITLE AND RISK**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.1&nbsp;&nbsp;&nbsp;&nbsp;Title to the Products shall pass to the Buyer upon delivery to the DAP (lncoterms 2000) Point.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2&nbsp;&nbsp;&nbsp;&nbsp;The Products shall be at the Supplier's risk until they are delivered to an authorised representative of the Buyer at the Delivery Point. The Supplier shall fully insure the Products for so long as they remain at the Supplier's risk.

**13&nbsp;&nbsp;&nbsp;&nbsp;CONFIDENTIAL INFORMATION AND INTELLECTUAL PROPERTY RIGHTS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.1&nbsp;&nbsp;&nbsp;&nbsp;Each party acknowledges that the Confidential Information may be disclosed to it by the other party (or its Affiliates) in connection with the Products, this Agreement and potentially in connection with other possible contract manufacturing. The recipient party shall keep such information strictly confidential (both during the subsistence and after the termination or expiry of this Agreement), shall not disclose it to any third party (including an Affiliate) and shall only disclose it to those of its employees who need to know it for the purposes of this Agreement and who have agreed to be bound by similar duties of confidentiality as the recipient party. In particular, and without limiting the foregoing, the Supplier shall not disclose to any third party (including an Affiliate) or use for any other purpose any information contained in the Specifications or the Technical Manual.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.2&nbsp;&nbsp;&nbsp;&nbsp;The Supplier agrees to use the Confidential Information of the Buyer or its Affiliates only for the purpose of manufacturing and supplying the Products for the Buyer or its Affiliates on the terms of this Agreement and for no other purpose or for its or any third party's benefit.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3&nbsp;&nbsp;&nbsp;&nbsp;The restrictions in clauses 13.1 and 13.2 shall not apply to any Confidential Information to the extent that such Confidential Information:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.1&nbsp;&nbsp;&nbsp;&nbsp;is or becomes public knowledge through no fault of the receiving party,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.2&nbsp;&nbsp;&nbsp;&nbsp;is required to be disclosed by applicable laws or order of the court or other competent authority, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.3&nbsp;&nbsp;&nbsp;&nbsp;is disclosed in confidence to professional advisers, auditors, insurers and bankers.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.4&nbsp;&nbsp;&nbsp;&nbsp;The Buyer or as the case may be any Affiliate of the Buyer retains the ownership of all rights (including without limitation Intellectual Property Rights) in the Product formulation for the duration of and at any time after the termination of this Agreement. For the avoidance of doubt, this information constitutes Confidential Information of the Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.5&nbsp;&nbsp;&nbsp;&nbsp;All copyright and other Intellectual Property Rights in any artwork and origination work supplied by the Buyer or its nominee for the labelling, packaging and, where applicable, package inserts for the Products is and shall remain the property of the Buyer or its nominee absolutely. The Supplier shall not supply or manufacture any such packaging or other components or finished Products or confusingly similar packaging or products other than to the Buyer or as it may direct.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.6&nbsp;&nbsp;&nbsp;&nbsp;If during the term of this Agreement the Supplier (or any agent or authorised sub contractor of it) develops or creates (whether with or without others) any Arising Product Intellectual Property Rights, the Supplier shall promptly disclose any such Arising Product Intellectual Property Rights to the Buyer and shall promptly upon request by the Buyer assign the entire right, title and interest to any and all such Arising Product Intellectual Property Rights to the Buyer or any of its Affiliates with full title guarantee for a nominal consideration.

Subject to the foregoing, the Supplier shall own all Arising Supplier Intellectual Property Rights the Supplier (or any agent or authorised sub-contractor of it) develops or creates (with or without others (excluding the Buyer)). The Buyer shall own all Arising Product Intellectual Property Rights the Buyer

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(or any agent or authorised sub-contractor of it) develops or creates (with or without others). All Existing Intellectual Property Rights are and shall remain the exclusive property of the party owning them (or, where applicable, the third party from whom its right to use the Existing Intellectual Property Rights has derived).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.7&nbsp;&nbsp;&nbsp;&nbsp;During the term of this Agreement, the Supplier shall not assign or license any of the Supplier's Existing Intellectual Property Rights to other parties for use in relation to the Products or similar to the Products (**"the Product Field"**).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.8&nbsp;&nbsp;&nbsp;&nbsp;During the term of this Agreement, and whether in isolation or for or with others, the Supplier shall not carry out research or research and development work in the Product Field which is other than pursuant to this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.9&nbsp;&nbsp;&nbsp;&nbsp;To the extent that the Buyer requires a licence from the Supplier of any of the (i) Supplier's Existing Intellectual Property Rights (excluding any trade marks and rights in passing off) owned or controlled by the Supplier or any of its Affiliates and/or (ii) Arising Supplier Intellectual Property Rights, in each case which are used by the Supplier in the then-current manufacturing process, for the purposes of the Technical Transfer and the related manufacture and commercialisation of Products, the Supplier hereby grants (and shall procure that its Affiliates grant) to the Buyer (to the extent permitted) a non-exclusive irrevocable, perpetual, world-wide, royalty-free, transferable and sub-licensable licence in respect thereof. For the avoidance of doubt, this licence shall survive the termination or expiry of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.10&nbsp;&nbsp;&nbsp;&nbsp;To the extent that the Supplier requires a licence from the Buyer of any of the (i) Buyer's Existing Intellectual Property Rights owned by the Buyer or any of its Affiliates and/or (ii) Arising Product Intellectual Property Rights, in each case in order to perform its obligations under this Agreement, the Buyer hereby grants (and shall procure the grant) to the Supplier for the duration of this Agreement a non-exclusive irrevocable, royalty-free, non-transferable and non-sublicensable licence in respect thereof, exercisable only at the Manufacturing Site.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.11&nbsp;&nbsp;&nbsp;&nbsp;In the event that the Supplier shall decide that it no longer wishes to prosecute or maintain any registered protection for any of the Supplier's Existing Intellectual Property Rights (excluding any trade marks and rights in passing off) in relation to the Product Field for any country it shall notify the Buyer in writing (and in any event **at least** 90 days before the date upon which any payment or step would be required to be taken to continue prosecuting or maintaining any such protection). If within 60 days of receipt of such notice from the Supplier, the Buyer indicates to the Supplier that it wishes to take an assignment of such Existing Intellectual Property Rights, it shall so notify the Supplier who immediately shall assign, with full title guarantee, the entire right, title and interest to such Existing Intellectual Property Rights to the Buyer for a nominal consideration. For the avoidance of doubt, this includes any registered protection which the company is entitled to claim priority from an earlier application at the end of the Paris Convention priority period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.12&nbsp;&nbsp;&nbsp;&nbsp;During the term of this Agreement and upon their knowledge of the occurrence of (i) any infringement or suspected or threatened infringement of any of the Arising Product Intellectual Property Rights, Arising Supplier Intellectual Property Rights or Existing Intellectual Property Rights, or (ii) any proceedings or suspected or threatened proceedings for the revocation or involving the validity of any such Intellectual Property Rights, the party with this knowledge shall notify the other and provide all details within their knowledge with respect to the same and thereafter the parties will assist each other in taking such steps as either party may reasonably consider to be appropriate at the expense of the party that considers such steps to be appropriate.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.13&nbsp;&nbsp;&nbsp;&nbsp;For any Existing Intellectual Property Rights and any Arising Product Intellectual Property Rights or Arising Supplier Intellectual Property Rights, in each case owned by or to be owned by the Buyer or Supplier (as applicable), the Buyer or Supplier shall provide all necessary assistance, required by the other party to complete the registration of such rights with the competent authorities in anywhere designated by the Buyer or Supplier (as applicable) (subject to the designating party bearing the reasonable costs and expenses incurred by the other party in respect of such assistance).

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.14&nbsp;&nbsp;&nbsp;&nbsp;For the purpose of protecting the Existing Intellectual Property Rights, the Arising Product Intellectual Property Rights or Arising Supplier Intellectual Property Rights each party shall also procure that its Affiliates shall comply with clauses 13.12, 13.13 and this clause 13.14.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.15&nbsp;&nbsp;&nbsp;&nbsp;Without prejudice to a party's right to challenge the validity of any registrations of Intellectual Property Rights owned by the other party, each party undertakes that it shall not at any time during the continuance of this Agreement do or suffer to be done any act or thing which would impair the rights of the other party in its Intellectual Property Rights relevant to this Agreement and further undertakes that it shall not represent that it has any title to or right of ownership in such Intellectual Property Rights of the other party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.16&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall at the request of the Buyer (and at the Buyer's cost) execute such registered user agreement in respect of the use of the trade marks of the Buyer or its Affiliates as the Buyer may reasonably require.

**14&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]**

**<u>[\*\*\*]</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.1.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*], and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.1.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*];

[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.3&nbsp;&nbsp;&nbsp;&nbsp;If, other than to the extent caused by the Buyer's breach of its obligations under this Agreement:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.3.1&nbsp;&nbsp;&nbsp;&nbsp;the Supplier's OTIF performance decreases such that it falls below the Emergency Trigger Level at any time, without prejudice to any other right or remedy of the Buyer, whether hereunder or at law, the Supplier shall use all reasonable endeavours to improve performance such that its OTIF performance returns to the Target OTIF Level, which endeavours shall include without limitation (a) allocation of any resource required (including people and/or funds) so as to return to the Target OTIF Level (including the allocation of additional, appropriately qualified, permanent and temporary staff and/or putting on additional shifts); and (b) at the Buyer's request, rapid approval of a new supplier of Raw Materials (as applicable),

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.3.2 &nbsp;&nbsp;&nbsp;&nbsp;the Supplier's OTIF performance falls below the Emergency Trigger Level over any four (4) consecutive weeks or any ten (10) weeks in any rolling twelve (12) months period or the Supplier is aware of circumstances that will result in the same (a **"Material OTIF Failure"**) the parties agree, without prejudice to any other right or remedy of the Buyer, whether hereunder or at law,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.3.2.1&nbsp;&nbsp;&nbsp;&nbsp;the Supplier shall:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(A)&nbsp;&nbsp;&nbsp;&nbsp;submit a draft rectification plan to the Buyer as soon as possible and in any event within five Business Days (or such other period as may be agreed between the parties), which draft rectification plan shall set out (1) full details of the Material OTIF Failure, including an analysis of the cause, and (2) the steps which the Supplier proposes to take (using all reasonable endeavours) to rectify the Material OTIF Failure and/or to prevent the Material OTIF Failure from continuing or recurring (as applicable), including timescales for such steps and for the rectification of the Material OTIF Failure, and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(B)&nbsp;&nbsp;&nbsp;&nbsp;provide to the Buyer any further documentation that the Buyer reasonably requires to assess the analysis of the cause and viability of the proposed rectification or preventative steps,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.3.2.2&nbsp;&nbsp;&nbsp;&nbsp;the Buyer shall notify the Supplier whether it consents to the draft rectification plan as soon as reasonably practicable. If the Buyer consents to the draft rectification plan (such draft then being the **"Rectification Plan"**), the Supplier shall immediately commence the actions set out in the Rectification Plan,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.3.2.3&nbsp;&nbsp;&nbsp;&nbsp;if (i) the Buyer, acting reasonably, does not consent to the draft rectification plan within five Business Days of receipt of the draft rectification plan, (ii) the Supplier has not submitted a draft rectification plan in accordance with clause 14.3.2.1 above or (iii) the Material OTIF Failure has not been cured or remedied in accordance with the Buyer's reasonably expected progress of an agreed Rectification Plan, then either party may serve notice to escalate this matter in accordance with clause 20.1 (such notice being an Escalation Notice for purpose of clause 20.1) and clause 20 shall apply save that the parties agree:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(A) &nbsp;&nbsp;&nbsp;&nbsp;the 14 (fourteen) day period in clause 20.1.1 shall be reduced to five (5) days,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(B)&nbsp;&nbsp;&nbsp;&nbsp;the 14 (fourteen) day period in clause 20.1.2 shall be reduced to five (5) days,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(C)&nbsp;&nbsp;&nbsp;&nbsp;in the event that the matter is not resolved by the parties in accordance with clause 20.1.2 (as amended by item ii. above) the issue shall be referred to (1) the Supplier's CEO on the one hand, and (2) the Buyer's CEO on the other hand, who shall meet and seek to resolve such issue within 10 (ten) days of such matter being referred to them (or within such longer period as the parties may agree in writing prior to the expiration of the initial 10 (ten)-day period), and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(D) &nbsp;&nbsp;&nbsp;&nbsp;in the event that the matter is not resolved by the parties under item iii. above within such 10 (ten)-day period (or longer period as agreed between the parties under item iii. above) the Buyer may, without prejudice to any other right or remedy whether hereunder or at law, exercise its rights under clause 14.3.2.4 below, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.3.2.4&nbsp;&nbsp;&nbsp;&nbsp;in the event that (i) the matter is not resolved via escalation under and in accordance with clause 14.3.2.3 above, or (ii) the Supplier does not return the OTIF performance level to the Target OTIF Level by performing the steps set out in the Rectification Plan within the time period set out in that Rectification Plan, the Buyer may, without prejudice to any other right or remedy whether hereunder or at law, give notice to the Supplier (a) of such failure and (b) [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.4&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.4.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*],

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.4.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*],

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.4.3&nbsp;&nbsp;&nbsp;&nbsp;without limiting the generality of clause 14.5.2, causing an appropriate number of analytical and quality control laboratory employees and representatives of the Supplier to meet with employees or representatives of the Transferee, at the Buyer's sole cost and expense as to reasonable costs and expenses, properly incurred, at both the manufacturing facility of the Supplier and the manufacturing facility of the Transferee and make available all necessary equipment, at mutually convenient times, to support and execute the transfer of all applicable analytical methods and the validation thereof,

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.4.4&nbsp;&nbsp;&nbsp;&nbsp;without limiting the generality of the preceding clauses, support for analytical method transfers / establishment of pharmacopieal methods (a collaborative inter-laboratory transfer of the analytical test methods required for the Product), equipment qualification and validation (of alternative supplier's equipment), cleaning validation (the provision of validated cleaning test method that is fit for purpose), engineering batch manufacture and validation (assisting alternative supplier as required to manufacture and validate such batches), registration stability *I* process validation batches (assist as required in the manufacture of full commercial scale batches, enabling the Buyer to generate stability data to be submitted as part of regulatory filing for the Product) and secondary packaging process validations (assisting as needed to ensure secondary packaging is performed according to validated processes and settings), and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.4.5&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]. For the purpose of this clause, successful technology transfer shall have taken place once the Transferee has produced three (3) commercial scale batches of the Product (or such greater number of batches as may then be required by cGMP or by the FDA or EMA to conclude that the practice of the then-current manufacturing process by the Transferee to manufacture the Product is validated) that conform to the Specification and at yields substantially comparable to the yields obtained by the Supplier.

**<u>Exclusive uses of manufacturing lines</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.5&nbsp;&nbsp;&nbsp;&nbsp;The parties agree that the manufacturing and packaging lines used for the manufacture of the products will:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.5.1&nbsp;&nbsp;&nbsp;&nbsp;be exclusively used for, and dedicated to, the production of the Products for the Buyer (unless otherwise agreed by the Buyer following the Supplier's written request for alternative use),

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.5.2&nbsp;&nbsp;&nbsp;&nbsp;be physically separated from areas of manufacture of any products other than the Products, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.5.3&nbsp;&nbsp;&nbsp;&nbsp;not be transferred from existing locations without the Buyer's prior written consent, such consent not to be unreasonably withheld following the Supplier's written request for such consent detailing reasons and impact of such transfer.

**15&nbsp;&nbsp;&nbsp;&nbsp;TERMINATION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15.1 &nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be terminated at any time upon either party giving to the other thirty (30) days' notice in writing if the other party commits a material breach of the terms of this Agreement and (where such breach is capable of remedy) fails to remedy such breach within thirty (30) days of receiving written notice from the other party specifying the breach and requiring its remedy.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15.2&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be terminated by either party immediately on written notice to the other, if,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15.2.1&nbsp;&nbsp;&nbsp;&nbsp;the other party shall go into liquidation whether voluntary or compulsory or is dissolved or becomes insolvent or if a petition shall be presented or an order made for the appointment of an administrator or if a receiver, administrative receiver or manager shall be appointed over any part of its assets or undertaking which appointment is not dismissed within thirty (30) days of having been made, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15.2.2&nbsp;&nbsp;&nbsp;&nbsp;any distress, execution, sequestration or other process is levied or enforced upon or sued out against the property of the other party which is not discharged within thirty (30) days, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15.2.3&nbsp;&nbsp;&nbsp;&nbsp;the other is unable to pay its debts in the normal course of business.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15.3&nbsp;&nbsp;&nbsp;&nbsp;Without prejudice to any other remedy (and the Buyer's rights generally under this Agreement) if and to the extent that the Supplier does not (i) supply or deliver the Products in accordance with the terms of the relevant Order or (ii) comply with (a) the relevant Order Requirements or (b) a request for Services under clause 7.4, then, unless and to the extent such failure is caused by the Buyer's breach of this Agreement, the Buyer at its sole option shall be entitled to treat such failure as a material breach in which case clause 15.1 shall apply. If, following the remedial period as set out in clause 15.1, such material breach has not been remedied, the Supplier shall forthwith repay the Price (or any part of the Price) the Buyer has paid for such Products or Services to the Buyer and return any Tooling owned by the Buyer or any of its Affiliates which are located at the Supplier's premises to the Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15.4&nbsp;&nbsp;&nbsp;&nbsp;Within 5 Business Days of this Agreement terminating for any reason, the Buyer shall have the option by serving written notice on the Supplier to acquire any Tooling used exclusively for the Products which it does not own, the consideration for which shall be an amount equal to the original purchase price for that Tooling paid by the Supplier less any amounts paid by the Buyer to the Supplier in respect of amortisation in respect of that Tooling. If the Buyer does not serve such notice the Supplier may elect, at its sole discretion to either (i) retain ownership of the Tooling, or (ii) by serving written notice on the Buyer within ten (10) Business Days of such termination, require the Buyer to take ownership and delivery of the Tooling for no consideration.

**16&nbsp;&nbsp;&nbsp;&nbsp;CONSEQUENCES OF TERMINATION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.1&nbsp;&nbsp;&nbsp;&nbsp;Upon termination or expiry of this Agreement for whatever reason:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.1.1&nbsp;&nbsp;&nbsp;&nbsp;the Supplier shall at the request of the Buyer, use its reasonable endeavours to novate those contracts that provide for the supply of all Raw Materials exclusively used in the production of the Products to the Buyer, or as the Buyer may direct and to meet any reasonable request from any competent authority and the Buyer required to transfer production or any registrations or licences or approvals to the Buyer, its Affiliates or any third party approved in writing by the Buyer. The parties shall discuss in good faith and attempt to agree as expeditiously as possible a mutually acceptable course of action with respect to any contracts that provide for the supply of Raw Materials that are used both in the production of the Products and products of the Supplier,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.1.2&nbsp;&nbsp;&nbsp;&nbsp;the Supplier shall at the request of the Buyer release and make available for immediate collection by or on behalf of the Buyer (i) all finished Products at the Prices set out in Schedule One, (ii) all API the Supplier has in stock and (iii) all Raw Materials attributable to the Products which the Supplier has in stock at cost price,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.1.3&nbsp;&nbsp;&nbsp;&nbsp;the Supplier shall at the request of the Buyer promptly and efficiently undertake and complete a Technical Transfer to the Transferee to enable the Transferee to establish and conduct cGMP manufacture of the Products,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.1.4&nbsp;&nbsp;&nbsp;&nbsp;each party shall promptly procure the delivery to the other party of, or destroy, all copies in its possession of all Confidential Information of the other party which is in documentary or other tangible form (including all copies thereof) and which has been disclosed to it together with all material relating to that Confidential Information prepared by, or on behalf of, it (save to the extent that first party is required by applicable law to maintain a copy of such information or as required by the first party to exercise any rights and licences that survive termination or expiry, including in the case of the Buyer to manufacture and commercialise Products following Technical Transfer in accordance with this Agreement) and, at the other party's request, undertake to the other party in writing that it has complied with the provisions of this clause 16, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.1.5&nbsp;&nbsp;&nbsp;&nbsp;the Supplier shall promptly collect, pack and make ready for delivery to the Buyer all Tooling, and follow all reasonable directions of the Buyer with respect to the disposition of such Tooling. In the event that the Buyer has not achieved the Purchase Terms with respect to any items of Tooling as of the termination of this Agreement, the Buyer shall pay the Supplier the unamortised portion of the purchase price thereof within thirty (30)

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days following the termination date, and the Supplier shall take such actions as the Buyer may reasonably request to confirm the Buyer's exclusive right, title and interest therein promptly following receipt of such payment, including tendering such Tooling for shipment in accordance with this clause.

**17&nbsp;&nbsp;&nbsp;&nbsp;ASSIGNMENT AND THIRD PARTY RIGHTS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.1&nbsp;&nbsp;&nbsp;&nbsp;Save as provided in clause 17.2 neither the benefit nor the obligations of this Agreement or of any provision of it may be assigned or transferred by either party without the prior written consent of the other.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.2&nbsp;&nbsp;&nbsp;&nbsp;The benefit subject to the obligations of this Agreement shall be assignable by the Buyer to any Affiliate of the Buyer or to the purchaser of all or a substantial part of the business of the Buyer (or any other Affiliate of the Buyer) and in the event of such assignment, the Buyer shall with effect from such assignment be released from its obligations hereunder and all references in this Agreement to the Buyer shall be deemed to include its assigns.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.3&nbsp;&nbsp;&nbsp;&nbsp;Any Affiliate of the Buyer may place orders under this Agreement (which orders shall be placed through one or more nominated contact points as agreed between the parties from time to time) and may accordingly in their own right enforce the provisions of this Agreement, as though it were the Buyer, provided that (a) each Affiliate of the Buyer that places an order shall by doing so be deemed to have assumed the Buyer's obligations under this Agreement, and (b) the Buyer shall remain obligated for the performance of all of the obligations of the Buyer and Affiliate of the Buyer arising from this paragraph.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.4&nbsp;&nbsp;&nbsp;&nbsp;The Buyer, or as the case may be any Affiliate of the Buyer, may upon written notice require that the Supplier deliver the Products from any order (in whole or part) to the place of business of the Buyer or any agent or sub-contractor of the Buyer or as the case may be any Affiliate of the Buyer provided however that such place of delivery is in the UK and that such notice(s) shall not affect the Buyer's obligations hereunder and such notice shall not be deemed to be any assignment of the benefits or obligations of the Buyer hereunder. The Supplier may charge the Buyer (on a passthrough basis) for any reasonable additional costs properly incurred by the Supplier as a direct result of a change of delivery destination.

**18&nbsp;&nbsp;&nbsp;&nbsp;FORCE MAJEURE**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1&nbsp;&nbsp;&nbsp;&nbsp;If either party (the **"Affected Party"**) is prevented or delayed in the performance of any of its obligations under this Agreement as a result of civil commotion, embargo, governmental legislation or regulation, not, invasion, war, threat of or preparation for war, fire, explosion, storm, flood, earthquake, subsidence, epidemic or other natural physical disaster or other event beyond the reasonable control of a party that has not occurred as a result of its negligence or other act or omission and which was not reasonably foreseeable (**"Force Majeure Event"**), it shall notify the other party, in writing, of the same as soon as practicable, fully detailing the background to, and all relevant matters connected with, such Force Majeure Event, together with such evidence thereof that it reasonably can give and specifying the period for which such prevention or delay can reasonably be expected to continue. The Affected Party shall use its reasonable endeavours to remove or overcome such Force Majeure Event as quickly as possible and shall also use its reasonable endeavours to mitigate the impact of such Force Majeure Event of the other party. Subject to clause 18.2, if the Affected Party has fully complied with its obligations under this clause 18.1, it shall be excused from performance of its unfulfilled obligations under this Agreement from the date of such notice until such Force Majeure Event no longer pertains.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.2&nbsp;&nbsp;&nbsp;&nbsp;If a Force Majeure Event prevents performance by the Affected Party of any obligations hereunder for a continuous period in excess of eight (8) weeks, the other party shall be entitled to terminate this Agreement by written notice at any time after such 8 week period provided the relevant Force Majeure Event remains subsisting at the time such notice is given.

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**19&nbsp;&nbsp;&nbsp;&nbsp;BUSINESS CONTINUITY PLAN**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.1&nbsp;&nbsp;&nbsp;&nbsp;The parties acknowledge that the regulatory requirements and associated timescales involved in switching manufacture of the Products to an alternative supplier are significant and as such the Supplier's business continuity plan shall focus on risk minimisation and mitigation to maintain the Supplier as the manufacturer of the Products. Within three (3) months of start of production or thirty (30) days of the Buyer's request, whichever is the sooner, the Supplier will provide the Buyer with a detailed, written business interruption and recovery plan, including business impact and risk assessment, crisis management, information technology disaster recovery, and business continuity (including plans to source Raw Materials and how a Technology Transfer would be performed in the event of an emergency) (the **"BCP Plan"**).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.2&nbsp;&nbsp;&nbsp;&nbsp;The Supplier will update the BCP Plan annually and provide a copy to the Buyer on 31 July each year demonstrating risk mitigation against the previous year. Such BCP Plan shall be discussed as part of the annual review set out in clause 7.1 above and the Supplier agrees to adhere to the BCP Plan, including any modifications or changes mutually agreed between the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.3&nbsp;&nbsp;&nbsp;&nbsp;The Supplier will notify the Buyer in writing within twenty-four (24) hours of any activation of the BCP Plan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.4&nbsp;&nbsp;&nbsp;&nbsp;Subject to clause 18, the Supplier agrees that in the event that the BCP Plan is activated and during such activation the Buyer, acting reasonably, concludes that the Supplier is not able to fulfil its obligations under this Agreement and the Products will go out of stock in markets, on the Buyer's request the Supplier will perform, at the Buyer's cost (as to reasonable expenses properly incurred), an emergency Technology Transfer to a third party identified by the Buyer as an alternative source of manufacture of the Products and the Buyer's obligations to purchase Products exclusively from the Supplier as set out under this Agreement shall cease to apply.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.5&nbsp;&nbsp;&nbsp;&nbsp;If the Supplier's ability to supply the Products to its customers becomes limited due to a Force Majeure Event, or otherwise limited due to circumstances not foreseen by this Agreement, such that the Supplier is making allocations of Raw Materials (other than Raw Materials supplied by the Buyer (if any), which may not be allocated) on a pro rata basis between Products and products of third party customers to its customers, the Supplier undertakes that it shall nevertheless use all reasonable endeavours to supply the Buyer with its requirement of Raw Materials (or such other pro rata volume as is agreed with the Buyer) as evidenced by any unfulfilled Order and in accordance with the terms of this Agreement.

**20&nbsp;&nbsp;&nbsp;&nbsp;DISPUTE RESOLUTION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.1&nbsp;&nbsp;&nbsp;&nbsp;Prior to the beginning of any arbitration process the parties hereby undertake to attempt to resolve any dispute arising under or in relation to this Agreement by way of negotiation between senior executives of the parties who have authority to settle such dispute, subject to the Buyer's rights under clause 14.3. In furtherance of the foregoing, any party shall initiate the negotiation by way of a notice (an **''Escalation Notice"**) demanding an in-person meeting or telephone conference involving representatives of the parties at a senior level of management of the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.1.1&nbsp;&nbsp;&nbsp;&nbsp;A copy of any Escalation Notice shall be given to, as a first stage (i) the Supplier's SVP Health Supply on the one hand, and (ii) the Buyer's Supply Director on the other, who shall meet and seek to resolve such issue within fourteen (14) days of such matter being referred to them (or within such longer period as the parties may agree in writing prior to the expiration of the initial fourteen (14) day period), and if the matter is not resolved between these parties within such fourteen (14) day period either of the representatives of such party may refer the matter to the second stage escalation as set out below.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.2.2&nbsp;&nbsp;&nbsp;&nbsp;As a second stage escalation, the matter shall be referred to (i) the Supplier's EVP Global Supply on the one hand, and (ii) the Buyer's Group Finance Director on the other hand, who shall meet and seek to resolve such issue within fourteen (14) days of such matter being referred to them (or within such longer period as the parties may agree in writing prior to the expiration of the initial fourteen (14) days period).

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.2.3&nbsp;&nbsp;&nbsp;&nbsp;In the event agreement cannot be reached in accordance with clauses 20.1.1 and 20.1.2, or clause 14.3 (as applicable) the dispute will be subject to arbitration as described in clauses 20.3 and 20.6.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.2&nbsp;&nbsp;&nbsp;&nbsp;The costs of the arbitration shall be fixed by the arbitral tribunal and shall be borne by the unsuccessful party, unless the arbitral tribunal, in its discretion, determines a different apportionment, taking all relevant circumstances into account. The costs of arbitration include: (i) the fees and disbursements of the arbitrator, (ii) the reasonable fees, travel and other expenses of expert witnesses, and (iii) the costs of legal representation and assistance, to the extent that the arbitral tribunal determines that the amount of such costs is reasonable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.3&nbsp;&nbsp;&nbsp;&nbsp;The arbitral tribunal shall endeavour to issue its award within sixty (60) days of the last hearing of the substantive issues in dispute between the parties, however, the arbitral tribunal shall not lose jurisdiction if it fails to respect this timescale. The arbitral award shall be final and binding.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.4&nbsp;&nbsp;&nbsp;&nbsp;Neither the parties (including their auditors and insurers) nor their counsel and any person necessary to the conduct of the arbitration nor the arbitrators shall disclose the existence, content, (including submissions and any evidence documents presented or exchanged), or results of any arbitration hereunder without the prior written consent of the parties, except as required by law or the applicable rules of a stock exchange.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.5&nbsp;&nbsp;&nbsp;&nbsp;The existence of a dispute with respect to this Agreement between the parties shall not relieve either party from performance of its obligations under this Agreement that are not the subject of such dispute.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20.6&nbsp;&nbsp;&nbsp;&nbsp;This Agreement shall be governed by and construed in accordance with the laws of England and Wales, save as to conflict of law provisions. If any dispute is not resolved in accordance with clause 20.1, the matter shall then be referred to arbitration to be conducted under the auspices of the London Court of International Arbitration. Proceedings will be heard by a single arbitrator and held in London in English and subject to the Arbitration Act 1996.

**21&nbsp;&nbsp;&nbsp;&nbsp;CODE OF CONDUCT**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall comply with the Buyers Code of Conduct referred to in Schedule Eight hereto and shall otherwise comply with all applicable national legal requirements, customs, and accepted international standards pertaining to employment and manufacturing.

**22&nbsp;&nbsp;&nbsp;&nbsp;MISCELLANEOUS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.1&nbsp;&nbsp;&nbsp;&nbsp;If there is any inconsistency between the terms and conditions set out in this Agreement and the terms and conditions set out in any quotation, order, acknowledgement or invoice, the terms and conditions of this Agreement shall prevail to the extent of the inconsistency.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.2&nbsp;&nbsp;&nbsp;&nbsp;If there is any inconsistency between the terms and conditions set out in this Agreement and the terms and conditions set out in the Technical Agreement with respect to quality-related activities, including, without limitation, compliance with cGMP, the terms and conditions of the Technical Agreement shall prevail to the extent of the inconsistency. If there is any inconsistency between the terms and conditions set out in this Agreement and the terms and conditions set out in the Technical Agreement with respect to commercial matters, including, without limitation, allocation of risk, liability and financial responsibility, the provisions of this Agreement shall prevail to the extent of the inconsistency.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.3&nbsp;&nbsp;&nbsp;&nbsp;This Agreement, the Specification or any Order may only be amended, modified or varied by the parties by an instrument in writing signed on behalf of each of the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.4&nbsp;&nbsp;&nbsp;&nbsp;The waiver by either party of any right under this Agreement or of any failure to perform or breach hereof by the other party shall not constitute or be deemed to be a waiver of any other or future right

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hereunder or of any other failure to perform or breach hereof by such other party, whether of a similar or dissimilar nature.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.5&nbsp;&nbsp;&nbsp;&nbsp;All notices, consents, approvals or other communications hereunder shall be in writing and shall be delivered personally or by registered or certified mail, postage prepaid, or sent by fax, addressed to the authorised personnel at relevant party and at such address as each party shall from time to time notify to the other in writing. Any such notice, consent, approval and other communication shall be deemed given, in the case of personal delivery, on the date of delivery, in the case of mailing, on the fifth day following its deposit in the mail and in the case of a fax, on the next business day after the day of transmission provided the sender's facsimile machine produces a report showing complete and successful transmission to the correct facsimile number.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.6&nbsp;&nbsp;&nbsp;&nbsp;The expiration or earlier termination of this Agreement will not operate to release either party hereto from its obligations under clauses 3.8, 10, 11, 13.1 and 13.9 or 16 which obligations will survive such expiration or termination, or from any liability which has already accrued to the other party as of the date of expiration or termination or which may thereafter accrue in respect of any act, omission or default occurring prior to expiration or termination.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.7&nbsp;&nbsp;&nbsp;&nbsp;Nothing in this Agreement shall constitute or be deemed to constitute the creation of a partnership, agency, or employer/employee relationship between the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.8&nbsp;&nbsp;&nbsp;&nbsp;This Agreement, together with the Specifications, Technical Manual and the Schedules attached hereto, constitutes the entire agreement and understanding of the parties and supersedes any previous agreement between the Buyer and the Supplier and their Affiliates in relation to the subject matter of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.9&nbsp;&nbsp;&nbsp;&nbsp;If any provision of this Agreement is held by any court or other competent authority to be invalid or unenforceable in whole or in part it shall be deemed severed from this Agreement and the validity of the other provisions and the remainder of the provision in question shall not be affected.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.10&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be executed in one or more counterparts, all of which shall be considered as one and the same agreement and shall become effective when one or more counterparts have been signed by each of the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22.11&nbsp;&nbsp;&nbsp;&nbsp;All royalties, taxes and duties imposed or levied on any Products delivered hereunder shall be for the account of and paid by the Supplier to the point where the Products have been delivered DAP. All royalties, taxes and duties imposed or levied on the Products after such delivery shall be for the account of and paid by the Buyer.

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**SCHEDULE ONE**

**THE PRICES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.&nbsp;&nbsp;&nbsp;&nbsp;Prices**

[\*\*\*]:

1)&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]:

a&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*],

b&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*], and

c&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

2)&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*], and

3)&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

API will be sold to the Supplier upon taking title to the API in accordance with clause 6.2.3.2. The Supplier will each week notify the Buyer of the volume of API used and will be invoiced by the Buyer for such volume of API at the Buyer's then current Price for the API at the time of transfer of title (and for the sake of clarity not the price at the time of delivery to the Supplier).

Any change in the cost of API shall mean the Assumed API Costs part of the Price for the Product shall be varied pro rata (such that by way of example only a [\*\*\*] per cent ([\*\*\*]%) increase in the API Price would mean a corresponding [\*\*\*] per cent ([\*\*\*]%) increase in the Assumed API Costs part of the Price for the Products, but the Manufacturing Costs shall remain unaffected).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.&nbsp;&nbsp;&nbsp;&nbsp;Price Reviews and Budgeting Process**

The parties agree that the Manufacturing Costs and Assumed API Costs shall be fixed under this Agreement until 31 December 2016.

The parties agree that thereafter the Manufacturing Costs shall be reviewed every year, and each such review shall commence by the Buyer notify the Supplier of (i) the number of Products that the Buyer anticipates ordering from the Supplier during the following calendar year (the **"Budget Order Volume"**) (the initial Budget Order Volume, effective until calendar year ending 31 December 2016, shall be [\*\*\*] ([\*\*\*]) Products per year (on a pro rata basis from the Commencement Date until 31 December 2015)) and (ii) the Assumed API Costs for the purpose of the Price before 31 May each year. Following the Buyers provision of such information, by 1 July of the then current year the Supplier shall produce an updated proposed FOS and by 31 July the Supplier shall produce a Price list using the principles set out below.

Within fourteen (14) days (or such other period agreed between the parties) following provision of an updated proposed FOS and Price list the parties shall hold a price review. The first such review shall take place following the Supplier's first proposal for the year 2017 (to be made within fourteen (14) days (or such other period agreed between the parties) of provision of the updated proposed FOS and Product Price list to be supplied before 31 July 2016).

The parties agree that the updated proposed FOS and Price list shall be calculated based on the below principles which can be assessed and discussed at such pricing review:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Raw Materials Manufacturing Cost are revised based on [\*\*\*] (averaged over a one (1) year period), [\*\*\*],

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Direct Manufacturing Cost are [\*\*\*] for the duration of the Agreement save for adjustment every year (based on the ILCH since the previous adjustment) as part of a price review as set out in clause 7.1, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Indirect Manufacturing Costs shall be calculated [\*\*\*]. The Supplier shall calculate its allocation of Indirect Manufacturing Costs per Product by dividing the Indirect Manufacturing Costs across the Budget Order Volume (the **"Indirect Manufacturing Cost Product Allocation"**). The Supplier shall provide the Buyer with reasonable supporting explanation of its calculation of Indirect Manufacturing Cost and Indirect Manufacturing Cost Product Allocation.

Following such review the parties shall agree proposed pricing and the Supplier shall create the revised FOS and revised Price list which shall be supplied to the Buyer for approval by the 31 August of the then current year, whereupon it shall be binding for the forthcoming year. In the absence of any approved FOS and Price list by such date, either party may serve notice on the other that it is to escalate the matter in accordance with clause 20.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.&nbsp;&nbsp;&nbsp;&nbsp;Exceptional Price reviews**

The parties agree that following 1 January 2017 either party may request a review of Raw Materials Manufacturing Costs if:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;the cost of a key Raw Material has varied +/- ten per cent (10%) over a period of six (6) months due to demonstrable feed-stock changes (provided always such exceptional price review shall be limited to the key Raw Material in question and any variation is limited only to the applicable variation associated with the key Raw Material), or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;a Price is agreed for new Product based on anticipated volumes, six (6) months has elapsed since launch of such new Product and a party wishes to discuss price for such new Product based on further information regarding sales volumes of such new Product (such Price review being particular to the Price for such new Product only).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.&nbsp;&nbsp;&nbsp;&nbsp;Indirect Manufacturing Costs and reconciliation**

[\*\*\*]:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*], and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*], or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

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**Appendix 1** - **Initial FOS**

[\*\*\*]

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**SCHEDULE TWO**

**THE PRODUCTS (AND SERVICES IF ANY)**

**<u>Finished Products</u>**

Temgesic Injection 0.3mg/ml

Temgesic Sublingual Tablets 0.2mg

Temgesic Sublingual Tablets 0.4mg

Subutex Tablets 0.4mg

Subutex Tablets 2mg

Subutex Tablets 8mg

Suboxone Tablets 2mg

Suboxone Tablets 8mg

Suboxone Tablets 12mg

Suboxone Tablets 16mg

(including, where applicable, the similar products sold under Buprex or Buprenex name)

**<u>Services</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Providing manufacturing section of annual product review

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Rolling stability according to annual stability commitment as per ICH guidelines for all finished products

------

**SCHEDULE THREE**

**TEMPORARY ADDITIONAL SERVICES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Weighing and dispensing Buprenorphine for the purpose of exportation

o&nbsp;&nbsp;&nbsp;&nbsp;Cost = [\*\*\*] GBP (£[\*\*\*])/event

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Perform receipt, testing, release and assembly for despatch of Naloxone (likely service required until Monosol is approved as an authorised source to perform release testing). Resolution of Non-conformance on receipt or test results with the material supplier remains with the Buyer

o&nbsp;&nbsp;&nbsp;&nbsp;Cost = [\*\*\*] GBP (£[\*\*\*])/event

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Micro laboratory testing

o&nbsp;&nbsp;&nbsp;&nbsp;Maintain established routine micro testing testing schedules for purified water, environmental monitoring, finished material testing and provide associated Certificates of Analysis. Monthly testing and administration fee: [\*\*\*] GBP (£[\*\*\*])

o&nbsp;&nbsp;&nbsp;&nbsp;Provide microbiological advise and investigation support up to a total of 5 days annually. Annual retention fee: [\*\*\*] GBP (£[\*\*\*])

o&nbsp;&nbsp;&nbsp;&nbsp;The Buyer can end such service on three (3) months' written notice to the Supplier

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Rolling stability programme API

o&nbsp;&nbsp;&nbsp;&nbsp;Maintain annual Buprenorphine HCI API rolling stability including all storage, testing and reporting to end of all protocols committed under RBH control. Report any out of trend or out of specification results to the Buyer within 3 days of confirmation. Report routine results annually or within seven (7) days of request for information. At Suppliers cost.

o&nbsp;&nbsp;&nbsp;&nbsp;Provide annual Buprenorphine HCI API rolling stability post plant day including all storage, testing and reporting in line with existing current testing protocols and shelf-life specifications. Report any out of trend or out of specification results to the Buyer within 3 days of confirmation. Report routine results annually or within 7 days of request for information. [\*\*\*] GBP (£[\*\*\*])/annum.

o&nbsp;&nbsp;&nbsp;&nbsp;The Buyer can end such service on three (3) months' written notice to the Supplier.

The parties acknowledge that the above Temporary Additional Services are not envisaged as being provided long term under this Agreement and as such may be terminated by the Buyer on three (3) months' written notice to the Supplier at any time, or in the event not so terminated by the third anniversary of the Commencement Date the Buyer may thereafter serve notice to terminate any or all of such Temporary Additional Services on six (6) months' written notice to the Buyer, such notice being served at any time following the third anniversary of the Commencement Date.

------

**SCHEDULE FOUR**

**THE SPECIFICATION**

Temgesic Injection 0.3mg/ml

[\*\*\*]

Temgesic Sublingual Tablets 0.2mg

[\*\*\*]

Temgesic Sublingual Tablets 0.4mg

[\*\*\*]

Subutex Tablets 0.4mg

[\*\*\*]

Subutex Tablets 2mg

[\*\*\*]

Subutex Tablets 8mg

[\*\*\*]

Suboxone Tablets 2mg

[\*\*\*]

Suboxone Tablets 8mg

[\*\*\*]

Suboxone Tablets 12mg

[\*\*\*]

Suboxone Tablets 16mg

[\*\*\*]

------

**SCHEDULE FIVE**

**KPls**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.&nbsp;&nbsp;&nbsp;&nbsp;On Time In Full (OTIF): Based on OTIF calculation in OTIF spreadsheet <u>Mechanism:</u>**

**Delivery**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Delivery = Released and sold

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Measure 1 delivery date vs delivery date promised (measured on a week basis not day basis so if delivery date was Monday and delivery is Friday then it counts as 100% - discounted on a daily basis 5% per day so effectively down to 0% after 4 weeks late

**Quantity**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Quantity promised vs received %

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Delivery and quantity. Weighed 50/50 = OTIF

This give an OTIF score for each country on a weekly basis. It also gives an <u>overall OTIF score</u> (this is weighed against the quantity of each delivery).

OTIF shall be maintained at the Target OTIF Level or better.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.&nbsp;&nbsp;&nbsp;&nbsp;Yield: agreed API waste level as follows:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]% tablets

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]% injection

This will impact:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;KPI - API yield is [\*\*\*]% for Product in tablet form and [\*\*\*]% for injection products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.&nbsp;&nbsp;&nbsp;&nbsp;QA:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Customer complaints - Serious complaints investigated and reported within 10 days of receipt, all other complaints investigated and reported within 20 days. Change control - Implementation actions >95% on time. None > 10 days late. Non-conformance CAPAs - All major actions on time, minor actions >95% on time

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Competent authority inspection actions - on time with commitment to authority. RBP audits - major actions on time, minor actions >95% on time recommendations monitored

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Agreed failure to meet KPls will enable RBP to seek remedy of the situation. Failure to meet a KPl (other than in respect of OTIF) does not, of itself, entitle the Buyer to terminate this Agreement.

------

**SCHEDULE SIX**

**BUYER'S PALLET POLICY**

EPAL pallets to be used for storage and shipment unless specified otherwise.

------

**SCHEDULE SEVEN**

**TOOLING AND EXISTING TOOLING**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**<u>1.</u>&nbsp;&nbsp;&nbsp;&nbsp;<u>Tooling</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**<u>1.1</u>&nbsp;&nbsp;&nbsp;&nbsp;<u>Existing Tooling</u>**

[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**<u>1.2</u>&nbsp;&nbsp;&nbsp;&nbsp;<u>Amortisation formula (applicable to Tooling)</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall obtain a quotation for such Tooling which is to be agreed by RBP. The cost of such Tooling shall be agreed upfront by RBP.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;The cost of Tooling shall be amortised over 12 months following the purchase of such Tooling by the Supplier on behalf of the Buyer in relation to the relevant volume.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Any outstanding balance upon such amortised costs in relation to the Tooling shall be paid by the Buyer to the Supplier as a lump sum after such 12 month period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;The Buyer may at the Buyer's own discretion pay the full sum for such Tooling upfront.

------

**SCHEDULE EIGHT**

**BUYER'S CODE OF CONDUCT**

<u>http·//www.rb com/Our-responsibility/Our-policies-reports</u> or as otherwise updated and notified to the supplier from time to time

------

**SCHEDULE NINE**

**RAW MATERIALS SUBJECT TO BUYER PRE-APPROVAL**

[\*\*\*]

------

**SCHEDULE TEN**

**ANTICIPATED CHANGES AND PARTY BEARING COST**

Costs shall, in each applicable case, be subject to the Buyer approving such costs prior to them being incurred by the Supplier.

---

| | | | |
|:---|:---|:---|:---|
| &nbsp;&nbsp;**Scenario** | &nbsp;&nbsp;**Initiator** | &nbsp;&nbsp;**Party**<br>**bearing**<br>**costs** | &nbsp;&nbsp;**Note** |
| &nbsp;&nbsp;Change to Licences or legislation specific to the Products only | &nbsp;&nbsp;Authority, regulator or third party | &nbsp;&nbsp;&nbsp;Buyer | &nbsp;&nbsp;See \*\*\* below. |
| &nbsp;&nbsp;Change to Licences or legislation not specific to the Products only | &nbsp;&nbsp;Authority, regulator or third party, | &nbsp;&nbsp;Supplier |  |
| &nbsp;&nbsp;Change to manufacturing or industry standards - such changes apply not only to the<br>Products | &nbsp;&nbsp;Authority, regulator or third party | &nbsp;&nbsp;Supplier |  |
| &nbsp;&nbsp;Artwork change\* | &nbsp;&nbsp;Buyer | &nbsp;&nbsp;Buyer | &nbsp;&nbsp;See \*\* below |
| &nbsp;&nbsp;Artwork change\* | &nbsp;&nbsp;Supplier | &nbsp;&nbsp;Supplier |  |
| &nbsp;&nbsp;Artwork change - specific to the Products\* | &nbsp;&nbsp;Authority,<br>regulator or third party | &nbsp;&nbsp;Buyer | &nbsp;&nbsp;See \*\* below |
| &nbsp;&nbsp;Artwork change - not specific to the Products\* | &nbsp;&nbsp;Authority,<br>regulator or third party | &nbsp;&nbsp;Supplier |  |
| &nbsp;&nbsp;New supplier - commercial reasons | &nbsp;&nbsp;Buyer/ Supplier | &nbsp;&nbsp;Buyer/ Supplier | &nbsp;&nbsp;Costs to be split pro-rata according to which party obtains what percentage of benefit (e.g. if the Buyer obtains 75% benefit the Buyer pays 75% costs).<br>See \*\*\* below |
| &nbsp;&nbsp;New supplier - business continuity | &nbsp;&nbsp;Buyer/ Supplier | &nbsp;&nbsp;Buyer | &nbsp;&nbsp;Supplier to notify the Buyer as soon as aware of risk, present case and obtain the Buyer's approval. |
| &nbsp;&nbsp;New equipment - replacement<br>of the Supplier's equipment | &nbsp;&nbsp;Supplier | &nbsp;&nbsp;Supplier | &nbsp;&nbsp;Owned by Supplier |
| &nbsp;&nbsp;New equipment - replacement of the Buyer's Equipment | &nbsp;&nbsp;Supplier/ Buyer | &nbsp;&nbsp;Buyer | &nbsp;&nbsp;Owned by Buyer See \*\*\* below |
| &nbsp;&nbsp;New equipment- requested<br>By the Buyer | &nbsp;&nbsp;Buyer | &nbsp;&nbsp;Buyer | &nbsp;&nbsp;Owned by Buyer See \*\*\* below |

---

\* For any artwork change the Supplier shall provide the Buyer with information on remaining materials and to enable the parties to minimise write off costs.

\*\* [\*\*\*].

\*\*\* [\*\*\*].

------

**SCHEDULE ELEVEN**

**<u>Consignment APJ stock arrangements</u>**

In this Schedule **"API Specification"** means the specification for the API as set out in the Technical Manual.

**1&nbsp;&nbsp;&nbsp;&nbsp;Title and API Specifications**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1&nbsp;&nbsp;&nbsp;&nbsp;Title in the API shall pass to the Supplier at the point the same is removed from consignment stock for consumption by the Supplier. The Supplier shall use such procedures (physical and administrative) as are reasonably necessary and customary to keep separate the API from the Supplier's other stock and to identify the API as the property of the Buyer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2&nbsp;&nbsp;&nbsp;&nbsp;The API shall comply with the API Specifications.

**2&nbsp;&nbsp;&nbsp;&nbsp;Reporting and audit**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1&nbsp;&nbsp;&nbsp;&nbsp;No later than five Business Days after the end of the previous calendar month, the Supplier will submit to the Buyer by email a report stating in detail the Product removed from consignment stock for consumption by the Supplier since the immediately preceding calendar month. Following delivery of such report, the Buyer may invoice the Supplier for the API detailed in such report at the Unit Price and each such invoice shall be payable in accordance with the terms of clause 7 of this Agreement *mutatis mutandis*.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2&nbsp;&nbsp;&nbsp;&nbsp;Once a month, the Supplier and the Buyer shall each provide to the other a stock list, being its believed level of API (being the amount of API delivered, less that removed from consignment stock for consumption by the Supplier and less that rejected in accordance with the terms of this Agreement).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3&nbsp;&nbsp;&nbsp;&nbsp;In the event of any inconsistency between the reports exchanged pursuant to paragraph 2.2, the parties shall commence immediate good faith negotiations to resolve the inconsistency. Following resolution, the Buyer shall promptly issue an invoice or credit note to address such agreed inconsistency.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4&nbsp;&nbsp;&nbsp;&nbsp;At reasonable intervals (and in any event at least once a year), the Buyer shall perform (or have performed by its representative) a physical audit of the inventory of the API held at the Supplier's site. In the event of any inconsistency between the physical level of API at such site and that which the Buyer believes should be present, the parties shall commence immediate good faith negotiations to resolve the inconsistency. Following resolution, the Buyer shall promptly issue an invoice or credit note to address such agreed inconsistency. If such agreement cannot be reached the parties will request adjudication from an independent third party acting as expert, the cost of which shall be borne equally between the parties. Should the parties not be able to agree on an expert they shall request a nomination from the President of the Institute of Chartered Accountants in England and Wales or any successor body to that institution.

------

---

| | | |
|:---|:---|:---|
| SIGNED by | */s/Patrick Clements* | */s/Patrick Clements* |
| for and on behalf of Reckitt Benckiser Healthcare (UK) Limited | for and on behalf of Reckitt Benckiser Healthcare (UK) Limited | for and on behalf of Reckitt Benckiser Healthcare (UK) Limited |
| PATRICK CLEMENTS | PATRICK CLEMENTS | |
| in the presents of&nbsp;&nbsp;&nbsp;&nbsp; Saiqa Panday | in the presents of&nbsp;&nbsp;&nbsp;&nbsp; Saiqa Panday | in the presents of&nbsp;&nbsp;&nbsp;&nbsp; Saiqa Panday |
| | | [\*\*\*] |
| | | */s/ Saiqa Panday* |
| SIGNED by | /s/Richard Jameson | /s/Richard Jameson |
| for and on behalf of RB Pharmaceuticals Limited | for and on behalf of RB Pharmaceuticals Limited | for and on behalf of RB Pharmaceuticals Limited |
| RICHARD JAMESON | RICHARD JAMESON | |
| in the presents of&nbsp;&nbsp;&nbsp;&nbsp; Steven Lucas | in the presents of&nbsp;&nbsp;&nbsp;&nbsp; Steven Lucas | in the presents of&nbsp;&nbsp;&nbsp;&nbsp; Steven Lucas |
| | | [\*\*\*] |
| | | */s/Steven Lucas* |

---

## Exhibit 4.14

**Exhibit 4.14.2**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**FIRST AMENDMENT TO COPACKER SUPPLY AGREEMENT DATED 23 DECEMBER 2014 BETWEEN**

**RECKITT BENCKISER HEALTHCARE (UK) LIMITED AND INDIVIOR UK LIMITED**

This First Amendment to Copacker Supply Agreement (the "Amendment") is effective as of the date of last signature below (the "**Amendment Effective Date**") by and between

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1) Reckitt Benckiser Healthcare (UK) Limited ("**Supplier**") and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2) lndivior UK Limited, formerly known as RB Pharmaceuticals Limited ("**Buyer**")

and collectively "the parties".

This Amendment amends the Copacker Supply Agreement dated 23 December 2014 between the parties (the "**Agreement**").

Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Agreement.

WHEREAS, the parties wish to amend the Agreement as set forth herein.

IT IS AGREED as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. Clause 1.1 – shall be amended by –

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. addition of the following definitions:

*"****Business****" shall mean the manufacture and sale of Subutex and Suboxone Tablets and Temgesic;*

*"****Buyer Ran TT****" shall mean those activities required by the Buyer to perform its own technical transfer of technology to a Buyer's TT Recipient, ran by and at the cost of the Buyer, pursuant to clauses 2.4 and/or 14.1;*

*"****Buyer's TT Recipient****" shall mean the PRC Purchaser (or their designee), and/or the party to whom the Buyer transfers demand in accordance with under clause 14.1;*

*"****Contractual Year****" shall mean January 1st to December 31st inclusive;*

*"****New Country****" shall mean any country additional to those countries for which the Supplier has already manufactured Products for the Buyer set out in Schedule 4 as at the Commencement Date;*

*"****PRC Purchaser****" means the Third-Party purchaser of the Buyer's business to exploit Suboxone Products in the People's Republic of China (excluding Hong Kong, Taiwan and Macao);*

*"****Products****" means those products listed in Schedule Two for potential sale worldwide or as otherwise agreed by the parties in writing, together with such additional, improved, modified or replacement products as shall be agreed between the parties from time to time as are manufactured by the Supplier and for supply to the Buyer under this Agreement and wherever "Products" is referred to in this Agreement it shall refer to the relevant Products or all Products as the case may be, as listed in Schedule Two;* 

*"****Suboxone Products****" means Suboxone Tablets 2 mg and Suboxone Tablets 8 mg.*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. the deletion of the definition "*Existing Tooling*" in its entirety and replaced with:

*"****Existing Tooling****" means the punch and die tooling which are required for the anticipated supply of the Products and which, as at the date of this Agreement, is owned by the Supplier, as indicated in Schedule Seven.*

Page **1** of **11**

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. The revision of the definition of" Commencement Date" such that:

*"****Commencement Date****" shall now refer to having the meaning set out in clause 2.6.*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. Clause 2.1 is deleted in its entirety and replaced with the following:

*"2.1&nbsp;&nbsp;&nbsp;&nbsp;This Agreement shall be effective from the Commencement Date and, subject to applicable laws and the provisions of clause 15 (Termination), shall have effect until ten (10) years following* the *Commencement Date. The parties agree that during the sixth (6th) year of this Agreement, they shall discuss renewal of this Agreement."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. Clause 2.2 is deleted in its entirety and replaced with the following:

*"2.2&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding anything to the contrary contained herein and only in the event that –*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*2.2.1 &nbsp;&nbsp;&nbsp;&nbsp;the Agreement enters the final four years the Agreement without the Supplier making any commitment of intent to renew this Agreement following discussion under 2.1; or*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*2.2.2&nbsp;&nbsp;&nbsp;&nbsp;the Buyer has given the Supplier notice and terminates the Agreement pursuant to clauses 15.1 or 15.2; or*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*2.2.3&nbsp;&nbsp;&nbsp;&nbsp;the Buyer has given the Supplier notice of an unjustified proposed price increase pursuant to discussion under 2.1, which unreasonable proposed price increase is calculated in contrary to clause 7.1 and/or Schedule One, which prevents a renewal of the Agreement;*

*and at the request of the Buyer any time during such notice period, the Supplier shall promptly and efficiently undertake and complete a Technical Transfer in accordance with clause 14 to the Buyer or a third party identified by the Buyer (the Buyer or the third party (or both) being the "****Transferee****") to enable the Transferee to establish and conduct cGMP manufacture of Products. For the sake of clarity, the parties agree that the provisions set out in clause 14 are subject to this clause 2.2. The Parties specifically agrees that the Supplier shall not be obliged to perform any Technical Transfer in the event that:*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(i) &nbsp;&nbsp;&nbsp;&nbsp;the Buyer provides the Supplier notice to terminate or terminates this Agreement for whatever reason, other than set out in clauses 15.1 or 15.2; or*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(ii) &nbsp;&nbsp;&nbsp;&nbsp;the Supplier provides the Buyer notice to in terms of clauses 2.4 or 14.1; or*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(iii) &nbsp;&nbsp;&nbsp;&nbsp;the Supplier provides the Buyer notice to terminate or terminates this Agreement as a result of a breach, including as set out in clauses 15.1 or 15.2, by the Buyer or as a result of any negligent act or omission, or any wilful misconduct of the Buyer."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. Clause 2.3 is deleted in its entirety and replaced with the following:

*"2.3&nbsp;&nbsp;&nbsp;&nbsp;Upon termination or expiry of this Agreement for whatever reason (apart from the circumstances outlined in clauses 2.2), the Supplier shall at the Buyer's cost and the request promptly and efficiently enable the Buyer access to all technical information needed to undertake and complete its own technical transfer to a Transferee to enable that Transferee to establish and conduct cGMP manufacture of the Products. The Supplier acknowledges that in the circumstances described in 2.2 the Supplier's obligations to perform a Technical Transfer shall include allowing the Buyer access to all technical information as described in this clause 2.3."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. The following clauses are inserted as clause 2.4 and 2.5:

*"2.4 &nbsp;&nbsp;&nbsp;&nbsp;The parties agree that in the event that the Buyer has given the Supplier 6 (six) months' prior written notice that the Buyer requires a Buyer Ran TT for the purposes of assisting a PRC Purchaser (as a Buyer's TT Recipient), the Supplier shall at the request, cost and reasonable instructions of the Buyer reasonably and actively assist the Buyer to undertake and complete the Buyer Ran TT. For the sake of clarity, the parties agree that the Supplier shall not be responsible for the cost or to lead such Buyer Ran TT, which shall be the sole responsibility of the Buyer with appropriate active support from the Supplier as set out in clause 2.5.*

Page **2** of **11**

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*2.5&nbsp;&nbsp;&nbsp;&nbsp;In this regard the parties agree that for a Buyer Ran TT:*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*2.5.1&nbsp;&nbsp;&nbsp;&nbsp;access to the Supplier's Manufacturing Site as part of any technical transfer shall not be granted to a Buyer's TT Recipient without prior written consent from the Supplier; such consent not to be unreasonably withheld;*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*2.5.2&nbsp;&nbsp;&nbsp;&nbsp;the Supplier gives no warranties or guarantees of success in transferring the technology under a Buyer Ran TT; and*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*2.5.3&nbsp;&nbsp;&nbsp;&nbsp;notwithstanding 2.5.1, the Supplier shall use all commercially reasonable endeavours (at cost and reasonable instructions of the Buyer) to actively facilitate such transfer which shall include without limitation:*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(i)&nbsp;&nbsp;&nbsp;&nbsp;providing reasonable access to the necessary data/technical information;*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(ii)&nbsp;&nbsp;&nbsp;&nbsp;reasonable participation in creation of the technical transfer plan;*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(iii)&nbsp;&nbsp;&nbsp;&nbsp;reasonable assistance in participation in 3-way communication with the Buyer and the Buyer's TT Recipient;*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(iv)&nbsp;&nbsp;&nbsp;&nbsp;reasonable assistance in resolving problems identified with item(s) transferred to the Buyer's TT Recipient but not meeting expected requirements despite Buyer action and support (including without limitation equipment set-up and validations, and in-process controls and process validation);*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(v)&nbsp;&nbsp;&nbsp;&nbsp;where reasonably required, travel and in-plant visit/support at as the designated plant of the Buyer's TT Recipient; and*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(vi)&nbsp;&nbsp;&nbsp;&nbsp;providing reasonable support in such activity consistent with that described in clause 14.4, as modified to reflect such activity is Buyer lead and at the Buyer's cost."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. The following is inserted as clause 2.6:

*"2.6&nbsp;&nbsp;&nbsp;&nbsp;The parties agree that this Agreement shall commence on 1st January 2019 (the "****Commencement Date****")."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7. The first sentence of clause 5.6 is deleted in its entirety and replaced with the following:

*"The Supplier represents and warrants that it shall have the capacity to fill the Buyer's requirements for the amount of Products set forth in any Order so long as such amount is limited to [\*\*\*] ([\*\*\*]) consumer units per annum ("****Annual Volume****") and does not exceed [\*\*\*]% of the forecast demand set forth in the immediately preceding Product Forecast. The Supplier agrees that it has the capacity to provide the Annual Volume to a maximum of [\*\*\*] ([\*\*\*]) consumer units per annum ("****Maximum Volume****")."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8. Clause 6.6 is deleted in its entirety and replaced with the following:

*"6.6&nbsp;&nbsp;&nbsp;&nbsp;The Buyer may agree in its sole discretion to provide the Supplier with sufficient funds to cover the Supplier's purchase of the punch and die tooling (as described in Schedule seven) required to support the capacity requirement for the anticipated supply of the Products, such tooling to be used for the production of the Products (being such tooling specified in Schedule Seven and hereinafter referred to as "****Tooling****"). The purchase of the Tooling, the Purchase Process and the commercial terms ("****Purchase Terms****") in respect thereof are set out in Schedule Seven."*

Page **3** of **11**

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9. Clause 6.7 is deleted in its entirety and replaced with the following:

*"6.7 &nbsp;&nbsp;&nbsp;&nbsp;The Supplier acknowledges and agrees that all designs, drawings, samples, prototypes and Intellectual Property Rights related thereto, with respect to the Products are the exclusive property of the Buyer."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10. Clause 6.8 is deleted in its entirety and replaced with the following:

*"6.8 &nbsp;&nbsp;&nbsp;&nbsp;The Buyer acknowledges and agrees that the Supplier is the sole and exclusive owner of the Tooling and the Existing Tooling and that legal ownership, title and interest in Tooling and the Existing Tooling (including but not limited to all designs, drawings, samples, prototypes and Intellectual Property Rights related thereto) shall at all times remain with Supplier. To the extent that the Supplier is not already the owner of the Tooling or the Existing Tooling, the Buyer agrees that it shall take all such actions as the Supplier may reasonably request (including without limitation, the execution and delivery to the Supplier of documents of title and other instruments) confirming the Suppliers exclusive right, title and interest therein."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11. Clause 6.11 is deleted in its entirety and replaced with the following:

*"6.11 &nbsp;&nbsp;&nbsp;&nbsp;[Reserved.]"*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12. The following Clause is inserted as Clause 6.12:

*"6.12 &nbsp;&nbsp;&nbsp;&nbsp;The Supplier, at its expense, shall maintain Existing Tooling in good working order and repair for at least Five (5) Contract Years from the date the Existing Tooling was or is commissioned, the date of commissioning of the Existing Tooling shall be set out in Schedule 7 ("****Existing Tooling Commissioned Date****"). The Supplier shall use reasonable endeavours to ensure that the Existing Tooling shall have a working life of at least Five (5) Contract Years from Existing Tooling Commissioned Date. The repair, maintenance or replacement of any such Existing Tooling that fails to achieve such capacity before Five (5) Contract Years from the Existing Tooling Commissioned Date shall be at Supplier's sole cost and expense. Thereafter, the Supplier shall continue to provide routine maintenance or repairs on Existing Tooling after the Five (5) Contract Years from the Existing Tooling Commissioned Date, at the sole cost and expense of the Buyer, and if any such Existing Tooling fails after Five (5) Contract Years from the Existing Tooling Commissioned Date and the Supplier is unable to return Existing Tooling to service through the application of routine maintenance, any further costs of repair or replacement of such Existing Tooling shall be at Buyer's sole cost and expense."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13. Clause 7.1 is deleted and replaced by the following one:

*"7.1 &nbsp;&nbsp;&nbsp;&nbsp;The price for the Products shall be those set out in Schedule One and shall be fixed for the period up to and including 31 December 2019. The parties agree that the Price shall be subject to review thereafter each year, and each such review shall commence following the Supplier's provision to the Buyer of the Supplier's proposed pricing for the forthcoming year by 31 July of the then current year. The first such review shall take place following the Supplier's first proposal for the year 2020 (to be made by 31 July 2019). The parties agree that the proposed pricing and review each year (and any corresponding adjustment) will reflect the principles set out in Schedule One."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14. There shall be added to clause 9 the following:

*"9.8 &nbsp;&nbsp;&nbsp;&nbsp;The parties specifically agree that for any New Country, the Supplier will comply with all requirements of this clause 9 (including in particular and without limitation, clause 9.1.1) save that for any products manufactured for or distributed to a New Country, the Supplier specifically does not warrant that manufacture will comply with any applicable laws local to such New Country to the extent such applicable laws demand additional requirements or standards than those required for production of products for the European market, and shall not be liable for the products in any New Country save for failure to meet the Specification."*

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15. Clause 11.2 is hereby deleted in its entirety and replaced with the following:

*"11.2 &nbsp;&nbsp;&nbsp;&nbsp;On the terms and subject to the conditions of this clause 11, the Supplier shall defend, indemnify and hold harmless the Buyer, its Affiliates, and their respective officers, directors, employees and agents (collectively, "****Buyer lndemnitees****"), from and against any and all Losses relating to any Proceeding to the extent arising out of or resulting from*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(i) &nbsp;&nbsp;&nbsp;&nbsp;any negligent act or omission, or any wilful misconduct, of the Supplier, its Affiliates, its contract manufacturers or Raw Material suppliers (other than Buyer), or any of their respective officers, directors, employees or agents in connection with the performance of this Agreement; or*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*(ii) &nbsp;&nbsp;&nbsp;&nbsp;any breach by the Supplier or its Affiliates of any of its representations, warranties, or obligations contained in this Agreement;*

*in each case (i) and (ii), except for those Losses which Buyer has an obligation to indemnify a Supplier lndemnitee pursuant to clause 11.1, as to which Losses each party shall indemnify the other to the extent of their respective liability for such Losses."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16. The following text is added to the end of clause 11.3:

*"The parties acknowledge that the Supplier does not have specific third-party insurance against loss arising out of a Cyber-Attack (being any malicious third party action which undermines the functions of the Supplier's information systems and/or the networks that deliver such information, including, without limitation, the unauthorised use of, or attempts to gain unauthorised access to, systems and/or to data, modification of a system's firmware, software or hardware without the Supplier's consent, and/or any actual or attempted malicious disruption or denial of service). Whilst the Buyer does not demand third party insurance against such risks, the parties acknowledge the absence of such insurance shall not be construed as an implied limitation of the Supplier's liability hereunder. Save to the extent that a Cyber Attack results from a failure by the Supplier to comply with its IT security or other obligations under this Agreement, the parties acknowledge and agree that the nature of Cyber Attacks is such that they cannot be completely prevented and as such will be deemed to constitute a "Force Majeure Event" for the purposes of this Agreement and the provisions of clause 18 shall apply."* 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17. Clauses 14.1, 14.1.1 and 14.1.2 are deleted in their entirety and replaced with the following:

*"14.1 &nbsp;&nbsp;&nbsp;&nbsp;Parties agree that the Buyer's obligations to [\*\*\*] the Supplier as set out under this Agreement shall be modified such that during the final four years of this Agreement, the Buyer shall upon written notice to the Supplier be [\*\*\*] over the remaining term of this Agreement [\*\*\*]. The parties agree that under this clause 14.1, in order to enable the Buyer to identify and utilise an [\*\*\*], the Supplier shall at the request, cost and reasonable instructions of the Buyer reasonably assist the Buyer to undertake and complete its own Buyer Ran TT to a Buyer's TT Recipient. The parties agree that such Buyer Ran TT will be supported by the Supplier in accordance with clause 2.5."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18. Clause 15.4 is deleted in its entirety and replaced with the following:

*"15.4 &nbsp;&nbsp;&nbsp;&nbsp;[Reserved.]"*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19. There shall be added to clause 15 the following:

*"15.5&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be terminated by the Buyer at any time;*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*15.5.1&nbsp;&nbsp;&nbsp;&nbsp;subject to clause 16.2, by giving not less than twelve (12) months written notice in the event of loss of main Market License (e.g. France or Canada);*

Page **5** of **11**

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*15.5.2&nbsp;&nbsp;&nbsp;&nbsp;by giving not less than twenty four (24) months written notice if the Buyer's annual demand from the Supplier falls below [\*\*\*] packs or if there are commercial pressures making it no longer economically viable for the Buyer to maintain the Business. In either case, should the Supplier find a replacement Business during that 24 month notice period, the Buyer shall be relieved from its financial responsibility for the remainder of the notice period."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;20. There shall be added to clause 16 the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*16.2&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding anything to the contrary contained in this Agreement and without prejudice to Supplier's other rights or remedies whether hereunder, at law or in equity, if the Agreement is terminated pursuant to clause 15.5.1 as a result of or attributed to the Buyer's negligent or wilful act(s) or omission(s), or any wilful misconduct, then the Buyer shall (i} give the Supplier not less than twenty four (24) months written notice (in lieu of twelve (12) months) and, (ii) pay all the Supplier's fixed cost for same notice period (twenty four (24) months), payable on/before the end of each the remaining Contractual Year. Should the Supplier find a replacement Business during that 24 months' notice period, the Buyer shall be relieved from its financial responsibility for the remainder of the notice period.*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*16.3&nbsp;&nbsp;&nbsp;&nbsp;Buyer acknowledges and agrees that the provisions set out in clause 16.2 does not constitute a penalty."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21. Clause 16.1.3 is deleted in its entirety and replaced with the following:

*"16.1.3&nbsp;&nbsp;&nbsp;&nbsp;Subject to clause 2.2, the Supplier shall at the request of the Buyer promptly and efficiently undertake and complete a Technical Transfer to the Transferee to enable the Transferee to establish and conduct cGMP manufacture of the Products."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;22. Clause 16.1.5 is deleted in its entirety and replaced with the following:

*"16.1.5 &nbsp;&nbsp;&nbsp;&nbsp;[Reserved.]"*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23. Clauses 17.1 and 17.2 are deleted in their entirety and replaced as follows:

*"17.1 &nbsp;&nbsp;&nbsp;&nbsp;Save as provided in clause 17.2 neither the benefit nor the obligations of this Agreement or of any provision of it may be assigned or transferred by either party without the prior written consent of the other, such consent not to be unreasonably withheld.*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*17.2 &nbsp;&nbsp;&nbsp;&nbsp;The benefit subject to the obligations of this Agreement shall be assignable by the Buyer to any Affiliate of the Buyer or to the purchaser of all or a substantial part of the Business of the Buyer (or any other Affiliate of the Buyer) (otherwise than to a competitor of the Supplier where clause 17.1 above shall continue to operate), and in the event of such assignment, the Buyer shall with effect from such assignment be released from its obligations hereunder and all references in this Agreement to the Buyer shall be deemed to include its assigns."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;23. The following Clause is inserted as Clause 18.3:

*"18.3 &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;24. Clause 21.1 is deleted in its entirety and replaced with the following:

*"21.1&nbsp;&nbsp;&nbsp;&nbsp;The Supplier shall comply with Supplier Code of Business Conduct and Anti-Bribery Policy (the "****Policies****") referred to in Schedule Eight hereto, and shall otherwise comply with all applicable national and legal requirements, customs, and accepted international standards pertaining to employment and manufacturing."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;25. Schedule Eight attached to this Amendment supersedes and replaces Schedule Eight of the Agreement.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;26. Clause 22.5 is deleted in its entirety and replaced with the following:

*"22.5&nbsp;&nbsp;&nbsp;&nbsp;All notice, consents, and approvals required or permitted to be given hereunder shall be in writing and shall be delivered (i) personally; (ii) by registered or certified mail, postage prepaid; or (iii) by reliable and nationally recognized overnight delivery service with parcel tracking enabled, addressed to the receiving party as follows (or to such other address as a party may designate in writing):*

---

| | |
|:---|:---|
| *TO SUPPLIER:* | ***Reckitt Benckiser Healthcare (UK) limited*** |
| | *[\*\*\*]* |
| | ***Attn****: SVP Manufacturing* |
| *With copy to:* | ***Reckitt Benckiser Health limited*** |
| | *[\*\*\*]* |
| | ***Attn****: Legal Department* |
| *TO BUYER:* | ***lndivior UK Ltd.*** |
| | *[\*\*\*]* |
| | ***Attn****: Company Secretary* |
| *With copy to:* | ***lndivior UK ltd.*** |
| | *[\*\*\*]* |
| | ***Attn****: Chief Legal Officer* |

---

*Any such notice, consent, or approval shall be deemed given, in the case of personal delivery, on the date of delivery; in the case of mailing, on the fifth calendar day following its deposit in the mail; and in the case of overnight delivery service, on the next business day following its deposit with the delivery service."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;27. Schedule One section 4(b)(i) is deleted and replaced by the following:

*"(i) if the Actual Volume is less than the Budget Order Volume (other than as a result of (A) Supplier's own fault or technical issues which leads to a breach of this Agreement or (B) a Force Majeure Event experienced by Supplier), invoice the Buyer for an amount equal to the following: (Budget Order Volume less Actual Volume), multiplied by the Indirect Manufacturing Cost Product Allocation, which invoice shall be paid by the Buyer within sixty (60) days of receipt thereof;]"*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;28. Schedule once section 1(3) is deleted and replaced by the following:

*"[\*\*\*]% margin on Manufacturing Costs, as agreed between the parties in accordance with clause 7.1 for the first (1) year after the Commencement Date. Such margin shall increase to [\*\*\*] per cent ([\*\*\*]%) for the remainder of the agreement, provided that in each individual contractual year, the Supplier meets an OTIF of >95% in at least nine (9) months of that year.*

*In the eventuality that the Supplier fails to meet the above requirement (except where failure to meet the OTIF target is entirely the fault of lndivior) in a specific contractual year, then the [\*\*\*]% margin applies for that specific year, and the Supplier shall reimburse the buyer for any margin overpayment by March 1st of the subsequent contractual year."*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;29. Schedule 4 attached to this Amendment supersedes and replaces the existing Schedule 4 to the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;30. Schedule 7 attached to this Amendment supersedes and replaces the existing Schedule 7 to the Agreement.

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31. Except as modified by this Amendment, the Agreement shall remain in full force and effect. If there is a conflict between the terms of this Amendment and the terms of this Agreement, the terms of this Amendment shall govern.

The parties have caused their duly authorized representatives to execute this Amendment as of the Effective Date.

---

| | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| RECKITT BENCKISER HEALTHCARE (UK) LTD | RECKITT BENCKISER HEALTHCARE (UK) LTD | RECKITT BENCKISER HEALTHCARE (UK) LTD | RECKITT BENCKISER HEALTHCARE (UK) LTD | RECKITT BENCKISER HEALTHCARE (UK) LTD | INDIVIOR UK LTD | INDIVIOR UK LTD | INDIVIOR UK LTD | INDIVIOR UK LTD | INDIVIOR UK LTD |
| By: | */s/Frederick Dutrenit* | */s/Frederick Dutrenit* | */s/Frederick Dutrenit* | */s/Frederick Dutrenit* | By: | */s/Frank Stier* | */s/Frank Stier* | */s/Frank Stier* | */s/Frank Stier* |
| Name: | Name: | Name: | Name: | *Frederick Dutrenit* | Name: | Name: | Name: | Name: | *Frank Stier* |
| Title: | Title: | *SVP Manufacturing Health* | *SVP Manufacturing Health* | *SVP Manufacturing Health* | Title: | Title: | *Chief Manufacturing and Supply Officer* | *Chief Manufacturing and Supply Officer* | *Chief Manufacturing and Supply Officer* |
| Date: | Date: | Date: | March 29, 2019 | March 29, 2019 | Date: | Date: | Date: | March 12, 2019 | March 12, 2019 |

---

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**SCHEDULE FOUR**

**THE SPECIFICATION**

Temgesic Injection 0.3mg/ml

[\*\*\*]

Temgesic Sublingual Tablets 0.2mg

[\*\*\*]

Temgesic Sublingual Tablets 0.4mg

[\*\*\*]

Subutex Tablets 0.4mg

[\*\*\*]

Subutex Tablets 2mg

[\*\*\*]

Subutex Tablets 8mg

[\*\*\*]

Suboxone Tablets 2mg

[\*\*\*]

Suboxone Tablets 8mg

[\*\*\*]

Suboxone Tablets 12mg

[\*\*\*]

Suboxone Tablets 16mg

[\*\*\*]

Page **9** of **11**

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**SCHEDULE SEVEN**

**TOOLING AND EXISTING TOOLING**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.Tooling**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.Existing Tooling**

[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.Purchasing process (applicable to Tooling)**

*The Supplier shall obtain a quotation for Tooling which is to be agreed by Buyer. The cost of such Tooling shall be agreed upfront by Buyer. The Buyer shall pay the full sum for such Tooling upfront.*

Page **10** of **11**

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**SCHEDULE EIGHT**

**SUPPLIER'S CODE OF CONDUCT AND ANTI-BRIBERY POLICY**

Supplier's Code of Conduct and Anti-Bribery Policy attached.

Page **11** of **11**

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## Exhibit 4.15

**Exhibit 4.15.1**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**DATED AUGUST 15, 2008**

**(1**) **MONOSOL RX LLC**

**(2**) **RECKITT BENCKISER PHARMACEUTICALS INC.**

**COMMERCIAL EXPLOITATION AGREEMENT**

------

**THIS AGREEMENT** (the "**Agreement**") is made on the 15th day of August, 2008 between:

**PARTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;MonoSol Rx, LLC, a company organized and existing under the laws of the USA, with offices at 30 Technology Drive, Warren, New Jersey 07059, USA ("**MSX**"),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Reckitt Benckiser Pharmaceuticals Inc, a company existing under the laws of the USA with offices at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia 23235 **(**"**RB**").

**WHEREAS,** RB wishes to engage MSX to manufacture and supply the Products (as defined below) on the terms of this Agreement and MSX wishes to manufacture and supply the Products to RB on the terms of this Agreement.

**IT IS AGREED** as follows:

1.&nbsp;&nbsp;&nbsp;&nbsp;**DEFINITIONS**

1.1.&nbsp;&nbsp;&nbsp;&nbsp;In this Agreement the following definitions shall apply, unless the context requires otherwise:

"**Affiliates**" means in relation to a company, any entity controlled by that company or any entity which controls that company or any entity which is controlled by another entity, which also controls that company whether such control is direct or indirect. For the purpose of this definition, a particular company is:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;directly controlled by another company or companies if the latter hold/holds in the aggregate fifty percent (50%) or more of (a) the shares carrying votes exercisable at a general meeting (or its equivalent) of the particular company if such company is a corporation issuing voting shares or (b) the control rights or interests if it is not a corporation; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;indirectly controlled by a company or companies ("the parent company or companies") if a series of companies can be specified, beginning with the parent company or companies and ending with the particular company, so related that each company or companies of the series, except the parent company or companies, is directly controlled by one or more companies earlier in the series.

"**MSX's Affiliates**" and "**RB's Affiliates**" shall be construed accordingly in relation to MSX and RB respectively. MSX's Affiliates shall expressly include MonoSol Rx, Inc., a Delaware corporation.

"**Arising Intellectual Property Rights**" means such Intellectual Property Rights as are created during the conduct of and pursuant to the work performed under this Agreement by either party (or its authorized Sub-Contractor) whether acting alone or in combination with the other party, including, without limitation, any Improvements.

"**Annual Review**" shall have the meaning given in **Clause 7.12**.

"**API**" means the active pharmaceutical ingredient buprenorphine and/or naloxone manufactured by or for RB and/or used in the manufacture of the Product, as further described in the API Specification.

"**API Specification**" means the specification for the API as set out in **Schedule Four Part B** attached to and incorporated by reference in this Agreement and which shall be deemed to include that API shall be manufactured and supplied in accordance with all applicable laws, codes of practice and regulations.

"**Certificate of Analysis**" means in respect of the Product a document, signed by the Quality Manager, setting out the results of the testing and analysis of the Product to which such document refers together with the Product Specification and methods against which, and by which, the tests were performed, and in respect of the API a document, signed by the Quality Manager, setting out the results of the testing and analysis of the API to which such document refers together with the API Specification and methods against which, and by which, the tests were performed.

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"**Certificate of Compliance**" means in respect of the Product a document, signed by the Quality Manager, confirming that the Product to which such document refers has been manufactured in accordance with, and in all respects complies with, the Health Registration, the Product Specification and cGMP and, in respect of the API a document, signed by the Quality Manager, confirming that the API to which such document refers has been manufactured in accordance with, and in all respects complies with, the API Specification and cGMP.

"**cGMP**" means current European Good Manufacturing Practice as set out in Commission Directive 2003/94/EC laying down the principles of good manufacturing practice in respect of medicinal products for human use and sale in the European Union, and as set out in the U.S. FDA, 21 Code of Federal Regulations, Parts 210 and 211 in respect of medicinal products for human use and sale in the U.S.

"**Commencement Date**" means the date of this Agreement.

"**Confidential Information**" means:

information concerning the existence and terms of this Agreement and the fact that MSX is manufacturing the Products for RB;

and

information related to Intellectual Property Rights generally, Arising Intellectual Property Rights, Existing Intellectual Property Rights, the API Specification, the Product Specification, formulations and Quality Agreement (all as defined herein), Know How, and data and information of a technical, operational, administrative, financial or business nature, whether oral or in some tangible form, such as in documents, papers, drawings, diagrams, discs, articles, samples, prototypes or otherwise, that is disclosed (intentionally or unintentionally) by one party or its Affiliates to the other party.

"**Cost of Goods Price**" shall have the meaning given in **Clause 7.13**.

"**Delivery Date**" shall have the meaning given in **Clause 4.2**.

"**DMF**" means the drug master file relating to the Product, containing all the information on the validation activities, manufacture, and testing of the Product.

"**Existing Intellectual Property Rights**" means any Intellectual Property Rights owned by or licensed to RB or MSX or their respective Affiliates prior to the Commencement Date or created or resulting after the Commencement Date otherwise than under, or pursuant to, this Agreement.

"**FDA**" means the United States Food and Drug Administration or any successor thereto.

"**Field**" means either (a) opiate (i) agonists, (ii) partial agonists, and (iii) antagonists, in each case alone or in combination with other opiate agonists, partial agonist or antagonists for administration to humans in the treatment of drug addiction, or (b) buprenorphine.

"**Film**" means the dissolvable film material impregnated with the API in the manufacture of the Products.

"**Foil**" means the primary packaging material for the Products.

"**Forecasts**" shall have the meaning given in **Clause 4.1.**

"**Half Year**" means the six month period ending 30 June or 31 December in each calendar year (or such part thereof as the case may be for the initial and final Half Year periods under this Agreement) and the term "**Half Yearly**" shall be construed accordingly.

"**Health Registration**" means the technical, medical and scientific licences, registration, authorisations or approvals required or deemed necessary by any Regulatory Authority for the advertising, distribution, import, export, marketing or sale of the Products in the Territory or any part thereof.

"**Improvements**" means any improvement, modification or adaptation to the Know-How, the Patents or the Products (whether itself patentable or not) created during the conduct of and pursuant to the work performed under this Agreement by either

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party (or its authorized Sub-Contractor) whether acting alone or in combination with the other party and related to the design, manufacture and supply of the Products.

"**Intellectual Property Rights**" means the patents (including the Patents), applications for patents, utility models, applications for utility models, trade marks or applications for trademarks or trading names (whether or not registered or registrable), rights in Improvements, Know How, designs (registered or unregistered and including applications for registered designs), copyright (including rights in computer software), rights in inventions, the right to claim damages for past infringements of any or all such rights and all rights having equivalent or similar effect wherever situated.

"**Know-How**" means all knowledge, experience, data, technical or commercial information, inventions and all other Intellectual Property Rights (other than the Patents) related to the design, manufacture and supply of Products (including, without limitation, trade secrets, technology, methods of manufacture, specifications, description of manufacturing processes, recopies, formulae or drawings relating to the design, development, manufacture and supply of the Products, and other information).

"**Losses**" means, collectively, any and all claims, liabilities, losses, damages, costs, expenses, including reasonable fees and disbursements of counsel (except as herein limited) and any consultants or experts and expenses of investigation, obligations, liens, assessments, judgments, fines and penalties imposed upon or incurred by an indemnified party under this Agreement.

"**Manufacturing Capacity**" means MSX's capacity to manufacture products (including, without limitation, the Products) using tooling and machines which are in some way used in the manufacture of the Products.

"**Major Raw Materials**" means Raw Materials constituting [\*\*\*] percent ([\*\*\*]) or more of the Price.

"**Manufacturing Site**" means MSX's manufacturing site used for the Manufacture of the Products located at [\*\*\*], or such other manufacturing facility as may be agreed in writing between the parties from time to time.

"**Milestone Payments**" means the payments to be made by RB to MSX upon the Product Launch in the U.S. and first Product Launch of the Products within any country within the ROW as set out in **Clause 7.10**.

"**Net Sales Value**" means the invoiced sales price of the Products after taking the deductions specified in **Schedule One** attached to and incorporated by reference in this Agreement.

"**Options**" means RB's option to make payments to MSX in accordance with **Clause 7.7** in order to buy out its obligation to continue making payments of the Royalties.

"**Order**" shall have the meaning given in **Clause 4.2.**

"**Packaging Specifications**" means each of the specifications for the packaging of the Products in a pouch/sachet (but for the avoidance of doubt not cartoned) as annexed in **Schedule Four Part A** and as listed in the relevant Quality Agreement signed for the purposes of identification by each party, as amended from time to time.

"**Patents**" means:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;the patents and applications for the patents in the MSX Arising Intellectual Property Rights and Existing Intellectual Property Rights and rights of a similar nature in the Territory and relating to the Products, the particulars of which are set out in **Schedule Two** attached to and incorporated by reference in this Agreement; and

ii)&nbsp;&nbsp;&nbsp;&nbsp;the patents granted in the Territory pursuant to the patent applications in (i) above including any patents for Improvements.

"**Pharma Price Index**" means the Producer Price Index for Finished Goods, Pharmaceutical Preparations, Series Id: WPU0638, issued by the Bureau of Labor Statistics, U.S. Department of Labor, or comparable successor index.

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"**Price**" means the price (described by reference in **Schedule One** to stock keeping units) to be charged by MSX to RB in respect of any Products supplied pursuant to this Agreement as set out in **Clause 7.1** (for the avoidance of doubt the Price shall not include any Milestone Payments).

"**Price Change**" means the documented price change in MSX's manufacturing costs from the preceding Year's manufacturing costs of MSX. For purposes of this definition, change in manufacturing costs includes all costs to manufacture the Products, including, without limitation, changes in the cost of Raw Materials (excluding the API) ("**Cost of Raw Materials**"), energy, transportation, legal and regulatory costs. The changes in manufacturing costs shall exclude labour and overhead allocation.

"**Product Launch**" means the first date that the Products are supplied by RB or its agents to a customer in a country within the Territory, save that for the avoidance of doubt such date shall not be before the date on which the Products have been approved and rated by the relevant Regulatory Authority in that country and RB or its Affiliates has obtained a Health Registration in that country.

"**Product Specification**" means each of the specifications for the Products annexed in **Schedule Four Part A** and as listed in the relevant Quality Agreement signed for the purposes of identification by each party, as amended from time to time by mutual written agreement of the parties, and in accordance with which MSX shall manufacture and supply the Products, and which, for the avoidance of doubt, shall from the point of MSX's compliance with its obligations at **Clause 3.14** include the Serialized Product Specifications (as defined in **Clause 3.11**).

"**Products**" means those products which are listed in **Schedule Three** attached to and incorporated by reference in this Agreement or as otherwise agreed by the parties in writing, together with such additional, improved, modified or replacement products as shall be agreed between the parties from time to time in writing as are manufactured by MSX under this Agreement and wherever "Products" is referred to in this Agreement it shall refer to the relevant Product or all Products as the case may be, as listed in **Schedule Three**.

"**Quality Agreement**" means the manual referred to in **Schedule Six** attached to and incorporated by reference in this Agreement, in respect of each of the Products (supplied by RB to MSX and signed for the purposes of identification by each party) containing the technical information for manufacture of the Products along with any and all manufacturing policies of RB together with such manufacturing policies which may be provided by RB or its Affiliates to MSX in writing prior to the Commencement Date or as periodically updated by mutual written agreement of the parties.

"**Quality Manager**" means in respect of the Product the person (independent of the person responsible for production) responsible for the inspection and testing of the Raw Materials, the Film and the Product and for confirming that the manufacture of the Product is in compliance with the requirements of this Agreement; and in respect of the API the person (independent of the person responsible for production) responsible for the inspection and testing of the raw materials used in the manufacture of the API, and the API, and for confirming that the manufacture of the API is in compliance with the requirements of this Agreement.

"**Raw Materials**" means the API, excipients, reagents, solvents, packaging, labelling and other materials used by MSX in connection with the manufacture of the Products.

"**Regulatory Authority**" means any governmental body or agency responsible for the regulation of narcotics or the granting of any health or pricing approvals, Health Registration or reimbursement prices required to be obtained before the Products can be lawfully advertised, imported, distributed, marketed or sold in the Territory or any part thereof (including, without limitation, the FDA in the U.S., the Medicines and Healthcare products Regulatory Agency in the UK and the Transparency Commission in France).

"**ROW**" means the Territory excluding the U.S.

"**Royalty**" means the payments to be made by RB to MSX in respect of the Net Sales Value of the Products as set out in **Clause 7.4**.

"**Sub-Contractors**" means in respect of each of the Products the sub-contractor (if any) listed in **Schedule Five** attached to and incorporated by reference in this Agreement together with any other person or company proposed by MSX as a sub-contractor and agreed to in writing by RB, which agreement shall not be unreasonably withheld, conditioned or delayed.

"**Term**" shall have the meaning set forth in **Clause 2.1**.

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"**Territory**" means the world.

"**Tooling**" means any moulds, machines, or equipment required for and specific to the manufacture of the Products under the terms of this Agreement

"**U.S.**" means the United States of America.

"**Year**" means the period from the Commencement Date until the 31 December in the calendar year of the Commencement Date and shall thereafter constitute any period of 365 days (or 366 days if the period includes 29<sup>th</sup> February) commencing on the 1<sup>st</sup> day of January in any calendar year.

1.2.&nbsp;&nbsp;&nbsp;&nbsp;Unless otherwise indicated, references to clauses and schedules are references to clauses and schedules in this Agreement.

2.&nbsp;&nbsp;&nbsp;&nbsp;**TERM**

2.1&nbsp;&nbsp;&nbsp;&nbsp;This Agreement shall be effective from the Commencement Date and shall continue until the latter of (i) the expiration of the last to expire of the Patents; or (ii) in the event that the Patents do not proceed to registration (or are otherwise declared void, terminated or revoked during the seven year period beginning with the Commencement Date), the expiration of the seven year period beginning with the Commencement Date; unless terminated by either party in accordance with the provisions of **Clause 17** (the "**Term**").

2.&nbsp;&nbsp;&nbsp;&nbsp;**MANUFACTURE AND SUPPLY**

3.1&nbsp;&nbsp;&nbsp;&nbsp;During the Term, MSX shall manufacture and supply RB's requirements of the Products on an exclusive basis and shall manufacture the Products:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.1&nbsp;&nbsp;&nbsp;&nbsp;in accordance with cGMP, the Product Specification and the processes set out in the Quality Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.2&nbsp;&nbsp;&nbsp;&nbsp;in accordance with any legislation applicable to the manufacture of the Products (including without limitation legislation and standards applicable to environmental protection such as waste disposal and any legislation or regulations regarding ePedigree requirements as and when enforced as further described in **Clause 3.13**); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.3&nbsp;&nbsp;&nbsp;&nbsp;subject to **Clause 3.3** below, at the Manufacturing Site.

3.2&nbsp;&nbsp;&nbsp;&nbsp;MSX shall not:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.1&nbsp;&nbsp;&nbsp;&nbsp;use any site other than the Manufacturing Site for the manufacture of the Products (including the process, plant or equipment used in the manufacture of the Products), without the prior written consent of RB, such consent not to be unreasonably withheld, conditioned or delayed, and RB to cooperate reasonably with MSX in respect of any proposals to utilise new manufacturing sites; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.2&nbsp;&nbsp;&nbsp;&nbsp;at any time during the Term carry out any activities that MSX actually knows or should reasonably know shall prejudice the quality, safety or efficacy of the Products.

3.3&nbsp;&nbsp;&nbsp;&nbsp;The parties acknowledge that MSX intends to use its facility located at [\*\*\*] as a manufacturing site for the manufacture of the Products, and RB hereby consents to such site transfer subject to RB conducting a quality review of the [\*\*\*] site in accordance with **Clause 3.2.1**.

3.4&nbsp;&nbsp;&nbsp;&nbsp;MSX shall:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.4.1&nbsp;&nbsp;&nbsp;&nbsp;only use API supplied from RB in the manufacture of the Products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.4.2&nbsp;&nbsp;&nbsp;&nbsp;ensure that all personnel employed by MSX in the manufacture of the Products are suitably trained, experienced and competent for their respective functions; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.4.3&nbsp;&nbsp;&nbsp;&nbsp;monitor, account for and keep RB regularly informed of the usage and waste of API and MSX shall ensure that in the manufacture of the Products MSX does not waste any more than a set percentage of the API to be determined by the parties in writing acting reasonably and assuming efficient manufacture of the Products.

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3.5&nbsp;&nbsp;&nbsp;&nbsp;Subject to **Clause 7.12**, MSX shall be entitled to obtain the Raw Materials and other components for the manufacture and delivery of the Products from qualified suppliers of its own choosing. In the event that MSX obtains Raw Materials from a third party supplier, MSX shall notify RB and MSX shall consider in good faith (but not be bound by) any reasonable objection by RB timely delivered to MSX as to the qualification of such third party supplier; provided, however, that (subject to **Clause 7.12**) RB shall have no right to object to any financial arrangement reached between MSX and such third party supplier, which shall be determined at the sole discretion of MSX. MSX shall ensure that such Raw Materials and other components are of the requisite standard to comply with the Product Specification and any applicable laws, codes of practice and regulations and the terms of this Agreement. Periodically, MSX will share with RB a list of all suppliers, so RB may voice to MSX any concerns in connection with them.

3.6&nbsp;&nbsp;&nbsp;&nbsp;Unless otherwise agreed with RB in writing and save for the fact that RB shall be responsible for cartoning the Products once delivered to RB, MSX shall operate on a full service basis (meaning that MSX shall be responsible for the purchase of all Raw Materials (except for API which shall be supplied by RB in accordance with **Clause 4.3** hereof) and the supply of the Products in individual sachet form to RB or its nominee). RB shall only be invoiced for the Cost of Goods Price as set out in **Schedule One** which shall be inclusive of such costs and expenses, including FCA (Incoterms 2000) delivery.

3.7&nbsp;&nbsp;&nbsp;&nbsp;For the purposes of ensuring that RB has the full protection of its business interests and the ongoing benefit of its and any of its Affiliates' Intellectual Property Rights, and subject to applicable laws, MSX covenants with RB that during the Term it will not, so far as it is aware, without the prior written consent of RB, whether directly or indirectly and whether alone or in conjunction with or on behalf of any other person and whether as principal, shareholder, director, employee, agent, consultant, partner or otherwise:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7.1&nbsp;&nbsp;&nbsp;&nbsp;subject to **Clause 3.9,** canvass, solicit or approach, or cause to be canvassed, solicited or approached, any person for orders of products within the Field who RB informs MSX in writing is or was at any time during the Term:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7.1.1&nbsp;&nbsp;&nbsp;&nbsp;negotiating with RB or any of its Affiliates for the supply by RB or any of its Affiliates of the Products; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7.1.2&nbsp;&nbsp;&nbsp;&nbsp;an actual customer of RB or any of its Affiliates in respect of the Products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7.2&nbsp;&nbsp;&nbsp;&nbsp;interfere, or seek to interfere, with the continuation of supplies to RB or any of its Affiliates from any supplier who RB informs MSX in writing has been supplying goods to RB or any of its Affiliates at any time during the Term if such interference causes or would cause that supplier to cease supplying, or materially reduce its supply of those goods; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7.3&nbsp;&nbsp;&nbsp;&nbsp;directly solicit or entice, or endeavour to solicit or entice, away from RB or its Affiliates, any person employed in a managerial, supervisory, technical or sales capacity by, or who is or who was a consultant to, RB or its Affiliates at a time during the Term; provided, that, general solicitations not directed to a specific individual shall not constitute a breach hereof; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7.4&nbsp;&nbsp;&nbsp;&nbsp;develop (subject to **Clause 3.9**), manufacture, market or sell any product within the Field.

3.8&nbsp;&nbsp;&nbsp;&nbsp;For the purposes of ensuring that MSX has the full protection of its business interests and the ongoing benefit of its and any of its Affiliates' Intellectual Property Rights, and subject to applicable laws, RB covenants with MSX that during the Term it will not, without the prior written consent of MSX whether directly or indirectly and whether alone or in conjunction with or on behalf of any other person and whether as principal, shareholder, director, employee, agent, consultant, partner or otherwise:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8.1&nbsp;&nbsp;&nbsp;&nbsp;subject to **Clause 6.5** and **Clause 3.9**, canvass, solicit or approach, or cause to be canvassed, solicited or approached; any person for the manufacture of the Products in the Field;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8.2&nbsp;&nbsp;&nbsp;&nbsp;interfere, or seek to interfere, with the continuation of supplies or Raw Materials to MSX or any of its Affiliates from any supplier who has been supplying supplies or Raw Materials to MSX or any of its Affiliates at any time during the Term if such interference causes or would cause that supplier to cease supplying, or materially reduce its supply of those goods;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8.3&nbsp;&nbsp;&nbsp;&nbsp;directly solicit or entice, or endeavour to solicit or entice, away from MSX or its Affiliates, any person employed in a managerial, supervisory, technical or sales capacity by, or who is or who was a consultant to, MSX or its

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Affiliates at a time during the Term; provided, that, general solicitations not directed to a specific individual shall not constitute a breach hereof; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8.4&nbsp;&nbsp;&nbsp;&nbsp;develop (subject to **Clause 3.9**), manufacture, make, have made, market or sell Products outside the Field.

3.9&nbsp;&nbsp;&nbsp;&nbsp;Each of RB and MSX agrees that at least one year prior to the expiration of the Term it will notify the other of its intent to renew or not to renew this Agreement. In the event that either party elects not to renew this Agreement upon the expiration of the Term, notwithstanding the restriction contained in **Clauses 3.7.1** and **3.7.4** as to MSX and **Clauses 3.8.1** and **3.8.4** as to RB, during the last twelve (12) months of the Term of this Agreement: (i) RB shall have the right to develop Products outside the Field and to canvass, solicit and approach, and cause to be canvassed, solicited and approached, any person for the manufacture of the Products in the Field to commence after the expiration of the Term, and (ii) MSX shall have the right to develop products in the Field and to canvass, solicit and approach, and cause to be canvassed, solicited and approached, any person for the manufacture of products in the Field to commence after the expiration of the Term. Notwithstanding anything to the contrary contained in this Agreement, no notice by either party under this **Clause 3.9** shall reduce or impair the respective obligations of each of the parties under this Agreement for the remainder of the Term except as set forth in this **Clause 3.9**.

3.10&nbsp;&nbsp;&nbsp;&nbsp;At the option of RB delivered by written notice to MSX at least ninety (90) days prior to the expiration of the Term, MSX shall continue to supply the Products to MSX in accordance with the terms and conditions of this Agreement for a period determined by RB not to exceed six (6) months after the expiration of the Term.

3.11&nbsp;&nbsp;&nbsp;&nbsp;The parties agree to use their best efforts to implement as soon as possible (including prior to Launch, or if this is not possible, as soon as possible thereafter) an electronic pedigree system in connection with the manufacture and supply of the Products which would satisfy the expected legal requirements of the E-Pedigree regulations of the State of California for the electronic tracking and tracing of prescription drugs through the supply chain, California Business and Professions Code § 4034 *et seq.* (the "**E-Pedigree Regulations**") (currently scheduled to become effective as of January 1, 2011) and in accordance with the Serialized Product Specifications (as defined below). The parties agreement set forth in the preceding sentence shall apply to the manufacture and supply of the Products throughout the Territory; provided that such manufacture and/or supply, as the case may be, is not in violation of any applicable law, code of practice or regulation in any country in the ROW in which instance it shall not apply in such country in the ROW. To that end, RB intends to purchase, or have purchased, technology (including equipment and software) from a third party manufacturer (the "**E-Pedigree Manufacturer**") which consists of a pouch image acquisition and collating system and affixes a unique serialization identifier on the packaging of each saleable unit of the Product/ Part of such technology will be installed at RB's third party packager of the Product (the "**Packager Serialization Technology**") and part of such technology will be purchased by and installed at the facility of MSX's third party Foil supplier (the "**Foil Supplier**") for the Product (the "**Foil Serialization Technology**") (the Foil Serialization Technology together with the Packager Serialization Technology, shall collectively be referred to as the "**Serialization Technology**"). The specifications for serialization of the Product using the Foil Serialization Technology (the "**Serialized Product Specifications**") are set forth in **Schedule Four Part A.1** and shall not be modified without the prior approval of RB. RB acknowledges that the Foil Serialization Technology is newly developed by the E-Pedigree Manufacturer and has never before been installed, tested, or validated by the E-Pedigree Manufacturer and, as a result, the parties are at the time of signing this Agreement unable to guarantee the performance of the Foil Serialization Technology or the effectiveness, value, safety, merchantability or fitness for any particular purpose of the Foil Serialization Technology, or any part thereof, or its impact on the manufacture or supply of the Products under this Agreement. MSX agrees to coordinate the purchase, installation, testing, validation and qualification of the Foil Serialization Technology by the Foil Supplier and to use its best efforts to ensure that the Foil Serialization Technology is purchased, installed, tested, validated and qualified, in order to enable MSX to manufacture and supply the Products in accordance with the Product Specifications (the "**Serialized Products**") for Launch (or if this is not possible as soon as soon as possible thereafter). Thereafter MSX shall manufacture and supply the Serialized Product in accordance with the Serialized Product Specifications subject to the following conditions, which conditions shall be and remain in effect only until such time as (i) MSX shall be required by state law to comply with the E-Pedigree Regulations, or be required by federal law to comply with a comparable electronic pedigree prescription drug supply chain tracking and tracing system, in connection with the manufacture and supply by MSX of Serialized Products under this Agreement (the "**Effective E-Pedigree Regulations**") in accordance with the provision of **Clause 3.13** or (ii) MSX has complied with its obligations under **Clause 3.14** and successfully manufactured such volume of Serialized Products (as specified in **Clause 3.14**) in accordance with the Serialized Product Specification such that MSX shall thereon be responsible for ensuring all Products produced

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under this Agreement comply with the Serialized Product Specifications (and MSX shall no longer be able to produce to the Non-Serialized Product Specifications (as defined below)), whichever is the earlier:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.11.1&nbsp;&nbsp;&nbsp;&nbsp;In the event that the Foil Serialization Technology fails or causes a material adverse impact on the manufacture and supply of the Film or the Products or the timely delivery of same, RB and MSX agree to suspend the use of the Serialization Technology in the manufacture and supply of the Product until the cause of such material adverse impact has been cured or the parties agree in writing to abandon the Serialization Technology, and MSX shall thereafter resume the manufacture and supply of the Products which meet the Product Specifications not including the Serialized Product Specifications, (the "**Non-Serialized Product Specifications**") in accordance with the terms of this Agreement. MSX shall promptly notify RB upon becoming aware of any such failure or material adverse impact. During the period while MSX is manufacturing and supplying the Product (including any Serialized Product or Non-Serialized Product) under this **Clause 3.11, MSX** shall arrange with the Foil Supplier to maintain an appropriate rolling amount of inventory of Foil (the "**Foil Stock**") which is reasonably anticipated as necessary to avoid any material delay In the manufacture and supply of Product in compliance (with the Non-Serialized Product Specifications required as a result of such failure or material adverse impact. RB shall reimburse MSX for the cost of any unused Foil Stock providing that MSX has used reasonable efforts to ensure such unused Foil waste is kept to a minimum;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.11.2&nbsp;&nbsp;&nbsp;&nbsp;MSX shall bear no cost for the purchase, installation, implementation, testing, validation or qualification of the Serialization Technology and RB agrees that the Cost of Goods Price shall be simultaneously increased to reflect any and all direct increases incurred by MSX (without mark-up thereof by MSX and based upon supporting documentation from MSX) during the Term in the purchase of Foil manufactured using the Foil Serialization Technology (the "**Serialized Foil**"), whether as an increase in the cost of purchase of the Serialized Foil and/or as an amortization charge by the Foil Supplier for the purchase, installation, implementation, testing, validation, and/or qualification of the Serialization Technology. MSX estimates that the Cost of Goods Price will be initially increased by the sum of (i) $[\*\*\*] per unit of Product for the cost associated with the purchase by MSX of the Serialized Foil plus (ii) $[\*\*\*] per unit of Product for the amortized cost of purchasing the Foil Serialization Technology by the Foil Supplier based upon the purchase by MSX of Serialized Foil required to make [\*\*\*] of Serialized Products (a total estimated initial cost increase per unit of Product of $[\*\*\*]). The parties agree that if the Cost of Goods Price is initially increased for the amortization of the cost of purchasing the Foil Serialization Technology by the Foil Supplier, when such cost is fully amortized by the Foil Supplier, or if RB has otherwise fully paid MSX or the Foil Supplier all sums due to the Foil Supplier in respect of the Foil Serialization Technology, the Cost of Goods Price per unit of Serialized Product would thereafter be reduced by an amount equal to any such increase in the Cost of Goods Price for the amortized cost of purchasing the Foil Serialization Technology by the Foil Supplier. Such estimates shall not be binding on MSX and shall be adjusted and finalized by MSX upon receipt by MSX from the Foil Supplier of all final costs incurred in purchasing the Foil Serialization Technology, producing and supplying the Serialized Foil and all other related costs and expenses of the Foil Supplier. In the event of any suspension or abandonment of the manufacture and supply of the Serialized Product in accordance with **Clause 3.11.1**, the Cost of Goods Price for the purchase of all Products manufactured and supplied following such suspension or abandonment in accordance with the Non-Serialization Specifications shall revert to the Cost of Goods Price in effect prior to such increase and any unamortized costs for the purchase of the Foil Serialization Technology shall be paid by RB; provided, however, that RB may exercise any right and remedy (and MSX shall assist RB therewith) against the Foil Supplies to dispute such payment in the event that such suspension is not due to a failure of the Serialization Technology but is due to the fault of the Foil Supplier, including failure by the Foil Supplier to manufacture the Foil in accordance with the Serialized Foil specifications agreed to by MSX and the Foil Supplier;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.11.3&nbsp;&nbsp;&nbsp;&nbsp;The provisions under **Clause 7.14** relating to RB's rights to obtain pricing for Major Raw Materials from third parties, and MSX's obligations to engage any other supplier or obtain a price reduction from its then-current Foil supplier in the event that a Price Change exceeds the Pharma Price Index shall not apply to any Price Change resulting from the purchase, installation, implementation, testing, validation, and/or qualification of the Foil Serialization Technology until RB has complied with its obligations under **Clause 3.11.7** in respect of identifying and qualifying an alternative secondary supplier for the Serialized Foil and such engagement of an alternate Foil supplier or obtaining a, price reduction from its then current Foil supplier would not result in a breach of the agreement between MSX and its then current Foil supplier. MSX shall remain obliged to show documentary evidence of the Price Change;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.11.4&nbsp;&nbsp;&nbsp;&nbsp;MSX makes no representation or warranty with respect to the Serialization Technology including any representation or warranty under **Clause 9** as it may relate to the Foil Serialization Technology;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.11.5&nbsp;&nbsp;&nbsp;&nbsp;MSX shall be excused from any and all unfulfilled manufacturing, supply and delivery performance obligations under this Agreement resulting from, relating to or in connection with Foil Serialization Technology including the purchase, installation, implementation, testing, validation, qualification and/or operation of the Foil Serialization Technology; provided, however, that nothing in this **Clause 3.11.5** shall limit MSX's obligation to manufacture and supply Product in compliance with the Non-Serialized Product Specifications as soon as possible in accordance with **Clause 3.11.1** in the event and for such period of time that the parties determine to suspend the manufacture of Serialized Product and, in the event that the parties determine to terminate and abandon the manufacture of Serialized Product in accordance with **Clause 3.11.1;** for the remainder of the Term or the date upon which the E-Pedigree Regulations become effective, whichever is earlier;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.11.6&nbsp;&nbsp;&nbsp;&nbsp;MSX shall not be in default or breach under this Agreement, and RB shall not be entitled to withhold payment for non-conforming Products, or to terminate this Agreement for any reason with respect to any delay or incomplete delivery of, failure to deliver or delivery of non-conforming Products relating to, as a result of or in connection with the Foil Serialization Technology (including the purchase, installation, implementation, testing, validation, qualification or failure of the Serialization Technology), except to the extent caused by the breach by MSX of any of its obligations under this **Clause 3.11**;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.11.7&nbsp;&nbsp;&nbsp;&nbsp;RB and MSX agree to use commercially reasonable efforts to qualify an FDA approved secondary supplier of the Serialized Foil as soon as practicable after the Commencement Date. It is acknowledged that, due to importance of obtaining a secondary supplier of the Serialized Foil in order to reduce the risk of failure to supply the Serialized Foil, both parties will use their best efforts to qualify such secondary supplier within one (1) year of the FDA approval of the Product or as soon as possible thereafter. The parties further agree that RB shall be responsible for payment to MSX of all costs and expenses incurred by MSX in connection with the qualification of any secondary and/or replacement supplier of Serialized Foil in connection with the manufacture and supply of the Products under this Agreement if RB continues to require that the Products be manufactured and supplied using the Serialization Technology, or any part thereof, or substitute therefore, including without limitation, the cost of the purchase, installation, implementation, testing, validation, and qualification of the Foil Serialization Technology by the secondary and/or replacement supplier.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.11.8&nbsp;&nbsp;&nbsp;&nbsp;In addition to the exceptions and exclusions set forth in the foregoing provisions of this **Clause 3.11,** notwithstanding anything to the contrary contained in this Agreement or otherwise, none of the provisions of **Clauses 5.5, 6.5, 6.6, 6.7, 7.9, 10.2, 13.10, 16.2, 17.3.4, 17.3.6,** and **17.4** shall during the course of manufacture under this **Clause 3.11** apply to the Foil Serialization Technology or any event or matter covered therein relating to, resulting from or in connection with the purchase, installation, implementation, testing, validation, qualification and/or failure of the Foil Serialization Technology, and MSX shall have no obligations or responsibilities with respect to the Foil Serialization Technology except as expressly set forth in this **Clause 3.11** which for the avoidance of doubt expressly includes MSX's obligations to manufacture and supply Products in compliance with Non-Serialized Product Specifications as soon as possible in accordance with **Clause 3.11.1** in the event and for such period of time that the parties determine to suspend the manufacture of Serialized Product, and for the remainder of this **Clause 3.11** in the event that the parties determine to terminate the manufacture of Serialized Product in accordance with **Clause 3.11.1**.

3.12&nbsp;&nbsp;&nbsp;&nbsp;RB acknowledges that MSX shall have no interest in the Serialization Technology and that, MSX shall have no obligations to transfer or grant to RB, or to arrange the transfer or grant to RB of, any interest in the Serialization Technology under any circumstances at any time whether during the Term or upon any expiration or termination of this Agreement for any reason, including, without limitation, the Foil Serialization Technology, and/or any Arising Intellectual Property Rights therein of the Foil Supplier under **Clause 15** except to the extent such interests or Arising Intellectual Property Rights are in the possession or control of MSX and not subject to any third party restrictions on such transfer or grant to RB.

3.13&nbsp;&nbsp;&nbsp;&nbsp;For the avoidance of doubt, in the event that MSX is required to comply with Effective E-Pedigree Regulations after the Commencement Date, MSX shall (i) use commercially reasonable efforts to deliver the Product serialization data produced by MSX in compliance with the Effective E-Pedigree Regulations in a format which is compatible with RB's Product distribution system; and (ii) from the date on which the Effective E-Pedigree Regulations come into effect (currently scheduled to become effective as of January 1, 2011) be fully responsible for ensuring all Products manufactured and supplied under this Agreement comply with all legislation and regulatory requirements including the Specifications and Serialized Product Specifications as may be amended to ensure compliance with the Effective E-Pedigree Regulations (including without limitation the envisaged requirement to ensure all Products are serialized and thereafter scanned before leaving the Manufacturing Site) and, for the avoidance of doubt, from this date MSX shall under no circumstances

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(including without limitation those set out **Clauses 3.11.1** to **3.11.8**) be released from any liability arising from the failure to manufacture and supply the Products to such Specifications in accordance with the terms of this Agreement.

3.14&nbsp;&nbsp;&nbsp;&nbsp;Following the date upon which each of the following has occurred (the "**Product Serialization Acceptance Date**"): (i) successful implementation of the Foil Serialization Technology; (ii) successful production of the Serialized Products in compliance with the Serialized Product Specifications at scale and consistent with applicable Product Order patterns for an uninterrupted period of three (3) consecutive months or a period of six (6) consecutive months after the Product Launch (whichever is the latter); and (iii) qualification of a secondary supplier of Serialized Foil in accordance with **Clause 3.11.7;** the Product Specification for the Products shall thereupon be permanently amended to include the Serialized Product Specifications. For the avoidance of doubt, from and after the Serialization Acceptance Date, MSX shall be responsible for ensuring that the Products manufactured and supplied under this Agreement are in compliance with the Serialized Product Specifications, and MSX shall be responsible for any failure to comply with such Serialized Product Specifications and, for the further avoidance of doubt, from and after the Product Serialization Date MSX shall under no circumstances (including without limitation those set out Clauses 3.11.1 to 3.11.8) be released from any liability arising from the failure to manufacture and supply the Products to such Serialized Product Specifications in accordance with the terms of this Agreement.

4.&nbsp;&nbsp;&nbsp;&nbsp;**FORECASTS, ORDERS AND SUPPLY OF THE API**

4.1&nbsp;&nbsp;&nbsp;&nbsp;No less than one (1) month prior to the end of every calendar month, RB shall provide (or cause to be provided from its Affiliates) a forecast of its requirements for the Products for the [\*\*\*] months (a "Forecast"), By way of example, this means that the Forecast for [\*\*\*] to [\*\*\*] (inclusive) of any year shall be provided by no later than the end of [\*\*\*] in the previous year, and the subsequent Forecast for [\*\*\*] to [\*\*\*] of any year shall be provided by no later than the end of [\*\*\*] in the previous year.

4.2&nbsp;&nbsp;&nbsp;&nbsp;In respect of the [\*\*\*] months of the Forecast, RB shall specify the date by which the Products are requested to be delivered ("**Delivery Date**"). RB's requirements as set out in the [\*\*\*] months of the Forecast shall be fixed and shall constitute a firm order binding on MSX (subject to the terms and conditions of this Agreement) for the delivery of, and on RB for the purchase of, those Products specified in the [\*\*\*] months of the Forecast by the Delivery Date with delivery in accordance with **Clause 5.1** (an "**Order**"). Once MSX receives the Forecast, MSX shall ensure that it has sufficient Raw Materials, packaging components and other materials necessary to manufacture RB's requirements for Products as set out in the Order, and MSX shall use commercially reasonable efforts to acquire sufficient Raw Materials, packaging components and other materials necessary to manufacture [\*\*\*] percent [([\*\*\*]%)] of RB's requirements as set out in the remaining [\*\*\*] months of the Forecast. For the avoidance of doubt this means that the Forecast given at the end of [\*\*\*] shall be a binding Order for [\*\*\*] and the Forecast given at the end of [\*\*\*] shall be a binding Order for [\*\*\*]. To the extent that the Forecast given in [\*\*\*] would increase the Order for [\*\*\*] as originally set in [\*\*\*], MSX agrees to liaise with RB and use reasonable endeavours to meet such increase but failure to supply such increase shall not in any way constitute a breach by MSX of this Agreement and shall not constitute a failure by MSX to deliver an Order on time for the purposes of **Clause 6.4**. Notwithstanding anything to the contrary contained in this Agreement, MSX shall be under no obligation to fill any Order that is for less than [\*\*\*] units of a Product (the "**Minimum Purchase Requirement**"). RB shall have the right to delay the issuance of any firm Order for a reasonable period of time in order to combine such Order with one or more subsequent Orders for the purpose of meeting the Minimum Purchase Requirement (meaning that in order to meet the [\*\*\*] unit Minimum Purchase Requirements RB can (subject to compliance with **Clause 7.12**) combine Orders for the same dose Product for different countries (such as [\*\*\*] 2mg dose units for the UK and [\*\*\*] 2mg dose units for the US (which therefore require different packaging requirements chargeable under **Clause 7.3.2**)) but cannot combine orders for different dose Products (such as [\*\*\*] 2mg dose units and [\*\*\*] 8mg dose units)).

4.3&nbsp;&nbsp;&nbsp;&nbsp;RB shall supply, or arrange the supply of, API that conforms to the API Specification to MSX at the Manufacturing Site free of charge on the dates and in such quantities as are required by MSX for manufacture of the Products in the Forecasts and in connection with manufacturing validation and site transfer, together with the API's Certificate of Analysis and Certificate of Compliance. Save as may be amended by the mutual written agreement of the parties in accordance with the terms of this Agreement, such supply shall be made by RB to MSX DDP (Incoterms 2000) and on or before the delivery dates reasonably required by MSX in writing. RB will promptly notify MSX of any changes to the safety and handling procedures in relation to the API that are required by applicable law or Regulatory Authorities after the Commencement Date, and MSX shall comply with such changes with respect to all future Orders placed by RB at least ninety (90) days following receipt of notice thereof, or such earlier time as required by applicable law or Regulatory Authority. The purchase orders by MSX for API shall be made and filled in accordance with the procedure specified in **Schedule Seven**. Subject to the terms of this Agreement, MSX shall only use the API to manufacture and test the Product and for no other purpose whatsoever.

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4.4&nbsp;&nbsp;&nbsp;&nbsp;MSX shall test each batch or stock of the API delivered to MSX in accordance with the testing procedure set out in the **Schedule Eight** to determine its conformance with the necessary amounts and API Specification or for contamination during transit. If in the reasonable opinion of MSX, MSX determines that such API is contaminated or does not meet the API Specification or necessary amounts, MSX shall within twenty-one (21) days from the date of completion of such tests notify RB in writing of such defect or non-conformance, including the test results supporting MSX's opinion.

4.5&nbsp;&nbsp;&nbsp;&nbsp;If RB agrees that the API is contaminated or does not meet the API Specification, RB shall at no charge to MSX replace the defective or non-conforming API with API that meets the API Specification. If RB disagrees with the alleged defective or non-conformity of the API, samples of the alleged defective or non-conforming API shall be retested by an independent laboratory, mutually agreed upon by the parties in writing, to determine compliance with the API Specification. MSX and RB shall be bound by the results of such independent laboratory testing. The costs incurred in connection with independent laboratory's testing of the API shall be borne by MSX if the API in question is found to conform to the API Specification or not defective and by RB if it is found not to conform to the API Specification or be defective. Any delay in the manufacture or supply of Products resulting from RB's failure or delay in supplying API in accordance with the API Specification or MSX's good faith reasonable belief pursuant to **Clause 4.4** and this **Clause 4.5** that the API does not meet the API Specifications or is defective, shall not constitute a default under or breach of this Agreement. The parties agree that in the event that the API is found to be defective, RB shall be responsible, at its costs, to identify and implement such remedial action as is necessary to rectify the issue and ensure that the API meets the API Specification.

4.6&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding the terms of any DDP delivery (or any other delivery) of the API by RB to MSX, legal title to the API shall remain with RB after delivery to MSX. MSX shall use reasonable efforts to ensure proper storage and handling of the API once delivered to MSX. Risk of damage to, or loss of, the API shall pass from RB to MSX upon delivery as set out in **Clause 4.3**. MSX shall retain casualty insurance coverage for the expected inventory of the API (amounts expected to be supplied to MSX by RB for manufacture of the Product in the amounts set forth in the Forecasts) to cover damage to or loss of the API for so long as the API remains at MSX's risk.

4.7&nbsp;&nbsp;&nbsp;&nbsp;In the event that MSX manufactures Products which cannot be sold due to latent defects in the API supplied (and such defects are not caused by MSX's negligent storage or handling), RB shall remunerate MSX for its costs of manufacturing such Products. In the event that MSX manufactures Products which cannot be sold due to latent defects in the API caused by MSX's negligent storage or handling, MSX shall remunerate RB for the Cost of Goods Price for such Products, to the extent such Cost of Goods Price has been paid to MSX for such Products.

5.&nbsp;&nbsp;&nbsp;&nbsp;**DELIVERY OF THE PRODUCTS**

5.1&nbsp;&nbsp;&nbsp;&nbsp;Unless otherwise specifically stated, the Delivery Date shall be the date by which the Order shall be made available FCA (Incoterms 2000) at MSX's loading dock at the Manufacturing Site, whereupon MSX shall be entitled to invoice RB for Cost of Goods Price in respect of the Products so delivered. An Order may request boxed shipping at an additional handling charge beyond the Cost of Goods Price. No Orders shall be shipped in boxes unless expressly agreed to by MSX in writing. Legal title to the Products and risk of damage to, or loss of, the Products shall pass from MSX to RB upon being made available at MSX's loading dock at the Manufacturing Site on the Delivery Date in accordance with Clause 5.7. Any invoices sent to RB under this Clause 5.1 shall specify the Price in respect of the Products delivered, the quantity of Products delivered, the date of delivery and the amount of VAT or other taxes due in respect of the Products delivered, together with any applicable transportation costs (if any) associated with delivery.

5.2&nbsp;&nbsp;&nbsp;&nbsp;MSX shall not be liable for any delay or failure to deliver hereunder after the Products leave MSX's loading dock at the Manufacturing Site as set out in **Clause 5.1**.

5.3&nbsp;&nbsp;&nbsp;&nbsp;Each shipment of Product shall be delivered to RB with:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3.1&nbsp;&nbsp;&nbsp;&nbsp;a Certificate of Analysis and Certificate of Compliance;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3.2&nbsp;&nbsp;&nbsp;&nbsp;in accordance with the Quality Agreement; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3.3&nbsp;&nbsp;&nbsp;&nbsp;any other documentation required by any applicable rule, law or regulation having jurisdiction over the shipment and supply of the Products.

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5.4&nbsp;&nbsp;&nbsp;&nbsp;RB shall be entitled to reject any Product delivered to RB (or its nominee) without a Certificate of Analysis, Certificate of Compliance or other documentation required under any applicable rule, law or regulation.

5.5&nbsp;&nbsp;&nbsp;&nbsp;MSX recognises that late delivery of the. Products may have an impact on RB's obligations to its customers. MSX shall make all reasonable efforts to deliver Products by the Delivery Date requested by RB. The Delivery Date shall be reasonable based on MSX's production capacity.

5.6&nbsp;&nbsp;&nbsp;&nbsp;MSX shall manage any mutually agreed upon changes in writing to the Product Specification and the Packaging Specification, whilst maintaining the supply and delivery performance as set out herein. Changes to the Products shall be made with commercially reasonable speed of implementation, and meet the launch timings mutually agreed upon by the parties in writing or required by applicable law or Regulatory Authority. Inventory levels of Raw Materials, Film and the Products are to be communicated at least ninety (90) days prior to the change and usage agreed with RB in writing before the change is implemented. The parties shall agree in writing to the implementation date at least sixty (60) days prior thereto.

5.7&nbsp;&nbsp;&nbsp;&nbsp;Legal title and risk in the Products shall pass to RB upon being made available FCA (Incoterms 2000) at MSX's loading dock at the Manufacturing Site on the Delivery Date. MSX shall fully insure the Products (at a valuation based on MSX's cost of manufacture plus the cost of API) for as long as they remain at MSX's risk.

5.8&nbsp;&nbsp;&nbsp;&nbsp;In the event there is an incomplete delivery of the Products to RB (or its nominee) pursuant to an Order, RB shall notify MSX in writing within twenty-one (21) days, identifying the amount of Product that has not been delivered. MSX shall use commercially reasonable efforts to rectify such incomplete delivery by supplying, the balance of the Products under such Order.

5.9&nbsp;&nbsp;&nbsp;&nbsp;RB shall inspect and test the Products within thirty (30) calendar days of receipt thereof, and shall be entitled to reject such Products which do not conform to the Product Specification and withhold payment of the Cost of Goods Price for such non-conforming Products by giving written notice to MSX within forty (40) calendar days from receipt of such Products by RB.

5.10&nbsp;&nbsp;&nbsp;&nbsp;Any written notice of rejection of the Products given by RB shall specify in sufficient detail the manner in which the Products fail to conform. If it is determined by written agreement between the parties (or, in the absence of written agreement of the parties, by an independent laboratory or consultant agreed upon by the parties in writing whose fees shall be paid by the non-prevailing party) that the non-conformity is due to:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.10.1&nbsp;&nbsp;&nbsp;&nbsp;damage to the Products caused by RB (or its nominee), including, without limitation, through improper Product storage or transit, after the delivery of the Products to RB (or its nominee), MSX shall have no liability to RB with respect thereto and RB shall promptly pay what is owed for such Products in accordance with the terms of this Agreement; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.10.2&nbsp;&nbsp;&nbsp;&nbsp;the negligence of MSX or breach by MSX of the terms of this Agreement, then MSX shall credit RB's account with the Cost of Goods Price invoiced for such non-conforming Products (or in the event the Cost of Goods Price has been withheld by RB, waive any right to claim the Cost of Goods Price for such non-conforming Products from RB under this Agreement). RB will either return such non-conforming Product to MSX, or lawfully destroy such non-conforming Products (in each case at MSX's written option and cost).

6.&nbsp;&nbsp;&nbsp;&nbsp;**CAPACITY, STOCK LEVELS AND TOOLING**

6.1&nbsp;&nbsp;&nbsp;&nbsp;Within six (6) months following the Commencement Date, and thereafter within the first calendar month of each Year, MSX shall provide to RB copies of its disaster recovery and contingency plans.

6.2&nbsp;&nbsp;&nbsp;&nbsp;MSX shall inform RB when:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.1&nbsp;&nbsp;&nbsp;&nbsp;the Forecasts; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.2&nbsp;&nbsp;&nbsp;&nbsp;any other third party orders for products other than the Products that use any tooling or machines which are used in the manufacture of the Products;

together meet or exceed [\*\*\*] percent ([\*\*\*]%) of the Manufacturing Capacity.

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6.3&nbsp;&nbsp;&nbsp;&nbsp;MSX represents and warrants that it will have the capacity to fill RB's requirements for the Products set forth in any Order so long as the amount specified in the Order does not exceed [\*\*\*] percent ([\*\*\*]%) of the forecasted volume for such period as set out in the previous Forecast (or such other figure as RB and MSX may agree in writing from time to time). At RB's reasonable written request, MSX shall provide RB with capacity information to demonstrate that the available capacity meets RB's requirements. MSX shall promptly take commercially reasonable action to address to RB's reasonable satisfaction any capacity issues identified in accordance with this **Clause 6.3** and **Clause 6.5**.

6.4&nbsp;&nbsp;&nbsp;&nbsp;MSX hereby agrees that, in the event that MSX's success in meeting Orders (whether in terms of failure to meet either or both of the volume and/or the Delivery Date specified in the Orders) falls below [\*\*\*] percent ([\*\*\*]%) for any consecutive [\*\*\*] period during which RB places less than [\*\*\*] Orders (provided that in the case of any Order which exceeds [\*\*\*] percent ([\*\*\*]%) of the volume as set out for that period in the previous Forecast, MSX shall only be deemed to have failed to meet that Order for the purposes of this **Clause 6.4** if it fails to deliver on the Delivery Date at least [\*\*\*] percent ([\*\*\*]%) of the volume set out in the previous Forecast), MSX shall thereafter hold [\*\*\*] month stock of the Products, as set out in the latest Forecast, in advance of any Orders from RB.

6.5&nbsp;&nbsp;&nbsp;&nbsp;In the event that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5.1&nbsp;&nbsp;&nbsp;&nbsp;MSX's success in meeting Orders (whether in terms of failure to meet either or both of the volume and/or the Delivery Date specified in the Orders) falls below either (i) [\*\*\*] percent ([\*\*\*]%) for any consecutive [\*\*\*] period during which RB places [\*\*\*] Orders or more, or (ii) [\*\*\*] percent ([\*\*\*]%) for any consecutive [\*\*\*] period during which RB places less than [\*\*\*] Orders (provided that in the case of any Order which exceeds [\*\*\*] percent ([\*\*\*]%) of the volume as set out for that period in the previous Forecast, MSX shall only be deemed to have failed to meet that Order for the purposes of this **Clause 6.5.1** if it fails to deliver on the Delivery Date at least [\*\*\*] percent ([\*\*\*]%) of the volume set out in the previous Forecast); or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5.2&nbsp;&nbsp;&nbsp;&nbsp;if MSX is prevented from performance in view of an event of Force Majeure as set out in **Clause 16.2**;

then RB shall have the right to retain a temporary alternative supplier to manufacture and supply the Product, without prejudicing any other rights RB may have under this Agreement.

6.6&nbsp;&nbsp;&nbsp;&nbsp;If RB elects to purchase the Product from an alternative supplier in accordance with Clause 6.5 above, MSX shall, if necessary:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6.1&nbsp;&nbsp;&nbsp;&nbsp;grant RB and the alternative supplier a limited, personal, non-exclusive, royalty-free licence, without the right to sublicense, to use MSX's applicable Intellectual Property Rights for such period as may be necessary for the alternative supplier to be able to supply Products pursuant to the Forecasts; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6.2&nbsp;&nbsp;&nbsp;&nbsp;use commercially reasonable efforts to promptly transfer such MSX Intellectual Property Rights under **Clause 6.6.1** above subject to confidentiality and intellectual property agreements in the form reasonably satisfactory to MSX.

6.7&nbsp;&nbsp;&nbsp;&nbsp;MSX shall provide all reasonable assistance regarding the identification, appointment and validation of any proposed alternative supplier of the Products in the event a supply issue under **Clause 6.5** hereof arises. The parties agree to work together in good faith to procure the continued manufacture and supply of the Products from MSX as soon as reasonably practicable following the resolution of the manufacturing problem by MSX.

6.8&nbsp;&nbsp;&nbsp;&nbsp;At the recommencement of the supply of the Product by MSX pursuant to **Clause 6.7** above, the licence to use MSX Intellectual Property Rights to make, have made and import the Products shall cease immediately thereupon. Supply of all Products to RB by MSX will resume immediately thereupon. Except as otherwise provided in **Clause 6.5** above, RB shall source the Products exclusively from MSX during the Term.

6.9&nbsp;&nbsp;&nbsp;&nbsp;The provisions of **Clause 6.5** and **6.6** shall not apply, and subject to **Clause 5.9,** RB shall not be entitled to withhold payment for Products, where a delay or failure to deliver arises due to the delay or failure of RB to deliver the quantities of API ordered by MSX, where the API delivered by RB fails to meet the API Specification or is contaminated, or is due to any other delay, fault or failure attributable to RB or any of its Affiliates or assigns and, in each case, MSX shall not be in default under or breach of this Agreement for any corresponding failure or delay in the manufacture or delivery of Products.

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6.10&nbsp;&nbsp;&nbsp;&nbsp;MSX represents and warrants that, subject to **Clause 6.12** and the receipt of binding Orders from RB for such stock materials, it will maintain sufficient stock levels of the Film (which subject to **Clause 6.11** below shall be no less than [\*\*\*] months) to provide flexibility and to respond in a commercially reasonable manner to increases in RB's demand.

6.11&nbsp;&nbsp;&nbsp;&nbsp;MSX will use commercially reasonable efforts to carry out such stability testing as is necessary to demonstrate that the storage of the Film (whether in the form of Master Rolls or in Daughter Rolls (being a Master Roll divided into approximately [\*\*\*] equal rolls)) in accordance with **Clause 6.8** shall not adversely affect the manufacture of the Products and that the Products will remain within the Product Specification and the Packaging Specification. If MSX is unable to demonstrate that the storage of the Film for [\*\*\*] months or more shall not adversely affect the manufacture of the Products and/or the maintenance of the Products within the Product Specification and the Packaging Specification, it will use commercially reasonable efforts to obtain a suitable shorter duration of commercially reasonably possible storage under the circumstances and the duration specified in **Clause 6.10** shall be adjusted accordingly.

6.12&nbsp;&nbsp;&nbsp;&nbsp;RB warrants and represents that it shall reimburse MSX for all reasonable third party costs incurred by MSX in storing the Film and carrying out the stability testing as specified in **Clauses 6.10** and **6.11,** respectively. Such costs shall be invoiced by MSX to RB following MSX incurring the obligation to make payment of such costs and these invoices shall be paid by RB within the time set forth in such invoices, but in no event later than thirty (30) days from receipt thereof.

6.13&nbsp;&nbsp;&nbsp;&nbsp;Where any Tooling is provided or funded by RB, if any (including in accordance with the provisions of **Clause 15.17**), ownership, title and interest in such Tooling shall at all times belong to RB and MSX shall throughout the Term keep and maintain the sign and/or sticker on the Tooling indicating the sole ownership of the property of RB.

7.&nbsp;&nbsp;&nbsp;&nbsp;**PRICE AND PAYMENT**

7.1&nbsp;&nbsp;&nbsp;&nbsp;The price for the Products (the "**Price**") shall be as set out in **Clause 7.2** and all references to sums payable shall be in U.S. dollars (USD) unless specifically indicated to the contrary in this Agreement.

7.2&nbsp;&nbsp;&nbsp;&nbsp;The Price payable by RB to MSX for the Products shall be the Cost of Goods Price for the Year of manufacture, subject to minimum Order price adjustments and additional packaging fees, if any, in accordance with **Clause 7.3** below.

7.3&nbsp;&nbsp;&nbsp;&nbsp;RB agrees that, during the Term, the Price for each of the Products shall be adjusted as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3.1&nbsp;&nbsp;&nbsp;&nbsp;the Price for each Product shall be increased in the event that RB fails to satisfy the minimum Order requirements for each Order as set forth below:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;each Order that is for [\*\*\*] or more, but less than [\*\*\*] units of a Product, the Price for each such Product shall be increased by [\*\*\*] U.S. dollars (USD$[\*\*\*]); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;each Order that is for less than [\*\*\*] units of a Product, the Price for each such Product shall be increased by [\*\*\*] U.S. dollars (USD$[\*\*\*]); and where in this **Clause 7.3 Order shall mean** any Order composed of the same dose Product for different countries (such that a requirement for [\*\*\*] 2mg dose units for the UK and [\*\*\*] 2mg dose units for the US would be an Order for [\*\*\*] units) but shall not include any combination of orders for different dose Products (such that a requirement for [\*\*\*] 2mg dose units and [\*\*\*] 8mg dose units would be considered as two separate Orders for [\*\*\*] units each).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3.2&nbsp;&nbsp;&nbsp;&nbsp;In the event that any Order requests more than one packaging for the Products covered by such Order, RB shall pay a [\*\*\*] amount for each additional packaging request in the amount of [\*\*\*] Dollars (USD $[\*\*\*]), regardless of the number of units of Product covered by such new packaging request (the "**Packaging Fee**"). For the avoidance of doubt, the parties agree that any Order that is for [\*\*\*] units of a Product or more shall not be adjusted as to price per each Product by a request under such Order for multiple packaging of such Products but RB will pay any applicable Packaging Fees for such Order.

7.4&nbsp;&nbsp;&nbsp;&nbsp;Subject to **Clauses 7.5** to **7.7**, in addition to the fees under **Clause 7.1**, RB shall pay to MSX a royalty of the sum of the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] of the Net Sales Value of the Products sold during the Term in the U.S. up to a maximum annual royalty of USD$[\*\*\*] ([\*\*\*] U.S. dollars) per Year of sale (pro rated accordingly for the period from the Product Launch of

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the Product in the U.S. to the 31<sup>st</sup> of December in the Year of the Product Launch in the U.S. and from the 1<sup>st</sup> of January until the expiry of the Royalty obligations in accordance with **Clauses 7.5** in any Year where those obligations expire, if applicable); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] of the Net Sales Value of the Products sold during the Term in the ROW up to a maximum annual royalty of GBP£[\*\*\*] ([\*\*\*] Pounds Sterling) per Year of sale (pro rated accordingly for the period from the Product Launch of the Product in the ROW to the 31<sup>st</sup> of December in the Year of the Product Launch in any country within the ROW and from the 1<sup>st</sup> of January until the expiry of the Royalty obligations in accordance with **Clause 7.6** in any Year where those obligations expire, if applicable).

7.5&nbsp;&nbsp;&nbsp;&nbsp;The obligations to pay Royalties as set out in **Clause 7.4.1** above shall end upon the occurrence of:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.5.1&nbsp;&nbsp;&nbsp;&nbsp;the expiry of all of the Patents in the U.S. and of all patents which issue in the U.S. in respect of any Improvements relating to the MSX Arising Intellectual Property Rights and/or Existing Intellectual Property Rights, as the case may be; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.5.2&nbsp;&nbsp;&nbsp;&nbsp;RB exercising the option under **Clause 7.7.1** in respect of the U.S., whichever is the sooner.

7.6&nbsp;&nbsp;&nbsp;&nbsp;The obligations to pay Royalties as set out in **Clause 7.4.2** above shall end, on a country by country basis, upon the occurrence of:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.6.1&nbsp;&nbsp;&nbsp;&nbsp;the expiry of all of the Patents in the ROW and of all patents which issue in any country within the ROW in respect of any Improvements relating to the MSX Arising Intellectual Property Rights and/or Existing Intellectual Property Rights, as the case may be; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.6.2&nbsp;&nbsp;&nbsp;&nbsp;RB exercising the option under **Clause 7.7.2** in respect of the ROW, whichever is the sooner.

7.7&nbsp;&nbsp;&nbsp;&nbsp;RB shall have the option upon prior written notice to MSX to stop making payments of the Royalties due under **Clauses 7.4.1** and/or **7.4.2** (the "**Options**") by making payment to MSX of:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.7.1&nbsp;&nbsp;&nbsp;&nbsp;with respect to Royalties due under **Clause 7.4.1**, USD$[\*\*\*] ([\*\*\*] U.S. dollars) immediately upon exercising such Option. The Option under this **Clause 7.7.1** shall be exercisable at any time commencing after the [\*\*\*] anniversary of the date of the Product Launch of the Product in the U.S.; and/or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.7.2&nbsp;&nbsp;&nbsp;&nbsp;with respect to Royalties due under **Clause 7.4.2**, GBP£[\*\*\*] ([\*\*\*] Pounds Sterling) immediately upon exercising such Option. The Option under this **Clause 7.7.2** shall be exercisable at any time commencing after the [\*\*\*] anniversary of the date of the Product Launch of the Product in any country of the European Union within the ROW.

Upon making payment to MSX of the amounts stated in **Clause 7.7.1** the obligations to pay Royalties to MSX in respect of the U.S. will immediately cease and upon making payment to MSX of the amounts stated in **Clause 7.7.2** the obligations to pay Royalties to MSX in respect of the ROW will immediately cease. For the avoidance of doubt, the Options granted under **Clauses 7.7.1** and **7.7.2** may be exercised independently of each other.

7.8&nbsp;&nbsp;&nbsp;&nbsp;For the avoidance of doubt, no credit will be given in respect of Royalties previously paid and where any of the Options are exercised part way through any Half Year Period, RB shall be responsible for making payments of any Royalties due in respect of sales of Products made before the date such of the Options was exercised and shall make such Royalty payments at the end of the Half Year period in which such of the Options was exercised.

7.9&nbsp;&nbsp;&nbsp;&nbsp;Third Party Claims

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9.1&nbsp;&nbsp;&nbsp;&nbsp;If a third party claims that the manufacture and supply of a Product by MSX under this Agreement (including manufacture in accordance with the MSX's Existing Intellectual Property Rights or MSX's Arising Intellectual Property Rights), or the subsequent use and sale of such. Products by RB, infringes any claims of patents of such third party (and such infringement claim is not a claim that (i) the buprenorphine or naloxone component of the Product, and (ii) the manufacture of the buprenorphine or naloxone component of the Product, infringes any claims of patents of such third party) (a "**TP Patent Claim**"), MSX shall be responsible, at its cost and expense, for either defending or settling such TP Patent Claim and paying any judgment recovered by such third party in a suit

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for such TP Patent Claim (including any amounts for past infringement of such third party's patent by the Product), and using commercially reasonable endeavours to obtain an exclusive license in the Field from such third party that would by the terms of such settlement or exclusive license allow RB the right to continue to sell during the Term such Product in the Field in the jurisdiction or country in which such claim is brought, consistent with the terms and conditions of this Agreement and without any additional royalty or remuneration therefore by RB. In the event that MSX has not successfully defended or settled such TP Patent Claim or obtained such exclusive license, the obligation for payment of Royalty by RB under **Clauses 7.4.1** and **7.4.2** (and, if applicable, **Clause 7.7**) in connection with continued sales of such Product (if any) shall be adjusted as set out in **Clauses 7.9.3.1** and **7.9.3.2**, as applicable, and in the event that the TP Patent Claim is brought more than [\*\*\*] years after the Commencement Date and RB is prohibited from selling Products (i) in any of the U.S. or that portion of the ROW that constitutes all of the European Union, then RB shall have the right upon [\*\*\*] days prior written notice to MSX to terminate this Agreement, or (ii) in any other jurisdiction in the Territory, then RB shall have the right upon [\*\*\*] days prior written notice to MSX to terminate this Agreement as to such other jurisdiction. For purposes of this **Clause 7.9.1**, MSX shall be deemed to have failed to use commercially reasonable efforts to obtain such a licence as set out above if MSX fails or elects not to use such efforts and resources (including, without limitation, the promptness in which such efforts and resources would be applied) consistent with its expression on and before the Commencement Date of MSX's commitment to obtaining such a licence should it be required in order to alleviate as a priority concern of MSX, including expending such additional funds and devoting such additional manpower and other resources as is necessary and appropriate to reasonably assure the grant of such a licence to allow RB to continue to sell during the Term the Products in the Field in the relevant jurisdiction or country and, in any circumstances, which are consistent with the general level of effort and resources that would be used in the pharmaceutical industry for a company with the intention to commercialize and exploit a product critical to the continued success of the company. In the event that despite the use of such endeavours as described above, MSX is unable to obtain the licence described above it shall inform RB of this fact and discuss with RB any further possibilities for the joint resolution of this issue including, without limitation, RB assisting MSX to obtain such a licence (which RB shall be entitled to consider in its absolute discretion) on the assumption that any sums paid by RB (if any) towards obtaining such a licence will be offset against any Royalties to be paid by RB to MSX pursuant to **Clause 7.4**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9.2&nbsp;&nbsp;&nbsp;&nbsp;If a third party brings a claim of invalidity of the Patents in any part of the Territory, then, subject to **Clause 7.9.4**, MSX shall be responsible for defending such claim, at its cost and expense, and seeking to maintain validity of the Patents and all obligations for payment of a Royalty under **Clauses 7.4.1** and **7.4.2** (and if applicable **Clause 7.7**) in connection with sales of Products following such claim shall be adjusted according to **Clause 7.9.3.1** and **7.9.3.2** below, as applicable, and RB shall have the other rights set forth in **Clause 7.9.3.3**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9.3&nbsp;&nbsp;&nbsp;&nbsp;For any claim brought by a third party which is successful or not yet finally adjudicated under **Clauses 7.9.1** or **7.9.2**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9.3.1&nbsp;&nbsp;&nbsp;&nbsp;and such third party introduces a product in the Field which gains a market share in the Field of at least a [\*\*\*] percent ([\*\*\*]%) but not more than [\*\*\*] percent ([\*\*\*]%) in any of (i) the U.S., (ii) that portion of the ROW that constitutes the European Union, or (iii) any other country in the Territory within [\*\*\*] months after such product introduction (the "**Market Review Period**"), RB's obligation to make such Royalty payments after the expiration of the Market Review Period with respect to sales of such Product in such jurisdiction or country shall be reduced by [\*\*\*]; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9.3.2&nbsp;&nbsp;&nbsp;&nbsp;and such party introduces a product in the Field which gains a market share in the Field of [\*\*\*] percent ([\*\*\*]%) or more in any of (i) the U.S., (ii) that portion of the ROW that constitutes the European Union, or (iii) any other country in the Territory during the Market Review Period, RB's obligation to make such Royalty payments after the expiration of the Market Review Period and thereafter with respect to sales of such Product in such jurisdiction or country shall be terminated; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9.3.3&nbsp;&nbsp;&nbsp;&nbsp;if such third party claim is brought within [\*\*\*] years after the Commencement Date and (i) RB is prohibited from achieving Product Launch in any of the U.S. or that portion of the ROW that constitutes all of the European Union, then RB shall have the right upon thirty (30) days prior written notice to MSX to terminate this Agreement, or (ii) RB is prohibited from selling all Products in any other jurisdiction in the Territory, then RB shall have the right upon thirty (30) days prior written notice to MSX to terminate this Agreement as to such other jurisdiction. Upon termination of this Agreement under this **Clause 7.9.3.3**, RB shall satisfy its obligations under **Clause 18.1.2** and MSX shall indemnify RB for the Losses incurred by RB as a result of such termination up to an amount equal to [\*\*\*] percent

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([\*\*\*]%) of the payments made by RB (and its Affiliated Companies) to MSX and its Affiliated Companies in developing the Products (which for the avoidance of doubt shall be all sums paid by RB (and its Affiliated Companies) to MSX excluding sums paid by RB (and its Affiliated Companies) in respect of the purchase of the Products and Royalties under this Agreement including, payments by RB under **Clause 7.7**, if any) prior to such termination. Payment of such amount to RB under this **Clause 7.9.3.3** shall be the sole and exclusive remedy of RB for any termination of this Agreement under this **Clause 7.9.3.3** and, upon payment thereof to RB, MSX shall have no further obligation or liability to RB under this Agreement or otherwise for such third party claim, except for MSX's obligations to pay the costs and expense of defending and settling such third party claim under **Clause 7.9.1.** This **Clause 7.9.3.3** shall not apply to any claim brought by [\*\*\*] within [\*\*\*] after the Commencement Date, which claim (and the rights and obligations of MSX and RB relating thereto) shall be solely covered under **Clause 7.10**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9.4&nbsp;&nbsp;&nbsp;&nbsp;For any such third party claim brought under **Clauses 7.9.1** or **7.9.2** in which such third party is unsuccessful (including a claim brought by [\*\*\*] as described in **Clause 7.10**), then RB's obligations to make payment of the Royalties shall remain unchanged and shall be in effect in accordance with the terms of this Agreement, subject to the following. If such third party introduces a product in the Field while such claim is being adjudicated and which is thereafter withdrawn from the Field after such adjudication, RB shall make payment of the Royalties (together will all future Royalties due under this Agreement) which would have been paid in accordance with the terms of this Agreement prior to such adjudication, subject to RB's rights in accordance with **Clauses 7.9.3.1** and **7.9.3.2** to reduce or terminate such Royalty payments, as the case may be, for the period prior to such withdrawal and subject to the last sentence of **Clause 7.9.1** in which RB may offset royalties paid by RB to such third party for a license under **Clause 7.9.1,** if any, against Royalties to be paid by RB to MSX pursuant to **Clause 7.4**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.9.5&nbsp;&nbsp;&nbsp;&nbsp;For any such third party claim that is brought alleging the invalidity of the Patents and MSX believes that defending such claim is unnecessary and uneconomical, then save in respect of the US and that portion of the ROW that constitutes all of the Europe Union (in which areas MSX shall be obliged to defend any claims for invalidity), MSX shall seek RB's consent not to defend such actions and RB agrees that such consent shall not be unreasonably withheld, conditioned or delayed.

7.10&nbsp;&nbsp;&nbsp;&nbsp;In the event that [\*\*\*] brings a claim that the manufacture and supply of a Product by MSX under this Agreement (including manufacture in accordance with MSX's Existing Intellectual Property Rights or MSX's Arising Intellectual Property Rights) or the subsequent use and sale of such Products by RB, infringes a claim of one of its patents described in Schedule 10 attached hereto (and such infringement claim is not a claim that (i) the buprenorphine or naloxone component of the Product, or (ii) the manufacture of the buprenorphine or naloxone component of the Product, infringes any claims of such patents), MSX shall have all of the obligations to defend, settle and obtain an exclusive license with respect thereto in accordance with the terms of **Clause 7.9.1**. If the claim is brought within one year after the Commencement Date and [\*\*\*] is successful in its claim, or such claim has not yet been finally adjudicated, and, as a result thereof, RB is prohibited from achieving Product Launch in the US or that portion of the ROW that constitutes all of the European Union, RB shall have the right to terminate this Agreement and, upon such termination, RB shall satisfy its obligations under **Clause 18.1.2** and MSX shall pay to RB as liquidated damages a lump sum amount equal to [\*\*\*] Dollars ($[\*\*\*]) for all Losses incurred or to be suffered by RB (the "[\*\*\*] **Settlement**") as a result thereof or in connection therewith. Payment of the [\*\*\*] Settlement to RB shall be the sole and exclusive remedy of RB for any termination of this Agreement with respect to a claim by [\*\*\*] under this **Clause 7.10** and, upon payment of the [\*\*\*] Settlement to RB, MSX shall have no further obligation or liability to RB under this Agreement or otherwise with respect to such [\*\*\*] claim, except for MSX's obligation to pay for the defense and settlement of such [\*\*\*] claim, including the payment of any judgement (including for past infringement of [\*\*\*] patents by the Product, if any) recovered by [\*\*\*] in a suit for such [\*\*\*] claim in accordance with **Clause 7.9.1**.

7.11&nbsp;&nbsp;&nbsp;&nbsp;In addition to the Price, RB shall make a payment to MSX of USD$[\*\*\*] ([\*\*\*] U.S. dollars) (the "**Milestone Payments**") on each of the following dates:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.11.1&nbsp;&nbsp;&nbsp;&nbsp;the Product Launch of the Product in the U.S.; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.11.2&nbsp;&nbsp;&nbsp;&nbsp;the first Product Launch of a Product within any country within the ROW.

For the avoidance of doubt, this shall amount to a maximum total payment of USD$[\*\*\*] ([\*\*\*] dollars) for Milestone Payments.

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7.12&nbsp;&nbsp;&nbsp;&nbsp;For the duration of this Agreement, MSX shall use commercially reasonable efforts to be technically and commercially competitive, taking into account the market for the supply and the cost from other suppliers of product(s) similar to the Products, and shall effect cost reductions and engage in all such technical innovations in respect of the Products which are commercially reasonably possible, taking into account MSX's manufacturing obligations to other parties, capital investment and any other relevant factor as determined by MSX.

7.13&nbsp;&nbsp;&nbsp;&nbsp;Promptly following the execution and delivery of this Agreement, MSX shall deliver to RB information regarding the Costs of Raw Materials. At least sixty (60) days prior to the beginning of each subsequent Year, the parties shall confer (each, an "**Annual Review**") regarding all costs of manufacturing the Products, including without limitation, Raw Materials, other components, energy, transportation, legal, regulatory and all other hard and soft costs of manufacture, but not labour, in order to determine if cost reductions are appropriate.

7.14&nbsp;&nbsp;&nbsp;&nbsp;The cost of goods price for the period from the Commencement Date and expiring on the 31<sup>St</sup> of December in the Year of the Commencement Date shall be the price as set out in **Schedule One** and, unless otherwise agreed by the parties in writing pursuant to this **Clause 7.14,** the cost of goods price for each subsequent Year, shall be increased or decreased in accordance with the Price Change (the "**Cost of Goods Price**"). In the event that the Price Change for a Year exceeds the change in the Pharma Price Index for the same period, RB may, at its option, obtain pricing for one or more of the Major Raw Materials from , third parties who are, to the reasonable satisfaction of MSX, qualified suppliers (as can be demonstrated through written documentation). If the pricing obtained by RB is at least [\*\*\*] percent ([\*\*\*]%) more favourable for a given Year than the costs provided by MSX during such Year, MSX shall engage in a good faith review of the obtained pricing. If MSX, acting with commercial reasonableness (including, without limitation, giving consideration to quality control, shipping fees, import duties, warehousing fees, time of transit, and the cost of certifying, qualifying and testing the Major Raw Materials of such proposed supplier), determines that the pricing obtained by RB is at least [\*\*\*] percent ([\*\*\*]%) more favourable for a given Year, MSX shall, at its sole option, either (i) engage the supplier offering the pricing obtained by RB for such period as the supplier pricing remains at least [\*\*\*] percent ([\*\*\*]%) more favourable, and adjust the Cost of Raw Materials for the given period, or (ii) obtain a price reduction from its then-current supplier to pricing similar (even if less favourable) to the reduced pricing obtained by RB. The parties agree that during the course of such discussions the Price chargeable for the Products shall be the Price for the previous Year as varied according to the Pharma Price Index and that following the determination of the Price in accordance with the above procedure RB shall be responsible to MSX for the payment of any excess sums due to MSX applying such determined price retrospectively against all Orders for the Products during such period. RB shall make such payment within [\*\*\*] days after determining the Price in accordance with the above procedures. For the avoidance of doubt, MSX acknowledges that in dealing with any third party suppliers of Raw Materials it will not disproportionately allocate any discounts in determining costs charged by the third party supplier for the Raw Materials, when such Raw Materials are purchased from a third party supplier supplying to MSX raw materials to be used by MSX in relation to products other than the Products. MSX hereby agrees that upon reasonable advance written notice to MSX, RB shall have a right to an audit of such records of MSX as is reasonable to ensure that the cost of such rat materials are in compliance with this **Clause 7.14**; provided, that, such access shall be limited to the period ending not more than [\*\*\*] years prior to the date of such audit and RB shall be responsible for the costs of such audit and MSX shall not charge RB for any of MSX's costs of such audit. For the avoidance of doubt, RB agrees that all information disclosed by MSX under this **Clause 7.14** shall be Confidential Information for the purpose of this Agreement and RB shall ensure that any nominee of RB participating in such audit shall enter into a confidentiality agreement with MSX obligating such nominee to maintain the confidentiality of any information disclosed by MSX pursuant to this **Clause 7.14**.

7.15&nbsp;&nbsp;&nbsp;&nbsp;All invoices to be sent to RB shall be sent to [\*\*\*].

7.16&nbsp;&nbsp;&nbsp;&nbsp;RB shall pay invoices in respect of the Cost of Goods Price, together with any other invoices submitted to it pursuant to this Agreement, within [\*\*\*] of receipt by RB from MSX of a valid VAT (or other applicable similar taxes) invoice therefore.

7.17&nbsp;&nbsp;&nbsp;&nbsp;If RB is required to withhold any tax, including, but not limited to, the value-added tax (VAT) and any similar taxes that can replace or append the existing ones, then RB shall make payment of the relevant fee after such withholding in accordance with the applicable law. The parties agree to co-operate in all commercially reasonable respects necessary to determine, prior to any such withholding, whether either party is responsible for any taxes in connection with the transactions contemplated under this Agreement and during the Term to take advantage of such double taxation agreement as may be available and the party responsible for securing any certificates or approvals that are necessary for the payment without any withholding of taxes at source is MSX, and all the expenses related to obtaining such certificates or approvals are for the remit of MSX.

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7.18&nbsp;&nbsp;&nbsp;&nbsp;RB shall pay the Royalty for Products (if any) within [\*\*\*] days of the expiry of the Half Year period in which the relevant Royalties are chargeable. Each Royalty payment shall be accompanied by a statement detailing the calculation of Royalties due to MSX, including, without limitation, the amount of Products sold and the corresponding Royalty amount.

7.19&nbsp;&nbsp;&nbsp;&nbsp;MSX shall be expressly permitted to assign any sums payable under this **Clause 7**.

7.20&nbsp;&nbsp;&nbsp;&nbsp;MSX shall have the right to have its independent certified accountants ("**MSX Accountants**") review and verify the accuracy of the records and accounts related to the Royalties (including records of sales as notified to it by its distributor in respect of certain countries within the Territory) hereunder for any Half Year ending not more than [\*\*\*] years prior to the date of such review (the "**Records**"); provided, that, MSX shall not have the right to conduct more than [\*\*\*] such inspection in any [\*\*\*] month period, unless MSX or RB shall have a good faith belief that during such period that a Regulatory Authority inspection is expected, or unless otherwise required by applicable law, regulation rule or Regulatory Authority. Following such review, MSX's accountants shall disclose to RB and MSX whether the Royalties paid to MSX hereunder are correct and accurate, and give details of any discrepancies between the Royalties due under the Records and Royalties paid. MSX shall be responsible for the costs of the MSX Accountants unless the MSX Accountants certify that RB has underpaid Royalties properly due to MSX by [\*\*\*] percent ([\*\*\*]%) or more in the period being audited, in which instance RB shall reimburse MSX for all costs of the MSX Accountants within [\*\*\*] of receipt of notice of such underpayment. In no event shall the MSX Accountants disclose to MSX information other than whether the Royalties payable by RB were accurate of inaccurate and the amount of any discrepancies due. For the avoidance of doubt, MSX agrees that all information disclosed by RB under this **Clause 7.20** shall be Confidential Information for the purpose of this Agreement and MSX shall ensure that the MSX Accountants shall enter into a confidentiality agreement with RB obligating the MSX Accountants to maintain the confidentiality of any information disclosed by RB pursuant to this **Clause 7.20.**

7.21&nbsp;&nbsp;&nbsp;&nbsp;In the event that the review conducted under **Clause 7.20** concludes that RB owes to MSX further Royalty payments, RB shall make such additional payments within [\*\*\*] days of a copy of the MSX Accountants' review being delivered to both parties. In the event that the review conducted under **Clause 7.20** concludes that RB has made Royalty payments to MSX in excess of those required, such excess payments shall be credited against future payments owed by RB to MSX under this Agreement (or, if no such payments are owed, shall be promptly refunded by MSX to RB within [\*\*\*] days of a copy of the MSX Accountants' review being delivered to MSX).

