EX-10.10 3 kymr-ex10_10.htm EX-10.10 EX-10.10

Exhibit 10.10

Certain identified information has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential. Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”.

 

 

 

 

AMENDED AND RESTATED

COLLABORATION AND LICENSE AGREEMENT

BETWEEN

GENZYME CORPORATION

AND

KYMERA THERAPEUTICS, INC.

 

November 15, 2022

 

 

 


Exhibit 10.10

 

TABLE OF CONTENTS

 

Article 1 DEFINITIONS

1

Article 2 Research

42

Article 3 EARLY DEVELOPMENT

55

Article 4 SANOFI PARTICIPATION ELECTION RIGHT

62

Article 5 DEVELOPMENT AFTER SANOFI PARTICIPATION ELECTION

64

Article 6 Commercialization

78

Article 7 Regulatory Matters

85

Article 8 Manufacturing

89

Article 9 GOVERNANCE

92

Article 10 LICENSE GRANTS; EXCLUSIVITY

109

Article 11 FINANCIAL PROVISIONS

115

Article 12 INTELLECTUAL PROPERTY

144

Article 13 REPRESENTATIONS AND WARRANTIES

162

Article 14 INDEMNIFICATION; INSURANCE; LIMITATIONS

169

Article 15 TERM; TERMINATION

171

Article 16 CONFIDENTIALITY

184

Article 17 GOVERNMENTAL APPROVALS

188

Article 18 MISCELLANEOUS

189

 

 

 

 

 

 

 

 

 

 


CONFIDENTIAL

 

SCHEDULES AND EXHIBITS

 

 

Schedules

Schedule 1.16 Approved Third Party Contractors

Schedule 1.157 [***]

Schedule 1.167 Initial Collaboration Target 1 Degrader

Schedule 1.187 [***]

Schedule 1.188 [***]

Schedule 1.189 [***]

Schedule 1.193 [***]

Schedule 1.214 [***]

Schedule 1.229 M2 Criteria

Schedule 1.259 Opt-In Data Package

Schedule 1.268 Participation Data Package

Schedule 1.275 Patent Resolution Procedures

Schedule 1.286 Phase 1 Patient Data Package

Schedule 1.287 Phase 1 Ready Criteria

Schedule 1.294 Phase 2 Ready Criteria

Schedule 1.318 Qualified Third Parties

Schedule 1.367 Screening Criteria

Schedule 2.3.1 Research Plan

Schedule 3.1.1(d) [***]

Schedule 3.2.1 Early Development Plan

Schedule 5.3.1 Late Development Plan

Schedule 8.4 CMOs

Schedule 9.9.2(b)(iii) Expert Disputes

Schedule 9.9.2(b)(iv) Arbitration

Schedule 9.9.2(b)(v) “Baseball” Arbitration

 

Exhibits

Exhibit A Terms and Conditions of Development Cost Sharing

Exhibit B Terms and Conditions of Co-Promotion Agreement

Exhibit C Terms and Conditions of Cost/Profit Sharing Agreement

Exhibit D Kymera Press Release

Exhibit E Sanofi’s form of Phase 2 Election Notice

 

 

 

 

 


CONFIDENTIAL

 

AMENDED AND RESTATED

COLLABORATION AND LICENSE AGREEMENT

This Amended and Restated Collaboration and License Agreement (this “Agreement”) is executed as of November 15, 2022 (the “Restatement Execution Date”) and is by and between Genzyme Corporation, a corporation organized under the laws of the Commonwealth of Massachusetts (“Sanofi”), and Kymera Therapeutics, Inc., a corporation organized under the laws of the State of Delaware (“Kymera”). Sanofi and Kymera each may be referred to herein individually as a “Party” or collectively as the “Parties.”

RECITALS

WHEREAS, Kymera controls certain Patents and Know-How, technology and expertise relating to ubiquitin-mediated protein degradation therapeutics;

WHEREAS, Sanofi is a global biopharmaceutical company that has expertise in the development and commercialization of pharmaceutical products;

WHEREAS, the Parties entered into that certain Collaboration and License Agreement dated as of Original Agreement Execution Date (the “Original Agreement”), pursuant to which the Parties established a strategic collaboration focused on the research, development and commercialization of ubiquitin-mediated protein degradation therapeutics Directed Against the Collaboration Targets for use in the applicable Field; and

WHEREAS, the Parties now desire to amend and restate the Original Agreement in its entirety and replace the Original Agreement with this Agreement.

NOW, THEREFORE, in consideration of the respective covenants, representations, warranties and agreements set forth herein, the Parties hereto agree as follows:

Article 1
DEFINITIONS

For purposes of this Agreement, the following capitalized terms will have the following meanings:

1.1 “A&R FAD Research Term” has the meaning set forth in Section 2.4.2.

1.2 “Accounting Standards” means, with respect to a Party or its Affiliate or Sublicensee, GAAP or IFRS, as such Party, Affiliate or Sublicensee uses for its financial reporting obligations, in each case, consistently applied.

1.3 “Acquired Party” has the meaning set forth in Section 10.8.1.

1.4 “Acquirer” has the meaning set forth in Section 1.44.

1.5 “Acquiring Parties” has the meaning set forth in Section 10.8.2.

1


CONFIDENTIAL

 

1.6 “Acquisition Transaction” has the meaning set forth in Section 10.7.1.

1.7 “Actions” has the meaning set forth in Section 18.11.

1.8 “Affiliate” means, as of any point in time and for so long as such relationship continues to exist with respect to any Person, any other Person that controls, is controlled by or is under common control with such Person. A Person will be regarded as in control of another Person if it (a) owns or controls, directly or indirectly, more than fifty percent (50%) of the equity securities of the subject Person entitled to vote in the election of directors (or, in the case of a Person that is not a corporation, for the election of the corresponding managing authority), or (b) possesses, directly or indirectly, the power to direct or cause the direction of the management or policies of such Person (whether through ownership of securities or other ownership interests, by contract or otherwise).

1.9 “Agreement” has the meaning set forth in the Preamble.

1.10 “Alliance Manager” has the meaning set forth in Section 9.12.1.

1.11 “Allocation Methodology” has the meaning set forth in Exhibit C.

1.12 “Allowable Expenses” has the meaning set forth in Exhibit C.

1.13 “Annual Net Sales” has the meaning set forth in Section 11.2.4.

1.14 “Applicable Law” means all applicable laws, statutes, rules, regulations and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, agency or other body, domestic or foreign, including any applicable rules, regulations, guidelines, or other requirements of the Regulatory Authorities that may be in effect from time to time, including the United States Federal Food, Drug, and Cosmetic Act, as amended, GCP, GLP and GMP, anti-bribery laws, such as the United States Anti-Kickback Statute, Foreign Corrupt Practices Act and UK Bribery Act, as well as all applicable data protection and privacy laws, rules and regulations, including the United States Department of Health and Human Services privacy rules under the Health Insurance Portability and Accountability Act, as amended, and the Health Information Technology for Economic and Clinical Health Act and the EU General Data Protection Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, along with other country-level data protection laws, as may be applicable.

1.15 “Approval Application” means an NDA or similar application or submission for a pharmaceutical product to a Regulatory Authority in a country or group of countries to obtain Marketing Approval for such pharmaceutical product in that country or group of countries, including any amendment thereof.

1.16 “Approved Third Party Contractors” means (a) the Third Party contractors set forth on Schedule 1.16, and (b) any Subcontractor approved by the JRDC (such approval not to be unreasonably withheld, conditioned or delayed by either Party’s representatives on the JRDC).

2


CONFIDENTIAL

 

1.17 “Arbitrator” means (a) with respect to Schedule 9.9.2(b)(iv), an individual who (i) is a qualified attorney in private practice or a retired judge, each admitted to practice law in the United States, with expertise in intellectual property matters in the pharmaceutical or biotechnology industry, (ii) is professionally fluent in English, (iii) is not from academia, (iv) has not worked for or been engaged by either Party or its Affiliates, or any other portfolio companies of its material investors, in the [***] period immediately prior to selection of such individual, or (v) does not own equity or debt in either Party or its Affiliates (other than equity or debt owned through a broad based mutual fund or exchange trade fund) and, (b) with respect to Schedule 9.9.2(b)(v), an individual who (i) is a qualified attorney in private practice or a retired judge, each admitted to practice law the United States, with relevant experience in financial disputes pertaining the pharmaceutical products, (ii) is professionally fluent in English, (iii) is not from academia, (iv) has not worked for or been engaged by either Party or its Affiliates, or any other portfolio companies of its material investors, in the [***] period immediately prior to selection of such individual, or (v) does not own equity or debt in either Party or its Affiliates (other than equity or debt owned through a broad based mutual fund or exchange trade fund).

1.18 “Audited Party” has the meaning set forth in Section 11.9.

1.19 “Auditing Party” has the meaning set forth in Section 11.9.

1.20 “Authorized Generic” means an authorized generic version of a Licensed Product that is Manufactured by or on behalf of Sanofi, its Affiliate or its Sublicensee or a Third Party designated by Sanofi or its Affiliate or Sublicensee.

1.21 “Backup Degrader Criteria” means [***].

1.22 “Backup Degraders” means (a) for Collaboration Target 1, the Backup Degraders for CT1, and (b) for Collaboration Target 2, the Backup Degraders for CT2.

1.23 “Backup Degraders for CT1” means [***]. Notwithstanding the foregoing exclusion, [***].

1.24 “Backup Degraders for CT2” means [***].

1.25 “Backup Research” has the meaning set forth in Section 5.5.1.

1.26 “Backup Research Budget” has the meaning set forth in Section 5.5.2.

1.27 “Backup Research Budget Excession” has the meaning set forth in Section 5.5.6.

1.28 “Backup Research Plan” has the meaning set forth in Section 5.5.2.

1.29 “Backup Research Term” has the meaning set forth in Section 5.5.2.

1.30 “Balancing Payment” has the meaning set forth in Exhibit C.

1.31 “Bankrupt Party” has the meaning set forth in Section 10.5.

3


CONFIDENTIAL

 

1.32 “Bankruptcy Code” has the meaning set forth in Section 10.5.

1.33 “Blocking Third Party Intellectual Property” means, with respect to a Collaboration Candidate or Licensed Product in any country, Patents or Know-How in such country owned or controlled by a Third Party (but not then included in Licensed Technology) that [***].

1.34 “Blocking Third Party Intellectual Property Costs” means [***].

1.35 “Branding Strategy” has the meaning set forth in Section 6.9.1.

1.36 “Breaching Party” means the Party that is believed by the other Party to be in material breach of this Agreement.

1.37 “Business Day” means a day, other than a Saturday or Sunday, on which national banks in each of the following locations are open for commercial banking business: Paris, France, Boston, Massachusetts, U.S. and Bridgewater, New Jersey, U.S.

1.38 “Calendar Period” has the meaning set forth in Exhibit B.

1.39 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, during the Term, or the applicable part thereof during the first or last calendar quarter of the Term.

1.40 “Calendar Year” means any year commencing on January 1 and ending on December 31, or the applicable part thereof during the first or last year of the Term.

1.41 “Calendar Year Net Sales” means, on a Licensed Product-by-Licensed Product basis, the total Net Sales by Sanofi, its Affiliates and Sublicensees in the Territory of such Licensed Product in a particular Calendar Year.

1.42 “CDA” has the meaning set forth in Section 1.76.

1.43 “[***]” means [***].

1.44 “Change of Control” means, with respect to a Party, (a) a merger or consolidation of such Party with an Acquirer that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, (b) a transaction or series of related transactions in which an Acquirer, together with its Affiliates, becomes the beneficial owner of more than fifty percent (50%) of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to an Acquirer of all or substantially all of such Party’s business to which the subject matter of this Agreement relates. Notwithstanding the foregoing, with respect to Kymera, the term “Change of Control” will not include any sale of shares of capital stock of Kymera, in a single transaction or series of related transactions in which Kymera issues new securities to institutional investors for cash or the cancellation or conversion of indebtedness or a combination thereof where such

4


CONFIDENTIAL

 

transaction(s) are conducted primarily for bona fide equity financing purposes. “Acquirer” means, in the context of a Change of Control, a Third Party or its Affiliates.

1.45 “Clinical Trial” means a study in humans that is required to be conducted in accordance with GCP and is designed to generate data in support of an Approval Application.

1.46 “CMC” means chemistry, manufacturing and controls.

1.47 “CMC Transfer Plan has the meaning set forth in Section 8.1.1(b).

1.48 “CMO” means any Third Party contract manufacturer.

1.49 “Co-Commercialization Budget” has the meaning set forth in Section 6.3.2.

1.50 “Co-Commercialization Plan” means, on a Collaboration Target-by-Collaboration Target basis, the [***] comprehensive plan for the Commercialization of the Opt-In Products Directed Against such Collaboration Target in [***], which will include the following:

1.50.1 [***]

1.50.2 [***]

1.50.3 [***]

1.50.4 [***]

1.50.5 [***].

1.51 “Co-Promote” means, on a Collaboration Target-by-Collaboration Target basis, with respect to the Opt-In Products Directed Against such Collaboration Target for which Kymera exercises the Kymera Co-Promote Right for such Collaboration Target in accordance with Section 9.2.2(i), Detailing activities with respect to such Opt-In Products undertaken by or on behalf of either Party in the United States pursuant to the terms set forth in Exhibit B. “Co-Promotion” and “Co-Promoting” will have a correlative meaning.

1.52 “Co-Promote Opt-Out Right” has the meaning set forth in Exhibit B.

