Document:

Exhibit 10.1

 

Certain information marked as [****] has been excluded from this
exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

Master Manufacturing
Services Agreement

June 10,
2022

 

     

     

    

 

Table of Contents

 

	ARTICLE 1	 	STRUCTURE OF AGREEMENT
    AND INTERPRETATION	1
	 	 	 	 
	1.1. 	 	Master Agreement	1
	1.2. 	 	Product Agreements	1
	1.3. 	 	Definitions	1
	1.4. 	 	Interpretation	7
	1.5. 	 	Currency	8
	1.6. 	 	Appendices and Exhibits	8
	 	 	 	 
	ARTICLE 2	 	PATHEON’S MANUFACTURING
    SERVICES	8
	 	 	 	 
	2.1. 	 	Manufacturing Services	8 
	2.2.	 	 Active Material Yield	10
	 	 	 	 
	ARTICLE 3	 	CLIENT’S OBLIGATIONS	12
	 	 	 	 
	3.1.	 	Payment	12
	3.2. 	 	Active Materials and Qualification
    of Additional Sources of Supply	12
	 	 	 	 
	ARTICLE 4	 	INITIAL PRICING AND ADJUSTMENTS	12
	 	 	 	 
	4.1. 	 	Initial Pricing	12
	4.2.	 	 Price Adjustments	13
	4.3. 	 	Price Adjustments –
    Current Year Pricing	14
	4.3. 	 	Reserved.	15
	4.4. 	 	Adjustments Due to Technical
    Changes	15
	4.5. 	 	Multi-Country Packaging Requirements	15
	4.6. 	 	Audits	16
	 	 	 	 
	ARTICLE 5	 	ORDERS, SHIPMENT, INVOICING,
    PAYMENT	16
	 	 	 	 
	5.1. 	 	Orders and Forecasts	16
	5.2. 	 	Reliance by Patheon	17
	5.3. 	 	Batch Order Quantities	18
	5.4. 	 	Delivery	18
	5.5. 	 	Invoices and Payment	18
	 	 	 	 
	ARTICLE 6	 	PRODUCT CLAIMS AND RECALLS	19
	 	 	 	 
	6.1. 	 	Product Claims	19
	6.2.	 	 Product Recalls and
    Returns	19
	6.3. 	 	Patheon’s Responsibility
    for Defective and Recalled Products	20
	6.4. 	 	Disposition of Defective or
    Recalled Products	21
	6.5. 	 	Healthcare Provider or Patient
    Questions and Complaints	21
	6.6. 	 	Remedies	21
	 	 	 	 
	ARTICLE 7	 	CO-OPERATION	22
	 	 	 	 
	7.1. 	 	Quarterly Review	22
	7.2. 	 	Authorities	22
	7.3. 	 	Records and Accounting by
    Patheon	22

 

    - i -

     

    

 

	7.4. 	 	Inspection	23
	7.5. 	 	Access	23
	7.6. 	 	Notification of Regulatory
    Inspections	23
	7.7. 	 	Reports	24
	7.8. 	 	Regulatory Filings	24
	 	 	 	 
	ARTICLE 8	 	TERM AND TERMINATION	25
	 	 	 	 
	8.1. 	 	Initial Term	25
	8.2. 	 	Termination for Cause	25
	8.3. 	 	Product Discontinuation	26
	8.4. 	 	Obligations on Termination	26
	 	 	 	 
	ARTICLE 9	 	REPRESENTATIONS, WARRANTIES
    AND COVENANTS	26
	 	 	 	 
	9.1. 	 	Authority	26
	9.2. 	 	Client Representations, Warranties,
    and Covenants	27
	9.3. 	 	Patheon Representations, Warranties,
    and Covenants	27
	9.4. 	 	Debarred Persons	28
	9.5. 	 	Permits	28
	9.6. 	 	No Warranty	29
	 	 	 	 
	ARTICLE 10	 	REMEDIES AND INDEMNITIES	29
	 	 	 	 
	10.1. 	 	Consequential Damages	29
	10.2. 	 	Limitation of Liability	29
	10.3.	 	 Indemnification by Patheon	29
	10.4. 	 	Indemnification by Client	30
	10.5.	 	 Indemnification Procedure	30
	10.6. 	 	Reasonable Allocation of Risk	32
	 	 	 	 
	ARTICLE 11	 	CONFIDENTIALITY	32
	 	 	 	 
	11.1. 	 	Confidentiality Agreement	32
	11.5. 	 	Notification	32
	 	 	 	 
	ARTICLE 12	 	DISPUTE RESOLUTION	32
	 	 	 	 
	12.1.	 	 Dispute Resolution	32
	 	 	 	 
	ARTICLE 13	 	MISCELLANEOUS	32
	 	 	 	 
	13.1.	 	Intellectual Property Ownership and Licenses	32
	13.2.	 	No Implied Rights.	33
	13.3.	 	Insurance	34
	13.4.	 	Independent Contractors	34
	13.5.	 	No Waiver	34
	13.6.	 	Assignment	34
	13.7.	 	Force Majeure	35
	13.8.	 	Additional Product	35
	13.9.	 	Notices	35
	13.10.	 	Severability	36
	13.11.	 	Entire Agreement; Amendment; Survival	36
	13.12.	 	Other Terms	37

 

 

    - ii- 

     

    

 

	13.13.	 	No Third Party Benefit or Right	37
	13.14.	 	Execution in Counterparts	37
	13.15.	 	Further Assurances	37
	13.16.	 	Export Control	37
	13.17.	 	Waiver	38
	13.18.	 	Use of Client Name	38
	13.19.	 	Governing Law; Jurisdiction; Venue; Service	38
	13.20.	 	No Exclusivity; English Language Controls	38

 

	Appendix 1	Form of Product Agreement
	Appendix 2	Non-Disclosure and Non-Use Terms and Conditions
	 	 
	Exhibit A	Form of Quarterly Active Materials Inventory Report
	Exhibit B	Form of Annual Active Materials Inventory Reconciliation
    and Calculation of Actual Annual Yield
	Exhibit C	Example of Price Adjustment Due to Currency Fluctuation

 

    - iii -

     

    

 

MASTER
MANUFACTURING SERVICES AGREEMENT

 

THIS
MASTER MANUFACTURING SERVICES AGREEMENT (this "Agreement") is made as of June 10, 2022 (the "Effective
Date")

 

BETWEEN

 

PATHEON
PHARMACEUTICALS INC.

a corporation existing under the laws of the State of Delaware

 

("Patheon"),

 

-
and -

 

NAPO PHARMACEUTICALS, INC.

a corporation existing under the laws of the State of Delaware

 

("Client").

 

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

 

STRUCTURE
OF AGREEMENT AND INTERPRETATION

 

	1.1.	Master Agreement.

 

This
Agreement establishes the general terms and conditions under which Patheon or any Patheon Affiliate may perform Manufacturing Services
for Client or any Client Affiliate. This "master" form of agreement is intended to allow Client or any of its Affiliates to
contract for the manufacture of multiple Products through Patheon's global network of Manufacturing Sites through the issuance of site
specific Product Agreements without having to re-negotiate the terms and conditions contained herein.

 

	1.2.	Product Agreements.

 

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 Manufacturing Site. Each Product Agreement will be governed by, and subject to, the terms and conditions of this
Agreement, except to the extent the parties agree to specifically modify the terms and conditions of this Agreement in the Product Agreement.
The terms of this Agreement or a Product Agreement may be modified by the parties in accordance with Section 13.11 below. Unless
otherwise agreed by the parties, each Product Agreement will be in the general form and contain the information set forth in Appendix
1.

 

	1.3.	Definitions.

 

The
following terms, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of these
terms have corresponding meanings:

 

"Active
Materials", "Active Pharmaceutical Ingredients" or "API" means the materials listed and identified
in Schedule D of a Product Agreement;

 

     

     

    

 

"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 thereto;

 

"Actual
Annual Yield" or "AAY" has the meaning specified in Section 2.2(a);

 

"Affiliate"
of an entity means:

 

		(a)	a
                                            business entity which owns, directly or indirectly, a controlling interest in the entity;
                                            or

 

		(b)	a
                                            business entity which is controlled by the entity, either directly or indirectly; or

 

		(c)	a
                                            business entity, the controlling interest of which is owned, either directly or indirectly,
                                            by a person or entity that also owns, directly or indirectly, a controlling interest in the
                                            first entity;

 

For this
definition, "control" means the ownership of equity carrying at least a majority of the votes for the election of the directors
of a business entity.

 

“Agreement
Term” has the meaning specified in Section 8.1;

 

"Annual
Product Review Report" means the annual product review report prepared by Patheon as described in Title 21 of the United States
Code of Federal Regulations, Section 211.180(e);

 

"Annual
Report" means, in respect of a Product, the annual report to the FDA prepared by Client regarding the Product as described in
Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2);

 

"Annual
Volume Tier" means one of the tiers set forth in Schedule B to a Product Agreement, showing the Price that would apply with
respect to a given quantity of Product;

 

"Applicable
Laws" means: (i) for Patheon, the Laws of the jurisdiction where the Manufacturing Site is located; and (ii) for Client
and the Product, the Laws of all jurisdictions where Product is manufactured, distributed, and marketed;

 

"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;

 

"Batch
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 thereto;

 

"Bill
Back Items" means the documented and itemized expenses for all third party supplier fees for the purchase or use of columns,
standards, tooling, non-standard pallets, powered air purifying respirator or personal protective equipment suits (where applicable),
RFID tags and supporting equipment, and other project-specific items necessary for Patheon to perform the Manufacturing Services, and
which are not included as Active Materials or Components;

 

"Breach
Notice" has the meaning specified in Section 8.2(a);

 

    	 	- 2 -	 

     

    

 

"Business
Day" means a day other than a Saturday, Sunday or a day that is a statutory holiday in the United States or in the jurisdiction
where the Manufacturing Site is located, and “day” means a calendar day;

 

"cGMPs"
means, as applicable, current good manufacturing practices as described in:

 

		(a)	Division
                                            2 of Part C of the Food and Drug Regulations (Canada);

 

		(b)	Parts
                                            210 and 211 of Title 21 of the United States' Code of Federal Regulations; and

 

		(c)	EC
                                            Directive 2003/94/EC and Volume 4 of the European Commission's Rules governing medicinal
                                            products in the European Union,

 

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;

 

"Client
Indemnitees" has the meaning specified in Section 10.3;

 

"Client
Intellectual Property" means (a) Intellectual Property generated, discovered by, or developed by Client and (b) Product
IP.

 

"Client
Property" has the meaning specified in Section 8.4(d);

 

"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
and Bill Back Items;

 

“Confidentiality
Terms” means the Non-Disclosure and Non-Use Terms and Conditions set forth in Appendix 2;

 

"Confidential
Information" has the meaning set forth in Appendix 2;

 

"Courts"
has the meaning specified in Section 13.20;

 

"Deficiency
Notice" has the meaning specified in Section 6.1(a);

 

"Delivery
Date" means the date scheduled for shipment of Product by Patheon under a Firm Order as set forth in Section 5.1(d);

 

"Disclosing
Party" has the meaning set forth in Appendix 2;

 

"Dispute"
has the meaning set forth in Section 12.1;

 

“DOL”
means the United States’ Department of Labor

 

"EMA"
means the European Medicines Agency and any successor Authority;

 

"Excluded
Lists" means the Department of Health and Human Service's List of Excluded Individuals/Entities and the General Services Administration's
Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs;

 

    	 	- 3 -	 

     

    

 

"FDA"
means the United States Food and Drug Administration and any successor Authority;

 

"FFDCA"
means the Federal Food, Drug, and Cosmetic Act, as amended;

 

"Firm
Order" has the meaning specified in Section 5.1(b);

 

"Force
Majeure Event" has the meaning specified in Section 13.7;

 

"Government
Approval" means any and all approvals, licenses, registrations or authorizations of Regulatory Authorities necessary for the
manufacture of Product in the Territory or for distribution or sale in the Territory and the performance of the other activities contemplated
in this Agreement;

 

"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 and any successor Authorities;

 

"Indemnification
Claim Notice" has the meaning specified in Section 10.5(a);

 

"Indemnified
Party" has the meaning specified in Section 10.5(a);

 

"Indemnifying
Party" has the meaning specified in Section 10.5(a);

 

“Initial
Agreement Term” has the meaning specified in Section 8.1;

 

"Initial
Product Term" has the meaning specified in Section 8.1

 

"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 Manufacturing Site’s local currency, calculated as the daily average
interbank exchange rate for conversion of one unit of the billing currency into the Manufacturing Site’s local currency during
the 90 day period immediately preceding the effective date as published by OANDA.com, "The Currency Site" under the heading
 "Historical Exchange Rates" at www.OANDA.com/convert/fxhistory;

 

"Intellectual
Property" means any and all intellectual property rights of whatever kind or nature and includes rights in patents, patent applications,
formulae, trademarks, trademark applications, trade secrets, trade-names, Inventions, copyrights, industrial designs, trade secrets,
and know how;

 

"Invention"
means any innovation, improvement, development or discovery;

 

"Inventory"
means all inventories of Components and work-in-process produced or held by Patheon for the manufacture of the Products but does not
include the Active Materials or Bill Back Items;

 

“Joint
Intellectual Property” means Intellectual Property generated, discovered or developed jointly by Patheon and Client, excluding
the Product IP;

 

“Joint
Invention Patents” has the meaning specified in Section 13.1(d)(iii);

 

"Laws"
means all laws, statutes, ordinances, regulations, rules, by-laws, judgments, decrees or orders of any Authority;

 

    	 	- 4 -	 

     

    

 

"Losses"
has the meaning specified in Section 10.3;

 

"Manufacturing
Services" means the manufacturing, validation, quality control, quality assurance, stability testing, laboratory analysis, packaging,
and related services, as set forth in this Agreement, required to manufacture and release Product or Products using the Active Materials,
Components, and Bill Back Items;

 

"Manufacturing
Site" means the facility owned and operated by Patheon where the Manufacturing Services are to be performed, as identified in
the relevant Product Agreement;

 

"Materials"
means all Components and Bill Back Items 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, established annually by Client, that may be credited by Patheon under
a Product Agreement, as set forth in the Product Agreement on Schedule D thereto;

 

"Patheon
Competitor" means a business that derives greater than 50% of its revenues from performing contract pharmaceutical development
or commercial manufacturing services for third parties;

 

"Patheon
Indemnitees" has the meaning specified in Section 10.4;

 

"Patheon
Intellectual Property" means Intellectual Property (a) generated, discovered or developed by Patheon before
performing any Manufacturing Services or receiving any Confidential Information from Client under this Agreement or (b) generated,
discovered or developed by Patheon while or as a result of performing the Manufacturing Services, , and (c) excluding only for the
purpose of this clause any Product IP and any Joint Intellectual Property;

 

“PPI”
has the meaning specified in Section 4.2(a);

 

“Product
IP” means Intellectual Property generated, discovered, or developed by Patheon, either alone or jointly with Client, while
or as a result of performing the Manufacturing Services, that has particular application to, or is otherwise related to, the development,
manufacture, use, marketing or sale of, or that is in any way dependent upon, any Active Material or Product;

 

"Price"
or “Pricing”, as the context requires, means the price measured in USD to be charged by Patheon for performing the
Manufacturing Services under a particular Product Agreement, and includes the cost of Components, certain cost items as set forth on
Schedule B to the relevant Product Agreement, and annual stability testing costs as set forth on Schedule C to the relevant Product Agreement;

 

"Product
Agreement" means an agreement between Patheon and Client issued under this Agreement in the form set forth in Appendix 1
(including Schedules A to D) under which Patheon is to perform Manufacturing Services at a particular Manufacturing Site;

 

"Product"
means the products listed in a Product Agreement on Schedule A thereto;

 

"Product
Claims" has the meaning specified in Section 6.3(c);

 

“Product
Term” has the meaning specified in Section 8.1;

 

    	 	- 5 -	 

     

    

 

"Quality
Agreement" means that certain agreement between Patheon and Client which is made a part of the applicable Product Agreement,
setting forth the quality assurance standards for the Manufacturing Services to be performed under each Product Agreement;

 

"Quantity
Converted" has the meaning specified in Section 2.2(a).

 

"Quantity
Dispensed" has the meaning specified in Section 2.2(a).

 

"Quantity
Received" has the meaning specified in Section 2.2(a).

 

"Recall"
has the meaning specified in Section 6.2(a);

 

"Receiving
Party" has the meaning set forth in set forth in Appendix 2;

 

"Regulatory
Authority" or “Regulatory Authorities” means the FDA, EMA, and Health Canada and any other Authority competent
to regulate the manufacture, sale or marketing of pharmaceutical products, including the Products, in the Territory;

 

"Remediation
Period" has the meaning specified in Section 8.2(a);

 

“Representatives”
has the meaning set forth in set forth in Appendix 2;

 

“Required
Percentage” has the meaning specified in Section 2.1;

 

“Required
Period” has the meaning specified in Section 2.1;

 

"RFID"
means Radio Frequency Identification Devices which (at present or in the future) may be affixed to Products, Active Materials, or Materials
to assist in inventory control, tracking, and identification;

 

“Rolling
Forecast” has the meaning specified in Section 5.1(a).

 

“Semi-Firm
Commitment” has the meaning specified in Section 5.1(b).

 

"Shortfall"
has the meaning specified in Section 2.2(b);

 

"Set
Exchange Rate" means the exchange rate to convert one unit of the billing currency into the 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 Manufacturing
Site local currency during the full year period (October 1st [preceding year] to September 30th), as published by OANDA.com
 "The Currency Site" under the heading "Fx History: historical currency exchange rates" at www.OANDA.com/convert/fxhistory;

 

"Shortfall"
has the meaning specified in Section 2.2(b);

 

"Specifications"
means the file, for each Product, which is given by Client or an Affiliate of Client to Patheon in accordance with the procedures listed
in a Product Agreement on Schedule A thereto and which contains documents relating to each Product, including:

 

		(a)	specifications
                                            for Active Materials and Components;

 

		(b)	manufacturing
                                            specifications, directions, and processes;

 

		(c)	storage
                                            requirements;

 

    	 	- 6 -	 

     

    

 

		(d)	all
                                            environmental, health and safety information for each Product including material safety data
                                            sheets; and

 

		(e)	the
                                            finished Product specifications, packaging specifications and shipping requirements for each
                                            Product;

 

all as
updated, amended and revised from time to time by Client in accordance with the terms of this Agreement and the applicable Product Agreement;

 

"Target
Yield" has the meaning specified in Section 2.2(a);

 

"Target
Yield Determination Batches" has the meaning specified in Section 2.2(a);

 

“Term”
has the meaning specified in Section 8.1;

 

"Territory"
means the countries comprising the geographic area described in a Product Agreement where Products manufactured by Patheon are to be
distributed, marketed and otherwise exploited by, or on behalf of, Client;

 

"Third
Party Claims" has the meaning specified in Section 10.3;

 

"Third
Party Rights" means the Intellectual Property of any third party;

 

"United
States" means the United States of America, including its territories and possessions, including the District of Columbia and
Puerto Rico;

 

“USD”
means United States Dollars.