7.22&nbsp;&nbsp;&nbsp;&nbsp;During the Term commencing with the period ending at December 31, 2008, RB shall be entitled to receive a rebate on volume purchases of the Products in accordance with the following (the "**Rebate**"):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.22.1&nbsp;&nbsp;&nbsp;&nbsp;In the event that RB purchases in any Year in the aggregate more than [\*\*\*], but less than [\*\*\*], units of Product, in any combination of one or more Products set forth on **Schedule 3**, RB shall be entitled to receive a Rebate of [\*\*\*] U.S. dollars (USD$[\*\*\*]) for each unit of Product over [\*\*\*] and less than [\*\*\*] purchased by RB during such Year; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.22.2&nbsp;&nbsp;&nbsp;&nbsp;In the event that RB purchases in any Year in the aggregate [\*\*\*] units of Products or more, in any combination of one or more Products set forth on Schedule 3, then in addition to the rebate payable under Clause 7.22.1 above, RB shall be entitled to receive a Rebate of [\*\*\*] U.S. dollars (USD$[\*\*\*]) for each unit of Product at and in excess of [\*\*\*] purchased by RB during such Year; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.22.3&nbsp;&nbsp;&nbsp;&nbsp;The Rebate due to RB in any Year, if any, shall be calculated by MSX on or before January 31<sup>st</sup> of the immediately succeeding Year (the "**Rebate Calculation**"); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.22.4&nbsp;&nbsp;&nbsp;&nbsp;At the option of MSX, exercised in its sole discretion, the Rebate for each Year, if any, shall be either: (i) paid by MSX to RB on or before February 15<sup>th</sup> of the immediately succeeding Year for which such Rebate Calculation is due; or (ii) granted as a credit by MSX in the amount of such Rebate against the payment or payments of Royalties due by RB after the Rebate Calculation; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.22.5&nbsp;&nbsp;&nbsp;&nbsp;No Rebate under this Agreement, if any, shall result in or entitle RB to any right of set-off, discount or similar reduction of the Price of any Product purchased by RB, or in any other payment due by RB under this Agreement, including, without limitation, any Milestone payment, Option payments, and Royalty payments except as specifically set forth in **Clause 7.22.4**(ii) above. No interim payments of Rebates, if any, due under this Agreement shall be made during the Term except any Rebates due and unpaid by MSX, pursuant to the terms of this Agreement, upon the expiration or termination of this Agreement and not theretofore applied by MSX as a credit against Royalties due and owing by RB upon such expiration or termination.

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8.&nbsp;&nbsp;&nbsp;&nbsp;**QUALITY DOCUMENTATION AND INSPECTION**

8.1&nbsp;&nbsp;&nbsp;&nbsp;MSX shall manufacture the Products in accordance with this Agreement and in particular with the provisions of Clause 3.1.1.

8.2&nbsp;&nbsp;&nbsp;&nbsp;If MSX has actual knowledge that any aspect of the Product Specification is liable to result in the manufacture of a defective Product which may lead to a liability being incurred, MSX shall, as soon as reasonably practicable, notify RB in writing.

8.3&nbsp;&nbsp;&nbsp;&nbsp;MSX shall establish and maintain a batch-tracking system to enable it to identify and procure the recall (if necessary) of Products which may be affected in any way by manufacturing and production problems. MSX shall provide details to RB of its batch-tracking system upon RB's reasonable written request to do so.

8.4&nbsp;&nbsp;&nbsp;&nbsp;MSX shall:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4.1&nbsp;&nbsp;&nbsp;&nbsp;complete the documentation relevant to the manufacture, testing, storage and delivery of the Product in accordance with cGMP and any other reasonable requirements of RB provided to MSX in advance in writing, and shall retain such documentation for a minimum period of six (6) years after delivery of the Product to RB (or its nominee);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4.2&nbsp;&nbsp;&nbsp;&nbsp;permit RB (or its nominee), on reasonable prior written notice to MSX, access to the Manufacturing Site from time to time during the Term as is reasonable (or if required by applicable law, regulation, rule or Regulatory Authority) for the inspection of any documentation relating solely to the manufacture, testing, storage or delivery of the Products, the Raw Materials or the Film for the period ending not more than [\*\*\*] years prior to the date of such inspection; provided, that, RB shall be responsible for the costs of such inspection and MSX shall not charge RB for MSX's costs of such inspection. For the avoidance of doubt, RB agrees that all information disclosed by MSX under this **Clause 8.4.2** shall be Confidential Information for the purpose of this Agreement and RB shall ensure that any nominee of RB participating in such inspection shall enter into a confidentiality agreement with MSX obligating such nominee to maintain the confidentiality of any information disclosed by MSX pursuant to this **Clause 8.4.2;**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4.3&nbsp;&nbsp;&nbsp;&nbsp;promptly, upon the reasonable written request of RB, provide RB with any Product validation report, including a summary of the analytical results, the stability results, details of any Product failures, process deviations and any out of Product Specification results; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4.4&nbsp;&nbsp;&nbsp;&nbsp;complete and lodge with the appropriate Regulatory Authorities where required all documentation relating to the export of the Products where delivery involves export from the country of manufacture.

8.5&nbsp;&nbsp;&nbsp;&nbsp;RB (or its nominee) shall have the right to perform any tests it wishes (at RB's expense) on any Product, Raw Materials or Film at MSX's Manufacturing Site as reasonably requested by RB upon ten (10) days advance written notice to MSX to ensure its compliance with the Product Specification, and without interference with MSX's operations.

8.6&nbsp;&nbsp;&nbsp;&nbsp;MSX shall, and shall use commercially reasonable efforts to, procure that its Affiliates shall, grant a right of reasonable access to RB (or its nominee) to inspect any records relevant to the manufacture of the Products subject to **Clause 8.4.2** or conduct any tests on the Products, Raw Materials or Film subject to **Clause 8.5.**

8.7&nbsp;&nbsp;&nbsp;&nbsp;RB shall, and shall use commercially reasonable efforts to procure that any Affiliate or third party API manufacturer shall:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.7.1&nbsp;&nbsp;&nbsp;&nbsp;complete the documentation relevant to the manufacture, testing, storage and delivery of the API in accordance with cGMP and any other reasonable requirements of MSX provided to RB in advance in writing, and shall retain such documentation for a minimum period of six (6) years after delivery of the API to MSX (or its nominee);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.7.2&nbsp;&nbsp;&nbsp;&nbsp;permit MSX (or its nominee), on reasonable prior written notice to RB, access to the manufacturing site of the API from time to time during the Term as is reasonable (or if required by applicable law, regulation, rule or Regulatory Authority) for the inspection of any documentation relating to the manufacture, testing, storage or delivery of the API for the period ending not more than [\*\*\*] years prior to the date of such inspection; provided, that, MSX shall be responsible for the costs of such inspection and RB shall not charge MSX for any of RB's costs for such inspection. For the avoidance of doubt, MSX agrees that all information disclosed by RB under this

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**Clause 8.7.2** shall be Confidential Information for the purpose of this Agreement and MSX shall ensure that any nominee of MSX participating in such inspection shall enter into a confidentiality agreement with RB obligating such nominee to maintain the confidentiality of any information disclosed by RB pursuant to this **Clause 8.7.2**;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.7.3&nbsp;&nbsp;&nbsp;&nbsp;promptly, upon reasonable request of MSX, provide MSX with any validation report for any API batch, including a summary of the analytical results, the stability results, details of any such batch failures, process deviations and any out of API Specification results; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.7.4&nbsp;&nbsp;&nbsp;&nbsp;complete and lodge with the appropriate Regulatory Authorities where required all documentation relating to the export of the API where delivery involves export from the country of manufacture.

8.8&nbsp;&nbsp;&nbsp;&nbsp;MSX shall have the right, but not the obligation, to perform any tests it wishes (at MSX's expense) on any API at the manufacturing site of the API or any other relevant sites as MSX reasonably requests to ensure its compliance with API Specifications.

8.9&nbsp;&nbsp;&nbsp;&nbsp;RB shall, and shall use commercially reasonable efforts to procure that its Affiliates and any third party API manufacturer shall, grant a right of reasonable access to MSX (or its nominee) to inspect any records relevant to the manufacture of the API subject to **Clause 8.7.2** or conduct any tests on the API subject to **Clause 8.7.4**.

8.10&nbsp;&nbsp;&nbsp;&nbsp;Each of the parties hereby warrant and represents to the other that (i) it is not debarred under the Generic Drug Enforcement Act of 1992, 21 U.S.C. 335[a] (the "**Generic Drug Enforcement Act**"), and that it has not been convicted of a crime for which it could be debarred under the Generic Drug Enforcement Act; and (ii) it shall not use in any capacity the services of any person debarred under the Generic Drug Enforcement Act, or convicted of a crime for which a person can be debarred under the Generic Drug Enforcement Act.

9.&nbsp;&nbsp;&nbsp;&nbsp;**WARRANTIES**

9.1&nbsp;&nbsp;&nbsp;&nbsp;MSX hereby warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.1&nbsp;&nbsp;&nbsp;&nbsp;the Manufacturing Site has as of the Commencement Date, and will maintain during the Term, all necessary or appropriate consents, approvals, licences, permits, registrations or authorisations (or waivers) required to manufacture the Products, in accordance with the terms of this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.2&nbsp;&nbsp;&nbsp;&nbsp;it has the necessary facilities, equipment, Know-How, procedures and personnel at the Manufacturing Site to manufacture the Products in accordance with the terms of this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.3&nbsp;&nbsp;&nbsp;&nbsp;any Products manufactured pursuant to this Agreement shall comply with the Product Specification and all provisions as to quality set out in the Quality Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.4&nbsp;&nbsp;&nbsp;&nbsp;subject to **Clause 6.9**, at the time that legal title and risk of loss passes to RB pursuant to **Clause 5.7**, the Products manufactured pursuant to this Agreement shall be free from adulteration or contamination and fit for their intended purpose under this Agreement; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.5&nbsp;&nbsp;&nbsp;&nbsp;the manufacture of the Products will comply with all applicable national and local laws, rules, regulations and guidelines in force in the jurisdiction of the country of distribution in respect of the manufacture of the Products and, to the knowledge of MSX, there are no circumstances or conditions in existence as of the Commencement Date which would reasonably be expected to prevent continuing compliance of the manufacture of the Products in accordance with the terms of this Agreement with all such national and local laws, rules, regulations and guidelines during the Term.

9.2&nbsp;&nbsp;&nbsp;&nbsp;MSX further warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.1&nbsp;&nbsp;&nbsp;&nbsp;subject to the terms of this Agreement, it will meet all Orders from RB for the Products that are consistent with the terms of this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.2&nbsp;&nbsp;&nbsp;&nbsp;it shall supply the Products within the periods set out in **Clause 5.1**;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.3&nbsp;&nbsp;&nbsp;&nbsp;it shall convey good title in any Products delivered to RB under this Agreement;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.4&nbsp;&nbsp;&nbsp;&nbsp;it is duly incorporated and organized and is validly existing under the laws of its jurisdiction of incorporation and has the corporate power and authority to own its assets and to conduct its businesses and to perform its obligations hereunder;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.5&nbsp;&nbsp;&nbsp;&nbsp;the execution and delivery of this Agreement by it and the completion by it of the transactions contemplated herein do not and will not result in the breach of, or violate any term or provision of, its articles of incorporation or by-laws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.6&nbsp;&nbsp;&nbsp;&nbsp;it is not subject to any outstanding injunction, judgement or order of any governmental authority which would prevent or materially delay the transactions contemplated by this Agreement; there are no civil, criminal or administrative claims, actions, suits, demands, proceedings, hearings or investigations pending or, to MSX's knowledge threatened, at law, in equity or otherwise, in, before, or by, any governmental authority which (if successful) would prevent or materially delay MSX's compliance with the provisions of this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.7&nbsp;&nbsp;&nbsp;&nbsp;no dissolution, winding up, bankruptcy, liquidation or similar proceeding has been commenced or is pending or, to MSX's knowledge, proposed in respect of it;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.8&nbsp;&nbsp;&nbsp;&nbsp;the execution and delivery of this Agreement and the completion of the transactions contemplated herein have been duly approved by appropriate persons within its organisation and this Agreement constitutes the legal, valid and binding obligation of MSX enforceable against it in accordance with its terms;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.9&nbsp;&nbsp;&nbsp;&nbsp;it or its Affiliates has taken or will take all action as may be required to obtain and maintain, comply and keep current any governmental licences, permits, approvals and/or registrations that are necessary for MSX and/or its Affiliates to manufacture and/or supply the Products and to carry out and perform its obligations under this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.10&nbsp;&nbsp;&nbsp;&nbsp;it shall, at its own cost, diligently prosecute to grant all subsisting patent applications within the Patents so as to secure the broadest monopoly legally and reasonably obtainable within the Field consistent with avoiding serious prejudice to the validity of such granted Patents and provide RB with a patent update report (which shall include details of the renewal dates of all Patents registered) every [\*\*\*] months during the Term;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.11&nbsp;&nbsp;&nbsp;&nbsp;it shall for the life of the Patents pay all renewal fees and do all such act: and things as may be necessary to maintain and keep the Patents and shall provide RB with written notice of its intent not to renew at least [\*\*\*] months before the last day for renewing the Patents; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.12&nbsp;&nbsp;&nbsp;&nbsp;it shall not during the Term, save following receipt of written notice that RB does not wish to acquire the Patents in accordance with **Clause 15.13**, abandon any of the Patents or allow any of them to lapse.

9.3&nbsp;&nbsp;&nbsp;&nbsp;RB hereby warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.1&nbsp;&nbsp;&nbsp;&nbsp;RB, the manufacturing site of the API and/or any third party API manufacturer, as applicable, has as of the Commencement Date, and to RB's knowledge will maintain during the Term, all necessary or appropriate consents, approvals, licences, permits, registrations or authorisations (or waivers) required to manufacture the API in accordance with the terms of this Agreement. For the avoidance of doubt this warranty is given without prejudice to RB's obligations to supply API in accordance with the API Specifications;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.2&nbsp;&nbsp;&nbsp;&nbsp;it and/or any third party API manufacturer, as applicable has the necessary facilities, equipment, Know-How, procedures and personnel at the manufacturing site of the API to manufacture the API in accordance with the terms of this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.3&nbsp;&nbsp;&nbsp;&nbsp;any API delivered pursuant to this Agreement shall comply with the provisions the API Specification;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.4&nbsp;&nbsp;&nbsp;&nbsp;the API supplied pursuant to this Agreement shall conform to the API Specification and shall be free from adulteration or contamination and fit for its intended purpose under this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.5&nbsp;&nbsp;&nbsp;&nbsp;it and/or any third party API manufacturer, as applicable shall comply with all applicable national and local laws, rules, regulations and guidelines in force in the U.S. and the European Union in respect of the manufacture of the API and, to the knowledge of RB, there are no circumstances or conditions in existence as of the Commencement

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Date which would reasonably be expected to prevent continuing compliance of the manufacture of the API in accordance with the terms of this Agreement with all such national and local laws, rules, regulations and guidelines during the Term; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.6&nbsp;&nbsp;&nbsp;&nbsp;MSX's use of the API in accordance with the terms of this Agreement shall not infringe any third party patent rights or other intellectual property rights which are known by RB (or ought reasonably to be known by RB) to exist as of the Commencement Date.

9.4&nbsp;&nbsp;&nbsp;&nbsp;RB further warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.1&nbsp;&nbsp;&nbsp;&nbsp;it shall supply the API within the time periods set out in **Clause 4.3**;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.2&nbsp;&nbsp;&nbsp;&nbsp;it is duly incorporated and organized and is validly existing under the laws of its jurisdiction of incorporation and has the corporate power and authority to own its assets and to conduct its businesses and to perform its obligations hereunder;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.3&nbsp;&nbsp;&nbsp;&nbsp;the execution and delivery of this Agreement by it and the completion by it of the transactions contemplated herein do not and will not result in the breach of, or violate any term or provision of its articles of formation or by-laws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.4&nbsp;&nbsp;&nbsp;&nbsp;it is not subject to any outstanding injunction, judgement or order of any governmental authority which would prevent or materially delay the transactions contemplated by this Agreement; there are no civil, criminal or administrative claims, actions, suits, demands, proceedings, hearings or investigations pending or, to RB's knowledge threatened, at law, in equity or otherwise, in, before, or by, any governmental authority which (if successful) would prevent or materially delay RB's compliance with the provisions of this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.5&nbsp;&nbsp;&nbsp;&nbsp;no dissolution, winding up, bankruptcy, liquidation or similar proceeding has been commenced or is pending or, to the knowledge of RB, proposed in respect of it;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.6&nbsp;&nbsp;&nbsp;&nbsp;the execution and delivery of this Agreement and the completion of the transactions contemplated herein have been duly approved by appropriate persons within its organisation and this Agreement constitutes the legal, valid and binding obligation of RB enforceable against it in accordance with its terms; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.7&nbsp;&nbsp;&nbsp;&nbsp;it or its Affiliates has taken or will take all action as may be required or necessary to obtain and maintain, comply and keep current any governmental licences, permits, approvals and/or registrations that are necessary for RB and/or its Affiliates to manufacture and/or supply the API and to carry out and perform its obligations under this Agreement.

9.5&nbsp;&nbsp;&nbsp;&nbsp;NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A WARRANTY OR REPRESENTATION BY EITHER PARTY (II) REGARDING THE EFFECTIVENESS, VALUE, SAFETY, NON-TOXICITY OR PATENTABILITY OF ANY PATENT TECHNOLOGY, THE PRODUCT OR ANY INFORMATION OR RESULTS PROVIDED BY EITHER PARTY PURSUANT TO THIS AGREEMENT, OR (II) THAT THE PRODUCT WILL BE APPROVED. EACH PARTY EXPRESSLY DISCLAIMS, WAIVES, RELEASES, AND RENOUNCES ANY WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, EXCEPT THOSE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT WHICH SHALL REMAIN IN FULL FORCE AND EFFECT IN ACCORDANCE WITH THE TERMS OF THIS AGREEMENT.

10.&nbsp;&nbsp;&nbsp;&nbsp;**INDEMNITY**

10.1&nbsp;&nbsp;&nbsp;&nbsp;Subject to the limitations in **Clause 22** below, RB shall indemnify, defend and hold harmless MSX, its Affiliates and its and their respective directors, officers, employees, representatives, agents and contractors ("**MSX Parties**") from any and all Losses that result from or arise in connection with any claim, action, suit or proceeding, made or brought by or on behalf of a third party (a "**Claim**") against any of the MSX Parties to the extent the Claim arises from (i) the marketing, distribution or sale of the Products by RB, its Affiliates and its agents, (ii) the use of the Products, (iii) the failure of API to meet the API Specification as a result of defects (latent or otherwise) in, or non-conformance of, the API (save for those defects or non-conformance which would have been discovered but for MSX's failure to perform the tests to be carried out by MSX in accordance with the terms under **Clause 4.4**) or the breach by RB of the warranties set forth in **Clauses 9.3** and **9.4.1**, or (iv) a material breach of this Agreement by RB or any of its Affiliates; provided, that:

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.1&nbsp;&nbsp;&nbsp;&nbsp;the Claim does not arise from the negligence, wilful default or breach of the terms of this Agreement (including the warranties by MSX in **Clause 9**) or the Quality Agreement by the MSX Parties; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.2&nbsp;&nbsp;&nbsp;&nbsp;the indemnity shall not extend to any part of a Claim that results from any failure by MSX to promptly notify RB in writing of any matter which may give rise to such a Claim to which this indemnity may apply, where such failure actually causes material prejudice to RB's rights or ability to defend against such Claim.

10.2&nbsp;&nbsp;&nbsp;&nbsp;MSX shall indemnify, defend and hold harmless RB, its Affiliates, and its and their respective directors, officers, employees and contractors ("**RB Parties**") from any and all Losses that result from or arise in connection with any Claim brought against the RB Parties to the extent the Claim arises from (i) the failure of the Products to meet the Product Specification or the breach by MSX of the warranties set forth in **Clause 9,** or (ii) a material breach of this Agreement by MSX or its Affiliates, provided, that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2.1&nbsp;&nbsp;&nbsp;&nbsp;the Claim does not arise from the negligence, wilful default or breach of the terms of this Agreement (including the warranties by RB in **Clause 9**) or the Quality Agreement by the RB Parties; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2.2&nbsp;&nbsp;&nbsp;&nbsp;the indemnity shall not extend to any part of a Claim that results from any failure by RB to promptly notify MSX in writing of any matter which may give rise to such a Claim to which this indemnity may apply, where such failure actually causes material prejudice to MSX's rights or ability to defend against such Claim.

10.3&nbsp;&nbsp;&nbsp;&nbsp;Each party shall be obliged to promptly notify the other in writing upon becoming aware of any indemnity claims likely to be made by a third party under the terms of this **Clause 10,** and shall promptly exchange all information relating to an indemnity claim to the extent reasonably practicable.

10.4&nbsp;&nbsp;&nbsp;&nbsp;The indemnifying party shall:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.1&nbsp;&nbsp;&nbsp;&nbsp;have sole control over the conduct, defense (including the right to select counsel) and settlement of any such Claim; provided that no compromise or settlement may be affected by the indemnifying party that indicates an admission of liability by the indemnified party or requires the indemnified party to make any monetary payments, without the prior written consent of the indemnified party, such consent not to be unreasonably withheld, conditioned or delayed; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4.2&nbsp;&nbsp;&nbsp;&nbsp;keep the indemnified party fully informed of the progress of the defense of such Claim.

10.5&nbsp;&nbsp;&nbsp;&nbsp;The indemnified party shall:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.5.1&nbsp;&nbsp;&nbsp;&nbsp;cooperate fully with the indemnifying party and its legal representatives in the investigation and defense of any Claim under this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.5.2&nbsp;&nbsp;&nbsp;&nbsp;not make any admissions or do anything that may compromise or prejudice the defense of such Claim without the prior written consent of the indemnifying party; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.5.3&nbsp;&nbsp;&nbsp;&nbsp;not make any payment or incur any expenses in connection with any such Claim or make any admission or do anything that may compromise or prejudice the defense of the Claim without the prior written consent of the indemnifying party, such consent not to be unreasonably withheld, conditioned or delayed.

10.6&nbsp;&nbsp;&nbsp;&nbsp;Subject to **Clause 10.5**, in the event a Claim is asserted, the indemnified party may elect to choose counsel independent from that representing the indemnifying party and participate in the Claim, in which case the indemnified party shall be solely responsible for any costs and expenses associated with such counsel including, legal costs, expert fees and all related costs.

10.7&nbsp;&nbsp;&nbsp;&nbsp;No later than the first shipment of Product to RB for commercial sale, throughout the remainder of the Term and for a period of [\*\*\*] months after its expiry or termination, the parties shall carry and keep in force a comprehensive general liability insurance policy, including product liability as well as blanket contractual liability coverage. This insurance policy shall provide a liability limit of not less than £[\*\*\*] ([\*\*\*] Pounds Sterling) for each occurrence or series of related occurrences within any twelve (12) month period. Each party shall, upon the reasonable request of the other, produce satisfactory evidence that all insurance premiums have been paid and kept up to date and are kept in accordance with

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local insurance laws or regulations from time to time in force. The existence of such insurance shall not be construed as a limitation of either party's liability hereunder.

11.&nbsp;&nbsp;&nbsp;&nbsp;**CONFIDENTIAL INFORMATION**

11.1&nbsp;&nbsp;&nbsp;&nbsp;For the avoidance of doubt, RB and MSX may be disclosing Confidential Information belonging to them or their Affiliates on behalf of those Affiliates and those Affiliates may also disclose such information themselves directly.

11.2&nbsp;&nbsp;&nbsp;&nbsp;"**Discloser**" means either party or any of its Affiliates disclosing Confidential Information to the Recipient.

11.3&nbsp;&nbsp;&nbsp;&nbsp;"**Recipient**" means either party or any of its Affiliates receiving Confidential Information from the Discloser.

11.4&nbsp;&nbsp;&nbsp;&nbsp;Each party will disclose to the other such Confidential Information as it considers necessary to further the purpose of this Agreement.

11.5&nbsp;&nbsp;&nbsp;&nbsp;Each party shall treat all Confidential Information disclosed hereunder with strict confidentiality.

11.6&nbsp;&nbsp;&nbsp;&nbsp;The Recipient shall only use Confidential Information to further the purpose of this Agreement and for no other purpose.

11.7&nbsp;&nbsp;&nbsp;&nbsp;The Recipient will not, without the prior written consent of the Discloser, make any notes, sketches, drawings, photographs or copies of any kind of any part of the Confidential Information, except when reasonably necessary for the purposes of this Agreement, in which case such copies will be regarded as Confidential Information of the Discloser.

11.8&nbsp;&nbsp;&nbsp;&nbsp;The Recipient shall not authorise any third party other than a Sub-Contractors as set forth in **Schedule Five** (and in the case of the API Specification which, for the avoidance of doubt, MSX shall not without the prior written consent of RB disclose or pass to, or allow use by, any party including a Sub-Contractor as set forth in **Schedule Five**) to act on or use in any way any Confidential Information belonging to the Discloser (whether or not such third party is aware of such Confidential Information), shall promptly notify the Discloser if it becomes aware of any third party so acting, and (without prejudice to any of its other obligations) shall provide the Discloser such assistance as the Discloser reasonably requires, at the Discloser's cost and expense, to prevent such third party from so acting.

11.9&nbsp;&nbsp;&nbsp;&nbsp;The Recipient will not without the prior written consent of the Discloser communicate or otherwise make available the Confidential Information to any third party save in so far as is necessary to make available the Confidential Information (other than the API Specification which for the avoidance of doubt shall be held in the strictest confidence and shall not be disclosed to any third party (otherwise than under **Clause 11.12.6)** without the prior written consent of RB) to a third party for any application for registration of any Intellectual Property Rights that it owns or in connection with the registration of any medicinal product provided that it does not prevent the registration of or destroy any registrable Intellectual Property Right. The Recipient will forthwith notify the Discloser of any such application and the Discloser may (in its absolute discretion) refuse permission to allow publication. The Recipient shall require each third party (including Sub-Contractors) to which it gives Confidential Information of the Discloser, including those covered under **Clause 11.8** and this **Clause 11.9**, to sign, prior to receipt of any of the Discloser's Confidential Information, an agreement of confidentiality having the same obligations on such third party as are placed on the Recipient under this Agreement.

11.10&nbsp;&nbsp;&nbsp;&nbsp;The Recipient will however be permitted to disclose Confidential Information to those of its officers and employees and/or officers and employees of its Affiliates who are required in the course of their duties to receive and acquire the Confidential Information for the purpose of this Agreement where such Affiliates and/or employees and/or officers are bound by obligations of confidentiality to the Recipient and/or the relevant Affiliate and are first made aware of the other terms of this Agreement. The Recipient will be liable to the Discloser for any breach of the terms of this Agreement by such Affiliates or by their employees or officers.

11.11&nbsp;&nbsp;&nbsp;&nbsp;The terms of this **Clause 11** will continue beyond the expiration or termination of this Agreement for a period of [\*\*\*] years, except in relation to the Know-How of the Discloser and the API Specification which shall remain confidential for the duration of its confidential nature.

11.12&nbsp;&nbsp;&nbsp;&nbsp;The undertakings given in **Clauses 11.4** to **11.11** above shall not apply, in relation to the Recipient, to Confidential Information that:

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.12.1&nbsp;&nbsp;&nbsp;&nbsp;the Recipient can show by written records was already in the Recipient's possession prior to the Commencement Date and was not obtained under a duty of confidentiality;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.12.2&nbsp;&nbsp;&nbsp;&nbsp;the Recipient can show by written records is subsequently developed independently by the Recipient without any reference to or use by the Recipient of Confidential Information disclosed by the Discloser;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.12.3&nbsp;&nbsp;&nbsp;&nbsp;is or becomes public knowledge other than through the default of the Recipient;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.12.4&nbsp;&nbsp;&nbsp;&nbsp;is disclosed to the Recipient by a third party where such third party did not obtain the same under an obligation of confidence to the Discloser and was not under an obligation of confidence to the Discloser at the time of disclosure;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.12.5&nbsp;&nbsp;&nbsp;&nbsp;is approved for release upon the written permission of the Discloser; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.12.6&nbsp;&nbsp;&nbsp;&nbsp;is required by applicable law, rule or regulation including, without limitation, the United States Securities Act of 1933, the Securities Exchange Act of 1934 and related regulations and interpretations thereof (collectively, the "**Securities Laws**") to be disclosed by the Recipient, in which case the Recipient shall first inform the Discloser of all relevant facts relating to such a disclosure and shall provide such opportunity as is reasonable in the circumstances for the Discloser to object to, or limit, such disclosure and will provide reasonable assistance to the Discloser in seeking to prevent or limit such disclosure, except that no such act by the Discloser to object to or limit, or assistance of the Recipient requested by the Discloser, shall interfere with, delay or hinder the Recipient's obligations under Securities Laws.

11.13&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding any other provision of this Agreement, neither party shall make any public disclosure or statement relating to the existence, nature, terms, subject matter or other item in connection with this Agreement, except as required by applicable law, rule or regulation (including, without limitation, Securities Laws), and shall follow the procedure stated in **Clause 11.12.6** in connection with issuing such statement.

12.&nbsp;&nbsp;&nbsp;&nbsp;**HEALTH REGISTRATIONS AND QUALITY ASSURANCE**

12.1&nbsp;&nbsp;&nbsp;&nbsp;RB shall be responsible for obtaining and maintaining the Health Registrations in the Territory and MSX shall provide such assistance as may be reasonably required in connection with obtaining and maintaining such Health Registrations.

12.2&nbsp;&nbsp;&nbsp;&nbsp;RB shall prepare, submit and maintain any relevant DMF dossiers for the Products and any relevant certificate of suitability for the Products in accordance with cGMP. Upon the reasonable request of MSX, MSX shall be given access to relevant information contained in DMF dossiers or the certificate of suitability necessary for its activities under this Agreement or required by applicable law.

12.3&nbsp;&nbsp;&nbsp;&nbsp;The parties shall comply, and procure that their Affiliates comply, with their respective obligations set out in the Quality Agreement.

12.4&nbsp;&nbsp;&nbsp;&nbsp;MSX shall, on reasonable written request by RB to MSX, provide RB with access to the Master Manufacturing File compiled by MSX in connection with the manufacture of the Products for review.

13.&nbsp;&nbsp;&nbsp;&nbsp;**REGULATORY COMPLIANCE, COMPLAINTS AND PRODUCT RECALLS**

13.1&nbsp;&nbsp;&nbsp;&nbsp;MSX shall promptly and at its own cost:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.1.1&nbsp;&nbsp;&nbsp;&nbsp;provide any Regulatory Authority all such documents and information as it may request in relation to the manufacture of the Products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.1.2&nbsp;&nbsp;&nbsp;&nbsp;allow any Regulatory Authority access in relation to the manufacture of the Products to the Manufacturing Site or any other relevant sites for the purpose of an audit or inspection promptly on request by such Regulatory Authority;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.1.3&nbsp;&nbsp;&nbsp;&nbsp;respond in a timely manner to any questions of a regulatory nature relating to the manufacture of the Products raised by any Regulatory Authority and copy RB into any such response; and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.1.4&nbsp;&nbsp;&nbsp;&nbsp;promptly provide to RB the findings of any such Regulatory Authority audits, inspections or enquires relating to the Manufacturing Site or other sites relevant to the manufacture of the Products.

13.2&nbsp;&nbsp;&nbsp;&nbsp;If any Regulatory Authority requires any changes to be made to the manufacture of the Products, the process, plant or equipment used in the manufacture of the Products or disposal of residue after such manufacture, MSX shall promptly notify RB and send it copies of any relevant documents. MSX shall consult with RB and shall use commercially reasonable efforts to defer implementation of any such changes until RB has been able to make any appropriate amendments to its Health Registrations as may be necessary for manufacture of the Products by MSX.

13.3&nbsp;&nbsp;&nbsp;&nbsp;Each party shall notify the other immediately by telephone and confirm in writing within twenty-four (24) hours upon having actual knowledge of any problem relating to the Products including where:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.1&nbsp;&nbsp;&nbsp;&nbsp;the Products do not comply with the Product Specification or any matter which may affect the safety or efficacy of the Products arising during their manufacture;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.2&nbsp;&nbsp;&nbsp;&nbsp;the Products are affected by bacteriological or other contamination; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.3&nbsp;&nbsp;&nbsp;&nbsp;the Products are affected by significant chemical, physical or other change or deterioration or stability failures.

13.4&nbsp;&nbsp;&nbsp;&nbsp;Upon written request by a party, the other party shall promptly investigate any problem identified under **Clause 13.3** above or any third party complaint it relation to the Products and shall promptly submit follow-up reports upon the receipt of any new information in connection with the problem or complaint. Upon written request by RB, MSX shall provide reasonable assistance to RB in investigating such problems or complaints. Such investigations by MSX shall include appropriate chemical or microbial analysis of the relevant Product sample (if available), analysis of any retained Product sample or the review of relevant batch documentation. MSX shall provide RB with a written report of its investigations and conclusions [\*\*\*] days from receipt of RB's written request (including samples, if available) for such investigation. RB shall provide all reasonable assistance to MSX in analyzing any such Product problems or complaints.

13.5&nbsp;&nbsp;&nbsp;&nbsp;All contact and correspondence with any Regulatory Authority in relation to a Product recall or complaint shall be made and co-ordinated by RB (unless otherwise required by applicable law). MSX shall not contact any Regulatory Authority or other government body in relation to any matter concerning the recall of or complaint concerning the Products, without the prior written consent of RB (unless required to do so by law), such consent not to be unreasonably withheld, conditioned or delayed.

13.6&nbsp;&nbsp;&nbsp;&nbsp;During the Term:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.6.1&nbsp;&nbsp;&nbsp;&nbsp;MSX shall provide RB with copies of any communications (which are known to MSX to exist and are within its possession or control) with any Regulatory Authority specifically relating to the Products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.6.2&nbsp;&nbsp;&nbsp;&nbsp;RB shall provide MSX with copies of relevant communications with any Regulatory Authority in relation to the API or the Products which would impact MSX's obligations under this Agreement; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.6.3&nbsp;&nbsp;&nbsp;&nbsp;If the communications with any Regulatory Authority referred to in this **Clause 13** require or directly lead to any change in or to the Manufacturing Site in so far as such change affects or impacts upon the manufacture of the Products, then MSX shall in every case provide RB with all information relating thereto and in addition shall keep RB regularly updated of all events occurring and all further communications from Regulatory Authorities from time to time.

13.7&nbsp;&nbsp;&nbsp;&nbsp;MSX shall, on written request by RB, provide RB with reasonable assistance at RB's cost in the event that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.7.1&nbsp;&nbsp;&nbsp;&nbsp;any Regulatory Authority issues a request, directive or order that the Products be recalled, corrected or withdrawn from market; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.7.2&nbsp;&nbsp;&nbsp;&nbsp;a court of competent jurisdiction orders such a recall, correction or withdrawal from market; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.7.3&nbsp;&nbsp;&nbsp;&nbsp;RB determines in its reasonable discretion that the Products shall be recalled, withdrawn from market or corrected for any reason.

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13.8&nbsp;&nbsp;&nbsp;&nbsp;RB shall at all times have sole responsibility for the initiation and co-ordination of any recall of the Products or the issue of corrective statements (unless otherwise required by applicable law or Regulatory Authorities). MSX shall not, without RB's prior written consent, communicate with any Regulatory Authority or other third party in connection with any such recall or complaint (unless required to do so by law). Notwithstanding the above, MSX and RB shall notify the other promptly if any of the Products are suspected or proven to be the subject of a complaint which may require a recall of the Products and the parties shall cooperate with each other in the handling and disposition of such complaint.

13.9&nbsp;&nbsp;&nbsp;&nbsp;If RB reasonably determines that a recall of the Products is required, the recall strategy shall be reasonably developed by RB and followed by MSX with strict regard to timing. RB shall promptly notify MSX in writing in the event that it deems that a recall of the Products is required.

13.10&nbsp;&nbsp;&nbsp;&nbsp;MSX shall be responsible for its own and RB's reasonable costs and expenses of all recalls of Products or complaints in the event that such recall or complaint is the result of any negligent act or omission or breach of the terms of this Agreement by MSX.

13.11&nbsp;&nbsp;&nbsp;&nbsp;RB shall be responsible for its own and MSX's reasonable costs and expenses of all recalls of Products or complaints in the event that such recall or complaint is the result of any negligent act or omission or breach of the terms of this Agreement by RB.

13.12&nbsp;&nbsp;&nbsp;&nbsp;In the event that a recall of Products results from the joint negligence of RB and MSX, each party shall be responsible for the expenses of such recall in direct proportion to each party's percentage of fault as determined jointly by written agreement of the parties or by a court of competent jurisdiction.

13.13&nbsp;&nbsp;&nbsp;&nbsp;In the event of a recall being initiated by a Regulatory Authority, where the scope of the recall is directed at all Products and where the purpose of such recall is not attributable to the fault of either RB or MSX, RB shall be responsible for MSX's expenses properly and necessarily incurred directly in connection with the recall.

13.14&nbsp;&nbsp;&nbsp;&nbsp;Provided that MSX has stocks of usable API, MSX shall use commercially reasonable efforts, subject to other MSX contractual commitments, in attempting to supply RB with replacement Products during the handling and disposition of such recall.

14.&nbsp;&nbsp;&nbsp;&nbsp;**AD HOC INSPECTION TESTING AND SAMPLES**

14.1&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding the provisions of **Clause 13** above, upon the reasonable written request of RB, MSX shall promptly, at RB's cost, submit samples of the Products for RB's approval before the Products are delivered. Such samples shall be marked by MSX for identification.

14.2&nbsp;&nbsp;&nbsp;&nbsp;On reasonable request and notice in writing, RB shall be entitled, without interfering with MSX's operations, to inspect and test the Products during manufacture, processing and storage and MSX shall at its own cost provide or shall procure the provision of all such facilities as may reasonably be required by RB including access to MSX's premises.

14.3&nbsp;&nbsp;&nbsp;&nbsp;The exercise by RB of its rights pursuant to **Clauses 14.1** or **14.2** shall not prejudice RB's right to reject, pursuant to the terms of this Agreement, any Products which do not comply with the Product Specification or the provisions of this Agreement (except the API Specification), or represent RB's assumption of liability in any manner whatsoever with respect to such non-compliant Products.

15.&nbsp;&nbsp;&nbsp;&nbsp;**INTELLECTUAL PROPERTY RIGHTS AND LABELLING**

15.1&nbsp;&nbsp;&nbsp;&nbsp;Nothing in this Agreement shall affect the ownership of any Existing Intellectual Property Rights which one party agrees to make available to the other during the Term and, save as otherwise set out in this Agreement, neither party shall have the right to use or exploit the Existing Intellectual Property Rights of the other party.

15.2&nbsp;&nbsp;&nbsp;&nbsp;MSX hereby grants RB and its Affiliates during the Term the exclusive (including to the exclusion of MSX) and only right and license (with the right to grant sub-licenses thereunder) under MSX's Existing Intellectual Property Rights to use and sell any product, including the Products, in the Field throughout the Territory. During the remainder of the Term after payment of Royalties stops under **Clause 7** (or otherwise in accordance with the terms of this Agreement) in the Territory or any portion thereof, as applicable, this license shall thereafter become royalty-free in the Field in that portion of the Territory, as applicable.

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15.3&nbsp;&nbsp;&nbsp;&nbsp;During the Term, MSX shall not assign or license any of MSX Existing Intellectual Property Rights to other parties for the use or sale of products within the Field.

15.4&nbsp;&nbsp;&nbsp;&nbsp;If, during the Term, either party (or any agent or authorised Sub-Contractor of it) develops or creates (whether with or without others and whether jointly with the other party or not) any Arising Intellectual Property Rights, it will forthwith disclose any such Arising Intellectual Property Rights to the other party. To this extent, MSX warrants to RB that in the event of MSX using any agent (including without limitation and authorised Sub-Contractor) for the performance of any tasks under this Agreement it has in place, or will put in place, agreements with such agents which provide that any Arising Intellectual Property Rights within the Field created in the performance of such tasks shall belong to RB.

15.6&nbsp;&nbsp;&nbsp;&nbsp;Claims of patent applications filed by RB shall be limited to the Field. To the extent that registered patent protection is obtained which is broader than the Field, RB grants MSX a royalty-free worldwide exclusive (including to the exclusion of RB) license, with rights to sublicense, outside the Field under the registered protection or applications therefor, which shall last for the duration of the registered protection or application therefor, to carry out all acts which would otherwise be prohibited due to RB's patent protection outside the Field.

15.8&nbsp;&nbsp;&nbsp;&nbsp;Claims of patent applications filed by MSX shall be limited to being outside the Field. To the extent that registered patent protection is obtained which is within the Field, MSX grants RB a royalty-free worldwide exclusive (including to the exclusion of MSX) license, with rights to sublicense, within the Field under the registered protection or applications therefor, which shall last for the duration of the registered protection or application therefor, to 'carry out all acts which would otherwise be prohibited due to MSX's patent protection within the Field.

15.9&nbsp;&nbsp;&nbsp;&nbsp;By way of illustration of **Clauses 15.5** through and including **Clause 15.8** and **Clause 15.10**, if the parties were to create an improved formulation for certain types of common compounds which would speed the production time for the product, RB would have all Arising Intellectual Property Rights (including the exclusive right to use or to license) within the Field and MSX would have all Arising Intellectual Property Rights (including the exclusive right to use or to license) outside of the Field. For the avoidance of doubt, following termination of this Agreement then, subject to any future written agreement of the parties expressly to the contrary, RB would have rights to the Arising Intellectual Property Rights within the Field but no rights to any Arising Intellectual Property Rights outside the Field or MSX's Existing Intellectual Property Rights, and MSX would have rights to Arising Intellectual Property Rights outside the Field but no rights to the Arising Intellectual Property Rights within the Field or any of RB's Existing Intellectual Property Rights.

15.10&nbsp;&nbsp;&nbsp;&nbsp;The parties agree that, in order (i) to allow RB to apply for, prosecute or maintain any registered protection for RB's rights in the Arising Intellectual Property as identified in **Clause 15.5** and (ii) to allow MSX to apply for, prosecute or maintain any registered protection for MSX's rights in the Arising Intellectual Property as identified in **Clause 15.7**, each in a manner which does not prejudice the prospects for registered protection of the other party. Each party shall work with and cooperate with the other prior to any disclosure of, or patent application filing for, any Arising Intellectual Property Right and shall act in accordance with **Schedule Nine**.

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15.11&nbsp;&nbsp;&nbsp;&nbsp;During the Term, MSX will not assign or license any of MSX's Existing Intellectual Property Rights to other parties for use in the Field.

15.12&nbsp;&nbsp;&nbsp;&nbsp;During the Term, except during the last twelve (12) month period thereof if the parties have elected not to extend the Term of this Agreement in accordance with the terms of **Clause 3.9,** and whether in isolation or for or with others, MSX shall not carry out research or research work related to the Field, other than pursuant to this Agreement.

15.13&nbsp;&nbsp;&nbsp;&nbsp;During the Term, in the event that MSX shall decide that it no longer wishes to apply for, prosecute or maintain any registered protection for any of MSX Existing Intellectual Property Rights for any country, it shall forthwith notify RB. If RB indicates to MSX that it wishes to take an assignment of such Existing Intellectual Property Rights within the Field, it shall so notify MSX who agrees to conduct good faith negotiations in attempting to reach a resolution to assign such Existing Intellectual Property Rights within the Field to RB. For the avoidance of doubt, this includes any registered protection which MSX is entitled to claim priority from an earlier application at the end of the Paris Convention priority period. If such Existing Intellectual Property Rights are assigned to RB, and to the extent that registered patent protection is obtained which is broader than the Field, RB will grant MSX an irrevocable, perpetual, exclusive (including to the exclusion of RB), royalty-free license (with the right to grant sub-licenses thereunder) under such registered protection or applications therefor outside the Field and throughout the Territory. Notwithstanding anything to the contrary, MSX is under no obligation to assign such Existing Intellectual Property Rights to RB.

15.14&nbsp;&nbsp;&nbsp;&nbsp;During the Term and upon its knowledge of the occurrence of any infringement or suspected or threatened infringement of any of the Patents, the Arising Intellectual Property rights or the Existing Intellectual Property Rights in the Product or in the Field, or of any proceedings or suspected or threatened proceedings for the revocation or involving the validity of any of the Intellectual Property Rights, the party with this knowledge shall notify the other and provide all details within its knowledge with respect to the same and thereafter upon receipt of a written request the parties will assist each other in taking such steps as either party may reasonably consider to be appropriate at the expense of the party that considers such steps to be appropriate.

15.15&nbsp;&nbsp;&nbsp;&nbsp;For the purpose of protecting the Intellectual Property Rights, each party shall also procure that its Affiliates shall comply with **Clause 3** and this **Clause 15**.

15.16&nbsp;&nbsp;&nbsp;&nbsp;Each party undertakes that it shall not at any time during the Term or after the termination or expiration of this Agreement knowingly do or suffer to be done any act or thing which may impair the rights of the other party in its Intellectual Property Rights and further undertakes that it shall not represent that it has any title to or right of ownership in the Intellectual Property Rights of the other party.

15.17&nbsp;&nbsp;&nbsp;&nbsp;MSX shall manufacture the Products incorporating such layout, content, design, trade marks and artwork as may be reasonably directed by RB in writing. RB shall bear the cost of designing the layout, content and appearance of the labelling, inserts and packaging, including costs of Tooling, used solely in connection with the Products.

15.18&nbsp;&nbsp;&nbsp;&nbsp;Except as may be required by any Regulatory Authority, MSX shall not make any change or modification to the Products' packaging or labelling, including the layout, content, design, trade marks or artwork used in connection with such packaging or labelling without the prior written consent of RB.

15.19&nbsp;&nbsp;&nbsp;&nbsp;RB may, on reasonable prior written notice, change any part of the packaging or labelling of the Products. In the event that such change results in any write-off of the cost of Raw Materials, RB shall bear the cost of such write-off to the extent that such Raw Materials were reasonably required to meet RB's Forecasts.

15.20&nbsp;&nbsp;&nbsp;&nbsp;In the event of any packaging or labelling changes, MSX shall, if requested in writing by RB, either destroy (in accordance with all applicable laws) or deliver to RB any Products which are to be written off. RB is to bear the cost of such write off for such Products at: (1) the Cost of Goods Price for such Products if the packaging or labelling change was at RB's choice; or (2) the manufacturing costs for such Products if the packaging or labelling change was done to meet a change in legal requirements. In addition to the foregoing, in either case, RB shall reimburse MSX for the acquisition costs of any unused packaging materials which can no longer be used for the Products to the extent that such Raw Materials were reasonably required to meet RB's Forecasts.

15.21&nbsp;&nbsp;&nbsp;&nbsp;For the avoidance of doubt, in the event of any packaging or labelling changes pursuant to **Clause 15.18** or **Clause 15.19**, upon receipt of written notice of such changes, MSX shall inform and keep RB informed of the stock levels of the Products and relevant Raw Materials and packaging components in order that RB may decide how it wishes to proceed under **Clauses 15.18** and **15.19**.

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15.22&nbsp;&nbsp;&nbsp;&nbsp;All copyright and other Intellectual Property Rights in any artwork and origination work supplied by RB or its nominee for the labelling, packaging and, where applicable, package inserts for the Products is and shall remain the property of RB or its nominee absolutely. MSX shall not supply or manufacture any such packaging or other components or finished Products or confusingly similar packaging or products other than to RB or as it may direct. Subject to RB being able to incorporate the trademark of MSX as set out in **Schedule Eleven** (or such variation thereto as is reasonably suggested by MSX and approved by RB, such approval not to be unreasonably withheld, conditioned or delayed) on the back of secondary packaging (being packaging containing one or more of the Products and of an appropriate size for such requirements) without impeding the artwork and information required by Regulatory Authorities to be placed on such secondary packaging, RB shall include the MSX trademark on the reverse of such secondary packaging with the size and location approved by RB (such approval not to be unreasonable withheld, conditioned or delayed but shall remain subject to RB's obligations to place information required by Regulatory Authorities on such secondary packaging).

16.&nbsp;&nbsp;&nbsp;&nbsp;**FORCE MAJEURE**

16.1&nbsp;&nbsp;&nbsp;&nbsp;If either party is prevented or delayed in the performance of any of its obligations under this Agreement as a result of civil commotion, strike (but excluding industrial action or strikes by employees of either party) embargo, governmental legislation or regulation, riot, invasion, war, threat of or preparation for war, fire, explosion, storm, flood, earthquake, subsidence, epidemic or other natural physical disaster or other event beyond the reasonable control of a party that has not occurred as a result of its negligence or other act or omission ("**Force Majeure Event**"), it shall notify the other party, in writing, of the same as soon as practicable, fully detailing the background to, and all relevant matters connected with, such Force Majeure Event, together with such evidence thereof that it reasonably can give and specifying the period for which such prevention or delay can reasonably be expected to continue. The affected party shall use commercially reasonable efforts to remove or overcome such Force Majeure Event as quickly as possible and shall also use its commercially reasonable efforts to mitigate the impact of such Force Majeure Event of the other party. Subject to **Clause 16.2**, if a party shall have fully complied with its obligations under this **Clause 16.1**, it shall be excused from performance of its unfulfilled obligations under this Agreement from the start date of the Force Majeure until such Force Majeure Event no longer pertains.

16.2&nbsp;&nbsp;&nbsp;&nbsp;If a Force Majeure Event prevents performance by a party of any obligations hereunder for a continuous period in excess of [\*\*\*] weeks, the other party shall be entitled to terminate this Agreement by written notice at any time after such [\*\*\*] week period provided the relevant Force Majeure Event remains subsisting at the time such notice is given.

17.&nbsp;&nbsp;&nbsp;&nbsp;**TERMINATION**

17.1&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be terminated at any time upon either party giving to the other [\*\*\*] days notice in writing if the other party commits a material breach of the terms of this Agreement and (where such breach is capable of remedy) fails to remedy such breach within [\*\*\*] days of receiving written notice from the other party specifying the breach and requiring its remedy.

17.2&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be terminated by either party, immediately on written notice to the other, if;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.2.1&nbsp;&nbsp;&nbsp;&nbsp;the other party shall go into liquidation whether voluntary or compulsory or is dissolved or becomes insolvent or if a petition shall be presented or an order made for the appointment of an administrator or if a receiver, administrative receiver or manager shall be appointed over any part of its assets or undertaking which appointment is not dismissed within thirty (30) days of having been made; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.2.2&nbsp;&nbsp;&nbsp;&nbsp;any distress, execution, sequestration or other process is levied or enforced upon or sued out against the property of the other party which is not discharged within thirty (30) days.

17.3&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be terminated by RB, forthwith upon written notice to MSX, in the event that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.3.1&nbsp;&nbsp;&nbsp;&nbsp;any applicable Regulatory Authority, state or local regulatory approvals, laws, ordinances or regulations, present or future, state that the Manufacturing Site is not suitable, or ceases to be suitable, for the manufacture of the Products; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.3.2&nbsp;&nbsp;&nbsp;&nbsp;the Product is not suitable for Manufacture by MSX due to environmental, health or safety reasons; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.3.3&nbsp;&nbsp;&nbsp;&nbsp;any of RB's Health Registrations for the Products is suspended or withdrawn; or

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.3.4&nbsp;&nbsp;&nbsp;&nbsp;it is determined that the formulation, use or sale of the Products infringes any third party Intellectual Property Rights; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.3.5&nbsp;&nbsp;&nbsp;&nbsp;RB is unable to demonstrate bio-equivalence between the Products and its Suboxone product; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.3.6&nbsp;&nbsp;&nbsp;&nbsp;MSX is unable to provide stability data demonstrating, and obtain appropriate authorisation specifying, a shelf life of the finished Products (i.e. Products packed in accordance with the Packaging Specification) at least equivalent to [\*\*\*] months; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.3.7&nbsp;&nbsp;&nbsp;&nbsp;RB exercises its right to terminate in accordance with the terms of **Clause 7.9**.

17.4&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be terminated by RB, forthwith upon written notice to MSX, in the event that MSX's cumulative on-time Product delivery falls below [\*\*\*] percent ([\*\*\*]%) during any six (6) month period as specified in **Clause 6.5.1**, provided that the reason for such failure is not due to the failure of RB to deliver the API on time or to any other fault or failure attributable to RB or its Affiliates or their respective assigns or sublicensees.

17.5&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be terminated by MSX, forthwith upon written notice to RB:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.5.1&nbsp;&nbsp;&nbsp;&nbsp;In the event that following RB's filing of a New Drug Application ("**NDA**") for FDA approval of the Product (which shall be filed on the assumption that both parties will act reasonably to obtain such filing) and after the expiry of the six (6) month period commencing with RB's receipt of final response from the FDA regarding RB's NDA filing, RB fails to use its commercially reasonable efforts to obtain and diligently pursue all approvals from the FDA as required by this Agreement. For purposes of this **Clause 17.5.1**, RB shall be deemed to have failed to use commercially reasonable efforts to obtain all approvals from the FDA as required by this Agreement if RB fails or elects not to use such efforts and resources (including, without limitation, the promptness in which such efforts and resources would be applied) consistent with its expression of commitment and intent regarding its regulatory strategy for the commercialization exploitation of the Products, on and before the Commencement Date, as a priority of its and its Affiliates product development program, including expending such additional funds and devoting such additional manpower and other resources as is necessary and appropriate to reasonably assure the timely grant of such approvals to effect the transactions contemplated under this Agreement and, in any circumstances, which are consistent with the general level of effort and resources that would be used in the pharmaceutical industry for a company similar in size and scope and with the intention to commercialize and exploit a product critical to the continued success of the company. The parties understand and agree that RB shall not be construed as failing to use commercially reasonable efforts for delays caused solely by the FDA in its review of the applications for U.S. Regulatory Approvals by RB if RB is diligently and timely responding to requests and demands by the FDA relating to such applications;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.5.2&nbsp;&nbsp;&nbsp;&nbsp;In the event that RB fails to make reasonable efforts toward a Product Launch in the U.S. after obtaining all necessary approvals from the relevant Regulatory Authorities within six (6) months after obtaining such approvals; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.5.3&nbsp;&nbsp;&nbsp;&nbsp;In the event that RB fails to reach minimum sales of the Products of at least USD$[\*\*\*] ([\*\*\*] U.S. dollars) within twenty-four (24) months from the Product Launch set forth in **Clause 17.5.2** above.

17.6&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be terminated by MSX, forthwith upon written notice to RB, in the event that MSX notifies RB that supplies of the API do not meet the API Specification in accordance with **Clause 4.4** and have not done so during the previous consecutive three (3) month period, and RB has not implemented an action plan and remedied the failure to supply the API to the API Specification in accordance with **Clause 4.5** within three (3) months after the end of such three (3) month period.

17.7&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be terminated by RB if a majority percentage of the issued share capital, or control of the management or voting rights, of MSX is taken over or acquired (collectively, a "**Change in Control**") by any third party or parties operating within the Field or expropriated or nationalised.

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18.&nbsp;&nbsp;&nbsp;&nbsp;**CONSEQUENCES OF TERMINATION**

18.1&nbsp;&nbsp;&nbsp;&nbsp;Upon termination or expiry of this Agreement for whatever reason, MSX shall:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.1&nbsp;&nbsp;&nbsp;&nbsp;at the written request of RB, use its best endeavours to novate the contracts for the supply of all Raw Materials, Film, packaging components and other materials used in the production of the Products to RB, or as RB may direct, and to meet any request from RB required to transfer production or any registrations or licences or approvals relating to the Products to RB, its Affiliates or any third party approved in writing by RB;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.2&nbsp;&nbsp;&nbsp;&nbsp;release and make available for immediate collection by or on behalf of RB, and RB shall forthwith purchase from MSX, (i) all finished Products (including stocks maintained in accordance with **Clause 6.4**) at the Cost of Goods Price and/or (ii) the Raw Materials at the relevant cost of Raw Materials, each as determined in the previous Annual Review;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.3&nbsp;&nbsp;&nbsp;&nbsp;promptly deliver to RB (or its nominee) a copy of the Master Manufacturing File;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.4&nbsp;&nbsp;&nbsp;&nbsp;in the case of termination of this Agreement by RB under **Clauses 17.1**, **17.2**, **17.3.1**, **17.3.2**, **17.3.6**, **17.3.7**, **17.4**, and **17.7** promptly provide to RB all relevant Intellectual Property which is necessary or reasonably useful for the manufacture of the Product in the Field by a qualified third party manufacturer including, but not limited to, those specified in **Clause 6.6,** subject to confidentiality and intellectual property agreements in the form reasonably satisfactory to MSX; MSX not to unreasonably withhold or delay the execution of such agreements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.5&nbsp;&nbsp;&nbsp;&nbsp;promptly collect, pack and make ready for delivery to RB all Tooling provided by or funded by RB, and follow all reasonable directions of RB with respect to the disposition of such Tooling, such delivery being at RB's cost, and the risk of loss or damage to such Tooling shall pass to RB at the time of removal from MSX's facility; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.6&nbsp;&nbsp;&nbsp;&nbsp;promptly procure the delivery to RB of, or at RB's request destroy, all copies in its possession of all Confidential Information which is in documentary or other tangible form (including all copies thereof) and which has been disclosed to MSX together with all material relating to that Confidential Information prepared by, or on behalf of, MSX and, at RB's written request, undertake to RB in writing that it has complied with the provisions of this **Clause 18**.

19.&nbsp;&nbsp;&nbsp;&nbsp;**ASSIGNMENT AND THIRD PARTY RIGHTS**

19.1&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly provided herein, neither the benefits nor the obligations of this Agreement (or any agreement hereunder) or of any provision of it may be assigned or transferred (including sub-contracting other than sub-contracting to the Sub-Contractors listed on Schedule Five) by either party without the prior written consent of the other.

19.2&nbsp;&nbsp;&nbsp;&nbsp;MSX's consent, this Agreement (including any agreements hereunder) shall be assignable by RB to any Affiliate and to any purchaser of all or a substantial part of the business of RB to which this Agreement relates and in the event of such assignment and written assumption by such purchaser, RB shall with effect from such assignment be released from its obligations hereunder and all references in this Agreement to RB shall be changed to mean its assigns.

19.3&nbsp;&nbsp;&nbsp;&nbsp;Any Affiliate of RB may place Orders for Products under this Agreement and may accordingly in their own right enforce the provisions of this Agreement, as though it were RB; provided, that (a) each Affiliate of RB that places an Order for Products shall by doing so be deemed to have assumed RB's obligations under this Agreement for purposes of such Order, and (b) RB shall remain obligated for the performance of all of the obligations of RB and the applicable Affiliate of RB arising from this **Clause 19.3**.

19.4&nbsp;&nbsp;&nbsp;&nbsp;MSX may, without the prior consent of RB, assign this Agreement (and any agreements hereunder): (i) to any purchaser of all or a substantial part of the assets or business of MSX to which this Agreement relates, or (ii) to MonoSol Rx, Inc., and, in each such case, MSX shall with effect from such assignment be released from its obligations hereunder and all references in this Agreement to MSX shall be deemed to include its assigns.

19.5&nbsp;&nbsp;&nbsp;&nbsp;MSX may, without the prior consent of RB, assign its rights and/or benefits under this Agreement or any provision of it, including, without limitation, any Royalties and/or any other payments due MSX, to any third party, including, without limitation, MonoSol Rx, Inc. or other Affiliate of MSX; provided, that in the event of such assignment under this **Clause 19.5**, MSX shall remain obligated for the performance of all of the obligations of MSX arising under this Agreement.

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20.&nbsp;&nbsp;&nbsp;&nbsp;**NOTICES**

20.1&nbsp;&nbsp;&nbsp;&nbsp;Any notice or other communication to be given under this Agreement shall be delivered personally, sent by first-class, pre-paid post or by fax to the following numbers and addresses:

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| | | |
|:---|:---|:---|
| RECKITT BENCKISER |  | With a copy to |
| Addressee | [\*\*\*] | [\*\*\*] |
|  | [\*\*\*] | [\*\*\*] |
| Fax | [\*\*\*] | [\*\*\*] |
| Address | 10710 Midlothian Turnpike, | 10710 Midlothian Turnpike, |
|  | Suite 430 | Suite 430 |
|  | Richmond, VA 23235 | Richmond, VA 23235 |
| MONOSOL RX, LLC |  | With a copy to |
| Addressee | Senior Vice President – |  |
|  | Business Development | [\*\*\*] |
| Fax | [\*\*\*] | [\*\*\*] |
| Address | 30 Technology Drive Warren, | Day Pitney LLP |
|  | NJ 07059 | *By Courier:* |
|  |  | 200 Campus Drive |
|  |  | Florham Park, New Jersey 07932 |
|  |  | Or |
|  |  | *By Mail:* |
|  |  | P.O. Box 1945 |
|  |  | Morristown, New Jersey 07962 |

---

and shall be deemed to have been served upon delivery to the above addresses (if served by hand), three (3) working days following postage to such addresses (if sewed by first-class pre-paid post), and upon transmission of the fax correctly sent to the above number (provided that the sender has proof of transmission and any notice sent after 16:30 shall be deemed to have been served on the recipient the next working day).

21.&nbsp;&nbsp;&nbsp;&nbsp;**MISCELLANEOUS**

21.1&nbsp;&nbsp;&nbsp;&nbsp;If there are any inconsistencies between the terms and conditions set forth in this Agreement and the terms and conditions set forth in any quotation, Order, acknowledgement or invoice, the terms and conditions of this Agreement shall prevail.

21.2&nbsp;&nbsp;&nbsp;&nbsp;This Agreement, the Product Specification, Packaging Specification, API Specification, or any Order may only be amended, modified or varied by the parties by an instrument in writing signed on behalf of each of the parties.

21.3&nbsp;&nbsp;&nbsp;&nbsp;The waiver by either party of any right under this Agreement or of any failure to perform or breach hereof by the other party shall not constitute or be deemed to be a waiver of any other or future right hereunder or of any other failure to perform or breach hereof by such other party, whether of a similar or dissimilar nature.

21.4&nbsp;&nbsp;&nbsp;&nbsp;The expiration or earlier termination of this Agreement will not operate to release either party hereto from its obligations which are expressed to or implicitly survive such expiration or termination (including, without limitation, **Clauses 9**, **10**, **11**, **12**, **13**, **15**, **18**, **20**, or **22** and any regulatory obligations imposed by Regulatory Authorities to the extent that these obligations by their terms require the parties to continue to perform such obligations beyond such expiration or termination), or from any liability which has already accrued to the other party as of the date of expiration or termination or which may thereafter accrue in respect of any act, omission or default occurring prior to expiration or termination.

------

21.5&nbsp;&nbsp;&nbsp;&nbsp;Nothing in this Agreement shall constitute or be deemed to constitute the creation of a partnership, agency, or employer/employee relationship between the parties.

21.6&nbsp;&nbsp;&nbsp;&nbsp;This Agreement, together with the Development Agreement for a Pharmaceutical Film between the parties dated 11 December 2006 (and associated amendments, collectively, the "**Development Agreement**"), Product Specification, API Specification, Quality Agreement and the Schedules attached hereto, constitute the entire agreement and understanding of the parties and supersede any previous agreement between RB and MSX and their Affiliates in relation to the subject matter of this Agreement. To the extent of any conflict or inconsistency between the Development Agreement and/or the Quality Agreement and this Agreement, the terms and conditions of this Agreement shall supersede and control such conflict and/or inconsistent term or condition of the Development Agreement and/or the Quality Agreement, as the case may be save that in the event that the Quality Agreement imposes an additional or greater responsibility than that contained in this Agreement, such additional or greater responsibility shall prevail and be binding on the parties.

21.7&nbsp;&nbsp;&nbsp;&nbsp;If any provision of this Agreement is held by any court or other competent authority to be invalid or unenforceable in whole or in part it shall be deemed severed from this Agreement and the validity of the other provisions and the remainder of the provision in question shall not be affected.

21.8&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be executed in one or more counterparts, all of which shall be considered as one and the same agreement and shall become effective when one or more counterparts have been signed by each of the parties.

21.9&nbsp;&nbsp;&nbsp;&nbsp;All royalties, taxes and duties imposed or levied on any Products delivered hereunder shall be for the account of and paid by MSX to the point where the Products have been delivered FCA in accordance with **Clause 5.7**. All royalties, taxes and duties imposed or levied on the Products after such delivery shall be for the account of and paid by RB.

22.&nbsp;&nbsp;&nbsp;&nbsp;**LIMITATION OF LIABILITY**

22.1&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding any provision of this Agreement to the contrary (save in respect of any liability for personal injury or death resulting from a party's negligence), in no event shall either party be liable to the other, or have any obligation to the other, as the case may be, for any consequential or indirect damages or Losses (including any loss of profits suffered by RB or MSX) however caused and on any theory of liability, regardless of any failure of essential purpose of any remedy available under this Agreement. For the avoidance of doubt, notwithstanding the foregoing limitation of liability, MSX shall 'remain liable for performance of its obligations as set out under **Clauses 7.9.3.3** and **7.10** and the foregoing limitation of liability shall not be applicable to consequential or indirect damages or Losses (including, without limitation, lost profits incurred by the indemnified party) suffered or incurred by an indemnified party as a direct result of any failure by the indemnifying party to perform its obligations under this Agreement which the indemnified party can demonstrate is due to wilful misconduct by the indemnifying party or any of its employees or Affiliates; provided, however, that the parties acknowledge and agree that any act or omission of the indemnifying party or any of its employees or Affiliates done in good faith shall not be and shall not be construed to be wilful misconduct of the indemnifying party or any of its employees or Affiliates. The indemnified party shall inform the indemnifying party in writing of its intent to seek damages pursuant to the foregoing sentence and provide the indemnifying party with reasonable opportunity to remediate any such Loss; provided that nothing in this sentence shall relieve the indemnifying party from performing its obligations in accordance with the terms of this Agreement.

23.&nbsp;&nbsp;&nbsp;&nbsp;**LAW AND JURISDICTION**

23.1&nbsp;&nbsp;&nbsp;&nbsp;This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, United States of America, save as to conflict of law provisions, and the parties hereby agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

24.&nbsp;&nbsp;&nbsp;&nbsp;**CODE OF CONDUCT**

24.1&nbsp;&nbsp;&nbsp;&nbsp;MSX and RB shall discuss at each Annual Review RB's Code of Conduct as published as at the time of such Annual Review and ways in which MSX may seek to be consistent with such Code of Conduct to the extent such Code of Conduct does not conflict with the laws of employment practices in the United States and the State of Indiana.

------

---

| | |
|:---|:---|
| Signed for and on behalf of Reckitt Benckiser Pharmaceuticals Inc. | Signed for and on behalf of Reckitt Benckiser Pharmaceuticals Inc. |
| */s/Shaun Thaxter* | */s/Shaun Thaxter* |
| Name: | Shaun Thaxter |
| Title: | President RB Pharma U.S. |
| Date: | 8/18/08 |
| Signed for and on behalf of MonoSol Rx, LLC | Signed for and on behalf of MonoSol Rx, LLC |
| */s/Alexander M. Schobel* | */s/Alexander M. Schobel* |
| Name: | Alexander M. Schobel |
| Title: | President & CEO |
| Date: | 8/18/08 |

---

------

**Schedule One**

Cost of Goods Price

**USD$[\*\*\*] per pouched single dose Product**

Net Sales Value

The Net Sales Value shall mean, in any case where a Product is sold or commercially disposed of for value by RB, its Affiliates or distributors, the gross invoiced sales price for such Product to third parties, on an arm's length basis, less the following discounts: (a) customary trade, quantity and trade discounts, charge backs, Medicare or other governmental rebates and customary rebates actually taken or allowed; (b) credits or allowances given or made for the rejection or return of any previously sold Product; (c) to the extent included and separately invoiced in such gross invoice price, any tax or government charge imposed and paid on sale, delivery or use of such Product including, without limitation, any value added or similar tax or government charge, but not including any tax levied with respect to income; and (d) to the extent included and separately invoiced in such gross invoice price any reasonable or documented transport charges.

------

**Schedule Two**

**Patents**

**<u>Filed MSRX IP Covering Reckitt-Benckiser</u>**

**<u>Current Film Formulations and Processes</u>**

[\*\*\*]

------

**Schedule Three**

**Products**

A pouched single dose of the following products:

Buprenorphine Active Ingredient

2 mg

8 mg

12 mg

16 mg

Buprenorphine plus Naloxone Active Ingredient

2 mg Buprenorphine + 0.5 mg Naloxone

8 mg Buprenorphine + 2 mg Naloxone

12 mg Buprenorphine + 3 mg Naloxone

16 mg Buprenorphine + 4 mg Naloxone

------

**Schedule Four**

**Specifications**

**PART A**

**Product and Packaging Specifications**

These specifications are as attached in the following pages

[\*\*\*]

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 1 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

---

| | | |
|:---|:---|:---|
| Test | Method | Specification |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 2 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**[\*\*\*]**

---

| | | | |
|:---|:---|:---|:---|
| Test | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | ***MonoSol Rx, LLC*** | [\*\*\*] | [\*\*\*] | Rev.<br>1 | Page:<br>2 of 2 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Author's Initial & Date | Reviewer's Initial & Date: | Reviewer's Initial & Date: | Approver's Initial & Date: | Approver's Initial & Date: | Approver's Initial & Date: | Approver's Initial & Date: |

---

---

| | | | |
|:---|:---|:---|:---|
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 2 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

[\*\*\*]

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | ***MonoSol Rx, LLC*** | [\*\*\*] | [\*\*\*] | Rev.<br>1 | Page:<br>2 of 2 | Page:<br>2 of 2 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Preparer's Initials & Date | Reviewer's Initials & Date | Reviewer's Initials & Date | Approvers' Initial & Date: | Approvers' Initial & Date: | Approvers' Initial & Date: | Approver's Initials & Date: | Approver's Initials & Date: |

---

---

| | | |
|:---|:---|:---|
| TEST | Method | Specification |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 3 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

[\*\*\*]

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | ***MonoSol Rx, LLC*** | [\*\*\*] | [\*\*\*] | Rev.<br>1 | Rev.<br>1 | Page:<br>2 of 3 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Preparer's Initials & Date | Reviewer's Initials & Date | Reviewer's Initials & Date | Approvers' Initial & Date: | Approvers' Initial & Date: | Approver's Initials & Date: | Approver's Initials & Date: | Approver's Initials & Date: |

---

---

| | | | |
|:---|:---|:---|:---|
| Test | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | ***MonoSol Rx, LLC*** | [\*\*\*] | [\*\*\*] | Rev.<br>1 | Rev.<br>1 | Page:<br>3 of 3 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Preparer's Initials & Date | Reviewer's Initials & Date | Reviewer's Initials & Date | Approvers' Initial & Date: | Approvers' Initial & Date: | Approver's Initials & Date: | Approver's Initials & Date: | Approver's Initials & Date: |

---

<u>[\*\*\*]</u> <u>[\*\*\*]</u> <u>[\*\*\*]</u> <u>[\*\*\*]</u>

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 1 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**[\*\*\*]**

---

| | | |
|:---|:---|:---|
| TEST | Method | Specification |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | ***MonoSol Rx, LLC*** | [\*\*\*] | [\*\*\*] | Rev.<br>1 | Rev.<br>1 | Page:<br>1 of 2 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Author's Initials & Date | Reviewer's Initials & Date | Reviewer's Initials & Date | Approvers' Initial & Date: | Approvers' Initial & Date: | Approver's Initials & Date: | Approver's Initials & Date: | Approver's Initials & Date: |

---

**[\*\*\*]**

---

| | | | |
|:---|:---|:---|:---|
| Test | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>2 of 2 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 1 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**[\*\*\*]**

---

| | | |
|:---|:---|:---|
| TEST | Method | Specification |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | ***MonoSol Rx, LLC*** | [\*\*\*] | [\*\*\*] | Rev.<br>1 | Rev.<br>1 | Page:<br>1 of 2 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Author's Initials & Date | Reviewer's Initials & Date | Reviewer's Initials & Date | Approvers' Initial & Date: | Approvers' Initial & Date: | Approver's Initials & Date: | Approver's Initials & Date: | Approver's Initials & Date: |

---

**[\*\*\*]**

---

| | | | |
|:---|:---|:---|:---|
| Test | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

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| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>2 of 2 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 1 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

---

| | | |
|:---|:---|:---|
| TEST | Method | Specification |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 1 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**[\*\*\*]**

---

| | | | |
|:---|:---|:---|:---|
| Test | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 1 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**[\*\*\*]**

---

| | | | |
|:---|:---|:---|:---|
| Test | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | |
|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>2 | Page:<br>1 of 1 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**[\*\*\*]**

---

| | | |
|:---|:---|:---|
| TEST | Method | Specification |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

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|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

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|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 1 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

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**[\*\*\*]**

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|:---|:---|:---|:---|
| Test | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
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| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

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|:---|:---|:---|:---|:---|
| ***MonoSol Rx, LLC*** | [\*\*\*] | Rev.<br>1 | Page:<br>1 of 1 | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

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**[\*\*\*]**

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| Test | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
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| | | | | |
|:---|:---|:---|:---|:---|
| | Name | Department | Signature | Date |
| Prepared by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Reviewed by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Approved by: | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

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------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 1**

**COMMERCIAL EXPLOITATION AGREEMENT**

**THIS AMENDMENT NO. 1** (this "**Amendment**") is made on the 19<sup>th</sup> day of August, 2009 (the "**Effective Date**") between:

**PARTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;MonoSol Rx, LLC, a company organized and existing under the laws of the USA, with offices at 30 Technology Drive, Warren, New Jersey 07059, USA ("**MSX**"),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Reckitt Benokiser Pharmaceuticals Inc., a company existing under the laws of the USA with offices at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia 23235 ("**RB**").

**WHEREAS,** MSX and RB entered into a Commercial Exploitation Agreement, dated August 15, 2008 (the "**Agreement**"), pursuant to which RB engaged MSX to manufacture and supply the Products on the terms of the Agreement and MSX agreed to manufacture and supply the Products to RB on the terms of the Agreement; and

**WHEREAS,** for valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the<sup>.</sup> parties mutually desire to amend and modify certain terms and conditions of the Agreement as set forth in this Amendment.

**IT IS AGREED** as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.&nbsp;&nbsp;&nbsp;&nbsp;Capitalized terms used In this Amendment without definition shall have the respective meanings ascribed thereto in the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that from the Effective Date through and until March 31, 2010 (the "**Expedited Release Approval Period**"), MSX shall manufacture and supply RB's requirements of the Products for the U.S. in accordance with the SUBOXONE<sup>®</sup> Sublingual Film — Batch Transfer and Batch Release Approval Process (the "**Expedited Release Approval Process**"), a copy of which is annexed hereto as **Schedule B** and made a part hereof. As between MSX and RB, RB shall be solely responsible for ensuring that the Products are not released for commercial distribution by RB or its secondary packager(s) until the prerequisites for release set forth in the Expedited Release Approval Process have been satisfied. RB shall indemnify, defend and hold harmless MSX Parties pursuant to **Clause 10** of the Agreement from any and all Losses that result from or arise in connection with any Claim against any of the MSX Parties to the extent the Claim arises from a release of Product by RB or its secondary packager(s) during the Expedited Release Approval Period in violation of the Expedited Release Approval Process. RB shall accept all shipments of Product subject to the Expedited Release Approval Process. The parties acknowledge and agree that MSX's release of Product under the Expedited Release Approval Process deviates from the release process set forth in the underlying Agreement and Quality Agreement and that, as such, such deviation by MSX shall not constitute a violation of the underlying Agreement or the Quality Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C.&nbsp;&nbsp;&nbsp;&nbsp;This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware, United States of America, save as to conflict of law provisions, and the parties hereby agree to submit to the Jurisdiction of the federal courts located in the State of Delaware.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;D.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly set forth herein, all other terms and provisions of the Agreement shall remain in full force and effect without modification or change.

------

**Signed for and on behalf Reckitt Benckiser Pharmaceuticals Inc.**

---

| |
|:---|
| */s/ Shaun Thaxter* |
| Name: Shaun Thaxter |
| Title: President |
| Date: August 19, 2009 |

---

**Signed for and on behalf of MonoSol Rx, LLC**

---

| |
|:---|
| */s/ Mark Schobel* |
| Name: Mark Schobel |
| Title: CEO |
| Date: August 19, 2009 |

---

------

**SCHEDULE B**

**SUBOXONE® SUBLINGUAL FILM – BATCH TRANSFER AND BATCH APPROVAL PROCESS**

------

**SUBOXONE® SUBLINGUAL FILM — BATCH TRANSFER AND BATCH RELEASE APPROVAL PROCESS**

[\*\*\*]

------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 2**

**COMMERCIAL EXPLOITATION AGREEMENT**

**THIS AMENDMENT NO. 2** (the "**Amendment**") is made effective as of the 13<sup>th</sup> day of November, 2009 (the "**Effective Date**") between:

**PARTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;MonoSol Rx, LLC, a company organized and existing under the laws of the USA, with offices at 30 Technology Drive, Warren, New Jersey 07059, USA ("**MSX**"),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Reckitt Benckiser Pharmaceuticals Inc., a company existing under the laws of the USA with offices at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia 23235 ("**RB**").

**WHEREAS**, MSX and RB entered into a Commercial Exploitation Agreement, dated August 15, 2008, as amended by Amendment No. 1, dated August 19, 2009 (the "**Agreement**"), pursuant to which RB engaged MSX to manufacture and supply the Products on the terms of the Agreement and MSX agreed to manufacture and supply the Products to RB on the terms of the Agreement; and

**WHEREAS**, for valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties mutually desire to amend and modify certain terms and conditions of the Agreement as set forth in this Amendment.

**IT IS AGREED** as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.&nbsp;&nbsp;&nbsp;&nbsp;Capitalized terms used in this Amendment without definition shall have the respective meanings ascribed thereto in the Agreement. This Amendment shall apply solely to Products supplied for sale or other uses in the U.S. and shall not be construed to amend, modify or change the Agreement as it relates to any Products supplied for sale or other uses the ROW, except as otherwise specifically set forth in this Amendment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.&nbsp;&nbsp;&nbsp;&nbsp;The parties acknowledge and agree that, as of the Effective Date, the Price payable by RB to MSX for purchases of Products for the U.S. shall be fixed at USD$[\*\*\*] per pouched single dose Product, subject only to price adjustments pursuant to **Clause 7.3** and **Clause 7.23** of the Agreement (a new provision to the Agreement as set forth in Section K below) (the "**Fixed Purchase Price**"), until the earlier of either: (i) RB's acceptance of the delivery of the [\*\*\*] unit of Product for the U.S., or (ii) January 1, 2011 (the "**Fixed Purchase Price Period**"). The parties further acknowledge and agree that, as of the Effective Date, RB shall not be entitled to receive any Rebate on any Products purchased for the U.S. during the Term pursuant to **Clause 7.22**; however, all of RB's purchases of Products during the Term, including without limitation, RB's purchases of Products for the U.S., shall be included in and counted towards the calculation of RB's aggregate volume purchases of Product in any Year for purposes of determining RB's entitlement to the Rebates on purchases of Products during the Term in the ROW pursuant to **Clause 7.22**. By way of example, if during any one Year, RB purchases [\*\*\*] units of Product for the U.S. and [\*\*\*] units of Product for the ROW, for an aggregate purchase of [\*\*\*] units of Product, RB would be entitled to receive a Rebate of [\*\*\*] U.S. Dollars (USD$[\*\*\*]) per unit of Product for the [\*\*\*] units of Product for the ROW [\*\*\*] on the units of Product for the U.S, By way of further example, if during any one Year, RB purchases [\*\*\*] units of Product for the U.S. and [\*\*\*] units of Product for the ROW, for an aggregate purchase of [\*\*\*] units of Product, RB would be entitled to receive a Rebate of [\*\*\*] U.S. Dollars (USD$[\*\*\*]) per unit of Product for the first [\*\*\*] units of Product for the ROW and a Rebate of [\*\*\*] U.S. Dollars (USD$[\*\*\*]) per unit of Product for the second [\*\*\*] units of Product for the ROW but no Rebate on the units of Product for the U.S.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that the definition of "Cost of Goods Price" under **Clause 1.1** of the **DEFINITIONS** section of the Agreement shall be amended and restated as follows:

------

"**Cost of Goods Price**" shall have the meaning given in **Clause 7.14**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;D.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree to amend the **DEFINITIONS** section of the Agreement to include the definition of "**Quarter Year**" under **Clause 1.1** as set forth below:

"**Quarter Year**" means the three month period ending 31 March, 30 June, 30 September, or 31 December in each calendar year (or such part thereof as the case may be for the initial and final Quarter Year periods under this Agreement).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;E.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that **Clause 2.1** set forth in the **TERM** section of the Agreement shall be amended and restated in its entirety to read as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1&nbsp;&nbsp;&nbsp;&nbsp;This Agreement shall be effective beginning as of the Commencement Date and shall continue, unless earlier terminated by either party in accordance with the provisions of **Clause 17**, for a period of seven (7) years (the "**Initial Term**"). Upon expiration of the Initial Term, this Agreement shall thereafter automatically renew for successive one (1) year periods (each, a "Renewal Term") on a continuous basis, unless and until RB delivers to MSX written notice of RB's intent not to renew the Agreement, which notice must be delivered at least one (1) year prior to the expiration of the Initial Term or of a Renewal Term (the Initial Term, together with any Renewal Terms, are hereinafter collectively referred to as the "**Term**"). In no case shall the Term of this Agreement extend beyond the expiration date of the last to expire of the Patents, without the written consent of both parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;F.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that Clause 6.3 set forth in the **CAPACITY, STOCK LEVELS AND TOOLING** section of the Agreement shall be amended and restated in its entirety to read as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.1&nbsp;&nbsp;&nbsp;&nbsp;MSX represents and warrants that it will have the capacity to fill RB's requirements for the Products set forth in any Order so long as the amount specified in the Order does not exceed [\*\*\*] percent ([\*\*\*]) of the forecasted volume for such period as set out in the previous Forecast (or such other figure as RB and MSX may agree in writing from time to time). In addition to the foregoing, MSX covenants, represents and warrants that it shall take commercially reasonable action to promptly validate and obtain cGMP approval of its [\*\*\*] and [\*\*\*] facilities for the manufacture of the Products at the [\*\*\*] batch size and that, by no later than [\*\*\*] months after the date on which the new drug application for the Products is approved by the FDA (the "**Capacity Increase Deadline**"), MSX will have the capacity to manufacture and supply to RB up to [\*\*\*] units of the Products for the U.S. per Quarter Year [\*\*\*] units of the Products for the U.S. per Year). At RB's reasonable written request, MSX shall provide RB with capacity information to demonstrate that the available capacity meets RB's requirements of Product. MSX shall promptly take commercially reasonable action to address to RB's reasonable satisfaction any capacity issues identified in accordance with this **Clause 6.3** and **Clause 6.6**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.2&nbsp;&nbsp;&nbsp;&nbsp;To ensure RB of Product supply continuity for the U.S. and ROW and in support of an extended shelf-life for the Products, MSX agrees that: (i) upon execution of this Amendment, it shall provide all necessary support to RB in order to expeditiously validate and obtain cGMP approval of an RB-designated third party packaging facility with the capability to package the Products [\*\*\*]; and (ii) in the event that MSX cannot supply RB's requirements for Products in the U.S. and/or ROW because MSX either does not have the capacity or capability to package sufficient Product [\*\*\*] or Product [\*\*\*], as determined by the longest Product shelf-life, to meet RB's requirements, then RB shall have the right to source packaging of the Products from the RB-designated third party packager but only until such time as MSX is able to meet RB's requirements for Products; and (iii) further to subsection (ii) of this **Clause 6.32**, MSX will supply to RB such quantities of unpackaged Product (i.e., the finished substrate) in bulk rolls, as needed by RB (within the capacity limits set forth in the Agreement), to meet RB's requirements for Product in accordance with the terms of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;G.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that **Clause 7.4.1** set forth in the **PRICE AND PAYMENT** section of the Agreement shall be amended and restated in its entirety to read as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] percent ([\*\*\*]%) of the Net Sales Value of the Products sold during the Term in the U.S. per Year up to a not to exceed amount of [\*\*\*] U.S. Dollars (USD$[\*\*\*]) per Year. Once the aggregate Royalties paid by RB to MSX with respect to Products sold in the U.S., inclusive of the Royalty prepayment pursuant to **Clause 7.18** and the advance on Royalties pursuant to **Clause 7.24**, equal [\*\*\*] U.S. Dollars (USD$[\*\*\*]), RB's

------

obligation to pay any further Royalties to MSX with respect to Products sold in the U.S. shall immediately and permanently cease; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;H.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that Clause 7.5.2 set forth in the **PRICE AND PAYMENT** section of the Agreement shall be amended and restated in its entirety to read as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.5.2&nbsp;&nbsp;&nbsp;&nbsp;The aggregate Royalties paid by RB to MSX with respect to Products sold in the U.S., inclusive of the Royalty prepayment pursuant to **Clause 7.18** and the advance on Royalties pursuant to **Clause 7.24**, reaching the amount of [\*\*\*] U.S. Dollars (USD$[\*\*\*]).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;I.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that **Clause 7.7** set forth in the **PRICE AND PAYMENT** section of the Agreement shall be amended to delete: (i) the reference to **Clause 7.4.1** in the first sentence, (ii) **Clause 7.7.1** in its entirety, and (iii) the last two sentences of **Clause 7.7** and replace these sentences with the following provision: "Upon making payment to MSX of the amounts stated in **Clause 7.7.2** the obligations to pay Royalties to MSX in respect of the ROW will immediately cease."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;J.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that Clause 7.16 set forth in the PRICE AND PAYMENT section of the Agreement shall be amended and restated in its entirety to read as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.16&nbsp;&nbsp;&nbsp;&nbsp;Invoices shall be paid in accordance with the following payment schedule:

7.16.1&nbsp;&nbsp;&nbsp;&nbsp;RB shall pay invoices in respect of the Cost of Goods Price for the U.S., together with any other invoices submitted to it pursuant to this Agreement for the U.S. prior to the expiry of the 2010 Year, within [\*\*\*] of receipt by RB from MSX of a valid invoice therefore (reflecting applicable sales tax, if any). RB shall thereafter pay invoices in respect of the Cost of Goods Price for the U.S., together with any other invoices submitted to it pursuant to this Agreement for the U.S. for the remainder of the Term, within [\*\*\*] of receipt by RB from MSX of a valid invoice therefore (reflecting applicable sales tax, if any); *provided, however*, that, commencing after the Price reduction in respect of the U.S. pursuant to Clause 7.23 below takes effect, RB shall thereafter pay for the remainder of the Term such invoices within [\*\*\*] of receipt by RB from MSX of a valid invoice therefore (reflecting applicable sales tax, if any).

7.16.2&nbsp;&nbsp;&nbsp;&nbsp;RB shall pay invoices in respect of the Cost of Goods Price for the ROW, together with any other invoices submitted to it pursuant to this Agreement for the ROW, within [\*\*\*] of receipt by RB from MSX of a valid invoice therefore (reflecting applicable sales tax, if any).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;K.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that **Clause 7.18** set forth in the **PRICE AND PAYMENT** section of the Agreement shall be amended and restated in its entirety to read as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.18&nbsp;&nbsp;&nbsp;&nbsp;RB shall pay the Royalty for Products (if any) pursuant to **Clause 7.4.1** within [\*\*\*] of the expiry of the Quarter Year period in which the relevant Royalties are chargeable. Once the aggregate Royalties paid by RB to MSX with respect to Products sold in the U.S., inclusive of the advance on Royalties pursuant to **Clause 7.24**, equal [\*\*\*] U.S. Dollars (USD$[\*\*\*]), RB shall, within [\*\*\*] days, prepay to MSX [\*\*\*] U.S. Dollars (USD$[\*\*\*]) on a non-refundable basis, which prepayment shall be credited by MSX against future Royalties payable by RB for Products sold in the U.S. Upon making the prepayment of [\*\*\*] U.S. Dollars (USD$[\*\*\*]) to MSX, RB's obligation to pay any further Royalties to MSX with respect to Products sold in the U.S. shall immediately and permanently cease. RB shall pay the royalty for Products (if any) pursuant to **Clause 7.4.2** within [\*\*\*] of the expiry of the Half Year period in which the relevant Royalties are chargeable. Each Royalty payment shall be accompanied by a statement detailing the calculation of Royalties due to MSX, including, without limitation, the amount of Products sold and the corresponding Royalty amount.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;L.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that the **PRICE AND PAYMENT** section of the Agreement shall be amended to include a new **Clause 7.23**, which shall be set forth as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.23&nbsp;&nbsp;&nbsp;&nbsp;Upon the payment by RB to MSX of [\*\*\*] U.S. Dollars (USD$[\*\*\*]) of Royalties for the U.S. (including the prepayment of Royalties pursuant to **Clause 7.18**), the then current Price payable by RB to MSX for purchases of Products in the U.S. shall automatically and immediately be reduced by [\*\*\*] percent ([\*\*\*]%) and this reduced Price shall thereafter remain in effect for a period of one (1) year before it is subject to adjustment pursuant to the terms of the Agreement.

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;M.&nbsp;&nbsp;&nbsp;&nbsp;the parties hereby agree that the **PRICE AND PAYMENT** section of the Agreement shall be amended to include a new **Clause 7.24**, which shall be set forth as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.24&nbsp;&nbsp;&nbsp;&nbsp;RB agrees to pay MSX an advance of [\*\*\*] U.S. Dollars (USD$[\*\*\*]) on the Royalties payable to MSX pursuant to **Clause 7.4.1** upon receiving approval of its new drug application (NDA) for the Products from the FDA. MSX hereby agrees that RB shall be entitled to receive interest on this advance in the amount of [\*\*\*] percent ([\*\*\*]%) per annum and that the total amount of the advance, plus accumulated interest, shall be credited against the Royalties payable by RB to MSX pursuant to **Clause 7.4.1**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;N.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly set forth herein, all other terms and provisions of the Agreement shall remain in full force and effect without modification or change. This Amendment shall be made a part of, and incorporated by reference into, the Agreement and shall be subject to the terms and provisions thereof, except as expressly set forth herein.

**Signed for and on behalf Reckitt Benckiser Pharmaceuticals Inc.**

---

| |
|:---|
| */s/ Shaun Thaxter* |
| Name: Shaun Thaxter |
| Title: President |
| Date: November 13, 2009 |

---

**Signed for and on behalf of MonoSol Rx, LLC**

---

| |
|:---|
| */s/ Mark Schobel* |
| Name: Mark Schobel |
| Title: CEO |
| Date: November 13, 2009 |

---

------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 3**

**COMMERCIAL EXPLOITATION AGREEMENT**

**THIS AMENDMENT NO. 3** (this "**Amendment**") is made on the 30th day of March 2010 (the "**Effective Date**") between:

**PARTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;MonoSol Rx, LLC, a company organized and existing under the laws of the USA, with offices at 30 Technology Drive, Warren, New Jersey 07059, USA ("**MSX**"),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Reckitt Benckiser Pharmaceuticals Inc., a company existing under the laws of the USA with offices at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia 23235 ("**RS**").

**WHEREAS**, MSX and RB entered into a Commercial Exploitation Agreement, dated August 15, 2008 (the "**Agreement"**), pursuant to which RB engaged MSX to manufacture and supply the Products on the terms of the Agreement and MSX agreed to manufacture and supply the Products to RB on the terms of the Agreement; and

**WHEREAS**, for valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties mutually desire to amend and modify certain terms and conditions of the Agreement as set forth in this Amendment.

**IT IS AGREED** as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.&nbsp;&nbsp;&nbsp;&nbsp;Capitalized terms used in this Amendment without definition shall have the respective meanings ascribed thereto in the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that from the Effective Date through and until May 31, 2010 (the "**Expedited Release Approval Period**"), MSX shall manufacture and supply RB's requirements of the Products for the U.S. in accordance with the SUBOXONE® Sublingual Film — Batch Transfer and Batch Release Approval Process (the "**Expedited Release Approval Process**"), a copy of which is annexed hereto as **Schedule B** and made a part hereof. As between MSX and RB, RB shall be solely responsible for ensuring that the Products are not released for commercial distribution by RB or its secondary packager(s) until the prerequisites for release set forth in the Expedited Release Approval Process have been satisfied. . RB shall indemnify, defend and hold harmless MSX Parties pursuant to **Clause 10** of the Agreement from any and all Losses that result from or arise in connection with any Claim against any of the MSX Parties to the extent the Claim arises from a release of Product by RB or its secondary packager(s) during the Expedited Release Approval Period in violation of the Expedited Release Approval Process. RB shall accept all shipments of Product subject to the Expedited Release Approval Process. The parties acknowledge and agree that MSX's release of Product under the Expedited Release Approval Process deviates from the release process set forth in the underlying Agreement and Quality Agreement and that, as such, such deviation by MSX shall not constitute a violation of the underlying Agreement or the Quality Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C.&nbsp;&nbsp;&nbsp;&nbsp;This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware, United States of America, save as to conflict of law provisions, and the parties hereby agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;D.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly set forth herein, all other terms and provisions of the Agreement shall remain in full force and effect without modification or change.

------

**Signed for and on behalf Reckitt Benckiser Pharmaceuticals Inc.**

---

| |
|:---|
| */s/ Shaun Thaxter* |
| Name: Shaun Thaxter |
| Title: President |
| Date: March 30, 2010 |

---

**Signed for and on behalf of MonoSol Rx, LLC**

---

| |
|:---|
| */s/ Mark Schobel* |
| Name: Mark Schobel |
| Title: CEO |
| Date: March 30, 2010 |

---

------

**SCHEDULE B**

**SUBOXONE® SUBLINGUAL FILM – BATCH TRANSFER AND BATCH APPROVAL PROCESS**

**[\*\*\*]**

------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 4**

**COMMERCIAL EXPLOITATION AGREEMENT**

**THIS AMENDMENT NO. 4** (this "**Amendment**") is made on the 13th day of October 2010 (the "**Effective Date**") between:

**PARTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;MonoSol Rx, LLC, a company organized and existing under the laws of the USA, with offices at 30 Technology Drive, Warren, New Jersey 07059, USA ("**MSX**"),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Reckitt Benckiser Pharmaceuticals Inc., a company existing under the laws of the USA with offices at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia 23235 ("**RB**").

**WHEREAS**, MSX and RB entered into a Commercial Exploitation Agreement, dated August 15, 2008 as amended by Amendment No, 1 thereto on August 19, 2009, Amendment No. 2 thereto on November 13, 2009, and Amendment No. 3 thereto on March 30, 2010 (collectively, the "**Agreement'**), pursuant to which RB engaged MSX to manufacture and supply the Products on the terms of the Agreement and MSX agreed to manufacture and supply the Products to RB on the terms of the Agreement; and

**WHEREAS**, for valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties mutually desire to amend and modify certain terms and conditions of the Agreement as set forth in this Amendment.

**IT IS AGREED** as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.&nbsp;&nbsp;&nbsp;&nbsp;Capitalized terms used in this Amendment without definition shall have the respective meanings ascribed thereto in the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that from the Effective Date through and until December 31, 2010 (the "**Expedited Release Approval Period**"), MSX shall manufacture and supply RB's requirements of the Products for the U.S. in accordance with the SUBOXONE4 Sublingual Film — Batch Transfer and Batch Release Approval Process (the "**Expedited Release Approval Process**"), a copy of which is annexed hereto as **Schedule B** and made a part hereof. As between MSX and RB, RB shall be solely responsible for ensuring that the Products are not released for commercial distribution by RB or its secondary packager(s) until the prerequisites for release set forth in the Expedited Release Approval Process have been satisfied. RB shall indemnify, defend and hold harmless MSX Parties pursuant to **Clause 10** of the Agreement from any and all Losses that result from or arise in connection with any Claim against any of the MSX Parties to the extent the Claim arises from a release of Product by RB or its secondary packager(s) during the Expedited Release Approval Period in violation of the Expedited Release Approval Process. RB shall accept all shipments of Product subject to the Expedited Release Approval Process. The parties acknowledge and agree that MSX's release of Product under the Expedited Release Approval Process deviates from the release process set forth in the underlying Agreement and Quality Agreement and that, as such, such deviation by MSX shall not constitute a violation of the underlying Agreement or the Quality Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C.&nbsp;&nbsp;&nbsp;&nbsp;This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware, United States of America, save as to conflict of law provisions, and the parties hereby agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;D.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly set forth herein, all other terms and provisions of the Agreement shall remain in full force and effect without modification or change.

------

**Signed for and on behalf Reckitt Benckiser Pharmaceuticals Inc.**

---

| |
|:---|
| */s/ Shaun Thaxter* |
| Name: Shaun Thaxter |
| Title: President |
| Date: 10/18/10 |

---

**Signed for and on behalf of MonoSol Rx, LLC**

---

| |
|:---|
| */s/ Mark Schobel* |
| Name: Mark Schobel |
| Title: CEO |
| Date: 10/19/10 |

---

------

**SCHEDULE B**

**SUBOXONE® SUBLINGUAL FILM – BATCH TRANSFER AND BATCH APPROVAL PROCESS**

**[\*\*\*]**

------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 5**

**COMMERCIAL EXPLOITATION AGREEMENT**

**THIS AMENDMENT NO. 5** (this "**Amendment**") is made on the 15th day of December 2010 (the "**Effective Date**") between:

**PARTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;MonoSol Rx, LLC, a company organized and existing under the laws of the USA, with offices at 30 Technology Drive, Warren, New Jersey 07059, USA ("**MSX**"),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Reckitt Benckiser Pharmaceuticals Inc., a company existing under the laws of the USA With office's at 10710 Midlothian Turnpike, Suite 430, ROMEO, Virginia 23235 ("**RB**").

**WHEREAS**, MSX and RB entered into A Commercial Exploitation Agreement, dated August 15, 2005 as amended by Amendment No. 1 thereto do August 19, 2009, Amendment No, 2 thereto on November 13, 2009, Amendment No, 3 thereto on March 30, 2010, and Amendment No. 4 thereto on October 13, 2010 (collectively the "**Agreement**"), pursuant to which RB engaged MSX to manufacture and supply the Products on the terms of the Agreement and MSX agreed to manufacture and supply the Products to RB on the terms of the Agreement; and

**WHEREAS**, for valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties mutually desire to amend and modify certain terms and conditions of the Agreement as set forth in this Amendment.

**IT TS AGREED** as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.&nbsp;&nbsp;&nbsp;&nbsp;Capitalized terms used In. this Amendment without definition Shell have the respective meanings ascribed thereto in the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that **Clause 7.16** set forth in the **PRICE AND PAYMENT** section of the Amendment No. 2 dated November 13, 2009 shall be amended and restated in its entirety to read as follows;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.16&nbsp;&nbsp;&nbsp;&nbsp;Invoices shall be paid in accordance with the following payment schedule:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.16.1&nbsp;&nbsp;&nbsp;&nbsp;RB shall pay Invoices in reaped of the Cost of Goods Price for the U.S., together with any other invoices submitted to it pursuant to this Agreement for the U.S. prior to the expiry of the 2010 Year, within [\*\*\*] of receipt by RB from MSX of a valid invoice therefore (reflecting applicable sales tax, if any). RB shall pay invoices in respect of the Cost of Goods Price for the U.S., together with any other invoices submitted to it pursuant to this Agreement for the U.S. from January 1, 2011 to March 31, 2011, within [\*\*\*] of receipt by RB from MSX of a valid invoice therefore (reflecting applicable safes tax, if any). RB shall thereafter pay invoices, in respect of the Cost of Goods Price for the U.S., together with, any other invoices submitted to pursuant to this Agreement for the U.S. for the remainder-of the Term, within [\*\*\*] of receipt by RB from MSX of a valid invoice therefore (reflecting applicable sales tax, if any) provided, however, that, commencing after the Price reduction in respect of the U.S. pursuant to Clause 7:23 of the Amendment No. 2 dated November 13, 2002 takes effect, RB shall thereafter pay for the remainder of the Term such invoices [\*\*\*] days of receipt by RB from MSX of a valid invoice therefore (reflecting applicable sales tax, if any).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.16.2&nbsp;&nbsp;&nbsp;&nbsp;RB shall pay invoices in respect of the Cost of Goods Price for the ROW, together with any other invoices submitted to if pursuant to this Agreement for the ROW, within [\*\*\*] of receipt by RB from MSX of a valid invoice therefore (reflecting applicable sales fax, if any).

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C.&nbsp;&nbsp;&nbsp;&nbsp;This Amendment shall be governed by and construed In accordance with the laws of the State of Delaware, United States of America, save as to conflict of law provisions, and the parties hereby agree to submit to the jurisdiction of the federal courts located In the State of Delaware.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;D.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly set forth herein, all other terms and provisions the Agreement shall remain in full force and effect without modification or change.

**Signed for and on behalf Reckitt Benckiser Pharmaceuticals Inc.**

---

| |
|:---|
| */s/ Shaun Thaxter* |
| Name: Shaun Thaxter |
| Title: President |
| Date: 12/16/10 |

---

**Signed for and on behalf of MonoSol Rx, LLC**

---

| |
|:---|
| */s/ Mark Schobel* |
| Name: Mark Schobel |
| Title: CEO |
| Date: 12/16/2010 |

---

------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 6**

**COMMERCIAL EXPLOITATION AGREEMENT**

**THIS AMENDMENT NO. 6** (this "**Amendment**") is made on the 9th day of December 2011 (the "**Effective Date**") between:

PARTIES

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;MonoSol Rx, LLC, a company organized and existing under the laws of the USA, with offices at 30 Technology Drive, Warren, New Jersey 07059, USA ("**MSX**"),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Reckitt Benckiser Pharmaceuticals Inc., a company existing under the laws of the USA with offices at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia 23235 ("**RB**").

**WHEREAS**, MSX and RB entered into a Commercial Exploitation Agreement, dated August 15, 2008, as amended (collectively, the "**Agreement**"), pursuant to which RB engaged MSX to manufacture and supply the Products on the terms of the Agreement and MSX agreed to manufacture and supply the Products to RB on the terms of the Agreement; and

**WHEREAS**, MSX currently maintains an existing packaging line pursuant to which MSX currently packages the Products at MSX's [\*\*\*] facility (the "**[\*\*\*] Packaging Line**"); and

**WHEREAS**, MSX has acquired a second packaging line more particularly described in <u>Schedule 1</u> to this Amendment (the "**[\*\*\*] Packaging Line**") from [\*\*\*] for use at MSX's [\*\*\*] facility for which capital investment is required to upgrade the [\*\*\*] facility, install the [\*\*\*] Packaging Line and validate the packaging of the Products on the [\*\*\*] Packaging Line to cGMP requirements; and

**WHEREAS**, RB has agreed to contribute towards such further capital investment in the [\*\*\*] Packaging Line in exchange for, *inter alia*, certain guarantees with respect to MSX's capacity to fill RB's requirements for the Products on the terms herein set forth;

**WHEREAS**, for valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties mutually desire to supplement, amend and/or modify certain terms and conditions of the Agreement as set forth in this Amendment.

**IT IS AGREED** as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.&nbsp;&nbsp;&nbsp;&nbsp;Capitalized terms used in this Amendment without definition shall have the respective meanings ascribed thereto in the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.&nbsp;&nbsp;&nbsp;&nbsp;RB shall provide up to [\*\*\*] US Dollars ($[\*\*\*]) in funding for the required build-out of the [\*\*\*] facility and installation of the [\*\*\*] Packaging Line (the "**Funding**"). The cost estimates for such build-out and installation are set forth on **Schedule 1** to this Amendment and are derived from that certain engineering study dated October 27, 2010 issued by [\*\*\*]. The Funding shall be made by RB to MSX in immediately available funds to an account designated by MSX as follows:

[\*\*\*]% to be paid on January 10, 2012;

[\*\*\*]% upon the achievement of certain milestones related to the build-out of the [\*\*\*] facility and installation of the [\*\*\*] Packaging Line, which milestones shall be agreed to by the parties in writing subsequent to the execution of this Amendment; and

------

The balance of the project costs incurred by MSX, not to exceed [\*\*\*]% of the total Funding, upon completion of the build-out and installation of the [\*\*\*] Packaging Line and receipt of all FDA approvals needed for commercial packaging of the Products to cGMP requirements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C.&nbsp;&nbsp;&nbsp;&nbsp;RB and MSX shall agree upon key suite build-out features of the [\*\*\*] Packaging Line and RB shall have the right to approve the cGMP suite build-out and the installation plans relating thereto, such approval not to be unreasonably withheld, delayed or conditioned. Selection of and negotiations with engineering and construction providers shall be undertaken jointly by MSX and RB; provided that, MSX shall have final approval rights with respect to the retention of any engineering and construction providers within the scope of the cost estimates referred to in paragraph B. of this Amendment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;D.&nbsp;&nbsp;&nbsp;&nbsp;RB and MSX mutually agree that certain activities related to the build-out of the [\*\*\*] facility and installation of the [\*\*\*] Packaging Line, including, but not limited to, engineering support, process work and qualification, may be performed more efficiently by MSX resources and that if such efficiencies can quantified, then the activities should be performed by MSX resources and reimbursed by RB as part of the Funding; provided, however, that the final decision on entitlement for reimbursement shall be at RB's discretion and that the performance of such activities by MSX resources follows certain agreed principles, including, but not limited to, the following:

-&nbsp;&nbsp;&nbsp;&nbsp;Said activities, if performed by MSX employees, would not be part of their normal duties or responsibilities, hence not part of MSX fixed costs;

-&nbsp;&nbsp;&nbsp;&nbsp;MSX can quantify that said activities would be performed more efficiently if carried out by MSX resources; and

-&nbsp;&nbsp;&nbsp;&nbsp;Said activities could be done by duly qualified temporary workers hired by MSX.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;E.&nbsp;&nbsp;&nbsp;&nbsp;In exchange for RB's contribution of the Funding: (i) MSX will increase its current annual capacity commitment under Clause 6.3 of the Agreement from [\*\*\*] units of the Products for the U.S. per Quarter Year (*i.e.*, [\*\*\*] units of the Products for the U.S. per Year) to [\*\*\*] units of the Products for the U.S. and ROW combined per Quarter Year (i.e., [\*\*\*] units of the Products for the U.S. and ROW combined per Year), with the intent of the parties being to utilize the [\*\*\*] Packaging Line as the primary line such that the majority of units of the Products shall be packaged on the [\*\*\*] Packaging Line; and (ii) MSX agrees to undertake commercially reasonable efforts to support peaks in demand of Product of up to [\*\*\*] units of Products per month.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;F.&nbsp;&nbsp;&nbsp;&nbsp;MSX shall have the right to use excess capacity on the [\*\*\*] Packaging Line for the packaging of other products for its other customers; provided, however, that RB's production requirements and service levels are not impacted. With respect to the [\*\*\*] Packaging Line only, any capacity utilized by MSX for the packaging of other commercial products shall be subject to the payment by MSX to RB of a fee of $[\*\*\*] per unit of packaged product, subject to the total fees receivable by RB shall not exceed the amount of Funding provided by RB hereunder. For the sake of clarity, MSX shall not be subject to the per unit fee for non-commercial usage of the [\*\*\*] Packaging Line.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;G.&nbsp;&nbsp;&nbsp;&nbsp;In the event of a business interruption impacting the [\*\*\*] Packaging Line, MSX hereby agrees to utilize the [\*\*\*] Packaging Line line as a contingency / business continuity solution, subject to MSX's other commercial commitments, for quantities of Product of up to [\*\*\*] units for U.S. and ROW per Year. In the event of a business interruption impacting the [\*\*\*] Packaging Line, MSX hereby agrees to utilize the [\*\*\*] Packaging Line as a contingency / business continuity solution, subject to MSX's other commercial commitments, for quantities of Product of up to [\*\*\*] units for U.S. and ROW per Year.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;H.&nbsp;&nbsp;&nbsp;&nbsp;From and after the date of this Amendment, other than as set forth In this paragraph H, RB shall place Orders for Product as: (i) [\*\*\*] batch sizes; and (ii) a maximum of [\*\*\*] SKU changeovers per batch or a maximum of [\*\*\*] SKUs per batch (the "**Ordering Criteria**"). The parties shall create a joint project team to develop and have in place the most cost-effective solution of packaging small runs by March 31, 2013.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;I.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that **Clause 7.3.2** set forth in the **PRICE AND PAYMENT** section of the Agreement shall be amended and restated in its entirety to read as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In the event that any Order requests more than [\*\*\*] packaging for the Products covered by such Order, RB shall pay a [\*\*\*] amount for each additional packaging request in an amount of [\*\*\*] Dollars (USD $[\*\*\*]), regardless of the number of units of Product covered by such new packaging request (the "**Packaging Fee**").

------

RB and MSX will review the documented costs for additional packaging ("**Changeover Costs**") on an annual basis and increase or decrease the Packaging Fee based on the annual increase or decrease in Changeover Costs. For Orders containing SKU runs of [\*\*\*] doses or less RB will pay the actual documented Changeover Costs by run as provided by MSX, which actual documented Changeover Costs are expected to be [\*\*\*] Dollars (USD $[\*\*\*])) or less.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;J.&nbsp;&nbsp;&nbsp;&nbsp;Consistent with **Section 7.12** of the Agreement, MSX will, together with RB, examine the costs associated with the [\*\*\*] Packaging Line on annual basis to determine if Product cost reductions are commercially reasonable based upon equipment or environmental improvements; provided, however, that such obligation on the part of MSX shall cease if and when the payments made by MSX to RB equal the full amount of the Funding provide by RB hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;K.&nbsp;&nbsp;&nbsp;&nbsp;MSX may buy out its obligations under paragraph E to utilize the [\*\*\*] Packaging Line as the primary line at any point within [\*\*\*] years of the Effective Date of the Amendment in return for payment to RB of an amount equal to the amount of Funding provided by RB hereunder net of any payments made by MSX to RB in respect to paragraph F. On the [\*\*\*] anniversary of the Effective Date of the Amendment, MSX's obligation to utilize the [\*\*\*] Packaging Line as the primary line will cease.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;L.&nbsp;&nbsp;&nbsp;&nbsp;This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware, United States of America, save as to conflict of law provisions, and the parties hereby agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;M.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly set forth herein, all other terms and provisions of the Agreement shall remain in full force and effect without modification or change.

**Signed for and on behalf Reckitt Benckiser Pharmaceuticals Inc.**

---

| |
|:---|
| */s/ Shaun Thaxter* |
| Name: Shaun Thaxter |
| Title: President |
| Date: December 9, 2011 |

---

**Signed for and on behalf of MonoSol Rx, LLC**

---

| |
|:---|
| */s/ Keith Kendall* |
| Name: Keith Kendall |
| Title: COO |
| Date: 12/9/01 |

---

------

**SCHEDULE 1**

[\*\*\*]

------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 7**

**COMMERCIAL EXPLOITATION AGREEMENT**

**THIS AMENDMENT NO. 7** (this "**Amendment**") is made on the 1<sup>st</sup> day of December 2012 (the "**Amendment Effective Date**") between:

**PARTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;MonoSol Rx, LLC, a company organized and existing under the laws of the USA, with offices at 30 Technology Drive, Warren, New Jersey 07059, USA ("**MSX**"),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Reckitt Benckiser Pharmaceuticals Inc., a company existing under the laws of the USA with offices at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia 23235 ("**RB**").

**WHEREAS**, MSX and RB entered into a Commercial Exploitation Agreement, dated August 15, 2008, as amended (collectively, the "**Agreement**"), pursuant to which RB engaged MSX to manufacture and supply the Products on the terms of the Agreement and MSX agreed to manufacture and supply the Products to RB on the terms of the Agreement; and

**WHEREAS**, for valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties mutually desire to amend and modify certain terms and conditions of the Agreement as set forth in this Amendment.

**IT IS AGREED** as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.&nbsp;&nbsp;&nbsp;&nbsp;Capitalized terms used in this Amendment without definition shall have the respective meanings ascribed thereto in the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.&nbsp;&nbsp;&nbsp;&nbsp;From and after the Amendment Effective Date, an additional formulation of Product is hereby added to <u>Schedule 3</u> of the Agreement as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

• 4 mg Buprenorphrine + 1 mg Naloxone

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C.&nbsp;&nbsp;&nbsp;&nbsp;The Cost of Goods Price for the 2012 and 2013 Years of manufacture per pouched single dose of Product for the following dosage strengths will be as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

---

| | |
|:---|:---|
| • 4 mg Buprenorphine + 1 mg Naloxone (US) | $[\*\*\*] |
| • 4 mg Buprenorphine + 1 mg Naloxone (ROW) | $[\*\*\*] |
| • 12 mg Buprenorphine + 3 mg Naloxone (US) | $[\*\*\*] |
| • 12 mg Buprenorphine + 3 mg Naloxone (ROW) | $[\*\*\*] |

---

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;D.&nbsp;&nbsp;&nbsp;&nbsp;The Cost of Goods Price per pouched single dose of Product for the 2013 Year of manufacture for the following dosage strengths will be as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

---

| | |
|:---|:---|
| • 2 mg Buprenorphine + 0.5 mg Naloxone (US) | $[\*\*\*] |
| • 2 mg Buprenorphine + 0.5 mg Naloxone (ROW) | $[\*\*\*] |
| • 8 mg Buprenorphine + 2 mg Naloxone (US) | $[\*\*\*] |
| • 8 mg Buprenorphine + 2 mg Naloxone (ROW) | $[\*\*\*] |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;E.&nbsp;&nbsp;&nbsp;&nbsp;As of the Amendment Effective Date, MSX will conduct a representative batch sampling of no less than [\*\*\*] doses per batch and no more than [\*\*\*] doses per batch of 8 mg Buprenorphine + 2 mg Naloxone and 12 mg Buprenorphine + 3 mg Naloxone for each such batch commenced on or after the Amendment Effective Date. The batch sampling quantities may be adjusted by written agreement from both parties. [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;F.&nbsp;&nbsp;&nbsp;&nbsp;For the 12 mg Buprenorphine + 3 mg Naloxone Product, MSX will warehouse Product until RB has provided MSX written instructions either to ship the Product or have the Product destroyed ("**Disposition Instructions**"). RB shall provide the Disposition Instructions to MSX within ten (10) business days after receipt by RB of the Summary Findings from the Visual Sampling unless RB has commercially reasonable questions on a given batch or seeks further clarification on existing data from a particular batch in order to aid RB in making a decision in which case MSX will make available an appropriate level of management to respond to RB. If RB does not provide the required Disposition Instructions within ten (10) business days of MSX having provided responses to commercially reasonable inquiries made by RB, then RB will have the subject batch shipped to a third party of RB's choosing for further warehousing (such Product, "**12 mg Warehoused Product**"). The Order for a batch will be fulfilled per Section 5.1 of the Agreement and legal title shall pass to RB per Section 5.7 of the Agreement upon MSX providing a Certificate of Analysis to RB. MSX will invoice RB upon providing a Certificate of Analysis to RB and RB shall pay the full batch Price plus associated Sampling Charges for all 12 mg Buprenorphine + 3 mg Naloxone Product with a Certificate of Analysis in accordance with the terms of the Agreement regardless of the associated Disposition Instructions. In the event that RB subsequently elects to have the 12 mg Warehoused Product destroyed, RB shall cause the Product to be shipped (at RB's cost) to MSX along with instructions to destroy the Product and MSX shall destroy the Product (at MSX's cost). Notwithstanding the foregoing, each shipment of Product (including 12 mg Warehoused Product) delivered by MSX shall comply with **Clause 5.3** of the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;G.&nbsp;&nbsp;&nbsp;&nbsp;For the 8 mg Buprenorphine + 2 mg Naloxone Product, MSX will warehouse Product until the summary findings from the Visual Sampling have been provided to RB. For batches with a **Visual Sampling Level** [\*\*\*] of [\*\*\*]% or less, MSX will ship Product per **Clause 5.1** of the Agreement and RB shall pay for all Product with a Certificate of Analysis. MSX will warehouse 8 mg Buprenorphine + 2 mg Naloxone Product for an additional ten (10) business days where the Visual Sampling Level for a batch exceeds [\*\*\*]%. RB shall provide MSX with Disposition Instructions within said ten (10) business day period unless RB submits to MSX commercially reasonable questions on a given batch or seeks further clarification on existing data from a particular batch in order to aid RB in making a decision, in which case MSX will make available an appropriate level of management to answer commercially reasonable questions on a given batch or provide further clarification on existing data from a particular batch in order to aid RB in making a decision. RB shall provide the required Disposition Instructions to MSX within five (5) business days of MSX having provided responses to commercially reasonable inquiries made by RB during the ten (10) business day period referenced in the immediately preceding sentence. If the Disposition Instructions provided to MSX require destruction of the Product, then MSX shall dispose of the subject batch and the parties respective liability for costs associated with the destroyed batch shall be as set forth below:

---

| | |
|:---|:---|
| **[**\*\*\***]** | **[**\*\*\***]** |
| [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] |

---

Responsibility for costs associated with destroyed batches with Visual Sampling Level above [\*\*\*]% which are in process as of the Amendment Effective Date shall be as follows: (i) for batch [\*\*\*] (produced in July) MSX shall be responsible for all MSX costs and all API costs shall be the responsibility of RB; (ii) for batch [\*\*\*] (presently warehoused at [\*\*\*]) RB shall accept the batch; (iii) for batch [\*\*\*] MSX shall be responsible for all MSX costs and all

------

API costs shall he split equally by MSX and RB; and (iv) all other remaining in process batches will be subject to this Amendment.

If the Disposition Instructions provided to MSX require shipment of the Product, then MSX will ship Product per **Clause 5.1** of the Agreement and RB shall pay for all Product with a Certificate of Analysis. Notwithstanding the foregoing, each shipment of Product (including 8 mg Warehoused Product) delivered by MSX shall comply with **Clause 5.3** of the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;H.&nbsp;&nbsp;&nbsp;&nbsp;Both parties acknowledge and agree that nothing in this Amendment relieves either party of its responsibilities to undertake commercially reasonable efforts to continuously improve the Products. Accordingly, the parties agree to establish and convene a joint technical team (the "**JTT**") consisting of members from each party who have the requisite expertise to analyze manufacturing and Product data, customer complaints on an ongoing basis, and utilize the Annual Product Review Process to continuously improve the Products. The parties hereby further agree that the JTT will meet on a quarterly basis and the first meeting of the JTT shall be convened within thirty (30) days of the Amendment Effective Date. MSX agrees to work diligently and in good faith, through the JTT, to improve the manufacturing process and quality of the Product output on [\*\*\*] of the production line. The JTT shall also work in good faith to evaluate the merits and feasibility of a robust Product reformulation and shall work in good faith to agree upon a commercially viable plan for such Product reformulation. The JTT may also, from time-to—time, with both parties written approval, develop other specific and limited projects to improve the overall quality of the existing Product or manufacturing process.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;I.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that **Clause 3.4.3** set forth in the **MANUFACTURE AND SUPPLY** section of the Agreement shall be amended and restated in its entirety to read as follows:

monitor, account for and keep RB regularly informed of the usage and waste of API. MSX will act reasonably to ensure maintenance of an overall yield percentage (the "**Yield Target**"), defined as the actual strips produced before samples divided by the theoretical strips available based on the amount of defect free API used in manufacturing. For the avoidance of doubt, this includes any API dispensed and/or used for commercial production regardless of whether film strips were yielded from said use but excluding API associated with batches destroyed based on Visual Sampling data. The parties will work in good faith to identify commercially reasonable Yield Targets for dosage strengths, batch sizes, and SKU configurations within ninety (90) days of the Amendment Effective Date. On an annual basis, MSX and RB will review and reconcile results against the Yield Target and MSX will, within thirty (30) days, remunerate RB for RB's documented API costs on an annual basis to the extent MSX falls below the Yield Target. For the sake of clarity, the formula for calculating API costs owed will be Yield Target minus the actual yield times the API costs. The parties hereby agree that **Clause 3.4.3** of the Agreement represents the sole mechanism for MSX reimbursement of API to RB associated with manufacturing usage and waste.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;J.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that **Clause 4.6** set forth in the **FORECASTS, ORDERS AND SUPPLY OF THE API** section of the Agreement shall be amended and restated in its entirety to read as follows:

Notwithstanding the terms of any DDP delivery (or any other delivery) of the API by RB to MSX, legal title to the API shall remain with RB after delivery to MSX. MSX shall use reasonable efforts to ensure proper storage and handling of the API once delivered to MSX and prior to manufacturing. Risk of damage to, or loss of, the API shall pass from RB to MSX upon delivery as set out in **Clause 4.3**. MSX shall retain casualty insurance coverage for the expected inventory of the API (amounts expected to be supplied to MSX by RB for manufacture of the Product in the amounts set forth in the Forecasts) to cover damage to or loss of the API during storage for so long as the API remains at MSX's risk. For the sake of clarity, the responsibilities of the parties with respect to usage and waste of API during manufacturing is covered under **Clause 3.4.3** and this **Clause 4.6** is in no way intended to address API usage and waste during manufacturing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;K.&nbsp;&nbsp;&nbsp;&nbsp;The parties hereby agree that **Clause 4.7** set forth in the **FORECASTS, ORDERS AND SUPPLY OF THE API** section of the Agreement shall be amended to include the following sentence at the end of the paragraph:

For the sake of clarity, MSX's obligation to remunerate RB under this **Clause 4.7** is limited to the amount paid to MSX by RB and shall not include remuneration for RB's API cost.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;L.&nbsp;&nbsp;&nbsp;&nbsp;RB agrees to waive any API loss claims to MSX for batches made prior to the Amendment Effective Date.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;M.&nbsp;&nbsp;&nbsp;&nbsp;This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware, United States of America, save as to conflict of law provisions, and the parties hereby agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;N.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly set forth herein, all other terms and provisions of the Agreement shall remain in full force and effect without modification or change.

**Signed for and on behalf Reckitt Benckiser Pharmaceuticals Inc.**

---

| |
|:---|
| */s/ Shaun Thaxter* |
| Name: Shaun Thaxter |
| Title: President |
| Date: 12/1/12 |

---

**Signed for and on behalf MonoSol Rx, LLC**

---

| |
|:---|
| */s/ Keith Kendall* |
| Name: Keith Kendall |
| Title: COO |
| Date: 12/1/12 |

---

------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**ADDENDUM A TO COMMERCIAL EXPLOITATION AGREEMENT:**

**SUBOXONE STRIP DEVELOPMENT AGREEMENT**

This Addendum A to Commercial Exploitation Agreement: Suboxone Strip Development Agreement (the "Addendum") is entered into as of this 14<sup>th</sup> day of October, 2013 the ("Addendum Effective Date"), by and between Reckitt Benckiser Pharmaceuticals Inc., with offices at 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235 ("RB") and MonoSol Rx, LLC, with offices at 30 Technology Drive, Warren, NJ 07059 ("MSX").

**BACKGROUND AND PURPOSE OF PROJECT**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.&nbsp;&nbsp;&nbsp;&nbsp;The parties entered into a Commercial Exploitation Agreement dated August 15, 2008, as amended (the "Agreement").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.&nbsp;&nbsp;&nbsp;&nbsp;Pursuant and subject to the Agreement, the parties now wish to enter into an addendum to the Agreement relating to the development and potential commercialization of improved formulations of the Products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C.&nbsp;&nbsp;&nbsp;&nbsp;This Addendum relates to a research and development project to develop and potentially commercialize improved formulations of the Products having a higher degree of product stability which MSX would manufacture and supply to RB pursuant to the terms of the Agreement. The parties intend that the Price for these improved formulations be the same as the Price which RB is currently paying for existing Products with the same API and dosage strengths, (subject only to variations in costs with respect to Raw Materials, Direct Labor, Release Testing, or use of manufacturing line time; provided however, that MSX shall validate with competent evidence any increase in costs with respect to Raw Materials, Direct Labor, Release Testing, or use of manufacturing line time).

NOW, THEREFORE, for and in consideration of the mutual covenants contained herein, the parties hereto agree as follows:

**1.**&nbsp;&nbsp;&nbsp;&nbsp;**Capitalized Terms**

Capitalized terms used in this Addendum without definition shall have the same meanings ascribed to those terms in the Agreement.

**2.**&nbsp;&nbsp;&nbsp;&nbsp;**Addendum is Part of Agreement**

This Addendum is hereby incorporated into and made a part of the Agreement as if fully set forth therein, and is subject to the terms of the Agreement.

Without limiting the foregoing and for the avoidance of doubt, rights to and ownership of any inventions and other intellectual property developed or created as a result of the work performed hereunder shall be governed by the Intellectual Property Rights provisions of the Agreement.

**3.**&nbsp;&nbsp;&nbsp;&nbsp;**Services and Payment**

MSX shall perform the services set forth in the attached Appendix A (the "Services"), which is hereby incorporated by reference and made a part of this Addendum as if fully set forth herein.

MSX represents and warrants that it will perform the Services in accordance with prevailing industry standards. MSX further represents and warrants that all personnel who perform the Services shall have appropriate training, experience and qualifications.

In consideration for performing the Services, MSX shall receive payments as set forth herein and in <u>Appendix A</u> and <u>Appendix B</u>. <u>Appendix B</u> is hereby incorporated by reference and made a part of this Addendum as if fully set forth herein.

The initial payment will be invoiced by MSX upon Signing (as defined below) and will be due upon receipt of said invoice by RB.

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Subsequent payments will be invoiced by MSX upon completion of all applicable criteria and will be due [\*\*\*] after receipt of said invoice by RB. In the event of any good faith disputes with respect to any such invoice, RB shall pay the undisputed portion of any such invoice within this time period.

**4.**&nbsp;&nbsp;&nbsp;&nbsp;**Project Specifics**

Project milestones and timelines as well as associated payments are outlined in <u>Appendix A</u>.

**4.1.**&nbsp;&nbsp;&nbsp;&nbsp;**Payment Triggers**

RB's obligation to make a payment for services rendered pursuant to each milestone phase is triggered by either the commencement or the completion of a milestone activity, as outlined in <u>Appendix A</u> and further described herein.

In order to receive payments for an applicable milestone activity whereby payment is due on "commencement of the activity" MSX shall first provide RB a project plan outlining critical activities and a definitive time period for the commencement of the milestone phase, which plan must be accepted in writing by RB (such approval not to be unreasonably withheld or delayed).

If payment is due upon completion, MSX shall first provide RB with written confirmation of completion, which confirmation shall be deemed accepted by RB unless RB delivers to MSX a written deficiency notice within twenty-one (21) business days of RB's receipt of written confirmation of completion. Any such deficiency notice delivered by RB hereunder shall contain a level of detail sufficient for MSX to assess the deficiency and propose a plan of corrective action to address the deficiency. In the event a deficiency notice is delivered by RB under this Section 4.1, the parties shall endeavor to agree promptly upon a corrective action plan and payment of the milestone payment in question will not be required and the milestone shall not be deemed completed until such time as the deficiency is remedied in accordance with the corrective action plan; provided that the time periods during which RB is responsible for responding under this Section 4.1 (i.e., the period of up to 21 business days during which RB is reviewing MSX's proposed completion of a milestone) shall not be counted for purposes of MSX's eligibility for any Milestone Bonus Payment or the assessment of any Milestone Reduction Penalty set forth in Appendix A.

As used in Sections 4.2 and 4.3 below (and elsewhere in this Addendum), the completion of a milestone or a project activity is considered to include both the completion of the specified activities by MSX and their acceptance by RB as set forth above.

**4.2.**&nbsp;&nbsp;&nbsp;&nbsp;**Bonus Payments**

RB will pay milestone bonus payments described in this Section 4.2 ("Milestone Bonus Payments") to MSX where MSX has completed all project activities as outlined in the project plan pertaining to a particular project milestone a minimum of [\*\*\*] in advance of the specified target delivery date, with larger bonuses payable if MSX completes all project activities pertaining to a particular milestone a minimum of [\*\*\*] in advance of the specified target delivery date. The Milestone Bonus Payment column indicates the percentage of the bonus, with the number to the left of the diagonal indicating the percentage bonus (expressed as a percentage of the base milestone payment) if the milestone is completed a minimum of [\*\*\*] before the target date and the (smaller) percentage to the right of the diagonal line indicating the percentage bonus payment if the milestone is completed a minimum of [\*\*\*] in advance of target date.

As an example, the Milestone Bonus Payment for the "Analytical Toolkit" phase is written "[\*\*\*]% / [\*\*\*]%," and the target delivery date is described as "[\*\*\*] from Signing" and the Milestone Amount is $[\*\*\*]. ("Signing" is the date on which the later to be executed of the [\*\*\*] and the [\*\*\*] is fully executed by both parties).

If MSX completes all of the activities in the Analytical Toolkit milestone a minimum of [\*\*\*] prior to the target delivery date, i.e., no more than [\*\*\*] from Signing, MSX would receive a bonus payment of [\*\*\*]% of the milestone payment. In such case, its bonus payment would be $[\*\*\*] ([\*\*\*]% x $[\*\*\*] = $[\*\*\*]) in addition to the base milestone payment of $[\*\*\*], which means that that total amount payable for this milestone to MSX would be $[\*\*\*].

If MSX completes all of the activities in the Analytical Toolkit milestone a minimum of [\*\*\*] prior to the target delivery date, i.e., no more than [\*\*\*] from Signing, MSX would receive a bonus payment of [\*\*\*]% of the milestone payment. In such case, its bonus payment would be $[\*\*\*] ([\*\*\*]% x $[\*\*\*] = $[\*\*\*]) in addition to the base milestone payment of $[\*\*\*], which means that that total amount payable for this milestone to MSX would be $[\*\*\*].

For the avoidance of doubt, bonus payments for completion of a particular milestone are not cumulative. MSX might receive either a [\*\*\*] bonus or a [\*\*\*] bonus, but it could not receive both bonuses for completing a single milestone (although MSX

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might receive separate bonuses, or penalties, for completing other milestones specified in <u>Appendix A</u> early or late, as applicable.)

**4.3.**&nbsp;&nbsp;&nbsp;&nbsp;**Penalty Payment Reductions**

Subject to Section 4.1 of this Addendum, milestone reduction penalties described in this Section 4.3 ("Milestone Reduction Penalties") will be deducted from the amounts payable to RB if MSX exceeds the applicable target delivery date for successfully completing all project activities pertaining to a particular milestone by more than [\*\*\*], with larger reduction penalties if MSX exceeds the applicable Target Delivery Date for successfully completing all project activities pertaining to a particular milestone by more than [\*\*\*]. The Milestone Reduction Penalty column indicates the percentage of the penalty, with the number to the left of the diagonal line indicating the percentage penalty if MSX completes the project activities more than [\*\*\*] after the target date and the (larger) percentage to the right of the diagonal line indicating the percentage penalty if MSX completes the project activities more than [\*\*\*] after the target date.

As an example, the Milestone Reduction Penalty for the "Analytical Toolkit" phase is written "[\*\*\*]% / [\*\*\*]%," and the target delivery date is described as "[\*\*\*] from Signing" and the Milestone Amount is $[\*\*\*].

If MSX completes all of the project activities in the Analytical Toolkit milestone at least [\*\*\*] after the target delivery date, i.e., a minimum of [\*\*\*] from Signing, MSX would receive a reduction penalty of [\*\*\*]% of the milestone payment. In such case, its reduction penalty would be $[\*\*\*] ([\*\*\*]% x $[\*\*\*] = $[\*\*\*]) deducted from the base milestone payment of $[\*\*\*], which means that that total amount payable for this milestone to MSX would be $[\*\*\*].

If MSX completes all of the project activities in the Analytical Toolkit milestone at least [\*\*\*] after the target delivery date, i.e., a minimum of [\*\*\*] from Signing, MSX would receive a reduction penalty of [\*\*\*]% of the milestone payment. In such case, its reduction penalty would be $[\*\*\*] ([\*\*\*]% x $[\*\*\*] = $[\*\*\*]) deducted from the base milestone payment of $[\*\*\*], which means that that total amount payable for this milestone to MSX would be $[\*\*\*].

**4.4.**&nbsp;&nbsp;&nbsp;&nbsp;**Termination and Termination Fee**

MSX may terminate this Addendum at any time with or without cause during the "Pre-Signing" and "Analytical Toolkit" phases of the project only by giving written notice of termination to RB.

4.4.1&nbsp;&nbsp;&nbsp;&nbsp;RB may terminate this Addendum or any individual milestone phase at any time with or without cause by giving written notice of termination to MSX. Each individual milestone phase, except the "Pre-Signing" and "Analytical Toolkit" milestones, requires the payment of a termination fee by RB (as specified in <u>Appendix A</u>) in the event that RB terminates the applicable milestone phase of the project, along with the milestone payment associated with any active and ongoing work. Any termination notice by RB shall specify the particular milestone phase or phases being terminated. In the event that RB terminates the entire project or multiple milestone phases at substantially the same time, RB shall pay only a single termination fee, which shall be equal to the largest individual termination fee applicable to any of the terminated milestone phases in addition to the milestone payments associated with any active and ongoing work (i.e., as an illustrative example, in the event that RB elects to pursue the optional "Delivery of [\*\*\*]" milestone phase (termination fee = $[\*\*\*]) and then subsequently terminates that phase, and, at substantially the same time, RB terminates the "[\*\*\*]" milestone phase (termination fee = $[\*\*\*]), then, in addition to the milestone payments associated with any active and ongoing work, RB would owe MSX a single termination fee of $[\*\*\*], which is the largest individual termination fee applicable to any of the terminated milestone phases).

4.4.2&nbsp;&nbsp;&nbsp;&nbsp;In addition to the amounts specified in 4.4.1 above, RB will make the following termination payments to MSX if RB without cause terminates either the entire Addendum or the milestone phases specified below prior to making the applicable milestone payments:

Batch Manufacture milestones

[\*\*\*] *Manufacture of [*\*\*\**] validation batches:* Payment of $[\*\*\*] for each batch manufactured in conformance with applicable specifications prior to termination (up to a maximum of $[\*\*\*]).

[\*\*\*]*:* Payment of $[\*\*\*] for each batch manufactured in conformance with applicable specifications prior to termination (up to a maximum of $[\*\*\*]).

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[\*\*\*]*:* Payment of $[\*\*\*] for each batch manufactured in conformance with applicable specifications prior to termination (up to a maximum of $[\*\*\*]).

[\*\*\*]*:* Provide cGMP hand-cut samples for clinical PK studies: Payment of $[\*\*\*] for manufacture of cGMP clinical supplies manufactured in conformance with applicable specifications prior to termination.

Stability Test milestones

[\*\*\*]*:* Payment of $[\*\*\*] upon both (i) manufacture of formulation in conformance with applicable specifications prior to termination and (ii) demonstration that such formulation satisfies applicable [\*\*\*] stability standards (even if this [\*\*\*] period concludes after termination by RB).

[\*\*\*]*:* Payment of $[\*\*\*] upon (i) manufacture of formulation in conformance with applicable specifications prior to termination and (ii) demonstration that such formulation satisfies applicable [\*\*\*] stability standards (even if this [\*\*\*] period concludes after termination by RB).

For the avoidance of doubt, in no case will the total amount payable by RB under this Section 4.4.2 with respect to any particular milestone exceed the total amount which would have been payable if MSX had completed such milestone in the absence of termination by RB.

Termination of this Addendum by either party does not, by itself, affect the remaining portions of the Agreement, nor does it affect any obligations of the parties under this Addendum which survive termination of the Addendum pursuant to the Agreement, including without limitation, the obligation of RB to pay for milestone payments as and when due under this Addendum.

**4.5.**&nbsp;&nbsp;&nbsp;&nbsp;**Inclusions and Exclusions**

For all milestones except the "Pre-Signing" and "Analytical Toolkit" milestones, any project activities involving the design of improved formulations prepared by MSX shall include stability analyses performed on sample materials front sample batches and formulations at the following time periods: [\*\*\*]. The costs of the performance of stability analyses at these intervals are covered and included in the applicable milestone payment, and no additional payments by RB for these stability analyses shall be required. If, however, RB requests stability analyses at time intervals beyond those specified in the previous sentence, additional reasonable charges for the cost of performing the additional requested stability analyses would apply.

Capital purchases required for final solutions (e.g., "[\*\*\*]") are not included in the milestone payments, and would be an additional charge. If purchased by MSX, the costs of such capital purchases would be passed through (without markup) to RB.

Except as expressly stated in this Section 4.5 (regarding extra stability tests, capital purchases for [\*\*\*]) or in Section 4.4 (regarding termination fees), the milestone payments specified for each activity shall be all-inclusive for all project activities pertaining to a particular milestone to be completed. Work outside the scope of such project activities, and the additional fees associated therewith, would require a separate written agreement by both parties.

**4.6.**&nbsp;&nbsp;&nbsp;&nbsp;**Optional Activities**

The activities classed as "optional" in <u>Appendix A</u> can only be commenced upon prior written approval by RB.

**4.7.**&nbsp;&nbsp;&nbsp;&nbsp;**API**

RB shall timely provide MSX with all necessary API free of charge. In the event that RB fails to provide API meeting the API Specification in a timely manner and MSX can demonstrate that such failure caused delays in MSX's ability to perform its obligations under this Addendum and MSX notifies RB of such delays in writing at the time such delays are occurring, then MSX may deduct the amount of time its performance of a particular milestone activity was delayed by such failure from the total amount of time MSX took to complete a particular milestone activity for purposes of determining whether MSX receives a bonus or penalty for its performance of the particular milestone under Appendix A. Failure of RB to timely deliver API or at all shall not be used by RB as grounds to avoid its obligation to make any milestone payment provided for in this Addendum.

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**5.**&nbsp;&nbsp;&nbsp;&nbsp;**Project Management**

5.1.&nbsp;&nbsp;&nbsp;&nbsp;MSX shall be responsible for the project management and for providing appropriate resources to deliver the project. RB shall be responsible for (1) attending monthly project update meetings either in person or via teleconference, (2) providing timely decisions on items requested by MSX, and (3) providing appropriate RB expertise on the project.

5.2.&nbsp;&nbsp;&nbsp;&nbsp;MSX is to present RB with a written project plan which shall be updated on a monthly basis.

5.3.&nbsp;&nbsp;&nbsp;&nbsp;Additionally, MSX shall give verbal updates on a monthly basis. This is to take place in the form of a monthly teleconference or alternatively face- to-face meeting with participation and attendance by the joint technical team ("JTT") and the supply team.

5.4.&nbsp;&nbsp;&nbsp;&nbsp;The JTT shall consist of an equal number of members front MSX and RB, shall guide the project team and provide technical support when needed.

**6.**&nbsp;&nbsp;&nbsp;&nbsp;**Pricing of Commercial Products**

Any products, designs or formulations which are developed pursuant to this Addendum or the performance of the Services herein and which are approved for commercial sale by at least one Regulatory Authority in at least one country or jurisdiction, or which have been supplied by RB or its agents to at least one customer (collectively, "Addendum Products") shall be considered "Products" as defined in Clause 1.1 of the Agreement and treated as Products for purposes of the Agreement and this Addendum except as expressly stated in the last two paragraphs of this Section 6.

Without limiting the foregoing, the parties agree that the Price payable by RB to MSX for any Addendum Product shall be the same as the then-current Cost of Goods Price for the "analogous Products" as set forth in Clauses 7.2 and 7.14 of the Agreement. An "analogous Product" refers to a Product containing the same amount of Buprenorphine API and dosage strength as an Addendum Product. As an illustrative example, if at a given time the then-current U.S. Cost of Goods Price per pouched single dose of pre-existing Product containing 2 mg Buprenorphine were $[\*\*\*] and the then-current ROW Cost of Goods Price per pouched single dose of pm-existing Product containing 2 mg Buprenorphine were $[\*\*\*], then the U.S. price of an Addendum Product containing an API of 2 mg Buprenorphine would also be $[\*\*\*] per pouched single dose and the ROW price of an Addendum Product containing an API of 2 mg Buprenorphine would also be $[\*\*\*] per pouched single dose). For the avoidance of doubt, the titles on pricing set forth in this paragraph apply both at the time of Product Launch of an Addendum Product and at all other times.

As the sole exception to the foregoing, in the event that the cost with respect to Raw Materials, Direct Labor, and/or manufacturing line time required to produce an Addendum Product is more or less expensive than that required to produce the analogous Product, then at the request of either party, the price of such Addendum Product shall be increased or decreased (as applicable) on a purely pass-through basis (without any markup by MSX) to account solely for the variations in costs with respect to Raw Materials, Direct Labor, Release Testing, or use of manufacturing line time; provided however, that MSX shall validate with competent evidence any increase in costs with respect to Raw Materials, Direct Labor, Release Testing, or use of manufacturing line time.

The parties acknowledge and agree that RB has completely fulfilled and satisfied its obligations under the Agreement to pay Royalties on Products sold in the U.S. Accordingly, RB shall have no obligation to make any royalty payments for any Products, including any Addendum Products, sold in the U.S. The parties acknowledge and agree that RB has continuing obligations to pay Royalties on the Net Sales Value of Products, including Addendum Products, sold in the ROW, pursuant to Section 7.4.2 of the Agreement.

**7.**&nbsp;&nbsp;&nbsp;&nbsp;**CONFLICTING TERMS**

In the event of a conflict between this Addendum and the Agreement, the Agreement shall govern. In the event of a conflict between this Addendum and an Appendix to this Addendum, this Addendum shall govern.

**8.**&nbsp;&nbsp;&nbsp;&nbsp;**EFFECTIVE DATE**

This Addendum shall be effective as of the Addendum Effective Date.

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**9.**&nbsp;&nbsp;&nbsp;&nbsp;**GOVERNING LAW; JURISDICTION**

This Addendum shall be governed by and construed in accordance with the laws of the State of Delaware, United States of America, save as to conflict of law provisions, and the parties hereby agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

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**IN WITNESS WHEREOF,** the parties have caused this Addendum to be executed as of the Addendum Effective Date.

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| |
|:---|
| **MonoSol Rx, LLC** |
| */s/ Keith Kendall* |
| Keith Kendall |
| Print Name |
| President - COO |
| Print Title |

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| |
|:---|
| **Reckitt Benckiser Pharmaceuticals, Inc.** |
| */s/ Shaun Thaxter* |
| Shaun Thaxter |
| Print Name |
| CEO |
| Print Title |

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| | | | | |
|:---|:---|:---|:---|:---|
| **APPENDIX A** | | | | |
| **Milestone** | **Milestone Amount** | **Target Delivery Date** | **Milestone Bonus Payment**<sup>1</sup> | **Milestone Reduction Penalty**<sup>2</sup> |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |  |  |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |  |  |
| **Analytical Toolkit** | **Analytical Toolkit** | **Analytical Toolkit** | **Analytical Toolkit** | **Analytical Toolkit** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] |  |  |  |  |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] |  |  |  |
| [\*\*\*] | [\*\*\*] |  |  |  |
| [\*\*\*] | [\*\*\*] |  |  |  |
| [\*\*\*] |  |  |  |  |
|  | [\*\*\*] |  |  |  |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] |  |  |  |  |
| [\*\*\*] |  |  |  |  |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] |  |  |  |  |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] |  |  |  |  |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] |  |  |  |  |
|  | [\*\*\*] |  |  |  |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] |  | [\*\*\*] |  |  |
| [\*\*\*] | [\*\*\*] |  |  |  |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

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[\*\*\*]

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**APPENDIX B**

[\*\*\*]

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| | | | | | | | | | | | | | | | | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| | **0** | **1** | **2** | **3** | **4** | **5** | **6** | **7** | **8** | **9** | **10** | **11** | **12** | **13** | **14** | **15** | **16** | **17** | **18** | **19** | **20** | **21** | **22** | **23** |
| [\*\*\*] | [\*\*\*] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| [\*\*\*] |  |  |  |  |  |  | [\*\*\*] |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |  |  |  |  |
| [\*\*\*] | [\*\*\*] |  |  |  |  |  |  |  |  | [\*\*\*] |  |  |  | [\*\*\*] |  |  |  |  |  |  | [\*\*\*] |  |  |  |
| [\*\*\*] | [\*\*\*] |  |  |  | [\*\*\*] |  |  |  |  | [\*\*\*] |  |  |  | [\*\*\*] |  |  |  |  |  |  | [\*\*\*] |  |  |  |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

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PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**ADDENDUM B TO COMMERCIAL EXPLOITATION AGREEMENT:**

**SUBOXONE STRIP DEVELOPMENT AGREEMENT**

This Addendum B to Commercial Exploitation Agreement: Suboxone Strip Development Agreement (this "Addendum B") is entered into as of this 30th day of July, 2014 the "("Addendum Effective Date"), by and between Reckitt Benckiser Pharmaceuticals Inc., with offices at 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235 ("RB") and MonoSol Rx, LLC, with offices at 30 Technology Drive, Warren, NJ 07059 ("MSX").

**BACKGROUND AND PURPOSE OF PROJECT**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.&nbsp;&nbsp;&nbsp;&nbsp;The parties entered into a Commercial Exploitation Agreement dated August 15, 2008, as amended (the "Agreement").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.&nbsp;&nbsp;&nbsp;&nbsp;The parties entered into Addendum A to the Agreement as of October 15, 2013 relating to the development and potential commercialization of improved formulations of the Products ("Appendix A").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C.&nbsp;&nbsp;&nbsp;&nbsp;Pursuant and subject to the Agreement, the parties now wish to amend Addendum A by entering into a further addendum to the Agreement relating to: (i) the accelerated completion of scale-up work and manufacture of the [\*\*\*] registration batches of the current development formulation of [\*\*\*] Suboxone Sublingual Film containing [\*\*\*] and the new development formulation, to be mutually agreed, of [\*\*\*] Suboxone Sublingual Film containing [\*\*\*] (the "[\*\*\*]") without [\*\*\*] as outlined under Addendum A in order to facilitate an accelerated launch of Suboxone Sublingual Film in [\*\*\*]; and (ii) a reformulation program for Suboxone Sublingual Film ([\*\*\*] or [\*\*\*] as determined by RB).

NOW, THEREFORE, for and in consideration of the mutual covenants contained herein, the parties hereto agree as follows:

**1.**&nbsp;&nbsp;&nbsp;&nbsp;**Capitalized Terms**

Capitalized terms used in this Addendum without definition shall have the same meanings ascribed to those terms in the Agreement.

**2.**&nbsp;&nbsp;&nbsp;&nbsp;**Addendum is Part of Agreement**

This Addendum B is hereby incorporated into and made a part of the Agreement as if fully set forth therein, and is subject to the terms of the Agreement.

Without limiting the foregoing and for the avoidance of doubt rights to and ownership of any inventions and other intellectual property developed or created as a result of the work performed hereunder shall be governed by the Intellectual Property Rights provisions of the Agreement.

**3.&nbsp;&nbsp;&nbsp;&nbsp;Project Specifics**

**3.1.&nbsp;&nbsp;&nbsp;&nbsp;**Scope of Work

Within the scope of work set forth in this Addendum B, the following shall apply;

MSX will undertake the scale-up and manufacture of [\*\*\*] registration batches each for the [\*\*\*] and [\*\*\*] dosage strengths required by Addendum A at MSX's [\*\*\*] facility ("[\*\*\*]").

As part of the scale-up work for each dosage strength, MSX will use commercially reasonable efforts to identify critical process parameters and in-process controls with limits where a control is deemed necessary. Parameters and control limits will be mutually agreed upon in writing between MSX and RB.

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As part of the scale-up work for each dosage strength, MSX will use commercially reasonable efforts to conduct an appropriate [\*\*\*] experiment to establish the working range for [\*\*\*]. RB and MSX will agree upon the experiment design in writing prior to the start of the experiment.

All methods utilized in the mutually agreed finished product specification (the "Finished Product Specification") will be validated prior to the delivery of the [\*\*\*] data for Suboxone [\*\*\*] Film registration batches.

MSX represents and warrants that it will perform the work under this Addendum B in accordance with prevailing industry standards. MSX further represents and warrants that all personnel who perform work under this Addendum B shall have appropriate training, experience and qualifications.

**3.2.**&nbsp;&nbsp;&nbsp;&nbsp;Timeline and Payments

Assuming this Addendum B is executed and delivered by the parties on or before August 1, 2014, the [\*\*\*] registration batches will be placed on stability by October 22, 2014 and the [\*\*\*] registration batches will be placed on stability by December 31, 2014. (If this Addendum B is not executed and delivered by August 1, then for each day after August 1 before this Addendum B is executed and delivered, the timelines of the previous sentence for placing the registration batches on stability will be pushed back by an equivalent number of days). RB acknowledges that the timeline represents an accelerated approach and that any additional batches (above and beyond the batches described in Section 3.1 or in Addendum A) required to obtain scale-up manufacturing at [\*\*\*] may impact the timeline. MSX will use commercially reasonable efforts to ensure that the registration batches meet the Finished Product Specifications; however, RB acknowledges and agrees that the accelerated approach outlined in this Addendum B increases the risk of the registration batches failing to meet the Finished Product Specifications. RB will make prompt payment to MSX upon the completion of the registration batches as outlined under Addendum A regardless of the final performance of the batches unless the registration batch failure(s) are due to MSX's gross negligence, intentional misconduct or breach of this Addendum B, Addendum A or the Agreement.

The parties recognize that the accelerated scope of work and timeline requested by RB related to the [\*\*\*] product under this Addendum B has a significant impact on MSX's business. In order to appropriately compensate MSX for this impact, RB will pay MSX [\*\*\*]. MSX shall invoice RB and RB shall make payment [\*\*\*] upon the execution and delivery of this Addendum B.

With the exception of the [\*\*\*] milestone, all other milestones and payments contemplated under Addendum A and any existing statements of work between the parties shall continue to apply. (The [\*\*\*] milestone, and any associated payment obligations to the extent not already paid on the part of RB, are hereby cancelled). MSX will credit RB [\*\*\*] Dollars ($[\*\*\*]) against the [\*\*\*] for the [\*\*\*] milestone payment already received by MSX under Addendum A.

RB and MSX will undertake a [\*\*\*] for Suboxone Sublingual Film ([\*\*\*] or [\*\*\*] as determined by RB; the "[\*\*\*]"). RB and MSX will build a project plan for the [\*\*\*] and begin work by the earlier of (i) the reported outcome of the planned clinical PK study for Suboxone [\*\*\*] Film or (ii) [\*\*\*]. MSX will complete the Reformulation Program at a cost to RB of no more than [\*\*\*] Dollars ($[\*\*\*]).

Payments will be invoiced by MSX upon completion of all applicable criteria and will be due [\*\*\*] after receipt of said invoice by RB.

For all purposes of this Addendum B, the term "completion" as applied to the fulfillment by MSX of any obligation of any obligations under either Addendum A or this Addendum B shall have the same meaning as defined in Section 4.1 of Addendum A.

In the event of any good faith disputes with respect to any such invoice, RB shall pay the undisputed portion of any such invoice within this time period.

**3.3.&nbsp;&nbsp;&nbsp;&nbsp;**Termination and Termination Fee

MSX may terminate this Addendum B by giving [\*\*\*] written notice of termination to RB if RB shall fail to make any undisputed payment to MSX as and when due under this Addendum B and such failure remains uncured at the end of such [\*\*\*] notice period.

RB may terminate this Addendum B at any time with or without cause by giving written notice of termination to MSX. In the event that RB terminates this Addendum B, or otherwise fails to start the Reformulation Program (defined in Appendix A) by

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October 1, 2015, RB shall pay MSX a termination fee of [\*\*\*] Dollars ($[\*\*\*]) upon the effective date of the applicable triggering event (such fee is in lieu of, and not in addition to, any otherwise applicable termination fee under Addendum A).

Termination of this Addendum B by either party does not, by itself, affect the remaining portions of the Agreement, including without limitation Addendum A, nor does it affect any obligations of the parties under this Addendum B which survive termination of this Addendum B pursuant to the Agreement, including without limitation, the obligation of RB to make payments as and when due under this Addendum B.

**3.4.**&nbsp;&nbsp;&nbsp;&nbsp;Inclusions and Exclusions

Work outside the scope of this Addendum B or the unmodified portions of Addendum A, and the additional fees associated therewith, would require a separate written agreement by both parties.

**3.5.**&nbsp;&nbsp;&nbsp;&nbsp;Quality

RB will identify and introduce to MSX the Qualified Person (the "QP") that RB has assigned to the launch of Suboxone Sublingual Film [\*\*\*] as soon as is practicable. The QP will engage with MSX on a plan of action for preparing for the necessary [\*\*\*] regulatory filings.

**3.6.**&nbsp;&nbsp;&nbsp;&nbsp;Product Risk

RB will be responsible for the product defect risks either associated intrinsically with the [\*\*\*] or the associated manufacturing process, in each case provided it is carried out in compliance with the mutually agreed upon written process parameters and in-process controls as defined in MSX's manufacturing batch record.

Any recalls or regulatory actions taken as a result of such [\*\*\*] product defects will be at RB's expense except to the extent such product defects result from MSX's failure to follow GMP or the mutually agreed upon written process parameters and in-process controls as defined in MSX's manufacturing batch record, or from MSX's gross negligence, willful misconduct or breach of the Agreement or any Addendum thereof.

Product defect risk for the [\*\*\*] will revert to the terms set forth in the Agreement upon the earlier of (1) the commercial launch of [\*\*\*] developed by MSX using an appropriate [\*\*\*] (although this is not part of the immediate RB strategy) and (2) the usage of [\*\*\*] doses in the marketplace.

**4.**&nbsp;&nbsp;&nbsp;&nbsp;**CONFLICTING TERMS**

In the event of a conflict between this Addendum B and the Agreement, the Agreement shall govern. In the event of a conflict between this Addendum B and Addendum A, this Addendum B shall govern.

**5.**&nbsp;&nbsp;&nbsp;&nbsp;**EFFECTIVE DATE**

This Addendum B shall be effective as of the Addendum Effective Date.

**6.**&nbsp;&nbsp;&nbsp;&nbsp;**GOVERNING LAW; JURISDICTION**

This Addendum B shall be governed by and construed in accordance with the laws of the State of Delaware, United States of America, save as to conflict of law provisions, and the parties hereby agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

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**IN WITNESS WHEREOF,** the parties have caused this Addendum B to be executed as of the Addendum Effective Date.

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| |
|:---|
| **MonoSol Rx, LLC** |
| */s/ Keith Kendall* |
| Keith Kendall |
| Print Name |
| COO |
| Print Title |

---

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| |
|:---|
| **Reckitt Benckiser Pharmaceuticals, Inc.** |
| */s/ Mark W. Crossley* |
| Mark Crossley |
| Print Name |
| Global Finance Director |
| Print Title |

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PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 8**

**COMMERCIAL EXPLOITATION AGREEMENT**

**THIS AMENDMENT NO. 8** (this "**Amendment**") is made as of the 12th day of January 2017 (the "**Effective Date**") between:

**PARTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;MonoSol Rx, LLC, a company organized and existing under the laws of Delaware with offices at 30 Technology Drive, Warren, New Jersey 07059 ("**MSX**"),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Indivior Inc. (formerly, Reckitt Benckiser Pharmaceuticals Inc.), a company organized and existing under the laws of Delaware with offices at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia 23235 ("**Indivior**").

MSX and Indivior are each referred to herein sometimes as a "**Party**" and, collectively, as the "**Parties**".

**WHEREAS**, MSX and Indivior entered into a Commercial Exploitation Agreement, dated August 15, 2008, as amended from time to time (collectively referred to herein as the "**Agreement**"), pursuant to which, among other things, Indivior engaged MSX to be the exclusive manufacturer and supplier of the Products on the terms of the Agreement and MSX agreed to manufacture and supply the Products to Indivior on the terms of the Agreement; and

**WHEREAS**, Indivior is interested in commercializing and marketing an authorized generic version of the Products through an identified authorized third party distributor; and

**WHEREAS**, Indivior desires to engage MSX to manufacture and supply the authorized generic Products, and MSX desires to manufacture and supply the authorized generic Products, on the terms and conditions of the Agreement and this Amendment.

**NOW, THEREFORE**, in consideration of the premises and the mutual agreements, covenants, and conditions set forth in this Amendment, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound hereby, agree to amend and modify certain terms and conditions of the Agreement as set forth in this Amendment.

**IT IS AGREED** as follows:

A.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Definitions</u>**. Capitalized terms used in this Amendment without definition shall have the respective meanings ascribed thereto in the Agreement. For purposes of the Agreement, the defined term "Products" shall be deemed to include the authorized generic Products and Schedule Three of the Agreement shall be deemed to be revised to list the authorized generic Products and, as such, whenever the term Product or Products is used in the Agreement, said terms shall be construed to mean and include the authorized generic Products and be subject to all of the terms and conditions of the Agreement.

B.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Project Fee</u>**. In consideration for the manufacture and supply of the authorized generic Products, Indivior shall pay MSX, in addition to the Price for the authorized generic Products in accordance with Section E below, the sum of [\*\*\*] dollars ($[\*\*\*]) payable as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] dollars ($[\*\*\*]) previously paid by Indivior to MSX on May 25, 2016 upon commencement of manufacture of the authorized generic Products; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] dollars ($[\*\*\*]) upon (i) execution of this Amendment <u>and</u> (ii) execution of the agreement referred to in Section D below.

C.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Restrictive Covenant</u>**. Notwithstanding anything to the contrary contained in this Agreement, the parties agree that, in addition to, and not in limitation of, any other restrictive covenants contained in the Agreement, during the last [\*\*\*] months

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of the Term, and for a period of [\*\*\*] after the expiration or termination of the Term, neither party shall, directly or indirectly, enter into any agreement or arrangement with [\*\*\*] or any of the Affiliates of [\*\*\*], or its or their respective successors and/or assigns, for the development, manufacture, marketing, promotion, distribution, offering for sale, sale, offering for license, license or similar activity of the Products in the Field. For the avoidance of doubt, the Parties agree that nothing contained in this Restrictive Covenant is intended to prohibit or prevent the continued manufacture and supply of authorized generic Product by MSX in accordance with the Agreement and this Amendment during the last [\*\*\*] of the Term.

D.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Delivery of the Products</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.&nbsp;&nbsp;&nbsp;&nbsp;The following shall be added to **Clause 5.1**:

For the avoidance of doubt, MSX agrees to deliver authorized generic Products directly to Indivior in accordance with the terms of **Clause 5** of the Agreement. Indivior shall ensure that any designated authorized generic third party distributor shall enter into a non-disclosure agreement with MSX and Indivior, in form and substance acceptable to MSX, which obligates such designated authorized generic third party distributor, among other things, to maintain the confidentiality of any MSX Confidential Information that may be disclosed by or on behalf of MSX pursuant to this **Clause 5**.

