Document:

Exhibit 10.2

 

EXECUTION VERSION

 

LICENSE AGREEMENT

 

BETWEEN

 

INDIVIOR UK LIMITED

 

AND

 

ADDEX PHARMA S.A.

 

 

TABLE OF CONTENTS

 

	
 
    	
 
    	
Page
    
	
 
    	
 
    	
 
    
	
1.
    	
DEFINITIONS
    	
1
    
	
 
    	
 
    	
 
    
	
2.
    	
LICENSE
    	
10
    
	
 
    	
 
    	
 
    
	
3.
    	
JOINT   RESEARCH ACTIVITIES
    	
12
    
	
 
    	
 
    	
 
    
	
4.
    	
DEVELOPMENT   ACTIVITIES
    	
16
    
	
 
    	
 
    	
 
    
	
5.
    	
DILIGENCE
    	
17
    
	
 
    	
 
    	
 
    
	
6.
    	
PAYMENT
    	
17
    
	
 
    	
 
    	
 
    
	
7.
    	
INTELLECTUAL   PROPERTY
    	
23
    
	
 
    	
 
    	
 
    
	
8.
    	
WARRANTIES
    	
29
    
	
 
    	
 
    	
 
    
	
9.
    	
CERTAIN   COVENANTS AND AGREEMENTS
    	
31
    
	
 
    	
 
    	
 
    
	
10.
    	
TERM;   TERMINATION
    	
32
    
	
 
    	
 
    	
 
    
	
11.
    	
INDEMNIFICATION
    	
35
    
	
 
    	
 
    	
 
    
	
12.
    	
INSURANCE
    	
37
    
	
 
    	
 
    	
 
    
	
13.
    	
CONFIDENTIALITY
    	
37
    
	
 
    	
 
    	
 
    
	
14.
    	
MISCELLANEOUS
    	
38
    

 

 

LICENSE AGREEMENT

 

This License Agreement (this “Agreement”) is entered into as of this 2nd day of January 2018, by and between Indivior UK Limited (Co. No. 7183451) with a registered address of 103-105 Bath Road, Slough, Berkshire, SL1 3UH (“Indivior”), and Addex Pharma S.A., a company organized under the laws of Switzerland (“Addex”).

 

INTRODUCTION

 

WHEREAS, Indivior is engaged in the business of, among other things, developing, marketing and distributing pharmaceutical products;

 

WHEREAS, Addex owns certain intellectual property rights related to its GABAb program, including, but not limited to, ADX 71441 compound for the treatment of addictive disorders; and

 

WHEREAS, the Parties desire to enter into an agreement granting Indivior a license to such intellectual property to enable Indivior to develop, manufacture, market and distribute Product(s) (as defined below), subject to and in accordance with the terms and conditions of this Agreement.

 

In consideration of the mutual covenants contained herein, and other good and valuable consideration, the receipt of which is hereby acknowledged, Addex and Indivior agree as follows:

 

1.                                      DEFINITIONS

 

When used in this Agreement, each of the following terms, whether used in the singular or plural, shall have the meanings set forth in this Section 1:

 

1.1          “Accounting Standards” means, with respect to a Person, International Financial Reporting Standards (IFRS), as consistently applied by such Person across its operations.

 

1.2          “Addex Development Patent Rights” means any Patent Right generated from the activities of this Agreement that Covers a Licensed Compound but which Patent Right does not Cover any Addex Retained Compound, and which is not an Indivior Improvement Patent Right or a Joint Patent Right.

 

1.3          “Addex Existing Patent Rights” means the patents and patent applications set forth on Schedule 1.3 and Patent Rights relating or claiming priority thereto.

 

1.4          “Addex Improvements” means any improvements, enhancements or modifications of the Licensed IP developed by or on behalf of Addex other than Joint Improvements.

 

1.5          “Addex Know-How” means all Know-How owned or controlled by (or, to the extent sublicensable, licensed to), Addex or its Affiliates (a) as of the date hereof or (b) which is created or acquired by Addex in the course of carrying out its obligations under this Agreement, in each case that is necessary or useful for the research, development, manufacture, use or commercialization of the Licensed Compounds and/or the Products.

 

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1.6          “Addex Other Patent Rights” means such rights that Addex has in any Patent Rights that are not: (a) Addex Existing Patent Rights, (b) Addex Development Patent Rights or (c) Addex Overlapping Patent Rights, but are other Patent Rights owned or controlled by (or, to the extent sublicensable, licensed to), Addex or its Affiliates and are filed or claim priority to an application filed before or during the Term and that contain a claim that Covers a Licensed Compound.

 

1.7          “Addex Overlapping Patent Rights” means any Patent Rights generated from the activities of this Agreement that Cover a Licensed Compound and also Cover an Addex Retained Compound, and which are not Indivior Improvement Patent Rights or Joint Patent Rights.

 

1.8          “Addex Patent Rights” means (a) the Addex Existing Patent Rights, (b) the Addex Development Patent Rights, (c) the Addex Overlapping Patent Rights and (d) Addex’s interest in any Addex Other Patent Rights and, to the extent Addex has a non-exclusive right to any Addex Other Patent Rights, reference to the Addex Other Patent Rights shall mean such non-exclusive right.

 

1.9          “Addex Product” means any pharmaceutical product that contains or comprises an Addex Retained Compound.

 

1.10        “Addex Retained Compounds” means (a) the Compounds that cease to be Development Compounds and become Addex Retained Compounds pursuant to Section 3.4 and (b) any Compounds discovered by Addex after the expiry of the Research Term.

 

1.11        “Addex Retained Patent Rights” means Patent Rights generated from the activities of this Agreement that Cover an Addex Retained Compound and that do not Cover any Licensed Compound.

 

1.12        “Affected Product” has the meaning set forth in Section 6.5(d).

 

1.13        “Agreed Assay” means the assay set out in Schedule 1.13.

 

1.14        “Affiliate(s)” means, with respect to a Party, any Person that is directly or indirectly controlled by, controlling, or under common control with such Party. For purposes of this definition only, the term “control” (including, with correlative meaning, the terms “controlling”, “controlled by”, and “under common control with”), as used with respect to the applicable Party, means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Party, whether through ownership of interests representing equity, securities, or partnership interests or by contract, or otherwise. Ownership of more than fifty percent (50%) of such equity, securities or partnership interests in a Person shall, without limitation, be deemed to be control for purposes of this definition. For the purposes of this Agreement, an Addex Affiliate shall exclude any entity that, after the Effective Date, acquires control of Addex.

 

1.15        “ANDA” means an abbreviated new drug application filed with the FDA pursuant to 21 U.S.C. § 355(j) and 21 C.F.R. § 314.3.

 

1.16        “Annual Net Sales” means, with respect to any jurisdiction, the total Net Sales of all Products sold in such jurisdiction during any twelve (12) month period.

 

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1.17        “Applicable Law” means federal, state, local and national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder.

 

1.18        “Bankruptcy Code” has the meaning set forth in Section 2.3.

 

1.19        “Commercially Reasonable Efforts” means, with respect to the performance of development or commercialization activities with respect to the Licensed Compound, Development Compound or a Product by a Party, the performance of obligations or tasks in a manner consistent with the reasonable practices of a similarly situated biotechnology (in the case of Addex) or pharmaceutical (in the case of Indivior) company having similar resources for the development or commercialization (as applicable) of a product having similar technical and regulatory factors and similar market potential, profit potential and strategic value, and that is at a similar stage in its development or product life cycle as such Licensed Compound, Development Compound or Product; provided that [***] Commercially Reasonable Efforts require a Party to take any actions that (a) require such Party to [***] under this Agreement, (b) would [***] or (c) [***] so long as [***].

 

1.20        “Compound” means any molecule that is a positive allosteric modulator of the GABAb receptors (a) with [***] or less as determined in the Agreed Assay and (b) at least [***], as determined in the Agreed Assay, and any racemate or enantiomer of such molecule, and any salt or hydrate of any of the foregoing.

 

1.21        “Cover” means, with respect to a patent or patent application for a Compound or Product, that a Third Party’s unlicensed research on, development, manufacture, or commercialization of such Compound, or a pharmaceutical product containing or comprising such Compound, or such Product would fall within at least one claim of such patent or patent application or would cause indirect infringement of the claim by a Third Party. With respect to a pending patent application, the phrase “would fall within the claim” intends such analysis to be based on the claims of such pending application as if they were contained in an issued or granted patent.

 

1.22        “Development Compound” has the meaning set forth in Section 3.4.

 

1.23        “Development Milestone Payments” has the meaning set forth in Section 6.3.

 

1.24        “Effective Date” means the date first written above.

 

1.25        “European Major Market” means any of the following countries in Europe: France, Germany, Italy, Spain and the United Kingdom.

 

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1.26        “FDA” means the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

 

1.27        “Field” means the use of pharmaceutical products containing or comprising Compounds in the treatment, diagnosis and/or prevention of any disease in humans other than for the Reserved Indications.

 

1.28        “Filing Acceptance” means, as applicable, the acceptance for filing of a complete NDA (or its equivalent) by the FDA in the United States, or acceptance for filing of a comparable application by a Regulatory Authority in Europe for the manufacture, supply, marketing and sale of a pharmaceutical product.

 

1.29        “FTE” means the equivalent of the work of one appropriately qualified individual working on a full-time basis in performing work in connection with this Agreement for a twelve (12) month period (consisting of at least a total of [***] hours per year of dedicated effort). FTE efforts shall not include the work of general corporate or administrative personnel but a single FTE may comprise the work of one or more individuals.

 

1.30        “FTE Rate” means, for the period from the Effective Date to 31 December 2018, [***]. Thereafter, the FTE Rate shall be increased or decreased on 1 January of each year by the annual percentage increase or decrease in the UK Consumer Price Inflation published by the UK Office of National Statistics.

 

1.31        “Generic Product” means, with respect to any Product, a non-proprietary drug product that is a pharmaceutical equivalent to such Product, meaning that: (a) it is placed on the market pursuant to a validly granted marketing authorization by a Third Party and such Third Party has not been granted any rights by Indivior to place such product on the market, except in cases where (i) such Third Party has filed an ANDA and such rights were granted as part of an ANDA litigation settlement, (ii) Indivior did not receive monetary consideration from such Third Party and (iii) the grant of rights by Indivior was a good faith attempt to maximize the expected length of market exclusivity for such Product; (b) it contains the same active ingredient(s), has the same dosage form and route of administration; (c) the marketing authorization for which such product was obtained by making a cross reference to the data provided by Indivior to the relevant Regulatory Authority in the application for Marketing Approval for the corresponding Product; and (d) it is AB rated in the United States (or similar designation of therapeutic substitutability outside the United States).

 

1.32        “Good Clinical Practice” or “GCP” means, as to the United States and the European Union, good clinical practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices as then in effect in the United States or the European Union, in each case to the extent relating to the pharmaceutical products hereunder.

 

1.33        “Good Manufacturing Practice” or “GMP” means (a) as to the United States and the European Union, good manufacturing practices and general biological products standards as promulgated by the FDA pursuant to 21 CFR Parts 210, 211, 600 and 610 and as promulgated by the European Union pursuant to Commission Directive 2003/94/EC, respectively, each as may be

 

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amended from time to time, and (b) with respect to any other jurisdiction, manufacturing practices equivalent to the aforementioned good manufacturing practices as then in effect in the United States or the European Union, in each case to the extent relating to the pharmaceutical products hereunder.

 

1.34        “Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of any government or a federal, state, province, county, city or other political subdivision thereof.

 

1.35        “Guaranteed Spend” has the meaning set forth in Section 3.1.

 

1.36        “IND” means an investigational new drug application filed with the FDA pursuant to 21 C.F.R. §312 or any similar authorization outside the US.

 

1.37        “Indication(s)” means a disease classification as defined within the “International Statistical Classification of Diseases and Related Health Problems” as published on the date hereof by the World Health Organization (e.g. F10 Mental and Behavioral Disorders due to the use of Alcohol is a distinct indication from F14 Mental and Behavioral Disorders due to the use of Cocaine).

 

1.38        “Indivior Exclusive Field” means the use of pharmaceutical products containing or comprising Compounds in the treatment, diagnosis and/or prevention of any disease in humans other than for the Reserved Indications and/or the Shared Indications.

 

1.39        “Indivior Improvements” means any improvements, enhancements or modifications of the Licensed IP developed by or on behalf of Indivior other than Joint Improvements.

 

1.40        “Indivior Improvement Patent Rights” means any Patent Rights, excluding any Joint Patent Rights, that Cover an Indivior Improvement.

 

1.41        “Initiation” means, with respect to a clinical study, the first dosing of the first patient in such client study.

 

1.42        “IP License” has the meaning set forth in Section 2.1.

 

1.43        “Joint Improvements” has the meaning set forth in Section 7.1(d).

 

1.44        “Joint Patent Rights” means any Patent Rights based on an invention made while carrying out the Parties’ activities pursuant to this Agreement which have multiple inventors, as defined by U.S. patent law, where there is at least one inventor, employed by or otherwise obligated to assign their rights in the invention to Addex, and at least one inventor employed by or otherwise obligated to assign their rights in the invention to Indivior.

 

1.45        “Joint Research Committee” and “JRC” have the meaning set forth in Section 3.8.

 

1.46        “Know-How” means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology (whether patentable or not) which

 

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are confidential to the relevant Party, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and quality control data (including drug stability data), manufacturing technology and data (including formulation data), and sales forecasts, data and descriptions.

 

1.47        “Knowledge” means, with respect to Addex, facts or other information [***].

 

1.48        “Launch Date” means, on a country-by-county basis, the date of the first commercial sale of a Product by Indivior, its Affiliate or sublicensee to a Third-Party after Marketing Approval together with any required pricing and reimbursement approvals for such·Product has been obtained in such country; provided that sales prior to receipt of Marketing Approval for such Product, such as so-called “treatment IND sales,” “named patient sales”, “Temporary Authorization for Use in France”, and “compassionate use sales,” shall not be construed as comprising a Launch Date.

 

1.49        “Licensed Compound” means any molecule that is (a) Covered by the Addex Existing Patent Rights, as well as any enantiomer or racemate of such molecule, and/or any salt or hydrate of any of the foregoing; and/or (b) any Compound that is selected by Indivior as a Licensed Compound pursuant to Section 3.4.

 

1.50        “Licensed IP” means the Addex Patent Rights and Addex Know-How and Addex’s ownership interest in Joint Improvements and Joint Patent Rights.

 

1.51        “Major Market” means the United States, Canada, Australia and each of the European Major Markets.

 

1.52        “Marketing Approval” means, as applicable, the approval of an NDA by the FDA in the United States or approval of a comparable application by a Regulatory Authority in any other country or jurisdiction for the manufacture, supply, marketing and sale of a pharmaceutical product. For clarity, “Marketing Approval” shall not include any governmental pricing and/or reimbursement approvals and/or authorizations issued by a Regulatory Authority or any other governmental agency in any country or jurisdiction.

 

1.53        “NDA” means a New Drug Application, as defined in 21 U.S.C. §355(b) et seq., and the regulations promulgated thereunder, as such application may be amended or supplemented from time to time.

 

1.54        “Net Sales” means the gross amounts invoiced by Indivior, its Affiliates or their respective sublicensees (each, an “Indivior Party”) for the sale of a Licensed Compound or Product to Third Parties, less the following:

 

(i)            customary trade, quantity and cash discounts and any other adjustments, including granted on account of price adjustments, billing errors, rejected goods, damaged or defective goods, recalls, returns, rebates, chargeback rebates, reimbursements or similar payments granted or given to wholesalers or distributors, buying groups, health care

 

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insurance carriers, governments, government-subsidized programs or managed care organizations, or other institutions, or adjustments arising from consumer discount programs, in each case actually allowed and taken by a Third Party with respect to amounts invoiced for such Product;

 

(ii)           sales taxes or similar taxes, including duties or other governmental charges imposed on the sale of Product to a Third Party (excluding any taxes imposed on or measured by the net income or profits of the Indivior Party), not reimbursable, refundable or creditable to the Indivior Party; and

 

(iii)          prepaid freight, insurance and handling fees actually invoiced (to the extent that the Indivior Party actually incurs the cost of freight, insurance and handling fees for Product and are not reimbursable, refundable or creditable to the Indivior Party);

 

in each case (i)-(iii) as determined from books and records of the Indivior Party maintained in accordance with applicable Accounting Standards. Amounts invoiced for sales or other transfer of such Product between or among Indivior, its Affiliates and/or other Indivior Parties shall be excluded from the computation of Net Sales unless such sales are intended for end use, in which case the fair market value of such sale shall be applied. If a sale or transfer of Product involves consideration other than cash or is not at arm’s length, then the Net Sales from such sale or transfer shall be the arm’s length fair market value, which generally will mean the Indivior Party’s average sales price for the Quarter.

 

1.55        “[***]” means [***].

 

1.56        “[***]” means [***].

 

1.57        “Party” means Indivior or Addex, as applicable, and “Parties” means both Indivior and Addex.

 

1.58        “Patent Filing Jurisdictions” means the United States, the European Major Markets and Japan.

 

1.59        “Patent Rights” means all issued patents, pending patent applications and additional patent applications, provisionals, continuations, continuations-in-part, divisions, reissues, reexaminations, extensions, supplementary protection certificates, substitutions and renewals of any of the foregoing, all foreign counterparts of any of the foregoing, and all new patents that may issue from or claim priority to any of the foregoing.

 

1.60        “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

 

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1.61        “Phase Ib Study” means a study in healthy subjects (rather than patients in the proposed indication) with a primary endpoint of safety and tolerability and which has the additional purpose of investigating the pharmacokinetics, pharmacodynamics and preliminary·indications of efficacy of the Product.

 

1.62        “Phase II” means a human clinical trial, the principal purpose of which is to establish a dose and/or dose range and which is intended to generate additional safety data that will support the design of Phase III research protocols in a patient population that has the disease or condition being studied, as further described in 21 C.F.R. §312.21(b).

 

1.63        “Phase III” means a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease or condition being studied, as further described in 21 C.F.R. §312.21(c), which is designed and intended to be of a size and statistical power sufficient to serve as a pivotal study to support the filing of an application for Marketing Approval for the indication being studied.

 

1.64        “Post-Grant Proceeding” means any re-examination, inter-partes review, re-issue, opposition, interference, cancellation, prior use, derivation, or other proceeding before an administrative agency or administrative tribunal (but excluding routine ex-parte patent prosecution and its associated administrative appeals) related to the validity, scope, ownership, or inventorship of a patent or allowed patent application, as well as any judicial appeals resulting from such a proceeding.

 

1.65        “Presentation” means, in relation to a Product or Generic Product, the pharmaceutical form of such product in combination with the route of administration such that, by way of example and without limitation, immediate release oral formulations are distinct presentations from sustained release formulations, buccal delivery is distinct from tablets that release in the digestive tract, injectable formulations are distinct presentations from tablets or inhalers and an injectable depot is a distinct presentation from a liquid injection.

 

1.66        “Product” means any pharmaceutical product that comprises or contains a Licensed Compound.

 

1.67        “Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Quarter shall end on the last day of the Term.

 

1.68        “Regulatory Authorities” means, with respect to any jurisdiction, the applicable Governmental Authority responsible for regulating the manufacture, distribution and sale of pharmaceutical products in such jurisdiction.

 

1.69        “Representatives” has the meaning set forth in Section 4.3.

 

1.70        “Research Activities” means the activities carried out by the Parties in the conduct of the Research Plan.

 

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1.71                        “Research Plan” has the meaning set forth in Section 3.2.

 

1.72                        “Research Term” means the period commencing on May 1, 2018 and expiring on the second anniversary thereof unless the Parties agree to extend the Research Term pursuant to Section 3.3.

 

1.73                        “Reserved Indications” means the following Indications:

 

(a)                                 [***] including but not limited to Charcot Marie Tooth (G60);

 

(b)                                 [***] including but not limited to [***];

 

(c)                                  [***] including but not limited to [***]; and

 

(d)                                 [Neuromuscular dysfunction of bladder and other disorders of bladder (N31 to N32)].

 

1.74                        “Royalty” has the meaning set forth in Section 6.4.

 

1.75                        “Royalty Term” means, with respect to each Product in a particular country, the period of time commencing on the Launch Date of such Product and ending on the later of (a) [***] after the Launch Date of the applicable Product in such country, (b) expiration in such country of the last Valid Patent Claim of the last-to-expire of any Joint Patent Rights or Addex Patent Rights that Cover such Product in the country of its manufacture or sale, and (c) expiration of any applicable marketing or data exclusivity conferred by, or as a consequence of a right, designation or authorisation granted by, a Regulatory Authority in a particular country with respect to such Product in such country.

 

1.76                        “Sales Milestone Payments” has the meaning set forth in Section 6.6.

 

1.77                        “Shared Field” means the use of pharmaceutical products containing or comprising Compounds in the treatment, diagnosis and/or prevention of any disease in humans for the Shared Indications.

 

1.78                        “Shared Indications” means following Indications: [***].