1.53 “Co-Promote Period” means, on a Collaboration Target-by-Collaboration Target basis, the period of time from the Kymera Co-Promote Effective Date (if any) until the termination or expiration of the Co-Promotion Agreement.

1.54 “Co-Promotion Agreement” has the meaning set forth in Section 6.2.7.

1.55 “Co-Promotion Plan” has the meaning set forth in Exhibit B.

1.56 “Co-Promotion Term” has the meaning set forth in Exhibit B.

5


CONFIDENTIAL

 

1.57 “Co-Promotion Wind-Down Period” has the meaning set forth in Section 5.7.11(b).

1.58 “Collaboration Candidates” means any [***].

1.59 “Collaboration Compounds” means, (a) for Collaboration Target 1, the Collaboration Target 1 Degraders, and (b) for Collaboration Target 2, the Collaboration Target 2 Degraders.

1.60 “Collaboration In-License” has the meaning set forth in Section 11.5.1(b).

1.61 “Collaboration In-License Agreement” has the meaning set forth in Section 11.5.2.

1.62 “Collaboration Target” means Collaboration Target 1 or Collaboration Target 2, as the context requires.

1.63 “Collaboration Target 1” means [***].

1.64 “Collaboration Target 1 Degraders” means [***]. For clarity, the Collaboration Target 1 Degraders exclude [***].

1.65 “Collaboration Target 2” means [***].

1.66 “Collaboration Target 2 Degraders” means (a) the Initial Collaboration Target 2 Degraders, and (b) the Backup Degraders for CT2.

1.67 “Combination Product” has the meaning set forth in Section 1.250(j).

1.68 “Commercial Milestone Event” has the meaning set forth in Section 11.2.4.

1.69 “Commercial Milestone Payment” has the meaning set forth in Section 11.2.4.

1.70 “Commercialize” or “Commercializing” means, in respect of a Licensed Product, to (a) market, advertise, promote, Detail, distribute, offer for sale, sell, have sold, import, have imported, export, have exported or otherwise exploit, (b) conduct activities, other than Research, Development and Manufacturing, in preparation for the foregoing activities, including obtaining Price Approval or (c) conduct post-Marketing Approval commitments or studies (including Phase 4 Clinical Trials). When used as a noun, “Commercialization” means any activities involved in Commercializing.

1.71 “Commercially Reasonable Efforts” means [***].

1.72 “Committee” means each of the JSC and each Subcommittee.

1.73 “Competing Party” has the meaning set forth in Section 10.7.1.

1.74 “Competing Product” has the meaning set forth in Section 10.7.1.

6


CONFIDENTIAL

 

1.75 “Competitive Infringement” has the meaning set forth in Section 12.4.1.

1.76 “Confidential Information” means, with respect to each Party, all Know-How or other information, including proprietary information (whether or not patentable) regarding or embodying such Party’s technology, products, business information or objectives, that is communicated in any way or form by or on behalf of the Disclosing Party to the Receiving Party or its permitted recipients, pursuant to this Agreement or that certain Confidentiality Agreement between Sanofi and Kymera dated July 31, 2018, as amended or restated from time to time (the “CDA”), whether or not such Know-How or other information is identified as confidential at the time of disclosure. For clarity, the Degrader Platform will be the Confidential Information of Kymera. Notwithstanding the foregoing, Confidential Information does not include any Know-How or information that: (a) was already known by the Receiving Party (other than under an obligation of confidentiality to the Disclosing Party) at the time of disclosure by or on behalf of the Disclosing Party; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party; (c) became generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party, other than through any act or omission of the Receiving Party in breach of its obligations under this Agreement; (d) was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to the Receiving Party; or (e) was independently discovered or developed by or on behalf of the Receiving Party without the use of any Confidential Information belonging to the Disclosing Party. Confidential Information disclosed to the Receiving Party hereunder will not be deemed to fall within the foregoing exceptions merely because broader or related information falls within such exceptions, nor will combinations of elements or principles be considered to fall within the foregoing exceptions merely because individual elements of such combinations fall within such exceptions. Without limiting the foregoing, and notwithstanding clauses (a), (d) and (e) of the preceding sentence: [***].

1.77 “Control” or “Controlled” means with respect to a Party any Know-How, Patent or Materials, possession of the ability by such Party or its Affiliate (whether by sole or joint ownership, license or otherwise), other than pursuant to this Agreement, to grant, without violating the terms of any agreement with a Third Party, a license, access or other right in, to or under such Know-How, Patent or Materials. Notwithstanding anything in this Agreement to the contrary, a Party and its Affiliates will be deemed to not Control any Know-How, Patents or Materials that are owned or controlled by a Third Party described in the definition of “Change of Control,” or such Third Party’s Affiliates (other than an Affiliate of such Party prior to the Change of Control), (a) prior to the closing of such Change of Control, except to the extent that any such Know-How, Patents or Materials were developed by such Third Party prior to such Change of Control using or incorporating such Party’s or its pre-existing Affiliate’s Know-How, Patents or Materials, or (b) after such Change of Control to the extent that such Know-How, Patents or Materials are developed or conceived by such Third Party or its Affiliates (other than such Party) after such Change of Control without using or incorporating such Party’s or its pre-existing Affiliate’s Know-How, Patents or Materials. Kymera and its Affiliates will not be deemed to Control any Patents or Know-How licensed to Kymera pursuant to a Potential In-License entered into after the Original Agreement Execution Date unless such Potential In-License becomes a Collaboration In-License Agreement in accordance with Sections 11.5.1(b)(i) or 11.5.2.

7


CONFIDENTIAL

 

1.78 “Corrective Plan” has the meaning set forth in Exhibit B.

1.79 “Cost/Profit Share” has the meaning set forth in Section 5.7.9.

1.80 “Cost/Profit Sharing Agreement” has the meaning set forth in Section 5.7.8.

1.81 “Counterparty” has the meaning set forth in Section 1.399.

1.82 “Cover,” “Covering” or “Covers” means (a) as to a compound or product (or [***]) and a Patent, that, in the absence of a license granted under, or ownership of, such Patent, the making, using, selling, offering for sale or importation of such compound or product (or [***]) would infringe such Patent or, as to a pending claim included in such Patent, the making, using, selling, offering for sale or importation of such compound or product (or [***]) would infringe such Patent if such pending claim were to issue in an issued patent without modification, (b) as to Know-How and a Patent, that, in the absence of a license granted under, or ownership of, such Patent, the use or practice of such Know-How would infringe such Patent or, as to a pending claim included in such Patent, the use or practice of such Know-How would infringe such Patent if such pending claim were to issue in an issued patent without modification and (c) as to a compound, product or technology and Know-How, that the exploitation of such compound, product or technology incorporates, uses, employs, embodies, or practices such Know-How.

1.83 “CTA” has the meaning set forth in Section 1.161.

1.84 “[***]” means, [***].

1.85 “Defending Party” has the meaning set forth in Section 12.3.

1.86 “Deferred Costs” has the meaning set forth in Exhibit A.

1.87 “Degrader” means [***].

1.88 “[***]” means, [***]. For clarity, [***].

1.89 “[***]” has the meaning set forth in Section 9.9.2(b)(iv).

1.90 “Degrader Platform” means Kymera’s proprietary Know-How with respect to the identification, development, synthesis, manufacture and optimization of Degraders, including any such proprietary Know-How with respect to [***], together with any and all Patents Controlled by Kymera or its Affiliates that Cover any of the foregoing Know-How; provided that, [***]. For clarity, Know-How of Kymera will be considered proprietary if [***].

1.91 “Designated Sales Force” has the meaning set forth in Exhibit B.

1.92 “Detail” or “Detailing” means, with respect to an Opt-In Product in the Field in [***], a person-to-person (including, for clarity, e-details) contact between a sales representative and a physician or other medical professional licensed or authorized to prescribe drugs (including a nurse practitioner or physician assistant with prescribing authority) (a “Healthcare Prescriber”), during which a primary position detail or a secondary position detail is made to

8


CONFIDENTIAL

 

such person, in each case as measured by each Party’s internal recording of such activity in accordance with the Co-Promotion Agreement; provided that such meeting is consistent with, and in accordance with, the requirements of Applicable Law, Exhibit B and the applicable Co-Promotion Agreement. For the avoidance of doubt, the following activities will not constitute a “Detail”: sample drops; activities conducted at conventions, exhibit booths, speaker meetings or similar gatherings; a delivery of savings cards or coupons without discussion with a Healthcare Prescriber or other office staff member involved in the prescribing or reimbursement of an Opt-In Product; and activities of medical science liaisons and activities conducted by market development specialists, managed care account directors and other personnel not performing person-to-person sales calls or not specifically trained with respect to an Opt-In Product. The definition of “Detail” may be further refined in the applicable Co-Promotion Agreement. When used as a verb, “Detail” or “Detailing” means to engage in a Detail.

1.93 “Development” means, with respect to a Collaboration Compound, Collaboration Candidate or Licensed Product, all (a) non-clinical and pre-clinical research and development activities and optimization completed prior to filing an IND with respect to such Collaboration Compound, Collaboration Candidate or Licensed Product, including animal and toxicology studies (“Pre-Clinical Development”), and (b) clinical and non-clinical research and development activities conducted after filing of an IND with respect to such Collaboration Compound, Collaboration Candidate or Licensed Product, including toxicology, pharmacology test method development and stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, Clinical Trials (other than Phase 4 Clinical Trials), regulatory affairs, pharmacovigilance, Clinical Trial regulatory activities and obtaining and maintaining Marketing Approval. When used as a verb, “Develop” or “Developing” means to engage in Development.

1.94 “Development Costs” means [***].

1.95 “Development Milestone Events” has the meaning set forth in Section 11.2.3.

1.96 “Development Milestone Payments” has the meaning set forth in Section 11.2.3.

1.97 “Different” with respect to two (2) Indications means that [***].

1.98 “Directed Against” means, with respect to a Degrader and a Target, that such Degrader [***].

1.99 “Disclose,” “Disclosed,” or “Disclosing” means, as to a compound or product and a Patent, that, [***].

1.100 “Disclosing Party” has the meaning set forth in Section 16.1.

1.101 “Dispute” has the meaning set forth in Section 18.12.

1.102 “Distinct Indication” means (a) with respect to Collaboration Target 1, an Indication with a diagnosed prevalence in humans in [***] of no less [***] and (b) with respect to Collaboration Target 2, an Indication with a diagnosed prevalence in human [***] of no less than [***].

9


CONFIDENTIAL

 

1.103 “Distribution Costs” has the meaning set forth in Exhibit C.

1.104 “Distributor” means a Person who distributes, markets, and sells Licensed Products in the Territory (with or without packaging rights), in circumstances where the Person purchases its requirements of Products from Sanofi or its Affiliates or Sublicensees pursuant to a written agreement but does not otherwise make any royalty or other payment to Sanofi or its Affiliates with respect to its intellectual property or other proprietary rights. The term “packaging rights” in this Section means the right for the Distributor to package and label Licensed Products supplied in unpackaged bulk form into individual ready-for-sale packs.

1.105 “Divest” means, with respect to a Competing Product, the sale, exclusive license or other transfer by the applicable Party and its Affiliates of all of their development and commercialization rights with respect to such Competing Product to a Third Party without the retention or reservation of any development or commercialization obligation, interest or participation rights (other than solely an economic interest or the right to enforce customary terms contained in the relevant agreements effectuating such transaction).

1.106 “Early Development Activities” has the meaning set forth in Section 3.1.1(a).

1.107 “Early Development Milestone Event” has the meaning set forth in Section 11.2.1.

1.108 “Early Development Milestone Payment” has the meaning set forth in Section 11.2.1.

1.109 “Early Development Plan” has the meaning set forth in Section 3.2.1.

1.110 “EMA” means the European Medicines Agency and any successor entity thereto.

1.111 “European Commission” means the European Commission or any successor entity that is responsible for granting marketing approvals authorizing the sale of pharmaceuticals in the European Union.

1.112 “European Union” or “EU” means the European Union and all its then-current member countries but including in any case France, Germany, Italy, Spain and the United Kingdom regardless of whether they are then-current member countries.

1.113 “Excepted Matter” means [***].

1.114 “Excluded Compounds” means [***].

1.115 “Excluded Field” means, solely with respect to Collaboration Target 1, diagnosis, treatment, cure, mitigation or prevention of any diseases, disorders or conditions in Oncology.

1.116 “Exclusions” has the meaning set forth in Exhibit C.

1.117 “Exclusive Licenses” has the meaning set forth in Section 10.1.3.

10


CONFIDENTIAL

 

1.118 “Executive Officers” means the [***].

1.119 “Expert Dispute” has the meaning set forth in Section 9.9.2(b)(iii).

1.120 “FAD Permitted Overrun” has the meaning set forth in Section 2.4.5.

1.121 “FAD Research Budget Excession” has the meaning set forth in Section 2.4.5.

1.122 “FAD Term Extension” has the meaning set forth in Section 2.4.2.

1.123 “Falsified Medicine” has the meaning set forth in Section 12.13.1.

1.124 “FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.

1.125 “FDA” means the United States Food and Drug Administration and any successor entity thereto.

1.126 “Field” means (a) for Collaboration Target 1, diagnosis, treatment, cure, mitigation or prevention of any diseases, disorders or conditions, excluding the Excluded Field or (b) for Collaboration Target 2, diagnosis, treatment, cure, mitigation or prevention of any diseases, disorders or conditions.