 

"Year"
means each consecutive period of 12 consecutive calendar months commencing on January 1 and ending on December 31, except that
the first Year of the Term will be the period from the Effective Date up to and including December 31 of the same calendar year,
and the last Year of the Term will commence on January 1 of the calendar year in which the Term ends and end on the last day of
the Term.

 

	1.4.	Interpretation.

 

The
division of this Agreement into Articles, Sections, Subsections, Appendices. Exhibits and Schedules, and the insertion of headings, are
for convenience of reference only and will not affect the interpretation of this Agreement. Any Appendices and Exhibits referenced in
this Agreement are, by such reference, incorporated into this Agreement and made a part hereof. Unless otherwise indicated, any reference
in this Agreement to a Section, Appendix, Exhibit or Schedule refers to the specified Section, Appendix, Exhibit or Schedule
to this Agreement. In this Agreement, the term "this Agreement" and similar expressions refer to this Agreement as a
whole and not to any part, Section, Appendix, Exhibit or Schedule of this Agreement. Unless otherwise expressly provided in this
Agreement or the context of this Agreement otherwise requires, (a) words of any gender include each other gender, (b) words
such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to
the particular provision in which these words appear, (c) words using the singular include the plural, and vice versa, (d) the
words “includes” and “including” will be considered to be followed by the phrase “but not limited to”,
 “without limitation” or words of similar import, and (e) the words “will” or “must” have the
same meaning and effect as the mandatory or obligatory sense of the word “shall”. If a payment under this Agreement is due
on a day which is not a Business Day, the due date for that payment will be the next Business Day. Terms other than those defined in
this Agreement will be given their plain English meaning and those terms, acronyms and phrases known in the pharmaceutical/ healthcare
industry will be interpreted in accordance with their generally accepted meanings.

 

    	 	- 7 -	 

     

    

 

	1.5.	Currency.

 

Unless
otherwise agreed in a Product Agreement, monetary amounts expressed in this Agreement are in USD.

 

	1.6.	Appendices and Exhibits.

 

The
following Appendices and Exhibits are attached to, incorporated into, and form an integral part of this Agreement:

 

	Appendix 1	-	Form of
    Product Agreement (including Schedules A to D)
	 	 	 
	Appendix 2	-	Non-Disclosure
    and Non-Use Terms and Conditions
	 	 	 
	Exhibit A	-	Quarterly
    Active Materials Inventory Report 
	 	 	 
	Exhibit B	-	Report
    of Annual Active Materials Inventory Reconciliation and Calculation of Actual Annual Yield 
	 	 	 
	Exhibit C	-	Example
    of Price Adjustment Due to Currency Fluctuation

 

ARTICLE 2

 

PATHEON'S
MANUFACTURING SERVICES

 

	2.1.	Manufacturing Services.

 

Patheon
will perform the Manufacturing Services for Products to be distributed and sold by Client in the Territory for the fees specified in
Schedules B and C to the relevant Product Agreement. Schedule B to each Product Agreement sets forth a list of cost items that are included
in the Price for Products; all cost items that are not included in this list are excluded from the Price and are subject to additional
fees to be paid by Client. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth in Article 4.
Patheon will perform the Manufacturing Services solely at the designated Manufacturing Site, unless otherwise agreed in writing by Client.
If the parties agree that Patheon will supply, and Client will purchase, at least a specified minimum percentage of Client’s requirements
for a Product under a Product Agreement (the “Required Percentage”), then the applicable Product Agreement will set
forth the Required Percentage and the time period during which the obligation will apply (the “Required Period”).
But this obligation (if any) will cease to apply to Client with respect to the Product if Patheon fails to remain in material compliance
with its obligations under this Agreement or the applicable Product Agreement, or Patheon suspends performance under this Agreement or
the applicable Product Agreement in connection with a Force Majeure Event or where Patheon is or will be prevented from supplying the
Product as a result of the action of a Regulatory Authority. Subject to its obligation (if any) to purchase the Required Percentage of
a Product during the Required Period, Client may, at any time, obtain Product from a third party or may, at any time, qualify a third
party to perform Manufacturing Services for the Product. In performing the Manufacturing Services, Patheon and Client agree that:

 

		(a)	Conversion
                                            of Active Materials and Components. Patheon will convert Active Materials and Components
                                            into Products.

 

    	 	- 8 -	 

     

    

 

		(b)	Quality
                                            Control and Quality Assurance. Patheon will perform the quality control and quality assurance
                                            testing specified in the applicable Quality Agreement. Batch review and release to Client
                                            will be the responsibility of Patheon's quality assurance group. Patheon will perform its
                                            batch review and release responsibilities in accordance with Patheon's standard operating
                                            procedures. Each time Patheon delivers Products to Client, it will give Client a certificate
                                            of analysis and certificate of compliance, in form and substance previously agreed between
                                            Patheon and Client, including a statement that the batch has been manufactured and tested
                                            in accordance with Specifications and cGMPs, together with any other documents that are required
                                            by the applicable Quality Agreement or are necessary for the distribution or sale of the
                                            Products in the Territory. Client will have sole responsibility for the release of Products
                                            to the market. The form and style of batch documents, including batch production records,
                                            lot packaging records, equipment set up control, operating parameters, and data printouts,
                                            raw material data, and laboratory notebooks will be the exclusive property of Patheon;
                                            provided, however, that all Product-related information contained in those batch documents
                                            will be Client Intellectual Property and will be made available to Client for review, and
                                            inspection upon reasonable request. Additionally, if Client reasonably requests copies, Patheon
                                            will provide copies.

 

		(c)	Components.
                                            Patheon will purchase all Components at Patheon's expense and as required by the Specifications.
                                            Patheon will inspect and test all Components as required by the Specifications.

 

		(d)	Stability
                                            Testing. 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 the relevant Product Agreement. Patheon will not make any changes
                                            to these testing protocols without prior written approval from Client. If a confirmed stability
                                            test failure occurs, Patheon will notify Client within one Business Day, after which Patheon
                                            and Client 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.
                                            Patheon will not be liable for these costs unless it has failed to perform the Manufacturing
                                            Services in accordance with the Specifications, the Quality Agreement, cGMPs, Applicable
                                            Laws, and other requirements specified herein. Patheon will give Client all stability test
                                            data and results at Client's request.

 

		(e)	Packaging.
                                            Patheon will package the Products as set out in the Specifications and Quality Agreement.
                                            Client will be responsible for the cost of artwork development. Patheon will determine and
                                            imprint the batch numbers, expiration dates and serialization information for each Product
                                            delivered. 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 and Applicable Laws. Client may, in its sole discretion, make changes to labels, product
                                            inserts, and other packaging for the Products. Those changes will be submitted by Client
                                            to all applicable Authorities and other third parties responsible for the approval of the
                                            Products. Client will be responsible for the cost of labelling obsolescence when changes
                                            occur, as contemplated in Section 4.4(c). Patheon's name will not appear on the label
                                            or anywhere else on the Products, except that Patheon hereby consents to the use of its name
                                            or the name of the appropriate Patheon Affiliate and the appropriate Manufacturing Site,
                                            together with required location and contact information, on labels that are applied to primary
                                            and secondary packaging, as required by Applicable Laws.

 

		(f)	Active
                                            Materials. At least 45 days before the scheduled production date for a Product, Client
                                            will deliver the Active Materials to the Manufacturing Site DDP (Incoterms 2020), at no cost
                                            to Patheon, in sufficient quantity to enable Patheon to manufacture the desired quantities
                                            of Product and to ship Product on the Delivery Date. If Client fails to deliver the API or
                                            Client-supplied Components within the agreed time period and, making commercially reasonable
                                            efforts, Patheon is unable to manufacture Product on the scheduled date because of the delay,
                                            the Firm Order will be considered cancelled by Client and Section 5.2(e) will apply. 
                                            All shipments of Active Materials will be accompanied by certificates of analysis from the
                                            Active Material manufacturer, as applicable, confirming the identity and purity of the Active
                                            Materials and its compliance with the Active Material specifications. The Active Materials
                                            will remain the property of Client. Patheon will inspect and test all Active Materials as
                                            required by the Specifications.

 

    	 	- 9 -	 

     

    

 

		(g)	Use
                                            of Active Materials. Patheon will use the Active Materials solely for manufacturing Product
                                            for Client and for related activities in accordance with the terms of this Agreement and
                                            the applicable Product Agreement and for no other purpose.

 

		(h)	Storage
                                            of Active Materials. Patheon will store the Active Materials exclusively at the applicable
                                            Manufacturing Site, in a physically secure area under conditions that maintain their stability,
                                            integrity, and effectiveness and in accordance with the storage instructions provided therefor
                                            by Client. Patheon will ensure that all Active Materials will be free from damage, contamination,
                                            deterioration, and adulteration and protected against theft. Patheon will store all Active
                                            Materials by lot number and all Active Materials will be physically segregated from other
                                            goods and materials stored in the applicable Manufacturing Site. Patheon will use all Active
                                            Materials on a first expired, first-out basis, and Patheon will not use any Active Materials
                                            after the applicable retest date thereof.

 

		(i)	Notifications.
                                            Patheon will promptly notify Client if any Active Materials are damaged, contaminated, adulterated,
                                            lost, or stolen, deteriorated, or are otherwise rendered unusable after delivery to Patheon
                                            (whether before or after incorporation into work in progress). If this occurs, the loss of
                                            Active Materials will be addressed under Section 2.2.

 

		(j)	Bill
                                            Back Items. Bill Back Items will be acquired by Patheon as required to perform the Manufacturing
                                            Services and charged to Client at Patheon's cost plus a 10% handling fee.

 

		(k)	Product
                                            Rejection for Finished Product Specification Failure. If the parties agree, after a full
                                            quality investigation by the parties in accordance with cGMP requirements, Applicable Laws,
                                            and the applicable Quality Agreement, that Patheon manufactured Product in accordance with
                                            the Specifications, the batch production record, Patheon's standard operating procedures
                                            for manufacturing, cGMPs, Applicable Laws, the applicable Quality Agreement and the other
                                            terms and conditions of this Agreement, and the batch or partial batch of Product does not
                                            meet a Specification, Client will pay Patheon 75% of the Component cost and 75% of the manufacturing
                                            labor cost directly incurred from manufacturing 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).

 

	2.2.	Active Material Yield.

 

		(a)	Reporting.
                                            Within 15 Business Days after the end of each quarter of each Year, Patheon will give Client
                                            a quarterly inventory report of the Active Materials held by Patheon using the inventory
                                            report form set out in Exhibit A, which will contain the following information
                                            for the quarter:

 

"Quantity
Received": The total quantity of Active Materials that complies with the Specifications and was received at the applicable Manufacturing
Site during the applicable quarter.

 

"Quantity
Dispensed": The total quantity of Active Materials dispensed at the applicable Manufacturing Site during the applicable quarter.
The Quantity Dispensed for each applicable quarter is calculated by adding the Quantity Received during the applicable quarter to the
inventory of Active Materials that complied with the Specifications held at the beginning of the applicable quarter, less the inventory
of Active Materials that complied with the Specifications held at the end of the quarter. The Quantity Dispensed during each applicable
quarter will only include Active Materials received and dispensed in commercial manufacturing of Products 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 quarter, including any regulatory, stability, validation or test batches manufactured
during the applicable quarter.

 

    	 	- 10 -	 

     

    

 

"Quantity
Converted": The total amount of Active Materials contained in the Products manufactured with the Quantity Dispensed during the
applicable quarter (including any additional Products produced in accordance with Section 6.3(a) or 6.3(b)), delivered by Patheon,
and not rejected, recalled or returned in accordance with Section 6.1 or 6.2 because of Patheon’s failure to perform the Manufacturing
Services in accordance with Specifications, cGMPs, and Applicable Laws.

 

Within
30 days after the end of each Year, Patheon will give Client an annual reconciliation of Active Materials on the reconciliation report
form set forth in Exhibit B, including the calculation of the "Actual Annual Yield" or "AAY" for
the Product at the applicable Manufacturing Site during the Year, which will be the percentage of the Quantity Dispensed that was converted
to Products and will be calculated as follows:

 

Quantity
Converted during the Year     x     100%

Quantity Dispensed during the Year

 

After Patheon
has produced a minimum of 15 successful commercial production batches of Product at the applicable Manufacturing Site and has produced
commercial production batches for at least six months at the applicable Manufacturing Site (collectively, the "Target Yield Determination
Batches"), the parties will agree in writing on the target yield for the Product at the applicable 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.

 

		(b)	Shortfall
                                            Calculation. If the Actual Annual Yield falls more than 5% below the applicable Target
                                            Yield for a Product in a Year, then the shortfall for the Year (the "Shortfall")
                                            will be calculated as follows:

 

Shortfall
= [(Target Yield – 5%) – AAY] * Active Materials Credit Value * Quantity Dispensed

 

		(c)	Credit
                                            for Shortfall. If there is a Shortfall for a Product in a Year, then Patheon will credit
                                            Client's account for the Shortfall no later than 60 days after the end of the Year.

 

Each Shortfall
and credit owed Client under this Section 2.2(c) will be summarized on the reconciliation report form set forth in Exhibit B.
Upon expiration or termination of a Product Agreement, any remaining credit owing under this Section 2.2, related to the Product
Agreement, will be paid to Client. The Annual Shortfall, if any, will be disclosed by Patheon on the reconciliation report form.

 

		(d)	Maximum
                                            Credit. Patheon's liability for Active Materials calculated in accordance with this Section 2.2
                                            for any Product in a Year under any Product Agreement will not exceed, in the aggregate,
                                            the Maximum Credit Value set forth in Schedule D to the applicable Product Agreement

 

    	 	- 11 -	 

     

    

 

		(e)	No
                                            Material Breach. The parties agree that, if the Actual Annual Yield is less than the
                                            Target Yield for a given Year, this fact will not by itself constitute a material breach
                                            of this Agreement by Patheon.

 

ARTICLE 3

 

CLIENT'S OBLIGATIONS

 

	3.1.	Payment.

 

Client
will pay Patheon for performing the Manufacturing Services according to the Prices specified in Schedules B and C to each Product Agreement.
Client will also pay Patheon for any Bill Back Items in accordance with Section 2.1(j)).

 

	3.2.	Active Materials and Qualification
of Additional Sources of Supply.

 

Client
will, at its sole cost and expense, deliver the Active Materials to Patheon (in accordance with Section 2.1(f)) sufficient for Patheon
to manufacture the desired quantities of Product. Patheon and Client will reasonably cooperate to permit the import of the Active Materials
to the applicable Manufacturing Site. Client's obligation will include obtaining the proper release of the Active Materials from the
applicable customs agency and Regulatory Authority, as applicable. Client or Client's designated agent will be the "Importer of
Record" for Active Materials imported to the applicable Manufacturing Site.

 

If
Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon will cooperate with Client 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 Client's cost. For an Active Material, this work at a minimum will include:

 

		(a)	laboratory
                                            testing to confirm the Active Material meets existing Specifications;

 

		(b)	manufacture
                                            of a GMP qualification batch of Product that will be placed at a minimum on three months
                                            accelerated stability;

 

		(c)	If
                                            applicable, 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 2.1(k) will
apply to all Product manufactured using the newly approved Active Material or Component because of the limited material characterization
that is performed on additional sources of supply.

 

ARTICLE 4

 

INITIAL PRICING
AND ADJUSTMENTS

 

	4.1.	Initial Pricing.

 

The
tiered Price and annual stability Price for the Products for the first Year are listed in Schedules B and C to the relevant Product Agreement
and are subject to the adjustments set forth in Sections 4.2 and 4.3.

 

    	 	- 12 -	 

     

    

 

	4.2.	Price Adjustments.

 

After
the first Year of a Product Agreement, Patheon may adjust the Price for the Product Agreement effective January 1st of each Year
as follows:

 

		(a)	Manufacturing
                                            and Stability Testing Costs. For Products manufactured in the United States, Patheon
                                            may adjust that portion of the Price attributable to Manufacturing Services (and not to Components)
                                            for inflation, based upon the preliminary number for any increase in the Producer Price Index
                                            pcu325412325412 for Pharmaceutical Preparation Manufacturing ("PPI") published
                                            by the DOL Bureau of Labor Statistics in August of the preceding Year compared to the
                                            final number for the same month of the Year prior to that, unless the parties otherwise agree
                                            in writing. On or about November 1st of each Year, Patheon will give Client 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, Patheon may
                                            similarly adjust the Price for inflation using an inflation index to be agreed by the parties
                                            in the Product Agreement. The maximum Price adjustment under this Section 4.2(a) will
                                            not exceed the lesser of (i) the PPI (as published by the DOL in August of
                                            the preceding Year compared to the final number for the same month of the Year prior to that,
                                            as may be otherwise agreed to by the parties) and (ii) 5%.

 

		(b)	Component
                                            Costs. If Patheon incurs an increase in Component costs during the Year, it may increase
                                            the Price for the next Year to pass through the additional Component costs. If Patheon's
                                            Component costs decrease during a Year, Patheon will decrease the Price for the next Year
                                            to pass through the reduced Component costs. On or about November 1st of each Year,
                                            Patheon will give Client information about any increase or decrease in Component costs, which
                                            will be applied to the calculation of the Price for the next Year, which information, in
                                            the case of a cost increase, will reasonably demonstrate that the Price increase is justified.
                                            If the price increase is less than 5%, Patheon will not be required to give information to
                                            Client that is subject to obligations of confidentiality between Patheon and its suppliers;
                                            however, if the price increase is 5% or more, then Patheon will provide Client with copies
                                            of invoices (which may be reasonably redacted by Patheon) issued to Patheon by those suppliers
                                            that have increased their respective prices. Disclosure by Patheon of the invoices is subject
                                            to Appendix 2.