E.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Pricing</u>**. For the avoidance of doubt, pricing for the supply of authorized generic Products equals the current U.S. Cost of Goods Price set forth below:

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| | |
|:---|:---|
| | **Cost/strip** |
| [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] |

---

The Price payable by Indivior to MSX for the authorized generic Products shall be adjusted according to Section 7.3 of the Agreement.

F.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Batch Tracking System</u>**. The Parties acknowledge that MSX shall not be obligated to establish and maintain a batch-tracking system that identifies the authorized generic Products for any purpose except as required by the FDA.

G.&nbsp;&nbsp;&nbsp;&nbsp;**<u>No Third Party Beneficiaries</u>**. This Amendment is for the sole benefit of the Parties and their respective successors and assigns permitted under the Agreement, and nothing herein, express or implied, is intended to or shall confer upon any other person or entity (including, without limitation, any authorized third party distributor of authorized generic Products) any legal or equitable right, benefit or remedy of any nature whatsoever under the Agreement or this Amendment by reason of or with respect to this Amendment.

H.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Governing Law</u>**. This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware, United States of America, save as to conflict of law provisions, and the parties hereby agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

I.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Survival</u>**. Except as expressly set forth herein, all other terms and provisions of the Agreement shall remain in full force and effect without modification or change.

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| |
|:---|
| **Signed for and on behalf Indivior Inc.** |
| */s/ Cary Claiborne* |
| Name: Cary Claiborne |
| Title: CFO |
| Date: 1/20/17 |

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| |
|:---|
| **Signed for and on behalf of MonoSol Rx, LLC** |
| */s/ Keith Kendall* |
| Name: Keith Kendall |
| Title: CEO |
| Date: 1/16/17 |

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PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 9**

**COMMERCIAL EXPLOITATION AGREEMENT**

**THIS AMENDMENT NO. 9** (this "**Amendment**") is made as of the last date of signature below (the "**Effective Date**") between:

**PARTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;Aquestive Therapeutics, Inc. (formerly known as MonoSol Rx, LLC), a company organized and existing under the laws of Delaware with offices at 30 Technology Drive, Warren, New Jersey 07059, USA (**"Aquestive"**),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals Inc.), a company organized and existing under the laws of Delaware with offices at 10710 Midlothian Turnpike, Suite 125, North Chesterfield, Virginia 23235, USA (**"Indivior"**).

Aquestive and Indivior are each referred to herein sometimes as a "Party" and, collectively, as the "Parties".

**WHEREAS**, Aquestive and Indivior entered into a Commercial Exploitation Agreement, dated August 15, 2008, as amended from time to time (collectively referred to herein as the "Agreement"), pursuant to which, among other things, Indivior engaged Aquestive to be the exclusive manufacturer and supplier the Products (as defined in the Agreement) on the terms of the Agreement and Aquestive agreed to manufacture and supply the Products to Indivior on the terms of the Agreement, and

**WHEREAS**, for valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties mutually desire to amend and modify certain terms and conditions of the Agreement as set forth in this Amendment,

**IT IS AGREED** as follows:

A.&nbsp;&nbsp;&nbsp;&nbsp;Capitalized terms used in this Amendment without definition shall have the respective meanings ascribed thereto in the Agreement.

B.&nbsp;&nbsp;&nbsp;&nbsp;Effective as of January 1, 2020 both Parties mutually agree that the Cost of Goods Price for the manufacture per pouched single dose of Product shall be as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

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| | |
|:---|:---|
| • 2 mg Buprenorphine + 1 mg Naloxone (US) | $[\*\*\*] |
| • 2 mg Buprenorphine + 1 mg Naloxone (ROW) | $[\*\*\*] |
| • 4 mg Buprenorphine + 1 mg Naloxone (US) | $[\*\*\*] |
| • 4 mg Buprenorphine + 1 mg Naloxone (ROW) | $[\*\*\*] |
| • 8 mg Buprenorphine + 2 mg Naloxone (US) | $[\*\*\*] |
| • 8 mg Buprenorphine + 2 mg Naloxone (ROW) | $[\*\*\*] |
| • 12 mg Buprenorphine + 3 mg Naloxone (US) | $[\*\*\*] |
| • 12 mg Buprenorphine + 3 mg Naloxone (ROW) | $[\*\*\*] |

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C.&nbsp;&nbsp;&nbsp;&nbsp;The Parties currently anticipate quarterly manufacturing demand in Year 2020 of [\*\*\*] to [\*\*\*] doses per Quarter Year. Aquestive will apply a [\*\*\*] ($[\*\*\*]) price decrease on Product manufactured above [\*\*\*] doses but below the maximum contractual capacity of [\*\*\*] doses (collectively, the "Volume Rebate"). Aquestive will apply a credit equal to the Volume Rebate within [\*\*\*] days of the end of each Quarter Year. Overage charges as communicated by Aquestive will continue to apply above [\*\*\*] doses manufactured per Quarter Year. The Parties agree to discuss further adjustments to Aquestive's cost base and Price if quarterly volumes fall below [\*\*\*] doses per Quarter Year.

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D.&nbsp;&nbsp;&nbsp;&nbsp;Effective January 1, 2020, the Packaging Fee as stated in Section 7 3 2 of the Agreement, as amended under Amendment #6 of the Agreement dated December 9, 2011, shall be [\*\*\*] US Dollars (USD$[\*\*\*]) per additional packaging request. For the sake of clarity, if Indivior requests [\*\*\*] different SKUs during the manufacture of [\*\*\*] batch, (the maximum number of packaging requests) then the total Packaging Fees for such manufactured batch would be [\*\*\*] US Dollars (USD$[\*\*\*]). The maximum number of packaging requests that Indivior may request for any [\*\*\*] manufactured batch shall be [\*\*\*] requests.

E.&nbsp;&nbsp;&nbsp;&nbsp;Aquestive agrees that it will continue to use commercially reasonable efforts to improve the electronic capabilities of the manufacturing site including instituting an electronic process for the management of change controls and events. The Parties will meet in the second half of Year 2020 to discuss further investments in electronic systems that may be appropriate in 2021.

F.&nbsp;&nbsp;&nbsp;&nbsp;Aquestive agrees that it will use commercially reasonable efforts to invest in Year 2020 at least [\*\*\*] US Dollars (USD$[\*\*\*]) in capital improvements focused on manufacturing capabilities. The Parties will meet in the second half of Year 2020 to discuss the state of Aquestive's manufacturing capabilities.

G.&nbsp;&nbsp;&nbsp;&nbsp;As of the Effective Date, Aquestive and Indivior each agrees that the ROW Rebate and any manufacturing overage charges will be calculated starting on July 1, 2019 and that neither Party will make any rebate or overage charge claims for Product manufactured prior to July 1, 2019. Furthermore, each Party agrees that is shall not make any claims for disputed batches / scrapped batches manufactured prior to the Effective Date. The Parties agree to split the costs for the currently disputed batches / scrapped batches [\*\*\*] and [\*\*\*]. For the sake of clarity, Indivior shall pay Aquestive [\*\*\*] US Dollars (USD$[\*\*\*]) within [\*\*\*] calendar days after the Effective Date and receipt of revised invoice, whichever is later, and Aquestive will destroy the batches and seek no further claim for payment for such destroyed batches against Indivior.

H.&nbsp;&nbsp;&nbsp;&nbsp;Indivior agrees to work in good faith to support Aquestive in reducing its cost base as Indivior volumes decrease. Specifically, Indivior will work with Aquestive to support moving any remaining Product manufacturing from the [\*\*\*] facility to the [\*\*\*] facility by Year 2021. Aquestive will continue to manufacture Product for Malaysia and Australia at [\*\*\*] while both Parties work diligently to gam regulatory approval of manufacturing at [\*\*\*] for the respective countries. The Parties will assess the viability of continuing to manufacture at [\*\*\*] after Year 2021 if the regulatory approval and/or technology transfer work has not been completed.

I.&nbsp;&nbsp;&nbsp;&nbsp;This Amendment shall be governed by and construed in accordance with the laws (procedural and substantive) of the State of Delaware, United States of America, save as to conflict of law provisions, and the Parties hereby agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

J.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly set forth herein, all other terms and provisions of the Agreement shall remain in full force and effect without modification or change.

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| |
|:---|
| **Signed for and on behalf of Indivior Inc. f/k/a Reckitt Benckiser Pharmaceuticals Inc.** |
| */s/ Shaun Thaxter* |
| Name: Shaun Thaxter |
| Title: Chief Executive Officer |
| Date: 11/25/2019 |

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| |
|:---|
| **Signed for and on behalf of Aquestive Therapeutics, Inc. f/k/a MonoSol Rx, LLC** |
| */s/ Daniel Barber* |
| Name: Daniel Barber |
| Title: COO |
| Date: 11/25/2019 |

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PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 10**

**COMMERCIAL EXPLOITATION AGREEMENT**

**THIS AMENDMENT NO. 10** (this "**Amendment**") is made as of the 29<sup>th</sup> day of December, 2020 (the "**Effective Date**") between:

**PARTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;Aquestive Therapeutics, Inc. (formerly, MonoSol Rx, LLC), a company organized and existing under the laws of Delaware with offices at 30 Technology Drive, Warren, New Jersey 07059, USA (**"Aquestive"**),

and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;Indivior Inc. (formerly, Reckitt Benckiser Pharmaceuticals Inc.), a company organized and existing under the laws of Delaware with offices at 10710 Midlothian Turnpike, Suite 125, North Chesterfield, Virginia 23235 (**"Indivior"**).

Aquestive and Indivior are each referred to herein sometimes as a "Party" and, collectively, as the "Parties".

**WHEREAS**, Aquestive and Indivior entered into a Commercial Exploitation Agreement, dated August 15, 2008, as amended from time to time (collectively referred to herein as the "Agreement"), pursuant to which, among other things, Indivior engaged Aquestive to be the exclusive manufacturer and supplier of the Products (as defined in the Agreement) on the terms of the Agreement and Aquestive agreed to manufacture and supply the Products to Indivior on the terms of the Agreement, and

**WHEREAS**, for valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties mutually desire to amend and modify certain terms and conditions of the Agreement as set forth in this Amendment,

**IT IS AGREED** as follows:

A.&nbsp;&nbsp;&nbsp;&nbsp;Capitalized terms used in this Amendment without definition shall have the respective meanings ascribed thereto in the Agreement.

B.&nbsp;&nbsp;&nbsp;&nbsp;Effective as of January 1, 2021, both Parties mutually agree that the Cost of Goods Price for the manufacture per pouched single dose of Product shall be increased by $[\*\*\*], subject to a maximum Cost of Goods Price of $[\*\*\*], and is as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

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| | |
|:---|:---|
| • 2 mg Buprenorphine + 1 mg Naloxone (US) | $[\*\*\*] |
| • 2 mg Buprenorphine + 1 mg Naloxone (ROW) | $[\*\*\*] |
| • 4 mg Buprenorphine + 1 mg Naloxone (US) | $[\*\*\*] |
| • 4 mg Buprenorphine + 1 mg Naloxone (ROW) | $[\*\*\*] |
| • 8 mg Buprenorphine + 2 mg Naloxone (US) | $[\*\*\*] |
| • 8 mg Buprenorphine + 2 mg Naloxone (ROW) | $[\*\*\*] |
| • 12 mg Buprenorphine + 3 mg Naloxone (US) | $[\*\*\*] |
| • 12 mg Buprenorphine + 3 mg Naloxone (ROW) | $[\*\*\*] |

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The Parties mutually agree that the above prices and below terms shall supersede and control in the event of any conflict between this Amendment and Amendment No. 9 to the Agreement, dated November 25, 2019.

C.&nbsp;&nbsp;&nbsp;&nbsp;The Parties currently anticipate minimum quarterly manufacturing demand (the "Minimum Quarterly Demand") in Year 2021 and the first two Quarters of Year 2022 of [\*\*\*] doses per Quarter Year. Aquestive will maintain the Cost of Goods Price in Paragraph B above during this period as long as the Minimum Quarterly Demand is met or exceeded by Indivior.

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D.&nbsp;&nbsp;&nbsp;&nbsp;Effective from January 1, 2021 through June 30, 2022, as long as Indivior maintains the Minimum Quarterly Demand, the maximum number of packaging requests that Indivior may request for any [\*\*\*] manufactured batch shall be [\*\*\*] requests. Aquestive will continue to invoice Indivior a Packaging Fee, which is maintained through the effective period at [\*\*\*] US Dollars (USD $[\*\*\*]), for each split packaging request included in a manufactured batch pursuant to the Section D of Amendment 9.

E.&nbsp;&nbsp;&nbsp;&nbsp;Effective from January 1, 2021 through June 30, 2022, Indivior will pay Aquestive $[\*\*\*] per dose to support manufacturing improvements and investments (the "Investment Fee"). Aquestive will invoice Indivior for the Investment Fee on a monthly basis. The Investment Fee will be equal to the number of doses invoiced in a given month times $[\*\*\*] per dose. Indivior will pay the Investment Fee under the same payment terms as invoices for the Cost of Goods Price.

F.&nbsp;&nbsp;&nbsp;&nbsp;In exchange for the Investment Fee, Aquestive will use commercially reasonable efforts to invest a similar amount, $[\*\*\*] per dose, and will pursue improvements and investments in manufacturing that are of equal or greater value to the Investment Fee received and the investment amount contributed by Aquestive. Improvements and investments considered under this agreement shall provide a benefit to Indivior in the form of reduced costs, improved performance, improved quality, and/or a reduced overhead burden assigned to Indivior. Examples of improvements and investments include but are not limited to investing in new capabilities [\*\*\*]. Aquestive and Indivior shall meet every six months to review the improvements, investments, and progress made by Aquestive.

G.&nbsp;&nbsp;&nbsp;&nbsp;In addition, Aquestive will lead (and Indivior will participate in) a cross-company project team that will examine (1) the feasibility of increasing packaging requests from [\*\*\*] to [\*\*\*] for a manufacturing batch and (2) how to improve the efficiency of providing [\*\*\*] SKU's. These improvements could include but are not limited to [\*\*\*]. It is the intention of both Parties to complete item one (1) above by March 31, 2021.

H.&nbsp;&nbsp;&nbsp;&nbsp;Section 19.3 of the Agreement is hereby deleted in its entirety and replaced with the following:

"Any Affiliate of RB may place Orders for Products under this Agreement and may enter into additional quality agreements hereunder on terms and conditions mutually acceptable to the Parties ("Additional Quality Agreements") and may accordingly in their own right enforce the provisions of this Agreement, as though it were RB, provided, that (a) each Affiliate of RB that places an Order for Products shall by doing so be deemed to have assumed RB's obligations under this Agreement for the purposes of such Order, (b) each Affiliate of RB that enters into any Additional Quality Agreement(s) hereunder shall be bound by the terms of this Agreement to the same extent as RB, and (c) RB shall remain obligated for the performance of all obligations of RB and the applicable Affiliate of RB arising from this **Clause 19.3**."

I.&nbsp;&nbsp;&nbsp;&nbsp;This Amendment shall be governed by and construed in accordance with the laws (procedural and substantive) of the State of Delaware, United States of America, save as to conflict of law provisions, and the Parties hereby agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

J.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly set forth herein, all other terms and provisions of the Agreement shall remain in full force and effect without modification or change.

------

---

| |
|:---|
| **Signed for and on behalf of Indivior Inc.** |
| */s/ Ryan Preblick* |
| Name: Ryan Preblick |
| Title: Chief Financial Officer |
| Date: 12/30/2020 |

---

---

| |
|:---|
| **Signed for and on behalf of Aquestive Therapeutics** |
| */s/ Daniel Barber* |
| Name: Daniel Barber |
| Title: COO |
| Date: 12/30/2020 |

---

------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 11 TO**

**COMMERCIAL EXPLOITATION AGREEMENT**

This Eleventh Amendment (this "Amendment"), effective as of March 2, 2023 (the "Amendment Effective Date"), amends and modifies the Commercial Exploitation Agreement, entered into by and between Aquestive Therapeutics, Inc. (formerly, MonoSol Rx, LLC) ("Aquestive"), located at 30 Technology Drive, Warren, New Jersey 07059, and Indivior Inc. (formerly, Reckitt Benckiser Pharmaceuticals Inc.) ("Indivior"), located at 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA 23235 on August 15, 2008 (as amended, the "Agreement"). Any capitalized terms not defined herein shall have the meanings prescribed in the Agreement.

**WHEREAS** the parties desire to amend the Agreement as set forth in this Amendment;

**NOW, THEREFORE**, for good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, the Parties intending to be legally bound do hereby agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;**Clause 2.1** of the Agreement is deleted in its entirety and replaced with the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1 This Agreement shall be effective beginning as of the Commencement Date and shall continue, unless earlier terminated by either party in accordance with the provisions of **Clause 17**, for a period of seven (7) years (the "**Initial Term**"). The parties acknowledge that, prior to the Amendment Effective Date, the Initial Term has been automatically renewed for continuous successive one (1) year periods. The parties agree to an additional extension of the term of the Agreement for a period of three (3) years expiring on August 16, 2026, unless earlier terminated by either party in accordance with the provisions of **Clause 17** (the "**2026 Term**"). Upon expiration of the 2026 Term, this Agreement shall thereafter automatically renew for successive one (1) year periods (each, a "**Renewal Term**") on a continuous basis, unless and until RB delivers to MSX written notice of RB's intent not to renew the Agreement, which notice must be delivered at least one (1) year prior to the expiration of the 2026 Term or of a Renewal Term (the Initial Term, 2026 Term and any Renewal Terms, are hereinafter collectively referred to as the "**Term**"). Notwithstanding anything to the contrary contained in this Agreement, this Agreement shall not be automatically renewed for any Renewal Term that begins after the expiration date of the last to expire of the Patents, unless both parties mutually agree in writing to renew this Agreement for each such Renewal Term.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;**Clause 11.10** of the Agreement is deleted in its entirety and replaced with the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.10 The Recipient will however be permitted to disclose Confidential Information to those of its officers and employees and/or officers and employees of its Affiliates who are required in the course of their duties to receive and acquire the Confidential Information for the purpose of compliance with this Agreement where such Affiliates and/or employees and/or officers are bound by obligations of confidentiality to the Recipient and/or the relevant Affiliate and are first made aware of the other terms of this Agreement. For the avoidance of doubt, MSX shall not, and shall cause its Affiliates not to, use any Confidential Information of RB to develop, manufacture, market or sell any product other than the Products. MSX shall establish appropriate firewall procedures to segregate activities conducted by or on behalf of it or any of its Affiliates in connection with the development, manufacture, marketing or sale of a product other than the Products (and the personnel conducting such activities) from the activities performed by or on behalf of MSX under this Agreement involving Confidential Information of RB with respect to the Product. The Recipient will be liable to the Discloser for any breach of the terms of this Agreement by such Affiliates or by their employees or officers.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.&nbsp;&nbsp;&nbsp;&nbsp;Each of the parties agrees that the Cost of Goods Price for the manufacture per pouched single dose of Product shall be increased by $[\*\*\*], effective as of July 1, 2022, through and including June 30, 2023, and by an additional $[\*\*\*], effective as of July 1, 2023. The Cost of Goods Price will remain unchanged thereafter until [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.&nbsp;&nbsp;&nbsp;&nbsp;**Clause 7.14** of the Agreement is deleted in its entirety and replaced with the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.14 Effective January 1, 2025, and each January 1 thereafter the annual Price Change shall be based on [\*\*\*].

------

For the sake of clarity, the parties agree that Aquestive will not be required to lower the Cost of Goods Price if the calculation shows an annual decrease, provided that to the extent that such calculation does show a decrease in a year, then for the calculation in the following year, the denominator shall instead be the denominator the last time the calculation showed an annual increase.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.&nbsp;&nbsp;&nbsp;&nbsp;Indivior will make a one-time prepayment equivalent to the forecasted volumes for 2023 multiplied by the increase in the Cost of Goods Price as provided for in Section 3 of this Amendment. For the sake of clarity, the prepayment will be as follows:

---

| | | | |
|:---|:---|:---|:---|
| **Line Item** | **Volume** | **Price Increase** | **Total** |
| **1**<sup>st</sup> **Half 2023 Forecast** | [\*\*\*] | $[\*\*\*] | $[\*\*\*] |
| **2**<sup>nd</sup> **Half 2023 Forecast** | [\*\*\*] | $[\*\*\*] | $[\*\*\*] |
| **Total Prepayment** | **Total Prepayment** | **Total Prepayment** | $[\*\*\*] |

---

The parties agree to review the volumes associated with the prepayment on January 1, 2024. The parties will calculate the underpayment or overpayment associated with this prepayment and determine if an adjustment should be made. A final calculation of the underpayment or overpayment will be agreed upon by January 15, 2024, with final payment made by the appropriate party within sixty (60) days thereafter.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.&nbsp;&nbsp;&nbsp;&nbsp;Except as provided herein, all other terms and conditions of the Agreement shall remain in full force and effect.

**IN WITNESS WHEREOF**, each of the parties hereto has caused this Amendment to be executed by its duly authorized representatives, as of the Amendment Effective Date.

---

| | | | |
|:---|:---|:---|:---|
| **Aquestive Therapeutics, Inc.** | **Aquestive Therapeutics, Inc.** | **Indivior Inc.** | **Indivior Inc.** |
| By: | */s/ Dan Barber* | By: | */s/ Ryan Preblick* |
| Name: | Dan Barber | Name: | Ryan Preblick |
| Title: | CEO | Title: | Treasurer |
| Date: | March 2, 2023 | Date: | March 2, 2023 |

---

## Exhibit 4.15

**Exhibit 4.15.2**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**<u>AGREEMENT</u>**

This Agreement (this "Agreement"), dated as of September 24, 2017, is by and between MonoSol Rx, LLC, a Delaware limited liability company ("MonoSol"); and Indivior Inc., a Delaware corporation, and Indivior UK Limited, a corporation organized under the laws of England and Wales, as successors in interest to Reckitt Benckiser Pharmaceuticals Inc. and RB Pharmaceuticals Limited, respectively (collectively, "Indivior").

MonoSol and Indivior are each sometimes referred to herein individually as a "Party" and are referred to collectively as the "Parties."

**WITNESSETH:**

WHEREAS, MonoSol and Indivior Inc. are parties to the Commercial Exploitation Agreement, dated August 15, 2008, as amended (the "Commercial Exploitation Agreement"); and

WHEREAS, MonoSol, in the Commercial Exploitation Agreement, has granted certain exclusive rights to Indivior Inc. and its Affiliates, including an exclusive license under MonoSol patents to use and sell Suboxone® (buprenorphine and naloxone) film, a pharmaceutical product containing the active ingredients buprenorphine hydrochloride and naloxone hydrochloride; and

WHEREAS, Indivior Inc., in the Commercial Exploitation Agreement, has granted certain exclusive rights to MonoSol including an exclusive right to manufacture Suboxone® (buprenorphine and naloxone) film, a pharmaceutical product containing the active ingredients buprenorphine hydrochloride and naloxone hydrochloride; and

WHEREAS, the Parties seek to clarify the scope of their relationship, including certain rights and obligations that may be impacted by the possible sale, offer for sale, or distribution of a Generic Buprenorphine Product, as defined below, in the United States, by a Third Party, as defined below.

NOW, THEREFORE, for good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, the Parties intending to be legally bound do hereby agree as follows:

**ARTICLE 1: DEFINITIONS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The capitalized terms used in this Agreement shall have the meanings defined in this Article or elsewhere in this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Unless the context requires otherwise, words referred to in the singular include the plural and vice versa, the words "include," "includes" and "including" will be deemed to be followed by the phrase "without limitation" (unless already present), the words "herein," "hereof' and "hereunder," and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, and the word "or" is used in the inclusive sense (and/or).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The term "Affiliate" shall mean, with respect to a Party, any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with such Party at any time for so long as such entity or person controls, is controlled by or is under common control with such Party. For purposes of this definition, "control" means (a) ownership, directly or through one or more intermediaries, of (i) more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or (ii) more than fifty percent (50%) of the equity interests in the case of any other type of legal entity or status as a general partner in any partnership, or (b) any other arrangement whereby an entity or person has the right to elect a majority of the board of directors or equivalent governing body of a corporation or other entity or the right to direct the management and policies of a corporation or other entity.

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The term "Approved Suboxone Product" shall mean any product sold, offered for sale or distributed pursuant to New Drug Application ("NDA") No. 22-410.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.5.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The term "Generic Buprenorphine Product" shall mean a film dosage drug product containing the buprenorphine and naloxone moieties that is sold, offered for sale or distributed under an ANDA or an application pursuant to 21 U.S.C. § 355(b)(2) that refers to the Approved Suboxone Product as the reference-listed drug.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.6.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The term "Third Party" shall mean any entity or person that is not a Party or an Affiliate of a Party.

**ARTICLE 2: PAYMENTS FROM INDIVIOR TO MONOSOL**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Five (5) business days following the date the Parties fully execute this Agreement, Indivior agrees to make a non-refundable payment of USD$[\*\*\*] ([\*\*\*] U.S. dollars) to MonoSol.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; On February 1, 2018, Indivior will make a non-refundable payment of USD$[\*\*\*] ([\*\*\*] U.S. dollars) to MonoSol.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Starting on January 1, 2018, Indivior shall make [\*\*\*] payments to MonoSol of USD$[\*\*\*] ([\*\*\*] U.S. dollars) [\*\*\*]; *provided, however*, that the payment obligation on Indivior pursuant to this Section shall immediately cease, and be null and void, on the first date a Third Party sells, offers for sale, or distributes an unlicensed Generic Buprenorphine Product in the United States.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Starting on April 1, 2019, and through and including the first date a Third Party sells, offers for sale, or distributes a Generic Buprenorphine Product in the United States, Indivior shall make [\*\*\*] payments equal to [\*\*\*] of the net revenue earned by Indivior on sales of Suboxone sublingual film in the United States for the previous [\*\*\*] with payment made within [\*\*\*] after the start of the current [\*\*\*], where:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(A)&nbsp;&nbsp;&nbsp;&nbsp;the total amount Indivior pays to MonoSol in a calendar year shall be not less than USD$[\*\*\*] ([\*\*\*] U.S. dollars) ("Minimum Annual Payment"), and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(B)&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding the foregoing, Indivior's obligation to make the Minimum Annual Payment shall immediately cease, and be null and void, once the total amount of the payments made from Indivior to MonoSol under this Article 2.4 is equal to USD$[\*\*\*] ([\*\*\*] U.S. dollars).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(C)&nbsp;&nbsp;&nbsp;&nbsp;MonoSol shall have annual audit rights for royalty payments as outlined in the Commercial Exploitation Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; On the date a new patent issues to MonoSol or a new claim is asserted by MonoSol from an existing patent and/or a divisional, reissue, continuation, or continuation-in-part of a MonoSol patent application with new claims that cover Suboxone® (buprenorphine and naloxone) film, Indivior shall make a one-time, non-refundable payment of USD$[\*\*\*] ([\*\*\*] U.S. dollars) to MonoSol in [\*\*\*] installments; provided, that the applicable conditions to payment are satisfied. The [\*\*\*] installment of USD$[\*\*\*] ([\*\*\*] U.S. dollars) shall be paid within [\*\*\*] days of the date a new patent issues to MonoSol or a new claim is asserted by MonoSol from an existing patent and/or a divisional, reissue, continuation, or continuation-in-part of a MonoSol patent application with new claims that cover Suboxone® (buprenorphine and naloxone) film, and the [\*\*\*] installment of USD$[\*\*\*] ([\*\*\*] U.S. dollars) shall be paid within [\*\*\*] days after the first (1st) anniversary of the issuance provided the new patent or new claim is valid and enforceable on this anniversary date. Within [\*\*\*] days of the date a second new patent issues to MonoSol or a second new claim is asserted by MonoSol from a different existing patent and/or a divisional, reissue, continuation, or continuation-in-part of a MonoSol patent application with new claims that cover Suboxone® (buprenorphine and naloxone) film, Indivior shall make a [\*\*\*] payment of USD$[\*\*\*] ([\*\*\*] U.S. dollars) to MonoSol in [\*\*\*] installments; provided, that the applicable conditions to payment are satisfied. The [\*\*\*] installment of USD$[\*\*\*] ([\*\*\*] U.S. dollars) shall be paid within [\*\*\*] days of the date a second new patent issues to MonoSol or a second new claim is asserted by MonoSol from a different existing patent and/or a divisional, reissue, continuation, or continuation-in-part of a MonoSol patent application with new claims that cover Suboxone® (buprenorphine and naloxone) film, and the [\*\*\*] installment of USD$[\*\*\*] ([\*\*\*] U.S. dollars) shall be paid within [\*\*\*] days after the first (1st) anniversary of the issuance provided the second new patent or second new claim is valid and enforceable on this anniversary date. [\*\*\*].

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.6.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In the event a Third Party sells, offers for sale, or distributes a licensed Generic Buprenorphine Product in the United States pursuant to a settlement agreement with Indivior prior to January 1, 2023, then Indivior will make a one-time non-refundable payment equal to USD$[\*\*\*] ([\*\*\*] U.S. dollars), minus total cumulative payments paid by Indivior to MonoSol under this Agreement as of the first date of entry of said licensed Third Party Generic Buprenorphine Product, paid in [\*\*\*] installments by January 1, 2023, beginning [\*\*\*] days following the first date of entry of a licensed Third Party Generic Buprenorphine Product. Notwithstanding the foregoing, the payment obligation on Indivior pursuant to this Section shall cease, and be null and void, if the sale, offer for sale, or distribution of a licensed Third Party Generic Buprenorphine Product is triggered by the sale, offer for sale, or distribution of an unlicensed Third Party Generic Buprenorphine Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.7.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; On January 1, 2023, Indivior will make a non-refundable payment of USD$[\*\*\*] ([\*\*\*] U.S. dollars) to MonoSol; provided, however, that if the first date a Third Party sells, offers for sale, or distributes an unlicensed Generic Buprenorphine Product in the United States occurs before January 1, 2023, then the payment obligation of Indivior pursuant to this Section shall immediately cease, and be null and void.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.8.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Notwithstanding the foregoing payment provisions, the Parties agree and acknowledge that the total cumulative amounts payable under the terms of this Agreement by Indivior to MonoSol shall be capped at USD$[\*\*\*] ([\*\*\*] U.S. dollars), provided the new patents or new claims pursuant to Article 2.5 hereof are issued, or be capped at USD$[\*\*\*] ([\*\*\*] U.S. dollars), if no new patents or new claims pursuant to Article 2.5 hereof are issued, and shall not, under any circumstances, exceed the applicable stated amount.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.9.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Notwithstanding the payment obligations set forth herein, if, at any time during the term of this Agreement, a Third Party sells, offers for sale, or distributes an unlicensed Generic Buprenorphine Product in the United States where Indivior has legal recourse to challenge the sale, offer for sale, or distribution of said product at the United States Court of Appeals for the Federal Circuit ("At-Risk Launch"), then any payments that would otherwise have become due under this Agreement by Indivior from the date of such At-Risk Launch through the date that the Federal Circuit Court of Appeals issues a ruling enjoining said Third Party from selling, offering for sale or distributing a Generic Buprenorphine Product ("At-Risk Launch Period") shall immediately cease, and be null and void, such that no further payments under this Agreement from Indivior to MonoSol shall be required to be made during the At-Risk Launch Period. If [\*\*\*], any payments cancelled under this Agreement during such At-Risk Launch Period, shall be paid to MonoSol by Indivior [\*\*\*] within [\*\*\*] days of [\*\*\*]. For clarity, Indivior's obligation to pay MonoSol for any payments cancelled during the At-Risk Launch period shall not exceed [\*\*\*]. For further clarity, once the At-Risk Launch Period ends, all payments owed by Indivior to MonoSol under this Agreement shall be reinstated.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.10.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Notwithstanding the payment obligations set forth herein, if, at any time during the term of this Agreement, a Third Party sells, offers for sale, or distributes an unlicensed Generic Buprenorphine Product in the United States where Indivior has no legal recourse to challenge the sale, offer for sale, or distribution of said product at the Federal Circuit Court of Appeals, then Indivior's payment obligations under this Agreement shall immediately cease, and be null and void, such that no further payments under this Agreement from Indivior to MonoSol shall be required. For the sake of clarity, the Commercial Exploitation Agreement shall remain in effect for the term thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.11.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indivior agrees to use reasonable efforts, with the objective of prevailing, to exercise its rights to enforce and protect intellectual property relating to Generic Buprenorphine Products. If an unauthorized and/or unlicensed Third Party sells, offers for sale, or distributes a Generic Buprenorphine Product in the United States, but later discontinues such activities as a result of Indivior's exercising its rights to enforce and protect intellectual property regarding those activities, whether through (1) the issuance of an injunction or damages award from a court of competent jurisdiction, or (2) the resolution of intellectual property rights in an agreement between the Third Party and Indivior, all payments owed to MonoSol under this Article 2 shall be retroactively reinstated.

**ARTICLE 3: LICENSE AND ENFORCEMENT**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Subject to the limitations of Article 3.2 below, if and to the extent that Indivior does not already hold the sole, exclusive and irrevocable right and entitlement to pursue, assert, enforce, litigate, settle and resolve all causes of action (whether known or unknown or whether currently pending, filed or otherwise) and all other enforcement rights involving Generic Buprenorphine Products ("the Enforcement Rights"), MonoSol, for itself and its Affiliates, hereby confirms that Indivior and its Affiliates hold and may exercise all such Enforcement Rights, and in connection with any settlement or other resolution of any such causes of action may sublicense rights to make, have made, use, sell or import a Generic Buprenorphine Product under any of the MonoSol patents, present and future, licensed to Indivior under the Commercial Exploitation Agreement. At

------

the request of Indivior, MonoSol will execute and deliver such other instruments and do and perform such other acts as may be necessary or desirable for effectuating or confirming the provisions of this Article. For clarity, this foregoing Article 3.1 does not alter or affect the supply and/or manufacturing arrangements between Indivior and MonoSol, as provided for under the Commercial Exploitation Agreement, with respect to the Approved Suboxone Product, and this foregoing Article 3.1 does not change the rights and obligations of Indivior and MonoSol under the Commercial Exploitation Agreement with respect to MonoSol's supply and/or manufacturing of the Approved Suboxone Product. If Indivior terminates this Agreement, and Indivior seeks to engage another party to manufacture the Approved Suboxone Product, nothing in this Agreement prevents MonoSol from seeking to enforce its intellectual property rights in suing either Indivior or that third party manufacturer, or both, consistent with the Commercial Exploitation Agreement, nor does anything in this Agreement prevent Indivior from contesting any such suit brought by MonoSol. For further clarity, nothing in this Agreement prohibits MonoSol, upon termination of the Commercial Exploitation Agreement, from manufacturing any product in the Field, as defined in the Commercial Exploitation Agreement, for anyone anywhere in the world, nor does anything in this Agreement prevent Indivior from contesting MonoSol's entitlement to engage in such manufacturing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; MonoSol agrees not to assert its rights regarding any agreements by Indivior with any Third Party under which a sale, offer for sale, or distribution of a Generic Buprenorphine Product by that Third Party would occur on or after [\*\*\*]. For the sake of clarity, MonoSol does not waive any such rights regarding any agreements by Indivior with any Third Party under which a sale, offer for sale, or distribution of a Generic Buprenorphine Product by a Third Party would occur prior to [\*\*\*].

**ARTICLE 4: BREACH AND INDEMNIFICATION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indivior hereby agrees to indemnify MonoSol and to hold it harmless with respect to all costs, including attorneys' fees and expert fees, and any penalties or monetary damages arising out of or relating to any investigation, enforcement action, and administrative or court proceeding regarding or relating to this Agreement under the Clayton Act § 7A, 15 U.S.C. § 18a and its implementing rules and regulations. For clarity, this Article 4.1 does not apply to any pre-existing investigations, enforcement actions, and administrative or court proceedings and applies only to the terms of this Agreement.

**ARTICLE 5: MISCELLANEOUS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Confidentiality</u>: Except as (a) required by statute, ordinance or regulation, (b) required pursuant to compulsory legal process, or (c) necessary for the exercise of the rights granted to the Parties under this Agreement, neither the Parties nor their Affiliates shall publicly announce or otherwise disclose to Third Parties any of the terms of this Agreement without the prior written approval of the other Party, not to be unreasonably withheld, conditioned or delayed. If a Party intends to disclose information relating to this Agreement because it is required to do so in order to comply with a statute, ordinance or regulation or compulsory legal process, including, without limitation, its reporting requirements under the Securities Exchange Act of 1934, as amended, such Party shall give the other Party at least three (3) business days' prior notice in writing of the text of the intended disclosure, unless such statute, ordinance, regulation or compulsory legal process would require earlier disclosure, in which event the notice shall be provided as early as practicable. A Party that determines that it is required to file this Agreement with the Securities and Exchange Commission or any other governmental authority, including any court proceeding, shall request confidential treatment with respect to the terms of this Agreement, shall consult in good faith with the other Party regarding such confidential treatment and shall use commercially reasonable efforts to have redacted from any publicly available version such provisions as the Parties may agree. Notwithstanding anything to the contrary above, each Party may disclose the terms of this Agreement to its respective Affiliates, and its and their respective insurers, lenders, attorneys, accountants, and prospective and actual acquirers, subject to such Affiliates, insurers, lenders, attorneys, accountants and prospective and actual acquirers undertaking to keep the terms of this Agreement strictly confidential in accordance with confidentiality terms at least as restrictive as the terms hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Notice</u>: Any notice or other communication to be given under this Agreement shall be given in the same manner identified in Article 2.1 of the Commercial Exploitation Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Modification</u>: This Agreement may only be amended, modified, or varied by the Parties by an instrument in writing signed on behalf of each of the Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Waiver</u>: No waiver of a breach, failure of any condition, or any right or remedy, contained in or granted by the provisions of this Agreement shall be effective unless it is in writing and signed by the Party waiving the breach, failure, right or remedy. No waiver of any breach, failure, right or remedy shall be deemed a waiver of any other breach, failure, right or remedy, whether or not similar, nor shall any waiver constitute a continuing waiver unless the writing so specifies.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.5.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>No Agency</u>: Nothing in this Agreement shall constitute or be deemed to constitute the creation of a partnership, agency, or employer/employee relationship between the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.6.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Entire Agreement</u>: This Agreement represents the entire understanding and agreement between the Parties with regard to the matters addressed herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.7.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Enforceability</u>: If any provision of this Agreement is held by any court or other competent authority to be invalid or unenforceable in whole or in part for any reason, the Parties agree to use commercially reasonable efforts to negotiate a provision, in replacement of the provision held illegal, unenforceable, or invalid, that is consistent with applicable law and accomplishes, as nearly as possible, the original intention of the Parties with respect thereto. In any event, the provision held illegal, unenforceable, or invalid shall be deemed severed from this Agreement and the validity of the other provisions and the remainder of the provision in question shall not be affected.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.8.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Counterparts</u>. This Agreement may be executed in any number of counterparts, and through pdf, facsimile or photocopy signatures. Each counterpart shall be deemed an original instrument, but all counterparts together shall be considered as one and the same agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.9.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Governing Law</u>: This Agreement and the rights and obligations of the Parties under this Agreement shall be governed and construed in accordance with the laws of the State of Delaware, without regard to its choice-of-law or conflicts-of-law principles that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction, and the Parties agree to submit to the jurisdiction of the federal courts located in the State of Delaware.

[SIGNATURE PAGE FOLLOWS]

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IN WITNESS WHEREOF, the Parties, through their authorized officers, have executed this Agreement as of the Signing Date.

**Signed for and on behalf of Indivior Inc.:**

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| | |
|:---|:---|
| By: | */s/ Shaun Thaxter* |
| Name: | Shaun Thaxter |
| Title: | CEO |
| Date: | 9/23/17 |

---

**Signed for and on behalf of Indivior UK Limited:**

---

| | |
|:---|:---|
| By: | */s/ Richard Simkin* |
| Name: | Richard Simkin |
| Title: | CCO |
| Date: | 9/23/17 |

---

**Signed for an on behalf of MonoSol Rx, LLC:**

---

| | |
|:---|:---|
| By: | */s/ Keith Kendall* |
| Name: | Keith Kendall |
| Title: | CEO |
| Date: | 9/24/17 |

---

## Exhibit 4.16

**Exhibit 4.16.1**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**PACKAGING AND SUPPLY AGREEMENT**

**BETWEEN**

**INDIVIOR UK LIMITED**

**AND**

**SHARP CORPORATION**

------

**<u>PACKAGING AND SUPPLY AGREEMENT</u>**

This Packaging and Supply Agreement (the "Agreement") dated as of the date of last signature below (the "Effective Date"), is entered into by and between Sharp Corporation, a corporation organized and existing under the laws of the Commonwealth of Pennsylvania having its principal office at 7451 Keebler Way, Allentown, Pennsylvania 18106 ("Sharp") and lndivior UK Limited (CO No. 7183451), a corporation organized and existing under the laws of England and Wales having its registered address at 103-105 Bath Road, Slough, Berkshire SL1 3UH, United Kingdom ("Manufacturer").

**<u>WITNESSETH:</u>**

WHEREAS. Manufacturer desires to engage Sharp on an exclusive basis, to package and supply to Manufacturer the product(s) listed on <u>Exhibit A</u> in the Territories; and

WHEREAS, Sharp desires to accept such exclusive engagement under the terms and conditions set forth in this Agreement;

NOW, THEREFORE, in consideration of these premises and the covenants, agreements and stipulations hereinafter set forth, and for other good and valuable consideration the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, agree as follows:

**1.<u>Definitions.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1"Applicable Law" shall mean the FDCA and all other laws, regulations, rules and guidelines promulgated by a Regulatory Authority relating to the packaging of the Products and the storage of the Products in the Territories, including, but not limited to, current Good Manufacturing Practices ("GMP") as specified in the United States Code of Federal Regulations, as amended from time to time, and similar applicable GMP requirements of other Regulatory Authorities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2"Brand Image" shall have the meaning set forth in Section 8.1

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.3"Facilities" shall mean Sharp's manufacturing facilities located at [\*\*\*] (primary facility) and [\*\*\*] (alternate facility) and/or any other facility as may be mutually agreed by the parties from time to time during the term.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.4"FDA" shall mean the United States Food and Drug Administration, and any successor agency having substantially the same functions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.5"FDCA" shall mean the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 321 et seq., as amended from time to time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.6"Firm Order" shall mean a firm order as described in Section 4.2(b).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.7"Forecast" shall have the meaning set forth in Section 4.2(a).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.8"Manufacturing Carrier" shall mean a carrier identified by Manufacturer to ship Packaged Products upon receipt of them from Sharp in accordance with Section 5.2.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.9"MHRA" shall mean the Medicines and Healthcare products Regulatory Agency.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.10"Packaging Materials" shall mean the Primary Packaging Materials and the Secondary Packaging Materials.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.11"Packaged Product(s)" shall mean the Products in packaged form.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.12"Price" shall mean the price to be paid by Manufacturer to Sharp for the Packaged Products as set forth on <u>Exhibit A</u> and as may be adjusted in accordance with Section 5.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.13"Primary Packaging Materials" shall mean the components and other materials utilized by Sharp in connection with the packaging of the Products supplied by Manufacturer.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.14"Products" shall mean the products described on <u>Exhibit A</u> to be manufactured by or on behalf of Manufacturer and shipped in bulk to Sharp for storage, serialization, packaging and labeling. Upon the parties' mutual written consent, the parties may from time to time during the Term amend <u>Exhibit A</u> to remove, add or substitute Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.15"Purchase Order" shall have the meaning set forth in Section 4.2(b).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.16"Regulatory Authority" shall mean any agency, authority, department, regulatory body or other instrumentality of any government or country or of any national, federal, state, provincial, regional, county, city or other political subdivision of any such government or any supranational organization of which any such country is a member that has the authority to regulate any aspect of the development, market approval, sale, distribution or use of the Product, the Packaging Materials or the Packaged Product in the Territories. The term "Regulatory Authority" shall include, without limitation, the FDA and MHRA.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.17"Revised Purchase Order" shall have the meaning set forth in Section 4.2(b).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.18"Secondary Packaging Materials" shall mean the components and other materials utilized by Sharp in connection with the packaging of the Products and supplied by Sharp on Manufacturer's behalf.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.19"Specifications" shall mean the specifications to be followed by Sharp in connection with obtaining and using the Packaging Materials and the storage, labeling and packaging of the Products and the storage and supply of the Packaged Products, which shall include standards of quality control, quality assurance and sanitation to be followed by Sharp. The Specifications are attached hereto as <u>Exhibit B</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.20"Start-Up Activities" shall have the meaning set forth in Section 3.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.21"Territories" shall mean the countries listed on <u>Exhibit C</u> hereto. <u>Exhibit C</u> may be amended, from time to time, by mutual written consent of the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.22"Term," "Initial Term" and "Subsequent Term" shall have the meanings set forth in Section 11.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.23"Tooling" shall mean the tooling made for the packaging and labeling of the Products.

The definitions in this Section 1 shall apply equally to both the singular and plural forms of the terms defined. The words "include," "includes" and "including" shall be deemed to be followed by the phrase "without limitation." All references herein to Sections and Exhibits shall be deemed references to Sections of this Agreement and Exhibits to this Agreement unless the context shall otherwise require.

**2.<u>Nature of Engagement.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1<u>Engagement</u>. Manufacturer hereby engages Sharp, and Sharp hereby accepts Manufacturer's engagement, as Manufacturer's exclusive independent contractor to store, serialize, package and label the Products and store and supply the serialized Packaged Products in accordance with the terms and conditions of this Agreement. Manufacturer agrees that Sharp shall be the sole supplier of such services with respect to the Products and the Packaged Products on the terms set forth herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2<u>Independent Contractor</u>. Sharp shall be deemed an Independent contractor with respect to the terms and provisions of this Agreement and shall not in any respect act as an agent or employee of Manufacturer. All persons employed by Sharp in connection with the storage, labeling, packaging, control, and supply of the Products and the Packaged Products to Manufacturer shall be employees or agents of Sharp and under no circumstances shall Sharp or any of its employees or agents be deemed to be employees or agents of Manufacturer.

**3.<u>Start-Up Activities.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1<u>[Reserved.]</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2<u>Purchase and Installation of Equipment, Molds and Tooling</u>. Sharp shall be responsible for installing at its Facilities any and all new equipment, molds and/or modifications to existing equipment and molds necessary for the packaging and labeling of the Products and for preparing the Packaged Products for shipment, and all costs and

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expenses associated therewith; provided, however, that Manufacturer shall be responsible for the costs and expenses associated with the development and manufacturing of the Tooling. Sharp shall maintain and store the Tooling at the Facilities and shall retain all right, title and interest in and to the Tooling during and after the Term; provided, however that during the Term, Sharp shall use the Tooling only in connection with the packaging of Products for Manufacturer and shall not modify the Tooling without the consent of Manufacturer, such consent not to be unreasonably withheld, conditioned or delayed. Notwithstanding the foregoing, in the event that the Agreement is terminated pursuant to Sections 11.2 or 13.2, Sharp shall, within thirty (30) days of the Effective Termination Date, transfer title of the Tooling to Manufacturer or one of Manufacturer's affiliated entitles, at Manufacturer's discretion. Notwithstanding any other language to the contrary in this Agreement, the parties agree that any Manufacturer-affiliated entity to whom title of the Tooling is transferred shall be deemed a third party beneficiary of this Agreement solely with respect to the preceding sentence and shall be entitled to rely upon and enforce the preceding sentence as though it were a party to this Agreement.

**4.<u>Agreement to Supply; Forecasts; Purchase Orders.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1<u>Generally</u>. During the Term, Sharp shall store, serialize, package and label the Products and store and supply to Manufacturer the serialized Packaged Products, all in accordance with the Specifications, Applicable Law, and the terms of this Agreement, and Manufacturer shall pay for the Packaged Products in accordance with Section 5 of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2<u>Forecasts and Purchase Orders</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)Beginning on the date hereof and hereafter on or prior to the fifth day preceding each calendar month of the Term, Manufacturer shall provide Sharp with a twelve (12) month rolling forecast (each, a "Forecast") of Manufacturer's quantity and delivery date requirements for the Packaged Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)The first three (3) months of each Forecast shall constitute a firm order ("Firm Order") and shall be binding upon Manufacturer (whether or not Sharp receives a Purchase Order in connection with such three month period). For the purposes of ordering Secondary Packaging Materials and scheduling capacity, Manufacturer shall provide Sharp with purchase orders (each, a "Purchase Order") in connection with such three (3) month period for the Packaged Products to be supplied during such period, which shall specify the quantities and delivery dates for the Packaged Products for such period. Sharp shall ensure it has sufficient packaging materials necessary to package the volume of Product in the Firm Order. So long as the quantity and delivery date requirements set forth in the Purchase Orders during such three (3) month period are within a tolerance range of minus/plus ten percent (-10%/+10%) of the Firm Order (the "Tolerance Range"), Sharp shall respond with an order acknowledgment within five (5) business days. If the quantity und delivery date requirements set forth In the Purchase Orders are outside the Tolerance Range, or in the event that Manufacturer desires to subsequently amend a Purchase Order, then the parties shall cooperate in good faith to develop a mutually agreeable purchase order (a "Revised Purchase Order") at least thirty (30) days prior to the scheduled start of production; provided, however that in the event a Revised Purchase Order is not agreed upon by the parties, both parties shall be obligated to perform in accordance with the Firm Order, within the tolerances set forth in the Tolerance Range.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)Nothing printed or written on any Purchase Order or Sharp order acknowledgement or on any other similar form or document shall modify or expand either party's obligations under this Agreement. In the event of any inconsistency between the terms of any Purchase Order or Sharp order acknowledgement, on the one hand, and the terms of this Agreement, on the other hand, the terms of this Agreement shall prevail.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3<u>Production Requirements</u>. Subject to the terms of this Agreement, Sharp shall (a) devote the necessary production capacity to fulfill the quantity and delivery date requirements set forth in each confirmed Purchase Order, and (b) use commercially reasonable efforts to make available sufficient additional production capacity, subject to overtime charges, to support all Forecasts; provided, that the parties shall cooperate in good faith to reach a mutually agreeable accommodation with respect to Sharp's available production capacity in the event that a Forecast is exceeded.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4<u>Manufacturer's Supply Obligations</u>. Sharp's obligations to fulfill any Purchase Order are subject to Manufacturer's obligation to provide Sharp with the following items within the following time periods:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)At least five (5) weeks prior to Sharp's commencement of the production of the Packaged Products, any text, graphics or other artwork to be printed by Sharp on the Packaging Materials, all of which shall be in conformity with all Applicable Laws (the foregoing notwithstanding, the parties agree that with respect to the initial product launch, the parties will cooperate to commence production of the Packaged Products as expeditiously as practicable after receipt of FDA approval);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)At least four (4) weeks prior to Sharp's commencement of the production of the Packaged Products, any Packaging Materials that are to be supplied by Manufacturer;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)At least three (3) weeks prior to Sharp's commencement of the production of the Packaged Products, the lot and expiry information for the Products; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)At least two (2) weeks prior to Sharp's commencement of the production of the Packaged Products, the Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.5<u>Storage Facilities; Inventory</u>. Sharp agrees to provide adequate storage space for the Products and the Packaged Products. Sharp will maintain adequate inventories of materials on hand or with suppliers to accommodate variations in packaging that may be required by Manufacturer hereunder, including cold chain where required.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.6<u>Packaged Product Samples</u>. Sharp shall provide Manufacturer with representative lot samples of Packaged Products and/or printed packaging component samples promptly upon request. Such Packaged Product samples shall be shipped to Manufacturer in accordance with the provisions set forth in Section 5.2.

**5.<u>Price; Payment; Shipping Instructions.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1<u>Determination of Prices</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)The Price to be paid to Sharp by Manufacturer for the supply of the Packaged Products shall be as set forth on <u>Exhibit A</u>. The Price will not be increased prior to January 1, 2019 except as expressly set forth below. Thereafter, the Parties will review the Price on an annual basis. Sharp shall submit to Manufacturer revised pricing, reflecting increases or decreases in labor or Packaging Material costs for the upcoming year at least sixty (60) days prior to the date on which such increase or decrease shall become effective, along with documentation in reasonable detail to support such increase or decrease. Manufacturer and Sharp shall execute an amended <u>Exhibit A</u> to this Agreement to reflect the adjustment to the Price. Sharp may adjust the Prices set forth on <u>Exhibit A</u> before January 1, 2019 only if a change in Packaging Materials costs would cause the final price per unit of Packaged Product to increase by [\*\*\*] percent ([\*\*\*]%) or more, and Sharp shall adjust the Prices set forth on Exhibit A before January 1, 2019 if a change in Packaging Materials costs would cause the final price per unit of Packaged Product to decrease by [\*\*\*] percent ([\*\*\*]%) or more, with each such adjustment to be made in accordance with the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)Sharp shall be entitled to increase, and shall decrease, the Price for labor charges and any other costs incurred by Sharp as a result of any Revised Purchase Order, whether it relates to quantities expressed or delivery dale requirements; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)In the event that the Packaging Materials cost increases, Sharp shall be entitled to increase the Price by the amount of the actual increase in such costs no more than once per calendar year. ln the event that the Packaging Materials cost decreases, Sharp shall decrease the Price by the amount of the actual decrease in such costs no less frequently than once per year.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Prior to the commencement of any Subsequent Term, the parties shall negotiate in good faith the Price that shall apply to such Subsequent Term. The parties shall take into account in any such negotiations Sharp's production rates and costs of production as of the end of the then current Term.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)The Prices set forth on <u>Exhibit A</u> do not include use, consumption, or excise taxes of any taxing authority. The amount of such taxes, if any, will be added to the Price of the Packaged Products in effect at the time of

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shipment thereof and shall be reflected in the invoices submitted to Manufacturer by Sharp pursuant to Section 5.3. Manufacturer shall pay the amount of such taxes to Sharp in accordance with the payment provisions relating to shipments of Packaged Products set forth in Section 5.3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.2<u>Shipping</u>. Sharp shall arrange for the shipment of the Packaged Products in accordance with Manufacturer's instructions, all of which shipments shalt be made F.O.B., Sharp's loading docks at the Facilities. For purposes of this Agreement, F.O.B. shall have the meaning ascribed thereto by the Uniform Commercial Code of the State of Delaware. Manufacturer shall provide Sharp with a list of the Manufacturer Carriers and Sharp shall schedule freight pick up by a Manufacturer Carrier, load the Manufacturer Carrier's trailer and complete any necessary documentation relating thereto. Manufacturer shall pay outbound freight delivery costs.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3<u>Invoices</u>. Sharp shall submit invoices to Manufacturer for all shipments of Packaged Products hereunder upon delivery or such Packaged Products to the Manufacturer Carrier at the Facilities (which invoices shall be directed by Sharp personnel to Manufacturer's Accounts Payable Department, or to such other persons, departments or locations as Manufacturer may instruct from time to time), and each invoice shall be payable within forty five (45) days of the date of such invoice.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.4<u>Risk of Loss</u>. Title to all Packaged Products, all work in process to produce Packaged Products and/or any other property of Manufacturer, including Primary Packaging Materials, shall at all times remain with Manufacturer; provided, however, that when such Packaged Product or Product is in the possession of Sharp, Sharp shall not be liable for risk of loss or damage to any Packaged Product, any Product, any work in process to produce Packaged Products or any other property of Manufacturer, except in the case of negligence or willful acts or omissions by Sharp.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.5<u>Non-Conforming Packaged Products and Quantitative Defects</u>. Manufacturer shall have the right, within sixty (60) days of Sharp's delivery of Packaged Products to the Manufacturer Carrier, to give Sharp written notice of rejection of the portion of such shipment of Packaged Products that fails to meet the Specifications or which otherwise breaches Sharp's warranties, covenants and obligations under this Agreement. Sharp, at its sole cost and expense, shall provide Manufacturer with any missing quantities and/or replace as soon as practicable any non-conforming Packaged Products. Manufacturer shall replace, to the extent necessary, applicable Products for such non-conforming Packaged Products and Sharp shall reimburse Manufacturer for its cost of replacing such Products, provided that Sharp's aggregate liability for such costs shall not exceed [\*\*\*] Dollars (US$[\*\*\*]) in the aggregate in any given year under this Agreement. Any claim of a non-conforming shipment must be made in writing to Sharp within the sixty (60) day period set forth above or it shall be deemed to have been waived by Manufacturer.

**6.<u>Quality Control; Access; Inspection; Samples.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1<u>Modification of Specifications</u>. The Specifications may not be modified or changed without the mutual written agreement of the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2<u>Storage Requirements</u>. Sharp shall use the Products and the Packaging Material on a first in, first out basis and shall not use either the Products or the Packaging Material beyond the shelf life required under any Applicable Law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3<u>Notices Regarding Packaging Materials</u>. Sharp shall promptly contact Manufacturer, c/o Manufacturer's Quality Assurance Department (or such other persons or departments as Manufacturer may instruct) in the event Sharp considers any current Packaging Material to be nonconforming with the Specifications or Applicable Law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4<u>Quality Tests and Checks</u>. Sharp shall perform all in-process and finished product tests or checks necessary to assure the quality of the Packaged Products and any tests or checks required by the Specifications or Applicable Law. For purposes of this Agreement, such tests shall be considered routine and shall be performed at Sharp's expense. All tests and test results shall be performed, documented and summarized by Sharp in accordance with the Specifications and Applicable Law. The parties hereto will negotiate in good faith any unanticipated burdens resulting from changes made to any Applicable Law after the date hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5<u>Production Codes; Records</u>. For the period set forth in Section 6.9, Sharp shall maintain detailed records on Packaging Material usage and Packaged Product production, including code dates and shipping information relating to the Packaged Products, so that the Packaged Products can be traced in case of a recall. Sharp's Packaged Product records shall be sufficient such that Sharp shall be capable of responding to Packaged Product inquiries by

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Manufacturer within twenty-four (24) hours of notification, including providing the code date and the location of the Packaged Products in question.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6<u>Recalls; Withdrawals</u>. Manufacturer shall have sole responsibility for initiating and managing any recall or withdrawal of the Packaged Products, and shall bear all costs and expenses relating thereto. At Manufacturer's cost and expense, Sharp shall provide such assistance as Manufacturer may reasonably request in connection with any such withdrawal or recall. Upon receiving from any authority having jurisdiction any direction to withdraw or recall any Packaged Product from the market, the receiving party shall promptly notify the other party. Sharp shall have no liability with respect to any recall or withdrawal of Packaged Products except to the extent of Sharp's negligence or willful misconduct or breach of the warranties set forth in Section 7.1, in which case Sharp's liability shall be limited to [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.7<u>Maintenance of Facilities</u>. In the event Sharp fails or anticipates it will fail to maintain the Facilities in accordance with the Specifications and all Applicable Laws, or in the event Sharp receives any notice from any Regulatory Authority with respect to its maintenance of the Facilities and only if such maintenance or notice effects the Products or Packaged Products, Sharp shall promptly notify Manufacturer, c/o Manufacturer's Quality Assurance Department (or such other persons or departments as Manufacturer may instruct), provide copies of such notice to Manufacturer and, if such notice relates specifically to the Products or Packaged Products, provide a copy of Sharp's proposed response to such authority for review and comment by the Manufacturer before submission to such authority.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.8<u>Inspections and Audits</u>. Manufacturer shall have access at reasonable times and with reasonable frequency to Sharp's Facilities for the purpose of conducting inspections of, performing quality control audits with respect to, or witnessing, the processing, storage or transportation of Products and Packaged Products or Packaging Materials, and Manufacturer shall have access at reasonable times and with reasonable frequency to the results of any tests relating to the Packaged Products performed by Sharp or at Sharp's direction. Sharp shall use its reasonable efforts to ensure that Manufacturer has similar access to the facilities, data and records of Sharp's suppliers or agents. Such inspections, audits and visits shall be conducted by Manufacturer's personnel upon reasonable notice and during normal business hours.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.9<u>Retention of Samples and Records</u>. Sharp shall retain and, upon request at reasonable times and with reasonable frequency by Manufacturer, make available to Manufacturer, (i) copies of the quality control records maintained in accordance with Section 6.5 and otherwise in relation to the Packaged Products, (ii) copies of testing results of all the tests performed in relation to the Packaged Products, and (iii) samples of the Packaging Materials. All quality control and assurance records will be maintained by Sharp for one (1) year following the Packaged Product expiration date or such longer time period as may be required by Applicable Law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.10<u>Government Inspections; Seizures and Recalls</u>. If any Regulatory Authority makes an inspection at Sharp's premises, seizes Products or Packaged Products or requests a recall of Packaged Products, Sharp shall promptly notify Manufacturer's Quality Assurance Department (or such other persons or departments as Manufacturer may instruct), and Sharp shall take such actions as may be required under the Specifications or as may be reasonably requested by Manufacturer; provided, however, that Sharp shall not be required to take any actions in contravention of any Applicable Law. Sharp shall promptly send duplicate reports relating to such inspections to Manufacturer c/o Manufacturer's Quality Assurance Department (or such other persons or departments as Manufacturer may instruct).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.11<u>Legal and Regulatory Filings and Requests</u>. Sharp and Manufacturer shall cooperate and be diligent in responding to all requests for information from, and in making all required filings, at Manufacturer's expense, with any Regulatory Authority having jurisdiction to make such requests or require such filings. Sharp shall, at its own expense, obtain and comply with all licenses, consents, permits and regulations which may from time to time be required by an appropriate Regulatory Authority in the Territories listed on Exhibit C (as in effect on the Effective Date) with respect to the performance of its obligations hereunder. The parties agree that in the event additional Territories are added to Exhibit C, the parties wilt mutually agree the allocation of expenses incurred to obtain and comply with any licenses, consents, permits or regulations with respect thereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.12<u>[Reserved.]</u>

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.13<u>Complaints</u>. In connection with any Packaged Product complaints forwarded by Manufacturer to Sharp, Sharp shall promptly conduct an investigation of such complaint (including reviewing its records) detailing the description of the event, root cause, and corrective actions, at no additional cost to Manufacturer.

**7.<u>Warranties; Limitation on Liability.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1<u>General Warranties</u>. Sharp warrants that (a) the Products shall be stored, processed, packaged and labeled in accordance with the Specifications and all Applicable Laws; (b) the Packaged Products furnished by Sharp to Manufacturer under this Agreement (i) shall be of the quality specified in, and shall conform with, the Specifications and any Applicable Law, (ii) shall be stored and supplied in conformity with the Specifications and any Applicable Law, and (iii) shall not contain any material provided by or on behalf of Sharp, which material has not been used or stored in accordance with the Specifications and any Applicable Law; (c) it will not introduce any materials not provided for in the Specifications that would cause the Packaged Products to be adulterated within the meaning of Section 501 of the FDCA; (d) the Packaged Products shall not be misbranded within the meaning of the FDCA (except with respect to misbranding resulting from the Specifications, for which Manufacturer shall bear responsibility); and (e) it does not have any obligations, contractual or otherwise, to any third party that would prohibit Sharp from entering into this Agreement and that prior to supplying Packaged Products to Manufacturer, Sharp will have received all necessary licenses (including, but not limited to, licenses under any patents applicable to Sharp's packaging processes) to package and supply Packaged Products. Any claim for breach of warranty under paragraphs (a) through and including (d) that is not brought within the one (1) year of the delivery of the applicable Packaged Product shall be deemed to have been waived by Manufacturer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.2<u>Disclaimer; Limit of Liability</u>. NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT TO THE CONTRARY, (A) THE WARRANTIES WITH RESPECT TO THE STORING, PACKAGING, LABELING AND DELIVERY OF THE PRODUCTS AND THE PACKAGED PRODUCTS STATED IN THIS ARTICLE 7 ARE IN LIEU OF ALL OTHER WARRANTIES OF SHARP, ORAL OR WRITTEN, EXPRESSED OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, (B) IN NO EVENT SHALL EITHER PARTY HAVE ANY LIABILITY FOR ANY EXEMPLARY, PUNITIVE, INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, WHETHER BASED ON CONTRACT, TORT, STRICT LIABILITY OR ANY OTHER THEORY OR FORM OF ACTION IN CONNECTION WITH THIS AGREEMENT AND (C) THE OBLIGATIONS OF SHARP SET FORTH IN SECTION 5.5 TO REPLACE NONCONFORMING PACKAGED PRODUCTS AND REIMBURSE MANUFACTURER'S COSTS, AND, IN SECTION 6.6 WITH RESPECT TO RECALLS, SHALL BE, AS APPLICABLE, MANUFACTURER'S EXCLUSIVE REMEDIES FOR NONCONFORMING PACKAGED PRODUCTS.

**8.<u>Intellectual Property Rights.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1<u>Intellectual Property Rights of Manufacturer; Grant of License</u>. Sharp acknowledges and agrees that Manufacturer possesses sole and exclusive right, title and interest in and to the Specifications, any and all dies, molds, printing plates and other equipment or supplies provided or paid for by Manufacturer for use by Sharp in connection with processing, labeling and packaging of the Products, any know-how relating to the design and manufacture of the Products and any components thereof, and any and all intellectual property rights, including any patent rights, related to any of the foregoing and any and all modifications and improvements thereof (including any developed or suggested by Sharp). All right, title and interest in and to any trademarks, trade names, slogans, logos, copyrights, trade dress, know-how and goodwill associated with the Products and the Packaged Products ("Brand Image") and all rights to any improvements or modifications to the Brand Image (including any developed or suggested by Sharp) are and shall remain owned solely by Manufacturer. Manufacturer hereby grants to Sharp a non-exclusive, royalty-free license to use the Brand Image as may be necessary for Sharp's fulfillment of its services in accordance with this Agreement (including in accordance with the Specifications) during the Term. Except as set forth in the immediately preceding sentence, Sharp shall have no other rights to use the Brand Image and Specifications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2<u>Ownership of Other Property</u>. Except as provided in Section 8.1, all right, title and interest in and to (i) any and all dies, molds, printing plates and other equipment or supplies owned by Sharp, and any and all methods or processes used by Sharp in connection with processing, labeling and packaging of the Products, and (ii) any and all modifications or improvements to any of the foregoing, are and shall remain owned solely by Sharp (including any developed or suggested by Manufacturer). Nothing in this Agreement shall be construed to grant to Manufacturer any right to any trademark, trade name, copyright, patent or other proprietary technology or know-how owned by Sharp.

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**9.<u>Indemnification.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1<u>Sharp's Indemnification of Manufacturer</u>. Sharp shall defend, indemnify and hold Manufacturer and its subsidiaries and affiliates and their officers, directors and employees (each, a "Manufacturer Indemnified Party") harmless from and against any and all losses, liabilities, damages, claims for damages, suits, recoveries, judgments or executions resulting from a third party claim (including reasonable attorneys' fees and expenses) (collectively, "Damages") that may be incurred by any Manufacturer Indemnified Party arising out of or on account of: (i) any willful misconduct, negligent or reckless act or omission on the part of Sharp or its officers, directors, employees or agents in connection with the storage, labeling or packaging of the Products or the Packaged Products pursuant to this Agreement; (ii) any breach by Sharp of any of its covenants, agreements, representations and/or warranties set forth herein; or (iii) any claim that the dies, molds, printing plates and other equipment or supplies, and any and all methods or processes, in each case, used by Sharp in connection with processing, labeling and packaging of the Products infringes the proprietary rights of another person or entity.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2<u>Manufacturer's Indemnification of Sharp</u>. Manufacturer shall defend indemnify and hold Sharp and its affiliated companies and the officers, directors and employees thereof (each, a "Sharp Indemnified Party") harmless from and against any and all Damages that may be incurred by any Sharp Indemnified Party arising out of or on account of: (i) the possession, sale, use or consumption of the Products or Packaged Products or any other product of Manufacturer (except lo the extent arising out of or on account of any willful misconduct, negligent or reckless act or omission on the part of Sharp or its officers, directors, employees or agents in connection with the storage, labeling or packaging of the Products or the Packaged Products, or any breach by Sharp of any of its covenants, agreements, representations and/or warranties set forth herein); (ii) Manufacturer's supply of Products to Sharp under this Agreement; (iii) any breach by Manufacturer of any of its covenants, agreements, representations and/or warranties set forth herein; (iv) any willful misconduct, negligent or reckless act or omission on the part of Manufacturer in connection with its performance pursuant to this Agreement; or (v) any claim that the Brand Image, the Products, the Packaged Products or any other product of Manufacturer, or any claim that Sharp's use of the Covectra software in performance of its obligations hereunder, infringes the proprietary rights of another person or entity.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3<u>Indemnification Procedure</u>. In the event any claim is asserted or any suit or action is brought against either party for which the other party may be required to indemnity such party under this Article 9, the party to be indemnified will promptly notify the indemnifying party of such claim or suit. Upon receipt of such notice, the indemnifying party shall at its expense undertake the defense of such suit or the settlement of any such claim. No settlement may be made without the consent of both parties, which consent shall not be unreasonably withheld. The indemnified party shall have the right to retain its own counsel at its own expense.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4<u>Survival</u>. The indemnification obligations set forth in this Section 9 shall survive the expiration or termination of this Agreement.

**10.<u>Insurance.</u>**

Sharp shall acquire and maintain at its sole cost and expense throughout the Term hereof and for a period of two (2) years after termination: (i) Statutory Worker's Compensation Insurance and Employer's Liability Insurance; (ii) general liability insurance of not less than [\*\*\*] dollars ($[\*\*\*]) per occurrence, and [\*\*\*] dollars ($[\*\*\*]) in the aggregate covering the physical loss or damage to Primary Packaging Materials, Products and Packaged Products while at the Facilities or under Sharp's control; and (iii) Products Liability, Bodily Injury and Property Damage Insurance with a combined single limit of not less than [\*\*\*] dollars ($[\*\*\*]) per occurrence, and [\*\*\*] dollars ($[\*\*\*]) in the aggregate. Sharp shall furnish Manufacturer "Certificates of Insurance" issued by such companies for all insurance required hereunder. The existence of such insurance is not to be construed as a limitation of Sharp's liability hereunder.

**11.<u>Term; Termination.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1<u>Initial Term; Term</u>. The initial term of this Agreement shall be for a period of three (3) years, beginning on the Effective Date and terminating on the third anniversary of the Effective Date (the "Initial Term"). This Agreement may be extended for additional one-year periods (such additional periods are each a "Subsequent Term," and collectively with the Initial Term, the "Term") by mutual written agreement reached by the parties not later than 180 days prior to the end of the Initial Term or any Subsequent Term. The Term shall end upon the expiration of this Agreement or its earlier termination as set forth herein.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2<u>Termination</u>. This Agreement may be terminated upon the occurrence of any of the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)The parties may terminate this Agreement by mutual written consent at any time by providing 36 months advance written notice to the other party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Either party may terminate this Agreement by giving thirty (30) days written notice to the other party in the event the other party has breached any representation, warranty or obligation contained in this Agreement and/or has defaulted in the performance of any of its duties or obligations hereunder in any material respect and such breach or default has not been remedied within thirty (30) days after written notice of the breach or default has been received;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)Either party may terminate this Agreement if a voluntary petition in bankruptcy should be filed by the other party under the United States Bankruptcy Code, if an involuntary petition under the United States Bankruptcy Code should be filed against the other party, or if a receiver should be appointed for the other party or its property;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Either party may terminate this Agreement pursuant to Section 13.2.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3<u>Effect of Expiration or Termination</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)The expiration or termination of this Agreement shall not release either party from any of its obligations accrued prior to the effective date of termination, and each party shall remain responsible for the performance of its respective obligations and agreements which are expressly stated to be obligations which survive the termination of this Agreement. Furthermore, the rights to terminate provided for hereinabove are in addition to any other right, remedy, or election either party may have hereunder or at law or in equity.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Within ninety (90) days of the effective date of the expiration or termination of this Agreement for any reason, Manufacturer shall purchase at Sharp's cost any Packaging Materials that Sharp has purchased exclusively for Manufacturer in accordance with this Agreement for the production of the Packaged Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)Upon the effective date of expiration or termination of this Agreement, Sharp shall immediately deliver to Manufacturer or its designee all Products, and all text, graphics and other artwork and Packaging Materials purchased or provided by Manufacturer. Sharp shall also deliver to Manufacturer or its designee all Packaged Products produced hereunder, and shall invoice Manufacturer therefor in accordance with the terms of Section 5.3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Upon the effective date of expiration or termination of this Agreement, Sharp shall, except as may be necessary to otherwise comply with its obligations under this Agreement, (i) cease to use the Specifications, dies, molds, printing plates and other equipment or supplies provided or paid for by Manufacturer for use in connection with processing, labeling and packaging of the Products, any trademarks, patents, trade secrets, know-how or other intellectual property of Manufacturer in any manner whatsoever, and (ii) cease to use the Confidential Information of Manufacturer, and at Manufacturer's request, return or destroy all copies of such Confidential Information and all related material in its possession and confirm to Manufacturer in writing that it has complied with this provision; provided that Sharp shall retain one copy of such Confidential Information for archival purposes.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)Upon the effective date of expiration or termination of this Agreement, the Tooling Agreement shall terminate and all amounts not yet fully amortized thereunder shall become immediately due and payable by Manufacturer to Sharp and all right, title and Interest to the Tooling shall immediately pass to and vest in Manufacturer upon the making of such payment in accordance with the Tooling Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.4<u>No Prejudice</u>. The termination of this Agreement as provided in this Section 11 shall be without prejudice to any rights or remedies of the parties already accrued, including without limitation remedies for breach.

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**12.<u>Confidentiality.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)<u>Confidentiality</u>. Sharp and Manufacturer agree to keep secret and confidential any and all information of the other party ("Confidential Information") disclosed by the other party hereunder or through any prior disclosure and not to disclose such Confidential Information to any person or entity, except (i) to employees of each party having a need to know the information in order to fulfill such party's obligations hereunder; or (ii) as reasonable requested by an applicable Regulatory Authority. The parties shall use the Confidential Information solely for the purpose of carrying out the obligations contained in the Agreement. The obligations imposed by this Section shall not apply to any Confidential Information:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)that, at the time of disclosure, is in the public domain;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)that, after disclosure, becomes part of the public domain by publication or otherwise, through no fault of the receiving party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)that, at the time of disclosure, is already in the receiving party's possession, except through prior disclosure by the disclosing party, and such possession can be properly documented by the receiving party in its written records, and was not made available to the receiving party by any person or party owing an obligation of confidentiality to the disclosing party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)that is rightfully made available to the receiving party from sources independent of the disclosing party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v)that is required to be disclosed in the course of litigation or other legal or administrative proceedings; provided that in all such cases the party receiving the Confidential Information shall, to the extent permitted, give the other party prompt written notice of the pending disclosure and shall cooperate in such other party's attempts, at such other party's sole expense, to seek an order maintaining the confidentiality of the Confidential Information; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vi)that is required to be disclosed by Applicable Laws; provided that in all such cases the party receiving the Confidential Information shall, to the extent permitted, give the other party prompt written notice of the pending disclosure and shall cooperate in such other party's attempts, at such other party's sole expense, to seek an order maintaining the confidentiality of the Confidential Information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)<u>Survival</u>. The obligation of confidentiality and nonuse set forth in this Article 12 shall survive for a period of ten (10) years beyond the termination or expiration of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)<u>Ownership of Confidential Information</u>. Confidential Information shall remain the exclusive property of the disclosing party. In no event shall any of either party's Confidential Information, technology, know-how, intellectual property (or rights thereto) become the property of the other party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Neither party shall release to any third party any non-public information with respect to the terms of this Agreement without the prior written consent of the other party.

**13.<u>Miscellaneous.</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.1<u>Authority to Enter Into Agreement</u>. Each party represents and warrants that it is authorized to enter into this Agreement and that in so doing it is not in violation or the terms and conditions of any contract or other agreement to which it may be a party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.2<u>Force Majeure</u>. Performance under this Agreement shall be excused to the extent prevented or delayed by any event or circumstance, which is beyond the reasonable control of the party whose performance is to be excused hereunder, including but not limited to fire, flood, explosion, unavoidable breakdown of machinery, widespread product tampering by third parties, changes to governmental acts or regulations, war, labor difficulties, shortages or unavailability of materials, or any act of God. The party affected shall promptly notify in writing the non-affected party of the event of force majeure and the probable duration of the delay. Any delay caused by an event of force majeure shall toll the Term, which shall be extended by the length thereof. In the event the probable duration of the force majeure event is expected to prevent performance by one party for more than eight (8) weeks, the other party shall have the right to terminate this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3<u>Public Announcements</u>. The parties agree to determine jointly the contents of any public announcement informing the public about the existence of this Agreement between the parties and, except as may be required by law or the rules of any national securities exchange, neither party shall issue or cause the issuance of any such public announcement without the express prior written approval of an executive officer of each party.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.4<u>Amendments</u>. This Agreement may not be modified, amended or altered except pursuant to a written instrument signed by both parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.5<u>Governing Law; Venue</u>. This Agreement is made subject to the laws of the State of Delaware, without reference to principles of conflicts of laws. Each party agrees that suit may be instituted at the U.S. District Court in Delaware or in the Delaware State Courts and each waives any objection which such party may now or hereafter have to the laying of the venue of any such action, suit or proceeding, and irrevocably submits to the jurisdiction of any such court. Any and all service of process and any other notice in any such action, suit or proceeding shall be effective against a party if given as provided in Section 13.7. Nothing contained herein shall prevent or delay either party from seeking, in any court of competent jurisdiction in Delaware, specific performance or other equitable remedies in the event of any breach or intended breach by the other party of any of its obligations hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.6<u>Assignment</u>. Sharp shall not assign, transfer, convey, or pledge this Agreement or any interest herein in whole or part (including, but not limited to, any transfer by operation of law) without the prior written approval of Manufacturer. Manufacturer shall have the right to assign any or all off its rights or obligations under this Agreement without the consent of Sharp; provided however that Manufacturer shall not assign, transfer, convey or pledge this Agreement in whole or part (including, but not limited to, any transfer by operation of law) to any third party whose primary business is the provision of contract packaging services without the prior written approval of Sharp. In the event of a permitted assignment hereunder, the assigning party shall continue to be bound by all pre-existing obligations under this Agreement, including all obligations of confidentiality and non-disclosure.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.7<u>Notice</u>. Any and all notices permitted or required to be given hereunder will be deemed duly given: (a) upon actual delivery, if delivery is by hand; (b) three (3) business days after delivery into the official mail, if delivery is by postage paid registered or certified return receipt request mail; (c) one business day after delivery to an overnight carrier, if delivery is made by overnight carrier guaranteeing next business day delivery; or (d) upon receipt of evidence of successful transmission, if delivery is by facsimile. Each such notice shall be sent to the respective party at the address of facsimile number indicated below or at any other address as the respective party may designate by notice delivered pursuant hereto.

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| |
|:---|
| If to Manufacturer: |
| Indivior UK Ltd |
| 215 Bath Road |
| Slough SL1 4AA |
| UK |
| Attention: Chief Supply Officer and Asst. General Counsel |
| Telecopier Number: [\*\*\*] |
| -and- |
| Indivior Inc. |
| 10710 Midlothian Turnpike, Suite 430 |
| Richmond, Virginia 23235 |
| Attn: Chief Legal Officer |
| If to Sharp: |
| SHARP CORPORATION |
| 7451 Keebler Way |
| Allentown, Pennsylvania 18106 |
| Attention: CFO |
| Telecopier Number: [\*\*\*] |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.8<u>Entire Agreement</u>. This Agreement, including all Exhibits attached hereto and made a part hereof contains the entire understanding of the parties, superseding in all respects any and all prior oral or written agreements or understandings pertaining to the subject matter hereof; and shall be amended or modified only by written agreement executed by the parties hereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.9<u>Severability</u>. If and to the extent that any court of competent jurisdiction holds any provision or part of this Agreement to be invalid or unenforceable, such holding shall in no way affect the validity of the remainder of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.10<u>Waiver</u>. A waiver by either party of any of the terms and conditions of this Agreement in any instance shall not be deemed or construed to be a waiver of such term or condition for the future.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.11<u>Headings</u>. Headings in this Agreement are included for ease of reference only and have no legal effect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.12<u>Counterparts</u>. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument.

*{signatures follow on the next page}*

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IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed in their respective names and on their behalf, as of the date first above written.

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| | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** |
| By: | */s/ Frank Stier* | */s/ Frank Stier* | */s/ Frank Stier* | */s/ Frank Stier* | By: | */s/ Jeff Benedict* | */s/ Jeff Benedict* | */s/ Jeff Benedict* | */s/ Jeff Benedict* |
| Name: | Name: | Name: | Name: | Frank Stier | Name: | Name: | Name: | Name: | Jeff Benedict |
| Title: | Title: | Chief Supply Officer | Chief Supply Officer | Chief Supply Officer | Title: | Title: | Senior Vice President | Senior Vice President | Senior Vice President |
| Date: | Date: | Date: | 23 August 2017 | 23 August 2017 | Date: | Date: | Date: | September 7, 2017 | September 7, 2017 |

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**<u>EXHIBIT A</u>**

**PRODUCTS / PRICES**

**1. MSA PRICING SMALL POUCH**

All purchases shall be made F.O.B. Sharp's dock. Subject to the adjustments described in Section 5.1, and as offered on the attached quotations, the Prices are as follows:

Product Sharp Design Price Per 1000 <br> RBP 6000

<u>Overtime Labour Charges</u>

**Project Description Summary**

1. Customer to supply bulk products for specialty packaging

2. Sharp Packaging Solutions to provide full service packaging

3. Sharp Packaging Solutions to prepare finished packed goods ready for shipment

**Pricelist**

Pricing is per finished carton (kit), each with one pouch containing [\*\*\*].

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| | | | | |
|:---|:---|:---|:---|:---|
| **Product** | **Price Per Unit** | **Lot Size** | **Campaign** | **Yearly Volume** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

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The foregoing pricing will be subject to modification (whether a decrease or increase in price) as a result of any Manufacturer-approved changes to the kit size volume.

**<u>Annual Volumes > [\*\*\*] – [\*\*\*]% Rebate</u>**

For kits of Packaged Product delivered by Sharp to Manufacturer in any calendar year during the Term which in the aggregate exceed [\*\*\*] kits, Sharp shall apply a rebate ("Annual Order Quantity Rebate") based on the percentages below against the lowest Price per kits of Packaged Product constituting such aggregate.

The application of the Annual Order Quantity Rebate shall be applied as set forth below. In 2018 through 2021, if the annual volume of delivered kits of Packaged Product exceeds [\*\*\*] kits, Sharp will rebate to Manufacture no later than February 1 of the follow year an Annual Order Quantity Rebate equal to [\*\*\*] percent ([\*\*\*]%) of the Price per kit, based on the lot size and campaign, for the volume of Packaged Product delivered in each preceding applicable year.

For example, if the Manufacturer orders [\*\*\*] kits of [\*\*\*], with a Lot Size of [\*\*\*] kits and Campaign of [\*\*\*] kits, at a price of $[\*\*\*] per kit, the total cost would be $[\*\*\*]. Sharp will rebate to Manufacturer [\*\*\*] percent ([\*\*\*]%) of the aggregate total, equalling $[\*\*\*], reducing the price per kit to $[\*\*\*].

**<u>Annual Volumes ></u>** <u>[\*\*\*]</u> **<u>–</u>** <u>[\*\*\*]</u>**<u>% Rebate</u>**

For kits of Packaged Product delivered by Sharp to Manufacturer in any calendar year during the Term which in the aggregate exceed [\*\*\*] kits, Sharp shall apply a rebate ("Annual Order Quantity Rebate") based on the percentages below against the lowest Price per kits of Packaged Product constituting such aggregate.

In 2018 through 2021, if the annual volume of delivered kits of Packaged Product exceeds [\*\*\*] kits, Sharp will rebate to Manufacture no later than February 1 of the follow year an Annual Order Quantity Rebate equal to [\*\*\*] percent ([\*\*\*]%) of the Price per kit, based on the lot size and campaign, for the volume of Packaged Product delivered in each preceding applicable year.

For example, if the Manufacturer orders [\*\*\*] kits of [\*\*\*], with a Lot Size of [\*\*\*] kits and Campaign of [\*\*\*] kits, at a price of $[\*\*\*] per kit, the total cost would be $[\*\*\*]. Sharp will rebate to Manufacturer [\*\*\*] percent ([\*\*\*]%) of the aggregate total, equalling $[\*\*\*], reducing the price per kit to $[\*\*\*].

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**<u>Annual Volumes ></u>** <u>[\*\*\*]</u> **<u>–</u>** <u>[\*\*\*]</u>**<u>% Rebate</u>**

For kits of Packaged Product delivered by Sharp to Manufacturer in any calendar year during the Term which in the aggregate exceed [\*\*\*] kits, Sharp shall apply a rebate ("Annual Order Quantity Rebate") based on the percentages below against the lowest Price per kits of Packaged Product constituting such aggregate.

In 2018 through 2021, if the annual volume of delivered kits of Packaged Product exceeds [\*\*\*] kits, Sharp will rebate to Manufacture no later than February 1 of the follow year an Annual Order Quantity Rebate equal to [\*\*\*] percent ([\*\*\*]%) of the Price per kit, based on the lot size and campaign, for the volume of Packaged Product delivered in each preceding applicable year.

For example, if the Manufacturer orders [\*\*\*] kits of [\*\*\*], with a Lot Size of [\*\*\*] kits and Campaign of [\*\*\*] kits, at a price of $[\*\*\*] per kit, the total cost would be $[\*\*\*]. Sharp will rebate to Manufacturer [\*\*\*] percent ([\*\*\*]%) of the aggregate total, equalling $[\*\*\*], reducing the price per kit to $[\*\*\*].

**Packaging Materials**

---

| | | |
|:---|:---|:---|
| **Component** | **Specifications** | **Supplied By** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**Detailed Packaging Process Description (Optional):**

[\*\*\*]

**Extras**

Lot Charge: $[\*\*\*] per lot

Project Management Fee: $[\*\*\*]

Cold Chain Controlled Drug Pallet Storage: $[\*\*\*] per month per pallet

**Validation**

Validation cost including Serialization: $[\*\*\*]

**Price includes**

Labour, Sharp supplied components, pallet handling, engineering, project management, line clearance including cleaning and batch change overs.

**Price excludes**

Bulk product, retain sample storage, analytical testing costs, and transportation.

**Supplied by Customer**

MSDS, Melamine and TSE/BSE statement on the bulk product.

Bulk products to Packaging Site, accompanied with Certificate Of Analysis and shipment list stating exact amount of bulk per container.

------

**2. MSA PRICING LARGE POUCH**

**Project Description Summary**

1. Customer to supply bulk products for specialty packaging

2. Sharp Packaging Solutions to provide full service packaging

3. Sharp Packaging Solutions to prepare finished packed goods ready for shipment

**Pricelist**

Pricing is per finished carton (kit), each with one pouch containing [\*\*\*].

---

| | | | | |
|:---|:---|:---|:---|:---|
| **Product** | **Price Per Unit** | **Lot Size** | **Campaign** | **Yearly Volume** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

In case other bulk specifications and primary & secondary packaging specifications, or supplier prices, differ as opposed to the costs included in our calculations, prices will be re-calculated for that specific SKU. In this case a new pricelist will be provided for that SKU.

**Packaging Materials**

---

| | | |
|:---|:---|:---|
| **Component** | **Specifications** | **Supplied By** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**Detailed Packaging Process Description (Optional):**

[\*\*\*]

**Extras**

Lot Charge: $[\*\*\*] per lot

Project Management Fee: $[\*\*\*]

Cold Chain Controlled Drug Pallet Storage: $[\*\*\*] per month per pallet

**Validation**

Validation cost including Serialization: $[\*\*\*]

**Price includes**

Labour, Sharp supplied components, pallet handling, engineering, project management, line clearance including cleaning and batch change overs.

**Price excludes**

Bulk product, retain sample storage, analytical testing costs, and transportation.

**Supplied by Customer**

MSDS, Melamine and TSE/BSE statement on the bulk product.

Bulk products to Packaging Site, accompanied with Certificate Of Analysis and shipment list stating exact amount of bulk per container.

------

**3. MULTISTEP LAUNCH BUILD**

**Project Description Summary**

1. Customer to supply bulk products for specialty packaging

2. Sharp Packaging Solutions to provide full service packaging

3. Sharp Packaging Solutions to prepare finished packed goods ready for shipment

**Pricelist**

**Item One Primary WIP Pouches**

---

| | | | | |
|:---|:---|:---|:---|:---|
| **Product** | **Price Per Unit** | **Lot Size** | **Campaign** | **Yearly Volume** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

In case other bulk specifications and primary & secondary packaging specifications, or supplier prices, differ as opposed to the costs included in our calculations, prices will be re-calculated for that specific SKU. In this case a new pricelist will be provided for that SKU.

**Packaging Materials**

---

| | | |
|:---|:---|:---|
| **Component** | **Specifications** | **Supplied By** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**Detailed Packaging Process Description (Optional):**

[\*\*\*]

**Pricelist**

**Item Two WIP Pouches to Finished goods**

---

| | | | | |
|:---|:---|:---|:---|:---|
| **Product** | **Price Per Unit** | **Lot Size** | **Campaign** | **Yearly Volume** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

In case other bulk specifications and primary & secondary packaging specifications, or supplier prices, differ as opposed to the costs included in our calculations, prices will be re-calculated for that specific SKU. In this case a new pricelist will be provided for that SKU.

---

| | | |
|:---|:---|:---|
| **Component** | **Specifications** | **Supplied By** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**Detailed Packaging Process Description:**

[\*\*\*]

**Pricelist**

**Item Three Rework of WIP Pouches to Finished goods**

---

| | | | | |
|:---|:---|:---|:---|:---|
| **Product** | **Price Per Unit** | **Lot Size** | **Campaign** | **Yearly Volume** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

In case other bulk specifications and primary & secondary packaging specifications, or supplier prices, differ as opposed to the costs included in our calculations, prices will be re-calculated for that specific SKU. In this case a new pricelist will be provided for that SKU.

**Packaging Materials**

---

| | | |
|:---|:---|:---|
| **Component** | **Specifications** | **Supplied By** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**Detailed Packaging Process Description:**

[\*\*\*]

------

**Extras**

Lot Charge: $[\*\*\*] per lot

Project Management Fee: $[\*\*\*]

Cold Chain Controlled Drug Pallet Storage: $[\*\*\*] per month per pallet

**Validation**

Validation cost including Serialization: $[\*\*\*]

**Price includes**

Labour, Sharp supplied components, pallet handling, engineering, project management, line clearance including cleaning and batch change overs.

**Price excludes**

Bulk product, retain sample storage, analytical testing costs, and transportation.

**Supplied by Customer**

MSDS, Melamine and TSE/BSE statement on the bulk product.

Bulk products to Packaging Site, accompanied with Certificate Of Analysis and shipment list stating exact amount of bulk per container.

------

**<u>EXHIBIT B</u>**

**CHANGE PARTS**

Tooling: [\*\*\*]

DESCRIPTION: [\*\*\*]

Item One.

Tool Set: [\*\*\*]

Item Two.

Tool Set: [\*\*\*]

Item Three.

Tool Set: [\*\*\*]

DESCRIPTION: [\*\*\*]

Item Four.

Tool Set: [\*\*\*]

------

**<u>EXHIBIT C</u>**

**TERRITORIES**

Global.

## Exhibit 4.16

**Exhibit 4.16.2**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**FIRST AMENDMENT TO THE PACKAGING AND SUPPLY AGREEMENT**

This Amendment ("First Amendment") dated as of the date of last signature below (the "Amendment Effective Date"), is entered into by and between Sharp Corporation, a corporation organized and existing under the laws of the Commonwealth of Pennsylvania having its principal office at 7451 Keebler Way, Allentown, Pennsylvania 18106 ("Sharp") and Indivior UK Limited (CO No. 7183451), a corporation organized and existing under the laws of England and Wales having its registered address at 103-105 Bath Road, Slough, Berkshire SL1 3UH, United Kingdom ("Manufacturer") (collectively "the parties") in relation to the Packaging and Supply Agreement made between the parties which has an effective date of 23rd August 2017 (the "Supply Agreement").

**<u>WITNESSETH:</u>**

**WHEREAS,** Manufacturer and Sharp desire to amend the Supply Agreement as set forth herein;

**NOW, THEREFORE,** for good and valuable consideration *the details of which are set out in the amended Annex A to the Supply Agreement which sets out -inter alia-amended prices for Sublocade Products and also introduces a pricing structure for Nalscue and Project [\*\*\*] products,* the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

**<u>AGREEMENT</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;By virtue of

-&nbsp;&nbsp;&nbsp;&nbsp;clause 5(1)(a) of the Supply Agreement as regards the Sublocade products listed in the amended Annex A (annexed hereto) and

-&nbsp;&nbsp;&nbsp;&nbsp;clause 13(4) of the Supply Agreement for all the products listed in the amended Annex A (annexed hereto),

Exhibit A to the Supply Agreement is hereby amended, such that

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a)&nbsp;&nbsp;&nbsp;&nbsp;the figures in table in section 1 marked "Lot Size" and "Price per Unit" (MSA Pricing Small Preprinted Pouch One Step) are deleted and the figures set out below are added in their stead

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b)&nbsp;&nbsp;&nbsp;&nbsp;the figures in the table in section 2 marked "Lot Size" and "Price Per Unit" are deleted and the figures set out below ("Sublocade Large Pouch One Step" and "Sublocade Large Pouch Two Step") are added in their stead

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c)&nbsp;&nbsp;&nbsp;&nbsp;Two new tables are added in the figures set out below; the first being "Nalscue France" and the second being "Project [\*\*\*]"

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;The Amendment Effective Date shall be the date upon which this amendment shall come into force, and shall be the date of the last signature below.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.&nbsp;&nbsp;&nbsp;&nbsp;Except as amended by their First Amendment all terms and conditions of the Supply Agreement are affirmed and remain in full force and effect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.&nbsp;&nbsp;&nbsp;&nbsp;The Supply Agreement as modified by this First Amendment contains the entire understanding between the parties hereto with respect to the transactions contemplated by the Supply Agreement and supersedes and replaces all prior and contemporaneous agreements and understandings oral or written with regard to such transactions.

------

**IN WITNESS WHEREOF**, each of the parties hereto has caused this Amendment to be executed by its duly authorized representatives, as of the Amendment Effective Date.

---

| | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** |
| By: | */s/ Frank Stier* | */s/ Frank Stier* | */s/ Frank Stier* | */s/ Frank Stier* | By: | */s/ Jeff Benedict* | */s/ Jeff Benedict* | */s/ Jeff Benedict* | */s/ Jeff Benedict* |
| Name: | Name: | Name: | Name: | Frank Stier | Name: | Name: | Name: | Name: | Jeff Benedict |
| Title: | Title: | Chief Manufacturing & Supply Officer | Chief Manufacturing & Supply Officer | Chief Manufacturing & Supply Officer | Title: | Title: | Senior Vice President | Senior Vice President | Senior Vice President |
| Date: | Date: | Date: | 23 March 2018 | 23 March 2018 | Date: | Date: | Date: | January 12, 2018 | January 12, 2018 |

---

------

**SCHEDULE A: PRODUCTS / PRICES**

All purchases shall be made F.O.B. Sharp's dock. Subject to the adjustments described in Section 5.1, and as offered on the attached quotations, the Prices are as follows:

---

| | | | |
|:---|:---|:---|:---|
| **<u>Product</u>** | **<u>Sharp Design</u>** | **<u>Lot Size</u>** | **<u>Price Per</u>** |
| Nalscue France | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Sublocade Large Pouch Two Step (Launch)<br>[\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Sublocade Large Pouch One Step<br>[\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Sublocade Small Preprinted Pouch One Step<br>[\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| Project [\*\*\*]<br>[\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

<u>Overtime Shift Charges</u>

---

| | |
|:---|:---|
| Saturdays | $[\*\*\*] per shift for one line |
| Sundays | $[\*\*\*] per shift for one line |
| Holidays | $[\*\*\*] per shift for one line |

---

**Sharp 2018 Holidays**

[\*\*\*]

## Exhibit 4.16

**Exhibit 4.16.3**

**SECOND AMENDMENT TO PACKAGING AND SUPPLY AGREEMENT**

This **SECOND AMENDMENT** to **PACKAGING AND SUPPLY AGREEMENT** ("Second Amendment"), effective as of the date of last signature below (the "Amendment Effective Date"), is entered into between Indivior UK Limited (CO No. 7183451), a corporation organized and existing under the laws of England and Wales having its registered address at 103-105 Bath Road, Slough, Berkshire SL1 3UH, United Kingdom ("Manufacturer") and Sharp Corporation, a Pennsylvania corporation with a principal place of business at 7451 Keebler Way, Allentown, Pennsylvania 18106 ("Sharp") (collectively the "parties").

**<u>WITNESSETH:</u>**

**WHEREAS,** Manufacturer and Sharp are parties to a Packaging and Supply Agreement effective as of September 7, 2017, as amended on March 23, 2018 (the "Agreement"), and

**WHEREAS,** the parties desire to amend the Agreement as described below.

**NOW, THEREFORE,** for good and valuable consideration*,* the receipt and sufficiency of which are hereby acknowledged, the parties, intending to be legally bound, agree as follows:

**<u>AGREEMENT</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;Section 11.1 of the Agreement, "Initial Term; Term" is deleted in its entirety and replaced with the following:

"<u>Initial Term; Term</u>. The initial term of this Agreement will begin on the Effective Date and, unless terminated in accordance with this Agreement, continue until December 31, 2020 (the "Initial Term"). This Agreement may be extended for additional periods (such additional periods are each a "Subsequent Term," and collectively with the Initial Term, the "Term") by mutual written agreement reached by the parties prior to expiration or termination of this Agreement. The terms and conditions of each Subsequent Term, including but not limited to the applicable Price per Section 5.1(b) and duration thereof, shall be mutually agreed upon in a written document signed by both parties. The Term shall end upon expiration of this Agreement or its earlier termination as set forth herein."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;Except as provided in this Amendment, the terms and conditions set forth in the Agreement shall remain unaffected by execution of this Amendment. To the extent any provisions or terms set forth in this Amendment conflict with the terms set forth in the Agreement, the terms set forth in this Amendment shall govern and control.

**IN WITNESS WHEREOF**, the parties, by their duly authorized representatives, have executed this Amendment as of the Amendment Effective Date.

---

| | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** |
| By: | */s/ Hillel West* | */s/ Hillel West* | */s/ Hillel West* | */s/ Hillel West* | By: | */s/ Jeff Benedict* | */s/ Jeff Benedict* | */s/ Jeff Benedict* | */s/ Jeff Benedict* |
| Name: | Name: | Name: | Name: | Hillel West | Name: | Name: | Name: | Name: | Jeff Benedict |
| Title: | Title: | Chief Manufacturing & Supply Officer | Chief Manufacturing & Supply Officer | Chief Manufacturing & Supply Officer | Title: | Title: | Senior Vice President | Senior Vice President | Senior Vice President |
| Date: | Date: | Date: | August 17, 2020 | August 17, 2020 | Date: | Date: | Date: | August 17, 2020 | August 17, 2020 |

---

## Exhibit 4.16

**Exhibit 4.16.4**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**AMENDMENT NO. 3 TO PACKAGING AND SUPPLY AGREEMENT**

This Amendment No. 3 (the "Amendment"), entered into and effective on January 1, 2021 (the "Amendment Effective Date"), to the Packaging and Supply Agreement, as amended, entered into by and between Sharp Corporation, a Pennsylvania corporation with principal place of business at 7451 Keebler Way, Allentown, Pennsylvania 18106 ("Sharp"), and Indivior UK Limited located at Chapleo Building, Henry Boot Way, Priory Park, Hull HU4 7BY, United Kingdom ("Manufacturer" or "Indivior") on September 7, 2017 (the " Agreement").

WHEREAS the parties desire to amend the Agreement as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;Section 11.1 of the Agreement, "Initial Term; Term" is deleted in its entirety and replaced with the following:

"<u>Initial Term; Term</u>. The initial term of this Agreement will begin on the Effective Date and, unless terminated in accordance with this Agreement, continue until December 31, 2021 (the "Initial Term"). This Agreement may be extended for additional periods (such additional periods are each a "Subsequent Term," and collectively with the Initial Term, the "Term") by mutual written agreement reached by the parties prior to expiration or termination of this Agreement. The terms and conditions of each Subsequent Term, including but not limited to the applicable Price per Section 5.1(b) and duration thereof, shall be mutually agreed upon in a written document signed by both parties. The Term shall end upon expiration of this Agreement or its earlier termination as set forth herein."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;Exhibit A of the Agreement, as amended by the First Amendment to the Packaging and Supply Agreement, dated March 23, 2018 (the "First Amendment") is hereby amended, such that

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a)&nbsp;&nbsp;&nbsp;&nbsp;The pricing tables for SUBLOCADE® ("SUBLOCADE") Large Pouch Two Step (Launch), SUBLOCADE Large Pouch One Step, SUBLOCADE Small Preprinted Pouch One Step and Project [\*\*\*] are hereby deleted; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b)&nbsp;&nbsp;&nbsp;&nbsp;New pricing tables (Current [\*\*\*] Operations) are hereby added for SUBLOCADE US, Canada (CA), Australia (AUS), MoW (Most of World) and PERSERIS® ("PERSERIS") US (formerly referred to as [\*\*\*] in the First Amendment) as set forth in the attached Exhibit A, which is hereby incorporated by reference into the Agreement as if fully set forth therein; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c)&nbsp;&nbsp;&nbsp;&nbsp;New lot sizes are hereby added for SUBLOCADE and PERSERIS as set forth in the attached Exhibit A; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d)&nbsp;&nbsp;&nbsp;&nbsp;New pricing tables with effective date of April 1, 2021 ([\*\*\*] and [\*\*\*] Operations) are hereby added as set forth in the attached Exhibit A for SUBLOCADE US, CA, AUS, MoW and PERSERIS US, driven by cost reductions through Indivior funded automation improvements; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e)&nbsp;&nbsp;&nbsp;&nbsp;Overtime shift charges as defined in the First Amendment are hereby deleted and replaced in their entirety with the SUBLOCADE and PERSERIS overtime shift charges as set forth in the attached Exhibit A; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;f)&nbsp;&nbsp;&nbsp;&nbsp;The Sharp 2018 Holidays table is hereby deleted in its entirety.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;g)&nbsp;&nbsp;&nbsp;&nbsp;Storage charges for SUBLOCADE (controlled drug) and PERSERIS (non-controlled drug) are hereby added as set forth in the attached Exhibit A.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.&nbsp;&nbsp;&nbsp;&nbsp;Except as provided herein, all other terms and conditions of the Agreement shall remain in full force and effect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.&nbsp;&nbsp;&nbsp;&nbsp;The Agreement as modified by this Third Amendment contains the entire understanding between the parties hereto with respect to the transactions contemplated by the Agreement and supersedes and replaces all prior and contemporaneous agreements and understandings oral or written with regard to such transactions.

------

**IN WITNESS WHEREOF**, each of the parties hereto has caused this Amendment to be executed by its duly authorized representatives, as of the Amendment Effective Date.

---

| | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** |
| By: | */s/ Hillel West* | */s/ Hillel West* | */s/ Hillel West* | */s/ Hillel West* | By: | */s/ Jeff Benedict* | */s/ Jeff Benedict* | */s/ Jeff Benedict* | */s/ Jeff Benedict* |
| Name: | Name: | Name: | Name: | Hillel West | Name: | Name: | Name: | Name: | Jeff Benedict |
| Title: | Title: | Chief Manufacturing & Supply Officer | Chief Manufacturing & Supply Officer | Chief Manufacturing & Supply Officer | Title: | Title: | Chief Commercial Officer | Chief Commercial Officer | Chief Commercial Officer |
| Date: | Date: | Date: | 1 January 2021 | 1 January 2021 | Date: | Date: | Date: | January 1, 2021 | January 1, 2021 |

---

------

**EXHIBIT A**

**SUBLOCADE® ("SUBLOCADE") and PERSERIS® ("PERSERIS") Products/Pricing**

**I. SUBLOCADE® Products/Pricing**

**PRICELIST:**

**Overtime Shift Rates:**

---

| | | |
|:---|:---|:---|
| Saturday Overtime | $[\*\*\*] | Per Shift |
| Sunday Overtime | $[\*\*\*] | Per Shift |
| Holiday Overtime | $[\*\*\*] | Per Shift |

---

**Storage Fees:**

---

| | | |
|:---|:---|:---|
| Storage – <br>Ambient, Controlled | $[\*\*\*] per Pallet | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pallet charges will be assessed according to the following schedule:<br>-&nbsp;&nbsp;&nbsp;&nbsp; Customer supplied materials: 90 days after receipt of material<br>-&nbsp;&nbsp;&nbsp;&nbsp; Inventory Destruction Requests: 30 days after issuance of quote <br>-&nbsp;&nbsp;&nbsp;&nbsp; Finished goods: 30 days after production<br>-&nbsp;&nbsp;&nbsp;&nbsp; Special circumstances as needed (for example, safety stock programs) |
| Storage –<br>Cold Chain, Controlled | $[\*\*\*] per Pallet | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pallet charges will be assessed according to the following schedule:<br>-&nbsp;&nbsp;&nbsp;&nbsp; Customer supplied materials: 90 days after receipt of material<br>-&nbsp;&nbsp;&nbsp;&nbsp; Inventory Destruction Requests: 30 days after issuance of quote <br>-&nbsp;&nbsp;&nbsp;&nbsp; Finished goods: 30 days after production<br>-&nbsp;&nbsp;&nbsp;&nbsp; Special circumstances as needed (for example, safety stock programs) |

---

------

**CURRENT [\*\*\*] OPERATIONS**

**Effective Date: January 1**<sup>st</sup> **2021**

**Price Per Carton:**

---

| | | | |
|:---|:---|:---|:---|
| **Lot Size** | **USA** | **Canada** | **Australia** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**SUBLOCADE US:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

**SUBLOCADE CANADA:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

**SUBLOCADE AUSTRALIA:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

**[\*\*\*] AND [\*\*\*] OPERATIONS**

**Effective Date: April 1**<sup>st</sup> **2021**

**Price Per Carton:**

---

| | | | |
|:---|:---|:---|:---|
| **Lot Size** | **US** | **Canada** | **AUS** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

**SUBLOCADE US:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

**SUBLOCADE CANADA:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

**SUBLOCADE AUSTRALIA:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

------

**SUBLOCADE MOW – 1 LABEL , SERIALIZED (SAME AS US):**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

**SUBLOCADE MOW – 1 LABEL, NOT SERIALIZED (SAME AS AUSTRALIA):**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

**SUBLOCADE MOW – 2 LABELS, SERIALIZED (SAME AS CANADA):**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

**SUBLOCADE MOW – 2 LABELS, NOT SERIALIZED (NEW CONFIGURATION):**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

---

| | |
|:---|:---|
| **Lot Size** | **Price Per Carton** |
| [\*\*\*] | [\*\*\*] |

---

------

**II. PERSERIS Products/Pricing**

**PRICELIST:**

**Spor-Klenz Cleaning:** $[\*\*\*] per clean

**Overtime Shift Rates:**

---

| | | |
|:---|:---|:---|
| Saturday Overtime | $[\*\*\*] | Per Shift |
| Sunday Overtime | $[\*\*\*] | Per Shift |
| Holiday Overtime | $[\*\*\*] | Per Shift |

---

**Storage Fees:**

---

| | | |
|:---|:---|:---|
| Storage – <br>Ambient | $[\*\*\*] per Pallet | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pallet charges will be assessed according to the following schedule:<br>-&nbsp;&nbsp;&nbsp;&nbsp; Customer supplied materials: 90 days after receipt of material<br>-&nbsp;&nbsp;&nbsp;&nbsp; Inventory Destruction Requests: 30 days after issuance of quote <br>-&nbsp;&nbsp;&nbsp;&nbsp; Finished goods: 30 days after production<br>-&nbsp;&nbsp;&nbsp;&nbsp; Special circumstances as needed (for example, safety stock programs) |
| Storage –<br>Cold Chain | $[\*\*\*] per Pallet | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pallet charges will be assessed according to the following schedule:<br>-&nbsp;&nbsp;&nbsp;&nbsp; Customer supplied materials: 90 days after receipt of material<br>-&nbsp;&nbsp;&nbsp;&nbsp; Inventory Destruction Requests: 30 days after issuance of quote <br>-&nbsp;&nbsp;&nbsp;&nbsp; Finished goods: 30 days after production<br>-&nbsp;&nbsp;&nbsp;&nbsp; Special circumstances as needed (for example, safety stock programs) |

---

------

**CURRENT [\*\*\*] OPERATIONS**

**Effective Date: January 1**<sup>st</sup> **2021**

**PERSERIS US WIP A – 90mg Trade, 90mg Sample, 120mg Trade, 120mg Sample:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

---

| | |
|:---|:---|
| **Lot Size** | **Price per Pouch** |
| [\*\*\*] | [\*\*\*] |

---

**PERSERIS US WIP B – 90mg Trade, 90mg Sample, 120mg Trade, 120mg Sample:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

---

| | |
|:---|:---|
| **Lot Size** | **Price per Pouch** |
| [\*\*\*] | [\*\*\*] |

---

**PERSERIS US FINISHED KITS – 90mg Trade, 90mg Sample, 120mg Trade, 120mg Sample:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

---

| | |
|:---|:---|
| **Lot Size** | **Price per Pouch** |
| [\*\*\*] | [\*\*\*] |

---

**[\*\*\*] AND [\*\*\*] OPERATIONS**

**Effective Date: April 1**<sup>st</sup> **2021**

**PERSERIS US WIP A – 90mg Trade, 90mg Sample, 120mg Trade, 120mg Sample:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

---

| | |
|:---|:---|
| **Lot Size** | **Price per Pouch** |
| [\*\*\*] | [\*\*\*] |

---

**PERSERIS US WIP B – 90mg Trade, 90mg Sample, 120mg Trade, 120mg Sample:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

---

| | |
|:---|:---|
| **Lot Size** | **Price per Pouch** |
| [\*\*\*] | [\*\*\*] |

---

**PERSERIS US FINISHED KITS – 90mg Trade, 90mg Sample, 120mg Trade, 120mg Sample:**

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

---

| | |
|:---|:---|
| **Lot Size** | **Price per Pouch** |
| [\*\*\*] | [\*\*\*] |

---

## Exhibit 4.16

**Exhibit 4.16.5**

**AMENDMENT NO. 4 TO THE**

**PACKAGING AND SUPPLY AGREEMENT**

This Amendment No. 4 (the "Fourth Amendment"), is entered into and effective as of the last signature date below (the "Effective Date"), between Sharp Corporation, a corporation organized and existing under the laws of Pennsylvania and having its principal office at 7451 Keebler Way, Allentown, Pennsylvania 18106 ("Provider"), and Indivior Inc., a Delaware corporation having its principal office at 10710 Midlothian Turnpike, Suite 125, North Chesterfield, 23235 ("Company"), pursuant to the Packaging and Supply Agreement dated September 15, 2009 (the "Agreement"), as amended, between Provider and Company, formerly known as, Reckitt Benckiser Pharmaceuticals Inc.

WHEREAS, the parties wish to amend the Agreement;

WHEREAS the Federal Supply Schedule requires compliance with all applicable federal contracting laws and regulations;

WHEREAS Company and Provider have complied with all applicable federal contracting laws and Federal Acquisition Regulations (FARs) and seek to ensure Company's and Provider's continued compliance with all applicable federal contracting laws and FARs;

WHEREAS Company and Provider each agree to abide by all applicable federal contracting laws and FARs as are applicable to each of them with respect to the commercial relationship between Company and Provider; and

WHEREAS the parties desire to amend the Agreement as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;Exhibit A to this Fourth Amendment is hereby incorporated into the terms of the Agreement as Exhibit G.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;Except as provided herein, all other terms and conditions of the Agreement shall remain in full force and effect.

**IN WITNESS WHEREOF**, each of the parties hereto has caused this Amendment to be executed by its duly authorized representatives, as of the Effective Date.

---

| | | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|:---|
| **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **INDIVIOR UK Limited** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** | **SHARP CORPORATION** |
| By: | */s/ Hillel West* | */s/ Hillel West* | */s/ Hillel West* | */s/ Hillel West* | By: | */s/ Jeff Benedict* | */s/ Jeff Benedict* | */s/ Jeff Benedict* | */s/ Jeff Benedict* |
| Name: | Name: | Name: | Name: | Hillel West | Name: | Name: | Name: | Name: | Jeff Benedict |
| Title: | Title: | Chief Manufacturing & Supply Officer | Chief Manufacturing & Supply Officer | Chief Manufacturing & Supply Officer | Title: | Title: | Chief Commercial Officer | Chief Commercial Officer | Chief Commercial Officer |
| Date: | Date: | Date: | 9 May 2021 | 9 May 2021 | Date: | Date: | Date: | May 9, 2021 | May 9, 2021 |

---

------

**EXHIBIT A**

**Provider's Representations & Warranties**

To the extent applicable, Sharp Corporation represents and warrants to Company, that it will comply with all applicable federal contracting laws and Federal Acquisition Regulations (FARs), which may include, but are not limited to:

---

| | |
|:---|:---|
| &nbsp;&nbsp;**Citation** | &nbsp;&nbsp;**Title** |
| &nbsp;&nbsp;FAR 52.203-6 (2020) | &nbsp;&nbsp;Restrictions on Subcontractor Sales to the Government |
| &nbsp;&nbsp;FAR 52.203-13 (2020) | &nbsp;&nbsp;Contractor Code of Business Ethics and Conduct |
| &nbsp;&nbsp;FAR 52.203-17 (2020) | &nbsp;&nbsp;Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights |
| &nbsp;&nbsp;FAR 52.203-19 (2017) | &nbsp;&nbsp;Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements |
| &nbsp;&nbsp;FAR 52.204-10 (2016) | &nbsp;&nbsp;Reporting Executive Compensation and First-Tier Subcontract Awards |
| &nbsp;&nbsp;FAR 52.204-21 (2016) | &nbsp;&nbsp;Basic Safeguarding of Covered Conti act Information Systems |
| &nbsp;&nbsp;FAR 52.204-23 (2018) | &nbsp;&nbsp;Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities |
| &nbsp;&nbsp;FAR 52.204-25 (2020) | &nbsp;&nbsp;Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment |
| &nbsp;&nbsp;FAR 52.209-6 (2020) | &nbsp;&nbsp;Protecting the Government's Interest when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment |
| &nbsp;&nbsp;&nbsp;FAR 52.209-9 (2013) | &nbsp;&nbsp;Updates of Publicly Available Information Regarding Responsibility Matters |
| &nbsp;&nbsp;&nbsp;FAR 52.209-10 (2015) | &nbsp;&nbsp;Prohibition on Contracting with Inverted Domestic Corporations |
| &nbsp;&nbsp;&nbsp;FAR 52.212-5 (2020) | &nbsp;&nbsp;Contract Terms and Conditions Required to Implement Statues or Executive Orders – Commercial Items |
| &nbsp;&nbsp;&nbsp;FAR 52.219-3 (2011) | &nbsp;&nbsp;Notice of HUBZone Set-Aside or Sole-Source Award |
| &nbsp;&nbsp;&nbsp;FAR 52.219-6 (2011) | &nbsp;&nbsp;Notice of Total Small Business Set-Aside |
| &nbsp;&nbsp;&nbsp;FAR 52.219-8 (2016) | &nbsp;&nbsp;Utilization of Small Business Concerns |
| &nbsp;&nbsp;&nbsp;FAR 52.219-14 (2017) | &nbsp;&nbsp;Limitations on Subcontracting |
| &nbsp;&nbsp;&nbsp;FAR 52.219-16 (1999) | &nbsp;&nbsp;Liquidated Damages-Subcontracting Plan |
| &nbsp;&nbsp;&nbsp;FAR 52.219-27 (2011) | &nbsp;&nbsp;Notice of Service-Disabled Veteran-Owned Small Business Set-Aside |
| &nbsp;&nbsp;&nbsp;FAR 52.219-28 (2013) | &nbsp;&nbsp;Post Award Small Business Program Representation |
| &nbsp;&nbsp;&nbsp;FAR 52.219-29 (2015) | &nbsp;&nbsp;Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns |
| &nbsp;&nbsp;&nbsp;FAR 52.219-30 (2015) | &nbsp;&nbsp;Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program |
| &nbsp;&nbsp;&nbsp;FAR 52.222-3 (2003) | &nbsp;&nbsp;Convict Labor |
| &nbsp;&nbsp;FAR 52.222-17 (2014) | &nbsp;&nbsp;Nondisplacement of Qualified Workers |
| &nbsp;&nbsp;&nbsp;FAR 52.222-19 (2018) | &nbsp;&nbsp;Child Labor-Cooperation with Authorities and Remedies |
| &nbsp;&nbsp;FAR 52.222-21 (2015) | &nbsp;&nbsp;Prohibition of Segregated Facilities |
| &nbsp;&nbsp;FAR 52.222-26 (2015) | &nbsp;&nbsp;Equal Opportunity |
| &nbsp;&nbsp;FAR 52.222-35 (2020) | &nbsp;&nbsp;Equal Opportunity for Veterans |
| &nbsp;&nbsp;FAR 52.222-36 (2020) | &nbsp;&nbsp;Equal Opportunity for Workers with Disabilities |
| &nbsp;&nbsp;FAR 52.222-37 (2020) | &nbsp;&nbsp;Employment Reports on Veterans |
| &nbsp;&nbsp;FAR 52.222-40 (2010) | &nbsp;&nbsp;Notification of Employee Rights Under the National Labor Relations Act |
| &nbsp;&nbsp;FAR 52.222-41 (2018) | &nbsp;&nbsp;Service Contract Labor Standards |
| &nbsp;&nbsp;&nbsp;FAR 52.222-42 (2014) | &nbsp;&nbsp;&nbsp;Statement of Equivalent Rates for Federal Hires |

---

------

---

| | |
|:---|:---|
| &nbsp;&nbsp;&nbsp;FAR 52.222-43 (2018) | &nbsp;&nbsp;&nbsp;Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) |
| &nbsp;&nbsp;&nbsp;FAR 52.222-44 (2014) | &nbsp;&nbsp;&nbsp;Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment |
| &nbsp;&nbsp;FAR 52.222-50 (2020) | &nbsp;&nbsp;Combating Trafficking in Persons |
| &nbsp;&nbsp;FAR 52.222-51 (2014) | &nbsp;&nbsp;Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements |
| &nbsp;&nbsp;FAR 52.222-53 (2014) | &nbsp;&nbsp;Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements |
| &nbsp;&nbsp;FAR 52.222-54 (2015) | &nbsp;&nbsp;Employment Eligibility Verification |
| &nbsp;&nbsp;FAR 52.222-55 (2020) | &nbsp;&nbsp;Minimum Wages Under Executive Order 13658 |
| &nbsp;&nbsp;FAR 52.222-62 (2017) | &nbsp;&nbsp;Paid Sick Leave Under Executive Order 13706 |
| &nbsp;&nbsp;&nbsp;FAR 52.223-11 (2016) | &nbsp;&nbsp;Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons |
| &nbsp;&nbsp;FAR 52.223-18 (2011) | &nbsp;&nbsp;Encouraging Contractor Policies to Ban Text Messaging While Driving |
| &nbsp;&nbsp;&nbsp;FAR 52.223-20 (2016) | &nbsp;&nbsp;Aerosols |
| &nbsp;&nbsp;&nbsp;FAR 52.223-21 (2016) | &nbsp;&nbsp;Foams |
| &nbsp;&nbsp;&nbsp;FAR 52.224-3 (2017) | &nbsp;&nbsp;Privacy Training |
| &nbsp;&nbsp;&nbsp;FAR 52.225-5 (2016) | &nbsp;&nbsp;Trade Agreements |
| &nbsp;&nbsp;FAR 52.225-13 (2008) | &nbsp;&nbsp;Restriction of Certain Foreign Purchases |
| &nbsp;&nbsp;&nbsp;FAR 52.225-26 (2016) | &nbsp;&nbsp;Contractors Performing Private Security Functions Outside the United States |
| &nbsp;&nbsp;&nbsp;FAR 52.226-6 (2020) | &nbsp;&nbsp;Promoting Excess Food Donation to Nonprofit Organizations |
| &nbsp;&nbsp;&nbsp;FAR 52.232-33 (2013) | &nbsp;&nbsp;Payment by Electronic Funds Transfer – System for Award Management |
| &nbsp;&nbsp;&nbsp;FAR 52.232-34 (2013) | &nbsp;&nbsp;Payment by Electronic Funds Transfer – Other than System for Award Management |
| &nbsp;&nbsp;&nbsp;FAR 52.232-36 (2014) | &nbsp;&nbsp;Payment by Third Party |
| &nbsp;&nbsp;FAR 52.232-40 (2013) | &nbsp;&nbsp;Providing Accelerated Payment to Small Business Subcontractors |
| &nbsp;&nbsp;&nbsp;FAR 52.233-3 (1996) | &nbsp;&nbsp;&nbsp;Protest After Award |
| &nbsp;&nbsp;&nbsp;FAR 52.233-4 (2004) | &nbsp;&nbsp;&nbsp;Applicable Law for Breach of Contract Claim |
| &nbsp;&nbsp;&nbsp;FAR 52.242-5 (2017) | &nbsp;&nbsp;&nbsp;Payments to Small Business Subcontractors |
| &nbsp;&nbsp;&nbsp;FAR 52.247-64 (2006) | &nbsp;&nbsp;&nbsp;Preference for Privately Owned U.S.-Flag Commercial Vessels |

---

All applicable federal contracting laws and FARs, with respect to the rights, duties, and obligations of Company and Provider, shall be interpreted and construed in such a manner as to recognize and give effect to: (i) the contractual relationship between Company and Provider under this Agreement; and (ii) the rights of the Federal Government with respect thereto.

## Exhibit 4.17

**Exhibit 4.17**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT

MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**MASTER DEVELOPMENT AND SUPPLY AGREEMENT**

This MASTER DEVELOPMENT AND SUPPLY AGREEMENT ("Agreement") is made effective the first (1<sup>st</sup>) day of January 2022 ("Effective Date"), by and between Curia Massachusetts, Inc., formerly known as AMRI Burlington, Inc. ("Curia"), with a place of business at 99 South Bedford Street, Burlington, MA 01803 and Indivior UK Limited ("Indivior"), with its registered address at Chapleo Building, Henry Boot Way, Priory Park, Hull HU4 7BY, UK.

WHEREAS, Indivior is engaged in the business of developing pharmaceutical products;

WHEREAS, Curia is engaged in the business of providing contract pharmaceutical development, manufacturing, packaging and analytical services to the pharmaceutical industry;

WHEREAS, Indivior desires to engage Curia to manufacture and supply certain Product(s) (as defined below), and to provide related development services, and Curia desires to provide such manufacture, supply, and development services, pursuant to the terms and conditions set forth in this Agreement; and

WHEREAS, Indivior and Curia executed this Agreement as of the date of last signature below ("Execution Date"), but each intend for this Agreement to be effective and binding on the parties as of the Effective Date above; and

WHEREAS, Indivior and Curia each conducted themselves in accordance with the terms of this Agreement as of the Effective Date, notwithstanding the Execution Date.

NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions set forth below, the parties agree as follows:

**ARTICLE 1**

**DEFINITIONS**

The following terms have the following meanings in this Agreement:

1.1&nbsp;&nbsp;&nbsp;&nbsp;"Affiliate(s)" means any corporation, firm, partnership or other entity which controls, is controlled by or is under common control with a party for as long as such control exists. For purposes of this definition, "control" shall mean the ownership of at least fifty percent (50%) of the voting share capital of such entity or any other comparable equity or ownership interest, provided that Affiliates of Curia shall be limited to its direct and indirect subsidiaries.

1.2&nbsp;&nbsp;&nbsp;&nbsp;"Annual Forecast" means the twelve (12) month forecast of Indivior's projected total volume of Product to be ordered in the applicable Calendar Year (beginning 2023); such forecast to be provided by Indivior to Curia by December 31 of the prior Calendar Year (beginning in 2022).

1.3&nbsp;&nbsp;&nbsp;&nbsp;"API" means the active pharmaceutical ingredient required to Process the Products which has been released by Indivior and provided to Curia, along with a Certificate of Analysis.

1.4&nbsp;&nbsp;&nbsp;&nbsp;"APMF" shall have the meaning set forth in Section 2.4.

1.5&nbsp;&nbsp;&nbsp;&nbsp;"Applicable Laws" means all laws, ordinances, rules and regulations within the Territory applicable to the Processing of the Product or any aspect thereof and the obligations of Curia or Indivior, as the context requires under this Agreement, including, without limitation, (i) all applicable federal, state and local laws and regulations of each Territory; (ii) the U.S. Federal Food, Drug and Cosmetic Act, and (iii) cGMPs.

------

1.6&nbsp;&nbsp;&nbsp;&nbsp;"Batch" means the quantity of Product comprising a specified number of units (e.g., syringes) as mutually agreed upon between the parties, that (a) is intended to have uniform character and quality within specified limits, and (b) is Processed according to a single manufacturing order during the same cycle of Processing.

1.7&nbsp;&nbsp;&nbsp;&nbsp;"Batch Record Review Period" shall have the meaning set forth in Section 6.1.

1.8&nbsp;&nbsp;&nbsp;&nbsp;"Calendar Quarter" means a period of three (3) consecutive months commencing on January 1, April 1, July 1 or October 1 of any Calendar Year.

1.9&nbsp;&nbsp;&nbsp;&nbsp;"Calendar Year" means the period from January 1 to December 31 of each year.

1.10&nbsp;&nbsp;&nbsp;&nbsp;"Certificate of Analysis" means (i) with reference to a Batch of Product, the certificate that accompanies each shipment of a Batch of Product and which lists the test methods, acceptance limits and release test results for that specific Batch of Product; and (ii) with reference to Indivior Materials, the certificate that accompanies each shipment of Indivior Materials and which lists the test methods, acceptance limits and release test results for that specific batch of Indivior Materials.

1.11&nbsp;&nbsp;&nbsp;&nbsp;"Certificate of Compliance" means (i) with reference to a Batch of Product, a certificate attesting that the particular Batch of Product was Processed in accordance with the applicable Manufacturing Standards, and (ii) with reference to Indivior Materials, a certificate attesting that the Indivior Materials were manufactured in accordance with cGMPs as applicable to such Indivior Materials and conform to applicable regulatory requirements.

1.12&nbsp;&nbsp;&nbsp;&nbsp;"cGMP" or "GMP" means the current good manufacturing practices in the United States for the manufacture, control and storage of human pharmaceutical products, and equivalent regulations in such other Territories as are expressly agreed upon by the parties in writing, in each case as applicable to Product or Indivior Materials, as the context may require, provided that in the event of any conflict among the applicable laws of the United States and other Territories, current good manufacturing practices in the applicable Territory shall be applied unless the parties otherwise agree in writing. In the event Indivior does not provide Curia with advance notice of the intended destination Territory for any Batch of Product, Curia shall default to current good manufacturing practices in the United States. For clarity, the current good manufacturing practices in the United States applicable to Product shall mean those set forth in 21 C.F.R. 210 and 21 C.F.R. 211, as may be amended or supplemented, and the related regulations and FDA guidance documents in effect from time to time.

1.13&nbsp;&nbsp;&nbsp;&nbsp;"Commercial Product" means Product which has completed the required clinical trials, if any, and has been approved by an applicable Regulatory Authority for commercial distribution.

1.14&nbsp;&nbsp;&nbsp;&nbsp;"Commercially Reasonable Efforts" shall mean, with respect to the efforts expended by a party under this Agreement, that degree of effort consistent with the practices and standards of the pharmaceutical industry in the United States normally used to achieve the fulfillment of obligations similar to those assumed by a party under this Agreement as expeditiously as possible.

1.15&nbsp;&nbsp;&nbsp;&nbsp;"Confidential Information" shall have the meaning set forth in Section 11.1.

1.16&nbsp;&nbsp;&nbsp;&nbsp;"Contract Year" means each period of twelve (12) consecutive months during the Term of this Agreement, with the first Contract Year commencing on the Effective Date, and with each subsequent Contract Year commencing on the anniversary of the Effective Date.

1.17&nbsp;&nbsp;&nbsp;&nbsp;"Curia Background Technology" means any Technology (i) owned or controlled by Curia or any of its Affiliates as of the Effective Date; or (ii) developed or obtained by or on behalf of Curia or any of its Affiliates after the Effective Date independent of this Agreement, and all intellectual property rights in any of the foregoing.

1.18&nbsp;&nbsp;&nbsp;&nbsp;"Curia Indemnitees" shall have the meaning set forth in Section 13.2.

1.19&nbsp;&nbsp;&nbsp;&nbsp;"Curia Program Technology" means Program Technology that (i) consists of improvements to Curia Background Technology, (ii) is developed using Confidential Information of Curia and does not incorporate Indivior Confidential Information, or (iii) consists of improvements to the manufacturing process that are generally applicable to multiple products (but which do not incorporate Indivior Confidential Information), and in each case of (i), (ii) and (iii), is not Product-specific Program Technology, and all intellectual property rights in any of the foregoing clauses (i), (ii) and (iii).

------

1.20&nbsp;&nbsp;&nbsp;&nbsp;"Curia Technology" means Curia Background Technology and Curia Program Technology.

1.21&nbsp;&nbsp;&nbsp;&nbsp;"Delivery" shall have the meaning set forth in Section 5.3.

1.22&nbsp;&nbsp;&nbsp;&nbsp;"Effective Date" shall have the meaning set forth in the Preamble.

1.23&nbsp;&nbsp;&nbsp;&nbsp;"Facility" or "Facilities" means Curia's facility in Burlington, MA, located at 99 South Bedford Street, Burlington, MA 01803.

1.24&nbsp;&nbsp;&nbsp;&nbsp;"FDA" means the United States Food and Drug Administration, and any successor agency thereto.

1.25&nbsp;&nbsp;&nbsp;&nbsp;"Firm Period Forecast" shall have the meaning set forth in Section 4.3.

1.26&nbsp;&nbsp;&nbsp;&nbsp;"Indivior Equipment" shall have the meaning set forth in Section 3.3.

1.27&nbsp;&nbsp;&nbsp;&nbsp;"Indivior Existing Technology" means (i) API; (ii) any intermediates or derivatives of API; (iii) any other Technology owned or controlled by Indivior or any of its Affiliates as of the Effective Date; or (iv) any Technology, other than Program Technology, developed or obtained by or on behalf of Indivior or any of its Affiliates after the Effective Date, and all intellectual property rights in any of the foregoing.

1.28&nbsp;&nbsp;&nbsp;&nbsp;"Indivior Indemnitees" shall have the meaning set forth in Section 13.1.

1.29&nbsp;&nbsp;&nbsp;&nbsp;"Indivior Materials" means API, Raw Materials, components, and any reference standards used in the Processing of Product that are to be provided by Indivior or as to which Indivior has specified a supplier who is not already on Curia's list of approved qualified suppliers, in each case as specified in this Agreement, the applicable Purchase Order or as otherwise agreed in writing by the parties.

1.30&nbsp;&nbsp;&nbsp;&nbsp;"lndivior Technology" means Indivior Existing Technology and rights assigned to Indivior under Section 12.3 of this Agreement in Product-specific Program Technology.

1.31&nbsp;&nbsp;&nbsp;&nbsp;"Latent Defect" means Non-conforming Product which could not have been ascertained by Indivior by the exercise of reasonable diligence and after the parties' investigation regarding the cause of such defect in accordance with Section 6.1, such defect is determined to have been caused by Curia's gross negligence or willful misconduct.

1.32&nbsp;&nbsp;&nbsp;&nbsp;"Losses" shall have the meaning set forth in Section 13.1.

1.33&nbsp;&nbsp;&nbsp;&nbsp;"Manufacturing Standards" means Processing of Product in accordance with procedures set forth in the Master Batch Record and cGMP (if applicable as per intended use of Product), and in conformance with Specifications, provided that a failure to conform to Specifications due to the use of any (i) defective, adulterated or misbranded API or other Indivior Materials as supplied by Indivior (including, but not limited to failure of API or other Indivior Materials to meet applicable Specifications or to have been manufactured in accordance with cGMP), or (ii) defective Other Raw Materials (other than Indivior Materials), where the defects were not reasonably discoverable by Curia as a result of testing in accordance with its standard operating procedures shall not prevent Product from being considered to have been Processed in accordance with Manufacturing Standards.

1.34&nbsp;&nbsp;&nbsp;&nbsp;"Master Batch Record" shall mean the document approved in writing by both parties, and as may be amended from time to time in accordance with this Agreement and the Quality Agreement, specifying or referencing the complete set of formal instructions agreed upon by the parties for the Processing of Product, including, but not limited to material descriptions, the formula, processing procedures, in-process testing specifications, Product Specifications and packaging and shipping specifications. For the avoidance of doubt, upon finalization, Indivior shall have full and sole rights, titles, and ownership to, in and of the Master Batch Record, provided, however, Indivior shall in no event have any ownership rights to Curia's Confidential Information contained therein. As of the Effective Date, the parties agree that no Curia Confidential Information is included in the Master Batch Record. In the event Curia does add any of its Confidential Information to the Master Batch Record, Curia shall give Indivior written notice of which such information is being added to the Master Batch Record that is identified as Curia's Confidential Information.

1.35&nbsp;&nbsp;&nbsp;&nbsp;"Minimum Requirement" shall have the meaning set forth in Section 4.1.

------

1.36&nbsp;&nbsp;&nbsp;&nbsp;"MSDS" shall have the meaning set forth in Section 3.1. "Non-commercial Product" means Product which is in developmental/clinical trial phases and has not yet been approved by an applicable Regulatory Authority for commercial distribution. Non-commercial Product includes Stability/Validation Batches.

1.37&nbsp;&nbsp;&nbsp;&nbsp;"Non-conforming Product" means Product, which, at the time of Delivery, was not Processed in accordance with Manufacturing Standards.

1.38&nbsp;&nbsp;&nbsp;&nbsp;"Notice Period" shall have the meaning set forth in Section 6.1.

1.39&nbsp;&nbsp;&nbsp;&nbsp;"Order Deficit" shall have the meaning set forth in Section 4.5.

1.40&nbsp;&nbsp;&nbsp;&nbsp;"Other Raw Materials" shall have the meaning set forth in Section 3.2.

1.41&nbsp;&nbsp;&nbsp;&nbsp;"Packaging" means the filling of syringes, and bulk packaging of naked syringes into containers for Delivery. For the avoidance of doubt, this shall exclude syringe labelling and Secondary Packaging.

1.42&nbsp;&nbsp;&nbsp;&nbsp;"Performance Standards" means key performance indicators against which Curia's performance will be continually measured as set out in **Exhibit D**.

1.43&nbsp;&nbsp;&nbsp;&nbsp;"PPI" shall have the meaning set forth in Section 7.2(i).

1.44&nbsp;&nbsp;&nbsp;&nbsp;"Price Increase Date" shall have the meaning set forth in Section 7.2(i).

1.45&nbsp;&nbsp;&nbsp;&nbsp;"Process," "Processed," or "Processing" means the compounding, filling, producing and/or Packaging of the API and Raw Materials into Product in accordance with the Specifications, Master Batch Record, Manufacturing Standards (if applicable) and the terms and conditions set forth in this Agreement.

1.46&nbsp;&nbsp;&nbsp;&nbsp;"Processing Date" means the day on which Curia will commence Processing a given Batch of Product.

1.47&nbsp;&nbsp;&nbsp;&nbsp;"Product" means the fully compounded bulk drug product in its final dosage form Processed under this Agreement as further described in **Exhibit B**, attached hereto, and includes both Commercial Product and Non-commercial Product.

1.48&nbsp;&nbsp;&nbsp;&nbsp;"Product-specific Program Technology" means any Program Technology that constitutes an improvement, modification, derivative, or new use of Indivior' s API, Product, or Indivior's Confidential Information, but which is not an improvement of general applicability to the manufacturing process, and, in each case, all intellectual property rights in any of the foregoing.

1.49&nbsp;&nbsp;&nbsp;&nbsp;"Program Technology" means Technology developed by or on behalf of either party or any of its Affiliates in the course of the activities contemplated by this Agreement.

1.50&nbsp;&nbsp;&nbsp;&nbsp;"Project Plan" shall have the meaning set forth in Section 2.1.

1.51&nbsp;&nbsp;&nbsp;&nbsp;"Purchase Order" shall mean the written order placed by Indivior for quantities of Product required to be Processed and released by Curia under this Agreement as well as for any services to be provided by Curia.

1.52&nbsp;&nbsp;&nbsp;&nbsp;"Quality Agreement" shall mean the agreement specifying the roles and responsibilities of the parties with respect to quality assurance/quality control activities, in a form mutually agreeable to both parties.

1.53&nbsp;&nbsp;&nbsp;&nbsp;"Raw Materials" means all raw materials, supplies, components and packaging necessary to manufacture and ship the Product in accordance with the Specifications, but not including the APL

1.54&nbsp;&nbsp;&nbsp;&nbsp;"Regulatory Approval" shall have the meaning set forth in Section 7.6.

1.55&nbsp;&nbsp;&nbsp;&nbsp;"Regulatory Authority" means any governmental regulatory authority within a Territory involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product.

1.56&nbsp;&nbsp;&nbsp;&nbsp;"Rolling Forecast" shall have the meaning set forth in Section 4.3.

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1.57&nbsp;&nbsp;&nbsp;&nbsp;"Secondary Packaging" means all packaging components or packaging activities not specifically included under the definition for Packaging, which activities are not and will not be in direct contact with the dosage form (for the avoidance of doubt, Secondary Packaging shall include the labelling of syringes containing the Product).

1.58&nbsp;&nbsp;&nbsp;&nbsp;"Specifications" shall mean, (a) with respect to Product, the written specifications and quality standards, including tests, analytical procedures and acceptance criteria established to confirm the characteristics and quality of Product, as set forth in the Master Batch Record applicable to the Product, and as amended from time to time in accordance with the terms of Section 8 of this Agreement; and (b) with respect to Indivior Materials, including API, the written specifications and quality standards, including tests, analytical procedures and acceptance criteria, to which such Indivior Materials must conform in order to be considered acceptable for use in Processing of Product.

1.59&nbsp;&nbsp;&nbsp;&nbsp;"Technology" means all discoveries, inventions, know-how, developments, methods, techniques, trade secrets, innovations, updates, modifications, enhancements, improvements, copyrights, data, documentation, processes, procedures, specifications and other intellectual property of any kind, whether or not protectable under patent, trademark, copyright or similar laws.

1.60&nbsp;&nbsp;&nbsp;&nbsp;"Technology Transfer" means the transfer from Curia to Indivior or any third party designated by Indivior of the full and complete procedures and tangible and intangible information that is reasonably necessary to Process Product, inclusive of, without limitation, documents, Process instructions, Master Batch Records, analytical methods, stability samples, retention samples and materials (including Specifications for Raw Materials).

1.61&nbsp;&nbsp;&nbsp;&nbsp;"Term" shall have the meaning set forth in Section 15.1.

1.62&nbsp;&nbsp;&nbsp;&nbsp;"Territory" means, as of the Effective Date and as applicable, the United States, Canada, countries within the European Union, Australia, Israel, New Zealand, Switzerland, and Norway, where such country or countries may be amended or added to from time to time by Indivior, as mutually agreed by the parties, where such consent shall not be unreasonably withheld by Curia.

1.63&nbsp;&nbsp;&nbsp;&nbsp;"Unit Pricing" or "Unit Price" shall have the meaning set forth in Section 7.1(i).

1.64&nbsp;&nbsp;&nbsp;&nbsp;"Validation Batches" shall mean a specified number of consecutive Batches, as agreed in the validation protocol, that have been processed in accordance with the Manufacturing Standards and such Validation Batch will be intended to be commercializable unless specified otherwise in the relevant validation protocol or SOW (defined below) for such Validation Batch.

1.65&nbsp;&nbsp;&nbsp;&nbsp;"Validated Manufacturing Process" shall mean the manufacturing process for Product that is established after the completion of Processing, at scale, of the Validation Batches in accordance with the Manufacturing Standards.

**ARTICLE 2**

**DEVELOPMENT, VALIDATION, PROCESSING & RELATED SERVICES**

2.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Development and Stability/Validation Services</u>. Curia shall perform any process development, qualification, validation and stability services described in the applicable SOW for the prices specified therein. With respect to the development and validation services described in the SOW, the parties shall agree on a project Gantt chart at the commencement of services (the "Project Plan"). The Project Plan shall specify the dates for receipt of information and materials, review and approval of documentation, scheduled engineering and manufacturing run dates and dates for other tasks for which Indivior is responsible consistent with the terms of this Agreement and the SOW. Upon mutual written approval of the Project Plan, any delay or departure from the specified dates caused solely by Indivior for Validation Batches shall result in the application of rescheduling or cancellation fees under Section 7.3.

2.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Failures Prior to Validation and Additional Validation Batches</u>. Notwithstanding anything in this Agreement to the contrary, Indivior shall pay for all Validation Batches that fail to meet the Manufacturing Standards in accordance with this Agreement and assume responsibility for all costs, including but not limited to the cost of API or other Indivior Materials, associated with such Validation Batch failures until such time as there exists a Validated Manufacturing Process for the Product, provided, however, that Curia shall be responsible for Validation Batch failures due to Curia's gross negligence or willful misconduct. In the event of a Validation Batch failure due to Curia's gross negligence or willful misconduct, Indivior shall have, in its sole discretion, the right to either (i) have Curia re-make the relevant Validation Batch at no further cost to Indivior (provided Indivior pays for the conforming replacement services solely in the event Indivior has not already paid for the non-conforming

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services) or (ii) to have Curia credit to Indivior the amount paid by Indivior for such failed Validation Batch. Indivior shall be responsible for supplying, at Indivior's expense, sufficient quantities of API and other Indivior Materials, as necessary for Curia to complete such replacement. The foregoing remedy shall be Indivior's sole and exclusive remedy for any failure of a Validation Batch to conform to the Manufacturing Standards. Indivior acknowledges that a change in Specifications, manufacturing Process or Master Batch Records may require a new Validated Manufacturing Process using the new Specifications, manufacturing Process or Master Batch Records, provided, however, the parties agree that Validation Batches Processed without changes to the Specifications or Process which are required solely for Indivior to make use of a previously validated Process for a Product in a new Territory shall not constitute a need for a new Validated Manufacturing Process and in such circumstances, each such Batch Processed by Curia shall remain subject to the terms of Section 6. In the event that Purchase Orders do not provide a continuity of processing so as to keep Curia's personnel trained on Product, the processing of additional Validation Batches before the next commercial manufacturing run may be necessary at Curia's discretion and, at Indivior's expense.

2.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Supply and Purchase of Product</u>. During the Term, Curia shall Process the Product in accordance with the terms and conditions of this Agreement. Indivior shall purchase the Product from Curia in accordance with Section 4 and other terms and conditions of this Agreement.

2.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Annual Product Maintenance Fee</u>. Indivior shall pay to Curia an Annual Product Maintenance Fee ("APMF") for each Product manufactured per Facility. For clarity, the APMF shall apply per Product family per Facility (i.e., SUBLOCADE® is one Product family Processed at the Facility and PERSERIS® is the second Product family Processed at the Facility). The APMF will cover an array of Product support activities, which are irrespective of manufactured Product volumes, and include the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;dedicated primary point of contact for all commercial manufacturing activities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;scheduling, planning, and communicating all commercial manufacturing activities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Drug Master File (DMF) updates with the FDA and EU;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;annual audit conducted by Indivior;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;annual Product Review in accordance with 21 CFR § 211.180;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;host all person-in-plant activities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Product license or permits from local, state and all federal authorities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;access to document library (additional copies of Batch paperwork or other Batch documentation when requested);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;storage of Indivior dedicated equipment;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;access to Curia common change parts for filling equipment;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Product documentation and sample storage (retains) relating to cGMP requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;re-qualification of Raw Material vendors;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;maintenance and storage of Raw Material vendor audit reports; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;storage of project dedicated components and excipients in Curia W.I.P. cages.

The APMF will be payable within sixty (60) days after the Effective Date, and then within sixty (60) days after the start of every subsequent Contract Year for the remainder of the Term. The APMF for the first Product manufactured at a Facility is fixed at [\*\*\*] dollars ($[\*\*\*]) per twelve (12) months, for the Term of the Agreement. Each additional Product at the same Facility will incur an APMF of [\*\*\*] dollars ($[\*\*\*]) per twelve (12) months, for the Term of the Agreement. As of the Effective Date, the APMF under this Agreement shall be [\*\*\*] dollars ($[\*\*\*]) (i.e., $[\*\*\*] for SUBLOCADE® + $[\*\*\*] for PERSERIS®), subject to adjustment in the event additional Product families are added or removed at any time during the Term. In the event that this Agreement is terminated prior to the expiration of the Term, Curia would provide a credit to Indivior for the pro-rated portion of the APMF for such partial Contract Year, unless Curia terminates based on Indivior's material breach of this Agreement, in which case, no such proration shall occur.

2.5&nbsp;&nbsp;&nbsp;&nbsp;Technology Transfer. Indivior may, during the course of this Agreement, name an alternate manufacturer for supply of the Product. Curia will cooperate in any Technology Transfer, and will cooperate in all reasonable requests made by Indivior to coordinate supply of Product, Indivior Materials, applicable Technology (including but not limited to Indivior Technology), and all other information or materials necessary to complete the Technology Transfer between such alternate manufacturer and Curia. All costs associated with a Technology Transfer shall be borne by Indivior in accordance with then-current market rates and reasonable man-hours as agreed by both parties in writing; provided, however, Curia shall use Commercially Reasonable Efforts to help complete the Technology Transfer. Each party shall continue to fulfill its obligations under the terms of this Agreement during any Technology Transfer.

2.6&nbsp;&nbsp;&nbsp;&nbsp;Other Related Services. Curia shall provide services other than the Processing of Product upon terms and conditions agreed to by the parties in writing from time to time, such other services to be set forth in a Scope of Work (each, an "SOW") signed by both parties. A sample form of an SOW is attached hereto as Exhibit C.

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**ARTICLE 3** 

**MATERIALS**

3.1&nbsp;&nbsp;&nbsp;&nbsp;<u>API and Indivior Materials</u>. Indivior shall supply to Curia for Processing, at Indivior' s sole cost, the API and other applicable Indivior Materials in quantities sufficient to meet Indivior's requirements for each Product as further set forth in Section 4. Prior to delivery of any of the API or other Indivior Material to Curia for Processing, Indivior shall provide to Curia a copy of the Material Safety Data Sheet ("MSDS") for such material, and follow up with any subsequent revisions thereto. Indivior shall supply the API, other Indivior Materials, and Certificates of Analysis and Certificates of Compliance DDP the Facility (Incoterm 2020). Indivior shall use Commercially Reasonable Efforts to at all times maintain at least a sixty (60) day supply of Indivior Materials with Curia. Upon receipt of the API/other Indivior Materials, Curia shall conduct the testing set forth in **Exhibit A**, attached hereto. Curia shall not be responsible for any further testing or for confirming that the API and other Indivior Materials meet applicable Specifications, unless otherwise agreed by the parties in writing. Curia shall use the Indivior Materials solely and exclusively for Processing under this Agreement. Title to and risk of loss of API and other Indivior Materials shall at all times remain with Indivior, and Curia shall have no liability with respect to cost, or loss of, API or other Indivior Materials, except to the extent of any losses attributable to Curia's gross negligence or willful misconduct. In the event of any API or Indivior Materials loss caused by Curia's gross negligence or willful misconduct, Curia shall provide Indivior with a credit for such API or Indivior Materials **in** the amount of the lesser of the replacement value of the API or Indivior Materials; or (ii) $[\*\*\*] (in the aggregate for the API and Indivior Materials) per event. The remedy set forth in the immediately foregoing sentence shall be Indivior's sole remedy in the event of any loss or damage to API or other Indivior Materials.

3.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Other Raw Materials</u>. The parties may agree in writing that Curia shall be responsible for procuring, inspecting and releasing certain Raw Materials necessary to meet Purchase Orders ("Other Raw Materials"). Curia shall procure such Other Raw Materials in sufficient quantities to meet the Firm Period Forecast. If lndivior requires a specific supplier for any Other Raw Material, Indivior will be responsible for all costs associated with qualification of that supplier, if not previously qualified by Curia, and such Other Raw Material will be deemed Indivior Material. If Indivior does not so request a specific supplier, then Curia shall be responsible for the costs of qualifying any supplier it so selects to the extent Curia has not already qualified such supplier. Unless a particular Other Raw Material can be replaced with the same raw material from another supplier, Curia shall not be liable for any delay in Processing of Product if (i) Curia is unable to obtain that Other Raw Material in a timely manner, and (ii) Curia placed orders for such Other Raw Material promptly following receipt of Indivior's Firm Period Forecast/Purchase Order. Curia shall test and release the Other Raw Materials for use in Processing activities in accordance with its standard operating procedures. Provided Curia has complied with such standard operating procedures with regard to testing of any batch of Other Raw Materials, Curia shall not be responsible for the consequences of any defects in that batch of Other Raw Materials that are not reasonably discoverable as a result of such testing.

3.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Equipment</u>. Indivior shall provide, or has provided, to Curia, at Indivior's expense, the equipment set forth in the applicable SOW, if any ("Indivior Equipment"). Indivior may alternatively request that such equipment be purchased by Curia on behalf of Indivior in which case, Indivior shall pay for such equipment at cost plus [\*\*\*] percent ([\*\*\*]%). Indivior shall be responsible for all freight, insurance and other costs of transporting Indivior Equipment to the Facility. Title to, and risk of loss of, all such Indivior Equipment shall be retained by Indivior at all times and Indivior shall obtain adequate insurance for such equipment if desired. The parties agree that they shall put into place appropriate documentation, such as a Purchase Order, specifically authorizing and identifying Indivior Equipment. Curia shall keep Indivior Equipment free and clear of any liens and/or encumbrances and provide reasonable documentation supporting the purchase (or allocation) of such equipment on behalf of Indivior. Curia shall be responsible for keeping all Indivior Equipment in good repair and in working order, scheduling and performing maintenance on Indivior Equipment as recommended by the applicable equipment manufacturer, and repairing Indivior Equipment, in each case, at Indivior's cost and expense. Indivior agrees that any delay in providing Indivior Equipment or reimbursing Curia for acquiring Indivior Equipment may cause a delay in Processing activities and that Curia will not be responsible for such a delay. In the event Curia's failure to properly maintain Indivior Equipment causes a delay in any scheduled Processing Date, Curia shall not charge Indivior any applicable rescheduling or cancellation fee for such Batch. Upon completion of the use of the Indivior Equipment, unless otherwise mutually agreed by the parties, the Indivior Equipment shall be shipped to Indivior, at Indivior's cost and expense. Notwithstanding the above, Curia shall be responsible for any repair or replacement costs for Indivior Equipment in the event such repair or replacement is necessary as a result of Curia's gross negligence, willful misconduct, or failure to perform its responsibilities as described in this Section 3.3.

3.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Packaging</u>. Indivior shall provide or approve, prior to the procurement of applicable components, all Packaging information necessary to Process the Product. For purposes of this Agreement, Curia's obligations relating to packaging shall be limited to Packaging. Such Packaging information is and shall remain the exclusive property of lndivior, and Indivior shall be solely responsible for the content thereof. Any changes or supplements to Packaging information should be submitted to Curia, in accordance with the applicable Curia SOP, in writing at least ninety (90) days prior to the desired implementation date (or as otherwise agreed by the parties in writing), together with the required documentation. Notwithstanding the forgoing, in the

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event of a required emergency change or supplement, changes may be requested by Indivior with less than ninety (90) days' prior written notice. Indivior shall reimburse Curia for any costs and/or expenses related to any such change, amendment or supplement and its implementation. Indivior shall also reimburse Curia for its actual costs plus [\*\*\*] percent ([\*\*\*]%) for any prior versions of Packaging that become obsolete due to the implementation of changes. Curia shall not use any Packaging information provided by Indivior or any reproduction thereof following the termination of this Agreement, or during the Term of this Agreement in any manner other than solely for the purpose of performing its obligations hereunder. Curia shall make changes to the syringes, for the purpose of Packaging, as may be requested by Indivior from time to time. Curia will make no changes to the syringes for Packaging without the prior written approval of Indivior. Any changes or supplements pursuant hereto should be submitted to Curia in writing at least one hundred twenty (120) days prior to the desired implementation date, together with the required documentation, provided that any changes or supplements that require new equipment, change parts, requalification of the manufacturing line may require a longer lead time, and with such longer lead time being established through good faith discussions by the parties. Indivior shall reimburse Curia for any costs and/or expenses related to any such change, amendment or supplement and its implementation. Indivior shall also reimburse Curia for any prior syringes that become obsolete due to the implementation of changes to the extent such stock of syringes does not exceed Curia's requirements for the Firm Period Forecast or any minimum supplier pack/delivery quantity required by the suppliers. Moreover, Indivior acknowledges that the manufacturing line may not be able to accommodate certain changes to the syringes.

3.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Reimbursement for Other Raw Materials</u>. In the event of (i) a Specification change for any reason, (ii) termination or expiration of this Agreement; or (iii) obsolescence of any Other Raw Material, Indivior shall bear the cost of any unused Other Raw Materials, provided that Curia purchased such Other Raw Materials in quantities consistent with the Firm Period Forecast/Purchase Order and any minimum purchase obligations required by the Other Raw Material supplier. In the event Indivior wishes to instead purchase such unused Other Raw Materials from Curia, Indivior shall pay to Curia the cost of such Other Raw Materials, plus [\*\*\*]%. Indivior shall also pay for all shipping costs associated with shipping such unused Other Raw Materials to Indivior and title to and risk of loss of such Other Raw Materials shall transfer to Indivior upon Curia's submission of an invoice to Indivior for such Other Raw Materials.

3.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Storage of lndivior Materials</u>. Curia shall use Commercially Reasonable Efforts to store all quantities of Indivior Materials at the Facility, at no cost to Indivior, for the period required to meet the Firm Period Forecast and thereafter at a monthly storage charge at Curia's then-current rates plus [\*\*\*]%. To the extent Curia's Facility does not have capacity to store such Indivior Materials, Curia shall store such excess Indivior Materials at a third party warehouse (qualified by Curia to store such Indivior Materials) at a monthly storage charge to Indivior for the duration of storage, billed at the third party's then current standard monthly storage fees and minimums, plus [\*\*\*]%, pro-rated for any partial month. For the avoidance of doubt, in no event shall Curia charge Indivior any amounts in excess of the cost of such third party storage services plus [\*\*\*]% and Curia shall absorb any excess costs associated with storing Indivior Materials at a third party facility *(e g,* transportation costs). In the event that a monthly storage fee will be incurred as described above, Curia will provide reasonable advance notice to Indivior of the amount of such fee(s) and projected date of implementation of the same.

3.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Physical Inventory Count</u>. Indivior shall have the right to conduct one (1) full, "wall-towall" physical inventory count once each twelve (12) month period ("Inventory Count") during the Term. To schedule the Inventory Count, Indivior shall give Curia reasonable advance notice, but not less than three (3) months' notice. At Indivior's request, Curia shall permit Indivior, and its external auditor(s) ("Inventory Auditor"), to conduct a full physical count of its Inventory (defined below) as close to the year-end as possible, preferably during the year-end shut down at Curia, to minimize inventory movements. The number of visitors during the Inventory Count shall be limited to two (2) Indivior personnel, and one (1) Inventory Auditor, for two (2) days. The Inventory Count shall be conducted in a manner that is consistent with the method historically used by Indivior to conduct a full physical count of its inventory, as conducted during the Indivior' s year-end book closing process. Curia agrees to provide reasonable support to Indivior during the Inventory Count. Indivior agrees to provide Curia with reasonable compensation for their efforts in preparation and execution of the Inventory Count, such compensation to be set forth in an SOW or other written documentation signed by both parties. The cost of such Inventory Count shall be $[\*\*\*] per day for Calendar Year 2022 and thereafter $[\*\*\*] shall be the base cost of an Inventory Count, subject to a price increase based on PPI for each subsequent Calendar Year during the Term.

3.8&nbsp;&nbsp;&nbsp;&nbsp;<u>Inventory and Consumption Reports</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;<u>Inventory Reports</u>. Month-end closing inventory reports ("Inventory Reports") shall be provided by Curia to Indivior no less than three (3) business days before each month-end; and no less than four (4) business days before each quarter-end. The Inventory Reports shall be inclusive of all Indivior owned inventory including but not limited to API and Indivior Materials and all Products (collectively, the "Inventory").

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;<u>Consumption Reports</u>. Curia shall use Commercially Reasonable Efforts to provide Consumption Reports (defined below) to Indivior within forty-five (45) days of the Processing Date of the applicable Batch. Consumption Reports shall detail the Inventory "consumption quantities" allocated to the Purchase Orders still being Processed, or pending Quality Assurance approval, net of any items returned to stock (the "Consumption Report"). Curia shall include the following information **in** each Consumption Report to ensure records are maintained with integrity:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Material Description

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Curia Lot Number

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Indivior Batch Number

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;Quantity issued (net of returns)

For those Products already Processed, released, and in the process of being shipped, or have already shipped, Curia will provide to Indivior the relevant Consumption Reports.

**ARTICLE 4** 

**FORECASTS & PURCHASE ORDERS**

4.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Minimum Requirement</u>. For Calendar Year 2022 only, Indivior agrees to purchase from Curia a minimum of [\*\*\*] units of Product, subject to Curia's ability to make such quantity ("Minimum Requirement"). Accordingly, Curia agrees to dedicate its Optima/Inova H3-5V with RABS line at the Facility (the "Line") to Processing Product for Indivior during Calendar Year 2022.