1.127 “Final Balancing Report” has the meaning set forth in Exhibit C.

1.128 “Finance Dispute” has the meaning set forth in Section 9.9.2(b)(v).

1.129 “First Additional Degrader Criteria” means, with respect to a given Degrader, [***].

1.130 [***].

1.131 [***].

1.132 [***].

1.133 “First Additional Degrader Research Budget” has the meaning set forth in Section 2.3.1.

1.134 “First Additional Degrader Research Term” has the meaning set forth in Section 2.4.2.

1.135 “First Additional Degraders” means, for Collaboration Target 1 [***].

1.136 “First Commercial Sale” means with respect to a Licensed Product, [***]; provided that the following will not constitute a First Commercial Sale: [***].

1.137 “Force Majeure” means a condition, the occurrence and continuation of which is beyond the reasonable control of a Party, including an act of God, governmental acts or

11


CONFIDENTIAL

 

restrictions, war, civil commotion, labor strike or lock-out, epidemic, pandemic (including, [***]), flood, failure or default of public utilities or common carriers, or destruction of production facilities or materials by fire, earthquake, storm or like catastrophe.

1.138 “Foreground Know-How” has the meaning set forth in Section 1.140.

1.139 “Foreground Patents” has the meaning set forth in Section 1.140.

1.140 “Foreground Technology” means (a) any and all Know-How discovered, developed, invented or created solely by a Party or its Affiliates or Third Parties acting on its or their behalf, or jointly by both Parties or their respective Affiliates or Third Parties acting on their behalf, in each case, in the performance of activities under this Agreement (the “Foreground Know-How”) and (b) any and all Patents that Cover any such Know-How described in clause (a) (the “Foreground Patents”).

1.141 “FTE” means [***], which number of hours will be pro-rated based on the number of days when used for [***], devoted to or in support of (a) the Research activities, Pre-Clinical Development, Clinical Development, other Development activities or Backup Research that is carried out by one or more qualified scientific or technical employees (excluding Third Party contractors) of a Party or its Affiliates or (b) the Late Development Plan, Manufacturing activities or Commercialization activities that is carried out by one or more qualified scientific or technical employees (excluding Third Party contractors) of a Party or its Affiliates, as applicable. Notwithstanding the foregoing, the time of a single individual will not account for more than [***].

1.142 “FTE Costs” means, for any period, the FTE Rate multiplied by the number of FTEs who perform a specified activity under this Agreement. FTEs will be pro-rated on a daily basis if necessary.

1.143 “FTE Rate” means, with respect to [***]; provided that each such rate will increase or decrease on January 1 of each Calendar Year (starting with January 1, 2021) in accordance with the percentage year-over-year increase or decrease in the Producer Price Index (PPI) for Pharmaceutical and Medicine Manufacturing (NAICS 325400) over the twelve (12)-month period preceding each such January 1. The FTE Rate includes (a) all wages and salaries, employee benefits, bonus, travel and entertainment, supplies and other direct expenses and (b) indirect allocations, including all general and administrative expenses, human resources, finance, occupancy and depreciation, in each case ((a) and (b)), expended in connection with relevant activities.

1.144 “Funding Failure” has the meaning set forth in Section 5.7.10.

1.145 “GAAP” means United States generally accepted accounting principles, consistently applied.

1.146 “GCP” means good clinical practices, which are the then-current standards for Clinical Trials for pharmaceuticals, as set forth in the FD&C Act, ICH Guideline Q7A, or other Applicable Law, and such standards of good clinical practice as are required by the Regulatory Authorities of the European Union and other organizations and governmental authorities in

12


CONFIDENTIAL

 

countries for which the applicable Collaboration Compound, Collaboration Candidate or Licensed Product is intended to be Developed, to the extent such standards are not less stringent than United States standards or ICH Guidelines.

1.147 “Generic Product” means, with respect to a particular Licensed Product in a particular country, a product on the market in such country commercialized by any Third Party that is not a Sublicensee and that did not purchase such product in a chain of distribution that included any of Sanofi or its Affiliates or Sublicensees, that (a) is approved by the applicable Regulatory Authority, under any then-existing Applicable Laws pertaining to approval of generic products, which approval is based on all or part of the clinical data referenced in any Regulatory Approval for the Licensed Product or which otherwise relies on the Regulatory Authority’s finding of safety or effectiveness for the Licensed Product, or (b) is otherwise recognized as an “substitution” product by the applicable Regulatory Authority. For clarity, Authorized Generics will not be classified as Generic Products for purposes of this Agreement.

1.148 “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the successor thereto, or comparable regulatory standards in jurisdictions outside of the United States as they may be updated from time to time, to the extent such standards are not less stringent than United States standards.

1.149 “GLP Toxicology Study” means a toxicology study of the relationship between dose and its effects on an exposed animal, where the study is to be conducted in accordance with GLP.

1.150 “GMP” means the then-current Good Manufacturing Practices as specified in Applicable Law, including the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules or regulations of an applicable Regulatory Authority at the time of manufacture.

1.151 “Governmental Authority” means any court, agency, department, authority or other instrumentality of any national, state, county, city or other political subdivision, including any relevant Regulatory Authority.

1.152 “Healthcare Prescriber” has the meaning set forth in Section 1.91.

1.153 “HEOR Costs” has the meaning set forth in Exhibit C.

1.154 “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

1.155 “ICH” means the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

1.156 “IFRS” means International Financial Reporting Standards, consistently applied.

1.157 [***].

1.158 [***].

13


CONFIDENTIAL

 

1.159 [***].

1.160 “In-License Costs” means [***].

1.161 “IND” means any Investigational New Drug application (including any amendment or supplement thereto) filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto or if applicable, a comparable application or submission filed with a Regulatory Authority outside the U.S. for the investigation of any product in any other country or group of countries (such as a Clinical Trial Application in the EU) (“CTA”).

1.162 “Indemnified Party” has the meaning set forth in Section 14.1.3.

1.163 “Indemnifying Party” has the meaning set forth in Section 14.1.3.

1.164 “Independent Third Party Patent Counsel” means an independent Third Party patent counsel (i) with expertise in the relevant matter at issue, (ii) who has not worked for or been engaged by either Party or its Affiliates, or any other portfolio companies of its material investors, in the [***] period immediately prior to selection of such individual, and (iii) who does not own equity or debt in either Party or its Affiliates (other than equity or debt owned through a broad based mutual fund or exchange traded fund).

1.165 “Indication” means a specific disease or medical condition in humans that is approved by a Regulatory Authority to be included as a discrete claim (as opposed to a variant or subdivision or subset of a claim) in the labeling of a Licensed Product based on the results of a separate Registrational Study(ies) sufficient to support Marketing Approval of such claim; provided, that, [***]. For clarity, the following will be part of the same Indication: [***].

1.166 “Initial Balancing Report” has the meaning set forth in Exhibit C.

1.167 “Initial Collaboration Target 1 Degrader” means [***].

1.168 “Initial Collaboration Target 2 Degraders” means [***].

1.169 “Initiation” or “Initiate” means, with respect to any Clinical Trial, dosing of the first human subject in such Clinical Trial.

1.170 “Insolvency Event” has the meaning set forth in Section 15.2.6.

1.171 “JAMS” means the JAMS Comprehensive Arbitration Rules and Procedures.

1.172 “JCC” has the meaning set forth in Section 9.6.1.

1.173 “JFC” has the meaning set forth in Section 9.7.1.

1.174 “JMC” has the meaning set forth in Section 9.4.1.

1.175 [***].

14


CONFIDENTIAL

 

1.176 [***].

1.177 “Joint Foreground Know-How” means any Foreground Know-How jointly owned by the Parties pursuant to Section 12.1.2(b).

1.178 “Joint Foreground Patent” means any Foreground Patent jointly owned by the Parties pursuant to Section 12.1.2(b).

1.179 “Joint Foreground Technology” means all Joint Foreground Know-How and Joint Foreground Patents.

1.180 [***].

1.181 “JPC” has the meaning set forth in Section 9.3.1.

1.182 “JRDC” has the meaning set forth in Section 9.2.1.

1.183 “JSC” has the meaning set forth in Section 9.1.1.

1.184 “JTT” has the meaning set forth in Section 9.5.1.

1.185 “Know-How” means all proprietary data, results, pre-clinical and clinical protocols and data from studies and Clinical Trials, chemical structures, chemical sequences, materials, information, inventions, know-how, formulas, trade secrets, techniques, methods, processes, procedures, technology, practices, knowledge and developments, whether or not patentable; provided that Know-How does not include Patents.

1.186 “Knowledge” means, with respect to Kymera (i) as of the Original Agreement Execution Date and the Restatement Execution Date, as applicable, the actual knowledge, following reasonable inquiry of Kymera personnel and advisors (including [***] and other external patent counsels as appropriate) that would reasonably be anticipated to have knowledge of the facts relating to the relevant subject matter, of [***], and (ii) as of the Original Agreement Effective Date and during the Term, the actual knowledge, following reasonable inquiry of Kymera personnel and advisors (including internal and external patent counsel) that would reasonably be anticipated to have knowledge of the facts relating to the relevant subject matter, of the Chief Executive Officer, the Chief Financial Officer, and the Chief Medical Officer.

1.187 [***].

1.188 [***].

1.189 [***].

1.190 “Kymera” has the meaning set forth in the Preamble.

1.191 [***].

15


CONFIDENTIAL

 

1.192 “Kymera Background Know-How” means, on a Collaboration Target-by-Collaboration Target basis, any Know-How, other than Kymera Foreground Know-How or Joint Foreground Know-How, that [***].

1.193 “Kymera Background Patents” means, on a Collaboration Target-by-Collaboration Target basis, any Patent (including any further Patent claiming priority thereto), other than [***] that [***].

1.194 “Kymera Background Technology” means all Kymera Background Know-How and Kymera Background Patents.

1.195 “Kymera Co-Promote Effective Date” has the meaning set forth in Section 6.2.5.

1.196 “Kymera Co-Promote Right” has the meaning set forth in Section 6.2.

1.197 “Kymera Co-Promote Right Deadline” has the meaning set forth in Section 6.2.4.

1.198 “Kymera Co-Promote Right Exercise Notice” has the meaning set forth in Section 6.2.4.

1.199 “Kymera Co-Promotion Expenses” has the meaning set forth in Exhibit B.

1.200 “Kymera Competitor” has the meaning set forth in Section 10.3.1(c).

1.201 [***] means [***].

1.202 “Kymera Existing Phase 1 Clinical Trial” means the Phase 1 Clinical Trial that is currently being conducted by or on behalf of Kymera for KT-474 under ClinicalTrials.gov Identifier: NCT04772885.

1.203 [***] means [***].

1.204 “Kymera Foreground Know-How” means [***].

1.205 “Kymera Foreground Patents” means [***].

1.206 [***] means [***].

1.207 “Kymera Indemnified Party” has the meaning set forth in Section 14.1.1.

1.208 “Kymera Material Safety Event Notice” has the meaning set forth in Section 7.6.2.

1.209 “Kymera’s Nonexclusive Negotiation Period” has the meaning set forth in Section 15.2.3(e)(iv).

1.210 “Kymera Opt-In Deadline” has the meaning set forth in Section 5.7.5.

1.211 “Kymera Opt-In Effective Date” has the meaning set forth in Section 5.7.6.

16


CONFIDENTIAL

 

1.212 “Kymera Opt-In Exercise Notice” has the meaning set forth in Section 5.7.5.

1.213 “Kymera Opt-In Right” has the meaning set forth in Section 5.7.1.

1.214 [***] means [***].

1.215 “Kymera Phase 1 Clinical Trials” means the Phase 1 Clinical Trials to be conducted by or on behalf of Kymera for the Collaboration Candidates and Licensed Products Directed Against Collaboration Target 1 for the first Indication in Field in the Territory in accordance with the Early Development Plan.

1.216 [***].

1.217 [***].

1.218 “Late Development Plan” has the meaning set forth in Section 5.3.1.

1.219 “Launch Window” has the meaning set forth in Exhibit B.

1.220 “LCM Development” has the meaning set forth in Exhibit C.

1.221 “LCM Development Costs” has the meaning set forth in Exhibit C.

1.222 “Liability” has the meaning set forth in Section 14.1.1.

1.223 “Licensed Know-How” means the Kymera Background Know-How, the Kymera Foreground Know-How and Kymera’s interest in the Joint Foreground Know-How.

1.224 “Licensed Patents” means the Kymera Background Patents, the Kymera Foreground Patents and Kymera’s interest in the Joint Foreground Patents.

1.225 “Licensed Product” means any pharmaceutical preparation in final form or other product, including any Combination Product, that contains a Collaboration Candidate, in all forms, presentations, strengths, doses and formulations thereof.

1.226 “Licensed Product Mark” has the meaning set forth in Section 12.12.

1.227 “Licensed Technology” means the Licensed Patents and Licensed Know-How.

1.228 “Ligand” has the meaning set forth in Section 1.86.

1.229 “M2 Criteria” means (a) for Collaboration Target 1, the criteria set forth on part (1) of Schedule 1.229 and (b) for Collaboration Target 2, the criteria set forth on part (2) of Schedule 1.229, in each case as may be amended by the JRDC.

1.230 “MAD Data Package” [***]:

(a) [***]

17


CONFIDENTIAL

 

(b) [***]

(c) [***].

1.231 [***].

1.232 “Major Indication” means [***].

1.233 [***].