 

1.79                        “Successful Completion of a Phase I Study of a Product” means the first to occur of the following:

 

(a)                                 (i) receipt by Indivior, its Affiliate or sublicensee of a statistical analysis of [***] that indicates that the [***] has met its primary endpoint and (ii) a study protocol has been agreed with FDA (or, outside the US, an application for clinical trial approval has been granted by the relevant Regulatory Authority) for a subsequent study in patients with the disease; or

 

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(b)                                 (i) receipt by Indivior, its Affiliate or sublicensee of a statistical analysis of [***] of a Product that indicates that the relevant study has met its primary endpoint and (ii) a study protocol has been agreed with FDA (or, outside the US, an application for clinical trial approval has been granted by the relevant Regulatory Authority) for a subsequent study in patients with the disease; or

 

(c)                                  the dosing by or on behalf of Indivior, an Affiliate or sublicensee of a Product in a Phase II study for a Product.

 

1.80                        “Term” has the meaning set forth in Section 10.1.

 

1.81                        “Territory” means, subject to Section 10.2, worldwide.

 

1.82                        “Third Party” means any Person other than Indivior, Addex or their respective Affiliates.

 

1.83                        “Third Party Licenses” has the meaning set forth in Section 2.4.

 

1.84                        “Valid Patent Claim” means an issued, unexpired claim of a patent or patent application within the Addex Patent Rights or Joint Patent Rights, in each case, that (a) has not been revoked, cancelled or held unenforceable, unpatentable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be, or has been, taken and (b) has not been abandoned or expired, except where such abandonment is a result of Indivior’s failure to maintain the Addex Patent Rights or Joint Patent Rights in the Patent Filing Jurisdictions as required herein, [***].

 

2.                                      LICENSE

 

2.1                               License Grant. Addex hereby grants to Indivior a world-wide, royalty-bearing, right and license, under the Licensed IP, to develop, conduct research related to, manufacture, make, have made, use, lease, license, import, offer for sale, commercialize, distribute, sell and have sold, or otherwise transfer the Licensed Compounds and/or Products in the Field (“IP License”). The IP License (a) is exclusive to Indivior (even as to Addex) and (b) includes the exclusive right to sublicense as described below.

 

2.2                               Affiliates; Right to Sublicense. Indivior shall have the right to (a) exercise the license granted under Section 2.1 through its Affiliates for so long as such entity remains an Affiliate of Indivior and (b) grant sublicenses of the Licensed IP to Third Parties without the prior written consent of Addex; provided that [***], Indivior shall not grant sublicenses of the Licensed IP to Third Parties for [***] without the prior written consent of Addex, which consent shall not be unreasonably withheld, delayed or conditioned. All such sublicenses shall be consistent with this Agreement and terminate automatically on the termination or expiry of this Agreement. Indivior shall remain responsible to Addex for all activities of its Affiliates and sublicensees to the same extent as if such activities had been undertaken by Indivior itself, subject to Section 10.2(c)(iv).

 

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2.3                               Rights Under Bankruptcy. All rights and licenses granted under or pursuant to any section of this Agreement in connection with U.S. intellectual property rights are and will otherwise be deemed to be for purposes of Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), as amended (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined in Section 101(35A) of the Bankruptcy Code. Indivior, as the licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. In the event of the commencement of a bankruptcy proceeding by or against Addex under the Bankruptcy Code, Indivior will be entitled to a complete duplicate of (or complete access to, as appropriate) such intellectual property and all embodiments of such intellectual property, which, if not already in Indivior’s possession, will be promptly delivered to it upon Indivior’s written request thereof. Any agreements supplemental hereto will be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of the Bankruptcy Code. Addex agrees that it shall not take any action in any bankruptcy or similar proceeding related solely to and commenced as a direct consequence of the insolvency of Addex to reject or object to this Agreement or any rights granted herein.

 

2.4                               Third Party Licenses.

 

(a)                                 In the event that it is necessary or useful to obtain licenses under any Patent Rights claiming the use of, or composition of matter of any Licensed Compound from any Third Party (“Third Party Licenses”) in order to commercialize any Product(s), Indivior may, in its discretion and cost, obtain such Third Party Licenses. For the avoidance of doubt, the term Third Party Licenses shall not include intellectual property licenses for new manufacturing process or formulation technologies that may be selected by Indivior.

 

(b)                                 Indivior shall be responsible for the royalty costs or other fees payable with respect to such Third Party Licenses; provided that Indivior may deduct up to [***] of the amounts paid to the relevant Third Party under the relevant Third Party License from the Royalty payable by Indivior to Addex pursuant to Section 6.4; provided further that in no event shall any such offset reduce the Royalty payable to Addex in respect of a country to less than [***] of the royalty rates set out in the table in Section 6.4.

 

2.5                               Retained Rights. Addex retains the right under any Licensed IP to research, develop, manufacture, commercialize and otherwise exploit any Addex Retained Compounds and/or Addex Products solely in the Reserved Indications and the Shared Indications by itself, through Affiliates and/or through sublicensees and Addex shall have no obligation to account to Indivior for any consideration it may receive in respect of such Addex activities; provided that any license granted by Addex in respect of any Addex Retained Compounds or Addex Products shall not be inconsistent with the terms of this Agreement. The Parties may, from time to time, discuss any advances in the understanding of the use of Compounds in the treatment, diagnosis and/or prevention of any disease in humans and, subject to the prior written agreement of the Parties, any indications discussed may be included in the Reserved Indications or the Shared Indications.

 

2.6                               Joint Patent Rights. It is agreed between the Parties as follows:

 

(a)                                 Unless otherwise expressly provided herein, Addex retains all of its ownership rights to the Joint Patent Rights. Addex’s rights to any Joint Patent Rights shall be

 

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included in the scope of the Licensed IP, solely to the extent they contain a claim that Covers a Licensed Compound and are applicable in the Field.

 

(b)                                 Unless otherwise expressly provided herein, Indivior retains all of its ownership rights to the Joint Patent Rights. Indivior’s rights to any Joint Patent Rights which relate solely to an Addex Retained Compound shall be licensed to Addex: (i) for the Reserved Indications only on an exclusive basis (even as to Indivior); and (ii) for the Shared Indications on a non-exclusive basis, and in each case on a sublicensable, perpetual, irrevocable and royalty free basis.

 

The Parties agree that, except to the extent that Indivior has exclusively licensed the relevant Joint Patent Rights to Addex or Addex has exclusively licensed the Joint Patent Rights to Indivior hereunder, either Party may license, assign, mortgage or exploit its interest in an invention claimed in such Joint Patent Rights without the consent of the other Party and either Party may otherwise undertake all activities a sole owner might undertake with respect to its interest in such joint invention without the consent of the other Party, except as otherwise provided for in this Agreement or as the Parties may otherwise agree in writing.

 

2.7                               Exclusivity. During the Term, neither Party, by itself, its Affiliates or through any Third Party (including licensees or sublicensees), shall develop, seek Marketing Approval for, manufacture, import, market, sell, distribute, license or otherwise commercialize any [***], except pursuant to this Agreement.

 

2.8                               Field Restrictions. During the Term, Indivior shall not, directly or indirectly (including through sublicensees and Affiliates), conduct activities with respect to Compounds, Licensed Compounds or Products outside of the Field and Addex shall not, directly or indirectly (including through licensees and Affiliates), conduct activities with respect to Compounds (except as expressly provided in this Agreement), Addex Retained Compounds or Addex Products within the Indivior Exclusive Field or, with respect to Licensed Compounds or Products, outside the Indivior Exclusive Field.

 

3.                                      JOINT RESEARCH ACTIVITIES

 

3.1                               Guaranteed Spend. Indivior shall pay to Addex at least $2 million ($2,000,000) per twelve (12) month period during the Research Term and Addex shall use such sums to carry out its research and/or discovery activities into the Compounds (including dedicating the number of FTEs required); provided that in no event shall Indivior be required to pay more than $2 million ($2,000,000) for such research and/or discovery activities in any 12-month period (“Guaranteed Spend”), unless otherwise agreed. Once the Research Plan has been agreed upon pursuant to Section 3.2, the Guaranteed Spend shall be used to fund the Research Plan. During the Research Term, payment of the Guaranteed Spend shall be paid [***] prior to agreement of the Research Plan and thereafter in accordance with the budget agreed as a part of the Research Plan, in each case within [***] days of receipt of an invoice from Addex.

 

3.2                               Research Plan. The Parties shall each use their reasonable endeavors to reach agreement on, and execute, within [***] days of the Effective Date, a written plan for joint

 

12

 

research and/or discovery of Compounds pursuant to this Article 3 (“Research Plan”), which plan shall specify, among other things, the obligations of each Party and the budget for implementing such Research Plan. Addex shall, subject to Sections 3.4 and 3.5 carry out its responsibilities (including dedicating the number of FTEs required) under the Research Plan during the Research Term. Any disputes related to the preparation of or amendment to the Research Plan shall be handled in accordance with Section 14.12.

 

3.3                               Research Term. The initial Research Term may be extended [***] if both Parties agree in writing, at least [***] days prior to the expiry of the then-current Research Term, to extend the Research Term, such agreement to include a revised Research Plan to cover the additional work, the number of FTEs to be provided by each Party for such work and a budget for the additional work.

 

3.4                               Selection of Compounds. Within [***] days of the end of the Research Term, Addex shall compile a report that sets out all of the Compounds identified in the course of undertaking the Research Plan and the Parties shall discuss whether any of the Compounds so identified meet the target product profile in the Research Plan and are suitable for further development (each such Compound, subject to this Section 3.4, a “Development Compound”). In the event that Indivior considers any of the Compounds suitable for further development, it shall have the right to select such Compounds as follows for further development on the following basis:

 

(a)                                 Indivior shall be entitled to designate in writing one (1) Development Compound for further development and, on such selection, the relevant Compound shall become a Licensed Compound and shall cease to be a Development Compound. In making any selection of a Development Compound pursuant to this Section 3.4(a). Indivior shall take account of the desire by both Parties that the Licensed Compounds and the Addex Retained Compounds should, to the extent reasonably practicable, be covered by separate patent rights;

 

(b)                                 Addex shall then be entitled to designate in writing one (1) Development Compound for further development and, on such selection the relevant Compound shall become an Addex Retained Compound and cease to be a Development Compound. In making any selection of a Development Compound pursuant to this Section 3.4(b), Addex shall take account of the desire by both Parties that the Licensed Compounds and the Addex Retained Compounds should, to the extent reasonably practicable, be covered by separate patent rights; and

 

(c)                                  to the extent that there are any further Development Compounds that have not been selected by a Party, the process in Sections 3.4(a) and 3.4(b) shall be repeated until no further Development Compounds remain or until one Party decides that it does not wish to designate any further Development Compounds in which case (i) if it is Addex that does not wish to designate any further Development Compounds then all remaining Development Compounds shall become Licensed Compounds and (ii) if it is Indivior that does not wish to designate any further Development Compounds then all remaining Development Compounds shall become Addex Retained Compounds.

 

13

 

3.5                               Diligence.

 

(a)                                 Each Party shall use Commercially Reasonable Efforts to carry out its obligations under the Research Plan. Each Party shall provide the other with [***] reports detailing the progress of its activities under the Research Plan. Further, each Party shall promptly provide a summary report on significant results where the Research Plan identifies an outcome as requiring prompt disclosure.

 

(b)                                 The Parties acknowledge and agree that no outcome or success is or can be assured and that failure to achieve desired results will not in and of itself constitute a breach or default of any obligation in this Agreement.

 

3.6                               Authority. Indivior (by itself or through its Affiliates) shall have sole responsibility, including sole responsibility for all funding, resourcing and decision-making, for all further research and development with respect to Licensed Compounds and Products.

 

3.7                               Subcontracting. Each Party shall have the right to subcontract its obligations under this Agreement to subcontractors and Affiliates; provided that such subcontractors and Affiliates agree in writing to be subject to the applicable terms and conditions of this Agreement, including the requirements under Section 3.5(a) and the confidentiality provisions of Article 13.

 

3.8                               Joint Research Committee.

 

(a)                                 Within [***] days after the Effective Date, the Parties shall establish a joint research committee (the “Joint Research Committee” or “JRC”). The JRC shall consist of [***] representatives with voting rights from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the Research Plan and each Party’s Research Activities, with each Party having one (1) vote. From time to time, each Party may substitute one (1) or more of its representatives to the JRC on written notice to the other Party. The chair and the co-chair of the JRC shall be one of the Indivior and Addex voting representatives on the JRC, respectively. From time to time, Indivior or Addex may change the representative who will serve as chairperson or co-chair, respectively, upon written notice to the other Party.

 

(b)                                 The JRC shall provide strategic direction for, and monitor, manage, coordinate and oversee the conduct of, the Research Activities by the Parties under the Research Plan. In particular, the JRC shall: (i) serve as a forum for discussing the proposed Research Activities and periodically review the Research Plan, and review and approve amendments thereto; (ii) oversee the Parties’ performance of the Research Plan; (iii) obtain and review each Party’s written reports detailing the progress of its activities under the Research Plan; and (iv) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

 

(c)                                  During the Research Term, the JRC shall meet [***], with the location of such meetings alternating between locations designated by Addex and locations designated by Indivior, provided that such meetings may be held via telephone conference upon mutual agreement of the Parties. The chairperson in collaboration with the co-chair of the JRC shall be responsible for calling meetings on no less than [***] days’ notice and the chairperson and

 

14

 

co-chair shall collaborate to prepare an agenda for circulation in advance of each such meeting. Each Party shall make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items at least [***] days in advance of the applicable meeting; provided, that under exigent circumstances requiring input by the JRC, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting. The chairperson and co-chair of the JRC shall prepare and circulate for review and approval of the Parties minutes of each meeting within [***] days after the meeting. The Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the JRC.

 

(d)                                 The JRC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JRC shall exist whenever there is present at a meeting at least one (1) voting representative appointed by each Party. Representatives of the Parties on the JRC may attend a meeting either in person or by telephone, video conference or similar means in which each participant can hear what is said by, and be heard by, the other participants. Representation by proxy shall be allowed. The JRC shall take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least one (1) representative appointed by each Party. Employees or consultants of either Party that are not representatives of the Parties on the JRC may attend meetings of the JRC; provided, that such attendees (i) shall not vote or otherwise participate in the decision-making process of the JRC, and (ii) are bound by obligations of confidentiality and non-disclosure equivalent to those set forth in Article 13.

 

(e)                                  If the JRC cannot, or does not, reach consensus on any matter relating to Research Activities or the Research Plan within [***] days after such dispute or lack of consensus was raised at a JRC meeting, then such dispute shall be escalated to the CEO of each Party, who shall amicably and in good faith attempt to resolve the dispute. The Parties acknowledge that, notwithstanding the creation of the JRC, each Party shall retain the rights, powers and discretion granted to it hereunder. The Parties further acknowledge that the JRC shall not have the power to amend this Agreement and that any amendments to this Agreement shall be subject to Section 14.10.

 

(f)                                   Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, the JRC.

 

3.9                               Records. Each Party shall, and shall ensure that its Affiliates subcontractors, maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law and regulatory guidance, which shall be complete and accurate and shall properly reflect all work done and results achieved in the performance of its obligations under the Research Plan, which, after the Effective Date, shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. Such records shall be retained by each Party and its Affiliates and

 

15

 

subcontractors for at least [***] after the expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law. Upon request, Addex shall provide, and shall procure that its Affiliates and subcontractors provide, copies of the records it has maintained pursuant to this Section 3.9 to Indivior.

 

3.10                        Joint Research. This Agreement is intended by the Parties to be considered a “Joint Research Agreement” for the purposes of 35 U.S.C. 102(c), or any successor to that statute in the United States, or other statutes having similar effect in jurisdictions outside the United States. Each Party consents to the other Party disclosing the names of the Parties to this agreement and identifying this Agreement as a “Joint Research Agreement” in any patent application filed pursuant to this Agreement, including, for the avoidance of doubt, patents claiming Indivior Improvements.

 

4.                                      DEVELOPMENT ACTIVITIES

 

4.1                               Regulatory Matters. As between the Parties, on a Licensed Compound-by-Licensed Compound basis, Indivior shall have the sole right to prepare, obtain, and maintain any applications for Marketing Approval (including the setting of the overall regulatory strategy) other regulatory approvals and other submissions, and to conduct communications with the Regulatory Authorities for Licensed Compounds or Products (which shall include filings of or with respect to INDs or CTAs and other filings or communications with the Regulatory Authorities).

 

4.2                               Pharmacovigilance. Within [***] days after IND effectiveness of the first Licensed Compound, Product, Addex Retained Compound or Addex Product, the Parties shall determine if it is necessary to, and if so, enter into an agreement to initiate a process for the exchange of safety data (including post-marketing spontaneous reports received by each Party and its Affiliates) in a mutually agreed format in order to monitor the safety of the Licensed Compounds, Products, Addex Retained Compounds and Addex Products and to meet reporting requirements with any applicable Regulatory Authority.

 

4.3                               [***]  Meetings. Each of the Parties shall keep the other informed about the status and results of its development activities with respect to the Licensed Compounds, Products, Addex Retained Compounds and Addex Products, as applicable. Promptly, and in any event within [***] days, after the Effective Date, each of the Parties shall designate an employee with sufficient knowledge such Party’s obligations hereunder (collectively, “Representatives”). From time to time, each Party may substitute one (1) or more of its Representatives on written notice to the other Party. From and after the Effective Date and until receipt of the first Marketing Approval, upon [***] days’ notice by either Party, the Representatives shall meet [***], to:

 

(a)                                 discuss the development plans for Licensed Compounds, Products, Addex Retained Compounds and Addex Products;

 

(b)                                 review of regulatory strategies for obtaining and maintaining Marketing Approval for Products;

 

(c)                                  share safety and other relevant data related to the development of Licensed Compounds, Products, Addex Retained Compounds and Addex Products;

 

16

 

(d)                                 inform Addex of material development/regulatory events and key Indivior decisions relating to the development activities for Licensed Compounds and Products; and

 

(e)                                  address safety issues relating to the development of Products and Addex Products.

 

Unless otherwise agreed by the Parties, at least one meeting per year required by this Section 4.3 will be in person [***] and all other meetings shall be by telephone conference.

 

4.4                               [***]  Reports. Following receipt of Marketing Approval for a Product and continuing until such time as Marketing Approval has been obtained for Products under development in four additional Major Markets, Indivior shall provide to Addex, [***], unless agreed otherwise in writing by the Parties, a written report of the status of its efforts to develop such Products hereunder.

 

5.                                      DILIGENCE

 

5.1                               In General. Indivior shall have the sole right to develop and commercialize (and shall be solely responsible for, and shall control all aspects of, development and commercialization) Licensed Compounds and Products in the Field in the Territory at its own cost and expense (except as otherwise expressly set forth herein).

 

5.2                               Diligence. Indivior will use Commercially Reasonable Efforts to (a) develop one Product [***] and (b) commercialize one Product [***] following receipt of Marketing Approval [***]. Indivior shall undertake such development and commercialization in accordance with GMP, GCP and all Applicable Laws. If at any time Addex has a reasonable basis to believe that Indivior is in material breach of its material obligations under this Section 5.2, then Addex shall so notify Indivior, specifying the basis for its belief, and, without prejudice to any other rights that Addex may have under this Agreement, the Parties, within [***] days after such notice, shall meet, in person or via telephone conference, to discuss in good faith Addex’s concerns and Indivior’s development or commercialization plans, as applicable, with respect to any Products.

 

5.3                               Product Trademarks. Indivior shall have the sole right to determine and own the trademarks to be used with respect to the exploitation of the Products on a worldwide basis.

 

6.                                      PAYMENT

 

6.1                               Upfront License Fee. As partial consideration for the rights granted to Indivior herein, Indivior shall pay Addex an upfront license fee in the amount of $5,000,000 no later than [***] days after the Effective Date.

 

6.2                               Reserved.

 

6.3                               Development Milestone Payments. As additional consideration for the rights granted to Indivior herein, after the achievement by Indivior of any of the milestones set forth

 

17

 

below, Indivior shall pay Addex the applicable milestone payment set forth next to such milestone below (“Development Milestone Payments”). For the avoidance of doubt, each Development Milestone Payment shall be payable one-time only upon the first occurrence of the event triggering the respective milestone set forth in the table below.

 

	
Development Milestone Event
    	
 
    	
Milestone Payment
    
	
1. [***]
    	
 
    	
[***]
    
	
2. [***]
    	
 
    	
[***]
    
	
3. [***]
    	
 
    	
[***]
    
	
4. [***]
    	
 
    	
[***]
    
	
5. [***]
    	
 
    	
[***]
    
	
6. [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
7. [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    

 

18

 

	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
8. [***]
    	
 
    	
[***]
    
	
9. [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
10. [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    

 

19

 

	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
[***]
    	
 
    	
 
    
	
Total
    	
 
    	
[***]
    

 

6.4                               Royalty.

 

(a)                                 As additional consideration for the rights granted to Indivior herein, during the Royalty Term (subject to Section 6.5(b)), Indivior shall pay to Addex, on a country­by-country basis, tiered royalty payments at the rates set out below on Net Sales of Products sold, on a country-by-country basis, by Indivior, its Affiliates and/or sublicensees (“Royalty”):

 

	
Annual Net Sales of Products in a Country
    	
 
    	
Royalty Rate
    
	
Portion of Annual Net Sales of Products in such   country less than [***]
    	
 
    	
[***]%
    
	
Portion of Annual Net Sales of Products in such   country equal to or greater than[***] but less than [***]
    	
 
    	
[***]%
    
	
Portion of Annual Net Sales of Products in such   country equal to or greater than [***] but less than [***]
    	
 
    	
[***]%
    
	
Portion of Annual Net Sales of Products in such   country equal to or greater than [***]
    	
 
    	
[***]%
    

 

(b)                                 Notwithstanding Section 6.4(a) above, with respect to [***], the Royalty payable with respect to each Product [***] shall be [***] once such Product [***].