4.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Capacity Guarantee</u>. For each subsequent Calendar Year during the Term, if Indivior's volume demand drops below the output of the Line (i.e., the demonstrated performance) during Calendar Year 2022 ("2022 Line Output"), then Curia shall not be required to dedicate the Line to Processing Product for Indivior; provided, however, Curia shall give Indivior the right of first refusal with respect to any unutilized capacity on the Line during the first Calendar Year in which Indivior's volume demand (based on the Annual Forecast) drops below the 2022 Line Output. Accordingly, Indivior may elect to have the Line dedicated to Indivior in any subsequent Calendar Year during the Term by paying a capacity reservation fee, based on the types of units of Product ordered during the previous Calendar Year and the associated Unit Pricing (i.e., the average per unit price) set forth in Column B in the table set fo1th in **Exhibit B**, subject to adjustment in accordance with Section 7.2 ("Capacity Reservation Fee"). In the event Indivior does not elect to pay the Capacity Reservation Fee during any Calendar Year during the Term, Curia shall have the right to sell the unutilized capacity to other customers and Indivior's right of first refusal set forth in this Section 4.2 shall lapse. Within ten (10) calendar days of the first (1<sup>st</sup>) day of each Calendar Year during the Term, Indivior shall provide Curia with notice of whether Indivior would like to reserve such unutilized capacity by paying the Capacity Reservation Fee. By way of example, if the 2022 Line Output is 800,000 units of Product and Indivior's volume demand for Calendar Year 2023 is 700,000 units of Product, then Indivior may elect to have the Line dedicated to Indivior during Calendar Year 2023 by paying a Capacity Reservation Fee for the 100,000 units of unutilized capacity. For clarity, for each Calendar Year in which Indivior elects to pay a Capacity Reservation Fee, if applicable, such Capacity Reservation fee shall be credited towards any amount of Product Curia Processes and Delivers in excess of the Annual Forecast during such Calendar Year.

4.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Forecasts and Purchase Orders</u>. On or before the twelfth (12<sup>th</sup>) day of each month, beginning on January 12, 2022, Indivior shall furnish to Curia a written twelve (12) month rolling forecast of the quantities of Product that Indivior intends to order from Curia during such period ("Rolling Forecast"). The first six (6) months of such Rolling Forecast shall constitute a firm and binding commitment to order quantities of Product specified therein ("Firm Period Forecast"), and the following six (6) months of the Rolling Forecast shall be non-binding, good faith estimates. Each month of the Rolling Forecast shall begin on the twelfth (12<sup>th</sup>) of the calendar month in which such Rolling Forecast is submitted and end on the eleventh (11<sup>th</sup>) day of the following calendar month. With exception to the Firm Period Forecast, Curia reserves the right to reject any Rolling Forecast that does not align with the physical Processing capabilities of the Facility(ies) and the parties shall work in good faith to adjust the Rolling Forecast based on available resources, Facility capacity and other relevant factors. Indivior shall have the right to request an increase of the Firm Period Forecast to include additional units of Product. Curia may, in its sole discretion, supply such additional quantities, subject to Curia's other supply commitments and manufacturing capacity. In the event Curia agrees to supply such additional quantities, Indivior shall submit a Purchase Order for such additional quantities, with the required lead times as specified below. In no event shall Curia's inability to fulfill Purchase Orders for quantities in excess of the Firm Period Forecast be deemed a breach of this Agreement, nor relieve Indivior of its obligations under this Agreement.

Indivior shall submit with each Rolling Forecast, a non-cancelable Purchase Order for the Firm Period Forecast (or such portion of the Firm Period Forecast not covered by previously submitted Purchase Orders). Indivior may alternatively submit Purchase Orders for certain portions of the Firm Period Forecast subsequent to the submission of the Rolling Forecast, provided the Purchase Orders provide the required lead time for Processing as set forth below. Curia shall notify Indivior of acceptance of the

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Rolling Forecast and any Purchase Order within seven (7) business days of receipt. Curia shall be deemed to have accepted Purchase Orders which it does not acknowledge within seven (7) business days of receipt. Curia shall have the right to reject Rolling Forecasts and Purchase Orders that are inconsistent with this Agreement. Each Purchase Order shall specify the quantity of Product being ordered, and the desired delivery date.

Upon mutual agreement in writing for additional quantities of Product beyond the Firm Period Forecast, including projected delivery date(s), Indivior shall issue the applicable Purchase Order to be accepted by Curia as described above. Once placed, all Purchase Orders for Product shall be non-cancelable. No different or additional terms or conditions set forth in any Purchase Order shall modify in any way the terms and conditions of this Agreement, and in the event of a conflict between terms in any Purchase Order and this Agreement, the terms of this Agreement shall control.

All Purchase Orders submitted in accordance with the terms of this Agreement shall be effective and binding on the parties upon acceptance by Curia. Except as otherwise provided herein, neither party shall have the right or power to refuse, reduce, or otherwise modify their obligations under any Purchase Order; however, Purchase Orders may be amended (i) upon written mutual agreement regarding such modification that is signed by both parties; or (ii) as otherwise provided in this Section 4.3 or Section 4.4.

4.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Indivior's Right to Modify</u>. For the avoidance of doubt, the parties expressly acknowledge and agree that (a) the Firm Period Forecast constitutes a reservation by Indivior of the corresponding manufacturing slots and that Indivior shall have the right to schedule the Processing of any Product (whether Commercial Product or a Validation Batch) in each such manufacturing slot (subject to Curia's right to reject a Purchase Order as set forth in Section 4.3 or cancel a Purchase Order as set forth in Section 4.6); and (b) Indivior shall be permitted to change the Product to be Processed in each such manufacturing slot, provided, (i) Curia otherwise possesses or can timely obtain the necessary Raw Materials and Indivior Materials necessary to Process the same; (ii) the alternative Product is on the same manufacturing line; and (iii) Indivior provides at least thirty (30) days' prior written notice to Curia of the requested change.

4.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Failure to Purchase</u>. In the event (i) for Calendar Year 2022 only, the quantities purchased by Indivior are less than the Minimum Requirement, or (ii) the quantities purchased by Indivior in a given Calendar Quarter are below the Firm Period Forecast for that Calendar Quarter (the difference in quantities deemed an "Order Deficit"), Curia shall invoice Indivior for the Order Deficit, and Indivior shall pay for the Order Deficit, at the Unit Pricing. The preceding sentence shall not apply, and Indivior shall not be liable nor responsible, nor shall pay for, any Order Deficit resulting from Curia's failure or inability, not due to the fault of Indivior, to Process the quantities defined in the Firm Period Forecast for the applicable Calendar Quarter. For clarity, Curia shall not be deemed to have failed to supply quantities defined in the Firm Period Forecast due to Indivior's failure to provide materials or documentation or otherwise fulfill its obligations pursuant to this Agreement.

4.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Curia's Cancellation of Purchase Orders or Purchase Orders Not Placed</u>. In the event Indivior refuses or fails to make scheduled deliveries of the API or other Indivior Materials with sufficient time before the scheduled Processing Date (which failure shall be deemed to include the delivery of API or other Indivior Materials which do satisfy the applicable Specifications), Curia reserves the right to cancel all, or any part of, a Purchase Order upon as much advance notice as possible, in writing, to Indivior, and Curia shall have no further obligations or liability with respect to such Purchase Order. Curia shall invoice Indivior for such Purchase Order amount not supplied for reasons outlined herein and payments shall be made by Indivior within sixty (60) days of the receipt of the invoice. Notwithstanding the forgoing, the parties shall work together in good faith to substitute a Product in any affected manufacturing slots pursuant to Section 4.4 prior to Curia's cancellation of any such affected Purchase Order, taking into consideration whether Curia has sufficient API, Indivior Materials, and Raw Materials in its possession to Process the requested Product. For the avoidance of doubt, Purchase Orders for Commercial Product are non-cancellable and, except as set forth in Section 4.4, any rescheduling or delays by Indivior will be deemed a cancellation by Indivior of the applicable Purchase Order, unless otherwise agreed by both parties in writing. In the event of any such cancellation or rescheduling of Purchase Orders by Indivior for Commercial Product, Indivior shall be charged I 00% of the aggregate Unit Price based on the theoretical yield, unless such rescheduling or cancellation of a Purchase Order for Commercial Product is due to events that are under Curia's control.

4.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Notice for Unplanned Delay</u>. Curia shall provide Indivior with as much advance notice as possible (and will use its best efforts to provide at least fifteen (15) days advance notice where possible) if Curia determines that any Processing will be delayed, cancelled, or will deviate from the terms of an accepted Purchase Order for any reason.

4.8&nbsp;&nbsp;&nbsp;&nbsp;<u>Penalties for Delay</u>. Beginning on January 1, 2023 and for the remainder of the Term, in the event Curia does not Deliver Product on or before the date set forth in the applicable Purchase Order, the penalties set forth in the table below shall apply to the Unit Price of the Product ("Delay Penalties"). For clarity, Delay Penalties shall apply only to small and/or medium scale Batches of Product for Most of World ("MOW Batches"). In addition, Delay Penalties shall in no event apply if a delivery

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delay is due to: (i) Indivior's failure to provide Indivior Materials and other required documentation or information in accordance with this Agreement which is required for Curia to Process the Product on the scheduled Processing Date; (ii) the applicable Product fails to meet the target molecular weight as defined in the Specifications; (iii) there is a delay caused by third party testing of the applicable Product; or (iv) Indivior exercises its right to modify a Purchase Order in accordance with Section 4.4 above within four (4) months of the scheduled Processing Date of the applicable Batch of Product.

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| | |
|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Number of Days** <br>**Delivery is Late** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**% of Price**<br>**Deducted\*** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;30-59 days | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]% |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;60 days or more | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]% |

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\*The Percentage of Price Deducted shall be applied to Column B of the table set forth in **Exhibit B**. By way of example, if a Batch of Product SKU# [\*\*\*] is Delivered 30 days after the delivery date set forth in the applicable Purchase Order, the Unit Price paid by Indivior for each unit of Product in such Batch shall be reduced by [\*\*\*]%; the Unit Price for each unit in such Batch would therefore be $[\*\*\*] - ($[\*\*\*] \* [\*\*\*]) = $[\*\*\*].

4.9&nbsp;&nbsp;&nbsp;&nbsp;<u>Exclusivity</u>. Nothing in this Agreement shall prevent Curia from processing product for parties other than Indivior, provided, however, Curia shall not process any generic version of Product for another customer at the Facility during the Term, or shall prevent Indivior from engaging other contractors to provide services with respect to Product, subject in each case to the obligations of confidentiality and restrictions on use contained in this Agreement with respect to the parties' Confidential Information and Technology. For purposes of this Section 4.9, a "generic version of Product" means an AB rated generic version of the Product.

**ARTICLE 5**

**RELEASE; BATCH RECORD REVIEW; DELIVERY AND STORAGE**

5.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Release</u>. Curia shall be responsible for release testing of the Product, and, subject to the terms of the Quality Agreement, shall release each Batch to Indivior on the basis of its manufacturing and controls documentation review. In connection with the release of the Product, Curia shall deliver Product documentation (such as executed Batch records, Certificate of Analysis, Certificate of Compliance or other quality document as determined by Curia) to its customer portal. Notwithstanding anything in this Agreement to the contrary, Indivior shall be responsible for final release of Product prior to distribution for its intended use.

5.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Review of Batch Records</u>. Curia shall provide written notice to Indivior that the Batch records for a given Batch have been delivered to Curia's Indivior portal and are available for review. Indivior shall have ten (10) calendar days from the date of such notice to review and approve or reject such Batch records (the "Batch Record Review Period"). During the Batch Record Review Period, the parties agree to respond promptly, but in any event within ten (10) calendar days, to any reasonable inquiry by the other party with respect to such Batch records.

5.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Delivery</u>. Title to and risk of loss of Product shall transfer from Curia to Indivior upon delivery of the Product EXW the Facility (Incoterms 2010) ("Delivery"). Evidence of Delivery will be through the issuance of the completed stamped Batch record, Certificate of Conformance and Certificate of Analysis to Indivior. Indivior is responsible for transportation of the Product to Indivior's final destination at the sole risk and expense of Indivior. For avoidance of doubt, Indivior is responsible for arranging pick up by the carrier and all shipping costs and risks. Should Indivior request Curia to assist with any arrangements with the carrier, such arrangements will be made by Curia on behalf of lndivior in accordance with Indivior's applicable instructions and at the sole risk and expense of Indivior.

5.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Failure to Take Delivery and Storage</u>. If lndivior does not pick up Product upon Delivery by Curia, Curia shall store such Product at the Facility or a third-party storage location for thirty (30) days at no cost and, thereafter, at a monthly storage charge to Indivior for the duration of storage, billed at Curia's (or third-party's as applicable) then current standard monthly storage fees and minimums, pro-rated for any partial month. For all Product stored by Curia upon Delivery, lndivior agrees that: (i) Indivior has title and risk of ownership; (ii) Indivior has made a fixed commitment to purchase such Product; (iii) Indivior is responsible for any decrease in market value of such Product that relates to factors and circumstances outside of Curia's control; (iv) Indivior is responsible for obtaining insurance for such Product during the storage period, if desired; and (v) lndivior is responsible for transportation of the Product to Indivior's final destination, at the sole risk and expense of the lndivior.

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5.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Curia's Release Cycle of Product</u>. Curia shall perform all release activities for which it is responsible (i) within five (5) months of the Processing Date for all MOW Batches of Product, and (ii) within seven (7) months of the Processing Date for all other Batches of Product that are not MOW Batches (each, as applicable, the "Release Deadline"). Each party agrees to use Commercially Reasonable Efforts to respond promptly to the other party during all release activities. In addition, Curia shall not be deemed to have failed to meet the Release Deadline due to: (i) Indivior's failure to provide Indivior Materials and other required documentation or information in accordance with this Agreement which is required for Curia to Process the Product on the scheduled Processing Date; (ii) there is a molecular weight issue associated with the applicable Batch of Product; or (iii) there is a delay caused by third party testing *(e.g,* sterility testing) of the applicable Batch of Product that is not under Curia's control. In the event Curia does not meet the Release Deadline for an applicable Batch of Product, Indivior shall have the right, in its sole discretion, to (a) have Curia Process a replacement Batch at no additional cost to Indivior (provided Indivior provides sufficient quantities of Indivior Materials to perform such replacement), or (b) have Curia credit to Indivior the amount paid for such Batch of Product. The remedy set forth in the immediately forgoing sentence shall be Indivior's sole and exclusive remedy for any Batch of Product for which Curia does not meet the Release Deadline.

**ARTICLE 6**

**REMEDIES FOR NON-CONFORMING PRODUCT**

6.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Notice of Rejection; Remedies</u>. All Batches and/or Products are deemed accepted upon Delivery unless rejected by Indivior in accordance with this Section. Indivior may reject a Batch or Product solely if such Batch is determined to be Non-conforming Product. Indivior shall notify Curia in writing of its rejection of any Batch or Product by (a) the earlier to occur of (i) the end of the Batch Record Review Period or (ii) ten (10) business days from notification of the availability for testing of quality control samples, if applicable, and (b) with respect to Latent Defects, promptly upon discovery of such Latent Defect but no later than fourteen (14) days following such discovery; provided that Indivior must so inform Curia of any Latent Defects within three (3) months of Delivery of such Product (as applicable, the "Notice Period"). Said notice of rejection by Indivior shall specify Indivior's reasons for rejection and be accompanied by any supporting analyses or documentation. Within (30) days of receiving a notice of rejection from the Indivior, Curia shall respond stating whether (i) it accepts the rejection or (ii) it disputes the rejection, in which case the parties shall, after good faith negotiation as to whether the rejection is justified, refer such dispute to a mutually acceptable independent third party with the appropriate expertise to assess the conformity or non-conformity of rejected Product to the Manufacturing Standards at the time of Delivery. Such independent third party shall test the applicable Product and shall review the relevant Batch Records and other relevant documentation to determine whether such Product was Processed in accordance with the Manufacturing Standards or not. The parties agree that such third party's determination shall be final and binding upon the parties. The party against whom the independent third party rules shall bear the costs of testing and review by such independent third party. If such third party determines that Indivior's rejection of Product was incorrect, Indivior shall purchase and pay for both the initially rejected Product and any replacement Product produced at Indivior's request. In the event that Indivior rightfully rejects a Batch after a Validated Manufacturing Process has been established, Curia shall have, in its sole discretion, the right to either (a) replace, as soon as possible, the rejected Batch or portion thereof (provided that Indivior pays for the conforming replacement Product solely to the extent it has not already paid for the Non-conforming Product), or (b) credit Indivior a pro-rata portion of the amount paid by Indivior to Curia with respect to such Batch based on the percentage of such Batch that is unusable. In the event Curia replaces or credits Indivior for Non-conforming Product per the immediately foregoing sentence, Curia shall provide Indivior with a credit for API or Indivior Materials in the amount of the lesser of (i) the replacement value of the API or Indivior Materials; or (ii) $[\*\*\*] (in the aggregate for the API and Indivior Materials) per Batch. The remedy set forth in the two immediately foregoing sentences shall be Indivior's sole remedy for failure of Non-conforming Product to have been Processed in accordance with the Manufacturing Standards and the other terms of this Agreement.

6.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Supply of Material for Replacement Product</u>. In the event Curia replaces Non-conforming Product pursuant to Section 6.1 above, Indivior shall supply Curia with sufficient quantities of API and other Indivior Materials at its sole cost as necessary for Curia to complete such replacement.

6.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Other Latent Defects</u>. In the event of any discovery of any latent defect other than a Latent Defect, each party shall use Commercially Reasonable Efforts to determine the cause of such latent defect and, in the event Curia is determined to have contributed to any such latent defect, the parties will negotiate in good faith how to address the issue, taking into account the extent to which such latent defect is reasonably associated with Curia's Processing failures under this Agreement.

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**ARTICLE 7** 

**PRICING AND PAYMENT**

7.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Pricing</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;<u>Unit Pricing</u>. Indivior shall pay for Product upon Delivery in the manner set forth in **Exhibit B**, attached hereto and incorporated by reference. Indivior and Curia agree that Indivior shall pay for Product on a per-unit basis ("Unit Price" or "Unit Pricing") which includes all costs to complete Delivery of the Product, including but not limited to, planning, Processing, release testing, Other Raw Materials, documentation, and project management. Indivior shall also pay Curia for any development, validation and regulatory support services as set forth in an SOW or change order. The parties acknowledge and agree that the pricing set forth in this Agreement benefits from the investments Indivior has made in the Facility and that this statement is applicable to this Agreement only and shall not set a precedent or impact any other agreement between the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;<u>Other Services</u>. In the event Indivior requests any other services in connection with the Processing of Product, Curia shall provide a written quote of the proposed fee, for such additional services and Indivior shall advise Curia whether it wishes to have such additional services performed by Curia. If the parties mutually agree that such additional services shall be performed by Curia, the parties shall enter into an SOW defining the services and fee in sufficient detail, and Curia shall perform, and Indivior shall pay Curia for, such additional services as set forth in the applicable, fully executed SOW.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;<u>Third Party Costs</u>. For any third party expense incurred by Curia on behalf of Indivior, in accordance with this Agreement, an applicable SOW or change order, Indivior agrees to reimburse Curia for such expense and pay Curia an additional fee of not more than [\*\*\*] percent ([\*\*\*]%) of such third party cost.

7.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Price Increase</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;Beginning in Calendar Year 2024 and for each subsequent year during the Term, Curia may implement an increase in the Unit Pricing once annually, on January 1 of each Calendar Year ("Price Increase Date"), in an amount equal to the total percentage change in the Producer Price Index, Pharmaceutical Preparations (Series ID PCU325412325412) as published by the U.S. Department of Labor, Bureau of Labor Statistics ("PPI") during the immediately preceding twelve (12) month period ending September 30 (or if such PPI data is not available for the timely implementation of the increase in Unit Pricing, the most recent twelve (12) month period for which such PPI data is available). In addition, if Curia's cost for any Raw Material increases by more than two percent (2%) during the relevant period, Curia shall be entitled to increase Unit Pricing by the amount of such price increase for the Raw Material, over and above the increase on account of PPL In the event of an increase tied to a change in Curia's cost of Raw Materials, Curia shall provide Indivior copies of invoices evidencing the increased cost of such Raw Materials.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;Curia reserves the right to increase the Unit Pricing or other fees if the parties mutually agree to implement changes in the Process or Specifications, and where such changes result in an increase in Processing costs to Curia. Such changes and price increase shall be agreed by the parties in writing and signed by each party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;Curia shall be required to notify Indivior in writing of any increase in Unit Pricing under Section 7.2(i) no less than thirty (30) days prior to the Price Increase Date (i.e., on or before December 1 of the preceding Calendar Year). Indivior shall be notified of an increase in Unit Pricing or other fees under Section 7.2(ii) at least sixty (60) days prior to the date on which such increase is to take effect, which shall be deemed the Price Increase Date for such increase. Any increase in Unit Pricing shall be applicable to all Product Delivered on or after the Price Increase Date, and Purchase Orders for Product ordered prior to the Price Increase Date but to be delivered on or after the Price Increase Date shall be modified/re-issued by Indivior to account for the increase in Unit.

7.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Rescheduling and Cancellation Fees for other Services and Validation Batches</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;If Indivior cancels or reschedules any services that make use of Processing equipment but are not manufacture of Product services, then Indivior shall pay to Curia 100% of the fees of such services having a scheduled start date within thirty (30) days after the date of Curia's receipt of the notice of cancellation or rescheduling, as applicable.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;If Indivior cancels or reschedules any Validation Batch for which the parties have signed a slot booking form, or if Curia needs to cancel or reschedule any Validation Batch due to delay by Indivior (including but not limited to delay in performance of Indivior's obligation to provide documentation, approvals, API and other materials) in Processing such Validation Batch, then Indivior shall pay to Curia the fee set forth in the table below. For clarity, upon full execution by the parties of any slot booking form, the date(s) set forth in the applicable slot booking form are firm and binding on both parties. Curia may not reschedule or cancel the date set forth in a fully executed slot booking form without the prior written consent of Indivior, provided that in no event shall Indivior incur a rescheduling/cancellation fee for a Processing date modification agreed to, in Indivior's sole discretion, at Curia's request. For the avoidance of doubt, in the event the manufacturing slot for a Validation Batch is replaced with a Batch of Commercial Product due to events that are under Curia's control, or pursuant to Section 4.4 above, Indivior shall not pay a rescheduling/cancellation fee for such rescheduled/cancelled Validation Batch.

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| | |
|:---|:---|
| Number of days before scheduled <br>Processing Date or when delay, <br>rescheduling or cancellation occurs\* | Rescheduling/Cancellation Fee <br>(expressed as a percentage of the <br>Validation Batch fee) |
| Greater than 60 days | [\*\*\*]% |
| 30 to 60 days | [\*\*\*]% |
| 14 to 29 days | [\*\*\*]% |
| Less than 14 days | [\*\*\*]% |

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\*In the event any cancellation by Indivior occurs after the commencement of Processing but prior to completion/release, it shall be deemed to have occurred with zero days' notice. Further, tasks/services rescheduled, delayed or put on hold more than once or rescheduled, delayed or put on hold beyond ninety (90) days of the initial scheduled date shall be deemed to have been cancelled, unless otherwise mutually agreed upon in writing.

7.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Invoicing Schedule</u>. Indivior shall be invoiced for payments due under this Agreement as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;<u>Processing and Supply of Commercial Product</u>: Purchase Orders for Commercial Product will be invoiced upon Delivery and due within sixty (60) days of the date of receipt of the invoice (which date shall be deemed to be the same date the invoice is issued to Indivior, provided the invoice is issued electronically). For clarity, administrative changes to invoices do not reset the clock with respect to the sixty (60) day payment window.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;<u>Other Services</u>: Any additional services (other than Processing of Commercial Product) shall be invoiced as set forth in the applicable SOW. Payment schedules shall be as set forth in the applicable SOW. Unless otherwise set forth in the applicable SOW, any payments in advance of performance shall not exceed [\*\*\*] percent ([\*\*\*]%), with any remaining balance to be invoiced upon performance and/or delivery by Curia.

7.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Taxes; Duty</u>. All taxes, duties and other amounts assessed on the Raw Materials, API or otherwise in connection with delivery of Product and the other services prior to or upon sale to Indivior are the responsibility of Indivior, and Indivior shall reimburse Curia for any such taxes, duties or other expenses paid by Curia.

7.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Product Approval</u>. Notwithstanding the terms set forth above, Indivior shall use its best efforts to expedite and obtain all regulatory approvals necessary for Curia to commence production at a Facility, as applicable ("Regulatory Approvals").

7.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Payment Terms</u>. Unless otherwise set forth in this Agreement, Indivior shall pay all undisputed invoices under this Agreement in full, or the portion of any invoice not in dispute, within sixty (60) days after the date of receipt of such invoice (which date shall be deemed to be the same date the invoice is issued to Indivior provided the invoice is issued electronically).

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All invoices and payments required to be paid hereunder shall be paid in U.S. dollars, and all such payments shall be made electronically in immediately available funds to an account designated by Curia, unless the parties agree to settle such payments through other means. Indivior shall notify Curia of any errors in an invoice submitted by Curia within fifteen (15) days of Indivior's receipt of such invoice and if such notice of any errors is not provided to Curia within such fifteen (15) day period, the invoice shall be deemed accepted as-is by Indivior and shall be paid within sixty (60) days of receipt by Indivior. Curia shall resolve any errors in an invoice of which it receives notice within fifteen (15) days of receipt of notice from Indivior. In the event such error is resolved by Curia within such fifteen (15) day period, payment of such invoice shall remain due within sixty (60) days of the date on which the defective invoice was received by Indivior. In the event such error is not resolved by Curia within its fifteen (15) day cure period, the payment due date shall be automatically extended to sixty (60) days from the date of Indivior's receipt of a corrected invoice. In the event payment is not received by Curia on or before the sixtieth (60<sup>th</sup>) day after the date of receipt of any undisputed invoice, then such unpaid amount shall accrue interest at the rate of one percent (1%) per month compounded monthly until paid in full. In addition, if Indivior fails to pay undisputed invoices when due, in addition to its other rights under this Agreement, in law or under equity, Curia will have the right, upon written notice to Indivior, to cease all activities hereunder until all outstanding invoices have been paid in full; provided, however, the foregoing shall not apply to any portions of an invoice that are subject to a good faith dispute. For purposes of this Section 7.7, "good faith dispute" shall mean that, within fifteen (15) days of receipt of an invoice, Indivior has substantiated with sufficient documentation the reason for any disputed portion of an invoice in writing to Curia.

**ARTICLE 8**

**SPECIFICATIONS**

8.1&nbsp;&nbsp;&nbsp;&nbsp;Curia will maintain, as part of its quality documentation, all Specifications as listed within global drug product applications and, additionally, will maintain internal Specifications for Raw Materials as agreed in writing between both parties. The parties agree that internal Specifications for molecular weight of the Indivior polymer may define stricter criteria for certain identified parameters than comparable parameters within global drug product Specifications and/or may be used to group together certain parameters or criteria to meet multiple-country specification commitments.

8.2&nbsp;&nbsp;&nbsp;&nbsp;Any changes to the Specifications as agreed to by the parties from time to time shall be in writing, dated and signed by the parties through the appropriate change control processes. No change in the Specifications, Facility, or Processes shall be implemented by Curia, whether requested by Indivior or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in fees associated with such change. Curia shall respond promptly to any request made by Indivior for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications or Processes, Curia shall notify Indivior of the fees associated with such change. Indivior shall pay all fees associated with such agreed upon changes.

Curia shall notify Indivior as soon as reasonably practical after Curia becomes aware of any changes in Applicable Laws which are likely to affect the supply of the Product under this Agreement (including rationale, expected timings, risk assessment, price impact and any impact on business continuity).

**ARTICLE 9**

**QUALITY & REGULATORY MATTERS; RECORDS; BUSINESS CONTINUITY**

9.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Quality Agreement</u>. Prior to Processing of the first Batch of Product, or at such other time as the parties may mutually agree upon, the parties shall execute a Quality Agreement. The Quality Agreement shall in no way determine liability or financial responsibility of the parties for the responsibilities set forth therein. In the event of a conflict between the terms of this Agreement and the Quality Agreement, this Agreement shall control except to the extent that such provision relates to compliance with cGMP requirements and/or applicable regulatory laws and regulations, in which the Quality Agreement's provision shall govern.

9.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Regulatory Compliance</u>. Indivior shall be solely responsible for all permits and licenses required by any regulatory agency with respect to Product and the Processing under this Agreement, including any product licenses, applications and amendments in connection therewith. Curia will be responsible for maintaining all applicable licensures and permits required by any Regulatory Authority with respect to a Facility so required for Curia to meet its obligations under this Agreement, subject to Indivior' s obligations set forth in the first sentence of this Section 9.2. During the Term, Curia will assist Indivior with all regulatory matters relating to Processing under this Agreement, at Indivior' s request and at Indivior' s expense. Each party intends and commits to cooperate to satisfy all Applicable Laws relating to Processing under this Agreement.

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9.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Regulatory Correspondence</u>. Indivior shall make available to Curia the Curia-specific portions of all regulatory applications and amendments thereto and all correspondence with a Regulatory Authority, in each case relating to the Product, including without limitation, an IND, NDA, ANDA, 505(6)(2) and DMF or their equivalent applications in foreign jurisdictions. For purposes of the foregoing sentence, "Curia-specific portions" shall mean those sections of the regulatory applications, amendments or correspondence that reference Curia's systems, documentation, facilities or capabilities. Indivior agrees to incorporate all changes provided by Curia which correct for factual inaccuracies and to reasonably consider all other comments.

Indivior shall provide this information, and Curia shall review, in accordance with the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Original Applications/ Amendments Not Requested by Regulatory Authority</u>: Indivior shall provide sixty (60) days prior notice of its intent to file. Upon receipt of the draft application or amendment, Curia shall provide any comments to Indivior within ten (10) business days.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Amendments/ Responses Requested by a Regulatory Authority</u>: Indivior shall notify Curia of the request by the Regulatory Authority within twenty-four hours of receipt of request. Upon receipt of the draft amendment or response, Curia shall provide any comments to Indivior within four (4) business days.

9.4&nbsp;&nbsp;&nbsp;&nbsp;<u>GMP Audits</u>. Indivior shall have the right to conduct one GMP audit, at no cost to Indivior, during each twelve (12) month period during the Term (i) to observe, inspect, and audit the manner in which Curia conducts Processing of Product; and (ii) inspect Curia's Facilities and records relating to Processing of Product, including Curia's quality and other controls related to its Processing of Product. Except for "for cause" audits which shall be conducted at no cost to Indivior, Indivior shall be charged for all additional audits, including any pre-approval inspections, at rates agreed upon by the parties based on timing of the audit, resource demand and any production disruption that may be caused by such an audit. The cost of any such additional GMP audit during the applicable twelve (12) month period shall be $[\*\*\*] per day for Calendar Year 2022 and thereafter such amount shall be the base cost and subject to a price increase based on PPI for each subsequent Calendar Year during the Term. To schedule any audit under this Section, except for a "for cause" audit, Indivior shall give Curia reasonable advance notice, but not less than four (4) weeks' notice. All audits shall be carried out during normal business hours, and performed in such a manner as not to unduly delay the performance of the services or interfere with Curia's business. The number of visitors during any audit is limited to two (2) persons for two (2) days. No financial information shall be made available for audit except with respect to supporting documentation for specific out-of-pocket expenses charged to Indivior. All findings from any audit conducted under this Section shall be communicated to Curia, in writing, within thirty (30) business days of such audit.

Curia shall notify Indivior of any audits by a Regulatory Authority which are Productspecific. Indivior shall cooperate with Curia with respect to any Product-specific audits and, at Curia's request, shall make one or more of its employees with relevant knowledge, available on site during any such audit to answer questions in connection with any such audit.

9.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Facility Audit</u>. Curia shall give Indivior or each of its authorized representatives, which are not competitors of Curia, access to the Facility for a site and/or Facility risk evaluation, any such audit to be at Indivior's cost and expense, as set forth in an SOW or other written documentation signed by the parties. The aforementioned access shall be granted if requested by Indivior, once per Calendar Year. The cost of such Facility audit shall be $6,700 per day for Calendar Year 2022 and thereafter such amount shall be the base cost and subject to a price increase based on PPI for each subsequent Calendar Year during the Term. Curia shall use reasonable endeavors to ensure that its employees, its Affiliates and their employees cooperate with and provide reasonable assistance to Indivior during such audit. To schedule any audit under this Section 9.5, Indivior shall give Curia reasonable advance notice, but not less than two (2) weeks' prior written notice. All audits shall be carried out during normal business hours and performed in such a manner as not to unduly delay the performance of the services hereunder or interfere with Curia's business. The number of visitors during any audit is limited to two (2) persons for two (2) days. Indivior shall ensure that any of its representatives who are sent to the Facility to perform an audit pursuant to this Section 9.5 shall comply with all confidentiality, security, safety, quality or similar guidelines that apply to persons present in the Facility and that are communicated by Curia, and Indivior shall be responsible for any breach of these guidelines by such representatives.

9.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Maintenance of Records</u>. Curia shall maintain complete and accurate records of all data obtained or generated by Curia relating to its performance of services under this Agreement. Curia shall retain such records in a secure area, reasonably protected from fire, theft, and destruction, for at least three (3) years following the completion of the relevant services, or as otherwise provided by Applicable Law, whichever time period is longer.

9.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Recalls</u>. In the event Curia believes a recall, field alert, Product withdrawal or field correction may be necessary with respect to any Product Processed and supplied under this Agreement, Curia shall immediately notify Indivior in writing. Curia will not act to initiate a recall, field alert, Product withdrawal or field correction without the express prior written approval of Indivior, unless otherwise required by Applicable Laws. In the event Indivior believes a recall, field alert, Product withdrawal or

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field correction may be necessary with respect to any Product Processed and supplied under this Agreement, Indivior shall immediately notify Curia in writing and Curia shall provide all reasonable cooperation and assistance to Indivior, at Indivior's expense. Indivior shall be financially responsible for the cost of, or expenses incurred in connection with, any recall, field alert, Product withdrawal or field correction, unless a recall, field alert, Product withdrawal or field correction is a result of Curia's gross negligence or willful misconduct. In the event a recall, field alert, Product withdrawal or field correction is caused by Curia's gross negligence or willful misconduct, Curia shall bear the reasonable, actual and documented administrative costs incurred by Indivior for such recall, field ale1t, Product withdrawal or field correction (e.g., expenses related to communications with regulatory authorities, cost of notifying customers, reasonable professional fees). Further, in the event of any recall, each patty shall use Commercially Reasonable Efforts to determine the cause of such recall and, in the event Curia is determined to have contributed to any necessary recall, the parties will negotiate in good faith how to address such recall, taking into account the extent to which such recall is reasonably associated with Curia's Processing failures under this Agreement. For the avoidance of doubt, in the event Indivior's use of Non-conforming Product results in a recall, field alert, Product withdrawal or field correction, Indivior shall be entitled to both the remedy set forth in this Section 9.7 with respect to the recall and the remedy set forth in Section 6.1 with respect to the Non-conforming Product.

9.8&nbsp;&nbsp;&nbsp;&nbsp;<u>Business Continuity Plan</u>. Curia shall maintain a business continuity plan ("BCP") for the Facility at which Product is Processed under this Agreement. The parties agree that in Calendar Year 2022, they will align on the expectations and timeline for implementation of the BCP. Curia shall share broadly what it may cover in any current, applicable BCP so the parties may work together to address any gaps in an applicable BCP.

**ARTICLE 10**

**REPRESENTATIONS AND WARRANTIES; FLOWDOWN TERMS**

10.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Indivior</u>. Indivior represents and warrants to Curia that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;Indivior Materials will comply with all applicable Specifications and will have been produced in compliance with the Applicable Laws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;it has all necessary authority and all right, title and interest in and to any Technology related to each Product as well as any Technology that is provided by Indivior to Curia under this Agreement, and Curia's use or application, in accordance with this Agreement, of any Technology provided by Indivior will not, to the best of Indivior's knowledge, infringe any third party intellectual property rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;it has provided all safe handling instructions, health and environmental information and MSDS(s) applicable to the Product or to any Indivior Materials, in sufficient time for review and training by Curia prior to delivery;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)&nbsp;&nbsp;&nbsp;&nbsp;all Product delivered to Indivior by Curia will be held, used and/or disposed of by Indivior in accordance with all Applicable Laws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v)&nbsp;&nbsp;&nbsp;&nbsp;it will comply with all Applicable Laws relating to Indivior's performance under this Agreement, and in particular, Indivior has obtained, and shall maintain, all necessary approvals from Regulatory Authorities for its use of any materials or Products provided by Curia under this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vi)&nbsp;&nbsp;&nbsp;&nbsp;it will not release Product for further distribution or use if the Batch record for a particular Batch of Product indicates that the Product does not comply with the Specifications or Applicable Laws; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vii)&nbsp;&nbsp;&nbsp;&nbsp;prior to distributing any Batch of Commercial Product, Indivior will review all Product-specific validation records and confirm that the Product has been validated in compliance with Applicable Laws.

10.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Curia</u>. Curia represents and warrants to Indivior that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;at the time of Delivery, Product will have been Processed in accordance with the Manufacturing Standards, provided, however, this Section 10.2(i) shall in no event apply to Product that is Processed by Curia in accordance with Section 2.2 of this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;it shall perform the services hereunder in a professional manner and in accordance with all Applicable Laws at a Facility that complies with all Applicable Laws;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;Any services supplied by Curia under this Agreement will be supplied by appropriately qualified and trained personnel, whom, to the best of Curia's knowledge:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;are not currently listed on the U.S. Department of Health Office of lnspector General's List of Excluded Individuals or Entities; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;have not been or are currently the subject of a proceeding that could lead to their becoming a debarred individual or debarred entity under Section 306 of the Food Drug and Cosmetic Act (21 U.S.C § 335a).

Curia further agrees that if, at any time after execution of this Agreement, it becomes aware of itself or any employees providing services under this Agreement that (a) become excluded from participation in any federal healthcare program (as that term is defined by 42 U.S.C § 1320a-7b(f)); (b) are convicted of any crime that could result in exclusion from federal health care programs under 42 U.S.C. §§ 1320a-7, 1320-7a, or (c) become excluded, suspended, debarred or otherwise ineligible to participate in federal procurement or non-procurement programs, or (d) becomes listed on the General Services Administration System or Award Management, then Curia shall promptly provide notice of such to Indivior in accordance with the following sentence. In the event that Curia or any of its officers, directors, or employees performing services under this Agreement has become or, to the best of its knowledge, is in the process of being charged, convicted, debarred, excluded, proposed to be excluded, suspended or otherwise rendered ineligible, or is on an enforcement list, Curia will immediately, but in any event within two (2) business days of becoming aware of such event, notify Indivior in writing via email to <u>ciacompliance@indivior.com</u> and a hard-copy sent to Indivior Inc., Attn: Chief Compliance Officer, 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA 23235. Curia understands that debarment or exclusion of itself or an employee performing services under this Agreement may result in termination by Indivior in accordance with Section 15.2(i) below; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)&nbsp;&nbsp;&nbsp;&nbsp;Curia will not use the intellectual property of any third party in the Processing of the Product under this Agreement, without the prior written consent of Indivior.

10.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Mutual Representations</u>. Each party represents and warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;It is duly organized and validly existing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;This Agreement is a legal and valid obligation of it, binding upon it and enforceable against it in accordance with the terms of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;The execution, delivery and performance of this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which such party may be bound, and does not violate any law or regulation of any court, governmental body or other administrative authority having authority over it.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)&nbsp;&nbsp;&nbsp;&nbsp;Compliance with Anti-Corruption Laws.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Indivior and Curia are committed to conduct business with the highest degree of ethics and integrity and will comply with all applicable local and international laws and regulations relating to anti-corruption including the U.S. Foreign Corrupt Practices Act (FCPA) and the U.K. Bribery Act 2010, as well as any applicable laws implementing the UN Convention Against Corruption and the OECD Anti-Bribery Convention.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Each party undertakes that in connection with its obligations under this Agreement, it, its directors, employees and officers have not and shall not directly or indirectly (a) offer, provide, authorize for or promise to another person, or (b) request, accept or agree to accept from another person, any financial or other advantage or anything of value ("Benefit"), if such Benefit is for the purpose of influencing the receiving person improperly in his/her official capacity for the purpose of obtaining a business advantage, or where such Benefit would constitute a violation of any Applicable Law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;In order to demonstrate compliance with Section 10.3(iv)(b) of this Agreement, each party shall keep books and records complete and accurate in order to reflect in reasonable detail the character and

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value of transact ions and expenditures made under this Agreement. Each party shall give prompt written notice to the other patty if it has failed to comply with or has breached Section 10.4(iv)(b) of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;If in the reasonable opinion of a party, the other party has failed to comply with Section 10.4(iv)(b) of this Agreement in any material respect, then the non-breaching party may be entitled to terminate this Agreement in accordance with Section l 5.2(i) below.

10.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Limitations; Disclaimer</u>. THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 10 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

10.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Flowdown Terms</u>. The parties acknowledge and agree that this Agreement will be considered to be a US Government subcontract pursuant to Indivior's Federal Supply Schedule (Contract#: 36F79720D0156) with the US Government and that this Agreement is subject to FAR 52.244-6 (Subcontracts for Commercial Items). Curia understands and agrees that its performance of services under this Agreement will be subject to certain applicable government requirements (the "Flowdown Terms") as set forth in **Exhibit E**, attached hereto. The parties further agree and acknowledge that (i) Curia is at all times responsible for determining which government requirements may apply as Flowdown Terms and ensuring its own compliance with the same; and (ii) the Flowdown Terms may be updated from time to time upon written notice from Indivior to Curia, which such written notice shall not require an amendment to this Agreement but shall be set forth in a separate writing.

**ARTICLE 11** 

**CONFIDENTIAL INFORMATION**

11.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Confidential Information</u>. As used in this Agreement, the term "Confidential Information" includes all confidential or proprietary scientific, technical, trade, business and/or financial information furnished by Curia or Indivior, or any of their respective representatives or Affiliates (collectively the "disclosing party"), to the other or its representatives or Affiliates (collectively the "receiving party"), whether furnished before, on or after the Effective Date and furnished in any form, including but not limited to written, verbal, visual, electronic or in any other media or manner, and whether or not identified as confidential. Confidential Information of Indivior includes, but is not limited to Indivior Existing Technology and Product-specific Program Technology. Confidential Information of Curia includes, but is not limited to Curia Background Technology, Curia Program Technology, the pricing information contained in any SOW, and the portions of the Master Batch Record and information provided in connection with Indivior's regulatory filings that are not Product-specific. Notwithstanding the other provisions of this Agreement, a party's Confidential Information does not include information which the receiving party can establish by competent proof (A) is or becomes generally available to the public other than as a result of a breach of this Agreement, or (B) is already known by the receiving party at the time of disclosure as evidenced by the receiving Party's written records, or (C) becomes available to the receiving party on a non-confidential basis from a source that is entitled to disclose it on a non-confidential basis, or (D) was or is independently developed by or for the receiving patty without reference to the disclosing patty's Confidential Information, as evidenced by the receiving patty's written records.

11.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Confidentiality Obligation</u>. The receiving party agrees to hold the Confidential Information of the disclosing party in trust and confidence and not to disclose such Confidential Information except (i) to those of its employees (including employees of its Affiliates) who have a need to know such information for purposes of performing such party's obligations under this Agreement and who are under an obligation of confidentiality no less restrictive than the obligations set forth in this Agreement that would apply to such information, (ii) by Curia to third parties who are involved in performing services under this Agreement and who are bound by written confidentiality restrictions no less stringent than those contained in this Agreement, (iii) by either party to Regulatory Authorities in connection with regulatory filings related to the Facilities or to Product Processed under this Agreement or (iv) as otherwise approved by the disclosing party in writing. Notwithstanding the foregoing limitations on disclosure, the receiving party may disclose such Confidential Information of the disclosing party as is required by any law, rule, regulation, order, decision, decree, subpoena or other legal process to be disclosed. If such disclosure is requested by legal process, the receiving party shall, if legally permitted, notify the disclosing party of such request promptly prior to any disclosure so as to permit the disclosing party to oppose or limit such disclosure by appropriate legal action.

11.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Restrictions on Use; No Implied License</u>. The receiving party agrees that it shall not use the disclosing patty's Confidential Information except for purposes of fulfilling its obligations under this Agreement or as otherwise expressly contemplated by this Agreement. The receiving party will obtain no right of any kind or license under any patent application or

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patent by reason of this Agreement, except as explicitly granted under this Agreement. All Confidential Information will remain the sole property of the party disclosing such information or data.

11.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Protective Measures</u>. In protecting the secrecy of and avoiding disclosure and unauthorized use of disclosing party's Confidential Information, the receiving pa1ty shall take at least those measures that it uses to protect its own confidential information; however, in no event, shall less than a reasonable standard of care be used. The receiving party shall immediately notify the disclosing party in the event of any unauthorized use or disclosure of the disclosing party's Confidential Information of which the receiving party is or becomes aware, provided that **in** no event shall such notification be deemed an admission for evidentiary purposes.

11.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Return of Confidential Information</u>. Upon the written request of the disclosing party, except as set forth **in** Section 9, the receiving party shall promptly return to disclosing party or destroy all of the tangible Confidential Information of the disclosing party in its possession or control, except that one (1) copy may be retained by receiving party solely for the purpose of determining the scope of obligations incurred under this Agreement and except that neither party shall have any obligation to return or destroy computer files that are created during automatic system back-up and that cannot be reasonably returned or destroyed. Any Confidential Information of the disclosing party retained by the receiving party under this section shall continue to be subject to the confidentiality and non-use obligations according to the terms and conditions set forth herein.

11.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Terms of Agreement</u>. The parties hereby acknowledge and agree that the terms of this Agreement and any SOW executed hereunder, but not the existence thereof, shall be considered Confidential Information of both parties.

11.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Term of Obligation</u>. The parties' obligations under this Section 11 shall continue in effect during the Term and for a period of seven (7) years following termination or expiration of the applicable SOW. Notwithstanding the foregoing, the parties' obligations with regard to confidentiality and non-disclosure of Trade Secrets shall survive the termination or expiration of this Agreement until such time as the Trade Secret is no longer a Trade Secret under Applicable Law. "Trade Secret" shall be defined as defined by Applicable Law.

**ARTICLE 12** 

**INTELLECTUAL PROPERTY**

12.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Indivior Pre-Existing Technology</u>. Curia agrees that Indivior has and shall retain sole and exclusive rights of ownership in and to any Indivior Confidential Information and other Indivior Existing Technology. Curia does not acquire any license or other right to Indivior Confidential Information or lndivior Existing Technology except for the limited purpose of carrying out its obligations under this Agreement.

12.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Curia Pre-Existing Technology</u>. Indivior agrees that Curia has and shall retain sole and exclusive rights of ownership in and to any Curia Confidential Information and other Curia Background Technology whether or not incorporated into the services under this Agreement. Indivior does not acquire any license or other right to Curia Confidential Information or Curia Background Technology except for the limited purpose of using Product Processed under this Agreement as expressly set forth in this Agreement.

12.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Program Technology</u>. All Product-specific Program Technology shall be the exclusive property of Indivior, and Curia hereby assigns any rights it may have in Product-specific Program Technology to Indivior, and further agrees to take such actions as are reasonably requested by Indivior, at Indivior's expense, to effect the foregoing assignment and in connection with Indivior's efforts to secure patent protection for such Product-specific Program Technology. All Curia Program Technology shall be the exclusive property of Curia, and Indivior agrees to assign its rights in Curia Program Technology to Curia, and to take such actions as are reasonably requested by Curia, at Curia expense, to effect the foregoing assignment and in connection with Curia efforts to secure patent protection for such Curia Program Technology.

12.4&nbsp;&nbsp;&nbsp;&nbsp;<u>No Other Licenses</u>. Except as expressly set forth in this Agreement, nothing in this Agreement shall be deemed to grant to either party any right or license under any patents, patent applications, know-how, technology, inventions or other Technology of the other party.

**ARTICLE 13** 

**INDEMNIFICATION**

13.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Indemnification by Curia</u>. Curia shall indemnify, defend and hold harmless Indivior, its Affiliates, and their respective directors, officers, employees, agents, successors and assigns ("Indivior Indemnitees") from and against any and all suits, claims,

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losses, demands, liabilities, damages, costs and expenses (including reasonable attorneys' fees) resulting from or arising out of, directly or indirectly, any suit, demand or action by any third party ("Losses") incurred in connection with, or arising out, of (A) any material breach by Curia of any of its representations, warranties, or covenants set forth in this Agreement, (B) any gross negligence or willful misconduct of any Curia Indemnitee (defined below), or (C) any violation of Applicable Laws, including cGMP (if applicable), by Curia or its Affiliates in performing Curia's obligations under this Agreement; except, in each case, to the extent that any of the foregoing Losses arises out of claims for which Indivior is obligated to indemnify Curia pursuant to Section 13.2.

13.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Indemnification by lndivior</u>. Indivior shall indemnify, defend and hold harmless Curia, its Affiliates, and their respective directors, officers, employees and agents ("Curia Indemnitees") from and against all Losses incurred in connection with, or arising out of (A) any material breach by Indivior of any of its representations, warranties or covenants set forth in this Agreement; (B) the marketing, sale, distribution or use of Product, including, but not limited to, use in clinical trials (if applicable), or any side effects, contraindications, illness, and/or death resulting from use of Product (whether based on strict liability, inherent design defect, negligence, failure to warn, breach of contracts or any other theory of liability); (C) the gross negligence or willful misconduct of any Indivior Indemnitees, as defined in Section 13.1, or (D) a claim by a third party that Curia's use of API or other Indivior Materials or of Technology provided to Curia by Indivior infringes such third party's intellectual prope1ty right; or (E) any violation of Applicable Laws by Indivior or its Affiliates in performing Indivior's obligations under this Agreement; except, in each case, to the extent that any of the foregoing Losses arises out of claims for which Curia is obligated to indemnify Indivior pursuant to Section 13.1.

13.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Indemnification Procedures</u>. In the event that either patty seeks indemnification under the terms of Sections 13.1 or 13.2 (the "Indemnified Party"), it shall promptly, but in any event within fifteen (15) days, inform the other party (the "Indemnifying Party") of the claim or liability of which the Indemnified Party becomes aware (including a copy of any related complaint, summons, notice or other instrument), provided that failure to provide such notice shall not eliminate the Indemnifying Party's obligation under this Section 13 except to the extent the Indemnifying Party has been prejudiced by such failure. The Indemnifying Party shall have the right to assume direction and control of the defense of any indemnified claim, provided that if the Indemnifying Party does not assume direction and control of the defense, the Indemnified Party shall do so, provided that such defense shall be, in both cases, solely at the Indemnifying Party's cost. The Indemnified Party shall cooperate as requested by, and at the expense of, the Indemnifying Party, in the defense of the claim. The Indemnifying Party shall not settle or otherwise compromise any claim or suit in any manner which requires the Indemnified Party to provide any consideration, admit fault or take any other action that would be binding on such Indemnified Party without the prior written consent of the Indemnified Party. The Indemnifying Party shall not have any obligation to the Indemnified Party under this Section 13 for any claim settled by the Indemnified Party without the Indemnifying Party's prior written consent.

**ARTICLE 14** 

**INSURANCE**

14.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Curia</u>. Curia shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the term of this Agreement: (i) Commercial General Liability insurance with per-occurrence and general aggregate limits of not less than $[\*\*\*]; (ii) Products and Completed Operations Liability Insurance with per-occurrence and general aggregate limits of not less than $[\*\*\*]; (iii) Workers' Compensation and Employer's Liability Insurance with statutory limits for Workers' Compensation and Employer's Liability insurance limits of not less than $[\*\*\*]; (iv) Professional Services Errors & Omissions Liability Insurance with per claim and aggregate limits of not less than $[\*\*\*] covering sums that Curia becomes legally obligated to pay as damages resulting from claims made by Indivior for errors or omissions committed in the conduct of the services outlined in the Agreement. In lieu of insurance, Curia may self-insure any or a portion of the above required insurance. In the event that any of the required policies of insurance are written on a claims-made basis, then such policies shall be maintained during the entire term of this Agreement and for a period of not less than three (3) years following the termination or expiration of this Agreement. Each insurance policy that is required under this Section shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII.

14.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Indivior Insurance</u>. Indivior shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the term of this Agreement: (i) Products and Completed Operations Liability Insurance with per-occurrence and general aggregate limits of not less than $[\*\*\*]; (ii) Workers' Compensation and Employer's Liability Insurance with statutory limits for Workers' Compensation and Employer's Liability insurance limits of not less than $[\*\*\*]; (iii) All Risk Property Insurance, including transit coverage, in an amount equal to full replacement value covering Indivior's property, including Indivior Materials, while it is at a Facility or in transit to or from a Facility. In the event that any of the required policies of insurance are written on claims-made basis, then such policies shall be maintained during the entire term of this Agreement and for a period of not less than three (3) years following the termination or expiration of this Agreement. Indivior shall not seek reimbursement for any property claim, or portion thereof that is not fully recovered from Indivior's Property Insurance policy.

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Each insurance policy that is required under this Section shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII.

**ARTICLE 15**

**TERM AND TERMINATION**

15.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Term</u>. This Agreement shall commence on the Effective Date and shall continue for five (5) years unless earlier terminated under Section 15.2 below (the "Term"). The term of this Agreement may be extended upon mutual agreement of the parties.

15.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Termination by Either Party</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;<u>Material Breach</u>. Either party may terminate this Agreement effective upon sixty (60) days prior written notice to the other party, if the other party commits a material breach of this Agreement and fails to cure such breach by the end of such sixty (60) day period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;<u>Bankruptcy</u>. Either party may terminate this Agreement effective upon written notice to the other party, if the other party becomes insolvent or admits in writing its inability to pay its debts as they become due, files a petition for bankruptcy, makes an assignment for the benefit of its creditors or has a receiver, trustee or other court officer appointed for its prope1iies or assets; and such filings or assignments are not voided within sixty (60) days.

15.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Effect of Termination</u>. In the event of any termination or expiration of this Agreement, Indivior shall be responsible for payment of (i) any outstanding invoices, (ii) any in-process Product not yet delivered or Product ordered pursuant to a Purchase Order, (iii) any Product specified in the most recent Firm Period Forecast for which a Purchase Order has not yet been submitted, (iv) any applicable cancellation fees pursuant to Section 7.3, (v) other actual costs and expenses incurred by Curia prior to the date of notice of termination, and (vi) costs relating to decommissioning activities, including Curia's documented costs, including the costs of packaging equipment and inventory. Without limiting the foregoing, upon termination of this Agreement, Curia shall ship to Indivior all Indivior Materials, Indivior Equipment and Product in Curia's possession and Indivior shall pay all costs associated therewith. Payment shall be due within sixty (60) days of the date of the final invoice. In the event any credit towards future payments is or will by owed by Curia to Indivior as of the date of termination or expiration of this Agreement, Curia shall pay Indivior directly the full balance of any such unused credit(s). Such payment shall be made no less than sixty (60) days after the date of termination or expiration of this Agreement.

15.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Termination by Indivior</u>. This Agreement may be terminated by Indivior upon twelve (12) months' prior written notice to Curia in the event a court of competent jurisdiction or a Regulatory Authority (1) withholds marketing approval of a Product; and/or (2) infringement litigation makes it impracticable for Indivior to continue production of the Product.

**ARTICLE 16** 

**LIMITATIONS OF LIABILITY**

16.1&nbsp;&nbsp;&nbsp;&nbsp;EXCEPT AS SET FORTH IN SECTION 3.1 AND 6.1, OR AS MAY OTHERWISE BE AGREED BY THE PARTIES IN A SEPARATE WRITING SIGNED BY THE PARTIES PURSUANT TO SECTIONS 6.3 OR 9.7, CURIA SHALL HAVE NO LIABILITY FOR THE COST OF, OR LOSS OR DAMAGE TO, API AND OTHER INDIVIOR MATERIALS , AT ANY TIME, WHETHER OR NOT SUCH API OR OTHER INDIVIOR MATERIALS ARE INCORPORATED INTO PRODUCT.

16.2&nbsp;&nbsp;&nbsp;&nbsp;EXCEPT IN THE EVENT OF CURIA'S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, CURIA'S AGGREGATE LIABILITY UNDER THIS AGREEMENT SHALL IN NO EVENT EXCEED THE TOTAL FEES PAID BY INDIVIOR TO CURIA FOR THE SERVICES AT ISSUE/BATCH OF PRODUCT GIVING RISE TO SUCH LIABILITIES, CLAIMS OR OBLIGATIONS, MINUS ANY THIRD-PARTY PASS THROUGH EXPENSES. THE FOREGOING CAP SHALL NOT INCLUDE ANY AMOUNTS PAID BY CURIA TO INDIVIOR IN ACCORDANCE WITH SECTION 16.1.

16.3&nbsp;&nbsp;&nbsp;&nbsp;EXCEPT IN THE EVENT OF A PARTY'S (I) GROSS NELIGENCE OR WILLFUL MISCONDUCT, (II) BREACH OF ITS CONFIDENTIALITY OBLIGATIONS PURSUANT TO ARTICLE 11, AND/OR (III) INDEMNITY OBLIGATIONS PURSUANT TO ARTICLE 13, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES OF THE OTHER PARTY OR ITS RELATED INDEMNIFIED PARTIES ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, LOSS OF REVENUES, PROFITS OR DATA, OR PENALTIES ARISING UNDER THIRD PARTY

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CONTRACTS, WHETHER IN CONTRACT OR TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING WAIYER SHALL IN NO EVENT LIMIT A PARTY'S INDEMNITY OBLIGATIONS HEREUNDER.

**ARTICLE 17** 

**NOTICE**

All notices and other communications hereunder shall be in writing and shall be deemed given: (A) when delivered personally; (B) when delivered by facsimile transmission (receipt verified); (C) when received or refused, if mailed by registered or certified mail (return receipt requested), postage prepaid; or (D) when delivered if sent by express courier service, to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof):

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| | |
|:---|:---|
| To Indivior: | Indivior UK Limited |
|  | Chapleo Building |
|  | Henry Boot Way, |
|  | Priory Park, |
|  | Hull HU4 7BY, United Kingdom |
|  | Attn: Assistant General Counsel, EMEA |
| With a copy to: | Indivior Inc. |
|  | 10710 Midlothian Turnpike, Suite 125 |
|  | North Chesterfield, VA 23235 |
|  | Attn: Chief Legal Officer |
| To Curia: | Curia Global, Inc. |
|  | 26 Corporate Circle |
|  | Albany, New York 12203 |
|  | Attn: Legal Department |

---

**ARTICLE 18** 

**MISCELLANEOUS**

18.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Entire Agreement; Amendments</u>. This Agreement, the attachments/Exhibits, Product Addenda and any amendments thereto constitute the entire understanding between the parties and supersede any contracts, agreements or understanding (oral or written) of the parties with respect to the subject matter hereof. The Burlington Supply Agreement dated October 31, 2017, as amended, between the parties (the "BUR Agreement") is hereby terminated, replaced and superseded by this Agreement, notwithstanding any provisions therein to the contrary, and the rights and obligations of the parties with respect to the services set forth in the BUR Agreement shall be subject to the terms and conditions of this Agreement. Any outstanding Purchase Orders issued pursuant to the BUR Agreement shall be governed by this Agreement as of the Effective Date without the need to amend the same. Further, the parties hereby agree the Development and Clinical Supply Master Services Agreement dated January 2, 2013, as amended, by and between Curia and Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals Inc.) (the "Development Agreement") is hereby terminated, replaced, and superseded by this Agreement, notwithstanding any provisions therein to the contrary, and the rights and obligations of the parties with respect to the services set forth in such agreement shall be subject to the terms and conditions of this Agreement. Any outstanding Work Orders, as defined in the Development Agreement, issued pursuant to the Development Agreement shall be governed by this Agreement as of the Effective Date without the need to amend the same. For the avoidance of doubt, the ABQ Agreement is not superseded by this Agreement and shall remain in full force and effect in accordance with its terms. No term of this Agreement may be amended except upon written agreement of both parties, unless otherwise provided in this Agreement. Except as expressly set forth herein, the terms and conditions set forth in this Agreement shall govern over any conflicting terms and conditions. Any additional terms and conditions proposed by or contained in any form provided by Indivior (including a purchase order, order acknowledgement/acceptance, or otherwise) are hereby rejected. The recitals at the start of this Agreement are hereby incorporated into and made a part of this Agreement.

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18.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Captions</u>. The captions and Section headers in this Agreement are for convenience only and are not to be interpreted or construed as a substantive part of this Agreement.

18.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Further Assurances</u>. The parties agree to execute, acknowledge and deliver such further instruments and to take all such other incidental acts as may be reasonably necessary or appropriate to carry out the purpose and intent of this Agreement.

18.4&nbsp;&nbsp;&nbsp;&nbsp;<u>No Waiver</u>. Failure by either party to insist upon strict compliance with any term of this Agreement in any one or more instances will not be deemed to be a waiver of its rights to insist upon such strict compliance with respect to any subsequent failure.

18.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Severability</u>. If any term of this Agreement is declared invalid or unenforceable by a court or other body of competent jurisdiction, the remaining terms of this Agreement will continue in full force and effect.

18.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Independent Contractors</u>. The relationship of the parties is that of independent contractors, and neither party will incur any debts or make any commitments for or on behalf of the other party except to the extent expressly provided in this Agreement. Nothing in this Agreement is intended to create or will be construed as creating between the parties the relationship of joint venturers, co partners, employer/employee or principal and agent.

18.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Successors and Assigns</u>. This Agreement will be binding upon and inure to the benefit of the parties, their successors and permitted assigns, and any entity that acquires rights to the services and/or Products that are subject hereof. Neither party may assign this Agreement, in whole or in part, without the prior written consent of the other party, except that either party may, without the other party's consent, assign this Agreement to an Affiliate or to a successor to all of the business or assets of the assigning party (which for the avoidance of doubt, shall include a sale of a division, site or specific business unit), provided that the assigning party provides written notice to the nonassigning party within thirty (30) days of such assignment not requiring consent.

18.8&nbsp;&nbsp;&nbsp;&nbsp;<u>Governing Law</u>. This Agreement shall be governed by and construed under the laws of the State of Delaware, excluding its conflicts of law provisions.

18.9&nbsp;&nbsp;&nbsp;&nbsp;<u>Dispute Resolution</u>. The parties shall first attempt in good faith to resolve any claim or controversy between the parties that arises out of this Agreement or breach thereof promptly by negotiations between senior executives who have authority to settle the controversy and who are not the persons with direct responsibility for the day-to-day administration of services provided under and received pursuant to this Agreement. Any such dispute that has not been resolved by negotiation as provided above shall be determined by binding arbitration.

All disputes arising from or related to this Agreement, which the parties are unable to resolve pursuant to the paragraph above, shall be submitted to arbitration before a single arbitrator, mutually agreeable to the parties, and administered by the American Arbitration Association (AAA) in Wilmington, DE (or at a location mutually agreed to by the parties) under the Commercial Arbitration Rules then existing of the AAA, and judgment on the award may be entered in a court of competent jurisdiction. The parties acknowledge and agree that the United Nations Convention on Contracts for the International Sale of Goods is specifically excluded from application to this Agreement.

The arbitrator shall have exclusive authority to resolve any dispute relating to the interpretation, applicability, enforceability, or formation of the agreement to arbitrate, including but not limited to, any claim that all or part of the agreement to arbitrate is void or voidable for any reason.

Unless the parties agree otherwise, the parties and the arbitrator shall treat the proceedings, any related discovery, and the decisions, as confidential, except in connection with judicial proceedings ancillary to the arbitration, such as a judicial challenge to, or enforcement of, an award, and unless otherwise required by law or to protect a legal right of a party. The arbitrator is empowered to impose reasonable limits on discovery, if any, and the time and manner for presenting evidence, with the goal of an efficient and economical arbitration process. The arbitrator must follow the rule of law in entering any award or relief in the arbitration.

Except as may be required by law, neither party nor an arbitrator may disclose the existence, content, or results of any arbitration hereunder without the prior written consent of both parties.

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18.10&nbsp;&nbsp;&nbsp;&nbsp;<u>Counterparts</u>. This Agreement may be executed in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. Any photocopy, facsimile or electronic reproduction of the executed Agreement shall constitute an original.

18.11&nbsp;&nbsp;&nbsp;&nbsp;<u>Publicity</u>. Neither party will make any press release or other public disclosure regarding this Agreement or the transactions contemplated hereby without the other party's express prior written consent, except as required under applicable law or by any governmental agency, in which case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or making the public disclosure. Neither party shall use the names, logos, or trademarks of any other party for publicity or advertising purposes without the prior written consent of such other party.

18.12&nbsp;&nbsp;&nbsp;&nbsp;<u>Survival</u>. Termination or expiration of this Agreement will not affect any rights and obligation of the parties that arose prior to such termination or expiration. In addition, Sections 6 (Remedies for Non-conforming Product), 11 (Confidentiality), 12 (Intellectual Property), 13 (Indemnification), 14 (Insurance), 16 (Limitations of Liability), 17 (Notice), 18 (Miscellaneous), and Sections 9.7 (Recalls) and 15.3 (Effect of Termination), and any other provisions of this Agreement which by their nature are intended to survive shall survive expiration or termination of this Agreement, provided that the obligations under Sections 11 and 6 shall survive only for the period stated therein.

18.13&nbsp;&nbsp;&nbsp;&nbsp;<u>Force Majeure</u>. Except as to payments required under this Agreement, neither party shall be liable in damages for, nor shall this Agreement be terminable or cancelable by reason of, any delay or default in such party's performance hereunder if such default or delay is caused by events beyond such party's reasonable control including, but not limited to, acts of God, regulation or law or other action or failure to act of any government or agency thereof, war or insurrection, civil commotion, destruction of production facilities or materials by earthquake, fire, flood or storm, labor disturbances, epidemic, or failure of suppliers, public utilities or common carriers; provided however, that the party seeking relief hereunder shall immediately notify the other party of such cause(s) beyond such party's reasonable control. The party that may invoke this Section 18.13 shall use all reasonable endeavors to reinstate its ongoing obligations to the other. If the cause(s) shall continue unabated for one hundred eighty (180) days, then both parties shall discuss and negotiate in good faith any required modifications to this Agreement.

18.14&nbsp;&nbsp;&nbsp;&nbsp;<u>Data Protection</u>. Indivior and Curia acknowledge and agree as follows: (i) in the performance of this Agreement, and the delivery of any documentation hereunder, certain Personal Data may be generated, disclosed to a party to this Agreement, and may be incorporated into files processed by either party or by the Affiliates of either party; (ii) Personal Data will be processed and stored solely for purposes of performing this Agreement and will be maintained for no longer than is necessary; (iii) each party represents and warrants that it has all legal right and authority to disclose any Personal Data of any third party it discloses to the other party to this Agreement, and that it has obtained the necessary consents from the relevant third party data subjects to so disclose such Personal Data; (iv) each party is aware that an individual whose Personal Data is processed hereunder has ce1tain rights to request access to, removal of or restriction on the processing of its Personal Data, and each patty will provide reasonable cooperation to the other as may be requested in the processing of any such request from such an individual. As used herein, "Personal Data" shall be as defined in Section 4 of Regulation (EU) 2016/679 (General Data Protection Regulation).

**ARTICLE 19**

**COLD STORAGE ROOM BUILD-OUT AND CAPITAL INVESTMENT**

19.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Cold Storage Room</u>. Curia and Indivior shall arrange for the design and construction of a cold storage room at the Facility, as more specifically described in **Exhibit F** (the "Cold Storage Room"). Title to, and risk of loss of, the Cold Storage Room shall be retained by Curia. Subject to Section 19.8 herein, Curia shall enter into a contract with a third party firm (the "Design and Construction Contract"), pursuant to which the development of detailed design drawings and construction of the Cold Storage Room (the "Build-Out") shall be conducted in conformance with Indivior's requirements (as mutually agreed by the Parties) and the terms and conditions of this Amendment. The parties agree that the Build-Out shall be a joint effort between the parties who shall share responsibility in ensuring that the Cold Storage Room satisfies Indivior's objectives.

19.2&nbsp;&nbsp;&nbsp;&nbsp;[Intentionally Omitted].

19.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Person-In-Plant</u>. A representative from Indivior and his/her designees (who shall be employees or contractors of Indivior) shall be permitted to be present during the period of the Build-Out to assess progress and monitor work as Indivior deems necessary. Such Indivior personnel shall comply with any and all confidentiality, security, safety, quality or similar guidelines that apply to persons present in the Facility and that are communicated in advance by Curia, and such other terms and conditions as further set forth in **Exhibit G**.

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19.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Indivior Capital Investment</u>. Indivior agrees to finance the costs of the Build-Out (such aggregate amount, the "Indivior Capital Investment"). Indivior has previously provided Curia with $[\*\*\*] (the "Deposit"). Curia issued a credit to Indivior in the amount of [\*\*\*] Dollars ($[\*\*\*]). Accordingly, the remaining balance of the Deposit is [\*\*\*] Dollars ($[\*\*\*]). The parties agree that no further payments are pending as of the Effective Date of this Agreement from Indivior for the Cold Storage Room. Curia shall use the Deposit to cover the costs of all goods and services provided by the third-party contractors and vendors in connection with the Build-Out as they are incurred by Curia, and shall provide a monthly report to Indivior accounting for such expenditures.

19.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Insufficient/ Excess Funds</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;In the event that the aggregate Build-Out costs exceed the Deposit, the parties shall work together in good faith to eliminate or minimize such excess amounts. In the event there continues to be excess amounts owed following such good faith efforts, Indivior shall be solely responsible for all costs over the Deposit. Curia shall invoice Indivior for any such amounts in accordance with Section 7.4 and Indivior shall pay such invoices in accordance with Section 7.7.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;In the event that the aggregate Build-Out costs are less than the Deposit, Curia shall credit Indivior the amount of any such excess which can be applied by Indivior against other invoices issued by Curia pursuant to this Agreement.

19.6&nbsp;&nbsp;&nbsp;&nbsp;[Intentionally Omitted].

19.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Indivior' s Rights to Cold Storage Room</u>. During the Term and in exchange for the Indivior Capital Investment, Curia agrees that the Cold Storage Room shall be for priority use of Indivior, pursuant to the terms and conditions set forth in this Amendment. In the event Indivior' s storage needs do not fill the capacity of the Cold Storage Room at any given time, Curia may use the Cold Storage Room for the storage needs of other customers. Curia shall prioritize Indivior's storage needs with respect to the Cold Storage Room at all times during the Term, including moving materials that do not belong to Indivior out of the Cold Storage Room should the need arise. In the event Indivior's storage needs have filled the entire capacity of the Cold Storage Room and Indivior requires additional storage space, Product shall be sent to a third-party storage facility and Indivior will pay the applicable third-party monthly storage fee for such third-party storage in accordance with Section 5.4. Following the expiration or termination of this Agreement, nothing shall restrict or prevent Curia from using the Cold Storage Room for other parties, in its sole discretion.

19.8&nbsp;&nbsp;&nbsp;&nbsp;<u>Build-Out Timing</u>. The parties expressly agree that the Design and Construction Contract shall be structured such that following the delivery of the detailed design and approval thereof by the pa1ties, Curia must expressly authorize the third patty contractor to begin construction and no construction-related costs shall be incurred until such authorization is provided. The decision to commence construction, and ongoing decisions to continue construction, shall be made by Curia, in consultation with Indivior, taking into account a variety of factors, including without limitation, the impact of the COVID-19 pandemic on local construction projects and any federal, state or local government or authoritative agency's orders, mandates, recommendations or requests related thereto. Curia shall in no event be responsible for any delay relating to the Build-Out caused by such factors or any other factors outside of Curia's direct control.

19.9&nbsp;&nbsp;&nbsp;&nbsp;<u>Consents</u>. Indivior acknowledges that the initiation of any construction relating to the Build-Out is further conditioned upon (i) receipt of all government permits required relating to the Build-Out, and (ii) receipt of approval from the landlord pursuant to the lease agreement governing the Facility. Curia shall not be required to seek any such permits, approvals or consents until such time as a decision is made to proceed with the construction pursuant to Section 19.8 above.

19.10&nbsp;&nbsp;&nbsp;&nbsp;<u>DISCLAIMER</u>. CURIA EXPRESSLY DISCLAIMS AND MAKES NO WARRANTY OR REPRESENTATION, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR OTHERWISE WITH RESPECT TO THE COLD STORAGE ROOM OR THE EQUIPMENT. CURIA IS NOT RESPONSIBLE NOR LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OR LOSSES OF INDIVIOR OR ANY THIRD PARTY RESULTING FROM INSTALLATION, OPERATION OR USE OF THE COLD STORAGE ROOM OR THE EQUIPMENT.

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IN WITNESS WHEREOF, the parties have caused their duly authorized representative to execute this Agreement as of the Execution Date, the same to binding and effective as of the Effective Date.

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| | |
|:---|:---|
| Curia Massachusetts, Inc. | Indivior UK Limited |
| By:*<u>/s/ Diane Beno</u>* | By: *<u>/s/ Hillel West</u>* |
| Name: <u>Diane Beno</u> | Name: <u>Hillel West</u> |
| Title: <u>SVP, Quality and Interim President, Manufacturing</u> | Title: <u>Chief Manufacturing and Supply Officer</u> |
| Date: <u>Feb 25, 2022</u> | Date: <u>Feb 27, 2022</u> |

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**<u>EXHIBIT A</u>**

**INDIVIOR MATERIALS TESTING**

Curia shall perform the testing listed in the table below, as applicable, for Indivior Materials. The parties agree all such testing is included in the Unit Price and shall not be a separate charge to Indivior, unless the parties agree in writing to any modifications to the testing and the costs associated with such modifications.

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| | | | | |
|:---|:---|:---|:---|:---|
| Indivior Materials | Indivior Materials | Indivior Materials | Indivior Materials | Indivior Materials |
| Client | Part Number | Name | Test | Testing Site |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

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**<u>EXHIBIT B</u>**

**UNIT PRICING**

Indivior shall pay to Curia the Unit Pricing set forth in the table below for all Commercial Product. The pricing for any Non-Commercial Product or Validation Batches shall be set forth in the applicable SOW. Indivior shall pay the Unit Price set forth in Column B for each unit Delivered during a Calendar Year, provided the parties shall do a final accounting of the amount due for each such unit of Product Delivered when the final unit count for each Calendar Year is available (i.e., Curia may owe Indivior a certain amount or Indivior may owe Curia a certain amount based on the total number of units of Product Delivered in the applicable Calendar Year), subject to any further pricing adjustment pursuant to Section 4.8 (Penalties for Delay). The Unit Price will be adjusted by end of February of the following Calendar Year (i.e., the 2022 reconciliation will be performed by February 28, 2023). For example, if Curia Delivered 800,001 units of SUBLOCADE® SKU # [\*\*\*] that met the Manufacturing Standards, and no penalties were applied to the Unit Price per Section 4.8, in Calendar Year 2022, then Indivior shall pay a price of $[\*\*\*] for each such unit, totaling ($[\*\*\*] x 800,001) = $[\*\*\*] and resulting in an end of year reconciliation amount due to Curia of $[\*\*\*] = $[\*\*\*] - (800,001 x $[\*\*\*]).

The parties agree that the Unit Pricing set forth herein shall be paid by Indivior to Curia in accordance with the terms of this Agreement for each unit of Product Delivered which is not Non-conforming Product, irrespective of the intended use of each unit of Product by Indivior.

The parties agree that the Unit Pricing for Calendar Years beyond 2022 shall be based on the Annual Forecast or, if the cumulative Firm Period Forecasts during the applicable Calendar Year are less than the Annual Forecast, the cumulative Firm Period Forecasts during the applicable Calendar Year. The following examples are to demonstrate various year-end accounting scenarios:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;For example, if Indivior's Annual Forecast for Calendar Year 2023 is for 800,000 units of Product, but Indivior's orders for Product in accordance with the Firm Period Forecasts for Calendar Year 2023 are for 700,000 units of Product and Curia Delivered 750,000 units of Product during Calendar Year 2023 in accordance with the applicable Purchase Orders, then Curia shall be entitled to the Unit Pricing set forth in Column C of the table below for each of the 750,000 units of Product Delivered by Curia in Calendar Year 2023.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;For example, if Indivior's Annual Forecast for Calendar Year 2023 is for 800,000 units of Product, and Indivior's orders for Product in accordance with the Firm Period Forecasts for Calendar Year 2023 are for 800,000 units of Product and Curia Delivered 750,000 units of Product during Calendar Year 2023, then Curia shall be entitled to the Unit Pricing set forth in Column B of the table below for each of the 750,000 units of Product Delivered by Curia in Calendar Year 2023.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;For example, if Indivior's Annual Forecast for Calendar Year 2023 is for 800,000 units of Product, and Indivior's orders for Product in accordance with the Firm Period Forecasts for Calendar Year 2023 are for 800,000 units of Product but Curia Delivered only 650,000 units of Product during Calendar Year 2023, then Curia shall be entitled to the Unit Pricing set forth in Column A of the table below for each of the 650,000 units of Product Delivered by Curia in Calendar Year 2023.

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| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
| Curia Material No. (SKU #) | Indivior Product No. | MD # | Description | Target Batch Size (No. Syringes) | A | B | C |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

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Columns:

**A**: Unit Price for <[\*\*\*] units in 2022. For 2023 and beyond, the Unit Price applies to <[\*\*\*]% units of Product Delivered of the Annual Forecast (or the cumulative Firm Period Forecasts for the applicable Calendar Year in the event such quantity is less than the Annual Forecast).

**B**: Unit Price for [\*\*\*]-[\*\*\*] units in 2022. For 2023 and beyond, the Unit Price applies for [\*\*\*]-[\*\*\*]% units of Product Delivered of the Annual Forecast (or the cumulative Firm Period Forecasts for the applicable Calendar Year in the event such quantity is less than the Annual Forecast).

**C**: Unit Price for >[\*\*\*] Units in 2022. For 2023 and beyond, the Unit Price applies for >[\*\*\*]% units of Product Delivered of the Annual Forecast (or the cumulative Firm Period Forecasts for the applicable Calendar Year in the event such quantity is less than the Annual Forecast).

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**<u>EXHIBIT C</u>**

**FORM OF SCOPE OF WORK**

**Scope of Work**

This Statement of Work (**"SOW"**), effective as of the date of last signature hereto (the **"SOW Effective Date"**), is entered into by and between [Curia Massachusetts, Inc. or other Curia entity performing the services], having an address of [99 S Bedford St., Burlington, MA 01803 or other Curia entity address] (**"Curia"**) and Indivior UK Limited, having an address of Chapleo Building, Henry Boot Way, Priory Park, Hull HU4 7BY, UK (**"Indivior"**) and is issued pursuant to the Master Development and Supply Agreement by and between Curia and Indivior, effective January 1, 2022 (the **"Agreement"**). This SOW is subject to the terms and conditions of the Agreement and is made a part thereof by reference. Any term not otherwise defined herein shall have the meaning specified in the Agreement. To the extent any terms or conditions of this SOW conflict with the terms and conditions of the Agreement, the terms and conditions of the Agreement shall control, unless this SOW expressly states the intent of the parties that a particular provision of this SOW supersede the Agreement with respect to a particular matter.

1.&nbsp;&nbsp;&nbsp;&nbsp;**Services.** [describe services with specificity]

2.&nbsp;&nbsp;&nbsp;&nbsp;**Costs and Fees.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**a.&nbsp;&nbsp;&nbsp;&nbsp;**[describe fees with specificity]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**b.&nbsp;&nbsp;&nbsp;&nbsp;Fees** shall not exceed: <u>[</u>AMOUNT] ($XXX); and **Expenses** shall not exceed: <u>[AMOUNT] ($XXX)</u>, for a total not to exceed amount of <u>[AMOUNT] ($XXX)</u> (the "NTE Amount"). Expenses may include travel, shipping, conference calls, materials duplication, and other expenses related to performing the services. The NTE Amount may be increased upon written approval by Indivior, which must be documented in an amendment to this SOW and signed by both parties.

3.&nbsp;&nbsp;&nbsp;&nbsp;**Term.** The term of this SOW shall commence on the SOW Effective Date and shall continue until completion of the Services, unless earlier terminated by a party in accordance with the Agreement.

4.&nbsp;&nbsp;&nbsp;&nbsp;**Entire Agreement; Change Order.** This SOW and the Agreement form the basis for the parties' agreement. Any change to this SOW shall be documented in a written change order mutually agreed upon and executed by the parties.

5.&nbsp;&nbsp;&nbsp;&nbsp;**Counterparts.** This SOW may be executed in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. Any photocopy, facsimile or electronic reproduction of the executed SOW shall constitute an original.

6.&nbsp;&nbsp;&nbsp;&nbsp;**Changes.** Any alterations or amendments to this SOW (including any handwritten changes) will be null and void except by an instrument in writing, signed by authorized representatives of both parties.

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IN WITNESS WHEREOF, this SOW has been executed by the parties hereto through their duly authorized representatives effective as of the SOW Effective Date.

**[Curia Massachusetts, Inc. or other Curia entity performing the services]** 

**Indivior UK Limited**

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| |
|:---|
| By: |
| Name: |
| Title: |
| Date: |

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**<u>EXHIBIT D</u>**

**PERFORMANCE STANDARDS**

The parties agree that the Performance Standards set forth herein represent the ideal targets of the parties as of the Effective Date. The parties will work in good faith to establish the final targets throughout Calendar Year 2022 and shall agree in writing to the final parameters of the Performance Standards, whether by SOW, an amendment to this Agreement or other written documentation signed by both parties. In no event will the Performance Standards be applied prior to January 1, 2023 unless otherwise agreed by the parties in writing, signed by an authorized representative of each party.

Key Performance <br>Indicator Definition Indivior Target Curia Target <br> <u>[\*\*\*]</u> <u>[\*\*\*]</u> <u>[\*\*\*]</u> <u>[\*\*\*]</u>

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**<u>EXHIBIT E</u>**

**FLOWDOWN TERMS**

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| | |
|:---|:---|
| &nbsp;&nbsp;**Citation** | &nbsp;&nbsp;**Title** |
| &nbsp;&nbsp;FAR 52.203-6 (2020) | &nbsp;&nbsp;Restrictions on Subcontractor Sales to the Government |
| &nbsp;&nbsp;FAR 52.203-13 (2020) | &nbsp;&nbsp;Contractor Code of Business Ethics and Conduct |
| &nbsp;&nbsp;FAR 52.203-17 (2020) | &nbsp;&nbsp;Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights |
| &nbsp;&nbsp;FAR 52.203-19 (2017) | &nbsp;&nbsp;Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements |
| &nbsp;&nbsp;FAR 52.204-10 (2016) | &nbsp;&nbsp;Reporting Executive Compensation and First-Tier Subcontract Awards |
| &nbsp;&nbsp;FAR 52.204-21 (2016) | &nbsp;&nbsp;Basic Safeguarding of Covered Conti act Information Systems |
| &nbsp;&nbsp;FAR 52.204-23 (2018) | &nbsp;&nbsp;Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities |
| &nbsp;&nbsp;FAR 52.204-25 (2020) | &nbsp;&nbsp;Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment |
| &nbsp;&nbsp;FAR 52.209-6 (2020) | &nbsp;&nbsp;Protecting the Government's Interest when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment |
| &nbsp;&nbsp;FAR 52.222-17 (2014) | &nbsp;&nbsp;Nondisplacement of Qualified Workers |
| &nbsp;&nbsp;FAR 52.222-21 (2015) | &nbsp;&nbsp;Prohibition of Segregated Facilities |
| &nbsp;&nbsp;FAR 52.222-26 (2015) | &nbsp;&nbsp;Equal Opportunity |
| &nbsp;&nbsp;FAR 52.222-35 (2020) | &nbsp;&nbsp;Equal Opportunity for Veterans |
| &nbsp;&nbsp;FAR 52.222-36 (2020) | &nbsp;&nbsp;Equal Opportunity for Workers with Disabilities |
| &nbsp;&nbsp;FAR 52.222-37 (2020) | &nbsp;&nbsp;Employment Reports on Veterans |
| &nbsp;&nbsp;FAR 52.222-40 (2010) | &nbsp;&nbsp;Notification of Employee Rights Under the National Labor Relations Act |
| &nbsp;&nbsp;FAR 52.222-41 (2018) | &nbsp;&nbsp;Service Contract Labor Standards |
| &nbsp;&nbsp;FAR 52.222-50 (2020) | &nbsp;&nbsp;Combating Trafficking in Persons |
| &nbsp;&nbsp;FAR 52.222-51 (2014) | &nbsp;&nbsp;Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements |
| &nbsp;&nbsp;FAR 52.222-53 (2014) | &nbsp;&nbsp;Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements |
| &nbsp;&nbsp;FAR 52.222-54 (2015) | &nbsp;&nbsp;Employment Eligibility Verification |
| &nbsp;&nbsp;FAR 52.222-55 (2020) | &nbsp;&nbsp;Minimum Wages Under Executive Order 13658 |
| &nbsp;&nbsp;FAR 52.222-62 (2017) | &nbsp;&nbsp;Paid Sick Leave Under Executive Order 13706 |
| &nbsp;&nbsp;FAR 52.223-18 (2011) | &nbsp;&nbsp;Encouraging Contractor Policies to Ban Text Messaging While Driving |
| &nbsp;&nbsp;FAR 52.225-13 (2008) | &nbsp;&nbsp;Restriction of Certain Foreign Purchases |
| &nbsp;&nbsp;FAR 52.232-40 (2013) | &nbsp;&nbsp;Providing Accelerated Payment to Small Business Subcontractors |

---

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**<u>EXHIBIT F</u>**

**COLD STORAGE ROOM**

• &nbsp;&nbsp;&nbsp;&nbsp;Dimensions, internal: [\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;Layout: [\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;Internal volume: [\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;Internal configuration: [\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;Temp range: [\*\*\*]

o&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

o&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

o&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;Dual, redundant refrigeration systems:

o&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

o&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

o&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

• &nbsp;&nbsp;&nbsp;&nbsp;Security (DEA) cage:

o&nbsp;&nbsp;&nbsp;&nbsp;Size: [\*\*\*]

o&nbsp;&nbsp;&nbsp;&nbsp;Construction:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

o&nbsp;&nbsp;&nbsp;&nbsp;Security features:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

------

**<u>EXHIBIT G</u>**

**CONDITIONS FOR INDIVIOR PERSONNEL AT FACILITY FOR BUILD-OUT**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.&nbsp;&nbsp;&nbsp;&nbsp;Definitions**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.&nbsp;&nbsp;&nbsp;&nbsp;"Person-in-Plant" means the lndivior employee or employees on-site at the Facility for the Build-Out.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b.&nbsp;&nbsp;&nbsp;&nbsp;"Purpose" means observing and facilitating the Build-Out, in accordance with the terms and conditions set forth in the Agreement.

Capitalized terms used but not defined herein have the meanings assigned to them in the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.&nbsp;&nbsp;&nbsp;&nbsp;Restricted Access**

Person-in-Plant agrees and understands that due to certain confidentiality concerns and requirements of Curia, Person-in-Plant's access shall be restricted solely to the Cold Storage Room area and such other areas in the Facility as may be determined by Curia, at Curia's reasonable discretion. The Person-in-Plant shall be accompanied at all times by a Curia employee at the Facility. The Person-in-Plant understands that he/ she will not be provided access to Curia computer networks.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.&nbsp;&nbsp;&nbsp;&nbsp;Specific Obligations**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.&nbsp;&nbsp;&nbsp;&nbsp;**Indivior's Obligations:** As between the parties, the Person-in-Plant shall be considered Indivior's employee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b.&nbsp;&nbsp;&nbsp;&nbsp;lndivior shall further be responsible for all actual expenses and/or costs incurred by Person-in-Plant relating to the Purpose, including all expenses relating to travel, accommodation and all other costs incurred by the Person-in-Plant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c.&nbsp;&nbsp;&nbsp;&nbsp;**Curia's Obligations:** Curia shall provide the Person-in-Plant reasonable access to areas of the Facility in direct connection with the Build-Out, subject to the restrictions set forth herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d.&nbsp;&nbsp;&nbsp;&nbsp;**Person-in-Plant's Obligations:** In addition to complying with all the terms set forth herein, Person-in-Plant shall follow all security, safety, and other policies of Curia for the Facility.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.&nbsp;&nbsp;&nbsp;&nbsp;Confidentiality**

The rights and obligations of Person-in-Plant with respect to Curia's Confidential Information shall be governed by Section 11 of the Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.&nbsp;&nbsp;&nbsp;&nbsp;Indemnification**

Indivior shall solely be responsible and shall indemnify, defend and hold harmless Curia and its Affiliates, their directors, officers, employees and agents ("Curia Indemnitees") for any and all claims, damages, liabilities, losses, costs and expenses, including but not limited to reasonable attorneys' fees (collectively, "Claims") arising from or related to Person-in-Plant's activities, including but not limited to any Claim brought by Person-in-Plant, except to the extent such Claims are caused by the negligence or willful misconduct of any of the Curia lndemnitees.

## Exhibit 4.18

**Exhibit 4.18.1**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**MASTER MANUFACTURING SERVICES AGREEMENT BETWEEN**

**(1)&nbsp;&nbsp;&nbsp;&nbsp;PATHEON MANUFACTURING SERVICES LLC**

**AND**

**(2)&nbsp;&nbsp;&nbsp;&nbsp;INDIVIOR UK LIMITED**

Page **1** of **77**

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**<u>**Table of Contents**</u>**

---

| | | |
|:---|:---|:---|
| **ARTICLE 1: STRUCTURE OF AGREEMENT AND INTERPRETATION** | **ARTICLE 1: STRUCTURE OF AGREEMENT AND INTERPRETATION** | **5** |
| 1.1 | MASTER AGREEMENT. | 5 |
| 1.2 | PRODUCT AGREEMENTS. | 5 |
| 1.3 | DEFINITIONS. | 6 |
| 1.4 | CURRENCY. | 10 |
| 1.5 | SECTIONS AND HEADINGS. | 10 |
| 1.6 | SINGULAR TERMS. | 11 |
| 1.7 | APPENDIX 1, SCHEDULES AND EXHIBITS. | 11 |
| **ARTICLE 2: PATHEON'S MANUFACTURING SERVICES** | **ARTICLE 2: PATHEON'S MANUFACTURING SERVICES** | **12** |
| 2.1 | MANUFACTURING SERVICES. | 12 |
| 2.2 | ACTIVE MATERIAL YIELD. | 14 |
| **ARTICLE 3: INDIVIOR'S OBLIGATIONS** | **ARTICLE 3: INDIVIOR'S OBLIGATIONS** | **15** |
| 3.1 | PAYMENT. | 15 |
| 3.2 | ACTIVE MATERIALS AND QUALIFICATION OF ADDITIONAL SOURCES OF SUPPLY. | 15 |
| **ARTICLE 4: FEES AN COMPONENT COSTS** | **ARTICLE 4: FEES AN COMPONENT COSTS** | **16** |
| 4.1 | PRICING. | 16 |
| 4.3 | PRICE ADJUSTMENTS – CURRENT YEAR PRICING. | 18 |
| 4.4 | ADJUSTMENTS DUE TO TECHNICAL CHANGES OR REGULATORY AUTHORITY REQUIREMENTS. | 18 |
| 4.5 | MULTI-COUNTRY PACKAGING REQUIREMENTS. | 18 |
| **ARTICLE 5: ORDERS, SHIPMENT, INVOICING, PAYMENT** | **ARTICLE 5: ORDERS, SHIPMENT, INVOICING, PAYMENT** | **18** |
| 5.1 | ORDERS AND FORECASTS. | 18 |
| 5.2 | RELIANCE BY PATHEON. | 20 |
| 5.3 | MINIMUM ORDERS. | 20 |
| 5.4 | DELIVERY AND SHIPPING. | 20 |
| 5.5 | INVOICES AND PAYMENT. | 21 |
| **ARTICLE 6: PRODUCT CLAIMS AND RECALLS** | **ARTICLE 6: PRODUCT CLAIMS AND RECALLS** | **22** |
| 6.1 | PRODUCT CLAIMS. | 22 |
| 6.2 | PRODUCT RECALLS AND RETURNS. | 22 |
| 6.3 | PATHEON'S RESPONSIBILITY FOR DEFECTIVE AND RECALLED PRODUCTS. | 23 |
| 6.4 | DISPOSITION OF DEFECTIVE OR RECALLED PRODUCTS. | 24 |
| 6.5 | HEALTHCARE PROVIDER OR PATIENT QUESTIONS AND COMPLAINTS. | 24 |
| 6.6 | SOLE REMEDY. | 24 |
| **ARTICLE 7: CO-OPERATION** | **ARTICLE 7: CO-OPERATION** | **24** |
| 7.1 | QUARTERLY REVIEW. | 24 |
| 7.2 | GOVERNMENTAL AGENCIES. | 24 |
| 7.3 | RECORDS AND ACCOUNTING BY PATHEON. | 25 |
| 7.4 | INSPECTION. | 25 |
| 7.5 | INSPECTION; RECORD MAINTENANCE; ACCESS. | 25 |
| 7.6 | NOTIFICATION OF REGULATORY INSPECTIONS. | 25 |
| 7.7 | REPORTS. | 25 |
| 7.8 | REGULATORY FILINGS. | 26 |

---

Page **2** of **70**

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---

| | | |
|:---|:---|:---|
| **ARTICLE 8: TERM AND TERMINATION** | **ARTICLE 8: TERM AND TERMINATION** | **27** |
| 8.1 | TERM. | 27 |
| 8.2 | TERMINATION FOR CAUSE. | 27 |
| 8.3 | OBLIGATIONS ON TERMINATION. | 28 |
| **ARTICLE 9: REPRESENTATIONS, WARRANTIES AND COVENANTS** | **ARTICLE 9: REPRESENTATIONS, WARRANTIES AND COVENANTS** | **29** |
| 9.1 | MUTUAL WARRANTIES. | 29 |
| 9.2 | INDIVIOR WARRANTIES. | 29 |
| 9.3 | PATHEON WARRANTIES. | 30 |
| 9.4 | PERMITS. | 30 |
| 9.5 | NO WARRANTY. | 30 |
| **ARTICLE 10: REMEDIES AND INDEMNITIES** | **ARTICLE 10: REMEDIES AND INDEMNITIES** | **30** |
| 10.1 | CONSEQUENTIAL AND OTHER DAMAGES. | 30 |
| 10.2 | LIMITATION OF LIABILITY. | 31 |
| (C) | MAXIMUM LIABILITY. | 31 |
| 10.3 | PATHEON INDEMNITY. | 31 |
| 10.4 | INDIVIOR INDEMNITY. | 31 |
| 10.5 | REASONABLE ALLOCATION OF RISK. | 32 |
| **ARTICLE 11: CONFINDENTIALITY** | **ARTICLE 11: CONFINDENTIALITY** | **32** |
| 11.1 | CONFIDENTIAL INFORMATION. | 32 |
| 11.2 | USE OF CONFIDENTIAL INFORMATION. | 32 |
| 11.3 | EXCLUSIONS. | 32 |
| 11.4 | PHOTOGRAPHS AND RECORDINGS. | 33 |
| 11.5 | PERMITTED DISCLOSURE. | 33 |
| 11.6 | MARKING. | 33 |
| 11.7 | RETURN OF CONFIDENTIAL INFORMATION. | 33 |
| 11.8 | REMEDIES. | 33 |
| **ARTICLE 12: DISPUTE RESOLUTION** | **ARTICLE 12: DISPUTE RESOLUTION** | **33** |
| 12.1 | COMMERCIAL DISPUTES. | 33 |
| 12.2 | TECHNICAL DISPUTE RESOLUTION. | 34 |
| **ARTICLE 13: MISCELLANEOUS** | **ARTICLE 13: MISCELLANEOUS** | **34** |
| 13.1 | INVENTIONS. | 34 |
| 13.2 | INTELLECTUAL PROPERTY. | 34 |
| 13.3 | INSURANCE. | 35 |
| 13.4 | INDEPENDENT CONTRACTORS. | 35 |
| 13.5 | NO WAIVER. | 35 |
| 13.6 | ASSIGNMENT AND SUBCONTRACTING. | 35 |
| 13.7 | FORCE MAJEURE. | 36 |
| 13.8 | ADDITIONAL PRODUCT. | 36 |
| 13.9 | NOTICES. | 36 |
| 13.10 | SEVERABILITY. | 37 |
| 13.11 | ENTIRE AGREEMENT. | 37 |
| 13.12 | OTHER TERMS. | 37 |
| 13.13 | NO THIRD PARTY BENEFIT OR RIGHT. | 37 |

---

Page **3** of **70**

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---

| | | | |
|:---|:---|:---|:---|
| | 13.14 | EXECUTION IN COUNTERPARTS. | 37 |
| | 13.15 | USE OF INDIVIOR NAME. | 37 |
| | 13.16 | TAXES. | 38 |
| | 13.17 | GOVERNING LAW. | 39 |
| **ARTICLE 14: ANTI-BRIBERY** | **ARTICLE 14: ANTI-BRIBERY** | **ARTICLE 14: ANTI-BRIBERY** | **39** |
| **ARTICLE 15: BUSINESS CONTINUITY PLAN** | **ARTICLE 15: BUSINESS CONTINUITY PLAN** | **ARTICLE 15: BUSINESS CONTINUITY PLAN** | **39** |
| **ARTICLE 16: EQUIPMENT** | **ARTICLE 16: EQUIPMENT** | **ARTICLE 16: EQUIPMENT** | **40** |

---

Page **4** of **70**

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**<u>MASTER MANUFACTURING SERVICES AGREEMENT</u>**

**THIS MASTER MANUFACTURING SERVICES AGREEMENT (the "Agreement")** is made as of April 6, 2018 (the "**Effective Date**")

B E T W E E N:

---

| |
|:---|
| **PATHEON MANUFACTURING SERVICES LLC,** |
| a limited liability company existing under the laws of the State of Delaware |
| ("**Patheon**"), |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;- and - |
| **INDIVIOR UK LIMITED,** |
| incorporated and registered under the laws of England |
| ("**Indivior**"). |

---

THIS AGREEMENT WITNESSES THAT in consideration of the rights conferred and the obligations assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each party), and intending to be legally bound the parties agree as follows:

**ARTICLE 1**

**<u>STRUCTURE OF AGREEMENT AND INTERPRETATION</u>**

**1.1 <u>Master Agreement</u>**.

This Agreement establishes the general terms and conditions under which Patheon or any Affiliate of Patheon may contract to perform Manufacturing Services for Indivior or any Affiliate of Indivior, at the Manufacturing Site where the Affiliate of Patheon resides. This "master" form of agreement is intended to allow the parties, or any of their Affiliates, to contract for the manufacture of multiple Products through Patheon's global network of manufacturing sites through the issuance of specific Product Agreements without having to re-negotiate the basic terms and conditions contained herein. This Agreement may be enforced by or against any such Affiliate of Patheon or Indivior (as applicable) in its own name. Where the context requires, any reference to "Patheon" or "Indivior" in this Agreement or any Product Agreement shall be deemed to include any Affiliate of Patheon or Indivior (as applicable) identified with respect to such Product Agreement. Each party shall cause its Affiliates to comply with the terms of the Agreement and any applicable Product Agreement and shall be responsible for any breach of the Agreement or any applicable Product Agreement by any of its Affiliates. Notwithstanding the foregoing, Patheon shall not subcontract any of its obligations under this Agreement or any Product Agreement to any subcontractor, including but not limited to a Patheon Affiliate, without Indivior's prior written approval.

**1.2 <u>Product Agreements</u>**.

This Agreement is structured so that a Product Agreement may be entered into by the parties for the manufacture of a particular Product or multiple Products at a Patheon Manufacturing Site. Each Product Agreement will be governed by the terms and conditions of this Agreement unless the parties to the Product Agreement expressly modify the terms and conditions of this Agreement in the Product Agreement. Unless otherwise agreed by the parties, each Product Agreement will be in the general form and contain the information set forth in Appendix 1 hereto. Unless the applicable portion of a Product Agreement expressly states that it supersedes the terms in the Agreement, to the extent any terms set forth in a Product Agreement conflict with the terms set forth in this Agreement, this Agreement shall control. Nothing in this Agreement obligates either party to enter into any minimum number of, or any, Product Agreements.

Page **5** of **70**

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**1.3 <u>Definitions</u>**.

The following terms will, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of these terms will have corresponding meanings:

"**Active Materials**", **"Active Pharmaceutical Ingredients" or "API"** means the materials listed in a Product Agreement on Schedule D;

"**Active Materials Credit Value**" means the value of the Active Materials for certain purposes of this Agreement, as set forth in a Product Agreement on Schedule D;

"**Actual Annual Yield**" or "**AAY**" has the meaning specified in Section 2.2(a);

"**Actual Yearly Volume**" or "**AYV**" has the meaning specified in Section 4.2.1;

"**Affiliate**" means:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;a business entity which owns, directly or indirectly, a controlling interest in a party to this Agreement, by stock ownership or otherwise; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;a business entity which is controlled by a party to this Agreement, either directly or indirectly, by stock ownership or otherwise; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;a business entity, the controlling interest of which is directly or indirectly common to the majority ownership of a party to this Agreement;

For this definition, "control" means the possession, directly or indirectly, of the power to affirmatively direct or affirmatively cause the direction of the management and policies of an entity, whether through the ownership of more than fifty percent (50%) of voting securities, by contract or otherwise.

**"Annual Product Review Report"** means the annual product review report prepared by Patheon or an Affiliate of Patheon as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e);

"**Annual Report"** means the annual report to the FDA which is required to be prepared and filed by Indivior regarding the Product as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2);

"**Annual Volume**" means the minimum volume of Product to be manufactured in any Year of this Agreement as set forth in a Product Agreement on Schedule B;

"**Applicable Laws**" means (i) for Patheon, any and all laws, rules, regulations, guidance, and policies of the United States (whether federal, state, or local in nature), the United Kingdom (whether national, regional, or local in nature), and the local jurisdiction where the Manufacturing Site is located, that are applicable to the manufacture of the Products; the cGMPs (as defined in this Agreement); and any applicable laws, statutes, rules, regulations, standards, policies, orders, or other requirements promulgated by the United States Food and Drug Administration (the "FDA"); and (ii) for Indivior and the Products, the Laws of all jurisdictions where the Products are manufactured, distributed, and marketed as these are agreed and understood by the parties in this Agreement;

"**Authority**" means any governmental or regulatory authority, department, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal;

"**BCP Plan**" has the meaning specified in Section 15.1;

"**Benefit**" has the meaning specified in Section 14.1(b);

"**Breach Notice**" has the meaning specified in Section 8.2(a);

Page **6** of **70**

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"**Business Day**" means a day other than a Saturday, Sunday or a day that is a statutory holiday in the State of North Carolina;

"**Capital Equipment Agreement**" means a separate written agreement that the parties may enter into that will address responsibility for the purchase of capital equipment and facility modifications that may be required to perform the Manufacturing Services under a particular Product Agreement;

"**cGMPs**" means, as applicable, current good manufacturing practices as promulgated under applicable Laws, including those described in:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Parts 210 and 211 of Title 21 of the United States' Code of Federal Regulations;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;EC Directive 2001/183/EC, 2003/94/EC, and any applicable guidance on good manufacturing practices adopted pursuant to Article 47 of Directive 2001/83/EC, in particular relevant guidance on good manufacturing practices contained in the Rules Governing Medicinal Products in the European Union, Volume IV Good Manufacturing Practice for Medicinal Products, the principles detailed in the ICH Q7A guidelines; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Division 2 of Part C of the *Food and Drug Regulations* (Canada);

together with the latest Health Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

"**Components**" means, collectively, all packaging components, raw materials, ingredients, and other materials (including labels, product inserts and other labelling for the Products) required to manufacture the Products in accordance with the Specifications, other than the Active Materials;

"**Confidential Information**" has the meaning specified in Section 11.1;

"**Conversion Fee**" means the Price for performing the Manufacturing Services excluding the cost of Components;

"**CTD**" has the meaning specified in Section 7.8(c);

**"C-TPAT**" has the meaning specified in Section 2.1(f);

"**Deficiencies**" have the meaning specified in Section 7.8(d);

"**Deficiency Notice**" has the meaning specified in Section 6.1(a);

**"Delivery"** has the meaning specified in Section 5.4(b);

**"Delivery Date"** means the date scheduled for shipment of Product under a Firm Order as set forth in Section 5.1(d);

**"Delivery Point"** means the point at which the risk of loss or damage to the Products is transferred from Patheon to Indivior.

**"Derivative Product"** has the meaning specified in Section 2.1(f);

**"Disclosing Party**" has the meaning specified in Section 11.1;

**"Duties"** has the meaning specified in Section 13.16(b);

"**EMA**" means the European Medicines Agency;

"**FDA**" means the United States Food and Drug Administration;

"**Firm Orders**" have the meaning specified in Section 5.1(c);

Page **7** of **70**

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"**Force Majeure Event**" has the meaning specified in Section 13.7;

"**Health Canada**" means the section of the Canadian Government known as Health Canada and includes, among other departments, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate;

"**Importer of Record**" has the meaning specified in Section 3.2(a);

**"Indivior Intellectual Property"** means Intellectual Property generated or derived by Indivior before entering into this Agreement, or by Patheon while performing any Manufacturing Services or otherwise generated or derived by Patheon in its business which Intellectual Property is specific to, or dependent upon, Indivior's Active Material or Product or Confidential Information;

"**Indivior Property**" has the meaning specified in Section 8.3(a)(v);

"**Indivior-Supplied Components**" means those Components to be supplied by Indivior or that have been supplied by Indivior;

"**Initial Set Exchange Rate**" means as of the Effective Date of a Product Agreement, the initial exchange rate set forth in the Product Agreement to convert one unit of the billing currency into the Patheon Manufacturing Site local currency, calculated as the daily average interbank exchange rate for conversion of one unit of the billing currency into the Patheon Manufacturing Site local currency during the 90 day period immediately preceding the Effective Date as published by xe.com "The Currency Site" under the heading ''xe.com'': historical currency exchange rates" at http://www.xe.com/currencyconverter/;

"**Intellectual Property**" includes, without limitation, rights in patents, patent applications, formulae, trademarks, trademark applications, trade-names, Inventions, copyrights, industrial designs, trade secrets, and know how (including trade secrets, technology, methods of manufacture, specifications and other information),utility models, applications for utility models, designs (registered or unregistered and including applications for registered designs), topography rights and other rights in semiconductor chips, rights in Inventions, the right to claim damages for past infringements of any or all such rights and all rights having equivalent or similar effect wherever situated;

"**Invention**" means information about any innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which it is contained and whether or not patentable or copyrightable;

"**Inventory**" means all inventories of Components and work-in-process produced or held by Patheon for the manufacture of the Products but, for greater certainty, does not include the Active Materials;

"**Late Delivery**" has the meaning specified in Section 5.4(c);

"**Laws**" means all laws, statutes, ordinances, regulations, rules, by-laws, judgments, decrees or orders of any Authority;

**"Long Term Forecast**" has the meaning specified in Section 5.1(a);

"**Manufacturing Services**" means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials and Components;

"**Manufacturing Site**" means the facility owned and operated by Patheon where the Manufacturing Services will be performed as identified in a Product Agreement;

**"Materials"** means all Components required to manufacture the Products in accordance with the Specifications, other than the Active Materials;

"**Maximum Credit Value**" means the maximum value of Active Materials that may be credited by Patheon under this Agreement, as set forth in a Product Agreement on Schedule D;

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**"Metrics"** means the set of quantifiable performance measures set forth in Schedule E of a Product Agreement;

"**Minimum Order Quantity**" means the minimum number of batches of a Product to be produced during the same cycle of manufacturing as set forth in a Product Agreement on Schedule B;

"**Obsolete Stock**" has the meaning specified in Section 5.2(b);

"**Patheon Competitor**" means a business that derives greater than 50% of its revenues from performing contract pharmaceutical development or commercial manufacturing services;

**"Patheon Intellectual Property"** means Intellectual Property generated or derived by Patheon before performing any Manufacturing Services, developed by Patheon while performing the Manufacturing Services, or otherwise generated or derived by Patheon in its business which Intellectual Property is not specific to, or dependent upon, and does not incorporate or use Indivior's Active Material or Product or Confidential Information;

**"Policies"** has the meaning specified in Section 14.1;

"**PPI**" has the meaning specified in Section 4.2(a);

**"Price"** means the fees to be charged by Patheon for performing the Manufacturing Services, and includes the cost of Components (other than Indivior-Supplied Components), certain cost items as set forth in a Product Agreement on Schedule B, and annual stability testing fees as set forth in a Product Agreement on Schedule C;

"**Product(s)**" means the product(s) listed in a Product Agreement on Schedule A;

"**Product Agreement**" means the agreement between Patheon and Indivior issued under this Agreement in the form set forth in Appendix 1 (including Schedules A to D) under which Patheon will perform Manufacturing Services at a particular Manufacturing Site;

"**Product Claims**" have the meaning specified in Section 6.3(c);

"**Quality Agreement**" means the agreement between the parties entering a Product Agreement that sets out the quality assurance standards for the Manufacturing Services to be performed by Patheon for Indivior;

"**Recall**" has the meaning specified in Section 6.2(a);

"**Recipient**" has the meaning specified in Section 11.1;

"**Regulatory Approval**" has the meaning specified in Section 7.8(a);

"**Regulatory Authority**" means the FDA, EMA, and Health Canada and any other foreign regulatory agencies competent to grant marketing approvals for pharmaceutical products including the Products in the Territory;

"**Remediation Period**" has the meaning specified in Section 8.2(a);

"**Representatives**" means a party's directors, officers, employees, advisers, agents, consultants, subcontractors, service partners, professional advisors, or representatives;

 **"Set Exchange Rate"** means the exchange rate to convert one unit of the billing currency into the Patheon Manufacturing Site local currency for each Year, calculated as the average daily interbank exchange rate for conversion of one unit of the billing currency into the Patheon Manufacturing Site local currency during the full year period (October 1<sup>st</sup> [preceding year] to September 30<sup>th</sup>) as published by xe.com "The Currency Site" under the heading "xe.com: historical currency exchange rates" at http://www.xe.com/currencyconverter/;;

"**Shortfall**" has the meaning specified in Section 2.2(b);

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"**Specifications**" means the file, for each Product, which is given by Indivior to Patheon in accordance with the procedures listed in a Product Agreement on Schedule A and which contains documents relating to each Product, including, without limitation:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;specifications for Active Materials and Components;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;manufacturing specifications, directions, and processes;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;storage requirements;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;all environmental, health and safety information for each Product including material safety data sheets; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;the finished Product specifications, packaging specifications and shipping requirements for each Product;

all as updated, amended and revised from time to time by Indivior in accordance with the terms of this Agreement;

**"Surplus"** has the meaning specified in Section 2.2(c);

"**Target Yield**" has the meaning specified in Section 2.2(a);

"**Target Yield Determination Batches**" has the meaning specified in Section 2.2(a);

"**Transaction Tax**" have the meaning specified in Section 13.16(a);

"**Technical Dispute**" has the meaning specified in Section 12.2;

**"Technology Transfer"** means the transfer of technology necessary to enable a recipient to establish and conduct cGMP-compliant manufacture of the Products, as further set out in Exhibit E

"**Term**" has the meaning specified in Section 8.1;

"**Territory**" means the geographic area described in a Product Agreement where Products manufactured by Patheon will be distributed by Indivior;

"**Third Party Rights**" means the Intellectual Property of any third party;

"**VAT**" has the meaning specified in Section 13.16(a)(i);

"**Year**" means in the first year of this Agreement or in the first year of a Product Agreement, the period from the Effective Date up to and including December 31 of the same calendar year, and thereafter will mean a calendar year.

"**Yearly Forecast Volume**" or "**YFV**" has the meaning specified in Section 4.2.1; and

"**Zero Forecast Period**" has the meaning specified in Section 5.1(f).

**1.4 <u>Currency</u>**.

Unless otherwise agreed in a Product Agreement, all monetary amounts expressed in this Agreement are in United States Dollars (USD).

**1.5 <u>Sections and Headings</u>**.

The division of this Agreement into Articles, Sections, Subsections, an Appendix, Schedules and Exhibits and the insertion of headings are for convenience of reference only and will not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section, Appendix, Schedule or Exhibit refers to the specified Section, Appendix, Schedule or Exhibit to this Agreement. In this Agreement, the terms "**this Agreement**", "**hereof**", "**herein**",

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"**hereunder**" and similar expressions refer to this Agreement as a whole and not to any particular part, Section, Appendix, Schedule or Exhibit of this Agreement.

**1.6 <u>Singular Terms</u>**.

Except as otherwise expressly stated or unless the context otherwise requires, all references to the singular will include the plural and vice versa.

**1.7 <u>Appendix 1, Schedules and Exhibits</u>**.

Appendix 1 (including the Schedules thereto) and the following Exhibits are attached to, incorporated in, and form part of this Agreement:

---

| | |
|:---|:---|
| Appendix 1 | Form of Product Agreement (Including Schedules A to E) |
| Exhibit A | Technical Dispute Resolution |
| Exhibit B | Quarterly Active Materials Inventory Report |
| Exhibit C | Report of Annual Active Materials Inventory Reconciliation and Calculation of <br>Actual Annual Yield |
| Exhibit D | Example of Price Adjustment Due to Currency Fluctuation |
| Exhibit E | Form of Technology Transfer Agreement |
| Exhibit F | Indivior Code of Business Conduct and Anti-Bribery Policies |

---

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**ARTICLE 2**

**<u>PATHEON'S MANUFACTURING SERVICES</u>**

**2.1 <u>Manufacturing Services</u>**.

Patheon will perform the Manufacturing Services for Indivior in the Territory for the Price, as specified in Schedules B and C to a Product Agreement and shall adhere to the Metrics specified in Schedule E to a Product Agreement. Schedule B to a Product Agreement sets forth a list of cost items and designates those that are included in the Price for Products; all cost items that are not included in the Price are subject to additional fees to be paid by Indivior, such fees to be set forth in the Product Agreement. The parties may amend the fees set out in Schedules B and C to a Product Agreement as set forth in Article 4. Patheon may change the Manufacturing Site for the Products only with the prior written consent of Indivior, this consent not to be unreasonably withheld. To the extent Indivior and Patheon agree that Indivior shall utilize Patheon to fulfill a certain minimum percentage of its commercial manufacturing requirements for a specific Product, language to that effect shall be set forth in the individual Product Agreement. Notwithstanding the foregoing, nothing in this Agreement requires Indivior to utilize Patheon for any specific minimum percentage of its commercial manufacturing requirements for any Product. Patheon will be entitled to any applicable manufacturing tax credits that arise from performing the Manufacturing Services under this Agreement.

In performing the Manufacturing Services, Patheon and Indivior agree that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Conversion of Active Materials and Components</u>. Patheon will convert Active Materials and Components into Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Quality Control and Quality Assurance</u>. Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement and shall, in each instance, manufacture, test, and store the Products and supply the Manufacturing Services strictly in accordance with the Specifications; the Quality Technical Agreement; cGMPs; all Applicable Laws; and the terms of this Agreement. Batch review and release to Indivior will be the responsibility of Patheon's quality assurance group. Patheon will perform its batch review and release responsibilities in accordance with the terms of the Quality Agreement. Patheon shall be solely responsible for compliance with all Laws, rules, and regulations relating to the handling, generation, transportation, treatment, storage, and disposal or other management of waste and regulated substances, including, without limitation, solid and hazardous waste and hazardous and toxic substances and materials. In the event of any seizure or other similar government action with respect to a Product, Patheon shall cooperate with Indivior and take such other actions in connection therewith as Indivior may reasonably request. Prior to the commencement of the manufacture of the Products, Patheon shall satisfy itself that the know-how and any other information provided by Indivior to Patheon is sufficient to enable Patheon to efficiently perform its obligations under this Agreement. If Patheon concludes that further information is necessary, it shall notify Indivior and obtain such information prior to the commencement of manufacture. Each time Patheon ships Products to Indivior, it will give Indivior a certificate of analysis and certificate of compliance including a statement that the batch has been manufactured and tested in accordance with Specifications and cGMPs. Such certificates shall comply with and be in the form set out in the quality assurance requirements included in the Specifications. Patheon shall not release the Products until the certificates of analysis relating to such Products demonstrate that the Products meet the Specifications and the cGMPs. If Patheon or Indivior becomes aware that any aspect of a Specification is liable to result in the manufacture of a defective Product which may lead to a liability being incurred, it shall, as soon as reasonably practicable, notify the other party in writing. Patheon and Indivior shall promptly meet to discuss and address the risk of manufacture of a defective Product and if Patheon can reasonably demonstrate that manufacture of the Product in accordance with the Specifications would, or would likely, result in a defective Product, Patheon may, while Patheon rectifies such risk, suspend its obligation to supply Product under this Agreement, without prejudice to any right or remedy of Indivior, and provided that Patheon uses all reasonable endeavors to rectify such risk as promptly as possible. Indivior will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Patheon hereby grants Indivior an irrevocable, perpetual license to retain, access, disclose, and otherwise use the batch documents solely as necessary to fulfill the terms of this Agreement, to comply with a request from an Authority, or otherwise as required to comply with Applicable Law. Specific Product related information contained in those batch documents is Indivior Property. Indivior will

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inform Patheon of any Product manufacturing complaints of which they become aware. Patheon shall investigate the issues promptly and provide a written report to Indivior, which will include a corrective action plan (if applicable). If Patheon becomes aware of any complaints, it will promptly notify Indivior and provide reasonable assistance in investigating such complaints.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;<u>Components</u>. Patheon will purchase and test all Components (with the exception of Indivior-Supplied Components) at Patheon's expense and as required by the Specifications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;<u>Stability Testing</u>. Patheon will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Indivior in the form of a signed amendment to the applicable Product Agreement. If a confirmed stability test failure occurs, Patheon will notify Indivior within one Business Day, after which Patheon and Indivior will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure; including which party will bear the cost of the investigation. If the failure is caused in part by Patheon and in part by Indivior, then the cost of the investigation shall be allocated in an equitable manner between the parties. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance with the terms of this Agreement, the Specifications, cGMPs and/or any other Applicable Laws. Within a reasonable time period following completion of the tests, Patheon will send Indivior all stability test data and results at Indivior's request and at Patheon's cost.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;<u>Packaging and Artwork</u>. Patheon will package the Products in accordance with the Specifications. Indivior will be responsible for the cost of artwork development. Patheon will determine and imprint the batch numbers and expiration dates for each Product shipped. The batch numbers and expiration dates will be affixed on the Products and on the shipping carton of each Product as outlined in the Specifications and as required by cGMPs. Indivior may, in its sole discretion, make changes to labels, Product inserts, and other packaging for the Products. Those changes will be submitted by Indivior to all applicable Regulatory Authorities and other third parties responsible for the approval of the Products. Indivior will be responsible for the cost of labelling obsolescence when changes occur, as contemplated in Section 4.4. Patheon's name will not appear on the label or anywhere else on the Products unless: (i) required by any Laws; or (ii) Patheon consents in writing to the use of its name. At least 120 days prior to the Delivery Date of Product for which new or modified artwork is required, Indivior will provide at no cost to Patheon, final camera-ready artwork for all packaging Components to be used in the manufacture of the Product that meet the Specifications. For the avoidance of doubt, the parties acknowledge and agree that Indivior will be responsible for complying with any and all regulatory requirements for the labeling of the Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f) &nbsp;&nbsp;&nbsp;&nbsp;<u>API and Indivior-Supplied Components</u>. Indivior, at its cost, must deliver the API and any Indivior-Supplied Components to the Manufacturing Site DDP (Incoterms 2010) at least 30 days (unless otherwise agreed in writing) before the scheduled manufacture date for Product covered by a Firm Order in sufficient quantity to enable Patheon to manufacture the agreed quantities of Product and to ship Product on the Delivery Date. Notwithstanding the foregoing or any terms to the contrary, legal title of the API and Indivior-Supplied Components shall remain with Indivior after delivery to Patheon. Patheon will control the unloading of API and Indivior-Supplied Components arriving at the Manufacturing Site and Indivior will comply and use commercially reasonable efforts to ensure that its carrier complies with all reasonable related directions of Patheon. If Indivior fails to deliver the API or Indivior-Supplied Components in accordance with the 30 day (or otherwise agreed in writing) time period and, making commercially reasonable efforts, Patheon is unable to manufacture Product on the scheduled date because of the delay, the Firm Orders will be considered cancelled by Indivior and Indivior will pay Patheon for the Conversion Fee associated with the cancelled Firm Order. Upon the occurrence of the foregoing, Patheon will reschedule manufacture under a replacement Firm Order at Indivior's request, subject to Patheon's manufacturing slot availability at the time of the request. Indivior will ensure that: (i) all delivered API meets the specifications for that API; and (ii) all shipments of API are accompanied by the required documentation as specified in the applicable Quality Agreement. For API or Indivior-Supplied Components which may be subject to import or export to or from the United States, Indivior agrees that its vendors and carriers will comply with applicable requirements of the U.S. Customs and Border Protection Service and the Customs Trade Partnership Against Terrorism ("**C-TPAT**"). Patheon shall ensure that all personnel involved in the manufacture of the Products are suitably trained for the handling of APIs and Indivior-Supplied Components used in the Products. Upon delivery, if applicable, Patheon will test each batch of API delivered in accordance with testing procedures and agreed by both parties to reasonably determine its conformance with the API Specifications. Patheon

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shall promptly notify Indivior in writing if the outcome of such test shows the API to be not in compliance with the API Specifications. If Indivior agrees with the non-conformity of the API, Indivior shall replace it without further costs to Patheon. If Indivior disagrees that the API is non-compliant, Indivior reserves the right to retest the API or have the API retested by an independent lab mutually agreed by both parties. The costs associated with the retesting of the API shall be carried by Patheon if the API retests as conforming, and by Indivior if the API retests as non-conforming. Patheon agrees that it shall use the API solely in accordance with the terms of this Agreement. Patheon agrees that it shall not, except as specifically authorized in this Agreement or in writing by Indivior; (a) copy or modify the API; (b) use the Indivior supplied API to develop, create, test, manufacture or distribute any product, system, ingredient, component or other article other than the Product ("Derivative Product"); (c) use the knowledge or information that it obtains from the performance of the Manufacturing Services to develop, create, test, manufacture, or distribute any Derivative Product for itself or any third party; (d) include the Indivior supplied API in any Derivative Product; (e) reverse engineer or otherwise attempt to analyze the API or its compatibility with any other material or system; (f) disclose to any third party any information concerning the Manufacturing Services, including without limitation, formulae, Specifications, analytical test methods/results, and/or compatibility with manufacturing equipment or other systems.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;<u>Validation Activities (if applicable)</u>. Patheon may assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products. The fees for this service are not included in the Price and will be set out separately in Schedule C to a Product Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h)&nbsp;&nbsp;&nbsp;&nbsp;<u>Additional Services</u>. If Indivior requests services other than those expressly set forth herein or in any Product Agreement (such as qualification of a new packaging configuration or shipping studies, or validation of alternative batch sizes), Patheon will provide a good faith and reasonable written quote of the fee for the additional services and Indivior will advise Patheon whether it wishes to have the additional services performed by Patheon. The scope of work and fees will be set forth in a separate agreement signed by the parties. The terms and conditions of this Agreement will apply to those services.

**2.2 <u>Active Material Yield</u>.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Reporting</u>. Patheon will give Indivior a monthly inventory report of the Active Materials held by Patheon using the inventory report form set out in Exhibit B, which will contain the following information for the month:

**Quantity Received:** The total quantity of Active Materials that complies with the Specifications and is received at the Manufacturing Site during the applicable period.

**Quantity Dispensed:** The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less the inventory of Active Materials that complies with the Specifications held at the end of the period. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of Products, including Active Materials lost in the warehouse prior to and during dispensing, and will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and (iv) Active Materials received or dispensed in technical transfer activities or development activities during the applicable period, including without limitation, any regulatory, stability, validation or test batches manufactured during the applicable period.

**Quantity Converted:** The total amount of Active Materials contained in the Products manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or6.3(b)), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1or 6.2 because of Patheon's failure to perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws.

Within 60 days after the end of each Year, Patheon will prepare an annual reconciliation of Active Materials on the reconciliation report form set forth in Exhibit C including the calculation of the "**Actual Annual Yield**"

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or "**AAY**" for the Product at the Manufacturing Site during the Year. AAY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows: [\*\*\*]

After Patheon has produced a minimum of [\*\*\*] successful commercial production batches of Product and has produced commercial production batches for at least [\*\*\*] months at the Manufacturing Site (collectively, the "**Target Yield Determination Batches**"), the parties will agree on the target yield for the Product at the Manufacturing Site (each, a "**Target Yield**"). The Target Yield will be revised annually to reflect the actual manufacturing experience as agreed to by the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Shortfall Calculation</u>. If the Actual Annual Yield falls more than [\*\*\*]% below the respective Target Yield in a Year, then the shortfall for the Year (the "**Shortfall**") will be calculated as follows: [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;<u>Surplus Calculation</u>. If the Actual Annual Yield is more than the respective Target Yield in a Year, then the surplus for that Year (the "**Surplus**") will be determined based on the following calculation: [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;<u>Credits</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;<u>Shortfall Credit</u>. If there is a Shortfall for a Product in a Year, then Patheon will credit Indivior's account for the amount of the Shortfall not later than 60 days after the end of each Year.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;<u>Surplus Credit</u>. If there is a Surplus for a Product in a Year, then Patheon will be entitled to apply the amount of the Surplus as a credit against any Shortfall for that Product which may occur in the next Year. If there is no Shortfall in the next Year the Surplus credit will expire.

Each credit under this Section 2.2 will be summarized on the reconciliation report prepared in the form set forth in Exhibit C. Upon expiration or termination of a Product Agreement, any remaining Shortfall credit amount owing under this Section 2.2 will be paid to Indivior.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;<u>Maximum Credit</u>. Patheon's liability for Active Materials calculated in accordance with this Section 2.2 for any Product in a Year will not exceed, in the aggregate, the Maximum Credit Value set forth in Schedule D to a Product Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;<u>No Material Breach</u>. It will not be a material breach of this Agreement by Patheon under Section 8.2(a) if the Actual Annual Yield is less than the Target Yield.

**ARTICLE 3**

**<u>INDIVIOR'S OBLIGATIONS</u>**

**3.1 <u>Payment</u>**.

Indivior will pay Patheon for performing the Manufacturing Services according to the Prices specified in Schedules B and C to a Product Agreement. These Prices may be subject to adjustment under other parts of this Agreement. Patheon will remit invoices to the address indicated on the Agreement.

**3.2 <u>Active Materials and Qualification of Additional Sources of Supply</u>.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Indivior will at its sole cost and expense deliver the Active Materials to Patheon in accordance with Section 2.1(f). If applicable, Patheon and Indivior will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Indivior's obligation will include obtaining the proper release of the Active Materials from the applicable Customs Agency and Regulatory Authority. Indivior or Indivior's designated broker will be the "**Importer of Record**" for Active Materials imported to the Manufacturing Site. The Active Materials will be held by Patheon on behalf of Indivior as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Indivior. Any Active Materials received by Patheon will only be used by Patheon to perform the Manufacturing Services. Indivior will be responsible for paying

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for all rejected Product that arises from defects in the Active Materials which could not be reasonably discoverable by Patheon using the test methods set forth in the Specifications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;If Indivior asks Patheon to qualify an additional source for the Active Material or any Component, Patheon may agree to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will agree on the scope of work to be performed by Patheon at Indivior's cost. For an Active Material, this work at a minimum will include: (i) laboratory testing to confirm the Active Material meets existing Specifications; (ii) manufacture of an experimental batch of Product that will be placed on three months accelerated stability; and (iii) manufacture of three full-scale validation batches that will be placed on concurrent stability (one batch may be the registration batch if manufactured at full scale). Section 6.1(d) will apply to all Products manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Patheon will promptly advise Indivior if it encounters supply problems, including delays and/or delivery of non-conforming Active Material or Components from an Indivior designated additional source. Patheon and Indivior will cooperate to reduce or eliminate any supply problems from these additional sources of supply. Indivior will be obligated to certify all Indivior designated sources of supply on an annual basis at its expense and will provide Patheon with copies of these annual certifications. If Patheon agrees to certify a Indivior designated additional sources of supply on behalf of Indivior, it will do so at Indivior's expense.

**ARTICLE 4**

**<u>FEES AND COMPONENT COSTS</u>**

**4.1 <u>Pricing</u>**.

The Price will be listed in Schedules B and C to a Product Agreement and will be subject to the adjustments set forth in Sections 4.2 and4.3. The Price may also be increased or decreased by Patheon if there are changes to the underlying manufacturing, packaging or testing assumptions set forth in Schedule B to the Product Agreement that result in an increase or decrease in the cost of performing the Manufacturing Services. Such changes in Price will be included in an amendment to the Product Agreement that is signed by both parties, the execution of which shall not be unreasonably withheld, conditioned, or delayed.

**4.2 &nbsp;&nbsp;&nbsp;&nbsp;<u>Price Adjustments – Subsequent Years' Pricing</u>**.

After the first Year of the Product Agreement, Patheon may adjust the Price effective January 1<sup>st</sup> of each Year as follows, and such adjusted Price shall be reflected in a fully executed amendment to this Agreement or the applicable Product Agreement(s):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Manufacturing and Stability Testing Costs</u>. For Products manufactured in the United States or Puerto Rico, Patheon may adjust the conversion component of the Price and the annual stability testing costs for inflation, based upon the preliminary number for any increase in the Producer Price Index pcu325412325412 for Pharmaceutical Preparation Manufacturing ("**PPI**") published by the United States Department of Labor, Bureau of Labor Statistics in June of the preceding Year compared to the final number for the same month of the Year prior to that (based on the average of the monthly changes over the 12-month period), unless the parties otherwise agree in writing. Patheon will give Indivior a statement setting forth the calculation for the inflation adjustment to be applied in calculating the Price for the next Year. For Products manufactured outside the United States or Puerto Rico, Patheon may similarly adjust the Price for inflation using an inflation index to be agreed by the parties in a Product Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Component Costs</u>. If Patheon incurs an increase or realizes a decrease in Component costs during the Year, it may increase (in the event of a Component cost increase) and shall decrease (in the event of a Component cost decrease) the Price for the next Year to pass through the additional Component costs or savings (as applicable). Patheon will give Indivior information about the increase or decrease in Component costs which will be applied to the calculation of the Price for the next Year to reasonably demonstrate that the Price adjustment is justified. In the event of an increase, the pass through of the additional Component

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costs to Indivior will be such that it matches Patheon's cost. In the event of a decrease, Patheon and Indivior will equally share the benefit of such savings

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;<u>Pricing Basis</u>. Indivior acknowledges that the Price in any Year is quoted based upon the Minimum Order Quantity and the Annual Volume specified in Schedule B to a Product Agreement. The Price is subject to change if the specified Minimum Order Quantity changes or if the Annual Volume is not ordered in a Year. For greater certainty, if Patheon and Indivior agree that the Minimum Order Quantity will be reduced or the Annual Volume in the lowest tier will not be ordered in a Year, then Patheon may increase the Price by an amount sufficient to absorb its documented increase in actual costs that result directly from the reduced Minimum Order Quantity or decrease in Annual Volume. Patheon will give Indivior a statement setting forth the information to be applied in calculating those cost increases for the next Year.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;<u>Adjustments Due to Currency Fluctuations</u>. If the parties agree in a Product Agreement to invoice in a currency other than the local currency for the Manufacturing Site, Patheon will adjust the Price to reflect currency fluctuations. The adjustment will be calculated after all other annual Price adjustments under this Section 4.2 have been made. The adjustment will proportionately reflect the increase or decrease, if any, in the Set Exchange Rate compared to the Set Exchange Rate established for the prior Year or the Initial Set Exchange Rate, as the case may be. An example of the calculation of the Price adjustment (for a Canadian Manufacturing Site invoiced in USD) is set forth in Exhibit D.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;<u>Tier Pricing (if applicable)</u>. The pricing in Schedule B to a Product Agreement is set forth in Annual Volume tiers based upon Indivior's volume forecasts under Section 5.1. Indivior will be invoiced during the Year for the unit price set forth in the Annual Volume tier based on the 12 months forecast provided in September of the previous Year. Within 30 days after the end of each Year or of the termination of the Product Agreement, Patheon will send Indivior a reconciliation of the actual volume of Product ordered by Indivior during the Year with the pricing tiers. If Indivior has overpaid during the Year, Patheon will issue a credit to Indivior for the amount of the overpayment within 60 days after the end of the Year or will issue payment to Indivior for the overpayment within 60 days after the termination of the Agreement. If Indivior has underpaid during the Year, Patheon will issue an invoice to Indivior under Section 5.5 for the amount of the underpayment within 60 days after the end of the Year or termination of the Agreement. If Indivior disagrees with the reconciliation, the parties will work in good faith to resolve the disagreement amicably. If the parties are unable to resolve the disagreement within 30 days, the matter will be handled under Section 12.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;For all Price adjustments under this Section 4.2, Patheon will deliver to Indivior on or about October 1, but no later than December 1 of each Year, a revised Schedule B to the Product Agreement, inclusive of all changes, to be effective for Product delivered on or after the first day of the next Year. The cumulative impact of all Price adjustments under this Section 4.2 are limited to [\*\*\*]% of the then-current Price. The revised Schedule B shall include budgetary pricing information, adjusted Component costs, and other documentation reasonably sufficient to demonstrate that a Price adjustment is justified. If in any Year Patheon would have been entitled to increase the Price based on any of the provisions of this Section 4.2 but Patheon did not exercise its right to do so, then at the expiry of any subsequent Year, Patheon will be entitled to make cumulative prospective adjustments as set out in Section 4.2 based on changes during all of the preceding Years since Patheon last adjusted the Price. Patheon will not be entitled to retrospectively invoice for prior unexercised Price adjustments.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.2.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Price Adjustment due to Volume Changes from Yearly Forecast Volumes for Sterile Products</u>**.

On the execution of a Product Agreement for a sterile Product, Indivior will give to Patheon a forecast of the volume of Product required for the first two Years of the Product Agreement (the "**Yearly Forecast Volume**" or "**YFV**") that will become part of the Product Agreement. The terms of any Price Adjustments that may be required due to volume changes between the Yearly Forecast Volumes and the aggregate actual volume of Product ordered by Indivior during the Year and invoiced by Patheon under Section 5.5. ("**Actual Yearly Volume"** or "**AYV**") shall be negotiated by the parties and set forth in the individual Product Agreement.

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**4.3 <u>Price Adjustments – Current Year Pricing</u>**.

During any Year, the Prices set out in Schedule B to a Product Agreement will be adjusted as follows:

<u>Extraordinary Increases in Component Costs</u>. If, at any time, market conditions result in Patheon's cost of Components being materially greater than normal forecasted increases, then Patheon will be entitled to adjust the Price for any affected Product to compensate it for the increased Component costs. Changes materially greater than normal forecasted increases will have occurred if: (i) the cost of a Component increases by [\*\*\*]% of the cost for that Component upon which the most recent Price or fee quote was based; or (ii) the aggregate cost for all Components required to manufacture a Product increases by [\*\*\*]% of the total Component costs for the Product upon which the most recent fee quote was based. If Component costs have been previously adjusted to reflect an increase in the cost of one or more Components, the adjustments set out in (i) and (ii) above will operate based on the last cost adjustment for the Components.

For a Price adjustment under this Section 4.3, Patheon will deliver to Indivior a revised Schedule B to the Product Agreement and budgetary pricing information, adjusted Component costs or other documents reasonably sufficient to demonstrate that a Price adjustment is justified. Patheon will have no obligation to deliver any supporting documents that are subject to obligations of confidentiality between Patheon and its suppliers. The revised Price will be effective for any Product delivered on or after the first day of the month following Indivior's receipt of the revised Schedule B to the Product Agreement.

**4.4 <u>Adjustments Due to Technical Changes or Regulatory Authority Requirements</u>**.

Amendments to the Specifications or the Quality Agreement requested by Indivior will be implemented only following a technical and cost review that Patheon will perform at Indivior's cost and are subject to Indivior and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Indivior, the approval not to be unreasonably withheld, conditioned or delayed. If Indivior accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented at Indivior's cost, and the Price change will become effective, only for those orders of Product that are manufactured under the revised Specifications. In addition, Indivior agrees to purchase, at the price paid by Patheon (including all reasonable costs incurred by Patheon for the purchase, handling, and transport of the Inventory), all Inventory held under the "old" Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.1, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.1 will be cancelled where possible, but if the orders may not be cancelled without penalty, they will be assigned to and paid for by Indivior. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements or changes in Applicable Laws which apply to the Manufacturing Services.

**4.5 <u>Multi-Country Packaging Requirements</u>.**

If Indivior decides to have Patheon perform Manufacturing Services for the Product for countries outside the Territory, then Indivior will inform Patheon of the packaging requirements for each new country and Patheon will prepare a quotation for consideration by Indivior of any additional costs for Components (other than Indivior-Supplied Components) and the change-over fees for the Product destined for each new country. The agreed additional packaging requirements and related packaging costs and change over fees will be set out in a written amendment to this Agreement that is signed by both parties.

**ARTICLE 5**

**<u>ORDERS, SHIPMENT, INVOICING, PAYMENT</u>**

**5.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Orders and Forecasts</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Long Term Forecast</u>. When each Product Agreement is executed, Indivior will use commercially reasonable efforts to give Patheon a non-binding forecast of up to three years of Indivior's volume requirements for the

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Product for each Year during the term of the Product Agreement (the "**Long Term Forecast**"). The Long Term Forecast will thereafter be updated every twelve months (as of June 1 and December 1) during the Product Term. If Patheon is unable to accommodate any portion of the Long Term Forecast, it will promptly notify Indivior and the parties will agree on any revisions to the forecast

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Rolling 12 Month Forecast</u>. When each Product Agreement is executed, Indivior will give Patheon a non-binding 12 months forecast of the volume of Product that Indivior expects to order in the first 12 months of commercial manufacture of the Product. This forecast will then be updated by Indivior on or before the tenth day of each month on a rolling forward basis.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;<u>Firm Orders.</u> On a rolling basis during the term of the Product Agreement, Indivior will issue an updated 12 months forecast on or before the tenth day of each month. This forecast will start on the first day of the next month. Unless otherwise agreed in the Product Agreement, the first three months of this updated forecast will be considered binding Firm Orders. Concurrent with the 12 months forecast, Indivior will issue a new firm written order in the form of a purchase order or otherwise ("**Firm Order**") by Indivior to purchase and, when accepted by Patheon, for Patheon to manufacture and deliver the agreed quantity of the Products. The Delivery Date will not be less than 90 days from the first day of the month following the date that the Firm Order is submitted. Firm Orders submitted to Patheon will specify the Delivery Date, Indivior's purchase order number, quantities by Product type, monthly delivery schedule, and any other elements necessary to ensure the timely manufacture and shipment of the Products. The quantities of Products ordered in those written orders will be firm and binding on Indivior and may not be reduced by Indivior. Expedited Firm Orders (i.e., any orders that Patheon, upon Indivior's request, delivers earlier than the original agreed upon Delivery Date) will be subject to reasonable additional fees, as agreed to by the parties in the Product Agreement or in a signed amendment thereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;<u>Acceptance of Firm Order</u>. Patheon will accept Firm Orders by sending an acknowledgement to Indivior within five Business Days of its receipt of the Firm Order. The acknowledgement will include, subject to confirmation from Indivior, the Delivery Date for the Product ordered or delivery month for any Firm Orders that do not relate to the first three months of the 12 months forecast, provided that the Delivery Date shall not be later than 90 days from the first day of the month following the date that the Firm Order is submitted. The Delivery Date may be amended by agreement of the parties or as set forth in Section 2.1(f). If Patheon fails to acknowledge receipt of a Firm Order within the five Business Day period, the Firm Order will be deemed to have been accepted by Patheon.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;<u>Cancellation of a Firm Order</u>. If Indivior cancels a Firm Order more than two days after its acceptance by Patheon for any reason other than (i) a material breach of this Agreement or an applicable Product Agreement by Patheon or (ii) due to Indivior's failure to timely deliver API or other Indivior-Supplied Components, as set forth in Section 2.1(f), Indivior will pay Patheon 100% of the Price for the Firm Order.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;<u>Zero Volume Forecast</u>. If Indivior forecasts zero volume for twelve successive months period during the term of a Product Agreement (the "**Zero Forecast Period**"), then Patheon will have the option, at its sole discretion, to provide a 60 day notice to Indivior of Patheon's intention to terminate the Product Agreement on a stated day within the Zero Forecast Period. Indivior thereafter will have 60 days to either (i) withdraw the zero forecast and re-submit a reasonable volume forecast, or (ii) negotiate other terms and conditions on which the Product Agreement will remain in effect. Otherwise, Patheon will have the right to terminate the Product Agreement at the end of the 60 day notice period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;<u>Controlled Substance Quota Requirements (if applicable)</u>. Indivior will give Patheon the information set forth below for obtaining any required DEA or equivalent agency quotas needed to perform the Manufacturing Services. Patheon will be responsible for routine management of DEA quota information in accordance with DEA regulations. Patheon and Indivior will cooperate to communicate the information and to assist each other in DEA information requirements related to the Product as follows: (i) as of April 1 of each Year for the applicable Product, Indivior will provide to Patheon the next Year's annual quota requirements for the Product; (ii) as of August 1 of each Year, Indivior will provide to Patheon any changes to the next Year's quota requirements; (iii) Indivior will pro-actively communicate any changes to the quota requirements for the then-current Year in sufficient time to allow Patheon to file and finalize DEA filings supporting the changes; (iv) upon Patheon receiving the necessary forecast information from Indivior in order to request additional quota, Patheon will submit to the DEA, on a timely basis, all filings necessary to obtain DEA or equivalent agency quotas for Active Materials and will use commercially reasonable efforts to

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secure sufficient quota from the DEA so as to achieve Delivery Dates for Product as set forth in applicable purchase orders and forecasts submitted to Patheon by Indivior or its designee; and (v) Patheon will not be responsible for DEA's refusal or failure to grant sufficient quota for reasons beyond the reasonable control of Patheon.

**5.2 <u>Reliance by Patheon</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Indivior understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted under Sections 5.1(a), and (b) in ordering the Components (other than Indivior-Supplied Components) required to meet the Firm Orders. In addition, Indivior understands that to ensure an orderly supply of the Components***,*** Patheon may want to purchase the Components in sufficient volumes to meet the production requirements for Products during part or all of the forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and Indivior. Accordingly, Indivior authorizes Patheon to purchase Components to satisfy the Manufacturing Services requirements for Products for the first six months contemplated in the most recent forecast given by Indivior under Section 5.1(a). Patheon may make other purchases of Components to meet Manufacturing Services requirements for longer periods if agreed to in writing by the parties. Indivior will give Patheon written authorization to order Components for any launch quantities of Product requested by Indivior which will be considered a Firm Order when accepted by Patheon.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Indivior will reimburse Patheon for the cost of Components ordered by Patheon under Firm Orders or under Section 5.2(a) that are not included in finished Products manufactured for Indivior within six months after the forecasted month for which the purchases have been made (or for a longer period as the parties may agree) or if the Components have expired or are rendered obsolete due to changes in artwork or applicable regulations during the period (collectively, "**Obsolete Stock**"). This reimbursement will include Patheon's cost to purchase (plus a [\*\*\*]% handling fee) and destroy the Obsolete Stock. If any non-expired Components are used in Products subsequently manufactured for Indivior or in third party products manufactured by Patheon, Indivior will receive credit for any costs of those Components previously paid to Patheon by Indivior. Patheon will provide Indivior with a monthly report of Indivior Supplied Component inventory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;If within 30 days of receipt of written notice from Patheon, Indivior fails to take possession or arrange for the destruction of non-expired Components within 12 months of purchase or, in the case of the delivery of conforming finished Product accepted by Indivior but not yet shipped or otherwise taken possession of by Indivior within one month of manufacture), Indivior will pay Patheon $[\*\*\*] per pallet, per month thereafter for storing the Components or finished Product. Storage fees for Components or Product which contain controlled substances or require refrigeration will be charged at $[\*\*\*] per pallet per month. Storage fees are subject to a [\*\*\*] pallet minimum charge per month.

**5.3 <u>Minimum Orders</u>**.

Indivior may order Manufacturing Services for batches of Products only in multiples of the Minimum Order Quantities as set out in Schedule B to a Product Agreement.

**5.4 <u>Delivery and Shipping</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Delivery of Products will be made EXW (Incoterms 2010) Patheon's shipping point unless otherwise agreed in a Product Agreement. Subject to Section 8.3(a)(v), risk of loss or of damage to Products will remain with Patheon until Patheon loads the Products onto the carrier's vehicle for shipment at the shipping point at which time risk of loss or damage will transfer to Indivior. Patheon will, in accordance with Indivior's instructions and as agent for Indivior, at Indivior's risk, arrange for shipping to be paid by Indivior. Indivior will arrange for insurance and will select the freight carrier used by Patheon to ship Products and may monitor Patheon's shipping and freight practices as they pertain to this Agreement. Products will be transported in accordance with the Specifications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;For the purposes of this Agreement, delivery of the Products shall be effectuated on the last to occur of (i) the physical delivery of the Products to the Delivery Point; or (ii) Indivior's receipt of the certificate of analysis from Patheon confirming such Products meet the Specifications ("**Delivery**"). Unless otherwise

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agreed in writing, Patheon agrees that at the time of Delivery, all Products will have a minimum shelf life remaining of no less [\*\*\*]% of the then current shelf life as filed with the Regulatory Authority.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Patheon recognizes that late Delivery of the Products will have a significant impact on Indivior's obligations to its customers. Indivior requires as a condition of this Agreement deliveries to be on time. Accordingly, without prejudice to Indivior's other rights whether hereunder or at law, if Delivery of the quantity Products set forth in an accepted Firm Order does not occur within 7 calendar days of the Delivery Date ("**Late Delivery**") Indivior shall be entitled to deduct from the Price the portion of the Firm Order delivered as a Late-Delivery, or to claim from Patheon by way of liquidated damages for delay, in accordance with the following principles. Patheon agrees that these provisions are a reasonable estimate of Indivior's loss and shall not constitute a penalty.

---

| | |
|:---|:---|
| **Delay in delivery** | **% of Price deducted from the Late Delivery** |
| [\*\*\*] | [\*\*\*]% |
| [\*\*\*] | [\*\*\*]% |
| [\*\*\*] | [\*\*\*]% |
| [\*\*\*] | [\*\*\*]% |
| [\*\*\*] | [\*\*\*]% |

---

For clarity, a Late Delivery will not include any delay in shipment of Product caused by events outside of Patheon's reasonable control, such as a Force Majeure Event, a delay in delivery of API or Materials (provided that Patheon ordered Materials with sufficient lead time for such Materials to be delivered on a timely basis), a delay in Product release approval from Indivior, a quality investigation or OOS results which are not determined to be the fault of Patheon, inaccurate Indivior forecasts, or receipt of non-conforming API or Components supplied by Indivior.

The parties acknowledge that any claim under this clause 5.4(c) are without prejudice to any other claims made or to be made by Indivior arising out of such Late Delivery (including for breach), and shall not constitute any acceptance of such Late Delivery or nor a waiver of any possible claims resulting from such Late Delivery.

**5.5 <u>Invoices and Payment</u>**.

Invoices will be sent by email to the email address given by Indivior to Patheon in writing. Invoices will be issued upon Product Delivery. Patheon will also submit to Indivior, with each shipment of Products, a duplicate copy of the invoice covering the shipment. Patheon will also give Indivior an invoice covering any Inventory or Components which are to be purchased by Indivior under Section 2 of this Agreement. Each invoice will, to the extent applicable, identify Indivior's Manufacturing Services purchase order number, Product numbers, names and quantities, unit price, freight charges, the total amount to be paid by Indivior, Patheon's name and address, Indivior point of contact, Patheon point of contact, net terms of payment, and remittance address (where check is to be sent). Indivior will pay all undisputed invoices within 45 days of the date thereof. If any portion of an invoice is disputed, Indivior will pay Patheon for the undisputed amount and the parties will use good faith efforts to reconcile the disputed amount as soon as practicable. Undisputed amounts that remain past due more than 45 days after the original due date will accrue interest at [\*\*\*]% per month, not to exceed [\*\*\*]% annually.

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**ARTICLE 6**

**<u>PRODUCT CLAIMS AND RECALLS</u>**

**6.1 <u>Product Claims</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Product Claims</u>. Indivior has the right to reject any portion of any shipment of Product that was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, without invalidating any remainder of the shipment. Indivior will inspect the Product manufactured by Patheon upon receipt and will give Patheon written notice (a "**Deficiency Notice**") of all claims for Product that was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, within 30 days after Indivior's receipt thereof (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, within 30 days after discovery by Indivior, but not after the expiration date of the Product). If Indivior fails to give Patheon the Deficiency Notice within the applicable 30 day period, then the Delivery will be deemed to have been accepted by Indivior on the 30<sup>th</sup> day after Delivery or discovery, as applicable. Patheon will have no liability for any deficiency for which it has not received notice within the applicable 30 day period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Determination of Deficiency</u>. Upon receipt of a Deficiency Notice, Patheon will have ten days to advise Indivior by notice in writing that it disagrees with the contents of the Deficiency Notice. Patheon's failure to issue such written notice to Indivior shall constitute Patheon's agreement with Indivior's Deficiency Notice If Indivior and Patheon fail to agree within ten days after Patheon's notice to Indivior as to whether any Product identified in the Deficiency Notice was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, the parties will proceed as follows: (i) if the issue is believed to be caused by a raw material deficiency, laboratory error or a suspect analytical method, representatives from both parties will jointly test the Product and/or materials side by side in the same laboratory to determine if a raw material or testing deficiency is the root cause and whether the Product and/or materials is acceptable; or (ii) if the issue is believed to be process related, representatives from both parties will jointly evaluate the Patheon deviation report to determine if any other investigation could identify the root cause and proceed as determined. If, after the joint testing or investigation has been performed, the parties still cannot agree on the root cause, executives from both parties will meet and use good faith efforts to resolve the deficiency and liability issues. If the parties' executives are unable to resolve the dispute within 30 days, the dispute will be handled as a Technical Dispute under Section 12.2.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;<u>Shortages and Price Disputes</u>. Claims for shortages in the amount of Product shipped by Patheon or a Price dispute will be dealt with by reasonable agreement of the parties. Any claim for a shortage or a Price dispute will be deemed waived if it has not been presented within 30 days of the date of invoice.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;<u>Product Rejection for Finished Product Specification Failure</u>. Internal process specifications will be defined and agreed upon. If after a full investigation as set forth in Section 6.1(b), it is determined that Patheon manufactured Product in accordance with the agreed upon process Specifications, the batch production record, and Patheon's standard operating procedures for manufacturing, and a batch or portion of batch of Product does not meet a finished Product Specification, Indivior will pay Patheon the applicable fee per unit for the non-conforming Product. The API in the non-conforming Product will be included in the "Quantity Converted" for purposes of calculating the "Actual Annual Yield" under Section 2.2(a).

**6.2 <u>Product Recalls and Returns</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Records and Notice</u>. Patheon and Indivior will each maintain records necessary to permit a Recall of any Product delivered to Indivior or customers of Indivior. Specifically, Patheon shall establish and maintain a batch-tracking process to enable it to identify and procure the Recall (if necessary) of Products which may be affected in any way by manufacturing and production problems. Patheon shall supply details to Indivior of its batch-tracking process upon request to do so. Each party will promptly notify the other by telephone (to be confirmed in writing) of any information which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall or seizure of the Product. Upon receiving this notice or upon this discovery, each party will stop making any further shipments of any Product in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action, if any, will be made and implemented by Indivior. All coordination of any Recall involving a Product shall be handled by Indivior. "**Recall**" will mean

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any action (i) by Indivior to recover title to or possession of quantities of the Product sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Product from the market); or (ii) by any regulatory authorities to detain or destroy any of the Product. Recall will also include any action by either party to refrain from selling or shipping quantities of the Product to third parties which would be subject to a Recall if sold or shipped.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Recalls</u>. If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Indivior determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Indivior, having regard to all applicable laws and regulations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;<u>Product Returns</u>. Indivior will have the responsibility for handling customer returns of the Product. Patheon will give Indivior any assistance that Indivior may reasonably require to handle the returns.

**6.3 <u>Patheon's Responsibility for Defective and Recalled Products</u>.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Defective Product</u>. If Indivior rejects Product under Section 6.1 and the deficiency is determined to have arisen from Patheon's failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs or Applicable Laws, Patheon will credit Indivior's account for Patheon's invoice price for the defective Product. If Indivior previously paid for the defective Product, Patheon will promptly, at Indivior's election, either: (i) refund the invoice price for the defective Product; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Product with conforming Product, (if Patheon is able to manufacture the replacement Product at the same Manufacturing Site as that of the rejected Product), without Indivior being liable for payment therefor under Section 3.1, contingent upon the receipt from Indivior of all Active Materials and Indivior-Supplied Components required for the manufacture of the replacement Product. For greater certainty, Patheon's responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Recalled Product</u>. If a Recall or return results from, or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance with this Agreement, the Specifications, cGMPs, or Applicable Laws, Patheon will be responsible for the documented out-of-pocket expenses of the Recall or return, including, without limitation, reasonable documented costs and expenses relating to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of Recalled Product from customers and shipment of an equal amount of replacement Product to those same customers. Patheon will use its commercially reasonable efforts to replace the Recalled or returned Products with new Products, contingent upon the receipt from Indivior of all Active Materials and Indivior-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon's responsibility for any loss of Active Materials in Recalled Product will be captured and calculated in the Active Materials Yield under Section 2.2. If Patheon is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the required Active Materials and Indivior-Supplied Components), then, in addition to any other remedies Indivior may have at law or in equity, at Indivior' request, Patheon shall reimburse Indivior for the price that Indivior paid to Patheon for Manufacturing Services for the affected Products. In all other circumstances, Recalls, returns, or other corrective actions will be made at Indivior's cost and expense; provided, however, that if a Recall is in part the responsibility of Patheon and in part the responsibility of Indivior, the costs and expenses associated with the Recall shall be allocated in an equitable manner between the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Except as set forth in Sections 6.3(a) and (b) above and Sections 6.4, 6.5, and 10.3 below, Patheon will not be liable to Indivior nor have any responsibility to Indivior for any Deficiencies in, or other liabilities associated with, any Product manufactured by it, (collectively, "**Product Claims**"). For greater certainty but not limitation, Patheon will have no obligation for any Product Claims to the extent the Product Claim (i) is caused by Deficiencies in the Specifications that relate to the safety, efficacy, or marketability of the Product or any distribution thereof, (ii) results from a defect in a Component that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications prior to use of the applicable Component in the performance of the Manufacturing Services, (iii) results from a defect in the Active Materials, Indivior-Supplied Components or Components supplied by a Indivior designated additional source that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications, (iv) is caused by actions of Indivior or third parties occurring after the Product is shipped by Patheon under Section 5.4, (v) is

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due to packaging design or labelling defects or omissions for which Patheon has no responsibility, (vi) is due to any unascertainable reason despite Patheon having performed the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws, or (vii) is due to any other breach by Indivior of its obligations under this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding anything to the contrary in this Agreement, Patheon will only be required to replace or refund any batch or portion of a batch of Recalled Product and will only be liable for Active Material contained therein to the extent the Product is unsold, returned, destroyed or otherwise disposed of by Indivior in accordance with the terms of this Agreement. The quantity of API contained in this Product will be included in the Quantity Dispensed but not in the Quantity Converted for purposes of calculating the Shortfall in Section 2.2(b).

**6.4 <u>Disposition of Defective or Recalled Products</u>**.

Indivior will not dispose of any damaged, defective, returned, or Recalled Products for which it intends to assert a claim against Patheon without Patheon's prior written authorization to do so. Alternatively, Patheon may instruct Indivior to return the Products to Patheon. Patheon will bear the cost of disposition for any damaged, defective, returned or Recalled Products for which it bears responsibility under Section 6.3. In all other circumstances, Indivior will bear the cost of disposition, including all applicable fees for Manufacturing Services, for any damaged, defective, returned, or Recalled Products.

**6.5 <u>Healthcare Provider or Patient Questions and Complaints</u>**.

Indivior will have the sole responsibility for responding to questions and complaints from its customers. Questions or complaints received by Patheon from Indivior's customers, healthcare providers or patients will be promptly referred to Indivior. Patheon will co-operate as reasonably required to allow Indivior to determine the cause of and resolve any questions and complaints. This assistance will include follow-up investigations, including testing. In addition, Patheon will give Indivior all agreed upon information that will enable Indivior to respond properly to questions or complaints about the Product as set forth in the Quality Agreement. Unless it is determined that the cause of the complaint resulted from a failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws, all costs incurred under this Section 6.5 will be borne by Indivior.

**6.6 <u>Sole Remedy</u>**.

Except for the indemnity set forth in Section 10.3 and subject to the limitations set forth in Sections 10.1 and 10.2, the remedies described in this Article 6 will be Indivior's sole remedy in contract, tort, equity or otherwise for any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws.

**ARTICLE 7**

**<u>CO-OPERATION</u>**

**7.1 <u>Quarterly Review</u>**.

Each party will forthwith upon execution of this Agreement appoint one of its employees to be a relationship manager responsible for liaison between the parties. The relationship managers will meet not less than quarterly to review the current status of the business relationship and manage any issues that have arisen.

**7.2 <u>Governmental Agencies</u>**.

Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting Regulatory Approval for the Products, regarding the Products if, in the opinion of that party's counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

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**7.3 <u>Records and Accounting by Patheon</u>**.

Patheon will keep records of the manufacture, testing, and shipping of the Products, and retain samples of the Products as are necessary to comply with manufacturing regulatory requirements applicable to Patheon, as well as to assist with resolving Product complaints and other similar investigations. Unless otherwise agreed to in the Quality Agreement, copies of the records and samples will be retained for ten years after the last Delivery of Products under this Agreement or as otherwise required under cGMP or Applicable Laws. Such records and books shall, in so far as they are applicable, be maintained in accordance with cGMP and Applicable Laws. Patheon reserves the right to destroy or return to Indivior, at Indivior's sole expense, any document or samples for which the retention period has expired if Indivior fails to arrange for destruction or return within 30 days of receipt of notice from Patheon. Indivior is responsible for retaining samples of the Products necessary to comply with the legal/regulatory requirements applicable to Indivior.

**7.4 <u>Inspection</u>**.

Indivior may inspect Patheon reports and records relating to this Agreement during normal business hours and with reasonable advance notice, but a Patheon representative must be present during the inspection.