1.234 “Manufacture” or “Manufactured” or “Manufacturing” means activities directed to making, having made, producing, manufacturing, processing, formulating, filling, finishing, packaging, labeling, quality control testing and quality assurance release, shipping or storage of a Collaboration Compound, Collaboration Candidate or Licensed Product by or on behalf of a Party or its Affiliate or (sub)licensee.

1.235 “Manufacturing Costs” has the meaning set forth in Exhibit C.

1.236 “Market Researcher” has the meaning set forth in Exhibit B.

1.237 “Marketing Approval” means, with respect to a product in a particular country or jurisdiction, all approvals (including approvals resulting from any priority review, breakthrough therapy, accelerated approval or fast track designation, application or submission), licenses, registrations or authorizations necessary for the Commercialization of such product in such country or jurisdiction, including, (a) with respect to the United States, approval of an Approval Application for such product by the FDA and with respect to the European Union, approval of an Approval Application for such product by the European Medicines Agency or the applicable Regulatory Authority in any particular country in the EU, (b) where applicable, Price Approval in such country or jurisdiction, (c) where applicable, pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto), and (d) where applicable, labeling approval.

1.238 “Material Communication” means [***].

1.239 “Material Safety Event” means an event occurring after the Original Agreement Effective Date that is caused by a Licensed Product, or based on objective scientific or clinical evidence, is reasonably likely to be caused by a Licensed Product, and results in [***].

1.240 “Material Submissions” has the meaning set forth in Section 7.5.

1.241 “Materials” means all biological materials, chemical compounds and other materials arising out of a Party’s activities under this Agreement and (i) provided by such Party to the other Party for use by the other Party or (ii) otherwise provided by a Party for use by the other Party, in each case, to conduct activities pursuant to this Agreement, including Collaboration Compounds, Collaboration Candidates, Clinical Trial samples, cell lines, compounds, lipids, assays, viruses and vectors.

1.242 “Maturity Date” has the meaning set forth in Exhibit A.

18


CONFIDENTIAL

 

1.243 “Medical Affairs Costs” has the meaning set forth in Exhibit C.

1.244 “Milestone Events” has the meaning set forth in Section 11.2.4.

1.245 “Milestone Payments” has the meaning set forth in Section 11.2.4.

1.246 “MTA Development Studies” has the meaning set forth in Section 3.4.2.

1.247 “MTA Research Studies” has the meaning set forth in Section 2.8.2.

1.248 “NDA” means a new drug application that is submitted to the FDA for marketing approval for a Licensed Product, pursuant to 21 USC § 355.

1.249 “Net Profits and Net Losses” has the meaning set forth in Exhibit C.

1.250 “Net Sales” means, with respect to a Licensed Product for any period, the aggregate gross amount billed or invoiced by Sanofi, its Affiliates or its or their Sublicensees for the sale of a Licensed Product to Third Parties (including Distributors) in bona fide arm’s-length transactions commencing with the First Commercial Sale of such Licensed Product less the following deductions determined in accordance with Accounting Standards as consistently applied from such gross amounts which are actually incurred, allowed, accrued or specifically allocated to the Licensed Product:

[***]

For the purposes of calculating Net Sales, all Net Sales will be converted into Dollars.

Subject to the above, Net Sales will be calculated in accordance with the standard internal policies and procedures of such Sanofi, its Affiliates or its or their Sublicensees, which must be in accordance with applicable Accounting Standards and applied consistently across their respective businesses.

As used herein, “Combination Product” means [***] (such other active ingredients, devices or other items of value described in the foregoing provisos (a) and (b), “Other Items”).

1.251 “[***]” has the meaning set forth in Section 15.2.3(e)(iii).

1.252 “Non-Approval Studies” means any surveys, registries and Clinical Trials not intended to gain Marketing Approval or any additional labeled Indications, excluding any open label extension studies of a Collaboration Candidate or Licensed Product.

1.253 “Non-Bankrupt Party” has the meaning set forth in Section 10.5.

1.254 “Non-Breaching Party” means the Party that believes the other Party is in material breach of this Agreement.

1.255 “Non-Defending Party” has the meaning set forth in Section 12.3.

1.256 “Non-Disclosing Party” has the meaning set forth in Section 16.6.1(c).

19


CONFIDENTIAL

 

1.257 [***].

1.258 “Oncology” means, the diagnosis, treatment, cure, mitigation or prevention of an Indication characterized by abnormal cellular proliferation, including solid or liquid malignancies (including primary and metastatic tumors), lymphoid and myeloid proliferative disorders (including myelodysplastic syndrome and myelofibrosis), and hematopoietic control or dysregulations. For clarity, “Oncology” also includes all cancer immunotherapy and immuno-oncology indications.

1.259 “Opt-In Data Package” means the data package described on Schedule 1.259.

1.260 “Opt-In Period” means, on a Collaboration Target-by-Collaboration Target basis, the period of time from the Kymera Opt-In Effective Date (if any) until the termination or expiration of the Cost/Profit Sharing Agreement.

1.261 “Opt-In Products” means, on a Collaboration Target-by-Collaboration Target basis, during the Opt-In Period, any and all Collaboration Candidates or Licensed Products Directed Against a given Collaboration Target.

1.262 “Opt-Out Right” has the meaning set forth in Section 5.7.9.

1.263 “Original Agreement” has the meaning set forth in the Recitals.

1.264 “Original Agreement Effective Date” means August 10, 2020.

1.265 “Original Agreement Execution Date” means July 7, 2020.

1.266 “Other Items” has the meaning set forth in Section 1.250.

1.267 “Out-of-Pocket Costs” means, with respect to a Party, costs and expenses paid by such Party or its Affiliates to Third Parties (or payable to Third Parties and accrued in accordance with Accounting Standards), other than employees of such Party or its Affiliates.

1.268 “Participation Data Package” means, (a) with respect to a given Collaboration Target, a data package containing the information set forth on Schedule 1.268 with respect to all Collaboration Candidates and Licensed Products Directed Against such Collaboration Target that exist as of the date of delivery of such Participation Data Package and (b) with respect to Collaboration Target 2, in addition to the information in clause (a), [***].

1.269 “Party” or “Parties” has the meaning set forth in the Preamble.

1.270 “Patent and Trademark Costs” has the meaning set forth in Exhibit C.

1.271 “Patent and Trademark Recoveries” has the meaning set forth in Exhibit C.

1.272 “Patent Challenge” has the meaning set forth in Section 15.2.3(d).

1.273 “Patent Family” means a group of Patents that share any priority relationship.

20


CONFIDENTIAL

 

1.274 “Patent Filing Jurisdictions” means, [***].

1.275 “Patent Resolution Procedures” means those procedures set forth on Schedule 1.275.

1.276 “Patents” means the rights and interests in and to issued patents and pending patent applications in any country, jurisdiction or region (including inventor’s certificates and utility models), including all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisionals, renewals and all patents granted thereon, and all reissues, reexaminations, extensions, confirmations, revalidations, registrations and patents of addition thereof, including patent term extensions and supplementary protection certificates, international patent applications filed under the Patent Cooperation Treaty (PCT) and any foreign equivalents to any of the foregoing.

1.277 “Patient Assistance Program Costs” has the meaning set forth in Exhibit C.

1.278 “PDE” has the meaning set forth in Exhibit B.

1.279 “PDE Cost” has the meaning set forth in Exhibit B.

1.280 “PDE Requirement” has the meaning set forth in Exhibit B.

1.281 “Permitted Backup Research Overrun” has the meaning set forth in Section 5.5.6.

1.282 “Permitted U.S. Budget Overrun” has the meaning set forth in Exhibit A.

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

1.284 “Pharmacovigilance Agreement” has the meaning set forth in Section 7.6.1.

1.285 “Phase 1 Clinical Trial” means any Clinical Trial as described in 21 C.F.R. §312.21(a), or, with respect to a jurisdiction other than the United States, a similar Clinical Trial; [***].

1.286 “Phase 1 Patient Data Package” [***]

[***]

(a) [***] (such patients, the “Remaining Patients”):

[***]

1.287 “Phase 1 Ready Criteria” means, for Collaboration Target 2, the criteria applicable to a Licensed Product Directed Against Collaboration Target 2, as set forth on Schedule

21


CONFIDENTIAL

 

1.286, as may be discussed by the JRDC and amended by the JSC in accordance with this Agreement.

1.288 “Phase 2 Activities” has the meaning set forth in Section 3.1.1(f).

1.289 “Phase 2 Clinical Trial” means: either (a) a Phase 2a Clinical Trial, (b) a Phase 2b Clinical Trial or (c) any other Clinical Trial as described in 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, a similar Clinical Trial. [***].

1.290 “Phase 2a Clinical Trial” means [***].

1.291 “Phase 2b Clinical Trial” means [***].

1.292 “Phase 2 Development Plan” has the meaning set forth in Section 3.1.1(d).

1.293 “Phase 2 Protocol” has the meaning set forth in Section 3.1.1(c).

1.294 “Phase 2 Ready Criteria” means, for Collaboration Target 1, the criteria applicable to a Licensed Product Directed Against Collaboration Target 1, as set forth on Schedule 1.294, as may be discussed by the JRDC and amended by the JSC in accordance with this Agreement.

1.295 “Phase 2 Trigger Point” has the meaning set forth in Section 1.403.

1.296 “Phase 3 Clinical Trial” means any Clinical Trial as described in 21 C.F.R. §312.21(c), or, with respect to a jurisdiction other than the United States, a similar Clinical Trial.

1.297 “Phase 4 Clinical Trial” means any (i) Clinical Trial of a product conducted in accordance with ICH and local standards, which is not required for receipt of Marketing Approval in the United States and which is principally intended to support the marketing and Commercialization of a product, including any investigator or institution initiated trial, or clinical experience trial, study conducted to fulfill local commitments made as a condition of any Marketing Approval and (ii) health and economic outcomes research and other reviews/analyses/studies relating to value and access issues.

1.298 “PIR” has the meaning set forth in Exhibit B.

1.299 “Platform Foreground Know-How” has the meaning set forth in Section 12.1.2(b).

1.300 “[***]” has the meaning set forth in Section 12.1.2(b).

1.301 “Platform Foreground Technology” has the meaning set forth in Section 12.1.2(b).

1.302 “Platform In-License” has the meaning set forth in Section 11.5.1(b).

1.303 “PMDA” means the Pharmaceuticals and Medical Devices Agency and any successor entity thereto.

22


CONFIDENTIAL

 

1.304 “Post-POC Milestone Event” has the meaning set forth in Section 11.2.3.

1.305 “Post-POC Milestone Payment” has the meaning set forth in Section 11.2.3.

1.306 “Potential In-License” has the meaning set forth in Section 11.5.1(a).

1.307 “Pre-Clinical Development” has the meaning set forth in Section 1.93.

1.308 “Pre-Clinical and SAD/MAD Data Package” [***].

1.309 “Pre-Existing Restriction” means [***].

1.310 “Pre-POC Milestone Event” has the meaning set forth in Section 11.2.2.

1.311 “Pre-POC Milestone Payment” has the meaning set forth in Section 11.2.2.

1.312 “Preexisting Affiliate” means, with respect to a Party that is subject to a Change of Control, any Affiliate of such Party following such Change of Control that was an Affiliate of such Party prior to such Change of Control.

1.313 “Price Approval” means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of any government approval, agreement determination or decision establishing such reimbursement authorization or pricing approval or determination.

1.314 “Proceeding” means any action, suit, litigation, arbitration, proceeding (including any civil, criminal, administrative, investigative or appellate proceeding), prosecution, contest, hearing, inquiry, inquest, audit, examination or investigation that is, has been or may in the future be commenced, brought, conducted or heard at law or in equity or before any Governmental Authority, excluding all administrative proceedings before any patent office.

1.315 “[***]” means [***].

1.316 “Promotional Materials” has the meaning set forth in Exhibit B.

1.317 “Prosecution and Maintenance” or “Prosecute and Maintain” means, with regard to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well as handling re-examinations and reissues with respect to such Patent, together with the conduct of interferences, derivation proceedings, pre- and post-grant opposition proceedings, post-grant patent proceedings (such as inter partes review and post grant review) and other similar proceedings with respect to the particular Patent. For clarification, “Prosecution and Maintenance” or “Prosecute and Maintain” will not include any enforcement actions taken with respect to a Patent.

1.318 “Qualified Third Parties” means the Third Parties set forth on Schedule 1.318.

23


CONFIDENTIAL

 

1.319 “R&D Expert” means an individual with sufficient experience for the relevant matter at issue, who (i) has both relevant scientific and business expertise in the research and development of human therapeutic products (and more specifically, if relevant to the matter at issue and if available, expertise in ubiquitin-mediated protein degradation therapeutics), (ii) has not worked for or been engaged by either Party or its Affiliates in the [***] period immediately prior to selection of such individual, and (iii) does not own equity or debt in either Party or its Affiliates (other than equity or debt owned through a broad based mutual fund or exchange trade fund).

1.320 “Receiving Party” has the meaning set forth in Section 16.1.

1.321 “Registrational Study” means a Clinical Trial that is intended to establish that a product is safe and efficacious for its intended use in the target population, and to determine warnings, precautions, and adverse reactions that may be associated with such pharmaceutical product in the dosage range to be prescribed, which clinical trial is a registration trial intended to enable submission of an Approval Application for such product, as and to the extent defined for the United States in 21 C.F.R. § 312.21(c) or 21 C.F.R. Part 314 Subpart H, or its successor regulations, or, with respect to a jurisdiction other than the United States, a similar Clinical Trial.