 

		(c)	Pricing
                                            Basis. Client acknowledges that the Price in any Year is quoted based upon the Batch
                                            Order Quantity and Annual Volume Tiers specified in Schedule B to the relevant Product Agreement.
                                            The Price may be subject to change if the specified Batch Order Quantity changes or the quantity
                                            specified in the lowest specified Annual Volume Tier is not ordered in a Year. If Patheon
                                            and Client agree that the Batch Order Quantity or lowest Annual Volume Tier will not be ordered
                                            in a Year, whether as a result of a decrease in Client's forecasts or otherwise, and, as
                                            a result of the reduction, Patheon demonstrates to Client that its costs to perform the Manufacturing
                                            Services or to acquire the Components for the Product will increase on a per-unit basis,
                                            and the amount of the increase, then Patheon may increase the Price by an amount sufficient
                                            to absorb the documented increased costs. On or about November 1st of each Year, Patheon
                                            will give Client a statement setting forth the information to be applied in calculating those
                                            cost increases (if any) for the next Year. If the price increase is less than 5%, Patheon
                                            will not be required to give information to Client that is subject to obligations of confidentiality
                                            between Patheon and its suppliers; however, if the price increase is 5% or more, then
                                            Patheon will provide Client with copies of invoices (which may be reasonably redacted by
                                            Patheon) issued to Patheon by those suppliers that have increased their respective prices.
                                            Disclosure by Patheon of the invoices is subject to Appendix 2.

 

		(d)	Adjustments
                                            Due to Currency Fluctuations. 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 C.

 

    	 	- 13 -	 

     

    

 

		(e)	Tier
                                            Pricing (if applicable). The Pricing in Schedule B to a Product Agreement is set forth
                                            in Annual Volume Tiers based upon Client's volume forecasts under Section 5.1. Client
                                            will be invoiced during the Year at the unit Price set forth in the applicable Annual Volume
                                            Tier based on the 18 month 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 Client a reconciliation of the actual volume of Product ordered by the Client during
                                            the Year with the applicable Pricing tiers. If Client has overpaid during the Year, Patheon
                                            will issue a credit or refund to the Client for the amount of the overpayment within 45 days
                                            after the earlier of (i) the end of the then-current Year or (ii) termination
                                            of the Product Agreement. If Client has underpaid during the Year, Patheon will issue an
                                            invoice to the Client under Section 5.5 for the amount of the underpayment within 45
                                            days after the earlier of (i) the end of the then-current Year or (ii) termination
                                            of the Product Agreement. If Client 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 of Client's notification to Patheon of its disagreement,
                                            the matter will be resolved in accordance with Section 12.1.

 

For all
Price adjustments under this Section 4.2, Patheon will deliver to Client on or about November 1st of each Year a revised Schedule
B to each Product Agreement to be effective for Product delivered under the Product Agreement on or after the first day of the next Year.

 

4.3.                         Price Adjustments – Current Year Pricing. During any Year, the Prices set out in Schedule B of a Product Agreement will be adjusted as follows:

 

		(a)	Extraordinary
                                            Increases in Component Costs. 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 an adjustment to the then-applicable Price for any affected Product to
                                            compensate Patheon for the increased Component costs. Changes materially greater than normal
                                            forecasted increases will have occurred if: (i) the cost of a Component increases by
                                            10% of the cost for that Component upon which the most recent fee quote was based; or (ii) the
                                            aggregate cost for all Components required to manufacture a Product increases by 5% 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.

 

		(b)	For
                                            a Price adjustment proposed under this Section 4.3, Patheon will deliver to Client 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. But, if requested by
                                            Client, Patheon will use commercially reasonable efforts to obtain permission to disclose
                                            these documents to Client or will provide these documents with appropriate redactions. The
                                            revised Price will be effective for any Product with a date of manufacture on or after the
                                            first day of the month following Client’s receipt of the revised Schedule B to the
                                            Product Agreement and the supporting documentation.

 

    	 	- 14 -	 

     

    

 

	4.4.	Adjustments Due to Technical
Changes.

 

		(a)	Amendments
                                            to Specifications Required by Applicable Laws. If an amendment to the Specifications
                                            is required by Applicable Laws, Client may amend the Specifications unilaterally and in its
                                            sole discretion. If this amendment will result in increased or decreased costs incurred by
                                            Patheon, then the parties will negotiate in good faith an appropriate adjustment to the Price
                                            on commercially reasonable terms to reflect the increased or decreased cost to Patheon. If
                                            the parties are not able to mutually agree to the Price changes within 30 days (or for a
                                            longer period as the parties may agree) and Patheon does not agree to implement the amendment
                                            at no increase or decrease in Price, then the dispute will be resolved in accordance with
                                            Section 12.1.

 

		(b)	Other
                                            Amendments. Amendments to the Specifications or the Quality Agreement requested by Client,
                                            other than those addressed in Section 4.4(a), will only be implemented following a technical
                                            and cost review. If this amendment will result in increased or decreased costs incurred by
                                            Patheon, then the parties will negotiate in good faith an appropriate adjustment to the Price
                                            on commercially reasonable terms to reflect the increased or decreased cost to Patheon. If
                                            the parties are not able to mutually agree to the Price adjustment within 30 days (or for
                                            a longer period as the parties may agree) and Patheon does not agree to implement the amendment
                                            at no increase or decrease in Price, Client at its option may either (i) determine not
                                            to implement the amendment and there will be no adjustment to the Price, or (ii) terminate
                                            this Agreement or the applicable Product Agreement. Client will notify Patheon of its election
                                            within five Business Days after the end of the 30-day period (or for a longer period as the
                                            parties may agree). If Client elects to terminate this Agreement or a Product Agreement as
                                            set forth above in this Section 4(b), the termination will be effective ten days after
                                            Client gives Patheon written notice of its election to terminate.

 

		(c)	Obsolete
                                            Inventory. Client agrees to purchase, at the price paid by Patheon (including documented
                                            out-of-pocket costs incurred by Patheon for the purchase and handling of the Inventory),
                                            all Inventory used under the previous Specifications or Quality Agreement and purchased or
                                            maintained by Patheon in order to fill current Firm Orders, if the Inventory can no longer
                                            be used to manufacture Product under the amended Specifications or Quality Agreement and
                                            if the revisions to the Specifications or the Quality Agreement were proposed by Client.
                                            Open purchase orders for Components no longer required under any revised Specifications that
                                            were placed by Patheon with suppliers in order to fill current Firm Orders will be cancelled
                                            where possible, and if the orders may not be cancelled without penalty, will be assigned
                                            to and satisfied by Client, unless these Components may be used by Patheon for some other
                                            purpose.

 

		(d)	Patheon-Requested
                                            Amendments. Amendments to the Specifications, the Quality Agreement, or the applicable
                                            Manufacturing Site requested by Patheon will only be implemented following the written approval
                                            of Client.

 

	4.5.	Multi-Country Packaging
Requirements.

 

If
Client requests that Patheon perform Manufacturing Services for the Product for countries outside the Territory, then Client will inform
Patheon of the packaging requirements for each new country and Patheon will prepare a quotation for consideration by Client of any additional
costs for Components and Bill-Back Items and the change-over fees for the Product destined for each new country. If Client agrees to,
and accepts, Patheon’s quotation, then the agreed additional packaging requirements and related packaging costs will be set out
in a written amendment to the applicable Product Agreement.

 

    	 	- 15 -	 

     

    

 

	4.6.	Audits.

 

Client
will have the right to have an independent accounting firm of nationally recognized standing, provided with access to, and cooperation
by, Patheon during normal business hours, and upon reasonable prior written notice, to examine only those records of Patheon (and, if
applicable, its Affiliates) as may be reasonably necessary to determine, with respect to any Year ending not more than three Years prior
to Client's request, the correctness of any Price increase taken by Patheon. These examinations may not be conducted more than once in
any Year (unless a previous audit during that Year revealed an overpayment by Client with respect to the period or an incorrect statement
submitted by Patheon during the period). Results of the audit will (a) be (i) limited to information related to the Products,
(ii) made available to both parties in writing, and (iii) subject to Article 11 and (b) not reveal any specific information
of Patheon to Client other than (i) whether statements submitted by Patheon with respect to any increase in Price are true and correct,
as the case may be, and (ii) the amount of any excess payment reimbursable to Client or any correction to statements submitted by
Patheon under this Agreement, as the case may be. The determination of the accounting firm will be final and binding as between the parties.
The cost of the examination will be borne by Client, unless the audit reveals a variance of more than 10% from the reported amounts for
the period under examination, in which case Patheon will bear the cost of the audit. If the audit concludes that excess payments were
made by Client during the period under examination, then Patheon will reimburse to Client the amount of the excess payment within 60
days after the date on which the auditor's written report is delivered to the parties.

 

ARTICLE 5

 

ORDERS, SHIPMENT, INVOICING,
PAYMENT

 

	5.1.	Orders and Forecasts.

 

		(a)	Rolling
                                            18 Month Forecast. When each Product Agreement is executed, Client will give Patheon
                                            a non-binding 18 month forecast of the volume of Product that Client expects to order in
                                            the first 18 months of commercial manufacture under the Product Agreement (“Rolling
                                            Forecast”). .

 

		(b)	Firm
                                            Orders. Unless otherwise agreed in a Product Agreement, Client will issue on a rolling
                                            basis during the term of the Product Agreement, an updated Rolling Forecast on or before
                                            the 15th day of each month (or, at Client's discretion, at any time from the 8th
                                            day of the month up to and including the 22nd day of the month), which updated Rolling
                                            Forecast will be non-binding except as set forth in this Section 5.1(b). Each updated
                                            Rolling Forecast will start on the first day of the next month. The first three months of
                                            each updated forecast will be considered binding. Thus, concurrent with each updated Rolling
                                            Forecast, Client will issue a new firm written purchase order ("Firm Order")
                                            for Client to purchase the quantity of Product forecasted for the third month of the updated
                                            Rolling Forecast, and, when the new Firm Order is accepted by Patheon, for Patheon to manufacture
                                            and deliver the agreed quantity of the Product. The Delivery Date will not be less than 90
                                            days following the date that the Firm Order is submitted. The following nine months of the
                                            Rolling Forecast will be 80% binding (the “Semi-Firm Commitment”). For
                                            example, of the Semi-Firm Commitment, if a forecast states ten batches in month 12 then Client
                                            may adjust the number of batches to no less than eight or no more than twelve in each of
                                            the following nine months until each month becomes part of the Firm Commitment. The following
                                            six months of the Rolling Forecast will be non-binding, good-faith estimates to facilitate
                                            Patheon’s production scheduling. Patheon will review each Rolling Forecast and notify
                                            Client within ten business days if Patheon is unable to accept any portion of the Rolling
                                            Forecast. Firm Orders submitted to Patheon will specify, at a minimum, Client's purchase
                                            order number, quantities by Product type, monthly shipment schedule, and any other elements
                                            necessary to ensure the timely manufacture and shipment of the Products. The quantities of
                                            Products ordered in Client’s Firm Orders, once accepted by Patheon, will be firm and
                                            binding on Client and may not be reduced by Client.

 

    	 	- 16 -	 

     

    

 

		(c)	Three
                                            Year Forecast. On or before the tenth day of June of each Year while a Product Agreement
                                            is in effect, Client will give Patheon a written non-binding three-Year forecast, broken
                                            down by quarters for the second and third Years of the forecast, of the volume of each Product
                                            Client then anticipates will be required to be manufactured and delivered to Client under
                                            each Product Agreement during the three-Year period.

 

		(d)	Acceptance
                                            of Firm Order. Patheon will accept Firm Orders by sending an acknowledgement to Client
                                            within ten Business Days of its receipt of the Firm Order. If no acknowledgement is sent
                                            by Patheon in the specified period, the Firm Order will be considered to have been accepted
                                            by Patheon. Patheon will be required to accept any Firm Order submitted by Client in accordance
                                            with Section 5.1(b). But Patheon will not be required to accept a Firm Order submitted
                                            by Client under Section 5.1(b) if the quantity of Product specified in the Firm
                                            Order exceeds 100% of the quantity specified in the most recent Rolling Forecast for the
                                            period to which the Firm Order relates. Patheon will use commercially reasonable efforts
                                            to accept Firm Orders up to 125% of the quantity specified in the most recent Rolling Forecast
                                            for the period to which the Firm Order relates. The acknowledgement will include, subject
                                            to confirmation from the Client, the Delivery Date for the Product ordered, and Patheon will
                                            be required to deliver the Product on the Delivery Date, subject to the following sentence.
                                            The Delivery Date may be amended by agreement of the parties or as set forth in Section 2.1(f).

 

	5.2.	Reliance by Patheon.

 

		(a)	Client
                                            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 required to meet the
                                            Firm Orders. In addition, Client 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) and
                                            (b) or to meet the production requirements of any longer period agreed to by Patheon
                                            and Client. Accordingly, Client 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 Client under Section 5.1(a) or (b), as the case
                                            may be. Patheon may make other purchases of Components to meet Manufacturing Services requirements
                                            for longer periods if agreed to in writing by the parties.

 

		(b)	If
                                            Client requests that Patheon manufacture launch quantities of a Product for which purchase
                                            of Components is not provided for by Section 5.2(a), then Client will give Patheon written
                                            authorization to order the necessary Components and, once the written authorization is accepted
                                            by Patheon, Components ordered in this manner will be considered to be properly ordered by
                                            Patheon as though they were ordered under Section 5.2(a).

 

		(c)	If
                                            Components properly ordered by Patheon under Firm Orders for use in finished Products, as
                                            set forth in Sections 5.2(a) or (b), are not included in finished Products manufactured
                                            for Client within six months after the forecasted month for which the purchases have been
                                            made (or for a longer period as the parties may agree), then Client will pay to Patheon its
                                            costs therefor (including all costs incurred by Patheon for the purchase and handling of
                                            the Components). But if these Components are used in Products subsequently manufactured for
                                            Client or in third party products manufactured by Patheon, Client will receive credit for
                                            any costs of those Components previously paid to Patheon by Client.

 

		(d)	If
                                            Client fails to take possession or arrange for the destruction of Components within 6 months
                                            after purchase in quantities and on a schedule as contemplated by Section 5.2(a), within
                                            30 days of receipt of written notice from Patheon identifying the obsolete Components or
                                            of finished Product within one month of batch release of finished Product to Client pursuant
                                            to a Firm Order, Patheon will notify Client, and Client will pay Patheon $300 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
                                            $600 per pallet per month. Storage fees are subject to a one pallet minimum charge per month.
                                            Patheon may ship finished Product held by it longer than three months following batch release
                                            of the Finished Product to Client or Client’s agent pursuant to a Firm Order to the
                                            Client at Client's expense on 14 days' prior written notice to the Client.

 

    	 	- 17 -	 

     

    

 

		(e)	Cancellation
                                            or Postponement. Patheon will determine, in accordance with Client’s Rolling Forecast,
                                            the manufacturing schedule of all Product covered by Firm Orders. If Client cancels or reduces
                                            a Firm Order, or wishes to postpone the applicable Delivery Date (subject to Section 5.1(d)),
                                            Client will remain liable to pay Patheon 100% of the Price for the Firm Order.

 

	5.3.	Batch Order Quantities.

 

Client
may only order Manufacturing Services for batches of Products in multiples of the Batch Order Quantities as set out in Schedule B to
a Product Agreement, unless otherwise agreed by the parties.

 

	5.4.	Delivery.

 

Shipments
of Products will be made EXW (Incoterms 2020) Patheon's Manufacturing Site or other shipping point as the parties may agree in writing
and specify in the relevant Product Agreement. Risk of loss or of damage to Products will remain with Patheon until the Products are
loaded onto the carrier's vehicle for shipment at the shipping point, at which time risk of loss or damage will transfer to Client. Patheon
will, in accordance with Client's instructions and as agent for Client, (a) arrange for shipping, to be paid by Client and at Client's
risk, and (b) at Client's expense, obtain any export license or other official authorization necessary to export the Products. Client
will arrange for insurance and will select the freight carrier to be used by Patheon to ship Products and Client may monitor Patheon's
shipping and freight practices as they pertain to this Agreement. Products will be transported in accordance with the Specifications.
Patheon will cooperate and help Client or Client's designee for purposes of obtaining any license or approval required for the import
of Products into a country in the Territory.

 

	5.5.	Invoices and Payment.

 

		(a)	Invoices
                                            will be sent by email to [****]

 

		(b)	][.
                                            Invoices will be sent and dated when the Product is manufactured and released by Patheon
                                            to Client. Patheon will also submit to Client, with each shipment of Products, a duplicate
                                            copy of the invoice covering the shipment. Patheon will also give Client an invoice covering
                                            storage of any Product under Section 5.2(d) of this Agreement. Each invoice will,
                                            to the extent applicable, identify Client's Manufacturing Services purchase order number,
                                            Product numbers, names and quantities, unit Price, freight charges to the local address set
                                            forth in the Product Agreement, and the total amount to be paid by Client. Client will pay
                                            the Manufacturing Site all undisputed invoices within 30 days of the date thereof. Interest
                                            on undisputed past due accounts will accrue at 1% per month, which is equal to an annual
                                            rate of 12%. Patheon agrees that, so long as Client remits payment in accordance with the
                                            “Payment Details” stated in each invoice issued pursuant to a Product Agreement,
                                            such payment will constitute payment under this Agreement.

 

    	 	- 18 -	 

     

    

 

ARTICLE 6

 

PRODUCT
CLAIMS AND RECALLS

 

	6.1.	Product Claims.

 

		(a)	Product
                                            Claims. Client has the right to reject any portion of any shipment of Products that deviates
                                            from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth
                                            herein without invalidating any remainder of the shipment. Client will inspect the Products
                                            manufactured by Patheon upon receipt and will give Patheon written notice (a "Deficiency
                                            Notice") of all claims for Products that deviate from the Specifications, cGMPs,
                                            Applicable Laws or other warranties or requirements set forth herein within 45 days after
                                            Client's receipt of the Product and full batch records therefor (or, in the case of any defects
                                            not reasonably susceptible to discovery upon receipt of the Product, within 45 days after
                                            discovery by Client, but not after the expiration date of the Product). If Client fails to
                                            give Patheon the Deficiency Notice within the applicable 45-day period, then the delivery
                                            will be considered to have been accepted by Client on the 45th day after delivery or discovery,
                                            as applicable. Patheon will not be liable under Section 6.3(a) for any deviations
                                            for which it has not received notice within the applicable 45-day period.