**7.5 <u>Inspection; Record Maintenance; Access</u>**.

If reasonably required by Indivior, Patheon shall, promptly and at Indivior's cost, submit samples of the Products for Indivior's approval before the Products are delivered. Such samples shall be marked by Patheon for identification. The exercise by Indivior of its rights pursuant to the preceding sentence shall not prejudice Indivior's right to reject or revoke acceptance of, pursuant to the terms of any legislative or contractual rights or otherwise, any Products which are defective or which do not comply with the Specifications or the provisions of this Agreement. (b) Patheon will give Indivior or its authorized representatives reasonable access (such access to be limited to normal business hours unless immediate access is required by Applicable Law) to the areas of the Manufacturing Site in which the Products are manufactured, stored, handled, or shipped, as well as to Products, reference samples, manufacturing records, and books (including without limitation, records relating to manufacturing processes, work in progress, operating procedures, sampling records, testing, packaging procedures and compliance with environmental health and safety regulations), to permit Indivior to verify that the Manufacturing Services are being performed in accordance with the Specifications, cGMPs, this Agreement (including but not limited to Section 14) and Applicable Laws. Indivior shall be entitled to conduct such an audit (i) upon reasonable prior written notice, nor more often than once per Year, lasting no more than two days, and involving no more than two auditors; (ii) if Indivior receives notice from any Regulatory Authority, with respect to the manufacture or packaging of a Product, during the Term of this Agreement or within ten years after the last Delivery of the Product, whichever is later; or (iii) in the event of a breach, or Indivior's reasonable suspicion or anticipation of a breach, of this Agreement by Patheon; or (iv) following implementation by Patheon of a Corrective and Preventive Action ("**CAPA**") in response to a previous audit incident. Indivior may request additional cGMP-type audits, additional audit days, or the participation of additional auditors subject to payment to Patheon of a fee of $[\*\*\*] for each additional audit day and $[\*\*\*] per audit day for each additional auditor over [\*\*\*]. The right of access set forth in Sections 7.4 and 7.5 will not include a right to access or inspect Patheon's financial records except for invoices and related supporting documentation directly related to the Manufacturing Services. Patheon will support the first Product Approval Inspection ("**PAI**") of the FDA or equivalent regulatory inspection for other jurisdictions (where applicable) and provide a copy of the resulting report to Indivior at no cost. Additional PAI or equivalent support will be subject to additional fees.

**7.6 <u>Notification of Regulatory Inspections</u>**.

Patheon will notify Indivior within one Business Day of any inspections by any governmental agency specifically involving the Products. Patheon will also notify Indivior of receipt of any form 483s or warning letters or any other significant regulatory action which Patheon's quality assurance group determines could impact the regulatory status of the Products.

**7.7 <u>Reports</u>**.

Upon request, Patheon will supply on an annual basis a copy of the Annual Product Review Report which includes all Product data in its control, including release test results, complaint test results, and all investigations (in manufacturing, testing, and storage), that Indivior reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that Indivior is required to file with the FDA. Any additional data or report requested by Indivior beyond the scope of cGMPs and customary FDA requirements, including Continuous Process Verification data, will be subject to an additional fee to be agreed upon between Patheon and Indivior.

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**7.8 Regulatory Filings**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Regulatory Authority</u>. Indivior will have the sole responsibility at Indivior's expense for filing all documents with all Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Regulatory Authority approval for the commercial manufacture, distribution and sale of the Products ("**Regulatory Approval**") and will provide copies thereof to Patheon on request. Patheon will assist Indivior, to the extent consistent with Patheon's obligations under this Agreement, to obtain Regulatory Approval for the commercial manufacture, distribution and sale of all Products as quickly as reasonably possible.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Verification of Data</u>. Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Indivior will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon requires 21 days to perform this review but the parties may agree to a shorter time for the review as needed.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;<u>Verification of CTD</u>. Prior to filing with any Regulatory Authority any documentation which is or is equivalent to the Quality Module (Drug Product Section) of the Common Technical Document (all such documentation herein referred to as "**CTD**") related to any Marketing Authorization, such as a US New Drug Application, US Abbreviated New Drug Application, US Biologics Licence Application, or EU Marketing Authorisation Application, Indivior will give Patheon a copy of the CTD as well as all supporting documents which have been relied upon to prepare the CTD. This disclosure will permit Patheon to verify that the CTD accurately describes the validation or scale-up work that Patheon has performed and the manufacturing processes that Patheon will perform under this Agreement. Patheon requires 21 days to perform this review but the parties may agree to a shorter time for the review as needed. Indivior will give Patheon copies of all relevant filings at the time of submission which contain CTD information regarding the Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;<u>Deficiencies</u>. If, in Patheon's sole discretion, acting reasonably, Patheon determines that any of the information given by Indivior under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the "**Deficiencies**"), Patheon will notify Indivior promptly in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to any pre-approval inspection.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;<u>Indivior Responsibility</u>. In reviewing the documents referred to in clause (b) above, Patheon's role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. Indivior is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by Indivior.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;<u>Inspection by Regulatory Authorities</u>. If Indivior does not give Patheon the documents requested under subsections (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon's standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;<u>Pharmacovigilance.</u> Indivior will be responsible, at its expense, for all pharmacovigilance obligations for the Products pursuant to Applicable Laws. Unless required by Applicable Law, neither party will be obliged to exchange with the other party any information or data which it compiles pursuant to pharmacovigilance obligations or activities.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h)&nbsp;&nbsp;&nbsp;&nbsp;<u>No Patheon Responsibility</u>. Patheon will not assume any responsibility for the accuracy or cost of any application for Regulatory Approval. If a Regulatory Authority, or other governmental body, requires Patheon to incur fees, costs or activities in relation to the Products which Patheon considers unexpected and extraordinary, then Patheon will notify Indivior in writing within two Business Days and the parties will discuss in good faith appropriate mutually acceptable actions, including fee/cost sharing, or termination of all or any part of this Agreement. Patheon will be not be obliged to undertake these activities or to pay for the fees or costs if, in Patheon's sole discretion, doing so is commercially inadvisable for Patheon.

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**ARTICLE 8**

**<u>TERM AND TERMINATION</u>**

**8.1 <u>Term</u>**.

This Agreement will become effective as of the Effective Date and will continue until December 31, 2022 (the "**Term**"), unless terminated earlier by one of the parties in accordance herewith; provided that if any Product Agreements are still in effect at the end of the Term, such Product Agreements shall continue until their completion or termination and the legal terms and conditions of this Agreement will continue to govern any Product Agreement in effect as provided in Section 1.2. Each Product Agreement will have a term agreed to by the parties in the Product Agreement.

**8.2 <u>Termination for Cause</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Either party at its sole option has the right to terminate this Agreement or a Product Agreement upon written notice where the other party has failed to remedy a material breach of any of its representations, warranties, or other obligations under this Agreement or the Product Agreement within 60 days following receipt of a written notice (the "**Remediation Period**") of the breach from the aggrieved party that expressly states that it is a notice under this Section 8.2(a) (a "**Breach Notice**"). The aggrieved party's right to terminate this Agreement or a Product Agreement under this Section 8.2(a) may only be exercised for a period of 60 days following the expiry of the Remediation Period (where the breach has not been remedied) and if the termination right is not exercised during this period then the aggrieved party will be deemed to have waived the breach of the representation, warranty, or obligation described in the Breach Notice.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Either party at its sole option has the right to immediately terminate this Agreement or a Product Agreement upon written notice, but without prior advance notice, to the other party if: (i) the other party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by the other party; or (iii) this Agreement or a Product Agreement is assigned by the other party for the benefit of creditors.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Indivior, at its sole option, has the right to terminate this Agreement or a Product Agreement immediately upon written notice, but without prior advance notice, to Patheon upon Patheon's breach of Section 9.3(d).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;Indivior may terminate a Product Agreement upon 30 days' prior written notice if any Authority takes any action, or raises any objection, that prevents Indivior from importing, exporting, purchasing, or selling the Product. But if this occurs, Indivior must still fulfill all of its obligations under Section 8.3 below and under any Capital Equipment Agreement regarding the Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;Indivior may terminate a Product Agreement upon six months' prior written notice if it intends to no longer order Manufacturing Services for a Product due to the Product's discontinuance in the Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;Patheon may terminate this Agreement or a Product Agreement upon six months' prior written notice if Indivior assigns under Section 13.6 any of its rights under this Agreement or a Product Agreement to an assignee that, in the opinion of Patheon acting reasonably, is: (i) not a credit worthy substitute for Indivior; or (ii) a Patheon Competitor; or (iii) an entity with whom Patheon has had prior unsatisfactory business relations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;Without prejudice to any other remedy (or to Indivior's rights generally under this Agreement), if and to the extent that Patheon does not (i) supply or deliver the Products in accordance with the terms of the relevant Product Agreement or (ii) provide the Manufacturing Services in accordance with the terms of this Agreement, then, unless and to the extent such failure is caused by Indivior's breach of this Agreement or the applicable Product Agreement, Indivior, at its sole option, shall be entitled to treat such failure as a material breach of this Agreement and/or of the relevant Product Agreement, in which case Section 8.2(a) shall apply. Except as otherwise expressly set forth in any Product Agreement, the failure to meet any Metric set forth in a Product Agreement (each a "Missed Metric") is not a material breach for purposes of this Section 8.1(g). Each Missed Metric shall be addressed according to the requirements of Section 12.1. If, following the Remediation Period as set forth in clause 8.2(a), such material breach has not been remedied and Indivior exercises its option to terminate this Agreement and/or the applicable Product Agreement,

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Patheon shall promptly repay Indivior the Price (or any part of the Price) Indivior has paid for any non-conforming Products or Services.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h)&nbsp;&nbsp;&nbsp;&nbsp;Except as specified in Section 8.1, the termination of this Agreement shall automatically terminate all then-pending Product Agreements, but the termination of an individual Product Agreement will not affect this Agreement or any other Product Agreements where there has been no material breach of the other Product Agreements.

**8.3 <u>Obligations on Termination</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;If a Product Agreement is completed, expires, or is terminated in whole or in part for any reason, then:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;Indivior will take delivery of and pay for all undelivered Products that are manufactured and/or packaged in accordance with this Agreement under a Firm Order, at the Price in effect at the time the Firm Order was placed;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;Indivior will purchase, at Patheon's cost (including all costs incurred by Patheon for the purchase, handling, and processing of the Inventory), the Inventory applicable to the Products which was purchased, maintained or produced by Patheon in contemplation of filling Firm Orders or in accordance with Section 5.2;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;Indivior will satisfy the purchase price payable under Patheon's orders with suppliers of Components, if the orders were made by Patheon in reliance on Firm Orders or in accordance with Section 5.2;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)&nbsp;&nbsp;&nbsp;&nbsp;Indivior acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v)&nbsp;&nbsp;&nbsp;&nbsp;Indivior will make commercially reasonable efforts, at its own expense, to remove from the Manufacturing Site, within 60 days of receipt of written notice, all unused Active Material and Indivior-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Indivior, related to the Product Agreement and located at a Patheon Manufacturing Site or that is otherwise under Patheon's care and control ("**Indivior Property**"). The written notice shall detail the Indivior Property remaining on the Manufacturing Site. If Indivior fails to remove Indivior Property within such timeframe, Indivior will pay Patheon $[\*\*\*] per pallet, per month, [\*\*\*] pallet minimum (except that Indivior will pay $[\*\*\*] per pallet, per month, [\*\*\*] pallet minimum, for any of Indivior Property that contains controlled substances, requires refrigeration or other special storage requirements) thereafter for storing Indivior Property and will assume any third party storage charges invoiced to Patheon regarding Indivior Property. Patheon will invoice Indivior for the storage charges as set forth in Section 5 of this Agreement. If Indivior fails to remove Indivior Property within 30 days following the completion, termination, or expiration of the Product Agreement, Indivior will assume all risk of loss or damage to the stored Indivior Property and it will be Indivior's responsibility to have appropriate insurance coverage in place for this risk. If Indivior asks Patheon to destroy any Indivior Property, Indivior will be responsible for the cost of destruction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Upon termination of this Agreement or any Product Agreement for any reason, Patheon and Indivior will work together in good faith to discontinue any third party agreements used exclusively to support the Manufacturing Services under this Agreement or applicable Product Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Any completion, termination or expiration of this Agreement or a Product Agreement will not affect any outstanding obligations or payments due prior to the completion, termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement or a Product Agreement or any related Capital Equipment Agreement. For greater certainty, completion, termination or expiration of this Agreement or of a Product Agreement for any reason will not affect the obligations and responsibilities of the parties under Articles 6, 10, 11, 12, and 14, and Sections 5.3, 5.4, 7.5(ii), 8.3, 13.1, 13.2, 13.3, 13.9, 13.10, 13.11, 13.15, 13.16, and 13.17, all of which survive any completion, termination or expiration.

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**ARTICLE 9**

**<u>REPRESENTATIONS, WARRANTIES AND COVENANTS</u>**

**9.1 <u>Mutual Warranties</u>**.

Each party covenants, represents, and warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) &nbsp;&nbsp;&nbsp;&nbsp;it has the full right and authority to enter into this Agreement and that it is not aware of any impediment that would inhibit its ability to perform its obligations hereunder;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) &nbsp;&nbsp;&nbsp;&nbsp;it is duly authorized and is validly existing under the Laws of its jurisdiction of incorporation and has the corporate power and authority to own its assets and to conduct its businesses and to perform its obligations hereunder;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) &nbsp;&nbsp;&nbsp;&nbsp;the execution and delivery of this Agreement and the completion of the obligations contemplated therein have been duly approved by the appropriate persons within its organization and this Agreement constitutes legal, valid and binding obligations on each party, enforceable against each in accordance with the terms herein.

**9.2 <u>Indivior Warranties</u>**.

Indivior covenants, represents, and warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Non-Infringement</u>. To Indivior's knowledge:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;the Specifications for each of the Products are its or its Affiliate's property and that Indivior may lawfully disclose the Specifications to Patheon;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;any Indivior Intellectual Property, used by Patheon in performing the Manufacturing Services according to the Specifications (A) is Indivior's or its Affiliate's unencumbered property, (B) may be lawfully used as directed by Indivior, and (C) does not infringe and will not infringe any Third Party Rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;the use or other disposition of any Product by Patheon as may be required to perform its obligations under this Agreement or under any Product Agreement does not and will not infringe any Third Party Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)&nbsp;&nbsp;&nbsp;&nbsp;there are no actions or other legal proceedings involving Indivior that concerns the infringement of Third Party Rights related to any of the Specifications, or any of the Active Materials and the Components, or the sale, use, or other disposition of any Product made in accordance with the Specifications;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Quality and Compliance</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;the Specifications for all Products conform to all applicable cGMPs and Applicable Laws;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Indivior markets the Products, (ii) will be fit for the purpose intended, and (iii) will be safe for human consumption;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;on the date of shipment, the API will conform to the Specifications for the API that Indivior has given to Patheon and that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container.

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**9.3 <u>Patheon Warranties</u>**.

Patheon covenants, represents, and warrants that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws and in a professional manner, in accordance with the standard of care and diligence practiced by recognized organizations in performing the services of a similar nature;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon's or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not knowingly infringe and will not knowingly infringe any Third Party Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); an

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the Laws of the United States for conduct relating to the regulation of any drug product under the United States *Federal Food, Drug, and Cosmetic Act* (the "Act") or debarred pursuant to the Act or excluded from any United States federal health care program, including but not limited to Medicare or Medicaid ("Federal Health Care Program"). In addition, Patheon agrees to notify Indivior promptly if Patheon or any officer, director, employee, or subcontractor is debarred under the Act or excluded under a Federal Health Care Program during the Term of this Agreement or upon becoming aware that either Patheon or any officer, director, employee, or subcontractor is the subject of any federal investigation into criminal conduct relating to the development or approval of new drugs, provided such notification does not contravene Applicable Law.

**9.4 <u>Permits</u>**.

Indivior will be solely responsible for obtaining or maintaining, on a timely basis, any permits or other Regulatory Approvals for the Products or the Specifications excluding those set forth in Section 9.4(b) below, including, without limitation, all marketing and post-marketing approvals.

Patheon will maintain at all relevant times all governmental permits, licenses, approval, and authorities required to enable it to lawfully and properly perform the Manufacturing Services and to otherwise carry out and perform its obligations under this Agreement.

**9.5 <u>No Warranty</u>**.

**PATHEON MAKES NO WARRANTY OR CONDITION OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT. PATHEON MAKES NO WARRANTY OR CONDITION OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY WARRANTY OR CONDITION OF MERCHANTABILITY FOR THE PRODUCTS.**

**ARTICLE 10**

**<u>REMEDIES AND INDEMNITIES</u>**

**10.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Consequential and Other Damages</u>**.

Excluding the parties' indemnity obligations with respect to third party claims, breaches of confidentiality, or any instances of willful misconduct, under no circumstances whatsoever will either party be liable to the other in contract, tort, negligence, breach of statutory duty, or otherwise for (i) any (direct or indirect) loss of profits, of production, of anticipated savings, of business, or goodwill or (ii) any reliance damages, including but not limited to costs or expenditures incurred to evaluate the viability of entering into this Agreement or to prepare for performance under this Agreement or (iii) for any other liability, damage, costs, penalty, or expense of any kind incurred by the other party of an indirect or consequential nature, regardless of any notice of the possibility of these damages.

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**10.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Limitation of Liability</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Defective or Recalled Product</u>. Patheon's maximum aggregate liability to Indivior for any obligation to (i) refund, offset or replace any defective Product under Section 6.3(a) or (ii) replace any Recalled Products under Section 6.3(b), will not exceed [\*\*\*]% of the Price for the defective or Recalled Product as applicable. This Section 10.2(a) will not be subject to Section 10.2(c).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Active Materials</u>. Except as expressly set forth in Section 2.2, under no circumstances will Patheon be responsible for any loss or damage to the Active Materials. Patheon's maximum responsibility for loss or damage to the Active Materials will not exceed the Maximum Credit Value set forth in Schedule D to a Product Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;<u>Maximum Liability</u>. Excluding Patheon's indemnity obligations with respect to third party claims, breach of its confidentiality obligations, and any instance of gross negligence or willful misconduct, Patheon's maximum liability to Indivior under this Agreement or any Product Agreement for any other reason whatsoever, including, without limitation, any liability arising under Section 6.3(b) relating to the expense of a Recall or Product return, Section 2.2, or resulting from any and all breaches of its representations, warranties, or any other obligations under this Agreement or any Product Agreement will not exceed, on a per Product basis, [\*\*\*]% of amounts paid or payable by Indivior under the applicable Product Agreement during the Year in which the underlying event occurred that gave rise to the liability (e.g. the date of the incident or manufacture)..

**10.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Patheon Indemnity</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Patheon agrees to defend and indemnify Indivior, its affiliates, and each of their respective officers and employees, against all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties (other than Affiliates) for any claim of infringement or alleged infringement of any Third Party Rights in the course of Patheon's provision of the Manufacturing Services, or any portion thereof (excluding those claims for which Indivior has an indemnity obligation as set forth in Section 10.4(a) below), or any claim of personal injury or property damage to the extent that the injury or damage is the result of a breach of this Agreement by Patheon, including, without limitation, any representation or warranty contained herein, except to the extent that the losses, damages, costs, claims, demands, judgments, and liability are due to the negligence or wrongful act(s) of Indivior, its officers, employees, or Affiliates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;If a claim occurs, Indivior will: (i) promptly notify Patheon of the claim; (ii) use commercially reasonable efforts to mitigate the effects of the claim; (iii) reasonably cooperate with Patheon in the defense of the claim; and (iv) permit Patheon to control the defense and settlement of the claim, all at Patheon's cost and expense, provided that Patheon shall not make an admission of liability, agreement, compromise, or settlement of any claim or matter which would or might result in additional or continuing liability to or obligation of Indivior without Indivior's prior written consent.

**10.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Indivior Indemnity</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Indivior agrees to defend and indemnify Patheon, its officers and employees, against all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties (other than Affiliates) for any claim of infringement or alleged infringement of any Third Party Rights in the Products, or any portion thereof, or any claim of personal injury or property damage to the extent that the injury or damage is the result of a breach of this Agreement by Indivior, including, without limitation, any representation or warranty contained herein, except to the extent that the losses, damages, costs, claims, demands, judgments, and liability are due to the negligence or wrongful act(s) of Patheon, its officers, employees, or Affiliates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (b)&nbsp;&nbsp;&nbsp;&nbsp;If a claim occurs, Patheon will: (i) promptly notify Indivior of the claim; (ii) use commercially reasonable efforts to mitigate the effects of the claim; (iii) reasonably cooperate with Indivior in the defense of the claim; and (iv) permit Indivior to control the defense and settlement of the claim, all at Indivior's cost and expense, provided that Indivior shall not make an admission of liability, agreement, compromise, or settlement of any claim or matter which would or might result in additional or continuing liability to or obligation of Patheon without Patheon's prior written consent.

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**10.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Reasonable Allocation of Risk</u>**.

This Agreement (including, without limitation, this Article 10) is reasonable and creates a reasonable allocation of risk for the relative profits the parties each expect to derive from the Products. Patheon assumes only a limited degree of risk arising from the manufacture, distribution, and use of the Products because Indivior has developed and holds the marketing approval for the Products, Indivior requires Patheon to manufacture and label the Products strictly in accordance with the Specifications, and Indivior, not Patheon, is best positioned to inform and advise potential users about the circumstances and manner of use of the Products.

**ARTICLE 11**

**<u>CONFIDENTIALITY</u>**

**11.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Confidential Information</u>**.

"**Confidential Information**" means any information disclosed by the Disclosing Party to the Recipient (whether disclosed in oral, written, electronic or visual form) that is non-public, confidential, commercially sensitive, or proprietary including, without limitation, information relating to the Disclosing Party's patent and trademark applications, process designs, process models, drawings, plans, designs, data, databases and extracts therefrom, formulae, methods, know-how and other intellectual property, its Indiviors or Indivior confidential information, finances, marketing, products and processes and all price quotations, manufacturing or professional services proposals, information relating to composition, proprietary technology, and all other information relating to manufacturing capabilities and operations; the existence of this Agreement and the fact that Patheon is manufacturing the Products for Indivior; any potential future contract manufacturing arrangements on similar or alternate products; any information relating to Indivior Intellectual Property Rights; the Specifications; and the Technical Manual. In addition, all analyses, compilations, studies, reports or other documents prepared by any party's Representatives containing the Confidential Information will be considered Confidential Information. Samples or materials provided hereunder as well as any and all information derived from the approved analysis of the samples or materials will also constitute Confidential Information. For the purposes of this Article 11, a party or its Representative receiving Confidential Information under this Agreement is a "**Recipient**," and a party or its Representative disclosing Confidential Information under this Agreement is the **"Disclosing Party**."

**11.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Use of Confidential Information</u>**.

The Recipient will use the Confidential Information solely for the purpose of meeting its obligations under this Agreement. The Recipient will keep the Confidential Information strictly confidential and will not disclose the Confidential Information in any manner whatsoever, in whole or in part, other than to those of its Representatives who (i) have a need to know the Confidential Information for the purpose of this Agreement; (ii) have been advised of the confidential nature of the Confidential Information and (iii) have obligations of confidentiality and non-use to the Recipient no less restrictive than those of this Agreement. Recipient will protect the Confidential Information disclosed to it by using reasonable precautions to prevent the unauthorized disclosure, dissemination or use of the Confidential Information, which precautions will in no event be less than those exercised by Recipient with respect to its own confidential or proprietary Confidential Information of a similar nature.

**11.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Exclusions</u>**.

The obligations of confidentiality will not apply to the extent that the information:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;is or becomes publicly known through no breach of this Agreement or fault of the Recipient or its Representatives;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;is in the Recipient's possession at the time of disclosure by the Disclosing Party other than as a result of the Recipient's breach of any legal obligation;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;is or becomes known to the Recipient on a non-confidential basis through disclosure by sources, other than the Disclosing Party, having the legal right to disclose the Confidential Information, provided that the other source is not known by the Recipient to be bound by any obligations (contractual, legal, fiduciary, or otherwise) of confidentiality to the Disclosing Party with respect to the Confidential Information;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;is independently developed by the Recipient without use of or reference to the Disclosing Party's Confidential Information as evidenced by Recipient's written records; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;is expressly authorized for release by the written authorization of the Disclosing Party.

Any combination of information which comprises part of the Confidential Information are not exempt from the obligations of confidentiality merely because individual parts of that Confidential Information were publicly known, in the Recipient's possession, or received by the Recipient, unless the combination itself was publicly known, in the Recipient's possession, or received by the Recipient.

**11.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Photographs and Recordings</u>**.

Neither party will take any photographs or videos of the other party's facilities, equipment or processes, nor use any other audio or visual recording equipment (such as camera phones) while at the other party's facilities, without that party's express written consent.

**11.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Permitted Disclosure</u>**.

Notwithstanding any other provision of this Agreement, the Recipient may disclose Confidential Information of the Disclosing Party to the extent required, as advised by counsel, in response to a valid order of a court or other governmental body or as required by law, regulation or stock exchange rule. But the Recipient will advise the Disclosing Party in advance of the disclosure to the extent practicable and permissible by the order, law, regulation or stock exchange rule and any other applicable law, will reasonably cooperate with the Disclosing Party, if required, in seeking an appropriate protective order or other remedy, and will otherwise continue to perform its obligations of confidentiality set out herein. If any public disclosure is required by law, the parties will consult concerning the form of announcement prior to the public disclosure being made.

**11.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Marking</u>**.

The Disclosing Party will use reasonable efforts to summarize in writing the content of any oral disclosure or other non-tangible disclosure of Confidential Information within 30 days of the disclosure, but failure to provide this summary will not affect the nature of the Confidential Information disclosed if the Confidential Information was identified as confidential or proprietary when disclosed orally or in any other non-tangible form.

**11.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Return of Confidential Information</u>**.

Upon the written request of the Disclosing Party, the Recipient will promptly return the Confidential Information to the Disclosing Party or, if the Disclosing Party directs, destroy all Confidential Information disclosed in or reduced to tangible form including any copies thereof and any summaries, compilations, analyses or other notes derived from the Confidential Information except for one copy which may be maintained by the Recipient for its records. The retained copy will remain subject to all confidentiality provisions contained in this Agreement.

**11.8&nbsp;&nbsp;&nbsp;&nbsp;<u>Remedies</u>**.

The parties acknowledge that monetary damages may not be sufficient to remedy a breach by either party of this Article 11 and agree that the non-breaching party will be entitled to seek specific performance, injunctive and/or other equitable relief to prevent breaches of this Article 11 and to specifically enforce the provisions hereof in addition to any other remedies available at law or in equity. These remedies will not be the exclusive remedies for breach of this Article 11 but will be in addition to any and all other remedies available at law or in equity.

**ARTICLE 12**

**<u>DISPUTE RESOLUTION</u>**

**12.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Commercial Disputes</u>**.

If any dispute arises out of this Agreement or any Product Agreement (other than a dispute under Section 6.1(b) or a Technical Dispute, as defined herein), the parties will first try to resolve it amicably. In that regard, any party may

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send a notice of dispute to the other, and each party will appoint, within ten Business Days from receipt of the notice of dispute, a single representative having full power and authority to resolve the dispute. The representatives will meet as necessary in order to resolve the dispute. If the representatives fail to resolve the matter within one month from their appointment, or if a party fails to appoint a representative within the ten Business Day period set forth above, the dispute will immediately be referred to the Chief Operating Officer (or another officer as he/she may designate) of each party who will meet and discuss as necessary to try to resolve the dispute amicably. Should the parties fail to reach a resolution under this Section 12.1, the dispute will be referred to a court of competent jurisdiction in accordance with Section 13.17.

**12.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Technical Dispute Resolution</u>**.

If a dispute arises (other than disputes under Section 12.1) between the parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, or other activities under this Agreement (a "**Technical Dispute**"), the parties will make all reasonable efforts to resolve the dispute by amicable negotiations. In that regard, senior representatives of each party will, as soon as possible and in any event no later than ten Business Days after a written request from either party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within 30 Business Days of the written request, the Technical Dispute will, at the request of either party, be referred for determination to an expert in accordance with Exhibit A. If the parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, the parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.

**ARTICLE 13**

**<u>MISCELLANEOUS</u>**

**13.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Inventions</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;For the term of this Agreement, Indivior hereby grants to Patheon a non-exclusive, paid-up, royalty-free, non-transferable license of Indivior's Intellectual Property which Patheon must use in order to perform the Manufacturing Services.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;All Indivior Intellectual Property will be the exclusive property of Indivior.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;All Patheon Intellectual Property will be the exclusive property of Patheon. Patheon hereby grants to Indivior a perpetual, irrevocable, non-exclusive, paid-up, royalty-free, transferable license to use the Patheon Intellectual Property used by Patheon to perform the Manufacturing Services to enable Indivior to manufacture, use, sell, offer for sale and import the Product(s).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;Each party will be solely responsible for the costs of filing, prosecution, and maintenance of patents and patent applications on its own Inventions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;Either party will give the other party written notice, as promptly as practicable, of all Inventions which can reasonably be deemed to constitute improvements or other modifications of the Products or processes or technology owned or otherwise controlled by the party.

**13.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Intellectual Property</u>**.

Neither party has, nor will it acquire, any interest in any of the other party's Intellectual Property unless otherwise expressly agreed to in writing. Neither party will use any Intellectual Property of the other party, except as specifically authorized by the other party under this Agreement or by an amendment hereto, or as required for the performance of its obligations under this Agreement.

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**13.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Insurance</u>**.

During the Term and for a period of two (2) years following its expiration or earlier termination, each party, at its own expense, with insurers maintaining an AM Best rating of not less than "A-VII," will maintain insurance coverage obligations and amounts as follows: commercial general liability insurance, including blanket contractual liability insurance covering the obligations of that party under this Agreement through the term of this Agreement and for a period of three years thereafter. This insurance will have policy limits of not less than (i) $[\*\*\*] for each occurrence for personal injury or property damage liability; and (ii) $[\*\*\*] in the aggregate per annum for product and completed operations liability. Patheon shall also retain insurance coverage for the expected inventory of the API and Indivior-Supplied Components to cover damage or loss of the API and/or the Indivior-Supplied Components for so long as the API and/or Indivior-Supplied Components remain at Patheon's risk. If requested each party will give the other a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date, and the limits of liability. The insurance certificate will further provide for a minimum of 30 days' written notice to the insured of a cancellation of, or material change in, the insurance. If a party is unable to maintain the insurance policies required under this Agreement through no fault of its own, then the party will forthwith notify the other party in writing and the parties will in good faith negotiate appropriate amendments to the insurance provision of this Agreement in order to provide adequate assurances. Patheon shall cause its insurers to name Indivior as an additional insured on the above—listed policies, waiving all rights of subrogation for liability arising out of Patheon's negligence.

**13.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Independent Contractors</u>**.

The parties are independent contractors and this Agreement and any Product Agreement will not be construed to create between Patheon and Indivior any other relationship such as, by way of example only, that of employer-employee, principal agent, joint-venturer, co-partners, or any similar relationship, the existence of which is expressly denied by the parties.

**13.5&nbsp;&nbsp;&nbsp;&nbsp;<u>No Waiver</u>**.

Neither party's failure to require the other party to comply with any provision of this Agreement or any Product Agreement will be deemed a waiver of the provision or any other provision of this Agreement or any Product Agreement, with the exception of Sections 6.1 and 8.2 of this Agreement.

**13.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Assignment and Subcontracting</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Patheon may not assign or subcontract this Agreement or any Product Agreement (in whole or in part), or any of its associated rights or obligations, without the written consent of Indivior, this consent not to be unreasonably withheld. As between Indivior and Patheon, it shall be Patheon's responsibility to supervise, coordinate, and compensate any such authorized subcontractors. Patheon shall assure that all such authorized subcontractors are subject to the provisions of this Agreement to the same extent as Patheon, and Patheon shall be responsible and liable for each such authorized subcontractor's performance of and compliance with this Agreement and any applicable Product Agreement to the same extent as if Patheon itself were performing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Subject to Section 8.2(e), Indivior may not assign this Agreement, or any Product Agreement, or any of its associated rights or obligations, without approval from Patheon, which such approval shall not be unreasonably withheld, conditioned, or delayed; provided, however, that Indivior has the right, without approval from Patheon, to assign this Agreement or any Product Agreement or any of its associated rights or obligations to any Affiliate of Indivior or to any entity resulting from the merger, consolidation, or other reorganization involving Indivior. Indivior will give Patheon prior written notice of any such assignment and any assignee must covenant in writing with Patheon to be bound by the terms of this Agreement or the Product Agreement. Any partial assignment will be subject to Patheon's cost review of the assigned Products and Patheon may terminate this Agreement or any Product Agreement or any assigned part thereof, on 12 months' prior written notice to Indivior and the assignee if good faith discussions do not lead to agreement on amended Manufacturing Service fees within a reasonable time. Indivior will reimburse Patheon for any reasonable costs incurred by Patheon in connection with the partial assignment including any reasonable expenses incurred by Patheon for any due diligence audits in connection with the partial assignment.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Despite the foregoing provisions of this Section 13.6, either party may assign this Agreement or any Product Agreement to any of its Affiliates or to a successor to or purchaser of all or substantially all of its business, but the assignee must execute an agreement with the non-assigning party whereby it agrees to be bound hereunder.

**13.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Force Majeure</u>**. Neither party will be liable for the failure to perform its obligations under this Agreement or any Product Agreement if the failure is caused by an event beyond that party's reasonable control, including, but not limited to, strikes or other labor disturbances, lockouts, riots, quarantines, communicable disease outbreaks, wars, acts of terrorism, fires, floods, storms, interruption of or delay in transportation, defective equipment, lack of or inability to obtain fuel, power or components, or compliance with any order or regulation of any government entity acting within colour of right (a "**Force Majeure Event**"). A party claiming a right to excused performance under this Section 13.7 will immediately notify the other party in writing of the extent of its inability to perform, which notice will specify the event beyond its reasonable control that prevents the performance. If a Force Majeure Event prevents Patheon's performance of any obligations hereunder for a continuous period in excess of 30 days, then Indivior shall have the right to purchase substitute Products from one or more third parties and such purchase shall count towards Indivior's fulfillment of any minimum purchase requirements set forth in this Agreement or any Product Agreement. If a Force Majeure Event prevents performance by a party of any obligations hereunder for a continuous period in excess of 12 weeks, the other party shall be entitled to terminate this Agreement by written notice at any time after such 12 week period provided the relevant Force Majeure Event remains subsisting at the time such notice is given.

**13.8&nbsp;&nbsp;&nbsp;&nbsp;<u>Additional Product</u>**.

Additional Products may be added to, or existing Products deleted from, any Product Agreement by amendments to the Product Agreement including Schedules A, B, C, and D as applicable.

**13.9&nbsp;&nbsp;&nbsp;&nbsp;<u>Notices</u>**.

Unless otherwise agreed in a Product Agreement, any notice, approval, instruction or other written communication required or permitted hereunder will be sufficient if made or given to the other party by personal delivery or by nationally recognized overnight courier service with parcel tracking enabled to the addresses set forth below:

---

| |
|:---|
| If to Indivior: |
| Indivior UK Limited |
| 215 Bath Road, Slough SL1 4AA |
| United Kingdom |
| Attention: Co Sec |
| With a copy to: |
| Indivior UK Limited c/o Indivior Inc. |
| 10710 Midlothian Turnpike, Suite 430 |
| North Chesterfield, VA 23235 |
| Attention: Chief Legal Officer |
| If to Patheon: |
| Patheon |
| 4815 Emperor Boulevard |
| Durham, NC 27703 |
| Attention: Director Legal Services, GRC |
| Email address: [\*\*\*] |

---

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---

| |
|:---|
| With a copy to: |
| Patheon Manufacturing Services LLC |
| 5900 Martin Luther King Jr. Highway |
| Greenville, NC 27834 |
| Attention: Business Management |

---

or to any other addresses given to the other party in accordance with the terms of this Section 13.9.

**13.10&nbsp;&nbsp;&nbsp;&nbsp;<u>Severability</u>**.

If any provision of this Agreement or any Product Agreement is determined by a court of competent jurisdiction to be invalid, illegal, or unenforceable in any respect, that determination will not impair or affect the validity, legality, or enforceability of the remaining provisions, because each provision is separate, severable, and distinct.

**13.11&nbsp;&nbsp;&nbsp;&nbsp;<u>Entire Agreement</u>**.

This Agreement, together with the applicable Product Agreement and the Quality Agreement, constitutes the full, complete, final and integrated agreement between the parties relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions, or understandings concerning the subject matter hereof. Any modification, amendment, or supplement to this Agreement or any Product Agreement must be in writing and signed by authorized representatives of both parties. In case of conflict, the prevailing order of documents will be this Agreement, the Product Agreement, and the Quality Agreement.

**13.12&nbsp;&nbsp;&nbsp;&nbsp;<u>Other Terms</u>**.

No terms, provisions or conditions of any purchase order or other business form or written authorization used by Indivior or Patheon will have any effect on the rights, duties, or obligations of the parties under or otherwise modify this Agreement or any Product Agreement, regardless of any failure of Indivior or Patheon to object to the terms, provisions, or conditions unless the document specifically refers to this Agreement or the applicable Product Agreement and is signed by both parties.

**13.13&nbsp;&nbsp;&nbsp;&nbsp;<u>No Third Party Benefit or Right</u>**.

For greater certainty, nothing in this Agreement or any Product Agreement will confer or be construed as conferring on any third party any benefit or the right to enforce any express or implied term of this Agreement or any Product Agreement.

**13.14&nbsp;&nbsp;&nbsp;&nbsp;<u>Execution in Counterparts</u>**.

This Agreement and any Product Agreement may be executed in two or more counterparts, by original, facsimile or "pdf" signature, each of which will be deemed an original, but all of which together will constitute one and the same instrument.

**13.15&nbsp;&nbsp;&nbsp;&nbsp;<u>Use of Indivior Name</u>**.

Patheon will not make any use of Indivior's name, trademarks or logo or any variations thereof, alone or with any other word or words, without the prior written consent of Indivior, which consent will not be unreasonably withheld.

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**13.16&nbsp;&nbsp;&nbsp;&nbsp;<u>Taxes</u>**.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>VAT</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;Any payment due to Patheon under this Agreement in consideration for the provision of Manufacturing Services to Indivior by Patheon is exclusive of value added taxes ("**VAT**"), turnover taxes, sales taxes or similar taxes, including any related interest and penalties (hereinafter all referred to as "**Transaction Tax**"). If any Transaction Tax is payable on a Manufacturing Service supplied by Patheon to Indivior under this Agreement, this Transaction Tax will be added to the invoice amount and will be for the account of (and reimbursable to Patheon by) Indivior.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;If any Transaction Tax on the supplies by Patheon is payable by Indivior under a reverse charge or withholding procedure (i.e., shifting of liability, accounting or payment requirement to recipient of supplies), Indivior will ensure that Patheon will not effectively be held liable for this Transaction Tax by the relevant taxing authorities or other parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;Where applicable, Patheon will use its reasonable commercial efforts to ensure that its invoices to Indivior are issued in such a way that these invoices meet the requirements for deduction of input VAT by Indivior, if Indivior is permitted by law to do so.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)&nbsp;&nbsp;&nbsp;&nbsp;Each party will provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Laws, of Transaction Tax resulting from payments made under this Agreement, this recovery to be for the benefit of the party bearing the Transaction Tax.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v)&nbsp;&nbsp;&nbsp;&nbsp;If Patheon is acting as Indivior's buying agent, Patheon will always charge to Indivior the Transaction Tax in the relevant territory in addition to the amount paid by Patheon to supplier.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vi)&nbsp;&nbsp;&nbsp;&nbsp;For the avoidance of doubt, reference to the Manufacturing Services in this Section 13.16 also includes any element (or the entirety) of the Manufacturing Services characterized as a supply of goods by Patheon, it's subcontractor or any tax authority for Transaction Tax purposes.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Duties</u>. Indivior will bear the cost of all duties, levies, tariffs and similar charges (and any related interest and penalties) (together "**Duties**") however designated, arising from the performance of the Manufacturing Services by Patheon, including (without limitation) those imposed as a result of the shipping of Materials (including drug substance, materials, Components and finished Product) to, from or between Patheon site(s). If these Duties are incurred by Patheon, then Patheon will be entitled to invoice Indivior for these Duties at the time that they are incurred.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;<u>Withholding Tax</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;Where any sum due to be paid to Patheon under this Agreement is subject to any withholding or similar tax, Indivior will pay the withholding or similar tax to the appropriate government authority without deduction from or offset of the amount then due to Patheon. The parties agree to cooperate with one another and use reasonable efforts to reduce or eliminate or enable the recovery of any tax withholding or similar obligations for royalties, milestone payments, and other payments made by Indivior to Patheon under this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;Patheon will provide Indivior any tax forms that may be reasonably necessary for Indivior not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;Each party will provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Laws, of withholding taxes, or similar obligations resulting from payments made under this Agreement, this recovery to be for the benefit of the party bearing the withholding tax.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;<u>No Offset</u>. Any Transaction Tax, Duty, withholding tax or other tax that Indivior pays, or is required to pay, but which Indivior believes should properly be paid by Patheon under this Section 13.16 may not be offset against sums due by Indivior to Patheon whether due under this Agreement or otherwise.

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**13.17&nbsp;&nbsp;&nbsp;&nbsp;<u>Governing Law</u>**.

This Agreement and any Product Agreement, unless otherwise agreed by the parties in the Product Agreement and then only for purposes of that Product Agreement, will be construed and enforced in accordance with the laws of the State of Delaware and the laws of the United States of America applicable therein and subject to the exclusive jurisdiction of the courts thereof. The UN Convention on Contracts for the International Sale of Goods will not apply to this Agreement.

**ARTICLE 14**

**<u>ANTI-BRIBERY</u>**

**14.1**&nbsp;&nbsp;&nbsp;&nbsp;Patheon shall comply with Indivior's Code of Business Conduct and Anti-Bribery Policy as amended from time to time (**"Policies")**, copies of which are attached as Exhibit F**.** The parties agree that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Indivior and Patheon are committed to conduct business with the highest degree of ethics and integrity and will comply with the letter and spirit of all relevant local and international laws and regulations such as the US Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act 2010 and all other applicable anti-corruption laws, as well as any laws implementing the UN Convention Against Corruption and the OECD Anti-Bribery Convention;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;In connection with this Agreement, each party undertakes that its directors, employees and officers have not and shall not directly or indirectly (i) offer, provide, authorise for or promise to another person, or (ii) request, accept or agree to accept from another person any financial or other advantage or anything of value ("**Benefit**"), if such Benefit is for the purpose of influencing the receiving person improperly in his/her official capacity for the purpose of obtaining a business advantage, or where such Benefit would constitute a violation of any Applicable Law;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;In order to demonstrate compliance with Article 14 of this Agreement, Patheon shall devise and maintain a system of adequate internal controls for expenditures made under this Agreement and keep books and records complete and accurate in order to reflect in reasonable detail the character and value of transactions and expenditures made under this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;Neither party shall take any action in violation of the laws mentioned in this Article 14 as it relates to this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;Each party shall give prompt written notice to the other if it has failed to comply with or has breached Article 14 of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;If in the reasonable opinion of a party, the other party fails to comply with applicable anti-corruption laws in any material respect, then such party shall be entitled to terminate this Agreement upon written notice to the other arty.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g) &nbsp;&nbsp;&nbsp;&nbsp;Any breach of the provisions of Article 14 shall constitute a material breach of this Agreement.

**ARTICLE 15**

**<u>BUSINESS CONTINUITY PLAN</u>**

**15.1&nbsp;&nbsp;&nbsp;&nbsp;**The parties acknowledge that the regulatory requirements and associated timescales involved in switching manufacture of the Products to an alternative supplier are significant and as such Patheon's business continuity plan shall focus on risk minimisation and mitigation to maintain Patheon as the manufacturer of the Products. Within three months of start of production or 30 days of Indivior's request, whichever is the sooner, Patheon will provide Indivior with a detailed, written business interruption and recovery plan, including business impact and risk assessment, crisis management, information technology disaster recovery, and business continuity (the "**BCP Plan**"). Patheon agrees to adhere to the BCP Plan. Patheon

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will notify Indivior in writing within 24 hours of any activation of the BCP Plan which directly impacts the Manufacture of Client Product.

**15.2&nbsp;&nbsp;&nbsp;&nbsp;**Subject to Section 13.7 (Force Majeure), Patheon agrees that in the event that the BCP Plan is activated which directly impacts the Manufacture of Client Product and during such activation Patheon is not able to fulfil its obligations under this Agreement and this results in the Products going out of stock in the Territory, on Indivior's request Patheon will perform an emergency Technology Transfer to a third party identified by Indivior as an alternative source of manufacture of the Products in accordance with terms and conditions set forth in Exhibit E and Indivior's obligations to purchase Products exclusively from the Patheon as set out under this Agreement shall cease to apply. Save where such an emergency Technology Transfer arises as a result of the Patheon's breach of this Agreement, such an emergency Technology Transfer shall be at Indivior's cost (as to reasonable expenses properly incurred) and on terms and conditions to be agreed upon by the Parties at such time.

**ARTICLE 16**

**<u>EQUIPMENT</u>**

**16.1&nbsp;&nbsp;&nbsp;&nbsp;**To the extent any new equipment, modifications to existing equipment, or facility modifications are necessary for Patheon to provide the Manufacturing Services under this Agreement or any Product Agreement or are otherwise requested by Indivior, then prior to any purchase or installation of the new equipment or modifications, the parties shall negotiate in good faith a Capital Equipment Agreement, to be signed by both parties, that contains each party's rights and responsibilities regarding such equipment and/or modifications, including but not limited to their purchase, ownership, development, manufacture, installation, and maintenance.

[Signature page to follow]

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IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Agreement as of the Effective Date.

---

| | | | |
|:---|:---|:---|:---|
| **PATHEON MANUFACTURING SERVICES LLC** | **PATHEON MANUFACTURING SERVICES LLC** | **PATHEON MANUFACTURING SERVICES LLC** | **PATHEON MANUFACTURING SERVICES LLC** |
| By: | */s/ Nick Buschur* | */s/ Nick Buschur* | */s/ Nick Buschur* |
| Name: | Name: | Name: | Nick Buschur |
| Title: | Title: | Executive Director and General Manager | Executive Director and General Manager |
| Date: | Date: | 20 April 2018 | 20 April 2018 |
| **INDIVIOR UK LIMITED** | **INDIVIOR UK LIMITED** | **INDIVIOR UK LIMITED** | **INDIVIOR UK LIMITED** |
| By: | */s/ Frank Stier* | */s/ Frank Stier* | */s/ Frank Stier* |
| Name: | Name: | Name: | Frank Stier |
| Title: | Title: | Chief Manufacturing & Supply Officer | Chief Manufacturing & Supply Officer |
| Date: | Date: | April 25, 2018 | April 25, 2018 |

---

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**<u>APPENDIX 1</u>**

**<u>FORM OF PRODUCT AGREEMENT</u>**

**<u>(Includes Schedules A to E)</u>**

**<u>PRODUCT AGREEMENT</u>**

This Product Agreement (this "**Product Agreement**") is issued under the Master Manufacturing Services Agreement dated **[insert date]** between **Patheon Manufacturing Services LLC**, and **Indivior UK Limited** (the "**Master Agreement**"), and is entered into on **[insert effective date]** (the "**Effective Date**"), between Patheon Manufacturing Services LLC, **[or applicable Patheon Affiliate]**a limited liability company existing under the laws of the State of Delaware **[or applicable founding jurisdiction for Patheon Affiliate]** having a principal place of business at 5900 Martin Luther King Jr. Hwy, Greenville, NC 27834 **[or Patheon Affiliate address]**("**Patheon**") and Indivior UK Limited, incorporated and registered in England with company number 7183451 with its registered office at 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom ("**Indivior**").

The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement. All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in the Master Agreement.

The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of this Product Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.&nbsp;&nbsp;&nbsp;&nbsp;Product List and Specifications** (See Schedule A attached hereto)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.&nbsp;&nbsp;&nbsp;&nbsp;Minimum Order Quantity, Annual Volume, and Price** (See Schedule B attached hereto)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.&nbsp;&nbsp;&nbsp;&nbsp;Annual Stability Testing and Validation Activities (if applicable)** (See Schedule C attached hereto)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.&nbsp;&nbsp;&nbsp;&nbsp;Active Materials, Active Materials Credit Value, and Maximum Credit Value** (See Schedule D attached hereto)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.&nbsp;&nbsp;&nbsp;&nbsp;Metrics:** (See Schedule E attached hereto)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.&nbsp;&nbsp;&nbsp;&nbsp;Yearly Forecasted Volume:** (insert for sterile products if applicable under Section 4.2.1 of the Master Agreement)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.&nbsp;&nbsp;&nbsp;&nbsp;Incoterm for Transport** (**if other than EXW):** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**8.&nbsp;&nbsp;&nbsp;&nbsp;Territory**: (insert the description of the Territory here)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**9.&nbsp;&nbsp;&nbsp;&nbsp;Manufacturing Site**: (insert address of Patheon Manufacturing Site where the Manufacturing Services will be performed)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**10.&nbsp;&nbsp;&nbsp;&nbsp;Governing Law**: (per Section 13.17 of the Master Agreement)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**11.&nbsp;&nbsp;&nbsp;&nbsp;Inflation Index**: (if applicable under Section 4.2(a) of the Master Agreement for Products manufactured outside of the Unites States or Puerto Rico)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**12.&nbsp;&nbsp;&nbsp;&nbsp;Currency**: (per Section 1.4 of the Master Agreement)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**13.&nbsp;&nbsp;&nbsp;&nbsp;Initial Set Exchange Rate**: (if applicable under Section 4.2(c) of the Master Agreement)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**14.&nbsp;&nbsp;&nbsp;&nbsp;Product Term:** (per Section 8.1 of the Master Agreement) from the Effective Date until December 31, 20__

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**15.&nbsp;&nbsp;&nbsp;&nbsp;Notices**: (if applicable under Section 13.9 of the Master Agreement)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**16.&nbsp;&nbsp;&nbsp;&nbsp;Other Modifications to the Master Agreement**: (if applicable under Section 1.2 of the Master Agreement)

IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Product Agreement as of the Effective Date set forth above.

---

| |
|:---|
| **PATHEON MANUFACTURING SERVICES LLC [or applicable <br>Patheon Affiliate]** |
| By: |
| Name: |
| Title: |
| Date: |
| **INDIVIOR UK LIMITED** |
| By: |
| Name: |
| Title: |
| Date: |

---

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**<u>SCHEDULE A</u>**

**<u>PRODUCT LIST AND SPECIFICATIONS</u>**

**<u>Product List</u>**

[insert product list]

**<u>Specifications</u>**

Prior to the start of commercial manufacturing of Product under this Agreement Indivior will give Patheon the originally executed copies of the Specifications as approved by the applicable Regulatory Authority. If the Specifications received are subsequently amended, then Indivior will give Patheon the revised and originally executed copies of the revised Specifications. Upon acceptance of the revised Specifications, Patheon will give Indivior a signed and dated receipt indicating Patheon's acceptance of the revised Specifications.

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**<u>SCHEDULE B</u>**

**<u>MINIMUM ORDER QUANTITY, ANNUAL VOLUME, AND PRICE</u>**

**<u>[Insert Price Table]</u>**

**<u>Manufacturing Assumptions</u>:**

**<u>Packaging Assumptions</u>:**

**<u>Testing Assumptions</u>:**

**<u>The following cost items are included in the Price for the Products</u>:** 

&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

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&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

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&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

**<u>The following cost items are not included in the Price for the Products</u>:**

&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

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&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

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&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

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&nbsp;&nbsp;&nbsp;&nbsp;●&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

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**<u>SCHEDULE C</u>**

**<u>ANNUAL STABILITY TESTING [and VALIDATION ACTIVITIES (if applicable)]</u>**

Patheon and Indivior will agree, in a written amendment to the applicable Product Agreement, on any stability testing to be performed by Patheon on the Products. The amendment will specify the commercial and Product stability protocols applicable to the stability testing and the fees payable by Indivior for this testing including the Price for the Product withdrawn for the stability testing.

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**<u>SCHEDULE D</u>**

**<u>ACTIVE MATERIALS</u>**

Active Materials Supplier <br> <u>●</u> <u>●</u>

**<u>ACTIVE MATERIALS CREDIT VALUE</u>**

The Active Materials Credit Value will be as follows:

---

| | | |
|:---|:---|:---|
| PRODUCT | ACTIVE MATERIALS | ACTIVE MATERIALS<br>CREDIT VALUE |
| | | Indivior's actual cost for Active Materials not to exceed $_____per kilogram |

---

**<u>MAXIMUM CREDIT VALUE</u>**

Patheon's liability for Active Materials calculated in accordance with Section 2.2 of the Master Agreement for any Product in a Year will not exceed, in the aggregate, the maximum credit value set forth below:

---

| | |
|:---|:---|
| PRODUCT | MAXIMUM CREDIT VALUE |
|  | ___% of revenues per Year to Patheon under this Product Agreement*.* |

---

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**<u>SCHEDULE E</u>**

**<u>METRICS</u>**

**<u>[Insert]</u>**

**[End of Product Agreement]** 

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**<u>EXHIBIT A</u>**

**<u>TECHNICAL DISPUTE RESOLUTION</u>**

Technical Disputes which cannot be resolved by negotiation as provided in Section 12.2 will be resolved in the following manner:

1.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Appointment of Expert</u>**. Within ten Business Days after a party requests under Section 12.2 that an expert be appointed to resolve a Technical Dispute, the parties will jointly appoint a mutually acceptable expert with experience and expertise in the subject matter of the dispute. If the parties are unable to so agree within the ten Business Day period, or if there is a disclosure of a conflict by an expert under Paragraph 2 hereof which results in the parties not confirming the appointment of the expert, then an expert (willing to act in that capacity hereunder) will be appointed by an experienced arbitrator on the roster of the American Arbitration Association.

2.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Conflicts of Interest</u>**. Any person appointed as an expert will be entitled to act and continue to act as an expert even if at the time of his appointment or at any time before he gives his determination, he has or may have some interest or duty which conflicts or may conflict with his appointment if before accepting the appointment (or as soon as practicable after he becomes aware of the conflict or potential conflict) he fully discloses the interest or duty and the parties will, after the disclosure, have confirmed his appointment.

3.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Not Arbitrator</u>**. No expert will be deemed to be an arbitrator and the provisions of the American Arbitration Act or of any other applicable statute (foreign or domestic) and the law relating to arbitration will not apply to the expert or the expert's determination or the procedure by which the expert reaches his determination under this Exhibit A.

4.&nbsp;&nbsp;&nbsp;&nbsp;**<u>Procedure</u>**. Where an expert is appointed:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;<u>Timing</u>. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days (or another date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;<u>Disclosure of Evidence</u>. The parties undertake one to the other to give to any expert all the evidence and information within their respective possession or control as the expert may reasonably consider necessary for determining the matter before him which they will disclose promptly and in any event within five Business Days of a written request from the relevant expert to do so.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;<u>Advisors</u>. Each party may appoint any counsel, consultants and advisors as it feels appropriate to assist the expert in his determination and so as to present their respective cases so that at all times the parties will co-operate and seek to narrow and limit the issues to be determined.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;<u>Appointment of New Expert</u>. If within the time specified in Paragraph 4(a) above the expert will not have rendered a decision in accordance with his appointment, a new expert may (at the request of either party) be appointed and the appointment of the existing expert will thereupon cease for the purposes of determining the matter at issue between the parties except if the existing expert renders his decision with full reasons prior to the appointment of the new expert, then this decision will have effect and the proposed appointment of the new expert will be withdrawn.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;<u>Final and Binding</u>. The determination of the expert will, except for fraud or manifest error, be final and binding upon the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;<u>Costs</u>. Each party will bear its own costs for any matter referred to an expert hereunder and, in the absence of express provision in the Agreement to the contrary, the costs and expenses of the expert will be shared equally by the parties.

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For greater certainty, the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including this Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.

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**<u>EXHIBIT B</u>**

**<u>MONTHLY ACTIVE MATERIALS INVENTORY REPORT</u>**

---

| | |
|:---|:---|
| TO: | INDIVIOR UK LIMITED |
| FROM: | PATHEON MANUFACTURING SERVICES LLC [or applicable Patheon Affiliate] |
| RE: | Active Materials monthly inventory report under Section 2.2(a) of the Master Manufacturing Services Agreement dated ______ (the "**Agreement**") |

---

[\*\*\*]

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**<u>EXHIBIT C</u>**

**<u>REPORT OF ANNUAL ACTIVE MATERIALS INVENTORY RECONCILIATION</u>**

**<u>AND CALCULATION OF ACTUAL ANNUAL YIELD</u>**

---

| | |
|:---|:---|
| TO: | INDIVIOR UK LIMITED |
| FROM: | PATHEON MANUFACTURING SERVICES LLC [or applicable Patheon Affiliate] |
| RE: | Active Materials annual inventory reconciliation report and calculation of Actual Annual Yield under Section 2.2(a) of the Master Manufacturing Services Agreement dated ______ (the "**Agreement**") |

---

[\*\*\*]

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**<u>EXHIBIT D</u>**

**<u>EXAMPLE OF PRICE ADJUSTMENT DUE TO CURRENCY FLUCTUATION</u>**

**<u>Section 4.2(c)</u>**

[\*\*\*]

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**<u>EXHIBIT E</u>**

**<u>FORM OF TECHNOLOGY TRANSFER AGREEMENT</u>**

Upon receipt of written notice from Indivior, Patheon shall promptly and efficiently undertake and complete a Technology Transfer to Indivior or a third party identified by Indivior (Indivior or the third party (or both) being the "**Transferee**") to enable the Transferee to establish and conduct cGMP manufacture of the Products.

The parties agree that a Technology Transfer includes, without limitation:

A.&nbsp;&nbsp;&nbsp;&nbsp;making available to the Transferee the then-current manufacturing process specific to the Products and all documentation constituting material support, specifications as to Raw Materials and control methods that are necessary to enable the Transferee to use and practice such manufacturing process;

B.&nbsp;&nbsp;&nbsp;&nbsp; providing reasonable Technology Transfer assistance to Indivior (and its designees) with respect to the manufacture of the Products, including a Technology Transfer, stability studies, analytical method transfer, and transfer of Indivior Confidential Information and Intellectual Property, and, only in cases where Patheon has activated the BCP Plan and this activation directly impacts the Manufacture of Client Product resulting in Client going out of stock in the Territory, providing access to certain Patheon Intellectual Property in order to facilitate such Technology Transfer that permits Indivior to have the applicable Product manufactured by a secondary supplier until such time as the BCP Plan is deactivated and supply may resume with Patheon. Any Patheon Confidential Information or Patheon Intellectual Property shared pursuant to this shall be used strictly for the purpose intended and for no other purposes. Patheon shall be afforded the remedies noted in [**Confidentiality**] should the information be used for any other purpose. For greater certainty, Patheon shall not be responsible for any regulatory filings costs of Indivior in connection with any Technology Transfer under this Exhibit E.

C.&nbsp;&nbsp;&nbsp;&nbsp;causing an appropriate number of employees and/or representatives of Patheon to meet with employees or representatives of Indivior, at Indivior's sole cost and expense as to reasonable costs and expenses, properly incurred to assist with transfer of the methods and manufacturing process in accordance with the Specifications relating to the Products to the extent necessary to enable the Transferee to use and practise such manufacturing process;

D.&nbsp;&nbsp;&nbsp;&nbsp;without limiting the generality of paragraph B above, causing an appropriate number of analytical and quality control laboratory employees and representatives of the Supplier to meet with employees or representatives of the Transferee, at Indivior's sole cost and expense as to reasonable costs and expenses, properly incurred at the manufacturing facility of the Supplier and make available all necessary equipment, at mutually convenient times, to support and execute the transfer of all applicable analytical methods and the validation thereof;

D.&nbsp;&nbsp;&nbsp;&nbsp;without limiting the generality of the preceding clauses, support for Analytical Method Transfers / Establishment of Pharmacopieal Methods (a collaborative inter-laboratory transfer of the analytical test methods required for the Product); and

E.&nbsp;&nbsp;&nbsp;&nbsp;provide such other assistance as the Transferee may reasonably request, at Indivior's sole cost and expense.

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**<u>EXHIBIT F</u>**

**<u>INDIVIOR POLICIES</u>**

---

| | | |
|:---|:---|:---|
| | **Subject** | **Number** |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) | **CODE OF BUSINESS CONDUCT** | **Version 1.0** |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) | **Section** |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) | **POLICY STATEMENT** |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) | **Sponsor** | **Effective Date** |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) | **CHIEF LEGAL OFFICER** | &nbsp;&nbsp;**December 2014** |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |

---

**Code of Business Conduct**

**Indivior PLC ts committed to responsible corporate behavior, this includes high standards of business conduct in our relationships with employees, contractors, customers, consumers, shareholders, suppliers, governments, competitors and the local communities in which we operate.**

**1.&nbsp;&nbsp;&nbsp;&nbsp;INTRODUCTION**

**1.1&nbsp;&nbsp;&nbsp;&nbsp;The purpose of this Code of Business Conduct (the "Code") is to promote and ensure the legal and ethical conduct of persons acting on behalf of Indivior PLC and its subsidiaries (the "Company") and to ensure that employees and contractors across the Company have a clear understanding of the principles and ethical values that the Company wants to uphold. It applies to all employees and contractors globally. Where the Company participates in joint ventures, the Code's standards should also be actively promoted.**

**1.2&nbsp;&nbsp;&nbsp;&nbsp;Compliance with the Code is an important factor in maintaining and building the reputation of Indivior PLC as a responsible and trustworthy business partner, employer, client, supplier and corporate citizen.**

**1.3&nbsp;&nbsp;&nbsp;&nbsp;Each director-employee, contractor and agent of the Company should read this Code thoroughly. Keep in mind that this Code is only a guide and if you are concerned about a legal or ethical situation, or are not sure whether specific conduct meets the Company's standards, feel free to discuss the situation with your supervisor, the Human Resources Department, or the Legal Department.**

**1.4&nbsp;&nbsp;&nbsp;&nbsp;The Code forms the core element of Indivior's Corporate Responsibility Framework; this comprises a set of policies and control arrangements that govern how we act as a Company and how we interact with our stakeholders in conducting the Company's business.**

**1.5&nbsp;&nbsp;&nbsp;&nbsp;It is not possible to anticipate every situation. The Code is necessarily broad and general in nature and is not intended to replace more detailed policies and procedures. Nevertheless, these basic principles and ethical values should serve as a guide to each person in his or her dealings with consumers, customers, suppliers, governments and regulators, shareholders, competitors, colleagues and others with whom the Company has relationships.**

**1.6&nbsp;&nbsp;&nbsp;&nbsp;The Code outlines the way the Company wants business conducted now and in the future.**

**2.&nbsp;&nbsp;&nbsp;&nbsp;COMPANY MISSION**

**To be the global leader who is a pioneer in developing innovative prescription treatments for addicted patients.**

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**3.&nbsp;&nbsp;&nbsp;&nbsp;GOVERNING PRINCIPLES / STANDARDS OF CONDUCT**

**The Company is committed to conducting its business on a foundation of strong ethical and moral principles. These principles apply from the top down and we seek to ensure that our board of directors (the "Board"), employees, consultants, contractors, agents and other persons engaged by the Company conduct themselves in accordance with the following policies which govern specific areas of Indivior's business and operations. In some areas, specific policies (or parts of them) are mandated by law, while others are considered by Indivior's board of directors (the "Board") to be vital to the ethical operations of the Company. Some of the policies expand on the principles out lined in this Code and all are subject to the Code's general provisions.**

**>&nbsp;&nbsp;&nbsp;&nbsp;Animal Care and Use Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Anti-Bribery Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Anti-Bribery Policy: Guidance**

**>&nbsp;&nbsp;&nbsp;&nbsp;Communicating with Care Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Competition Law Compliance Manual**

**>&nbsp;&nbsp;&nbsp;&nbsp;Competitor Contact Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Computer Resources Acceptable Usage Pol icy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Corporate Diversity and Inclusion Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Data Classification Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Data Protection Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Document Retention and File Maintenance Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Electronic Device Security Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Employee Communications with News Media Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Environmental Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Global Policy on Healthcare Business Ethics**

**>&nbsp;&nbsp;&nbsp;&nbsp;Global Security Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Inside Information and Disclosure Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Investor Relations Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Occupational Health and Safety Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Password Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Product Safety Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Protection of Proprietary Information Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Quality Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Share Dealing Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Social Media Engagement Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;US-EU Safe Harbor Employee Data Privacy Policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Whistleblower Policy**

**4.&nbsp;&nbsp;&nbsp;&nbsp;ETHICAL BUSINESS CONDUCT AND FAIR DEALING**

**All employees and contractors must accept responsibility for maintaining and enhancing the Company's reputation for integrity and fairness in its business dealings. In its everyday business transactions, the Company must be seen to be dealing even-handedly and honestly with all its consumers, customers, suppliers, employees, contractors, governments and regulators and others with whom the Company has a relationship.**

**5.&nbsp;&nbsp;&nbsp;&nbsp;COMPLIANCE WITH LAWS, REGULATIONS AND COMPANY POLICIES**

**General Principles**

**5.1&nbsp;&nbsp;&nbsp;&nbsp;There are many laws and regulations applicable to the Company's business. All employees and contractors must be aware of and observe all laws and regulations governing their activities. Some specific areas of legal and regulatory attention include: health and safety; anti-bribery laws, employment and work place practices; protection of the environment; competition; intellectual property; and the payment of taxes and social security. Compliance with the Company's internal operating policies and procedures is of equal importance.**

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**Regulatory Compliance**

**5.2&nbsp;&nbsp;&nbsp;&nbsp;The Company's global operations include products that are highly regulated by local laws, regulations, and government agencies. Failure to comply with local registration, manufacturing, sales, and reporting obligations can expose the Company, individual employees, contracting firms and individual contractors to significant penalties, including personal fines and imprisonment. All employees and contractors are required to support the Company's regulatory compliance obligations, which include the appropriate reporting of adverse events.**

**Competition Law**

**5.3&nbsp;&nbsp;&nbsp;&nbsp;It is Company policy that all Indivior companies and their employees and contractors comply with the competition, antitrust and anti-monopoly laws of all countries in which they conduct Company business. Directors, managers and others with supervisory responsibility have a duty to ensure that employees and contractors under their supervision are aware of and comply with this policy. Violation of this policy may subject the individual to disciplinary action, including dismissal and cessation of contract. Severe civil, and in some cases criminal, penalties may be imposed on the Company and the responsible employee or contractors if you authorise or participate in a violation of competition laws.**

**5.4&nbsp;&nbsp;&nbsp;&nbsp;Without limiting the general Company policy stated above, there are several specific guidelines that apply to all Indivior colleagues (employees and contractors) in every country:**

**>&nbsp;&nbsp;&nbsp;&nbsp;Indivior PLC colleagues do not share non-public price information or sensitive product information with competitors under any circumstances. Indivior PLC colleagues also strive to ensure that such information is not indirectly shared with competitors, whether purposefully or inadvertently, through third parties.**

**>&nbsp;&nbsp;&nbsp;&nbsp;Indivior PLC, as well at its customers and consumers, benefit from a competitive market in which all companies are able to fairly present their product and benefits in the market. Indivior PLC competes actively in this marketplace, but Indivior PLC will not use its market position to illegally prohibit the legitimate activity of a competitor.**

**6.&nbsp;&nbsp;&nbsp;&nbsp;INTERACTIONS WITH HEALTHCARE PROFESSIONALS**

**6.1&nbsp;&nbsp;&nbsp;&nbsp;The Company adheres to its Governing Principles when interacting with healthcare professionals ("HCPs"), committing to the highest ethical standards and legal requirements. We act responsibly and with integrity and interact with HCPs in accordance with applicable laws when providing information about our products, which are at all times intended to provide up-to-date data regarding the use of our products and associated benefits to consumers and to the larger public.**

**6.2&nbsp;&nbsp;&nbsp;&nbsp;We promote dissemination of information based on empirical results and do not allow business pressures to influence our interactions with HCPs. Our goal is to ensure that HCPs are provided with all data and information relating to our products that helps to improve end-user treatment and care.**

**6.3&nbsp;&nbsp;&nbsp;&nbsp;All representatives of the Company must adhere strictly to our Anti-Bribery policy when interacting with HCPs. In particular, employees and contractors must not offer anything to HCPs that could be considered or construed as a bribe or an attempt to solicit favourable treatment.**

**7.&nbsp;&nbsp;&nbsp;&nbsp;PRODUCT PROMOTION**

**7.1&nbsp;&nbsp;&nbsp;&nbsp;The U.S., European and wider global pharmaceutical industry is highly regulated because our products directly impact on consumer health. We comply with the wide array of applicable laws and regulations concerning promotion of our products.**

**7.2&nbsp;&nbsp;&nbsp;&nbsp;We have adopted an internal "Promotional Review" policy that requires all product promotional materials to be cleared before use to ensure that they are appropriate from a medical, regulatory and legal perspective. We consult with appropriate professionals on a case-by-case basis where independent advice is required. Use of any unapproved promotional materials or advertisements is strictly prohibited.**

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**7.3&nbsp;&nbsp;&nbsp;&nbsp;Our strict policy is to solicit and obtain business only through marketing programmes that have been reviewed and approved by the Company. We build our customer relationships on the basis of integrity and mutual trust, in line with our Governing Principles. Our promotions comply with applicable standards and regulations while our product labels are dearly printed and contain accurate information that is not misleading to HCPs or consumers. We are committed to promoting our products in a transparent and accurate manner.**

**7.4&nbsp;&nbsp;&nbsp;&nbsp;The Company will never -- and its employees and contractors are prohibited from -- marketing to consumers directly unless permitted by local law. Regardless whether such direct promotion is permitted, our employees and contractors are required in each case to seek appropriate internal approvals prior to engaging with consumers.**

**8.&nbsp;&nbsp;&nbsp;&nbsp;ANTI-BRIBERY**

**8.1&nbsp;&nbsp;&nbsp;&nbsp;Indivior has a zero tolerance policy towards bribery and anti-corruption.**

**8.2&nbsp;&nbsp;&nbsp;&nbsp;It is Company policy that all Indivior companies and their employees and contractors comply with the anti-bribery/anti-corruption laws of the U.K., U.S., and all other countries in which they conduct Company business (including the U.K. Bribery Act 2010 and the U.S. Foreign Corrupt Practices Act). Directors, managers and others with supervisory responsibility have a duty to ensure that employees and contractors under their supervision are aware of and comply with this policy.**

**8.3&nbsp;&nbsp;&nbsp;&nbsp;Company employees are prohibited from directly or indirectly making, promising, authorizing, or offering anything of value to a government official on behalf of Indivior. A "government official" includes elected and unelected individuals that hold administrative, judicial or legislative functions (e.g., a person who performs public functions for any branch of national, municipal or local government or even for public enterprises or agencies, such as public health agencies) and can include political parties, international governmental organisations, state-owned enterprises or enterprises controlled by a government entity. HCPs can be considered government officials when working in public hospitals.**

**8.4&nbsp;&nbsp;&nbsp;&nbsp;All persons engaged by the Company must consult with their supervisor or the Legal Department if they have any doubts as to whether a proposed gift or hospitality event might infringe the Company's anti-bribery policy.**

**8.5&nbsp;&nbsp;&nbsp;&nbsp;Violation of this policy may subject the individual to disciplinary action, including dismissal and cessation of contract. Severe civil, and in some cases criminal, penalties may be imposed on the Company and the responsible employee or contractors if you authorise or participate in a violation of anti-bribery laws. Employees and contractors must read the Company's Anti-Bribery Policy and associated documents.**

**9.&nbsp;&nbsp;&nbsp;&nbsp;CONSUMER SAFETY & RESEARCH AND DEVELOPMENT**

**9.1&nbsp;&nbsp;&nbsp;&nbsp;Promoting and maintaining patient health and safety are top priorities for the Company and we continually monitor our research and development processes to maintain product quality. We take seriously our responsibility to detect and report adverse events and quality complaints associated with our products, including unfavourable side effects, dosing errors, misuse, malfunctions and concerns about performance or efficacy of a product. If you are aware of any such adverse events, please ensure you report to the Pharmacovigilance Department.**

**9.2&nbsp;&nbsp;&nbsp;&nbsp;We work actively alongside regulatory authorities to combat counterfeiting and it is each employee and contractor's responsibility to report any counterfeit products to their- supervisor or the Legal Department.**

**9.3&nbsp;&nbsp;&nbsp;&nbsp;The Company has established policies and procedures to assure compliance with Food and Drug Administration and other applicable European and national regulatory authorities (including, for example, the MHRA) regulations and guidance in regards to current good manufacturing, laboratory and clinical practices, as well as certain activities conducted in connection with the sales and marketing of pharmaceuticals. The Company has also adopted SOPs applicable to certain activities regarding the reporting of safety information about our products and maintaining the integrity of our automated record keeping systems. The appropriate departments draft, review, approve and update written procedures relevant to their group functions and responsibilities. Appropriate company departments then perform a final review and approval and issues these written procedures as SOPs. Employees and other Company representatives acting on our behalf in connection with the testing, manufacturing or selling of our products must read, be familiar with, and comply with those SOPs that impact their activities. In certain cases, specific training on such SOPs (and employee certification of completion of training} may also be required.**

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**9.4&nbsp;&nbsp;&nbsp;&nbsp;The Company complies with all applicable laws and regulations regarding our research, development, manufacturing and distribution activities, including Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices.**

**9.5&nbsp;&nbsp;&nbsp;&nbsp;We ensure that appropriate informed consent procedures are followed where necessary in connection with our research and development activities. Any research involving animals is carefully considered and in each case justified and continually monitored to the highest professional and ethical standards.**

**9.6&nbsp;&nbsp;&nbsp;&nbsp;The Company investigates all substantive quality-related complaints with due process, and will ensure that such complaints are properly reported, as required, to the appropriate regulatory authorities.**

**10.&nbsp;&nbsp;&nbsp;&nbsp;EMPLOYEES & CONTRACTORS**

**10.1&nbsp;&nbsp;&nbsp;&nbsp;Equal opportunities / no discrimination - in employment related matters (including recruitment, access to training and promotion, transfers, employment termination, discipline, compensation and benefits), decisions are made on the basis of the qualifications, performance record and abilities needed for the work to be undertaken, and relevant business circumstances. The Company is committed to equal opportunities at work and in the work place; colleagues should not engage in or support discrimination based on race, colour, language, caste, national origin, indigenous status, religion, disability, gender, marital status, sexual orientation, union membership, political affiliation, or age.**

**10.2&nbsp;&nbsp;&nbsp;&nbsp;Working environment - the Company is committed to providing a safe and healthy working environment and to assuring, so far as is reasonably practicable, the health, safety and welfare at work of its colleagues. The Company's premises are alcohol and drug-free and employees and contractors must report any breach of this policy.**

**10.3&nbsp;&nbsp;&nbsp;&nbsp;Occupational health & safety - employees and contractors have a duty to take reasonable care for their own health & safety and that of others who may be affected by their acts or omissions. Employees and contractors must be aware of applicable health and safety laws and regulations and must use all work items provided by the Company correctly; in accordance with their training and the instructions they received to use them safely. All hazardous materials must be handled appropriately and disposed of in accordance with applicable laws and regulations.**

**10.4&nbsp;&nbsp;&nbsp;&nbsp;Colleague Communication - the Company is committed to providing timely and effective communication with its colleagues.**

**11.&nbsp;&nbsp;&nbsp;&nbsp;CONFLICTS OF INTEREST**

**11.1&nbsp;&nbsp;&nbsp;&nbsp;Employees and contractors must avoid situations where their personal interests might, or might appear to be, in conflict with the interests of the Company. In particular, employees may not exploit knowledge or information gained from employment within the Company or take advantage of a corporate opportunity in order to obtain a personal gain or benefit for themselves, family members or any other connected person.**

**11.2&nbsp;&nbsp;&nbsp;&nbsp;Any situation which gives rise, or might give rise to a conflict of interest should be disclosed as soon as it arises and, where required, written authority to proceed should be sought from the Company. Examples of situations where conflicts of interest may arise and the principles that should be applied include, but are not limited to, the following:**

**11.2.1&nbsp;&nbsp;&nbsp;&nbsp;Outside engagements - employees of the Company should not undertake any other business or profession, be an employee or agent of any other company, or have any financial interest in any other business or profession, other than: non-executive positions approved by the Company; community voluntary activities; and bona fide investment holdings of shares or other securities in entities that are not direct competitors of the Company, or minor holdings in competitors. Any exceptions to this requirement, which could for example apply to a part-time employee, must be approved by the Company.**

**11.2.2&nbsp;&nbsp;&nbsp;&nbsp;Dealings with related parties - employees and contractors should not enter into any business dealings on behalf of the Company with a family member, any business controlled by a family member or any other connected person with whom business dealings may result in a potential conflict of interest without first disclosing this to the Company and obtaining approval.**

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**11.2.3&nbsp;&nbsp;&nbsp;&nbsp;Insider trading - employees and contractors in possession of information on the basis of which an effect on the Company's securities may reasonably be predicted, may not trade in any of the Company's securities as long as they could take advantage of such sensitive information. Additional trading restrictions exist for senior executives during the two months prior to publication of the year-end results and for one month prior to the publication of quarterly results, and at other times indicated by the Executive Committee when the Company may be deemed to be in receipt of insider information.**

**11.2.4&nbsp;&nbsp;&nbsp;&nbsp;Gifts and entertainment - employees and contractors of the Company must ensure that they deal with customers, suppliers and other business relationships in a way that avoids their independent judgment on behalf of the Company being influenced by personal advantage, or any appearance that this may be the case. Local Company entities shall have in place specific rules governing gifts and entertainment, which reflects and is consistent with this Code and the Company's Anti-Bribery policy. In no instance, however, will any local policy conflict with the goals of this Code.**

**12.&nbsp;&nbsp;&nbsp;&nbsp;SUPPLIERS AND THEIR CONTRACTORS**

**12.1&nbsp;&nbsp;&nbsp;&nbsp;The Company is committed to proactively encouraging its suppliers and contractors to demonstrate responsible business behaviour and high standards of business conduct. This commitment is presently focussed on direct suppliers involved in the manufacture, assembly or distribution of products on behalf of Indivior companies, and on those suppliers' contractors who are actively engaged in work at Company facilities.**

**12.2&nbsp;&nbsp;&nbsp;&nbsp;The Company sets out minimum levels of performance and performance expectations for all suppliers manufacturing, assembling or distributing products on behalf of Indivior companies.**

**12.3&nbsp;&nbsp;&nbsp;&nbsp;The Company's environmental and occupational health and safety management systems include in their scope the activities of suppliers and contractors who are actively engaged in work at Company facilities.**

**13.&nbsp;&nbsp;&nbsp;&nbsp;SUSTAINABILITY AND THE ENVIRONMENT**

**13.1&nbsp;&nbsp;&nbsp;&nbsp;Indivior views corporate responsibility and sustainability as one and the same and is committed to moving its business towards greater sustainability across the economic, social and environmental dimensions of its activities. The Company believes that a more sustainable business will not only better fulfil our responsibilities to society but also contribute to delivering our vision of better consumer solutions and greater long-term shareholder value.**

**13.2&nbsp;&nbsp;&nbsp;&nbsp;The Company's Environmental Policy is publicly available and in place to coordinate environmental management across the Company.**

**14.&nbsp;&nbsp;&nbsp;&nbsp;COMPANY ASSETS**

**14.1&nbsp;&nbsp;&nbsp;&nbsp;Protecting Company assets - employees and contractors are responsible for the proper use, the protection and the maintaining of company assets, including intellectual property (e.g., patents, trademarks and designs). Company assets may only be used in relation to the Company's business. Our intellectual property rights are some of the Company's most variable assets and protecting them is critical to our continued success and growth. All employees and contractors are required to acknowledge their written agreement to maintain the confidentiality of the Company's proprietary information and the information of its business partners.**

**14.2&nbsp;&nbsp;&nbsp;&nbsp;Authorities - the existence of an agreed authorities structure is an essential requirement for establishing an effective financial and operational control environment. All business units are required to establish and maintain appropriate levels of authority, including appropriate signature authorities, to cover all items of asset value / expenditure and all transactions which need to be subject to management approval.**

**14.3&nbsp;&nbsp;&nbsp;&nbsp;Integrity of company financial records - the books and records of the Company must accurately reflect the nature of the underlying transactions and no undisclosed or unrecorded liabilities or assets shall be established or maintained. Books and records must be maintained in all respects according to law and the accounting principles, policies and procedures that the Company has adopted. The Company will not evade tax obligations and all taxable benefits which employees may receive will be listed and declared for tax purposes.**

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**14.4&nbsp;&nbsp;&nbsp;&nbsp;Protecting confidential information - employees and contractors must ensure that confidential information is preserved and protected. Confidential information is that which is not generally known outside the organisation and either gives or could give the Company a competitive advantage or disadvantage, or could lead to the loss of an existing competitive advantage, if it became known to others or became known in the public domain. This kind of information may not be revealed to anyone outside of the organisation unless an appropriate confidentiality agreement is in place and such disclosure is necessary for business purposes. Employees and contractors are required to respect these confidentiality provisions after their employment with the Company comes to an end.**

**15.&nbsp;&nbsp;&nbsp;&nbsp;DATA PRIVACY**

**15.1&nbsp;&nbsp;&nbsp;&nbsp;The Company values the personal data entrusted to it and respects the privacy of its employees, contractors and consumers and it will exercise appropriate and due care to legally ensure that sensitive personal information about employees, contractors and customers is not publicly disclosed.**

**15.2&nbsp;&nbsp;&nbsp;&nbsp;The Company is committed to collecting, using, retaining and disclosing personal data in a fair, transparent and secure way, which is at all times in accordance with applicable law. We may from time to time hold personal data about our employees, suppliers, patients/consumers and HCPs, among others, and where we collect and retain such data, we ensure that it is the minimum necessary for our business needs (e.g., administrative, scientific or legal purposes). In certain cases we will seek consent from individuals to process their personal data, for example, when we conduct clinical trials.**

**15.3&nbsp;&nbsp;&nbsp;&nbsp;We ensure the protection of the personal data we collect with appropriate safe-guards and filters to ensure that it does not fall into the wrong hands.**

**16.&nbsp;&nbsp;&nbsp;&nbsp;OTHER ISSUES**

**16.1&nbsp;&nbsp;&nbsp;&nbsp;Product safety and quality - the Company is committed to delivering quality products to its customers and consumers that are safe when used as directed for their intended purpose. We believe that this is implicit in our Company Mission and fundamental to our brands, our business and our long-term success. The Company has in place:**

**>&nbsp;&nbsp;&nbsp;&nbsp;a Product Safety Policy to fulfill our commitment to developing and marketing products that can be manufactured and used safely as directed; and**

**>&nbsp;&nbsp;&nbsp;&nbsp;a Quality Policy and Quality Management Systems (QMS) to control the quality of our products.**

**16.2&nbsp;&nbsp;&nbsp;&nbsp;Human rights - the Company believes that human rights are an absolute and universal standard. The Company subscribes to the United Nations Universal Declaration of Human Rights and the Convention on the Rights of the Child. In countries where the Company is present, we will aim to support progress on human rights issues in accordance with what reasonably can be expected from a commercial organisation.**

**16.3&nbsp;&nbsp;&nbsp;&nbsp;Political activities - the Company is not a political organsation. It neither supports political parties nor contributes to the funds of groups whose activities are calculated to promote party interests or the election of a specific candidate. In some limited instances, where permitted by local law and regulation and specifically approved by the Area Business Director, the Company may contribute funds toward organizations or entities that engage in the political process to address an issue that directly affects the Company and its business activity.**

**17.&nbsp;&nbsp;&nbsp;&nbsp;WHISTLE-BLOWING**

**Indivior has in place a confidential "whistle blower" policy and process, communicated globally, to encourage the reporting of any non-compliance with this Code. If in any doubt, employees and contractors can obtain full information on this process from the local Human Resources and Legal Departments. Whenever needed, the Company provides a confidential "whistle blower" hotline that employees and contractors anywhere in the world may use to report any violation of this Code, as well as any violation of any local law or regulation or any unethical behaviour.**

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**18.&nbsp;&nbsp;&nbsp;&nbsp;COMPLIANCE WITH THIS CODE**

**18.1&nbsp;&nbsp;&nbsp;&nbsp;All employees and contractors are required to comply with this Code and are personally responsible for doing so. It is the responsibility of the Board to ensure, so far as is reasonably practicable, that the principles and ethical values embodied in this Code are communicated to all colleagues of the Company.**

**18.2&nbsp;&nbsp;&nbsp;&nbsp;Employees and contractors must comply with any rules set out in this Code. Breach of any of the principles within the Code may result in disciplinary action, and a serious breach – such as if an employee or contractor is found to be in wanton abuse of the code and their actions cause reputational risk or damage and/or financial loss to the business – may amount to gross misconduct, which may result in summary dismissal and contract cessation. Fines to a company or part of a company within the group will impact on the P&L and performance payments of that business. In addition, the Company reserves the right to seek redress and damages from the individual(s) who has been found to have breached the code of conduct, irrespective of the position and location the individual(s) might hold, in or out of the company, at the time the breach of this Code comes to light.**

**18.3&nbsp;&nbsp;&nbsp;&nbsp;Employees and contractors at all levels will be required to certify, annually, that they understand the code and that they (and those they supervise who do not have a Company email address) are in full compliance with this Code for the operations for which they have responsibility. On an annual basis by Internal Audit, the Board monitors the findings of this certification. Those who do not have a Company email address will have the Code communicated to them. Those that supervise these colleague groups will be required to sign that these groups are in full compliance with the Code.**

**18.4&nbsp;&nbsp;&nbsp;&nbsp;The Board will not criticise management for any loss of business resulting from adherence to this Code. The Company undertakes that no employee or contractor will suffer as a consequence of bringing to the attention of the Board or senior management a known or suspected breach of this Code nor will any employee or contractors suffer any adverse employment or contract decision for abiding by this Code.**

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| | | |
|:---|:---|:---|
| | **Subject** | **Number** |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) | **ANTI-BRIBERY POLICY** | **Version 1.0** |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) | **Section** |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) | **POLICY STATEMENT** |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) | **Sponsor** | **Effective Date** |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) | **CHIEF LEGAL OFFICER** | **December 2014** |
| ![indiviorlogoa.jpg](indiviorlogoa.jpg) |  |  |

---

**Anti-Bribery Policy**

**Indivior PLC, its subsidiaries and related companies (the "Company") is committed to observing the laws and regulations which govern our operations in ever, country where we do business. This policy explains our individual responsibility in complying with anti-bribery or anti-corruption laws around the world and ensuring that any third parties that we engage to act on our behalf, do the same.**

**If you have any questions about this policy you should contact the Legal Department.**

**Any Company employee who violates the rules in this policy or who permits anyone to violate those rules may be subject to appropriate disciplinary action, up to and including dismissal, and may be subject to personal civil or criminal sanction.**

**1.&nbsp;&nbsp;&nbsp;&nbsp;Background**

**Our Code or Business Conduct requires all employees and contractors to accept responsibility for maintaining and enhancing the Company's reputation for integrity and fairness in its business dealings. We do not tolerate bribery. This policy is intended to help employees, contractors and other third parties acting on the Company's behalf to understand where issues might arise and to support them in making the right decisions in line with our corporate position as stated in this policy.**

**2.&nbsp;&nbsp;&nbsp;&nbsp;Board endorsement**

**The Board of Indivior PLC wilt not criticise management for any loss of business resulting from adherence to this policy. No employee or contractor will suffer as a consequence of bringing to the attention of the Board or senior management, in good faith, a known or suspected breach of this policy nor will any employee or contractors suffer any adverse employment or contract decision for abiding by this policy.**

**3.&nbsp;&nbsp;&nbsp;&nbsp;What's the risk?**

**Potential penalties for the Company include unlimited fines, costly litigation and adverse publicity. For individuals, penalties can include very large fines. Additionally, in the UK, US and some other countries, long terms of imprisonment are also possible.**

**4.&nbsp;&nbsp;&nbsp;&nbsp;What do we mean by bribery?**

**Bribery is the offering, promising or giving of a financial or other non-financial advantage to somebody, directly or indirectly, in order to influence improperly their views or actions. It also covers requesting, agreeing to receive or receiving a financial or other non-financial advantage, directly or indirectly, to influence improperly your views or actions. The law defines improper performance as a breach of trust, lack of impartiality or performance in bad faith.**

**Bribery of public officials (directly or indirectly, and in order to obtain or retain business or an advantage in doing business) as well as companies and private individuals are all equally prohibited under the laws of many countries and under this policy. The law Is intentionally drafted to cover a wide range of behaviour.**

**There is an accompanying Anti-Bribery Guidance document which gives specific examples to assist with compliance.**

Page **64** of **70**

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**5.&nbsp;&nbsp;&nbsp;&nbsp;What is my responsibility?**

---

| | |
|:---|:---|
| **You must not** | **You must** |
| **• offer, promise or give a bribe or utilise a third party to do so as the Company can be prosecuted for breaches of anti-bribery laws by third parties acting on its behalf** | **• be vigilant to the "red flag" issues set out (in section 11) below which indicate where further investigation or due diligence is necessary** |
| **• request, agree to receive or actually receive a bribe intended for your benefit or the benefit of your family, friends or acquaintances**  | **• report concerns to your local management, where possible, or through the Legal Department or through the The Company's confidential whistleblowing hotline** |

---

**6.&nbsp;&nbsp;&nbsp;&nbsp;Third parties**

**The Company could be held responsible for the actions of a third party (e.g. distributor, agent, contractor, supplier, joint venture partner) acting on its behalf. As such, care must be taken to ensure that those third parties do not attempt to engage in bribery.**

**All Indivior companies shall implement due diligence and approval procedures relating to the engagement of third parties. In general terms, all Indivior companies shall:**

**>&nbsp;&nbsp;&nbsp;&nbsp;ensure that any new third parties (or third parties whose contracts are being renewed) who provide services on behalf of the Company contractually agree to abide by applicable anti-bribery and anti-corruption laws, the principles set out in our Code of Business Conduct and this policy.**

**>&nbsp;&nbsp;&nbsp;&nbsp;undertake sufficient due diligence in relation to any proposed acquisition or joint venture to ensure that bribery is unlikely. This shall include checking for relationships with public officials. The results of the due diligence process shall be documented and produced on request by Internal Audit or the Legal Department.**

**>&nbsp;&nbsp;&nbsp;&nbsp;undertake sufficient due diligence (including checking of responses) in relation to the new third party's background, capability and reputation to ensure that bribery is unlikely, where any of the "red flags" and financial thresholds in section 11 of this policy are met. This shall include checking for relationships with public officials and documenting the reasons for choosing a particular third party. The results of the due diligence process shall be documented and produced on request by Internal Audit or the Legal Department. Further details are provided in the Anti-Bribery Guidance document. If the due diligence process raises concerns, you must contact the Legal Department immediately.**

**>&nbsp;&nbsp;&nbsp;&nbsp;repeat due diligence every two years for ongoing third party relationships or those which have not previously been checked but which meet the requirements above**

**A third party may only be engaged pursuant to a written contract that accurately and completely describes the goods or services to be provided, as well as the remuneration that the third party is to receive in return for those goods or services. Payment of third parties should be on commercially reasonable terms. Any payments to third parties shall be as provided under their contract which shall also set out the detail of the services which they shall provide. Requests for one-off changes to the payments shall be rejected unless the reason is clearly documented in writing.**

**7.&nbsp;&nbsp;&nbsp;&nbsp;Gifts and hospitality**

**There are legitimate reasons for the occasional giving/receiving of gifts and business-related hospitality but this area can pose a risk where excessive gifts or hospitality could be viewed as a bribe and/or a conflict of interest. The principles set out here apply regardless of whether the gift or hospitality is to be provided to a Company employee, a third party employee or to members of their respective families, friends or acquaintances. Indivior companies shall implement local spending limits and approval procedures relating to the provision of gifts and hospitality, as well as local procedures regarding the reporting of gifts received by Company employees above specified values.**

**<u>General principles:</u>**

**>&nbsp;&nbsp;&nbsp;&nbsp;Company employees must never ask or encourage a third party to provide a gift or hospitality to them**

**>&nbsp;&nbsp;&nbsp;&nbsp;The impression should never be given that the award of business is conditional on gifts or hospitality**

**>&nbsp;&nbsp;&nbsp;&nbsp;Under no circumstances should gifts of cash be given or received**

Page **65** of **70**

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**>&nbsp;&nbsp;&nbsp;&nbsp;Gifts and hospitality should be provided on an occasional basis and always in accordance with local laws**

**>&nbsp;&nbsp;&nbsp;&nbsp;Tickets to sporting events may be acceptable (provided that they are not offered or given to public officials or healthcare professionals) if they comply with the General Principles in this section**

**>&nbsp;&nbsp;&nbsp;&nbsp;Gifts and hospitality around the time of contracts being awarded/tendered should be avoided**

**>&nbsp;&nbsp;&nbsp;&nbsp;A useful test could be to consider whether you or the third party would have the resources to or would be likely to buy the gift/hospitality themselves**

**>&nbsp;&nbsp;&nbsp;&nbsp;Cultural sensitivities are important but they must not be used as an excuse to avoid the effect of this policy**

**>&nbsp;&nbsp;&nbsp;&nbsp;Gifts or hospitality of excessive value are not permitted**

**>&nbsp;&nbsp;&nbsp;&nbsp;All gifts and hospitality provided by the Company <u>must be</u> accurately recorded in the books of the relevant Indivior company**

**>&nbsp;&nbsp;&nbsp;&nbsp;Consider whether you would be happy to defend giving or receiving the relevant gift or hospitality to your peers, to senior management, to the media or to a judge.**

**<u>Special requirements for procurement of goods or services:</u>**

**When discussing tenders or award of contracts to provide goods or services to the Company, the relevant employees must not accept:**

**>&nbsp;&nbsp;&nbsp;&nbsp;payment of any travel or accommodation costs by the potential supplier**

**>&nbsp;&nbsp;&nbsp;&nbsp;kickbacks for awarding the business to that supplier**

**>&nbsp;&nbsp;&nbsp;&nbsp;tickets to entertainment events (e.g. sports events, theatre, opera)**

**>&nbsp;&nbsp;&nbsp;&nbsp;anything of value resulting from the Company awarding business to a third party which would benefit that individual or another third party, rather than the Company.**

**8.&nbsp;&nbsp;&nbsp;&nbsp;Facilitation payments**

**Facilitation payments are small unofficial payments to public officials to ensure or speed up performance of routine and non-discretionary governmental actions such as processing a visa application, securing a mail service, or connecting utilities. These will be seen as bribes under UK law, regardless of whether they may be a part of the "way of doing business" in a particular country. As a representative of the Company, you must not make any facilitation payment.**

**The prohibition on facilitation payments does not apply to situations in which a Company employee is faced with a serious medical or safety emergency. An employee faced with such an emergency must either seek prior approval from the Legal Department or, in circumstances where seeking prior approval is deemed impossible, record the details of any such payment and submit that information in writing to the Legal Department within 48 hours of the payment being made. Any such payments should be accurately recorded as facilitation payments in the Company's books and records.**

**9.&nbsp;&nbsp;&nbsp;&nbsp;Political contributions**

**As stated in our Code of Business Conduct (the "Code"), the Company is not a political organisation. It does not support political parties or contribute funds to groups whose activities are calculated to promote party interests or the election of a specific candidate. In some limited instances, if permitted by local law and regulation and with specific approval from the respective Area Business Director, the Company may contribute funds toward organisations or entities that engage in the political process to address an issue that directly affects the Company and its business activity. Any such request for approval for such payments and the permission must be documented in writing and the payments property recorded.**

**10.&nbsp;&nbsp;&nbsp;&nbsp;Charitable contributions**

**Charitable contributions may only be given to recognised non-profit charitable organisations with the prior approval of senior management. Indivior companies shall implement approval procedures regarding the making of charitable donations.**

**All donations must be:**

**>&nbsp;&nbsp;&nbsp;&nbsp;approved in accordance with applicable procedures;**

**>&nbsp;&nbsp;&nbsp;&nbsp;transparent and properly recorded in our books and records, and**

**>&nbsp;&nbsp;&nbsp;&nbsp;receipted or have a letter of acknowledgement from the charity to ensure that the donations receive the proper tax treatment**

Page **66** of **70**

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**Donations must not:**

**>&nbsp;&nbsp;&nbsp;&nbsp;be made to individuals or in cash;**

**>&nbsp;&nbsp;&nbsp;&nbsp;be made at the request of a public official as an inducement to or reward for acting improperly.**

**11.&nbsp;&nbsp;&nbsp;&nbsp;"Red flags"**

**There are a number of issues which should cause us to do some further investigation into whether a particular transaction or relationship may present a potential bribery issue. Please see the accompanying guidance for a list of countries where there is perceived to be high levels of corruption.**

**Potential issues which call for further investigation include:**

**>&nbsp;&nbsp;&nbsp;&nbsp;the prevalence of bribery in a country**

**>&nbsp;&nbsp;&nbsp;&nbsp;payments of unusually high fees or commissions**

**>&nbsp;&nbsp;&nbsp;&nbsp;requests for cash payments**

**>&nbsp;&nbsp;&nbsp;&nbsp;requests for payments to different companies or through different countries**

**>&nbsp;&nbsp;&nbsp;&nbsp;undefined or unreported payments to third parties made on the Company's behalf**

**>&nbsp;&nbsp;&nbsp;&nbsp;no written agreements**

**>&nbsp;&nbsp;&nbsp;&nbsp;unusually close relationships with government officials**

**>&nbsp;&nbsp;&nbsp;&nbsp;a refusal to certify compliance with this policy.**

**Financial thresholds for third party due diligence: where expected fees or commissions with a third party are likely** 

**to exceed 10,000 GBP per year or 100,000 GBP in the case of suppliers to an individual Company factory. In addition, due diligence should be conducted on any prospective third party that will be interacting with healthcare professionals, public officials and customers on behalf of the Company, regardless of the fee or commission values.**

**12.&nbsp;&nbsp;&nbsp;&nbsp;Guidance and Training**

**Training is an important part of the implementation of the Company's Anti-Bribery Policy and procedures. Online training will be provided to all employees with computer access and more detailed face to face training will be provided to certain groups of employees.**

**In recognition of the large number of queries which this policy may raise, there is an accompanying Anti-Bribery Guidance document which gives specific examples to assist with compliance.**

**13.&nbsp;&nbsp;&nbsp;&nbsp;Review, certification and Audit**

**This policy shall be reviewed regularly by the Legal Department and shall be amended to reflect any changes in law or practice. Under the annual certification procedure in relation to the Code, employees and contractors must certify compliance with that Code which includes a prohibition of bribery. The Board will monitor this policy at least annually and through periodic review of Internal Audit findings by the Audit Committee.**

Page **67** of **70**

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**AMENDMENT NO. 1 TO THE**

**MASTER MANUFACTURING SERVICES AGREEMENT**

This Amendment No. 1 (this "**Amendment**"), is entered into and effective as of the last signature date below (the "**Effective Date**"), to the Master Manufacturing Services Agreement between Patheon Manufacturing Services LLC, a limited liability company existing under the laws of the State of Delaware, located at 1675 S State Street, Suite B, Dover, DE 19901 ("**Patheon**"), and Indivior UK Limited (CO No. 7183451), a corporation organized and existing under the laws of England and Wales having its registered address at Chapleo Building, Henry Boot Way, Priory Park, Hull, HU4 7BY, United Kingdom ("**Indivior**") on April 6, 2018 (the "**Agreement**").

WHEREAS the Federal Supply Schedule requires compliance with all applicable federal contracting laws and regulations;

WHEREAS Indivior and Patheon have complied with all applicable federal contracting laws and Federal Acquisition Regulations (FARs) and seek to ensure Indivior's and Patheon's continued compliance with all applicable federal contracting laws and FARs;

WHEREAS Indivior and Patheon each agree to abide by all applicable federal contracting laws and FARs as are applicable to each of them with respect to the commercial relationship between Indivior and Patheon; and

WHEREAS the parties desire to amend the Agreement as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;Exhibit A to this Amendment is hereby incorporated into the terms of the Agreement as <u>Exhibit G</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;Except as provided herein, all other terms and conditions of the Agreement shall remain in full force and effect.

3.&nbsp;&nbsp;&nbsp;&nbsp;

**IN WITNESS WHEREOF,** each of the parties hereto has caused this Amendment to be executed by its duly authorized representatives, as of the Effective Date.

---

| | |
|:---|:---|
| **Patheon Manufacturing Services LLC** | **Indivior UK Limited** |
| By: *<u>/s/ Michelle Logan</u>* | By: *<u>Miriam McCloskey</u>* |
| Name: Michelle Logan | Name: Miriam McCloskey |
| Title: VP GM Greenville, NC | Title: Head of Global Direct Procurement |
| Date: May 27, 2021 | Date: May 27, 2021 |

---

Page **68** of **70**

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**Exhibit A**

**Patheon's Representations & Warranties**

To the extent applicable, Patheon represents and warrants to Indivior, that it will comply with all applicable federal contracting laws and Federal Acquisition Regulations (FARs), which may include, but are not limited to:

---

| | |
|:---|:---|
| Citation | Title |
| FAR 52.203-6 (2020) | Restrictions on Subcontractor Sales to the Government |
| FAR 52.203-13 (2020) | Contractor Code of Business Ethics and Conduct" |
| FAR 52.203-17 (2020) | Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights |
| FAR 52.203-19 (2017) | Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements |
| FAR 52.204-10 (2016) | Reporting Executive Compensation and First-Tier Subcontract Awards |
| FAR 52.204-21 (2016) | Basic Safeguarding of Covered Contract Information Systems |
| FAR 52.204-23 (2018) | Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities |
| FAR 52.204-25 (2020) | Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment |
| FAR 52.209-6 (2020) | Protecting the Government's Interest when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment |
| FAR 52.209-9 (2013) | Updates of Publicly Available Information Regarding Responsibility Matters |
| FAR 52.209-10 (2015) | Prohibition on Contracting with Inverted Domestic Corporations |
| FAR 52.212-5 (2020) | Contract Terms and Conditions Required to Implement Statues or Executive Orders - Commercial Items |
| FAR 52.219-3 (2011) | Notice of HUBZone Set-Aside or Sole-Source Award |
| FAR 52.219-6 (2011) | Notice of Total Small Business Set-Aside |
| FAR 52.219-8 (2016) | Utilization of Small Business Concerns |
| FAR 52.219-14 (2017) | Limitations on Subcontracting |
| FAR 52.219-16 (1999) | Liquidated Damages-Subcontracting Plan |
| FAR 52.219-27 (2011) | Notice of Service-Disabled Veteran-Owned Small Business Set-Aside |
| FAR 52.219-28 (2013) | Post Award Small Business Program Rerepresentation |
| FAR 52.219-29 (2015) | Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns |
| FAR 52.219-30 (2015) | Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program |
| FAR 52.222-3 (2003) | Convict Labor |
| FAR 52.222-17 (2014) | Nondisplacement of Qualified Workers |
| FAR 52.222-19 (2018) | Child Labor-Cooperation with Authorities and Remedies |
| FAR 52.222-21 (2015) | Prohibition of Segregated Facilities |
| FAR 52.222-26 (2015) | Equal Opportunity |
| FAR 52.222-35 (2020) | Equal Opportunity for Veterans |
| FAR 52.222-36 (2020) | Equal Opportunity for Workers with Disabilities |
| FAR 52.222-37 (2020) | Employment Reports on Veterans |
| FAR 52.222-40 (2010) | Notification of Employee Rights Under the National Labor Relations Act |
| FAR 52.222-41 (2018) | Service Contract Labor Standards |
| FAR 52.222-42 (2014) | Statement of Equivalent Rates for Federal Hires |
| FAR 52.222-43 (2018) | Fair Lavor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) |

---

Page **69** of **70**

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---

| | |
|:---|:---|
| FAR 52.222-44 (2014) | Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment |
| FAR 52.222-50 (2020) | Combating Trafficking in Persons |
| FAR 52.222-51 (2014) | Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements |
| FAR 52.222-53 (2014) | Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements |
| FAR 52.222-54 (2015) | Employment Eligibility Verification |
| FAR 52.222-55 (2020) | Minimum Wages Under Executive Order 13658 |
| FAR 52.222-62 (2017) | Paid Sick Leave Under Executive Order 13706 |
| FAR 52.223-11 (2016) | Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons |
| FAR 52.223-18 (2011) | Encouraging Contractor Policies to Ban Text Messaging While Driving |
| FAR 52.223-20 (2016) | Aerosols |
| FAR 52.223-21 (2016) | Foams |
| FAR 52.224-3 (2017) | Privacy Training |
| FAR 52.225-5 (2016) | Trade Agreements |
| FAR 52.225-13 (2008) | Restriction of Certain Foreign Purchases |
| FAR 52.225-26 (2016) | Contractors Performing Private Security Functions Outside the United States |
| FAR 52.226-6 (2020) | Promoting Excess Food Donation to Nonprofit Organizations |
| FAR 52.232-33 (2013) | Payment by Electronic Funds Transfer—System for Award Management |
| FAR 52.232-34 (2013) | Payment by Electronic Funds Transfer—Other than System for Award Management |
| FAR 52.232-36 (2014) | Payment by Third Party |
| FAR 52.232-40 (2013) | Providing Accelerated Payment to Small Business Subcontractors |
| FAR 52.233-3 (1996) | Protest After Award |
| FAR 52.233-4 (2004) | Applicable Law for Breach of Contract Claim |
| FAR 52.242-5 (2017) | Payments to Small Business Subcontractors |
| FAR 52.247-64 (2006) | Preference for Privately Owned U.S.-Flag Commercial Vessels |

---

All applicable federal contracting laws and FARs, with respect to the rights, duties, and obligations of Indivior and Patheon, shall be interpreted and construed in such a manner as to recognize and give effect to: (i) the contractual relationship between Indivior and Patheon under this Agreement; and (ii) the rights of the Federal Government with respect thereto. To the extent that any FAR listed above is not applicable to the Manufacturing Services provided by Patheon under the Agreement, that FAR will be considered self-deleting.

Page **70** of **70**

## Exhibit 4.18

**Exhibit 4.18.2**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**<u>RISPERIDONE PRODUCT AGREEMENT</u>**

**<u>(Includes Schedules A to E)</u>**

**<u>PRODUCT AGREEMENT</u>**

This Product Agreement (this "**Product Amendment**") is issued under the Master Manufacturing Services Agreement dated April 6, 2018 between **Patheon Manufacturing Services LLC**, and **lndivior UK Limited** (the "**Master Agreement**"), and is entered into on the date of last signature below (the "**Effectlve Date**"), between Patheon Manufacturing Services LLC, a limited liability company existing under the laws of the State of Delaware having a principal place of business at 5900 Martin Luther King Jr. Hwy, Greenville, NC 27834 (**"Patheon"**) and lndivior UK Limited, incorporated and registered in England with company number 7183451 with its registered office at 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom ("**lndivior**").

The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement. All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in the Master Agreement.

The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of this Product Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;**Product List and Specifications** (See Schedule A attached hereto)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;**Minimum Order Quantity, Annual Volume, and Price** (See Schedule B attached hereto)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.&nbsp;&nbsp;&nbsp;&nbsp;**Annual Stability Testing and Validation Activities (if applicable)** (See Schedule C attached hereto)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.&nbsp;&nbsp;&nbsp;&nbsp;**Active Materials, Active Materials Credit Value, and Maximum Credit Value** (See Schedule D attached hereto)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.&nbsp;&nbsp;&nbsp;&nbsp;**Metrics:** (See Schedule E attached hereto)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.&nbsp;&nbsp;&nbsp;&nbsp;**Yearly Forecasted Volume:** Not applicable

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.&nbsp;&nbsp;&nbsp;&nbsp;**lncoterm for Transport (If other than EXW):** FCA

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.&nbsp;&nbsp;&nbsp;&nbsp;**Territory:** United States

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.&nbsp;&nbsp;&nbsp;&nbsp;**Manufacturing Site:** [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.&nbsp;&nbsp;&nbsp;&nbsp;**Governing Law:** Per Section 13.17 of the Master Agreement

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.&nbsp;&nbsp;&nbsp;&nbsp;**Inflation Index:** Per Section 4.2(a) of the Master Agreement

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.&nbsp;&nbsp;&nbsp;&nbsp;**Currency:** $USD

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.&nbsp;&nbsp;&nbsp;&nbsp;**Initial Set Exchange Rate:** Not applicable

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.&nbsp;&nbsp;&nbsp;&nbsp;**Initial Product Term**: From the Effective Date until December 31, 2020, unless otherwise terminated as set forth in Section 8.2 of the Master Agreement. This Product Agreement may be renewed after the Initial Product Term for further successive terms of two Years each (each a **"Renewal Product Term"**), as reflected in an amendment to this Product Agreement that is signed by both parties . The parties shall agree to any such extension at least 18 months prior to the end of the Initial Product Term or then current Renewal Product Term, as applicable. The Initial Product Term and the Renewal Product Term shall be referred to collectively herein as the "**Product Term**."

It is the understanding of the parties that they will negotiate the purchase of an automated filler pursuant to the terms of a separate written Capital Equipment Agreement between the parties and the parties will use commercially reasonable efforts to install and have the automated filler validated by September 30, 2019. If the automated filler is not validated by December 31, 2019, beginning January 1, 2020, the Price in Schedule B will be increased by [\*\*\*]%. If the automated filler is not validated by September 30, 2020, Patheon may terminate this Product Agreement by providing lndivior with three months' prior written notice . The parties will negotiate in good faith to amend this Product Agreement to reflect the inclusion of the automated filler in the manufacturing process. Both parties agree that the Price of the Product produced on the automated filler will reflect the efficiencies gained in the change from manual to automatic process . Both parties agree to use commercially reasonable efforts to execute the Capital Equipment Agreement by July 31, 2018.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;15.&nbsp;&nbsp;&nbsp;&nbsp;**Notices**: Per Section 13.9 of the Master Agreement

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.&nbsp;&nbsp;&nbsp;&nbsp;**Other Modifications to the Master Agreement**: Not applicable

IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Product Agreement as of the Effective Date set forth above.

---

| |
|:---|
| **PATHEON MANUFACTURING SERVICES LLC** |
| By: *<u>/s/ Lukas Utiger</u>* |
| Name: <u>Lukas Utiger</u> |
| Title: <u>President DSS & PDS</u> |
| Date: <u>20 April 2018</u> |
| **INDIVIOR UK LIMITED** |
| By: *<u>/s/ Frank Stier</u>* |
| Name: <u>Frank Stier</u> |
| Title: <u>Chief Manufacturing & Supply Officer</u> |
| Date: <u>April 25, 2018</u> |

---

------

**<u>SCHEDULE A</u>**

**<u>PRODUCT LIST AND SPECIFICATIONS</u>**

**<u>Product List</u>**

Risperidone Powder Filled Syringes, 90mg and 120mg 1.2 ml syringe

**<u>Specifications</u>**

Prior to the start of commercial manufacturing of Product under this Product Agreement, lndivior will give Patheon the originally executed copies of the Specifications as approved by the applicable Regulatory Authority. If the Specifications received are subsequently amended, then lndivior will give Patheon the revised and originally executed copies of the revised Specifications. Upon acceptance of the revised Specifications, Patheon will give lndivior a signed and dated receipt indicating Patheon's acceptance of the revised Specifications. Current specifications are as follows.

90mg Drug Product Analytical Standard&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

120mg Drug Product Analytical Standard&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

------

**<u>SCHEDULE B</u>**

**<u>MINIMUM ORDER QUANTITY, ANNUAL VOLUME, AND PRICE</u>**

**Annual Volume Assumptions**

For this Product Agreement, Patheon is assuming a minimum of [\*\*\*] commercial batches ([\*\*\*] per strength) in 2018 (after PVs but prior to approval) per lndivior's request. For efficiency purposes, the commercial batch campaign (Post PVs) should commence within [\*\*\*] weeks of completion of the PV campaign and run continuously until completion. For 2019, Patheon is assuming a minimum of [\*\*\*] commercial batches ([\*\*\*] per strength). For efficiency purposes, lndivior will provide the timing for manufacture at least [\*\*\*] months in advance prior to each campaign and the batches should be executed in [\*\*\*] campaigns. For the purposes of this Product Agreement, **"campaign"** means a series of batches manufactured continuously until completion of the Firm Order. Beginning in 2020, Patheon assumes that commercial batches will be produced utilizing the automated filler and pricing for these batches is not included in this Product Agreement. If the automated filler is not validated in 2020, Patheon shall not be obligated to support more than [\*\*\*] campaigns in 2020.

**Pricing Tables**

Commercial Batch Prices:

---

| | | |
|:---|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Product** | **Product Strength** | **Price per batch ($)** |
| &nbsp;&nbsp;Risperidone Powder Filled Syringes | 90mg | $[\*\*\*] |
| &nbsp;&nbsp;Risperidone Powder Filled Syringes | 120mg | $[\*\*\*] |

---

**Minimum Annual Revenue Commitment**

lndivior will pay Patheon a minimum annual revenue of $[\*\*\*] for each calendar year during the Product Term (the **"Minimum Annual Revenue Commitment"**). The parties acknowledge and agree that the Product volume and total fees set forth in Project Proposal [\*\*\*] between the parties dated 5 March 2018 shall count towards Indivior's fulfillment of the Minimum Annual Revenue Commitment for calendar year 2018. If lndivior fails to order sufficient Product volume to reach the Minimum Annual Revenue Commitment during any such calendar year, Patheon shall invoice lndivior for a true-up payment within 30 days of the end of the calendar year.

**Costs Included in Price**

1.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.3&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.4&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.5&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.6&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.7&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

**2.&nbsp;&nbsp;&nbsp;&nbsp; Costs Not Included in Price**

2.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.3&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.4&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.5&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.6&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

------

2.7&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.8&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.9&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.10&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.11&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.12&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

**3.&nbsp;&nbsp;&nbsp;&nbsp;Capital Requirements**

This Product Agreement assumes no additional capital is required at this time.

**Key Technical Parameters**

The following technical parameters apply to the production of Product and the Materials used therein. Pricing may be adjusted to reflect any technical changes foreseen during the technology transfer project or after the manufacture of validation batches to reflect any Specification or process changes.

**1.&nbsp;&nbsp;&nbsp;&nbsp;Manufacturing Parameters**

1.1&nbsp;&nbsp;&nbsp;&nbsp;**API** – [\*\*\*]

1.2&nbsp;&nbsp;&nbsp;&nbsp;**Batch size** – [\*\*\*].

1.3&nbsp;&nbsp;&nbsp;&nbsp;**Manufacturing campaign** – [\*\*\*].

1.4&nbsp;&nbsp;&nbsp;&nbsp;**Product filling process**: [\*\*\*].

1.5&nbsp;&nbsp;&nbsp;&nbsp;**Weight Checks** – [\*\*\*].

1.6&nbsp;&nbsp;&nbsp;&nbsp;**Visual inspection** – [\*\*\*].

**2.&nbsp;&nbsp;&nbsp;&nbsp;Packaging Parameters**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.&nbsp;&nbsp;&nbsp;&nbsp;**

2.1&nbsp;&nbsp;&nbsp;&nbsp;**Primary packaging Components (Indivior-Supplied Components):**

---

| | |
|:---|:---|
| &nbsp;&nbsp;**Component** | &nbsp;&nbsp;**Specification** |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;[\*\*\*] |

---

2.2&nbsp;&nbsp;&nbsp;&nbsp;**Secondary packaging** – [\*\*\*]

**3.&nbsp;&nbsp;&nbsp;&nbsp;Testing Conditions**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.&nbsp;&nbsp;&nbsp;&nbsp;**

3.1&nbsp;&nbsp;&nbsp;&nbsp;QC test methods must be fully validated and robust at the time of manufacture.

---

| | |
|:---|:---|
| **Testing Requirements** | **Testing Requirements** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**In-Process Controls** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Finished Product Testing** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;- | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;- | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] |

---

------

**4.&nbsp;&nbsp;&nbsp;&nbsp; Supply Chain**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.&nbsp;&nbsp;&nbsp;&nbsp;**

4.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

4.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

4.3&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

4.4&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

4.5&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

------

**<u>SCHEDULE C</u>**

**<u>ANNUAL STABILITY TESTING</u>**

Patheon and lndivior will agree in writing on any stability testing to be performed by Patheon on the Products. This agreement will specify the commercial and Product stability protocols applicable to the stability testing and the fees payable by lndivior for this testing including the Price for the Product withdrawn for the stability testing.

------

**<u>SCHEDULE D</u>**

**<u>ACTIVE MATERIALS</u>**

---

| | |
|:---|:---|
| &nbsp;&nbsp;**Active Materials** | &nbsp;&nbsp;**Supplier** |
| &nbsp;&nbsp;Risperidone | &nbsp;&nbsp;[\*\*\*] |

---

**<u>ACTIVE MATERIALS CREDIT VALUE</u>**

The Active Materials Credit Value will be as follows:

---

| | | |
|:---|:---|:---|
| &nbsp;&nbsp;**PRODUCT** | &nbsp;&nbsp;**ACTIVE MATERIALS** | &nbsp;&nbsp;**ACTIVE MATERIALS CREDIT VALUE** |
| &nbsp;&nbsp;Risperidone | &nbsp;&nbsp;Risperidone | &nbsp;&nbsp;[\*\*\*] |

---

**<u>MAXIMUM CREDIT VALUE</u>**

Patheon's liability for Active Materials calculated in accordance with Section 2.2 of the Master Agreement for any Product in a Year will not exceed, in the aggregate, the maximum credit value set forth below:

---

| | |
|:---|:---|
| &nbsp;&nbsp;**PRODUCT** | &nbsp;&nbsp;**MAXIMUM CREDIT VALUE** |
| &nbsp;&nbsp;Risperidone | &nbsp;&nbsp;[\*\*\*] |

---

------

**<u>SCHEDULE E</u>**

**<u>METRICS</u>**

---

| | | | | |
|:---|:---|:---|:---|:---|
| **#** | **Metric** | **Definition** | **Time of measurement** | **Target** |
| 1 | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 2 | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 3 | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 4 | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 5 | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**FIRST AMENDMENT TO RISPERIDONE PRODUCT AGREEMENT**

THIS FIRST AMENDMENT TO **RISPERIDONE PRODUCT AGREEMENT** (this "**Amendment**"), effective as of January 1, 2019 ("**Amendment Effective Date**"), is made between Indivior UK Limited ("**Indivior**") and Patheon Manufacturing Services LLC ("**Patheon**"). Indivior and Patheon may be referred to herein individually as a "Party" or collectively, as "Parties."

**Background**

The Parties entered into a Master Manufacturing Services Agreement effective April 6, 2018 (the "**MSA**") under which they entered into the Risperidone Product Agreement effective April 25, 2018 (the "**Product Agreement**"). The Parties desire to revise Section 14 and update the pricing for 2019 in Schedule B of the Product Agreement ("**Schedule B**").

**Agreement**

NOW THEREFORE in consideration of the rights conferred and the obligations assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each Party), and intending to be legally bound the Parties agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;**Section 14, Initial Product Term,** is hereby deleted in its entirety and replaced with the following:

**Initial Product Term**: From the Effective Date until December 31, 2022, unless otherwise terminated as set forth in Section 8.2 of the Master Agreement. The parties will agree to any extension at least 18 months prior to the end of the Initial Product Term. The Initial Product Term and the Renewal Product Term will be referred to collectively herein as the "**Product Term**."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;**Schedule B** is hereby deleted in its entirety and replaced with the **new Schedule B** attached hereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly provided in this Amendment, all other terms, conditions and provisions of the MSA and Product Agreement remain in full force and effect. To the extent there are any inconsistencies or ambiguities between the terms of this Amendment and the MSA or Product Agreement, the terms of this Amendment will prevail.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.&nbsp;&nbsp;&nbsp;&nbsp;The Background section of this document is expressly incorporated into this Amendment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.&nbsp;&nbsp;&nbsp;&nbsp;This Amendment may be executed in two counterparts each of which will be deemed an original but both of which taken together will constitute one and the same instrument.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.&nbsp;&nbsp;&nbsp;&nbsp;The Parties agree that all statements requiring the negotiation and purchase of an automated filler pursuant to the terms of a separate written Capital Equipment Agreement, whether stated in the Product Agreement, MSA, or Project Proposal [\*\*\*], are hereby declared null and void and of no effect.

------

IN WITNESS WHEREOF, the Parties have caused their duly appointed representatives to execute this Amendment as of the Amendment Effective Date.

---

| | |
|:---|:---|
| **Patheon Manufacturing Services LLC** | **Indivior UK Limited** |
| By: *<u>/s/ Nick Buschur</u>*<br>Name: <u>Nick Buschur</u><br>Title: <u>Vice President and General Manager</u><br>Date: January 1, 2019 | By: *<u>/s/ Frank Stier</u>*<br>Name: <u>Frank Stier</u><br>Title: <u>Chief Supply Officer</u><br>Date: January 1, 2019 |

---

------

**<u>SCHEDULE B</u>**

**<u>MINIMUM ORDER QUANTITY, ANNUAL VOLUME, AND PRICE</u>**

**Annual Volume Assumptions**

For 2019, Patheon is assuming a minimum of [\*\*\*] commercial batches ([\*\*\*] per strength). For efficiency purposes, Indivior will provide the timing for manufacture at least [\*\*\*] months in advance prior to each campaign and the batches should be executed in [\*\*\*] campaigns. For the purposes of this Product Agreement, "**campaign**" means a series of batches manufactured continuously until completion of the Firm Order.

**Pricing Tables**

Commercial Batch Prices: The following manual filling commercial Prices will be in effect for 2019 and include the PPI increases for the Year per Agreement

---

| | | |
|:---|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Product** | **Product Strength** | **Price per batch ($)** |
| &nbsp;&nbsp;Risperidone Powder Filled Syringes | 90mg | $[\*\*\*] |
| &nbsp;&nbsp;Risperidone Powder Filled Syringes | 120mg | $[\*\*\*] |

---

**Minimum Annual Revenue Commitment**

Indivior will pay Patheon a minimum annual revenue of $[\*\*\*] for each calendar year during the Product Term (the "**Minimum Annual Revenue Commitment**"). If Indivior fails to order sufficient Product volume to reach the Minimum Annual Revenue Commitment during any calendar year, Patheon will invoice Indivior for a true-up payment within 30 days of the end of the calendar year.

**Costs Included in Price**

1.8&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.9&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.10&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.11&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.12&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.13&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

1.14&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

**Costs Not Included in Price**

2.13&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.14&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.15&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.16&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.17&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.18&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.19&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.20&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.21&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.22&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

2.23&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

------

2.24&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

**Capital Requirements**

Capital Requirements for the manufacture of the Product will be addressed in a separate Capital Expenditure and Equipment Agreement between the Parties.

**Key Technical Parameters**

The following technical parameters apply to the production of Product and the Materials used therein. Pricing may be adjusted to reflect any technical changes foreseen during the technology transfer project or after the manufacture of validation batches to reflect any Specification or process changes.

**Manufacturing Parameters**

4.6&nbsp;&nbsp;&nbsp;&nbsp;**API** – [\*\*\*]

4.7&nbsp;&nbsp;&nbsp;&nbsp;**Batch size** – [\*\*\*].

4.8&nbsp;&nbsp;&nbsp;&nbsp;**Manufacturing campaign** – [\*\*\*].

4.9&nbsp;&nbsp;&nbsp;&nbsp;**Product filling process**: [\*\*\*].

4.10&nbsp;&nbsp;&nbsp;&nbsp;**Weight Checks** – [\*\*\*].

4.11&nbsp;&nbsp;&nbsp;&nbsp;**Visual inspection** – [\*\*\*].

**Packaging Parameters**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.&nbsp;&nbsp;&nbsp;&nbsp;**

**Primary packaging Components (Indivior-Supplied Components):**

---

| | |
|:---|:---|
| &nbsp;&nbsp;**Component** | &nbsp;&nbsp;**Specification** |
| &nbsp;&nbsp;[\*\*\*]  | &nbsp;&nbsp;[\*\*\*]  |
| &nbsp;&nbsp;[\*\*\*]  | &nbsp;&nbsp;[\*\*\*]  |

---

5.1&nbsp;&nbsp;&nbsp;&nbsp;**Secondary packaging** – [\*\*\*]

**Testing Conditions**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**6.&nbsp;&nbsp;&nbsp;&nbsp;**

6.1&nbsp;&nbsp;&nbsp;&nbsp;QC test methods must be fully validated and robust at the time of manufacture.

---

| | |
|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Testing Requirements** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Testing Requirements** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**In-Process Controls** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Finished Product Testing** |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]  | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;- | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;- | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]  |

---

------

**Supply Chain**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**7.&nbsp;&nbsp;&nbsp;&nbsp;**

7.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

7.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

7.3&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

7.4&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

7.5&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

------

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**SECOND AMENDMENT TO RISPERIDONE PRODUCT AGREEMENT**

THIS SECOND AMENDMENT TO THE **RISPERIDONE PRODUCT AGREEMENT** (this "**Amendment**"), effective as of March 1, 2019 ("**Amendment Effective Date**"), is made between Indivior UK Limited ("**Indivior**") and Patheon Manufacturing Services LLC ("**Patheon**"). Indivior and Patheon may be referred to herein individually as a "Party" or collectively, as "Parties."

**Background**

The Parties entered into a Master Manufacturing Services Agreement effective dated April 6, 2018 (the "**MSA**") under which they entered into the Risperidone Product Agreement effective April 25, 2018 as amended by the First Amendment to the Risperidone Product Agreement (the "**First Amendment**") effective January 1, 2019 (collectively, the "**Product Agreement**"). The Parties are currently negotiating, and intend to finalize by June 1, 2019, a Capital Expenditure and Equipment Agreement (the "**Capital Equipment Agreement**") to install an automated filler in the Manufacturing Site. In this Amendment the Parties intend to confirm the business terms arising from the installation of the automated filler for the Product, transfer the current manual process to the automated filler, and amend the Prices in Schedule B of the Product Agreement ("**Schedule B**").

**Agreement**

NOW THEREFORE in consideration of the rights conferred and the obligations assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each Party), and intending to be legally bound the Parties agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.&nbsp;&nbsp;&nbsp;&nbsp;Section 14 is hereby deleted in its entirety and replaced with the following:

**Initial Product Term**: From the Effective Date until December 31, 2027, unless otherwise terminated as set forth in Section 8.2 of the Master Agreement. This Product Agreement may be renewed after the Initial Product Term for further successive terms of two Years each (each a "**Renewal Product Term**"), as reflected in an amendment to this Product Agreement that is signed by both parties. The parties will agree to any such extension at least 18 months prior to the end of the Initial Product Term or then current Renewal Product Term, as applicable. The Initial Product Term and the Renewal Product Term will be referred to collectively herein as the "**Product Term**."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.&nbsp;&nbsp;&nbsp;&nbsp;For purposes of this Product Agreement only, Section 8.3 (a) of the MSA is modified to include the following new Section 8.3 (a)(vi):

If the Agreement is terminated by Indivior under Section 8.2(a), Patheon will support Indivior in the transfer of the Product to a third party and will pay for the reasonable costs of the transfer. Patheon will use commercially reasonable efforts to transfer from the Manufacturing Site, within 60 days of receipt of written notice from Indivior, all unused Active Material and Indivior-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, equipment or other moveable property owned by Indivior, related to the Product Agreement and located at the Manufacturing Site or that is otherwise under Patheon's care and control ("**Indivior Property**") at Patheon's reasonable cost. The costs for the transfer to the third party and the costs to transfer the Indivior Property will not exceed $[\*\*\*].

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.&nbsp;&nbsp;&nbsp;&nbsp;Schedule B is hereby deleted in its entirety and replaced with the new Schedule B attached hereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.&nbsp;&nbsp;&nbsp;&nbsp;The following will be added to Section 16 of the Product Agreement:

"For the purposes of this Product Agreement only, the following additional termination provision will apply:

After December 31, 2022, Indivior may terminate this Product Agreement at any time and for any reason upon 12 months prior written notice to Patheon. If this occurs, Indivior will pay Patheon a termination fee of $[\*\*\*] on the termination date. In addition, after December 31, 2022, Indivior may terminate this Product Agreement at any time and for any reason upon 60 days' prior written notice to Patheon. If this occurs, Indivior will pay Patheon a termination fee of $[\*\*\*] on the termination date."

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly provided in this Amendment, all other terms, conditions and provisions of the MSA and Product Agreement remain in full force and effect. To the extent there are any inconsistencies or ambiguities between the terms of this Amendment and the MSA or Product Agreement, the terms of this Amendment will prevail.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.&nbsp;&nbsp;&nbsp;&nbsp;The Background section of this document is expressly incorporated into this Amendment.

------

IN WITNESS WHEREOF, the Parties have caused their duly appointed representatives to execute this Amendment as of the Amendment Effective Date.

---

| | |
|:---|:---|
| **Patheon Manufacturing Services LLC** | **Indivior UK Limited** |
| By: *<u>/s/ Nick Buschur</u>*<br>Name: <u>Nick Buschur</u><br>Title: <u>Vice President and General Manager</u><br>Date: 26 July 2019 | By: *<u>/s/ Frank Stier</u>*<br>Name: <u>Frank Stier</u><br>Title: <u>Chief Supply Officer</u><br>Date: 25 July 2019 |

---

------

**<u>SCHEDULE B</u>**

**<u>MINIMUM ORDER QUANTITY, ANNUAL VOLUME, AND PRICE</u>**

**Manual Filling Annual Volume Assumptions**

The manual filling Price will start in Year 2019 and continue until the manufacturing process is transferred and commercialized on the automated filler. Indivior must provide the timing for manufacture at least [\*\*\*] months prior to each campaign and the batches should be manufactured in no more than [\*\*\*] campaigns. For the purposes of this Product Agreement, "**campaign**" means a series of batches manufactured continuously until completion of the Firm Order. Manual filling of Product will continue as provided in the First Amendment until the automated filler line can be commercialized but in no case later than December 31, 2022 unless otherwise agreed to by the Parties in writing.

**Manual Filling Pricing Tables**

Commercial Batch Prices for the manual filling are set forth below. These Prices will apply until the first commercial batches are manufactured for Indivior on the automated filler line. When this occurs, manual filling will cease and automated line filling will continue.

Commercial Batch Prices:

---

| | | |
|:---|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Product** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Product Strength** | &nbsp;&nbsp;&nbsp;&nbsp;**Price per batch ($)** |
| &nbsp;&nbsp;&nbsp;&nbsp;Risperidone Powder Filled Syringes | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;90mg | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;$[\*\*\*] |
| &nbsp;&nbsp;&nbsp;&nbsp;Risperidone Powder Filled Syringes | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;120mg | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;$[\*\*\*] |

---

[\*\*\*].

**<u>INDIVIOR NEW AUTOMATED POWDER FILLER</u>**

**Executive Summary** 

Following execution of this Amendment and in parallel with the ongoing manual filling commercial operations, Patheon will purchase, install, and qualify an automated filler for the production of [\*\*\*] as will be set forth in the Capital Equipment Agreement. The scope includes development work to install the new line and transfer the manufacturing process to the automated line, registration activities and validation work, and creation of a commercial pricing model for the automated filler. The work will occur at the Manufacturing Site.

Patheon will provide the following core services:

• [\*\*\*].

• [\*\*\*].

• [\*\*\*].

• [\*\*\*].

• [\*\*\*].

Indivior will provide:

• [\*\*\*].

• [\*\*\*].

------

• [\*\*\*].

• [\*\*\*]:

o&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

o&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

o&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

**Automated Filling Budget Summary**

The Capital Equipment Agreement will cover the design and construction of a suitable suite and installation of the [\*\*\*] powder filler. In addition to the fees to manufacture Product in the manual filling suite, Indivior will also pay to Patheon Base and Batch fees for the automated filler suite during the 2019-2021 construction period (the "**Construction Period**") and from the earlier of commercial launch of the automated filler Product or January 1, 2022 going forward (the "**Commercial Period**") as follows:

**Base Fees for Operation** 

Indivior will pay the following Base Fees during the Construction and Commercial Periods. These annual fees are payable regardless of whether Patheon manufactures Product for Indivior on the Automated Line or uses the equipment. The fees will be paid equally in monthly payments starting on [\*\*\*].

---

| | | | |
|:---|:---|:---|:---|
| **Period** | **Base Fee** | **Included PFS unit volume** | **Price per PFS <br>in excess of included <br>volume** |
| [\*\*\*] | $[\*\*\*]/Year | [\*\*\*] | NA |
| [\*\*\*] | $[\*\*\*]/Year | [\*\*\*] | NA |
| [\*\*\*] | $[\*\*\*]/Year | [\*\*\*] | NA |
| [\*\*\*] | $[\*\*\*]/Year | [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*]/Year | [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*]/Year | [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*]/Year | [\*\*\*] | $[\*\*\*] |

---

No discount in Base Fee is due if Indivior takes less than [\*\*\*] units in a Year as applicable. The Base Fees and the Price per pre-filled syringe for incremental volumes in excess of the included PFS volumes will not be subject to Price adjustments as set forth in the MSA until January 1, 2026.

Base fee and pricing above was established assuming batch sizes of [\*\*\*] units. Smaller batch sizes are possible with no further costs except that minimum commercial batch size is [\*\*\*] units. If batch sizes below [\*\*\*] units are required, additional costs may be involved and both parties will work together to define the appropriate incremental pricing depending on the chosen batch size.

[\*\*\*].

------

**Costs Included in Construction Pricing**:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

[\*\*\*].

[\*\*\*].

[\*\*\*].

[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

[\*\*\*].

[\*\*\*].

[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.3&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

**Costs Included in Automated Filler Commercial Pricing:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

**Costs Not Included in Auto Filler Construction and Commercial Pricing:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.4&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.5&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

**Key Pricing Requisites:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*].

**Project Activities**

Patheon will perform the following activities to ensure commercial readiness of the automated filler line and the suite:

**Project Start Up &nbsp;&nbsp;&nbsp;&nbsp;** 

[\*\*\*]

**Project/Operational Documentation**

[\*\*\*]

**Analytical Transfer and Validation Services**

[\*\*\*]

------

**Visual Inspection Assessment (Semiautomatic)**

[\*\*\*]

**Cleaning Process Verification/Validation**

[\*\*\*]

**Engineering Batch Manufacturing**

[\*\*\*]

**Feasibility Batch Manufacturing**

[\*\*\*]

**Process Validation Batches (**[\*\*\*] **batches)** 

[\*\*\*]

**Regulatory Management or Documentation Support** 

[\*\*\*]

*Subject to the Product's specifications and following detailed discussions with Indivior, Patheon can provide additional services as listed below:* 

**Stability Testing Program**

[\*\*\*]

**Container Closure Integrity - Microbial Intrusion Test**

[\*\*\*]

**Key Technical Parameters**

The following technical parameters apply to the production of [\*\*\*] and the materials used therein. Pricing may be adjusted to reflect any technical changes foreseen during the project or after the manufacture of validation batches to reflect any specification or process changes.

**Manufacturing Parameters**

• **Manufacturing campaign** – [\*\*\*].

• **Cleaning** – [\*\*\*].

• **Visual inspection** – [\*\*\*]

------

**Testing Conditions**

• [\*\*\*].

• QC test methods must be fully validated and robust at the time of manufacture.

---

| | |
|:---|:---|
| **Testing Requirements** | **Testing Requirements** |
| **In-Process Controls** | **Finished Product Testing** |
| • [\*\*\*]<br>• [\*\*\*]<br>• [\*\*\*] | &nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*]<br>&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*] |

---

[\*\*\*].

Analytical method transfer/validation and/or QC testing may be performed by Patheon or outsourced to Patheon's third party laboratory. Analytical method transfer/validation and QC testing costs to be conducted by third party/Patheon are not included in the batch Price proposed. Third party services will be charged at direct cost to Patheon plus Patheon's handling fee of [\*\*\*]%.

**Supply Chain**

• [\*\*\*].

• [\*\*\*].

• [\*\*\*].

• [\*\*\*].

• [\*\*\*].

• [\*\*\*].

------

**THIRD AMENDMENT TO RISPERIDONE PRODUCT AGREEMENT**

THIS THIRD AMENDMENT TO THE **RISPERIDONE PRODUCT AGREEMENT** (this "**Amendment**"), effective as of April 17, 2020 ("**Amendment Effective Date**"), is made between Indivior UK Limited ("**Indivior**") and Patheon Manufacturing Services LLC ("**Patheon**"). Indivior and Patheon may be referred to herein individually as a "Party" or collectively, as "Parties."

**Background**

The Parties entered into a Master Manufacturing Services Agreement effective dated April 6, 2018 (the "**MSA**") under which they entered into the Risperidone Product Agreement effective April 25, 2018 as amended by the First Amendment to the Risperidone Product Agreement (the "**First Amendment**") effective January 1, 2019 and amended by the Second Amendment to the Risperidone Product Agreement (the "**Second Amendment**") effective March 1, 2019 (collectively, the "**Product Agreement**").

**Agreement**

NOW THEREFORE in consideration of the rights conferred and the obligations assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each Party), and intending to be legally bound the Parties agree as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.&nbsp;&nbsp;&nbsp;&nbsp;Section 8 of the Product Agreement is hereby deleted in its entirety and replaced with the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**8. Territory (as may be amended from time to time):** United States and Canada.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.&nbsp;&nbsp;&nbsp;&nbsp;Except as expressly provided in this Amendment, all other terms, conditions and provisions of the MSA and Product Agreement, as amended, remain in full force and effect. To the extent there are any inconsistencies or ambiguities between the terms of this Amendment and the MSA or Product Agreement, the terms of this Amendment will prevail.

---

| | |
|:---|:---|
| **Patheon Manufacturing Services LLC** | **Indivior UK Limited** |
| By: *<u>/s/ Michelle P. Logan</u>*<br>Name: <u>Michelle P. Logan</u><br>Title: <u>VP GM Greenville NC</u><br>Date: April 17, 2020 | By: *<u>/s/ Miriam McCloskey</u>*<br>Name: <u>Miriam McCloskey</u><br>Title: <u>Head of Global Direct Procurement</u><br>Date: April 17, 2020 |

---

## Exhibit 4.18

**Exhibit 4.18.3**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii)

WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**CAPITAL EXPENDITURE AND EQUIPMENT AGREEMENT**

**THIS CAPITAL EXPENDITURE AND EQUIPMENT AGREEMENT** (this "**Agreement**") is made as of June 30, 2019 (the "**Effective Date**") between:

**Indivior UK Limited,** incorporated and registered under the laws of England and Wales with company number 7183451, having its registered office at The Chapleo Building, Henry Boot Way, Priory Park, Hull HU4 7DY, United Kingdom ("**Indivior**").

- and -

**Patheon Manufacturing Services LLC**, a limited liablity company existing under the laws of the State of Delaware, having a principal place of business at 5900 Martin Luther King Jr. Highway, Greenville, North Carolina 27834 (**"Patheon"**).

**<u>BACKGROUND</u>**

Indivior and Patheon entered into a Master Manufacturing Services Agreement effective April 6, 2018, (the "**MSA**") under which Patheon Manufacturing Services LLC entered into the Risperidone Product Agreement to perform certain commercial manufacturing services for Indivior effective April 25, 2018 (the "**Product Agreement**") for Indivior's Risperidone Pre-Filled Syringe Powder (the "**Product**"). In order for Patheon to perform the commercial manufacturing services under the Product Agreement, (the "**Services**"), certain capital expenditures will be required for the purchase and installation of capital equipment at Patheon's facility (the "**Facility**") to automate the filling of Product. The purpose of this Agreement is to set out the parties' agreement and undertakings regarding the capital expenditures.

**<u>AGREEMENT</u>**

NOW, THEREFORE, in consideration of the rights conferred and the obligations assumed herein, and intending to be legally bound, the parties hereby agree as follows:

**1.&nbsp;&nbsp;&nbsp;&nbsp;Definitions**

**"Automated Filling Equipment"** means the machine purchased by Indivior and provided to Patheon to fulfil the manufacture of the product as specified in the URS in Schedule C

**"Facility Modifications"** means the items listed in that category on Schedule A.

**2.&nbsp;&nbsp;&nbsp;&nbsp;Expenditures and Payment**

The estimated cost for the purchase and installation of the Automated Filling Equipment and Facility Modifications and the support and SAT for the installation of the Automated Filling Equipment for the project are set forth in Schedule A. Notwithstanding any other provisions of this Agreement, the individual amount of each item on Schedule A may be increased or decreased to reflect Patheon's actual cost but the aggregate amount contributed by Indivior for the Facility Modifications and support of the installation and SAT of the Automated Filling Equipment will not exceed $[\*\*\*] unless there are modifications or changes in the Services or related assumptions or subsequent changes requested by Client. If this occurs, the parties will agree on revised cost estimates and a revised maximum aggregate amount to be contributed by Indivior. No change in the aggregate cost of the Facility Modifications will be made without Indivior's prior written consent. Patheon will give Indivior a final Schedule A with the actual costs for each item.

Subject to these limitations, Indivior hereby agrees to to be invoiced by Patheon for $[\*\*\*] towards the Facility Modifications shown on Schedule A immediately upon execution of this Agreement (the "**Initial Payment**") and Indivior directs Patheon to incur, on its behalf, pre-approved, direct, out-of-pocket costs for the Facility Modifications listed on Schedule A. Patheon will give Indivior copies of third party invoices for these items (where applicable) within 30 days after Patheon's receipt thereof and will issue its invoice to Indivior.

Page **1** of **8**

------

Indivior will pay all invoiced amounts owing to Patheon within 45 days of the date of Patheon's invoice after the Initial Payment has been spent to enable Patheon to pay all amounts owed under the third party invoices. Indivior's payment of these costs in advance of the performance of the Services is made in contemplation of those Services to be performed by Patheon.

**3.&nbsp;&nbsp;&nbsp;&nbsp;Patheon Use of Automated Filling Equipment and Facility Modifications** 

Patheon may use the Automated Filling Equipment and Facility Modifications to manufacture products for third parties. Notwithstanding the prior sentence, Indivior's needs will be prioritized over Patheon's use of the Automated Filling Equipment and Facility Modifications for third parties and Patheon will ensure that Indivior's Product supply will not be adversely impacted by this use. Should Patheon use the Automated Filling Equipment for any third parties, Indivior will receive $[\*\*\*] per batch for each third-party batch manufactured on the Automated Filling Equipment up to 100% of the annual fees due from Indivior. Patheon will provide Indivior with detailed written records of all third party batches that have been manufactured during any Year on the Automated Filling Equipment and will credit Indivior for the cumulative third–party use fees by March 1 of the Year immediately following the Year that the batches were manufactured.

**4**.**&nbsp;&nbsp;&nbsp;&nbsp;Maintenance of the Automated Filling Equipment** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Patheon will, at its own expense, perform routine repairs, preventive maintenance, and calibration on the Automated Filling Equipment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Patheon will give Indivior reasonable access during normal working hours for the inspection of the Automated Filling Equipment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Patheon will immediately notify Indivior if the Automated Filling Equipment fails to meet the KPIs demonstrated at SAT. KPIs will be included in SAT certification.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;Patheon will immediately notify Indivior if any breakdown, accident, loss of or damage occurs to the Automated Filling Equipment.

**5.&nbsp;&nbsp;&nbsp;&nbsp;Title and Risk of Loss of the Equipment**

The Automated Filling Equipment will be owned by Indivior which will be the sole legal and beneficial owner thereof. The Facility Modifications will be owned by Patheon which will be the sole legal and beneficial owner thereof. Patheon will at all times keep the Automated Filling Equipment and Facility Modifications insured at replacement cost with inflation adjustment, and Patheon will replace any of these items that are lost, damaged or destroyed.

Notwithstanding any limitation or exclusion prescribed by Section 5 or any other provision of this Agreement, Patheon will hold harmless Indivior, its directors, officers, employees, agents, and contractors for, against, and from any and all claims for personal injury, death, or damage to the property of any third party arising from or out of (i) the negligence, gross negligence, or willful misconduct of Patheon, its affiliates, or their respective directors, officers, employees, agents, contractors, or (ii) any event, circumstance, act, or incident first occurring or existing during the period when the Automated Filling Equipment is installed at Patheon, but the obligations set forth in this sentence will not apply to the extent these claims are determined to be attributable to the negligence, gross negligence, or willful misconduct of Indivior, its affiliates, or their respective directors, officers, employees, agents or contractors.

**6.&nbsp;&nbsp;&nbsp;&nbsp;Term; Termination; Effect of Termination on Future Funding**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;**Term; Termination.** This Agreement will commence on the Effective Date and, unless earlier terminated as set forth in this Section 6, will continue in effect until the expiration or termination of the Product Agreement, including any extensions thereof. Either party at its sole option may terminate this Agreement upon written notice where the other party has failed to remedy a material breach of any of its obligations under this Agreement within 60 days following receipt of a written notice of the breach that expressly states in reasonable detail the nature of the breach. Patheon's failure to meet the estimated timeline set forth in Schedule B will not be considered a material breach of this Agreement.

Page **2** of **8**

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;**Effect of Termination on Future Funding.** If this Agreement or the Product Agreement is terminated by Indivior, Indivior's obligation to further fund expenditures under this Agreement will cease upon Patheon's receipt of the notice of termination, except for the cost of non-cancellable commitments that are made by Patheon prior to receiving written notice of the termination, and for which Indivior is responsible under Section 2 of this Agreement. If this Agreement or the Product Agreement is terminated by Indivior for reasons other than Patheon's failure to remedy a material breach, Indivior will remove the Automated Filling Equipment from the Facility at Indivior's expense. If this Agreement or the Product Agreement is terminated by Indivior due to Patheon's failure to to remedy a material breach, Patheon will be responsible for the cost of removal of Automated Filling Equipment from the Facility.

**7.&nbsp;&nbsp;&nbsp;&nbsp;General**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;All monetary amounts are expressed in the lawful currency of the United States of America.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;This Agreement will be construed and enforced in accordance with the laws of the State of Delaware (without regard to principles of conflicts of law).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;This Agreement contains the entire understanding of the parties about the subject matter herein and supersedes all previous agreements (oral and written), negotiations and discussions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;The parties may modify or amend the provisions hereof only by an instrument in writing duly executed by both of the parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;Neither party may assign or otherwise transfer its rights or obligations hereunder without the prior written consent of the other party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;This Agreement may be signed by facsimile or in two counterparts, each of which when executed and delivered or transmitted, will be considered an original and both of which together will constitute one and the same instrument.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;The "Background" section of this document is expressly incorporated into the Agreement.

Page **3** of **8**

------

IN WITNESS WHEREOF the duly authorized representatives of the parties have executed this Agreement.

---

| | |
|:---|:---|
| **Patheon Manufacturing Services LLC** | **Indivior UK Limited** |
| By: *<u>/s/ Nick Buschur</u>* | By: *<u>/s/ Frank Stier</u>* |
| Name: <u>Nick Buschur</u> | Name: <u>Frank Stier</u> |
| Title: <u>Vice President and General Manager</u> | Title: <u>Chief Supply Officer</u> |
| Date: 26 July 2019 | Date: 25 July 2019 |

---

Page **4** of **8**

------

SCHEDULE A

An Indivior affiliate is purchasing and will own the Automated Filling Equipment, and will supply the equipment without charge to Patheon for purposes of performing those commercial manufacturing services as specified in the User Requirement Specificiation (URS) in Schedule C and installed per the estimated timeline in Schedule B. The list of equipment and services included in the Automated Filling Equipment provided by Indivior is listed below and the estimated cost to Indivior for the sole purpose of documenting the expected deliverables.

---

| | |
|:---|:---|
| **The Automated Filling Equipment** | **Estimated Cost (**€) |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| [\*\*\*] | [\*\*\*] € |
| **TOTAL** | **[\*\*\*] €** |

---

Page **5** of **8**

------

---

| | |
|:---|:---|
| **Facility Modifications** | **Costs (USD)** |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| **GRAND TOTAL** | **$[\*\*\*]** |

---

Page **6** of **8**

------

Schedule B

The parties will meet within [\*\*\*] month of the execution of this Agreement to agree on the estimated timeline for the installation of the Automated Filling Equipment.

---

| | | | |
|:---|:---|:---|:---|
| **Indivior Engineering Timeline** | **Indivior Engineering Timeline** | **Indivior Engineering Timeline** | **Indivior Engineering Timeline** |
| **ACTIVITY** | **2019 (by month)** | **2020 (by month)** | **2021 (by month)** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

Page **7** of **8**

------

Schedule C

User Requirement Specification for Automated Filling Equipment

To be updated based on agreement between the Parties

**Supplier Response Matrix (SRM)**

[\*\*\*]

---

| | | | |
|:---|:---|:---|:---|
| **URS ID** | **URS Requirement Description Section** | **Supplier Response** | **Classification** |
| 1 | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 2 | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 3 | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 4 | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 5 | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 6 | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 7 | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 8 | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| 9 | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

Page **8** of **8**

## Exhibit 4.19

**Exhibit 4.19.1**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**LICENSE AGREEMENT** 

**BY AND AMONG** 

**INDIVIOR UK LIMITED** 

**AND**

**AELIS FARMA** 

**DATED JUNE 3, 2021**

------

**CONTENTS**

---

| | | |
|:---|:---|:---|
| **Page** | | |
| 1. | SECTION 1: DEFINITIONS | 1 |
| 2. | SECTION 2: LICENSE OPTION; LICENSE GRANT; NON-COMPETITION | 14 |
| 3. | SECTION 3: INDIVIOR STUDIES; JOINT STEERING COMMITTEE | 17 |
| 4. | SECTION 4: DEVELOPMENT | 20 |
| 5. | SECTION 5: REGULATORY RESPONSIBILITIES | 20 |
| 6. | SECTION 6: TECHNOLOGY TRANSFER | 20 |
| 7. | SECTION 7: COMMERCIALIZATION | 21 |
| 8. | SECTION 8: PAYMENTS | 23 |
| 9. | SECTION 9: PAYMENT TERMS | 25 |
| 10. | SECTION 10: CONFIDENTIALITY AND PUBLICITY | 26 |
| 11. | SECTION 11: INTELLECTUAL PROPERTY RIGHTS | 29 |
| 12. | SECTION 12: REPRESENTATIONS, WARRANTIES AND UNDERTAKINGS | 33 |
| 13. | SECTION 13: INDEMNIFICATION | 37 |
| 14. | SECTION 14: LIABILITY | 38 |
| 15. | SECTION 15: ANTI-BRIBERY | 38 |
| 16. | SECTION 16: TERM | 39 |
| 17. | SECTION 17: TERMINATION | 39 |
| 18. | SECTION 18 EFFECTS OF TERMINATION | 40 |
| 19. | SECTION 19: INJUNCTIVE RELIEF | 42 |
| 20. | SECTION 20: INSURANCE | 42 |
| 21. | SECTION 21: MISCELLANEOUS | 42 |

---

------

**LICENSE AGREEMENT**

This License Agreement (this "<u>Agreement</u>") is entered into as of this 3<sup>rd</sup> day of June 2021 (the "<u>Effective Date</u>"), by and between Indivior UK Limited, a company incorporated in England and Wales with a registered number of 07183451 and registered office at The Chapleo Building, Henry Boot Way, Priory Park, Hull, United Kingdom, HU4 7DY ("<u>Indivior</u>"), and Aelis Farma, a company organized under the laws of France with a registered number of 797 707 627 and registered office at 146 rue Léo Saignat Institut François Magendie, 33000 Bordeaux, France ("<u>Aelis</u>"). Indivior and Aelis may be referred to herein collectively as the "<u>Parties</u>" and individually as a "<u>Party</u>".

**WHEREAS**:

&nbsp;&nbsp;&nbsp;&nbsp;(A)Aelis, a clinical stage biotech company, owns or controls certain rights to the Licensed Compounds and Licensed Technology, including the right to develop, make and sell Licensed Compounds and Licensed Products (each as defined below).

&nbsp;&nbsp;&nbsp;&nbsp;(B)Indivior is engaged in the business of, among other things, developing, marketing and distributing pharmaceutical products.

&nbsp;&nbsp;&nbsp;&nbsp;(C)Indivior wishes to obtain from Aelis an option to obtain an exclusive license to develop, make and sell Licensed Products in the Field, and Aelis wishes to (i) grant such option and (ii) subject to the exercise of the option, grant such exclusive license to Indivior, on the terms and conditions of this Agreement.