1.322 “Regulatory Authority” means, with respect to a country in the Territory, any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the EMA), regional, state or local regulatory agency, department, bureau, board, commission, council or other Governmental Authority that holds responsibility for development, commercialization or manufacturing of, and the granting of Marketing Approval for a pharmaceutical product in such country or region.

1.323 “Regulatory Exclusivity” means, with respect to a Licensed Product in a country, any data exclusivity rights, market exclusivity rights, or other exclusive right, other than a Patent, granted, conferred or afforded by any Regulatory Authority in such country or otherwise under Applicable Law with respect to such Licensed Product in such country, which either confers exclusive marketing rights with respect to a product or prevents another party from using or otherwise relying on the data supporting the approval of the Marketing Approval for a product without the prior written authorization of the Marketing Approval holder, as applicable, such as new chemical entity exclusivity, exclusivity associated with new Clinical Trials necessary to approval of a change (e.g., new indication or use), orphan drug exclusivity, non-patent-related pediatric exclusivity, or any other applicable marketing or data exclusivity, including any such periods under national implementations in the EU of Article 10 of Directive 2001/83/EC, Article 14(11) of Parliament and Council Regulation (EC) No 726/2004, Parliament and Council Regulation (EC) No 141/2000 on orphan medicines, Parliament and Council Regulation (EC) No 1901/2006 on medicinal products for pediatric use and all international equivalents.

1.324 “Regulatory Expenses” has the meaning set forth in Exhibit C.

1.325 “Regulatory Filings” means, collectively: (a) all INDs, Approval Applications, establishment license applications, Drug Master Files, applications for designation (including as an “Orphan Product(s)” under the Orphan Drug Act, for “Fast Track” status under Section 506 of the FD&C Act (21 U.S.C. § 356) or for a Special Protocol Assessment under Section 505(b)(4)(B)

24


CONFIDENTIAL

 

and (C) of the FD&C Act (21 U.S.C. § 355(b)(4)(B))) and all other similar filings (including counterparts of any of the foregoing in any country or region in the Territory); (b) any applications for Marketing Approval or Price Approval and other applications, filings, dossiers or similar documents submitted to a Regulatory Authority in any country for the purpose of obtaining Marketing Approval or Price Approval from that Regulatory Authority; (c) any Patent-related filings with any Regulatory Authority; (d) all supplements and amendments to any of the foregoing and submissions made related to any of the foregoing; (e) all documents referenced in the complete regulatory chronology for each Marketing Approval; (f) confirmed meeting requests and meeting minutes; (g) foreign equivalents of any of the foregoing; and (h) all data and other information contained in, and correspondence with any Regulatory Authority relating to, any of the foregoing.

1.326 “Regulatory Lead” means, unless otherwise agreed by the Parties: [***] on a Collaboration Target-by-Collaboration Target basis, during the Sanofi Participation Term with respect to such Collaboration Target (if any), Sanofi for all Collaboration Candidates and Licensed Products Directed Against such Collaboration Target.

1.327 “Remaining Patient Data Package:” [***]

1.328 “Remaining Patients” as the meaning set forth in Section 1.286(b).

1.329 “Reporting Company” means (a) a reporting company under the United States Securities and Exchange Act of 1934, or (b) a company that has publicly filed with the Securities and Exchange Commission, and has not withdrawn, a Form S-1.

1.330 “Research” means conducting research activities to discover, design, optimize, deliver and advance Collaboration Compounds, Collaboration Candidates or Licensed Products, but (a) specifically excluding Development, Manufacture and Commercialization, and (b) [***]. When used as a verb, “Researching” means to engage in Research.

1.331 “Research Plan” has the meaning set forth in Section 2.3.1.

1.332 “Research Term” means, on a Collaboration Target-by-Collaboration Target basis, the period commencing on the Original Agreement Effective Date and ending upon the earliest to occur of (i) the Sanofi Participation Election Deadline without Sanofi’s exercise of the Sanofi Participation Election Right with respect to such Collaboration Target, (ii) the Sanofi Participation Election Effective Date with respect to such Collaboration Target, or (iii) the effective date of termination of this Agreement (with respect to such Collaboration Target or in its entirety). For the avoidance of doubt, (a) the expiration of the Research Term pursuant to clause (ii) shall not result in the expiration of the First Additional Degrader Research Term or Second Additional Degrader Research Term, which shall only expire in accordance with the terms thereof, and (b) the expiration of the Research Term with respect to Collaboration Target 1 pursuant to clause (i) or (iii) of this definition shall result in the contemporaneously expiration of both the First Additional Degrader Research Term and the Second Additional Degrader Research Term on such the effective date of expiration of the Research Term.

1.333 “Rest of World” means [***].

25


CONFIDENTIAL

 

1.334 “Restatement Effective Date” has the meaning set forth in Section 17.2.

1.335 “Restatement Execution Date” has the meaning set forth in the Preamble.

1.336 “Reversion Compound Data” means any data that is generated by or on behalf of the Parties under this Agreement for any Reversion Compounds.

1.337 “Reversion Compounds” has the meaning set forth in Section 5.6.1.

1.338 “Reversion Date” has the meaning set forth in Section 5.6.4.

1.339 “[***]” has the meaning set forth in Section 15.2.3(e)(iii).

1.340 “Royalty Term” means, on a Licensed Product-by-Licensed Product and country-by-country basis, the period commencing on the First Commercial Sale of such Licensed Product in such country and ending upon the latest of: (a) the date on which the use or sale of such Licensed Product is no longer Covered by a Valid Claim of [***] that Cover [***]; (b) the [***] of the First Commercial Sale of such Licensed Product in such country; or (c) expiration of Regulatory Exclusivity in such country with respect to such Licensed Product.

1.341 “SAD Permitted Overrun” has the meaning set forth in Section 2.5.5.

1.342 “SAD Research Budget Excession” has the meaning set forth in Section 2.5.5.

1.343 “SAD Term Commencement Date” has the meaning set forth in Section 2.5.3.

1.344 “SAD Termination” has the meaning set forth in Section 15.2.3(f).

1.345 “Safety Concern” means, with respect to any compound or product, (a) any safety concern required to be reported under 21 C.F.R. § 312.32 if an IND with respect to such product was open at the time of the observation (or that would be so reportable to a Regulatory Authority if an IND was not open at such time), or (b) a toxicity or drug safety issue or a Serious Adverse Event reasonably related to or observed in connection with development or commercialization activities with respect to a product, as determined by (i) prior to a Sanofi Participation Election Effective Date (if any), either Party, in accordance with its standard operating procedures and (ii) on or after a Sanofi Participation Election Effective Date (if any), Sanofi, in accordance with its standard operating procedures.

1.346 “Safety Termination” has the meaning set forth in Section 15.2.3(b).

1.347 “Sales and Marketing Costs” has the meaning set forth in Exhibit C.

1.348 “Sanofi” has the meaning set forth in the Preamble.

1.349 “Sanofi Background Know-How” means, on a Collaboration Target-by-Collaboration Target basis, [***].

1.350 “Sanofi Background Patent” means, on a Collaboration Target-by-Collaboration Target basis, [***].

26


CONFIDENTIAL

 

1.351 “Sanofi Background Technology” means the Sanofi Background Know-How and the Sanofi Background Patents.

1.352 “Sanofi Foreground Know-How” means [***].

1.353 “Sanofi Foreground Patent” means [***].

1.354 “Sanofi Foreground Technology” means all Sanofi Foreground Know-How and Sanofi Foreground Patents.

1.355 “Sanofi Indemnified Party” has the meaning set forth in Section 14.1.2.

1.356 “Sanofi Material Safety Event Notice” has the meaning set forth in Section 7.6.2.

1.357 “Sanofi Participation Election Deadline” has the meaning set forth in Section 4.3.

1.358 “Sanofi Participation Election Effective Date” has the meaning set forth in Section 4.3.

1.359 “Sanofi Participation Election Right” has the meaning set forth in Section 4.1.

1.360 “Sanofi Participation Election Right Exercise” has the meaning set forth in Section 4.3.

1.361 “Sanofi Participation Election Right Exercise Notice” has the meaning set forth in Section 4.3.

1.362 “Sanofi Participation Term” means, on a Collaboration Target-by-Collaboration Target basis, the period commencing on the Sanofi Participation Election Effective Date (if any) with respect to such Collaboration Target and ending upon the effective date of expiration or termination of this Agreement with respect to such Collaboration Target. On a Collaboration Target-by-Collaboration Target basis, the Backup Research Term (if any) for a given Collaboration Target will be considered part of the applicable Sanofi Participation Term for such Collaboration Target.

1.363 “Sanofi Phase 2 Election Notice” means a written notice delivered by Sanofi by Kymera in the format set forth on Exhibit E.

1.364 “Sanofi Reversion Technology” means, with respect to a Terminated Target, [***].

1.365 “Sanofi Safety Review Committee” means [***].

1.366 “Sanofi Technology” means the Sanofi Background Technology, the Sanofi Foreground Technology and Sanofi’s interest in the Joint Foreground Technology.

1.367 “Screening Criteria” means the criteria set forth on Schedule 1.367, as may be reviewed and discussed by the JRDC and amended by the JSC.

27


CONFIDENTIAL

 

1.368 “Second Additional Degrader Criteria” means, with respect to a given Degrader, such Degrader meets all of the following criteria: [***].

1.369 “Second Additional Degrader Research Budget” has the meaning set forth in Section 2.3.1.

1.370 “Second Additional Degrader Research Term” has the meaning set forth in Section 2.5.3.

1.371 “Second Additional Degraders” means [***].

1.372 “Series 2 Permitted Overrun” has the meaning set forth in Section 2.6.4.

1.373 “Series 2 Research Budget” has the meaning set forth in Section 2.3.1.

1.374 “Series 2 Research Budget Excession” has the meaning set forth in Section 2.6.4.

1.375 “Series 2 Research Term” has the meaning set forth in Section 2.6.3.

1.376 “Serious Adverse Event” means an adverse drug experience or circumstance that results in any of the following outcomes (a) death, (b) life threatening condition, (c) inpatient hospitalization or a prolongation of existing hospitalization, (d) persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, (e) or a congenital anomaly/birth defect, (f) significant intervention required to prevent permanent impairment or damage, or (g) a medical event that may not result in death, be life threatening, or require hospitalization but, based on appropriate medical judgment, that may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes described in clauses (a) through (f).

1.377 “SOPs” has the meaning set forth in Exhibit B.

1.378 “Specifically Claim” or “Specifically Claims” means, as to a compound, product or [***] and a Patent, that, [***].

1.379 “Specifically Disclose,” “Specifically Disclosed,” “Specifically Discloses” or “Specifically Disclosing” means, as to a [***], compound or product and a Patent, that [***].

1.380 “Standard Cost” has the meaning set forth in Exhibit C.

1.381 “Step-In Activities” has the meaning set forth in Section 15.2.4.

1.382 “Step-In Triggers” has the meaning set forth in Section 15.2.4.

1.383 “Subcommittee” means JCC, JFC, JMC, JPC, JRDC, JTT and any other subcommittee formed by the JSC in accordance with Section 9.1.2(s).

1.384 “Subcontractor” means a consultant, subcontractor, contract researcher, contract manufacturer, academic researcher or other vendor engaged by a Party to conduct activities on behalf of such Party or its Affiliate under this Agreement.

28


CONFIDENTIAL

 

1.385 “Sublicense” means, directly or indirectly, to sublicense, grant any other right with respect to, or agree not to assert, the rights granted to Sanofi hereunder. When used as a noun, “Sublicense” means any agreement to Sublicense.

1.386 “Sublicense Revenues” has the meaning set forth in Exhibit C.

1.387 “Sublicensee” means an Affiliate or Third Party, other than a Distributor, to whom Sanofi (or a Sublicensee or Affiliate) sublicenses any of the rights granted to Sanofi hereunder during the Term.

1.388 “Successful Completion” means, (a) with respect to a Licensed Product containing a First Additional Degrader or Second Additional Degrader, [***], (b) with respect to a Licensed Product Directed Against Collaboration Target 2, [***].

1.389 “Target” means a specific protein that is associated with an ENSEMBL GENE ID (as listed in the database available at https://www.genenames.org or any successor website) (together with any and all naturally occurring mutations, variants and alternative sequences thereof).

1.390 “Target Binding Moiety” has the meaning set forth in Section 1.86.

1.391 [***].

1.392 [***].

1.393 “Term” has the meaning set forth in Section 15.1.

1.394 “Terminated Degraders” has the meaning set forth in Section 15.2.3(f).

1.395 “Terminated Products” means [***].

1.396 “Terminated Target” means any Collaboration Target with respect to which this Agreement has been terminated in accordance with any of the provisions of Sections 15.2.1, 15.2.2, 15.2.3, and 15.2.6. For clarity, (a) if Sanofi fails to timely exercise the Sanofi Participation Election Right with respect to a Collaboration Target prior to the Sanofi Participation Election Deadline in accordance with Section 4.3, this Agreement will automatically terminate with respect to such Collaboration Target in accordance with Section 15.2.1 and such Collaboration Target will become a Terminated Target and (b) if this Agreement is terminated in its entirety, all Collaboration Targets will be Terminated Targets.

1.397 “Territory” means worldwide.

1.398 “Third Party” means any Person other than Sanofi, Kymera or their respective Affiliates.

1.399 “Third Party Agreement” means [***].

1.400 “Third-Party Infringement Claim” has the meaning set forth in Section 12.3.