 

		(b)	Determination
                                            of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have ten days to advise
                                            Client by notice in writing that it disagrees with the contents of the Deficiency Notice.
                                            Should Patheon fail to object to the Deficiency Notice on a timely basis, Patheon will be
                                            considered to have accepted and agreed with the Deficiency Notice. If Client and Patheon
                                            fail to agree within ten days after any Patheon notice to Client objecting to a Deficiency
                                            Notice as to whether any Products identified in the Deficiency Notice deviate from the Specifications,
                                            cGMPs, Applicable Laws or other warranties or requirements set forth herein, then, on the
                                            tenth (10th) day after receipt of the Deficiency Notice, the parties will mutually
                                            select an independent laboratory that is properly qualified to make the relevant determination
                                            to determine whether the Products deviate from the Specifications, cGMPs, Applicable Laws
                                            or other warranties or requirements set forth herein. The determination of the independent
                                            laboratory will be binding on the parties. If the independent laboratory determines that
                                            any Products deviate from the Specifications, cGMPs, Applicable Laws, or other warranties
                                            or requirements set forth herein, Client may reject those Products in the manner contemplated
                                            in this Section 6.1 and Patheon will be responsible for the cost of the evaluation.
                                            If the independent laboratory finds that none of the Products deviates from the Specifications,
                                            cGMPs, Applicable Laws or other warranties or requirements set forth herein, then (i) Client
                                            will be considered to have accepted delivery of the Products on or before the 45th day after
                                            delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt
                                            of the Product, on or before the 45th day after discovery thereof by Client), (ii) the
                                            invoice for the Product will be considered to be dated as of the date when the finding is
                                            made, and (iii) Client will be responsible for the cost of the evaluation.

 

		(c)	Shortages.
                                            Claims for shortages of Products shipped by Patheon will be dealt with by reasonable agreement
                                            of the parties.

 

	6.2.	Product Recalls and Returns.

 

		(a)	Records
                                            and Notice. Patheon and Client will each maintain records necessary to permit a Recall
                                            of any Products delivered to Client or to customers of Client. 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 Products or which might result in the Recall
                                            or seizure of the Products. Upon receiving this notice or upon this discovery, each party
                                            will stop making any further shipments of any Products 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 Client. "Recall" will mean any action (i) by Client
                                            to recover title to or possession of quantities of the Products sold or shipped to third
                                            parties (including the voluntary withdrawal of Products from the market); or (ii) by
                                            any Authorities to detain or destroy any of the Products. Recall will also include any action
                                            by either party to refrain from selling or shipping quantities of the Products to third parties
                                            which would have been subject to a Recall if sold or shipped.

 

    	 	- 19 -	 

     

    

 

		(b)	Recalls.
                                            If (i) any 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) Client 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 Client, having regard to all Applicable Laws.

 

		(c)	Product
                                            Returns. Client will have the responsibility for handling customer returns of the Products.
                                            Patheon will give Client any assistance that Client may reasonably require to handle the
                                            returns.

 

	6.3.	Patheon's Responsibility
for Defective and Recalled Products.

 

		(a)	Defective
                                            Product. If Client rejects Products under Section 6.1 and the deviation is determined
                                            to have arisen from Patheon's failure to provide the Manufacturing Services or Products in
                                            accordance with the Specifications, cGMPs, Applicable Laws, or other warranties or requirements
                                            set forth herein, Patheon will credit Client's account for Patheon's invoice Price for the
                                            defective Products and for any reasonable costs that Client may have incurred to store and
                                            ship the defective Product. If Client previously paid for the defective Products, Patheon
                                            will promptly, at Client's election: (i) refund the invoice Price for the defective
                                            Products; (ii) offset the amount paid against other amounts due to Patheon hereunder;
                                            or (iii) replace the Products with conforming Products without Client being liable for
                                            payment therefor, contingent upon Patheon's receipt from Client, of all Active Materials
                                            required for the manufacture of the replacement Products. 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.

 

		(b)	Recalled
                                            Product. If a Recall, return or other corrective action for the Products results from,
                                            or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance
                                            with the Specifications, cGMPs, Applicable Laws, or other warranties or requirements set
                                            forth herein, Patheon will (i) be responsible for all documented out-of-pocket expenses
                                            (including attorneys' fees and amounts paid to Authorities) of Client and customers of Client
                                            of the Recall, return or other corrective action, and (ii) promptly, at Client's election:
                                            (A) refund the invoice Price for the Products that are subject to the Recall, return
                                            or other corrective action and the reasonable costs that Client incurred to insure, store
                                            and ship the Products; (B) offset the amount paid for the Products that are subject
                                            to the Recall, return or other corrective action against other amounts due to Patheon hereunder;
                                            or (C) replace the Products that are subject to the Recall, return or other corrective
                                            action with conforming Products without Client being liable for payment therefor, contingent
                                            upon Patheon's receipt from Client, at Patheon’s expense, of all Active Materials required
                                            for the manufacture of the replacement Products. Patheon's responsibility for any loss of
                                            Active Materials in Products that are subject to a Recall, return or other corrective action
                                            will be captured and calculated in the Active Materials Yield under Section 2.2. In
                                            all circumstances other than those addressed in this Section 6.3(b), Recalls, returns,
                                            or other corrective actions will be made at Client's cost and expense.

 

    	 	- 20 -	 

     

    

 

		(c)	Product
                                            Claims. Patheon will not be liable to Client, nor have any responsibility to Client,
                                            for any deficiencies in, or other liabilities associated with, any Product manufactured by
                                            Patheon (collectively, "Product Claims") to the extent the Product Claim
                                            (i) is caused by deficiencies in the Specifications or Client's marketing or distribution
                                            of the Products, (ii) results from a defect in the Active Materials or Components supplied
                                            by Client that (x) is not reasonably discoverable by Patheon using the test methods
                                            set forth in the Specifications, and (y) has not resulted from Patheon's storage or
                                            handling of the Active Materials or Components, (iii) is caused by actions of third
                                            parties occurring after the Product is shipped by Patheon in accordance with Section 5.4,
                                            (iv) is due to packaging design or labelling defects or omissions for which Patheon
                                            has no responsibility, (v) is determined, by agreement of the parties, after a full
                                            quality investigation by the parties in accordance with cGMP requirements, Applicable Laws,
                                            and the applicable Quality Agreement, to be due to any unascertainable reason despite Patheon
                                            having performed the Manufacturing Services in accordance with the Specifications, the batch
                                            production record, Patheon’s standard operating procedures for manufacturing, cGMPs,
                                            Applicable Laws, and the other terms and conditions of this Agreement, or (vi) is due
                                            to any breach by Client of its manufacturing obligations, under this Agreement.

 

		(d)	Notice
                                            by Patheon. Patheon immediately will notify Client if at any time Patheon discovers that
                                            any Product delivered hereunder does not conform to the Specifications, cGMPs, Applicable
                                            Laws, or other warranties or requirements set forth herein.

 

	6.4.	Disposition of Defective
or Recalled Products.

 

Client
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. Any storage of this Product (including at Client's facilities) will be at Patheon's cost
and expense. Alternatively, Patheon may instruct Client to return any damaged, defective, returned or Recalled Products to Patheon. Patheon
will bear the cost of storage, return and disposition for any damaged, defective, returned or Recalled Products for which it bears responsibility
under Section 6.3. In all other circumstances, Client will bear the cost of disposition, including all applicable fees for Manufacturing
Services, for any damaged, defective, returned, or Recalled Products.

 

	6.5.	Healthcare Provider or Patient
Questions and Complaints.

 

Client
will have the sole responsibility for responding to questions and complaints from its customers, healthcare providers, and patients.
Questions or complaints received by Patheon from Client's customers, healthcare providers or patients will be promptly referred to Client
in accordance with the terms of the applicable Quality Agreement. Patheon will co-operate as reasonably requested to allow Client to
determine the cause of, and resolve, any questions and complaints. This assistance will include follow-up investigations, including testing.
In addition, Patheon will promptly give Client all agreed upon information to enable Client to respond properly and timely to questions
or complaints about the Products as set forth in the applicable Quality Agreement. Unless it is determined that the cause of the complaint
resulted from a failure by Patheon to provide the Manufacturing Services and Products in accordance with the Specifications, cGMPs, Applicable
Laws or other warranties or requirements set forth herein, all costs incurred under this Section 6.5 will be borne by Client.

 

	6.6.	Remedies.

 

Client's
exercise of its rights and remedies under this Article 6 will not limit its exercise of other rights or remedies to which Client
is entitled by the terms of this Agreement.

 

    	 	- 21 -	 

     

    

 

ARTICLE 7

 

CO-OPERATION

 

	7.1.	Quarterly Review.

 

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. Commencing on the Effective Date, the relationship managers will make commercially reasonable efforts
to meet on a quarterly basis to review the current status of the business relationship and manage any issues that have arisen.

 

	7.2.	Authorities.

 

Subject
to Section 7.8, each party may communicate with any Authority with regard to the activities described in this Agreement, including
Regulatory Authorities responsible for granting regulatory approval for the Products, if, in the opinion of that party's regulatory counsel,
the communication is necessary to allow that party to comply with the terms of this Agreement or the requirements of any Applicable Laws.
Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will (a) notify the other
party of its intention to make these communications prior to making them to any Authority, (b) permit the other party to accompany
and take part in any relevant communications with the Authority, (c) provide the other party with the contents of the proposed communication
on a schedule designed to afford the receiving party an opportunity to review and comment thereon, and (d) provide the other party
with copies of all communications with the Authority.

 

	7.3.	Records and Accounting by
Patheon.

 

		(a)	Patheon
                                            will generate, retain, and maintain:

 

		(i)	all
                                            records necessary to comply with cGMPs and all other Applicable Laws relating to the manufacture
                                            of the Products or any component or intermediate thereof. Without limiting the foregoing,
                                            records will be made concurrently with the performance of each step in the manufacture of
                                            Products and in a way so that at any time successive steps in the manufacture and distribution
                                            of any batch may be traced by an inspector. These records will be legible and indelible,
                                            will identify the person immediately responsible, will include dates of the various steps
                                            and be as detailed as necessary for a clear understanding of each step by an individual experienced
                                            in the manufacture of pharmaceutical products;

 

		(ii)	all
                                            manufacturing records, standard operating procedures, equipment log books, batch manufacturing
                                            records, laboratory notebooks and all raw data relating to the manufacturing of Products
                                            and any Component or intermediate thereof;

 

		(iii)	samples
                                            of each batch of Product and of Active Materials and Components. Samples will include a quantity
                                            of representative material of each batch, Active Materials and Components sufficient to perform
                                            at least full duplicate quality control testing and will specify the dates of manufacture
                                            and packaging thereof. These retained samples will be selected at random from either final
                                            container material or from bulk and final containers and must include at least one final
                                            container as a final package, or package-equivalent of the filling of each batch. Each sample
                                            will be stored at temperatures and under conditions which will maintain the identity and
                                            integrity of the relevant sample; and

 

		(iv)	any
                                            other records and samples that Client reasonably may require to ensure compliance by Patheon
                                            with the terms of this Agreement and Applicable Laws.

 

    	 	- 22 -	 

     

    

 

		(b)	Patheon
                                            will diligently complete the master batch record for each Product during the manufacture
                                            of the Product.

 

		(c)	Copies
                                            of the records and samples will be retained for one year following the date of Product expiry,
                                            or longer if required by Applicable Laws, at which time Client will be contacted concerning
                                            the delivery to Client or the destruction of the documents or samples of Products. Patheon
                                            will not destroy any samples or records without Client's prior written consent. Without limiting
                                            the preceding sentence, following the expiration of Patheon's obligation to retain samples,
                                            Client will be responsible for retaining samples of the Products necessary to comply with
                                            the legal/regulatory requirements applicable to Client.

 

	7.4.	Inspection.

 

Client
may inspect Patheon's reports and records relating to this Agreement and Product Agreements, and may request copies of the reports and
records (with the exception of standard operating procedures), at Client’s expense, during normal business hours and with reasonable
advance notice, but a Patheon representative must be present during the inspection. Standard operating procedures (as referenced in 7.3(a)(ii) may
be viewed by Client during on-site visits at the relevant Manufacturing Site. On an exception-only basis, Patheon may agree to allow
for standard operating procedures to be viewed by Client as long as Client agrees to refrain from recording or taking any screen snapshot
of th video audit/visit and to notify Patheon promptly if any video or photograph has been taken and is used or disclosed in violation
of the terms of this Agreement. Violation of this provision will be considered a material breach.

 

	7.5.	Access.

 

Patheon
will give Client reasonable access at agreed times to the areas of the applicable Manufacturing Site in which all phases of the Manufacturing
Services are performed to permit Client to observe manufacturing of the Product and to verify that the Manufacturing Services are being
performed in accordance with the Specifications, cGMPs, Applicable Laws and other warranties and requirements set forth herein. With
the exception of "for-cause" audits, Client will be limited each Year to one cGMP-type audit and one inventory observation
audit, each lasting no more than two days and involving no more than two auditors, which auditors may be Client's employees or designated
agents. At Client’s request, Patheon will grant additional cGMP-type audits, additional inventory observation audits, additional
audit days, or the participation of additional auditors subject to payment to Patheon of a fee of $5,000 for each additional audit day
and $1,000 per audit day for each additional auditor. The right of access set forth in this Section 7.5 will not include a right
to access or inspect Patheon's financial records.

 

	7.6.	Notification of Regulatory
Inspections.

 

		(a)	Patheon
                                            will notify Client by telephone within 24 hours, and in writing within two Business Days,
                                            after learning of any proposed visit to, or inspection of, a Manufacturing Site by any Regulatory
                                            Authority, and immediately by telephone after learning of any unannounced visit to, or inspection
                                            of, a Manufacturing Site by any Regulatory Authority if the visit or inspection primarily
                                            relates to the Manufacturing Site's compliance with cGMPs or the manufacture of the Product.

 

		(b)	In
                                            the case of any visit or inspection that relates to the Manufacturing Site's compliance with
                                            cGMPs in respect of the manufacture of the Product or directly to the manufacture of the
                                            Product, Patheon will permit Client or its agents to be present at the Manufacturing Site
                                            during the visit or inspection.

 

		(c)	Patheon
                                            will provide to Client a copy of (i) any report and other written communication (or
                                            the relevant portions thereof) received from a Regulatory Authority in connection with a
                                            visit to or inspection of the Manufacturing Site that relates to compliance with cGMPs in
                                            respect of the manufacture of the Product or directly to the manufacture of the Product;
                                            (ii) any warning letters or similar communications from a Regulatory Authority in respect
                                            of the Manufacturing Site; and (iii) any written communications received from a Regulatory
                                            Authority relating to the Manufacturing Site's compliance with cGMPs in respect of the manufacture
                                            of the Product or directly to the manufacture of the Product or any component or intermediate
                                            thereof or any equipment or manufacturing process used in connection with the manufacture
                                            of Product or any component or intermediate thereof, in each case within three Business Days
                                            after receipt thereof. Patheon will consult with Client concerning the response of Patheon
                                            to each communication. Patheon will provide Client with a copy of all draft responses for
                                            comment as soon as possible and all final responses for review and approval, at least five
                                            Business Days prior to submission thereof.

 

    	 	- 23 -	 

     

    

 

	7.7.	Reports.

 

Patheon
will, at its cost, supply on an annual basis all Product data in its control, including release test results, complaint test results,
and all investigations (in manufacturing, testing, and storage), that Client reasonably requires in order to complete any filing under
any applicable regulatory regime, including any Annual Report that Client is required to file with the FDA. At Client's request, Patheon
will promptly (in no event later than March 31 each Year) provide a copy of the Annual Product Review Report to Client at no additional
cost. Patheon will also promptly provide any additional reports that Client may reasonably request, but any additional reports requested
by Client beyond the scope of cGMPs and customary FDA requirements will be subject to an additional fee to be agreed upon between Patheon
and Client.

 

	7.8.	Regulatory Filings.

 

Except
as otherwise contemplated by Sections 9.3 and 9.5(b), Client will have the sole responsibility and authority for filing all documents
with all Regulatory Authorities and taking any other actions that may be required for the receipt or maintenance of Regulatory Authority
approval for the commercial manufacture of the Products. Client will be responsible for ensuring the accuracy of the documents provided
to the Regulatory Authorities by Client for the Products, and will ensure through use of the change control process that Patheon is provided
with the currently filed, active Specifications for Products and the information needed to enable Patheon to comply with the applicable
requirements of the Product marketing authorizations. Patheon will assist Client to obtain Regulatory Authority approval for the commercial
manufacture of all Products as quickly as reasonably possible. Without limiting the foregoing, Patheon will cooperate with any reasonable
requests for assistance from Client with respect to obtaining and maintaining any and all regulatory approvals required in connection
with the sourcing of Product by Client hereunder and the sale of Product in the Territory, including by:

 

		(a)	at
                                            Client's cost, making its employees, consultants and other staff available upon reasonable
                                            notice during normal business hours to attend meetings with Regulatory Authorities concerning
                                            Product or any component or intermediate thereof; and

 

		(b)	at
                                            Patheon's cost, disclosing and making available to Client, in whatever form Client may reasonably
                                            request, all manufacturing and quality control data, CMC data and other information related
                                            to Product or any component or intermediate thereof and the manufacturing process therefor
                                            as is reasonably necessary or desirable to prepare, file, obtain and maintain any regulatory
                                            approval required in connection with the sourcing of Product by Client hereunder and the
                                            sale of Product in the Territory.