 

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6.5                               Royalty Term; Generic Competition.

 

(a)                                 Indivior’s obligation to pay a Royalty on Net Sales for each Product in a particular country shall terminate upon the expiration of the Royalty Term with respect to such Product, except as provided in Section 6.5(b) below.

 

(b)                                 Indivior’s obligation pursuant to Section 6.4 to pay a Royalty in respect of a particular Presentation of a Product (such Presentation being an “Affected Product”) in a country shall be reduced [***] in respect of a Quarter if, in respect of such Quarter, (i) a Generic Product [***] is marketed in such country and (ii) the Net Sales of such Affected Product in such country in the Quarter are less than [***] of the Net Sales generated by [***] such Product in such country in the Quarter immediately prior to the launch of [***] such Generic Product in such country.

 

6.6                               Sales Milestone Payments. As additional consideration for the rights granted to Indivior herein, Indivior shall pay to Addex a one-time milestone payment upon first achieving each of the Annual Net Sales thresholds set forth below (“Sales Milestone Payments”). For the avoidance of doubt, each Milestone Payment shall be payable one-time only upon the first occurrence of the event triggering the respective milestone provided below.

 

	
Sales Milestone Event
    	
 
    	
Milestone Payment
    
	
First time Annual Net Sales exceed [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
First time Annual Net Sales exceed [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
First time Annual Net Sales exceed [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
First time Annual Net Sales exceed [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
First time Annual Net Sales exceed [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
First time Annual Net Sales exceed [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
First time Annual Net Sales exceed [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
First time Annual Net Sales exceed [***]
    	
 
    	
[***]
    
	
 
    	
 
    	
 
    
	
Total
    	
 
    	
[***]
    

 

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6.7                               Payment/Reports.

 

(a)                                 All Development Milestone Payments shall be due and payable by Indivior within [***] days after completion of any of the milestones set forth in Section 6.3 above. Together with any such payment, Indivior shall deliver a written statement of completion and other pertinent and available information.

 

(b)                                 All Royalty payments owed for each country shall be due and payable by Indivior on a Quarterly basis within [***] days after the last day of each calendar Quarter during the Royalty Term. Together with any such payment, Indivior shall deliver a report specifying, with respect to the applicable calendar Quarter: the (i) total gross invoiced amount from sales of Product in each country by or on behalf of Indivior and its Affiliates; (ii) amounts deducted by category from gross invoiced amounts to calculate Net Sales; (iii) Net Sales for such country; and (iv) the Royalty payment payable.

 

(c)                                  All Sales Milestone Payments shall be due and payable by Indivior within [***] days after the last day of the Quarter in which the relevant milestone event was achieved. Together with any such payment, Indivior shall deliver a report specifying, with respect to such 12-month period: the (i) total gross invoiced amount from sales of Product in such country by or on behalf of Indivior and its Affiliates; (ii) amounts deducted by category from such gross invoiced amounts to calculate Net Sales; (iii) Net Sales; and (iv) Sales Milestone Payment payable.

 

6.8                               Inspection of Records. Indivior shall keep records of its sales of Products reasonably necessary for the calculation of payment to be made to Addex hereunder. During the Term, and for a period of [***] thereafter, Addex shall have the right to have an independent certified public accountant, mutually agreed upon by Indivior, audit the records of Indivior. Addex, upon providing at least [***] days’ prior written notice to Indivior, may initiate such an audit no more than [***] during the Term and [***] thereafter. Any such audit shall be conducted during the normal business hours of Indivior, at a single location where Indivior shall make the records sought to be audited available, and in such a manner as shall not disrupt Indivior’s business operations. All personnel conducting the audit on behalf of the independent auditor shall enter into confidentiality agreements with Indivior. Each·such audit shall be conducted at the expense of Addex; provided that if the inspection and audit shows an underpayment of more than [***] of the amount due for the applicable period covered by the inspection, then Indivior shall reimburse Addex for all costs incurred in connection with such inspection within [***] days thereafter. Indivior shall pay to Addex the amount of any undisputed underpayment revealed by an examination and review. Any overpayment by Indivior revealed by an examination and review shall be deducted by Indivior from the next payment due to Addex.

 

6.9                               Payment Method.

 

(a)                                 All payments due under this Agreement shall be made by bank wire transfer in immediately available funds from the United Kingdom or the United States to an account in Switzerland, the United Kingdom or the United States designated by Addex in writing. In the event that Indivior pays from an account in a country other than the United States or the United Kingdom, then Indivior shall pay an amount such that, when any withholding or other deductions described

 

22

 

in Section 6.9(c) have been applied, Addex receives the amount that it would have done had no deduction been made.

 

(b)                                 All payments hereunder shall be made in the legal currency of the United States of America, and all references to “$” or “Dollars” shall refer to United States dollars. For the purpose of converting any amount owed hereunder to $, such conversion shall be calculated using the average exchange rate for the conversion of foreign currency into United States Dollars, quoted for current transactions for both buying and selling United States Dollars, as reported in The Wall Street Journal (Internet Edition) for the last business day of each month of the calendar Quarter to which such payment pertains. Without limiting any other remedy of Addex, if Indivior fails to make any payment that is due by the due date, Addex may charge interest in the amount overdue at the rate of [***]. Interest will be calculated on a daily basis.

 

(c)                                  Where any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, the Parties shall use reasonable endeavors to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation agreement or treaty. In the event there is no applicable double taxation agreement or treaty, or if an applicable double taxation agreement or treaty reduces but does not eliminate such withholding or similar tax, the payor shall remit such withholding or similar tax to the appropriate government authority, deduct the amount paid from the amount due to payee and secure and send to payee the best available evidence of the payment of such withholding or similar tax. If withholding or similar taxes are paid to a government authority, each Party will provide the other such assistance as is reasonably required to obtain a refund of the withheld or similar taxes, or obtain a credit with respect to such taxes paid.

 

(d)                                 Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the “Indirect Taxes”). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by the receiving Party to receive a refund of these undue Indirect Taxes from the applicable governmental authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority to the receiving Party will be transferred to the paying Party within [***] days of receipt.

 

7.                                      INTELLECTUAL PROPERTY

 

7.1                               Ownership; Improvements.

 

(a)                                 As between the Parties, Addex shall remain the sole owner of all right, title and interest in and to the Licensed IP, subject to the rights and licenses granted to Indivior herein.

 

23

 

(b)                                 Indivior has the right when exercising its rights under the licenses granted in Section 2.1 hereunder to create Indivior Improvements and to file Indivior Improvement Patent Rights. All right, title and interest in any Indivior Improvements and Indivior Improvement Patent Rights shall remain the sole and exclusive property of Indivior and shall not be licensed to Addex. To the extent that Addex acquires rights in any Indivior Improvements or Indivior Improvement Patent Rights, Addex hereby irrevocably assigns, and shall cause to be assigned, to Indivior, such rights, and Indivior hereby accepts such assignment. Addex further acknowledges and agrees that Indivior is the sole and exclusive owner of, all right, title and interest in and to such Indivior Improvements and Indivior Improvement Patent Rights. Addex shall take all action reasonably requested by Indivior to effect the foregoing, at Indivior’s expense. Indivior shall, in its own name and at its sole expense, take all actions which Indivior deems to be necessary or appropriate to protect and maintain the Indivior Improvements and Indivior Improvement Patent Rights. At Indivior’s request and expense, Addex shall cooperate with Indivior in taking any action reasonably necessary to protect and maintain Indivior Improvements and Indivior Improvement Patent Rights.

 

(c)                                  All right, title and interest in any Addex Improvements and all patents and patent applications directed to Addex Improvements shall remain the sole and exclusive property of Addex and shall be included in the scope of the Licensed IP. All such Addex Improvements and patents and patent applications directed to Addex Improvements that are made in connection with this Agreement shall constitute (i) Addex Development Patent Rights if they Cover Licensed Compounds but not Addex Retained Compounds, (ii) Addex Overlapping Patent Rights if they cover both Licensed Compounds and Addex Retained Compounds and (iii) Addex Retained Patent Rights if they Cover Addex Retained Compounds but not Licensed Compounds. To the extent that Indivior acquires rights, other than the licenses granted in this Agreement, in any Addex Improvements, Indivior hereby irrevocably assigns, and shall cause to be assigned, to Addex, such rights, and Addex hereby accepts such assignment. Indivior further acknowledges and agrees that Addex is the sole and exclusive owner of, all right, title and interest in and to such Addex Improvements. Indivior shall take all action reasonably requested by Addex to effect the foregoing, at Addex’s expense. Except as otherwise provided in this Article 7, Addex may, in its own name and at its sole expense and in consultation with Indivior, take all actions which Addex deems to be necessary or appropriate to protect and maintain the Addex Improvements. Except where otherwise provided in this Article 7, at Addex’s request and, in respect of Addex Improvements only, at Addex’s expense, Indivior shall cooperate with Addex in taking any action reasonably necessary to protect and maintain the Licensed IP and Addex Improvements.

 

(d)                                 In the event employees (or consultants) of both Parties (or their respective Affiliates) jointly develop any improvements, enhancements or modifications to the Licensed IP during the Term (“Joint Improvements”), such Joint Improvements shall be jointly owned by·both Parties; provided that Addex’s interest in such Joint Improvements shall be included in the scope of the Licensed IP. Each of Indivior and Addex shall promptly disclose to the other all inventions that it considers to be a Joint Improvement. Indivior shall have the right, but not the obligation, to file, prosecute and maintain any patent application directed to any such Joint Improvement in the name of Indivior and Addex jointly.

 

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7.2                               Patent Prosecution and Maintenance.

 

(a)                                 Addex Existing Patent Rights. Indivior shall be responsible for and shall undertake, and Addex shall cooperate with Indivior with regards to Indivior’s activities associated with, the preparation, filing and prosecution of Addex Existing Patent Rights. Indivior may conduct such activities in Addex’s name where reasonably necessary. If Indivior decides to abandon any Addex Existing Patent Rights, Indivior shall provide prior written notice sufficiently in advance of any abandonment to enable Addex to have the right, at its sole expense to, assume control of the preparation, filing, prosecution and maintenance of such patent application or patent for such Addex Existing Patent Rights in the applicable jurisdiction and Indivior shall transfer control of such prosecution in such jurisdiction to Addex. Upon delivery of such notice, such Addex Existing Patent Right shall cease to be an Addex Existing Patent Right and all of Indivior’s rights and licenses under and in respect of such Addex Existing Patent Right shall terminate. Except where Indivior abandons an Addex Existing Patent Right in accordance with this Section 7.2, Indivior shall pay renewal fees and take reasonable actions to maintain such Addex Existing Patent Rights in the Patent Filing Jurisdictions.

 

(b)                                 Addex Development Patent Rights. Indivior shall be responsible for and shall undertake, and Addex shall cooperate with Indivior with regards to Indivior’s activities associated with, the preparation, filing and prosecution of Addex Development Patent Rights. Indivior may conduct such activities in Addex’s name where reasonably necessary. If Indivior decides to abandon any Addex Development Patent Rights, Indivior shall provide prior written notice sufficiently in advance of any abandonment to enable Addex to have the right, at Addex’s sole expense, to assume control of the preparation, filing, prosecution and maintenance of such patent application or patent for such Addex Development Patent Rights in the applicable jurisdiction. In the case of such abandonment, Indivior shall transfer control of such prosecution in such jurisdiction to Addex, except where such abandonment is made as a part of a reasonable prosecution strategy, such as, for example, an abandonment made in favor of another Addex Patent Right covering the same Licensed Compound to improve its term or allowability. Except where Indivior elects not to file or abandons an Addex Development Patent Right in accordance with this Section 7.2, Indivior shall pay renewal fees and take reasonable actions to maintain such Addex Development Patent Rights in the Patent Filing Jurisdictions (including using reasonable endeavors to prosecute any Addex Development Patent Rights not yet granted in the Patent Filing Jurisdictions).

 

(c)                                  Addex Overlapping Patent Rights. Addex shall, at its cost, be responsible for and shall undertake the preparation, filing and prosecution of Addex Overlapping Patent Rights, and Indivior shall cooperate with Addex in connection therewith. The Parties shall use Commercially Reasonable Efforts to reach agreement on matters involving the preparation, filing, and prosecution of the Addex Overlapping Patent Rights in a manner that does not jeopardize the scope, allowability, validity or term of Addex Development Patent Rights or any claims Covering Addex Retained Compounds, or Licensed Compounds. Where it is reasonable to file separately or divide Addex Overlapping Patent Rights into separate Addex Development Patent Rights and an application or applications that Cover Addex Retained Compounds, and where such action shall not jeopardize the scope or term of such Addex Overlapping Patent Rights, then, at the request of either Party, such Addex Overlapping Patent Rights shall be so filed separately or divided. If Addex decides not to file a patent application reasonably requested by Indivior, or to abandon any

 

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Addex Overlapping Patent Rights in a Patent Filing Jurisdiction, Addex shall provide prior written notice sufficiently in advance of such abandonment to enable Indivior to, and Indivior shall have the right at its sole expense to, assume control of the preparation, filing, prosecution and maintenance of such patent application or patent in such jurisdiction at its own expense (in Addex’s name) and Addex shall transfer such prosecution in such jurisdiction to Indivior and such patent application or patent shall be treated as an Addex Development Patent Right for the purposes of this Section 7.2. Unless Addex elects not to file or abandons an Addex Overlapping Patent Right in accordance with this Section 7.2(c), the Parties shall be equally responsible for renewal fees and take reasonable actions to maintain such Addex Overlapping Patent Rights in the Patent Filing Jurisdictions. Addex shall use reasonable endeavors to prosecute any Addex Overlapping Patent Rights not yet granted to cover the Licensed Compounds and the Addex Retained Compounds.

 

(d)                                 Joint Patent Rights. Indivior shall at its cost be responsible for and shall undertake, and Addex shall cooperate with Indivior with regards to Indivior’s activities associated with, the preparation, filing and prosecution of Joint Patent Rights in the Patent Filing Jurisdictions (it being understood that filings may occur in additional jurisdictions, but that there shall be no obligation hereunder regarding filings in such jurisdictions). If Indivior decides not to file a patent application for a Joint Patent Right or decides to abandon a Joint Patent Right in any country in the Territory, Indivior shall provide prior written notice to Addex sufficiently in advance of any abandonment to enable Addex to, and Addex shall have the right at its sole expense to, assume control of the preparation, filing, prosecution and maintenance of such patent application or patent in such country in the Parties’ joint names. In such case, Indivior shall transfer control of such prosecution in such country to Addex. Unless Indivior elects not to file or abandons a Joint Patent Right in accordance with this Section 7.2(d), Indivior shall pay renewal fees and use reasonable endeavors to maintain and prosecute such Joint Patent Right.

 

(e)                                  Sharing of Information. Any Party controlling filing and prosecution of Addex Patent Rights or Joint Patent Rights shall keep the other Party reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance strategy (including timing of filing, data to be included, and scope of claims of patent applications), and shall discuss steps with regard to the preparation, filing, and strategy (including timing of filing, data to be included, and scope of claims of patent applications) with respect to such Patents and shall reasonably consider the other Parties’ comments in respect of the same. The Parties shall promptly provide copies of all substantive correspondence to and from patent offices and patent attorneys/agents, including any available translations. A Party controlling prosecution shall provide copies of proposed substantive filings or foreign patent agent instructions for such filings reasonably in advance of any due date, to allow comment by the other Party, and shall take reasonable steps to accommodate suggestions or requests of the other Party when received. The obligation hereunder for a Party to use reasonable efforts to pursue a patent application shall not extend to taking a judicial appeal of an administrative decision at its own expense. The obligation hereunder for a Party to pay for the other Party’s prosecution of a patent application shall not extend to payment for a judicial appeal of an administrative decision for such application. When reasonably requested by the Party controlling prosecution, the other Party shall provide reasonable assistance to the Party controlling prosecution, including signing or executing any necessary documents. If the Party controlling prosecution elects to abandon a patent application, or not to pursue a patent application in a particular jurisdiction, it shall provide reasonable advance notice to the other Party to enable the other Party to file such application or assume control of the

 

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prosecution, at its own expense, in the name of the original controlling Party if reasonably necessary.

 

(f)                                   Post-Grant Proceedings. With respect to this Article 7:

 

(i)                                     the Party controlling prosecution of a patent or patent application (x) shall have the right to control any Post-Grant Proceeding related to such patent or patent application in the other Party’s name if reasonably necessary and (y) use reasonable endeavors to accommodate suggestions or requests made by the non-controlling Party;

 

(ii)                                  the Party that is not controlling a Post-Grant Proceeding shall cooperate with the other Party as reasonable requested;

 

(iii)                               the Party that is responsible for the cost of patent prosecution for the patent or patent application at issue in the Post-Grant Proceeding shall also bear the cost of the Post-Grant Proceeding;

 

(iv)                              the Party that is not obligated to prosecute (or pay) for the prosecution of a patent application shall not be obligated to pursue (or pay) for a Post-Grant Proceeding;

 

(v)                                 the obligation on a Party hereunder to use reasonable endeavors to conduct a Post-Grant Proceeding shall not extend to pursuing a judicial appeal of an administrative tribunal or agency decision; and

 

(vi)                              in the event that Party controlling a Post-Grant Proceeding elects not to participate in or continue such proceeding (including any appeal), such Party shall provide reasonable notice to the other Party to allow such other Party to conduct or assume control the Post-Grant Proceeding, which may be assumed in the controlling Party’s name, if necessary.

 

(g)                                  Disputes. In the event that the Parties have a dispute regarding any of their respective rights or obligations under this Article 7, such dispute shall be escalated to the CEO of each Party, who shall amicably and in good faith attempt to resolve the dispute. The foregoing shall not limit either Party’s remedies at law or equity with respect to a breach by the other Party of this Article 7.

 

7.3                               Patent Term Extensions. Each Party agrees to cooperate with the other, and to do all such acts and provide and sign all documents or copies thereof which may be reasonably necessary or desirable, in connection with the filing or prosecution of any application for any Addex Patent Rights or any Joint Patent Rights.

 

7.4                               Enforcement Actions.

 

(a)                                 Indivior shall have the initial right, but not the obligation, using counsel of its choice and at its own cost to enforce the Addex Existing Patent Rights, Addex Development Patent Rights, Addex Overlapping Patent Rights, and/or Joint Patent Rights in the Field or defend any declaratory action with respect thereto, as well as any nullity, inventorship or other action brought in a judicial proceeding affecting the scope, validity, or enforceability of the Addex

 

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Existing Patent Rights, Addex Development Patent Rights, Addex Overlapping Patent Rights, or Joint Patent Rights. Indivior shall have sole control of any decisions or other aspects of such action, subject to Section 7.4(b), and Addex shall, upon request, give to Indivior such reasonable assistance as Indivior may reasonably request, including by signing or executing any necessary documents and consenting to its name being used in the proceedings; provided that Indivior shall reimburse Addex for any reasonable out-of-pocket expenses incurred while providing such assistance and provide an indemnity in respect of any costs order made against Addex by reason of lending its name to the proceedings, where such costs order did not result from Addex wrongdoing or from conduct that would require Addex to indemnify Indivior under this Agreement. Indivior shall keep Addex reasonably informed of the progress of the action and shall consider the comments and observations of Addex in prosecuting the action. If Indivior does not, within [***] days of a notice from Addex requiring bringing or defending such action, institute or defend such an action, then Addex shall have the right, but not the obligation, at its own cost, to commence proceedings or assume the defense in the Territory regarding the action and, in such case, Addex shall, subject to Section 7.4(b), have sole control of any decisions or other aspects of the action, and Indivior shall, upon request, give to Addex such reasonable assistance as Addex may reasonably request; provided that Addex shall reimburse Indivior for any reasonable out-of-pocket expenses incurred while providing such assistance and provide an indemnity in respect of any costs order made against Indivior in connection therewith, where such costs order did not result from Indivior’s wrongdoing or from conduct that would require Indivior to indemnify Addex under this Agreement; provided further that nothing in this Section 7.4(a) shall oblige Indivior to lend its name to, or be joined in, any proceedings commenced by Addex pursuant to the foregoing.

 

(b)                                 In the event that Addex desires to bring an action based on Addex Overlapping Patent Rights in the Indivior Exclusive Field, or in the Shared Field if such action relates to Licensed Compounds or Products, Addex shall provide reasonable advance notice to Indivior, and Addex shall consider comments and observations of Indivior before undertaking such action. Addex shall keep Indivior reasonably informed of the progress of any such action, including any issues affecting the validity or enforceability of Addex Overlapping Patent Rights or the scope of the Addex Overlapping Patent Rights with respect to Licensed Compounds or Products. Addex shall not take any position negatively affecting the scope of the Addex Overlapping Patent Rights with respect to their coverage of Licensed Compounds or Products. To the extent an invalidity or unenforceability defense or counterclaim is raised in such action, where permitted by the law of the relevant jurisdiction, Indivior shall have the right to intervene or join in such action to protect its interests in the Addex Overlapping Patent Rights. Addex shall not, without Indivior’s prior written consent (which consent shall not be unreasonably withheld or delayed) bring an action for infringement of (i) Addex Existing Patent Rights or (ii) Addex Development Patent Rights outside of the Field.