29


CONFIDENTIAL

 

1.401 “Third Party Payments” has the meaning set forth in Exhibit C.

1.402 “Trigger End Date” means, (a) in respect of Collaboration Target 1, [***], and (b) in respect of Collaboration Target 2, [***].

1.403 “Trigger Point” means (a) for Collaboration Target 1, [***], and (b) for Collaboration Target 2, [***].

1.404 “United States” or “U.S.” means the United States of America and its territories, possessions and districts.

1.405 “U.S. Budget Excession” has the meaning set forth in Exhibit A.

1.406 “U.S. Development Activities” has the meaning set forth in Section 5.3.3(a).

1.407 “U.S. Development Budget” has the meaning set forth in Section 5.3.3(a).

1.408 “U.S. Development Costs” [***].

1.409 “Valid Claim” means a claim (a) of any issued, unexpired United States or foreign Patent, which has not, in the country of issuance, been irrevocably donated to the public, disclaimed, held invalid or unenforceable by a court of competent jurisdiction in an unappealed or unappealable decision, or (b) of any United States or foreign patent application, which has not, in the country in question, been finally cancelled, withdrawn, or abandoned; provided that, for purposes of this clause (b), (i) notwithstanding the foregoing, on a country-by-country basis, a patent application pending beyond the [***] will not be considered to have any Valid Claim for purposes of this Agreement unless and until a patent that meets the criteria set forth in clause (a) above with respect to such application issues, and (ii) a patent application filed after the date of the First Commercial Sale of a Licensed Product in a country will not be included in clause (b) of the definition of Valid Claim for such Licensed Product in such country unless and until (A) a patent that meets the criteria set forth in clause (a) above with respect to such application issues, or (B) Sanofi consents to the filing of such patent application (evidence of such consent may be given to the JPC).

1.410 “Withholding Action” has the meaning set forth in Section 11.8.

 

Article 2
Research

2.1 Generally. Subject to the terms and conditions of this Agreement, on a Collaboration Target-by-Collaboration Target basis, during the Research Term, Kymera will be responsible for conducting certain Research activities for the Collaboration Compounds and Collaboration Candidates (but not, for clarity, Excluded Compounds) Directed Against such Collaboration Target in the Field (and not, for clarity, in the Excluded Field) in the Territory in accordance with the Research Plan, as further set forth in this Article 2.

2.2 Prior Research.

30


CONFIDENTIAL

 

2.2.1 The Parties acknowledge that Kymera has performed certain Research Activities with respect to Collaboration Target 1 prior to the Original Agreement Execution Date, and agree that for purposes of this Agreement, [***].

2.2.2 Under the Original Agreement, Kymera provided Sanofi (via the JRDC) a list of [***], for discussion by the JRDC. Kymera will provide a list of [***] to the JRDC at the first JRDC meeting after the Restatement Effective Date.

2.2.3 [***].

2.3 Research Plan.

2.3.1 On a Collaboration Target-by-Collaboration Target basis, during the Research Term, Kymera will conduct the Research activities under this Article 2 for the Collaboration Compounds and Collaboration Candidates Directed Against each Collaboration Target in the Field in accordance with a written plan (the “Research Plan”) that includes (a) [***] (b) [***] (c) [***] (d) [***] (e) [***] (f) [***]; provided that, an updated draft of each such budget will be provided by Kymera every [***]. A copy of the current Research Plan as of the Restatement Execution Date is attached hereto as Schedule 2.3.1; provided that, [***]. In the event Sanofi provides notice to Kymera under Section 2.5.2 that Sanofi desires to have Kymera conduct new Research activities with respect to Second Additional Degraders, Kymera will prepare an amendment to the Research Plan to include such new Research Activities no later than [***] from the date of Kymera’s receipt of written notice thereof [***]. [***]. Any amendments to the Research Plan will be subject to Section 2.3.2 and Section 9.2.2(b). In the event of any inconsistency between the Research Plan and this Agreement, the terms of this Agreement will prevail.

2.3.2 Kymera may propose amendments to the Research Plan at any time to reflect any material developments or adjustments to the applicable Research activities, provided that (a) any such amended Research Plan will at all times meet the requirements set forth in Section 2.3.1[[***] through [***], and (b) in no event will Sanofi conduct any activities under the Research Plan except as provided in Section 2.8 or as mutually agreed by the Parties. Kymera will promptly provide any such proposed amendment to the Research Plan to the JRDC for review and discussion. No update or material amendment to the Research Plan will be effective unless and until approved by the JRDC in accordance with Section 9.2.2(b).

2.4 First Additional Degraders.

2.4.1 For Collaboration Target 1, in addition to the Research activities relating to the Initial Collaboration Target 1 Degrader and the Second Additional Degraders (as set forth more fully in Section 2.5 below), Kymera will conduct Research activities, in accordance with the Research Plan during the First Additional Degrader Research Term with the goal of identifying one (1) new Collaboration Compound that satisfies the First Additional Degrader Criteria. For clarity, a “new Collaboration Compound”, as used in the prior sentence, may be a Degrader which was identified or synthesized prior to the Original Agreement Effective Date, so long as it has not previously been designated as the Initial

31


CONFIDENTIAL

 

Collaboration Target 1 Degrader or a Second Additional Degrader. Without limiting the foregoing, Kymera shall assign personnel under this Section 2.4 in accordance with the Research Plan.

2.4.2 Kymera will conduct the Research activities under Section 2.4 during the period commencing on the Original Agreement Effective Date and ending on the earliest to occur of the following: (a) the date of selection of the First Additional Degrader in accordance with Section 2.4.7, (b) [***], and (c) the effective date of termination of this Agreement with respect to Collaboration Target 1 or in its entirety (the “A&R FAD Research Term”); provided that, as long as the A&R FAD Research Term has not otherwise expired or terminated, Sanofi will [***] have the one-time right upon written notice to Kymera to extend the term of Kymera’s Research activities under this Section 2.4 until the [***] (the “FAD Term Extension”, and with the A&R FAD Research Term, collectively, the “First Additional Degrader Research Term”).

2.4.3 [***].

2.4.4 [***].

2.4.5 [***].

2.4.6 During the First Additional Degrader Research Term, Kymera will use the screening assays in accordance with the procedures set forth in the Research Plan to determine whether a given Degrader that is Researched under Section 2.4 satisfies the Screening Criteria or the First Additional Degrader Criteria. All Degraders that meet the Screening Criteria during the First Additional Degrader Research Term will be Collaboration Compounds under this Agreement, subject to the reversion rights set forth in Section 5.6. Notwithstanding anything herein to the contrary, any Degraders that are Researched by or on behalf of Kymera under Section 2.4 that do not meet the Screening Criteria will be classified as Excluded Compounds, unless [***].

2.4.7 During the First Additional Degrader Research Term, within [***] after Kymera reasonably believes that it has identified a Collaboration Compound that has satisfied all of the First Additional Degrader Criteria, Kymera will present a written report to Sanofi that identifies [***]. In addition, Sanofi may, in its discretion and through the JRDC, request that Kymera provide additional information, results or data in accordance with Section 2.11.3. Within [***] after the delivery of such report (or such longer period of time as may be reasonably determined by the JRDC, but in no event longer than [***]), the JRDC will (a) meet, discuss and review the report and associated material data, results and information and (b) determine whether such Collaboration Compound satisfies the First Additional Degrader Criteria. If the JRDC determines that such Collaboration Compound satisfies the First Additional Degrader Criteria, then (i) such Collaboration Compound will be classified as a “First Additional Degrader” under this Agreement, (ii) the First Additional Degrader Research Term will expire, (iii) Kymera will perform Early Development Activities with respect to such First Additional Degrader in accordance with Article 3 and the Early Development Plan, and (iv) Kymera will have no further obligation to conduct any further additional Research activities under Section 2.4. If the JRDC does not believe that such

32


CONFIDENTIAL

 

Collaboration Compound satisfies the First Additional Degrader Criteria, then Kymera will use diligent efforts during the remainder of the First Additional Degrader Research Term to conduct additional Research activities in accordance with the Research Plan, and thereafter present a report to the JRDC as and to the extent applicable in Section 2.4. In the event that the JRDC does not agree on whether such Collaboration Compound satisfies the First Additional Degrader Criteria, then such dispute will be resolved in accordance with Section 9.9.2(b)(iii). Notwithstanding the foregoing, Sanofi may determine [***]. Any selection of a Collaboration Compound as a First Additional Degrader by the JRDC, by the R&D Expert in accordance with Section 9.9.2(b), or by Sanofi pursuant to the preceding sentence, will be recorded in the minutes of the JRDC.

2.5 Second Additional Degraders.

2.5.1 Under the Original Agreement, Research activities relating to [***].

2.5.2 During the period commencing on the Restatement Effective Date and ending on [***], Sanofi will have the right to provide written notice to Kymera that Sanofi desires to have Kymera conduct new Research activities in accordance with the Research Plan during the Second Additional Degrader Research Term with the goal of identifying one (1) new Collaboration Compound that satisfies the Second Additional Degrader Criteria. For clarity, a “new Collaboration Compound”, as used in the prior sentence, may be a Degrader which was identified or synthesized by or on behalf of Kymera or its Affiliates prior to the Restatement Effective Date, so long as such Degrader has not previously been identified by the Parties pursuant to this Agreement as the Initial Collaboration Target 1 Degrader or a First Additional Degrader. In addition, in the event that the Sanofi provides written notice to Kymera in accordance with the first sentence of this Section 2.5.2, the Degraders to be researched under the Research Plan during the Second Additional Degrader Research Term may include all [***] that the Parties believe in good faith, as of the date of such written notice to Kymera, would have [***].

2.5.3 In the event that Sanofi provides written notice to Kymera in accordance with Section 2.5.2, Kymera provide the JRDC with an amendment to the Research Plan in accordance with Section 2.3.1. [***] Kymera will conduct new Research activities under this Section 2.5 pursuant to the amended Research Plan during the period commencing [***] after the date of [***] (“SAD Term Commencement Date”) and ending on the earliest to occur of the following: (i) the date of selection of the Second Additional Degrader in accordance with Section 2.5.6, (ii) [***] (iii) the effective date of termination of this Agreement with respect to Collaboration Target 1 or in its entirety or (iv) the effective date of termination of the SAD Termination. The period of time during which Kymera conducts new Research activities under this Section 2.5 (if any) will be the “Second Additional Degrader Research Term”.

2.5.4 During the Second Additional Degrader Research Term (if any), Sanofi will reimburse Kymera in accordance with Section 11.6.2 for [***] actually incurred by or on behalf of Kymera or its Affiliates (a) in accordance with the Second Additional Degrader Research Budget, and (b) in connection with conducting Research activities under Section 2.5 in accordance with the Research Plan.

33


CONFIDENTIAL

 

2.5.5 During the Second Additional Degrader Research Term (if any), Kymera will use Commercially Reasonable Efforts to ensure that [***].

2.5.6 During the Second Additional Degrader Research Term (if any), Kymera will use the screening assays in accordance with the procedures set forth in the Research Plan to determine whether a given Degrader that is Researched under this Section 2.5 satisfies the Screening Criteria or the Second Additional Degrader Criteria. All Degraders that meet the Screening Criteria during the Second Additional Degrader Research Term will be Collaboration Compounds under this Agreement, subject to the reversion rights set forth in Section 5.6. Notwithstanding anything herein to the contrary, any Degraders that are Researched by or on behalf of Kymera under Section 2.5 that do not meet the Screening Criteria will be classified as Excluded Compounds, unless [***].

2.5.7 During the Second Additional Degrader Research Term (if any), within [***] after Kymera reasonably believes that it has identified a Collaboration Compound that has satisfied all of the Second Additional Degrader Criteria, Kymera will present a written report to Sanofi [***]. In addition, Sanofi may, in its discretion and through the JRDC, request that Kymera provide additional information, results or data in accordance with Section 2.11.3. Within [***] after the delivery of such report (or such longer period of time as may be reasonably determined by the JRDC, but in no event longer than [***]), the JRDC will (a) meet, discuss and review the report and associated material data, results and information, and (b) determine whether such Collaboration Compound satisfies the Second Additional Degrader Criteria. If the JRDC determines that such Collaboration Compound satisfies the Second Additional Degrader Criteria, then (i) such Collaboration Compound will be classified as a “Second Additional Degrader” under this Agreement, (ii) the Second Additional Degrader Research Term will expire, (iii) Kymera will perform Early Development Activities with respect to such Second Additional Degrader in accordance with Article 3 and the Early Development Plan, and (iv) Kymera will have no further obligation to conduct any further additional Research activities under Section 2.5. If the JRDC does not believe that such Collaboration Compound satisfies the Second Additional Degrader Criteria, then Kymera will use diligent efforts during the remainder of the Second Additional Degrader Research Term to conduct additional Research activities in accordance with the Research Plan, and thereafter present a report to the JRDC as and to the extent applicable in Section 2.5. In the event that the JRDC does not agree on whether such Collaboration Compound satisfies the Second Additional Degrader Criteria, then such dispute will be resolved in accordance with Section 9.9.2(b)(iii). Notwithstanding the foregoing, [***]. Any selection of a Collaboration Compound as a Second Additional Degrader by the JRDC, by the R&D Expert in accordance with Section 9.9.2(b)(iii), or by Sanofi pursuant to the preceding sentence, will be recorded in the minutes of the JRDC.