 

    	 	- 24 -	 

     

    

 

ARTICLE 8

 

TERM AND TERMINATION

 

	8.1.	Initial Agreement Term.

 

This
Agreement will become effective as of the Effective Date and will continue until January 31, 2027 (the "Initial Agreement
Term"). Unless sooner terminated as set forth below, this Agreement will automatically renew after the Initial Agreement Term
for successive terms of two Years each unless either party gives written notice to the other party of its intention to terminate this
Agreement at least (a) 18 months prior to the end of the then current term (the Initial Agreement Term, together with any renewal
periods, the “Agreement Term”). In any event, this Agreement will continue to govern any Product Agreement in effect
as provided in Section 1.2. Each Product Agreement will have an initial term of five Years from the effective date of the Product
Agreement unless the parties agree to a different initial term in the applicable Product Agreement (each, an "Initial Product
Term"). Unless otherwise agreed in the applicable Product Agreement, Product Agreements will automatically renew after the Initial
Product Term for successive terms of two Years each unless either party gives written notice to the other party of its intention to terminate
the Product Agreement at least 18 months prior to the end of the then current term (the Initial Product Term, together with any renewal
periods, the “Product Term”). Notwithstanding the foregoing, this Agreement and any Product Agreement may be terminated
in accordance with the provisions of Section 8.2.

 

	8.2.	Termination for Cause.

 

		(a)	Either
                                            party at its sole option may 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 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 considered to have waived the breach of the representation, warranty,
                                            or obligation in the instance described in the Breach Notice.

 

		(b)	Either
                                            party may terminate this Agreement immediately upon notice to the other party if the other
                                            party (i) files in any court or agency under any statute or regulation of any state,
                                            country or jurisdiction a petition in bankruptcy or insolvency or for reorganization or for
                                            arrangement or for the appointment of a receiver or trustee of that party or its assets;
                                            (ii) is served with an involuntary petition against it, filed in any insolvency proceeding,
                                            and this petition is not dismissed within 60 days after the filing thereof; (iii) becomes
                                            a party to any dissolution or liquidation; (iv) makes an assignment for the benefit
                                            of its creditors; or (v) admits in writing its inability generally to pay its debts
                                            as they become due in the general course.

 

		(c)	Client
                                            may terminate a Product Agreement immediately if any Authority takes any action, or raises
                                            any objection, that prevents Client from importing, exporting, purchasing, or selling the
                                            Product or Client withdraws the relevant Product from the market, but Client will still be
                                            required to fulfill all of its obligations under Section 8.4 below.

 

		(d)	Patheon
                                            may terminate this Agreement or a Product Agreement upon six months' prior written notice
                                            if Client 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 creditworthy substitute for Client; or (ii) a Patheon Competitor.

 

    	 	- 25 -	 

     

    

 

	8.3.	Product Discontinuation.

 

Except
if a Product is withdrawn for the reasons specified in Section 8.2(c), Client will give at least six months' advance notice if it
intends to no longer order Manufacturing Services for a Product due to this Product’s discontinuance in the market.

 

	8.4.	Obligations on Termination.

 

If
this Agreement is terminated for any reason, then:

 

		(a)	Client
                                            will take delivery of and pay for all undelivered Products that have been manufactured or
                                            packaged under a Firm Order, at the Price in effect at the time the Firm Order was placed;

 

		(b)	Client
                                            will purchase, at Patheon's documented cost (including all costs incurred by Patheon for
                                            the purchase and handling of the Inventory), the Inventory that was purchased, produced or
                                            maintained by Patheon for use in then-current Firm Orders and prior to the notice of termination
                                            being given;

 

		(c)	Client
                                            acknowledges that Patheon will not be required to permit a Patheon Competitor to access the
                                            Manufacturing Site; and

 

		(d)	Client
                                            will make commercially reasonable efforts, at its own expense, to remove from the Manufacturing
                                            Site, within 30 days after termination or within such longer time as the parties may agree,
                                            all unused Active Material, all applicable Inventory and Materials (whether current or obsolete),
                                            supplies, undelivered Product, chattels, equipment or other moveable property owned by Client,
                                            related to the Product Agreement and located at a Manufacturing Site or that is otherwise
                                            under Patheon's care and control ("Client Property"). If Client fails to
                                            remove the Client Property within 30 days or within such longer time as the parties may agree
                                            following written notice from Patheon describing the nature and location of all Client Property
                                            to be removed by Client due to the completion, termination or expiration of a Product Agreement,
                                            Client will pay Patheon $300.00 per pallet, per month, one pallet minimum (except that Client
                                            will pay $600 per pallet, per month, one pallet minimum, for any of the Client Property that
                                            contains controlled substances, requires refrigeration or other special storage requirements)
                                            thereafter for storing the Client Property and will assume any reasonable third party storage
                                            charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for
                                            the storage charges as set forth in Section 5.5 of this Agreement.

 

ARTICLE 9

 

REPRESENTATIONS,
WARRANTIES AND COVENANTS

 

	9.1.	Authority.

 

Each
party hereby represents and warrants to the other party as follows:

 

		(a)	The
                                            party (i) is duly formed and in good standing under the laws of the jurisdiction of
                                            its formation, (ii) has the power and authority and the legal right to enter into this
                                            Agreement and perform its obligations hereunder, and (iii) has taken all necessary action
                                            on its part required to authorize the execution and delivery of this Agreement and the performance
                                            of its obligations hereunder. This Agreement has been duly executed and delivered by the
                                            party and constitutes a legal, valid and binding obligation of the party and is enforceable
                                            against it in accordance with its terms, subject to the effects of bankruptcy, insolvency
                                            or other similar laws of general application affecting the enforcement of creditor rights
                                            and judicial principles affecting the availability of specific performance and general principles
                                            of equity, whether enforceability is considered in a proceeding at law or equity.

 

    	 	- 26 -	 

     

    

 

		(b)	All
                                            necessary consents, approvals and authorizations of all Authorities and other persons required
                                            to be obtained by the party in connection with (i) the execution and delivery of this
                                            Agreement have been obtained and (ii) the performance of its obligations hereunder have
                                            been obtained or will be obtained prior to the time that these consents, approvals and authorizations
                                            are required.

 

		(c)	The
                                            execution and delivery of this Agreement and the performance of the party's obligations hereunder
                                            (i) do not and will not conflict with or violate any requirement of Applicable Laws
                                            or any provision of the articles of incorporation, bylaws or any other constitutive document
                                            of the party and (ii) do not and will not conflict with, violate, or breach, or constitute
                                            a default or require any consent under, any contractual obligation or court or administrative
                                            order by which the party is bound.

 

	9.2.	Client Representations,
Warranties, and Covenants.

 

Client
covenants, represents, and warrants that:

 

		(a)	Non-Infringement.

 

		(i)	the
                                            Specifications for each of the Products do not infringe any Third Party Rights and Client
                                            may lawfully disclose the Specifications to Patheon;

 

		(ii)	any
                                            Client Intellectual Property used by Patheon in performing the Manufacturing Services according
                                            to the Specifications may be lawfully used as directed by Client without infringing any Third
                                            Party Rights; and

 

		(iii)	to
                                            Client's knowledge, there are no pending legal proceedings claiming that 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 infringes any Third Party Rights.

 

		(b)	Quality
                                            and Compliance.

 

		(i)	the
                                            Specifications for a Product will be consistent with the specifications set forth in the
                                            Product’s applicable marketing authorization;

 

		(ii)	the
                                            Products, if labelled and manufactured in accordance with the Specifications and in compliance
                                            with applicable cGMPs and Applicable Laws, may be lawfully sold and distributed in every
                                            jurisdiction in which Client will sell and distribute the Products; and

 

		(iii)	on
                                            the date of shipment by or on behalf of Client to Patheon, the Active Materials will conform
                                            to the Specifications for the Active Materials that Client has given to Patheon and the Active
                                            Materials will be adequately contained, packaged, and labelled and will conform to the affirmations
                                            of fact on the container.

 

	9.3.	Patheon Representations,
Warranties, and Covenants.

 

Patheon
covenants, represents, and warrants that:

 

		(a)	it
                                            will perform the Manufacturing Services and provide Products to Client in accordance with
                                            the Specifications, cGMPs, Applicable Laws and any other warranties or other requirements
                                            herein;

 

    	 	- 27 -	 

     

    

 

		(b)	At
                                            the time of delivery of Product by Patheon:

 

		(i)	the
                                            Manufacturing Site at which the Product was manufactured, at the time of manufacture, was
                                            in compliance with all cGMPs and other Applicable Laws (including applicable inspection requirements
                                            of the FDA);

 

		(ii)	the
                                            Product will have been manufactured in strict compliance with the requirements of cGMPs,
                                            this Agreement, the Quality Agreement, the Specifications and all Applicable Laws;

 

		(iii)	the
                                            Product will be in conformity with the Specifications;

 

		(iv)	the
                                            Product will have a remaining shelf life of at least 80% of the Product's approved shelf
                                            life from the date of manufacture;

 

		(v)	title
                                            to the Product will pass to Client free and clear of any security interest, lien or other
                                            encumbrance;

 

		(vi)	the
                                            Product will not be adulterated or misbranded under the FFDCA; and

 

		(vii)	no
                                            act or omission of Patheon would cause or result in the Product being a product that cannot
                                            be introduced into interstate commerce under the FFDCA.

 

		(c)	any
                                            Intellectual Property used by Patheon to perform the Manufacturing Services (other than Intellectual
                                            Property provided by Client) may be lawfully used by Patheon without infringing any Third
                                            Party Rights.

 

	9.4.	Debarred Persons.

 

Patheon
hereby represents, warrants, and covenants to Client that (a) neither Patheon nor any of its Affiliates has been debarred or is
subject to debarment under Section 306 of the FFDCA or any similar law in any country in the Territory or listed on either Excluded
List, and (b) neither Patheon nor any of its Affiliates will use in any capacity, including as officer, director, managing employee,
or any other way, in connection with the services to be performed under this Agreement, any person who has been debarred under Section 306
of the FFDCA or any similar law in any country in the Territory, or who is the subject of a conviction described in that section or listed
on either Excluded List. Patheon will inform Client in writing immediately if it or any person who is performing services hereunder is
debarred or is the subject of a conviction described in Section 306 of the FFDCA or any similar law in any country in the Territory
or listed on either Excluded List, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or,
to the best of Patheon's knowledge, is threatened, relating to the debarment or conviction Section 306 of the FFDCA or any similar
law in any country in the Territory, or listing on either Excluded List, of Patheon or any person performing services hereunder.

 

	9.5.	Permits.

 

		(a)	Client
                                            will be solely responsible for obtaining or maintaining, on a timely basis, any permits or
                                            other regulatory approvals for the marketing and sale of the Products, including all marketing
                                            and post-marketing approvals.

 

    	 	- 28 -	 

     

    

 

		(b)	Patheon
                                            represents, warrants and covenants to Client that it has obtained, or will obtain prior to
                                            the time that Governmental Approval is required, and will maintain in full force and effect
                                            and in good standing, any and all Governmental Approvals required by Applicable Laws to be
                                            held by Patheon in order to provide the Manufacturing Services for the Products at its Manufacturing
                                            Sites and to perform all of its other obligations hereunder in accordance with the terms
                                            of this Agreement and the Product Agreements.

 

	9.6.	No Warranty.

 

EXCEPT
FOR THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY
AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

 

ARTICLE 10

 

REMEDIES AND
INDEMNITIES

 

	10.1.	Consequential Damages.

 

Except
for breaches of Article 11 and Appendix 2, neither party will be liable to the other in contract, tort, negligence,
breach of statutory duty, or otherwise for any loss of profits, of production, of anticipated savings, of business, or goodwill or for
any other liability, damage, costs, 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. This disclaimer does not extend to damages owed to third parties under Sections 10.3
or 10.4.

 

	10.2.	Limitation of Liability.

 

(a)             Active
Materials. Except for loss and damage for which provision is made 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 with respect
to a Product in a Year will not exceed the Maximum Credit Value set forth in Schedule D of the applicable Product Agreement.

 

(b)            Maximum
Liability. Patheon’s maximum aggregate liability to Client under this Agreement or any Product Agreement in any Year for any
reason whatsoever, including any liability arising 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, (the “Maximum Amount”) specified
in the applicable Product Agreement. Notwithstanding the foregoing, the parties agree that the limitation on liability described in this
Section 10.2(b) will not apply to, nor take into account, any Patheon liability arising under Section 10.3 or Article 11
or from Patheon’s fraudulent misrepresentation, or Patheon’s internal Component and conversion costs to manufacture replacement
Product under Article 6.

 

	10.3.	Indemnification by Patheon.

 

Patheon
will defend, hold harmless and indemnify Client, its Affiliates and its and their respective directors, officers, employees and agents
(the "Client Indemnitees"), from all losses, damages, liabilities, penalties, costs and expenses (including reasonable
attorneys' fees and disbursements) (collectively, "Losses") arising from or occurring as a result of (a) any third
party claims, lawsuits, actions, proceedings, subpoenas, ("Third Party Claims") against a Client Indemnitee arising
from or occurring as a result of (i) the breach by Patheon, of this Agreement; (ii) the negligence or willful misconduct of
any Patheon Indemnitee or of any Manufacturing Site in connection with the performance of this Agreement or any Product Agreement; (iii) any
claim that the use or practice of Patheon Intellectual Property in connection with the manufacture of any Product violates, breaches,
or infringes any Third Party Rights, or (iv) the handling, release, or disposal of any waste by Patheon; (b) any personal injury
or death suffered by any Patheon Indemnitee in connection with the manufacturing of Products hereunder or the performance of Patheon's
other obligations hereunder; or (c) the enforcement by a Client Indemnitee of its rights under this Section 10.3; except in
each case for those Losses for which Client has an obligation to indemnify the Patheon Indemnitees under Section 10.4, as to which
Losses each party will indemnify the other party to the extent of its respective liability for the Losses.

 

    	 	- 29 -	 

     

    

 

	10.4.	Indemnification by Client.

 

Client
will defend, hold harmless and indemnify Patheon, its Affiliates and its and their respective directors, officers, employees and agents
(collectively, the "Patheon Indemnitees from all Losses arising from or occurring as a result of (a) any Third Party
Claims against a Patheon Indemnitee due to (i) the breach by Client of this Agreement; (ii) the negligence or willful misconduct
of any Client Indemnitee in connection with the performance of this Agreement; or (iii) any claim that the use of Active Materials
or the use or practice of Client Intellectual Property in connection with the manufacture of any Product in accordance with the terms
of this Agreement violates, breaches, or infringes any Third Party Rights; and (b) the enforcement by a Patheon Indemnitee of its
rights under this Section 10.4; except in each case for those Losses for which Patheon has an obligation to indemnify the Client
Indemnitees under Section 10.3, as to which Losses each party will indemnify the other party to the extent of its respective liability
for the Losses.

 

	10.5.	Indemnification Procedure.

 

		(a)	Notice.
                                            The indemnified party (the "Indemnified Party") will promptly provide the
                                            indemnifying party (the "Indemnifying Party") notice ("Indemnification
                                            Claim Notice") of any Loss or discovery of fact upon which the Indemnified Party
                                            intends to base a request for indemnification under Section 10.3 or 10.4, but any delay
                                            in providing the notice will qualify the obligations of the Indemnifying Party under Section 10.3
                                            or 10.4, as relevant, only to the extent of actual prejudice to the ability of the Indemnifying
                                            Party to defend the claim. Each Indemnification Claim Notice must contain a description of
                                            the claim and the nature and amount of the Loss (to the extent that the nature and amount
                                            of the Loss are known at that time).

 

		(b)	Third
                                            Party Claims. The obligations of an Indemnifying Party under this Article 10 with
                                            respect to Third Party Claims will be governed by and be contingent upon the following:

 

		(i)	Defense.
                                            At its option, the Indemnifying Party may assume the defense of any Third Party Claim by
                                            giving notice to the Indemnified Party within 30 days after the Indemnifying Party's receipt
                                            of an Indemnification Claim Notice. The assumption of the defense of a Third Party Claim
                                            by the Indemnifying Party will constitute an acknowledgment that the Indemnifying Party is
                                            liable to indemnify hereunder the Indemnified Party for the Third Party Claim. Upon assuming
                                            the defense of a Third Party Claim, the Indemnifying Party may appoint as lead counsel in
                                            the defense of the Third Party Claim any legal counsel selected by the Indemnifying Party
                                            which will be reasonably acceptable to the Indemnified Party. If the Indemnifying Party assumes
                                            the defense of a Third Party Claim, the Indemnified Party will immediately deliver to the
                                            Indemnifying Party all original notices and documents (including court papers) received by
                                            the Indemnified Party in connection with the Third Party Claim. Subject to Section 10.5(b)(ii),
                                            if the Indemnifying Party assumes the defense of a Third Party Claim, the Indemnifying Party
                                            will not be liable to the Indemnified Party for any legal expenses subsequently incurred
                                            by the Indemnified Party in connection with the analysis, defense or settlement of the Third
                                            Party Claim.

 

    	 	- 30 -	 

     

    

 

		(ii)	Right
                                            to Participate in Defense. Without limiting Section 10.5(b)(i), any Indemnified
                                            Party will be entitled to participate in, but not control, the defense of the Third Party
                                            Claim and to employ counsel of its choice for this purpose, but this employment will be at
                                            the Indemnified Party's own expense unless:

 

(A)           the
employment thereof, and the assumption by the Indemnifying Party of the expense, has been specifically authorized by the Indemnifying
Party in writing;

 

(B)            the
Indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 10.5(b)(i) (in which case
the Indemnified Party will control the defense); or

 

(C)            the
interests of the Indemnified Party and the Indemnifying Party with respect to the Third Party Claim are sufficiently adverse to make
inappropriate or impermissible the representation by the same counsel of both parties under Applicable Laws, ethical rules or equitable
principles.

 

		(iii)	Settlement.
                                            With respect to any Losses relating solely to the payment of money damages in connection
                                            with a Third Party Claim and that will not constitute an admission of liability by the Indemnified
                                            Party, result in the Indemnified Party's becoming subject to injunctive or other relief or
                                            otherwise adversely affect the business of the Indemnified Party in any manner, and as to
                                            which the Indemnifying Party will have acknowledged in writing the obligation to indemnify
                                            the Indemnified Party hereunder, the Indemnifying Party will have the sole right to consent
                                            to the entry of any judgment, enter into any settlement or otherwise dispose of the Loss,
                                            on the terms that the Indemnifying Party, in its sole discretion, considers appropriate.
                                            For all other Losses in connection with Third Party Claims, where the Indemnifying Party
                                            has assumed the defense of the Third Party Claim in accordance with Section 10.5(b)(i),
                                            the Indemnifying Party will have authority to consent to the entry of any judgment, enter
                                            into any settlement or otherwise dispose of the Loss if it obtains the prior written consent
                                            of the Indemnified Party (which consent will not be unreasonably withheld, conditioned, or
                                            delayed). The Indemnifying Party will not be liable for any settlement or other disposition
                                            of a Loss by an Indemnified Party that is reached without the written consent of the Indemnifying
                                            Party. Regardless of whether the Indemnifying Party chooses to defend any Third Party Claim,
                                            no Indemnified Party will admit any liability with respect to, or settle, compromise or dispose
                                            of, any Third Party Claim for which it intends to seek indemnification under Section 10.3
                                            or 10.4, as applicable, without the prior written consent of the Indemnifying Party (which
                                            consent will not be unreasonably withheld, conditioned or delayed).