 

(c)                                  Addex shall have the option, but not the duty, to enforce the Addex Retained Patent Rights against Third Party infringement in the Field. Addex shall bear the costs of such enforcement.

 

(d)                                 Indivior shall not, without the prior written consent of Addex, which shall not be unreasonably withheld, delayed or conditioned, make any admission or enter into a settlement, consent to judgement or other voluntary final disposition in connection with any such

 

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proceedings under this Section 7.4 that: (i) extends, or purports to exercise, Indivior’s rights under the Licensed IP beyond the rights granted pursuant to this Agreement, (ii) makes any admission regarding wrongdoing by Addex, or the invalidity, unenforceability or absence of infringement of any Patent Rights within the Licensed IP; (iii) subjects Addex to an injunction or other equitable relief; or (iv) obligates Addex to make a monetary payment. Similarly, in no case may Addex enter into any settlement or consent judgment or other voluntary final disposition that: (a) limits Indivior’s rights under the Licensed IP or under this Agreement other than as expressly stated herein; (b) makes any admission regarding wrongdoing on the part of Indivior, an Affiliate or sublicensee, or the invalidity, unenforceability or absence of infringement of any Licensed IP or Addex Patent Rights; (c) subjects Indivior to an injunction or other equitable relief; or (d) obligates Indivior to make a monetary payment; in all cases without the prior written consent of Indivior, which consent shall not be unreasonably withheld, delayed or conditioned. In no case shall Addex grant or have the power to grant any license for Compounds or pharmaceutical products containing or comprising Compounds in the Indivior Exclusive Field under the Addex Patent Rights, Addex Retained Patent Rights or Licensed IP. In no case shall Addex grant or have the power to grant any license for Licensed Compounds or Products in the Shared Field under the Licensed IP.

 

(e)                                  Any damages or award (including any award of costs) made in the proceedings shall be used first to reimburse each Party for any costs or expenses that it may have incurred in connection with the infringement proceedings (including without limitation, any amounts paid by the Party bringing the action to the other Party as reimbursement for expenses related to assisting in the proceedings) and any remaining amounts shall be retained by the Party to which they were awarded, save that (i) any award [***] shall be [***] and (ii) any award [***] shall, following reimbursement of costs and expenses in accordance with the foregoing, be [***]; provided that any such award shall [***].

 

7.5                               Third Party Infringement Claims. If the production or use of any Licensed Compound or the production, sale or use any Product pursuant to this Agreement results in a claim, suit or proceeding alleging patent infringement against Indivior or Addex or their respective Affiliates or sublicensees, such Party shall promptly notify the other Party hereto in writing. Indivior shall have the right to direct and control the defense and settlement thereof; provided, however, that Addex may participate in (but not control) the defense of such action and employ counsel at its own expense.

 

8.                                      WARRANTIES

 

8.1                               General Warranties. Each Party warrants to the other that:

 

(a)                                 such Party is duly organized and validly existing under the laws of its·jurisdiction of organization, and has full power and authority to enter into this Agreement and to carry out the provisions hereof;

 

(b)                                 such Party is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder;

 

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(c)                                  this Agreement has been duly executed and delivered by such Party and constitutes the legal, valid and binding obligation of such Party enforceable against such Party in accordance with its terms, except to the extent that the enforceability thereof may be limited by (i) applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium or similar laws from time to time in effect affecting generally the enforcement of creditors’ rights and (ii) general principles of equity;

 

(d)                                 the execution, delivery and performance of this Agreement by such Party does not conflict with its organizational documents or any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any Governmental Authority having jurisdiction over it;

 

(e)                                  such Party is aware of no action, suit or inquiry or investigation instituted by any governmental agency that questions or threatens the validity of this Agreement; and

 

(f)                                   has the full power and authority and has obtained all Third Party consents, approvals, and/or other authorizations required to enter into this Agreement and to carry out its obligations hereunder.

 

8.2                               Addex Warranties. As at the Effective Date, Addex warrants to Indivior that:

 

(a)                                 Addex exclusively owns all right, title, and interest to the Addex Existing Patent Rights, free and clear of all liens, security interests and encumbrances. As of the Effective Date, there are no existing licenses with respect to the Licensed IP, except for the IP License granted to Indivior herein.

 

(b)                                 The Addex Patent Rights listed on Schedule 1.3 are, as of the Effective Date, the only patents or patent applications owned or controlled by Addex or its Affiliates that Cover Licensed Compounds.

 

(c)                                  Addex and/or its Affiliates have obtained and properly recorded previously executed assignments for the Licensed IP as necessary to fully perfect its rights and title therein in accordance with governing law and regulations in each applicable jurisdiction.

 

(d)                                 There are no actions, suits, investigations, lawsuits, claims or proceedings pending or, to Addex’s Knowledge, threatened, involving the Licensed IP.

 

(e)                                  No invention claimed or described in the Addex Existing Patent Rights was made with government funding in circumstances that could negatively affect Indivior’s rights to exclusivity under this Agreement.

 

(f)                                   None of the Addex Patent Rights has been declared abandoned, or been found invalid, unpatentable, or unenforceable for any reason including in a final decision in any administrative, arbitration, judicial, or other proceeding. Addex does not have Knowledge of existing facts and circumstances that would reasonably lead it to believe that any of the Addex Existing Patent Rights are invalid, unpatentable, or unenforceable for any reason. Addex does not have any Knowledge of existing facts and circumstances that would reasonably lead it to believe

 

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that material prior art was withheld from the United States Patent Office during the prosecution of Addex Existing Patent Rights.

 

(g)                                  Addex does not have Knowledge of existing facts and circumstances that·would reasonably lead it to believe that the development manufacture, sale or commercialization of the ADX 71441 Compound in the Field will infringe any rights of any Third Party.

 

(h)                                 Addex has not misappropriated trade secrets or misused the confidential information of any Third Party in developing the Licensed IP.

 

(i)                                     To Addex’s Knowledge, no Third Party is infringing the Addex Existing Patent Rights. Addex has taken reasonable measures to protect the confidentiality of the Addex Know How and, to Addex’s Knowledge, the Addex Know How remains a protected trade secret of Addex.

 

(j)                                    Neither Addex, nor to Addex’s Knowledge, any Third Party, owns or has rights to any Marketing Approvals for any Products.

 

(k)                                 Neither Addex nor any of its Affiliates is a party to or otherwise bound by any oral or written contract or agreement that will result in any Third Party obtaining any interest in, or that would give to any Third Party any right to assert any claim in or with respect to, any rights granted to Indivior under this Agreement.

 

(l)                                     [***] that would adversely affect the rights of Indivior hereunder.

 

8.3                               No Other Warranties. The representations and warranties provided in this Article 8 are in lieu of any other representations or warranties, express or implied, and nothing herein shall be construed as a representation or warranty by either Party of any kind, including without limitation, any implied warranty of fitness for a specific purpose or merchantable quality, all of which are expressly and specifically excluded. No director, officer, employee or agent of any Party or its Affiliates is authorized to make any further representation or warranty to the other Party which is not contained in this Agreement and, without limiting Section 11.1, each Party acknowledges that it has not relied on any such oral or written representations or warranties.

 

9.                                      CERTAIN COVENANTS AND AGREEMENTS

 

9.1                               Disclosure; Technology Transfer.

 

(a)                                 Promptly after the Effective Date and as applicable during the Term, Addex shall disclose to Indivior all Licensed IP that Addex reasonably considers would be necessary or useful, or that Indivior reasonably requests, for the development of Licensed Compounds or Products as the same shall become available to it. If and as requested by Indivior, Addex will use reasonable efforts to disclose to Indivior or any Regulatory Authority all relevant Licensed IP in its possession required for Indivior to register for sale or obtain Marketing Approval for the Products.

 

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(b)                                 Promptly after the Effective Date, Addex will, [***], make available to Indivior all Addex Know-How that Addex, acting reasonably, considers necessary or useful for Indivior to develop and/or commercialize Products, and Addex Know-How that Indivior reasonably requests, including all research data, pharmacology data, preclinical data, and/or clinical data for the Licensed Compounds.

 

9.2                               No Third-Party Rights; Liens. During the Term, Addex shall not (a) grant any rights to any Third Party in or relating to Licensed IP or (b) encumber any portion of the Licensed IP with liens, mortgages, security interests or another similar interest in any way that would have a negative effect on Indivior’s rights hereunder; provided that for the avoidance of doubt any such liens, mortgages, and security interests shall be expressly subordinate to Indivior’s rights hereunder; and provided further that Addex shall be entitled to grant licenses in respect of Addex Retained Compounds and Addex Products, in each case solely outside the Indivior Exclusive Field.

 

9.3                               [***]. Addex will [***] (which, for clarity, shall not require Addex to [***] other than [***]), to facilitate [***]. Addex has delivered to Indivior all [agreements that it has with Friends Research] with respect to the Licensed Compounds as of the date hereof and, after the date hereof, Addex shall not [***] with respect to the Licensed Compounds without the prior written consent of Indivior.

 

9.4                               Compliance with Laws. Each Party shall comply with all Applicable Laws related to its performance of this Agreement.

 

9.5                               Restructuring. Promptly after the Effective Date, Indivior and Addex will discuss ways to protect Indivior’s rights herein in the event of insolvency of Addex and, in its sole discretion, Addex will take such protective steps as agreed upon by the Parties.

 

9.6                               Insolvency Notice. Addex will promptly notify Indivior if (a) to its Knowledge, Addex becomes subject to bankruptcy or similar proceedings or if a receiver or trustee is appointed to take possession of its assets, (b) Addex gives notice to any of its creditors that it has suspended payment of, or is unable to pay, its debts generally or (c) Addex takes or suffers any similar or analogous action in any jurisdiction in consequence of its insolvency.

 

9.7                               No Assignment. During the Term, Addex shall not transfer or assign the Licensed IP to any Person without the prior written consent of Indivior, except to an Affiliate of Addex or to an acquirer of all or substantially all of the business of Addex to which this Agreement relates who, in each case, has expressly agreed in writing to be bound by the terms hereof.

 

10.                               TERM; TERMINATION

 

10.1                        Term. The term of this Agreement shall commence on the Effective Date and continue in full force on a country-by-country or Product-by-Product basis until Indivior has no remaining payment obligations with respect to such country or Product, unless earlier terminated pursuant to Section 10.2 below (the “Term”). Upon expiration (but not an earlier termination) of this Agreement in a particular country or with respect to a particular Product, then the IP License

 

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with respect to such country or with respect to such Product to which the Term has expired, as applicable, shall become an exclusive, perpetual, fully paid-up, royalty-free, license of the scope described in Section 2.1 above.

 

10.2                        Termination.

 

(a)                                 Indivior may terminate this Agreement in its entirety or with respect to one or more countries or Products (i) if before [***], upon [***] days prior written notice to Addex and (ii) if after [***], upon [***] prior written notice to Addex; or

 

(b)                                 [***] Addex may terminate this Agreement [***] if Indivior commits a material breach of this Agreement and fails to cure such breach within [***] days of Addex’s written notification to Indivior, or, with respect to [***], fails to cure such breach within [***]; provided that, in the case of non-payment pursuant to Article 6, Addex shall not be entitled to serve a notice of termination if such payment obligation has been disputed by Indivior and Indivior has paid any undisputed amounts.

 

(c)                                  Without prejudice to Addex’s right to [***], Addex’s right to terminate this Agreement in respect of [***] or in respect of [***] shall [***] the following basis;

 

(i)                                     [***] Addex may terminate this Agreement [***] if Indivior commits a material breach of [***], and with respect to [***], fails to cure such breach within [***] days of Addex’s written notification to Indivior or, with respect [***], fails to cure such breach within [***] days of Addex’s written notification to Indivior or, with respect to [***], fails to cure such breach within [***] days after [***]; provided that, in the case of non-payment pursuant to Article 6, Addex shall not be entitled to serve a notice of termination if such payment obligation has been disputed by Indivior and Indivior has paid any undisputed amounts.

 

(ii)                                  [***] terminate this Agreement in respect of [***] and [***], subject to [***] in respect of [***].

 

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(iii)                               [***] to terminate this Agreement in respect of [***] in respect of [***], subject to [***] in respect of [***].

 

(iv)                              For the avoidance of doubt, Addex’s right of termination [***] shall [***] including, in the case of a breach of [***] provided that [***] and in the case of [***] where such breach [***].

 

10.3                        Effects of Termination.

 

(a)                                 Termination of Rights. Except as otherwise expressly set forth herein, all of the rights of Indivior in respect of Licensed Compounds and Products in a country shall terminate upon the termination date in respect of such Licensed Compound and/or Products in such country pursuant to Section 10.2.

 

(b)                                 Supplies of Products After Termination. In the event this Agreement is terminated pursuant to Section 10.2 in its entirety or with respect to any Products or countries, Indivior and its Affiliates and permitted sublicensees shall have the right, for a period of up to [***] following such termination, to sell (in the Field) Indivior’s inventory of Licensed Compounds and Products to which such termination applies, subject to all applicable payment and other related obligations in this Agreement. Upon expiration of such [***] period, Indivior shall, at Addex’s request, sell to Addex [***] any and all remaining quantities of any Licensed Compound and Products subject to the termination that are in its possession or control.

 

(c)                                  Clinical Studies After Termination. In the event this Agreement is terminated pursuant to Section 10.2 in its entirety or with respect to a Product, Indivior shall be responsible for completing (in accordance with the established protocols and its customary business practices) any clinical studies on Licensed Compounds and/or Products that it commenced prior to the termination of this Agreement in its entirety or with respect to such terminated Products. The foregoing shall be at [***] where this Agreement is terminated [***]. Indivior shall not commence any clinical study of Products at any time after it has given or received a notice of termination with respect to such Products pursuant to Section 10.2.

 

(d)                                 Transfer of Marketing Approvals and Other Regulatory Approvals After Termination. In the event this Agreement is terminated pursuant to Section 10.2 in its entirety or with respect to any Products or countries pursuant to Section 10.2, Indivior shall, upon request by Addex, use reasonable endeavors to transfer to Addex or to its designee, all Marketing Approvals and any other regulatory approvals relating to any Licensed Compounds or Products subject to such termination, together with any applications for the foregoing (including Marketing Approval

 

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applications or other such applications, as well as all existing INDs and other similar regulatory filings for the conduct of clinical trials with respect to Licensed Compounds or Products), together with a copy of all Know-How of Indivior solely relating to such Licensed Compounds or Products. All such transfers shall be completed in accordance with Applicable Laws. In the event that such a transfer is not possible, Indivior shall use reasonable endeavors to provide Addex with the benefit of the existing Marketing Approvals and applications therefor for Products, including, without limitation, granting Addex and/or its designees rights to cross-refer to the data and information on file with Regulatory Authorities as may be necessary to facilitate the granting of separate Marketing Approvals to Addex.

 

(e)                                  Return of Confidential Information After Termination. Upon termination of this Agreement in its entirety pursuant to Section 10.2, Indivior shall, at Addex’s option, either return to Addex all tangible Confidential Information disclosed to Indivior by or on behalf of Addex (including all copies thereof) or destroy such Confidential Information; provided that Indivior shall have the right to retain one (1) copy of the Confidential Information in a secure location solely for purposes of identifying its confidentiality obligations under Article 13. Upon termination by Addex or by Indivior, Indivior shall use reasonable endeavors to delete all electronic copies of such Confidential Information from its systems (other than Confidential Information stored on electronic archival, back-up, security, or disaster recovery systems). Upon termination, Addex shall, at Indivior’s option, either return to Indivior all tangible Confidential Information disclosed to Addex by or on behalf of Indivior (including all copies thereof) or destroy such Confidential Information; provided that Addex shall have the right to retain one (1) copy of the Confidential Information in a secure location solely for purposes of identifying its confidentiality obligations under Article 13. Addex shall use reasonable endeavors to delete all electronic copies of such Confidential Information from its systems other than Confidential Information stored on electronic archival, back-up, security, or disaster recovery systems).

 

10.4                        Survival. Termination of this Agreement shall not impair or prejudice any cause of action or claim that one Party may have against the other Party for breach of this Agreement. Subject to the foregoing sentence, upon expiration of this Agreement, Articles 7, 11, 12, 13 and 14 and Sections 2.3, 2.4, 2.6, 3.9, 6.8, 10.3 and 10.4 and any other the provisions that expressly survive termination or expiration of the Term, shall be so performed and extended and shall continue to be subject to the terms and conditions of this Agreement.

 

11.                               INDEMNIFICATION

 

11.1                        Restriction on Limitation of Liability. Neither Party limits or excludes its liability for fraud, fraudulent concealment or fraudulent misrepresentation, nor for death or personal injury arising from its negligence.

 

11.2                        Indemnification by Indivior. Indivior shall defend, indemnify and hold harmless Addex, its Affiliates and their respective officers, directors, employees and agents (the “Addex Indemnified Parties”) against all claims, liabilities, losses, costs, expenses (including reasonable attorney’s fees and costs of investigation), which arise out of claims that are brought by a Third Party against the Addex Indemnified Parties resulting or arising from (a) any breach by Indivior of its representations and warranties, covenants or other obligations hereunder, (b) the negligent acts or omissions or willful misconduct of Indivior or its representatives, and (c) Third Party claims

 

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or suits in connection with the marketing, sale or distribution of the Products, except to the extent such claim is indemnifiable by Addex pursuant to Section 11.3 below.

 

11.3                        Indemnification by Addex. Addex shall defend, indemnify and hold harmless Indivior, its Affiliates and their respective officers, directors, employees and agents (“Indivior Indemnified Parties”) against all claims, liabilities, losses, costs, expenses (including reasonable attorney’s fees and costs of investigation), which arise out of claims that are brought by a Third Party against the Indivior Indemnified Parties resulting or arising from (a) any breach by Addex of its warranties, covenants or other obligations hereunder and (b) the negligent acts or omissions or willful misconduct of Addex or its representatives except to the extent such claim is indemnifiable by Indivior pursuant to Sections 11.2(a)-(b) above.

 

11.4                        Procedure. Any Party seeking to be indemnified by virtue of this Article 11 (the “Indemnitee”) shall promptly notify the other Party (“Indemnifying Party”) in writing of any Third-Party claim, action, proceeding or liability in respect of which it intends to seek indemnification hereunder. The Indemnitor shall have the right to control the defense of, and enter into any settlement with respect to, any such action, claim or liability; provided, that such settlement (a) includes an unconditional release of the Indemnitee from any and all liability to any Third Party, (b) does not adversely affect the Indemnitee’s rights hereunder or impose any obligations on the Indemnitee in addition to those set forth herein in order for it to exercise such rights, (c) does not involve any injunctive or other equitable relief which would be imposed on Indemnitee, and (d) does not provide for any finding or admission of a violation of law or violation of the rights of any person or entity by the Indemnitee or any of its Affiliates. No such action, claim or liability shall be settled by the Indemnitee without the prior written consent of the Indemnitor, and the Indemnitor shall not be responsible for any fees or other costs incurred other than as provided herein. The Indemnitee, its employees, agents and Affiliates shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any action, claim or liability covered by this indemnification. The Indemnitee shall have the right, but not the obligation to be represented by counsel of its own selection and at its own expense.

 

11.5                        Mitigation. Any Party making a claim under this Article 11 shall take reasonable steps to mitigate and/or minimize the losses or damages suffered.

 

11.6                        LIMITATION OF LIABILITY. NEITHER PARTY WILL HAVE ANY OBLIGATION OR LIABILITY (WHETHER IN CONTRACT, WARRANTY, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND NOTWITHSTANDING ANY FAULT, NEGLIGENCE (WHETHER ACTIVE, PASSIVE, OR IMPUTED), REPRESENTATION, STRICT LIABILITY, OR PRODUCT LIABILITY), OR FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL, MULTIPLIED, PUNITIVE, SPECIAL, OR EXEMPLARY DAMAGES OR LOSS OF REVENUE, PROFIT, SAVINGS OR BUSINESS ARISING FROM OR OTHERWISE RELATED TO THIS AGREEMENT, EVEN IF A PARTY OR ITS REPRESENTATIVES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT TO THE EXTENT THAT SUCH DAMAGES (A) ARISE FROM THE FRAUD OF SUCH PARTY, OR (B) ARE AWARDED TO A THIRD PARTY IN A CLAIM FOR WHICH SUCH PARTY IS RESPONSIBLE FOR INDEMNIFICATION HEREUNDER.

 

36

 

12.                               INSURANCE

 

12.1                        Each Party shall maintain at all times during the Term, and for [***] thereafter, comprehensive insurance coverage to cover its activities related to this Agreement, including, in the case of Indivior, products liability insurance and coverage for clinical trials, underwritten by insurers maintaining an AM Best rating of not less than “A-VII” for insurance coverage obligations. Indivior and Addex hereby agree to provide written notice to the other upon becoming aware of any material change, non-renewal or cancellation of insurance.