2.6 Initial Collaboration Target 2 Degraders.

2.6.1 For Collaboration Target 2, during the Research Term, Kymera will, at its cost and expense, conduct Research activities in accordance with the Research Plan with the goal of advancing [***].

34


CONFIDENTIAL

 

2.6.2 In the event that the first Collaboration Candidate Directed Against Collaboration Target 2 is designated in accordance with Section 2.6.5, Kymera will [***] continue to conduct any applicable Research activities with respect to such first Collaboration Candidate in accordance with the Research Plan or Development activities with respect to such Collaboration Candidate in accordance with the Early Development Plan, as applicable.

2.6.3 In addition, from and after the designation of the first Collaboration Candidate Directed Against Collaboration Target 2 in accordance with Section 2.6.5, Kymera will continue to conduct Research activities in accordance with the Research Plan in order to [***]. Kymera will conduct activities under this Section 2.6.3 until the earliest of (a) the date that the JRDC or the R&D Expert determines that a second Collaboration Compound Directed Against Collaboration Target 2 satisfies [***] and is classified as a Collaboration Candidate, (b) the Sanofi Participation Election Effective Date for Collaboration Target 2, (c) the date that the JRDC determines such Research Activities should be discontinued, or (d) the expiration or termination of the Research Term with respect to Collaboration Target 2 (the “Series 2 Research Term”). During the Series 2 Research Term, Sanofi will reimburse Kymera in accordance with Section 11.6.1 for Kymera’s [***] actually incurred by or on behalf of Kymera or its Affiliates in connection with conducting Research activities under this Section 2.6.3; provided that if [***].

2.6.4 [***].

2.6.5 During the Research Term, within [***] after Kymera reasonably believes that it has identified a Collaboration Compound Directed Against Collaboration Target 2 that has satisfied [***], Kymera will present a written report to Sanofi that [***]. Sanofi may, in its discretion and through the JRDC, request any other information, results or data with respect to such Collaboration Compound as set forth more fully in Section 2.11.3. Within [***] after the delivery of such report (or such longer period of time as may be reasonably determined by the JRDC, but in no event longer than [***]), the JRDC will (a) meet, discuss and review the report and associated material data, results and information, and (b) determine whether such Collaboration Compound satisfies [***]. If the JRDC determines that such Collaboration Compound satisfies [***], then such Collaboration Compound will be classified as a Collaboration Candidate. If the JRDC does not believe that such Collaboration Compound satisfies [***], then Kymera will use diligent efforts during the remainder of the Research Term to conduct additional Research activities in accordance with the Research Plan, and thereafter present a report to the JRDC as and to the extent applicable in this Section 2.6. In the event that the JRDC does not agree on whether such Collaboration Compound satisfies [***], then such dispute will be resolved in accordance with Section 9.9.2(b)(iii). Any designation of a Collaboration Compound as a Collaboration Candidate by the JRDC, by the R&D Expert in accordance with Section 9.9.2(b)(iii) will be recorded in the minutes of the JRDC.

2.6.6 If the JRDC designates [***] Collaboration Candidates under Section 2.6.3, then Kymera will have no further obligation to conduct any further additional Research activities under this Section 2.6.

2.7 Diligence; Decision-Making.

35


CONFIDENTIAL

 

2.7.1 On a Collaboration Target-by-Collaboration Target basis, during the Research Term, Kymera, directly or through its Affiliates or Subcontractors, will [***].

2.7.2 Subject to Sections 2.4.7, 2.5.6 and 9.9.2(b)(i), on a Collaboration Target-by-Collaboration Target basis, during the Research Term, Kymera will have the final decision-making authority with respect to the Research activities for the Collaboration Compounds, Collaboration Candidates and Licensed Products Directed Against such Collaboration Target under this Agreement prior to the Sanofi Participation Election Right Exercise (if any) with respect to such Collaboration Target, including the prioritization of the Research activities and allocation of resources among the Research activities; provided that any such decision is consistent with the terms and conditions of this Agreement.

2.8 [***].

2.8.1 Sanofi shall be entitled to conduct [***]. Sanofi also may, with Kymera’s prior agreement, conduct additional Research activities (including [***]) under the Research Plan. Sanofi will obtain prior written consent from Kymera prior to [***].

2.8.2 Any and all [***] constitutes “MTA Research Studies,” and all such MTA Research Studies will be documented in the applicable Research Plan or the relevant JRDC minutes.

2.9 Transfer of Materials.

2.9.1 To facilitate the conduct of activities under each Research Plan: (a) Sanofi may, at its election, provide Materials to Kymera to facilitate Kymera’s Research activities under the Research Plan (in which case the transfer of such Materials shall be specified in the Research Plan or the minutes of the JRDC), and (b) Kymera will provide to Sanofi reasonable quantities of such Materials as are reasonably necessary to permit Sanofi to [***].

2.9.2 All Materials transferred pursuant to this Section 2.9 (a) will remain the sole property of the supplying Party (it being understood that jointly-owned Materials will remain jointly-owned, notwithstanding any physical transfer between the Parties), (b) will be used only in the fulfillment of the receiving Party’s obligations or exercise of rights under this Agreement, (c) will remain solely under the control of the receiving Party, (d) will not be used or delivered by the receiving Party to or for the benefit of any Third Party (other than a permitted Subcontractor or Sublicensee) without the prior written consent of the supplying Party, and (e) will not be used in research or testing involving human subjects, unless expressly agreed in writing. The receiving Party will use the Materials in compliance with Applicable Laws and the terms and conditions of this Agreement, and will not reverse engineer or chemically analyze such Materials, except as specified in the Research Plan.

36


CONFIDENTIAL

 

2.9.3 Any intellectual property generated by or on behalf of either Party in connection with the use of Materials transferred pursuant to this Section 2.9 will be governed by the following:

(a) Subject to the licenses granted under Article 10, the supplying Party will solely own all right, title and interest in and to any data, information, results and reports generated by or on behalf of either Party directly from the use of any transferred Materials that comprise Collaboration Compounds, Collaboration Candidates or Licensed Products, solely within any MTA Research Studies permitted and conducted under Section 2.8 (including [***]), and such data, information, results and reports will be shared with the supplying Party via the JRDC,

(b) Except as set forth in Section 2.9.3(a), all intellectual property created, conceived or generated by or on behalf of either Party using Collaboration Compounds, Collaboration Candidates or Licensed Products under this Agreement in connection with the MTA Research Studies will be governed by the provisions of this Agreement, including Article 10 and Article 12.

2.9.4 All Materials supplied under this Section 2.9 are supplied “as is”, with no warranties of fitness for a particular purpose and must be used with prudence and appropriate caution in any experimental work, as not all of their characteristics may be known. The receiving Party assumes all liability for damages that may arise from its use, storage or disposal of the Materials. Except as otherwise set forth in this Agreement, the supplying Party will not be liable to the receiving Party for any loss, claim or demand made by the receiving Party, or made against the receiving Party by any Third Party, due to or arising from the use of the Materials under this Agreement, except to the extent such loss, claim or demand is caused by the gross negligence or willful misconduct of the supplying Party.

2.9.5 For clarity, the transfer of any material owned or Controlled by Sanofi other than Materials will be governed by a to-be-negotiated material transfer agreement.

2.10 Subcontracting. During the Research Term, Kymera may engage Approved Third Party Contractors to perform Research activities hereunder; provided that (a) each contract between Kymera and an Approved Third Party Contractor entered into after the Original Agreement Execution Date will include confidentiality and non-use provisions that are substantially similar to those set forth in Article 16 (or such other terms as are otherwise agreed by Sanofi) (but of duration customary in confidentiality agreements entered into for a similar purpose, provided that the duration of confidentiality for any information which constitutes a trade secret will be for as long as such information remains a trade secret under Applicable Law), (b) Kymera will remain at all times fully liable for the acts and omissions by such Approved Third Party Contractors under this Agreement as if they were acts or omissions by Kymera, (c) subject to Section 2.5.3, Kymera will be responsible for the effective and timely management of and payment of its Approved Third Party Contractors hereunder and (d) each contract between Kymera and an Approved Third Party Contractor entered into after the Original Agreement Execution Date will provide that [***].

37


CONFIDENTIAL

 

2.11 Records; Reporting.

2.11.1 Each Party will maintain, and [***] to maintain, records of the Research activities under this Agreement in sufficient detail and in good scientific manner appropriate for scientific, patent and regulatory purposes, which will be complete and accurate in all material respects and will fully and properly reflect all work done, data and developments made, and results achieved.

2.11.2 Each Party will furnish to the JRDC, within [***] after the end of each Calendar Quarter, to the extent applicable to such Party, an update on such Party’s progress under the Research Plan for the applicable Collaboration Target (including with respect to any MTA Research Studies or other activities governed by a separate material transfer agreement) during the relevant Calendar Quarter, including a summary of any results and data generated by such Party under such Research Plan and an overview of the resources (including a summary of all expenditures incurred by such Party in connection with such Research activities and reasonable documentation relating thereto, and an overview of FTEs used by such Party for such Research activities) allocated to activities under such Research Plan during the relevant Calendar Quarter. Such Party will provide the JRDC with such other information, results and data with respect to the Research activities under the Research Plan as any member of the JRDC may reasonably request that are in such Party’s possession or control. Kymera will provide Sanofi a reasonable opportunity via the JRDC to discuss and provide input with respect to Kymera’s Research activities under the Research Plan, including with respect to the prioritization of Research activities for Collaboration Compounds.

2.11.3 In addition to, and without limiting, the reporting requirements in Section 2.11.2, during the First Additional Degrader Research Term, Kymera will furnish to the JRDC, within [***], a written report on Kymera’s Research activities with respect to Collaboration Compounds that are Researched under Section 2.4 and have the potential to be classified as First Additional Degraders. Such reports will [***]. Kymera will provide the JRDC with such other information, results and data with respect to the Research activities under Section 2.4 as any member of the JRDC may reasonably request that are in Kymera’s possession or control.

2.11.4 In addition to, and without limiting, the reporting requirements in Section 2.11.2 or 2.11.3, during the Second Additional Degrader Research Term, Kymera will furnish to the JRDC, within [***], a written report on Kymera’s Research activities with respect to Collaboration Compounds that are Researched under Section 2.5 and have the potential to be classified as Second Additional Degraders. Such reports will [***]. Kymera will provide the JRDC with such other information, results and data with respect to the Research activities under Section 2.5 as any member of the JRDC may reasonably request that are in Kymera’s possession or control.

2.11.5 In the event that Sanofi has provided written notice to Kymera that [***], then, within [***] of the date of receipt of such written notice, Kymera will permit Sanofi to examine the relevant books and records of Kymera and its Affiliates, as may be reasonably necessary to verify the reports provided by Kymera in accordance with Section 2.11.2 or 2.11.3; provided that such examination will be subject to customary and reasonable

38


CONFIDENTIAL

 

due diligence procedures to preserve the confidential nature of any books or records. An examination by Sanofi under this Section 2.11.5 (a) will occur not more than [***], (b) will be limited to the pertinent books and records for any Calendar Year ending not more than [***]before the date of the written notice, (c) will be conducted in such a manner to minimize, to the extent reasonably possible, the period of examination and in no case shall such period exceed [***], and (d) will be conducted by the minimum number of Sanofi employees as necessary to provide requisite subject matter expertise and conduct the review in the allotted timeframe, each of whom shall have appropriate experience in the Research of small molecule compounds and candidates; provided, that if any examination by Sanofi under this Section 2.11.5 reveals any material discrepancy, Kymera will permit Sanofi to conduct additional examination of pertinent books and records for Calendar Years ending not more than [***] before the date of the written notice, during a period limited to minimize the days of examination as much as possible and in no case more than [***]. Sanofi will be provided access to such books and records at Kymera’s facility or facilities where such books and records are normally kept and such examination will be conducted during Kymera’s normal business hours. Upon completion of the examination, Sanofi will provide Kymera and the JRDC a written report disclosing the reason(s) for the difference between the relevant report provided by Kymera and the results and data that should have been generated and the activities that should have been conducted by Kymera during the relevant time. The costs and fees of any examination conducted by Sanofi under this Section 2.11.5 will be borne by Sanofi.

Article 3
EARLY DEVELOPMENT

3.1 Early Development Activities.

3.1.1 With respect to Collaboration Target 1, during the Research Term prior to Sanofi’s exercise of the Sanofi Participation Election Right with respect to Collaboration Target 1, the terms and conditions set forth in this Section 3.1.1 will apply.

(a) Kymera will be solely responsible for (a) conducting all Pre-Clinical Development of Collaboration Candidates and Licensed Products that are Directed Against Collaboration Target 1 in the Field in the Territory, (b) filing all INDs for all Collaboration Candidates and Licensed Products Directed Against Collaboration Target 1 in the Field in the Territory, and (c) for conducting the Kymera Phase 1 Clinical Trials therefor, in each case ((a)-(c)) in accordance with the Early Development Plan (the “Early Development Activities”); provided that, following the Restatement Effective Date, Kymera will only be required to conduct [***]. For example, Kymera may conduct the [***], but shall not be required to [***].

(b) [***], and subject to the last sentence of this Section 3.1.1(b), Sanofi will be solely responsible for [***], to conduct [***] pursuant to the Phase 2 Development Plan; provided that, subject to any [***], (i) Sanofi shall use Commercially Reasonable Efforts to [***], (ii) [***] Sanofi shall use Commercially Reasonable Efforts to [***] and (iii) Sanofi must [***]. The Parties acknowledge and agree that [***] to determine whether the applicable [***] that are conducted by Sanofi under this Section 3.1.1(b) are designed as [***]; provided, for clarity, that all [***] will be determined in accordance with, and as defined by, Applicable Law and the definitions set forth herein.