 

		(iv)	Cooperation.
                                            If the Indemnifying Party chooses to defend any Third Party Claim, the Indemnified Party
                                            will cooperate in the defense thereof and will furnish records, information and testimony,
                                            provide witnesses and attend conferences, discovery proceedings, hearings, trials and appeals
                                            as may be reasonably requested in connection therewith. This cooperation will include access
                                            during normal business hours afforded to the Indemnifying Party to, and reasonable retention
                                            by the Indemnified Party of, records and information that are reasonably relevant to the
                                            Third Party Claim, and making employees and agents available on a mutually convenient basis
                                            to provide additional information and explanation of any material provided hereunder. The
                                            Indemnifying Party will reimburse the Indemnified Party for all its reasonable out-of-pocket
                                            expenses in connection with the foregoing.

 

    	 	- 31 -	 

     

    

 

		(v)	Expenses.
                                            Except as set forth above, the reasonable and verifiable out-of-pocket costs and expenses,
                                            including documented fees and disbursements of counsel, incurred by the Indemnified Party
                                            in connection with any Third Party Claim will be reimbursed on a monthly basis in arrears
                                            by the Indemnifying Party.

 

	10.6.	Reasonable Allocation of
Risk.

 

The
parties acknowledge and agree that this Agreement (including 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.

 

ARTICLE 11

 

CONFIDENTIALITY

 

11.1.                        Confidentiality.
By executing this Agreement, the parties are hereby expressly agreeing to abide by, and comply with the Confidentiality Terms set
forth in Appendix 2 attached hereto and incorporated into this Agreement by this reference.

 

11.2.                        Notification.
The Receiving Party will notify the Disclosing Party immediately, and cooperate with the Disclosing Party as the Disclosing Party
may reasonably request, upon the Receiving Party's discovery of any loss or compromise of the Disclosing Party's Confidential Information.

 

ARTICLE 12

 

DISPUTE RESOLUTION

 

12.1.                        Dispute
Resolution. Any dispute, controversy or claim arising out of or relating to this Agreement or the breach, termination, or validity
thereof (each, a "Dispute"), will be referred to a senior executive of each party. The senior executives will meet to
attempt to resolve the Dispute by good faith negotiations within 30 days of referral of the Dispute. If the Dispute remains unresolved
after this 30-day negotiation period, then, at the election of either party, the Dispute will be decided in accordance with Section 13.20.

 

ARTICLE 13

 

MISCELLANEOUS

 

	13.1.	Intellectual Property Ownership
and Licenses

 

		(a)	License
                                            Grants to Patheon.

 

		(i)	For
                                            the term of this Agreement, Client hereby grants to Patheon a non-exclusive, paid-up, royalty-free,
                                            non-transferable license, solely for purposes of Patheon's performing the Manufacturing Services,
                                            of Client Intellectual Property, and all other Intellectual Property as to which Client may
                                            grant a license, that Patheon must use in order to perform the Manufacturing Services.

 

		(ii)	Client
                                            hereby grants to Patheon a perpetual, non-exclusive, paid-up, royalty-free, transferable
                                            license, solely to enable Patheon to manufacture or develop products for any of its third-party
                                            clients, of any Intellectual Property included in the Product IP that has general application
                                            to manufacturing processes, the formulation or development of drug products, drug product
                                            dosage forms or drug delivery systems and is not specific to any Product or Active Materials.

 

    	 	- 32 -	 

     

    

 

		(b)	License
                                            Grant to Client. Patheon hereby grants to Client a perpetual, irrevocable, non-exclusive,
                                            paid-up, royalty-free, transferable and sublicensable (with the right to grant sublicenses
                                            through multiple tiers) license to use the Patheon Intellectual Property and any Information
                                            used by Patheon to perform the Manufacturing Services to enable Client to manufacture, develop,
                                            commercialize, market and sell the Products.

 

		(c)	Ownership
                                            of Intellectual Property.

 

		(i)	Client
                                            Intellectual Property will be the exclusive property of Client. Patheon will, and will cause
                                            the Manufacturing Site at which the Product is being manufactured and its other relevant
                                            Affiliates to, promptly disclose in writing to Client the discovery, development, making,
                                            conception, or reduction to practice of any Invention included in or giving rise to Client
                                            Intellectual Property and, promptly upon Client's request, execute all instruments and other
                                            documents that are required to vest ownership in Client.

 

		(ii)	Patheon
                                            Intellectual Property will be the exclusive property of Patheon.

 

		(iii)	Except
                                            as otherwise provided in Section 13.1(d)(iii) for Joint Invention Patents, each
                                            party will be solely responsible for the costs of filing, prosecution, and maintenance of
                                            patents and patent applications included in or claiming Intellectual Property as to which
                                            it is allocated ownership hereunder.

 

		(d)	Joint
                                            Intellectual Property

 

		(i)	The
                                            parties will jointly own all right, title, and interest in and to Joint Intellectual Property.
                                            Each party will, and will cause its Affiliates to, promptly disclose in writing to the other
                                            party the discovery, development, making, conception, or reduction to practice of any Invention
                                            included in or giving rise to Joint Intellectual Property.

 

		(ii)	Patheon
                                            will, and does hereby, grant to Client an irrevocable, perpetual, fully paid-up, royalty-free,
                                            non-exclusive license, transferable, sublicensable (with the right to grant sublicenses through
                                            multiple tiers), to use for any purpose all of Patheon’s right, title and interest
                                            in and to all Joint Intellectual Property. Client will, and does hereby, grant to Patheon
                                            an irrevocable, perpetual, fully paid-up, royalty-free, non-exclusive license, with the right
                                            to grant sublicenses through multiple tiers, to use for any purpose all of Client’s
                                            right, title and interest in and to all Joint Intellectual Property.

 

		(iii)	Client
                                            will have the first right, but not the obligation, to prepare, file, prosecute, and maintain
                                            any patent applications and patents included in or giving rise to Joint Intellectual Property
                                            (the “Joint Invention Patents”) and, if Client elects to file, prosecute
                                            and maintain any patent application, then Client will be responsible for related interference,
                                            re-issuance, re-examination and opposition proceedings. But if Client plans to abandon any
                                            Joint Invention Patent, then Client will notify Patheon in writing at least 60 days in advance
                                            of the due date of any payment or other action that is required to prepare, file, prosecute
                                            or maintain the Joint Invention Patent, and Patheon may elect, upon written notice within
                                            the 60 day period to Client, to make the payment or take the action, at its own expense.

 

	13.2.	No Implied Rights.

 

Except
as provided in Section 13.1, 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 herein or in writing by the other party.

 

    	 	- 33 -	 

     

    

 

	13.3.	Insurance.

 

(a)            Subject
to Section 13.3(b), each party will maintain commercial general 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) $5,000,000 for each occurrence for personal injury or property damage liability, and (ii) $5,000,000 in
the aggregate per annum for product and completed operations liability. If requested, each party will give the other a certificate of
insurance annually 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.

 

(b)            If
a party is unable to maintain the insurance policies required under this Agreement on commercially reasonable terms and at commercially
reasonable cost 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 on commercially
reasonable terms and at commercially reasonable cost.

 

	13.4.	Independent Contractors.

 

The
parties are independent contractors and this Agreement and any Product Agreement will not be construed to create between Patheon and
Client 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.	No Waiver.

 

Either
party's failure to require the other party to comply with any provision of this Agreement or any Product Agreement will not be considered
a waiver of the provision or any other provision of this Agreement or any Product Agreement, except as expressly set forth in Sections
6.1 and 8.2(a).

 

	13.6.	Assignment.

 

		(a)	Patheon
                                            may not assign this Agreement or any Product Agreement or any of its associated rights or
                                            obligations without the written consent of Client. Patheon will not arrange for any subcontractor
                                            to perform testing or other services arising under any Product Agreement without obtaining
                                            Client's prior written consent for the use of the approved subcontractor, this consent not
                                            to be unreasonably withheld. Patheon may subcontract any part of the Manufacturing Services
                                            under a Product Agreement to any of its Affiliates but the subcontract must be in writing
                                            and signed by both Patheon and the Affiliate.

 

		(b)	Subject
                                            to Section 8.2(d), Client may assign this Agreement or any Product Agreement or any
                                            of its associated rights or obligations without approval from Patheon. But Client will give
                                            Patheon written notice of any assignment within 30 Business Days after the effective date
                                            of the assignment, and any assignee will be required to agree in writing with Patheon to
                                            be bound by the terms of this Agreement or the applicable Product Agreement. If there is
                                            a partial assignment in which Client assigns one or more (but not all) Product Agreements
                                            and this Agreement solely as it relates to the assigned Product Agreement to a third party
                                            who is not an Affiliate of Client, then Patheon will have the right to request a re-negotiation
                                            of fees paid under the assigned agreements with the assignee and, if good faith discussions
                                            do not lead to agreement on amended fees applicable to the assigned agreement within a reasonable
                                            time, then on 12 months' prior written notice to Client and the assignee, Patheon will have
                                            the right to terminate the assigned Product Agreement.

 

    	 	- 34 -	 

     

    

 

		(c)	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.

 

		(d)	Any
                                            purported assignment in breach of the provisions of this Section 13.6 will be void and
                                            of no effect.

 

	13.7.	Force Majeure.

 

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 strikes or other labor disturbances, lockouts, riots, quarantines, communicable
disease outbreaks, wars, acts of terrorism, fires, floods, storms, interruption of or delay in transportation, lack of or inability to
obtain fuel, power or components, or compliance with any order or regulation of any government entity acting within color 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 and steps to be taken by it to remedy the same. The suspension of performance will be of no greater
scope and no longer duration than is reasonably required and the non-performing party will use commercially reasonable efforts to remedy
its inability to perform as soon as possible. If the suspension of performance continues for 60 days after the date of the occurrence,
and the failure to perform would constitute a material breach of this Agreement in the absence of the Force Majeure Event, the nonaffected
party may terminate this Agreement immediately by written notice to the affected party. Neither party will be entitled to rely on a Force
Majeure Event to relieve it from an obligation to pay money (including any interest for delayed payment) which would otherwise be due
and payable under this Agreement or any Product Agreement.

 

	13.8.	Additional Product.

 

Additional
Products may be added to, or existing Products deleted from, any Product Agreement by amendments to the Product Agreement, in accordance
with Section 13.11 below, including Schedules A, B, C, and D as applicable.

 

	13.9.	Notices.

 

		(a)	Any
                                            notice, request, demand, waiver, consent, approval, or other communication permitted or required
                                            under this Agreement will be in writing, will refer specifically to this Agreement, and will
                                            be considered given only if delivered by hand or sent by facsimile transmission (with transmission
                                            confirmed) or by nationally recognized overnight delivery service that maintains records
                                            of delivery, addressed to the parties at their respective addresses specified in Section 13.9(b) or
                                            to another address as the party to whom notice is to be given may have provided to the other
                                            party in accordance with this Section 13.9. This notice will be considered to have been
                                            given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed)
                                            or on the second Business Day (at the place of delivery) after deposit with a nationally
                                            recognized overnight delivery service. Any notice delivered by facsimile will be confirmed
                                            by a hard copy delivered as soon as practicable thereafter. This Section 13.9 is not
                                            intended to govern the day-to-day business communications necessary between the parties in
                                            performing their obligations under the terms of this Agreement.

 

    	 	- 35 -	 

     

    

 

		(b)	Address
                                            for Notice:

 

If
to Client:

 

Napo
Pharmaceuticals, Inc.

200
Pine Street, Suite 400

San
Francisco, CA 94104

Attention:
Chief Executive Officer

Email
address: [****]

 

with
a copy to:

 

Napo
Pharmaceuticals, Inc.

200
Pine Street, Suite 400

San
Francisco, CA 94104

Attention:
General Counsel

Email
address: [****]

 

If
to Patheon:

 

Patheon
Pharmaceuticals Inc

2110
East Galbraith Road

Cincinnati,
OH 45237-1625

Attention:
Director of Legal Services

Telecopier
No.: [****]

Email
address: [****]

 

With
a copy to:

 

Patheon
Inc.

4721
Emperor Boulevard

Research
Triangle Park,

NC
27703

Attention:
General Counsel

Telecopier
No.: [****]

Email
address:

 

	13.10.	Severability.

 

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.	Entire Agreement; Amendment;
Survival

 

		(a)	This
                                            Agreement, together with the applicable Product Agreement and 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.

 

    	 	- 36 -	 

     

    

 

		(b)	Any
                                            modification, amendment, or supplement to this Agreement must be in writing, must specifically
                                            reference the Sections of this Agreement to be modified and must be signed by authorized
                                            representatives of both parties. Likewise, any modification, amendment, or supplement to
                                            a Product Agreement must be in writing, must specifically reference the Sections of the Product
                                            Agreement to be modified and must be signed by authorized representatives of both parties.
                                            In case of conflict, the prevailing order of documents will be this Agreement, then the Product
                                            Agreement and then the Quality Agreement.

 

		(c)	Any
                                            termination of this Agreement or a Product Agreement will not affect any outstanding Manufacturing
                                            obligations or payments due that have arisen prior to the date of termination, nor will it
                                            prejudice any other remedies that the parties may have under this Agreement or a Product
                                            Agreement. The provisions of Articles 6, 7, 9, 10, 11, and 12 and Sections 1.3, 1.4, 2.1
                                            (e), 2.2, 4.6, , 5.5, 8.4, 13.1 through 13.3, 13.9, 13.11, 13.13 and 13.17 through 13.20,
                                            will survive termination of this Agreement, as well as any other provisions that are by implication
                                            or otherwise intended to survive termination.

 

	13.12.	Other Terms.

 

No
terms, provisions or conditions of any purchase order or other business form or written authorization used by Client 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 Client or Patheon to object to the terms, provisions, or conditions.

 

	13.13.	No Third Party Benefit or
Right.

 

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.	Execution in Counterparts.

 

This
Agreement and any Product Agreement may be executed in two or more counterparts, by original or facsimile or electronically-transmitted
signature, each of which, if the signature is identified, will be considered an original, but all of which together will constitute one
and the same instrument.

 

	13.15.	Further Assurances.

 

Each
party will duly execute and deliver, or cause to be duly executed and delivered, any further instruments and will do and cause to be
done any further acts and things, including the executing or filing of assignments, agreements, documents and instruments as may be necessary
or as the other party may reasonably request, in connection with this Agreement or to carry out more effectively the provisions and purposes
hereof or to better assure and confirm unto the other party its rights and remedies under this Agreement.

 

	13.16.	Export Control.

 

This
Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other
countries that may be imposed on the parties from time to time. Each party agrees that it will not export, directly or indirectly, any
technical or confidential information acquired from the other party under this Agreement or any products using the technical or confidential
information to a location or in a manner that at the time of export requires an export license or other governmental approval, without
first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Laws.

 

    	 	- 37 -	 

     

    

 

	13.17.	Waiver.

 

Any
term or condition of this Agreement may be waived at any time by the party that is entitled to the benefit thereof, but this waiver will
not be effective unless set forth in a written instrument duly executed by or on behalf of the party waiving the term or condition. A
waiver by either party of any term or condition of this Agreement, in any one or more instances, will not be a waiver of the same or
any other term or condition of this Agreement on any future occasion.

 

	13.18.	Use of Client Name.

 

Patheon
will not make any use of Client's name, trademarks or logo or any variations thereof, alone or with any other word or words, without
the prior written consent of Client.

 

	13.19.	Governing Law; Jurisdiction;
Venue; Service.

 

		(a)	This
                                            Agreement and any Product Agreement will be construed and enforced in accordance with the
                                            laws of the State of Delaware, excluding any conflicts or choice of law rule or principle
                                            that might otherwise refer construction or interpretation of this Agreement to the substantive
                                            law of another jurisdiction. The UN Convention on Contracts for the International Sale of
                                            Goods will not apply to this Agreement.

 

		(b)	Subject
                                            to Section 12.1, each party irrevocably and unconditionally consents to the exclusive
                                            jurisdiction of the Court in the State of Delaware and to the United States District Court
                                            for the District of Delaware located in Wilmington, Delaware (collectively, the "Courts")
                                            for any action, suit or proceeding (other than appeals therefrom) concerning any matter arising
                                            out of or relating to this Agreement, and agrees not to commence any action, suit or proceeding
                                            (other than appeals therefrom) related thereto except in those Courts.

 

		(c)	Each
                                            party hereto further hereby irrevocably and unconditionally waives any objection to the laying
                                            of venue of any action, suit or proceeding (other than appeals therefrom) arising out of
                                            or relating to this Agreement in the Courts and hereby further irrevocably and unconditionally
                                            agrees not to raise any objection at any time to the laying or maintaining of the venue of
                                            the action, suit or proceeding in any of the Courts, irrevocably waives any claim that the
                                            action, suit or other proceeding has been brought in an inconvenient forum and further irrevocably
                                            waives the right to object, to the action, suit or other proceeding, that the Court does
                                            not have any jurisdiction over the party.

 

		(d)	Each
                                            party hereto further agrees that, to the maximum extent permitted by Applicable Laws, service
                                            of any process, summons, notice or document by United States registered mail to its address
                                            and contact person for notices provided for in Section 13.9 will be effective service
                                            of process for any action, suit or proceeding brought against it under this Agreement in
                                            any of the Courts.

 

	13.20.	No Exclusivity; English
Language Controls

 

		(a)	Nothing
                                            in this Agreement, nor unless otherwise agreed in any Product Agreement, will be construed
                                            in any way to state or to imply that either party considers this Agreement to be an exclusive
                                            arrangement. Client reserves its right to order and purchase Products from other manufacturer-suppliers;
                                            and, nothing in this Agreement is to be interpreted or construed to prohibit Client from
                                            ordering and purchasing Products from any third party manufacturer-supplier.