 

13.                               CONFIDENTIALITY

 

13.1                        In carrying out the terms of this Agreement, either Party may disclose (the “Disclosing Party”) to the other Party (the “Recipient”) information regarding the Disclosing Party and/or its Affiliates which is of a proprietary and of confidential nature, including any and all information, information regarding its business, Know-How, methods, trade secrets, financial information, customers and technology (collectively, “Confidential Information”). Confidential Information also includes the terms of this Agreement. The Recipient shall not use the Disclosing Party’s Confidential Information for any purpose other than as permitted herein and shall not disclose the Confidential Information to any Third Party, except to its employees, directors and other representatives who have a need to know such information to fulfill the provisions and intent of this Agreement, and who are bound by written obligations of confidentiality with respect to such information. The Recipient agrees that it will exercise the same degree of care and protection to preserve the proprietary and confidential nature of the Confidential Information disclosed by the Disclosing Party, as Recipient would exercise to preserve its own proprietary and confidential information, and in any case no less than a reasonable degree of care. The Recipient shall promptly notify the Disclosing Party of any unauthorized use or disclosure, or suspected unauthorized use or disclosure, of the Disclosing Party’s Confidential Information of which the Recipient becomes aware. Each Party shall be liable for any failure of its employees, directors or other representatives to comply with the terms of this Article 13.

 

13.2                        The confidentiality obligations set forth in this Article 13 shall not apply to confidential information which: (a) is or becomes publicly known through no wrongful act or inaction of the Recipient; (b) the Recipient can demonstrate by written records was lawfully received by it from a Third-Party that is not legally or contractually prohibited from disclosing such information; (c) the Recipient can demonstrate by written records was developed by or for such Recipient independently of, and without the use of, such information disclosed by the Disclosing Party, (d) the Recipient is required by legal order to disclose, provided that the Recipient shall, where permitted, give the Disclosing Party immediate written notice of any such request so that the Disclosing Party may seek a protective order or other reliable assurance that confidential treatment will be accorded to the information so disclosed or (e) Indivior discloses to Regulatory Authorities in connection with obtaining Marketing Approval or other communications relating to commercialization of the Products.

 

13.3                        Addex shall not, and shall not permit any of its Affiliates to, grant any license or other right or permission to any entity that, after the Effective Date, acquires control of Addex, to use any confidential or non-public information regarding Addex Know-How in the Indivior

 

37

 

Exclusive Field. Addex shall not, and shall not permit any of its Affiliates to, disclose any Addex Know How related solely and exclusively to Licensed Compounds or Products to such an entity.

 

13.4                        The confidentiality obligations set forth in this Article 13 shall survive for [***] years after termination or expiration of this Agreement.

 

14.                               MISCELLANEOUS

 

14.1                        Expenses. Except as otherwise expressly provided herein, each Party to this Agreement shall bear its respective expenses incurred in connection with the preparation, execution and performance of this Agreement and the transactions contemplated hereby, including without limitation all fees and expenses of agents, legal counsel, accountants, tax and financial advisors and other facilitators and advisors.

 

14.2                        Force Majeure. Notwithstanding anything to the contrary herein, neither Party shall be liable or in breach of any provision of this Agreement for any failure or delay on their·part to perform any obligation set out in this agreement because of a force majeure event caused by acts of nature, flood, fire, explosion, war, terrorism, civil unrest, national or regional emergency or any cause beyond the reasonable control of the Party affected; provided that such Party gives prompt written notice to the other Party promptly after such event occurs and shall use Commercially Reasonable Efforts to fulfill its commitments hereunder as soon as possible.

 

14.3                        Recordation. Indivior may, at its cost and discretion, record the license granted herein, including by use of a short form document, as permitted or required by Applicable Law or otherwise, including recording a security interest in those jurisdictions which permit a licensee to do so. Addex hereby irrevocably designates and appoints Indivior and its duly authorized officers and agents, as Addex’s agent and attorney-in-fact to execute such documents and to do all other acts necessary or useful to record the license granted herein. Addex shall, upon request and at Indivior’s cost, give to Indivior such reasonable assistance as Indivior may reasonably request in connection with recording the license.

 

14.4                        Publicity. The Parties agree that the terms and contents of this Agreement (including the Schedules hereto) shall be treated as Confidential Information of both Parties, subject to the special authorized disclosure provisions set forth in this Section 14.4. Neither Party shall make any press release or public announcement regarding the execution or terms of this Agreement or the transaction contemplated by this Agreement without the consent of the other Party in accordance with this Section 14.4.

 

(a)                                 Subject to the other Party’s prior written consent (which shall not be unreasonably withheld), each Party shall have the right to make a press release announcing the achievement of each milestone payment under this Agreement as it is achieved, and the achievements of Marketing Approvals in the Major Markets as they occur. Indivior shall be given at least [***] Business Days to review such Addex announcements and may make specific, reasonable comments on such proposed press release; thereafter, Addex and Indivior may each disclose to Third Parties the information contained in such press release without the need for further approval by the other Party.

 

38

 

(b)                                 Except as set forth in Sections 14.4(a) and 14.4(c), neither Party shall make a public announcement concerning the existence, terms and/or contents of this Agreement, except in the case of a press release or governmental filing required by Applicable Law (where reasonably advised by the disclosing Party’s counsel), in which event the disclosing Party shall provide the other Party with such advance notice as it reasonably can and shall not be required to obtain approval therefor. A Party commenting on such a proposed press release shall provide its comments, if any, within [***] Business Days (or within [***] Business Days in the event that such shorter period is required to comply with Applicable Law) after receiving the press release for review and the other Party shall give good faith consideration to same.

 

(c)                                  The Parties acknowledge that either or both Parties may be obligated to file under Applicable Law a copy of this Agreement with the SEC or other government authorities. Each Party shall be entitled to make such a required filing, provided that it requests confidential treatment of at least the financial terms and sensitive technical terms hereof and thereof to the extent such confidential treatment is reasonably available to such Party. In the event of any such filing, each Party will provide the other Party with a copy of this Agreement marked to show provisions for which such Party intends to seek confidential treatment not less than [***] Business Days prior to such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), and shall reasonably consider the other Party’s comments thereon to the extent consistent with the legal requirements, with respect to the filing Party, governing disclosure of material agreements and material information that must be publicly filed, and shall only disclose Confidential Information which it is advised by counsel or the applicable governmental authority is legally required to be disclosed. No such notice shall be required under this Section 14.4(c) if the substance of the description of or reference to this Agreement contained in the proposed filing has been included in any previous filing made by either Party hereunder or otherwise approved by the other Party.

 

14.5                        Independent Contractors. It is understood and agreed that nothing in this Agreement nor any agreement related hereto is intended to nor shall create a partnership between the Parties. The Parties are independent contractors and neither Party is to be considered the agent, partner, joint venturer or employee of the other Party for any purpose whatsoever and neither Party shall have any authority to enter into any contracts or assume any obligations for the other Party.

 

14.6                        Further Assurances. Each of the Parties shall take, or cause to be taken, all actions necessary, proper, or advisable under applicable laws to give effect to the provisions of this Agreement.

 

14.7                        Assignment; Binding Effect. Neither Party shall, without the prior written consent of the other Party, assign, novate, transfer or convey this Agreement (in whole or in part) or any of its rights and obligations hereunder to any Third Party except as set forth in Sections 2.2 and 3.7); provided always that either Party may assign or novate this Agreement (in whole or in part) without such consent to any Affiliate or to an acquirer of all or substantially all of the business of the assigning Party to which this Agreement relates, whether in a merger, sale of stock, sale of assets or otherwise, without such consent; subject only to that assigning or novating Party giving written notice to the non-assigning Party and the acquirer agreeing in writing to be bound by the terms hereof.

 

39

 

14.8                        Entire Agreement. This Agreement constitutes the entire contract between the Parties pertaining to the subject matter hereof, and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions, whether written or oral, of the Parties; and there are no representations, warranties, or other agreements between the Parties in connection with the subject matter hereof except as specifically set forth herein.

 

14.9                        Waiver. The waiver by either Party of any right hereunder, or the failure to exercise such right, shall not be deemed a waiver of exercising such right in the future or of any other right hereunder in case of breach or failure by the other Party whether of a similar nature or otherwise.

 

14.10                 Amendments. No amendment and/or modification to this Agreement shall be effective unless set forth in a writing signed by both Parties.

 

14.11                 Notice. Any notice, request, delivery, approval or consent required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently given upon delivery in person, the next day after delivery by express courier service (signature required) or five (5) days after the date of mailing by registered or certified mail, return receipt requested (or its equivalent), as the address shown below or such other address as a Party provides in accordance with this Section 14.11.

 

Notices sent to Addex shall be addressed to:

 

Addex Pharma SA
 12, Chemin des Aulx
 CH1228 Plan-les-Ouates
 Geneva, Switzerland
 Attention: Chief Executive Officer

 

With a copy to:

 

Addex Pharma SA
 12, Chemin des Aulx
 CHI 228 Plan-les-Ouates
 Geneva, Switzerland
 Attention: Chief Financial Officer

 

and

 

Cooley (UK) LLP 
 Dashwood
 69 Old Broad Street
 London, EC2M 1QS 
 Attention: John Wilkinson

 

Notices sent to Indivior shall be addressed to:

 

Indivior UK Limited 
 103-105 Bath Road

 

40

 

Slough, Berkshire 
 SL1 3UH
 Attention: Assistant General Counsel, EMEA

 

With a copy to:

 

Indivior Inc.
 10710 Midlothian Turnpike
 Suite 430
 Richmond, VA 23235
 Attention: Chief Legal Officer 
 Telephone:

 

and

 

K&L Gates LLP
 599 Lexington Avenue 
 New York, NY 10022 
 Attn: Calvina Bostick
          Whitney J. Smith

 

Notwithstanding the foregoing, reports required to be delivered pursuant to Sections 3.8, 4.4 and 6.7 shall be in writing and shall be deemed to have been sufficiently delivered upon transmission by email in accordance with the below (provided that if such email is not sent during normal business hours, such notice or communication shall be deemed to have been sent the next business day:

 

Addex: [***]

 

Indivior: [***]

 

14.12                 Governing Law; Jurisdiction. This Agreement shall be governed by and construed in accordance with the laws of England and Wales, except that the construction or effect of a patent or patent application licensed under this Agreement shall be decided in accordance with the laws of the country in which the patent or patent application was granted or filed. Each Party irrevocably agrees that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute arising out of or in connection with this Agreement.

 

14.13                 Severability. If any provision in this Agreement is held to be invalid, void or unenforceable, then the remainder of this Agreement, or the application of such provision to the Parties or to the circumstances other than those as to which it is held invalid or unenforceable, shall not be affected thereby and shall be enforced to the fullest extent permitted by law. The Parties agree to renegotiate any such invalid, void or unenforceable provision in good faith in order to provide a reasonably acceptable alternative consistent with the basic purposes of this Agreement.

 

14.14                 Counterparts. This Agreement may be executed in one or more counterparts, none of which need contain the signatures of both Parties, each of which shall be deemed an·original,

 

41

 

and all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or electronic signature, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered.

 

14.15                 Interpretation and Construction. Unless the context of this Agreement otherwise requires, (a) the terms “include,” “includes,” or “including” shall be deemed to be followed by the words “without limitation” unless otherwise indicated; (b) the terms “hereof,” “herein,” “hereby,” and derivative or similar words refer to this entire Agreement; and (c) the terms “Section” and “Schedule” refer to the specified Section and Schedule of this Agreement.

 

Whenever this Agreement refers to a number of days, unless otherwise specified, such number shall refer to calendar days. The headings and paragraph captions in this Agreement are for reference and convenience purposes only and shall not affect the meaning or interpretation of this Agreement. This Agreement shall not be interpreted or constructed in favor of or against either Party because of its effort in preparing it.

 

***

 

42

 

This Agreement is signed by duly authorised representativesof the Parties:

 

	
 
    	
Signed for an on behalf   of
    
	
 
    	
INDIVIOR UK LIMITED
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ Richard Simkin
    
	
 
    	
 
    	
Name: Richard Simkin
    
	
 
    	
 
    	
Title: Chief Commercial   Officer
    
	
 
    	
 
    
	
 
    	
Signed for an on behalf   of
    
	
 
    	
ADDEX PHARMA SA.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/ Tim Dyer
    
	
 
    	
 
    	
Name: Tim Dyer
    
	
 
    	
 
    	
Title: Chief Executive   Officer
    

 

 

SCHEDULE 1.3

 

ADDEX EXISTING PATENT RIGHTS

 

	
Reference
    	
 
    	
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Patent Number
    	
 
    	
Grant Date
    	
 
    	
Expiry Date
    	
 
    	
Status
    
	
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[***]

 

 

SCHEDULE 1.13

 

AGREED ASSAY

 

The details of the Agreed Assay are as follows:

 

[***]

 

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[***]Exhibit 10.3

 

Execution Version

 

ADDEX THERAPEUTICS LTD. 

REGISTRATION RIGHTS AGREEMENT

 

 

TABLE OF CONTENTS

 

	
 
    	
 
    	
 
    	
Page
    
	
 
    	
 
    	
 
    	
 
    
	
1.
    	
Definitions
    	
1
    
	
 
    	
 
    	
 
    
	
2.
    	
Registration Rights
    	
6
    
	
 
    	
2.1
    	
Demand Registration
    	
6
    
	
 
    	
2.2
    	
Company Registration
    	
11
    
	
 
    	
2.3
    	
Underwriting   Requirements
    	
11
    
	
 
    	
2.4
    	
Reserved
    	
13
    
	
 
    	
2.5
    	
Obligations of the   Company
    	
13
    
	
 
    	
2.6
    	
Furnish Information
    	
16
    
	
 
    	
2.7
    	
Expenses of   Registration
    	
16
    
	
 
    	
2.8
    	
Indemnification
    	
17
    
	
 
    	
2.9
    	
Reports Under Exchange   Act
    	
19
    
	
 
    	
2.10
    	
Limitations on   Subsequent Registration Rights
    	
19
    
	
 
    	
2.11
    	
“Market Stand-off”   Agreement
    	
19
    
	
 
    	
2.12
    	
Termination of   Registration Rights
    	
20
    
	
 
    	
 
    	
 
    	
 
    
	
3.
    	
Additional Covenants
    	
21
    
	
 
    	
3.1
    	
Successor   Indemnification
    	
21
    
	
 
    	
3.2
    	
Right to Conduct   Activities
    	
21
    
	
 
    	
3.3
    	
Termination of   Covenants
    	
21
    
	
 
    	
 
    	
 
    	
 
    
	
4.
    	
Miscellaneous
    	
21
    
	
 
    	
4.1
    	
Successors and Assigns
    	
21
    
	
 
    	
4.2
    	
Governing Law
    	
22
    
	
 
    	
4.3
    	
Counterparts
    	
22
    
	
 
    	
4.4
    	
Titles and Subtitles
    	
22
    
	
 
    	
4.5
    	
Notices
    	
22
    
	
 
    	
4.6
    	
Amendments and Waivers
    	
22
    
	
 
    	
4.7
    	
Severability
    	
23
    
	
 
    	
4.8
    	
Aggregation of Stock
    	
23
    
	
 
    	
4.9
    	
Additional Investors
    	
23
    
	
 
    	
4.10
    	
Entire Agreement
    	
23
    
	
 
    	
4.11
    	
Dispute Resolution
    	
23
    
	
 
    	
4.12
    	
Delays or Omissions
    	
24
    
	
 
    	
4.13
    	
Acknowledgment
    	
24
    

 

	
Schedule A
    	
-
    	
Schedule of Investors
    
	
Annex A
    	
-
    	
Plan of Distribution
    

 

i

 

REGISTRATION RIGHTS AGREEMENT

 

THIS REGISTRATION RIGHTS AGREEMENT (this “Agreement”), is made as of the 22 day of March 2018, by and among Addex Therapeutics Ltd., a corporation organized under the laws of Switzerland (the “Company”), and each of the investors listed on Schedule A hereto, each of which is referred to in this Agreement as an “Investor.”

 

RECITALS

 

WHEREAS, the Company, Growth Equity Opportunities Fund IV, LLC (“NEA”) and New Leaf Biopharma Opportunities I, L.P. (“New Leaf”) are parties to the Investment Agreement dated February 14, 2018 (the “Investment Agreement”); and

 

WHEREAS, in order to induce the Company to enter into the Investment Agreement and to induce the Investors to invest funds in the Company pursuant to the Investment Agreement or a separate agreement, the Investors and the Company hereby agree that this Agreement shall govern the rights of the Investors to cause the Company to register shares of Common Stock issuable to the Investors, and shall govern certain other matters as set forth in this Agreement;

 

NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Agreement, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and each of the Investors agree as follows:

 

1.                                      Definitions. Capitalized terms used and not otherwise defined herein that are defined in the Investment Agreement shall have the meanings given such terms in the Investment Agreement. As used in this Agreement, the following terms shall have the following meanings:

 

1.1                               “ADR” means American Depository Receipts representing the Common Stock.

 

1.2                               “Affiliate” means, with respect to any specified Person, any other Person who, directly or indirectly, controls, is controlled by, or is under common control with such Person, including without limitation any general partner, managing member, officer or director of such Person or any venture capital fund now or hereafter existing that is controlled by one or more general partners or managing members of, or shares the same management company with, such Person.

 

1.3                               “Business Day” means a day, other than a Saturday or Sunday, on which banks in New York City are open for the general transaction of business.

 

1.4                               “Change of Control” means either: (a) any sale or transfer of all or substantially all of the assets of the Company to another Person; (b) the acquisition of the Company by another entity by means of any transaction or series of related transactions (including, without limitation, any reorganization, merger or consolidation or stock transfer, but excluding any such transaction effected primarily for the purpose of changing the domicile of the Company), unless such the Company’s stockholders of record immediately prior to such

 

 

transaction or series of related transactions hold, immediately after such transaction or series of related transactions, at least fifty percent (50%) of the voting power of the surviving or acquiring entity (provided that the sale by the Company of its securities for the purposes of raising additional funds shall not constitute a Change of Control hereunder); or (c) a disclosure that any person (as the term “person” is used in Section 13(d)(3) or Section 14(d)(2) of the Exchange Act) has become the beneficial owner (as the term “beneficial owner” is defined under Rule 13d-3 or any successor rule or regulation thereto under the Exchange Act) of securities representing fifty percent (50%) or more of the combined voting power of the then outstanding voting securities of the Company.

 

1.5                                    “Commission” means the Securities and Exchange Commission.

 

1.6                                    “Common Stock” means the registered common shares, nominal value CHF 1.00 per share, issued or issuable to the Investors pursuant to the Investment Agreement and any securities into which such common shares may hereinafter be reclassified.

 

1.7                                    “Damages” means any loss, damage, claim or liability (joint or several) to which a party hereto may become subject under the Securities Act, the Exchange Act, or other federal or state law, insofar as such loss, damage, claim or liability (or any action in respect thereof) arises out of or is based upon: (i) any untrue statement or alleged untrue statement of a material fact contained in any registration statement of the Company, including any preliminary Prospectus or final Prospectus contained therein or any amendments or supplements thereto; (ii) an omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make the statements therein not misleading; or (iii) any violation or alleged violation by the indemnifying party (or any of its agents or Affiliates) of the Securities Act, the Exchange Act, any state securities law, or any rule or regulation promulgated under the Securities Act, the Exchange Act, or any state securities law.

 

1.8                                    “Derivative Securities” means any securities or rights convertible into, or exercisable or exchangeable for (in each case, directly or indirectly),  Common Stock, including options and warrants.

 

1.9                                    “Effective Date” means the date that a Registration Statement filed pursuant to this Agreement is first declared effective by the Commission.

 

1.10                           “Effectiveness Deadline” means, with respect to the Initial Registration Statement or the New Registration Statement, ninety (90) calendar days after the filing date of such Registration Statement (or, in the event the Commission reviews and has written comments to the Initial Registration Statement or the New Registration Statement, no later than one hundred eighty (180) calendar days from the filing date of such Registration Statement provided, however, that if the Company is notified by the Commission that the Initial Registration Statement or the New Registration Statement will not be reviewed or is no longer subject to further review and comments, the Effectiveness Deadline as to such Registration Statement shall be the tenth (10th) Trading Day following the date on which the Company is so notified if such date precedes the dates otherwise required above; provided, further, that if the Effectiveness Deadline falls on a Saturday, Sunday or other day that the Commission is closed

 

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for business, the Effectiveness Deadline shall be extended to the next Business Day on which the Commission is open for business.

 

1.11          “Event Date Investment Amount” means the number of Registrable Securities held by the applicable Holder on the Event Date.

 

1.12          “Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

1.13          “Excluded Registration” means (i) a registration relating to the sale of securities to employees of the Company or a subsidiary pursuant to a stock option, stock purchase, or similar plan (including equity incentives, such as equity sharing certificates, under Swiss law); (ii) a registration relating to an SEC Rule 145 transaction; (iii) a registration on any form that does not include substantially the same information as would be required to be included in a Registration Statement covering the sale of the Registrable Securities; or (iv) a registration in which the only Common Stock being registered is Common Stock issuable upon conversion of debt securities that are also being registered.

 

1.14          “Form F-1” means such form under the Securities Act as in effect on the date hereof or any successor registration form under the Securities Act subsequently adopted by the SEC.

 

1.15          “Form F-3” means such form under the Securities Act as in effect on the date hereof or any registration form under the Securities Act subsequently adopted by the SEC that permits incorporation of substantial information by reference to other documents filed by the Company with the SEC.

 

1.16          “Holder” means any holder of Registrable Securities who is a party to this Agreement.

 

1.17          “Immediate Family Member” means a child, stepchild, grandchild, parent, stepparent, grandparent, spouse, sibling, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law, including, adoptive relationships, of a natural person referred to herein.

 

1.18          “Initiating Holders” means, collectively, Holders who properly initiate a registration request under this Agreement.

 

1.19          “Investment Agreement” has the meaning set forth in the Recitals.