**NOW, THEREFORE**, in consideration of the foregoing and the mutual covenants contained herein, the Parties, intending to be legally bound, agree as follows:

1.**SECTION 1: DEFINITIONS**

1.1Capitalized terms used in this Agreement shall have the following definitions:

---

| | |
|:---|:---|
| "**505(b)(2)**<br>**Application**" | means a new drug application filed with the FDA pursuant to 21 U.S.C. § 355(b)(2) (Section 505(b)(2) of the U.S. Food, Drug and Cosmetic Act, as amended). |
| "**Aelis Indemnitees**" | shall have the meaning set out in <u>Section 13.1</u>. |
| "**Aelis Know-How**" | means all Know-How Controlled by Aelis as of the Effective Date or during the Term that is reasonably necessary or useful to Develop, Manufacture or use Licensed Compounds or to Develop, Manufacture, Commercialize, use, import, offer to sell or sell Licensed Products.<br>provided that, with respect to any Know-How that becomes Controlled by Aelis after the Effective Date that (i) is not necessary for the Development, Manufacture or Commercialization of the Licensed Compound and Licensed Product in the Field and (ii) would trigger payments to a Third Party if included in the License herein, then such Know-How will not be included in the Aelis Know-How unless and until Indivior makes such payments. |

---

------

---

| | |
|:---|:---|
| "**Aelis Patents**" | means all Patents Controlled by Aelis or its Affiliate(s) at any time during the Term that claim the composition, Development, Manufacture, Commercialization or use of Licensed Compounds and/or Licensed Products, including, but not limited to, those listed in **Schedule I**, and excluding Joint Patents.<br>provided that with respect to any Patent that becomes Controlled by Aelis after the Effective Date that (i) is not necessary for the Development, Manufacture or Commercialization of the Licensed Compound and Licensed Product in the Field and (ii) would trigger payments to a Third Party if included in the License herein, then such Patent will not be included in the Aelis Patents unless and until Indivior makes such payments. |
| "**Aelis Studies**" | means all the studies that are performed by Aelis, directly or through subcontractors, during the License Term. These could be Phase I, Phase II or Phase III Studies, CMC and ADMET studies or any other studies that the JSC decides should be performed by Aelis. |
| "**Affiliate**" | means, with respect to a Party, any Person that, directly or indirectly, controls, is controlled by or is under common control with such Party; for the purposes of this definition, "control" shall refer to: (i) the possession, directly or indirectly, of the power to direct the management or policies of an entity whether through ownership of interests representing equity, securities, or partnership interests, by contract, or otherwise, or (ii) the ownership, directly or indirectly, of more than fifty per cent (50%) of the voting securities or capital stock or other ownership interest of an entity. For the purposes of the definition of Aelis Know-How, Aelis Patents and <u>Section 2.4</u> of this Agreement, this definition shall exclude any direct or indirect acquirer of Aelis (the "**Acquirer**") or any Affiliates of such Acquirer other than Aelis and its Affiliates prior to the acquisition of Aelis, subject to the confidentiality requirements set forth in <u>Section</u> <u>10.1.3</u>. |
| "**ANDA**" | means an abbreviated new drug application filed with the FDA pursuant to 21 U.S.C. § 355(j) and 21 C.F.R. § 314.3. |
| "**Applicable Law(s)**"  | means all federal, state, national and local laws, statutes, ordinances, rules, regulations, codes, guidelines as amended, re- enacted or in force from time to time applicable to the particular activities and jurisdictions hereunder, including, as applicable, Bribery Legislation, GCP, GDP, GMP, GLP and the rules and regulations of relevant Governmental Authorities having jurisdiction over the Research, Development, Manufacture and/or Commercialization of the Licensed Products. |

---

------

---

| | |
|:---|:---|
| "**Bribery Legislation**" | means the U.S. Foreign Corrupt Practices Act, as amended, the UK Bribery Act 2010, as amended, and all other Applicable Laws relating to anti-corruption or anti-bribery laws affecting companies doing business in the Territory, as well as Applicable Laws related to the prevention of fraud, racketeering, money laundering or terrorism. |
| "**Business Day**" | means a day on which banking institutions in London, England, Paris, France and Richmond, Virginia are all open for business, excluding any Saturday or Sunday. |
| "**Calendar Quarter**" | means a period of three (3) consecutive months ending on the last day of March, June, September, and December, respectively. |
| "**Claim(s)**" | means all charges, complaints, actions, suits, proceedings, hearings, investigations, claims and demands. |
| "**CMC**" | means chemistry, manufacturing, control and other activities that deal with the nature of the drug substance and drug product, the manner in which they were developed and are made, and the control aspects of the manufacturing process. |
| "**Commercialization**" and "**Commercialize**" | means activities directed to marketing, promoting, packaging and distributing, supplying, offering for sale, selling or other commercial exploitation of a Licensed Product and/or importing a Licensed Product for sale. |
| "**Control**" | means, with respect to any Intellectual Property Right or other tangible or intangible property, that a Party or one of its Affiliates owns or has a license or sublicense to such right, or property, and has the ability to grant access, a license or sublicense to such right, or property, without violating the terms of any agreement or other arrangement with any Third Party. |
| "**Controlling Party**" | shall have the meaning set out in <u>Section 11.3.1(b)</u>. |
| "**Develop**" and<br>"**Development**" | means activities necessary or desirable to develop Licensed Compounds and/or Licensed Products and to obtain and maintain Regulatory Approval of Licensed Products, including, as applicable, development activities related to the process development, optimisation use and production of Licensed Products, test method development and stability testing, toxicology, clinical trials, quality assurance/quality control, delivery systems, formulation, statistical analysis, report writing, generation of data, product approval and registration activities and all activities related thereto, but excluding Research. |
| "**Development Milestone Event**" | shall have the meaning set out in <u>Section 8.4.1</u>. |
| "**Development Milestone Payment**" | shall have the meaning set out in <u>Section 8.4.1</u>. |
| "**Disclosing Party**" | shall have the meaning set out in <u>Section 10.1.1</u>. |
| "**Effective Date**" | has the meaning set forth in the introductory paragraph. |

---

------

---

| | |
|:---|:---|
| "**EMA**" | means the European Medicines Agency or any successor agency thereto. |
| "**Europe**" | means the European Union as of the Effective Date. |
| "**Ex-US Countries**" | means all countries of the world excluding the US. |
| "**FDA**" | means the United States Food and Drug Administration or any successor agency thereto. |
| "**Field**" | means all addiction and substance use disorders, compulsive disorders (*e.g*. gambling, binge eating, OCD, intermittent explosive disorder (IED)), cannabis use disorder, cannabis intoxication, cannabis withdrawal, other cannabis-induced disorders (*e.g.* cannabis-induced psychotic disorder, cannabis- induced anxiety disorder, cannabis-induced sleep disorder, and cannabis intoxication delirium), unspecified cannabis-related disorders and, subject to Indivior's exercise of the Pain Option pursuant to <u>Section 2.3.1</u>, pain Indications. |
| "**Filing Acceptance**" | means, as applicable, the acceptance for filing of a complete NDA (or its equivalent) by the FDA in the United States, or acceptance for filing of a comparable application by a Regulatory Authority in another applicable jurisdiction in the Territory for the Commercialization of a pharmaceutical product. |
| "**First Commercial Sale**" | means, with respect to any given Licensed Product, on a country- by-country and Indication-by-Indication basis, the first commercial sale of such Licensed Product to a Third Party by Indivior or any of its Affiliates or any of their respective sublicensees in such country for such Indication following the applicable Regulatory Approval of the Licensed Product in such country for such Indication. |
| "**Force Majeure Event**" | has the meaning set out in <u>Section 21.1.2</u>. |
| "**GCP**" | means, as to the US, the UK and the European Union, good clinical practices as in effect in the US, the UK and the European Union, respectively, during the Term and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices as then in effect in the US, the UK or the European Union, in each case to the extent relating to the pharmaceutical products hereunder regulations of any Governmental Authority and applicable ICH GCP. |
| "**GDP**" | means current good distribution practices with respect to the wholesale distribution of medicinal products for human use as set forth in Applicable Laws and regulations, including Directive 2001/83/EC and Commission Guideline 2013/C 343/01. |

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|:---|:---|
| "**Generic Competition**" | means that, with respect to any Licensed Product in a country, the market share of the Generic Product exceeds 50%, i.e., the total sales amount of the Generic Products of such Licensed Product in such country exceeds 50% of the aggregated sales amount of such Licensed Product and Generic Products for the current Calendar Quarter (i.e., the Calendar Quarter for which Royalties are due). Such sales amount shall be determined based on data provided by a reputable Third Party data source generally accepted in the pharmaceutical industry in the relevant country and mutually agreed by the Parties, such as IQVIA. |
| "**Generic Product**" | means, with respect to any Licensed Product, (a) a drug product that is a pharmaceutical equivalent to such Licensed Product meaning that it (i) contains the same active ingredient(s), has the same dosage form and route of administration, (ii) is identical in strength or concentration to that of the given Licensed Product and (iii) is A rated in the United States (or similar designation outside the United States) ("**ANDA Product**") or (b) any other drug product that (i) contains the same active ingredient(s) and the same dosage form and route of administration as the Licensed Product and (ii) references the Licensed Product as a Reference Listed Drug in the 505(b)(2) Application for such drug product or, with respect to jurisdictions outside of the US, references the data provided by Indivior in its Regulatory Submission for such Licensed Product ("**505(b)(2) Product**"). |
| "**GLP**" | means regulations of any Governmental Authority (including Directives 2004/9/EC and 2004/10/EC and any similar or equivalent legislation in any other relevant jurisdiction) for conducting non-clinical laboratory studies that support or are intended to support applications for Research or Regulatory Approvals, as applicable to the Development in the Territory from time to time. |
| "**GMP**" | means (a) as to the US and the European Union, good manufacturing practices and general biological products standards as promulgated by the FDA pursuant to 21 CFR Parts 210, 211, 600 and 610 and as promulgated by the European Union pursuant to Commission Directive 2003/94/EC, respectively, each as may be amended from time to time, and (b) with respect to any other jurisdiction, manufacturing practices substantially equivalent to the aforementioned good manufacturing practices as then in effect in the US or the European Union, in each case to the extent relating to the pharmaceutical products hereunder. |
| "**Governmental Authority**" | means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of (a) any government of any country, (b) a federal, state, province, county, city or other political subdivision thereof or (c) any supranational body. |

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|:---|:---|
| "**Handle**" | shall mean preparing, filing, prosecuting (including interference and opposition proceedings) and maintaining (including interferences, reissue, re-examination, post-grant reviews, derivation proceedings, cancellation or nullity proceedings and opposition proceedings). |
| "**Head License**" | means the license agreement [\*\*\*] dated January 21, 2020, entered into between Inserm Transfert SA, Université Bordeaux, SC Belenos (together the "**Head Licensor**") and Aelis. |
| "**ICH GCP**" | means the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and also such other good clinical practice requirements which are specified in Directive 2001/20/EC and relating to medicinal products for human use and in guidance published by the European Commission pursuant to such Directive. |
| "**IFRS**" | means International Financial Reporting Standards (IFRS).  |
| "**Indication**" | means a disease classification as defined within the "International Statistical Classification of Diseases and Related Health Problems" as published on the date hereof by the World Health Organization or the DSM5; provided that, for purposes hereof, the following shall be considered different Indications: a) cessation of cannabis use in non-abstinent cannabis addicts; b) prevention of relapse in abstinent cannabis users; and c) reduction of psychotic symptomatology induced by cannabis or in dual diagnosis patients. |
| "**Indivior** <br>**Indemnitees**" | shall have the meaning set out in <u>Section 13.2</u>. |
| "**Indivior Patents**" | any Patent that is (a) Controlled by Indivior (or its Affiliates) as of the Effective Date or at any time during the Term and/or (b) based on an invention made while carrying out the clinical studies or other activities pursuant to this Agreement where there is at least one inventor that is an employee, contractor or other agent of Indivior or otherwise obligated to assign their rights in the invention to Indivior, excluding Joint Patents. |
| "**Indivior Studies**" | means all the studies that are performed by Indivior, its Affiliates or sublicensees, directly or through subcontractors, during the License Term. These could be Phase I, Phase II or Phase III Studies, CMC and ADMET studies or any other studies that are necessary to the Development and Regulatory Approval of the Licensed Product. |
| "**Infringement Actions**" | has the meaning set forth in <u>Section 11.3.2(c)</u>. |
| "**Infringement Claim**" | shall have the meaning set out in <u>Section 11.3.1(a)</u> |
| "**Initiation**" | means, with respect to a clinical study, the first dosing of the first patient in such clinical study. |

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|:---|:---|
| "**Insolvency Event**" | means, with respect to either Party, that such Party:<br>a.gives notice to any of its creditors that it has suspended or is about to suspend payment of its debts or is unable to pay its debts as they fall due or admits inability to pay its debts or (being a company or limited liability partnership) is deemed unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 or (being an individual) is deemed either unable to pay its debts or as having no reasonable prospect of so doing, in either case, within the meaning of section 268 of the Insolvency Act 1986 or (being a partnership) has any partner to whom any of the foregoing apply;<br>b.commences negotiations with all or any class of its creditors with a view to rescheduling any of its debts, or makes a proposal for or enters into any compromise or arrangement with any of its creditors or makes a proposal for or enters into a reorganisation (by way of voluntary arrangement, scheme or arrangement or otherwise), other than, in each case, for the purpose of a scheme for a solvent amalgamation of the other Party with one or more other companies or the solvent reconstruction of such Party or a solvent reorganisation of such Party;<br>c.a petition is filed, a notice is given, a resolution is passed, or an order is made, for or in connection with the winding up of any of such Party, other than, in each case, a solvent liquidation of such Party;<br>d.an application is made to court, or an order is made, for the appointment of an administrator, or a notice of intention to appoint an administrator is filed or if an administrator is appointed, over such Party;<br>e.the holder of a qualifying floating charge over the assets of such Party has become entitled to appoint or has appointed an administrative receiver;<br>f.a person becomes entitled to appoint a receiver, compulsory manager or other similar officer over all or any of the assets of such Party or a receiver is appointed over all or any of its assets; or<br>g.a distress, execution, sequestration or other such process is levied or enforced on or sued against, the whole or any part of any of their assets and such attachment or process is not discharged within 90 days;<br>h.the opening of a judicial reorganization proceedings (procédure de redressement judiciaire) or judicial liquidation proceedings (procédure de liquidation judiciaire); or<br>i.any event occurs, or proceeding is taken, with respect to such Party in any jurisdiction to which it is subject that has an effect equivalent or similar to any of the events mentioned in (a) to (h) above. |

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|:---|:---|
| "**Intellectual Property Rights**" | means Patents, rights to inventions, copyright (including software) and related rights, trade marks, business names and domain names, rights in get-up, goodwill and the right to sue for passing off, rights in designs, database rights, rights in Know- How and all other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world. |
| "**Joint Patent**" | means any Patent based on an invention made while carrying out the activities pursuant to this Agreement, where there is at least one inventor that is an employee, contractor or other agent of Aelis or is otherwise obligated to assign its rights in the invention to Aelis, and at least one inventor that is an employee, contractor or agent of Indivior or is otherwise obligated to assign its rights in the invention to Indivior. |
| "**Joint Steering Committee**" or "**JSC**" | shall have the meaning set out in <u>Section 3.2.1</u>. |
| "**Know-How**" | means any information or material, whether proprietary or not and whether patentable or not, which is not in the public domain including inventions, discoveries, concepts, data, formulae, ideas, specifications, procedures for experiments and tests and results of experiments, experimentation and testing, results of research and development, laboratory records, clinical trials data, case reports, data analysis and summaries, and information in submissions to and information from ethics committees and Governmental Authorities. |
| "**License**" | shall have the meaning set out in <u>Section 2.2.1</u>. |
| "**License Exercise Notice**" | shall have the meaning set out in <u>Section 2.1.2</u>. |
| "**License Fee**" | means $[\*\*\*]. |
| **"License Option Period**" | means the period commencing on the Effective Date and ending three (3) months following the completion of the End-of-Phase 2 meeting (as defined in 21 CFR 312.47) between Aelis and FDA relating to the Option Study 1. |
| "**License Term**" | means with respect to any given country, the period of time commencing on the date of delivery of the License Exercise Notice by Indivior and ending on the earlier of (a) expiration of the Royalty Term in such country or (b) the termination of the Agreement in such country. |

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|:---|:---|
| "**Licensed Compound**" | means (i) AEF0117 as described on **Schedule II**, (ii) all other pregnenolone derivatives disclosed in (a) PCT/EP2013/074886 (b) PCT/EP2019/054217 and (c) all patents and patent applications, substitutions, divisions, continuations, continuations-in-part, reissues, re-examinations, renewals, and patents of addition thereof, including all foreign equivalents thereof, substitutions, divisions, continuations, continuations-in- part, reissues, re-examinations, renewals, and patents of addition that claim priority to or from PCT/EP2013/074886 or PCT/EP2019/054217 in whole or in part. |
| "**Licensed Product**" | means a pharmaceutical product in finished form (in all formulations, dosages and delivery systems) that incorporate a Licensed Compound. |
| "**Licensed Product Trademarks and** <br>**Trade Dress**" | shall have the meaning set out in <u>Section 7.3</u>. |
| "**Licensed Technology**" | means the (i) Aelis Know-How and (ii) the Aelis Patents and (iii) Aelis' ownership interest in the Joint Patents. |
| "**Losses**" | means any and all damages, awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, costs, fees, liabilities, obligations, Taxes, liens, losses, and expenses (including reasonable fees of attorneys). |
| "**Manufacture**" | means all activities related to the manufacture of Licensed Compounds and/or Licensed Products including manufacturing supplies for Development and Commercialization, packaging, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance and quality control activities related to manufacturing and release of product, ongoing stability tests, storage, shipment, and regulatory activities related to any of the foregoing. |

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|:---|:---|
| "**Net Sales**" | means the gross amounts invoiced by Indivior, its Affiliates or their respective Third Party sublicensees (each, an "**Indivior Party**") for the sale of a Licensed Product to Third Parties, less the following deductions to the extent solely related to the Licensed Product and consistently applied through Indivior's range of products:<br>(i)customary trade, quantity and cash discounts and any other adjustments, including granted on account of price adjustments, billing errors, rejected goods, damaged or defective goods, recalls, returns, rebates, chargeback rebates, reimbursements or similar payments granted or given to wholesalers or distributors, buying groups, health care insurance carriers, governments, government-subsidized programs or managed care organizations, or other institutions, adjustments arising from consumer discount programs, in each case actually allowed and taken by a Third Party with respect to amounts invoiced for such Licensed Product;<br>(ii)sales taxes or similar taxes, including duties or other governmental charges imposed on the sale of Licensed Product to a Third Party (excluding any taxes imposed on or measured by the net income or profits of the Indivior Party), not refundable or creditable to the Indivior Party; and<br>(iii)prepaid freight, insurance and handling fees actually invoiced (that are not refundable or creditable to the Indivior Party);<br>in each case (i)-(iii) to the extent reasonable and consistent with customary practices, as determined from books and records of the Indivior Party maintained in accordance with IFRS. Amounts invoiced for sales or other transfer of such Licensed Product between or among Indivior, its Affiliates and other Indivior Parties shall be excluded from the computation of Net Sales unless such sales are intended for end use. If a sale or transfer of Licensed Product involves consideration other than cash or is not at arm's length, then the Net Sales from such sale or transfer shall be the arm's length fair market value, which generally will mean the Indivior Party's average sales price for the Calendar Quarter. |
| "**Option Studies**" | shall have the meaning set out in <u>Section 2.1.5(b)</u>. |
| "**Option Study 1**" | shall have the meaning set out in <u>Section 2.1.5(b)</u>. |
| "**Option Study 2**" | shall have the meaning set out in <u>Section 2.1.5(b)</u>. |
| "**Orange Book**" | means the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, as may be amended from time to time. |
| "**Pain Option**" | shall have the meaning set out in <u>Section 2.3.1</u>. |
| "**Pain Option Period**" | means the period commencing on the Effective Date and ending upon expiry of the License Option Period. |

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|:---|:---|
| "**Patent**" | means patents and patent applications and all substitutions, divisions, continuations, continuations-in-part, any patent issued with respect to any such patent applications (including certificates of invention and certificates of correction), any reissue, re-examination, utility models or designs, renewal or extension of any such patent, any term extension, any term adjustment, a supplementary protection certificate and any confirmation patent or registration patent or patent of addition based on any such patent, all counterparts and patents and patent applications based on, corresponding to or claiming the priority date thereof in any country, and all foreign equivalents of such patents and patent applications. |
| "**Payee**" | shall have the meaning set out in <u>Section 9.3.2</u>. |
| "**Payor**" | shall have the meaning set out in <u>Section 9.3.2</u>. |
| "**Person**" | means any natural person, corporation, firm, business trust, joint venture, association, organisation, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof. |
| "**Phase II Study**" | means a controlled clinical study in a relatively small number of subjects (usually no more than several hundred) designed to evaluate the effectiveness of a pharmaceutical product for a particular Indication or Indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with such pharmaceutical product, as further described in 21 C.F.R. §312.21(b) or equivalent studies outside of the US. By way of example, such a study may be designed to establish a dose and/or dose range for the study drug or to obtain additional safety or efficacy data to support the development of research methods and the design of Phase III research protocols in a patient population with the disease or condition under study. |
| "**Phase III Study**" | means an expanded controlled clinical study in a large number of patients (usually more than several hundred to several thousand) that is performed after preliminary evidence suggesting effectiveness of a pharmaceutical product has been obtained, and is intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of such pharmaceutical product and to provide an adequate basis for physician labelling, as further described in 21 C.F.R. §312.21(c) or equivalent studies outside of the US. Such a study is designed and intended to be of a size and statistical power sufficient to serve as a pivotal study to support the Regulatory Submission for the Indication being studied. |

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| "**Product Liability Claim**" | means any Claim that is commenced or threatened against a Party alleging product liability, product defect, design, packaging or labelling defect, failure to warn, or any similar action relating to the use or safety of the Licensed Products, as well as all resulting Losses. |
| "**Recipient**" | has the meaning set out in <u>Section 10.1.1</u>. |
| "**Regulatory** <br>**Approval**" | means, as applicable, the approval of an NDA by the FDA in the United States or approval of a comparable application by a Regulatory Authority in another jurisdiction in the Territory for the manufacture, supply, marketing and sale of a pharmaceutical product. For clarity, "Regulatory Approval" shall not include any governmental pricing and/or reimbursement approvals and/or authorizations issued by a Regulatory Authority or any other governmental agency in any country or jurisdiction. |
| "**Regulatory Authority**" | means, with respect to any jurisdiction, the applicable Governmental Authority responsible for regulating the manufacture, distribution, marketing and/or sale of pharmaceutical products in such jurisdiction. |
| "**Regulatory Exclusivity**" | means, with respect to a Licensed Product, exclusive marketing rights or data exclusivity rights conferred by an applicable Regulatory Authority in a particular country with respect to such Licensed Product in such country. |
| "**Regulatory** <br>**Materials**" | means any regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Governmental Authority that are related to Developing, Manufacturing, obtaining marketing authorisation, and/or Commercialising in a particular country or regulatory jurisdiction. |
| "**Regulatory Submission**" | means a marketing authorisation application filed with the FDA, EMA, or any comparable application or filing with any analogous Governmental Authority in the Territory. |
| "**Research**" | means the discovery, identification, research, characterization, modification, derivatization and optimization of pharmaceutical compounds and products. |
| "**Royalty**" | has the meaning set forth in <u>Section 8.5</u>. |

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|:---|:---|
| "**Royalty Term**" | means, with respect to each Licensed Product on a country-by- country basis, the period of time beginning on the Effective Date and ending on the last of: (a) the date of expiration in such country of the last to expire Valid Claim of any Aelis Patents or (b) the date of expiration in such country of the last to expire Valid Claim of a Joint Patent, which Valid Claim was covering the composition-of-matter, formulation or method of use of the Licensed Compound or the Licensed Product that meets the requirements for listing in the Orange Book, (c) the ten (10) year anniversary of the First Commercial Sale of such Licensed Product in such country, and (d) the date of the last expiration or other termination of any applicable Regulatory Exclusivity for such Licensed Product in such country. |
| "**Sales Milestones**" | shall have the meaning set out in <u>Section 8.4.2</u>. |
| "**Sales Milestone Payment**" | shall have the meaning set out in <u>Section 8.4.2</u>. |
| "**Scientific Paper**" | shall have the meaning set out in <u>Section 10.3</u> |
| "**Side Letter**" | shall have the meaning set out in <u>Section 7.4</u>. |
| "**Tax**" or "**Taxes**" | means any present or future sales, turnover, income, revenue, value added taxes, levies, imposts, duties, charges, assessments and/or fees in each case in the nature of tax (including any interest thereon). |
| "**Term**" | shall have the meaning set out in <u>Section 16</u>. |
| "**Territory**" | means worldwide, subject to <u>Section 17.2</u>. |
| "**Third Party**" | means a person other than (a) Aelis or any of its Affiliates, or (b) Indivior or any of its Affiliates. |
| "**UK**" | means the United Kingdom as at the Effective Date. |
| "**US**" | means the United States of America and its territories, possessions and commonwealths. |
| "**Valid Claim**" | means a claim of (a) an issued Patent that (i) has not been rejected, revoked or held to be invalid or unenforceable by a court or other authority of competent jurisdiction, from which decision no appeal can be further taken or (ii) has not expired, been finally abandoned, disclaimed or admitted to be invalid or unenforceable through reissue or disclaimer or (b) a Patent application that has been pending for not more than seven (7) years. |
| "**VAT**" | means value added tax chargeable under or pursuant to the Council Directive 2006/112/EC or any legislation implementing such Directive, or any other sales, purchase or turnover tax and any customs or excise duties or import levies. |

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| "**Viable**" | means, with respect to a Licensed Product, at the relevant time there is/are not and have not been (a) occurrences of serious adverse events in clinical trials relating to such Licensed Product, or (b) failure to achieve the efficacy endpoints of one or more clinical trials relating to such Licensed Product, but in any event in each case of (a) or (b), only if the Parties agree such occurrence or failure does render the program no longer viable in accordance with Applicable Laws. |

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2.**SECTION 2: LICENSE OPTION; LICENSE GRANT; NON-COMPETITION**

2.1<u>License Option</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.1During the License Option Period, Aelis hereby grants Indivior an exclusive option to receive an exclusive (even as to Aelis), sublicensable and transferable License (as defined below) in the Territory (the "**License Option**").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.2Indivior may exercise the License Option by delivering written notice thereof ("**License Exercise Notice**") to Aelis within the License Option Period, and by paying Aelis the License Fee within fifteen (15) days after delivery of the License Exercise Notice. The License Option shall lapse and be of no effect should Indivior fail to deliver the License Exercise Notice within the License Option Period and pay the License Fee within the said period of fifteen days. The License Option Period shall terminate for purposes hereof upon payment of the License Fee following delivery by Indivior of the License Exercise Notice.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.3If Indivior has decided to not exercise the License Option before the end of the License Option Period, Indivior may elect to terminate the License Option Period by sending a written notice to Aelis waiving its right to exercise the License Option. This Agreement shall automatically terminate upon receipt of such written notice.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.4If Indivior fails to deliver a License Exercise Notice within the License Option Period, it shall be deemed to have waived any right to exercise the License Option and this Agreement shall automatically terminate upon expiration of the License Option Period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1.5During the License Option Period:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)Aelis shall deliver to Indivior all studies, study results, chemical structure information, records and other materials related to the Licensed Compounds that are reasonably requested by Indivior in connection with its due diligence and evaluation of the Licensed Compounds and its exercise of the License Option. Indivior and its representatives shall be permitted to make reasonable inquiries of Aelis to the extent possible through the JSC or otherwise through its CEO or the point of contact designated by the CEO regarding the Licensed Compounds and the Option Studies.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Promptly after the Effective Date, Aelis will use commercially reasonable efforts to perform (i) a multicentric Phase IIb study with Columbia University as coordinating center that evaluates the effects of AEF0117 on cannabis intake in Cannabis Use Disorders patient CUD in demand for

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treatment, which protocol may, for the avoidance of doubt, be modified by Aelis for regulatory reasons, including upon request by the FDA, subject to discussion and review by the JSC (the "**Option Study 1**"); (ii) the Fertility and Embryonic Development Study (FEED), also named Segment I of the Developmental and Reproductive Toxicity Studies (DART) according to guidance ICH S5(R3): Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals (Revision 3, May, 2021) in full compliance with GLP (the "**Option Study 2**", and together with the Option Study 1, the "**Option Studies**"). The protocol for the Option Study 1 and a description of the Option Study 2 are set forth in <u>Schedule III</u>.

2.2<u>License Grant</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.1During the License Term and subject to Aelis' retained rights as set forth in <u>Section</u> <u>2.2.4</u>, Aelis hereby grants to Indivior an exclusive (even as to Aelis), sublicensable, transferable license under the Licensed Technology to Develop, use, Manufacture, have Manufactured, import, export, obtain Regulatory Approval and Commercialize the Licensed Compound(s) and/or Licensed Product(s) for use in the Field and in the Territory ("**License**").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.2Indivior shall have the right to grant sublicenses under the License to its Affiliates and Third Parties, subject to this <u>Section 2.2.2</u>. Indivior shall provide Aelis with written notice at least twenty-five (25) days prior to granting any sublicense under the License to enable Aelis to seek approval for such sublicense from the Head Licensor pursuant to the Head License. Aelis shall promptly, but in any event, within five (5) days after receiving the Sublicense Notice, deliver the Sublicense Notice to the Head Licensor pursuant to the Head License. In the event that, within twenty (20) days of delivery by Aelis of such notice to the Head Licensor ("**Notice Period**"), the Head Licensor does not approve such sublicense pursuant to the terms of the Head License, then Aelis shall promptly notify Indivior and Indivior shall not grant such sublicense. Notwithstanding the foregoing, failure by Head Licensor to respond within the Notice Period shall constitute acceptance of the sublicense. A copy of each sublicense granted by Indivior will be provided to Aelis promptly after execution thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.3All such sublicenses shall be consistent with this Agreement including, without limitation, that the Sublicensee shall be bound by the provisions of <u>Section 2.4</u> (Non- Competition) as if it is a Party to this Agreement and shall terminate automatically on the termination of this Agreement. Indivior shall not grant sublicenses or appoint sublicensees other than in accordance with <u>Section 2.2.2</u> and <u>Section 2.2.3</u> and shall in all cases remain responsible for any acts or omissions of its sublicensees exercising rights under a sublicense of the rights granted by Aelis to Indivior under this Agreement to the same extent as if such acts or omissions had been taken by Indivior itself. For the avoidance of doubt, Aelis shall have no right to, and shall not, grant any sublicenses to any Person under the Licensed Technology with respect to the Licensed Compound(s) and/or Licensed Product(s) in the Field and in the Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.4Except as expressly provided in this Agreement, neither Party grants to the other Party any right or license in any Intellectual Property Rights, whether by implication, estoppel or otherwise. In particular, subject to <u>Section 2.4</u> and <u>Section 10.3</u> with respect to publications, Aelis retains the right (i) to conduct Research with the Licensed Compound and Licensed Product inside and outside

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of the Field solely for the purpose of conducting lab experiments and for publishing certain Scientific Papers, (ii) to exploit directly or indirectly the Licensed Technology for compounds and products other than the Licensed Compounds and Licensed Products inside or outside of the Field.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.5Indivior acknowledges and agrees that the Know-How licensed by Aelis pursuant to the Head License has been licensed on a non-exclusive basis and that the Head Licensor has retained the right to use certain Licensed Technology for certain educational, academic and research purposes pursuant to the terms of the Head License; <u>provided</u> that Aelis covenants and agrees that it shall not, directly or indirectly, provide Licensed Compounds to the Head Licensor except as approved by the JSC.

2.3<u>Option for Pain Indication</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3.1Aelis hereby grants to Indivior the option to expand the Field to include pain Indications ("**Pain Option**") at any time during the Pain Option Period. Indivior may exercise the Pain Option by delivering written notice thereof to Aelis within the Pain Option Period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3.2In the event that Indivior does not exercise the Pain Option during the Pain Option Period, the Pain Option shall terminate and Aelis shall have the right to pursue pain Indications for pregnenolone derivatives and any other compounds that are not Licensed Compounds, subject to <u>Section 2.4</u>. In the event that Aelis pursues such pain Indications, Aelis shall keep Indivior informed of (i) the start of a Development program in the pain Indication and (ii) Aelis' decision to start a partnering process for this Indication so that the Parties may consider strategic partnerships with respect thereto.

2.4<u>Non-Competition</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.1During the License Option Period, Indivior and its Affiliates shall not Research, Develop, Manufacture or otherwise Commercialize any Licensed Compound, Licensed Product or any pregnenolone derivatives inside or outside of the Field in the Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.2During the License Term in any country:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)neither Party, by itself, its Affiliates or through any Third Party (including, with respect to Indivior, its sublicensees pursuant to <u>Section 2.2.2)</u>, shall Research, Develop, Manufacture or otherwise Commercialize any Licensed Compound or Licensed Product inside or outside of the Field in such country, except as permitted pursuant to this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)neither Party may, by itself or its Affiliates or through any Third Party (including, with respect to Indivior, its sublicensees pursuant to <u>Section 2.2.2)</u>, Develop, Manufacture or Commercialize any pregnenolone derivatives in the Field in such country, other than Licensed Compounds or Licensed Products pursuant to this Agreement, including <u>Section 2.3</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)neither Party may, by itself or its Affiliates, or through any Third Party (including with respect to Indivior, its sublicensees pursuant to <u>Section 2.2.2)</u>, Develop, Manufacture or Commercialize any CB1 antagonists in the Field in such country; and

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Indivior, its Affiliates or its sublicensees pursuant to <u>Section 2.2.2</u> shall not Research, Develop, Manufacture or Commercialize Licensed Compounds or Licensed Products outside of the Field in the Territory.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.3Notwithstanding the foregoing, (i) during the License Option Period, Aelis shall have the right to engage in Research and Development activities with respect to the Licensed Compounds or Licensed Products inside or outside of the Field; <u>provided</u> that Aelis shall consult with the JSC with respect to any such Development activities; and (ii) during the Term, Aelis shall have the right to engage in Research activities with respect to the Licensed Compounds or Licensed Products inside or outside of the Field solely for the purpose of conducting lab experiments and for publishing certain Scientific Papers, subject to <u>Section 10.3</u>.

2.5<u>Rights Under Bankruptcy</u>

If Aelis or an Affiliate become subject to bankruptcy proceedings in the US, then the Parties agree that all rights and licenses granted under or pursuant to any section of this Agreement in connection with US intellectual property rights are and will otherwise be deemed to be for purposes of Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), as amended (the "**Bankruptcy Code**"), licenses of rights to "intellectual property" as defined in Section 101(35A) of the Bankruptcy Code. Indivior, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. In the event of the commencement of a bankruptcy proceeding by or against an Affiliate of Aelis under the Bankruptcy Code, Indivior will be entitled to a complete duplicate of (or complete access to, as appropriate) such intellectual property and all embodiments of such intellectual property, which, if not already in Indivior's possession, will be promptly delivered to it upon Indivior's written request thereof. Any agreements supplemental hereto will be deemed to be "agreements supplementary to" this Agreement for purposes of Section 365(n) of the Bankruptcy Code. Aelis agrees that it shall not take any action in any bankruptcy proceeding or in any other judicial, administrative, arbitral or other proceeding to reject, object to or challenge the legality, validity or enforceability of any of this Agreement or any rights granted herein.

3.**SECTION 3: INDIVIOR STUDIES; JOINT STEERING COMMITTEE**

3.1Indivior Studies.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.1As soon as reasonably practicably after commencement of the License Term, Indivior shall use commercially reasonable efforts to conduct the Phase III Study and any other necessary, clinical, non-clinical, and CMC, studies required by Regulatory Authorities to submit a Regulatory Approval application to the FDA and in Europe. These studies, clinical, non-clinical, and CMC, on AEF0117 will be first approved by the JSC. It is agreed that after the commencement of the License Term, clinical, non-clinical, and CMC studies may be conducted simultaneously in order to satisfy the regulatory requirements necessary for the submission of the Regulatory Approval of a Licensed Compound.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.2Pursuant to <u>Section 3.2</u>, the JSC may also propose to Aelis to perform some of the Indivior Studies. Aelis may accept to perform one or more of such studies and, subject to Section 3.1.4, at Indivior's costs, on a full cost basis.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.3Without limiting the foregoing, the Parties agree that Indivior shall use commercially reasonable efforts to (i) obtain approval by the applicable institutional review board to perform and (ii) if such approval is obtained, perform, one or two Phase III Studies to evaluate the effects of AEF0117 in one or more Indications, such Indications selected by Indivior at its sole discretion. The following separate clinical Indications are foreseen at the time of the Agreement:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)psychotic symptomatology in cannabis-induced psychosis or in dual diagnosis patients (schizophrenic using cannabis) and/or other toxic effect of cannabis requiring hospitalization.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)the prevention of relapse in cannabis use in abstinent cannabis addicts; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)the cessation of cannabis use in non-abstinent cannabis addicts.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.4If, at any time during the License Term, Aelis receives grants or other Third Party funding to finance any of Aelis Studies, the Parties will equally share the revenues from such sources (the "**Shared Grants**"), excluding any tax credit, loans and grants from French national, regional or local authorities or organizations, which will be retained by Aelis. For clarity, half of the amount of Shared Grants covering expenses of the Aelis Studies, will be deducted from the amount of the costs of the study that should have been repaid by Indivior or refunded to Indivior if Indivior has already made such payments.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.5Subject to <u>Section 3.1.4</u> and <u>Section 3.2</u>, Indivior will bear the full reasonable and documented costs of the Aelis Studies which will be paid to Aelis on quarterly basis.

3.2Joint Steering Committee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.1Within sixty (60) days after the Effective Date, the Parties shall establish a joint development committee (the "**Joint Steering Committee**" or "**JSC**"). The JSC shall be responsible during the License Option Period and the License Term for:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)determining (i) the scope of the Indivior and Aelis Studies, including the Indications that will be evaluated, (ii) the design and scientific coordination of such studies, (iii) the costs of such studies and payment schedule thereof if any of these study are Aelis Studies and (iv) the regulatory strategy and interactions with worldwide Regulatory Authorities related to the CMC, preclinical and clinical development (including any required paediatric study);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)determining the Party that will conduct the Indivior Studies or any other study necessary to the development of AEF0117;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)during the License Option Period, discussing the status of the Option Studies and any developments relating thereto, including reviewing and discussing any proposed changes to the protocol of the Option Studies;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)during the License Option Period, establishing a Development plan for nonclinical and CMC studies in order to satisfy the regulatory requirements necessary for a Licensed Compound to enter a Phase III Study and obtain Regulatory Approval. The JSC will determine when it is the ideal time to

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conduct these studies. If Indivior decides that one or more of these studies should be performed during the License Option Period by Aelis and the studies are approved by the JSC, the reasonable and documented costs of these studies shall be refunded by Indivior to Aelis on a full cost basis;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)discussing additional studies that Aelis may conduct in its sole discretion during the License Option Period to accelerate the Development, <u>provided</u> that, notwithstanding <u>Section 3.2.4(a)</u>, if and only if such studies are approved by Indivior, their reasonable and documented costs will be refunded by Indivior to Aelis on a full cost basis; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)during the License Term, discussing Indivior's Development and, when applicable, Commercialization plans and timelines in reasonable detail and any update thereof, including a summary of the work performed in the past 12 months, the works in progress and the anticipated activities including the anticipated timeline of achievement of the Development Milestones, Regulatory Approvals, launch, the status of Manufacture and any sublicensing process (the "**Plans**").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.2The JSC will be composed of an equal number of representatives appointed by each of Indivior and Aelis. Each individual appointed will be an employee or contractor of such Party or such Party's Affiliate. Each Party may replace any of its JSC representatives at any time upon written notice to the other Party, which notice may be given by e-mail, sent to the other Party. Each JSC representative will be subject to confidentiality obligations no less stringent than those in <u>Section 10</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.3From and after establishment of the JSC until the approval of the last filing of a Regulatory Submission hereunder by Indivior with respect to a Licensed Compound or Licensed Product, the JSC shall meet at least once each Calendar Quarter. Such meetings shall place on the dates and times, and may be in person or by audio or video conference, as the JSC representatives may agree. No action taken at a meeting will be effective unless at least one representative of each Party is present or participating. Neither Party will unreasonably withhold attendance of at least one representative of such Party at any meeting of the JSC for which reasonable advance notice was provided. Each Party shall bear the costs and expenses incurred by its own JSC representatives in participating in the JSC meetings.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.4The Parties will endeavor in good faith to reach unanimous agreement with respect to all matters within the JSC's authority. Should the JSC not be able to reach unanimous agreement with respect to such matter at a duly called meeting of the JSC, then:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)Subject to sub clause (b) below, for all matters during the License Option Period, including any Option Studies or other study to be performed during the License Option Period, the decision of Aelis shall prevail, <u>provided</u> that Aelis shall use good faith efforts to take into account Indivior's comments.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)For all matters during the License Term including all studies that will be initiated after the exercise of the License Option by Indivior, and will be performed either by Aelis or Indivior, the decision of Indivior shall prevail,

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<u>provided</u> that Indivior shall use good faith efforts to take into account Aelis' comments.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.5Notwithstanding the foregoing, Indivior shall not take the following decision without Aelis' consent:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)decrease the number of Phase III Studies or nonclinical and CMC studies necessary to file for Regulatory Approval in the US and EU after such number of studies is approved by the JSC, provided that such approval is mutually agreed by both Indivior and Aelis.

4.**SECTION 4: DEVELOPMENT**

4.1Except as set forth in <u>Section 3.1</u>, during the License Term, Indivior shall have the sole right to Develop the Licensed Compounds and Licensed Products in the Field and shall control all aspects of such Development at its own cost and expense (except as otherwise expressly set forth herein).

4.2Upon request by Indivior, Aelis shall provide reasonable assistance to Indivior in connection with Development of the Licensed Compounds and Licensed Products. The first [\*\*\*] hours of such assistance shall be at Aelis' cost but any hours of Aelis' personnel time in excess of [\*\*\*] hours shall be charged to and be payable by Indivior; <u>provided</u> that Aelis shall not exceed such initial [\*\*\*] hours of service without the prior consent of Indivior. All reasonable and documented amounts owed by Indivior to Aelis pursuant to this <u>Section 4.2</u> shall be reimbursed to Aelis within thirty (30) days after receipt of an invoice therefor.

5.**SECTION 5: REGULATORY RESPONSIBILITIES**

5.1As between the Parties, during the License Term, on a Licensed Product-by-Licensed Product basis, and except for the Aelis Studies and the other activities to be conducted by Aelis pursuant to <u>Section 3.1</u>, Indivior (through its Affiliates and agents) shall have the sole right to (a) prepare and file all Regulatory Materials and seek and maintain all Regulatory Approvals for Licensed Products, including preparation of all Regulatory Materials (including in connection with labeling and packaging for Licensed Products) and communications with applicable Governmental Authorities and (b) complete all pharmacovigilance responsibilities required under and in accordance with Applicable Laws. Through the JSC, Indivior shall provide to Aelis (a) copies of Regulatory Submissions with respect to the Licensed Compounds or Licensed Products prior to the filing thereof and all material correspondence it receives from, a Regulatory Authority, and, (b) copies of the proposed labeling for the Licensed Product.

5.2As between the Parties, Indivior shall own all Regulatory Approvals for Licensed Products in the Territory.

6.**SECTION 6: TECHNOLOGY TRANSFER**

6.1<u>Technology Transfer</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1.1Within thirty (30) days after the commencement of the License Term or at such other time as determined by the JSC, Aelis shall disclose to Indivior all relevant information as shall become available to it relating to the Licensed Technology, Licensed Compounds and Licensed Products. If and as requested by Indivior, Aelis will disclose to Indivior or any Regulatory Authority all relevant

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information in its possession required for Indivior to register for sale or obtain Regulatory Approval for the Licensed Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1.2Within thirty (30) days after commencement of the License Term or at such other time as determined by the JSC, Aelis will make available to Indivior all Aelis Know-How that is reasonably necessary, or useful, for Indivior to Develop and/or Commercialize Licensed Products, including all research data, pharmacology data, preclinical data, and/or clinical data for the Licensed Compounds.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1.3Within ninety (90) days after commencement of the License Term, Aelis shall promptly provide technical assistance to Indivior as Indivior reasonably requests regarding the Licensed Technology for the Licensed Compound and/or the Licensed Product, and Indivior's efforts with respect to obtaining Regulatory Approval for any Licensed Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1.4Aelis shall use commercially reasonable efforts to transfer to Indivior all rights Aelis may have in any agreements with Third Parties to the extent such rights relate to Manufacturing; <u>provided</u> that if Indivior requests Aelis to transfer such agreements to a Third-Party, Indivior shall bear Aelis' out-of-pocket costs of such transfer.

7.**SECTION 7: COMMERCIALIZATION**

7.1<u>Right to Commercialize</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1.1As between the Parties, Indivior shall have the sole right to Commercialize the Licensed Products in the Field and shall control all aspects of Commercialization, including: (a) receiving, accepting and filling orders for Licensed Products in the Field, (b) handling all returns of Licensed Product in the Field, (c) controlling invoicing, order processing and collection of accounts receivable for the sales of Licensed Product in the Field, (d) distributing and managing inventory of Licensed Product in the Field, and (e) the sale of Licensed Products in the Field, including the price or prices at which each Licensed Product will be sold, any discount applicable to payments or receivables, and similar matters.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1.2Upon Indivior's reasonable request, Aelis shall provide reasonable assistance to Indivior in connection with Commercialization of the Licensed Product in the Field, <u>provided</u> that Indivior shall bear all Third Party expenses related to such assistance, as applicable.

7.2<u>Diligence & Reporting</u>. Indivior shall use commercially reasonable efforts to Develop at least one Licensed Product and use commercially reasonable efforts to Commercialize at least one Licensed Product in the Territory. For purposes of the foregoing, commercially reasonable efforts means the commitment of efforts and resources by Indivior, consistent with those normally applied in the pharmaceutical industry by companies of similar size and with similar resources as Indivior with respect to a compound or product having similar regulatory factors and similar market potential, profit potential and strategic value, and that is at a similar stage in its development or product life cycle as the Licensed Compound or Licensed Product; provided that in no event shall commercially reasonable efforts require Indivior to take any actions that require Indivior to incur costs or liabilities out of proportion to the benefits under this Agreement. Indivior shall not be in breach of this Section 7.2 to the extent any failure or delay by Indivior in Developing or Commercializing any Licensed Product is the result of any action or omission by Aelis, including any delays or failure to

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provide Licensed Product as clinical trial material. Without limitation to the foregoing, Indivior's Development and Commercialization activities shall include and be consistent with the obligations set forth in **t**he Head License, subject to the Side Letter (as defined below). Following dismantlement of the JSC, Indivior shall submit its update of the Plans to Aelis in June and December of each year, and will offer to Aelis the ability to discuss the same by telephone or in person.

7.3<u>Trademarks and Trade Dress</u>. Indivior shall have the right, in its sole discretion, to select, register and own the trade marks, trade dress, logos, slogans and internet domain names with respect to the Licensed Products (collectively, the "**Licensed Product Trademarks and Trade Dress**"), except for the name and trademark, if any, that define the pharmacological class (i.e. CB1-SSi) or the pharmacological name of the compound as will be notified by Aelis to Indivior. If Aelis files a trade mark or other Intellectual Property Right on such names and trade mark, Aelis will grant to Indivior a non-exclusive, fully paid-up license thereunder for the Licensed Product in the Field and for the duration of the License Term. As between the Parties, Indivior shall own all rights to Licensed Product Trademarks and Trade Dress (in each case, together with all goodwill associated therewith).

7.4<u>Side Letter Agreement</u>. Prior to the Effective Date, Aelis and the Head Licensor shall enter into a side letter agreement, in the form of <u>Exhibit A</u> ("**Side Letter**"), which provides, in pertinent part, that the Head Licensor shall have no right to terminate the Head License or convert the license thereunder into a non-exclusive license as a result of any failure by Indivior or Aelis to obtain Regulatory Approval for, or Commercialize, the Licensed Product so long as Indivior is not in material breach of <u>Section 7.2</u> hereof. Aelis shall deliver a duly executed copy of such Side Letter to Indivior on the Effective Date.

7.5<u>Head License</u>. Aelis will maintain in full effect and perform all of its obligations in a timely manner under the Head License. Aelis will not take any action or omit to take any action that would cause Aelis to be in breach of the Head License or give rise to a right by Head Licensor to terminate the Head License. Aelis will use commercially reasonable efforts to facilitate any communications between Indivior and the Head Licensor required for Indivior to exercise the rights granted to Indivior under this Agreement and will use commercially reasonable efforts to cause the Head Licensor to perform all of its obligations under the Head License. In the event that the Head License is terminated by the Head Licensor for reasons not attributable to Indivior's breach of this Agreement, and, as of the effective date of such termination, this Agreement has not otherwise expired or been terminated, Indivior, to the extent permitted by the Head License, will have the right without prejudice to its other remedies against Aelis, at Indivior's election, to convert the sublicenses granted under this Agreement by Aelis to Indivior under the Head License to a direct license from the Head Licensor to Indivior on the terms and conditions contained in the Head License (with Indivior assuming the applicable obligations of Aelis thereunder) or such other terms and conditions as may be negotiated by Indivior and the Head Licensor. In such case, Indivior may deduct all payments that it will owe to the Head Licensor under such direct license from the payments due to Aelis under this Agreement, <u>provided that</u>, subject to the Head Licensor agreeing in the Side Letter that it will not require in such direct license any payments in consideration of the license rights currently granted pursuant to this Agreement that exceed the payments due to the Head Licensor that are currently contemplated in case of (i) direct exploitation under the Head License pursuant to Section 5.4.1 of the Head License and (ii) payments under Section 5.3 of the Head License (together, the "**Current Head License Payments**"), then such deductions cannot exceed the Current Head License Payments.

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8.**SECTION 8: PAYMENTS**

8.1<u>License Option Fee</u>. As consideration for the exclusive License Option granted to Indivior pursuant to <u>Section 2.1</u>, Indivior shall pay to Aelis an amount equal to $[\*\*\*], payable within 15 days after the Effective Date.

8.2<u>License Fee</u>. In the event that Indivior exercises the License Option, as partial consideration for the License granted to Indivior hereunder, Indivior shall pay to Aelis the License Fee within fifteen (15) days after delivery by Indivior of the License Exercise Notice.

8.3<u>Pain Option Fee</u>. In the event that Indivior exercises the Pain Option, in consideration thereof, Indivior shall pay Aelis an amount equal to $[\*\*\*] within fifteen (15) days after exercise by Indivior of such option.

8.4<u>Milestones</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4.1<u>Development Milestone Payments</u>. In partial consideration for the License granted to Indivior hereunder, after first achievement by Indivior or its Affiliates, or by Aelis or its Affiliates, pursuant to this Agreement, of any of the milestone events set forth in the following table (each, a "**Development Milestone Event**"), Indivior shall pay to Aelis the corresponding amount set forth in the following table (each, a "**Development Milestone Payment**").

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| | |
|:---|:---|
| **Development Milestone Events** | With respect to one Indication for a Licensed Product |
| 1.&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] | $[\*\*\*] |
| 2.&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] | $[\*\*\*] |
| 3.&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] | $[\*\*\*] |
| 4.&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] | $[\*\*\*] |
| 5.&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] | $[\*\*\*] |
| 6.&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] | $[\*\*\*] |
| 7.&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] | $[\*\*\*] |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)For the avoidance of doubt:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)each Development Milestone Payment shall be payable one- time only upon the first occurrence of the event triggering the respective milestone set forth above and no payments would be owed with respect to supplementary trials of the same stage;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Indivior shall notify Aelis of the achievement of each Development Milestone Event within thirty (30) days after the achievement thereof. Aelis shall notify Indivior of the achievement of each Development Milestone Event in the case of any Aelis Studies or further studies that, pursuant to this Agreement, will be performed by Aelis, within thirty (30) days after the achievement thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4.2<u>Sales Milestone Payments</u>. As additional consideration for the rights granted to Indivior herein, Indivior shall pay to Aelis a one-time milestone payment ("**Sales Milestone Payments**") upon first achieving each of the thresholds for the annual global Net Sales aggregated for all Licensed Products set forth below ("**Sales** 

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**Milestones**"). For the avoidance of doubt, each Sales Milestone Payment shall be payable one-time only upon the first occurrence of the event triggering the respective milestone provided below.

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| | |
|:---|:---|
| **Sales Milestones** | **Sales Milestone Payment** |
| [\*\*\*] $[\*\*\*] | $[\*\*\*] |
| [\*\*\*] $[\*\*\*] | $[\*\*\*] |
| [\*\*\*] $[\*\*\*] | $[\*\*\*] |
| [\*\*\*] $[\*\*\*] | $[\*\*\*] |
| [\*\*\*] $[\*\*\*] | $[\*\*\*] |
| [\*\*\*] $[\*\*\*] | $[\*\*\*] |
| [\*\*\*] $[\*\*\*] | $[\*\*\*] |
| [\*\*\*] $[\*\*\*] | $[\*\*\*] |
| Total potential Sales Milestone Payments | $[\*\*\*] |

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8.5<u>Royalty</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.5.1As additional consideration for the rights granted to Indivior herein, during the Royalty Term (on a country-by-country and Licensed Product by Licensed Product basis), Indivior shall pay to Aelis tiered royalty payments at the rates set out below on Net Sales ("**Royalty**"):

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| | |
|:---|:---|
| **Annual aggregated global Net Sales of Licensed Products** | **Royalty Rate** |
| Portion of Annual aggregated global Net Sales of Licensed Products less than $[\*\*\*] | [\*\*\*]% |
| Portion of Annual aggregated global Net Sales of Licensed Products equal to or greater than<br>$[\*\*\*] but less than $[\*\*\*] | [\*\*\*]% |
| Portion of Annual aggregated global Net Sales of Licensed Products equal to or greater than<br>$[\*\*\*] but less than $[\*\*\*] | [\*\*\*]% |
| Portion of Annual aggregated global Net Sales of Licensed Products equal to or greater than<br>$[\*\*\*] | [\*\*\*]% |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.5.2Notwithstanding <u>Section 8.5.1</u> above, the Royalty payable with respect to any Licensed Product shall be reduced by 50% on a country-by-country basis as long as there is a Generic Competition with respect to such Licensed Product in such country.

8.6<u>Third Party Licenses.</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.6.1In the event that it is reasonably necessary or useful for Indivior, in consultation with Aelis, to pay royalties to a Third Party (other than an Affiliate) in connection with a license for a Patent (to which such Third Party has rights), for the Development, Manufacture and/or Commercialization of a Licensed Product, then Indivior and Aelis shall equally share the responsibility for such royalties payable with respect to such Third Party licenses. Indivior shall pay such royalties to such Third Party. To recover Aelis' share of the responsibility, Indivior may deduct fifty percent (50%) of the royalties paid to the relevant Third Party from the

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Royalty due to Aelis under <u>Section 8.5</u> up to a maximum amount of fifty per cent (50%) of such Royalty due to Aelis under <u>Section 8.5.1</u>. Indivior shall make all payments other than royalties with respect to such Third Party licenses.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.6.2All existing licenses or contractual obligations of Aelis that are necessary for the maintenance of the licenses under the Licensed Technology for the Licensed Compound and Licensed Product in the Field as set forth in <u>Section 2.2.1</u> shall be, except as otherwise expressly set forth herein, maintained by Aelis and Aelis shall pay all royalties and other fees therefor.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.6.3Notwithstanding anything to the contrary, the Royalty rate shall not be less than 1% of the sales of the Licensed Products by Indivior Parties in the Territory as required by the Head License.

9.**SECTION 9: PAYMENT TERMS**

9.1<u>Payment Methods</u>. All amounts due hereunder will be paid in US Dollars, and all references to "$" or "Dollars" shall refer to US Dollars. For the purpose of converting any amount owed hereunder to $, such conversion shall be calculated using the exchange rate sourced at each month end from Bloomberg. All payments due to Aelis under this Agreement shall be made by wire transfer in immediately available funds to an account in designated by the applicable Party in writing.

9.2<u>Payments</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.1Royalty payments due pursuant to <u>Section 8.5</u> shall be due and payable quarterly, sixty (60) days after the end of each Calendar Quarter. Indivior will accompany each payment of royalties under this Agreement with a report setting forth, on a Licensed Product-by-Licensed Product and country-by-country basis, the amount invoiced from gross sales of each Licensed Product, the number of units of Licensed Products, a calculation of Net Sales, and a calculation of the amount of Royalty payment due on such Net Sales.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.2Development Milestone Payments shall be due and payable by Indivior within sixty (60) days after completion of the applicable Development Milestone Event. Together with any such payment, Indivior shall deliver a written statement of completion and other pertinent and available information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.3Sales Milestone Payments shall be due and payable by Indivior within sixty (60) days after the last day of the Calendar Quarter in which the relevant milestone event was achieved. Together with any such payment, Indivior shall deliver a report specifying, with respect to such Calendar Quarter: the total gross invoiced amount from sales of each Licensed Product in such country by or on behalf of Indivior, amounts deducted by category from such gross invoiced amounts to calculate Net Sales, and a calculation of the Sales Milestone Payment payable.

9.3<u>Taxes</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.1Indivior will make all payments to Aelis under this Agreement without deduction or withholding for Taxes except to the extent that such payments are made from the UK or the US and any such deduction or withholding is required by Applicable Laws. In such case, , Indivior shall notify Aelis of such withholding requirement at least thirty (30) days in advance of the payment, cooperate with Aelis and take all reasonable actions as may be necessary to ensure that no

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withholding or the lowest withholding Tax possible is made on payments under this Agreement. Any Tax required to be withheld on amounts payable under this Agreement will be properly and timely paid by Indivior on behalf of Aelis to the appropriate Tax authority, Indivior shall further send evidence of the obligation together with proof of Tax payment to Aelis within thirty (30) days following such payment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.2All amounts set out or expressed in this Agreement to be payable by any Party (the "**Payor**") to the other Party (the "**Payee**") which (in whole or in part) constitute the consideration for a supply or supplies which attract VAT (for which the Payee (or another member of the Payee's group) is accountable to the relevant Tax authority) shall be deemed to be exclusive of any VAT which is chargeable on such supply or supplies, and accordingly, if VAT is or becomes chargeable on any such supply or supplies, then the Payor shall pay to the Payee (in addition to and at the same time as paying any other consideration for such supply) an amount equal to the amount of such VAT at the rate prevailing at the time the supply is made on the provision by, or the procurement by, the Payee to the Payor of a VAT invoice or such other documentary evidence as the Applicable Law may require. All amounts specified in this Agreement are exclusive of VAT and any other similar taxes. Those amounts shall be payable by the Payor to the Payee against the presentation of a valid VAT invoice. If applicable, VAT, or any other similar taxes, shall become payable in addition to the amounts specified in this Agreement, subject to the normal rules.

9.4<u>Inspection of Records.</u>

Indivior shall keep records of its sales of Licensed Products reasonably necessary for the calculation of payment to be made to Aelis hereunder. During the Term, and for a period of one (1) year thereafter, Aelis shall have the right to have an independent certified public accountant, mutually agreed upon by Indivior, audit the records of Indivior. Aelis, upon providing at least thirty (30) days' prior written notice to Indivior, may initiate such an audit no more than once per calendar year during the Term and one year thereafter. Any such audit shall be conducted during the normal business hours of Indivior, at a single location where Indivior shall make the records sought to be audited available, and in such a manner as shall not disrupt Indivior' business operations. All personnel conducting the audit on behalf of the independent auditor shall enter into confidentiality agreements with Indivior. Each such audit shall be conducted at the expense of Aelis; <u>provided</u> that if the inspection and audit shows an underpayment of more than five percent (5%) of the amount due for the applicable period covered by the inspection, then Indivior shall reimburse Aelis for all costs incurred in connection with such inspection within thirty (30) days thereafter. Indivior shall pay to Aelis the amount of any undisputed underpayment revealed by an examination and review. Any overpayment by Indivior revealed by an examination and review shall be deducted by Indivior from the next payment due to Aelis or, if after the Term, refunded by Aelis to Indivior within thirty (30) days.

10.**SECTION 10: CONFIDENTIALITY AND PUBLICITY**

10.1<u>Confidentiality</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.1In carrying out the terms of this Agreement, either Party may disclose (the "**Disclosing Party**") to the other Party (the "**Recipient**") information regarding the Disclosing Party and/or its Affiliates which is of a proprietary and of

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confidential nature, including any and all information, information regarding its business, know-how, methods, trade secrets, financial information, customers and technology (collectively, "**Confidential Information**"). Confidential Information also includes the terms of this Agreement. The Recipient shall not use the Disclosing Party's Confidential Information for any purpose other than as permitted herein and shall not disclose the Confidential Information to any Third Party, except to its employees, directors, contractors and other representatives who have a need to know such information to fulfill the provisions and intent of this Agreement, and who are bound by written obligations of confidentiality with respect to such information. Aelis may disclose the Confidential Information to current and prospective investors or possible acquirers or partners, <u>provided</u> that they are bound by written obligations of confidentiality with respect to such information in a form consistent with the provisions of this clause. The Recipient agrees that it will exercise the same degree of care and protection to preserve the proprietary and confidential nature of the Confidential Information disclosed by the Disclosing Party, as Recipient would exercise to preserve its own proprietary and confidential information, and in any case no less than a reasonable degree of care. The Recipient shall promptly notify the Disclosing Party of any unauthorized use or disclosure, or suspected unauthorized use or disclosure, of the Disclosing Party's Confidential Information of which the Recipient becomes aware. Each Party shall be liable for any failure of its employees, directors, other representatives or other persons with whom they disclose Confidential Information to comply with the terms of this <u>Section 10</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.2The confidentiality obligations set forth in this <u>Section 10</u> shall not apply to confidential information which: (a) is or becomes publicly known through no wrongful act or inaction of the Recipient; (b) the Recipient can demonstrate by written records was lawfully received by it from a Third-Party that is not legally or contractually prohibited from disclosing such information; (c) the Recipient can demonstrate by written records was developed by or for such Recipient independently of, and without the use of, such information disclosed by the Disclosing Party, (d) the Recipient is required by legal order to disclose, provided that the Recipient shall, where permitted, give the Disclosing Party immediate written notice of any such request so that the Disclosing Party may seek a protective order or other reliable assurance that confidential treatment will be accorded to the information so disclosed, (e) the Recipient must disclose to comply with the reporting requirements of any Applicable Laws or any securities exchange on which the securities of the Receiving Party or its Affiliates are traded, provided that the Recipient shall, where permitted, give the Disclosing Party immediate written notice of any such request so that the Disclosing Party may seek a protective order or other reliable assurance that confidential treatment will be accorded to the information so disclosed, (f) to any actual or bona fide potential investors or acquirors solely for the purpose of evaluating or carrying out an actual or potential investment or acquisition; <u>provided</u> that in each such case on the condition that such actual or potential investors or acquirors are bound by confidentiality and non-use obligations substantially consistent with those contained in the Agreement, or (g) Indivior discloses to Regulatory Authorities in connection with obtaining Regulatory Approval or other communications relating to Commercialization of the Licensed Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.3In the event the stock or assets of Aelis are acquired by an Acquirer during the Term, Aelis shall ensure that the Acquirer remains subject to a confidentiality agreement with respect to the Licensed Technology as it relates to the Licensed

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Compound(s) and/or Licensed Product(s) in the Field and any Confidential Information of Indivior and shall create an internal firewall to protect against the use by the Acquirer of such information; <u>provided</u> that the aforementioned obligation shall not apply to any Aelis Know-How that does not exclusively relate to the Licensed Compounds and Licensed Products in the Field.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.4In the event that Aelis desires to disclose any Confidential Information of Indivior with the Head Licensor where such Confidential Information is required by the terms of the Head License to be disclosed to the Head Licensor, Aelis shall: (i) first provide written notice to Indivior, (ii) only disclose such Confidential Information pursuant to the confidentiality provisions of the Head License, and (iii) only disclose such Confidential Information as is necessary for Aelis to comply with the terms of the Head License. The disclosure of the following information is hereby notified to Indivior for purposes of subclause (i) of the preceding sentence: (A) a copy of this Agreement, (B) Development updates pursuant to Section 3.11 of the Head License, (C) financial reports pursuant to Section 5.7.1 of the Head License, and (D) patent prosecution and infringement updates pursuant to Section 6 of the Head License, <u>provided</u> that such notified disclosures shall be subject to the remaining requirements of this <u>Section 10.1.4</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.5The confidentiality obligations set forth in this <u>Sections 10.1</u> and <u>10.2</u> shall survive for ten (10) years after termination or expiration of this Agreement.

10.2<u>Publicity</u>. The Parties agree that the terms and contents of this Agreement shall be treated as Confidential Information of both Parties and neither Party shall make any press release or public announcement regarding the execution or terms of this Agreement or the transaction contemplated by this Agreement without the consent of the other Party.

10.3<u>Publications</u>. Each Party, through the JSC or its designee shall provide to the other, prior to submission for publication, a draft of any articles and papers containing unpublished data relating to the Licensed Compounds or Licensed Products which have been prepared by or on behalf of such Party (the "**Scientific Paper**"). With respect to Scientific Papers prepared by Aelis, Indivior shall have forty-five (45) days after receipt thereof to notify Aelis of its observations and suggestions with respect thereto (it being understood that, during such forty- five (45) day period, no submission for publication thereof shall take place) and the Parties shall discuss these observations and suggestions. With respect to Scientific Papers prepared by Indivior, Aelis shall have thirty (30) days after receipt thereof to notify Indivior of its observations and suggestions with respect thereto (it being understood that, during such thirty (30) day period, no submission for publication thereof shall take place) and the Parties shall discuss these observations and suggestions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.3.1With respect to publications of Scientific Papers during the License Option Period, Aelis shall reasonably incorporate the comments made by Indivior, particularly if disclosure may be prejudicial to Indivior's opportunity to obtain, maintain, enforce or defend any Patent. Without limiting the foregoing, Indivior may require that the publication be suspended for a period of time not exceeding ninety (90) days if a Patent may be filed using Know-How covered in the proposed publication. Aelis shall provide to Indivior copies of any final Scientific Paper accepted by the journal, within ten (10) days after the approval thereof (upon availability and distribution of such information assuming that providing such information is acceptable taking into consideration the publishers' need to comply with any healthcare compliance guidelines). This provision will apply mutatis mutandis to the presentations, abstracts, posters or slides decks at

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symposia or other meetings of healthcare professionals, or congresses, conferences or meetings organized by a professional society or organization, except if these presentations abstracts, posters or slide decks incorporate data that have been approved in the context of a Scientific Paper or that have been already presented before the exercise of the License Option.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.3.2With respect to publications of Scientific Papers during the License Term, Aelis shall incorporate the comments made by Indivior, particularly if disclosure may be prejudicial to Indivior's opportunity to obtain, maintain, enforce or defend any Patent, and Indivior shall incorporate reasonable comments made by Aelis. Without limiting the foregoing, Indivior may also require that the publication be (a) suspended for a period of time not exceeding ninety (90) days if a Patent may be filed using Know- How covered in the proposed publication or (b) delayed indefinitely if Indivior reasonably determines that such publication would be detrimental to its patent prosecution, litigation, or other intellectual property strategy or position.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.3.3The party submitting the paper shall provide to the other party copies of any final Scientific Paper accepted by the journal, within ten (10) days after the approval thereof (upon availability and distribution of such information assuming that providing such information is acceptable taking into consideration the publishers' need to comply with any healthcare compliance guidelines). This provision will apply *mutatis mutandis* to the presentations, abstracts, posters or slides desks at symposia or other meetings of healthcare professionals, or congresses, conferences or meetings organized by a professional society or organization.

11.**SECTION 11: INTELLECTUAL PROPERTY RIGHTS**

11.1<u>Filing, Prosecution and Maintenance of Patents</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1.1Aelis shall have the first right, but not the obligation, to Handle the Aelis Patents in each applicable country, in each case in consultation with Indivior pursuant to <u>Section</u> <u>11.1.3</u>, at Aelis' cost. Aelis shall notify Indivior of any intent or decision to cease prosecution of or abandon any Aelis Patents at least thirty (30) days prior to any filing deadline or payment due date. In such event, Indivior shall have the right at its costs to take over prosecution and maintenance of the Aelis Patents in such country in Aelis' name.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1.2As between the Parties, Joint Patents shall be jointly owned by the Parties and inventorship thereof shall be determined in accordance with, and subject to, United States or other applicable patent law. Except to the extent a Party is expressly limited by the terms hereof, including <u>Section 2.2.1</u> and <u>Section 2.4</u>, each Party shall be entitled to exploit its co-ownership interest in the Joint Patents, including through Third Party licenses, without consent or otherwise accounting to the other Party. Each Party shall obtain proper assignments from each inventor that is (a) an employee, contractor or other agent of such Party (b) or that is otherwise obligated to assign their rights in the invention to such Party, in each case to effectuate the foregoing ownership of the Joint Patents. A joint patent committee to be formed by the JSC will decide which Party will Handle the Joint Patents. If such joint patent committee is unable to reach unanimous agreement, Aelis shall have the right to do so at its cost. Each Party shall notify the other Party of any intent or decision to cease prosecution of or abandon any Joint Patents at least thirty (30) days prior to any filing deadline or payment due date.

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In such event, the other Party shall have the right at its costs to take over prosecution and maintenance of the Joint Patents in such country and, if necessary, in the other Party's name.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1.3The Party Handling a Patent agrees to inform with sufficient advance notice and coordinate with the other Party with respect to patent prosecution or other proceedings with respect to the Patents. The Handling Party shall provide the other Party with copies of each office action received from the relevant patent offices and intended response, with enough lead time where reasonably practicable, to enable the other Party to review and comment on such action or proposed response, which the Handling Party shall take into account in good faith. Additionally, the Handling Party will provide the other Party with copies of the responses to offices actions it ultimately files with the patent offices.

11.2<u>Cooperation</u>. Each Party shall make available to the other Party (and to the other Party's authorised attorneys, agents or representatives) its employees, agents, subcontractors and consultants and relevant information and documentation in such Party's Control, in each case to the extent reasonably available, necessary and appropriate to enable the prosecuting Party to Handle Aelis Patents and Joint Patents as set forth in <u>Section 11.1 and 11.1.2,</u> and for periods of time reasonably sufficient for such Party to obtain the assistance it needs from such personnel. Where appropriate and without prejudice to <u>Section 11.1 and 11.1.2</u>, each Party shall execute or use commercially reasonable efforts to procure the execution of all documents relating to such Aelis Patent or Joint Patent applications or Aelis Patents or Joint Patents at no charge to the other Party.

11.3<u>Infringement Claims</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3.1Infringement of Third Party Rights

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)Each Party shall promptly, but in any event no later than ten (10) days after receipt of notice of such action (but no less than ten (10) Business Days before the expiry of any statutory timeline for taking action), notify the other in writing if any Third Party at any time provides written notice of a claim to, or brings an action, suit or proceeding against, either Party, or any of their respective Affiliates or sublicensees or subcontractors, claiming that the Development, Manufacture or Commercialization of the Licensed Compound or Licensed Product infringes a Third Party Patent or constitutes an unauthorised use or misappropriation of Third Party Know-How (an "**Infringement Claim**").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Indivior shall have the first right but not the obligation to control the defence of any Infringement Claim. If Indivior assumes the defence of such Infringement Claim, Indivior shall bear the costs of such defence (unless such Infringement Claim is indemnifiable by Aelis pursuant to <u>Section 13.2</u>). Aelis will cooperate and assist Indivior in any such litigation controlled by Indivior. For purposes of <u>Section 11</u>, the Party that defends the Infringement Claim and/or Infringement Actions (as defined below in <u>Section 11.3.2(b)</u>) shall be referred to as the "**Controlling Party**".

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)In the event that Indivior is the Controlling Party in any action that was brought solely against Aelis, Aelis shall take actions to enable Indivior to assume control of such action, in the name of Aelis if reasonably necessary.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)The Controlling Party will have the exclusive right to hire, dismiss and direct attorney(ies) and/or solicitor(s) to represent it (and in the event that the claim is brought against both Parties, to represent it and the other Party) with respect to the applicable Infringement Claims. The Controlling Party will have the exclusive right to settle any Infringement Claim, in consultation with the other Party but without consent of the other Party, unless such settlement: (i) would have an adverse impact on the other Party's rights or ability to perform its obligations under this Agreement, (ii) makes any admission regarding wrongdoing by the other Party, or the invalidity, unenforceability, limitation or absence of infringement of any Licensed Technology; (iii) subjects the other Party to an injunction or other equitable relief; or (iv) obligates the other Party to make a monetary payment, in each such case of (i)-(iv), the consent of the other Party shall be required and shall not be unreasonably withheld, conditioned or delayed. For purposes of clarity, any settlement that would involve the waiver of rights shall be deemed to have an adverse impact and shall require the consent of such other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)If Indivior wishes to assume control of the defence of any such Infringement Claim pursuant to <u>Section 11.3.1(b)</u>, then Indivior may do so upon written notice to Aelis. If Indivior does not exercise its right to control the defence of an Infringement Claim pursuant to <u>Section 11.3.1(b)</u>, then Aelis shall have the right, but no obligation, to control the defence of such Infringement Claim.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)If either Party becomes engaged in or participates in any suit described in this <u>Section 11.3</u>, the other Party shall cooperate, and shall cause its and its Affiliates' employees to cooperate, with such Party in all reasonable respects in connection therewith.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3.2Infringement by Third Parties

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)In the event that either Party becomes aware of actual or suspected infringement of Aelis Patents, Joint Patents or misappropriation of Aelis Know-How by a Third Party, such Party shall promptly provide written notice thereof to the other Party, <u>provided</u> that if Aelis is the receiving Party for such notice, Aelis shall promptly provide written notice to the Head Licensor pursuant to the terms of the Head License. In the event of such actual or suspected infringement, including the defence of declaratory judgement actions or counterclaims challenging the validity or enforceability of the Aelis Patents, Joint Patents or Aelis Know-How, the following provisions in <u>Section 11.3.2</u> shall apply.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Indivior shall have the first right to send written notices, warnings, or claims of infringement to such Third Party that may be infringing or misappropriating the (i) Aelis Patents, (ii) Joint Patents inside of the Field or (iii) Aelis Know- How ("**Indivior Infringement Actions**"**)**. Indivior shall have the first right, but not the obligation, to institute and prosecute Indivior Infringement Actions, including the right to settle such Indivior Infringement Actions pursuant to <u>Section 11.3.2(d)</u>. In the event a declaratory judgement action is brought against Indivior or Aelis, including any counterclaims challenging the validity or enforceability of the Aelis Patents, Joint Patents inside of the Field or Aelis Know-How, Indivior shall

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have the right, but not the obligation to be the Controlling Party for such action, even if Aelis is the named defendant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)Aelis shall have the first right to send written notices, warnings, or claims of infringement to such Third Party that may be infringing or misappropriating the Joint Patents outside of the Field ("**Aelis Infringement Action**s," together with Indivior Infringement Actions, "**Infringement Actions**") and the first right, but not the obligation, to institute and prosecute Aelis Infringement Actions, including the right to settle such Aelis Infringement Actions pursuant to <u>Section 11.3.2(d)</u>. In the event a declaratory judgement action is brought against Indivior or Aelis, including any counterclaims challenging the validity or enforceability of the Joint Patents outside of the Field, Aelis shall have the right, but not the obligation to be the Controlling Party for such action, even if Indivior is the named defendant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)With respect to any such action or proceeding that a Party initiates and maintains pursuant to this <u>Section 11.3.2</u>, the other Party shall cooperate as may be reasonably requested by the Controlling Party, including by joining as a party claimant if required to do so by Applicable Laws to maintain such action or proceeding, to collect any and all damages, profits and awards of any nature recoverable for such infringements, by executing and making available such documents and witnesses as the Controlling Party may reasonably request, and by performing all other acts which are or may become necessary to vest in the Controlling Party the right to institute any such suit, including by using commercially reasonable efforts to obtain any necessary joinder and/or cooperation in any such action or proceeding from applicable Third Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)If the Party with the first right to be the Controlling Party does not initiate such action within ninety (60) days of becoming aware of a notice of such infringement or misappropriation (but no less than ten (10) Business Days before the expiry of any statutory timeline for taking action), then the other Party shall have the right, but not the obligation, at its own cost, to be the Controlling Party in such action.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)The Controlling Party will have the exclusive right to settle any Infringement Claim without consent of the other Party, unless such settlement would have an adverse impact on the other Party's rights or ability to perform its obligations under this Agreement (including a waiver of such Party's rights) or subjects the other Party to any obligations, which, in each such case, the consent of the other Party shall be required and shall not be unreasonably withheld, conditioned or delayed.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)If the Parties obtain any damages, license fees, royalties or other compensation (including any amount received in settlement of such litigation) from a Third Party in connection with a suit brought by a Party pursuant to this <u>Section</u> <u>11.3.2</u>, such amounts shall be allocated as follows: (i) each Party shall be reimbursed for its out-of-pocket expenses incurred in connection with such litigation, including reasonable attorneys' fees and disbursements, court costs and other litigation expenses, if any, and (ii) the balance, (x) if Indivior is the Controlling Party, shall be retained by Indivior, with Indivior paying a Royalty on such recovery as if such

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recovery were Net Sales of Licensed Product hereunder, (y) if Aelis is the Controlling Party, shall be retained by Aelis.

11.4<u>Patent Term Extensions</u>. The Parties shall discuss the strategy with respect to Patent term extensions or supplemental protection certificates and use good faith efforts to consider in priority extending one or more Aelis Patents or Joint Patents. The Party responsible for filing, prosecuting and maintaining the Aelis Patents or Joint Patents shall control these proceedings in accordance with the Head License. The non-controlling Party shall cooperate with the other Party to obtain any Patent term extensions or supplemental protection certificates, including making available all required regulatory data and information under its Control and executing any required authorizations in a timely fashion to enable the timely filing of any and all documents for procurement of such extensions.

11.5<u>Indivior Patents</u>. As between the Parties, Indivior shall be and shall remain the sole owner of all right, title and interest in and to the Indivior Patents, subject to any license granted to Aelis pursuant to <u>Section 18.1.2(a)</u>.

12.**SECTION 12: REPRESENTATIONS, WARRANTIES AND UNDERTAKINGS**

12.1<u>Representations and Warranties</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.1.1Mutual Representations and Warranties

Each of the Parties hereby represents and warrants to the other Party that, as of the Effective Date:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)such Party is duly incorporated and validly existing under the laws of its jurisdiction of incorporation or organisation, as applicable. Such Party has full corporate (or other organisational) right, power and authority, and has taken all action necessary, to enter into this Agreement and to perform its respective obligations under this Agreement and that it has the right to grant the rights, licenses and sub-licenses granted pursuant to this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)this Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms, except to the extent that the enforceability may be limited by applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium or similar laws from time to time in effect affecting generally the enforcement of creditors' rights and general principles of equity The execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it (or any of its Affiliates) is a Party or by which it (or any of its Affiliates) is bound, nor, to its knowledge, violate any Applicable Law of any Governmental Authority having jurisdiction over it (or any of its Affiliates);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)the Person executing this Agreement on behalf of such Party is duly authorised to do so by all requisite corporate action (or other organisational action, as applicable); and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)each Party has obtained all necessary consents, approvals and authorisations of all Governmental Authorities and other Persons required to be obtained by it as of the Effective Date in connection with the execution, delivery and performance of this Agreement.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.1.2Representations and Warranties of Aelis

Aelis hereby represents and warrants to Indivior that, as of the Effective Date:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)except as set forth on <u>Schedule 12.1.2(a)</u>, Aelis exclusively Controls all right, title and interest in and to the Licensed Compounds and Licensed Technology, free and clear of all liens, security interests, licenses and encumbrances, except for the license granted to Indivior herein. <u>Schedule 12.1.2(a)</u> sets forth a true and complete list of all existing licenses and other agreements relating to the Licensed Technology with respect to the Licensed Compounds in the Field;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)except for the Head License, no existing licenses or other agreements relating to the Licensed Technology will impact Indivior's rights herein or impose any obligations on Indivior;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)all the Aelis Patents existing as of the Effective Date are identified in <u>Schedule I</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)all material transfer agreements regarding the Licensed Compounds to which Aelis is a party or which it is subject were made available to Indivior in the virtual data room entitled "[\*\*\*]" at least fifteen (15) days prior to the Effective Date;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)each institution and other Third Party that received Licensed Compounds from Aelis prior to the Effective Date are listed on <u>Schedule 12.1.2(e)</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)prior to the Effective Date, Aelis has not authorized the Head Licensor or any other Third Party to prepare or issue articles or publications with respect to the Licensed Compounds;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)Aelis has not withheld from Indivior any material information relating to the Licensed Technology which would result in the statements contained in this <u>Section 12.1.2</u> being misleading;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h)Aelis has not received written notice from a Third Party alleging that the practice of the Aelis Patents or the Licensed Technology infringe the Patent or other proprietary rights of such Third Party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)Aelis has not received any claim made against it in writing asserting the invalidity or unenforceability of any of the Aelis Patents, and no claim or demand of any Person has been asserted in writing to Aelis that challenges Aelis' ownership of or the rights of Aelis to use or license any of the Licensed Technology;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(j)Aelis has not granted any Third Party (including any Affiliate or investor in Aelis) any right, title or interest to, or any encumbrances over, the Licensed Technology with respect to the Licensed Compound or the Licensed Product in the Field;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(k)Aelis, its Affiliates, and any inventors of the Aelis Patents Controlled by Aelis have complied with their duty of candor and disclosure to the United States Patent and Trademark Office with respect to those Aelis Patents being prosecuted in the United States, and have also complied with any

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similar rules applicable in any relevant foreign patent office where such Aelis Patents are being prosecuted; and to Aelis' actual knowledge, all prior art to the Aelis Patents has been cited in each applicable country;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(l)Aelis does not have any actual knowledge that the Development, Manufacture, sale or Commercialization of the Licensed Compounds as currently anticipated would infringe any Patent of any Third Party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(m)Aelis has not misappropriated trade secrets or misused the confidential information of any Third Party in developing the Licensed Technology;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(n)To Aelis' actual knowledge, no Third Party is infringing or misappropriating the Licensed Technology;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(o)Aelis has taken reasonable measures to protect the confidentiality of the Aelis Know-How owned by Aelis;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(p)all renewals and fees payable in respect of the Aelis Patents have been made/paid when due and none is outstanding;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(q)All inventors named on Aelis Patents have executed appropriate assignment documents to assign or have a legal obligation to assign their rights in any invention to Aelis or the Head Licensor; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(r)All studies that have been conducted by Aelis with respect to the Licensed Compounds were conducted in accordance with all Applicable Laws and industry standards;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(s)Neither Aelis nor any of its officers, directors, employees or, to Aelis' actual knowledge, its subcontractors performing services under this Agreement:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)has been convicted for an offense related to any federal, state or international anti-bribery or corruption laws; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)has been excluded from participation in any federal healthcare program (as that term is defined by 42 U.S.C. § 1320a-7b(f)) or is currently listed on the U.S. Department of Health Office of Inspector General's List of Excluded Individuals or Entities; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)has been convicted of any crime that could result in exclusion from federal health care programs under 42 U.S.C. §§ 1320a-7, 1320-7a; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)has been excluded, suspended, debarred, or is otherwise ineligible to participate in federal procurement or non- procurement programs, or is currently listed on the General Services Administration System or Award Management; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v)has been, will be, or are currently the subject of a proceeding that could lead to their or their employees, agents, or subcontractors becoming a debarred individual

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or debarred entity under Section 306 of the Food Drug and Cosmetic Act (21 U.S.C § 335a); or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vi)is on any of the FDA Clinical Investigator enforcement lists, including without limitation:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)the Disqualified/Totally Restricted List, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)the Restricted List, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3)the Adequate Assurances List, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(4)is subject to an ongoing disqualification proceeding as defined by FDA.

12.2<u>Covenants of Aelis</u>

Aelis shall, during the Term:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.1not provide Licensed Compounds to the Head Licensor or any other Third Parties except as approved by the JSC;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.2promptly after the Effective Date, cause the Head Licensor to return to Aelis any Licensed Compounds that are not being used in connection with an ongoing study with respect to the Licensed Compounds as of the Effective Date;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.3not permit or grant approval to the Head Licensor or other Third Parties to prepare or issue articles or publications regarding the Licensed Compounds without JSC approval;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.4not assign, transfer, convey or otherwise encumber its right, title and interest in the Licensed Compounds or Licensed Technology in the Field without the prior written consent of Indivior;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.5not amend or modify the Head License without the prior written consent of Indivior;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.6not grant any rights to any Third Party in or relating to the Licensed Compounds or Licensed Technology that are inconsistent with, or adversely impact, the license granted to Indivior herein; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.7comply with all Applicable Laws and good scientific practices in connection with the performance of its obligations hereunder, including the completion of the Aelis Studies.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.8if, at any time after execution of this Agreement, it becomes aware of any circumstances that may affect the accuracy of the representations under <u>Section</u> <u>12.1.2(s)</u> or that it or any of its officers, directors, employees or subcontractors performing services under this Agreement has become or is in the process of being charged, convicted, debarred, excluded, proposed to be excluded, suspended or otherwise rendered ineligible, or is on an enforcement list, Aelis will immediately notify Indivior in writing via email to <u>ciacompliance@indivior.com</u> and a hard-copy sent to Indivior Inc., Attn: Chief Compliance Officer, 10710 Midlothian Turnpike, Suite 125, North Chesterfield, VA 23235. Aelis understands

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that debarment or exclusion may result in termination for cause and for a material breach of this Agreement.

12.3<u>Covenants of Indivior</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.3.1Indivior shall, during the Term, comply with Applicable Laws in the performance of its obligations hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.3.2Indivior shall, directly or indirectly, Develop, Manufacture and Commercialize the Licensed Compounds and Licensed Products in compliance with Applicable Laws and good scientific practices.

13.**SECTION 13: INDEMNIFICATION**

13.1<u>Indemnification by Indivior</u>

Indivior shall defend, indemnify and hold harmless Aelis, its Affiliates and the Head Licensor and each of their officers, directors, shareholders, employees, successors and permitted assigns ("**Aelis Indemnitees**") from and against all Losses resulting from Third Parties' claims arising out of: (a) Indivior's gross negligence or willful misconduct in performing any of its obligations under this Agreement; (b) a breach by Indivior of any of its representations, warranties, covenants or obligations under this Agreement; and (c) the Development, Manufacture and Commercialization of the Licensed Compounds and Licensed Products by or on behalf of Indivior, its Affiliates or sublicensees, including any Product Liability Claim; <u>provided</u>, <u>however,</u> that Indivior shall not be liable to indemnify Aelis Indemnitees for any Losses of Aelis Indemnitees to the extent that such Losses result from Aelis' gross negligence or willful misconduct in performing any of its obligations under this Agreement.

13.2<u>Indemnification by Aelis</u>

Aelis shall defend, indemnify and hold harmless Indivior and its Affiliates and each of their officers, directors, shareholders, and employees successors and permitted assigns ("**Indivior Indemnitees**") from and against all Losses resulting from Third Parties' claims arising out of: (a) breach by Aelis of any of its representations, warranties, covenants or obligations under this Agreement and (b) Aelis' gross negligence or willful misconduct in performing any of its obligations under this Agreement, provided, however, that Aelis shall not be liable to indemnify Indivior Indemnitees for any Losses of Indivior Indemnitees to the extent that such Losses of Indivior Indemnitees are indemnifiable by Indivior pursuant to <u>Section 13.1</u>.

For the avoidance of doubt, each Party will be liable to the other in contract for its breach of its representations or warranties, covenants or obligations under this Agreement.

13.3<u>Procedure for Indemnification</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.1Each Party, on behalf of itself and its respective Aelis Indemnitees or Indivior Indemnitees (each such Person, an "**Indemnitee**"), shall provide the other Party ("**Indemnifying Party**") prompt written notice of any Claim for which such Indemnitee intends to seek indemnification under this Agreement; provided, however, that failure to give such notification shall not affect each applicable Indemnitee's entitlement to indemnification (or the corresponding indemnifying Party's indemnification obligations) hereunder except to the extent that the indemnifying Party shall have been materially prejudiced as a result of such failure. The Indemnifying Party shall have the initial right (but not obligation) to

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defend any Claim for which an Indemnitee seeks indemnification under this Agreement as contemplated in the preceding sentence so long as the Indemnifying Party provides notice of its assumption of defence within thirty (30) days of receiving such indemnification notice. If the Indemnifying Party fails to state in a written notice during such thirty (30) day period its willingness to assume the defence of such a Claim, Aelis Indemnitee(s) or Indivior Indemnitee(s), as the case may be, shall have the right to defend, settle or otherwise dispose of such Claim at the Indemnifying Party's cost, subject to the terms hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.2The Indemnifying Party may enter into any settlement with respect to, any such Claim for which it has assumed defence; <u>provided</u> that such settlement (a) includes an unconditional release of the Indemnitee from any and all liability to any Third Party, (b) does not adversely affect the Indemnitee's rights hereunder or impose any obligations on the Indemnitee in addition to those set forth herein, (c) does not involve any injunctive or other equitable relief which would be imposed on Indemnitee, and (d) does not provide for any finding or admission of a violation of law or violation of the rights of any Person by the Indemnitee or any of its Affiliates. The Indemnitee, its employees, agents and Affiliates shall cooperate with the Indemnifying Party and its legal representatives in the investigation and defense of any action, claim or liability covered by this indemnification. The Indemnitee shall have the right to be represented by counsel of its own selection and at its own expense.

14.**SECTION 14: LIABILITY**

14.1Subject to <u>Section 14.2</u>, under no circumstances shall either Party be liable to the other Party under any legal or equitable claim or cause of action, whether in contract, tort or otherwise, for indirect, special, punitive or consequential damages.

14.2Notwithstanding any other provision of this Agreement, the liability of the Parties shall not be limited in any way in respect of (a) death or personal injury caused by negligence, (b) fraud or fraudulent misrepresentation, or (c) Losses resulting from Third Party claims that are indemnifiable pursuant to <u>Sections 13.1</u> or <u>13.2</u>.

15.**SECTION 15: ANTI-BRIBERY**

15.1The Parties are committed to conduct business with the highest degree of ethics and integrity and will comply with the letter and spirit of all applicable local and international laws and regulations such as the US Foreign Corrupt Practices Act ("**FCPA**") and the UK Bribery Act 2010 and all other applicable anti-corruption laws, as well as any laws implementing the UN Convention Against Corruption and the OECD Anti-Bribery Convention.

15.2In connection with this Agreement, each Party undertakes that it, its directors, employees, and officers have not and shall not directly or indirectly (a) offer, provide, authorize for or promise to another person, or (b) request, accept, or agree to accept from another person, any financial or other advantage or anything of value ("**Benefit**"), if such Benefit is for the purpose of influencing the receiving person improperly in his/her official capacity for the purpose of obtaining a business advantage, or where such Benefit would constitute a violation of any Applicable Law.

15.3Each Party shall take no action in violation of the laws and regulations mentioned in this <u>Section 15</u> as it relates to this Agreement.

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15.4A Party shall give prompt written notice to the other Party if it has failed to comply with or has breached any provision contained within this <u>Section 15</u>.

16.**SECTION 16: TERM**

The term of this Agreement shall commence on the Effective Date and shall continue on a Licensed Product-by-Licensed Product basis until the expiration of the last Royalty Term with respect to such Licensed Product anywhere in the world (the "**Term**"), in each case, unless earlier terminated by a Party in accordance with <u>Section 17</u>. Upon expiration of this Agreement with respect to a Licensed Product, Indivior shall have a non-exclusive, perpetual, fully paid-up, royalty-free license of the scope described in <u>Section 2.2</u> above.

17.**SECTION 17: TERMINATION**

17.1<u>Termination by Either Party</u>.

Either Party may terminate this Agreement upon delivery of written notice:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.1.1in the event that the other Party fails to make a payment hereunder and fails to cure such breach within sixty (60) days after receipt of a written notice thereof, unless the obligation to make such payment has been disputed by such other Party in good faith;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.1.2in the event that the other Party commits a material breach of its obligations under this Agreement (other than, in each case, a breach set forth in <u>Section 17.3.1</u>, <u>17.3.2</u> or <u>Section 18.1.3</u>) and fails to cure such breach within ninety (90) days after receipt of a written notice thereof; <u>provided</u>, <u>however</u>, that, if the material breach is due to a licensee or sublicensee of such other Party, the termination of the license or sublicense with such licensee or sublicensee within ninety (90) days of the notice of breach would be deemed to cure such breach for the purposes of this <u>Section 17.1.2</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.1.3pursuant to <u>Section 21.1.2</u> due to a Force Majeure Event; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.1.4upon an Insolvency Event of the other Party.

17.2<u>Termination by Indivior</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.2.1Indivior shall have the right to terminate this Agreement in its entirety or with respect to one or more Regions, without cause, upon ninety (90) days' prior written notice to Aelis. For purposes of the foregoing, a "**Region**" shall mean (i) the United States, (ii) Europe, the United Kingdom and Canada, (iii) Australia, Japan and China, (iv) each other country individually;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.2.2Indivior shall have further rights to terminate this Agreement as set forth in <u>Section</u> <u>18.1.3</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.2.3Indivior shall have the right to terminate this Agreement in the event that the Head License is terminated by the Head Licensor, except if Indivior chooses to execute a direct license with the Head Licensor pursuant to <u>Section 7.5</u>.

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17.3<u>Termination by Aelis</u>. Aelis shall have the right to terminate this Agreement upon delivery of written notice to Indivior:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.3.1In case of any breach by Indivior of <u>Section 2.4</u> (Non-Competition) which Indivior fails to cure within ninety (90) days after receipt of a written notice thereof;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;17.3.2In case of any intentional breach by Indivior of <u>Section 10.1</u> (Confidentiality) for commercial gain; <u>provided</u> that, if such breach was committed by an employee or agent of Indivior without the knowledge of Indivior's executives or management, Aelis shall have no right to terminate this Agreement pursuant to this <u>Section 17.3.2</u> if, after such breach, Indivior promptly takes appropriate measures to limit disclosure and the use of such Confidential Information, at Indivior's cost, including pursuing legal and equitable remedies against such employee, agent and other third-parties.

17.4<u>Automatic Termination</u>. This Agreement shall terminate automatically without any further action by either Party in the event that Indivior does not exercise the License Option within the License Option Period in accordance with <u>Section 2.1.2</u>.

18.**SECTION 18 EFFECTS OF TERMINATION**

18.1<u>Termination of Rights and Licenses</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.1In the event that this Agreement is terminated pursuant to <u>Section 17.1.1</u>, <u>17.3.1</u> or <u>17.3.2</u> by Aelis or by either Party pursuant to <u>Section 17.1.2</u>, or by Indivior pursuant to <u>Sections 17.2.1</u> or <u>17.2.3</u>:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)all rights and licenses granted to Indivior in respect of the Licensed Compound and/or Licensed Products that are subject to such termination shall terminate as of such termination date, and Indivior shall cease Developing, Manufacturing and Commercializing such Licensed Product (except as otherwise set forth in this <u>Section 18.1.1</u>). Notwithstanding the foregoing, at Indivior's option Indivior may complete and sell any work-in-progress and inventory of the Licensed Products that exist in the Field as of the termination date for a period of six (6) months after the termination date to Aelis or to Third-Parties, at Aelis' option, <u>provided</u> that Indivior pays Aelis the applicable amounts due on such sales of Licensed Products in accordance with <u>Section 8</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)Unless otherwise agreed between the Parties, each Party shall complete in accordance with the established protocols and Applicable Laws and ethical practices any clinical studies on Licensed Compounds and/or Licensed Products that it commenced prior to the termination of this Agreement, provided that Indivior shall pay for the costs of the Aelis Studies that have been commenced.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.2In the event that this Agreement is terminated with respect to any Region or in its entirety for any reason (other than as set forth in <u>Section 18.1.3</u>) with respect to a Licensed Product that is Viable, Indivior:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)hereby grants to Aelis a non-exclusive license, with the right to sublicense, under the Patents, Know-How and Licensed Product Trademarks and Trade Dress (excluding Indivior's corporate trademarks and brand names) owned

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by or licensed to (to the extent sublicensable by) Indivior at the time of the termination and that are necessary or reasonably useful to continue to Develop, Manufacture and Commercialize the terminated Licensed Compound and Licensed Product in the Field in the applicable Region;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)shall use reasonable efforts to assign and transfer to Aelis, within sixty (60) days of the date of termination, any and all Regulatory Approvals and Regulatory Materials for the Licensed Products subject to such termination. In the event that such a transfer is not possible, Indivior shall use reasonable efforts to provide Aelis with the benefit of the existing Regulatory Approvals and applications therefor for such Licensed Products, including, without limitation, granting Aelis and/or its designees rights to cross-refer to the data and information on file with Regulatory Authorities as may be necessary to facilitate the granting of separate Regulatory Approvals to Aelis; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)shall use reasonable efforts to cooperate with Aelis and/or its designee to transition the Development, Manufacture, and Commercialization of the Licensed Product, including by assigning at Aelis' request all related agreements, to the extent assignable, at Aelis' cost.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.3In the event that this Agreement is terminated by Indivior as a result of any of the following acts by Aelis (subject to the cure period set forth in <u>Section 17.1.2</u>), then Indivior shall retain all Regulatory Approvals and Regulatory Materials and the License granted herein shall survive such termination and shall become fully paid-up (subject to payments due to the Head Licensor pursuant to the Head License, which shall be made to Aelis on a pass through basis):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)any breach by Aelis of <u>Section 2.4</u> (Non-Competition) which Aelis fails to cure within ninety (90) days of written notice thereof;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)a knowing and intentional false representation by Aelis of a material fact or matter set forth in the representations and warranties in <u>Section 12.1.2</u> which has the effect of depriving Indivior of significant value under this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)any intentional breach by Aelis of <u>Section 10.1</u> (Confidentiality) for commercial gain; <u>provided</u> that, if such breach was committed by an employee or agent of Aelis without the knowledge of Aelis' executives or management, Indivior shall have no right to terminate this Agreement pursuant to this <u>Section 18.1.3</u> if, after such breach, Aelis promptly takes appropriate measures to limit disclosure and the use of such Confidential Information, at Aelis' cost, including pursuing legal and equitable remedies against such employee, agent and other third-parties, at Aelis' cost; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)any breach by Aelis of <u>Section 2.5</u> (Rights under Bankruptcy).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.4The Parties acknowledge and agree that upon the Insolvency Event of Aelis, this Agreement shall not terminate and shall remain in full force and effect in accordance with the terms hereof. The Parties acknowledge and agree that upon the Insolvency Event of Indivior, Aelis may terminate this Agreement and shall recover any and all Regulatory Approvals and Regulatory Materials for the Licensed Products.

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18.2<u>Return of Confidential Information</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.2.1Upon termination of this Agreement other than by Indivior pursuant to <u>Section 18.1.3</u>, Indivior shall, at Aelis' option, either return to Aelis all tangible Confidential Information disclosed to Indivior by or on behalf of Aelis (including all copies thereof) or destroy such Confidential Information; <u>provided</u> that Indivior shall have the right to retain one (1) copy of the Confidential Information in a secure location for purposes of identifying its confidentiality obligations under <u>Section 10</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.2.2Upon termination of this Agreement for any reason, subject to Aelis' rights in <u>Section</u> <u>18.1.2</u>, Aelis shall, at Indivior's option, either return to Indivior all tangible Confidential Information disclosed to Aelis by or on behalf of Indivior (including all copies thereof) or destroy such Confidential Information; <u>provided</u> that Aelis shall have the right to retain one (1) copy of the Confidential Information in a secure location solely for purposes of identifying its confidentiality obligations under <u>Section 10</u>.

18.3<u>Accrued Rights</u>. Termination or expiration of this Agreement for any reason will be without prejudice to and shall not affect any accrued rights, remedies and/or liabilities of either Party at any time up to the date of termination or expiry of this Agreement.

18.4<u>Survival</u>. The following Sections, together with any definitions used and Schedules referenced therein, will survive any termination or expiration of this Agreement: <u>Section 8.1</u>, <u>Sections 10.1, 10.2</u>, <u>18</u>, <u>19</u>, <u>20</u> (as set forth therein) and <u>21</u>.

19.**SECTION 19: INJUNCTIVE RELIEF**

Notwithstanding anything to the contrary in this Agreement, either Party will have the right to seek temporary or permanent injunctive relief in any court of competent jurisdiction as may be available to such Party with respect to any matters arising out of the other Party's performance of its obligations under this Agreement.

20.**SECTION 20: INSURANCE**

Each Party shall, during the Term and two (2) years thereafter, carry comprehensive insurance and in such amounts as a prudent business person would carry to cover such Party's obligations under this Agreement.

21.**SECTION 21: MISCELLANEOUS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.1<u>Expenses</u>. Except as otherwise expressly provided herein, each Party shall bear its respective expenses incurred in connection with the preparation, execution and performance of this Agreement and the transactions contemplated hereby, including without limitation all fees and expenses of agents, legal counsel, accountants, tax and financial advisors and other facilitators and advisors.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.2<u>Force Majeure</u>. A Party shall not be liable for non-performance or delay in performance of its obligations hereunder to the extent that and solely for so long as such non-performance or delay in performance is not due to its negligence or breach of this Agreement and is caused by any event reasonably beyond the control of such Party, including wars, hostilities, revolutions, riots, civil commotion, national emergency, unavailability of supplies, epidemics, fire, flood, earthquake, force of nature, explosion, terrorist act, embargo, or any other Act of

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God, or any law, proclamation, regulation, ordinance, or other act or order of any court or Governmental Authority (each, a "**Force Majeure Event**"). In the event of any such Force Majeure Event, the delayed Party shall give the other Party written notice thereof promptly and, in any event, within five (5) Business Days of discovery thereof. If either Party is unable to perform its obligations hereunder as a result of a Force Majeure Event for a period of 270 days or longer and is not continuously exercising diligent good faith efforts to remedy, overcome or work around the Force Majeure Event, then the other Party shall have the right, upon its issuance of written notice to the other Party, to terminate this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.3<u>Recordation</u>. Indivior may record the License granted herein, including by use of a short form document, as permitted or required by Applicable Law or otherwise, including recording a security interest in those jurisdictions which permit a licensee to do so. Aelis hereby irrevocably designates and appoints Indivior and its duly authorized officers and agents, as Aelis's agent and attorney-in-fact to execute such documents and to do all other acts necessary or useful to record the license granted herein. Aelis shall, upon request, give to Indivior such reasonable assistance as Indivior may reasonably request in connection with recording the License.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.4<u>Independent Contractors</u>. It is understood and agreed that nothing in this Agreement nor any agreement related hereto is intended to nor shall be deemed or construed to create a partnership or any relationship between the Parties. The Parties are independent contractors and neither Party is to be considered the agent, partner, joint venturer or employee of the other Party for any purpose whatsoever and neither Party shall have any authority to act in the name or on behalf of the other or otherwise to bind the other Party in any way.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.5<u>Further Assurances</u>. Each of the Parties shall use commercially reasonable efforts to take, or cause to be taken, all actions necessary, proper, or advisable under Applicable Laws to give effect to the provisions of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.6<u>Assignment; Binding Effect</u>. Neither Party shall, without the prior written consent of the other Party, assign, novate, transfer or convey this Agreement (in whole or in part) or any of its rights and obligations hereunder to any Affiliate or Third Party without the written consent of the other Party, which shall not be unreasonably withheld or delayed; <u>provided</u> that Indivior's right to grant sublicenses hereunder shall be governed by <u>Section 2.2.2</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.7<u>Entire Agreement</u>. This Agreement constitutes the entire contract between the Parties pertaining to the subject matter hereof, and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions, whether written or oral, of the Parties; and there are no representations, warranties, or other agreements between the Parties in connection with the subject matter hereof except as specifically set forth herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.8<u>Waiver</u>. The waiver by either Party of any right hereunder, or the failure to exercise such right, shall be deemed not to be a waiver of exercising such right in the future or of any other right hereunder in case of breach or failure by the other Party whether of a similar nature or otherwise.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.9<u>Amendments</u>. No amendment and/or modification to this Agreement shall be effective unless set forth in a writing signed by both Parties.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.10<u>Notice</u>. Any notice or other communication to be given under this Agreement by any Party to the other Party shall be in writing and shall be either (a) personally delivered, (b) mailed by registered or certified mail, postage prepaid with return receipt requested, (c) delivered by overnight express delivery service or same-day local courier service, or (d) delivered by facsimile transmission (followed by a copy by the preceding methods in clause (a), (b) or (c)), to the email address of the applicable Party as set forth below, or to such other address as may be designated by the Parties from time to time in accordance with this <u>Section 21.1.10</u>. Notices delivered personally, by overnight express delivery service or by local courier service shall be deemed given as of actual receipt. Mailed notices shall be deemed given five (5) Business Days after mailing. Notices delivered by facsimile transmission shall be deemed given upon receipt by the sender of the transmission confirmation (in the case of a facsimile transmission) if transmitted before 5:00 p.m. (recipient's local time) on a Business Day, and otherwise on the following Business Day.

Notices sent to Aelis shall be addressed to:

Aelis Farma

146 rue Léo Saignat Institut François Magendie

33000 Bordeaux, France

Email : [\*\*\*]

With a copy to:

McDermott Will & Emery AARPI

23 rue de l'Université,

75007 Paris, France

Attn : [\*\*\*]

Email [\*\*\*]

Notices sent to Indivior shall be addressed to:

Indivior UK Limited

The Chapleo Building

Henry Boot Way, Priory Park, Hull

United Kingdom, HU4 7DY

Attention: [\*\*\*]

Facsimile: [\*\*\*]

Email: [\*\*\*]

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With a copy to:

Indivior Inc.

10710 Midlothian Turnpike

Suite 430

Richmond, VA 23235

Attention: [\*\*\*]

Facsimile: [\*\*\*]

Email: [\*\*\*]

and

Clifford Chance US LLP

31 West 52nd Street

New York, NY 10019

Attention: [\*\*\*]

Facsimile: [\*\*\*]

Email: [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.11<u>Governing Law; Arbitration</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)This Agreement shall be governed by and construed in accordance with the laws of England and Wales, except that the construction or effect of a patent or patent application licensed under this Agreement shall be decided in accordance with the laws of the country in which the patent or patent application was granted or filed. Subject to disputes being determined by arbitration in accordance with the remainder of this section, the Parties irrevocably submit to the exclusive jurisdiction of the Courts of England and Wales.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)All disputes arising out of or in connection with this Agreement shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with the said Rules. The arbitration shall be seated in London, England. The language of arbitration shall be English. The Parties and the Arbitration Tribunal shall endeavour to complete any arbitration within twelve (12) months following the full constitution of the Arbitration Tribunal, provided that failure to comply with such timeline shall not be a ground to invalidate the award. Unless the Parties expressly agree in writing to the contrary, the Parties undertake as a general principle to keep confidential all awards in their arbitration, together with all materials in the proceedings created for the purpose of the arbitration and all other documents produced to the other Party in the proceedings not otherwise in the public domain - save and to the extent that disclosure may be required of a Party by legal duty, to protect or pursue a legal right or to enforce or challenge an award in bona fide legal proceedings before a court or other judicial authority.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)The parties hereby exclude all rights to seek a determination by the court of a preliminary point of law under section 45 of the Arbitration Act 1996 and all rights of appeal on a point of law from any arbitration award under section 69 of the Arbitration Act 1996.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)Notwithstanding anything to the contrary herein, in the event that a Party alleges that the other Party is in breach of this Agreement pursuant to <u>Section</u> <u>17.1.2</u>, <u>Section 17.1.5</u> or <u>Section 18.1.3</u> and the other Party disputes such allegation, the Parties shall refer such dispute to arbitration in accordance with <u>Section 21.1.11</u>. The Party alleging such breach shall have no right to terminate this Agreement pursuant to <u>Section 17.1.2</u>, <u>Section 17.1.5</u> or <u>Section</u> <u>18.1.3</u>, as the case may be, unless and until such breach is confirmed in arbitration.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.12<u>Severability</u>. If any provision in this Agreement is held to be invalid, void or unenforceable, then the remainder of this Agreement, or the application of such provision to the Parties or to the circumstances other than those as to which it is held invalid or unenforceable, shall not be affected thereby and shall be enforced to the fullest extent permitted by law. The Parties agree to renegotiate any such invalid, void or unenforceable provision in good faith in order to provide a reasonably acceptable alternative consistent with the basic purposes of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.13<u>Counterparts</u>. This Agreement may be executed in one or more counterparts, none of which need contain the signatures of both Parties, each of which shall be deemed an original, and all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.14<u>Interpretation and Construction</u>. Unless the context of this Agreement otherwise requires, (a) the terms "include," "includes," or "including" shall be deemed to be followed by the words "without limitation" unless otherwise indicated; (b) the terms "hereof," "herein," "hereby," and derivative or similar words refer to this entire Agreement; and (c) the terms "Section" and "Schedule" refer to the specified Section and Schedule of this Agreement. Whenever this Agreement refers to a number of days, unless otherwise specified, such number shall refer to calendar days. The headings and paragraph captions in this Agreement are for reference and convenience purposes only and shall not affect the meaning or interpretation of this Agreement. This Agreement shall not be interpreted or constructed in favor of or against either Party because of its effort in preparing it.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.15<u>Third Party Rights</u>. Unless expressly stated in this Agreement, a Third Party shall have no right under the Contracts (Rights of Third Parties) Act 1999 to enforce or enjoy the benefit of any term of this Agreement. Notwithstanding any right of a third party arising hereunder, this Agreement may be amended, varied or terminated by the written agreement of the Parties hereto without reference to, consultation with or the consent of any such third party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.16<u>Agent for Service.</u> Aelis irrevocably appoints London Central Services Ltd to be its agent for the receipt of service of process in England and Wales and agrees that any Process Document may be effectively served on Aelis by service on London Central Services Ltd. A Process Document shall be deemed to have been duly served if delivered by hand or by courier or sent by prepaid first class post to London Central Services Ltd, at 4, Old Park Lane, London W1K 1QW and shall be deemed to have been received by London Central Services Ltd in accordance with <u>Section 21.1.10</u>.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;21.1.17<u>Language</u>. This Agreement was drafted and negotiated in English and, to be valid, any notice or other communication given or made under or in connection with this Agreement must also be in English. If, for any reason, this Agreement or any such notice or other communication (or any part thereof) is translated into any language other than English, the English text shall prevail.

[Signature Page Follows]

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The Parties have executed and delivered this Agreement as of the date first written above.

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| |
|:---|
| Indivior UK Limited |
| By: *<u>/s/ Thomas Weis</u>* |
| Name: <u>Thomas Weis</u> |
| Title: <u>Director</u> |
| Aelis Farma |
| By: *<u>/s/ Pier Vincenzo Piazza</u>* |
| Name: <u>Pier Vincenzo Piazza</u> |
| Title: <u>Chief Executive Officer</u> |

---

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**SCHEDULE I**

**AELIS PATENTS**

**I.3-(4'-substituted)-benzyl-ether derivatives of pregnenolone**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• PCT /EP13/074886 filed on November 27, 2013

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Publication number: WO2014083068 A1

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| | | | | |
|:---|:---|:---|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Country** | **Application Number** | **Status** | **Grant Date** | **Grant Number** |
| Australia | 2013351190 | Granted | 12-Jul-18 | 2013351190 |
| Brazil | 112015012194-2 | Pending | na | na |
| Canada | 2892347 | Granted | 2-Apr-19 | 2892347 |
| Chile | 2015/1438 | Granted | 5-Sep-17 | 54727 |
| China | 201380062354.2 | Granted | 5-Sep-17 | 201380062354.2 |
| Colombia | 15144580 | Granted | 23-Nov-16 | 30575 |
| India | 01087/MUMNP/15 | Pending | na | na |
| Japan | 2015-544455 | Granted | 11-May-18 | 6335915 |
| Mexico | MX/A/15/006724 | Granted | 8-Aug-17 | 349703 |
| New Zealand | 708086 | Granted | 21-Apr-20 | 708086 |
| Peru | 001377-2017-DIN | Granted | 25-May-18 | 9161 |
| Russian Federation | 2015125568 | Granted | 14-Sep-18 | 2667065 |
| South Africa | 2015/03326 | Granted | 30-Nov-16 | 2015/03326 |
| United States of America | 14/443778 | Granted | 16-Apr-19 | 10259839 |
| United States of America | 17/108163<sup>a</sup> | Pending | na | na |
| Europe | 13795536.5 | Granted | 18-Jan-17 | 2925770 |
| *Albania* | *13795536.5* | *Granted* | *18-Jan-17* | *AL/P/17/181* |
| *Austria* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Belgium* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Bulgaria* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Croatia* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Cyprus* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Czech Republic* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Denmark* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Estonia* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Finland* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *France* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Germany* | *13795536.5* | *Granted* | *18-Jan-17* | *602013016801.6* |
| *Greece* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Hungary* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Iceland* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Ireland* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Italy* | *13795536.5* | *Granted* | *18-Jan-17* | *502017000035590* |
| *Latvia* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Lithuania* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Luxembourg* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Macedonia* | *13795536.5* | *Granted* | *18-Jan-17* | *MK/P/2017/227* |
| *Malta* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Monaco* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Netherlands* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Norway* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Poland* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Portugal* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Romania* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *San Marino* | *13795536.5* | *Granted* | *18-Jan-17* | *SM-T-201700194* |
| *Serbia* | *13795536.5* | *Granted* | *18-Jan-17* | *55803* |
| *Slovakia* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Slovenia* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Spain* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Sweden* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Switzerland* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *Turkey* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |
| *United Kingdom* | *13795536.5* | *Granted* | *18-Jan-17* | *2925770* |

---

na: not applicable, (a) Continuation filed on December 01, 2020

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**II.3β-(4-methoxybenzyloxy)pregn-5-en-20-one for use in the treatment of Cannabinoids- Related Disorders**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• PCT /EP19/054217 filed on February 20, 2019

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Publication number: WO2019162328 A1

---

| | | | | |
|:---|:---|:---|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**Country** | **Application Number** | **Status** | **Grant Date** | **Grant Number** |
| Australia | 2019223049 | Pending | na | na |
| Brazil | 11 2020 017026 7 | Pending | na | na |
| Canada | 3 090 975 | Pending | na | na |
| Chile | 2020-2147 | Pending | na | na |
| China | 201980013958.5 | Pending | na | na |
| Europe | 19705190.7 | Pending | na | na |
| Israel | 276697 | Pending | na | na |
| Japan | EP2019/054217 | Pending | na | na |
| Mexico | MX/a/2020/008687 | Pending | na | na |
| New Zealand | 766623 | Pending | na | na |
| Russian Federation | 2020130586 | Pending | na | na |
| South Africa | 2020/04602 | Pending | na | na |
| South Korea | 10-2020-7024076 | Pending | na | na |
| United States of America | 16/968,237 | Pending | na | na |

---

na: not applicable

------

**SCHEDULE II** 

**LICENSED COMPOUNDS**

**AEF0117 Chemical Structure**

![schedule2-1a.jpg](schedule2-1a.jpg)

**IUPAC Name:** 1-((3S,8S,9S,10R,13S,14S,17S)-3-((4-methoxybenzyl)oxy)-10,13-dimethyl- 2,3,4,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl)ethan-1- one

**Chemical names:** 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one; Pregnenolone, 3ß-(4- methoxybenzyl)ether

**Chemical Abstracts Service (CAS) registry number:** 1610878-71-1

**Other pregnenolone derivatives chemical structures** 

**disclosed in PCT/EP2013/074886**

![schedule2-2a.jpg](schedule2-2a.jpg)

wherein:

R1 is: C1-8 alkyl, C1-8 alkoxy, CN, NO2, amino, COOH, COOCH3, OH, N3, or halogen

and

R2 is: H, OH, C1-8 alkyl, C1-8 alkoxy, C2-C6 alkenyl, halogen, Bn-O-, Bn- optionally

substituted with C1-8 alkyl, C1-8 alkoxy, CN, NO2, amino, COOH or halogen or Ph-

optionally substituted with C1-8 alkyl, C1-8 alkoxy, CN, NO2, amino, COOH or halogen.

------

**SCHEDULE III**

**OPTION STUDIES**

[\*\*\* draft option study(s) protocol(s) (97 pages) \*\*\*]

------

**SCHEDULE 12.1.2(A)**

**EXISTING LICENSES AND OTHER AGREEMENTS RELATING TO THE LICENSED TECHNOLOGY WITH RESPECT TO THE LICENSED COMPOUNDS IN THE FIELD**

**I.Existing licenses relating to the Licensed Technology with respect to the Licensed Compound in the Field:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.[\*\*\*].

[\*\*\*]

**II.Other agreements relating to the Licensed Technology with respect to the Licensed Compound in the Field:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.[\*\*\*] :

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*].

[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*].

[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• [\*\*\*].

[\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.[\*\*\*].

[\*\*\*]

[\*\*\*]

------

**SCHEDULE 12.1.2(E)**

**INSTITUTION AND OTHER THIRD PARTY THAT RECEIVED LICENSED COMPOUNDS FROM AELIS PRIOR TO THE EFFECTIVE DATE**

**I.List of R&D subcontractors / CROs / CDMOs which received the Licensed Compounds under a commercial / service contract**

---

| | | |
|:---|:---|:---|
| **Categories** | **Names of the subcontractors** | **Locations** |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **PRE-CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **CHEMISTRY, CMC** | [\*\*\*] | [\*\*\*] |
| **CHEMISTRY, CMC** | [\*\*\*] | [\*\*\*] |
| **CHEMISTRY, CMC** | [\*\*\*] | [\*\*\*] |
| **CHEMISTRY, CMC** | [\*\*\*] | [\*\*\*] |
| **CHEMISTRY, CMC** | [\*\*\*] | [\*\*\*] |
| **CHEMISTRY, CMC** | [\*\*\*] | [\*\*\*] |
| **CHEMISTRY, CMC** | [\*\*\*] | [\*\*\*] |
| **CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |
| **CLINICAL DVLPMT** | [\*\*\*] | [\*\*\*] |

---

------

**II.List of academic partners which received the Licensed Compounds**

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| **Categories** | **Institution Names** | **Contractual relationships** | **Contractual relationships** | **Contractual relationships** | **Addresses** | **Status** |
| **Categories** | **Institution Names** | **MTA** <sup>(a)</sup> | **Under INSERM**<br>**collabo- ration**<br>**contract** <sup>(b)</sup> | &nbsp;&nbsp;**Other** | **Addresses** | **Status** |
| **PRE- CLINICAL PROOF OF CONCEPT** | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| **PRE- CLINICAL PROOF OF CONCEPT** | &nbsp;&nbsp;[\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| **PRE- CLINICAL PROOF OF CONCEPT** | &nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | &nbsp;&nbsp;&nbsp;[\*\*\*] | [\*\*\*] |
| **PRE- CLINICAL PROOF OF CONCEPT** | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| **PRE- CLINICAL PROOF OF CONCEPT** | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| **PRE- CLINICAL PROOF OF CONCEPT** | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | &nbsp;&nbsp;[\*\*\*] | [\*\*\*] |
| **PRE- CLINICAL PROOF OF CONCEPT** | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| **PRE- CLINICAL PROOF OF CONCEPT** | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| **PRE- CLINICAL PROOF OF CONCEPT** | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| **CLINICAL STUDIES** | &nbsp;&nbsp;&nbsp;[\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

<sup>[\*\*\*]</sup>

------

**EXHIBIT A**

**SIDE LETTER BETWEEN AELIS AND HEAD LICENSOR**

------

**Side Letter / Lettre Accord**

2 juin 2021

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| | |
|:---|:---|
| Inserm Transfert <br>SA 7 rue Watt<br>75013 Paris | Inserm Transfert SA <br>7 rue Watt<br>75013 Paris |
| Université Bordeaux <br>35 place Pey Berland <br>33000 Bordeaux | Université Bordeaux <br>35 place Pey Berland <br>33000 Bordeaux |
| SC Belenos<br>6 rue de Candale <br>33000 Bordeaux | SC Belenos<br>6 rue de Candale <br>33000 Bordeaux |
| Ladies and Gentlemen: | Mesdames, Messieurs : |
| Reference is made to the Licensing Contract, No.[\*\*\*], between Inserm Transfert SA, Université Bordeaux, SC Belenos (collectively, the "<u>Head Licensor</u>") and Aelis Farma ("Aelis"), dated January 21, 2020 ("<u>Head License Agreement</u>"). All capitalized terms used but not herein defined shall have the meanings set forth in the Head License Agreement. | Il est fait référence au Contrat de Licence n° [\*\*\*], entre Inserm Transfert SA, Université Bordeaux, SC Belenos (collectivement, le « <u>Concédant Principal</u> ») et Aelis Farma (« Aelis »), en date du 21 janvier 2020 (le<br>« <u>Contrat de Licence Principal »</u>). Tous les termes en majuscules utilisés mais non définis dans la présente lettre accord ont la signification qui leur est donnée dans le Contrat de Licence Principal. |
| As previously discussed, Aelis is in the process of negotiating a license agreement with Indivior UK Limited ("<u>Indivior</u>") pursuant to which Aelis will grant Indivior an option to obtain an exclusive license under the Patents to develop, manufacture and commercialize products in the field of addiction and substance use disorders, compulsive disorders, cannabis related disorders and, subject to Indivior's exercise of an additional option, pain indications ("<u>Indivior License Agreement</u>"), it being specified that Aelis shall remain entirely responsible for the proper performance of Indivior and shall be solely responsible towards the Head Licensor for the performance by Indivior of all obligations binding upon Aelis under the Head License Agreement. This letter agreement, when countersigned, shall evidence the agreement among Aelis and the Head Licensor to amend the Head License Agreement. | Comme discuté précédemment, Aelis négocie un contrat de licence avec Indivior UK Limited (« <u>Indivior</u> ») aux termes duquel Aelis accordera à Indivior une option pour obtenir une licence exclusive sur les Brevets pour développer, fabriquer et commercialiser des produits dans le domaine de la dépendance et des troubles liés à l'utilisation de drogues, des troubles compulsifs, des troubles liés au cannabis et, sous réserve de l'exercice par Indivior d'une option supplémentaire, les indications de la douleur (« <u>Contrat de Licence Indivior</u> »), étant précisé qu'Aelis restera entièrement responsable de la bonne exécution par Indivior et sera seule responsable vis-à-vis du Concédant Principal pour l'exécution par Indivior de toutes les obligations d'Aelis au titre du Contrat de Licence Principal. Cette lettre accord, lorsqu'elle sera contresignée, constituera la preuve de l'accord entre Aelis et le Concédant Principal pour modifier le Contrat de Licence Principal. |

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| | |
|:---|:---|
| 1.Section 6.1 paragraph 2 of the Head License is amended as follows: | 1.L'Article 6.1 paragraphe 2 du Contrat de Licence Principal est modifié comme suit : |
| "*If Licensee, directly or through its Sublicensees, does not wish to maintain in force, or to continue the procedures for filing, granting, extending, maintaining in force and defending the Patent(s) in a country, it shall inform Inserm Transfert in a timely manner so that Inserm Transfert may, if it so desires, continue the procedures for applying for, defending and maintaining the Patents in the name of the Joint-Owners and at their expense, in that country, in France or abroad*". | *« Si le Licencié, directement ou par l'intermédiaire de ses Sous-Licenciés, ne souhaite pas maintenir en vigueur, ou poursuivre les procédures de dépôt, de délivrance, d'extension, de maintien en vigueur et de défense de(s) Brevet(s) dans un pays, il en informera Inserm Transfert en temps utile afin que celle-ci puisse, si elle le désire, poursuivre les procédures de demande, de défense et de maintien de(s) Brevet(s) au nom des Copropriétaires et à leurs frais, dans ce pays, en France ou à l'étranger ».* |
| 2.A new Section 8.8 is added to the Head License Agreement: | 2.Un nouvel Article 8.8 est ajouté au Contrat de Licence Principal : |
| "*Inserm Transfert may terminate the Agreement in case of breach of this confidentiality provision by Licensee, directly or through its Sublicensees or subcontractors, only if such breach is intentional or for commercial gain."* | *« Inserm Transfert peut résilier le Contrat en cas de violation de la présente clause de confidentialité par le Licencié, directement ou par l'intermédiaire de ses Sous-Licenciés ou sous-traitants, uniquement si cette violation est intentionnelle ou à des fins commerciales ».* |
| 3.Notwithstanding anything to the contrary in the Head License Agreement, during the term of the Indivior License Agreement, as long as the Indivior License Agreement is valid and with regard to the license granted to Indivior only, the Head Licensor shall have no right to, and shall not attempt to, terminate the Head License Agreement in any country or convert the license with respect to the Patents in any country into a non-exclusive license pursuant to Sections 3.5 or 3.6 of the Head License Agreement as long as Indivior uses commercially reasonable efforts to develop and commercialize at least one Product as soon as practicable. For purposes of the foregoing, commercially reasonable efforts means the commitment of efforts and resources by Indivior, consistent with those normally applied in the pharmaceutical industry by companies of similar size and with similar resources as Indivior and its Affiliates with respect to a compound or product having similar regulatory  | 3.Nonobstant toute disposition contraire dans le Contrat de Licence Principal, pendant la durée du Contrat de Licence Indivior, aussi longtemps que le Contrat de Licence Indivior est valide et en ce qui concerne la licence accordée à Indivior uniquement, le Concédant Principal n'aura pas le droit de, et ne tentera pas de, résilier le Contrat de Licence Principal dans un quelconque pays ou de convertir la licence sur les Brevets dans un quelconque pays en une licence non exclusive conformément aux articles 3.5 ou 3.6 du Contrat de Licence Principal tant qu'Indivior fait des efforts commercialement raisonnables pour développer et commercialiser au moins un Produit dès que possible. Aux fins de ce qui précède, des efforts commercialement raisonnables signifient l'engagement d'efforts et de ressources par Indivior, en accord avec ceux normalement appliqués dans l'industrie pharmaceutique par des sociétés de taille et de ressources similaires à celles d'Indivior et de ses Affiliées en ce qui concerne un composé  |

---

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| | |
|:---|:---|
| factors and similar market potential, profit potential and strategic value, and that is at a similar stage in its development or product life cycle as the Product; provided that in no event shall commercially reasonable efforts require Indivior to take any actions that require Indivior to incur costs or liabilities out of proportion to the benefits under the Indivior License Agreement. In particular, but not exclusively, Indivior shall use commercially reasonable efforts to: | ou un produit soumis à des contraintes réglementaires et ayant un potentiel de marché, un potentiel de profits et une valeur stratégique similaires, et qui est à un stade similaire de son développement ou du cycle de vie du Produit ; étant entendu qu'en aucun cas les efforts commercialement raisonnables n'obligeront Indivior à prendre des mesures qui l'obligent à engager des coûts ou des responsabilités hors de proportion avec les avantages prévus par le Contrat de Licence Indivior. En particulier, mais pas exclusivement, Indivior doit faire des efforts commercialement raisonnables pour : |
| &nbsp;&nbsp;&nbsp;&nbsp;i.not interrupt the development the Product for more than eighteen (18) months;<br>&nbsp;&nbsp;&nbsp;&nbsp;ii.not interrupt the commercialization of the Product for more than twelve (12) months after a first commercialization in a country of the Territory;<br>&nbsp;&nbsp;&nbsp;&nbsp;iii.market the Product within two (2) years following the obtaining of its marketing approval or any other equivalent authorization in a country of the Territory. | &nbsp;&nbsp;&nbsp;&nbsp;i.ne pas interrompre le développement du Produit pendant plus de dix-huit (18) mois ;<br>&nbsp;&nbsp;&nbsp;&nbsp;ii.ne pas interrompre la commercialisation du Produit pendant plus de douze (12) mois après une première commercialisation dans un pays du Territoire ;<br>&nbsp;&nbsp;&nbsp;&nbsp;iii.commercialiser le Produit dans les deux (2) ans suivant l'obtention de son autorisation de mise sur le marché ou toute autre autorisation équivalente dans un pays du Territoire. |
| Consequently, the Head Licensor shall be entitled to terminate the Head License Agreement in the event it considers, in light of the development report provided by Aelis pursuant to <u>Section 3.11</u> of the Head License Agreement and in accordance with the aforementioned conditions, Indivior does not use its commercially reasonable efforts to develop at least one Product, and Aelis does not seek to terminate the Indivior License Agreement in accordance with the terms thereof and take over the development of the Products pursuant to the Head License Agreement. | En conséquence, le Concédant Principal sera en droit de résilier le Contrat de Licence Principal s'il considère, au vu du compte-rendu de développement fourni par Aelis conformément à l'<u>Article 3.11</u> du Contrat de Licence Principal et conformément aux conditions susmentionnées, qu'Indivior ne fait pas des efforts commercialement raisonnables pour développer au moins un Produit, et qu'Aelis ne cherche pas à résilier le Contrat de Licence Indivior conformément aux termes de celui-ci et à reprendre le développement des Produits conformément au Contrat de Licence Principal. |
| For the avoidance of doubt and subject to the foregoing, nothing in this letter agreement shall be construed as preventing the Head Licensor to terminate the Head License Agreement for breach by Aelis of its obligations under the Head License Agreement. | Pour éviter toute ambiguïté, et sous réserve de ce qui précède, rien dans cette lettre accord ne doit être interprété comme empêchant le Concédant Principal de résilier le Contrat de Licence Principal en cas de violation par Aelis de ses obligations en vertu du Contrat de Licence Principal. |

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------

---

| | |
|:---|:---|
| 4. In the event that the Head License Agreement is terminated and the Indivior License Agreement as of the effective date of such termination has not otherwise expired or been terminated, the Head Licensor shall give full effect to <u>Section 9.9</u> of the Head License Agreement and shall, upon Head Licensor's request directly or through Indivior's request, undertake to sign with Indivior a license agreement under the same conditions as the Head License Agreement, it being however specified that with regard to payment obligations, only payments set forth in Section 5 of the Head License would be due by Indivior. If the conditions requested by Indivior are different from the Head License Agreement, the Head Licensor nevertheless undertakes to negotiate such conditions in good faith but shall be under no obligation to sign a license agreement with Indivior. | 4. Dans le cas où le Contrat de Licence Principal est résilié et le Contrat de Licence Indivior, à la date effective de cette résiliation, n'a pas autrement expiré ou été résilié, le Concédant Principal devra donner plein effet à l'<u>Article 9.9</u> du Contrat de Licence Principal et devra, à la demande du Concédant Principal, directement ou à travers la demande d'Indivior, s'engager à signer avec Indivior un contrat de licence dans les mêmes conditions que le Contrat de Licence Principal, étant cependant précisé s'agissant des obligations de paiement qu'Indivior sera seulement tenue aux conditions financières de l'article 5 du Contrat de Licence Principal. Si les conditions demandées par Indivior sont différentes du Contrat de Licence Principal, le Concédant Principal s'engage néanmoins à négocier de telles conditions de bonne foi mais n'est pas tenu de signer un contrat de licence avec Indivior. |
| 5.Section 9.1 of the Head License Agreement is amended as follows: | 5.L'article 9.1 du Contrat de Licence Principal est modifié comme suit : |
| "*This Agreement may be terminated as of right by either Party (or in the event of non-performance by the Licensee, be converted into a non- exclusive license with respect to Patents at the discretion of Inserm Transfert) in the event of non-performance by the other Party of any of its obligations hereunder, and in particular under Article 5, if the said Party has not remedied the said non-performance within a maximum period of ninety (90) days from the receipt of a written notification of the said non-performance, except in the event of force majeure*". | *« Le présent Contrat pourra être résilié de plein droit par l'une ou l'autre des Parties (ou en cas d'inexécution par le Licencié, être converti en licence non-exclusive s'agissant des Brevets à la discrétion d'Inserm Transfert) en cas d'inexécution par l'autre Partie de l'une quelconque de ses obligations au titre des présentes, et en particulier au titre de l'article 5, si ladite Partie n'a pas remédié à ladite inexécution dans un délai maximum de quatre-vingt-dix (90) jours à compter de la date de notification écrite de ladite inexécution, sauf cas de force majeure ».* |

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------

---

| | |
|:---|:---|
| 6.Section 10.8 of the Head License Agreement is amended as follows: | 6.L'Article 10.8 du Contrat de Licence Principal est modifié comme suit : |
| "*A Party shall not be liable for non-performance or delay in performance of its obligations hereunder to the extent that and solely for so long as such non-performance or delay in performance is not due to its negligence or breach of this Agreement and is caused by any event reasonably beyond the control of such Party, including wars, hostilities, revolutions, riots, civil commotion, national emergency, unavailability of supplies, epidemics, fire, flood, earthquake, force of nature, explosion, terrorist act, embargo, or any other Act of God, or any law, proclamation, regulation, ordinance, or other act or order of any court or Governmental Authority (each, a "<u>Force Majeure Event</u>"). In the event of any such Force Majeure Event, the delayed Party shall give the other Party written notice thereof promptly and, in any event, within five (5) business days of discovery thereof. If either Party is unable to perform its obligations hereunder as a result of a Force Majeure Event for a period of two hundred and seventy (270) days or longer and is not continuously exercising diligent good faith efforts to remedy, overcome or work around the Force Majeure Event, then the other Party shall have the right, upon its issuance of written notice to the other Party, to terminate this Agreement*". | *« Une Partie ne sera pas responsable de l'inexécution ou du retard dans l'exécution de ses obligations au titre des présentes dans la mesure où et uniquement pour autant que cette inexécution ou ce retard d'exécution ne soit pas dû à sa négligence ou à une violation du présent Contrat et qu'elle/il soit causé par tout événement raisonnablement hors du contrôle de cette Partie, y compris les guerres, hostilités, révolutions, émeutes, troubles civils, urgences nationales, indisponibilité des fournitures, épidémies, incendies, inondations, tremblements de terre, forces de la nature, explosions, actes terroristes, embargos ou tout autre cas de force majeure, ou toute loi, proclamation, réglementation, ordonnance ou autre acte ou jugement d'une juridiction ou d'une Autorité Gouvernementale (« <u>Cas de Force</u> <u>Majeure</u> »). Dans l'éventualité d'un tel Cas de Force Majeure, la Partie empêchée en informera l'autre Partie par écrit dans les meilleurs délais et, en tout état de cause, dans les cinq (5) jours ouvrables suivant sa découverte. Si l'une des Parties n'est pas en mesure d'exécuter ses obligations en vertu des présentes en raison d'un Cas de Force Majeure pendant une période de deux cent soixante-dix (270) jours ou plus et qu'elle ne déploie pas continuellement des efforts diligents et de bonne foi pour remédier, surmonter ou contourner le Cas de Force Majeure, l'autre Partie aura le droit, dès notification écrite à l'autre Partie, de résilier le présent Contrat ».* |

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------

---

| | |
|:---|:---|
| 7. The terms of this letter agreement shall be incorporated in the Head License Agreement and all references to the Head License Agreement shall be deemed to refer to such agreement as amended by this letter agreement. Except as modified hereby, the Head License Agreement shall remain in full force and effect. As to Paragraphs 3 and 4 of the present letter agreement, Indivior shall be considered as a third party beneficiary within the meaning of Article 1205 of the Civil Code whereby Aelis requires the Head Licensor to promise to make a commitment to Indivior. As a result, the parties already agree to notify the present letter agreement to Indivior for acceptance by the later. | 7. Les termes de cette lettre accord seront integres dans le Contrat de Licence Principal et toutes les references au Contrat de Licence Principal seront considerees comme faisant reference a ce contrat tel que modifie par la presente lettre accord. Sous reserve des modifications apportees par la presente, le Contrat de Licence Principal reste pleinement en vigueur. En ce qui concerne les articles 3 et 4 de la presente lettre accord, ils doivent etre interpretes comme une stipulation pour autrui au sens de l'article 1205 du Code civil au terme de laquelle Aelis fait promettre au Concedant Principal de prendre un engagement au benefice d'Indivior. A ce titre, les parties conviennent expressement que la presente lettre accord sera notifiee a Indivior pour acceptation. |
| Sincerely, | Cordialement, |
| Aelis Farma | Aelis Farma  |
| By: *<u>/s/ Pier Vincenzo Piazza</u>* | Par: *<u>/s/ Pier Vincenzo Piazza</u>* |
| Name: Pier Vincenzo Piazza | Nom: Pier Vincenzo Piazza |
| Title: President | Titre: President |
| In four (4) originals, | En quatre (4) exemplaires originaux, |

---

------

**Bon pour accord:**

Inserm Transfert SA

Par: *<u>/s/ Pascale AUGE</u>*

Nom: Pascale AUGE

Titre: President du Directoire

Date: 02 Juin 2021

*[Page de Signature de la Lettre Accord en/re Aelis Farma, 1nserm Transfer/ SA, Universite Bordeazcr: et* SC *Belenos Signature Page of the Side Letter between Aelis Farma, Inserm Transfer/ SA, Universite Bordeazcc et* SC *Belenos]*

------

**Bon pour accord:**

Universite Bordeaux

Par: *<u>/s/ Manuel Tunon de Lara</u>*

Nom: Manuel Tunon de Lara

Titre: President de l'Univesite de Bordeaux

Date: 02 Juin 2021

[*Page de Signature de la Lettre Accord entre Aelis Farma, Inserm Transfert SA, Université Bordeaux et SC Belenos / Signature Page of the Side Letter between Aelis Farma, Inserm Transfert SA, Université Bordeaux et SC Belenos*]

------

**Bon pour accord:**

SC Belenos

Par: *<u>/s/ Chantal Balateau</u>*

Nom: Chantal Balateau

Titre: Gerante

Date: 02 Juin 2021

*[Page de Signature de la Lettre Accord entre Aelis Farma, Inserm Transfer! SA, Universite Bordeaux et SC Belenos I Signature Page of the Side Letter between Aelis Farma, lnserm Transfer! SA, Universite Bordeaux et* SC *Belenos]*

## Exhibit 4.19

**Exhibit 4.19.2**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**<u>MASTER COLLABORATION AGREEMENT</u>**

THIS MASTER COLLABORATION AGREEMENT (the "**Agreement**") is made between the parties listed below on the date of the last signature set out below (the "**Effective Date**").

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| | | | |
|:---|:---|:---|:---|
| **"Indivior"** | **"Indivior"** | **"Aelis"** | **"Aelis"** |
| **Name (and Co No):** | Indivior UK Limited<br>07183451 | **Name and address** | Aelis Farma SAS<br>Institut Magendie 146 Rue Leo Saignat, 33077 Bordeaux |
| **Signed:** | */s/ Frank Gray* | **Signed:** | */s/ Pier Vincenzo Piazza* |
| **Name, Title and date** | Frank Gray, SVP – GMD<br>August 3, 2021 | **Name, Title and date** | Pier Vincenzo Piazza, CEO<br>August 3, 2021 |

---

**<u>Recitals</u>**

Whereas on June 3, 2021, Indivior and Aelis entered into an agreement pursuant to which Aelis granted Indivior an option to obtain an exclusive license (the **"License Agreement"**);

Whereas Indivior wishes for Aelis to perform certain activities to enable the Parties to move forward with the Development of the Licensed Compounds, in the Field (as defined in the License Agreement);

Whereas Aelis (the **"Provider"**), wishes to supply such activities subject to the following (i) Key Commercial Terms and (ii) the attached MCA Terms and Conditions.

The Parties hereby agree as follows:

**<u>Key Commercial Terms</u>**

---

| | |
|:---|:---|
| **Scope** | This Agreement, including the Key Commercial Terms and the MCA Terms and Conditions, shall govern all Activities during the Term (as the terms are defined in the MCA Terms and Conditions). |
| **Option Period Aelis Studies** | Complemental pharmaceutical, clinical and pre-clinical activities to be Phase III ready at completion of Phase lib of AEF0117 in cannabis addiction or other Licensed Compounds (as defined in the License Agreement). |
| **Statements of Work** | If the Parties agree to perform an Option Period Aelis Study, the Parties shall submit the proposed Option Period Aelis Study to the JSC (as defined in the License Agreement) for prior approval. The Parties shall negotiate and agree the terms and conditions of all activities related to the Option Period Aelis Study in writing (**"Statement of Work"** or **"SOW"**). Each SOW shall include the description of the Activities, the timelines for performance of the Activities, the deliverables, if any, and the Fees. No SOW shall be effective or binding on the Parties until it has been signed by an authorized representative of each Party. Nothing in this Agreement or any SOW shall oblige any Party to enter into any SOW. When signed, each SOW shall be a separate contract that is subject to the terms and conditions of this Agreement. Each SOW shall become effective on the date it is signed by the Parties and shall continue until the earlier of (i) the date specified in the SOW, or if no such date is specified, the date the Option Period Aelis Study, or part of the Option Period Aelis Study referred to in the SOW, is completed, or (ii) termination of this Agreement or the relevant SOW in accordance with the terms of this Agreement. |

---

------

---

| | |
|:---|:---|
| **Aelis Key Contact** | Account Mgr: [\*\*\*] Address: [\*\*\*] Tel: |
| **Indivior Key Contact** | Indivior Contact: [\*\*\*] Address: [\*\*\*] Tel: |
| **Fees** | The fees set out in an SOW to be paid by Indivior in consideration for Aelis performing Activities set out in that SOW. |
| **Payment term** | 60 days following receipt of the Aelis' invoice. |
| **Pharmacovigilance** | The Provider will ensure that in respect of the Activities it complies when appropriate with the requirements of Schedule 1. |
| **Date Protection Legislation** | The Parties shall comply with all applicable legislation and regulatory requirements in force from time to time relating to the use of personal data and the privacy of electronic communications, including without limitation the Data Protection Act 2018 and, for so long as it applies to either party the General Data Protection Regulation ((EU) 2016/679). |

---

**<u>Master Collaboration Agreement Terms and Conditions ("Terms")</u>**

**1.&nbsp;&nbsp;&nbsp;&nbsp;<u>DEFINITIONS</u>**

When used in this Agreement the following capitalized terms shall have the meanings set forth below:

**"Activities"** means the Option Period Aelis Studies and activities related thereto to be performed by the Provider as set out in more detail in each SOW.

**"Affiliates"** shall have the meaning in the License Agreement.

**"Applicable Laws"** has the meaning set out in the License Agreement.

**"Commercially Reasonable Efforts"** means with respect to the performance of Activities and its other obligations under this Agreement, the carrying out of such activities in a sustained and diligent manner and using efforts and resources that Aelis would typically devote to products at a similar stage in development or product life.

**"Direct costs"** means invoiced costs of Subcontractor to perform an activity and external costs directly connected to the performance of an activity such as, but not limited to, travel expenses and audit costs.

**"Effective Date"** has the meaning set out on the first page of this Agreement.

**"Fees"** shall have the meaning set out in the Key Commercial Terms.

**"Force Majeure Event"** any event or circumstances outside the reasonable control of a Party affecting its ability to perform any of its obligations under this Agreement including act of God, fire, flood, severe weather, epidemic or pandemic, war, revolution, acts of terrorism, not or civil commotion, acts of government, trade embargo, labor disputes (excluding labor disputes involving the Party in question), lockouts, interruption of utility service, restraints or delays affecting shipping or carriers, inability or delay in obtaining supplies of adequate or suitable materials, inability or delay in obtaining Third Party services, breakdown or failure in equipment or machinery, cyber-attack, currency restrictions.

**"Intellectual Property Rights"** or **"IPR"** shall have the meaning in the License Agreement.

**"Joint Steering Committee"** or **"JSC"** has the meaning as described in Section 3.2.1 of the License Agreement.

**"Option Period Aelis Studies"** shall have the meaning set out in the Key Commercial Terms.

**"Party"** means Indivior and Aelis individually.

**"Parties"** means Indivior and Aelis jointly.

------

**"Provider"** has the meaning in the Recitals, or if the context so requires, any of Aelis' Affiliates undertaking work pursuant to SOW.

**"Statement of Work"** or **"SoW"** shall have the meaning set out in the Key Commercial Terms.

**"Subcontractor(s)"** means any contract research organization, academic institution, or other service provider that a Party may wish to engage to perform the activities Subcontractors must be specifically approved by Indivior.

**"Third Party"** shall have the meaning set out in the License Agreement.

**"Term"** has the meaning set out in Section 12.1.

**"Territory"** those countries described in the relevant SOW or as otherwise agreed or updated between the parties in writing.

Any capitalized term that is not defined in this Agreement shall have the meaning set out in the License Agreement.

**2.&nbsp;&nbsp;&nbsp;&nbsp;<u>APPOINTMENT</u>**

2.1&nbsp;&nbsp;&nbsp;&nbsp;In consideration of the payment of the Fees by Indivior, and subject to the terms and conditions of this Agreement, Aelis agrees to perform the Activities, including the Option Period Aelis Studies, and share the results of the Option Period Aelis Studies with Indivior in accordance with this Agreement and the terms of the SoW under which such Activities are performed.

2.2&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall have no obligation to perform any Option Period Aelis Studies, including clinical, non-clinical, and CMC, on AEF0117 that have not obtained the prior approval of the JSC.

2.3&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall have the right to subcontract the Activities to Subcontractors.

2.4&nbsp;&nbsp;&nbsp;&nbsp;For all Option Period Aelis Studies performed during the License Option Period (as defined in the License Agreement), Aelis will be the Sponsor, as defined under Applicable Laws.

**3.&nbsp;&nbsp;&nbsp;&nbsp;<u>COVENANTS</u>**

3.1&nbsp;&nbsp;&nbsp;&nbsp;Aelis undertakes to Indivior that in performing the Activities, including the Option Period Aelis Studies:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.1&nbsp;&nbsp;&nbsp;&nbsp;Aelis and its employees, agents or Sub-contractors shall devote, such time, attention and skill as is necessary for the proper performance of the Aelis' obligations under this Agreement,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.2&nbsp;&nbsp;&nbsp;&nbsp;Aelis has the necessary skill and expertise to provide the Activities,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.3&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall perform the Activities as set out in any SOW and in a professional manner and shall use Commercially Reasonable Efforts to meet the time frames set out in the SOW,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.4&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall comply with all Applicable Laws regarding the Activities in the Territory in which the Activities are performed or take place (and where the Activities includes market research, the European Pharmaceutical Market Research Association Code of Conduct as applied in the Territory (or equivalent local code where outside Europe), and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1.5&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall comply with International Conference Harmonization (ICH) guidelines. The Parties agree that it shall not be considered a breach of this Agreement by Aelis if an objective of an SOW is not achieved provided that Aelis has complied with its obligations set out in Section 3.1. Notwithstanding any contrary provisions in this Agreement, the Parties acknowledge and agree that the Activities are by their nature developmental and, Aelis cannot (and consequently does not) guarantee to Indivior the achievement of a successful outcome of an SOW.

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3.2&nbsp;&nbsp;&nbsp;&nbsp;Additional Covenants

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.1&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall comply with Indivior's Code of Conduct & Anti-Bribery Policies (at http//www.indivior.com/corporate-governance/conduct-policies/) as amended from time to time ("Policies") and promptly report any violation of the Policies to Indivior,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.2&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall maintain during the Term professional indemnity insurance and will not do or omit to do anything whereby this insurance may be wholly or partially vitiated,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.3&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall obtain any approval or license required in any country to perform the Activities in the Territory (including without limitation any ethics committee or regulatory authority approval) and shall always act in accordance with such approval, immediately informing Indivior of any deviations from, or variations to, such approval,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.4&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall allow Indivior to audit Aelis on reasonable notice, at Indivior cost, during regular business hours, and in a manner that does not adversely impact Aelis' regular business activities (at Indivior's discretion and expense but no more frequently than annually),

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.5&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall not, and undertakes to have adequate and appropriate procedures to ensure that it shall not, partake in or facilitate any tax avoidance, and will promptly report to Indivior any breach or suspected breach of this clause, and in the event of such breach, will allow Indivior to reasonably audit Aelis in this regard,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.6&nbsp;&nbsp;&nbsp;&nbsp;Indivior shall reasonably assist Aelis in performing the Activities by timely providing any materials or information as set out in the SOW,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.7&nbsp;&nbsp;&nbsp;&nbsp;Payments made pursuant to this Agreement may be subject to disclosure by Indivior to Governmental Authorities and/or Regulatory Authorities, in accordance with Applicable Laws. Aelis shall retain all records, including but not limited to consents, contracts, invoices, proof of payment, of all funds expended under this Agreement, and will promptly provide such records to Indivior upon Indivior's request, in no case less than one (1) week, as may be required for Indivior to comply with Applicable Laws. Indivior shall make such disclosures deemed necessary in its reasonable discretion for compliance with such laws without the need to request or obtain consent from Aelis. Aelis shall be responsible for ensuring its and its Affiliates', as applicable, officers, directors, employees, agents, advisors, consultants, representatives, subcontractors, investigators, and Option Period Aelis Studies personnel comply with the requirements of this Section 3.2.7,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.8&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall, under any SOW, obtain any necessary prior approval and ongoing review as required by: (i) any appropriate and necessary review authorities, including without limitation, any applicable ethics committee or institutional review board (IRB) that is properly constituted in accordance with applicable country, national, state and local laws and standards to act as a human subjects research review board ("Ethics Committee") ("IRB"), and all Applicable Laws,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2.9&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall comply with all Applicable Laws with respect to the reporting of adverse events ("AE") or serious adverse events ("SAE"). Aelis shall report all AE and SAE to Indivior, as applicable, in accordance with the outlined process and timelines stipulated in the SOW and the relevant protocol.

3.3&nbsp;&nbsp;&nbsp;&nbsp;ALL WARRANTIES, CONDITIONS AND OTHER TERMS, EXPRESS (OTHER THAN THOSE SET OUT IN THIS AGREEMENT) OR IMPLIED, STATUTORY, CUSTOMARY OR OTHERWISE WHICH BUT FOR THIS CLAUSE WOULD OR MIGHT SUBSIST IN FAVOR OF INDIVIOR, ARE (TO THE FULLEST EXTENT PERMITTED BY LAW) EXCLUDED FROM THIS AGREEMENT INCLUDING, IN PARTICULAR, ANY IMPLIED WARRANTIES RELATING TO MERCHANTABILITY, FITNESS FOR A PARTICULAR USE AND NON-INFRINGEMENT.

------

**4.&nbsp;&nbsp;&nbsp;&nbsp;<u>FEES AND EXPENSES</u>**

4.1&nbsp;&nbsp;&nbsp;&nbsp;Save as set out in the SOW, the Fees are inclusive of all costs and expenses (including without limitation reasonable travel expenses, Third Party costs or other expenses).

4.2&nbsp;&nbsp;&nbsp;&nbsp;Indivior shall only reimburse Aelis for direct costs on a pass-through basis as per the SOW (or otherwise approved in writing in advance) and subject to Aelis providing receipts.

4.3&nbsp;&nbsp;&nbsp;&nbsp;If any payment due to either Party under this Agreement is not paid when due, then such paying Party shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of two hundred (200) basis points above the U.S. effective federal funds rate (or in the event that the U.S. effective federal funds rate is no longer an applicable reference rate, such reasonably equivalent alternative as may be selected by Aelis in its reasonable discretion), such interest to run from the date on which payment of such sum became due until payment thereof in full together with such interest. Notwithstanding the previous sentence, the total payable interest rate shall never be less than two hundred (200) basis points.

**5.&nbsp;&nbsp;&nbsp;&nbsp;<u>INVOICES AND PAYMENT</u>**

5.1&nbsp;&nbsp;&nbsp;&nbsp;Aelis will submit invoices to Indivior as per the SOW. Invoices will include PO number, approved expenses (if any) and VAT (if any). Indivior shall make payment on undisputed invoices, or portions thereof, within sixty (60) days from receipt of the invoice.

5.2&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall not submit any invoices nor make any charges until SOW is agreed and signed.

5.3&nbsp;&nbsp;&nbsp;&nbsp;Invoiced amounts shall include only Direct Costs.

5.4&nbsp;&nbsp;&nbsp;&nbsp;Aelis shall be responsible for the indirect costs incurred in the performance of the Activities.

5.5&nbsp;&nbsp;&nbsp;&nbsp;Without prejudice to any other right or remedy that it may have, if the Indivior fails to pay any sum to Aelis on the due date for payment, Aelis may notify the Indivior that if it does not pay, Aelis will suspend work on the SOW in respect of which payment is overdue, and if payment is not made within 10 (ten) days after such notice, Aelis may suspend such work until payment has been made in full.

**6.&nbsp;&nbsp;&nbsp;&nbsp;<u>LIABILITY</u>**

6.1&nbsp;&nbsp;&nbsp;&nbsp;AELIS' TOTAL LIABILITY, IN CONTRACT, TORT (INCLUDING NEGLIGENCE OR BREACH OF STATUTORY DUTY), MISREPRESENTATION, RESTITUTION OR OTHERWISE ARISING UNDER THIS AGREEMENT OR AN SOW OR IN CONNECTION WITH THE PERFORMANCE OR CONTEMPLATED PERFORMANCE OF THIS AGREEMENT OR AN SOW SHALL IN ALL CIRCUMSTANCES BE LIMITED TO THE AMOUNTS PAID BY INDIVIOR UNDER THE SOW UNDER WHICH THE LIABILITY AROSE.

6.2&nbsp;&nbsp;&nbsp;&nbsp;UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE TO THE OTHER, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), FOR BREACH OF STATUTORY DUTY OR OTHERWISE, ARISING UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR: LOSS OF PROFIT; LOSS OF BUSINESS; DEPLETION OF GOODWILL; LOSS OF ANTICIPATED SAVINGS; LOSS OR CORRUPTION OF DATA OR INFORMATION; OR ANY SPECIAL, INDIRECT, CONSEQUENTIAL LOSSES, COSTS, DAMAGES, CHARGES OR EXPENSES INCLUDING THE COSTS OF ANY RECALL.

**7.&nbsp;&nbsp;&nbsp;&nbsp;<u>INTELLECTUAL PROPERTY</u>**

The ownership and rights to Intellectual Property Rights that are generated during the performance of Activities will be governed by Section 11 of the License Agreement.

------

**8.&nbsp;&nbsp;&nbsp;&nbsp;<u>CONFIDENTIALITY</u>**

The managing of Confidential Information during the performance of the Activities will be governed by Section 10.1 of the License Agreement.

**9.&nbsp;&nbsp;&nbsp;&nbsp;<u>PUBLICATIONS</u>**

Any publication that may result from the Activities will be governed by Section 10.3 of the License Agreement.

**10.&nbsp;&nbsp;&nbsp;&nbsp;<u>REPRESENTATIONS, WARRANTIES, AND UNDERTAKINGS</u>**

The Parties' respective representations, warranties, and undertakings under this Agreement shall be governed by Section 12 of the License Agreement.

**11.&nbsp;&nbsp;&nbsp;&nbsp;<u>ANTI-BRIBERY</u>**

The Parties' rights and obligations with regard to anti-bribery shall be governed by Section 15 of the License Agreement.

**12.&nbsp;&nbsp;&nbsp;&nbsp;<u>TERM AND TERMINATION</u>**

12.1&nbsp;&nbsp;&nbsp;&nbsp;This Agreement shall become effective on the Effective Date and, unless earlier terminated in accordance with this Article, shall expire on the fifth (5) anniversary of the Effective Date (**"Term"**).

12.2&nbsp;&nbsp;&nbsp;&nbsp;This Agreement or any SOWs may be terminated immediately by a Party on written notice if:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.1&nbsp;&nbsp;&nbsp;&nbsp;The other Party shall have a receiver appointed, or a moratorium declared, pass a resolution (or have an order made) for winding-up or administration, enter into any voluntary arrangement with its creditors or cease or threaten to cease to carry on business; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.2&nbsp;&nbsp;&nbsp;&nbsp;The other Party is in material breach of this Agreement, or the SOW and has failed to cure such breach (if capable of remedy) within 30 days after receiving a written notice requiring it to do so (**"Cure Period"**), provided that unless the material breach relates to a payment obligation, such Cure Period shall be suspended during any time that a Party seeks good faith resolution of a dispute as to whether an alleged material breach occurred pursuant to this Section 12.2.2; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.3&nbsp;&nbsp;&nbsp;&nbsp;(a) The License Option Period expires without Indivior having exercised the License Option or (b) if Indivior has sent a notice to Aelis waiving its right to exercise the License Option.

12.3&nbsp;&nbsp;&nbsp;&nbsp;Indivior shall have the right to terminate this Agreement or any SOW on two weeks' written notice to the Provider. In such an event or if a Party terminates this Agreement pursuant to Section 12.2.3, Indivior shall pay the Provider (a) on a pro-rata basis for the Activities actually and demonstrably (by Aelis, to Indivior's satisfaction) performed and (b) any approved costs which the Provider can show it has (prior to the date of notice of termination) contractually committed to pay, and for which such payment cannot be cancelled or refunded to Aelis as part of the Activities. In the event that there has been any overpayment, this will be refunded to Indivior within 60 days following the termination date.

12.4&nbsp;&nbsp;&nbsp;&nbsp;Any termination of an SOW shall not affect the continuation of other SOWs or of this Agreement. Upon any termination or expiry of this Agreement itself, the terms of this Agreement shall continue to apply to any SOWs then existing until completion (or if applicable termination) of such SOWs.

12.5&nbsp;&nbsp;&nbsp;&nbsp;The following provisions shall survive expiration or termination of this Agreement: Article 1 (to the extent necessary to interpret the other surviving provision), Section 3.3, Article 0 (to the extent of accrued rights to payment that were not satisfied prior to expiration or termination), Section 5.1 (to the extent of accrued rights to payment that were not satisfied prior to expiration or termination), Articles 6, 7, 8, and 9 and Section 12.3, Section 12.4, Section 12.5, Section 13.1, Section 13.3, and Section 13.4.

------

**13.&nbsp;&nbsp;&nbsp;&nbsp;<u>GENERAL</u>**

13.1&nbsp;&nbsp;&nbsp;&nbsp;This Agreement shall be governed by the laws of England and Wales and subject to the exclusively jurisdiction of English Courts.

13.2&nbsp;&nbsp;&nbsp;&nbsp;The rights arising under this Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, provided, however, that either Party may assign such rights without the consent of the other Party to any of its Affiliates. No assignment of rights under this Agreement shall act as a novation. Any assignment not in accordance with this Section 13.2 shall be void.

13.3&nbsp;&nbsp;&nbsp;&nbsp;Sections 19 (Injunctive Relief), 20 (Insurance), 21.1.1 (Expenses), 21.1.4 (Independent Contractors), 21.1.5 (Further Assurances), 21.1.8 (Waiver), 21.1.9 (Amendments), 21.1.10 (Notices), 21.1.12 (Severability), 21.1.12 (Counterparts), 21.1.14 (Interpretation and Construction), 21.1.15 (Third Party Rights), 21.1.17 (Language) of the License Agreement are incorporated herein and shall apply to this Agreement.

13.4&nbsp;&nbsp;&nbsp;&nbsp;This Agreement and the License Agreement constitute the entire Agreement of the Parties with respect to the subject matter and shall supersede any previous agreement, whether written or oral, in respect to the subject matter of this Agreement and the Agreement shall apply to the exclusion of all other terms (including any estimates, quotes, or pitches) and no variation or amendment to this Agreement, SOW nor any Activities shall be made except in writing signed by both Parties. In the event of conflict between the provisions of the License Agreement and this Agreement, the terms and conditions of this Agreement shall prevail. In the event of conflict between an SOW and this Agreement, the terms of this Agreement shall prevail.

13.5&nbsp;&nbsp;&nbsp;&nbsp;No Party shall be liable to the other Party for any delay or non-performance of its obligations under any SOW (except for the payment of money) arising from a Force Majeure Event. If a Party is delayed or prevented from performing its obligations due to a Force Majeure Event such Party shall: (i) give notice of such delay or prevention due to the Force Majeure Event to the non-affected Party as soon as reasonably practical stating the commencement date and extent of such delay or prevention, the cause thereof and its estimated duration, (ii) use reasonable endeavors to mitigate the effects of such Force Majeure Event provided that such Party shall not be required to procure materials or services at unreasonable prices or under unreasonable terms, and (iii) resume performance of its obligations as soon as reasonably practicable.

13.6&nbsp;&nbsp;&nbsp;&nbsp;Each Party's Affiliates may enforce a SOW and this Agreement in their own right, save Aelis and Indivior may vary or rescind this Agreement without any Affiliates' consent.

## Exhibit 4.19

**Exhibit 4.19.3**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

January 6, 2022

Aelis Farma

146 rue Leo Saignat Institut Francoise Magendie

33000 Bordeux, France

Re:&nbsp;&nbsp;&nbsp;&nbsp;License Agreement by and among Indivior UK Limited ("Indivior UK") and Aelis Farma ("Aelis"), dated June 3, 2021 (the "License Agreement") and that certain Letter Agreement regarding an Irrevocable Subscription Agreement and Irrevocable Lock-Up Commitment, dated January 6, 2022 (the "Subscription Agreement").

Dear Mr. Piazza:

This letter agreement is to memorialize certain agreements between Indivior UK and Aelis.

Pursuant to Section 3.2.1(d) of the License Agreement, Indivior UK has decided that certain studies approved by the JSC as set forth on <u>Schedule A</u> attached hereto should be performed during the License Option Period, as such term is defined in the License Agreement (the "Development Nonclinical and CMC Studies"). Pursuant to Section 3.2.1(d) of the License Agreement, the reasonable and documented costs of these studies shall be refunded by Indivior to Aelis on a full cost basis.

Indivior UK has agreed to participate in the private placement described in the Subscription Agreement with a total subscription amount set forth therein.

Aelis agrees that if the fund raise described in the Subscription Agreement occurs, then notwithstanding the terms of the License Agreement and Section 3.2.1(d), Indivior UK shall not be required to refund the reasonable and document costs of these studies and instead Aelis shall be responsible for the costs and expenses of the these Development Nonclinical and CMC studies up to the amount set forth in <u>Schedule A</u>, with any further costs to be subject to the approval and review of the JSC pursuant to the terms of the License Agreement.

It is hereby agreed that, as a matter of evidence agreement *(convention de preuve),* this letter is signed electronically in accordance with the European and French Laws in force, in particular Regulation (EU) No 910/2014 of the European Parliament and of the Council dated 23 July 2014 and Articles 1366 *et seq.* of the French Civil Code. For this purpose, it is agreed to use the online platform DocuSign (<u>www.docusign.com</u>). It is further agreed (i) that the electronic signature which it attaches to this document has the same legal value as its handwritten signature and (ii) that the technical means implemented in the context of this signature confer a definite date *(date certaine)* to this document.

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It is acknowledged and accepted that the signature process used to electronically sign this document enables the parties to have a copy of this document on a durable medium or to have access to it, in accordance with Article 1375 paragraph 4 of the French Civil Code.

Please indicate your agreement by executing below.

Sincerely,

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| | |
|:---|:---|
| INDIVIOR UK LIMITED | INDIVIOR UK LIMITED |
| By: | */s/ Gilles Picard* |
| Name: | Gilles Picard |
| Title: | Head of EUCAN Operations |

---

Agreed to this date of January 6, 2022 by:

---

| | |
|:---|:---|
| AELIS PHARMA | AELIS PHARMA |
| By: | */s/ Pier Vincenzo Piazza* |
| Name: | Pier Vicenzo Piazza |
| Title: | Chief Executive Officer |

---

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**SCHEDULE A**

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| | | | | |
|:---|:---|:---|:---|:---|
| **Studies and budgets approved by the JSC and internal Indivior team** | **Studies and budgets approved by the JSC and internal Indivior team** | **Studies and budgets approved by the JSC and internal Indivior team** | **Budget** | **Date JSC Approval** |
| **Non Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **Non Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **Non Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **Non Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **Non Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **Non Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **Non Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **Clinical Development** | [\*\*\*] | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **TOTAL** | **TOTAL** | **TOTAL** | **$[\*\*\*]** | |

---

---

| | | | |
|:---|:---|:---|:---|
| **CMC activities approved by the JSC and internal Indivior team** | **CMC activities approved by the JSC and internal Indivior team** | **Adjusted Budget** | **Date JSC Approval** |
| **CMC** | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **CMC** | [\*\*\*] | $[\*\*\*] | [\*\*\*] |
| **TOTAL CMC COSTS** | **TOTAL CMC COSTS** | **$[\*\*\*]** | |

---

---

| | |
|:---|:---|
| **GRAND TOTAL COSTS** | **$[\*\*\*]** |

---

------

January 6, 2022

To:

**AELIS FARMA**

Institut Frangois Magendie

146 rue Leo Saignat, 33000 Bordeaux

(the **"Company"**)

**Bryan Garnier & Co. Ltd**

16 Old Queen Street,

London SW1H 9HP,

United Kingdom

**Bryan Garnier Securities**

26 avenue des Champs Elysees,

75008 Paris

France

**ODDO BHF SCA,**

12 boulevard de la Madeleine,

75440 Paris Cedex 09

France

**<u>Re: Subscription and Lock-Up Agreement</u>**

Dear Sirs,

We, Indivior UK Limited, a private limited company organized under the laws of the United Kingdom, whose registered office is located at The Chapleo Building Henry Boot Way, Priory Park, Hull, United Kingdom, HU4 7DY, registered with the Companies house under number 07183451, understand that Aelis Farma, a *societe par actions* organized under the laws of France, whose registered office is located at Institut Francois Magendie, 146 rue Leo Saignat, 33000 Bordeaux, France, registered with the *Registre du Commerce et des Societes* of Bordeaux under number 797 707 627, intends, subject to market conditions and the approval by the AMF of the Prospectus (as such terms are defined below), to offer newly issued ordinary shares of the Company on a non pre-emptive basis (the **"New Shares"**) in the context of the admission of the New Shares and of all the existing ordinary shares of the Company (together with the New Shares, the **"Shares"**) to listing and trading on the regulated market of Euronext in Paris (the **"Admission"**, and together with the Offering (as defined below), the **"IPO"**).