 

		(b)	This
                                            Agreement is written and executed in the English language; and, all other communications
                                            between the parties in connection with this Agreement will also be in the English language.
                                            Any translation into any other language may be for the convenience of a Manufacturing Site,
                                            but the English language version will remain the official version hereof. If there is of
                                            any conflict in interpretation between the English version and any translation, the English
                                            version will control.

 

[Signature page to
follow]

 

    	 	- 38 -	 

     

    

 

IN
WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Agreement as of the date first written above.

 

	 	PATHEON PHARMACEUTICALS INC.
	 	 
	 	By:	/s/
    Peter Ercoli         
	 	Name:	Peter Ercoli
	 	Title:	Vice President / General Manager
	 	 
	 	NAPO PHARMACEUTICALS, INC.
	 	 
	 	By:	/s/ Lisa Conte
	 	Name:	Lisa Conte
	 	Title:	President &  CEO

 

    	 	- 39 -	 

     

    

 

FORM OF
PRODUCT AGREEMENT

 

(Includes
Schedules A to D)

 

PRODUCT AGREEMENT

 

This
Product Agreement (this "Product Agreement") is issued under the Master Manufacturing Services Agreement dated June _,
2022 between Patheon Pharmaceuticals Inc., and Napo Pharmaceuticals, Inc., (the "Master Agreement"), and is entered
into [insert effective date] (the "Product Effective Date"), between [Patheon Pharmaceuticals Inc. or
applicable Patheon Affiliate], a corporation existing under the laws of [the State of Delaware or applicable founding jurisdiction
for Patheon Affiliate], having a principal place of business at [2110 East Galbraith Road, Cincinnati, OH 45237-1625 or
Patheon Affiliate address] ("Patheon") and [Napo Pharmaceuticals, Inc. or applicable Napo Affiliate],
a corporation existing under the laws of the [State of Delaware or applicable founding jurisdiction for Napo Affiliate],
having a principal place of business at 200 Pine Street, Suite 400, San Francisco, CA 94104 [or Napo Affiliate address] ("Client").

 

The
terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references
a 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.

 

		1.	Product
                                            List and Specifications (See Schedule A attached hereto)

 

		2.	Batch
                                            Order Quantity, Annual Volume Tiers, and Price (See Schedule B attached hereto)

 

		3.	Annual
                                            Stability Testing and Validation Activities (if applicable) (See Schedule C attached
                                            hereto)

 

		4.	Active
                                            Materials, Active Materials Credit Value, and Maximum Credit Value (See Schedule D attached
                                            hereto)

 

		5.	Yearly
                                            Forecasted Volume: (insert for sterile Products manufactured at a Manufacturing Site in Italy,
                                            if applicable)

 

		6.	Required
                                            Percentage:

 

		7.	Required
                                            Period:

 

		8.	Territory:
                                            (insert the description of the Territory here)

 

		9.	Manufacturing
                                            Site: (insert address of the Patheon Manufacturing Site where the Manufacturing Services
                                            will be performed)

 

		10.	Initial
                                            Product Term: (if applicable under Section 8.1 of the Master Agreement)

 

     

     

    

 

		11.	Maximum
                                            Amount of Liability: (per Section 10.2 of the Master Agreement)

 

		12.	Notices:
                                            (if applicable under Section 13.9 of the Master Agreement)

 

		13.	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 Product Effective
Date set forth above.

 

	 	PATHEON PHARMACEUTICALS
    INC. [or applicable Patheon Affiliate]
	 	 
	 	By:	                  
	 	Name:	 
	 	Title:	 
	 	 
	 	NAPO
    PHARMACEUTICALS, INC. [or applicable Napo Affiliate]
	 	 
	 	By:	 
	 	Name:	 
	 	Title:	 

 

    	 	- 2 -	 

     

    

 

SCHEDULE A
TO PRODUCT AGREEMENT

 

PRODUCT LIST
AND SPECIFICATIONS

 

Product List

 

[insert product list]

 

Specifications

 

Prior to the start
of commercial manufacturing of Product under this Product Agreement, Client 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 Client will give Patheon
the originally executed copies of the revised Specifications. Upon acceptance of the revised Specifications, Patheon will give Client
a signed and dated receipt indicating Patheon's acceptance of the revised Specifications.

 

    	 	- 3 -	 

     

    

 

SCHEDULE B
TO PRODUCT AGREEMENT

 

ANNUAL VOLUME
TIERS AND PRICE

 

[Insert
Price Table] 

 

Manufacturing
Assumptions:

 

Packaging
Assumptions:

 

Testing Assumptions:

 

The following
cost items are included in the Price for the Products:

 

		•	Product
                                            manufactured and packaged under this Product Agreement

 

		•	Standard
                                            certificate of analysis ("COA")

 

		•	Standard
                                            certificate of compliance ("COC")

 

		•	cGMP
                                            required retention samples

 

		•	Copies
                                            of deviation reports

 

		•	Batch
                                            Production Records ("BPR")/Lot Packaging Records ("LPR") copies for validation
                                            batches, first ten (subject to increase by Client in its reasonable discretion based on any
                                            failure by Patheon to develop extended compliance history, to provide consistently compliant
                                            and high quality documentation, site audit failures, or other matters considered relevant
                                            by Client in its reasonable discretion) commercial batches, and one commercial batch per
                                            Year thereafter

 

		•	One
                                            label copy change per Year

 

		•	BPR/LPR
                                            changes [one change per Year]

 

		•	Common
                                            HPLC/GC columns, reagents, and lab supplies

 

		•	Copy
                                            of the Annual Product Review Report

 

    	 	- 4 -	 

     

    

 

		•	Product
                                            Approval Inspection ("PAI") and copy of FDA Report

 

		•	Simple,
                                            routine statistical review

 

		•	Storage
                                            of Production Test Record ("PTR") batches and other experimental batches for three
                                            months

 

		•	Storage
                                            of registration batches and other experimental batches for two Years or until Product approval,
                                            whichever comes first

 

		•	Routine
                                            sampling and analysis as part of Product manufacture and release

 

		•	Warehousing
                                            of equipment, raw materials, API, and finished goods for normal commercial supply

 

    	 	- 5 -	 

     

    

 

SCHEDULE C
TO PRODUCT AGREEMENT

 

ANNUAL STABILITY
TESTING (if applicable)]

 

Patheon and Client
will agree in writing on any stability testing to be performed by Patheon on the Products. This Product Agreement will specify the commercial
and Product stability protocols applicable to the stability testing and the fees payable by Client for this testing.

 

    	 	- 6 -	 

     

    

 

SCHEDULE D
TO PRODUCT AGREEMENT

 

ACTIVE MATERIALS

 

	Active
    Materials	Supplier
	●	●

 

ACTIVE MATERIALS
CREDIT VALUE

 

The
Active Materials Credit Value will be as follows:

 

	PRODUCT	ACTIVE
    MATERIALS	ACTIVE
                                            MATERIALS

    CREDIT
    VALUE

	 	 	Client's
    actual cost for Active Materials, not to exceed $_____per kilogram, as reasonably documented

 

MAXIMUM CREDIT
VALUE

 

Patheon's
liability for Active Materials calculated in accordance with Section 2.2 of the Master Agreement for the Product in a Year will
not exceed, in the aggregate for purposes of this Product Agreement, the maximum credit value set forth below:

 

	PRODUCT	MAXIMUM
    CREDIT VALUE
	 	[_  ]%
    of revenues per Year to Patheon under this Product Agreement, up to a maximum of $[          ]
    in the aggregate per Year.

 

[End of Product
Agreement]

 

    	 	- 7 -	 

     

    

 

APPENDIX 2

 

NON-DISCLOSURE
AND NON-USE TERMS AND CONDITIONS

 

This Appendix
2 contains the Confidentiality Terms between Patheon and Client. For purposes of these Confidentiality Terms, the party receiving
Confidential Information of the other party is the “Receiving Party” and the party disclosing its Confidential Information
is the “Disclosing Party.”

 

1.            Confidential
Information Defined. As used in this Appendix 2, and subject to the exclusions listed in Section 2 (Exclusions) below, the term
 “Confidential Information” means all information disclosed by, or on behalf of, the Disclosing Party (including by
a third party) to the Receiving Party (captured on any media whatsoever or orally), that concerns the business and affairs of the Disclosing
Party or any of its affiliates, including intellectual property and related applications, specifications, research, development, inventions,
designs or drawings, data, algorithms, formulae, chemical entities, compounds, mixtures, prospective and current products, product plans,
ideas, concepts, financial information, marketing, personnel, customers, suppliers, licensors, prospective licensors, licensees, prospective
licensees, strategic partners, and other materials (tangible or intangible, machine or human readable), processes, techniques, know-how,
analyses, plans, and procedures contained in or related to any of the foregoing, and any other nonpublic technical or business information
of the Disclosing Party that a reasonably prudent business person would consider confidential, proprietary or of value to the Disclosing
Party’s business, and all summaries, extracts, memos, reports, analyses and other documents containing or based on the Confidential
Information prepared by the Disclosing Party, Receiving Party or any other person, whether disclosed orally, by observation or disclosed
or accessed in written, electronic or other form or media, and whether or not marked, designated or otherwise identified as “confidential”.
The Disclosing Party will not have any obligation to specifically identify any information as to which the protection of the Confidentiality
Terms extend by any notice or other action.

 

2.            Exclusions.
Confidential Information does not include information that: (i) was already lawfully in the Receiving Party’s possession at
the time of disclosure by the Disclosing Party; (ii) is or becomes publicly available other than by the violation of these Confidentiality
Terms or other fault of the Receiving Party or anyone affiliated with, or in privity of contract with, the Receiving Party; (iii) is
received by the Receiving Party from a third party which, to the knowledge of the Receiving Party after its reasonable inquiry and investigation,
is rightfully in possession of the information free of any obligation to maintain its confidentiality; or (iv) is independently
developed by or on behalf of the Receiving Party without reference to, benefit of, or reliance on any Confidential Information of the
Disclosing Party.

 

3.            Nonuse
and Nondisclosure. The Receiving Party will use the Confidential Information solely for discussions specific to the performance of
performing Manufacturing Services for the Disclosing Party and not for any other purpose, including the benefit of the Receiving Party
or the benefit of any third party. The Receiving Party will hold the Confidential Information in strict confidence, and will not, without
the prior written consent of the Disclosing Party, copy, or provide or disclose to any third party, all or any portion thereof; thus,
the Receiving Party will not convey the Disclosing Party’s Confidential Information (unless specifically authorized in writing
by the Disclosing Party), and will convey only information about the Disclosing Party that has been disclosed in the Disclosing Party’s
public filings. With respect to Confidential Information, the Receiving Party may make tangible copies of the Confidential Information
but these copies will be subject to the provisions of Section 5 (Return of Documents) hereof (these copies will be considered within
Receiving Party’s control for purposes of these Confidentiality Terms, this Agreement and all Product Agreements). Without limiting
the foregoing, the Receiving Party will protect Confidential Information from reproduction, use, propagation or disclosure other than
as permitted herein including taking all steps that the Receiving Party takes to protect its own information that it considers confidential,
proprietary, or trade secret. The Receiving Party must employ reasonable care to protect the Confidential Information. The Receiving
Party may disclose Confidential Information to its employees, officers, directors, and advisors (collectively, “Representatives”)
with a bona fide need to know the Confidential Information, but only to the extent necessary for the Receiving Party to expeditiously
further its progress on performance of Manufacturing Services; but before any such disclosure to the applicable Representative, the Representative
must execute a written agreement with the Receiving Party containing use and disclosure restrictions at least as protective of the Confidential
Information as those imposed on the Receiving Party herein, without any right of further disclosure. The Receiving Party will remain
liable to the Disclosing Party for the conduct of all of its Representatives in violation of these Confidentiality Terms and financially
responsible for any damage caused by the violation. If the Receiving Party becomes obliged to disclose the Confidential Information to
any governmental authority, court, or other tribunal or applicable securities exchange or in response to a subpoena, the Receiving Party
promptly will notify the Disclosing Party, to the extent reasonably practicable under the circumstances and not otherwise prohibited
by applicable law, so that the Disclosing Party may seek an appropriate protective order or other remedy to resist or narrow the scope
of the required disclosure. In the absence of a protective order or other remedy, the Receiving Party will limit the disclosure to the
portion of the Confidential Information as is required by laws or the rules of any applicable securities exchange to be disclosed
and take reasonable steps (at the Disclosing Party’s cost) to have the entity requiring the disclosure to protect to the greatest
extent possible the confidentiality of the information disclosed. This disclosure by the Receiving Party will not change, alter or diminish
the confidential, proprietary, or trade secret status of the Confidential Information, or treatment as such by the Receiving Party, under
these Confidentiality Terms. Notwithstanding the foregoing, Client may disclose Confidential Information to the extent that the disclosure
is made to Regulatory Authorities as required for with any filing or application but reasonable measures must will be taken to assure
confidential treatment of the Confidential information.

 

    	 	- 8 -	 

     

    

 

4.            Equitable
Relief. The Receiving Party agrees and acknowledges that (i) any breach or threatened breach of these Confidentiality Terms
by the Receiving Party or any of its Representatives may irreparably harm the Disclosing Party and (ii) any remedy at law for the
breach or threatened breach may be inadequate to fully and properly compensate and otherwise protect the Disclosing Party. Therefore,
the parties agree that the Disclosing Party will be entitled to injunctive relief for the breach or threatened breach without posting
any bond, unless such bond is required by statute and the applicable statute does not permit the bond to be waived, and without a showing
of actual damages. Equitable relief will be in addition to, not in lieu of, other available remedies.

 

5.            Return
of Documents. Upon the Disclosing Party’s written request, the Receiving Party will promptly: (i) return or, at the Disclosing
Party’s option, destroy or permanently delete from the Receiving Party’s computer systems, all originals and copies, whether
tangible, electronic, or on any other media whatsoever, of all documents, data, materials, and other information thereof in the Receiving
Party’s possession, custody, or control that constitute Confidential Information of the Disclosing Party; and (ii) provide
a written statement executed by a duly authorized officer of the Receiving Party to the Disclosing Party certifying that all documents,
data, materials, and other media containing this information have been so delivered, deleted or destroyed. For purposes of this Section 5,
 “documents, data, materials, and other media containing this information” includes all information fixed in any tangible
medium of expression, in whatever form or format. The Receiving Party may keep Confidential Information of the Disclosing Party to the
extent (i) required by law, rule or regulation provided no attempt is made to use the Confidential Information except for compliance
purposes or (ii) it is held as a backup in electronic form in backup tapes, servers or other sources as a result of Receiving Party’s
normal back up procedures for electronic data, provided that no attempt is made to recover the Confidential Information from back-up
tapes, servers or other sources (except for compliance purposes).

 

6.            No
Obligation. Each party hereto acknowledges and agrees that nothing herein is intended to, or will, obligate either party (i) to
provide or disclose any Confidential Information to the other party, and these Confidentiality Terms will apply only to the Confidential
Information that the party elects, in its sole discretion, to provide or disclose to the other party or (ii) to enter into any other
agreement with the other party, for services or otherwise. These agreements may be entered into upon the terms and conditions as the
parties may hereafter agree.

 

7.            Disclaimer.
ALL CONFIDENTIAL INFORMATION IS PROVIDED BY THE DISCLOSING PARTY “AS IS” AND WITHOUT WARRANTY OF ANY KIND, WHETHER EXPRESS, IMPLIED,
OR OTHERWISE, INCLUDING ANY WARRANTIES REGARDING ITS ACCURACY, COMPLETENESS, PERFORMANCE, NON-INFRINGEMENT OF THIRD PARTY RIGHTS,
OR ITS MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

    	 	- 9 -	 

     

    

 

8.            No
License. All Confidential Information of the Disclosing Party is and will remain the exclusive property of the Disclosing Party,
and the Receiving Party acknowledges and agrees that nothing contained in these Confidentiality Terms grants, or will be construed as
granting, any rights, whether oral or written or express or implied or by license or otherwise, to the Receiving Party or any other party
in or to any Confidential Information, except as expressly specified in these Confidentiality Terms.

 

9.             Term.
The Receiving Party’s obligations herein will survive for five Years after any expiration or termination of this Agreement. Further,
Receiving Party’s obligations hereunder will survive and continue in effect in perpetuity thereafter with respect to any Confidential
Information that is a trade secret of the Disclosing Party under applicable law and any Confidential Information that has been retained
by the Receiving Party under Section 5 of these Confidentiality Terms.

 

10.          Material
Non-Public Information. Confidential Information disclosed to Receiving Party may include material non-public information about the
Disclosing Party or other third parties. Receiving Party, acknowledges and will ensure that its agents and Representatives who receive
Confidential Information under this Agreement, are aware that securities laws prohibit any person or entity who has material non-public
information about a company from purchasing, selling or otherwise trading in securities of that company or from communicating the information
to any other person or entity under circumstances in which it is reasonably foreseeable that that person or entity is likely to purchase,
sell or trade in those securities.

 

11.          General.
These Confidentiality Terms will be binding upon and will inure to the benefit of the parties and their respective successors and permitted
assigns and may be amended only by a written instrument signed by both parties. No provision of these Confidentiality Terms may be waived
except by a writing executed by the party against whom the waiver is to be effective. A party's failure to enforce any of these Confidentiality
Terms will neither be construed as a waiver of the provision nor prevent the party from enforcing any of the other Confidentiality Terms.
Neither party will assign any of its rights or delegate any of its duties or obligations herein without the prior written consent of
the other party, except to an affiliated company or any acquirer of all or substantially all of a party’s business or assets or
of the business division or product line of the party to which the Confidential Information primarily relates.

 

END OF APPENDIX
2

 

    	 	- 10 -	 

     

    

 

EXHIBIT A

 

QUARTERLY
ACTIVE MATERIALS INVENTORY REPORT

 

	TO:	NAPO PHARMACEUTICALS, INC.
	FROM:	PATHEON PHARMACEUTICALS
                                            INC. [or applicable Patheon entity]
	 	 
	RE:	Active
                                            Materials quarterly inventory report under Section 2.2(a) of the Master Manufacturing
                                            Services Agreement dated June __, 2022 (the "Master Agreement")

 

 

	Reporting quarter:	 	 	
	 	 	 	 
	Active Materials on hand at beginning of quarter:	 	kg	(A)
	 	 	 	 
	Active Materials on hand at end of quarter:	 	kg	(B)
	 	 	 	 
	Quantity Received during quarter:	 	kg	(C)
	 	 	 	 
	Quantity Dispensed1 during quarter:	 	kg	 
	(A + C – B)	 	 	 
	 	 	 	 
	Quantity Converted during quarter:	 	kg	 
	(total Active Materials in Products produced and not rejected, recalled, or returned)	 	 	 

 

Capitalized terms
used in this report have the meanings given to the terms in the Master Agreement.