 

1.20          “Investor” or “Investors” has the meaning set forth in the Preamble.

 

1.21          “IPO” means the Company’s first underwritten public offering of its Common Stock under the Securities Act.

 

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1.22          “NEA” means Growth Equity Opportunities Fund IV, LLC.

 

1.23          “New Leaf” means New Leaf Biopharma Opportunities I, L.P.

 

1.24          “NYSE” means the New York Stock Exchange, the NYSE Alternext and/or NYSE MKT (formerly the American Stock Exchange), as may be applicable.

 

1.25          “Person” means any individual, corporation, partnership, trust, limited liability company, association or other entity.

 

1.26          “Principal Market” means the Trading Market on which the Shares are primarily listed on and quoted for trading, which, as of the Closing Date, shall be the SIX.

 

1.27          “Prospectus” means the prospectus included in a Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective Registration Statement in reliance upon Rule 430A promulgated under the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by a Registration Statement, and all other amendments and supplements to the Prospectus, including post-effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.

 

1.28          “Registrable Securities” means (i) the Common Stock; (ii) any Common Stock issued or issuable upon exercise of the Warrants (disregarding for this purpose any and all limitations of any kind on exercise of any Warrants); (iii) ADRs, if any, and (iv) any Common Stock issued as (or issuable upon the conversion or exercise of any warrant, right, or other security that is issued as) a dividend or other distribution with respect to, or in exchange for or in replacement of, the shares referenced in clauses (i) through (iii) above; excluding in all cases, however, any Registrable Securities sold by a Person in a transaction in which the applicable rights under this Agreement are not assigned pursuant to Subsection 4.1, and excluding for purposes of Section 2 any shares for which registration rights have terminated pursuant to Subsection 2.12 of this Agreement.

 

1.29          “Registrable Securities then outstanding” means the number of shares determined by adding the number of shares of outstanding Common Stock that are Registrable Securities and the number of shares of Common Stock issuable (directly or indirectly) pursuant to then exercisable and/or convertible securities that are Registrable Securities.

 

1.30          “Registration Expenses” means (i) all expenses incurred by the Company incident to the Company’s performance of and compliance with this Agreement, including, without limitation, all stock exchange, Commission, FINRA and, to the extent applicable, state securities registration, listing and filing fees, printing expenses, fees, expenses and disbursements of counsel for the Company and one counsel for all of the Investors, “blue sky” fees and expenses, and the expense of any special audits incident to or required by any such registration (but excluding the compensation of regular employees of the Company which shall

 

4

 

be paid in any event by the Company) and (ii) the reasonable and documented fees and expenses of one legal counsel to the Investors, subject to an aggregate limit of fifty thousand dollars ($50,000).

 

1.31          “Registration Statements” means any one or more registration statements of the Company filed under the Securities Act that covers the resale of any of the Registrable Securities pursuant to the provisions of this Agreement (including without limitation the Initial Registration Statement, the New Registration Statement, any Remainder Registration Statements and any Piggyback Registration), amendments and supplements to such Registration Statements, including post-effective amendments, all exhibits and all material incorporated by reference or deemed to be incorporated by reference in such Registration Statements.

 

1.32          “SEC” means the Securities and Exchange Commission.

 

1.33          “SEC Guidance” means (i) any publicly-available written or oral guidance, comments requirements or requests of the Commission staff and (ii) the Securities Act.

 

1.34          “SEC Rule 144” means Rule 144 promulgated by the SEC under the Securities Act.

 

1.35          “SEC Rule 145” means Rule 145 promulgated by the SEC under the Securities Act.

 

1.36          “SEC Rule 415” means Rule 415 promulgated by the SEC under the Securities Act.

 

1.37          “SEC Rule 424” means Rule 424 promulgated by the SEC under the Securities Act.

 

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

 

1.39          “Selling Expenses” means all underwriting discounts, selling commissions, and stock transfer taxes applicable to the sale of Registrable Securities, and fees and disbursements of counsel for any Holder, except for the fees and disbursements of the Selling Holder Counsel borne and paid by the Company as provided in Subsection 2.7.

 

1.40          “Selling Stockholder Questionnaire” means a questionnaire in the form attached as Annex B hereto, or such other form of questionnaire as may reasonably be adopted by the Company from time to time.

 

1.41          “SIX” means the SIX Swiss Exchange Ltd.

 

1.42          “Trading Day” means (i) a day on which the shares of Common Stock are listed or quoted and traded on its Principal Market (other than the OTC Bulletin Board), or (ii) if the shares of Common Stock are not listed on a Trading Market (other than the OTC Bulletin Board), a day on which the shares of Common Stock are traded in the over-the-

 

5

 

counter market, as reported by the OTC Bulletin Board, or (iii) if the shares of Common Stock are not quoted on any Trading Market, a day on which the shares of Common Stock are quoted in the over-the-counter market as reported in the “pink sheets” by Pink Sheets LLC (or any similar organization or agency succeeding to its functions of reporting prices); provided, that in the event that the shares of Common Stock are not listed or quoted as set forth in (i), (ii) and (iii) hereof, then Trading Day shall mean a Business Day.

 

1.43          “Trading Market” means whichever of the SIX, NYSE, the NASDAQ Global Select Market, the NASDAQ Global Market, the NASDAQ Capital Market or OTC Bulletin Board on which the Shares are listed or quoted for trading on the date in question.

 

1.44          “U.S. Trading Market” means any of the NYSE, Nasdaq Global Market or Nasdaq Capital Market, as applicable.

 

1.45          “Warrants” means the warrants issued to the Investors pursuant to the Investment Agreement.

 

2.                                 Registration Rights. The Company covenants and agrees as follows:

 

2.1                               Demand Registration.

 

(a)                                 Form F-1 Demand. If (A) at any time after the earlier of (i) three (3) years after the date of this Agreement or (ii) one hundred eighty (180) days after the effective date of the Registration Statement for the IPO, the Company receives a request from Holders of at least ten percent (10%) of the Common Stock then outstanding that the Company effect an underwritten public offering (a “Demand Offering”) of Common Stock held by the Initiating Holders and any other participating Holders (the “Selling Holders”) (and, if the Company has not effected an IPO, of the Common Stock (or ADRs) of the Company in an IPO that includes the resale of the Common Stock of the Selling Holders) on a U.S. Trading Market and in connection therewith file a Form F-1 Registration Statement with the Commission with respect to at least thirty percent (30%) of the Registrable Securities then outstanding (or a lesser percent if the anticipated aggregate offering price, net of Selling Expenses, would exceed fifteen million ($15 million)), and (B) a major, “bulge bracket” U.S. investment bank selected by the Initiating Holder (and reasonably acceptable to the Company) is prepared to effect a firm commitment underwritten registered public offering of the Common Stock held by the Selling Holders on a U.S. Trading Market (the “U.S. Listing”), then the Company shall (x) within ten (10) days after the date such request is given, give notice thereof (the “Demand Notice”) to all Holders other than the Initiating Holders; and (y) as soon as practicable, and in any event within ninety (90) days after the date such request is given by the Initiating Holders, file a Form F-1 Registration Statement under the Securities Act covering all Registrable Securities that the Initiating Holders requested to be registered and any additional Registrable Securities requested to be included in such registration by any other Holders, as specified by notice given by each such Holder to the Company within twenty (20) days of the date the Demand Notice is given. The Company shall also exercise commercially reasonable efforts to take all actions necessary to register such class of securities under the Exchange Act, as well as (X) pay all Registration Expenses (exclusive of Selling Expenses), and (Y) to the extent applicable, to cause the

 

6

 

registration of the issuance of such Common Stock or ADRs, if applicable, and obtain all required approvals for the listing of the Shares or ADRs representing the Shares with the applicable U.S. Trading Market. The Company shall also exercise commercially reasonable efforts to continue the U.S. Listing and trading of its Shares on the applicable U.S. Trading Market and, in accordance, therewith, will use commercially reasonable efforts to comply in all respects with the Company’s reporting, filing and other obligations applicable to issuers whose securities are listed on such U.S. Trading Market. The Company also agrees that the Investors shall have the rights set forth in this Agreement with respect to the registration for resale of the Registrable Securities of the Investors in the event of and immediately effective upon such U.S. Listing.

 

(b)                                      Shelf Registration. No later than the Lockup Termination Date of the earlier to occur of (i) an IPO of the Company, or (ii) a Demand Offering (and in the case of a Demand Offering, if no Company lock-up exists, then ninety (90) calendar days following the Effective Date of such Demand Offering) (such date, the “Filing Deadline”), the Company shall prepare and file with the Commission a Registration Statement covering the resale of all outstanding Registrable Securities not already covered by an effective Registration Statement for an offering to be made on a delayed or continuous basis pursuant to SEC Rule 415 or, if SEC Rule 415 is not available for offers and sales of the Registrable Securities, by such other means of distribution of the Registrable Securities as the Holders may reasonably specify (the “Initial Registration Statement”). The Initial Registration Statement shall be on Form F-3 (except if the Company is then ineligible to register for resale the Registrable Securities on Form F-3, in which case such registration shall be on Form F-1 or such other form available to register for resale the Registrable Securities as a secondary offering), subject to the provisions of Subsection 2.1(e), and shall contain (except if otherwise required pursuant to written comments received from the Commission upon a review of such Registration Statement) the “Plan of Distribution” section attached hereto as Annex A (which may be modified to respond to comments, if any, provided by the Commission). Notwithstanding the registration obligations set forth in this Section 2, in the event the Commission informs the Company that all of the Registrable Securities cannot, as a result of the application of SEC Rule 415, be registered for resale as a secondary offering on a single Registration Statement, the Company agrees to promptly (i) inform each of the Holders and use its commercially reasonable efforts to file amendments to the Initial Registration Statement as required by the Commission and/or (ii) withdraw the Initial Registration Statement and file a new Registration Statement (a “New Registration Statement”), in either case covering the maximum number of Registrable Securities permitted to be registered by the Commission, on Form F-3 or such other form available to register for resale the Registrable Securities as a secondary offering; provided, however, that prior to filing such amendment or New Registration Statement, the Company shall be obligated to use its commercially reasonable efforts to advocate with the Commission for the registration of all of the Registrable Securities in accordance with the SEC Guidance, including without limitation, the Manual of Publicly Available Telephone Interpretations D.29. Notwithstanding any other provision of this Agreement, if any SEC Guidance sets forth a limitation of the number of Registrable Securities permitted to be registered on a particular Registration Statement as a secondary offering (and notwithstanding that the Company used diligent efforts to advocate with the Commission for the registration of all or a greater number of Registrable Securities), unless otherwise directed in writing by a Holder as to its Registrable

 

7

 

Securities, the number of Registrable Securities to be registered on such Registration Statement will first be reduced by Registrable Securities not acquired pursuant to the Investment Agreement (whether pursuant to registration rights or otherwise) and second by Registrable Securities represented by shares of Common Stock (applied, in the case that some shares of Common Stock may be registered, to the Holders on a pro rata basis based on the total number of unregistered shares of Common Stock held by such Holders, subject to a determination by the Commission that certain Holders must be reduced first based on the number of shares of Common Stock held by such Holders). In the event the Company amends the Initial Registration Statement or files a New Registration Statement, as the case may be, under clauses (i) or (ii) above, the Company will use its commercially reasonable efforts to file with the Commission, as promptly as allowed by Commission or SEC Guidance provided to the Company or to registrants of securities in general, one or more Registration Statements on Form F-3 or such other form available to register for resale those Registrable Securities that were not registered for resale on the Initial Registration Statement, as amended, or the New Registration Statement (the “Remainder Registration Statements”). The Company shall cause each Registration Statement required to be filed by the Filing Deadline and to be declared effective by the Commission no later than the Effectiveness Deadline (including filing with the Commission a request for acceleration of effectiveness in accordance with Rule 461 promulgated under the Securities Act), and shall use its reasonable best efforts to keep each Registration Statement continuously effective under the Securities Act for so long as Registrable Securities remain outstanding (the “Effectiveness Period”). The Company shall telephonically request effectiveness of a Registration Statement as of 5:00 P.M. New York City time on a Trading Day. The Company shall promptly notify the Holders via facsimile or electronic mail of a “.pdf” format data file of the effectiveness of a Registration Statement on the same Trading Day that the Company telephonically confirms effectiveness with the Commission, which date of confirmation shall initially be the date requested for effectiveness of such Registration Statement. The Company shall, by 9:30 A.M. New York City time on the first Trading Day after the Effective Date, file a final Prospectus with the Commission, as required by Rule 424(b). Failure to so notify the Holders on or before the second Trading Day after such notification or effectiveness or failure to file a final Prospectus as aforesaid shall be deemed an Event under Subsection 2.1(c).

 

(c)                                       If: in respect of any Registration Statement filed pursuant to Subsection 2.1(b), (i) the Initial Registration Statement is not filed with the Commission on or prior to the Filing Deadline, (ii) the Initial Registration Statement or the New Registration Statement, as applicable, is not declared effective by the Commission (or otherwise does not become effective) on or prior to the Effectiveness Deadline or (iii) after its Effective Date, (A) such Registration Statement ceases (including without limitation by reason of a stop order, or the Company’s failure to update the Registration Statement), to remain continuously effective as to all Registrable Securities included in such Registration Statement or (B) the Holders are not permitted to utilize the Prospectus therein to resell such Registrable Securities for any reason for more than an aggregate of either thirty (30) consecutive calendar days or sixty (60) calendar days in the aggregate (which need not be consecutive days) during any twelve (12) month period, or (iv) the Company fails to satisfy the current public information requirement pursuant to Rule 144(c)(1) as a result of which the Holders who are not affiliates are unable to sell Registrable Securities without restriction under Rule 144 (or any successor thereto), (any such

 

8

 

failure or breach in clauses (i) through (iv) above being referred to as an “Event,” and, for purposes of clauses (i), (ii) or (iv), the date on which such Event occurs, or for purposes of clause (iii), the date on which either such thirty (30) or sixty (60) calendar day period is exceeded, being referred to as an “Event Date”), then in addition to any other rights the Holders may have hereunder or under applicable law, on each such Event Date and on each additional thirty (30) consecutive day or sixty (60) day aggregate period, as may be applicable, following such Event Date until the applicable Event is cured, the Company shall pay to each Holder an amount in cash, as partial liquidated damages and not as a penalty (“Liquidated Damages”), equal to four tenths of one percent (0.4%) of the aggregate purchase price paid by such Holder pursuant to the Investment Agreement for any unregistered Registrable Securities then held by such Holder (the “Liquidated Damages Amount”). The parties agree that notwithstanding anything to the contrary herein or in the Investment Agreement, (1) no Liquidated Damages shall be payable with respect to any period after the expiration of the Effectiveness Period (except in respect of an Event described in Subsection 2.1(c)(iv) hereof), (it being understood that this sentence shall not relieve the Company of any Liquidated Damages accruing prior to the Effectiveness Deadline), (2) the Liquidated Damages Amount for any Holder in any twelve (12) month period following an Event Date shall not exceed a cap of four and eight tenths percent (4.8%) of the Event Date Investment Amount (e.g., for purposes of illustration and to avoid ambiguity, assuming twenty-five million dollars ($25,000,000) of unregistered Registrable Securities are outstanding on an Event Date, the applicable cap on the Liquidated Damages Amount would be one million two hundred thousand dollars ($1,200,000) in any twelve (12) month period assuming continuous, uncured breach during such period), and (3) no Liquidated Damages shall accrue during any period covered by the exercise of the Company’s rights in accordance with Subsection 2.1(e) hereof. The Liquidated Damages pursuant to the terms hereof shall apply on a daily pro-rata basis for any portion of an applicable period prior to the cure of an Event, except in the case of the first Event Date. The Company shall not be liable for Liquidated Damages under this Agreement as to any Registrable Securities which are not permitted by the Commission to be included in a Registration Statement due solely to SEC Guidance from the time that it is determined that such Registrable Securities are not permitted to be registered until such time as the provisions of this Agreement as to the Remainder Registration Statements required to be filed hereunder are triggered, in which case the provisions of this Subsection 2.1(c) shall once again apply, if applicable. In such case, the Liquidated Damages shall be calculated to only apply to the percentage of Registrable Securities which are permitted in accordance with SEC Guidance to be included in such Registration Statement. The Effectiveness Deadline for a Registration Statement shall be extended without default or Liquidated Damages hereunder in the event that the Company’s failure to obtain the effectiveness of the Registration Statement on a timely basis results from the failure of an Investor to timely provide the Company with information requested by the Company and necessary to complete the Registration Statement in accordance with the requirements of the Securities Act (in which the Effectiveness Deadline would be extended with respect to Registrable Securities held by such Investor).

 

(d)                                      In the event that Form F-3 is not available for the registration of the resale of Registrable Securities hereunder, the Company shall (i) register the resale of the Registrable Securities on another appropriate form reasonably acceptable to the Holders and (ii) undertake to register the Registrable Securities on Form F-3 promptly after such

 

9

 

form becomes available to the Company, provided, that the Company shall maintain the effectiveness of the Registration Statement then in effect until such time as a Registration Statement on Form F-3 covering the resale of the Registrable Securities has been declared effective by the Commission.

 

(e)                                  Notwithstanding the foregoing obligations, if the Company furnishes to Holders requesting a registration pursuant to this Subsection 2.1 a certificate signed by the Company’s chief executive officer stating that in the good faith judgment of the Company’s Board of Directors it would be materially detrimental to the Company and its stockholders for such Registration Statement to either become effective or remain effective for as long as such Registration Statement otherwise would be required to remain effective, because such action would (i) materially interfere with a significant acquisition, corporate reorganization, or other similar transaction involving the Company; (ii) require premature disclosure of material information that the Company has a bona fide business purpose for preserving as confidential; or (iii) render the Company unable to comply with requirements under the Securities Act or Exchange Act, then the Company shall have the right to defer taking action with respect to such filing or suspend the right of Holder to use a Prospectus in connection with the resale of Common Stock pursuant to Subsection 2.1(e) hereof, as may be applicable, and any time periods with respect to filing or effectiveness thereof shall be tolled correspondingly, for a period of not more than ninety (90) days after the request of the Initiating Holders is given or the date the Company notifies Holders of the suspension of a Registration Statement filed under Subsection 2.1(b), as may be applicable (such period, the “Blackout Period”); provided, however, that the Company may not invoke this right more than once in any twelve (12) month period; and provided  further that the Company shall not register any securities for its own account or that of any other stockholder during such ninety (90) day period other than an Excluded Registration. Neither the delivery of a certificate described herein nor the passage of such ninety (90) day period shall be considered an Event and neither shall trigger the Company’s obligations to pay to the Holders Liquidated Damages hereunder. Notwithstanding any of the foregoing to the contrary, the Company shall not be entitled to exercise its rights pursuant to this Subsection 2.1(e) for the period of ninety (90) days immediately following the Lockup Termination Date if (x) the basis for such exercise is the Company’s intent to effect a registered public offering (a “Secondary Offering”) for the account of the Company and/or other stockholders of the Company and (y) the Company has not included all of the shares of Common Stock requested by the Holders for resale in the IPO, unless the Company includes all shares of Common Stock requested by the Holders for registration in such Secondary Offering.

 

(f)                                   The Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to Subsection 2.1(a) during the period that is sixty (60) days before the Company’s good faith estimate of the date of filing of, and ending on a date that is one hundred eighty (180) days after the effective date of, a Company-initiated registration, provided that the Company is actively employing in good faith commercially reasonable efforts to cause such Registration Statement to become effective; (ii) after the Company has effected two registrations pursuant to Subsection 2.1(a); or (iii) if the Initiating Holders propose to dispose of shares of Registrable Securities that may be immediately registered on Form F-3 pursuant to the obligations of Subsection 2.1(b). The Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to Subsection 2.1(b) during the period

 

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that is thirty (30) days before the Company’s good faith estimate of the date of filing of, and ending on a date that is ninety (90) days after the effective date of, a Company-initiated IPO, provided that the Company is actively employing in good faith commercially reasonable efforts to cause such Registration Statement to become effective in connection to such IPO. A registration shall not be counted as “effected” for purposes of this Subsection 2.1(f) until such time as the applicable Registration Statement has been declared effective by the SEC, unless the Initiating Holders withdraw their request for such registration, elect not to pay the registration expenses therefor, and forfeit their right to one demand Registration Statement pursuant to Subsection 2.7, in which case such withdrawn Registration Statement shall be counted as “effected” for purposes of this Subsection 2.1(f).

 

2.2                            Company Registration. If the Company proposes to register (including, for this purpose, a registration effected by the Company for stockholders other than the Holders) any of its Common Stock under the Securities Act in connection with the public offering of such securities solely for cash (other than in an Excluded Registration) (a “Piggyback Registration”), the Company shall, at such time, promptly give each Holder notice of such registration. Upon the request of each Holder given within twenty (20) days after such notice is given by the Company, the Company shall, subject to the provisions of Subsection 2.3, cause to be registered all of the Registrable Securities that each such Holder has requested to be included in such registration. The Company shall have the right to terminate or withdraw any registration initiated by it under this Subsection 2.2 before the effective date of such registration, whether or not any Holder has elected to include Registrable Securities in such registration. The expenses (other than Selling Expenses) of such withdrawn registration shall be borne by the Company in accordance with Subsection 2.7. Notwithstanding the foregoing, assuming a Requesting Investor has given notice of its desire to participate in such registration, if, at any time after giving a Notice of Piggyback Registration and prior to the effective date of the Registration Statement filed in connection with such registration, the Company shall determine for any reason not to register or to delay registration of such securities, the Company may, at its election, give written notice of such determination to such Requesting Investor and, thereupon, (a) in the case of a determination not to register the Company’s securities for its own account, shall be relieved of its obligation to register any Registrable Securities in connection with such registration, and (b) in the case of a determination to delay registering the Company’s securities for its own account, shall be permitted to delay registering any Registrable Securities for the same period as the delay in registering such other securities to be sold for the account of the Company. No registration effected under this Subsection 2.2 shall (i) relieve the Company of its obligations to effect any Registration under Subsections 2.1(a) or 2.1(b) herein, or (ii) entitle the Company to treat Registrable Securities differently in any such decision not to register or to delay pursuant to this Subsection 2.2(a). Subject to Subsection 2.1(e), the failure to register or to delay registration of securities under this Subsection 2.2 shall not obligate the Company to pay any Liquidated Damages pursuant to Subsection 2.1(c).