We also understand and acknowledge that:

–The offering of Shares of the Company (the **"Offered Shares"**) is expected to be made through (i) an offering to retail investors in France pursuant to a public offering (the **"French Public Offering"**), (ii) a private placement to selected investors outside the United States, Canada, Australia and Japan in offshore transactions as defined in accordance with, and in reliance on, Regulation S **("Regulation S"**) under the U.S. Securities Act of 1933, as amended (the **"Securities Act"**) (the **"Reg S Tranche"**), and (iii) a private placement in the United States to a limited number of qualified institutional buyers (**"QIBs"**) as defined in Rule 144A (**"Rule 144A"**) under the Securities Act pursuant to the exemption from registration under Section 4(a)(2) of the Securities Act or another exemption from, or in a transaction not subject to, the registration requirements of the Securities Act (the **"US Tranche"**, and together with the Reg S Tranche, the **"International Private Placement"** and, together with the French Public Offering, the **"Offering"**). The Offered Shares have not been and will not be registered under the Securities Act.

–The Company has appointed Bryan Garnier & Co, Ltd., Bryan Garnier Securities and Oddo BHF SCA as joint global coordinators and joint bookrunners for the Offering (together, the **"Managers"**.

–Based on the current indicative timetable, the French Public Offering is expected to take place from February 2 to February 14, 2022 at 18.00 and the International Private Placement is expected to take place from February 2 to February 15, 2022 at noon (Paris time) (the **"Offering Period"**).

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–The initial proposed Offering price per Offered Share for both the French Public Offering and the International Private Placement, as indicated in the Offering Documents, is to be freely set by the Company's Board of Directors pursuant to applicable Euronext Paris and French offering and listing rules for open price offers *(Offre a prix ouvert)* within a maximum range between minus 15% to plus 15% around the midpoint of the range (the **"Offering Price Range"**).

–The final Offer Price per Offered Share (the **"Final Offer Price"**) is to be freely determined within the Offering Price Range by the Company's Board of directors on the final day of the Offering Period (as defined below), in consultation with the Managers, following, and on the basis of, the International Private Placement bookbuilding process as undertaken under standard professional market practices.

–In accordance with French corporate law, the issuance of the New Shares shall only be realized (and accordingly the listing of the Company's shares shall only take place), if, as a result of the Offering, a minimum of 75% of the IPO capital increase is being subscribed by investors at a Final Offer Price at least equal to the lower point of the Offering Price Range.

–The Final Offering Price in the International Private Placement and the French Public Offering will be identical.

–The final number of Offered Shares and the Final Offer Price of the Offered Shares will be decided by the Company's board of directors (the **"Board of Directors"**) on the final day of the Offering Period based on the outcome of a standard market practice bookbuilding process and will be published on the same date by means of an *ad hoc* press release through an electronic dissemination system across the entire European Economic Area and on the Company's website (www.aelisfarma.com).

–Based on the current indicative timetable, the Offered Shares are currently expected to be delivered through the book-entry facilities of Euroclear France S.A. against payment on February 17, 2022 and the first day of trading of all the existing shares of the Company and the New Shares is expected to occur on February 18, 2022.

–The terms and conditions of the Offering will be set out (i) in connection with the French Public Offering, in a prospectus drafted in French, to be approved by the French Financial Markets Authority (the **"AMF"**) hereinafter the **"Prospectus"**, as such Prospectus may be amended or supplemented and including any documents incorporated by reference therein, as the case may be, and (ii) in connection with the Reg S Tranche, an offering memorandum drafted in English and containing an English language translation of relevant sections of the Prospectus (the **"Preliminary International Offering Memorandum"**) and (iii) in connection with the US Tranche, an English language Private Placement Memorandum prepared by the Company (the **"Preliminary US PPM"**), in the case of each of (ii) and (iii), as will be amended or supplemented respectively by a final international offering memorandum (the **"Final International Offering Memorandum"**) and a final US PPM (the **"Final US PPM"**), including the pricing of the New Shares and certain amendments to, respectively, the Preliminary International Offering Memorandum and the Preliminary US PPM (each of the Prospectus, the Final International Offering Memorandum and the Final US PPM being collectively referred to, together with any press release on the Offering - including relating to the price (the **"Offering Price"**) - as the **"Offering Documents"**, and each individually an **"Offering Document"**).

–As of the date hereof, the issued share capital of the Company amounts to 3996,98 euros, divided into 399.680 ordinary shares, each having a nominal value of 0.01 euro; it is expected that the general shareholders meeting of the Company expected to take place on January 11, 2022 shall decide that the share capital of the Company will be increased to 38,371.01 euros and that the nominal value of the shares of the Company will be subsequently divided by 24 resulting in 9,592,752 shares, each having a nominal value of 0,004 euros. Subject to any exercise of outstanding warrants of the Company prior to the Offering, the number of shares of the Company, and as a result the share capital of the Company, may be higher than such number and amount.

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Based on the foregoing, we undertake, represent and agree to the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**1.&nbsp;&nbsp;&nbsp;&nbsp;<u>IRREVOCABLE SUBSCRIPTION AGREEMENT</u>**

(a)&nbsp;&nbsp;&nbsp;&nbsp;Subject to (i) the terms of this letter, and (ii) the approval by the AMF of the Prospectus, and publication of the price range, we irrevocably and unconditionally undertake to the Company and the Managers to place a subscription order in the context of the Offering for (i) an aggregate amount in euro equal to USD 11 million, as calculated on the basis of the Federal Reserve Bank of New York noon buying rate for euro/USD exchange rate two days prior to the date the Board of Directors shall determine the Offering Price Range (the **"Subscription Amount"**), to be paid exclusively in cash (the **"Subscription Agreement"**) and (ii) for the number of Offered Shares (rounded down to the nearest whole number) corresponding to the Subscription Amount, for a price per Offered Share within the Offering Price Range to be freely determined by the Board of the Company, which shall be the same price paid by all investors in the Offering.

(b)&nbsp;&nbsp;&nbsp;&nbsp;We acknowledge and understand that our order pursuant to the Subscription Agreement should in principle be fulfilled in full but may be reduced based on, among other things, market demand, in accordance with market practice allocation by the Managers (including notably if market demand is significantly higher than the number of Offered Shares).

(c)&nbsp;&nbsp;&nbsp;&nbsp;The payment of our Subscription Amount shall be made in accordance with § 100 of <u>Schedule 1</u>.

(d)&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding any other provision of this letter, we will rely on, and base our investment decision solely on, the information contained in (i) the Preliminary International Offering Memorandum made available to us after the opening date of the Offering book-building and (ii) the Final International Offering Memorandum.

(e)&nbsp;&nbsp;&nbsp;&nbsp;We understand that the information to be contained in the Preliminary International Offering Memorandum and the Final International Offering Memorandum restores the equal access to sensitive and confidential information pertaining to the Company between the current shareholders of the Company and the public or third party institutional investors, as applicable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**2.&nbsp;&nbsp;&nbsp;&nbsp;<u>IRREVOCABLE LOCK-UP COMMITMENT</u>**

(a)&nbsp;&nbsp;&nbsp;&nbsp;We unconditionally and irrevocably undertake, agree and covenant to the Managers, not to, directly or indirectly, except with the prior written agreement of the Managers, during the period beginning from the date hereof and continuing to and including the date which is 365 calendar days after the settlement-delivery date of the IPO, in relation to the totality of the Offered Shares to be subscribed by Indivior in the IPO (the **"Indivior Offered Shares"**) pursuant to the Subscription Agreement (the **"Lock Up Period"**):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;A.&nbsp;&nbsp;&nbsp;&nbsp;offer, lend, mortgage, assign, charge, pledge, sell, contract to sell or sell any option or contract to purchase, purchase any option or contract to sell or grant any option, right or warrant to purchase, lend or otherwise transfer or dispose of, directly or indirectly, any of the Indivior Offered Shares, or any interest in such Indivior Offered Shares;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;B.&nbsp;&nbsp;&nbsp;&nbsp;enter into any derivative or other agreement or transaction that transfers, in whole or in part, any of the economic consequences of ownership of the Indivior Offered Shares; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;C.&nbsp;&nbsp;&nbsp;&nbsp;publicly announce such an intention to effect any transaction mentioned in the two paragraphs above.

provided however, that (i) this will not prevent Indivior accepting, or voting in favour of, an offer made to all investors in the Company by way of public tender offer or equivalent structure and (ii) these restrictions shall not prevent us to transfer shares of the Company between controlled (within the meaning of Article L. 233-3 of the French Commercial Code) entities or companies of the Indivior group, provided that the acquirer shall continue to be bound by the foregoing restrictions for the remainder of the Lock-Up Period (the **"Lock-Up Commitment"**).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.&nbsp;&nbsp;&nbsp;&nbsp;<u>DURATION</u>**

In the event that the Admission does not occur by March 31, 2022 at the latest, the provisions of this letter (notably including the Subscription Agreement and the Lock-Up Commitment provisions), other than in Article 5.5 below, shall automatically lapse. No other termination shall be permitted.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**4.&nbsp;&nbsp;&nbsp;&nbsp;<u>REPRESENTATIONS</u>**

We agree, acknowledge, represent, warrant and undertake to the Company and each Manager that, on the date hereof and the date of our subscription for Offered Shares:

(a)&nbsp;&nbsp;&nbsp;&nbsp;We have the requisite power and authority to enter into and to perform this letter. This letter and any act, agreement and any other document to be executed by us in accordance with this letter constitute or will, when executed, constitute our binding obligations in accordance with their terms. No consent, approval, authorisation, order, filing, registration or qualification of or with any court, governmental authority or third person is required to be obtained by us in connection with the execution and delivery of this letter by us or the performance of our obligations under this letter.

(b)&nbsp;&nbsp;&nbsp;&nbsp;We agree that irreparable damage may occur if any provision of this letter were not performed in accordance with the terms hereof and that each Manager shall be entitled to an injunction or injunctions to prevent breaches of the undertakings contained in this letter or to enforce specifically the performance of the terms and provisions hereof in any court, in addition to any other remedy to which it is entitled at law or in equity.

(c)&nbsp;&nbsp;&nbsp;&nbsp;The representations, warranties and undertakings contained in <u>Schedule 1</u> are true and correct.

(d)&nbsp;&nbsp;&nbsp;&nbsp;Any authorized signatory purchasing the Offered Shares on our behalf per the Subscription Agreement shall furthermore be deemed to represent and warrant that (i) such person has the power, capacity and authority to represent such purchasing entity and to make and subscribe to each of the representations, warranties and undertakings on behalf of such purchasing entity contained in <u>Schedule 1</u>, and (ii) each of the representations, warranties and undertakings contained in <u>Schedule 1</u> is true and correct as regards such purchasing entity, and such purchasing entity is bound by all such representations, warranties and undertakings.

(e)&nbsp;&nbsp;&nbsp;&nbsp;The Company and the Managers will rely upon the truth and accuracy of the representations, warranties and undertakings set forth in this letter, and we agree to notify the Company which will notify each Manager as soon as practicable in writing if any of the representations, warranties or undertakings contained in this letter cease to be accurate and complete or become misleading on or before the closing date of the Offering.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**5.&nbsp;&nbsp;&nbsp;&nbsp;<u>MISCELLANEOUS</u>**

5.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Partial Invalidity – Interpretation</u>

(a)&nbsp;&nbsp;&nbsp;&nbsp;The preamble of this letter forms a full part of this letter.

(b)&nbsp;&nbsp;&nbsp;&nbsp;If, at any time, any provision of this letter is or becomes illegal, invalid or unenforceable in any respect under any applicable laws of any relevant jurisdiction, neither the legality, validity or enforceability of the remaining provisions will in any way be affected or impaired.

(c)&nbsp;&nbsp;&nbsp;&nbsp;The titles of the Articles in this letter are for convenience only and shall not be taken into account in the interpretation of this letter.

5.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Third Party Stipulation</u>

This letter is enforceable by any Manager and their respective affiliates (as defined in Rule 501 of Regulation D under the Securities Act (the **"Affiliates"**)) as a third party stipulation *(stipulation pour autrui).* The Managers and each of their respective Affiliates are entitled to rely and will rely upon the truth and accuracy of the representations, warranties, agreements and acknowledgements contained in this letter, and have the benefit of the provisions of this letter as if they were a party.

5.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Amendments</u>

Changes and amendments made to the provisions of this letter shall only be made in writing in a document signed by us and the Company and with the prior written consent of the Managers.

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5.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Waiver</u>

If the Company or the Managers do not exercise a right hereunder, none of them shall be deemed to have waived their right and their respective capacity to exercise their right shall not be affected in any way.

5.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Confidentiality – Publicity</u>

(a)&nbsp;&nbsp;&nbsp;&nbsp;We undertake to treat as confidential and not disclose to a third party this letter, the provisions of this letter, the transactions consummated pursuant to this letter and any confidential information concerning any of the Company or the Managers that may come into our possession, without the prior written consent of such person.

(b)&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding the preceding paragraph, we may disclose or use any such confidential information to the extent that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;such disclosure or use is authorized by this letter;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;such disclosure or use is required by any law or any governmental authority;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;such disclosure or use is necessary to defend our interests in connection with any judicial or administrative proceedings; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)&nbsp;&nbsp;&nbsp;&nbsp;the relevant confidential information becomes publicly available, other than by a breach of a confidentiality undertaking on our part,

*provided that,* prior to such disclosure or use, we shall promptly notify the Company and each Manager, to the extent legally permitted.

(c)&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding the preceding paragraphs, we agree that the existence of this letter, its terms and conditions (including the Subscription Agreement and the Lock-Up Commitment) may be disclosed (i) in the context of the IPO, to the AMF and to the public, including the Registration Document (and any translation thereof), the Offering Documents, the press releases (including in the *intention to float* press release that will be published following the approval by the AMF of the Registration Document) and in any other document relating to the IPO and, more generally (ii) by the Company and each Manager following its execution, including if required by applicable laws or regulations or any competent regulator.

(d)&nbsp;&nbsp;&nbsp;&nbsp;If the undertakings of this letter terminate pursuant to Article 3 above, this Article 5.5 shall remain in full force and effect for a period of one (1) year after such termination.

5.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Entire Agreement</u>

(a)&nbsp;&nbsp;&nbsp;&nbsp;This letter, its forewords, its schedule and exhibit, and any documents referred to therein, shall constitute our whole undertaking with respect to the purpose of this letter.

(b)&nbsp;&nbsp;&nbsp;&nbsp;This letter replaces and cancels all previous undertaking or agreement between the Company and us relating specifically to such purpose.

5.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Electronic Signature</u>

(a)&nbsp;&nbsp;&nbsp;&nbsp;It is hereby agreed that, as a matter of evidence agreement (*convention de preuve*), this letter is signed electronically in accordance with the European and French Laws in force, in particular Regulation (EU) No. 910/2014 of the European Parliament and of the Council dated 23 July 2014 and Articles 1366 *et seq* of the French Civil Code. For this purpose, it is agreed to use the online platform DocuSign (www.docusign com). It is further agreed (i) that the electronic signature which it attaches to this document has the same legal value as its handwritten signature and (ii) that the technical means implemented in the context of this signature confer a definite date *(date certaine*) to this document.

(b)&nbsp;&nbsp;&nbsp;&nbsp;It is acknowledged and accepted that the signature process used to electronically sign this document enables the parties to have a copy of this document on a durable medium or to have access to it, in accordance with Article 1375 paragraph 4 of the French Civil Code.

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5.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Applicable Law – Disputes</u>

(a)&nbsp;&nbsp;&nbsp;&nbsp;This letter shall be governed in all respects, including as to validity, interpretation and effect, by the laws of France, without giving effect to its principles of conflict of laws.

(b)&nbsp;&nbsp;&nbsp;&nbsp;All disputes arising out of or in connection with this letter shall be submitted to the exclusive jurisdiction of the commercial court of Paris (*Tribunal de commerce de Pans*).

\*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \*

Executed on January 6, 2022, in London by:

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|:---|
| **INDIVIOR UK LIMITED** |
| */s/ Gilles Picard* |
| Represented by Mr. Gilles Picard, Head of EUCAN operations |

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Accepted on January 6, 2022, in Bordeaux by:

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| |
|:---|
| **AELIS FARMA SAS** |
| */s/ Pier Vincenzo Piazza* |
| Represented by Mr. Pier Vincenzo Piazza, President |

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Accepted in relation to the Lock-Up Commitment on January 6, 2022, in Paris by:

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| |
|:---|
| */s/ Olivier Garnier* |
| **Bryan Garnier & Co. Ltd** |
| Represented by Olivier Garnier |

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| |
|:---|
| */s/ Gregoire Gillingham* |
| **Bryan Garnier Securities** |
| Represented by Gregoire Gillingham |

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| |
|:---|
| */s/ Nicolas Delage* |
| **ODDO BHF SCA** |
| Represented by Nicolas Delage |

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**<u>SCHEDULE 1</u>**

**<u>Representations, Warranties and Undertakings</u>**

We hereby agree, acknowledge, represent, warrant and undertake as follows:

1.&nbsp;&nbsp;&nbsp;&nbsp;None of Aelis Farma and the Managers or any of their respective Affiliates and then and their respective Affiliates' officers, directors, employees, advisors, agents, representatives, or associates makes any representations or gives any warranty or undertaking that the Offering will be launched or completed (within any particular time period or at all) or will be under any liability whatsoever to us in the event that the Offering is not launched or completed for any reason.

2.&nbsp;&nbsp;&nbsp;&nbsp;Each Manager is acting on behalf of the Company and no one else in connection with the Offering. They will not regard any other person as their client in relation to the Offering and will not be responsible to anyone other than the Company for providing the protections afforded to their respective clients nor for providing advice in relation to the Offering or the contents of any Offering Document. Our subscription and acquisition of Offered Shares is not deemed to constitute a client relation between us and any of the Managers or any of their respective Affiliates.

3.&nbsp;&nbsp;&nbsp;&nbsp;None of the Managers or any of their respective Affiliates or any of their respective officers, directors, employees, advisors, agents, representatives or associates accepts any responsibility or liability whatsoever for, or makes any representation, warranty or undertaking, express or implied, as to the truth, accuracy, completeness or fairness of the information or opinions in any Offering Document (or whether any information has been omitted from any Offering Document) or any other information relating to the Company or its Affiliates, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of any Offering Document or their contents or otherwise arising in connection therewith and/oi our participation in the Offering. Accordingly, each of the Managers and then respective Affiliates disclaims, to the fullest extent permitted by applicable law, all and any liability, whether arising in tort or contract or that they might otherwise be found to have in respect of any Offering Document, any such statement and/or our participation in the Offering.

4.&nbsp;&nbsp;&nbsp;&nbsp;We have not relied on and are not and will not be entitled to rely on any investigation that any of the Managers or their respective Affiliates or any person acting on them or their Affiliates behalf may have conducted with respect to the Shares or the Company.

5.&nbsp;&nbsp;&nbsp;&nbsp;We have conducted our own investigation and made our own investment decision regarding our investment in the Shares based on our own judgement, knowledge, due diligence and analysis with respect to the Shares and the Company and have satisfied ourselves concerning the relevant financial, intellectual property and other considerations relevant to our undertakings in this letter and our investment in the Shares.

6.&nbsp;&nbsp;&nbsp;&nbsp;We have available to us, and have reviewed, all information that we believe is necessary or appropriate in connection with our investment in the Shares.

7.&nbsp;&nbsp;&nbsp;&nbsp;We have had the opportunity to ask management of the Company questions while making our investment decision and received answers fully satisfactory to us from representatives of the Company.

8.&nbsp;&nbsp;&nbsp;&nbsp;We have sufficient knowledge, sophistication and experience in financial and business matters to be capable of evaluating the merits and risks of an investment decision in the Company by subscribing for the Shares, and we are able to bear the economic risk, have adequate means of providing for our current and contingent needs, have no need for liquidity with respect to our investment in the Shares, and are able to withstand a complete loss of an investment in the Shares.

9.&nbsp;&nbsp;&nbsp;&nbsp;We agree that the Offering Price Range will be freely determined by the Company, and that the and the Final Offer Price will be freely determined (within the Offer Price Range) by the Company following consultations with the Managers, and on the basis of a bookbuilding process undertaken under standard professional market practices.

10.&nbsp;&nbsp;&nbsp;&nbsp;We agree to have our order corresponding to the Subscription Amount of the Indivior Investment being entered by the Managers in the order book of the International Private Placement maintained by the Managers, and to transfer the cash corresponding to the Subscription Amount at the latest five business days before the settlement date of the Offering (the **"Settlement Date"**) on an account opened by us with one of the Managers. Arrangements shall be made by us, with the

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assistance of the Managers, reasonably prior to the launch of the IPO (including in relation to KYC requirements) in order for the cash transfer of the Subscription Amount to be made on the Settlement Date as described below.

Payment of the aggregate subscription price for the Offered Shares will be made in accordance with French delivery versus payment settlement procedures.

On the Settlement Date, simultaneously against receipt by the Company of a *certificat du depositaire des fonds* conforming to Article L 225-146 of the French *Code de commerce* from the financial institution appointed by the Company to act as centralizing bank in relation to the IPO (which name and details will be provided to us prior to the Prospectus approval by the AMF) confirming receipt of payment of the aggregate amount of the Subscription Amount for the Offered Shares, the centralizing bank shall credit the number of shares subscribed and purchased by us in a securities account opened in each of the books of the custodians for the Managers. The shares subscribed pursuant to this letter will be subsequently delivered to us by the relevant Manager to the account specified by us against payment by us of the aggregate subscription price of such shares .The centralizing bank will then deliver the subscription monies to the Company.

We and the Company acknowledge that the intermediation of the settlement and delivery process of the Offered Shares in connection with the settlement as described herein is undertaken by the Managers (i) solely in their capacity as agent of the Company and not as principal and (ii) to facilitate the settlement of the subscription of the Offered Shares and delivery of the Offered Shares as provided herein. In no event shall the Managers have any liability or obligation in respect of any failure on the part of the Company or the subscribers to perform their respective obligations.

11.&nbsp;&nbsp;&nbsp;&nbsp;The Company and the Managers may enter into agreements similar to the letter entered into with us with one or more investors as part of the Offering.

12.&nbsp;&nbsp;&nbsp;&nbsp;We are purchasing the Offered Shares in the context of the Offering pursuant to the terms of the Offering Documents.

13.&nbsp;&nbsp;&nbsp;&nbsp;We are not an Affiliate of the Company, and are not acting on behalf of an Affiliate of the Company.

14.&nbsp;&nbsp;&nbsp;&nbsp;We are purchasing the Offered Shares solely for our account, for investment purposes.

15.&nbsp;&nbsp;&nbsp;&nbsp;We acknowledge that the Offered Shares are being offered in a transaction not involving any public offering in the United States within the meaning of the Securities Act, and that the Shares have not been and will not be registered under the Securities Act or with any state or other jurisdiction of the United States. We agree and acknowledge that we are purchasing the Shares in an "offshore transaction" as defined in Rule 902 of the Securities Act, in reliance on Regulation S of the Securities Act.

16.&nbsp;&nbsp;&nbsp;&nbsp;We are knowledgeable of, or have been independently advised as to the applicable securities laws of the securities regulatory authorities (the **"Authorities"**) having application in the jurisdiction in which we are resident (the **"International Jurisdiction"**) which would apply to the acquisition by us of the Shares, if any.

17.&nbsp;&nbsp;&nbsp;&nbsp;Neither we nor any of our Affiliates and our and their respective directors, officers, agents or, to the best of our knowledge, employees, affiliates or other persons acting on its behalf, (i) is a person, or is owned or controlled by a person that is, designated in the most current version of the Specially Designated Nationals and Blocked Persons List or the List of Foreign Financial Institutions Subject to Part 561, which are both maintained by the Office of Foreign Assets Control of the U.S. Treasury Department (**"OFAC"**), or any applicable prohibited party list maintained by any U.S. government agency, French government agency, the European Union, or Her Majesty's Treasury, (ii) has been or is currently subject to, and the aggregate Offering Price has not been or will not be directly or indirectly derived, obtained, received, taken, acquired or gained from sources prohibited under, any sanctions programs administered by OFAC, the United Nations Security Council, the European Union, Her Majesty's Treasury, or any French government agency, or (iii) is located or registered or is a resident in a country subject to these sanctions.

18.&nbsp;&nbsp;&nbsp;&nbsp;(i) Our operations are, and have been conducted at all times, in compliance with applicable financial record keeping and reporting requirements of the anti-money laundering laws and regulations of the European Union, United States, United Kingdom and France, the rules and regulations thereunder and any related or similar applicable rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the **"Money Laundering Laws"**), in each case to the extent applicable to our activities, (ii) no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving us with respect to Money Laundering Laws is pending or, to our knowledge, threatened, and (iii) neither us nor any of our Affiliates and our and their respective directors or

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officers, nor, to the best of our knowledge after due enquiry, our and their respective agents, employees, affiliates, representatives, or any person associated with or acting on behalf, of any of them has caused us to be in violation of any law, directive, national statute or administrative regulation relating to money-laundering, unlawful financial activities or unlawful use or appropriation of corporate funds.

19.&nbsp;&nbsp;&nbsp;&nbsp;We undertake not to, directly or indirectly, take any steps or measures that (i) aim to influence or manipulate the market price of the Company's Shares and (ii) constitute a market manipulation under section 12 of regulation (EU) no 596/2014 of the European parliament and of the council of 16 April 2014 on market abuse;

20.&nbsp;&nbsp;&nbsp;&nbsp;We have full power and authority to make the representations, warranties, agreements and acknowledgements made herein.

## Exhibit 4.21

**Exhibit 4.21**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**CONTINGENT VALUE RIGHTS AGREEMENT**

THIS CONTINGENT VALUE RIGHTS AGREEMENT, dated as of March 2, 2023, (this "<u>Agreement</u>"), is entered into by and between Indivior Inc., a Delaware corporation ("<u>Parent</u>"), and Computershare Inc. ("<u>Computershare</u>") and its affiliate, Computershare Trust Company, N.A., together, as Rights Agent (in such capacity, the "<u>Rights Agent</u>").

**RECITALS**

WHEREAS, Parent, Olive Acquisition Subsidiary, Inc., a Delaware corporation ("<u>Merger</u> <u>Sub</u>"), and Opiant Pharmaceuticals, Inc., a Delaware corporation (the "<u>Company</u>"), have entered into an Agreement and Plan of Merger, dated as of November 13, 2022 (as it may be amended or supplemented from time to time pursuant to the terms thereof, the "<u>Merger Agreement</u>"), pursuant to which Merger Sub will merge with and into the Company (the "<u>Merger</u>"), with the Company surviving the Merger as a subsidiary of Parent;

WHEREAS, pursuant to the Merger Agreement, Parent has agreed to provide to the holders of shares of Company Common Stock (excluding the holders of any Dissenting Shares), the holders of Company Warrants that are cancelled as of the Effective Time pursuant to the Merger Agreement, the holders of the Convertible Notes that are converted as of the Effective Time, the holders of In the Money Options, Company RSU Awards and Company PSU Awards immediately prior to the Effective Time that are validly converted into Merger Consideration pursuant to terms set forth in the Merger Agreement, the right to receive contingent cash payments (each, a "<u>CVR</u>") as hereinafter described; and

WHEREAS, pursuant to this Agreement, the maximum potential amount payable per CVR (as hereinafter defined) is $8.00 in cash, without interest.

NOW, THEREFORE, in consideration of the foregoing and the consummation of the transactions referred to above, Parent and Rights Agent agree, for the equal and proportionate benefit of all Holders, as follows:

**ARTICLE I**

**<u>DEFINITIONS; CERTAIN RULES OF CONSTRUCTION</u>**

Section 1.1 <u>Definitions</u>. Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in the Merger Agreement. As used in this Agreement, the following terms will have the following meanings:

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"<u>225M Annual Net Sales Milestone</u>" means, during the Sales Milestone Period, the first achievement in any Sales Measurement Period of worldwide Net Sales of the Product exceeding $225,000,000.

"<u>225M Annual Net Sales Milestone Payment</u>" means $2.00 per CVR.

"<u>300M Annual Net Sales Milestone</u>" means, during the Sales Milestone Period, the first achievement in any Sales Measurement Period of worldwide Net Sales of the Product exceeding

$300,000,000.

"<u>300M Annual Net Sales Milestone Payment</u>" means $2.00 per CVR.

"<u>325M Annual Net Sales Milestone</u>" means, during the Sales Milestone Period, the first achievement in any Sales Measurement Period of worldwide Net Sales of the Product exceeding

$325,000,000.

"<u>325M Annual Net Sales Milestone Payment</u>" means $2.00 per CVR.

"<u>Acting Holders</u>" means, at the time of determination, Holders of at least thirty percent (30%) of the outstanding CVRs as set forth in the CVR Register.

"<u>Affiliate</u>" of any particular Person means any other Person controlling, controlled by or under common control with such particular Person. For the purposes of this definition, "controlling," "controlled" and "control" mean the possession, directly or indirectly, of the power to direct the management and policies of a Person whether through the ownership of voting securities, contract or otherwise.

"<u>Annual Net Sales Milestone</u>" means any of the 225M Annual Net Sales Milestone, the 300M Annual Net Sales Milestone or the 325M Annual Net Sales Milestone.

"<u>Assignee</u>" has the meaning set forth in <u>[Section 6.3](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>.

"<u>Authorized Representative</u>" means an employee of Parent with the title of President, Vice President, Secretary, Treasurer or Assistant Treasurer, or a director of Ultimate Parent, as the case may be.

"<u>Board of Directors</u>" means the board of directors of Ultimate Parent.

"<u>Board Resolution</u>" means a copy of a resolution certified by an Authorized Representative of the Ultimate Parent to have been duly adopted by the Board of Directors and to be in full force and effect on the date of such certification, and delivered to the Rights Agent.

"<u>Business Day</u>" means any day other than a Saturday, Sunday or a day on which banking institutions in New York, New York, or London, United Kingdom, are authorized or obligated by law or executive order to remain closed.

"<u>Code</u>" shall mean the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder.

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"<u>Commercially Reasonable Efforts</u>" means, with respect to the performance of development activities with respect to the Product, the carrying out of such activities using reasonable and diligent efforts in good faith and the expending of such resources that Parent would expend with respect to a product candidate at a similar stage in its development or product life as the Product, considering conditions then prevailing and taking into account, without limitation, issues of safety and efficacy, expected time to develop, market potential, anticipated pricing and reimbursement rates, costs, expected profitability (including development costs, intellectual property defense costs, distribution and logistics, marketing and promotional expense and all other costs associated with the Product), anticipated product labeling, pricing reimbursement, methods of distribution, the competitiveness of alternative products in the marketplace or under development, market exclusivity (including the patent, regulatory and other proprietary position of the Product), the applicable regulatory environment, anticipated timing of commercial entry, and all other relevant commercial, financial, technical, legal, scientific and/or medical factors. For the avoidance of doubt, Commercially Reasonable Efforts will not mean that a party guarantees that it will actually obtain FDA Approval of the Product or to achieve U.S. Commercial Launch, and a failure to obtain FDA Approval of the Product or to achieve U.S. Commercial Launch may still be consistent with Commercially Reasonable Efforts.

"<u>CVR Register</u>" has the meaning set forth in <u>[Section 2.3(b)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>.

"<u>CVR Shortfall</u>" has the meaning set forth in <u>Section 4.7(b)</u>.

"<u>Delaware Courts</u>" has the meaning set forth in <u>[Section 6.5(b)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>.

"<u>DTC</u>" means The Depository Trust Company or any successor thereto.

"<u>Early Achievement Milestone</u>" means, during the Early Achievement Period, the first achievement in any Sales Measurement Period of worldwide Net Sales of the Product exceeding

$250,000,000. For the avoidance of doubt, the Early Achievement Milestone cannot be achieved following the expiration of the Early Achievement Period.

"<u>Early Achievement Milestone Payment</u>" means $2.00 per CVR.

"<u>Early Achievement Period</u>" means the period beginning at the beginning of the Sales Milestone Period and ending on the third (3rd) anniversary thereof.

"<u>Entity</u>" means any corporation (including any non-profit corporation), general partnership, limited partnership, limited liability partnership, joint venture, estate, trust, company (including any company limited by shares, limited liability company or joint stock company), firm, society or other enterprise, association, organization or entity.

"<u>Equity Award Holders</u>" means the Holders of CVRs granted with respect to Company Stock Options, Company RSU Awards and Company PSU Awards.

"<u>FDA</u>" means the United States Food and Drug Administration, or any successor agency. "<u>FDA Approval</u>" means written receipt from the FDA of approval for marketing

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a Product in the United States with an approved label including an indication for the Opioid Overdose Indication.

"<u>GAAP</u>" means, with respect to Parent, either (a) generally accepted accounting principles in the United States or (b) International Financial Reporting Standards, in either case, which principals or standards are currently used at the applicable time by Ultimate Parent in the preparation of the consolidated financial statements of Ultimate Parent included the Annual Report and Accounts of Ultimate Parent, and as applied by the Ultimate Parent for external reporting in its primary listed market.

"<u>Governmental Body</u>" means any: (a) nation, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; or (c) governmental or quasi-governmental authority of any nature including any governmental division, department, agency, commission, instrumentality, official, ministry, fund, foundation, center, organization, unit, body or Entity and any court, arbitrator or other tribunal.

"<u>Holder</u>" means a Person in whose name a CVR is registered in the CVR Register at the applicable time.

"<u>Independent Accountant</u>" means an independent certified public accounting firm of nationally recognized standing designated either (a) jointly by the Acting Holders and Parent, or

(b) if such parties fail to make a designation, jointly by an independent public accounting firm selected by Parent and an independent public accounting firm selected by the Acting Holders.

"<u>Milestone</u>" means any of the Annual Net Sales Milestones or the Early Achievement Milestone.

"<u>Milestone Determination Date</u>" means, with respect to any Milestone, the date that is sixty (60) days following the last day of the Sales Measurement Period in which such Milestone was achieved.

"<u>Milestone Notice</u>" has the meaning set forth in <u>[Section 2.4(a)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>.

"<u>Milestone Payment</u>" means any of the 225M Annual Net Sales Milestone Payment, the 300M Annual Net Sales Milestone Payment, the 325M Annual Net Sales Milestone Payment or the Early Achievement Milestone Payment.

"<u>Milestone Payment Amount</u>" means, in respect of a Milestone, for a given Holder, the product of (a) the Milestone Payment in respect of such Milestone and (b) the number of CVRs held by such Holder as reflected on the CVR Register as of the close of business on the date of the applicable Milestone Notice.

"<u>Milestone Payment Date</u>" has the meaning set forth in <u>Section 2.4(b)</u>.

"<u>Net Sales</u>" means the gross amount charged or invoiced by each Selling Entity for the Product sold to third parties, *plus* any additional amount pursuant to the proviso contained in clause (6) of the definition of "Permitted Deductions", *less* the Permitted Deductions, all as

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determined in accordance with the Selling Entity's usual and customary accounting methods consistent with the treatment of other branded prescription products commercialized by the applicable Selling Entity, which shall be in accordance with GAAP, including the accounting methods for translating activity denominated in foreign currencies into United States dollar amounts. In the case of any sale of the Product between or among Parent, its Affiliates, licensees and sublicensees, for resale, Net Sales will be calculated as above only on the value charged or invoiced on the first arm's- length sale thereafter to a third party. If a Product is sold or otherwise commercially disposed of for consideration other than cash or in a transaction that is not at arm's length between the buyer of such Product and the applicable Selling Entity (other than with respect to Products supplied expressly for sampling purposes), then the gross amount to be included in the calculation of Net Sales shall be the amount that would have been received had the transaction been conducted at arm's length and for cash. Such amount that would have been received shall be determined, wherever possible, by reference to the average selling price of such Product in arm's length transactions in the relevant jurisdiction for that type of customer (Governmental Entity, retail, etc.). Notwithstanding the foregoing, the following shall not be included in Net Sales: (i) Product provided for administration to patients enrolled in clinical trials or for other research purposes, or(ii) Product provided without consideration or for nominal consideration for any bona fide charitable, compassionate use or indigent patient program purpose or as a sample.

"<u>Net Sales Statement</u>" means, for a given Sales Measurement Period, a written statement of Parent, setting forth with reasonable detail (a) a delineation and calculation of Net Sales during such Sales Measurement Period, (b) a delineation and calculation of the Permitted Deductions during such Sales Measurement Period, and (c) to the extent that sales for the Product is recorded in currencies other than United States dollars during such Sales Measurement Period, the exchange rates used for conversion of such foreign currency into United States dollars.

"<u>Officer's Certificate</u>" means a certificate signed by an Authorized Representative of Parent or Ultimate Parent, as applicable, in such capacity, and delivered to the Rights Agent.

"<u>Opioid Overdose Indication</u>" means the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids and for the emergency treatment of known or suspected opioid overdose.

"<u>OPNT003</u>" shall mean an intranasal formulation of nalmefene.

"<u>Permitted Deductions</u>" means, to the extent not already excluded from Net Sales, the following deductions that are either included in the billing as a line item as part of the amount charged or invoiced, or otherwise documented as a deduction and accrued in accordance with GAAP specifically attributable to sales of the Product:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(1)&nbsp;&nbsp;&nbsp;&nbsp;normal and customary trade, quantity and prompt settlement discounts;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(2)&nbsp;&nbsp;&nbsp;&nbsp;accrued price reductions or discounts by reasons of defects, recalls, returns, rebates or allowances of goods or because of retroactive price reductions specifically attributable to the Product;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(3)&nbsp;&nbsp;&nbsp;&nbsp;chargebacks, rebates (or the equivalent thereof) and other amounts accrued on sale of the Product, including such amounts mandated by programs of Governmental Entities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(4)&nbsp;&nbsp;&nbsp;&nbsp;accruals for rebates (or the equivalent thereof) and administrative fees payable to medical healthcare organizations, to group purchasing organizations or to trade customers in line with approved contract terms or other normal and customary understandings and arrangements; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(5)&nbsp;&nbsp;&nbsp;&nbsp;accruals for tariffs, duties, excise, sales, value-added and other Taxes (other than Taxes based on net income) and charges of Governmental Entities;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(6)&nbsp;&nbsp;&nbsp;&nbsp;bad debts not exceeding five percent (5%) of the value of the sales of Product during the then-current calendar year, <u>provided</u> that any recovery of bad debts shall be included in Net Sales in the period in which recovered;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(7)&nbsp;&nbsp;&nbsp;&nbsp;transportation, freight, postage, importation, insurance and other handling expenses to the extent included in gross amounts invoiced;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(8)&nbsp;&nbsp;&nbsp;&nbsp;discounts pursuant to patient discount programs and coupon discounts;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(9)&nbsp;&nbsp;&nbsp;&nbsp;accruals for amounts payable to wholesalers for services related to sales or distribution of the Product; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(10)&nbsp;&nbsp;&nbsp;&nbsp;accruals for distribution commissions and fees (including administrative fees and fees related to services provided pursuant to distribution service agreements with wholesalers, fee- for-service wholesaler fees and inventory management fees) payable to any third party providing distribution services to the Selling Entities.

For the avoidance of doubt, if a single item falls into more than one of the categories set forth in clauses (1) through (10) above, such item may not be deducted more than once.

True-ups, changes in estimate, and other adjustments to Permitted Deduction amounts (whether positive or negative) shall be included in Permitted Deductions in the calendar quarter as such items are recorded in accordance with GAAP.

"<u>Permitted Transfer</u>" means: a Transfer of CVRs (a) upon death of a Holder by will or intestacy; (b) pursuant to a court order; (c) by operation of law (including by consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other Person; or (d) in the case of CVRs held in book-entry or other similar nominee form, from a nominee to a beneficial owner and, if applicable, through an intermediary, to the extent allowable by DTC.

"<u>Person</u>" means any individual, Entity or Governmental Entity.

"<u>Product</u>" means any pharmaceutical product combined with an intranasal delivery device that contain(s) OPNT003 as an active pharmaceutical ingredient, alone or in combination with one or more additional active pharmaceutical ingredients and formulated for intranasal administration.

"<u>Review Request Period</u>" has the meaning set forth in <u>[Section 4.7(a)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>.

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"<u>Rights Agent</u>" means the Rights Agent named in the first paragraph of this Agreement, until a successor Rights Agent will have become such pursuant to the applicable provisions of this Agreement, and thereafter "Rights Agent" will mean such successor Rights Agent.

"<u>Sales Measurement Period</u>" means any four (4) consecutive calendar quarters commencing with the first calendar quarter of the Sales Milestone Period.

"<u>Sales Milestone Period</u>" means the period beginning with the U.S. Commercial Launch (<u>provided</u> that if the U.S. Commercial Launch occurs less than forty-five (45) days prior to the end of the calendar quarter, then the period beginning with the first day of the first calendar quarter immediately following the quarter in which the U.S. Commercial Launch occurred) and ending on the seventh (7th) anniversary of the beginning of such period.

"<u>Selling Entity</u>" means Parent, any Assignee and each of their respective Affiliates, licensees and sublicensees with respect to rights to develop or commercialize the Product, and any direct or indirect transferee, successor or assignee (including through any change of control) of the rights to sell the Product of any of the foregoing (but not a distributor of the Product acting solely in the capacity of a distributor and not otherwise an Assignee, licensee or sublicensee with respect to development or commercialization rights as to the Product or transferee, successor or assignee of the rights to sell the Product).

"<u>Status Report</u>" has the meaning set forth in <u>Section 4.5</u>.

"<u>Tax</u>" shall mean any tax (including any income tax, franchise tax, capital gains tax, gross receipts tax, value-added tax, surtax, estimated tax, unemployment tax, national health insurance tax, excise tax, premium, alternative or minimum tax, ad valorem tax, transfer tax, stamp tax, sales tax, use tax, property tax, business tax, escheat or unclaimed property, withholding tax or payroll tax), levy, assessment, tariff, impost, imposition, duty (including any customs duty) or other tax or charge of any kind whatsoever, including any charge or amount (including any fine, penalty, interest or other additions thereto) related thereto, imposed, assessed or collected by or under the authority of any Governmental Body, including as a result of being or having been a member of an affiliated, consolidated, controlled, fiscal, combined, unitary or aggregate group or being a transferee of or successor to any Person or as a result of any express obligation to assume such Taxes or to indemnify any other Person.

"<u>Transfer</u>" means any transfer, pledge, hypothecation, encumbrance, assignment or other disposition (whether by sale, merger, consolidation, liquidation, dissolution, dividend, distribution or otherwise), the offer to make such a transfer or other disposition, and each contract, arrangement or understanding, whether or not in writing, to effect any of the foregoing.

"<u>U.S. Commercial Launch</u>" means the first sale for monetary value for commercial use in the United States in an arm's length transaction to a third party by a Selling Entity of the Product whose approved label includes an indication for the Opioid Overdose Indication following receipt of FDA Approval of the Product. U.S. Commercial Launch may only be achieved once and only for the first Product to satisfy the foregoing conditions.

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"<u>Ultimate Parent</u>" means Indivior plc, a company registered under the laws of England and Wales, and an Affiliate of Parent, or the successor thereto.

Section 1.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Rules of Construction</u>. Except as otherwise explicitly specified to the contrary, (a) references to a Section means a Section of this Agreement unless another agreement is specified, (b) the word "including" (in its various forms) means "including without limitation," (c) references to a particular statute or regulation include all rules and regulations thereunder and any successor statute, rules or regulation, in each case as amended or otherwise modified from time to time, (d) words in the singular or plural form include the plural and singular form, respectively, (e) references to a particular Person include such Person's successors and assigns to the extent not prohibited by this Agreement and (f) all references to dollars or "$" refer to United States dollars.

**ARTICLE II**

**<u>CONTINGENT VALUE RIGHTS</u>**

Section 2.1&nbsp;&nbsp;&nbsp;&nbsp;<u>CVRs</u>. The CVRs represent the rights of Holders to receive contingent cash payments pursuant to this Agreement. The initial Holders will be the holders of shares of Company Common Stock (excluding the holders of any Dissenting Shares), the holders of Company Warrants that are cancelled as of the Effective Time pursuant to the Merger Agreement, the holders of the Convertible Notes that are converted as of the Effective Time, and the holders of In the Money Options, Company RSU Awards and Company PSU Awards immediately prior to the Effective Time that are validly converted into Merger Consideration pursuant to terms set forth in the Merger Agreement. A list of all the initial Holders shall be furnished to the Rights Agent by or on behalf of Parent in accordance with <u>Section 4.1</u> hereof.

Section 2.2 <u>Nontransferable</u>. The CVRs may not be sold, assigned, Transferred, pledged, encumbered or in any other manner transferred or disposed of, in whole or in part, other than through a Permitted Transfer. Any attempted Transfer, pledge, encumbrance or disposition of CVRs, in whole or in part, in violation of this <u>[Section 2.2](#i150b1bb788404249b8ea7b00d2e36e76_1)</u> shall be void *ab initio* and of no effect.

Section 2.3&nbsp;&nbsp;&nbsp;&nbsp;<u>No Certificate; Registration; Registration of Transfer; Change of Address</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;The CVRs will not be evidenced by a certificate or other instrument.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;The Rights Agent will keep a register (the "<u>CVR Register</u>") for the purpose of registering CVRs and Permitted Transfers thereof. The CVR Register will initially show one position for Cede & Co. representing all the CVRs provided to the holders of shares of Company Common Stock held by DTC on behalf of the street holders of the shares of Company Common Stock held by such holders as of immediately prior to the Effective Time. The Rights Agent will have no responsibility whatsoever to the street name holders with respect to Transfers of CVRs unless and until such CVRs are Transferred into the name of such street name holders in accordance with <u>Section 2.2</u> of this Agreement. With respect to any payments to be made under <u>[Section 2.4](#i150b1bb788404249b8ea7b00d2e36e76_1)</u> below, the Rights Agent will accomplish the payment to any

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former street name holders of shares of Company Common Stock by sending one lump-sum payment to DTC. The Rights Agent will have no responsibilities whatsoever with regard to the distribution of payments by DTC to such street name holders.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Subject to the restrictions on transferability set forth in <u>[Section 2.2](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>, every request made to Transfer a CVR must be in writing and accompanied by a written instrument of Transfer and other reasonably requested documentation in form reasonably satisfactory to the Rights Agent pursuant to its guidelines, duly executed by the Holder thereof, the Holder's attorney or other personal representative duly authorized in writing or the Holder's survivor, and setting forth in reasonable detail the circumstances relating to the Transfer. Promptly upon receipt of such written notice from such Holder, and in any event within ten (10) Business Days of receipt of such written notice, the Rights Agent will, subject to its reasonable determination that the Transfer instrument is in proper form, notify Parent that it has received such written notice. Promptly upon receipt of such notice from the Rights Agent, and in any event within ten (10) Business Days of receipt of such notice, Parent shall, subject to its reasonable determination that the Transfer otherwise complies with the other terms and conditions of this Agreement (including the provisions of <u>[Section 2.2](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>), instruct the Rights Agent in writing to register the Transfer of the CVRs in the CVR Register. The Rights Agent shall not be obligated to undertake any action with respect to the Transfer of the CVRs until it shall have been provided with such additional information or material as it may reasonably require to determine that the Transfer complies with the terms and conditions of this Agreement. No service charge shall be required of a Holder or its representative or survivor for any Transfer of a CVR, but Parent and Rights Agent may require payment of a sum sufficient to cover any stamp or other Tax or governmental charge that is imposed in connection with any such registration of Transfer. The Rights Agent shall have no duty or obligation to take any action under any section of this Agreement that requires the payment by a Holder of applicable Taxes or charges unless and until the Rights Agent is satisfied that all such Taxes or charges have been paid. All duly Transferred CVRs registered in the CVR Register will be the valid obligations of Parent and will entitle the transferee to the same benefits and rights under this Agreement as those held immediately prior to the Transfer by the transferor. No Transfer of a CVR will be valid until registered in the CVR Register in accordance with this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;A Holder may make a written request to the Rights Agent to change such Holder's address of record in the CVR Register. The written request must be duly executed by the Holder. Upon receipt of such written request, the Rights Agent will promptly record the change of address in the CVR Register.

Section 2.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Payment Procedures; Notices</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;If a Milestone is attained, then, on or prior to the applicable Milestone Determination Date, Parent shall deliver to the Rights Agent written notice indicating that a Milestone has been achieved and specifying such Milestone and the applicable Milestone Payment Amount (a "<u>Milestone Notice</u>"). Parent will duly deposit or cause to be deposited with the Rights Agent, upon or prior to the delivery of the Milestone Notice, the applicable Milestone Payment Amount to be made to the Holders in accordance with the terms of this Agreement other than Equity Award Holders (with respect to which any such amounts payable

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shall be retained by Parent for payment pursuant to Section 2.4(b)) and instruct the Rights Agent to deliver the Milestone Payment Amount to the Holders (other than Equity Award Holders). Such amounts shall be considered paid if on such date the Rights Agent has received in accordance with this Agreement money sufficient to pay all such amounts required by <u>[Section 4.2](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;The Rights Agent will, within twenty (20) calendar days of receipt of the Milestone Notice (each such date, a "<u>Milestone Payment Date</u>"), send each Holder at its registered address a copy of the Milestone Notice. At the time the Rights Agent sends a copy of the Milestone Notice to the Holders, the Rights Agent will also pay the applicable Milestone Payment Amount (less any applicable tax withholding) to each of the Holders (other than Equity Award Holders) by check mailed to the address of each Holder as reflected in the CVR Register as of the close of business on the last Business Day prior to such Milestone Payment Date. Notwithstanding the foregoing, with respect to any Milestone Payment that is payable in respect of Company Equity Awards, Parent shall, as soon as reasonably practicable following the Milestone Payment Date (but in any event no later than the second regular payroll date following the Milestone Payment Date, and in all events no later than March 15th of the year following the year in which the Milestone is attained), or shall cause the Company or an Affiliate thereof to, pay, through Parent's or any of its Affiliate's (including the Surviving Corporation's) payroll system, the applicable Milestone Payment Amount to the applicable Equity Award Holder in accordance with the Merger Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Parent or its Affiliate (including the Surviving Corporation) shall be entitled to deduct and withhold, or cause the Rights Agent to deduct and withhold, from any Milestone Payment Amount or any other amounts otherwise payable pursuant to this Agreement such amounts as may be required to be deducted and withheld therefrom under applicable Tax law, as may be determined by Parent or the Rights Agent. Any such withholding shall be made, or caused to be made, by Parent through making payments with respect to Equity Award Holders through Parent's or any of its Affiliate's (including the Surviving Corporation's) payroll system or any successor payroll system. To the extent any amounts are so deducted and withheld and properly remitted to the appropriate Governmental Entity, such amounts shall be treated for all purposes of this Agreement as having been paid to the Person in respect of whom such deduction and withholding was made, and as soon as practicable after any payment of such Taxes by Parent or, at the written instruction of the Parent, the Rights Agent, Parent shall deliver (or shall cause the Rights Agent to deliver) to the Person to whom such amounts would otherwise have been paid an original IRS Form 1099 (or in the case of payments to Equity Award Holders, an original IRS Form W-2, if applicable) or other reasonably acceptable evidence of such withholding.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;Any portion of any Milestone Payment Amount that remains undistributed to a Holder six (6) months after the date of the delivery of the Milestone Notice will be delivered by the Rights Agent to Parent, upon demand, and any Holder will thereafter look only to Parent for payment of such Milestone Payment Amount, without interest, but such Holder will have no greater rights against Parent than those accorded to general unsecured creditors of Parent under applicable law.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;Neither Parent nor the Rights Agent will be liable to any person in respect of any Milestone Payment Amount delivered to a public official pursuant to any applicable abandoned property, escheat or similar law.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;The indemnification provided by Parent to the Rights Agent pursuant to this <u>Section 2.4</u> shall survive the resignation, replacement or removal of the Rights Agent and the termination of this Agreement.

Section 2.5&nbsp;&nbsp;&nbsp;&nbsp;<u>No Voting, Dividends or Interest; No Equity or Ownership Interest in Parent</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;The CVRs will not have any voting or dividend rights, and interest will not accrue on any amounts payable on the CVRs to any Holder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;The CVRs will not represent any equity or ownership interest in Parent, any constituent company to the Merger or any of their respective Affiliates. The sole right of each Holder to receive property hereunder is the right to receive the Milestone Payment Amount, in accordance with the terms hereof.

Section 2.6 <u>Ability to Abandon CVR</u>. A Holder may at any time, at such Holder's option, abandon all of such Holder's remaining rights in a CVR by transferring such CVR to Parent or a Person nominated in writing by Parent (with written notice thereof from Parent to the Rights Agent) without consideration therefor, and such rights will be cancelled, with the Rights Agent being promptly notified in writing by Parent of such Transfer and cancellation. Nothing in this Agreement shall prohibit Parent or any of its Affiliates from offering to acquire or acquiring any CVRs for consideration from the Holders, in private transactions or otherwise, in its sole discretion. Any CVRs acquired by Parent or any of its Affiliates shall be automatically deemed extinguished and no longer outstanding for purposes of this Agreement.

**ARTICLE III** 

**<u>THE RIGHTS AGENT</u>**

Section 3.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Certain Duties and Responsibilities</u>. The Rights Agent will be authorized and protected and will not have any liability for or in respect of any actions taken, suffered or omitted to be taken by it in connection with its acceptance and administration of this Agreement and the exercise and performance of its duties hereunder, except to the extent of its willful misconduct, bad faith or gross negligence (each as determined by a final non-appealable judgment of a court of competent jurisdiction). Notwithstanding anything in this Agreement to the contrary, in no event will the Rights Agent be liable for special, punitive, indirect, incidental or consequential loss or damages of any kind whatsoever (including, without limitation, lost profits), even if the Rights Agent has been advised of the likelihood of such loss or damages and regardless of the form of action.

Section 3.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Certain Rights of Rights Agent</u>. Parent hereby appoints the Rights Agent to act as rights agent for Parent in accordance with the express terms and conditions hereof and the Rights Agent undertakes to perform such duties and only such duties as are specifically set forth in this Agreement, and no implied duties, covenants or obligations will be read into this

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Agreement against the Rights Agent. The Rights Agent shall not assume any obligations or relationship of agency or trust with any Holder. In addition:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;the Rights Agent may rely and will be protected and held harmless by Parent in acting or refraining from acting upon any resolution, certificate, statement, instrument, opinion, report, notice, request, direction, consent, order or other paper or document believed by it to be genuine and to have been signed or presented by the proper party or parties;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;whenever the Rights Agent will deem it desirable that a matter be proved or established prior to taking, suffering or omitting any action hereunder, the Rights Agent may, request and rely upon an Officer's Certificate with respect to such matter delivered to the Rights Agent, which Officer's Certificate shall be full authorization and protection to the Rights Agent, and the Rights Agent shall, in the absence of gross negligence, bad faith or willful or intentional misconduct (each as determined by a final non appealable judgment of a court of competent jurisdiction) on its part, incur no liability and be held harmless by Parent for or in respect of any action taken, suffered or omitted to be taken by it in reliance upon such Officer's Certificate;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;the Rights Agent may engage and consult with counsel of its selection (who may be legal counsel for the Rights Agent or the Parent or an employee of the Rights Agent) and the written advice of such counsel or any written opinion of counsel will be full and complete authorization and protection to the Rights Agent and the Rights Agent shall be held harmless by Parent and shall incur no liability for or in respect of any action taken, suffered or omitted by it hereunder in the absence of bad faith and in reliance thereon;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;the permissive rights of the Rights Agent to do things enumerated in this Agreement will not be construed as a duty;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;the Rights Agent will not be required to give any note or surety in respect of the execution of such powers or otherwise in respect of the premises;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;Parent agrees to indemnify the Rights Agent for, and hold the Rights Agent harmless against, any loss, liability, damage, judgment, fine, penalty, settlement, claim, demands, suits, cost or expense (including without limitation, the reasonable and documented fees and expenses of legal counsel) for any action taken, suffered or omitted to be taken by the Rights Agent or arising out of or in connection with the Rights Agent's duties under this Agreement, including the reasonable costs and expenses of defending the Rights Agent against any claims, charges, demands, suits or loss arising therefrom, directly or indirectly, or enforcement of its rights hereunder, unless such loss has been determined by a a final non-appealable judgment of court of competent jurisdiction to be a result of the Rights Agent's gross negligence, bad faith or willful misconduct;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;anything to the contrary notwithstanding, except with respect to the Rights Agent's own fraud, bad faith or willful misconduct (each as determined by a final non-appealable judgment of a court of competent jurisdiction), any liability of the Rights Agent under this Agreement will be limited to the aggregate amount of the annual fees (but not reimbursed expenses) paid by Parent to the Rights Agent under this Agreement during the twelve months immediately preceding the event for which recovery is sought;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h)&nbsp;&nbsp;&nbsp;&nbsp;Parent agrees (i) to pay the fees and expenses of the Rights Agent in connection with the Rights Agent's duties under this Agreement in accordance with the fee schedule agreed upon in writing by the Rights Agent and Parent on or prior to the date hereof and incorporated herein by reference and (ii) to reimburse the Rights Agent for all Taxes and governmental charges (other than Taxes imposed on or measured by the Rights Agent's net income and franchise or similar Taxes imposed on it (in lieu of net income Taxes)). The Rights Agent will also be entitled to reimbursement from Parent for all reasonable and necessary out-of- pocket expenses paid or incurred by it in connection with the administration, preparation, delivery, amendment and execution of this Agreement by the Rights Agent of its duties hereunder;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;in the event the Rights Agent reasonably believes any ambiguity or uncertainty exists hereunder or in any notice, instruction, direction, request or other communication, paper or document received by the Rights Agent hereunder, the Rights Agent, may, in its sole discretion, refrain from taking any action, and shall be fully protected and shall not be liable in any way to Parent, any Holder or any other person or entity for refraining from taking such action, unless the Rights Agent receives written instructions from the Parent which eliminates such ambiguity or uncertainty to the satisfaction of the Rights Agent;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(j)&nbsp;&nbsp;&nbsp;&nbsp;the Rights Agent shall not be liable for or by reason of, and shall be held harmless by Parent with respect to any of the statements of fact or recitals contained in this Agreement or be required to verify the same, but all such statements and recitals are and shall be deemed to have been made by the Parent only and the Rights Agent will have no liability and shall be held harmless by Parent in respect of the validity of this Agreement or the execution and delivery hereof (except the due execution and delivery hereof by the Rights Agent), nor shall the Rights Agent be responsible for any breach by Parent of any covenant or condition contained in this Agreement;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(k)&nbsp;&nbsp;&nbsp;&nbsp;the Rights Agent shall not be deemed to have knowledge of any event of which it was supposed to receive notice thereof hereunder, and the Rights Agent shall be fully protected and shall incur no liability for failing to take action in connection therewith, unless and until it has received such notice in writing from the Parent and all notices or other instruments required by this Agreement to be delivered to the Rights Agent must, in order to be effective, be received by the Rights Agent as specified herein, and in the absence of such notice so delivered the Rights Agent may conclusively assume no such event or condition exists;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(l)&nbsp;&nbsp;&nbsp;&nbsp;subject to any applicable restrictions of applicable law (including laws restricting trading based on non-public information), the Rights Agent and any shareholder, affiliate, director, officer or employee of the Rights Agent may buy, sell or deal in any securities of the Parent or become peculiarly interested in any transaction in which the Parent may be interested, or contract with or lend money to the Parent or otherwise act as fully and freely as though it were not the Rights Agent under this Agreement. Nothing herein shall preclude the Rights Agent from acting in any other capacity for the Parent or for any other Person;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(m)&nbsp;&nbsp;&nbsp;&nbsp;the Rights Agent may execute and exercise any of the rights or powers hereby vested in it or perform any duty hereunder either itself or by or through its attorneys or agents;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(n)&nbsp;&nbsp;&nbsp;&nbsp;no provision of this Agreement shall require the Rights Agent to expend or risk its own funds or otherwise incur any financial liability in the performance of any of its duties hereunder or in the exercise of its rights if there shall be reasonable grounds for believing that repayment of such funds or adequate indemnification against such risk or liability is not reasonably assured to it (it being understood that this Section 3.2(n) shall not apply to the ordinary course operating expenses of Rights Agent in connection with the services contemplated hereby for which the fees payable to the Rights Agent are intended compensation);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(o)&nbsp;&nbsp;&nbsp;&nbsp;the Rights Agent shall not have any duty or responsibility in the case of the receipt of any written demand from any Holder with respect to any action or default by the Parent or its Affiliates, including, without limiting the generality of the foregoing, any duty or responsibility to initiate or attempt to initiate any proceedings at law or otherwise or to make any demand upon the Parent;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(p)&nbsp;&nbsp;&nbsp;&nbsp;the Rights Agent shall neither be responsible for, nor chargeable with, knowledge of, nor have any requirements to comply with, the terms and conditions of any other agreement, instrument or document, including, without limitation, the Merger Agreement, nor shall the Rights Agent be required to determine if any person or entity has complied with any such agreements, instruments or documents, nor shall any additional obligations of the Rights Agent be inferred from the terms of such agreements, instruments or documents even though reference thereto may be made in this Agreement. In the event of any conflict between the terms and provisions of this Agreement and those of any other agreement, instrument or document, including but not limited to the Merger Agreement, the terms and conditions of this Agreement shall control as they relate to the Rights Agent; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(q)&nbsp;&nbsp;&nbsp;&nbsp;The provisions of <u>Section 2.4(d)</u>, <u>Section 3.1</u> and this <u>Section 3.2</u> shall survive the termination of this Agreement, the resignation, replacement or removal of the Rights Agent, and the payment, termination and the expiration of the CVRs.

Section 3.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Resignation and Removal; Appointment of Successor</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;The Rights Agent may resign at any time by giving written notice thereof to Parent specifying a date when such resignation will take effect, which notice will be sent at least sixty (60) days prior to the date so specified but in no event will such resignation become effective on the earlier of (i) the date so specified in such notice, or (ii) the appointment of a successor Rights Agent has been appointed. Parent has the right to remove Rights Agent at any time by a Board Resolution specifying a date when such removal will take effect (or, if earlier, the appointment of the successor Rights Agent). Notice of such removal will be given by Parent to Rights Agent, which notice will be sent at least sixty (60) days prior to the date so specified. Notwithstanding anything to the contrary contained herein, such replacement or removal of the Rights Agent shall not affect any of the provisions of this Agreement that expressly survive the termination of this Agreement, or the resignation, replacement or removal of the Rights Agent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;If the Rights Agent provides notice of its intent to resign, is removed pursuant to <u>[Section 3.3(a)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u> or becomes incapable of acting, Parent, by a Board Resolution, will promptly appoint a qualified successor Rights Agent who, unless otherwise consented to in writing by the

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Acting Holders, shall be a stock transfer agent of national reputation or the corporate trust department of a commercial bank. The successor Rights Agent so appointed will, forthwith upon its acceptance of such appointment in accordance with <u>[Section 3.4](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>, become the successor Rights Agent. Notwithstanding the foregoing, if Parent shall fail to make such appointment within a period of sixty (60) days after giving notice of such removal or after it has been notified in writing of such resignation or incapacity by the resigning or incapacitated Rights Agent, then the incumbent Rights Agent may apply to any court of competent jurisdiction for the appointment of a new Rights Agent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Parent will give notice of each resignation and each removal of a Rights Agent and each appointment of a successor Rights Agent by delivering a written notice of such event in accordance with <u>Section 6.2</u> to the Holders as their names and addresses appear in the CVR Register. Each notice will include the name and address of the successor Rights Agent. If Parent fails to send such notice within ten (10) days after acceptance of appointment by a successor Rights Agent in accordance with <u>[Section 3.4](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>, the successor Rights Agent will cause the notice to be mailed at the expense of Parent. Failure to give any notice provided for in this Section 3.3<u>,</u> however, and any defect therein, shall not affect the legality or validity of the resignation or removal of the Rights Agent or the appointment of the successor Rights Agent, as the case may be.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;The Rights Agent will reasonably cooperate with Parent and any successor Rights Agent in connection with the transition of the duties and responsibilities of the Rights Agent to the successor Rights Agent, including the transfer of all relevant data, including the CVR Register, to the successor Rights Agent.

Section 3.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Acceptance of Appointment by Successor</u>. Every successor Rights Agent appointed pursuant to <u>[Section 3.3(b)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u> hereunder will execute, acknowledge and deliver to Parent and to the predecessor Rights Agent an instrument accepting such appointment and a counterpart of this Agreement, and thereupon such successor Rights Agent, without any further act, deed or conveyance, will become vested with all the rights, powers, trusts and duties of the predecessor Rights Agent. On request of Parent or the successor Rights Agent, the predecessor Rights Agent will execute and deliver an instrument transferring to the successor Rights Agent all the rights (except such rights of the predecessor Rights Agent which survive pursuant to <u>Section 3.3</u> of this Agreement), powers and trusts of the predecessor Rights Agent, but such predecessor Rights Agent shall not be required to make any additional expenditure or assume any additional liability in connection with the foregoing, unless, if requested by Rights Agent, it has been furnished with assurances of repayment or indemnity satisfactory to it.

**ARTICLE IV** 

**<u>COVENANTS</u>**

Section 4.1&nbsp;&nbsp;&nbsp;&nbsp;<u>List of Holders</u>. Parent will furnish or cause to be furnished to the Rights Agent in such form as Parent receives from the Company's transfer agent (or other agent performing similar services for the Company), the names and addresses of the Holders within twenty (20) Business Days of the Effective Time. Until such initial list of Holders is furnished

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to the Rights Agent, the Rights Agent shall have no duties, responsibilities or obligations with respect to such Holders.

Section 4.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Payment of Milestone Payment Amounts</u>. If a Milestone has been achieved in accordance with this Agreement, Parent will, promptly following the delivery of the applicable Milestone Notice to the Rights Agent, deposit with the Rights Agent, for payment to the Holders in accordance with <u>[Section 2.4](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>, the aggregate amount necessary to pay the Milestone Payment Amount to each Holder (other than the Equity Award Holders, in respect of which any Milestone Payment Amounts shall be paid in accordance with Section 2.4(b)). For the avoidance of doubt, the Milestone Payment Amount shall only be paid in respect of each given Milestone, if at all, one time under this Agreement.

Section 4.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Efforts to Achieve Milestones</u>. Until the earlier of (a) the seventh (7th) anniversary of the Closing and (b) the achievement of U.S. Commercial Launch, Parent shall, and shall cause its controlled Affiliates and Ultimate Parent to, use their Commercially Reasonable Efforts to (i) develop and seek FDA Approval for the Product, and (ii) following receipt of FDA Approval for the Product, achieve U.S. Commercial Launch; provided, that the use of Commercially Reasonable Efforts in accordance with this Agreement does not guarantee that Parent will obtain FDA Approval for the Product, achieve U.S. Commercial Launch, or guarantee that Parent will achieve any of the Milestones at all or by a specific date. Notwithstanding anything in this Agreement to the contrary, in no event shall Parent or any of its Affiliates be required to undertake any level of efforts, or employ any level of resources, to (A) conduct, or commit to conduct, any additional clinical, safety or efficacy studies (including any randomized controlled trial) in connection with obtaining regulatory approvals of the Product, (B) achieve any Milestone, (C) seek regulatory approval for, maintain market availability or commercialize, the Product outside the United States or (D) develop, market or commercialize any Product at any time following achievement of U.S. Commercial Launch.

Section 4.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Books and Records</u>. Parent shall, and shall cause its Affiliates to, keep true, complete and accurate records in sufficient detail to enable the Holders and the Independent Accountant to determine the amounts payable hereunder.

Section 4.5 <u>Status Reports.</u> Prior to the occurrence of the U.S. Commercial Launch, within thirty (30) days after each of June 30 and December 31 in each calendar year, Parent shall provide the Rights Agent with a written report describing in reasonable detail the activities Parent and its Affiliates have undertaken in the preceding 6-month period to develop, achieve U.S. Commercial Launch of and seek FDA Approval for the Product (each, a "<u>Status Report</u>"). The Rights Agent shall keep a copy of the Status Report in its records and shall have no other duty or obligation with respect to the Status Report.

Section 4.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Net Sales Statements</u>. Following the U.S. Commercial Launch and until the earlier of (a) achievement of each of the Annual Net Sales Milestones or (b) delivery of the Net Sales Statement with respect to the final calendar quarter of the Sales Milestone Period, on or prior to the Milestone Determination Date with respect to each calendar quarter, Parent shall provide the Rights Agent with a Net Sales Statement covering the preceding four calendar quarters (or shorter period to have elapsed since the beginning of the Sales Milestone Period).

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The Rights Agent keep a copy of the Net Sales Statement in its records and shall have no other duty or obligation with respect to the Net Sales Statement.

Section 4.7&nbsp;&nbsp;&nbsp;&nbsp;<u>Audits</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Upon the written request of the Acting Holders provided to Parent within forty-five (45) days of the delivery of any Net Sales Statement pursuant to <u>Section 4.6</u> of this Agreement (the "<u>Review Request Period</u>"), but no more than once during any period of four consecutive calendar quarters and not more than three times during the term of this Agreement, Parent shall permit, and shall cause its Affiliates to permit, the Independent Accountant to have access during normal business hours to such of the records of Parent or its Affiliates as may be reasonably necessary to verify the accuracy of the Net Sales Statement and the figures underlying the calculations set forth therein, provided that such access does not unreasonably interfere with the conduct of the business of Parent or any of its Affiliates. The Independent Accountant shall be charged to come to a final determination with respect to those specific items in the Net Sales Statement that the parties disagree on and submit to it for resolution. All other items in the Net Sales Statement that the parties do not submit, prior to the end of the Review Request Period, to the Independent Accountant for resolution shall be deemed to be agreed by the parties and the Independent Accountant shall not be charged with calculating or validating those agreed upon items. If issues are submitted to the Independent Accountant for resolution, Parent shall, and shall cause its Affiliates to, furnish to the Independent Accountant such access, work papers and other documents and information related to those disputed issues as the Independent Accountant may request and as are available to Parent or any other Selling Entity. The Independent Accountant shall disclose to the Acting Holders whether a Milestone was achieved and such additional information directly related to its findings. The Independent Accountant shall provide Parent with a copy of all disclosures made to the Acting Holders. The fees charged by such accounting firm shall be paid by Parent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;If the Independent Accountant concludes that a Milestone Payment that was properly due was not paid to the Holders, Parent shall pay or cause to be paid to the Rights Agent (for further distribution to the Holders) or to each Holder the applicable Milestone Payment, *plus* interest on such Milestone Payment at the "prime rate" as published in the Wall Street Journal or similar reputable data source from time to time calculated from when the Milestone Payment should have been paid (if Parent had given notice of achievement of the Milestone pursuant to the terms of this Agreement), as applicable, to the date of actual payment (such amount, including interest, being the "<u>CVR Shortfall</u>"). The CVR Shortfall shall be paid by Parent within twenty (20) calendar days of the date the Independent Accountant's written report is provided to Parent. Absent manifest error, the decision of the Independent Accountant shall be final, conclusive and binding on Parent and the Holders, shall be non-appealable and shall not be subject to further review.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;If, upon the expiration of the applicable Review Request Period, the Acting Holders have not requested a review of the Net Sales Statement in accordance with this <u>[Section 4.7](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>, the calculations set forth in the Net Sales Statement shall be binding and conclusive upon the Holders.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;Each Person seeking to receive information from Parent in connection with a review pursuant to this <u>[Section 4.7](#i150b1bb788404249b8ea7b00d2e36e76_1)</u> shall enter into, and shall cause its accounting firm to enter

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into, a reasonable and mutually satisfactory confidentiality agreement with Parent or any Affiliate obligating such party to retain all such information disclosed to such party in confidence pursuant to such confidentiality agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;Parent shall not, and shall cause its Affiliates not to, enter into any license or distribution agreement with any third party (other than Parent or its Affiliates) with respect to a Product unless such agreement contains provisions that would allow any Independent Accountant appointed pursuant to this <u>[Section 4.7](#i150b1bb788404249b8ea7b00d2e36e76_1)</u> such access to the records of the other party to such license or distribution agreement as may be reasonably necessary to perform its duties pursuant to this <u>[Section 4.7](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>; <u>provided</u> that Parent and its Affiliates shall not be required to amend any of its existing licenses or distribution agreements. The parties hereto agree that, if Parent or its Affiliates have exercised audit rights under any license or distribution agreement prior to the Acting Holders' request for an audit under this <u>[Section 4.7](#i150b1bb788404249b8ea7b00d2e36e76_1)</u> and under such license or distribution agreement Parent and its Affiliates cannot request another audit, the results of Parent's prior audit of such licensee or distributor shall be used for purposes of the audit requested by the Acting Holders under this <u>[Section 4.7](#i150b1bb788404249b8ea7b00d2e36e76_1)</u> and that Parent shall not have any further obligation to provide access to an Independent Accountant with respect to such licensee or distributor until such time as Parent may again exercise its rights of audit under the license or distribution agreement with such licensee or distributor.

**ARTICLE V** 

**<u>AMENDMENTS</u>**

Section 5.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Amendments without Consent of Holders</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Without the consent of any Holders, Parent, when authorized by a Board Resolution, at any time and from time to time, may and the Rights Agent shall, if directed by the Parent, enter into one or more amendments hereto, for any of the following purposes:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;to evidence the succession of another Person to Parent and the assumption by any such successor of the covenants of Parent herein as provided in <u>[Section 6.3](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;to add to the covenants of Parent such further covenants, restrictions, conditions or provisions as Parent and the Rights Agent will consider to be for the

protection of the Holders; <u>provided</u> that, in each case, such provisions do not adversely affect the interests of the Holders;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;to cure any ambiguity, to correct or supplement any provision herein that may be defective or inconsistent with any other provision herein, or to make any other provisions with respect to matters or questions arising under this Agreement; <u>provided</u> that, in each case, such provisions do not adversely affect the interests of the Holders;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)&nbsp;&nbsp;&nbsp;&nbsp;as may be necessary or appropriate to ensure that the CVRs are not subject to registration under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder; <u>provided</u> that, in each case, such provisions do not adversely affect the interests of the Holders;

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v)&nbsp;&nbsp;&nbsp;&nbsp;to evidence the succession of another Person as a successor Rights Agent and the assumption by any such successor of the covenants and obligations of the Rights Agent herein in accordance with <u>Sections 3.3</u> and <u>3.4</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vi)&nbsp;&nbsp;&nbsp;&nbsp;as may be necessary to comply with or be exempt from the requirements of Section 409A of the Code;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vii)&nbsp;&nbsp;&nbsp;&nbsp;to cancel CVRs in the event that (i) any Holder has abandoned its rights to such CVRs in accordance with <u>Section 2.6</u> or (ii) following a Transfer of such CVRs to Parent or its Affiliates in accordance with <u>Section 2.2</u> or <u>Section 2.3</u>;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(viii)&nbsp;&nbsp;&nbsp;&nbsp;as may be necessary to ensure that Parent complies with applicable Law; <u>provided</u> that in each case, such amendments shall not adversely affect the interests of the Holders; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ix)&nbsp;&nbsp;&nbsp;&nbsp;any other amendments hereto for the purpose of adding, eliminating or changing any provisions of this Agreement, unless such addition, elimination or change is adverse to the interests of the Holders.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Promptly after the execution by Parent and the Rights Agent of any amendment pursuant to the provisions of this <u>[Section 5.1](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>, Parent will deliver (or cause the Rights Agent to deliver, at Parent's expense) a notice thereof in accordance with <u>Section 6.2</u> to the Holders at their addresses as they appear on the CVR Register, setting forth such amendment.

Section 5.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Amendments with Consent of Holders</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Subject to <u>[Section 5.1](#i150b1bb788404249b8ea7b00d2e36e76_1)</u> (which amendments pursuant to <u>[Section 5.1](#i150b1bb788404249b8ea7b00d2e36e76_1)</u> may be made without the consent of the Holders), with the consent of the Holders of at least a majority of the outstanding CVRs, whether evidenced in writing or taken at a meeting of the Holders, Parent, when authorized by a Board Resolution, and the Rights Agent may enter into one or more amendments hereto for the purpose of adding, eliminating or changing any provisions of this Agreement, even if such addition, elimination or change is materially adverse to the interest of the Holders; <u>provided</u>, <u>however</u>, that no such amendment shall, without the consent of the Holders of sixty-five percent (65%) of the outstanding CVRs:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;modify in a manner adverse to the Holders (A) any provision contained herein with respect to the termination of this Agreement or the CVRs, (B) the time for, and amount of, any payment to be made to the Holders pursuant to this Agreement, or (C) the Milestones;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;reduce the number of CVRs (except as contemplated by <u>Section 5.1(a)(vii))</u>; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;modify any provisions of this <u>Section 5.2</u>, except to increase the percentage of Holders from whom consent is required or to provide that certain provisions of this Agreement cannot be modified or waived without the consent of the Holder of each outstanding CVR affected thereby.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Promptly after the execution by Parent and the Rights Agent of any amendment pursuant to the provisions of this <u>[Section 5.2](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>, Parent will deliver (or cause the Rights Agent to deliver, at Parent's expense) a notice thereof in accordance with <u>Section 6.2</u> to the Holders at their addresses as they appear on the CVR Register, setting forth such amendment.

Section 5.3 <u>Execution of Amendments</u>. In executing any amendment permitted by this <u>[Article V](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>, the Rights Agent will be entitled to receive, and will be fully protected in relying upon, an opinion of counsel selected by Parent stating that the execution of such amendment is authorized or permitted by this Agreement. The Rights Agent may, but is not obligated to, enter into any such amendment that affects the Rights Agent's own rights, privileges, covenants or duties under this Agreement or otherwise, including any amendments pursuant to <u>[Section 5.1(a](#i150b1bb788404249b8ea7b00d2e36e76_1))(viii)</u>. No supplement or amendment to this Agreement shall be effective unless duly executed by the Rights Agent.

Section 5.4 <u>Effect of Amendments</u>. Upon the execution of any amendment under this <u>[Article V](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>, this Agreement will be modified in accordance therewith, such amendment will form a part of this Agreement for all purposes and every Holder will be bound thereby.

**ARTICLE VI**

**<u>OTHER PROVISIONS OF GENERAL APPLICATION</u>**

Section 6.1 <u>Notices to Rights Agent and Parent</u>. Any notice or other communication required or permitted hereunder shall be in writing and shall be deemed given when delivered in person, by overnight courier, by email (with receipt confirmed by telephone) or two (2) Business Days after being sent by registered or certified mail (postage prepaid, return receipt requested), as follows:

If to the Rights Agent, to it at:

Computershare Inc. and Computershare Trust Company, N.A.

150 Royall Street, 2nd Floor

Canton, MA 02021

Attention: Relationship Manager

with a copy to:

Computershare Inc. and Computershare Trust Company, N.A.

150 Royall Street, 2nd Floor

Canton, MA 02021

Attention: General Counsel

If to Parent, to it at:

Indivior Inc.

10710 Midlothian Tpke, Suite 125

North Chesterfield, VA 23235

Attention: General Counsel

Email [\*\*\*]

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with a copy to:

Covington & Burling LLP

The New York Times Building

620 Eighth Avenue

New York, NY 10018-1405

Attention: [\*\*\*]

Email: [\*\*\*]

The Rights Agent or Parent may specify a different address by giving notice in accordance with this <u>[Section 6.1](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>.

Section 6.2 <u>Notice to Holders</u>. Where this Agreement provides for notice to Holders, such notice will be sufficiently given (unless otherwise herein expressly provided) if in writing and mailed, first-class postage prepaid, or, if applicable, transmitted through the facilities of DTC in accordance with DTC's procedures, to each Holder affected by such event, at the Holder's address as it appears in the CVR Register, not later than the latest date, and not earlier than the earliest date, if any, prescribed for the giving of such notice. In any case where notice to Holders is given by mail, neither the failure to mail such notice, nor any defect in any notice so mailed, to any particular Holder will affect the sufficiency of such notice with respect to other Holders.

Section 6.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Parent Successors and Assigns</u>. Parent may assign any or all of its rights, interests and obligations hereunder to (a) in its sole discretion and without the consent of any other party, (i) any controlled Affiliate of Parent, but only for so long as it remains a controlled Affiliate of Parent, (ii) to any purchaser or licensee of substantial rights to OPNT003 or (b) with the prior written consent of the Acting Holders, any other Person (any permitted assignee under clause (a) or (b), an "<u>Assignee</u>"), in each case provided that the Assignee agrees to assume and be bound by all of the terms of this Agreement. Any Assignee may thereafter assign any or all of its rights, interests and obligations hereunder in the same manner as Parent pursuant to the prior sentence. In connection with any assignment to an Assignee described in clause (a) above in this <u>[Section 6.3](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>, Parent (and such other assignor, if applicable) shall agree to remain liable for the performance by each Assignee (and such other assignor, if applicable) of all obligations of Parent hereunder (provided that no assignor shall be obligated with respect to any amendment to the obligations hereunder effected following such assignee's assignment). This Agreement will be binding upon, inure to the benefit of and be enforceable by Parent's successors and each Assignee. Each of Parent's successors and Assignees shall expressly assume by an instrument supplemental hereto, executed and delivered to the Rights Agent, the due and punctual payment of the CVRs and the due and punctual performance and observance of all of the covenants and obligations of this Agreement to be performed or observed by Parent. Unless a successor assignee meets the requirements set forth in <u>Section 3.3(b)</u> and, as of the date of such assignment, is an Affiliate of the Rights Agent, the Rights Agent may not assign this Agreement or its rights hereunder without Parent's written consent. Any attempted assignment in violation of this <u>Section 6.3</u> shall be void ab initio and of no effect.

Section 6.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Benefits of Agreement</u>. Nothing in this Agreement, express or implied, will give to any Person (other than the Rights Agent and its successors and assigns, Parent,

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Parent's successors and Assignees, the Holders and the Holders' successors and assigns pursuant to a Permitted Transfer) any benefit or any legal or equitable right, remedy or claim under this Agreement or under any covenant or provision herein contained, all such covenants and provisions being for the sole benefit of the foregoing. The rights of Holders and their successors and assigns pursuant to Permitted Transfers are limited to those expressly provided in this Agreement and the Merger Agreement. Notwithstanding anything to the contrary contained herein, any Holder or Holder's successor or assign pursuant to a Permitted Transfer may agree to renounce, in whole or in part, its rights under this Agreement by written notice to the Rights Agent and Parent, which notice, if given, shall be irrevocable.

Section 6.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Governing Law; Jurisdiction; Waiver of Jury Trial</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;This Agreement, the CVRs and all actions arising under or in connection therewith shall be governed by and construed in accordance with the laws of the State of Delaware, regardless of the laws that might otherwise govern under applicable principles of conflicts of law thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Each of the parties hereto (i) irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the Chancery Court of the State of Delaware and any state appellate court therefrom or, if (but only if) such court lacks subject matter jurisdiction, the United States District Court sitting in New Castle County in the State of Delaware and any appellate court therefrom (collectively, the "<u>Delaware Courts</u>"); and (ii) consents to service of process by first class certified mail, return receipt requested, postage prepaid, to the address at which such party is to receive notice in accordance with <u>[Section 6.1](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>. Each of the parties irrevocably and unconditionally (1) agrees not to commence any such action or proceeding except in the Delaware courts, (2) agrees that any claim in respect of any such action or proceeding may be heard and determined in the Delaware Courts, (3) waives, to the fullest extent it may legally and effectively do so, any objection that it may now or hereafter have to the jurisdiction or laying of venue of any such action or proceeding in the Delaware Courts and (4) waives, to the fullest extent permitted by law, the defense of an inconvenient forum to the maintenance of such action or proceeding in the Delaware Courts.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;EACH OF THE PARTIES HERETO IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING BETWEEN THE PARTIES (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE), INCLUDING ANY COUNTERCLAIM, ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THE ACTIONS OF ANY PARTY IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT THEREOF. EACH PARTY HERETO (A) MAKES THIS WAIVER VOLUNTARILY AND(B) ACKNOWLEDGES THAT SUCH PARTY HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS CONTAINED IN THIS <u>[SECTION 6.5(C)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>.

Section 6.6 <u>Severability</u>. If any provision of this Agreement is held invalid or unenforceable by any court of competent jurisdiction, the other provisions of this Agreement shall remain in full force and effect. Any provision of this Agreement held invalid or unenforceable only in part or degree shall remain in full force and effect to the extent not held

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invalid or unenforceable. The parties further agree to replace such invalid or unenforceable provision of this Agreement with a valid and enforceable provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable provision. Notwithstanding anything to the contrary herein, if any such excluded provision shall affect the rights, immunities, liabilities, duties or obligations of the Rights Agent, the Rights Agent shall be entitled to resign upon ten (10) days' prior written notice to Parent.

Section 6.7 <u>Counterparts and Signature</u>. This Agreement may be executed in two or more counterparts (including by facsimile or by an electronic scan delivered by electronic mail), each of which shall be deemed an original but all of which together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each of the parties hereto and delivered to the other party, it being understood that the parties need not sign the same counterpart.

Section 6.8&nbsp;&nbsp;&nbsp;&nbsp;<u>Termination</u>. This Agreement will be terminated and of no force or effect, the parties hereto will have no liability hereunder (including the monies due and owing by Parent to Rights Agent) and no payments will be required to be made, upon the earliest to occur of (a) the delivery by the Rights Agent to the address of each Holder as reflected in the CVR Register the full amount of all potential Milestone Payment Amounts required to be paid under the terms of this Agreement, (b) the delivery of a written notice of termination duly executed by Parent and the Acting Holders, (c) expiration of the Review Request Period following the expiration of the Sales Milestone Period (provided no written request is received during such Review Request Period pursuant to <u>[Section 4.7(a)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>), (d) if a written request is received during the Review Request Period immediately following the expiration of the Sales Milestone Period, the decision of the Independent Accountant (and, if applicable, payment of any CVR Shortfall as determined to be owing by the Independent Accountant) pursuant to <u>[Section 4.7(a)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>.

Section 6.9&nbsp;&nbsp;&nbsp;&nbsp;<u>Entire Agreement</u>. As between Parent and the Holders, this Agreement (including the fee schedule referred to in <u>[Section 3.2(g)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>) and the Merger Agreement contains the entire understanding of the parties hereto with reference to the transactions and matters contemplated hereby and supersedes all prior agreements, written or oral, between the parties hereto. As between Parent and the Rights Agent, this Agreement (including the fee schedule referred to in <u>[Section 3.2(g)](#i150b1bb788404249b8ea7b00d2e36e76_1)</u>) contains the entire understanding of the parties hereto with reference to the transactions and matters contemplated hereby and supersedes all prior agreements, written or oral, between the parties hereto.

Section 6.10 <u>Legal Holiday</u>. In the event that a Milestone Payment Date shall not be a Business Day, then, notwithstanding any provision of this Agreement to the contrary, any payment required to be made in respect of the CVRs on such date need not be made on such date, but may be made on the next succeeding Business Day with the same force and effect as if made on the applicable Milestone Payment Date.

Section 6.11 <u>Force Majeure</u>. Notwithstanding anything to the contrary contained herein, the Rights Agent shall not be liable for any delays or failures in performance resulting from acts beyond its reasonable control including, without limitation, acts of God, terrorist acts, pandemics, epidemics, shortage of supply, breakdowns or malfunctions, interruptions or

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malfunctions of any utilities, communications, or computer facilities, or loss of data due to power failures or mechanical difficulties with information storage or retrieval systems, labor difficulties, war or civil unrest.

Section 6.12 <u>Funds</u>. All funds received by the Rights Agent under this Agreement that are to be distributed or applied by Computershare in the performance of services hereunder (the "Funds") shall be held by Computershare as agent for Parent and deposited in one or more bank accounts to be maintained by Computershare in its name as agent for Parent. Until paid pursuant to the terms of this Agreement, Computershare will hold the Funds through such accounts in: deposit accounts of commercial banks with Tier 1 capital exceeding $1 billion or with an average rating above investment grade by S&P (LT Local Issuer Credit Rating), Moody's (Long Term Rating) and Fitch Ratings, Inc. (LT Issuer Default Rating) (each as reported by Bloomberg Finance L.P.). The Rights Agent shall have no responsibility or liability for any diminution of the Funds that may result from any deposit made by the Rights Agent in accordance with this paragraph, including any losses resulting from a default by any bank, financial institution or other Third Party. The Rights Agent may from time to time receive interest, dividends or other earnings in connection with such deposits. The Rights Agent shall not be obligated to pay such interest, dividends or earnings to Parent, any Holder or any other party.

[*Remainder of page intentionally left blank*]

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IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed on its behalf by its duly authorized officers as of the day and year first above written.

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| | |
|:---|:---|
| INDIVIOR INC. | INDIVIOR INC. |
| By: | */s/ Ryan Preblick* |
| Name: Ryan Preblick | Name: Ryan Preblick |
| Title: Chief Financial Officer | Title: Chief Financial Officer |
| COMPUTERSHARE INC. and<br>COMPUTERSHARE TRUST COMPANY,<br>N.A., jointly as Rights Agent | COMPUTERSHARE INC. and<br>COMPUTERSHARE TRUST COMPANY,<br>N.A., jointly as Rights Agent |
| By: | */s/ Collin Ekeogu* |
| Name: Collin Ekeogu | Name: Collin Ekeogu |
| Title: Manager, Corporate Affairs | Title: Manager, Corporate Affairs |

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## Exhibit 4.22

**Exhibit 4.22**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**DATED 28 MARCH 2018**

**(1)&nbsp;&nbsp;&nbsp;&nbsp;C4X DISCOVERY LIMITED**

**(2)&nbsp;&nbsp;&nbsp;&nbsp;INDIVIOR UK LIMITED**

**LICENSE AGREEMENT**

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CONTENTS

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| | | | |
|:---|:---|:---|:---|
| 1 | CLAUSE | 1 | DEFINITIONS |
| 2 | CLAUSE | 2 | License AND OTHER COVENANTS |
| 3 | CLAUSE | 3 | REPORTING |
| 4 | CLAUSE | 4 | DEVELOPMENT |
| 5 | CLAUSE | 5 | REGULATORY RESPONSIBILITIES |
| 6 | CLAUSE | 6 | MANUFACTURING |
| 7 | CLAUSE | 7 | COMMERCIALISATION |
| 8 | CLAUSE | 8 | FINANCIAL TERMS |
| 9 | CLAUSE | 9 | PAYMENT TERMS |
| 10 | CLAUSE | 10 | CONFIDENTIALITY, PUBLICITY AND PUBLICATIONS |
| 11 | CLAUSE | 11 | OWNERSHIP OF INTELLECTUAL PROPERTY RIGHTS |
| 12 | CLAUSE | 12 | REPRESENTATIONS, WARRANTIES AND UNDERTAKINGS |
| 13 | CLAUSE | 13 | INDEMNIFICATION |
| 14 | CLAUSE | 14 | LIABILITY |
| 15 | CLAUSE | 15 | SET-OFF |
| 16 | CLAUSE | 16 | ANTI-BRIBERY |
| 17 | CLAUSE | 17 | TERM |
| 18 | CLAUSE | 18 | TERMINATION |
| 19 | CLAUSE | 19 | EFFECTS OF TERMINATION |
| 20 | CLAUSE | 20 | DISPUTE RESOLUTION |
| 21 | CLAUSE | 21 | INJUNCTIVE RELIEF |
| 22 | CLAUSE | 22 | INSURANCE |
| 23 | CLAUSE | 23 | ENTIRE AGREEMENT |
| 24 | CLAUSE | 24 | FORCE MAJEURE |
| 25 | CLAUSE | 25 | NOTICES |
| 26 | CLAUSE | 26 | INDEPENDENT CONTRACTORS |
| 27 | CLAUSE | 27 | RECORDATION |
| 28 | CLAUSE | 28 | ASSIGNMENT |
| 29 | CLAUSE | 29 | COUNTERPARTS |
| 30 | CLAUSE | 30 | FURTHER ASSURANCE |
| 31 | CLAUSE | 31 | THIRD PARTY RIGHTS |
| 32 | CLAUSE | 32 | SEVERABILITY |
| 33 | CLAUSE | 33 | EXPENSES |
| 34 | CLAUSE | 34 | VARIATION |
| 35 | CLAUSE | 35 | WAIVERS |
| 36 | CLAUSE | 36 | GOVERNING LAW |
| 37 | CLAUSE | 37 | JURISDICTION |
| **SCHEDULES LIST** | **SCHEDULES LIST** | **SCHEDULES LIST** |  |

---

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**LICENSE AGREEMENT**

**THIS LICENSE AGREEMENT** (this "**Agreement**") is dated as of 28 March 2018 (the "**Effective Date**")

**BETWEEN**

(1)&nbsp;&nbsp;&nbsp;&nbsp;**C4X DISCOVERY LIMITED**, a company incorporated in England and Wales under company number 06324250, whose registered office is at Manchester One, 53 Portland Street, Manchester, M1 3LD (**"C4X"**), and

(2)&nbsp;&nbsp;&nbsp;&nbsp;**Indivior UK Limited (Co.)**, a company incorporated in England and Wales under company number 7183451, whose registered office is at 103-105 Bath Road, Slough, Berkshire, SL1 SUH (**"Company"**),

each a "**Party**" and together the "**Parties**".

**WHEREAS**

(A)&nbsp;&nbsp;&nbsp;&nbsp;C4X, a drug discovery company, owns rights to the Licensed Compounds, including the right to develop, make and sell Licensed Products for use in the Field (each as defined below).

(B)&nbsp;&nbsp;&nbsp;&nbsp;Company is engaged in the business of, among other things, developing, marketing and distributing pharmaceutical products.

(C)&nbsp;&nbsp;&nbsp;&nbsp;Company wishes to obtain from C4X an exclusive license to develop, make and sell Licensed Products for use in the Field, and C4X wishes to grant such rights to Company, on the terms and conditions of this Agreement.

**NOW, THEREFORE**, in consideration of the foregoing and the mutual covenants contained herein, the Parties, intending to be legally bound, agree as follows:

**1.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 1: DEFINITIONS**

1.1&nbsp;&nbsp;&nbsp;&nbsp;The following terms shall have the following meanings as used in this Agreement:

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| | |
|:---|:---|
| **"505(b)(2) Application"** | means a new drug application filed with the FDA pursuant to 21 U.S.C §355(b)(2)(Section 505(b)(2), |
| **"Affiliate"** | means, with respect to a Party, any Person that, directly or indirectly, controls, is controlled by or is under common control with such Party, for the purposes of this definition, "control" shall refer to (i) the possession, directly or indirectly, of the power to direct the management or policies of an entity whether through ownership of interests representing equity, securities, or partnership interests, by contract, or otherwise, or (n) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or capital stock or other ownership interest of an entity, |

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| | |
|:---|:---|
| **"ANDA"** | means an abbreviated new drug application filed with the FDA pursuant to 21 U.S.C § 355(j) and 21 C.F.R § 314.3, |
| **"API"** | means an active pharmaceutical ingredient, |
| **"Applicable Law(s)"** | means all federal, state, national and local laws, statutes, ordinances, rules, regulations, codes, guidelines as amended, re-enacted or in force from time to time applicable to the particular activities and jurisdictions hereunder, including, as applicable, Bribery Legislation, GOP, GDP, GMP, GLP and the rules and regulations of relevant Governmental Authority having jurisdiction over the Development, Manufacture and/or Commercialisation of the Licensed Products, |
| **"Bi-Annual Report"** | means a written report with the contents set out in <u>Schedule 4</u>, |
| **"Bribery Legislation"** | means the Bribery Act 2010 and all other applicable UK legislation, regulations and codes in relation to bribery and/or corruption and any similar or equivalent legislation in any other relevant jurisdiction, |
| **"Business Day"** | means a day on which banking institutions in London, England and Richmond, Virginia are open for business, excluding any Saturday or Sunday, |
| **"C4X Attorneys"** | means HGF Limited, a company registered in England and Wales, under company number 08998652, whose registered office is at 1 City Walk, Leeds, West Yorkshire, LS11 9DX, |
| **"C4X Indemnitees"** | shall have the meaning set out in <u>Clause 13.1</u>, |
| **"C4X Know-How"** | means all Know-How (including the Data) Controlled by C4X as of the Effective Date that is reasonably necessary or useful to develop, make or use Licensed Compounds or to Develop, Manufacture, Commercialise, use, import, offer to sell or sell Licensed Products in the Field, |

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| | |
|:---|:---|
| **"C4X Patents"** | means all Patents Controlled by C4X or its Affiliate(s) at any time during the Term that claim the composition, Development, Manufacture, Commercialisation or use of Licensed Compounds and/or Licensed Products, including, but not limited to, those specifically listed in <u>Schedule 1</u> For the avoidance of doubt, C4X Patents do not include Company Applied Patents |
| **"C4X Press Release"** | means the press release set out in <u>Schedule 5</u>, |
| **"Calendar Quarter"** | means a period of three (3) consecutive months ending on the last day of March, June, September, and December, respectively, |
| **"Calendar Year"** | means a period of four (4) consecutive Calendar Quarters ending on the last day of December, |
| **"Claims"** | means all charges, complaints, actions, suits, proceedings, hearings, investigations, claims and demands, |
| **"Clinical Overview"** | means an overview of Company's clinical plans for the Development of a Licensed Compound and Licensed Product, |
| **"Combination Product"** | means any pharmaceutical product that comprises both a Licensed Compound and other active compounds and/or APIs, |
| **"Commercialisation" and "Commercialise"** | means activities directed to marketing, promoting, packaging and distributing, supplying, offering for sale, selling or other commercial exploitation of a Licensed Product and/or importing a Licensed Product for sale. When used as a verb, "Commercialise" means to engage in Commercialisation, |
| **"Commercially<br>Reasonable Efforts"** | means those efforts reasonably used by a pharmaceutical company of similar size and resource to Company in relation to one of its own products in active development of equivalent market potential, having regard in particular to the stage of development of the Licensed Compounds, any clinical trial results relating to a Licensed Compound, and the Patent landscape of an applicable country or jurisdiction, and in all cases the use of sound scientific and commercial judgment, |

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| | |
|:---|:---|
| **"Company Applied <br>Know-How"** | means all Know-How that meets the following criteria (a) is developed by Company, its Affiliates, or other Persons with an obligation to assign such Know How to Company, in connection with the exercise of the license under Clause 2, (b) is Controlled by Company (or any of its Affiliates) during the Term (other than C4X Know-How licensed to Company under this Agreement), (c) is used in a Licensed Product, a Licensed Compound, a method of using the Licensed Product, or a method of manufacturing the Licensed Product, and (d) is necessary for Development, Manufacture and/or Commercialisation of such Licensed Product. For the avoidance of doubt, Know How Controlled by any entity that becomes an Affiliate of Company pursuant to a merger or acquisition after the Effective Date shall not be deemed "Company Applied Know-How" if such Know-How was Controlled by such entity prior to such merger or acquisition, |
| **"Company Applied<br>Patents"** | means Patents that meet all of the following criteria: (a) have claimed inventions that are conceived by Company, its Affiliates or other Persons with an obligation to assign such inventions to Company in connection with the exercise of the license under Clause 2, (b) are Controlled by Company (or any of its Affiliates) (other than C4X Patents licensed to Company under this Agreement), (c) claims a Licensed Product, a Licensed Compound, a method of using the Licensed Product, or a method of manufacturing the Licensed Product, and (d) are necessary for the Development, Manufacture and/or Commercialisation of such Licensed Product. For the avoidance of doubt, Patents Controlled by any entity that becomes an Affiliate of Company pursuant to a merger or acquisition after the Effective Date shall not be deemed "Company Applied Patents" if such Patents were filed, claim a priority date or are based on an invention made by or on behalf of such entity prior to such merger or acquisition, |
| **"Company <br>Indemnitees"** | shall have the meaning set out in <u>Clause 13.2,</u> |
| **"Compound Variant"** | means any development, improvement, enhancement or derivative of a Licensed Compound, including but not limited to any polymorph, crystalline form, salt, ester, hydrate or other solvate, prodrug, metabolite, reformulation, enantiomer or other stereoisomer of such Licensed Compound, |

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| | |
|:---|:---|
| **"Confidential <br>Information"** | means, with respect to a Party, all information regarding such Party or its Affiliates which is non-public and of confidential nature, in whatever form (including in written, oral or electronic form or on any magnetic or optical disk or memory and wherever located), including information relating to: (a) the research, development, data and/or results, pharmaceutical or biologic candidates and product information (including replacement costs and the reasons for any product recall), (b) inventions, works of authorship, processes, operations, intentions, methodologies, (c) the business, sales targets, sales statistics, market share statistics, prices, market research reports and surveys, and advertising and other promotional materials, future projects, (d) business development or planning, commercial relationships and negotiations, customers, products, affairs and finances and employees of a Party or its Affiliates, (e) trade secrets and all commercial information relating to a Party's products including technology, technical data and Know-How relating to the business of such Party or its Affiliates or any of their suppliers, customers, agents, distributors, shareholders, management or business contacts, in each case (a)-(e), whether or not such information is marked or identified as confidential, including information relating to the terms of this Agreement, |
| **"Control"** | means, with respect to any Intellectual Property Right or other tangible or intangible property, that a Party or one of its Affiliates owns or has a license or sublicense to such right, or property, and has the ability to grant access, a license or sublicense to such right, or property, without violating the terms of any agreement or other arrangement with any Third Party, |
| **"Controlling Party"** | shall have the meaning set out in <u>Clause 11.3.1(b)</u>, |
| **"Co-Packaged<br>Product"** | means any pharmaceutical product(s) or regulated medical device(s) with which the Licensed Product is bundled or packaged and the two (2) (or more) products (or devices) are sold together, |
| **"Data"** | means the following data: (a) pre-clinical study results and (b) chemical structure information, to the extent such data relates to a Licensed Compound and is in the Control of C4X, |

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| | |
|:---|:---|
| **"Data Room"** | means the data room operated and managed by C4X and using the corporate version of Google Drive and relating to the Licensed Technology, provided by and accessible to Company as part of the due diligence process relating to this Agreement, a copy of the Data Room's index is set out in <u>Schedule 6</u>, |
| **"Designee"** | shall have the meaning set out in <u>Clause 20.2</u>, |
| **"Develop" and<br>"Development"** | means activities necessary or desirable to research and develop Licensed Products and to obtain and maintain Regulatory Approval of Licensed Products, including, as applicable, research and development activities related to the generation, characterisation, optimisation, construction, expression, process development, use and production of Licensed Products, test method development and stability testing, toxicology, clinical trials, quality assurance/quality control, delivery systems, formulation, statistical analysis, report writing, generation of data, product approval and registration activities and all activities related thereto, |
| **"Development<br>Milestone Event"** | shall have the meaning set out in <u>Clause 8.2.1</u>, |
| **"Development**<br>**Milestone Event"** | shall have the meaning set out in <u>Clause 8.2.1</u>, |
| **"Diligence<br>Obligations"** | shall have the meaning set out in <u>Clause 18.1.2</u>, |
| **"Disclosing Party"** | means a Party that discloses or makes available directly or indirectly any Confidential Information to the other Party or its Affiliates, employees and/or agents in connection with this Agreement, |
| **"EMA"** | means the European Medicines Agency or any successor agency thereto, |
| **"Ex-US Countries"** | means all countries of the world excluding the US, |

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|:---|:---|
| **"Ex-US Generic<br>Competition"** | means, with respect to a Licensed Product in an Ex-US Country after one or more Generic Products have been commercially launched in such Ex-US Country, that during any Calendar Quarter after such launch (including the Calendar Quarter such Generic Product is launched), the aggregate Net Sales of such Licensed Product in such country in such Calendar Quarter equal less than fifty percent (50%) of the average aggregate Net Sales of the Licensed Product in such country over the four (4) Calendar Quarters immediately prior to the Calendar Quarter in which one or more Generic Products first became commercially available in such country, |
| **"Expert"** | shall have the meaning set out in <u>Schedule 2</u>, |
| **"FDA"** | means the United States Food and Drug Administration or any successor agency thereto, |
| **"Field"** | means all human and veterinary applications (including without limitation diagnosis, therapeutic treatment and prevention), |
| **"Filing Acceptance"** | means, as applicable, the acceptance for filing of a complete NDA (or its equivalent) by the FDA in the United States, or acceptance for filing of a comparable application by a Governmental Authority in another applicable jurisdiction in the Territory for the Commercialisation of a pharmaceutical product, |
| **"First Commercial<br>Sale"** | means, on a country-by-country and Indication-by-lndication basis, the first commercial sale of any Licensed Product to a Third Party by Company or any of its Affiliates or any of their respective Sublicensees in such country for such Indication following the applicable Regulatory Approval of the Licensed Product in such country for such Indication, |

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|:---|:---|
| **"Force Majeure"** | means in relation to either Party, any cause affecting the performance of this Agreement arising from or attributable to any acts, events, non-happenings, omissions or accidents beyond the reasonable control of the Party and in particular, but without limiting the generality thereof, shall include (to the extent they are beyond the reasonable control of the Party) strikes, lock-outs, industrial action, civil commotion, not, invasion, war, threat of or preparation for war, terrorist activity, fire, explosion, storm, flood, earthquake, subsidence, epidemic or other natural physical disaster, impossibility of the use of railways, shipping, aircraft, motor transport, or other means of public or private transport, failure or suspension of utilities, and political interference with the normal operation of such Party, |
| **"GAAP"** | means United States generally accepted accounting principles in effect from time to time, |
| **"OCR"** | means, as to the US and the European Union, good clinical practices as in effect in the US and the European Union, respectively, during the Term and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices as then in effect in the US or the European Union, in each case to the extent relating to the pharmaceutical products hereunder regulations of any Governmental Authority and applicable ICH GCP, |
| **"GDP"** | means current good distribution practices with respect to the wholesale distribution of medicinal products for human use as set forth in applicable laws and regulations, including Directive 2001/83/EC and Commission Guideline 2013/C 343/01, |

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|:---|:---|
| **"Generic Product"** | means, with respect to any Licensed Product, (a) a drug product that is a pharmaceutical equivalent to such Licensed Product meaning that it (i) contains the same active ingredient(s), has the same dosage form and route of administration, (ii) is identical in strength or concentration to that of the given Licensed Product and (iii) is A rated in the United States (or similar designation outside the United States) (**"ANDA Product"**) or (b) any other drug product that (i) contains the same active ingredient(s) and the same dosage form and route of administration as the Licensed Product and (ii) references the Licensed Product as a Reference Listed Drug in the 505(b)(2) Application for such drug product or, with respect to jurisdictions outside of the US, references the data provided by Company in its Regulatory Submission for such Licensed Product (**"505(b)(2) Product"**), |
| **"GLP"** | means regulations of any Governmental Authority (including Directives 2004/9/EC and 2004/10/EC and any similar or equivalent legislation in any other relevant jurisdiction) for conducting non-clinical laboratory studies that support or are intended to support applications for research or Regulatory Approvals, as applicable to the Development in the Territory from time to time, |
| **"GMP"** | means (a) as to the US and the European Union, good manufacturing practices and general biological products standards as promulgated by the FDA pursuant to 21 CFR Parts 210, 211, 600 and 610 and as promulgated by the European Union pursuant to Commission Directive 2003/94/EC, respectively, each as may be amended from time to time, and (b) with respect to any other jurisdiction, manufacturing practices equivalent to the aforementioned good manufacturing practices as then in effect in the US or the European Union, in each case to the extent relating to the pharmaceutical products hereunder, |
| **"Governmental<br>Authority"** | means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of (a) any government of any country, (b) a federal, state, province, county, city or other political subdivision thereof or (c) any supranational body, |

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|:---|:---|
| **"Handle"** | shall mean preparing, filing, prosecuting (including interference and opposition proceedings) and maintaining (including interferences, reissue, re-examination, post-grant reviews, derivation proceedings, cancellation or nullity proceedings and opposition proceedings), |
| **"ICH GCP"** | means the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and also such other good clinical practice requirements which are specified in Directive 2001/20/EC and relating to medicinal products for human use and in guidance published by the European Commission pursuant to such Directive, |
| **"IFRS"** | means International Financial Reporting Standards (IFRS), |
| **"Indication"** | means a disease classification as defined within the "International Statistical Classification of Diseases and Related Health Problems" as published on the date hereof by the World Health Organization (e.g. F10 Mental and Behavioral Disorders due to the use of Alcohol is a distinct indication from F14 Mental and Behavioral Disorders due to the use of Cocaine), |
| **"Infringement Claim"** | shall have the meaning set out in <u>Clause 11.3.1(a)</u>, |
| **"Initiation"** | means, with respect to a clinical study, the first dosing of the first patient in such client study, |
| **"Intellectual Property <br>Rights"** | means Patents, rights to inventions, copyright (including software) and related rights, trade marks, business names and domain names, rights in get-up, goodwill and the right to sue for passing off, rights in designs, database rights and all other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world, |
| **"Interest"** | means simple interest on the amount of the applicable payment of [\*\*\*] percent ([\*\*\*]%) above the Bank of England base rate (which is current on the date such payment became overdue) and accruing on a daily basis from the final date for such payment until the date such payment is actually received, |

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|:---|:---|
| **"Inventory"** | means the API specified in <u>Schedule 3</u>, |
| **"Joint Patent"** | means any Patent based on an invention made while carrying out the activities pursuant to this Agreement which has multiple inventors as defined by US patent law, where there is at least one inventor employed by or otherwise obligated to assign their rights in the invention to C4X and at least one inventor employed by or otherwise obligated to assign their rights in the invention to Company, |
| **"Know-How"** | means any information or material, whether proprietary or not and whether patentable or not, which is not in the public domain including inventions, discoveries, concepts, data, formulae, ideas, specifications, procedures for experiments and tests and results of experiments, experimentation and testing, results of research and development, laboratory records, clinical trials data, case reports, data analysis and summaries, and information in submissions to and information from ethics committees and Governmental Authorities, |
| **"Licensed Compound"** | means (i) C4X_3256, (ii) any other compound covered by the claims of the C4X Patents, (iii) any Compound Variant of (i) and/or (ii) that has the same Mechanism of Action as the molecules described in (i) and/or (ii), (iv) any molecules that are specifically derived from any of the molecules described in (i), (ii) and/or (iii) using the C4X Know-How and identified to have the same Mechanism of Action as the molecules described in (i), (ii) and/or (iii) above, and (v) any molecules created using the C4X Know-How or in connection with the Development of any Licensed Products and identified to have the same Mechanism of Action as the molecules described in (i), (ii) and/or (iii) above, |
| **"Licensed Product"** | means a pharmaceutical product in finished form (in all formulations, dosages and delivery systems) that incorporate a Licensed Compound, |
| **Licensed Product<br>Trademarks and<br>Trade Dress** | shall have the meaning set out in <u>Clause 7.3.1</u>, |
| **Licensed<br>Technology** | means the C4X Know-How and the C4X Patents, |

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|:---|:---|
| **"Losses"** | means any and all damages, awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, costs, fees, liabilities, obligations, Taxes, hens, losses, and expenses (including court costs, interest and reasonable fees of attorneys, accountants and other experts but excluding, in each case, any recoverable VAT) incurred by or awarded to Third Parties and required to be paid to Third Parties with respect to a Claim by reason of any judgment, order, decree, stipulation or injunction, or any settlement entered into in accordance with the provisions of this Agreement, |
| **"Major Market"** | means any of the following United States, Canada, UK, Australia, Japan, China, France, Germany, Italy and Spain, |
| **"Manufacture"** | means all activities related to the manufacture of Licensed Compounds and/or Licensed Products including manufacturing supplies for Development and Commercialisation, packaging, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance and quality control activities related to manufacturing and release of product, ongoing stability tests, storage, shipment, and regulatory activities related to any of the foregoing, |
| **"Mechanism of<br>Action"** | means Orexin-1 receptor antagonism, |
| **"Milestone Payment"** | means a Development Milestone Payment and/or a Sales Milestone Payment, as applicable, |

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|:---|:---|
| **"Net Sales"** | means the gross amount invoiced on sales of Licensed Product in the Territory by Company, its Affiliates and Sublicensees ("**Company Party**") to any Third Party purchaser in an arm's length transaction, less all applicable deductions to the extent incurred, allowed, paid or accrued by Company with respect to such Licensed Product, including (without duplication)the following deductions, in each case determined in accordance with GAAP or IFRS (as determined by the applicable Company Party) and standard internal policies and procedures and accounting standards of the applicable Company Party, consistently applied<br>(a)&nbsp;&nbsp;&nbsp;&nbsp;customary trade, cash and/or quantity discounts, allowances, fees, credits and any other adjustments, including granted on account of price adjustments, billing errors, rejected goods, damaged or defective goods, recalls, returns, rebates, chargeback rebates, reimbursements or similar payments granted or given to wholesalers or distributors, buying groups, health care insurance carriers, governments, government subsidized programs or managed care organizations, or other institutions, or adjustments arising from consumer discount programs, allowed or paid, in the form of deductions allowed or taken by the Third Party or fees paid by a Company Party with respect to sales of such Licensed Product (to the extent not already reflected in the amount invoiced),<br>(b)&nbsp;&nbsp;&nbsp;&nbsp;retroactive price reductions, allowances or credits granted upon rejections or returns of Licensed Product, including for recalls or damaged good and billing errors,<br>(c)&nbsp;&nbsp;&nbsp;&nbsp;discounts, chargeback payments, rebates, and reimbursements (or equivalent thereof) granted to managed health care organisations, group purchasing organisations or other buying groups, pharmacy benefit management companies (or equivalent thereof), health maintenance organisations, federal, state/provincial, local or other governments or their agencies or purchasers, reimbursers or trade customers, and any other providers of health insurance coverage, health care organisations or other health care institutions (including hospitals), health care administrators or patient assistance or other similar programs,<br>(d)&nbsp;&nbsp;&nbsp;&nbsp;compulsory payments and cash rebates related to the sales of such Licensed Product paid to a Governmental Authority (or agent thereof) pursuant to governmental regulations by reason of any national or local health insurance program or similar program, to the extent allowed and taken, including government levied fees as a result of healthcare reform policies,<br>(e)&nbsp;&nbsp;&nbsp;&nbsp;outbound freight, shipping, insurance and other transportation expenses to the extent included in the price and separately itemised on the invoice price, |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

(f)&nbsp;&nbsp;&nbsp;&nbsp;tariffs, duties, excise, sales, use, value-added and other similar Taxes (other than Taxes based on income), customs duties, or other government charges, in each case imposed on the sale of Licensed Product to the extent included in the price and separately itemised on the invoice, including VAT, but only to the extent that such VAT is not reimbursable or refundable, and<br>(g)&nbsp;&nbsp;&nbsp;&nbsp;amounts previously included in Net Sales of Licensed Product that are written off as uncollectible after reasonable collection efforts, in accordance with standard practices of the applicable Party<br>

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Notwithstanding anything in this Agreement to the contrary, the transfer of a Licensed Product between or among Company, its Affiliates and Sublicensees (and Affiliates of the Sublicensees) will not be considered a sale, provided, that in the event an Affiliate or Sublicensee is the end-user of Licensed Product, the transfer of Licensed Product to such Affiliate or Sublicensee shall be included in the calculation of Net Sales at the average selling price charged in an arm's length sale to a Third Party who is not an Affiliate or Sublicensee (or an Affiliate of the Sublicensee) in the relevant period. Net Sales will include the cash consideration received on a sale and the fair market value of all non-cash consideration, which generally will mean the Company Party's average sales price for the applicable time period.<br>Disposition of Licensed Product for, or use of the Licensed Product in, clinical trials or other scientific testing, as free samples, or under compassionate use, named patient sales, patient assistance, or test marketing programs or other similar programs or studies where a Licensed Product is supplied without charge shall not result in any Net Sales, [however, if any Company Party charges for such Licensed Product, the amount billed will be included in the calculation of Net Sales], but for the sake of clarity such disposition or use of the Licensed Product shall never constitute a First Commercial Sale.<br>In the event a Licensed Product is sold as part of a Combination Product or a Co-Packaged Product, the Net Sales from the Combination Product or the Co-Packaged Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Combination Product or the Co-Packaged Product (as defined in the Net Sales definition), during the applicable royalty reporting period, by the fraction<br>A/A+B<br>where A is the average sale price of the Licensed Product when sold separately in finished form and B is the average sale price of the other product(s) included in the Combination Product or Co-Packaged Product when sold separately in finished form, in each case during the applicable royalty reporting period or, if sales of both the Licensed Product and the other product(s) did not occur in such period, then in the most recent royalty reporting period in which sales of both occurred.<br>In the event that such average sale price cannot be determined for the Licensed Product and all other product(s) included in the Combination Product or Co-Packaged Product, then the Net Sales for the purposes of determining royalty payments for a Combination Product or a Co-Packaged Product shall be calculated by multiplying the Net Sales of the Combination Product by the fraction of<br>

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| | |
|:---|:---|
| | C/C+D<br>where C is the direct Manufacturing cost (or, if acquired from a Third Party, the direct acquisition cost) of the Licensed Product and D is the direct Manufacturing cost (or, if acquired from a Third Party, the direct acquisition cost) of all other pharmaceutical product(s) included in the Combination Product or Co-Packaged Product (such definition of direct Manufacturing cost to be used mutatis mutandis in the circumstances of other pharmaceutical product(s)) In such event, Company shall in good faith make a determination of the respective Manufacturing or acquisition costs of the Licensed Product and all other pharmaceutical products included in the Combination Product or Co-Packaged Product, and shall notify C4X of such determination and provide C4X with data to support such determination.<br>In the event that the Licensed Product is never sold individually and is only ever sold as a Co-Packaged Product, then the gross invoiced sales figure to be used in the determination of the Net Sales shall be the volume of Licensed Product sold multiplied by the difference between the price of the Co-Packaged Product and the price of the other product (or aggregate price of the other products, as the case may be) with which the Licensed Product is co-packaged or combined, less (a) through (d) (inclusive) of the first paragraph of this definition, |
| **"Patent"** | means patents and patent applications and all substitutions, divisions, continuations, continuations-m-part, any patent issued with respect to any such patent applications (including certificates of invention), any reissue, re-examination, utility models or designs, renewal or extension of any such patent, any term extension, a supplementary protection certificate and any confirmation patent or registration patent or patent of addition based on any such patent, and all counterparts and patents and patent applications based on, corresponding to or claiming the priority date thereof in any country, |
| **"Payee"** | shall have the meaning set out in <u>Clause 9.3.5</u>, |
| **"Payor"** | shall have the meaning set out in <u>Clause 9.3.5</u>, |

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|:---|:---|
| **"Person"** | means any natural person, corporation, firm, business trust, joint venture, association, organisation, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof, |
| **"Phase II Trial"** | means a controlled clinical study in a relatively small number of subjects (usually no more than several hundred) designed to evaluate the effectiveness of a pharmaceutical product for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with such pharmaceutical product, as further described in 21 C.F.R §312 21(b). By way of example, such a study may be designed to establish a dose and/or dose range for the study drug or to obtain additional safety or efficacy data to support the development of research methods and the design of Phase III research protocols in a patient population with the disease or condition under study, |
| **"Phase III Trial"** | means an expanded controlled or uncontrolled clinical study in a large number of patients (usually more than several hundred to several thousand) that is performed after preliminary evidence suggesting effectiveness of a pharmaceutical product has been obtained, and is intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of such pharmaceutical product and to provide an adequate basis for physician labelling, as further described in 21 C.F.R §312 21(c). Such a study is designed and intended to be of a size and statistical power sufficient to serve as a pivotal study to support the Regulatory Submission for the indication being studied, |
| **"Promotional<br>Materials"** | means all written, printed, video and/or graphic advertising, promotional and educational communication materials for the purposes of marketing, advertising and promoting of Licensed Product, |
| **"Receiving Party"** | means a Party that receives or has had made available to it directly or indirectly any Confidential Information from the other Party or its Affiliates, employees and/or agents in connection with this Agreement, |

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|:---|:---|
| **"Regulatory Approval"** | means, as applicable, the approval of an NDA by the FDA in the United States or approval of a comparable application by a Regulatory Authority in another jurisdiction in the Territory for the manufacture, supply, marketing and sale of a pharmaceutical product. For clarity, "Regulatory Approval" shall not include any governmental pricing and/or reimbursement approvals and/or authorizations issued by a Regulatory Authority or any other governmental agency in any country or jurisdiction, |
| **"Regulatory Authority"** | means, with respect to any jurisdiction, the applicable Governmental Authority responsible for regulating the manufacture, distribution, marketing and/or sale of pharmaceutical products in such jurisdiction, |
| **"Regulatory<br>Exclusivity"** | means, with respect to a Licensed Product, exclusive marketing rights or data exclusivity rights conferred by an applicable Regulatory Authority in a particular country with respect to such Licensed Product in such country |
| **"Regulatory Materials"** | means any regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Governmental Authority that are related to Developing, Manufacturing, obtaining marketing authorisation, and/or Commercialising in a particular country or regulatory jurisdiction, |
| **"Regulatory<br>Submission"** | means a marketing authorisation application filed with the FDA, EMA, or any comparable application or filing with any analogous Governmental Authority in the Territory, |
| **"Representatives"** | means the directors, officers and/or employees of the Receiving Party and/or its Affiliates and its professional advisers (meaning solicitors and/or accountants or financial advisers), |
| **"Royalty"** | has the meaning set forth in <u>Clause 8.3.1</u>, |

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|:---|:---|
| **"Royalty Term"** | means, with respect to each Licensed Product on a country-by-country basis, the period of time (a) beginning upon the later of (i) the First Commercial Sale of such Licensed Product in a country and (ii) the issuance of a Valid Claim in such country covering the composition-of-matter of the Licensed Compound in the Licensed Product, and<br>(b) with respect to each Ex-US Country, ending on the later date of (i) the expiration in a country of the last to expire Valid Claim covering the composition-of-matter of the Licensed Compound in the Licensed Product, (ii) the tenth (10th) year anniversary of the First Commercial Sale of such Licensed Product in such country, (iii) the last expiration or other termination of any applicable Regulatory Exclusivity for such Licensed Product in such country, but, in any event, ending on Ex-US Generic Competition with respect to such Licensed Product in such country, or<br>(c) with respect to the US, ending on the later of the (i) expiration in the US of the last to expire Valid Claim covering the composition-of-matter of the Licensed Compound in the Licensed Product, or (ii) first expiration or other termination of any applicable Regulatory Exclusivity for such Licensed Product in the US, but, in any event ending upon US Generic Competition with respect to such Licensed Product, |
| **"Sales Milestones"** | shall have the meaning set out in <u>Clause 8.2.2</u>, |
| **"Sales Milestone<br>Payment"** | shall have the meaning set out in <u>Clause 8.2.2</u>, |
| **"Sublicensee"** | means a Third Party to which Company or its Affiliate has granted or grants rights to develop, make, have made, use, import, sell, have sold or offer for sale Licensed Product(s), or any further sublicensee of such rights (regardless of the number of tiers, layers or levels of sublicenses of such rights), |
| **"Tax" or "Taxes"** | means any present or future sales, turnover, income, revenue, value added taxes, levies, imposts, duties, charges, assessments and/or fees in each case in the nature of tax (including any interest thereon), |

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|:---|:---|
| **"Tax Authority"** | means any government, state or municipality or any local, state, federal or other fiscal, revenue, customs or excise authority, body or official anywhere in the world having functions in relation to Tax, |
| **"Tax Credit"** | means a credit against, relief or remission for, or repayment of any Tax, |
| **"Term"** | shall have the meaning set out in Clause 17, |
| **"Territory"** | means worldwide, |
| **"Third Party"** | means a person other than (a) C4X or any of its Affiliates, or (b) Company or any of its Affiliates, |
| **"UK"** | means the United Kingdom as at the Effective Date, |
| **"US"** | means the United States of America and its territories, possessions and commonwealths, |
| **"US Generic Competition"** | means, with respect to a Licensed Product in the US, (a) the date of commercial launch of an ANDA Product (as defined in the definition of Generic Product) in the US or (b) after one or more 505(b)(2) Products (as defined in the definition of Generic Product) have been commercially launched in the US and during any Calendar Quarter after such launch (including the Calendar Quarter such 505(b)(2) Product is launched), the aggregate Net Sales of such Licensed Product in the US in such Calendar Quarter equal less than fifty percent (50%) of the average aggregate Net Sales of the Licensed Product in the US over the four (4) Calendar Quarters immediately prior to the Calendar Quarter in which one or more 505(b)(2) Products first became commercially available in the US, |
| **"Valid Claim"** | means a claim of a C4X issued Patent that (a) has not been rejected, revoked or held to be invalid or unenforceable by a court or other authority of competent jurisdiction, from which decision no appeal can be further taken or (b) has not expired, been finally abandoned, disclaimed or admitted to be invalid or unenforceable through reissue or disclaimer, |

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|:---|:---|
| **"VAT"** | means value added tax chargeable under or pursuant to the Council Directive 2006/112/EC or any legislation implementing such Directive, or any other sales, purchase or turnover tax and any customs or excise duties or import levies, and |
| **"Viable"** | means, with respect to a Licensed Product, at the relevant time there is/are not and have not been (a) occurrences of serious adverse events in clinical trials relating to such Licensed Product, or (b) failure to achieve the efficacy endpoints of one or more clinical trials relating to such Licensed Product, as to render the programme no longer technically viable or viable in accordance with Applicable Laws. |

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1.2&nbsp;&nbsp;&nbsp;&nbsp;Clause headings shall not affect the interpretation or construction of this Agreement.

1.3&nbsp;&nbsp;&nbsp;&nbsp;References to Clauses and Schedules are to the Clauses and Schedules of this Agreement.

1.4&nbsp;&nbsp;&nbsp;&nbsp;Unless the context otherwise requires, words in the singular include the plural and in the plural, include the singular and a reference to one gender shall include a reference to all other genders.

1.5&nbsp;&nbsp;&nbsp;&nbsp;A reference to a statute, statutory provision or subordinated legislation is a reference to it as it is in force from time to time A reference to a statute or statutory provision shall include any subordinate legislation made from time to time under that statute or statutory provision.

1.6&nbsp;&nbsp;&nbsp;&nbsp;A reference to a company shall include any company, corporation or other body corporate, wherever and however incorporated or established.

1.7&nbsp;&nbsp;&nbsp;&nbsp;A reference to this Agreement or to any other agreement or document referred to in this Agreement is a reference to this Agreement or such other agreement or document as varied or novated (in each case, other than in breach of the provisions of this Agreement) from time to time.

1.8&nbsp;&nbsp;&nbsp;&nbsp;Any words following the terms including, include, in particular or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms.

**2.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 2: License AND OTHER COVENANTS**

2.1&nbsp;&nbsp;&nbsp;&nbsp;<u>license</u>

Effective on the Effective Date, C4X hereby grants to Company an exclusive (even as to C4X), sublicensable (subject to <u>Clause 2.2</u>), and perpetual (subject to <u>Clause 18</u>), transferable (subject to <u>Clause 28</u>) license under the Licensed Technology to Develop, use, Manufacture, have Manufactured, import, export, obtain Regulatory Approval and Commercialise the Licensed Compound(s) and/or Licensed Product(s) for use in the Field and in the Territory.

2.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Sublicensing</u>

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.1&nbsp;&nbsp;&nbsp;&nbsp;Subject to <u>Clauses 2.2.3</u> and <u>2.2.4</u>, Company shall have the right to grant sublicenses under the Licensed Technology to its Affiliates without the prior approval of C4X.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.2&nbsp;&nbsp;&nbsp;&nbsp;Subject to <u>Clauses 2.2.3</u> and <u>2.2.4</u>, Company shall have the right to grant written sublicenses under the Licensed Technology to Third Parties without the prior approval of C4X.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.3&nbsp;&nbsp;&nbsp;&nbsp;Each sublicense agreement shall:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;contain terms and conditions which are consistent with the terms and conditions of this Agreement,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;not in any way diminish, reduce or eliminate any of Company's obligations under this Agreement,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;impose on the Sublicensee all applicable obligations under the terms of this Agreement including the confidentiality and restricted use, reporting, audit and inspection provisions hereunder, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;upon termination of this Agreement, automatically terminate.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.4&nbsp;&nbsp;&nbsp;&nbsp;Company shall:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;following execution of an agreement under <u>Clause 2.2.3</u> for the promotion, distribution, sale or other commercialisation of Licensed Compounds and/or Licensed Products, promptly notify C4X of the same giving C4X the (a) name of the Sublicensee and (b) scope of any territory rights granted including the countries applicable to such sublicense agreement,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;be responsible for the performance of all obligations imposed on the Sublicensees and to C4X for any breaches of the Agreement that occur as a result of actions or omissions by any Sublicensees that would, if such actions or omissions had been those of Company, have caused Company to be in breach of its obligations under this Agreement, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;itself account to C4X for all payments due under this Agreement by reason of such sublicense.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2.5&nbsp;&nbsp;&nbsp;&nbsp;In the event that Company sublicenses any rights hereunder to a Third Party, Company shall ensure that C4X shall receive the same Milestone Payments and the same Royalty payments in respect of Development Milestone Events, Sales Milestones and Net Sales achieved by the Third Party as C4X would have obtained in the case that Company itself had achieved the Development Milestone Events, Sales Milestones and Net Sales. For the sake of clarity, it is the intention of the Parties that C4X's Royalty entitlement shall be calculated on the basis of in market sales to Third Parties of any Licensed Product.

2.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Implied licenses</u>

Except as expressly provided in this Agreement, neither Party grants to the other Party any right or license in any Intellectual Property Rights, whether by implication, estoppel or otherwise. No implied licenses are granted under this Agreement. Company hereby covenants and agrees not to use or

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sublicense any of its rights under the licenses hereunder except as expressly permitted in this Agreement. C4X hereby covenants and agrees not to use or sublicense any of its rights under the licenses hereunder except as expressly permitted in this Agreement.

2.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Retained Rights</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.1&nbsp;&nbsp;&nbsp;&nbsp;Any rights of C4X not expressly granted to Company under the provisions of this Agreement shall be retained by C4X.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4.2&nbsp;&nbsp;&nbsp;&nbsp;Any rights of Company not expressly granted to C4X under the provisions of this Agreement, and any rights that may be considered as joint rights between C4X and Company, shall be retained by Company.

2.5&nbsp;&nbsp;&nbsp;&nbsp;<u>Non-Competition</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5.1&nbsp;&nbsp;&nbsp;&nbsp;Except where permitted by Company in writing, during the Term, neither C4X nor its Affiliates will, by itself or through any Third Party, Develop or Commercialise compounds, molecules, and/or products with the Mechanism of Action.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5.2&nbsp;&nbsp;&nbsp;&nbsp;For clarity and subject to <u>Clause 2.5.1</u>, nothing in this Agreement shall restrict C4X's ability and right to (including without limitation) conduct research, develop, manufacture and/or commercialise compounds, molecules and/or products without the Mechanism of Action, including but not limited to Orexin-1 receptor agonists.

2.6&nbsp;&nbsp;&nbsp;&nbsp;<u>Rights Under Bankruptcy</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.6.1&nbsp;&nbsp;&nbsp;&nbsp;If C4X or an Affiliate become subject to bankruptcy proceedings in the US, then the Parties agree that all rights and licenses granted under or pursuant to any section of this Agreement in connection with US intellectual property rights are and will otherwise be deemed to be for purposes of Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), as amended (the "Bankruptcy Code"), licenses of rights to "intellectual property" as defined in Section 101(35A) of the Bankruptcy Code. Company, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. In the event of the commencement of a bankruptcy proceeding by or against an Affiliate of C4X under the Bankruptcy Code, Company will be entitled to a complete duplicate of (or complete access to, as appropriate) such intellectual property and all embodiments of such intellectual property, which, if not already in Company's possession, will be promptly delivered to it upon Company's written request thereof. Any agreements supplemental hereto will be deemed to be "agreements supplementary to" this Agreement for purposes of Section 365(n) of the Bankruptcy Code. C4X agrees that it shall not take any action in any bankruptcy proceeding or in any other judicial, administrative, arbitral or other proceeding to reject, object to or challenge the legality, validity or enforceability of any of this Agreement or any rights granted herein.

**3.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 3: REPORTING**

3.1&nbsp;&nbsp;&nbsp;&nbsp;Company shall provide a Bi-Annual Report to C4X twice (2) each Calendar Year. The first Bi-Annual Report shall be provided to C4X before the final day of the month of December 2018, and each subsequent Bi-Annual Report shall be provided by the final day of the month of (a) June and (b)

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December each Calendar Year. Each Bi-Annual Report shall contain the information set out in <u>Schedule 4</u>.

3.2&nbsp;&nbsp;&nbsp;&nbsp;Company shall also provide the Clinical Overview to C4X with Company's provision of the first Bi-Annual Report in accordance with <u>Clause 3.1</u>.

3.3&nbsp;&nbsp;&nbsp;&nbsp;Promptly upon C4X's request, prior to the First Commercial Sale in a Major Market, Company shall provide in writing to C4X (to the extent the below relates to Licensed Compounds and/or Licensed Products):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3.1&nbsp;&nbsp;&nbsp;&nbsp;copies Clinical Trial reports,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3.2&nbsp;&nbsp;&nbsp;&nbsp;raw study data,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3.3&nbsp;&nbsp;&nbsp;&nbsp;copies of Clinical Trial applications,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3.4&nbsp;&nbsp;&nbsp;&nbsp;copies of correspondence with Governmental Authorities, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3.5&nbsp;&nbsp;&nbsp;&nbsp;copies of minutes of meetings with Governmental Authorities.

**4.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 4: DEVELOPMENT**

4.1&nbsp;&nbsp;&nbsp;&nbsp;Development

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1.1&nbsp;&nbsp;&nbsp;&nbsp;Company shall have the sole right to Develop the Licensed Compounds and Licensed Products and shall control all aspects of such Development at its own cost and expense (except as otherwise expressly set forth herein).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1.2&nbsp;&nbsp;&nbsp;&nbsp;C4X shall not be required to conduct any Development (preclinical or clinical) activities. Notwithstanding the foregoing, upon request by Company, C4X shall provide reasonable assistance to Company in connection with aspects of Development that are within C4X's expertise or ability, all at Company's cost except as otherwise set forth herein.

**5.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 5: REGULATORY RESPONSIBILITIES**

5.1&nbsp;&nbsp;&nbsp;&nbsp;As between the Parties, during the Term, on a Licensed Product-by-Licensed Product basis, Company have the sole right (at its cost) to:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1.1&nbsp;&nbsp;&nbsp;&nbsp;prepare and file all Regulatory Materials and seek and maintain all Regulatory Approvals for Licensed Products in the Field, including preparation of all Regulatory Materials (including in connection with labelling and packaging for Licensed Products) and communications with applicable Governmental Authorities, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1.2&nbsp;&nbsp;&nbsp;&nbsp;complete all pharmacovigilance responsibilities required under and in accordance with Applicable Laws.

5.2&nbsp;&nbsp;&nbsp;&nbsp;As between the Parties, Company shall own all Regulatory Approvals for Licensed Products in the Territory. C4X shall have no responsibility with respect to the Regulatory Materials, Regulatory Submissions and/or Regulatory Approvals (whether through assisting Company at the Company's cost or otherwise), except as expressly set forth herein.

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**6.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 6: MANUFACTURING**

6.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Relationships with Third Parties</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1.1&nbsp;&nbsp;&nbsp;&nbsp;C4X shall use commercially reasonable efforts to conduct the activities and manage the Third Party relationships that relate to the Licensed Technology as set out in <u>Schedule 7</u>, upon Company's request. C4X shall conduct the foregoing in consultation with Company, at Company's cost. Company shall reimburse C4X for reasonable out-of-pocket costs arising from such management of Third Party relationships requested by Company within thirty (30) days of receiving each invoice from C4X. C4X shall promptly provide Company with copies of all material documents relating to such Third Party relationships.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1.2&nbsp;&nbsp;&nbsp;&nbsp;Without prejudice to the other provisions of this <u>Clause 6</u>, Company shall have the right, but not the obligation, to take over the activities and management of the Third Party relationships and the agreements listed in <u>Schedule 7</u>. The Company may exercise such right at any time. If Company wishes to take over such activities, management and agreements, Company shall notify C4X and C4X shall, with the co-operation of Company, use commercially reasonable efforts to transfer, to the extent transferable, such activities, management and agreements within any timelines set out in such notice, at Company's cost.

6.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Inventory, Technology Transfer</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.1&nbsp;&nbsp;&nbsp;&nbsp;Upon request by Company, C4X shall transfer to Company, at C4X's reasonable cost and expense, the physical possession and control of all Inventory and tangible C4X Know-How promptly following the Effective Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.2&nbsp;&nbsp;&nbsp;&nbsp;Promptly after the Effective Date and as applicable during the Term, C4X shall disclose to Company all Licensed Technology that would be necessary or useful for the development of Licensed Compounds or Licensed Products. If and as requested by Company, C4X will disclose to Company or any Regulatory Authority all relevant Licensed Technology in its possession required for Company to register for sale or obtain Regulatory Approval for the Licensed Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.3&nbsp;&nbsp;&nbsp;&nbsp;C4X shall provide to Company copies of all Data in its possession or Control promptly after the Effective Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.4&nbsp;&nbsp;&nbsp;&nbsp;C4X shall (and shall procure that its Affiliates and agents shall) transfer to Company all Manufacturing-related documents, related materials and information in C4X's Control or possession that may be reasonably necessary for Company to Manufacture or have Manufactured a Licensed Product, at C4X's cost and expense.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2.5&nbsp;&nbsp;&nbsp;&nbsp;C4X shall promptly provide technical assistance to Company as Company reasonably requests regarding the Licensed Technology, and Company's efforts with respect to obtaining Regulatory Approval for any Licensed Products. Company shall reimburse C4X for C4X's reasonable out-of-pocket costs incurred in connection with such technical assistance, except as otherwise set forth in this <u>Clause 6.2</u>.

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6.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Manufacturing</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.1&nbsp;&nbsp;&nbsp;&nbsp;As between the Parties, Company shall have the sole right to Manufacture and supply Licensed Compounds and Licensed Product and shall control all aspects of such Manufacturing at its own cost and expense (except as otherwise expressly set forth herein).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.2&nbsp;&nbsp;&nbsp;&nbsp;Without limiting <u>Clause 6.2</u>, C4X shall promptly after the Effective Date, support the transfer of such Manufacturing activities to Company or Company's designee.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3.3&nbsp;&nbsp;&nbsp;&nbsp;Company shall perform its Manufacturing activities in accordance with Applicable Laws and all applicable Regulatory Approvals for the Licensed Products.

**7.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 7: COMMERCIALISATION**

7.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Responsibility</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1.1&nbsp;&nbsp;&nbsp;&nbsp;As between the Parties, Company shall have the sole right to Commercialise the Licensed Products and shall control all aspects of Commercialisation at its own cost and expense (except as otherwise expressly set forth herein), including (a) receiving, accepting and filling orders for Licensed Products, (b) handling all returns of Licensed Product, (c) controlling invoicing, order processing and collection of accounts receivable for the sales of Licensed Product, (d) distributing and managing inventory of Licensed Product, and (e) the sale of Licensed Products in the Field, including the price or prices at which each Licensed Product will be sold, any discount applicable to payments or receivables, and similar matters.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1.2&nbsp;&nbsp;&nbsp;&nbsp;C4X shall have no responsibility with respect to Commercialisation (whether through assisting Company at Company's cost or otherwise).

7.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Diligence</u>

Company shall use Commercially Reasonable Efforts to Develop at least one Licensed Product and use Commercially Reasonable Efforts to Commercialise such Licensed Product in the US and two (2) additional Major Markets.

7.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Trademarks, Trade Dress and Promotional Materials</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3.1&nbsp;&nbsp;&nbsp;&nbsp;Company shall have the right, in its sole discretion and at its cost, to select, register and own the trade marks, trade dress, logos, slogans and internet domain names with respect to the Licensed Products in the Field (collectively, the "**Licensed Product Trademarks and Trade Dress**"). All uses of the Licensed Product Trademarks and Trade Dress by Company in connection with Commercialisation shall be in accordance with the applicable Regulatory Approvals and Applicable Laws. As between the Parties, Company shall own all rights to Licensed Product Trademarks and Trade Dress (in each case, together with all goodwill associated therewith).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3.2&nbsp;&nbsp;&nbsp;&nbsp;Company, in its sole discretion, will create and develop Promotional Materials for the Licensed Products, which Promotional Materials shall be in accordance with the applicable Regulatory Approvals and Applicable Laws.

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**8.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 8: FINANCIAL TERMS**

8.1&nbsp;&nbsp;&nbsp;&nbsp;<u>license Fee</u>

In partial consideration for the license rights granted to Company hereunder, Company shall pay C4X [\*\*\*] Dollars ($[\*\*\*]) within ten (10) days after the Effective Date. This payment shall be made in accordance with <u>Clause 9</u> and shall be non-creditable and non-refundable.

8.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Milestones</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Development Milestone Payments</u>. In partial consideration for the license rights granted to Company hereunder, after first achievement by Company or its Affiliates of any of the milestone events set forth in the following table (each, a **"Development Milestone Event"**), Company shall pay to C4X the corresponding amount set forth in the following table (each, a **"Development Milestone Payment"**)**.** For the avoidance of doubt, each Development Milestone Payment shall be payable one-time only upon the first occurrence of the event triggering the respective milestone set forth below:

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| | | | |
|:---|:---|:---|:---|
| **Development Milestone Events** | **Development Milestone Payment** | **Development Milestone Payment** | **Development Milestone Payment** |
| **Development Milestone Events** | A<br>[\*\*\*] | B<br>[\*\*\*] | C<br>[\*\*\*] |
| 1 [\*\*\*] | $[\*\*\*] | $[\*\*\*] | $[\*\*\*] |
| 2 [\*\*\*] | $[\*\*\*] | $[\*\*\*] | $[\*\*\*] |
| 3 [\*\*\*] | $[\*\*\*] | $[\*\*\*] | $[\*\*\*] |
| 4 [\*\*\*] | $[\*\*\*] | $[\*\*\*] | $[\*\*\*] |
| 5 [\*\*\*] | $[\*\*\*] | $[\*\*\*] | $[\*\*\*] |
| 6 [\*\*\*] | $[\*\*\*] | $[\*\*\*] | $[\*\*\*] |
| 7 [\*\*\*] | $[\*\*\*] | $[\*\*\*] | $[\*\*\*] |
| 8 [\*\*\*] | $[\*\*\*] | $[\*\*\*] | $[\*\*\*] |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;For the avoidance of doubt, Indications shall be determined by Company and may include, but shall not be limited to, any of the following (i) mental and behavioural disorders due to use of alcohol, (ii) mental and behavioural disorders due to use of cocaine, (iii) mental and behavioural disorders due to use of opioids, (iv) mental and behavioural disorders due to use of other stimulants, including caffeine, (v) eating disorders, (vi) anxiety disorders, (vii) mood affective disorders, and (viii) habit and impulse disorders.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Company shall notify C4X of the achievement of each Development Milestone Event within thirty (30) days after the achievement thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Sales Milestone Payments</u>. As additional consideration for the rights granted to Company herein, Company shall pay to C4X a one-time milestone payment (**"Sales Milestone Payments"**) upon first achieving each of the annual Net Sales thresholds set forth below (**"Sales Milestones"**). For the avoidance of doubt, each Sales Milestone Payment shall be

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payable one-time only upon the first occurrence of the event triggering the respective milestone provided below:

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| | |
|:---|:---|
| **Sales Milestones** | **Sales Milestone Payment** |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |
| [\*\*\*] | $[\*\*\*] |

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8.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Royalty and Sub-license Revenues</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.1&nbsp;&nbsp;&nbsp;&nbsp;Subject to <u>Clause 8.3.2</u>, as additional consideration for the rights granted to Company herein, during the Royalty Term for each Licensed Product in each country as applicable, Company shall pay a royalty of [\*\*\*] percent ([\*\*\*]%) on annual Net Sales of such Licensed Product (**"Royalty"**).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.2&nbsp;&nbsp;&nbsp;&nbsp;During the Royalty Term, when the last Valid Claim in the US covering the composition of matter of a Licensed Product is no longer in effect, the Royalty payable with respect to such Licensed Product in the US shall be reduced to [\*\*\*] percent ([\*\*\*]%) for the remainder of the Royalty Term, commencing on the date that such Valid Claim is no longer in effect.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.3&nbsp;&nbsp;&nbsp;&nbsp;Except as set forth herein, all Royalty payments shall be non-creditable and non-refundable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3.4&nbsp;&nbsp;&nbsp;&nbsp;Company will pay to C4X [\*\*\*] percent ([\*\*\*]%) of any Sub-license Revenues received and/or invoiced during the first [\*\*\*] years of the Term.

8.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Third Party Licenses</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4.1&nbsp;&nbsp;&nbsp;&nbsp;In the event that it is reasonably necessary for Company to pay royalties or other fees to a Third Party (other than an Affiliate) in connection with a license for a Patent (to which such Third Party has rights), for the Development, Manufacture and/or Commercialisation of a Licensed Product, then Company and C4X shall equally share the responsibility for such royalties or fees payable with respect to such Third Party licenses. Company shall pay such royalties or fees to such Third Party. To recover C4X's share of the responsibility, Company may deduct up to fifty percent (50%) of the royalties or fees paid to the relevant Third Party from the Royalty due to C4X under <u>Clause 8.3</u> up to a maximum amount of fifty percent (50%) of such Royalty due to C4X under <u>Clause 8.3</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.4.2&nbsp;&nbsp;&nbsp;&nbsp;All existing licenses or contractual obligations of C4X that are necessary for the exploitation of the Licensed Technology shall be, except as otherwise expressly set forth herein, maintained by C4X and C4X shall pay all royalties and other fees therefor.

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**9.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 9: PAYMENT TERMS**

9.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Payment Methods</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1.1&nbsp;&nbsp;&nbsp;&nbsp;All amounts due hereunder will be paid in US Dollars, and all references to or "Dollars" shall refer to US Dollars. For the purpose of converting any amount owed hereunder to $, such conversion shall be calculated using the exchange rate sourced at each month end from Bloomberg and provided to the Parties by Company. All payments due to C4X under this Agreement shall be made by wire transfer in immediately available funds to an account in designated by C4X in writing.

9.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Payments</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.1&nbsp;&nbsp;&nbsp;&nbsp;Royalty payments due pursuant to <u>Clause 8.3</u> shall be due and payable quarterly, sixty (60) days after the end of each Calendar Quarter. Company will accompany each payment of royalties under this Agreement with a report setting forth, on a Licensed Product-by-Licensed Product and country-by-country basis, [\*\*\*], any currency conversions made in accordance with <u>Clause 9.11</u>, and a calculation of the amount of Royalty payment due on such Net Sales.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.2&nbsp;&nbsp;&nbsp;&nbsp;Development Milestone Payments shall be due and payable by Company within sixty (60) days after completion of the applicable Development Milestone Event. Together with any such payment, Company shall deliver a written statement of completion and other pertinent and available information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2.3&nbsp;&nbsp;&nbsp;&nbsp;Sales Milestone Payments shall be due and payable by Company on an annual basis within sixty (60) days after the last day of each calendar year during the Royalty Term. Together with any such payment, Company shall deliver a report specifying, with respect to such calendar year [\*\*\*], and a calculation of the Sales Milestone Payment payable.

9.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Taxes</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.1&nbsp;&nbsp;&nbsp;&nbsp;Company will make all payments to C4X under this Agreement without deduction or withholding for Taxes except to the extent that any such deduction or withholding is required by Applicable Laws in effect at the time of payments.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.2&nbsp;&nbsp;&nbsp;&nbsp;Any Tax required to be withheld on amounts payable under this Agreement will be paid by Company on behalf of C4X to the appropriate Tax Authority, and Company will furnish C4X with proof of payment of such Tax. If any such Tax is required to be withheld or deducted, Company shall pay such additional amounts as shall be required to ensure that the net amount received and retained by C4X (after Tax) will equal the full amount as would have been received and retained by it had no withholding or deduction been made.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.3&nbsp;&nbsp;&nbsp;&nbsp;If Company pays an additional amount pursuant to <u>Clause 9.3.2</u> (a "**Tax Payment**") and C4X reasonably determines that both: (a) a Tax Credit is attributable such amount, and (b) C4X has obtained and utilised that Tax Credit, then C4X shall pay an amount to Company which C4X reasonably determines will leave it (after that payment) in the same after-Tax position it would have been in had the Tax Payment not been required to be made by Company.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.4&nbsp;&nbsp;&nbsp;&nbsp;Each Party shall reasonably assist and cooperate with the other Party (a) with respect to all documentation required by any Tax Authority or reasonably requested by Company or C4X to secure a reduction in the rate of applicable withholding Taxes, and/or (b) in claiming exemption from such deductions or withholdings under double taxation or similar agreement or treaty from time to time in force and in minimising the amount required to be so withheld or deducted.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.5&nbsp;&nbsp;&nbsp;&nbsp;All amounts set out or expressed in this Agreement to be payable by any Party (the "**Payor**") to the other Party (the "**Payee**") which (in whole or in part) constitute the consideration for a supply or supplies which attract VAT (for which the Payee (or another member of the Payee's group) is accountable to the relevant Tax Authority) shall be deemed to be exclusive of any VAT which is chargeable on such supply or supplies, and accordingly, if VAT is or becomes chargeable on any such supply or supplies, then the Payor shall pay to the Payee (in addition to and at the same time as paying any other consideration for such supply) an amount equal to the amount of such VAT at the rate prevailing at the time the supply is made on the provision by, or the procurement by, the Payee to the Payor of a VAT invoice or such other documentary evidence as the Applicable Law may require.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.6&nbsp;&nbsp;&nbsp;&nbsp;All amounts specified in this Agreement are exclusive of VAT and any other similar taxes. Those amounts shall be payable by the Payor to the Payee against the presentation of a valid VAT invoice. If applicable, VAT, or any other similar taxes, shall become payable in addition to the amounts specified in this Agreement, subject to the normal rules.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3.7&nbsp;&nbsp;&nbsp;&nbsp;Any reference in <u>Clause 9.3.5</u> and <u>Clause 9.3.6</u> to any Party shall, at any time when such Party is treated as a member of a group for VAT purposes, include (where appropriate and unless the context otherwise requires) a reference to any representative or nominated member of such group charged at such time with the administration, collection and/or payment of VAT to the relevant Tax Authority under Applicable Law.

9.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Records Retention, Audit and Certification</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.1&nbsp;&nbsp;&nbsp;&nbsp;Records Retention

Company will, and will cause its Affiliates and Sublicensees to maintain complete and accurate books, records and accounts containing all particulars necessary for the purpose of the calculation of Net Sales and Sales Milestone Payments payable to C4X hereunder, in sufficient detail to confirm the accuracy of the Royalty and Sales Milestone Payments, which books, records and accounts will be retained by Company, and its Affiliates and Sublicensees as applicable, for two (2) years after the end of the period to which such books, records and accounts pertain.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.2&nbsp;&nbsp;&nbsp;&nbsp;Audit

C4X will have the right to have an independent certified public accounting firm of internationally recognised standing, reasonably acceptable to Company, have access during normal business hours, upon reasonable prior written notice from time to time but not more often than once per Calendar Year (but in any event within thirty (30) days of such notice) during the Term and for one (1) year thereafter, to such records of Company (and its Affiliates and Sublicensees) that are necessary to verify the accuracy of the calculation of the

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Royalty and Sales Milestone Payments (including calculation of Net Sales). Such audits shall be subject to the auditor entering into a customary confidentiality agreement with Company and shall not cover any payment previously audited pursuant hereto .Results of such audits shall be made available to both C4X and Company and shall be final and binding on the Parties (absent manifest error). Unless Company disputes the results of such audit pursuant to <u>Clause 9.4.3</u>, C4X will bear all costs of such audit save where the audit shows an underpayment to C4X of more than [\*\*\*] percent ([\*\*\*]%) of the sum actually paid in which case Company shall reimburse C4X for the costs of such audit. If a Party disputes whether or not there is any manifest error in relation to such results, such Party may refer such dispute to an Expert for determination in accordance with <u>Schedule 2</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.3&nbsp;&nbsp;&nbsp;&nbsp;Over or Underpayment

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;If, based on the results of any audit, additional payments are owed to C4X under this Agreement, then Company shall have the right to obtain, at its sole expense, a second independent certified public accounting firm of internationally recognised standing reasonably acceptable to C4X to verify the accuracy of the calculation of royalties or any other amount payable hereunder (including calculation of Net Sales). If Company does not obtain a second audit or the second audit concurs with the first audit, Company will make such additional payments within forty-five (45) days after the last accounting firm's written report is delivered to the Parties and such payment shall include Interest on the additional payment. If the audits do not concur, the Parties shall and shall procure that their respective accounting firms discuss diligently, reasonably and in good faith to identify the discrepancy between the firms' audit results and agree on a final determinative result. In the event they are unable to agree, the matter shall be finally resolved by an Expert in accordance with <u>Schedule 2</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;If the audit reveals an overpayment by Company, C4X shall reimburse Company the amount of overpayment within forty-five (45) days after the accounting firm's written report is delivered to the Parties and such payment shall include Interest on the overpayment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4.4&nbsp;&nbsp;&nbsp;&nbsp;Confidentiality

All information that is shared in connection with any audit under this <u>Clause 9.4</u> shall be treated by the Parties in accordance with the provisions of <u>Clause 10</u>.

**10.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 10: CONFIDENTIALITY, PUBLICITY AND PUBLICATIONS**

10.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Confidentiality</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.1&nbsp;&nbsp;&nbsp;&nbsp;The Receiving Party shall keep confidential by not disclosing to any Third Party any Confidential Information of the Disclosing Party, and shall not use such Confidential Information except to meet its obligations or exercise its rights expressly given under this Agreement.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Clause 10.1.1</u> does not prohibit the disclosure or use of Confidential Information if and to the extent the Receiving Party may demonstrate with written evidence:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;it is lawfully in the possession of the Receiving Party at the time of disclosure and was not communicated to the Receiving Party subject to any restrictions on disclosure or use,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;it is in the public domain at the time of disclosure hereunder or later enters the public domain through no fault of the Receiving Party or its Affiliates (whether in breach of this Agreement or breach of any other obligation of confidentiality to which the Confidential Information relates),

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;it is received in good faith by the Receiving Party from a Third Party and is not subject to an obligation of confidentiality, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;it is independently developed by the Receiving Party without the aid, use of or reference to Confidential Information received hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.3&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding the foregoing, the Receiving Party may disclose Confidential Information which is required to be disclosed by a court or Governmental Authority (including any stock exchange on which securities issued by the Receiving Party are traded and any Tax Authority) provided, however, that the Receiving Party has, where legally possible, provided reasonable advance notice of the impending disclosure to the Disclosing Party and provided further that the Receiving Party shall only disclose the Confidential Information to the extent legally required (or, in the case of a Tax Authority, in accordance with the common practice of such taxation authority) and to such Governmental Authority only.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.4&nbsp;&nbsp;&nbsp;&nbsp;The Receiving Party agrees to limit disclosure, copying and analysis of the Confidential Information of the Disclosing Party to only those of its Representatives who have a need to know such information to fulfill the provisions and intent of this Agreement, and who are bound by written obligations of confidentiality with respect to such information. The Receiving Party shall be liable for any failure by such Representatives to comply with the confidentiality obligations hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1.5&nbsp;&nbsp;&nbsp;&nbsp;The obligations in this <u>Clause 10</u> shall survive for a period of three (3) years following the expiry or termination of this Agreement.

10.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Publicity and Publications</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2.1&nbsp;&nbsp;&nbsp;&nbsp;Any publication, news release or other public announcement of a Party relating to this Agreement, or a Party's performance hereunder, shall first be reviewed and approved by the other Party, provided, however, that a Party may, once a press release or other public announcement is approved in writing by both Parties (and for clarity, the information in the C4X Press Release in <u>Schedule 5</u> is deemed approved by Company), make subsequent public disclosure of the information contained in such press release or other public announcement without the further approval of the other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2.2&nbsp;&nbsp;&nbsp;&nbsp;The Parties agree that the results of clinical trials to be conducted pursuant to the Development will be published as required by and in accordance with Applicable Laws.