 

	PATHEON PHARMACEUTICALS INC.	DATE:	 
	[or applicable Patheon entity]	 	 
	 	 	 

 

	Per:	 	 
	Name:	 
	Title:	 

 

 

1 Excludes 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 consumed in technical transfer activities or
development activities, including any regulatory, stability, validation, or test batches manufactured during the quarter.

 

    	 	- 1 -	 

     

    

 

EXHIBIT B

 

REPORT OF
ANNUAL ACTIVE MATERIALS INVENTORY RECONCILIATION

 

AND CALCULATION
OF ACTUAL ANNUAL YIELD

 

	TO:	NAPO PHARMACEUTICALS, INC.
	FROM:	PATHEON PHARMACEUTICALS
                                            INC. [or applicable Patheon entity]
	 	 
	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 June ___,
                                            2022 (the "Master Agreement")

 

	Reporting Year ending:	 	 	
	 	 	 	 
	Active Materials on hand at beginning of Year:	 	kg	(A)
	 	 	 	 
	Active Materials on hand at end of Year:	 	kg	(B)
	 	 	 	 
	Quantity Received during Year:	 	kg	(C)
	 	 	 	 
	Quantity Dispensed2 during Year:	 	kg	(D)
	(A + C – B)	 	 	 
	 	 	 	 
	Quantity Converted during Year:	 	kg	(E)
	(total Active Materials in Products produced and not rejected, recalled, or returned)	 	 	 
	 	 	 	 
	Active Materials Credit Value:	$	 	/kg	(F)
	 	 	 	 
	Target Yield:	 	%	(G)
	 	 	 	 
	Actual Annual Yield:	 	%	(H)
	((E ∕ D) * 100)	 	 	 
	 	 	 	 
	Shortfall:	$	 		(I)
	 	 	 	 

 

 

2 Excludes 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 consumed in technical transfer activities or
development activities, including any regulatory, stability, validation, or test batches manufactured during the Year.

 

    	 	- 2 -	 

     

    

 

	(((G – 5) - H) ∕ 100) * F * D	(if a negative number, insert zero)

 

Based on the foregoing
reimbursement calculation Patheon will reimburse Client the amount of $                    .

 

Capitalized terms
used in this report have the meanings given to the terms in the Master Agreement.

 

DATE:                             

 

	PATHEON PHARMACEUTICALS INC.	 
	[or applicable Patheon entity]	 
	 	 
	Per:	           	 
	Name:	 
	Title:	 

 

    	 	- 3 -	 

     

    

 

EXHIBIT C

 

EXAMPLE OF
PRICE ADJUSTMENT DUE TO CURRENCY FLUCTUATION

 

Section 4.2(e)

 

 

 

    	 	- 4 -Exhibit
4.3

 

Form
of Warrant

 

NEITHER THIS SECURITY NOR THE SECURITIES
FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF
ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”),
AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT
TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE
WITH APPLICABLE STATE SECURITIES LAWS AS EVIDENCED BY A LEGAL OPINION OF COUNSEL TO THE TRANSFEROR TO SUCH EFFECT, THE SUBSTANCE OF WHICH
SHALL BE REASONABLY ACCEPTABLE TO THE COMPANY. THIS SECURITY AND THE SECURITIES ISSUABLE UPON EXERCISE OF THIS SECURITY MAY BE PLEDGED
IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR OTHER LOAN SECURED BY SUCH SECURITIES.

 

	Warrant No. _____	 	Issue Date: _________2022

 

THIS COMMON STOCK PURCHASE WARRANT
(the “Warrant”) certifies that, for value received, [             ] or any registered assigns (the “Holder”)
is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time following
the Issue Date (the “Initial Exercise Date”) and on or prior to the close of business on ____________, 20271
(the “Termination Date”) but not thereafter, to subscribe for and purchase from Shuttle Pharmaceuticals Holdings,
Inc., a Delaware corporation (the “Company”), up to [         ] shares of Common Stock (the “Warrant
Shares”). The purchase price of one share of Common Stock under this Warrant shall be the lower of $2.50 per share or 50%
of the per share purchase price of the Company’s initial public offering.

 

Section 1.
Definitions. For the purposes hereof, in addition to the terms defined elsewhere in this Warrant, (a) capitalized terms not otherwise
defined herein shall have the meanings set forth in the Subscription Agreement entered into by the Company and the Holder of even day
herewith and (b) the following terms shall have the following meanings:

 

“Business
Day” means any day except any Saturday, any Sunday, any day which shall be a federal legal holiday in the United States
or any day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.

 

“Common
Stock” means the shares of common stock, $0.00001 par value per share, of the Company.

 

“Common
Stock Equivalents” means any securities of the Company which would entitle the holder thereof to acquire at any time Common
Stock, including, without limitation, any debt, preferred stock, rights, options, warrants or other instrument that is at any time convertible
into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive Common Stock.

 

 

 

1
Five years from the Issue Date

 

    	1

     

    

 

“Exercise
Period” shall have the meaning as that term is defined in Section 2(a) below.

 

“Person”
means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company,
joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

 

“Securities
Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

“Trading
Day” means a day on which the New York Stock Exchange is open for business.

 

“Trading
Market” means the following markets or exchanges on which the Common Stock may be listed or quoted for trading on the date
in question: the NYSE MKT, LLC, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, or the New York
Stock Exchange.

 

“Transfer
Agent” means VStock Transfer LLC.

 

Section 2. Exercise.

 

a) Exercise of
Warrant. Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or
after the Initial Exercise Date and on or before the Termination Date (the “Exercise Period”) by delivery to
the Company (or such other office or agency of the Company as it may designate by notice in writing to the registered Holder at the address
of the Holder appearing on the books of the Company) of a duly executed notice of exercise (“Notice of Exercise”)
form attached hereto as Exhibit A(i); and, within three (3) Trading Days of the date said Notice of Exercise is delivered to the Company,
the Company shall have received payment of the aggregate Exercise Price of the shares thereby purchased by wire transfer or cashier’s
check drawn on a United States bank. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender
this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has been exercised
in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within three (3) Trading Days of the date
the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the
total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable
hereunder in an amount equal to the applicable number of Warrant Shares purchased. The Holder and the Company shall maintain records showing
the number of Warrant Shares purchased and the date of such purchases. In the event of any dispute or discrepancy, the records of the
Company shall be controlling and determinative in the absence of manifest error.

 

b)
Exercise Price. The exercise price per share of the Common Stock under this Warrant shall be $2.50 per share or 50% of the
initial public offering price, whichever is lower. 

 

    	2

     

    

 

c) Mechanics of Exercise.

 

i. Delivery
of Warrant Shares Upon Exercise. Certificates for shares purchased hereunder shall be transmitted by the Company’s transfer
agent (the “Transfer Agent”) to the Holder by crediting the account of the Holder’s prime broker with
the Depository Trust Company through its Deposit Withdrawal Agent Commission (“DWAC”) system if the Company
is then a participant in such system and either (A) there is an effective registration statement for its initial public offering registering
the Warrants Shares, in which case the Holder will simultaneously exercise this Warrant upon the effectiveness of such registration statement,
(B) there is a registration statement permitting the resale of the Warrant Shares by the Holder or (C) the shares are eligible for resale
without volume or manner-of-sale limitations pursuant to Rule 144, and otherwise by physical delivery of certificates to the address specified
by the Holder in the Notice of Exercise within four (4) Trading Days from the delivery to the Company of the Notice of Exercise Form,
surrender of this Warrant (if required) and payment of the aggregate Exercise Price as set forth above (the “Warrant Share
Delivery Date”). This Warrant shall be deemed to have been exercised on the date the Exercise Price is received by the Company.
The Warrant Shares shall be deemed to have been issued, and Holder or any other person so designated to be named therein shall be deemed
to have become a holder of record of such shares for all purposes, as of the date the Warrant has been exercised by payment to the Company
of the Exercise Price and all taxes required to be paid by the Holder, if any, pursuant to Section 2(d)(vi) prior to the issuance of such
shares, have been paid. .

 

ii. Delivery of
Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon
surrender of this Warrant certificate, at the time of delivery of the certificate or certificates representing Warrant Shares, deliver
to Holder a new Warrant evidencing the rights of Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new
Warrant shall in all other respects be identical with this Warrant.

 

iii. Rescission
Rights. If the Company fails to cause the Transfer Agent to transmit to the Holder a certificate or the certificates representing
the Warrant Shares pursuant to Section 2(d)(i) by the Warrant Share Delivery Date, then the Holder will have the right to rescind such
exercise.

 

iv. No Fractional
Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As
to any fraction of a share which Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election,
either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or
round up to the next whole share.

 

v. Charges, Taxes
and Expenses. Issuance of certificates for Warrant Shares shall be made without charge to the Holder for any issue or transfer tax
or other incidental expense in respect of the issuance of such certificate, all of which taxes and expenses shall be paid by the Company,
and such certificates shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided,
however, that in the event certificates for Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant
when surrendered for exercise shall be accompanied by the assignment form (“Assignment Form”) attached hereto
as Exhibit A(ii) duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse
it for any transfer tax incidental thereto.

 

vi. Closing of
Books. The Company will not close its shareholder books or records in any manner which prevents the timely exercise of this Warrant,
pursuant to the terms hereof.

 

    	3

     

    

 

Section 3.
Certain Adjustments.

 

a)
Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend or
otherwise make a distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities payable
in shares of Common Stock (which, for avoidance of doubt, shall not include any Warrant Shares issued by the Company upon exercise of
this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of
reverse stock split) outstanding shares of Common Stock into a smaller number of shares or (iv) issues by reclassification of shares of
the Common Stock any shares of capital stock of the Company, then in each case the Exercise Price shall be multiplied by a fraction of
which the numerator shall be the number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately before such
event and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event and the number
of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant
shall remain unchanged. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for
the determination of shareholders entitled to receive such dividend or distribution and shall become effective immediately after the effective
date in the case of a subdivision, combination or re-classification.

 

b)
Calculations. All calculations under this Section 4 shall be made to the nearest cent or the nearest 1/100th of a share,
as the case may be. For purposes of this Section 4, the number of shares of Common Stock deemed to be issued and outstanding as of a given
date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any) issued and outstanding.

 

c)
 Notice to Holder.

 

i. Adjustment to Exercise Price.
Whenever the Exercise Price is adjusted pursuant to any provision of this Section 4, the Company shall promptly mail to the Holder
a notice setting forth the Exercise Price after such adjustment and setting forth a brief statement of the facts requiring such adjustment.

 

ii. Notice to Allow Exercise by Holder.
If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Stock, (B) the Company shall declare
a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company shall authorize the granting to all holders
of the Common Stock rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights, (D) the
approval of any shareholders of the Company shall be required in connection with any reclassification of the Common Stock, any consolidation
or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, of any compulsory
share exchange whereby the Common Stock is converted into other securities, cash or property, or (E) the Company shall authorize the voluntary
or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be
mailed to the Holder at its last address as it shall appear upon the Warrant Register of the Company, at least 20 calendar days prior
to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the
purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders
of the Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y)
the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close,
and the date as of which it is expected that holders of the Common Stock of record shall be entitled to exchange their shares of the Common
Stock for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange;
provided that the failure to mail such notice or any defect therein or in the mailing thereof shall not affect the validity of the corporate
action required to be specified in such notice. The Holder is entitled to exercise this Warrant during the period commencing on the date
of such notice to the effective date of the event triggering such notice.

 

    	4

     

    

 

Section 4. Transfer of Warrant.

 

	 	a)	Transferability. This Warrant and all rights hereunder (including, without limitation, any registration rights) are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer. Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled. The Warrant, if properly assigned, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued.
	 	 	 
	 	b)	Warrants. This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney. Subject to compliance with Section 5(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the Initial Exercise Date and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.

 

c)
Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose
(the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may deem and
treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to
the Holder, and for all other purposes, absent actual notice to the contrary.

 

Section 5. Miscellaneous.

 

c)
No Rights as Shareholder Until Exercise. This Warrant does not entitle the Holder to any voting rights or other rights as
a shareholder of the Company prior to the exercise hereof.

 

d)
Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the Company of evidence reasonably
satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares,
and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which, in the case of the Warrant,
shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the
Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant
or stock certificate.

 

    	5

     

    

 

e)
Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right
required or granted herein shall not be a Business Day, then, such action may be taken or such right may be exercised on the next succeeding
Business Day.

 

f) Authorized
Shares.

 

The Company covenants that, during the
period the Warrant is outstanding, it will reserve from its authorized and unissued Common Stock one hundred (100%) of the number of shares
to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. In case such amount of
Common Stock is insufficient at any time, the Company shall call and hold a special meeting to increase the number of authorized shares
of common stock. Management of the Company shall recommend to shareholders to vote in favor of increasing the number of authorized shares
of common stock.

 

The Company further covenants that
its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of executing stock certificates
to execute and issue the necessary certificates for the Warrant Shares upon the exercise of the purchase rights under this Warrant. The
Company will take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided herein without
violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Stock may be listed.
The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant
will, upon exercise of the purchase rights represented by this Warrant, be duly authorized, validly issued, fully paid and nonassessable
and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any
transfer occurring contemporaneously with such issue).

 

Except and to the extent as waived
or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its amended and restated certificate
of incorporation, as amended, or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of
securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but
will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary
or appropriate to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the
foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise
immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company
may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially
reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof,
as may be, necessary to enable the Company to perform its obligations under this Warrant.

 

Before taking any action which would
result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall
obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies
having jurisdiction thereof.

 

g)
Jurisdiction. All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall
be determined in accordance with the provisions of the laws of the State of Delaware.

 

    	6

     

    

 

h)
Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered,
will have restrictions upon resale imposed by state and federal securities laws.

 

i)
Nonwaiver and Expenses. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder
shall operate as a waiver of such right or otherwise prejudice Holder’s rights, powers or remedies, notwithstanding the fact that
all rights hereunder terminate on the Termination Date. If the Company willfully and knowingly fails to comply with any provision of this
Warrant, which results in any material damages to the Holder, the Company shall pay to Holder such amounts as shall be sufficient to cover
any costs and expenses including, but not limited to, reasonable attorneys’ fees, including those of appellate proceedings, incurred
by Holder in collecting any amounts due pursuant hereto or in otherwise enforcing any of its rights, powers or remedies hereunder.

 

j)
Notices. Any notice, request or other document required or permitted to be given or delivered to the Holder by the Company
shall be delivered in accordance with the addresses provided by the Holder of this Warrant.

 

k)
Limitation of Liability. No provision hereof, in the absence of any affirmative action by Holder to exercise this Warrant
to purchase Warrant Shares, and no enumeration herein of the rights or privileges of Holder, shall give rise to any liability of Holder
for the purchase price of any Common Stock or as a shareholder of the Company, whether such liability is asserted by the Company or by
creditors of the Company.

 

l)
Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages,
will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would not be adequate
compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to
assert the defense in any action for specific performance that a remedy at law would be adequate.

 

m)
Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby
shall inure to the benefit of and be binding upon the successors of the Company and the successors and permitted assigns of Holder. The
provisions of this Warrant are intended to be for the benefit of all Holders from time to time of this Warrant and shall be enforceable
by the Holder or holder of Warrant Shares.

 

n)
Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company
and the Holder.

 

o)
Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and
valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision
shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining
provisions of this Warrant.

 

p)
Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be
deemed a part of this Warrant.

 

[Signature Page Follows.]

 

    	7

     

    

 

IN WITNESS WHEREOF, the Company has caused this Warrant to be
executed by its officer thereunto duly authorized as of the date first above indicated.

 

	SHUTTLE PHARMACEUTICALS HOLDINGS, INC.	 
	 	 	 
	By:	 	 
	Name:	Anatoly Dritschilo	 
	Title:	Chief Executive Officer	 

 

    	 

     

    

 

EXHIBIT A(i)

 

NOTICE OF EXERCISE

 

TO:

 

(1) The undersigned hereby elects to purchase_________
Warrant Shares of the Company pursuant to the terms of the attached Warrant and tenders herewith payment of the exercise price in full,
together with all applicable transfer taxes, if any.

 

(2) Please issue a certificate or certificates
representing said Warrant Shares in the name of the undersigned or in such other name as is specified below:

 

____________________________________

 

The Warrant Shares shall be delivered to the following DWAC
Account Number or by physical delivery of a certificate to:

 

____________________________________

 

____________________________________

 

____________________________________

 

(3) Accredited Investor. The undersigned
is an “accredited investor” as defined in Regulation D promulgated under the Securities Act of 1933, as amended.

 

 

[SIGNATURE OF HOLDER]

 

Name of Investing Entity:

____________________________________________________

 

Signature of Authorized Signatory of Investing Entity:

____________________________________________________

 

Name of Authorized Signatory:

____________________________________________________

 

Title of Authorized Signatory:

____________________________________________________

 

Date:

____________________________________________________

 

    	 

     

    

 

EXHIBIT A(ii)

 

ASSIGNMENT FORM

 

(To assign
the foregoing warrant, execute this form and supply required information. Do not use this form to exercise the warrant.)

 

FOR VALUE RECEIVED, [_____] all of or [_____] shares
of the foregoing Warrant and all rights evidenced thereby are hereby assigned to

 

______________________________________________________whose address is

 

______________________________________________________________________.

 

_________________________________________________________________

 

	 	 	Dated:____________________ ,
    _____
	 	 	 
	 	Holder’s
Signature:	_______________________
	 	 	 
	 	Holder’s
Address:	_______________________
	 	 	 
	 	 	_______________________

 

Signature Guaranteed:

 

NOTE: The signature to this Assignment Form must correspond
with the name as it appears on the face of the Warrant, without alteration or enlargement or any change whatsoever, and must be guaranteed
by a bank or trust company. Officers of corporations and those acting in a fiduciary or other representative capacity should file proper
evidence of authority to assign the foregoing Warrant.

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