 

2.3                            Underwriting Requirements.

 

(a)                            If, pursuant to Subsection 2.1, the Initiating Holders intend to distribute the Registrable Securities covered by their request by means of an underwriting, they shall so advise the Company as a part of their request made pursuant to Subsection 2.1, and

 

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the Company shall include such information in the Demand Notice. The underwriter(s) will be selected by the Company and shall be reasonably acceptable to a majority in interest of the Initiating Holders; provided; however, in the event of a Demand Offering (other than an IPO) the underwriter(s) shall be selected by the Initiating Holders and shall be reasonably acceptable to the Company. In such event, the right of any Holder to include such Holder’s Registrable Securities in such registration shall be conditioned upon such Holder’s participation in such underwriting and the inclusion of such Holder’s Registrable Securities in the underwriting to the extent provided herein. All Holders proposing to distribute their securities through such underwriting shall (together with the Company as provided in Subsection 2.5(e)) enter into an underwriting agreement in customary form with the underwriter(s) selected for such underwriting. Notwithstanding any other provision of this Subsection 2.3, if the managing underwriter(s) advise(s) the Initiating Holders in writing that marketing factors require a limitation on the number of shares to be underwritten, then the Initiating Holders shall so advise all Holders of Registrable Securities that otherwise would be underwritten pursuant hereto, and the number of Registrable Securities that may be included in the underwriting shall be allocated among such Holders of Registrable Securities, including the Initiating Holders, in proportion (as nearly as practicable) to the number of Registrable Securities owned by each Holder or in such other proportion as shall mutually be agreed to by all such selling Holders; provided, however, that the number of Registrable Securities held by the Holders to be included in such underwriting shall not be reduced unless all other securities are first entirely excluded from the underwriting. To facilitate the allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to any Holder to the nearest one hundred (100) shares.

 

(b)                                      In connection with any offering involving an underwriting of shares of the Company’s capital stock pursuant to Subsection 2.2, the Company shall not be required to include any of the Holders’ Registrable Securities in such underwriting unless the Holders accept the terms of the underwriting as agreed upon between the Company and its underwriters, and then only in such quantity as the underwriters in their sole discretion determine will not jeopardize the success of the offering by the Company. If the total number of securities, including Registrable Securities, requested by stockholders to be included in such offering exceeds the number of securities to be sold (other than by the Company) that the underwriters in their reasonable discretion determine is compatible with the success of the offering, then the Company shall be required to include in the offering only that number of such securities, including Registrable Securities, which the underwriters and the Company in their sole discretion determine will not jeopardize the success of the offering. If the underwriters determine that less than all of the Registrable Securities requested to be registered can be included in such offering, then the Registrable Securities that are included in such offering shall be allocated among the selling Holders in proportion (as nearly as practicable to) the number of Registrable Securities owned by each selling Holder or in such other proportions as shall mutually be agreed to by all such selling Holders. To facilitate the allocation of shares in accordance with the above provisions, the Company or the underwriters may round the number of shares allocated to any Holder to the nearest one hundred (100) shares. Notwithstanding the foregoing, in no event shall (i) the number of Registrable Securities included in the offering be reduced unless all other securities (other than securities to be sold by the Company) are first entirely excluded from the offering, (ii) subject to Subsection 2.1(e), the number of Registrable Securities included in the

 

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offering be reduced below thirty percent (30%) of the total number of securities included in such offering, unless such offering is the IPO, in which case the selling Holders may be excluded further if the underwriters make the determination described above and no other stockholder’s securities are included in such offering, and (iii) notwithstanding (ii) above, in the event that an Event has occurred and so long as such Event shall continue without being cured by the Company, the Company shall include in the Registration Statement all Registrable Securities which have been requested to be included by the Holders. For purposes of the provision in this Subsection 2.3(b) concerning apportionment, for any selling Holder that is a partnership, limited liability company, or corporation, the partners, members, retired partners, retired members, stockholders, and Affiliates of such Holder, or the estates and Immediate Family Members of any such partners, retired partners, members, and retired members and any trusts for the benefit of any of the foregoing Persons, shall be deemed to be a single “selling Holder,” and any pro rata reduction with respect to such “selling Holder” shall be based upon the aggregate number of Registrable Securities owned by all Persons included in such “selling Holder,” as defined in this sentence.

 

(c)                             For purposes of Subsection 2.1, a registration shall not be counted as “effected” if, as a result of an exercise of the underwriter’s cutback provisions in Subsection 2.3(a), fewer than fifty percent (50%) of the total number of Registrable Securities that Holders have requested to be included in such Registration Statement are actually included.

 

2.4                            Reserved.

 

2.5                            Obligations of the Company. Whenever required under this Section 2 to effect the registration of any Registrable Securities, the Company shall, as expeditiously as reasonably possible:

 

(a)                            prepare and file with the SEC a Registration Statement with respect to such Registrable Securities and use its commercially reasonable efforts to cause such Registration Statement to become effective and, upon the request of the Holders of a majority of the Registrable Securities registered thereunder, keep such Registration Statement effective for a period of up to one hundred twenty (120) days or, if earlier, until the distribution contemplated in the Registration Statement has been completed; provided, however, that (i) such one hundred twenty (120) day period shall be extended for a period of time equal to the period the Holder refrains, at the request of an underwriter of Common Stock (or other securities) of the Company, from selling any securities included in such registration, and (ii) in the case of any registration of Registrable Securities covered by a Registration Statement filed pursuant to Subsection 2.1(b) hereof that are intended to be offered on a continuous or delayed basis, subject to compliance with applicable SEC rules, such one hundred twenty (120) day period shall be extended indefinitely, if necessary, to keep the Registration Statement effective until all such Registrable Securities are sold and use commercially reasonable efforts to avoid the issuance of, or, if issued, obtain the withdrawal of (x) any order suspending the effectiveness of a Registration Statement, or (y) any suspension of the qualification (or exemption from qualification) of any of the Registrable Securities for sale in any jurisdiction, as soon as practicable;

 

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(b)                                 (i) prepare and file with the SEC such amendments and supplements to such Registration Statement, and the Prospectus used in connection with such Registration Statement, as may be necessary to comply with the Securities Act in order to enable the disposition of all securities covered by such Registration Statement, (ii) cause the related Prospectus to be amended or supplemented by any required Prospectus supplement (subject to the terms of this Agreement), and, as so supplemented or amended, to be filed pursuant to SEC Rule 424, (iii) respond as promptly as reasonably practicable to any comments received from the Commission with respect to each Registration Statement or any amendment thereto and, as promptly as reasonably possible, provide the Holders true and complete copies of all correspondence from and to the Commission relating to such Registration Statement that pertains to the Holders as “Selling Stockholders” but not any comments that would result in the disclosure to the Holders of material and non-public information concerning the Company, and (iv) comply with the provisions of the Securities Act and the Exchange Act with respect to the disposition of all Registrable Securities covered by a Registration Statement until such time as all of such Registrable Securities shall have been disposed of (subject to the terms of this Agreement) in accordance with the intended methods of disposition by the Holders thereof as set forth in such Registration Statement as so amended or in such Prospectus as so supplemented; provided, however, that each Investor shall be responsible for the delivery of the Prospectus to the Persons to whom such Investor sells any of the shares of Common Stock (including in accordance with Rule 172 under the Securities Act), and each Investor agrees to dispose of Registrable Securities in compliance with the “Plan of Distribution” described in the Registration Statement and otherwise in compliance with applicable federal and state securities laws;

 

(c)                                  furnish to the selling Holders such numbers of copies of such Registration Statements and a Prospectus, including a preliminary Prospectus, amendments or supplements, and all exhibits and attachments thereto, as required by the Securities Act, and such other documents as the Holders may reasonably request in order to facilitate their disposition of their Registrable Securities;

 

(d)                                 use its commercially reasonable efforts to register and qualify the securities covered by such Registration Statement under such other securities or blue-sky laws of such jurisdictions as shall be reasonably requested by the selling Holders and keep such registration and qualification effective until all such Registrable Securities are sold; provided that the Company shall not be required to qualify to do business or to file a general consent to service of process in any such states or jurisdictions, unless the Company is already subject to service in such jurisdiction and except as may be required by the Securities Act;

 

(e)                                  in the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the underwriter(s) of such offering;

 

(f)                                   use its commercially reasonable efforts to cause all such Registrable Securities covered by such Registration Statement to be listed on a national securities exchange or trading system and each securities exchange and trading system (if any) on which similar securities issued by the Company are then listed;

 

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(g)                                  provide a transfer agent and registrar for all Registrable Securities registered pursuant to this Agreement and provide a CUSIP number for all such Registrable Securities, in each case not later than the effective date of such registration;

 

(h)                                 promptly make available for inspection by the selling Holders, any managing underwriter(s) participating in any disposition pursuant to such Registration Statement, and any attorney or accountant or other agent retained by any such underwriter or selected by the selling Holders, all financial and other records, pertinent corporate documents, and properties of the Company, and cause the Company’s officers, directors, employees, and independent accountants to supply all information reasonably requested by any such seller, underwriter, attorney, accountant, or agent, in each case, as necessary or advisable to verify the accuracy of the information in such Registration Statement and to conduct appropriate due diligence in connection therewith;

 

(i)                                     notify each selling Holder, promptly after the Company receives notice thereof, (1) of the time when such Registration Statement has been declared effective or a supplement to any Prospectus forming a part of such Registration Statement has been filed, (2) of any request by the Commission or any other federal or state governmental authority for amendments or supplements to a Registration Statement or Prospectus or for additional information that pertains to the Holders as “Selling Stockholders” or the “Plan of Distribution”, (3) of the issuance by the Commission or any other federal or state governmental authority of any stop order suspending the effectiveness of a Registration Statement covering any or all of the Registrable Securities or the initiation of any Proceedings for that purpose, (4) of the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Registrable Securities for sale in any jurisdiction, or the initiation or threatening of any proceeding for such purpose, (5) of the occurrence of any event or passage of time that makes the financial statements included in a Registration Statement ineligible for inclusion therein or any statement made in such Registration Statement or Prospectus or any document incorporated or deemed to be incorporated therein by reference untrue in any material respect or that requires any revisions to such Registration Statement, Prospectus or other documents so that, in the case of such Registration Statement or the Prospectus, as the case may be, it will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, form of prospectus or supplement thereto, in light of the circumstances under which they were made), not misleading and (6) of the occurrence or existence of any pending corporate development with respect to the Company that the Company believes may be material and that, in the determination of the Company, makes it not in the best interest of the Company to allow continued availability of a Registration Statement or Prospectus, provided that, any and all such information shall remain confidential to each Holder until such information otherwise becomes public, unless disclosure by a Holder is required by law; and provided, further, that notwithstanding each Holder’s agreement to keep such information confidential, each such Holder makes no acknowledgement that any such information is material, non-public information. In the event of an occurrence of any event contemplated by this Subsection 2.5(i), as promptly as reasonably practicable (taking into account the Company’s good faith assessment of any adverse consequences to the Company and its stockholders of the premature disclosure of such event), the Company shall prepare a

 

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supplement or amendment, including a post-effective amendment, to the affected Registration Statements or a supplement to the related Prospectus or any document incorporated or deemed to be incorporated therein by reference, and file any other required document so that, as thereafter delivered, no Registration Statement nor any Prospectus will contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein (in the case of any Prospectus, form of prospectus or supplement thereto, in light of the circumstances under which they were made), not misleading. Subject to Subsection 2.1(e), the Company will use its commercially reasonable efforts to ensure that the use of the Prospectus may be resumed as promptly as is practicable. The Company shall be entitled to exercise its right under this Subsection 2.5(i), and if applicable, under Subsection 2.1(e), to suspend the availability of a Registration Statement and Prospectus, and shall be liable for the payment of Liquidated Damages only in accordance with the provisions and time periods of Subsections 2.1(c)(iii)(A) and (B), except no such Liquidated Damages shall accrue during any Blackout Period permitted under Subsection 2.1(e); and

 

(j)                               after such Registration Statement becomes effective, notify each selling Holder of any request by the SEC that the Company amend or supplement such Registration Statement or Prospectus.

 

In addition, the Company shall ensure that, at all times after any Registration Statement covering a public offering of securities of the Company under the Securities Act shall have become effective, its insider trading policy shall provide that the Company’s directors may implement a trading program under Rule 10b5-1 of the Exchange Act.

 

2.6                            Furnish Information. It shall be a condition precedent to the obligations of the Company to take any action pursuant to this Section 2 with respect to the Registrable Securities of any selling Holder that such Holder shall furnish to the Company such information regarding itself, the Registrable Securities held by it, and the intended method of disposition of such securities as is reasonably required to effect the registration of such Holder’s Registrable Securities.

 

2.7                            Expenses of Registration. All expenses (other than Selling Expenses) incurred in connection with registrations, filings, or qualifications pursuant to this Section 2, including all registration, filing, and qualification fees; printers’ and accounting fees; fees and disbursements of counsel for the Company; and the reasonable fees and disbursements, not to exceed fifty thousand dollars ($50,000), of one counsel for the selling Holders (“Selling Holder Counsel”), shall be borne and paid by the Company; provided, however, that the Company shall not be required to pay for any expenses of any registration proceeding begun pursuant to Subsection 2.1 if the registration request is subsequently withdrawn at the request of the Holders of a majority of the Registrable Securities to be registered (in which case all selling Holders shall bear such expenses pro rata based upon the number of Registrable Securities that were to be included in the withdrawn registration), unless the Holders of a majority of the Registrable Securities agree to forfeit their right to one registration pursuant to Subsection 2.1(a); provided  further that if, at the time of such withdrawal, the Holders shall have learned of a material adverse change in the condition, business, or prospects of the Company from that known to the Holders at the time of their request and have withdrawn the request with reasonable

 

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promptness after learning of such information then the Holders shall not be required to pay any of such expenses and shall not forfeit their right to one registration pursuant to Subsection 2.1(a). All Selling Expenses relating to Registrable Securities registered pursuant to this Section 2 shall be borne and paid by the Holders pro rata on the basis of the number of Registrable Securities registered on their behalf.

 

2.8                               Indemnification. If any Registrable Securities are included in a Registration Statement under this Section 2:

 

(a)                                 To the extent permitted by law, the Company will indemnify and hold harmless each selling Holder, and the partners, members, officers, directors, and stockholders of each such Holder; legal counsel and accountants for each such Holder; any underwriter (as defined in the Securities Act) for each such Holder; and each Person, if any, who controls such Holder or underwriter within the meaning of the Securities Act or the Exchange Act, against any Damages, and the Company will pay to each such Holder, underwriter, controlling Person, or other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided, however, that the indemnity agreement contained in this Subsection 2.8(a) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Company, which consent shall not be unreasonably withheld, nor shall the Company be liable for any Damages to the extent that they arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of any such Holder, underwriter, controlling Person, or other aforementioned Person expressly for use in connection with such registration.

 

(b)                                 To the extent permitted by law, each selling Holder, severally and not jointly, will indemnify and hold harmless the Company, and each of its directors, each of its officers who has signed the Registration Statement, each Person (if any), who controls the Company within the meaning of the Securities Act, legal counsel and accountants for the Company, any underwriter (as defined in the Securities Act), any other Holder selling securities in such Registration Statement, and any controlling Person of any such underwriter or other Holder, against any Damages, in each case only to the extent that such Damages arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of such selling Holder expressly for use in connection with such registration; and each such selling Holder will pay to the Company and each other aforementioned Person any legal or other expenses reasonably incurred thereby in connection with investigating or defending any claim or proceeding from which Damages may result, as such expenses are incurred; provided, however, that the indemnity agreement contained in this Subsection 2.8(b) shall not apply to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Holder, which consent shall not be unreasonably withheld; and provided  further that in no event shall the aggregate amounts payable by any Holder by way of indemnity or contribution under Subsections 2.8(b) and 2.8(d) exceed the proceeds from the offering received by such Holder (net of any Selling Expenses paid by such Holder), except in the case of fraud or willful misconduct by such Holder.

 

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(c)                                  Promptly after receipt by an indemnified party under this Subsection 2.8 of notice of the commencement of any action (including any governmental action) for which a party may be entitled to indemnification hereunder, such indemnified party will, if a claim in respect thereof is to be made against any indemnifying party under this Subsection 2.8, give the indemnifying party notice of the commencement thereof. The indemnifying party shall have the right to participate in such action and, to the extent the indemnifying party so desires, participate jointly with any other indemnifying party to which notice has been given, and to assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an indemnified party (together with all other indemnified parties that may be represented without conflict by one counsel) shall have the right to retain one separate counsel, with the fees and expenses to be paid by the indemnifying party, if representation of such indemnified party by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between such indemnified party and any other party represented by such counsel in such action.

 

(d)                                 To provide for just and equitable contribution to joint liability under the Securities Act in any case in which either: (i) any party otherwise entitled to indemnification hereunder makes a claim for indemnification pursuant to this Subsection 2.8 but it is judicially determined (by the entry of a final judgment or decree by a court of competent jurisdiction and the expiration of time to appeal or the denial of the last right of appeal) that such indemnification may not be enforced in such case, notwithstanding the fact that this Subsection 2.8 provides for indemnification in such case, or (ii) contribution under the Securities Act may be required on the part of any party hereto for which indemnification is provided under this Subsection 2.8, then, and in each such case, such parties will contribute to the aggregate losses, claims, damages, liabilities, or expenses to which they may be subject (after contribution from others) in such proportion as is appropriate to reflect the relative fault of each of the indemnifying party and the indemnified party in connection with the statements, omissions, or other actions that resulted in such loss, claim, damage, liability, or expense, as well as to reflect any other relevant equitable considerations. The relative fault of the indemnifying party and of the indemnified party shall be determined by reference to, among other things, whether the untrue or allegedly untrue statement of a material fact, or the omission or alleged omission of a material fact, relates to information supplied by the indemnifying party or by the indemnified party and the parties’ relative intent, knowledge, access to information, and opportunity to correct or prevent such statement or omission; provided, however, that, in any such case (x) no Holder will be required to contribute any amount in excess of the public offering price of all such Registrable Securities offered and sold by such Holder pursuant to such Registration Statement, and (y) no Person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation; and provided  further that in no event shall a Holder’s liability pursuant to this Subsection 2.8(d), when combined with the amounts paid or payable by such Holder pursuant to Subsection 2.8(b), exceed the proceeds from the offering received by such Holder (net of any Selling Expenses paid by such Holder), except in the case of willful misconduct or fraud by such Holder.

 

(e)                                  Notwithstanding the foregoing, to the extent that the provisions on indemnification and contribution contained in the underwriting agreement entered

 

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into in connection with the underwritten public offering are in conflict with the foregoing provisions, the provisions in the underwriting agreement shall control.

 

(f)                              Unless otherwise superseded by an underwriting agreement entered into in connection with the underwritten public offering, the obligations of the Company and Holders under this Subsection 2.8 shall survive the completion of any offering of Registrable Securities in a registration under this Section 2, and otherwise shall survive the termination of this Agreement.

 

2.9                               Reports Under Exchange Act. With a view to making available to the Holders the benefits of SEC Rule 144 and any other rule or regulation of the SEC that may at any time permit a Holder to sell securities of the Company to the public without registration or pursuant to a registration on Form F-3, the Company shall:

 

(a)                                 make and keep available adequate current public information, as those terms are understood and defined in SEC Rule 144, at all times after the effective date of the Registration Statement filed by the Company for the IPO;

 

(b)                                 use commercially reasonable efforts to file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act (at any time after the Company has become subject to such reporting requirements); and

 

(c)                                  furnish to any Holder, so long as the Holder owns any Registrable Securities, forthwith upon request (i) to the extent accurate, a written statement by the Company that it has complied with the reporting requirements of SEC Rule 144 (at any time after ninety (90) days after the effective date of the Registration Statement filed by the Company for the IPO), the Securities Act, and the Exchange Act (at any time after the Company has become subject to such reporting requirements), or that it qualifies as a registrant whose securities may be resold pursuant to Form F-3 (at any time after the Company so qualifies); and (ii) such other information as may be reasonably requested in availing any Holder of any rule or regulation of the SEC that permits the selling of any such securities without registration (at any time after the Company has become subject to the reporting requirements under the Exchange Act) or pursuant to Form F-3 (at any time after the Company so qualifies to use such form).