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**11.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 11: INTELLECTUAL PROPERTY RIGHTS**

11.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Filing, Prosecution and Maintenance of Patents</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1.1&nbsp;&nbsp;&nbsp;&nbsp;Subject to <u>Clause 11.1.2</u>, C4X shall use commercially reasonable efforts to prosecute and maintain the C4X Patents in each Major Market and each other country requested by Company, in each case in consultation with Company and at Company's cost. Company shall reimburse C4X for C4X's reasonable out-of-pocket costs arising from such prosecution and maintenance within thirty (30) days of receiving each invoice therefor. In the event that C4X desires to prosecute and maintain Patents in any country that Company has not so requested ("**Additional Country**"), C4X shall notify Company of such desire and, if Company does not instruct C4X to commence prosecution in such Additional Country within thirty (30) after such notice, then C4X may prosecute and maintain C4X Patents in such Additional Country, at C4X's cost. C4X shall provide Company with copies of all material documents relating to the Handling of the C4X Patents in a timely manner. Without limiting the foregoing, C4X shall provide to Company, for review and comment, drafts of filings relating to the C4X Patents no less than seven (7) days prior to making such filing. C4X shall (a) use best efforts to accommodate Company's comments and suggestions in the Handling of C4X Patents (including with respect to Additional Countries) and (b) not take patent prosecution positions in any Additional Countries that would undermine or contradict positions taken in the prosecution of the C4X Patents in any Major Markets or other countries selected by Company or that would otherwise negatively impact the scope or validity of the C4X Patents in any Major Markets or other countries selected by Company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1.2&nbsp;&nbsp;&nbsp;&nbsp;Company shall have the right, but not the obligation, to take over prosecution and maintenance of the C4X Patents on a country-by-country basis, the costs of which shall be borne by Company. The Company may exercise such right at any time. If Company wishes to take over such prosecution and maintenance Company shall notify C4X and C4X shall, with the co-operation of Company, use commercially reasonable efforts to transfer such prosecution and maintenance within any timelines set out in such notice. Company shall provide C4X with copies of all material documents relating to the Handling of such Patents in a timely manner following C4X's request.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1.3&nbsp;&nbsp;&nbsp;&nbsp;Should Company wish to exercise its right under <u>Clause 11.1.2</u>, C4X shall use commercially reasonable efforts to make available to Company its authorised attorneys, agents or representatives, such of its employees as are reasonably necessary to assist Company in obtaining and maintaining the patent protection described under <u>Clause 11.1.2</u>. C4X further consents to the use by Company of the C4X Attorneys for the Handling of the C4X Patents. C4X shall execute or use commercially reasonable efforts to have executed all legal documents necessary to file and prosecute the applicable C4X Patents or to obtain or maintain such C4X Patents.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1.4&nbsp;&nbsp;&nbsp;&nbsp;Should Company, following taking over the maintenance and prosecution of the C4X Patents, decide that it does not desire to Handle any C4X Patent, it shall promptly advise C4X thereof in writing in sufficient time as is reasonably needed so that C4X's rights in such C4X's Patent are not extinguished. C4X may thereafter Handle the same at C4X's own cost and expense, at its sole discretion.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1.5&nbsp;&nbsp;&nbsp;&nbsp;Should C4X wish to exercise its right to Handle the C4X Patents under <u>Clause 11.1.4</u>, Company shall, at C4X's cost, use commercially reasonable efforts to make available to C4X its authorised attorneys, agents or representatives, such of its employees as are reasonably necessary to assist C4X in obtaining and maintaining the patent protection described under <u>Clause 11.1.4</u>. Company shall execute or use commercially reasonable efforts to have executed all legal documents necessary to file and prosecute the applicable C4X Patents or to obtain or maintain such C4X Patents, at C4X's cost.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1.6&nbsp;&nbsp;&nbsp;&nbsp;As between the Parties, Company shall own all rights in and to any Company Applied Patents. Company shall have the first right, but not the obligation, to Handle Company Applied Patents, at its sole cost and expense.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1.7&nbsp;&nbsp;&nbsp;&nbsp;As between the Parties, Company shall own all rights in and to any Joint Patents and such Joint Patents shall be deemed Company Applied Patents. C4X hereby assigns its entire interest in such Joint Patents to Company and shall execute, or cause its employees (or other persons with an obligation to assign their interest in such Joint Patents to C4X) to execute, any documents reasonably requested by Company to perfect Company's title in such Joint Patents.

11.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Cooperation</u>

Each Party shall make available to the other Party (and to the other Party's authorised attorneys, agents or representatives) its employees, agents, subcontractors and consultants and relevant information and documentation in such Party's Control, in each case to the extent reasonably available, necessary and appropriate to enable the prosecuting Party to Handle Patents as set forth in <u>Clause 11.1</u> and for periods of time reasonably sufficient for such Party to obtain the assistance it needs from such personnel. Where appropriate and without prejudice to <u>Clause 11.1</u>, each Party shall execute or use commercially reasonable efforts to procure the execution of all documents relating to such Patent applications or Patents at no charge to the other Party.

11.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Infringement Claims</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3.1&nbsp;&nbsp;&nbsp;&nbsp;Infringement of Third Party Rights

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;Each Party shall promptly, but in any event no later than ten (10) days after receipt of notice of such action, notify the other in writing if any Third Party at any time provides written notice of a claim to, or brings an action, suit or proceeding against, either Party, or any of their respective Affiliates or sublicensees or subcontractors, claiming infringement of its Patent rights or unauthorised use or misappropriation of its Know-How, based upon an assertion or claim arising out of the Development, Manufacture or Commercialisation of a Licensed Product (an "**Infringement Claim**").

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;In the event that such Infringement Claim is brought (i) solely against Company in respect of a Licensed Product or Licensed Compound, (ii) jointly against Company and C4X in respect of a Licensed Product or Licensed Compound or (iii) solely against C4X in respect of a Licensed Product or Licensed Compound which claim against C4X, if successful, would adversely affect Company's rights hereunder, then, in each case, Company shall have the first right but not the obligation to control the defence of such Infringement Claim. If Company assumes the defence of such Infringement Claim,

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Company shall bear the costs of such defence (unless such Infringement Claim is indemnifiable by C4X pursuant to <u>Clause 13.2</u>). C4X will cooperate and assist Company in any such litigation controlled by Company and, unless such Infringement Claim is indemnifiable by C4X pursuant to <u>Clause 13.2</u>, Company shall reimburse C4X for any reasonable out of pocket costs in providing such assistance. For purposes of <u>Clause 11</u>, the Party that defends the Infringement Claim shall be referred to as the "**Controlling Party**". In the event that Company is the Controlling Party in any action that was brought solely against C4X, C4X shall take actions to enable Company to assume control of such action, in the name of C4X if reasonably necessary.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;In the event that such Infringement Claim is brought solely against C4X in respect of a Licensed Product or Licensed Compound, which claim, if successful, would not adversely affect Company's rights hereunder, then C4X shall have the right but not obligation to defend such Infringement Claim at its sole expense, except to the extent such Infringement Claim is indemnifiable by Company pursuant to <u>Clause 13.1</u>. Company shall have the right to participate in (but not control), the defence of such action, at its cost and with its own counsel.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;The Controlling Party will have the exclusive right to hire, dismiss and direct attorney(ies) and/or solicitor(s) to represent it (and in the event that the claim is brought against both Parties, to represent it and the other Party) with respect to the applicable Infringement Claims. The Controlling Party will have the exclusive right to settle any Infringement Claim without consent of the other Party, unless such settlement (i) would have an adverse impact on the other Party's rights or ability to perform its obligations under this Agreement, (ii) makes any admission regarding wrongdoing by the other Party, or the invalidity, unenforceability or absence of infringement of any Licensed Technology, (iii) subjects the other Party to an injunction or other equitable relief, or (iv) obligates the other Party to make a monetary payment, in each such case of (i)-(iv), the consent of the other Party shall be required and shall not be unreasonably withheld or delayed. For purposes of clarity, any settlement that would involve the waiver of rights shall be deemed to have an adverse impact and shall require the consent of such other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;If Company wishes to assume control of the defence of any such Infringement Claim pursuant to <u>Clause 11.3.1(b)(ii)</u> or <u>(iii)</u>, then Company may do so upon written notice to C4X. If Company does not exercise its right to control the defence of an Infringement Claim pursuant to <u>Clause 11.3.1(b)(ii)</u> or <u>(iii)</u>, then the Parties shall jointly control the defence of such Infringement Claim. In such event, each Party shall have the right to retain its own counsel to participate in the defence of such Infringement Claim at its sole expense, and neither Party may settle such Infringement Claim without the consent of the other Party, which consent shall not be unreasonably withheld.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;If either Party becomes engaged in or participate in any suit described in this <u>Clause 11.3</u>, the other Party shall cooperate, and shall cause its and its Affiliates' employees to cooperate, with such Party in all reasonable respects in connection therewith.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;If, as a result of any Infringement Claim, any royalties or other Losses are payable to a Third Party as a result of the Development, Manufacture or Commercialisation of a Licensed Product in the Field, then Company shall be solely responsible for the payment

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of all such amounts, unless such Infringement Claim is indemnifiable by C4X pursuant to <u>Clause 13.2</u>. Any such royalties payable by Company shall be treated as a Third Party royalty payments subject to <u>Clause 8.4</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3.2&nbsp;&nbsp;&nbsp;&nbsp;Infringement by Third Parties

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;In the event that either Party becomes aware of actual or suspected infringement of C4X Patents or misappropriation of C4X Know-How by a Third Party, such Party shall provide written notice thereof to the other Party. In the event of such actual or suspected infringement or defence of declaratory judgement actions regarding Third Party infringement or misappropriation, or the validity or enforceability of the C4X Patents, the following provisions in this <u>Clause 11.3.2</u> shall apply.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;Company shall have the sole right to send written notices, warnings, or claims of infringement to such Third Party that may be infringing or misappropriating the C4X Patents, Company Applied Patents or C4X Know How. Company shall have the first right, but not the obligation, to institute and prosecute an action or proceeding to abate such infringement or misappropriation and to resolve such matter by settlement or otherwise. In the event a declaratory judgement action is brought regarding such Third-Party infringement, misappropriation, or the validity or enforceability of the C4X Patents, Company shall have the right, but not the obligation to be the Controlling Party for such action, even if C4X is the named defendant.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;Company shall be responsible for all costs and expenses of any action or proceeding that Company initiates and maintains C4X shall cooperate fully as may be reasonably requested by Company upon reasonable notice, including by joining as a party claimant if required to do so by Applicable Laws to maintain such action or proceeding, to collect for Company's sole and exclusive benefit any and all damages, profits and awards of any nature recoverable for such infringements, by executing and making available such documents as Company may reasonably request, and by performing all other acts which are or may become necessary to vest in Company the right to institute any such suit, including by using commercially reasonable efforts to obtain any necessary joinder and/or cooperation in any such action or proceeding from applicable Third Parties. Company shall reimburse C4X for its reasonable out-of-pocket expenses in providing such cooperation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;If the Parties obtain any damages, license fees, royalties or other compensation (including any amount received in settlement of such litigation) from a Third Party in connection with a suit brought by a Party pursuant to this <u>Clause 11.3.2</u>, such amounts shall be allocated as follows: (i) in all cases to reimburse each Party for all expenses of such litigation, including reasonable attorneys' fees and disbursements, court costs and other litigation expenses (except attorneys' fees incurred pursuant to <u>Clause 11.3.3</u>) and (ii) the balance shall be retained by Company, with Company paying a Royalty on such recovery as if such recovery were Net Sales of Licensed Product hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Right to Participate</u>. C4X may, at its option and cost, participate in an advisory (and not controlling) capacity in any action brought pursuant to <u>Clause 11.3</u> in which Company is the Controlling Party.

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11.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Patent Term Extensions</u>

C4X shall and shall use reasonable efforts to procure that its Affiliates and any relevant Third Parties cooperate fully with Company to obtain any Patent term extensions, adjustment, restorations or supplemental protection certificates, including making available all required regulatory data and information under its Control and executing any required authorisations. All reasonable out-of-pocket expenses incurred by C4X in connection with cooperation under this <u>Clause 11.4</u> shall be borne by Company.

**12.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 12: REPRESENTATIONS, WARRANTIES AND UNDERTAKINGS**

12.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Representations and Warranties</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.1.1&nbsp;&nbsp;&nbsp;&nbsp;Mutual Representations and Warranties

Each of the Parties hereby represents and warrants to the other Party that, as of the Effective Date:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;such Party is duly organised, validly existing and in good standing under the laws of its jurisdiction of incorporation or organisation, as applicable. Such Party has full corporate (or other organisational) right, power and authority to enter into this Agreement and to perform its respective obligations under this Agreement and that it has the right to grant the rights, licenses and sub-licenses granted pursuant to this Agreement,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;this Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms, except to the extent that the enforceability may be limited by applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium or similar laws from time to time in effect affecting generally the enforcement of creditors' rights and general principles of equity. The execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it (or any of its Affiliates) is a Party or by which it (or any of its Affiliates) is bound, nor, to its knowledge, violate any Applicable Law of any Governmental Authority having jurisdiction over it (or any of its Affiliates),

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;the Person executing this Agreement on behalf of such Party is duly authorised to do so by all requisite corporate action (or other organisational action, as applicable), and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;each Party has obtained all necessary consents, approvals and authorisations of all Governmental Authorities and other Persons required to be obtained by it as of the Effective Date in connection with the execution, delivery and performance of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.1.2&nbsp;&nbsp;&nbsp;&nbsp;Additional Representations and Warranties of C4X

C4X hereby represents and warrants to Company that, as of the Effective Date:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;except as set forth on <u>Schedule 7</u>, C4X exclusively owns all right, title and interest in and to the Licensed Technology, free and clear of all liens, security interests and encumbrances, except for the license granted to Company herein. <u>Schedule 7</u> sets forth

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a true and complete list of all (i) existing licenses and CMO agreements relating to the Licensed Technology and (ii) any other agreements with respect to the Licensed Technology that could impact Company's Development or Commercialization of the Licensed Compounds or Licensed Products,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;no existing licenses, CMO or other agreements relating to the Licensed Technology will impact Company's rights herein or impose any obligations on Company, unless such agreements are transferred to Company pursuant to <u>Clause 6.12</u>,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;all the C4X Patents existing as of the Effective Date are identified in <u>Schedule 1</u>,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;the contents of the Data Room are accurate and complete in all material respects,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;C4X has not withheld from Company any material information relating to the Licensed Technology which would result in the contents in the Data Room or the statements contained herein being misleading,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;C4X has not received written notice from a Third Party alleging that the practice of the C4X Patents or the Licensed Technology infringe the Patent or other proprietary rights of such Third Party,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;C4X has not received any claim made against it in writing asserting the invalidity or unenforceability of any of the C4X Patents (excluding any search reports and correspondence or communications with patent offices), and no claim or demand of any Person has been asserted in writing to C4X that challenges C4X's ownership of or the rights of C4X to use or license any of the Licensed Technology,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h)&nbsp;&nbsp;&nbsp;&nbsp;C4X has not granted any Third Party (including any Affiliate or investor in C4X) any right, title or interest to, or any encumbrances over, the Licensed Technology, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;C4X its Affiliates, and any inventors of the C4X Patents have complied with their duty of candor and disclosure to the United States Patent and Trademark Office ("**USPTO**") with respect to those C4X Patents being prosecuted in the United States, and have also complied with any similar rules applicable in any relevant foreign patent office where C4X Patents are being prosecuted, and all material prior art to the C4X Patents has been cited the USPTO,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(j)&nbsp;&nbsp;&nbsp;&nbsp;C4X does not have any actual knowledge that the development manufacture, sale or commercialisation of the C4X_3256 would infringe any Intellectual Property Rights of any Third Party,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(k)&nbsp;&nbsp;&nbsp;&nbsp;C4X has not misappropriated trade secrets or misused the confidential information of any Third Party in developing the Licensed Technology,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(l)&nbsp;&nbsp;&nbsp;&nbsp;C4X does not have actual knowledge that a Third Party is infringing or misappropriating the Licensed Technology (for clarity C4X has not conducted any literature searches or competitor analysis),

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(m)&nbsp;&nbsp;&nbsp;&nbsp;C4X has taken reasonable measures to protect the confidentiality of the C4X Know How and, to C4X's knowledge, the C4X Know How remains a protected trade secret of C4X,

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(n)&nbsp;&nbsp;&nbsp;&nbsp;all applications, filings, registrations, renewals and fees payable in respect of the C4X Patents have been made/paid when due and none is outstanding.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.1.3&nbsp;&nbsp;&nbsp;&nbsp;Additional Representations and Warranties of Company

Company hereby represents and warrants to C4X that, as of the Effective Date, it:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;has the financial, technical and human resources and expertise to comply with its obligations hereunder, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;does not have any actual knowledge that it does Control or otherwise have any rights in any compound that has the Mechanism of Action.

12.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Disclaimer</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.1&nbsp;&nbsp;&nbsp;&nbsp;C4X has not conducted human clinical testing of any Licensed Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.2&nbsp;&nbsp;&nbsp;&nbsp;Save as expressly provided in <u>Clause 12.1.2</u>, to the fullest extent permissible by law, and save as expressly set forth above, C4X does not make any warranties of any kind including warranties with respect to:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;merchantability or fitness for a particular purpose of the Data,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;the Data not being subject to errors or defects,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;the quality of the Licensed Technology,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;the suitability of the Licensed Technology for any particular use,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;whether use of the Licensed Technology and/or Data will infringe Third Party rights, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;whether any relevant Patent applications will be granted or the validity of any Patent that issues in response to such applications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.3&nbsp;&nbsp;&nbsp;&nbsp;Each Party acknowledges that the Licensed Technology and the Development (including without limitation any clinical trials) is experimental and exploratory in nature and that neither C4X nor Company makes any representation or warranty that it shall be successful nor that it shall result in any Licensed Products or Commercialisation.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.4&nbsp;&nbsp;&nbsp;&nbsp;Except as otherwise provided in this Agreement, the foregoing representations and warranties are the sole and exclusive representations and warranties, express, statutory or implied and whether written or oral related to the subject matter of this Agreement, including without limitation, warranties of merchantability or fitness for a particular purpose of products (including Licensed Products) or non-infringement. Further, any advice given to Company under <u>Clauses 6.2.5</u> and/or <u>6.3.2</u> by C4X comes with no representations or warranties, express or implied, including any warranty of merchantability or fitness for a particular purpose or non-infringement.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.2.5&nbsp;&nbsp;&nbsp;&nbsp;Company acknowledges that it has relied solely upon (a) its own investigation and analysis, (b) the representations and warranties of C4X expressly set forth in this Agreement and (c) the contents of the Data Room in entering into this Agreement.

12.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Undertakings of C4X</u>

C4X shall, during the Term:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.3.1&nbsp;&nbsp;&nbsp;&nbsp;not assign, transfer, convey or otherwise encumber its right, title and interest in the Licensed Technology without the prior written consent of Company, except (a) as expressly set forth in <u>Clause 28</u> and (b) C4X may assign its rights to payments or revenues hereunder,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.3.2&nbsp;&nbsp;&nbsp;&nbsp;not grant any rights to any Third Party in or relating to the Licensed Technology that are inconsistent with, or impose any limitations on, the license granted to Company herein,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.3.3&nbsp;&nbsp;&nbsp;&nbsp;comply with all Applicable Laws in connection with the performance of its obligations hereunder, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.3.4&nbsp;&nbsp;&nbsp;&nbsp;not to employ or directly or indirectly solicit or endeavour to entice away from the employment of Company any of Company's employees, contractors or consultants, either now or in the future, involved in the Commercialisation of the Licensed Compounds or Licensed Products.

C4X shall deliver to Company one copy of a compact disc or DVD-ROM containing a true, correct and complete copy of the materials in the Data Room no more than ten (10) days after the Effective Date.

12.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Undertakings of Company</u>

Company shall, during the Term:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.4.1&nbsp;&nbsp;&nbsp;&nbsp;comply with all Applicable Laws in the Development, Manufacturing, Commercialisation and disposal of the Licensed Products and the elements contained therein,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.4.2&nbsp;&nbsp;&nbsp;&nbsp;to the extent permitted by Applicable Law, notify C4X in writing after Company determines that a clinical trial for a Licensed Product or Licensed Compound will be put on a long-term or indefinite hold or will be terminated. Company will use its best efforts to notify C4X within forty-eight (48) hours of making such determination, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.4.3&nbsp;&nbsp;&nbsp;&nbsp;not employ or directly or indirectly solicit or endeavour to entice away from the employment of C4X any of C4X's employees, contractors or consultants involved in the discovery and development of Licensed Compounds.

**13.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 13: INDEMNIFICATION**

13.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Indemnification by Company</u>

Company shall defend, indemnify and hold harmless C4X and its Affiliates and each of their officers, directors, shareholders, employees, successors and permitted assigns ("**C4X Indemnitees**") from and against all Third Party Claims, and all associated Losses arising out of (a) Company's negligence,

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recklessness or wilful misconduct in performing any of its obligations under this Agreement, (b) a breach by Company of any of its representations, warranties, covenants or obligations under this Agreement, and (c) the Development, Manufacture, use, or Commercialisation of the Licensed Compounds and/or Licensed Products by, or on behalf of, Company, its Affiliates and/or its Sublicensees, provided, however, that in all cases referred to in this <u>Clause 13.1</u>, Company shall not be liable to indemnify C4X Indemnitees for any Losses of C4X Indemnitees to the extent that such Losses are indemnifiable by C4X pursuant to <u>Clause 13.2</u>.

13.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Indemnification by C4X</u>

C4X shall defend, indemnify and hold harmless Company and its Affiliates and each of their officers, directors, shareholders, and employees successors and permitted assigns ("**Company Indemnitees**") from and against all Third Party Claims, and all associated Losses arising out of (a) C4X's negligence, recklessness or wilful misconduct in performing any of its obligations under this Agreement, or (b) a breach by C4X of any of its representations or warranties, covenants or obligations under this Agreement, provided however, that in all cases referred to in this <u>Clause 13.2</u>, C4X shall not be liable to indemnify Company Indemnitees for any Losses of Company Indemnitees to the extent that such Losses of Company Indemnitees are indemnifiable by Company pursuant to <u>Clause 13.1</u>.

13.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Procedure for Indemnification</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.1&nbsp;&nbsp;&nbsp;&nbsp;Each Party, on behalf of itself and its respective C4X Indemnitees or Company Indemnitees (each such Person, an "**Indemnitee**"), shall provide the other Party ("**Indemnifying Party**") prompt written notice of any Claim for which such Indemnitee intends to seek indemnification under this Agreement, provided, however, that failure to give such notification shall not affect each applicable Indemnitee's entitlement to indemnification (or the corresponding indemnifying Party's indemnification obligations) hereunder except to the extent that the indemnifying Party shall have been materially prejudiced as a result of such failure. The Indemnifying Party shall have the initial right (but not obligation) to defend any Claim for which an Indemnitee seeks indemnification under this Agreement as contemplated in the preceding sentence so long as the Indemnifying Party provides notice of its assumption of defence within thirty (30) days of receiving such indemnification notice. If the Indemnifying Party fails to state in a written notice during such thirty (30) day period its willingness to assume the defence of such a Claim, C4X Indemnitee(s) or Company Indemnitee(s), as the case may be, shall have the right to defend, settle or otherwise dispose of such Claim at the Indemnifying Party's cost, subject to the terms hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.2&nbsp;&nbsp;&nbsp;&nbsp;The Indemnifying Party may enter into any settlement with respect to, any such Claim for which it has assumed defence, <u>provided</u> that such settlement (a) includes an unconditional release of the Indemnitee from any and all liability to any Third Party, (b) does not adversely affect the Indemnitee's rights hereunder or impose any obligations on the Indemnitee in addition to those set forth herein, (c) does not involve any injunctive or other equitable relief which would be imposed on Indemnitee, and (d) does not provide for any finding or admission of a violation of law or violation of the rights of any Person by the Indemnitee or any of its Affiliates. The Indemnitee, its employees, agents and Affiliates shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defence of any action, claim or liability covered by this indemnification. The Indemnitee shall have the right, but not the obligation to be represented by counsel of its own selection and at its own expense.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3.3&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding <u>Clauses 13.3.1</u> and <u>13.3.2</u>, upon written notice to the Indemnifying Party, an Indemnitee shall be entitled to assume the defence of any Third Party Claim for which it has sought indemnification hereunder, in which case the Indemnifying Party shall be relieved of liability under <u>Clause 13.1</u> or <u>13.2</u>, as applicable, solely for such Third Party Claim and related Losses. In such event, the Indemnitee may enter into any settlement with respect to, such Third Party Claim, provided that such settlement (a) does not adversely affect the Indemnifying Party's rights hereunder or impose any obligations on the Indemnifying Party in addition to those set forth herein, (b) does not involve any injunctive or other equitable relief which would be imposed on Indemnifying Party, and (c) does not provide for any finding or admission of a violation of law or violation of the rights of any Person by the Indemnifying Party or any of its Affiliates.

**14.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 14: LIABILITY**

14.1&nbsp;&nbsp;&nbsp;&nbsp;Subject to <u>Clause 14.2</u>, under no circumstances shall either Party be liable to the other Party under any legal or equitable claim or cause of action, whether in contract, tort or otherwise, for indirect, special or consequential damages (including, without limitation, loss of profits).

14.2&nbsp;&nbsp;&nbsp;&nbsp;Notwithstanding any other provision of this Agreement, the liability of the Parties shall not be limited in any way in respect of the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.2.1&nbsp;&nbsp;&nbsp;&nbsp;death or personal injury caused by negligence,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.2.2&nbsp;&nbsp;&nbsp;&nbsp;fraud or fraudulent misrepresentation, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.2.3&nbsp;&nbsp;&nbsp;&nbsp;any other losses which cannot be excluded or limited by Applicable Laws.

**15.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 15: SET-OFF**

15.1&nbsp;&nbsp;&nbsp;&nbsp;Subject to <u>Clauses 8.4.1</u> and <u>15.2</u>, each Party must pay all sums that it owes to the other Party under this Agreement free and clear without any set-off, counterclaim, deduction or withholding of any kind, save as may be required by law.

15.2&nbsp;&nbsp;&nbsp;&nbsp;The Parties acknowledge and agree that if C4X should breach its obligations in <u>Clauses 2.5.1</u> and/or <u>10</u>, any award of damages that C4X owes to Company may be set off from any amount due to C4X from Company.

**16.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 16: ANTI-BRIBERY**

16.1&nbsp;&nbsp;&nbsp;&nbsp;Each Party shall comply with applicable Bribery Legislation, including ensuring that it has in place adequate procedures to ensure compliance with the Bribery Legislation and each shall ensure that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.1.1&nbsp;&nbsp;&nbsp;&nbsp;all of such Party's personnel,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.1.2&nbsp;&nbsp;&nbsp;&nbsp;all others associated with such Party, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16.1.3&nbsp;&nbsp;&nbsp;&nbsp;each of such Party's sub-contractors,

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involved with this Agreement so comply. The expressions 'adequate procedures' and 'associated' shall be construed in accordance with the Bribery Act 2010 and documents published by or on behalf of the applicable Governmental Authority in connection with it.

16.2&nbsp;&nbsp;&nbsp;&nbsp;Without limitation to <u>Clause 16.1</u>, neither Party shall make or receive any bribe (as defined in the Bribery Act 2010) or other improper payment, or allow any such to be made or received on its behalf, either in the UK or elsewhere, and will implement and maintain adequate procedures to ensure that such bribes or payments are not made or received directly or indirectly on its behalf.

**17.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 17: TERM**

The term of this Agreement shall commence on the Effective Date and shall continue on a Licensed Product-by-Licensed Product basis until the expiration of the last Royalty Term with respect to such Licensed Product anywhere in the world (the "**Term**"), in each case, unless earlier terminated by a Party in accordance with <u>Clause 18</u>. Upon expiration of this Agreement with respect to a Licensed Product, Company shall have a non-exclusive, perpetual, fully paid-up, royalty-free license of the scope described in <u>Clause 2.1</u> above.

**18.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 18: TERMINATION**

18.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Both Parties</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.1&nbsp;&nbsp;&nbsp;&nbsp;Subject to <u>Clause 18.1.2</u>, without prejudice to any other rights under this Agreement, each Party shall be entitled to terminate this Agreement with immediate effect by written notice to the other Party in the event that the other Party commits a material breach of its obligations under this Agreement (being one that deprives such Party of the whole or substantially the whole of its benefit under this Agreement) and fails to cure such breach within six months after receipt of a written notice thereof from the Party not in breach giving full particulars of the breach and requiring it to be remedied.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.1.2&nbsp;&nbsp;&nbsp;&nbsp;Without prejudice to any other rights that C4X may have under this Agreement, the Parties acknowledge and agree that C4X may only terminate this Agreement for material breach of Company's obligations under <u>Clause 7.2</u> ("**Diligence Obligations**"), until the date upon which Company or any of its Affiliates, or Sublicensees achieves the first commercial sale of any Licensed Product to a Third Party in the US following the applicable Regulatory Approval of the Licensed Product in the US. Following such date, C4X may no longer terminate this Agreement for material breach of the Diligence Obligations.

18.2&nbsp;&nbsp;&nbsp;&nbsp;<u>C4X Termination</u>. Without prejudice to any other rights under this Agreement, C4X shall have the right to terminate this Agreement immediately:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.2.1&nbsp;&nbsp;&nbsp;&nbsp;upon (a) the insolvency of, assignment for the benefit of creditors by, or the initiation of insolvency proceedings by Company or (b) the initiation of insolvency proceedings against Company without Company's consent if such proceeding is not dismissed within 90 days, or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;18.2.2&nbsp;&nbsp;&nbsp;&nbsp;if Company opposes or challenges the validity of the Licensed Technology.

18.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Company Termination</u>. Without prejudice to any other rights under this Agreement, Company shall have the right to terminate this Agreement in its entirety or with respect to one or more

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countries or Products, without cause, upon ninety (90) days' prior written notice to C4X. Company shall include in such notice whether or not the applicable Licensed Product is Viable.

18.4&nbsp;&nbsp;&nbsp;&nbsp;The Parties acknowledge and agree that upon the insolvency of, assignment for the benefit of creditors by, or the initiation of administration proceedings by or against, C4X this Agreement shall not terminate and shall remain in full force and effect in accordance with the terms hereof.

**19.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 19: EFFECTS OF TERMINATION**

19.1&nbsp;&nbsp;&nbsp;&nbsp;The following provisions in this <u>Clause 19</u> shall apply upon termination of this Agreement by C4X under <u>Clause 18.1</u> or <u>18.2</u> or by Company under <u>Clause 18.3</u> (without prejudice to any other remedies which may be available to a Party under Applicable Laws or in equity).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.1.1&nbsp;&nbsp;&nbsp;&nbsp;<u>Termination of Rights and Licenses</u>

In the event that this Agreement is terminated in pursuant to <u>Clause 18.1</u> or <u>18.2</u> by C4X or by Company pursuant to Clause <u>18.3</u> in its entirety or in respect of certain Licensed Products, all rights and licenses granted to Company in respect of the Licensed Products subject to such termination shall terminate as of such termination date, and Company shall (and shall procure that its Affiliates and Sublicensees shall) immediately cease Developing, Manufacturing and Commercialising such Licensed Product (except as otherwise set forth in this <u>Clause 19.1</u>). Notwithstanding the foregoing, Company may complete and sell any work-in-progress and inventory of the Licensed Products that exist as of the termination date for a period of six (6) months after the termination date, provided that Company pays C4X the applicable amounts due on such sales of Licensed Products in accordance with <u>Clause 8</u>. Upon expiration of such six (6) month period, at C4X's option, Company shall sell to C4X at cost any stock of Licensed Product remaining.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.1.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Company Obligations</u>

In the event that this Agreement is terminated (a) pursuant to <u>Clause 18.1</u> or <u>18.2</u> by C4X or (b) pursuant to <u>Clause 18.3</u> by Company with respect to a Licensed Product that is Viable, Company shall:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;subject to <u>Clause 19.1.2(b)</u>, at Company's cost and expense, bring to a close any existing clinical trial for the Licensed Product(s) subject to such termination in a controlled and ordered manner and at all times in accordance with the directions and guidance of the relevant Governmental Authority,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;if so requested by C4X, assign and transfer to C4X, at C4X's cost and expense, to the extent assignable by Company in accordance with Applicable Laws, the management and continued performance of any clinical trials for any Licensed Product that is subject to such termination ongoing as of the effective date of such termination (provided that if the management and continued performance thereof is not assignable, then at the request of C4X, Company shall be responsible for completing (in accordance with the established protocols and its customary business practices) such clinical trials),

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;use reasonable efforts to assign and transfer to C4X, within sixty (60) days of the date of termination, any and all Regulatory Approvals and Regulatory Materials for the Licensed Products subject to such termination,

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;to the extent that any of the foregoing items set forth in this <u>Clause 19.1.2</u> are owned or otherwise controlled by an Affiliate or Sublicensee of Company, use reasonable efforts to procure that such Affiliate or Sublicensee make the assignments to C4X or otherwise meets the obligations as set forth in this <u>Clause 19.1.2</u>,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;grant to C4X a non-exclusive, irrevocable, transferable, royalty-free license (or sub-license as applicable), solely in the country(ies) that the license granted in <u>Clause 2</u> has been terminated, with unrestricted rights to sub-license and sub-contract to use any and all (i) Company Applied Patents exclusively related to the Licensed Compounds and Company Applied Know-How exclusively related to the Licensed Compounds, in each case to Develop, make, use, import, sell and offer for sale Licensed Product in the Field, and (ii) other Intellectual Property Rights owned by Company and exclusively related to the Licensed Products (including any trade mark or brand name, being a Licensed Product Trade Mark or otherwise) to use, research, develop, have developed, make, have made, sell, offer to sell, import, export or otherwise dispose of any Licensed Products. For clarity, the use of any trade mark or brand name under this <u>Clause 19.1.2(e)</u>, shall exclude any general corporate branding, such as Company's company name and logo or the company name and logo of its Affiliates,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;within a reasonable time after such termination, use commercially reasonable efforts to assist Company in identifying the Company Applied Patents and accessing any documentation reasonably necessary to allow C4X to enjoy its non-exclusive license rights under <u>Clause 19.1.2(e)</u>, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;with respect to any Company Applied Know-How referenced in <u>Clause 19.1.2(e)</u>, (i) deliver to C4X a copy of the physical embodiment of such Company Applied Know-How exclusively related to the Licensed Compound and is embodied in documents or biological or chemical materials, and to the extent that such Company Applied Know-How is not fully embodied in documents or biological or chemical materials, Company shall procure that its employees and agents who have knowledge of such Company Applied Know-How use commercially reasonable efforts to fully embody the same and (ii) provide such technical assistance and documentation (including the Drug Master File) as is necessary to enable transfer of the Manufacturing technology to C4X's chosen Third Party manufacturer.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h)&nbsp;&nbsp;&nbsp;&nbsp;In the event this Agreement is terminated (a) pursuant to <u>Clause 18.1</u> or <u>18.2</u> by C4X or (b) pursuant to <u>Clause 18.3</u> by Company with respect to a Licensed Product that is not Viable, the Company shall fulfil the obligations set forth in sub-Clauses (c), (d), (e), (f), and (g) above.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.1.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Return of Confidential Information</u>

Upon termination of this Agreement in its entirety pursuant to <u>Clause 18.1</u> or <u>18.2</u> by C4X or by Company pursuant to <u>Clause 18.3</u>, Company shall, at C4X's option, either return to C4X all tangible Confidential Information disclosed to Company by or on behalf of C4X or destroy such Confidential Information, provided that Company shall have the right to retain one (1) copy of the Confidential Information in a secure location solely for purposes of identifying its confidentiality obligations under <u>Clause 10</u>. Upon termination by C4X or by Company, Company shall use reasonable efforts to delete all electronic copies of such Confidential

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Information from its systems (other than Confidential Information stored on electronic archival, back-up, security, or disaster recovery systems). Upon termination, C4X shall, at Company's option, either return to Company all tangible Confidential Information disclosed to C4X by or on behalf of Company (including all copies thereof) or destroy such Confidential Information, provided that C4X shall have the right to retain one (1) copy of the Confidential Information in a secure location solely for purposes of identifying its confidentiality obligations under <u>Clause 10</u>. C4X shall use reasonable efforts to delete all electronic copies of such Confidential Information from its systems other than Confidential Information stored on electronic archival, back-up, security, or disaster recovery systems).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;19.1.4&nbsp;&nbsp;&nbsp;&nbsp;<u>Company Applied Patents</u>

Nothing in this Agreement shall require Company to assign or transfer any rights in the Company Applied Patents to C4X.

19.2&nbsp;&nbsp;&nbsp;&nbsp;<u>Accrued Rights</u>

Termination or expiration of this Agreement for any reason will be without prejudice to and shall not affect any accrued rights, remedies and/or liabilities of either Party at any time up to the date of termination or expiry of this Agreement. Such termination or expiration will not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement nor shall it relieve Company of any obligation to make payments under <u>Clauses 8.2</u> and <u>8.3</u> in respect of Development Milestone Events and Sales Milestones achieved or Net Sales of the Licensed Product made up to the effective date of termination or pursuant to <u>Clause 19.1.1</u>.

19.3&nbsp;&nbsp;&nbsp;&nbsp;<u>Survival</u>

The following Clauses, together with any definitions used and Schedules referenced therein, will survive any termination or expiration of this Agreement: <u>Clauses 1, 2.6, 8.4, 9.4.2, 10, 11.1.4, 11.1.5, 11.1.6, 11.1.7, 11.3, 12.2, 13, 14, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 34, 35, 36 and 37</u>.

**20.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 20: DISPUTE RESOLUTION**

20.1&nbsp;&nbsp;&nbsp;&nbsp;The Parties recognise that, from time to time during the Term, disputes may arise as to certain matters which relate to either Party's rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this <u>Clause 20</u> to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement.

20.2&nbsp;&nbsp;&nbsp;&nbsp;With respect to all disputes arising between the Parties, including any alleged failure to perform, or breach, of this Agreement, or any issue relating to the interpretation or application of this Agreement, if the Parties are unable to resolve such dispute within [\*\*\*] days after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to a designee from senior management with decision-making authority (the "**Designee**") for attempted resolution by good-faith negotiations within [\*\*\*] days after such notice is received.

20.3&nbsp;&nbsp;&nbsp;&nbsp;If the Designees are not able to resolve such dispute referred to them under <u>Clause 20.2</u> within such [\*\*\*] day period, then the dispute shall be referred to the respective Chief Executive Officers of the Parties.

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20.4&nbsp;&nbsp;&nbsp;&nbsp;If the Chief Executive Officers are not able to resolve such dispute referred to them under <u>Clause 20.3</u> within a [\*\*\*] day period from the date of such referral to the Chief Executive Officers, then the dispute shall be referred to the respective Chairs of the Board of the Parties.

20.5&nbsp;&nbsp;&nbsp;&nbsp;If the Chairs of the Board cannot resolve the dispute within [\*\*\*] days of it having been referred to them the matter may be submitted for litigation in accordance with the terms of this Agreement save that any matters that are specifically stated herein to be for reference for determination by an Expert, shall be so referred to the Expert.

**21.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 21: INJUNCTIVE RELIEF**

Notwithstanding anything to the contrary in this Agreement, either Party will have the right to seek temporary or permanent injunctive relief in any court of competent jurisdiction as may be available to such Party under the laws and rules applicable in such jurisdiction with respect to any matters arising out of the other Party's performance of its obligations under this Agreement and, for clarity, the Parties are not required to comply with <u>Clause 20</u> before seeking interim injunctive relief.

**22.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 22: INSURANCE**

Each Party shall, during the Term and [\*\*\*] years thereafter, carry comprehensive insurance and in such amounts as a prudent business person would carry to cover such Party's obligations under this Agreement.

**23.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 23: ENTIRE AGREEMENT**

23.1&nbsp;&nbsp;&nbsp;&nbsp;This Agreement (including the Schedules) contains all the terms agreed by the Parties in relation to its subject matter and supersedes any and all prior agreements, understandings or arrangements between them, whether oral or in writing in relation to such matters. Without limiting <u>Clause 14.2</u> neither Party shall have any right or liability in respect of any statement, representation or promise made prior to the date of this Agreement. Nothing herein shall prevent or restrict either Party's rights to pursue remedies for breach provided for in this Agreement. The Parties acknowledge and agree that Third Party Claims shall be exclusively governed by <u>Clause 13</u>.

23.2&nbsp;&nbsp;&nbsp;&nbsp;Each Party acknowledges and accepts that, in entering into this Agreement, it has not relied upon any statement, representation, warranty or promise except as set out in this Agreement.

**24.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 24: FORCE MAJEURE**

The failure of either of the Parties to perform any obligation under this Agreement solely by reason of Force Majeure shall not be deemed to be a breach of this Agreement, provided, however, that the Party so prevented from complying herewith shall continue to take all reasonable actions within its power to comply as fully as possible herewith.

**25.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 25: NOTICES**

Any notice or written communication given under or in relation to this Agreement shall be in writing and sent to a Party's address as set forth below or to such other address as it has previously notified to the sending Party in writing Notices may be given, and shall be deemed received by express courier service (signature required), the next Business Day, by registered or certified mail (return

------

receipt requested or its equivalent), seven (7) Business Days after posting, and by hand, upon delivery.

Notices sent to C4X shall be addressed to:

C4X Discovery Limited

Manchester One

53 Portland Street

Manchester

M1 3LD

Notices sent to Company shall be addressed to:

Indivior UK Limited

103-105 Bath Road

Slough, Berkshire

SL1 SUH

Attention: Assistant General Counsel, EMEA

With a copy to:

Indivior Inc.

10710 Midlothian Turnpike

Suite 430

North Chesterfield, VA 23235

Attention: Chief Legal Officer

and

K&L Gates LLP

599 Lexington Avenue

New York, NY 10022

Attn: [\*\*\*]

**26.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 26: INDEPENDENT CONTRACTORS**

For the purposes of this Agreement, each Party shall be an independent contractor and nothing in this Agreement shall create a partnership or joint venture. Neither Party is an agent or employee of the other Party and neither Party shall have the authority or power to make any statements, representations or commitments of any kind, nor to take any action which is binding on the other Party, except as may be explicitly provided for herein or authorised by the other Party in writing.

**27.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 27: RECORDATION**

Company may, at its cost and discretion, record in any country the license granted herein, including by use of a short form document, as permitted or required by Applicable Law or otherwise, including recording a security interest in those jurisdictions which permit a licensee to do so. C4X hereby irrevocably designates and appoints Company and its duly authorized officers and agents, as C4X's agent and attorney-in-fact to execute such documents and to do all other acts necessary or useful to record the license granted herein. C4X shall, upon request and at Company's cost, give to Company

------

such reasonable assistance as Company may reasonably request in connection with recording the license.

**28.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 28: ASSIGNMENT**

28.1&nbsp;&nbsp;&nbsp;&nbsp;This Agreement and all rights and obligations hereunder are personal to the Parties hereto and may not be assigned, novated or subcontracted without the prior written consent of the other Party hereto, except (a) as set forth in <u>Clauses 2.2</u> and <u>12.3</u> and (b) either Party shall be entitled to assign, novate, subcontract or delegate this Agreement (in whole or in part) to a Third Party taking over all or substantially all of its business or, subject to <u>Clause 28.2</u>, to an Affiliate of such Party provided such Affiliate or Third Party agrees to be bound by all terms and conditions hereof. The identity of such Affiliate or Third Party to whom a Party assigns, novates or subcontracts this Agreement in accordance with the foregoing shall be disclosed in writing to the other Party upon such assignment, novation or subcontracting. Except as expressly set out herein, any assignment or sub-contracting, or attempt at the same, in the absence of such prior written consent shall be void and without effect.

28.2&nbsp;&nbsp;&nbsp;&nbsp;Company acknowledges and agrees that to the extent that any of Company's obligations herein are sublicensed, sub-contracted or delegated to an Affiliate of Company, Company shall be responsible for any breaches by such Affiliate to such obligations as if such breach was committed by Company.

**29.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 29: COUNTERPARTS**

This Agreement may be executed in any number of counterparts, each of which when executed and delivered shall constitute an original of this Agreement, but all the counterparts shall together constitute the same agreement.

**30.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 30: FURTHER ASSURANCE**

Each of the Parties shall take, or cause to be taken, all actions necessary, proper, or advisable under Applicable Laws to give effect to the provisions of this Agreement. Without limiting the foregoing, each Party shall, at its own cost and expense, use commercially reasonable efforts procure that any necessary Third Party shall, promptly execute and deliver such documents and perform such acts as may be required for the purpose of giving full effect to this Agreement.

**31.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 31: THIRD PARTY RIGHTS**

The Contracts (Rights of Third Parties) Act 1999 shall not apply to this Agreement and no person other than the Parties shall have any rights under it.

**32.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 32: SEVERABILITY**

32.1&nbsp;&nbsp;&nbsp;&nbsp;If any provision of this Agreement (or part of a provision) is found by any court or administrative body of competent jurisdiction to be invalid, unenforceable or illegal, the other provisions shall remain in force.

32.2&nbsp;&nbsp;&nbsp;&nbsp;If any provision of this Agreement (or part of any provision) is or becomes illegal, invalid or unenforceable but would be legal, valid and enforceable if some part of it was deleted or modified, the provision or part-provision in question shall apply with such deletions or modifications as may

------

be necessary to make the provision legal, valid and enforceable. In the event of such deletion or modification, the Parties shall negotiate in good faith and acting reasonably in order to agree the terms of a mutually acceptable alternative provision.

**33.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 33: EXPENSES**

Except as expressly provided for in this Agreement, each Party shall pay its own costs and expenses incurred in connection with negotiating, preparing and executing this Agreement.

**34.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 34: VARIATION**

No variation of or amendment to this Agreement shall be effective unless made in writing and signed by authorised representatives of the Parties.

**35.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 35: WAIVERS**

The failure or delay of either Party to enforce or to exercise, at any time or for any period of time, any term of or any right, power or privilege arising pursuant to this Agreement does not constitute and shall not be construed as a waiver of such term, right, power or privilege and shall in no way affect either Party's right later to enforce or exercise it, nor shall any single or partial exercise of any remedy, right, power or privilege preclude any further exercise of the same or the exercise of any other remedy, right, power or privilege.

**36.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 36: GOVERNING LAW**

This Agreement and any dispute or claim arising out of, or in connection with, it, its subject matter or formation (including non-contractual disputes or claims) shall be governed by, and construed in accordance with, the laws of England and Wales.

**37.&nbsp;&nbsp;&nbsp;&nbsp;CLAUSE 37: JURISDICTION**

The Parties irrevocably agree that the courts of England shall have exclusive jurisdiction to settle any dispute or claim arising out of, or in connection with, this Agreement, its subject matter or formation (including non-contractual disputes or claims).

------

**IN WITNESS WHEREOF**, the Parties have executed this Agreement through their duly authorised representatives.

**SIGNED** for and on behalf of **C4X DISCOVERY LIMITED**

---

| | |
|:---|:---|
| */s/ Craig Fox* | */s/ Craig Fox* |
| Name: | Craig Fox |
| Title: | Chief Scientific Officer |
| Date: | 3/28/2018 |
| */s/ Brad Hoy* | */s/ Brad Hoy* |
| Name: | Brad Hoy |
| Title: | Chief Financial Officer |
| Date: | 3/28/2018 |

---

**SIGNED** for and on behalf of **INDIVIOR UK LIMITED**

---

| | |
|:---|:---|
| */s/ Gilles Picard* | */s/ Gilles Picard* |
| Name: | Gilles Picard |
| Title: | SVP, Strategy & EMEA, Commercial |
| Date: | 43187 |

---

------

**SCHEDULES LIST**

1 - C4X Patents

2 - Expert

3 - Inventory

4 - Bi-Annual Report

5 - C4X Press Release

6 - Data Room Index

7- Material Agreements

------

**SCHEDULE 1**

**C4X PATENTS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;Patents covering potential PET ligand C4X_3172 and backup compounds ('ethyl case') - PCT published as WO 2016/034882 on 10 March 2016.

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| **Country** | **Application no** | **Filing date** | **Priority Date** | **Status** | **Estimated Expiry date #** |
| AU | 2015310662 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| BR | 112017004173-1 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| CA | 2959942 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| CN | 2015800576964 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| EA\* | 201790519 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| EP\*\* | EP157626789 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| GB\*\*\* | 1516146.6 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| HK\*\*\*\* | TBC | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| ID | P00201702070 | 03-Sep-15 | 03-Sep-I4 | pending | 03-Sep-35 |
| IL | 250883 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| IN | 201727008919 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| JP | 2017-513035 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| KR | 2017-7008975 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| MX | MX/A/2017/002877 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| MY | 2017700738 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| NZ | 730422 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| PCT | PCT/GB2015/052546 | 03-Sep-15 | 03-Sep-14 | converted | 03-Sep-35 |
| PH | 12017500401 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| SO | 11201701715P | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| US | 15/508,392 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |
| ZA | 2017/01644 | 03-Sep-15 | 03-Sep-14 | pending | 03-Sep-35 |

---

*# Standard 20-yearpatent term. Does not include potential additional 5 year SPC/PTA extension* 

*\*EPC states in which the EP patent is to be validated have not yet been nominated* 

*\*\*Eurasian (EA) states are Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan and Turkmenistan. \*\*\* Separate GB filing allows prosecution strategy to be tested ahead of EP prosecution - granted GB patent may be achieved via GB application or EPO validation*

***\*\*\*\*HONG KONG PATENT APPLICATION WILL BE OBTAINED VIA CHINA PROSECUTION***

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;Patents covering C4X_3256 and analogue compound (primary 'methyl' case) - PCT published as WO 2017/129829 on 03 August 2017.

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| **Country** | **Application no** | **Filing date** | **Priority Date** | **Status** | **Estimated Expiry date #** |
| PCT | PCT/EP2017/051960 | 30-Jan-17 | 29-Jan-16 | Published | 30-Jan-37 |

---

*For information national phase nomination will be due 30 months after priority date - August 2018*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.&nbsp;&nbsp;&nbsp;&nbsp;Priority filings covering novel analogues of C4X_3256.

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| **Country** | **Application no** | **Filing date** | **Priority Date** | **Status** | **Estimated Expiry date #** |
| GB | 1712388.6 |  | 01-Aug-17 | pending | 01-Aug-38 |
| GB | 1712390.2 |  | 01-Aug-17 | pending | 01-Aug-38 |
| GB | 1712392.8 |  | 01-Aug-17 | pending | 01-Aug-38 |
| GB | 1712393.6 |  | 01-Aug-17 | pending | 01-Aug-38 |
| GB | 1712394.4 |  | 01-Aug-17 | pending | 01-Aug-38 |
| GB | 1712395.1 |  | 01-Aug-17 | pending | 01-Aug-38 |

---

------

**SCHEDULE 2**

**EXPERT**

If any Party wishes to appoint an independent expert (the "**Expert**") to resolve any matter pursuant to <u>Clauses 9.4.2</u>, <u>9.4.3(a)</u>, or <u>20.5</u>, of this Agreement, the following procedures will apply:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;The Party wishing to appoint the Expert (the "**Appointing Party**") will serve a written notice on the other Party (the "**Responding Party**"). The written notice will specify the Clause pursuant to which the appointment is to be made and will contain reasonable details of the matter(s) which the Appointing Party wishes to refer to the Expert for determination.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;The relevant Parties shall within [\*\*\*] days following the date of the Appointing Party's written notice use commercially reasonable efforts to agree who is to be appointed as the Expert to determine the relevant matter(s). If the relevant Parties are unable to agree upon the identity of the Expert within that timescale, the Expert shall be appointed by the President (for the time being) of the Licensing Executives Society Britain and Ireland upon written request of a Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.&nbsp;&nbsp;&nbsp;&nbsp;Each Party will, within [\*\*\*] days following appointment of the Expert, prepare and submit to the Expert and the other Party a detailed written statement setting out its position on the matter(s) in question and including any proposals which it may wish to make for settlement or resolution of the relevant matter.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.&nbsp;&nbsp;&nbsp;&nbsp;Each Party will have [\*\*\*] days following receipt of the other Party's written statement to respond in writing thereto. Any such response shall be submitted to the other Party and the Expert.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.&nbsp;&nbsp;&nbsp;&nbsp;The Expert will if he/she deems appropriate be entitled to seek clarification from each Party as to any of the statements or proposals made by such Party in their written statement or responses. Each Party will on request make available all information in its possession and shall give such assistance to the Expert as may be reasonably necessary to permit the Expert to make his/her determination.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.&nbsp;&nbsp;&nbsp;&nbsp;The Expert will issue his/her decision on the matter(s) referred to him/her in writing as soon as reasonably possible, but at latest within [\*\*\*] months following the date of his/her appointment. The Expert's decision shall (except in the case of manifest error) be final and binding on the Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.&nbsp;&nbsp;&nbsp;&nbsp;The Expert will at all times act as an independent and impartial expert and not as an arbitrator.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.&nbsp;&nbsp;&nbsp;&nbsp;The Expert's charges will be borne as he/she determines in his/her written decision.

------

**SCHEDULE 3**

**INVENTORY**

[\*\*\* fifteen (15) pages \*\*\*]

------

**SCHEDULE 4**

**BI-ANNUAL REPORT**

The Bi-Annual Report shall include the following information –

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.&nbsp;&nbsp;&nbsp;&nbsp;the Development activities undertaken by or on behalf of Company in the previous six (6) months including but not limited to updates or regulatory and Manufacturing progress pertaining to Licensed Product,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.&nbsp;&nbsp;&nbsp;&nbsp;Development, regulatory and Manufacturing activities relating to the Licensed Products planned for the next 6 months,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.&nbsp;&nbsp;&nbsp;&nbsp;the status of and strategy relating to any Company Applied Patents,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.&nbsp;&nbsp;&nbsp;&nbsp;the status of and strategy relating to the C4X Patents,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.&nbsp;&nbsp;&nbsp;&nbsp;details of any changes to the Development Plan (including reasons for such changes),

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.&nbsp;&nbsp;&nbsp;&nbsp;Regulatory Submissions update,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.&nbsp;&nbsp;&nbsp;&nbsp;once initiated, a detailed update on Commercialisation,

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.&nbsp;&nbsp;&nbsp;&nbsp;chemistry, manufacturing and controls activity updates relating to Licensed Products, and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.&nbsp;&nbsp;&nbsp;&nbsp;pharmacovigilance update relating to Licensed Products

------

**SCHEDULE 5**

**C4X PRESS RELEASE**

![c4xdiscoverylogo.jpg](c4xdiscoverylogo.jpg)

**C4X Discovery Holdings plc**

("C4XD" or the "Company")

**C4X Discovery signs licensing agreement with Indivior for addiction programme worth up to $294m**

—&nbsp;&nbsp;&nbsp;&nbsp; C4XD receives $10 million upfront, potential milestones totalling $284 million plus royalties

**29 March 2018** - C4X Discovery Holdings plc (AIM: C4XD), a pioneering drug discovery company, today announces that it has signed a licensing agreement with Indivior UK Limited ("Indivior") to further develop and commercialise C4XD's oral Orexin-1 receptor antagonist ("C4X3256") for the treatment of addiction. C4X3256 aims to treat addiction by targeting the "craving" process itself and, therefore, can be applied across a broad range of substance use disorders. The treatment of addiction represents a substantial area of unmet medical need, forecast to be worth an estimated $13 billion per annum in 2018<sup>1</sup>.

Under the terms of the agreement, C4XD will receive an upfront payment of $10 million and could receive up to $284 million of potential development, regulatory and commercialization milestones in addition to royalties. In turn, Indivior receives a global and exclusive license to C4X3256 and all other compounds in the same patent family and is responsible for the cost and execution of all further development of C4X3256. The agreement covers the development of Orexin-1 antagonists for multiple indications

C4X3256 has the potential to represent a major new method of treating addiction and related disorders. The Orexin-1 receptor is considered to be central to the brain's craving and reward pathways but to date a lack of specificity has hindered clinical development. C4XD's drug discovery engine has allowed the discovery of a highly specific Orexin-1 antagonist that targets Orexin-1 but not Orexin-2, which is targeted in the treatment of insomnia. C4X3256 is a novel, potent and selective oral Orexin-1 antagonist. It has demonstrated excellent preclinical efficacy and tolerability in several preclinical models of addiction.

**Dr Clive Dix, CEO of C4X Discovery, said:** *"C4X Discovery is a pioneer in drug discovery and today's licensing agreement with Indivior, a world-leader in developing and commercialising treatments for addiction, highlights the ability of our drug discovery engine to generate best-in-class small-molecule candidates in high value therapeutic areas. Our goal is to drive returns through early-stage revenue-generating deals with the pharmaceutical industry. This agreement will allow us to accelerate the development of our portfolio to similar successful commercial arrangements and validates our business model."*

The C4XD portfolio continues to progress as planned, and a full portfolio update will be given in C4XD's Interim Results in April 2018.

**-ENDS-**

<sup>1</sup> Source: *GBI Research 2012*

------

**For further information, please contact:**

---

| | |
|:---|:---|
| **C4X Discovery Holdings plc** | |
| Clive Dix, Chief Executive Officer | 07801 865 803 |
| **Panmure Gordon (UK) Limited (NOMAD and Broker)** |  |
| Freddy Crossley (Corporate Finance) | 020 7886 2500 |
| Tom Salvesen (Corporate Broking) |  |
| **Consilium Strategic Communications** |  |
| Mary-Jane Elliott, Chris Gardner, Matthew Neal | 0203 709 5700 |

---

**About C4X Discovery**

C4X Discovery aims to become the world's most productive drug discovery engine by exploiting cutting edge technologies to design and create best-in-class small-molecule candidates targeting a range of high value therapeutic areas. The company's goal is to drive returns through early-stage revenue-generating deals with the pharmaceutical industry.

C4X Discovery has a state-of-the-art suite of proprietary technologies across the drug discovery process. The company's innovative DNA-based target identification platform (Taxonomy3®) utilises human genetic datasets to identify novel patient-specific targets leading to greater discovery productivity and increased probability of clinical success. This is complemented by C4XD's novel drug design platform which comprises two innovative chemistry technologies, Conformetrix and Molplex, that combine 4D molecular shape analyses (based on experimental data) with best-in-class computational chemistry. This provides new and unprecedented insight into the behaviour of drug molecules, enabling the production of potent selective compounds faster and more cost effectively than the industry standard.

C4X Discovery is advancing its in-house pipeline in addiction, diabetes and inflammation with a number of new drug candidates identified and further progress made towards the clinic. In selecting new targets C4X Discovery will focus on the high-value disease areas of inflammation and neurodegeneration, and will continue to maximise value from opportunistic areas, for example, immuno-oncology, addiction, and diabetes.

The Company was founded as a spin-out from the University of Manchester. It has a highly experienced management team and Board who have delivered significant value creation within the healthcare sector historically and have enabled C4XD to reach multiple value inflexion points since IPO For additional information please go to <u>www.c4xdiscovery.com</u>.

**About Indivior**

Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment. The name is the fusion of the words individual and endeavour, and the tagline "Focus on you" makes the Company's commitment clear. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 900 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more.

------

**SCHEDULE 6**

**DATA ROOM INDEX**

[\*\*\* fifteen (15) pages \*\*\*]

------

**SCHEDULE 7**

**MATERIAL AGREEMENTS**

[\*\*\* three (3) pages \*\*\*]

## Exhibit 4.23

**Exhibit 4.23**

PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED.

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE LIKELY TO CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

REDACTED MATERIAL IS MARKED WITH [\*\*\*].

**LICENSE AGREEMENT**

**BETWEEN**

**INDIVIOR UK LIMITED**

**AND**

**ADDEX PHARMA S.A.**

------

**TABLE OF CONTENTS**

**1.** **DEFINITIONS**

**2.** **LICENSE**

**3.** **JOINT RESEARCH ACTIVITIES**

**4.** **DEVELOPMENT ACTIVITIES**

**5.** **DILIGENCE**

**6.** **PAYMENT**

**7.** **INTELLECTUAL PROPERTY**

**8.** **WARRANTIES**

**9.** **CERTAIN COVENANTS AND AGREEMENTS**

**10.** **TERM; TERMINATION**

**11.** **INDEMNIFICATION**

**12.** **INSURANCE**

**13.** **CONFIDENTIALITY**

**14.** **MISCELLANEOUS**

------

**LICENSE AGREEMENT**

This License Agreement (this "<u>Agreement</u>") is entered into as of this 2nd day of January 2018, by and between Indivior UK Limited (Co. No. 7183451) with a registered address of 103-105 Bath Road, Slough, Berkshire, SL1 3UH ("<u>Indivior</u>"), and Addex Pharma S.A., a company organized under the laws of Switzerland ("<u>Addex</u>").

**INTRODUCTION**

WHEREAS, Indivior is engaged in the business of, among other things, developing, marketing and distributing pharmaceutical products;

WHEREAS, Addex owns certain intellectual property rights related to its GABAb program, including, but not limited to, ADX 71441 compound for the treatment of addictive disorders; and

WHEREAS, the Parties desire to enter into an agreement granting Indivior a license to such intellectual property to enable Indivior to develop, manufacture, market and distribute Product(s) (as defined below), subject to and in accordance with the terms and conditions of this Agreement.

In consideration of the mutual covenants contained herein, and other good and valuable consideration, the receipt of which is hereby acknowledged, Addex and Indivior agree as follows:

**1.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **DEFINITIONS**

When used in this Agreement, each of the following terms, whether used in the singular or plural, shall have the meanings set forth in this <u>Section 1</u>:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; "<u>Accounting Standards</u>" means, with respect to a Person, International Financial Reporting Standards (IFRS), as consistently applied by such Person across its operations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; "<u>Addex Development Patent Rights</u>" means any Patent Right generated from the activities of this Agreement that Covers a Licensed Compound but which Patent Right does not Cover any Addex Retained Compound, and which is not an Indivior Improvement Patent Right or a Joint Patent Right.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; "<u>Addex Existing Patent Rights</u>" means the patents and patent applications set forth on Schedule 1.3 and Patent Rights relating or claiming priority thereto.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; "<u>Addex Improvements</u>" means any improvements, enhancements or modifications of the Licensed IP developed by or on behalf of Addex other than Joint Improvements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.5&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; "<u>Addex Know-How</u>" means all Know-How owned or controlled by (or, to the extent sublicensable, licensed to), Addex or its Affiliates (a) as of the date hereof or (b) which is created or acquired by Addex in the course of carrying out its obligations under this Agreement, in each case that is necessary or useful for the research, development, manufacture, use or commercialization of the Licensed Compounds and/or the Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.6&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; "<u>Addex Other Patent Rights</u>" means such rights that Addex has in any Patent Rights that are not: (a) Addex Existing Patent Rights, (b) Addex Development Patent Rights or (c) Addex Overlapping Patent Rights, but are other Patent Rights owned or controlled by (or, to the extent sublicensable, licensed to), Addex or its Affiliates and are filed or claim priority to an application filed before or during the Term and that contain a claim that Covers a Licensed Compound.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; "<u>Addex Overlapping Patent Rights</u>" means any Patent Rights generated from the activities of this Agreement that Cover a Licensed Compound and also Cover an Addex Retained Compound, and which are not Indivior Improvement Patent Rights or Joint Patent Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.8&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; "<u>Addex Patent Rights</u>" means (a) the Addex Existing Patent Rights, (b) the Addex Development Patent Rights, (c) the Addex Overlapping Patent Rights and (d) Addex's interest in any Addex Other Patent Rights and, to the extent Addex has a non-exclusive right to any Addex Other Patent Rights, reference to the Addex Other Patent Rights shall mean such non-exclusive right.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.9&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; "<u>Addex Product</u>" means any pharmaceutical product that contains or comprises an Addex Retained Compound.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.10&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Addex Retained Compounds</u>" means (a) the Compounds that cease to be Development Compounds and become Addex Retained Compounds pursuant to <u>Section 3.4</u> and (b) any Compounds discovered by Addex after the expiry of the Research Term.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.11&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Addex Retained Patent Rights</u>" means Patent Rights generated from the activities of this Agreement that Cover an Addex Retained Compound and that do not Cover any Licensed Compound.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.12&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Affected Product</u>" has the meaning set forth in <u>Section 6.5(d)</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.13&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Agreed Assay</u>" means the assay set out in <u>Schedule 1.13</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.14&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Affiliate(s)</u>" means, with respect to a Party, any Person that is directly or indirectly controlled by, controlling, or under common control with such Party. For purposes of this definition only, the term "control" (including, with correlative meaning, the terms "controlling", "controlled by", and "under common control with"), as used with respect to the applicable Party, means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Party, whether through ownership of interests representing equity, securities, or partnership interests or by contract, or otherwise. Ownership of more than fifty percent (50%) of such equity, securities or partnership interests in a Person shall, without limitation, be deemed to be control for purposes of this definition. For the purposes of this Agreement, an Addex Affiliate shall exclude any entity that, after the Effective Date, acquires control of Addex.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.15&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>ANDA</u>" means an abbreviated new drug application filed with the FDA pursuant to 21 U.S.C. § 355(j) and 21 C.F.R. § 314.3.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.16&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Annual Net Sales</u>" means, with respect to any jurisdiction, the total Net Sales of all Products sold in such jurisdiction during any twelve (12) month period.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.17&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Applicable Law</u>" means federal, state, local and national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1.18&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Bankruptcy Code</u>" has the meaning set forth in <u>Section 2.3</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.19&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Commercially Reasonable Efforts</u>" means, with respect to the performance of development or commercialization activities with respect to the Licensed Compound, Development Compound or a Product by a Party, the performance of obligations or tasks in a manner consistent with the reasonable practices of a similarly situated biotechnology (in the case of Addex) or pharmaceutical (in the case of Indivior) company having similar resources for the development or commercialization (as applicable) of a product having similar technical and regulatory factors and similar market potential, profit potential and strategic value, and that is at a similar stage in its development or product life cycle as such Licensed Compound, Development Compound or Product; provided that [\*\*\*] Commercially Reasonable Efforts require a Party to take any actions that (a) require such Party to [\*\*\*] under this Agreement, (b) would [\*\*\*] or (c) [\*\*\*] so long as [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.20&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Compound</u>" means any molecule that is a positive allosteric modulator of the GABAb receptors (a) with [\*\*\*] or less as determined in the Agreed Assay and (b) at least [\*\*\*], as determined in the Agreed Assay, and any racemate or enantiomer of such molecule, and any salt or hydrate of any of the foregoing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.21&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Cover</u>" means, with respect to a patent or patent application for a Compound or Product, that a Third Party's unlicensed research on, development, manufacture, or commercialization of such Compound, or a pharmaceutical product containing or comprising such Compound, or such Product would fall within at least one claim of such patent or patent application or would cause indirect infringement of the claim by a Third Party. With respect to a pending patent application, the phrase "would fall within the claim" intends such analysis to be based on the claims of such pending application as if they were contained in an issued or granted patent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.22&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Development Compound</u>" has the meaning set forth in <u>Section 3.4</u>.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.23&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Development Milestone Payments</u>" has the meaning set forth in <u>Section 6.3</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.24&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Effective Date</u>" means the date first written above.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.25&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>European Major Market</u>" means any of the following countries in Europe: France, Germany, Italy, Spain and the United Kingdom.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.26&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>FDA</u>" means the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.27&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Field</u>" means the use of pharmaceutical products containing or comprising Compounds in the treatment, diagnosis and/or prevention of any disease in humans other than for the Reserved Indications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.28&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Filing Acceptance</u>" means, as applicable, the acceptance for filing of a complete NDA (or its equivalent) by the FDA in the United States, or acceptance for filing of a comparable application by a Regulatory Authority in Europe for the manufacture, supply, marketing and sale of a pharmaceutical product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.29&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>FTE</u>" means the equivalent of the work of one appropriately qualified individual working on a full-time basis in performing work in connection with this Agreement for a twelve (12) month period (consisting of at least a total of [\*\*\*] hours per year of dedicated effort). FTE efforts shall not include the work of general corporate or administrative personnel but a single FTE may comprise the work of one or more individuals.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.30&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>FTE Rate</u>" means, for the period from the Effective Date to 31 December 2018, [\*\*\*]. Thereafter, the FTE Rate shall be increased or decreased on 1 January of each year by the annual percentage increase or decrease in the UK Consumer Price Inflation published by the UK Office of National Statistics.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.31&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Generic Product</u>" means, with respect to any Product, a non-proprietary drug product that is a pharmaceutical equivalent to such Product, meaning that: (a) it is placed on the market pursuant to a validly granted marketing authorization by a Third Party and such Third Party has not been granted any rights by Indivior to place such product on the market, except in cases where (i) such Third Party has filed an ANDA and such rights were granted as part of an ANDA litigation settlement, (ii) Indivior did not receive monetary consideration from such Third Party and (iii) the grant of rights by Indivior was a good faith attempt to maximize the expected length of market exclusivity for such Product; (b) it contains the same active ingredient(s), has the same dosage form and route of administration; (c) the marketing authorization for which such product was obtained by making a cross reference to the data provided by Indivior to the relevant Regulatory Authority in the application for Marketing Approval for the corresponding Product; and (d) it is AB rated in the United States (or similar designation of therapeutic substitutability outside the United States).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.32&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Good Clinical Practice</u>" or "<u>GCP</u>" means, as to the United States and the European Union, good clinical practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices as then in effect in the United States or the European Union, in each case to the extent relating to the pharmaceutical products hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.33&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Good Manufacturing Practice</u>" or "<u>GMP</u>" means (a) as to the United States and the European Union, good manufacturing practices and general biological products standards as promulgated by the FDA pursuant to 21 CFR Parts 210, 211, 600 and 610 and as promulgated by the European Union pursuant to Commission Directive 2003/94/EC, respectively, each as may be amended from time to time, and (b) with respect to any other jurisdiction, manufacturing practices equivalent to the aforementioned good manufacturing practices as then in effect in the United States or the European Union, in each case to the extent relating to the pharmaceutical products hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.34&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Governmental Authority</u>" means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of any government or a federal, state, province, county, city or other political subdivision thereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.35&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Guaranteed Spend</u>" has the meaning set forth in Section 3.1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.36&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>IND</u>" means an investigational new drug application filed with the FDA pursuant to 21 C.F.R. §312 or any similar authorization outside the US.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.37&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Indication(s)</u>" means a disease classification as defined within the "International Statistical Classification of Diseases and Related Health Problems" as published on the date hereof by the World Health Organization (e.g. F10 Mental and Behavioral Disorders due to the use of Alcohol is a distinct indication from F14 Mental and Behavioral Disorders due to the use of Cocaine).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.38&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Indivior Exclusive Field</u>" means the use of pharmaceutical products containing or comprising Compounds in the treatment, diagnosis and/or prevention of any disease in humans other than for the Reserved Indications and/or the Shared Indications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.39&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Indivior Improvements</u>" means any improvements, enhancements or modifications of the Licensed IP developed by or on behalf of Indivior other than Joint Improvements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.40&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Indivior Improvement Patent Rights</u>" means any Patent Rights, excluding any Joint Patent Rights, that Cover an Indivior Improvement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.41&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Initiation</u>" means, with respect to a clinical study, the first dosing of the first patient in such client study.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.42&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>IP License</u>" has the meaning set forth in <u>Section 2.1</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.43&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Joint Improvements</u>" has the meaning set forth in <u>Section 7.1(d)</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.44&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Joint Patent Rights</u>" means any Patent Rights based on an invention made while carrying out the Parties' activities pursuant to this Agreement which have multiple inventors, as defined by U.S. patent law, where there is at least one inventor, employed by or otherwise obligated to assign their rights in the invention to Addex, and at least one inventor employed by or otherwise obligated to assign their rights in the invention to Indivior.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.45&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Joint Research Committee</u>" and "<u>JRC</u>" have the meaning set forth in <u>Section 3.8</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.46&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Know-How</u>" means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology (whether patentable or not) which are confidential to the relevant Party, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.47&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Knowledge</u>" means, with respect to Addex, facts or other information [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.48&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Launch Date</u>" means, on a country-by-county basis, the date of the first commercial sale of a Product by Indivior, its Affiliate or sublicensee to a Third-Party after Marketing Approval together with any required pricing and reimbursement approvals for such·Product has been obtained in such country; <u>provided</u> that sales prior to receipt of Marketing Approval for such Product, such as so-called "treatment IND sales," "named patient sales", "Temporary Authorization for Use in France", and "compassionate use sales," shall not be construed as comprising a Launch Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.49&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Licensed Compound</u>" means any molecule that is (a) Covered by the Addex Existing Patent Rights, as well as any enantiomer or racemate of such molecule, and/or any salt or hydrate of any of the foregoing; and/or (b) any Compound that is selected by Indivior as a Licensed Compound pursuant to <u>Section 3.4</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.50&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Licensed IP</u>" means the Addex Patent Rights and Addex Know-How and Addex's ownership interest in Joint Improvements and Joint Patent Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.51&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Major Market</u>" means the United States, Canada, Australia and each of the European Major Markets.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.52&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Marketing Approval</u>" means, as applicable, the approval of an NDA by the FDA in the United States or approval of a comparable application by a Regulatory Authority in any other country or jurisdiction for the manufacture, supply, marketing and sale of a pharmaceutical product. For clarity, "Marketing Approval" shall not include any governmental

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pricing and/or reimbursement approvals and/or authorizations issued by a Regulatory Authority or any other governmental agency in any country or jurisdiction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.53&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>NDA</u>" means a New Drug Application, as defined in 21 U.S.C. §355(b) et seq., and the regulations promulgated thereunder, as such application may be amended or supplemented from time to time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.54&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Net Sales</u>" means the gross amounts invoiced by Indivior, its Affiliates or their respective sublicensees (each, an "<u>Indivior Part</u>y") for the sale of a Licensed Compound or Product to Third Parties, less the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; customary trade, quantity and cash discounts and any other adjustments, including granted on account of price adjustments, billing errors, rejected goods, damaged or defective goods, recalls, returns, rebates, chargeback rebates, reimbursements or similar payments granted or given to wholesalers or distributors, buying groups, health care insurance carriers, governments, government-subsidized programs or managed care organizations, or other institutions, or adjustments arising from consumer discount programs, in each case actually allowed and taken by a Third Party with respect to amounts invoiced for such Product;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; sales taxes or similar taxes, including duties or other governmental charges imposed on the sale of Product to a Third Party (excluding any taxes imposed on or measured by the net income or profits of the Indivior Party), not reimbursable, refundable or creditable to the Indivior Party; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; prepaid freight, insurance and handling fees actually invoiced (to the extent that the Indivior Party actually incurs the cost of freight, insurance and handling fees for Product and are not reimbursable, refundable or creditable to the Indivior Party);

in each case (i)-(iii) as determined from books and records of the Indivior Party maintained in accordance with applicable Accounting Standards. Amounts invoiced for sales or other transfer of such Product between or among Indivior, its Affiliates and/or other Indivior Parties shall be excluded from the computation of Net Sales unless such sales are intended for end use, in which case the fair market value of such sale shall be applied. If a sale or transfer of Product involves consideration other than cash or is not at arm's length, then the Net Sales from such sale or transfer shall be the arm's length fair market value, which generally will mean the Indivior Party's average sales price for the Quarter.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.55&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"[<u>\*\*\*]</u>" means [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.56&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"[<u>\*\*\*]</u>" means [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.57&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Party</u>" means Indivior or Addex, as applicable, and "<u>Parties</u>" means both Indivior and Addex.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.58&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Patent Filing Jurisdictions</u>" means the United States, the European Major Markets and Japan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.59&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Patent Rights</u>" means all issued patents, pending patent applications and additional patent applications, provisionals, continuations, continuations-in-part, divisions, reissues, reexaminations, extensions, supplementary protection certificates, substitutions and renewals of any of the foregoing, all foreign counterparts of any of the foregoing, and all new patents that may issue from or claim priority to any of the foregoing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.60&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Person</u>" means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.61&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Phase Ib Study</u>" means a study in healthy subjects (rather than patients in the proposed indication) with a primary endpoint of safety and tolerability and which has the additional purpose of investigating the pharmacokinetics, pharmacodynamics and preliminary indications of efficacy of the Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.62&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Phase II</u>" means a human clinical trial, the principal purpose of which is to establish a dose and/or dose range and which is intended to generate additional safety data that will support the design of Phase III research protocols in a patient population that has the disease or condition being studied, as further described in 21 C.F.R. §312.21(b).

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.63&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Phase III</u>" means a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease or condition being studied, as further described in 21 C.F.R. §312.21(c), which is designed and intended to be of a size and statistical power sufficient to serve as a pivotal study to support the filing of an application for Marketing Approval for the indication being studied.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.64&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Post-Grant Proceeding</u>" means any re-examination, inter-partes review, re-issue, opposition, interference, cancellation, prior use, derivation, or other proceeding before an administrative agency or administrative tribunal (but excluding routine ex-parte patent prosecution and its associated administrative appeals) related to the validity, scope, ownership, or inventorship of a patent or allowed patent application, as well as any judicial appeals resulting from such a proceeding.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.65&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Presentation</u>" means, in relation to a Product or Generic Product, the pharmaceutical form of such product in combination with the route of administration such that, by way of example and without limitation, immediate release oral formulations are distinct presentations from sustained release formulations, buccal delivery is distinct from tablets that release in the digestive tract, injectable formulations are distinct presentations from tablets or inhalers and an injectable depot is a distinct presentation from a liquid injection.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.66&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Product</u>" means any pharmaceutical product that comprises or contains a Licensed Compound.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.67&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Quarter</u>" means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Quarter shall end on the last day of the Term.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.68&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Regulatory Authorities</u>" means, with respect to any jurisdiction, the applicable Governmental Authority responsible for regulating the manufacture, distribution and sale of pharmaceutical products in such jurisdiction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.69&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Representatives</u>" has the meaning set forth in <u>Section 4.3</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.70&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Research Activities</u>" means the activities carried out by the Parties in the conduct of the Research Plan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.71&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Research Plan</u>" has the meaning set forth in <u>Section 3.2</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.72&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Research Term</u>" means the period commencing on May 1, 2018 and expiring on the second anniversary thereof unless the Parties agree to extend the Research Term pursuant to <u>Section 3.3</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.73&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Reserved Indications</u>" means the following Indications:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; [\*\*\*] including but not limited to Charcot Marie Tooth (G60);

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; [\*\*\*] including but not limited to [\*\*\*];

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; [\*\*\*] including but not limited to [\*\*\*]; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.74&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Royalty</u>" has the meaning set forth in <u>Section 6.4</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.75&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Royalty Term</u>" means, with respect to each Product in a particular country, the period of time commencing on the Launch Date of such Product and ending on the later of (a) ten (10) years after the Launch Date of the applicable Product in such country, (b) expiration in such country of the last Valid Patent Claim of the last-to-expire of any Joint Patent Rights or Addex Patent Rights that Cover such Product in the country of its manufacture or sale, and (c) expiration of any applicable marketing or data exclusivity conferred by, or as a consequence of a right, designation or authorisation granted by, a Regulatory Authority in a particular country with respect to such Product in such country.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.76&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Sales Milestone Payments</u>" has the meaning set forth in <u>Section 6.6</u>.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.77&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Shared Field</u>" means the use of pharmaceutical products containing or comprising Compounds in the treatment, diagnosis and/or prevention of any disease in humans for the Shared Indications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.78&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Shared Indications</u>" means following Indications: [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.79&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Successful Completion of a Phase I Study of a Product</u>" means the first to occur of the following:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (i) receipt by Indivior, its Affiliate or sublicensee of a statistical analysis of [\*\*\*] that indicates that the [\*\*\*] has met its primary endpoint and (ii) a study protocol has been agreed with FDA (or, outside the US, an application for clinical trial approval has been granted by the relevant Regulatory Authority) for a subsequent study in patients with the disease; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (i) receipt by Indivior, its Affiliate or sublicensee of a statistical analysis of [\*\*\*] of a Product that indicates that the relevant study has met its primary endpoint and (ii) a study protocol has been agreed with FDA (or, outside the US, an application for clinical trial approval has been granted by the relevant Regulatory Authority) for a subsequent study in patients with the disease; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the dosing by or on behalf of Indivior, an Affiliate or sublicensee of a Product in a Phase II study for a Product.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.80&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Term</u>" has the meaning set forth in <u>Section 10.1</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.81&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Territory</u>" means, subject to <u>Section 10.2</u>, worldwide.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.82&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Third Party</u>" means any Person other than Indivior, Addex or their respective Affiliates.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.83&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Third Party Licenses</u>" has the meaning set forth in <u>Section 2.4</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.84&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;"<u>Valid Patent Claim</u>" means an issued, unexpired claim of a patent or patent application within the Addex Patent Rights or Joint Patent Rights, in each case, that (a) has not been revoked, cancelled or held unenforceable, unpatentable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be, or has been, taken and (b) has not been abandoned or expired, except where such abandonment is a result of Indivior's failure to maintain the Addex Patent Rights or Joint Patent Rights in the Patent Filing Jurisdictions as required herein, [\*\*\*].

**2.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **LICENSE**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>License Grant</u>. Addex hereby grants to Indivior a world-wide, royalty-bearing, right and license, under the Licensed IP, to develop, conduct research related to, manufacture, make, have made, use, lease, license, import, offer for sale, commercialize, distribute, sell and have sold, or otherwise transfer the Licensed Compounds and/or Products in the Field ("<u>IP License</u>"). The IP License (a) is exclusive to Indivior (even as to Addex) and (b) includes the exclusive right to sublicense as described below.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Affiliates; Right to Sublicense</u>. Indivior shall have the right to (a) exercise the license granted under Section 2.1 through its Affiliates for so long as such entity remains an Affiliate of Indivior and (b) grant sublicenses of the Licensed IP to Third Parties without the prior written consent of Addex; provided that [\*\*\*], Indivior shall not grant sublicenses of the Licensed IP to Third Parties for [\*\*\*] without the prior written consent of Addex, which consent shall not be unreasonably withheld, delayed or conditioned. All such sublicenses shall be consistent with this Agreement and terminate automatically on the termination or expiry of this Agreement. Indivior shall remain responsible to Addex for all activities of its Affiliates and sublicensees to the same extent as if such activities had been undertaken by Indivior itself, subject to Section <u>10.2(c)(iv)</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Rights Under Bankruptcy</u>. All rights and licenses granted under or pursuant to any section of this Agreement in connection with U.S. intellectual property rights are and will otherwise be deemed to be for purposes of Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), as amended (the "<u>Bankruptcy Code</u>"), licenses of rights to "intellectual property" as defined in Section 101(35A) of the Bankruptcy Code. Indivior, as the licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. In the event of the commencement of a bankruptcy proceeding by or against Addex under the Bankruptcy Code, Indivior will be entitled to a complete duplicate of (or complete access to, as appropriate) such intellectual property and all embodiments of such intellectual property, which, if not already in Indivior's possession, will be promptly delivered to it upon Indivior's written

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request thereof. Any agreements supplemental hereto will be deemed to be "agreements supplementary to" this Agreement for purposes of Section 365(n) of the Bankruptcy Code. Addex agrees that it shall not take any action in any bankruptcy or similar proceeding related solely to and commenced as a direct consequence of the insolvency of Addex to reject or object to this Agreement or any rights granted herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Third Party Licenses</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In the event that it is necessary or useful to obtain licenses under any Patent Rights claiming the use of, or composition of matter of any Licensed Compound from any Third Party ("<u>Third Party Licenses</u>") in order to commercialize any Product(s), Indivior may, in its discretion and cost, obtain such Third Party Licenses. For the avoidance of doubt, the term Third Party Licenses shall not include intellectual property licenses for new manufacturing process or formulation technologies that may be selected by Indivior.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indivior shall be responsible for the royalty costs or other fees payable with respect to such Third Party Licenses; <u>provided</u> that Indivior may deduct up to [\*\*\*] of the amounts paid to the relevant Third Party under the relevant Third Party License from the Royalty payable by Indivior to Addex pursuant to <u>Section 6.4</u>; <u>provided further</u> that in no event shall any such offset reduce the Royalty payable to Addex in respect of a country to less than [\*\*\*] of the royalty rates set out in the table in <u>Section 6.4</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.5&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Retained Rights</u>. Addex retains the right under any Licensed IP to research, develop, manufacture, commercialize and otherwise exploit any Addex Retained Compounds and/or Addex Products solely in the Reserved Indications and the Shared Indications by itself, through Affiliates and/or through sublicensees and Addex shall have no obligation to account to Indivior for any consideration it may receive in respect of such Addex activities; <u>provided</u> that any license granted by Addex in respect of any Addex Retained Compounds or Addex Products shall not be inconsistent with the terms of this Agreement. The Parties may, from time to time, discuss any advances in the understanding of the use of Compounds in the treatment, diagnosis and/or prevention of any disease in humans and, subject to the prior written agreement of the Parties, any indications discussed may be included in the Reserved Indications or the Shared Indications.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.6&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Joint Patent Rights</u>. It is agreed between the Parties as follows:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Unless otherwise expressly provided herein, Addex retains all of its ownership rights to the Joint Patent Rights. Addex's rights to any Joint Patent Rights shall be included in the scope of the Licensed IP, solely to the extent they contain a claim that Covers a Licensed Compound and are applicable in the Field.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Unless otherwise expressly provided herein, Indivior retains all of its ownership rights to the Joint Patent Rights. Indivior's rights to any Joint Patent Rights which relate solely to an Addex Retained Compound shall be licensed to Addex: (i) for the Reserved Indications only on an exclusive basis (even as to Indivior); and (ii) for the Shared Indications on a non-exclusive basis, and in each case on a sublicensable, perpetual, irrevocable and royalty free basis.

The Parties agree that, except to the extent that Indivior has exclusively licensed the relevant Joint Patent Rights to Addex or Addex has exclusively licensed the Joint Patent Rights to Indivior hereunder, either Party may license, assign, mortgage or exploit its interest in an invention claimed in such Joint Patent Rights without the consent of the other Party and either Party may otherwise undertake all activities a sole owner might undertake with respect to its interest in such joint invention without the consent of the other Party, except as otherwise provided for in this Agreement or as the Parties may otherwise agree in writing.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Exclusivity</u>. During the Term, neither Party, by itself, its Affiliates or through any Third Party (including licensees or sublicensees), shall develop, seek Marketing Approval for, manufacture, import, market, sell, distribute, license or otherwise commercialize any [\*\*\*], except pursuant to this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.8&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Field Restrictions</u>. During the Term, Indivior shall not, directly or indirectly (including through sublicensees and Affiliates), conduct activities with respect to Compounds, Licensed Compounds or Products outside of the Field and Addex shall not, directly or indirectly (including through licensees and Affiliates), conduct activities with respect to Compounds (except as expressly provided in this Agreement), Addex Retained Compounds or Addex Products within the Indivior Exclusive Field or, with respect to Licensed Compounds or Products, outside the Indivior Exclusive Field.

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**3.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **JOINT RESEARCH ACTIVITIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Guaranteed Spend</u>. Indivior shall pay to Addex at least $2 million ($2,000,000) per twelve (12) month period during the Research Term and Addex shall use such sums to carry out its research and/or discovery activities into the Compounds (including dedicating the number of FTEs required); <u>provided</u> that in no event shall Indivior be required to pay more than $2 million ($2,000,000) for such research and/or discovery activities in any 12-month period ("<u>Guaranteed Spend</u>"), unless otherwise agreed. Once the Research Plan has been agreed upon pursuant to <u>Section 3.2</u>, the Guaranteed Spend shall be used to fund the Research Plan. During the Research Term, payment of the Guaranteed Spend shall be paid [\*\*\*] prior to agreement of the Research Plan and thereafter in accordance with the budget agreed as a part of the Research Plan, in each case within [\*\*\*] days of receipt of an invoice from Addex.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Research Plan</u>. The Parties shall each use their reasonable endeavors to reach agreement on, and execute, within [\*\*\*] days of the Effective Date, a written plan for joint research and/or discovery of Compounds pursuant to this <u>Article 3</u> ("<u>Research Plan</u>"), which plan shall specify, among other things, the obligations of each Party and the budget for implementing such Research Plan. Addex shall, subject to <u>Sections 3.4</u> and <u>3.5</u> carry out its responsibilities (including dedicating the number of FTEs required) under the Research Plan during the Research Term. Any disputes related to the preparation of or amendment to the Research Plan shall be handled in accordance with <u>Section 14.12</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Research Term</u>. The initial Research Term may be extended [\*\*\*] if both Parties agree in writing, at least [\*\*\*] days prior to the expiry of the then-current Research Term, to extend the Research Term, such agreement to include a revised Research Plan to cover the additional work, the number of FTEs to be provided by each Party for such work and a budget for the additional work.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Selection of Compounds</u>. Within [\*\*\*] days of the end of the Research Term, Addex shall compile a report that sets out all of the Compounds identified in the course of undertaking the Research Plan and the Parties shall discuss whether any of the Compounds so identified meet the target product profile in the Research Plan and are suitable for further development (each such Compound, subject to this <u>Section 3.4</u>, a "<u>Development Compound</u>"). In the event that Indivior considers any of the Compounds suitable for further development, it shall have the right to select such Compounds as follows for further development on the following basis:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indivior shall be entitled to designate in writing one (1) Development Compound for further development and, on such selection, the relevant Compound shall become a Licensed Compound and shall cease to be a Development Compound. In making any selection of a Development Compound pursuant to this <u>Section 3.4(a)</u>. Indivior shall take account of the desire by both Parties that the Licensed Compounds and the Addex Retained Compounds should, to the extent reasonably practicable, be covered by separate patent rights;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Addex shall then be entitled to designate in writing one (1) Development Compound for further development and, on such selection the relevant Compound shall become an Addex Retained Compound and cease to be a Development Compound. In making any selection of a Development Compound pursuant to this <u>Section 3.4(b)</u>, Addex shall take account of the desire by both Parties that the Licensed Compounds and the Addex Retained Compounds should, to the extent reasonably practicable, be covered by separate patent rights; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; to the extent that there are any further Development Compounds that have not been selected by a Party, the process in <u>Sections 3.4(a)</u> and <u>3.4(b)</u> shall be repeated until no further Development Compounds remain or until one Party decides that it does not wish to designate any further Development Compounds in which case (i) if it is Addex that does not wish to designate any further Development Compounds then all remaining Development Compounds shall become Licensed Compounds and (ii) if it is Indivior that does not wish to designate any further Development Compounds then all remaining Development Compounds shall become Addex Retained Compounds.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.5&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Diligence</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Each Party shall use Commercially Reasonable Efforts to carry out its obligations under the Research Plan. Each Party shall provide the other with [\*\*\*] reports detailing the progress of its activities under the Research Plan. Further, each Party shall promptly provide a summary report on significant results where the Research Plan identifies an outcome as requiring prompt disclosure.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Parties acknowledge and agree that no outcome or success is or can be assured and that failure to achieve desired results will not in and of itself constitute a breach or default of any obligation in this Agreement.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.6&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Authority</u>. Indivior (by itself or through its Affiliates) shall have sole responsibility, including sole responsibility for all funding, resourcing and decision-making, for all further research and development with respect to Licensed Compounds and Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Subcontracting</u>. Each Party shall have the right to subcontract its obligations under this Agreement to subcontractors and Affiliates; <u>provided</u> that such subcontractors and Affiliates agree in writing to be subject to the applicable terms and conditions of this Agreement, including the requirements under Section 3.5(a) and the confidentiality provisions of <u>Article 13</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.8&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Joint Research Committee</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Within [\*\*\*] days after the Effective Date, the Parties shall establish a joint research committee (the "<u>Joint Research Committee</u>" or "<u>JRC</u>"). The JRC shall consist of [\*\*\*] representatives with voting rights from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the Research Plan and each Party's Research Activities, with each Party having one (1) vote. From time to time, each Party may substitute one (1) or more of its representatives to the JRC on written notice to the other Party. The chair and the co-chair of the JRC shall be one of the Indivior and Addex voting representatives on the JRC, respectively. From time to time, Indivior or Addex may change the representative who will serve as chairperson or co-chair, respectively, upon written notice to the other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The JRC shall provide strategic direction for, and monitor, manage, coordinate and oversee the conduct of, the Research Activities by the Parties under the Research Plan. In particular, the JRC shall: (i) serve as a forum for discussing the proposed Research Activities and periodically review the Research Plan, and review and approve amendments thereto; (ii) oversee the Parties' performance of the Research Plan; (iii) obtain and review each Party's written reports detailing the progress of its activities under the Research Plan; and (iv) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; During the Research Term, the JRC shall meet [\*\*\*], with the location of such meetings alternating between locations designated by Addex and locations designated by Indivior, provided that such meetings may be held via telephone conference upon mutual agreement of the Parties. The chairperson in collaboration with the co-chair of the JRC shall be responsible for calling meetings on no less than [\*\*\*] days' notice and the chairperson and co-chair shall collaborate to prepare an agenda for circulation in advance of each such meeting. Each Party shall make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items at least [\*\*\*] days in advance of the applicable meeting; <u>provided</u>, that under exigent circumstances requiring input by the JRC, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting. The chairperson and co-chair of the JRC shall prepare and circulate for review and approval of the Parties minutes of each meeting within [\*\*\*] days after the meeting. The Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the JRC.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The JRC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JRC shall exist whenever there is present at a meeting at least one (1) voting representative appointed by each Party. Representatives of the Parties on the JRC may attend a meeting either in person or by telephone, video conference or similar means in which each participant can hear what is said by, and be heard by, the other participants. Representation by proxy shall be allowed. The JRC shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one (1) representative appointed by each Party. Employees or consultants of either Party that are not representatives of the Parties on the JRC may attend meetings of the JRC; <u>provided</u>, that such attendees (i) shall not vote or otherwise participate in the decision-making process of the JRC, and (ii) are bound by obligations of confidentiality and non-disclosure equivalent to those set forth in <u>Article 13</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; If the JRC cannot, or does not, reach consensus on any matter relating to Research Activities or the Research Plan within [\*\*\*] days after such dispute or lack of consensus was raised at a JRC meeting, then such dispute shall be escalated to the CEO of each Party, who shall amicably and in good faith attempt to resolve the dispute. The Parties acknowledge that, notwithstanding the creation of the JRC, each Party shall retain the rights, powers and discretion granted to it hereunder. The Parties further acknowledge that the JRC shall not have the power to amend this Agreement and that any amendments to this Agreement shall be subject to <u>Section 14.10</u>.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, the JRC.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.9&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Records</u>. Each Party shall, and shall ensure that its Affiliates subcontractors, maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law and regulatory guidance, which shall be complete and accurate and shall properly reflect all work done and results achieved in the performance of its obligations under the Research Plan, which, after the Effective Date, shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. Such records shall be retained by each Party and its Affiliates and subcontractors for at least [\*\*\*] after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Upon request, Addex shall provide, and shall procure that its Affiliates and subcontractors provide, copies of the records it has maintained pursuant to this <u>Section 3.9</u> to Indivior.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.10&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Joint Research</u>. This Agreement is intended by the Parties to be considered a "Joint Research Agreement" for the purposes of 35 U.S.C. 102(c), or any successor to that statute in the United States, or other statutes having similar effect in jurisdictions outside the United States. Each Party consents to the other Party disclosing the names of the Parties to this agreement and identifying this Agreement as a "<u>Joint Research Agreement</u>" in any patent application filed pursuant to this Agreement, including, for the avoidance of doubt, patents claiming Indivior Improvements.

**4.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **DEVELOPMENT ACTIVITIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Regulatory Matters</u>. As between the Parties, on a Licensed Compound-by-Licensed Compound basis, Indivior shall have the sole right to prepare, obtain, and maintain any applications for Marketing Approval (including the setting of the overall regulatory strategy) other regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities for Licensed Compounds or Products (which shall include filings of or with respect to INDs or CTAs and other filings or communications with the Regulatory Authorities).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Pharmacovigilance</u>. Within [\*\*\*] days after IND effectiveness of the first Licensed Compound, Product, Addex Retained Compound or Addex Product, the Parties shall determine if it is necessary to, and if so, enter into an agreement to initiate a process for the exchange of safety data (including post-marketing spontaneous reports received by each Party and its Affiliates) in a mutually agreed format in order to monitor the safety of the Licensed Compounds, Products, Addex Retained Compounds and Addex Products and to meet reporting requirements with any applicable Regulatory Authority.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>[\*\*\*] Meetings</u>. Each of the Parties shall keep the other informed about the status and results of its development activities with respect to the Licensed Compounds, Products, Addex Retained Compounds and Addex Products, as applicable. Promptly, and in any event within [\*\*\*] days, after the Effective Date, each of the Parties shall designate an employee with sufficient knowledge such Party's obligations hereunder (collectively, "<u>Representatives</u>"). From time to time, each Party may substitute one (1) or more of its Representatives on written notice to the other Party. From and after the Effective Date and until receipt of the first Marketing Approval, upon [\*\*\*] days' notice by either Party, the Representatives shall meet [\*\*\*], to:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; discuss the development plans for Licensed Compounds, Products, Addex Retained Compounds and Addex Products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; review of regulatory strategies for obtaining and maintaining Marketing Approval for Products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; share safety and other relevant data related to the development of Licensed Compounds, Products, Addex Retained Compounds and Addex Products;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; inform Addex of material development/regulatory events and key Indivior decisions relating to the development activities for Licensed Compounds and Products; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; address safety issues relating to the development of Products and Addex Products.

Unless otherwise agreed by the Parties, at least one meeting per year required by this Section 4.3 will be in person [\*\*\*] and all other meetings shall be by telephone conference.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>[\*\*\*] Reports</u>. Following receipt of Marketing Approval for a Product and continuing until such time as Marketing Approval has been obtained for Products under development in four additional Major Markets, Indivior shall provide to Addex, [\*\*\*], unless agreed otherwise in writing by the Parties, a written report of the status of its efforts to develop such Products hereunder.

**5.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **DILIGENCE**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>In General</u>. Indivior shall have the sole right to develop and commercialize (and shall be solely responsible for, and shall control all aspects of, development and commercialization) Licensed Compounds and Products in the Field in the Territory at its own cost and expense (except as otherwise expressly set forth herein).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Diligence</u>. Indivior will use Commercially Reasonable Efforts to (a) develop one Product [\*\*\*] and (b) commercialize one Product [\*\*\*] following receipt of Marketing Approval [\*\*\*]. Indivior shall undertake such development and commercialization in accordance with GMP, GCP and all Applicable Laws. If at any time Addex has a reasonable basis to believe that Indivior is in material breach of its material obligations under this Section 5.2, then Addex shall so notify Indivior, specifying the basis for its belief, and, without prejudice to any other rights that Addex may have under this Agreement, the Parties, within [\*\*\*] days after such notice, shall meet, in person or via telephone conference, to discuss in good faith Addex's concerns and Indivior's development or commercialization plans, as applicable, with respect to any Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Product Trademarks</u>. Indivior shall have the sole right to determine and own the trademarks to be used with respect to the exploitation of the Products on a worldwide basis.

**6.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **PAYMENT**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Upfront License Fee</u>. As partial consideration for the rights granted to Indivior herein, Indivior shall pay Addex an upfront license fee in the amount of $5,000,000 no later than [\*\*\*] days after the Effective Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Reserved</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Development Milestone Payments</u>. As additional consideration for the rights granted to Indivior herein, after the achievement by Indivior of any of the milestones set forth below, Indivior shall pay Addex the applicable milestone payment set forth next to such milestone below ("Development Milestone Payments"). For the avoidance of doubt, each Development Milestone Payment shall be payable one-time only upon the first occurrence of the event triggering the respective milestone set forth in the table below.

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| | |
|:---|:---|
| **Development Milestone Event** | **Milestone Payment** |
| 1. [\*\*\*] | [\*\*\*] |
| 2. [\*\*\*] | [\*\*\*] |
| 3. [\*\*\*] | [\*\*\*] |
| 4. [\*\*\*] | [\*\*\*] |
| 5. [\*\*\*] | [\*\*\*] |
| 6. [\*\*\*] | [\*\*\*] |
| 7. [\*\*\*] | [\*\*\*] |
| 8. [\*\*\*] | [\*\*\*] |
| 9. [\*\*\*] | [\*\*\*] |
| 10. [\*\*\*] | [\*\*\*] |
| **Total** | [\*\*\*] |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Royalty</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; As additional consideration for the rights granted to Indivior herein, during the Royalty Term (subject to Section 6.5(b)), Indivior shall pay to Addex, on a country-by-country basis, tiered royalty payments at the rates

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set out below on Net Sales of Products sold, on a country-by-country basis, by Indivior, its Affiliates and/or sublicensees ("<u>Royalty</u>"):

---

| | |
|:---|:---|
| **Annual Net Sales of Products in a Country** | **Royalty Rate** |
| Portion of Annual Net Sales of Products in such country less than [\*\*\*] | [\*\*\*] |
| Portion of Annual Net Sales of Products in such country equal to or greater than [\*\*\*] but less than [\*\*\*] | [\*\*\*] |
| Portion of Annual Net Sales of Products in such country equal to or greater than [\*\*\*] but less than [\*\*\*] | [\*\*\*] |
| Portion of Annual Net Sales of Products in such country equal to or greater than [\*\*\*] | [\*\*\*] |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Notwithstanding Section 6.4(a) above, with respect to [\*\*\*], the Royalty payable with respect to each Product [\*\*\*] shall be [\*\*\*] once such Product [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.5&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Royalty Term; Generic Competition</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indivior's obligation to pay a Royalty on Net Sales for each Product in a particular country shall terminate upon the expiration of the Royalty Term with respect to such Product, except as provided in Section 6.5(b) below.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indivior's obligation pursuant to Section 6.4 to pay a Royalty in respect of a particular Presentation of a Product (such Presentation being an "<u>Affected Product</u>") in a country shall be reduced [\*\*\*] in respect of a Quarter if, in respect of such Quarter, (i) a Generic Product [\*\*\*] is marketed in such country and (ii) the Net Sales of such Affected Product in such country in the Quarter are less than [\*\*\*] of the Net Sales generated by [\*\*\*] such Product in such country in the Quarter immediately prior to the launch of [\*\*\*] such Generic Product in such country.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.6&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Sales Milestone Payments</u>. As additional consideration for the rights granted to Indivior herein, Indivior shall pay to Addex a one-time milestone payment upon first achieving each of the Annual Net Sales thresholds set forth below ("<u>Sales Milestone Payments</u>"). For the avoidance of doubt, each Milestone Payment shall be payable one-time only upon the first occurrence of the event triggering the respective milestone provided below.

---

| | |
|:---|:---|
| **Sales Milestone Event** | **Milestone Payment** |
| First time Annual Net Sales exceed [\*\*\*] | [\*\*\*] |
| First time Annual Net Sales exceed [\*\*\*] | [\*\*\*] |
| First time Annual Net Sales exceed [\*\*\*] | [\*\*\*] |
| First time Annual Net Sales exceed [\*\*\*] | [\*\*\*] |
| First time Annual Net Sales exceed [\*\*\*] | [\*\*\*] |
| First time Annual Net Sales exceed [\*\*\*] | [\*\*\*] |
| First time Annual Net Sales exceed [\*\*\*] | [\*\*\*] |
| First time Annual Net Sales exceed [\*\*\*] | [\*\*\*] |
| Total | [\*\*\*] |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Payment/Reports</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; All Development Milestone Payments shall be due and payable by Indivior within [\*\*\*] days after completion of any of the milestones set forth in <u>Section 6.3</u> above. Together with any such payment, Indivior shall deliver a written statement of completion and other pertinent and available information.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; All Royalty payments owed for each country shall be due and payable by Indivior on a Quarterly basis within [\*\*\*] days after the last day of each calendar Quarter during the Royalty Term. Together with any such payment, Indivior shall deliver a report specifying, with respect to the applicable calendar Quarter: the (i) total gross invoiced amount from sales of Product in each country by or on behalf of Indivior and its Affiliates; (ii) amounts deducted by category from gross invoiced amounts to calculate Net Sales; (iii) Net Sales for such country; and (iv) the Royalty payment payable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; All Sales Milestone Payments shall be due and payable by Indivior within [\*\*\*] days after the last day of the Quarter in which the relevant milestone event was achieved. Together with any such payment, Indivior

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shall deliver a report specifying, with respect to such 12-month period: the (i) total gross invoiced amount from sales of Product in such country by or on behalf of Indivior and its Affiliates; (ii) amounts deducted by category from such gross invoiced amounts to calculate Net Sales; (iii) Net Sales; and (iv) Sales Milestone Payment payable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.8&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Inspection of Records</u>. Indivior shall keep records of its sales of Products reasonably necessary for the calculation of payment to be made to Addex hereunder. During the Term, and for a period of [\*\*\*] thereafter, Addex shall have the right to have an independent certified public accountant, mutually agreed upon by Indivior, audit the records of Indivior. Addex, upon providing at least [\*\*\*] days' prior written notice to Indivior, may initiate such an audit no more than [\*\*\*] during the Term and [\*\*\*] thereafter. Any such audit shall be conducted during the normal business hours of Indivior, at a single location where Indivior shall make the records sought to be audited available, and in such a manner as shall not disrupt Indivior's business operations. All personnel conducting the audit on behalf of the independent auditor shall enter into confidentiality agreements with Indivior. Each·such audit shall be conducted at the expense of Addex; provided that if the inspection and audit shows an underpayment of more than [\*\*\*] of the amount due for the applicable period covered by the inspection, then Indivior shall reimburse Addex for all costs incurred in connection with such inspection within [\*\*\*] days thereafter. Indivior shall pay to Addex the amount of any undisputed underpayment revealed by an examination and review. Any overpayment by Indivior revealed by an examination and review shall be deducted by Indivior from the next payment due to Addex.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6.9&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Payment Method</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; All payments due under this Agreement shall be made by bank wire transfer in immediately available funds from the United Kingdom or the United States to an account in Switzerland, the United Kingdom or the United States designated by Addex in writing. In the event that Indivior pays from an account in a country other than the United States or the United Kingdom, then Indivior shall pay an amount such that, when any withholding or other deductions described in <u>Section 6.9(c)</u> have been applied, Addex receives the amount that it would have done had no deduction been made.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; All payments hereunder shall be made in the legal currency of the United States of America, and all references to "$" or "<u>Dollars</u>" shall refer to United States dollars. For the purpose of converting any amount owed hereunder to $, such conversion shall be calculated using the average exchange rate for the conversion of foreign currency into United States Dollars, quoted for current transactions for both buying and selling United States Dollars, as reported in The Wall Street Journal (Internet Edition) for the last business day of each month of the calendar Quarter to which such payment pertains. Without limiting any other remedy of Addex, if Indivior fails to make any payment that is due by the due date, Addex may charge interest in the amount overdue at the rate of [\*\*\*]. Interest will be calculated on a daily basis.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Where any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, the Parties shall use reasonable endeavors to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation agreement or treaty. In the event there is no applicable double taxation agreement or treaty, or if an applicable double taxation agreement or treaty reduces but does not eliminate such withholding or similar tax, the payor shall remit such withholding or similar tax to the appropriate government authority, deduct the amount paid from the amount due to payee and secure and send to payee the best available evidence of the payment of such withholding or similar tax. If withholding or similar taxes are paid to a government authority, each Party will provide the other such assistance as is reasonably required to obtain a refund of the withheld or similar taxes, or obtain a credit with respect to such taxes paid.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the "<u>Indirect Taxes</u>"). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by the receiving Party to receive a refund of these undue Indirect Taxes from the applicable governmental authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to the receiving Party will be transferred to the paying Party within [\*\*\*] days of receipt.

**7.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **INTELLECTUAL PROPERTY**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Ownership; Improvements</u>.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; As between the Parties, Addex shall remain the sole owner of all right, title and interest in and to the Licensed IP, subject to the rights and licenses granted to Indivior herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indivior has the right when exercising its rights under the licenses granted in <u>Section 2.1</u> hereunder to create Indivior Improvements and to file Indivior Improvement Patent Rights. All right, title and interest in any Indivior Improvements and Indivior Improvement Patent Rights shall remain the sole and exclusive property of Indivior and shall not be licensed to Addex. To the extent that Addex acquires rights in any Indivior Improvements or Indivior Improvement Patent Rights, Addex hereby irrevocably assigns, and shall cause to be assigned, to Indivior, such rights, and Indivior hereby accepts such assignment. Addex further acknowledges and agrees that Indivior is the sole and exclusive owner of, all right, title and interest in and to such Indivior Improvements and Indivior Improvement Patent Rights. Addex shall take all action reasonably requested by Indivior to effect the foregoing, at Indivior's expense. Indivior shall, in its own name and at its sole expense, take all actions which Indivior deems to be necessary or appropriate to protect and maintain the Indivior Improvements and Indivior Improvement Patent Rights. At Indivior's request and expense, Addex shall cooperate with Indivior in taking any action reasonably necessary to protect and maintain Indivior Improvements and Indivior Improvement Patent Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; All right, title and interest in any Addex Improvements and all patents and patent applications directed to Addex Improvements shall remain the sole and exclusive property of Addex and shall be included in the scope of the Licensed IP. All such Addex Improvements and patents and patent applications directed to Addex Improvements that are made in connection with this Agreement shall constitute (i) Addex Development Patent Rights if they Cover Licensed Compounds but not Addex Retained Compounds, (ii) Addex Overlapping Patent Rights if they cover both Licensed Compounds and Addex Retained Compounds and (iii) Addex Retained Patent Rights if they Cover Addex Retained Compounds but not Licensed Compounds. To the extent that Indivior acquires rights, other than the licenses granted in this Agreement, in any Addex Improvements, Indivior hereby irrevocably assigns, and shall cause to be assigned, to Addex, such rights, and Addex hereby accepts such assignment. Indivior further acknowledges and agrees that Addex is the sole and exclusive owner of, all right, title and interest in and to such Addex Improvements. Indivior shall take all action reasonably requested by Addex to effect the foregoing, at Addex's expense. Except as otherwise provided in this <u>Article 7</u>, Addex may, in its own name and at its sole expense and in consultation with Indivior, take all actions which Addex deems to be necessary or appropriate to protect and maintain the Addex Improvements. Except where otherwise provided in this <u>Article 7</u>, at Addex's request and, in respect of Addex Improvements only, at Addex's expense, Indivior shall cooperate with Addex in taking any action reasonably necessary to protect and maintain the Licensed IP and Addex Improvements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In the event employees (or consultants) of both Parties (or their respective Affiliates) jointly develop any improvements, enhancements or modifications to the Licensed IP during the Term ("<u>Joint Improvements</u>"), such Joint Improvements shall be jointly owned by·both Parties; <u>provided</u> that Addex's interest in such Joint Improvements shall be included in the scope of the Licensed IP. Each of Indivior and Addex shall promptly disclose to the other all inventions that it considers to be a Joint Improvement. Indivior shall have the right, but not the obligation, to file, prosecute and maintain any patent application directed to any such Joint Improvement in the name of Indivior and Addex jointly.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Patent Prosecution and Maintenance</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Addex Existing Patent Rights</u>. Indivior shall be responsible for and shall undertake, and Addex shall cooperate with Indivior with regards to Indivior's activities associated with, the preparation, filing and prosecution of Addex Existing Patent Rights. Indivior may conduct such activities in Addex's name where reasonably necessary. If Indivior decides to abandon any Addex Existing Patent Rights, Indivior shall provide prior written notice sufficiently in advance of any abandonment to enable Addex to have the right, at its sole expense to, assume control of the preparation, filing, prosecution and maintenance of such patent application or patent for such Addex Existing Patent Rights in the applicable jurisdiction and Indivior shall transfer control of such prosecution in such jurisdiction to Addex. Upon delivery of such notice, such Addex Existing Patent Right shall cease to be an Addex Existing Patent Right and all of Indivior's rights and licenses under and in respect of such Addex Existing Patent Right shall terminate. Except where Indivior abandons an Addex Existing Patent Right in accordance with this <u>Section 7.2</u>, Indivior shall pay renewal fees and take reasonable actions to maintain such Addex Existing Patent Rights in the Patent Filing Jurisdictions.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Addex Development Patent Rights</u>. Indivior shall be responsible for and shall undertake, and Addex shall cooperate with Indivior with regards to Indivior's activities associated with, the preparation, filing and prosecution of Addex Development Patent Rights. Indivior may conduct such activities in Addex's name where reasonably necessary. If Indivior decides to abandon any Addex Development Patent Rights, Indivior shall provide prior written notice

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sufficiently in advance of any abandonment to enable Addex to have the right, at Addex's sole expense, to assume control of the preparation, filing, prosecution and maintenance of such patent application or patent for such Addex Development Patent Rights in the applicable jurisdiction. In the case of such abandonment, Indivior shall transfer control of such prosecution in such jurisdiction to Addex, except where such abandonment is made as a part of a reasonable prosecution strategy, such as, for example, an abandonment made in favor of another Addex Patent Right covering the same Licensed Compound to improve its term or allowability. Except where Indivior elects not to file or abandons an Addex Development Patent Right in accordance with this Section 7.2, Indivior shall pay renewal fees and take reasonable actions to maintain such Addex Development Patent Rights in the Patent Filing Jurisdictions (including using reasonable endeavors to prosecute any Addex Development Patent Rights not yet granted in the Patent Filing Jurisdictions).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Addex Overlapping Patent Rights</u>. Addex shall, at its cost, be responsible for and shall undertake the preparation, filing and prosecution of Addex Overlapping Patent Rights, and Indivior shall cooperate with Addex in connection therewith. The Parties shall use Commercially Reasonable Efforts to reach agreement on matters involving the preparation, filing, and prosecution of the Addex Overlapping Patent Rights in a manner that does not jeopardize the scope, allowability, validity or term of Addex Development Patent Rights or any claims Covering Addex Retained Compounds, or Licensed Compounds. Where it is reasonable to file separately or divide Addex Overlapping Patent Rights into separate Addex Development Patent Rights and an application or applications that Cover Addex Retained Compounds, and where such action shall not jeopardize the scope or term of such Addex Overlapping Patent Rights, then, at the request of either Party, such Addex Overlapping Patent Rights shall be so filed separately or divided. If Addex decides not to file a patent application reasonably requested by Indivior, or to abandon any Addex Overlapping Patent Rights in a Patent Filing Jurisdiction, Addex shall provide prior written notice sufficiently in advance of such abandonment to enable Indivior to, and Indivior shall have the right at its sole expense to, assume control of the preparation, filing, prosecution and maintenance of such patent application or patent in such jurisdiction at its own expense (in Addex's name) and Addex shall transfer such prosecution in such jurisdiction to Indivior and such patent application or patent shall be treated as an Addex Development Patent Right for the purposes of this Section 7.2. Unless Addex elects not to file or abandons an Addex Overlapping Patent Right in accordance with this Section 7.2(c), the Parties shall be equally responsible for renewal fees and take reasonable actions to maintain such Addex Overlapping Patent Rights in the Patent Filing Jurisdictions. Addex shall use reasonable endeavors to prosecute any Addex Overlapping Patent Rights not yet granted to cover the Licensed Compounds and the Addex Retained Compounds.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Joint Patent Rights</u>. Indivior shall at its cost be responsible for and shall undertake, and Addex shall cooperate with Indivior with regards to Indivior's activities associated with, the preparation, filing and prosecution of Joint Patent Rights in the Patent Filing Jurisdictions (it being understood that filings may occur in additional jurisdictions, but that there shall be no obligation hereunder regarding filings in such jurisdictions). If Indivior decides not to file a patent application for a Joint Patent Right or decides to abandon a Joint Patent Right in any country in the Territory, Indivior shall provide prior written notice to Addex sufficiently in advance of any abandonment to enable Addex to, and Addex shall have the right at its sole expense to, assume control of the preparation, filing, prosecution and maintenance of such patent application or patent in such country in the Parties' joint names. In such case, Indivior shall transfer control of such prosecution in such country to Addex. Unless Indivior elects not to file or abandons a Joint Patent Right in accordance with this <u>Section 7.2(d)</u>, Indivior shall pay renewal fees and use reasonable endeavors to maintain and prosecute such Joint Patent Right.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Sharing of Information</u>. Any Party controlling filing and prosecution of Addex Patent Rights or Joint Patent Rights shall keep the other Party reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance strategy (including timing of filing, data to be included, and scope of claims of patent applications), and shall discuss steps with regard to the preparation, filing, and strategy (including timing of filing, data to be included, and scope of claims of patent applications) with respect to such Patents and shall reasonably consider the other Parties' comments in respect of the same. The Parties shall promptly provide copies of all substantive correspondence to and from patent offices and patent attorneys/agents, including any available translations. A Party controlling prosecution shall provide copies of proposed substantive filings or foreign patent agent instructions for such filings reasonably in advance of any due date, to allow comment by the other Party, and shall take reasonable steps to accommodate suggestions or requests of the other Party when received. The obligation hereunder for a Party to use reasonable efforts to pursue a patent application shall not extend to taking a judicial appeal of an administrative decision at its own expense. The obligation hereunder for a Party to pay for the other Party's prosecution of a patent application shall not extend to payment for a judicial appeal of an administrative decision for such application. When reasonably requested by the Party controlling prosecution, the other Party shall provide reasonable assistance to the Party controlling prosecution, including signing or executing any necessary documents. If the Party controlling prosecution elects to abandon a patent application, or not to pursue a patent application in a particular jurisdiction, it shall provide reasonable advance notice to the other Party to enable the other Party to file such application or assume control of the prosecution, at its own expense, in the name of the original controlling Party if reasonably necessary.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Post-Grant Proceedings</u>. With respect to this <u>Article 7</u>:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the Party controlling prosecution of a patent or patent application (x) shall have the right to control any Post-Grant Proceeding related to such patent or patent application in the other Party's name if reasonably necessary and (y) use reasonable endeavors to accommodate suggestions or requests made by the non-controlling Party;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the Party that is not controlling a Post-Grant Proceeding shall cooperate with the other Party as reasonable requested;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the Party that is responsible for the cost of patent prosecution for the patent or patent application at issue in the Post-Grant Proceeding shall also bear the cost of the Post-Grant Proceeding;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the Party that is not obligated to prosecute (or pay) for the prosecution of a patent application shall not be obligated to pursue (or pay) for a Post-Grant Proceeding;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(v)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the obligation on a Party hereunder to use reasonable endeavors to conduct a Post-Grant Proceeding shall not extend to pursuing a judicial appeal of an administrative tribunal or agency decision; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(vi)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; in the event that Party controlling a Post-Grant Proceeding elects not to participate in or continue such proceeding (including any appeal), such Party shall provide reasonable notice to the other Party to allow such other Party to conduct or assume control the Post-Grant Proceeding, which may be assumed in the controlling Party's name, if necessary.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Disputes</u>. In the event that the Parties have a dispute regarding any of their respective rights or obligations under this Article 7, such dispute shall be escalated to the CEO of each Party, who shall amicably and in good faith attempt to resolve the dispute. The foregoing shall not limit either Party's remedies at law or equity with respect to a breach by the other Party of this Article 7.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Patent Term Extensions</u>. Each Party agrees to cooperate with the other, and to do all such acts and provide and sign all documents or copies thereof which may be reasonably necessary or desirable, in connection with the filing or prosecution of any application for any Addex Patent Rights or any Joint Patent Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Enforcement Actions</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indivior shall have the initial right, but not the obligation, using counsel of its choice and at its own cost to enforce the Addex Existing Patent Rights, Addex Development Patent Rights, Addex Overlapping Patent Rights, and/or Joint Patent Rights in the Field or defend any declaratory action with respect thereto, as well as any nullity, inventorship or other action brought in a judicial proceeding affecting the scope, validity, or enforceability of the Addex Existing Patent Rights, Addex Development Patent Rights, Addex Overlapping Patent Rights, or Joint Patent Rights. Indivior shall have sole control of any decisions or other aspects of such action, subject to <u>Section 7.4(b)</u>, and Addex shall, upon request, give to Indivior such reasonable assistance as Indivior may reasonably request, including by signing or executing any necessary documents and consenting to its name being used in the proceedings; provided that Indivior shall reimburse Addex for any reasonable out-of-pocket expenses incurred while providing such assistance and provide an indemnity in respect of any costs order made against Addex by reason of lending its name to the proceedings, where such costs order did not result from Addex wrongdoing or from conduct that would require Addex to indemnify Indivior under this Agreement. Indivior shall keep Addex reasonably informed of the progress of the action and shall consider the comments and observations of Addex in prosecuting the action. If Indivior does not, within [\*\*\*] days of a notice from Addex requiring bringing or defending such action, institute or defend such an action, then Addex shall have the right, but not the obligation, at its own cost, to commence proceedings or assume the defense in the Territory regarding the action and, in such case, Addex shall, subject to <u>Section 7.4(b)</u>, have sole control of any decisions or other aspects of the action, and Indivior shall, upon request, give to Addex such reasonable assistance as Addex may reasonably request; provided that Addex shall reimburse Indivior for any reasonable out-of-pocket expenses incurred while providing such assistance and provide an indemnity in respect of any costs order made against Indivior in connection therewith, where such costs order did not result from Indivior's wrongdoing or from conduct that would require Indivior to indemnify Addex under this Agreement; provided further that nothing in this <u>Section 7.4(a)</u> shall oblige Indivior to lend its name to, or be joined in, any proceedings commenced by Addex pursuant to the foregoing.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In the event that Addex desires to bring an action based on Addex Overlapping Patent Rights in the Indivior Exclusive Field, or in the Shared Field if such action relates to Licensed Compounds or Products, Addex shall provide reasonable advance notice to Indivior, and Addex shall consider comments and observations of Indivior before undertaking such action. Addex shall keep Indivior reasonably informed of the progress of any such action, including any issues affecting the validity or enforceability of Addex Overlapping Patent Rights or the scope of the Addex Overlapping Patent Rights with respect to Licensed Compounds or Products. Addex shall not take any position negatively affecting the scope of the Addex Overlapping Patent Rights with respect to their coverage of Licensed Compounds or Products. To the extent an invalidity or unenforceability defense or counterclaim is raised in such action, where permitted by the law of the relevant jurisdiction, Indivior shall have the right to intervene or join in such action to protect its interests in the Addex Overlapping Patent Rights. Addex shall not, without Indivior's prior written consent (which consent shall not be unreasonably withheld or delayed) bring an action for infringement of (i) Addex Existing Patent Rights or (ii) Addex Development Patent Rights outside of the Field.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Addex shall have the option, but not the duty, to enforce the Addex Retained Patent Rights against Third Party infringement in the Field. Addex shall bear the costs of such enforcement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indivior shall not, without the prior written consent of Addex, which shall not be unreasonably withheld, delayed or conditioned, make any admission or enter into a settlement, consent to judgement or other voluntary final disposition in connection with any such proceedings under this Section 7.4 that: (i) extends, or purports to exercise, Indivior's rights under the Licensed IP beyond the rights granted pursuant to this Agreement, (ii) makes any admission regarding wrongdoing by Addex, or the invalidity, unenforceability or absence of infringement of any Patent Rights within the Licensed IP; (iii) subjects Addex to an injunction or other equitable relief; or (iv) obligates Addex to make a monetary payment. Similarly, in no case may Addex enter into any settlement or consent judgment or other voluntary final disposition that: (a) limits Indivior's rights under the Licensed IP or under this Agreement other than as expressly stated herein; (b) makes any admission regarding wrongdoing on the part of Indivior, an Affiliate or sublicensee, or the invalidity, unenforceability or absence of infringement of any Licensed IP or Addex Patent Rights; (c) subjects Indivior to an injunction or other equitable relief; or (d) obligates Indivior to make a monetary payment; in all cases without the prior written consent of Indivior, which consent shall not be unreasonably withheld, delayed or conditioned. In no case shall Addex grant or have the power to grant any license for Compounds or pharmaceutical products containing or comprising Compounds in the Indivior Exclusive Field under the Addex Patent Rights, Addex Retained Patent Rights or Licensed IP. In no case shall Addex grant or have the power to grant any license for Licensed Compounds or Products in the Shared Field under the Licensed IP.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Any damages or award (including any award of costs) made in the proceedings shall be used first to reimburse each Party for any costs or expenses that it may have incurred in connection with the infringement proceedings (including without limitation, any amounts paid by the Party bringing the action to the other Party as reimbursement for expenses related to assisting in the proceedings) and any remaining amounts shall be retained by the Party to which they were awarded, save that (i) any award [\*\*\*] shall be [\*\*\*] and (ii) any award [\*\*\*] shall, following reimbursement of costs and expenses in accordance with the foregoing, be [\*\*\*]; <u>provided</u> that any such award shall [\*\*\*].

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7.5&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Third Party Infringement Claims</u>. If the production or use of any Licensed Compound or the production, sale or use any Product pursuant to this Agreement results in a claim, suit or proceeding alleging patent infringement against Indivior or Addex or their respective Affiliates or sublicensees, such Party shall promptly notify the other Party hereto in writing. Indivior shall have the right to direct and control the defense and settlement thereof; provided, however, that Addex may participate in (but not control) the defense of such action and employ counsel at its own expense.

**8.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **WARRANTIES**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>General Warranties</u>. Each Party warrants to the other that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; such Party is duly organized and validly existing under the laws of its·jurisdiction of organization, and has full power and authority to enter into this Agreement and to carry out the provisions hereof;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; such Party is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; this Agreement has been duly executed and delivered by such Party and constitutes the legal, valid and binding obligation of such Party enforceable against such Party in accordance with its terms, except to the extent that the enforceability thereof may be limited by (i) applicable bankruptcy, insolvency, fraudulent conveyance,

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reorganization, moratorium or similar laws from time to time in effect affecting generally the enforcement of creditors' rights and (ii) general principles of equity;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; the execution, delivery and performance of this Agreement by such Party does not conflict with its organizational documents or any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any Governmental Authority having jurisdiction over it;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; such Party is aware of no action, suit or inquiry or investigation instituted by any governmental agency that questions or threatens the validity of this Agreement; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; has the full power and authority and has obtained all Third Party consents, approvals, and/or other authorizations required to enter into this Agreement and to carry out its obligations hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Addex Warranties</u>. As at the Effective Date, Addex warrants to Indivior that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Addex exclusively owns all right, title, and interest to the Addex Existing Patent Rights, free and clear of all liens, security interests and encumbrances. As of the Effective Date, there are no existing licenses with respect to the Licensed IP, except for the IP License granted to Indivior herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Addex Patent Rights listed on Schedule 1.3 are, as of the Effective Date, the only patents or patent applications owned or controlled by Addex or its Affiliates that Cover Licensed Compounds.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Addex and/or its Affiliates have obtained and properly recorded previously executed assignments for the Licensed IP as necessary to fully perfect its rights and title therein in accordance with governing law and regulations in each applicable jurisdiction.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; There are no actions, suits, investigations, lawsuits, claims or proceedings pending or, to Addex's Knowledge, threatened, involving the Licensed IP.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; No invention claimed or described in the Addex Existing Patent Rights was made with government funding in circumstances that could negatively affect Indivior's rights to exclusivity under this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(f)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; None of the Addex Patent Rights has been declared abandoned, or been found invalid, unpatentable, or unenforceable for any reason including in a final decision in any administrative, arbitration, judicial, or other proceeding. Addex does not have Knowledge of existing facts and circumstances that would reasonably lead it to believe that any of the Addex Existing Patent Rights are invalid, unpatentable, or unenforceable for any reason. Addex does not have any Knowledge of existing facts and circumstances that would reasonably lead it to believe that material prior art was withheld from the United States Patent Office during the prosecution of Addex Existing Patent Rights.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(g)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Addex does not have Knowledge of existing facts and circumstances that·would reasonably lead it to believe that the development manufacture, sale or commercialization of the ADX 71441 Compound in the Field will infringe any rights of any Third Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(h)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Addex has not misappropriated trade secrets or misused the confidential information of any Third Party in developing the Licensed IP.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; To Addex's Knowledge, no Third Party is infringing the Addex Existing Patent Rights. Addex has taken reasonable measures to protect the confidentiality of the Addex Know How and, to Addex's Knowledge, the Addex Know How remains a protected trade secret of Addex.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(j)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Neither Addex, nor to Addex's Knowledge, any Third Party, owns or has rights to any Marketing Approvals for any Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(k)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Neither Addex nor any of its Affiliates is a party to or otherwise bound by any oral or written contract or agreement that will result in any Third Party obtaining any interest in, or that would give to any Third Party any right to assert any claim in or with respect to, any rights granted to Indivior under this Agreement.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(l)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; [\*\*\*] that would adversely affect the rights of Indivior hereunder.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>No Other Warranties</u>. The representations and warranties provided in this <u>Article 8</u> are in lieu of any other representations or warranties, express or implied, and nothing herein shall be construed as a representation or warranty by either Party of any kind, including without limitation, any implied warranty of fitness for a specific purpose or merchantable quality, all of which are expressly and specifically excluded. No director, officer, employee or agent of any Party or its Affiliates is authorized to make any further representation or warranty to the other Party which is not contained in this Agreement and, without limiting <u>Section 11.1</u>, each Party acknowledges that it has not relied on any such oral or written representations or warranties.

**9.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **CERTAIN COVENANTS AND AGREEMENTS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Disclosure; Technology Transfer</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Promptly after the Effective Date and as applicable during the Term, Addex shall disclose to Indivior all Licensed IP that Addex reasonably considers would be necessary or useful, or that Indivior reasonably requests, for the development of Licensed Compounds or Products as the same shall become available to it. If and as requested by Indivior, Addex will use reasonable efforts to disclose to Indivior or any Regulatory Authority all relevant Licensed IP in its possession required for Indivior to register for sale or obtain Marketing Approval for the Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Promptly after the Effective Date, Addex will, [\*\*\*], make available to Indivior all Addex Know-How that Addex, acting reasonably, considers necessary or useful for Indivior to develop and/or commercialize Products, and Addex Know-How that Indivior reasonably requests, including all research data, pharmacology data, preclinical data, and/or clinical data for the Licensed Compounds.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>No Third-Party Rights; Liens</u>. During the Term, Addex shall not (a) grant any rights to any Third Party in or relating to Licensed IP or (b) encumber any portion of the Licensed IP with liens, mortgages, security interests or another similar interest in any way that would have a negative effect on Indivior's rights hereunder; <u>provided</u> that for the avoidance of doubt any such liens, mortgages, and security interests shall be expressly subordinate to Indivior's rights hereunder; and <u>provided further</u> that Addex shall be entitled to grant licenses in respect of Addex Retained Compounds and Addex Products, in each case solely outside the Indivior Exclusive Field.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>[\*\*\*]</u>. Addex will [\*\*\*] (which, for clarity, shall not require Addex to [\*\*\*] other than [\*\*\*]), to facilitate [\*\*\*]. Addex has delivered to Indivior all [\*\*\*] with respect to the Licensed Compounds as of the date hereof and, after the date hereof, Addex shall not [\*\*\*] with respect to the Licensed Compounds without the prior written consent of Indivior.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Compliance with Laws</u>. Each Party shall comply with all Applicable Laws related to its performance of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.5&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Restructuring</u>. Promptly after the Effective Date, Indivior and Addex will discuss ways to protect Indivior's rights herein in the event of insolvency of Addex and, in its sole discretion, Addex will take such protective steps as agreed upon by the Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.6&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Insolvency Notice</u>. Addex will promptly notify Indivior if (a) to its Knowledge, Addex becomes subject to bankruptcy or similar proceedings or if a receiver or trustee is appointed to take possession of its assets, (b) Addex gives notice to any of its creditors that it has suspended payment of, or is unable to pay, its debts generally or (c) Addex takes or suffers any similar or analogous action in any jurisdiction in consequence of its insolvency.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9.7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>No Assignment</u>. During the Term, Addex shall not transfer or assign the Licensed IP to any Person without the prior written consent of Indivior, except to an Affiliate of Addex or to an acquirer of all or substantially all of the business of Addex to which this Agreement relates who, in each case, has expressly agreed in writing to be bound by the terms hereof.

**10.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **TERM; TERMINATION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Term</u>. The term of this Agreement shall commence on the Effective Date and continue in full force on a country-by-country or Product-by-Product basis until Indivior has no remaining payment obligations with respect to such

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country or Product, unless earlier terminated pursuant to <u>Section 10.2</u> below (the "<u>Term</u>"). Upon expiration (but not an earlier termination) of this Agreement in a particular country or with respect to a particular Product, then the IP License with respect to such country or with respect to such Product to which the Term has expired, as applicable, shall become an exclusive, perpetual, fully paid-up, royalty-free, license of the scope described in Section 2.1 above.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Termination</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Indivior may terminate this Agreement in its entirety or with respect to one or more countries or Products (i) if before Indivior's receipt of Marketing Approval in the applicable country, upon ninety (90) days prior written notice to Addex and (ii) if after Indivior's receipt of Marketing Approval in the applicable country, upon twelve (12) months prior written notice to Addex; or

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Prior to Indivior's receipt of Marketing Approval in a specific Major Market ("<u>Non-Approval Market</u>"), Addex may terminate this Agreement solely with respect to such Non-Approval Market or in its entirety (subject to <u>Section 10.2(c)</u>) if Indivior commits a material breach of this Agreement and fails to cure such breach within 90 days of Addex's written notification to Indivior, or, with respect to its payment obligations set forth in <u>Article 3.1</u> or <u>Article 6</u>, fails to cure such breach within 30 days after receiving two separate notices of such payment breach from Addex at least 30 days apart; provided that, in the case of non-payment pursuant to <u>Article 6</u>, Addex shall not be entitled to serve a notice of termination if such payment obligation has been disputed by Indivior and Indivior has paid any undisputed amounts.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Without prejudice to Addex's right to seek damages or injunctive relief, Addex's right to terminate this Agreement in respect of a Major Market where Indivior has received Marketing Approval or in respect of all markets where Indivior has received Marketing Approval in five of the eight Major Markets shall be limited to termination on the following basis;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(i)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; After Indivior's receipt of Marketing Approval in a specific Major Market ("<u>Approval Market</u>"), Addex may terminate this Agreement solely with respect to such Approval Market or in its entirety if Indivior commits a material breach of its obligations set forth in <u>Article 13</u> or <u>Section 6.8</u> or its payment obligations set forth in <u>Article 6</u>, and with respect to <u>Article 13</u>, fails to cure such breach within 30 days of Addex's written notification to Indivior or, with respect <u>Section 6.8</u>, fails to cure such breach within 90 days of Addex's written notification to Indivior or, with respect to <u>Article 6</u>, fails to cure such breach within 30 days after receiving two separate notices of such payment breach from Addex at least 30 days apart; provided that, in the case of non-payment pursuant to <u>Article 6</u>, Addex shall not be entitled to serve a notice of termination if such payment obligation has been disputed by Indivior and Indivior has paid any undisputed amounts.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(ii)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; This <u>Section 10.2(c)</u> sets out Addex's sole right to terminate this Agreement in respect of a Major Market where Indivior has received Marketing Approval to the exclusion of any common law or statute based law and after receiving such Marketing Approval, subject to the right of termination set out in this <u>Section 10.2(c)</u>, the exclusive licenses granted in <u>Section 2.1</u> in respect of such Major Market shall become perpetual and irrevocable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iii)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; This <u>Section 10.2(c)</u> sets out Addex's sole right to terminate this Agreement in respect of all markets where Indivior has received Marketing Approval in respect of at least five of the eight Major Markets to the exclusion of any common law or statute based law and after receiving such Marketing Approval, subject to the right of termination set out in this <u>Section 10.2(c)</u>, the exclusive licenses granted in <u>Section 2.1</u> in respect of all markets shall become perpetual and irrevocable.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(iv)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; For the avoidance of doubt, Addex's right of termination under <u>Section 10.2(c)</u> is limited to circumstances in Indivior's reasonable control and shall not include circumstances where the cause of the breach was outside Indivior's reasonable control including, in the case of a breach of <u>Section 6.8</u> because a sublicensee is not permitting an audit provided that Indivior has used its best efforts to secure the compliance of the sublicensee and in the case of <u>Article 13</u> where such breach was committed by a Person without Indivior's prior knowledge or consent.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Effects of Termination</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Termination of Rights</u>. Except as otherwise expressly set forth herein, all of the rights of Indivior in respect of Licensed Compounds and Products in a country shall terminate upon the termination date in respect of such Licensed Compound and/or Products in such country pursuant to <u>Section 10.2</u>.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Supplies of Products After Termination</u>. In the event this Agreement is terminated pursuant to <u>Section 10.2</u> in its entirety or with respect to any Products or countries, Indivior and its Affiliates and permitted sublicensees shall have the right, for a period of up to six (6) months following such termination, to sell (in the Field) Indivior's inventory of Licensed Compounds and Products to which such termination applies, subject to all applicable payment and other related obligations in this Agreement. Upon expiration of such six (6) month period, Indivior shall, at Addex's request, sell to Addex at cost any and all remaining quantities of any Licensed Compound and Products subject to the termination that are in its possession or control.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Clinical Studies After Termination</u>. In the event this Agreement is terminated pursuant to <u>Section 10.2</u> in its entirety or with respect to a Product, Indivior shall be responsible for completing (in accordance with the established protocols and its customary business practices) any clinical studies on Licensed Compounds and/or Products that it commenced prior to the termination of this Agreement in its entirety or with respect to such terminated Products. The foregoing shall be at Indivior's cost where this Agreement is terminated by Indivior pursuant to <u>Section 10.2(a)</u> or Addex pursuant to <u>Section 10.2(b)</u>. Indivior shall not commence any clinical study of Products at any time after it has given or received a notice of termination with respect to such Products pursuant to <u>Section 10.2</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Transfer of Marketing Approvals and Other Regulatory Approvals After Termination</u>. In the event this Agreement is terminated pursuant to <u>Section 10.2</u> in its entirety or with respect to any Products or countries pursuant to <u>Section 10.2</u>, Indivior shall, upon request by Addex, use reasonable endeavors to transfer to Addex or to its designee, all Marketing Approvals and any other regulatory approvals relating to any Licensed Compounds or Products subject to such termination, together with any applications for the foregoing (including Marketing Approval applications or other such applications, as well as all existing INDs and other similar regulatory filings for the conduct of clinical trials with respect to Licensed Compounds or Products), together with a copy of all Know-How of Indivior solely relating to such Licensed Compounds or Products. All such transfers shall be completed in accordance with Applicable Laws. In the event that such a transfer is not possible, Indivior shall use reasonable endeavors to provide Addex with the benefit of the existing Marketing Approvals and applications therefor for Products, including, without limitation, granting Addex and/or its designees rights to cross-refer to the data and information on file with Regulatory Authorities as may be necessary to facilitate the granting of separate Marketing Approvals to Addex.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(e)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Return of Confidential Information After Termination</u>. Upon termination of this Agreement in its entirety pursuant to <u>Section 10.2</u>, Indivior shall, at Addex's option, either return to Addex all tangible Confidential Information disclosed to Indivior by or on behalf of Addex (including all copies thereof) or destroy such Confidential Information; provided that Indivior shall have the right to retain one (1) copy of the Confidential Information in a secure location solely for purposes of identifying its confidentiality obligations under <u>Article 13</u>. Upon termination by Addex or by Indivior, Indivior shall use reasonable endeavors to delete all electronic copies of such Confidential Information from its systems (other than Confidential Information stored on electronic archival, back-up, security, or disaster recovery systems). Upon termination, Addex shall, at Indivior's option, either return to Indivior all tangible Confidential Information disclosed to Addex by or on behalf of Indivior (including all copies thereof) or destroy such Confidential Information; provided that Addex shall have the right to retain one (1) copy of the Confidential Information in a secure location solely for purposes of identifying its confidentiality obligations under <u>Article 13</u>. Addex shall use reasonable endeavors to delete all electronic copies of such Confidential Information from its systems other than Confidential Information stored on electronic archival, back-up, security, or disaster recovery systems).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Survival</u>. Termination of this Agreement shall not impair or prejudice any cause of action or claim that one Party may have against the other Party for breach of this Agreement. Subject to the foregoing sentence, upon expiration of this Agreement, <u>Articles 7</u>, <u>11</u>, <u>12</u>, <u>13</u> and <u>14</u> and <u>Sections 2.3</u>, <u>2.4</u>, <u>2.6</u>, <u>3.9</u>, <u>6.8</u>, <u>10.3</u> and <u>10.4</u> and any other the provisions that expressly survive termination or expiration of the Term, shall be so performed and extended and shall continue to be subject to the terms and conditions of this Agreement.

**11.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **INDEMNIFICATION**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Restriction on Limitation of Liability</u>. Neither Party limits or excludes its liability for fraud, fraudulent concealment or fraudulent misrepresentation, nor for death or personal injury arising from its negligence.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Indemnification by Indivior</u>. Indivior shall defend, indemnify and hold harmless Addex, its Affiliates and their respective officers, directors, employees and agents (the "<u>Addex Indemnified Parties</u>") against all claims, liabilities, losses, costs, expenses (including reasonable attorney's fees and costs of investigation), which arise out of claims that are brought by a Third Party against the Addex Indemnified Parties resulting or arising from (a) any breach by Indivior of its representations and warranties, covenants or other obligations hereunder, (b) the negligent acts or omissions or willful

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misconduct of Indivior or its representatives, and (c) Third Party claims or suits in connection with the marketing, sale or distribution of the Products, except to the extent such claim is indemnifiable by Addex pursuant to <u>Section 11.3</u> below.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Indemnification by Addex</u>. Addex shall defend, indemnify and hold harmless Indivior, its Affiliates and their respective officers, directors, employees and agents ("<u>Indivior Indemnified Parties</u>") against all claims, liabilities, losses, costs, expenses (including reasonable attorney's fees and costs of investigation), which arise out of claims that are brought by a Third Party against the Indivior Indemnified Parties resulting or arising from (a) any breach by Addex of its warranties, covenants or other obligations hereunder and (b) the negligent acts or omissions or willful misconduct of Addex or its representatives except to the extent such claim is indemnifiable by Indivior pursuant to <u>Sections 11.2(a)-(b)</u> above.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Procedure</u>. Any Party seeking to be indemnified by virtue of this Article 11 (the "<u>Indemnitee</u>") shall promptly notify the other Party ("<u>Indemnifying Party</u>") in writing of any Third-Party claim, action, proceeding or liability in respect of which it intends to seek indemnification hereunder. The Indemnitor shall have the right to control the defense of, and enter into any settlement with respect to, any such action, claim or liability; provided, that such settlement (a) includes an unconditional release of the Indemnitee from any and all liability to any Third Party, (b) does not adversely affect the Indemnitee's rights hereunder or impose any obligations on the Indemnitee in addition to those set forth herein in order for it to exercise such rights, (c) does not involve any injunctive or other equitable relief which would be imposed on Indemnitee, and (d) does not provide for any finding or admission of a violation of law or violation of the rights of any person or entity by the Indemnitee or any of its Affiliates. No such action, claim or liability shall be settled by the Indemnitee without the prior written consent of the Indemnitor, and the Indemnitor shall not be responsible for any fees or other costs incurred other than as provided herein. The Indemnitee, its employees, agents and Affiliates shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any action, claim or liability covered by this indemnification. The Indemnitee shall have the right, but not the obligation to be represented by counsel of its own selection and at its own expense.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.5&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Mitigation</u>. Any Party making a claim under this <u>Article 11</u> shall take reasonable steps to mitigate and/or minimize the losses or damages suffered.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11.6&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>LIMITATION OF LIABILITY</u>. NEITHER PARTY WILL HAVE ANY OBLIGATION OR LIABILITY (WHETHER IN CONTRACT, WARRANTY, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND NOTWITHSTANDING ANY FAULT, NEGLIGENCE (WHETHER ACTIVE, PASSIVE, OR IMPUTED), REPRESENTATION, STRICT LIABILITY, OR PRODUCT LIABILITY), OR FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL, MULTIPLIED, PUNITIVE, SPECIAL, OR EXEMPLARY DAMAGES OR LOSS OF REVENUE, PROFIT, SAVINGS OR BUSINESS ARISING FROM OR OTHERWISE RELATED TO THIS AGREEMENT, EVEN IF A PARTY OR ITS REPRESENTATIVES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT TO THE EXTENT THAT SUCH DAMAGES (A) ARISE FROM THE FRAUD OF SUCH PARTY, OR (B) ARE AWARDED TO A THIRD PARTY IN A CLAIM FOR WHICH SUCH PARTY IS RESPONSIBLE FOR INDEMNIFICATION HEREUNDER.

**12.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **INSURANCE**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;12.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Each Party shall maintain at all times during the Term, and for [\*\*\*] thereafter, comprehensive insurance coverage to cover its activities related to this Agreement, including, in the case of Indivior, products liability insurance and coverage for clinical trials, underwritten by insurers maintaining an AM Best rating of not less than "A-VII" for insurance coverage obligations. Indivior and Addex hereby agree to provide written notice to the other upon becoming aware of any material change, non-renewal or cancellation of insurance.

**13.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **CONFIDENTIALITY**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;In carrying out the terms of this Agreement, either Party may disclose (the "<u>Disclosing Party</u>") to the other Party (the "<u>Recipient</u>") information regarding the Disclosing Party and/or its Affiliates which is of a proprietary and of confidential nature, including any and all information, information regarding its business, Know-How, methods, trade secrets, financial information, customers and technology (collectively, "<u>Confidential Information</u>"). Confidential Information also includes the terms of this Agreement. The Recipient shall not use the Disclosing Party's Confidential Information for any purpose other than as permitted herein and shall not disclose the Confidential Information to any Third Party, except to its employees, directors and other representatives who have a need to know such information to fulfill the provisions and intent of this Agreement, and who are bound by written obligations of confidentiality with respect to such information. The Recipient agrees that it will exercise the same degree of care and protection to preserve the proprietary and confidential nature of the Confidential Information disclosed by the Disclosing Party, as Recipient would exercise to preserve its own proprietary and confidential information, and in any case no less than a reasonable degree of care. The Recipient shall promptly notify the Disclosing Party of any unauthorized use or disclosure, or suspected unauthorized use or disclosure, of the Disclosing Party's

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Confidential Information of which the Recipient becomes aware. Each Party shall be liable for any failure of its employees, directors or other representatives to comply with the terms of this <u>Article 13</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;The confidentiality obligations set forth in this <u>Article 13</u> shall not apply to confidential information which: (a) is or becomes publicly known through no wrongful act or inaction of the Recipient; (b) the Recipient can demonstrate by written records was lawfully received by it from a Third-Party that is not legally or contractually prohibited from disclosing such information; (c) the Recipient can demonstrate by written records was developed by or for such Recipient independently of, and without the use of, such information disclosed by the Disclosing Party, (d) the Recipient is required by legal order to disclose, provided that the Recipient shall, where permitted, give the Disclosing Party immediate written notice of any such request so that the Disclosing Party may seek a protective order or other reliable assurance that confidential treatment will be accorded to the information so disclosed or (e) Indivior discloses to Regulatory Authorities in connection with obtaining Marketing Approval or other communications relating to commercialization of the Products.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Addex shall not, and shall not permit any of its Affiliates to, grant any license or other right or permission to any entity that, after the Effective Date, acquires control of Addex, to use any confidential or non-public information regarding Addex Know-How in the Indivior Exclusive Field. Addex shall not, and shall not permit any of its Affiliates to, disclose any Addex Know How related solely and exclusively to Licensed Compounds or Products to such an entity.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;13.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;The confidentiality obligations set forth in this <u>Article 13</u> shall survive for [\*\*\*] years after termination or expiration of this Agreement.

**14.**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **MISCELLANEOUS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Expenses</u>. Except as otherwise expressly provided herein, each Party to this Agreement shall bear its respective expenses incurred in connection with the preparation, execution and performance of this Agreement and the transactions contemplated hereby, including without limitation all fees and expenses of agents, legal counsel, accountants, tax and financial advisors and other facilitators and advisors.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Force Majeure</u>. Notwithstanding anything to the contrary herein, neither Party shall be liable or in breach of any provision of this Agreement for any failure or delay on their·part to perform any obligation set out in this agreement because of a force majeure event caused by acts of nature, flood, fire, explosion, war, terrorism, civil unrest, national or regional emergency or any cause beyond the reasonable control of the Party affected; provided that such Party gives prompt written notice to the other Party promptly after such event occurs and shall use Commercially Reasonable Efforts to fulfill its commitments hereunder as soon as possible.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Recordation</u>. Indivior may, at its cost and discretion, record the license granted herein, including by use of a short form document, as permitted or required by Applicable Law or otherwise, including recording a security interest in those jurisdictions which permit a licensee to do so. Addex hereby irrevocably designates and appoints Indivior and its duly authorized officers and agents, as Addex's agent and attorney-in-fact to execute such documents and to do all other acts necessary or useful to record the license granted herein. Addex shall, upon request and at Indivior's cost, give to Indivior such reasonable assistance as Indivior may reasonably request in connection with recording the license.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Publicity</u>. The Parties agree that the terms and contents of this Agreement (including the Schedules hereto) shall be treated as Confidential Information of both Parties, subject to the special authorized disclosure provisions set forth in this <u>Section 14.4</u>. Neither Party shall make any press release or public announcement regarding the execution or terms of this Agreement or the transaction contemplated by this Agreement without the consent of the other Party in accordance with this <u>Section 14.4</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Subject to the other Party's prior written consent (which shall not be unreasonably withheld), each Party shall have the right to make a press release announcing the achievement of each milestone payment under this Agreement as it is achieved, and the achievements of Marketing Approvals in the Major Markets as they occur. Indivior shall be given at least [\*\*\*] Business Days to review such Addex announcements and may make specific, reasonable comments on such proposed press release; thereafter, Addex and Indivior may each disclose to Third Parties the information contained in such press release without the need for further approval by the other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Except as set forth in <u>Sections 14.4(a)</u> and <u>14.4(c)</u>, neither Party shall make a public announcement concerning the existence, terms and/or contents of this Agreement, except in the case of a press release or governmental filing required by Applicable Law (where reasonably advised by the disclosing Party's counsel), in which event the disclosing Party shall provide the other Party with such advance notice as it reasonably can and shall not be required to obtain

------

approval therefor. A Party commenting on such a proposed press release shall provide its comments, if any, within [\*\*\*] Business Days (or within [\*\*\*] Business Days in the event that such shorter period is required to comply with Applicable Law) after receiving the press release for review and the other Party shall give good faith consideration to same.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Parties acknowledge that either or both Parties may be obligated to file under Applicable Law a copy of this Agreement with the SEC or other government authorities. Each Party shall be entitled to make such a required filing, provided that it requests confidential treatment of at least the financial terms and sensitive technical terms hereof and thereof to the extent such confidential treatment is reasonably available to such Party. In the event of any such filing, each Party will provide the other Party with a copy of this Agreement marked to show provisions for which such Party intends to seek confidential treatment not less than [\*\*\*] Business Days prior to such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), and shall reasonably consider the other Party's comments thereon to the extent consistent with the legal requirements, with respect to the filing Party, governing disclosure of material agreements and material information that must be publicly filed, and shall only disclose Confidential Information which it is advised by counsel or the applicable governmental authority is legally required to be disclosed. No such notice shall be required under this <u>Section 14.4(c)</u> if the substance of the description of or reference to this Agreement contained in the proposed filing has been included in any previous filing made by either Party hereunder or otherwise approved by the other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.5&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Independent Contractors</u>. It is understood and agreed that nothing in this Agreement nor any agreement related hereto is intended to nor shall create a partnership between the Parties. The Parties are independent contractors and neither Party is to be considered the agent, partner, joint venturer or employee of the other Party for any purpose whatsoever and neither Party shall have any authority to enter into any contracts or assume any obligations for the other Party.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.6&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Further Assurances</u>. Each of the Parties shall take, or cause to be taken, all actions necessary, proper, or advisable under applicable laws to give effect to the provisions of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.7&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Assignment; Binding Effect</u>. Neither Party shall, without the prior written consent of the other Party, assign, novate, transfer or convey this Agreement (in whole or in part) or any of its rights and obligations hereunder to any Third Party except as set forth in <u>Sections 2.2</u> and <u>3.7</u>); <u>provided</u> always that either Party may assign or novate this Agreement (in whole or in part) without such consent to any Affiliate or to an acquirer of all or substantially all of the business of the assigning Party to which this Agreement relates, whether in a merger, sale of stock, sale of assets or otherwise, without such consent; subject only to that assigning or novating Party giving written notice to the non-assigning Party and the acquirer agreeing in writing to be bound by the terms hereof.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.8&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Entire Agreement</u>. This Agreement constitutes the entire contract between the Parties pertaining to the subject matter hereof, and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions, whether written or oral, of the Parties; and there are no representations, warranties, or other agreements between the Parties in connection with the subject matter hereof except as specifically set forth herein.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.9&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Waiver</u>. The waiver by either Party of any right hereunder, or the failure to exercise such right, shall not be deemed a waiver of exercising such right in the future or of any other right hereunder in case of breach or failure by the other Party whether of a similar nature or otherwise.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.10&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Amendments</u>. No amendment and/or modification to this Agreement shall be effective unless set forth in a writing signed by both Parties.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.11&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Notice</u>. Any notice, request, delivery, approval or consent required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently given upon delivery in person, the next day after delivery by express courier service (signature required) or five (5) days after the date of mailing by registered or certified mail, return receipt requested (or its equivalent), as the address shown below or such other address as a Party provides in accordance with this <u>Section 14.11</u>.

------

Notices sent to Addex shall be addressed to:

Addex Pharma SA

12, Chemin des Aulx

CH1228 Plan-les-Ouates

Geneva, Switzerland

Attention: Chief Executive Officer

With a copy to:

Addex Pharma SA

12, Chemin des Aulx

CHI 228 Plan-les-Ouates

Geneva, Switzerland

Attention: Chief Financial Officer

and

Cooley (UK) LLP

Dashwood

69 Old Broad Street

London, EC2M 1QS

Attention: John Wilkinson

Notices sent to Indivior shall be addressed to:

Indivior UK Limited

103-105 Bath Road

Slough, Berkshire

SL1 3UH

Attention: Assistant General Counsel, EMEA

------

With a copy to:

Indivior Inc.

10710 Midlothian Turnpike

Suite 430

Richmond, VA 23235

Attention: Chief Legal Officer

Telephone: (804) 594-4442

and

K&L Gates LLP

599 Lexington Avenue

New York, NY 10022

Attn: Calvina Bostick

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Whitney J. Smith

Notwithstanding the foregoing, reports required to be delivered pursuant to Sections 3.8, 4.4 and 6.7 shall be in writing and shall be deemed to have been sufficiently delivered upon transmission by email in accordance with the below (provided that if such email is not sent during normal business hours, such notice or communication shall be deemed to have been sent the next business day:

Addex: [\*\*\*]

Indivior: [\*\*\*]

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.12&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Governing Law; Jurisdiction</u>. This Agreement shall be governed by and construed in accordance with the laws of England and Wales, except that the construction or effect of a patent or patent application licensed under this Agreement shall be decided in accordance with the laws of the country in which the patent or patent application was granted or filed. Each Party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute arising out of or in connection with this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.13&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Severability</u>. If any provision in this Agreement is held to be invalid, void or unenforceable, then the remainder of this Agreement, or the application of such provision to the Parties or to the circumstances other than those as to which it is held invalid or unenforceable, shall not be affected thereby and shall be enforced to the fullest extent permitted by law. The Parties agree to renegotiate any such invalid, void or unenforceable provision in good faith in order to provide a reasonably acceptable alternative consistent with the basic purposes of this Agreement.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.14&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Counterparts</u>. This Agreement may be executed in one or more counterparts, none of which need contain the signatures of both Parties, each of which shall be deemed an·original, and all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or electronic signature, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;14.15&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <u>Interpretation and Construction</u>. Unless the context of this Agreement otherwise requires, (a) the terms "include," "includes," or "including" shall be deemed to be followed by the words "without limitation" unless otherwise indicated; (b) the terms "hereof," "herein," "hereby," and derivative or similar words refer to this entire Agreement; and (c) the terms "<u>Section</u>" and "<u>Schedule</u>" refer to the specified Section and Schedule of this Agreement.

Whenever this Agreement refers to a number of days, unless otherwise specified, such number shall refer to calendar days. The headings and paragraph captions in this Agreement are for reference and convenience purposes only and shall not affect the meaning or interpretation of this Agreement. This Agreement shall not be interpreted or constructed in favor of or against either Party because of its effort in preparing it.

\*\*\*

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This Agreement is signed by duly authorised representatives of the Parties:

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| | | |
|:---|:---|:---|
| Signed for an on behalf of | Signed for an on behalf of | Signed for an on behalf of |
| INDIVIOR UK LIMITED | INDIVIOR UK LIMITED | INDIVIOR UK LIMITED |
| By: | /s/ Richard Simkin | /s/ Richard Simkin |
|  | Name: | Richard Simkin |
|  | Title: | Chief Commercial Officer |
| Signed for an on behalf of | Signed for an on behalf of | Signed for an on behalf of |
| ADDEX PHARMA S.A. | ADDEX PHARMA S.A. | ADDEX PHARMA S.A. |
| By: | /s/ Tim Dyer | /s/ Tim Dyer |
|  | Name: | Tim Dyer |
|  | Title: | Chief Executive Officer |

---

------

**SCHEDULE 1.3**

**ADDEX EXISTING PATENT RIGHTS**

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| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| **Reference** | **Country** | **Application Number** | **Patent Number** | **Grant Date** | **Expiry Date** | **Status** |
| **[\*\*\*]** | **[\*\*\*]** | **[\*\*\*]** | **[\*\*\*]** | **[\*\*\*]** | **[\*\*\*]** | **[\*\*\*]** |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |

---

------

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | | [\*\*\*] | | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | | [\*\*\*] | | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | | [\*\*\*] | | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | | [\*\*\*] | | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | | [\*\*\*] | | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | | [\*\*\*] | | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | | [\*\*\*] | | [\*\*\*] | [\*\*\*] |
| [\*\*\*] | | [\*\*\*] | | [\*\*\*] | [\*\*\*] |

---

------

 [\*\*\*] [\*\*\*] [\*\*\*] [\*\*\*]

_________________

<sup>(1)</sup> [\*\*\*]

<sup>(2)</sup> [\*\*\*]

------

**SCHEDULE 1.13**

**AGREED ASSAY**

The details of the Agreed Assay are as follows:

-&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

OR

-&nbsp;&nbsp;&nbsp;&nbsp;[\*\*\*]

## Exhibit 8.1

**Exhibit 8.1**

**SUBSIDIARIES OF THE REGISTRANT**

**Subsidiaries**

The subsidiaries as of December 31, 2022, all of which are included in the consolidated financial statements, are shown below, in accordance with s410 of the Companies Act.

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| | |
|:---|:---|
| **<u>Name</u>** | **<u>Country of Incorporation</u>** |
| Bio-Found Limited | England and Wales |
| Indivior Austria GmbH | Austria |
| Indivior Belgium SRL | Belgium |
| Indivior Canada Ltd | Canada |
| Indivior Česko s.r.o | Czech Republic |
| Indivior Deutschland GmbH | Germany |
| Indivior España S.L.U. | Spain |
| Indivior EU Limited | England and Wales |
| Indivior Europe Limited | Ireland |
| Indivior Finance LLC | US |
| Indivior Finance (2014) LLC | US |
| Indivior Finance S.àr.l | Luxembourg |
| Indivior France SAS | France |
| Indivior Global Holdings Limited | England and Wales |
| Indivior Hrvatska d.o.o. | Croatia |
| Indivior Inc. | US |
| Indivior Israel Ltd | Israel |
| Indivior Italia S.r.l | Italy |
| Indivior Jersey Limited | Jersey |
| Indivior Jersey Finance LLC | US |
| Indivior Jersey Finance (2021) Limited | Jersey |
| Indivior Nederland B.V. | Netherlands |
| Indivior Nordics ApS | Denmark |
| Indivior Pty Ltd | Australia |
| Indivior Schweiz AG | Switzerland |
| Indivior SMTM LLC | US |
| Indivior Solutions Inc. | US |
| Indivior South Africa (Pty) Ltd | South Africa |
| Indivior Treatment Services, Inc. | US |
| Indivior UK Limited | England and Wales |
| Indivior UK Finance No1 Limited | England and Wales |

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------

---

| | |
|:---|:---|
| Indivior UK Finance No2 Limited | England and Wales |
| Indivior UK Finance No3 Limited | England and Wales |
| Indivior US Holdings Inc. | US |
| Olive Acquisition Subsidiary, Inc. | US |
| RBP Global Holdings Limited | England and Wales |

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