 

2.10          Limitations on Subsequent Registration Rights. From and after the date of this Agreement, the Company shall not, without the prior written consent of the Holders of a majority of the Registrable Securities then outstanding, enter into any agreement with any holder or prospective holder of any securities of the Company that would provide to such holder the right to include securities in any registration on other than either a pro rata basis with respect to the Registrable Securities or on a subordinate basis after all Holders have had the opportunity to include in the registration and offering all shares of Registrable Securities that they wish to so include; provided that this limitation shall not apply to any additional Investor who becomes a party to this Agreement in accordance with Subsection 4.9.

 

2.11          “Market Stand-off” Agreement. Each Holder hereby agrees that it will not, without the prior written consent of the managing underwriter, during the period

 

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commencing on the date of the final Prospectus relating to the registration by the Company for its own behalf of shares of its Common Stock or any other equity securities under the Securities Act on a Registration Statement on Form F-1 or Form F-3, and ending on the date specified by the Company and the managing underwriter (such period not to exceed one hundred eighty (180) days in the case of the IPO, or such other period as may be requested by the Company or an underwriter to accommodate regulatory restrictions on (1) the publication or other distribution of research reports, and (2) analyst recommendations and opinions, including, but not limited to, the restrictions contained in FINRA Rule 2711(f)(4) or NYSE Rule 472(f)(4), or any successor provisions or amendments thereto), or such other period as may be requested by the Company or an underwriter to accommodate regulatory restrictions on (1) the publication or other distribution of research reports and (2) analyst recommendations and opinions, including, but not limited to, the restrictions contained in FINRA Rule 2711(f)(4) or NYSE Rule 472(f)(4), or any successor provisions or amendments thereto) (the applicable termination date of each such period, the “Lockup Termination Date”), (i) lend; offer; pledge; sell; contract to sell; sell any option or contract to purchase; purchase any option or contract to sell; grant any option, right, or warrant to purchase; or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock or any securities convertible into or exercisable or exchangeable (directly or indirectly) for Common Stock (whether such shares or any such securities are then owned by the Holder or are thereafter acquired) or (ii) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of such securities, whether any such transaction described in clause (i) or (ii) above is to be settled by delivery of Common Stock or other securities, in cash, or otherwise. The foregoing provisions of this Subsection 2.11 shall apply only to an IPO, shall not apply to the sale of any shares to an underwriter pursuant to an underwriting agreement, or the transfer of any shares to any trust for the direct or indirect benefit of the Holder or the immediate family of the Holder, provided that the trustee of the trust agrees to be bound in writing by the restrictions set forth herein, and provided  further that any such transfer shall not involve a disposition for value, and shall be applicable to the Holders only if all officers and directors are subject to the same restrictions and the Company uses commercially reasonable efforts to obtain a similar agreement from all stockholders individually owning more than one percent (1%) of the Company’s outstanding Common Stock. The underwriters in connection with such registration are intended third-party beneficiaries of this Subsection 2.11 and shall have the right, power and authority to enforce the provisions hereof as though they were a party hereto. Each Holder further agrees to execute such agreements as may be reasonably requested by the underwriters in connection with such registration that are consistent with this Subsection 2.11 or that are necessary to give further effect thereto. Any discretionary waiver or termination of the restrictions of any or all of such agreements by the Company or the underwriters shall apply pro rata to all Holders subject to such agreements, based on the number of shares subject to such agreements.

 

2.12          Termination of Registration Rights. The rights of any Holder to request registration or inclusion of Registrable Securities in any registration pursuant to Subsections 2.1 or 2.2 shall terminate only at such time as SEC Rule 144 or other similar exemption under the Securities Act is available for the sale of all of such Holder’s shares without any restriction including volume or any other limitations.

 

20

 

3.                                      Additional Covenants.

 

3.1          Successor Indemnification. If the Company or any of its successors or assignees consolidates with or merges into any other Person and is not the continuing or surviving corporation or entity of such consolidation or merger, then to the extent necessary, proper provision shall be made so that the successors and assignees of the Company assume the obligations of the Company with respect to indemnification of members of the Board of Directors as in effect immediately before such transaction, whether such obligations are contained in the Company’s Bylaws, its Certificate of Incorporation, or elsewhere, as the case may be.

 

3.2          Right to Conduct Activities. The Company hereby agrees and acknowledges that NEA and New Leaf (together with their respective affiliates) are a professional investment funds, and as such invests in numerous portfolio companies, some of which may be deemed competitive with the Company’s business (as currently conducted or as currently propose to be conducted). The Company hereby agrees that, to the extent permitted under applicable law, NEA and New Leaf shall not be liable to the Company for any claim arising out of, or based upon, (i) the investment by NEA or New Leaf in any entity competitive with the Company, or (ii) actions taken by any partner, officer or other representative of NEA and New Leaf to assist any such competitive company, whether or not such action was taken as a member of the board of directors of such competitive company or otherwise, and whether or not such action has a detrimental effect on the Company; provided, however, that the foregoing shall not relieve (x) any of the Investors from liability associated with the unauthorized disclosure of the Company’s confidential information obtained pursuant to this Agreement, or (y) any director or officer of the Company from any liability associated with his or her fiduciary duties to the Company.

 

3.3          Termination of Covenants. The covenants set forth in this Section 3, except for Subsection 3.1, shall terminate and be of no further force or effect (i) immediately before the consummation of the IPO or (ii) when the Company first becomes subject to the periodic reporting requirements of Section 12(g) or 15(d) of the Exchange Act, or (iii) upon a Change of Control.

 

4.             Miscellaneous.

 

4.1          Successors and Assigns. The rights under this Agreement may be assigned (but only with all related obligations) by a Holder to a transferee of Registrable Securities that (i) is an Affiliate of a Holder; (ii) is a Holder’s Immediate Family Member or trust for the benefit of an individual Holder or one or more of such Holder’s Immediate Family Members; or (iii) after such transfer, holds at least ten percent (10%) of the Registrable Securities (subject to appropriate adjustment for stock splits, stock dividends, combinations, and other recapitalizations); provided, however, that (x) the Company is, within a reasonable time after such transfer, furnished with written notice of the name and address of such transferee and the Registrable Securities with respect to which such rights are being transferred; and (y) such transferee agrees in a written instrument delivered to the Company to be bound by and subject to the terms and conditions of this Agreement, including the provisions of Subsection 2.11. For the purposes of determining the number of shares of Registrable Securities held by a transferee, the holdings of a transferee (1) that is an Affiliate or stockholder of a Holder; (2) who is a Holder’s

 

21

 

Immediate Family Member; or (3) that is a trust for the benefit of an individual Holder or such Holder’s Immediate Family Member shall be aggregated together and with those of the transferring Holder; provided  further that all transferees who would not qualify individually for assignment of rights shall have a single attorney-in-fact for the purpose of exercising any rights, receiving notices, or taking any action under this Agreement. The terms and conditions of this Agreement inure to the benefit of and are binding upon the respective successors and permitted assignees of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and permitted assignees any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided herein.

 

4.2          Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be determined in accordance with the internal law of the State of Delaware.

 

4.3          Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

 

4.4          Titles and Subtitles. The titles and subtitles used in this Agreement are for convenience only and are not to be considered in construing or interpreting this Agreement.

 

4.5          Notices. All notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively given upon the earlier of actual receipt or (i) personal delivery to the party to be notified; (ii) when sent, if sent by electronic mail or facsimile during the recipient’s normal business hours, and if not sent during normal business hours, then on the recipient’s next business day; (iii) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid; or (iv) one (1) business day after the business day of deposit with a nationally recognized overnight courier, freight prepaid, specifying next-day delivery, with written verification of receipt. All communications shall be sent to the respective parties at their addresses as set forth on Schedule A hereto, or to the principal office of the Company and to the attention of the Chief Executive Officer, in the case of the Company, or to such email address, facsimile number, or address as subsequently modified by written notice given in accordance with this Subsection 4.5. If notice is given to the Company, a copy shall also be sent to Dr.iur. Frank Gerhard, LL.M., Homburger AG, Prime Tower, Hardstrasse 201, CH-8005 Zurich, Switzerland.

 

4.6          Amendments and Waivers. Any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance, and either retroactively or prospectively) only with the written consent of the Company and the holders of a majority of the Registrable Securities then outstanding; provided that any provision hereof may be waived by any waiving party on such party’s own

 

22

 

behalf, without the consent of any other party. Notwithstanding the foregoing, this Agreement may not be amended or terminated and the observance of any term hereof may not be waived with respect to any Investor without the written consent of such Investor, unless such amendment, termination, or waiver applies to all Investors in the same fashion. The Company shall give prompt notice of any amendment or termination hereof or waiver hereunder to any party hereto that did not consent in writing to such amendment, termination, or waiver. Any amendment, termination, or waiver effected in accordance with this Subsection 4.6 shall be binding on all parties hereto, regardless of whether any such party has consented thereto. No waivers of or exceptions to any term, condition, or provision of this Agreement, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such term, condition, or provision.

 

4.7          Severability. In case any one or more of the provisions contained in this Agreement is for any reason held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provision of this Agreement, and such invalid, illegal, or unenforceable provision shall be reformed and construed so that it will be valid, legal, and enforceable to the maximum extent permitted by law.

 

4.8          Aggregation of Stock. All shares of Registrable Securities held or acquired by Affiliates shall be aggregated together for the purpose of determining the availability of any rights under this Agreement and such Affiliated persons may apportion such rights as among themselves in any manner they deem appropriate.

 

4.9          Additional Investors. Notwithstanding anything to the contrary contained herein, if the Company issues additional shares of the Company’s Common Stock after the date hereof, pursuant to the Investment Agreement, any purchaser of such shares of Common Stock may become a party to this Agreement by executing and delivering an additional counterpart signature page to this Agreement, and thereafter shall be deemed an “Investor” for all purposes hereunder. No action or consent by the Investors shall be required for such joinder to this Agreement by such additional Investor, so long as such additional Investor has agreed in writing to be bound by all of the obligations as an “Investor” hereunder.

 

4.10          Entire Agreement. This Agreement (including any Schedules and Exhibits hereto) constitutes the full and entire understanding and agreement among the parties with respect to the subject matter hereof, and any other written or oral agreement relating to the subject matter hereof existing between the parties is expressly canceled.

 

4.11          Dispute Resolution. The parties (a) hereby irrevocably and unconditionally submit to the jurisdiction of the state courts of Delaware and to the jurisdiction of the United States District Court for the District of Delaware for the purpose of any suit, action or other proceeding arising out of or based upon this Agreement, (b) agree not to commence any suit, action or other proceeding arising out of or based upon this Agreement except in the state courts of Delaware or the United States District Court for the District of Delaware, and (c) hereby waive, and agree not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that

 

23

 

the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court.

 

WAIVER OF JURY TRIAL: EACH PARTY HEREBY WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF THIS AGREEMENT, THE INVESTMENT AGREEMENT, THE SECURITIES OR THE SUBJECT MATTER HEREOF OR THEREOF. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS TRANSACTION, INCLUDING, WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS (INCLUDING NEGLIGENCE), BREACH OF DUTY CLAIMS, AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THIS SECTION HAS BEEN FULLY DISCUSSED BY EACH OF THE PARTIES HERETO AND THESE PROVISIONS WILL NOT BE SUBJECT TO ANY EXCEPTIONS. EACH PARTY HERETO HEREBY FURTHER WARRANTS AND REPRESENTS THAT SUCH PARTY HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT SUCH PARTY KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL.

 

4.12          Delays or Omissions. No delay or omission to exercise any right, power, or remedy accruing to any party under this Agreement, upon any breach or default of any other party under this Agreement, shall impair any such right, power, or remedy of such nonbreaching or nondefaulting party, nor shall it be construed to be a waiver of or acquiescence to any such breach or default, or to any similar breach or default thereafter occurring, nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. All remedies, whether under this Agreement or by law or otherwise afforded to any party, shall be cumulative and not alternative.

 

4.13          Acknowledgment. The Company acknowledges that the Investors are in the business of venture capital investing and therefore review the business plans and related proprietary information of many enterprises, including enterprises which may have products or services which compete directly or indirectly with those of the Company. Nothing in this Agreement shall preclude or in any way restrict the Investors from investing or participating in any particular enterprise whether or not such enterprise has products or services which compete with those of the Company.

 

[Remainder of Page Intentionally Left Blank]

 

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

 

	
 
    	
ADDEX THERAPEUTICS LTD.
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ T.M. Dyer
    
	
 
    	
Name:
    	
T.M. Dyer
    
	
 
    	
Title: 
    	
CEO
    
	
 
    	
 
    	
 
    
	
 
    	
INVESTORS:
    
	
 
    	
 
    	
 
    
	
 
    	
Growth Equity Opportunities   Fund IV, LLC
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
 
    
	
 
    	
Name:
    	
 
    
	
 
    	
Title:
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
New Leaf Biopharma   Opportunities I, L.P.
    
	
 
    	
 
    	
 
    
	
 
    	
By:New Leaf BPO   Associates I, L.P. 
    
	
 
    	
Its: General Partner
    
	
 
    	
 
    	
 
    
	
 
    	
By:New Leaf Venture   Management III, L.L.C. 
    
	
 
    	
Its: General Partner
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ Craig L. Slutzkin
    
	
 
    	
 
    	
Craig L. Slutzkin
    
	
 
    	
 
    	
Chief Financial Officer
    

 

SIGNATURE PAGE REGISTRATION RIGHTS AGREEMENT

 

 

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

 

	
 
    	
ADDEX THERAPEUTICS LTD.
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
 
    
	
 
    	
Name:
    	
 
    
	
 
    	
Title:
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
INVESTORS:
    
	
 
    	
 
    	
 
    
	
 
    	
Growth Equity Opportunities   Fund IV, LLC
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ Louis s. Citron
    
	
 
    	
Name: 
    	
Louis s. Citron
    
	
 
    	
Title:
    	
Chief legal officer
    
	
 
    	
 
    	
 
    
	
 
    	
New Leaf Biopharma   Opportunities I, L.P.
    
	
 
    	
 
    	
 
    
	
 
    	
By:New Leaf BPO   Associates I, L.P. 
    
	
 
    	
Its: General Partner
    
	
 
    	
 
    
	
 
    	
By:New Leaf Venture   Management III, L.L.C. 
    
	
 
    	
Its: General Partner
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
 
    
	
 
    	
 
    	
Craig L. Slutzkin
    
	
 
    	
 
    	
Chief Financial Officer
    

 

SIGNATURE PAGE REGISTRATION RIGHTS AGREEMENT

 

 

	
 
    	
CDK Associates. L.L.C
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ Karen Cross
    
	
 
    	
Name: 
    	
Karen Cross
    
	
 
    	
Title:
    	
Treasurer
    

 

SIGNATURE PAGE REGISTRATION RIGHTS AGREEMENT

 

 

SCHEDULE A

 

Investors

 

1)             Growth Equity Opportunities Fund IV, LLC

c/o New Enterprise Associates 16, L.P.

Attn.: Louis S. Citron

1954 Greenspring Drive, Suite 600

Timonium, MD 21093

Email: LCitron@NEA.com

Fax: +1 410 842 4115

 

With copy, which copy shall not constitute notice, to:

 

Greenberg Traurig, LLP 
 Attn.: Trevor Chaplick 
 2101 L St. NW, Suite 1000 
 Washington, DC 20037 
 Email: 

Fax: 

 

2)             New Leaf Biopharma Opportunities I, L.P.

Attn: Craig L. Slutzkin

7 Times Square, Suite 3502

New York, NY 10036

Email: 

Fax: 

 

3)             CDK Associates. L.L.C

Attn: Heath N. Weisberg

CAM Capital

731 Alexander Road

Bldg. 2, Suite 500

Princeton, NJ 08540

Email: 

Fax: 

 

 

ANNEX A

 

PLAN OF DISTRIBUTION

 

We are registering the shares of Common Stock issued to the selling stockholders and issuable upon the exercise of the warrants issued to the selling stockholders to permit the resale of these shares of Common Stock by the holders of the shares of Common Stock and warrants from time to time after the date of this prospectus. We will not receive any of the proceeds from the sale by the selling stockholders of the shares of Common Stock. We will bear all fees and expenses incident to our obligation to register the shares of Common Stock.

 

The selling stockholders may sell all or a portion of the shares of Common Stock beneficially owned by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers or agents. If the shares of Common Stock are sold through underwriters or broker-dealers, the selling stockholders will be responsible for underwriting discounts or commissions or agent’s commissions. The shares of Common Stock may be sold on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale, in the over-the-counter market or in transactions otherwise than on these exchanges or systems or in the over-the-counter market and in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions. The selling stockholders may use any one or more of the following methods when selling shares:

 

·                  ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

 

·                  block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;

 

·                  purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

 

·                  an exchange distribution in accordance with the rules of the applicable exchange;

 

·                  privately negotiated transactions;

 

·                  settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part;

 

·                  broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share;

 

·                  through the writing or settlement of options or other hedging transactions, whether such options are listed on an options exchange or otherwise;

 

·                  a combination of any such methods of sale; and

 

·                  any other method permitted pursuant to applicable law.

 

The selling stockholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, as permitted by that rule, or Section 4(1) under the Securities Act, if available, rather than under this prospectus, provided that they meet the criteria and conform to the requirements of those provisions.

 

Broker-dealers engaged by the selling stockholders may arrange for other broker-dealers to participate in sales. If the selling stockholders effect such transactions by selling shares of Common Stock to or through underwriters, broker-dealers or agents, such underwriters, broker-

 

 

dealers or agents may receive commissions in the form of discounts, concessions or commissions from the selling stockholders or commissions from purchasers of the shares of Common Stock for whom they may act as agent or to whom they may sell as principal. Such commissions will be in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction will not be in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or markdown in compliance with FINRA IM-2440.

 

In connection with sales of the shares of Common Stock or otherwise, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the shares of Common Stock in the course of hedging in positions they assume. The selling stockholders may also sell shares of Common Stock short and if such short sale shall take place after the date that this Registration Statement is declared effective by the Commission, the selling stockholders may deliver shares of Common Stock covered by this prospectus to close out short positions and to return borrowed shares in connection with such short sales. The selling stockholders may also loan or pledge shares of Common Stock to broker-dealers that in turn may sell such shares, to the extent permitted by applicable law. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction). Notwithstanding the foregoing, the selling stockholders have been advised that they may not use shares registered on this registration statement to cover short sales of our shares of Common Stock made prior to the date the registration statement, of which this prospectus forms a part, has been declared effective by the SEC.

 

The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the shares of Common Stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of Common Stock from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act of 1933, as amended, amending, if necessary, the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders also may transfer and donate the shares of Common Stock in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

 

The selling stockholders and any broker-dealer or agents participating in the distribution of the shares of Common Stock may be deemed to be “underwriters” within the meaning of Section 2(11) of the Securities Act in connection with such sales. In such event, any commissions paid, or any discounts or concessions allowed to, any such broker-dealer or agent and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Selling Stockholders who are “underwriters” within the meaning of Section 2(11) of the Securities Act will be subject to the applicable prospectus delivery requirements of the Securities Act including Rule 172 thereunder and may be subject to certain statutory liabilities of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

 

Each selling stockholder has informed the Company that it is not a registered broker-dealer and does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the shares of Common Stock. Upon the Company being notified in writing by a selling stockholder that any material arrangement has been entered into with a broker-dealer for the sale of shares of Common Stock through a block trade, special offering, exchange distribution or secondary distribution or a purchase by a broker or dealer, a supplement to this prospectus will be filed, if required, pursuant to Rule 424(b) under the Securities Act, disclosing (i) the name of each such selling stockholder and of the participating broker-dealer(s),

 

 

(ii) the number of shares involved, (iii) the price at which such the shares of Common Stock were sold, (iv) the commissions paid or discounts or concessions allowed to such broker-dealer(s), where applicable, (v) that such broker-dealer(s) did not conduct any investigation to verify the information set out or incorporated by reference in this prospectus, and (vi) other facts material to the transaction. In no event shall any broker-dealer receive fees, commissions and markups, which, in the aggregate, would exceed eight percent (8.0%).

 

Under the securities laws of some states, the shares of Common Stock may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the shares of Common Stock may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with.

 

There can be no assurance that any selling stockholder will sell any or all of the shares of Common Stock registered pursuant to the shelf registration statement, of which this prospectus forms a part.

 

Each selling stockholder and any other person participating in such distribution will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including, without limitation, to the extent applicable, Regulation M of the Exchange Act, which may limit the timing of purchases and sales of any of the shares of Common Stock by the selling stockholder and any other participating person. To the extent applicable, Regulation M may also restrict the ability of any person engaged in the distribution of the shares of Common Stock to engage in market-making activities with respect to the shares of Common Stock. All of the foregoing may affect the marketability of the shares of Common Stock and the ability of any person or entity to engage in market-making activities with respect to the shares of Common Stock.

 

We will pay all expenses of the registration of the shares of Common Stock pursuant to the registration rights agreement, including, without limitation, Securities and Exchange Commission filing fees and expenses of compliance with state securities or “blue sky” laws; provided, however, that each selling stockholder will pay all underwriting discounts and selling commissions, if any and any related legal expenses incurred by it. We will indemnify the selling stockholders against certain liabilities, including some liabilities under the Securities Act, in accordance with the registration rights agreement, or the selling stockholders will be entitled to contribution. We may be indemnified by the selling stockholders against civil liabilities, including liabilities under the Securities Act, that may arise from any written information furnished to us by the selling stockholders specifically for use in this prospectus, in accordance with the related registration rights agreements, or we may be entitled to contribution.

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