39


CONFIDENTIAL

 

(c) No later than [***] prior to the expected submission of a clinical trial protocol for each Phase 2 Clinical Trial sponsored by Sanofi pursuant to the Phase 2 Development Plan, Sanofi shall provide Kymera with such protocol for each such trial, and within [***] of receipt of such protocol, Kymera may provide Sanofi with comments to such protocol, which Sanofi shall consider in good faith (each such protocol, a “Phase 2 Protocol”); provided that, [***]. [***] shall be permitted to make amendments to the Phase 2 Protocol; provided that, it shall promptly notify [***] of any material changes to any Phase 2 Protocol.

(d) The initial Phase 2 Development Plan as agreed by the Parties as of the Restatement Execution Date is attached as Schedule 3.1.1(d), and sets forth the high-level details with respect to the [***] (the “Phase 2 Development Plan”). Each Party may propose amendments to the Phase 2 Development Plan at any time. Such Party will promptly provide any such proposed amendment to the Phase 2 Development Plan to the JRDC for review and discussion. No update or amendment to the Phase 2 Development Plan will be effective unless and until approved by the JRDC in accordance with Section 9.2.2(b); provided that, [***].

(e) The Parties acknowledge that pursuant to the Original Agreement any Phase 2 Clinical Trial with respect to [***] would have constituted an activity occurring during the Sanofi Participation Term under the Late Development Plan. However, pursuant to this Agreement, any such Phase 2 Clinical Trials for [***] conducted prior to Sanofi’s Participant Election Deadline shall be deemed activities occurring during the Research Term. [***].

(f) All Development activities conducted under Section 3.1.1(b) for the Phase 2 Clinical Trials for [***] by or on behalf of Sanofi pursuant to the Phase 2 Development Plan will be the “Phase 2 Activities.”

(g) The Parties will be responsible for the costs and expenses of the Development activities contemplated in this Section 3.1.1 in accordance with Section 11.6.4.

3.1.2 With respect to Collaboration Target 2, during the Research Term prior to Sanofi’s exercise of the Sanofi Participation Election Right with respect to Collaboration Target 2, Kymera will be solely responsible, at its cost and expense and in accordance with the applicable Early Development Plan, for (a) conducting all Pre-Clinical Development of Collaboration Candidates and Licensed Products Directed Against Collaboration Target 2 in the Field in the Territory, and (b) filing the first IND therefor for the first Indication in the Field in the first Major Market Country, in each case ((a)-(b)) in accordance with the Early Development Plan.

3.2 Early Development Plan.

3.2.1 On a Collaboration Target-by-Collaboration Target basis, during the Research Term, Kymera will conduct its Development activities under Section 3.1 for the Collaboration Candidates and Licensed Products Directed Against each Collaboration Target in the Field in accordance with a written plan (the “Early Development Plan”) that includes [***]. A copy of the current Early Development Plan as of the Restatement Execution Date is attached hereto as Schedule 3.2.1. Any amendments to the Early Development Plan will

40


CONFIDENTIAL

 

be subject to Section 3.2.2 and Section 9.2.2(b). In the event of any inconsistency between the Early Development Plan and this Agreement, the terms of this Agreement will prevail.

3.2.2 Kymera may propose amendments to the Early Development Plan at any time to reflect any material developments or adjustments to the applicable Development activities, provided that (a) any such amended Early Development Plan will at all times meet the requirements set forth in Section 3.2.1, and (b) in no event will Sanofi conduct any activities under the Early Development Plan except as provided in Section 3.1, Section 3.2.3, Section 3.4 or as otherwise mutually agreed by the Parties. Kymera will promptly provide any such proposed amendment to the Early Development Plan to the JRDC for review and discussion. No update or material amendment to the Early Development Plan will be effective unless and until approved by the JRDC in accordance with Section 9.2.2(b).

3.2.3 Sanofi may propose amendments to the Early Development Plan at any time to include [***] to be conducted by or on behalf of Sanofi [***]. Sanofi will promptly provide any such proposed amendment to the Early Development Plan to the JRDC for review and discussion. No update or material amendment to the Early Development Plan will be effective unless and until approved by the JRDC in accordance with Section 9.2.2(b); provided that, Sanofi shall have final decision-making authority in the event that such [***].

3.3 Diligence; Decision-Making.

3.3.1 On a Collaboration Target-by-Collaboration Target basis, during the Research Term, Kymera, directly or through its Affiliates or Subcontractors, will (a) [***] (b) use Commercially Reasonable Efforts to Research and Develop one (1) Collaboration Candidate that achieves Successful Completion for Collaboration Target 2, (c) use Commercially Reasonable Efforts to Research and Develop one (1) Collaboration Candidate that achieves Successful Completion for Collaboration Target 1, and (d) use Commercially Reasonable Efforts to conduct the Kymera Existing Phase 1 Clinical Trial.

3.3.2 Subject to Section 9.9.2(b)(i), on a Collaboration Target-by-Collaboration Target basis, during the Research Term, Kymera will have the final decision-making authority with respect to its Development activities for the Collaboration Candidates and Licensed Products Directed Against such Collaboration Target under this Agreement prior to the Sanofi Participation Election Right Exercise (if any) with respect to such Collaboration Target, including the prioritization of its Development activities and the allocation of resources among the Development activities; provided that any such decision is consistent with the terms and conditions of this Agreement. In the event that a Material Safety Event occurs in connection with any Clinical Trials conducted by or on behalf of Kymera, then Kymera will have the right, at its sole election, to wind-down such Clinical Trials in accordance with Applicable Law.

3.3.3 Subject to Section 9.9.2(b)(i), during the Research Term, Sanofi will have the final decision-making authority with respect to [***]; provided that any such decision is consistent with the terms and conditions of this Agreement. In the event that a Material Safety Event occurs in connection with any Phase 2 Clinical Trial that Sanofi is

41


CONFIDENTIAL

 

conducting for [***], then Sanofi will have the right, at its sole election, to wind-down such Phase 2 Clinical Trial in accordance with Applicable Law.

3.4 [***]

3.4.1 Sanofi shall be entitled to conduct [***]. Sanofi also may, with Kymera’s prior agreement, conduct additional Development activities (including [***]) under the Early Development Plan; provided that, for the avoidance of doubt, no such consent shall be required for Sanofi to perform the Phase 2 Activities. Sanofi will obtain prior written consent from Kymera prior to [***].

3.4.2 Any and all [***] permitted and conducted under Section 3.4.1, collectively, constitute “MTA Development Studies,” and all such MTA Development Studies will be documented in the applicable Early Development Plan or the relevant JRDC minutes.

3.5 Transfer of Materials.

3.5.1 To facilitate the conduct of activities under each Early Development Plan: (a) Sanofi may, at its election, provide Materials to Kymera to facilitate Kymera’s Development activities under the Early Development Plan (in which case the transfer of such Materials shall be specified in the Early Development Plan or the minutes of the JRDC), and (b) Kymera will provide to Sanofi reasonable quantities of such Materials as are reasonably necessary to permit Sanofi to conduct [***].

3.5.2 All Materials transferred pursuant to this Section 3.5 (a) will remain the sole property of the supplying Party (it being understood that jointly-owned Materials will remain jointly-owned, notwithstanding any physical transfer between the Parties), (b) will be used only in the fulfillment of the receiving Party’s obligations or exercise of rights under this Agreement, (c) will remain solely under the control of the receiving Party, (d) will not be used or delivered by the receiving Party to or for the benefit of any Third Party (other than a permitted Subcontractor or Sublicensee) without the prior written consent of the supplying Party, and (e) will not be used in research or testing involving human subjects, unless expressly agreed in writing. The receiving Party will use the Materials in compliance with Applicable Laws and the terms and conditions of this Agreement, and will not reverse engineer or chemically analyze such Materials, except as specified in the Early Development Plan.

3.5.3 Any intellectual property generated by or on behalf of either Party in connection with the use of Materials transferred pursuant to this Section 3.5 will be governed by the following:

(a) Subject to the licenses granted under Article 10, the supplying Party will solely own all right, title and interest in and to any data, information, results and reports generated by or on behalf of either Party directly from the use of any transferred Materials that comprise Collaboration Compounds, Collaboration Candidates or Licensed Products, solely within any MTA Development Studies permitted and conducted under Section 3.5.1, and such data, information, results and reports will be shared with the supplying Party via the JRDC;

42


CONFIDENTIAL

 

(b) Except as set forth in Section 3.5.3(a), all intellectual property created, conceived or generated by or on behalf of either Party using Collaboration Compounds, Collaboration Candidates or Licensed Products under this Agreement in connection with the MTA Development Studies will be governed by the provisions of this Agreement, including Article 10 and Article 12.

3.5.4 All Materials supplied under this Section 3.5 are supplied “as is”, with no warranties of fitness for a particular purpose and must be used with prudence and appropriate caution in any experimental work, as not all of their characteristics may be known. The receiving Party assumes all liability for damages that may arise from its use, storage or disposal of the Materials. Except as otherwise set forth in this Agreement, the supplying Party will not be liable to the receiving Party for any loss, claim or demand made by the receiving Party, or made against the receiving Party by any Third Party, due to or arising from the use of the Materials under this Agreement, except to the extent such loss, claim or demand is caused by the gross negligence or willful misconduct of the supplying Party.

3.5.5 For clarity, the transfer of any material owned or Controlled by Sanofi other than Materials will be governed by a to-be-negotiated material transfer agreement.

3.6 Subcontracting. During the Research Term, Kymera may engage Approved Third Party Contractors to perform Development activities hereunder; (a) each contract between Kymera and an Approved Third Party Contractor entered into after the Original Agreement Execution Date will be consistent with the provisions of this Agreement, including Section 12.1, and will include confidentiality provisions that are at least as restrictive as those described in Article 16, (b) Kymera will remain at all times fully liable for the acts and omissions such Approved Third Party Contractors under this Agreement as if they were acts or omissions by Kymera, and (c) Kymera will be responsible for the effective and timely management of and payment of its Approved Third Party Contractors hereunder. The engagement of any Approved Third Party Contractor in compliance with this Section 3.6 will not relieve Kymera of its obligations under this Agreement. Additionally, Sanofi may engage Third Party contractors to perform the Phase 2 Activities; provided that, (a) each contract between Sanofi and a Third Party contractor entered into after the Restatement Execution Date will be consistent with the provisions of this Agreement, including Section 12.1, and will include confidentiality provisions that are at least as restrictive as those described in Article 16, (b) Sanofi will remain at all times fully liable for the acts and omissions such Third Party contractors under this Agreement as if they were acts or omissions by Sanofi, (c) Sanofi will be responsible for the effective and timely management of and payment of its Third Party contractors hereunder and (d) the engagement of any Approved Third Party Contractor in compliance with this Section 3.6 will not relieve Sanofi of its obligations under this Agreement.

3.7 Records; Reporting.

3.7.1 Each Party will maintain, and [***] to maintain, records of the Development activities under this Agreement in sufficient detail and in good scientific manner appropriate for scientific, patent and regulatory purposes, which will be complete and accurate

43


CONFIDENTIAL

 

in all material respects and will fully and properly reflect all work done, data and developments made, and results achieved.

(a) The Parties acknowledge and agree that, prior to the Restatement Effective Date, Kymera provided to Sanofi the Pre-Clinical and SAD/MAD Data Package for the Kymera Existing Phase 1 Clinical Trial, the MAD Data Package, the Phase 1 Patient Data Package for the Kymera Existing Phase 1 Clinical Trial and the Remaining Patient Data Package. [***].

3.7.2 Each Party will furnish to the JRDC, within [***], to the extent applicable to such Party, an update on such Party’s progress under the Early Development Plan or the Phase 2 Development Plan (as applicable) for the applicable Collaboration Target (including with respect to any MTA Development Studies or other activities governed by a separate material transfer agreement) during the relevant Calendar Quarter, including a summary of any results and data generated by such Party under such Early Development Plan or the Phase 2 Development Plan (as applicable) and an overview of the resources (including a summary of all expenditures incurred by such Party in connection with such Development activities and reasonable documentation relating thereto, and an overview of FTEs used by such Party for such Development activities), allocated to activities under such Early Development Plan or the Phase 2 Development Plan (as applicable) during the relevant Calendar Quarter. Such Party will provide the JRDC with such other information, results and data with respect to the Development activities under the Early Development Plan or the Phase 2 Development Plan (as applicable) as any member of the JRDC may reasonably request that are in such Party’s possession or control. Each Party will provide the other Party a reasonable opportunity via the JRDC to discuss and provide input with respect to such Party’s Development activities under the Early Development Plan or the Phase 2 Development Plan (as applicable), including with respect to the prioritization of Development activities for Collaboration Candidates and Licensed Products.

3.7.3 In the event that Sanofi has provided written notice to Kymera (including via the JRDC) that [***], then, within [***] of the date of receipt of such written notice, Kymera will permit Sanofi to examine the relevant books and records of Kymera and its Affiliates, as may be reasonably necessary to verify the Research updates and progress reports submitted by Kymera in accordance with this Section 3.7; provided that such examination will be subject to customary and reasonable due diligence procedures to preserve the confidential nature of any books or records. An examination by Sanofi under this Section 3.7.3 (a) will occur not more than [***], (b) will be limited to the pertinent books and records for any Calendar Year ending not more than [***] before the date of the written notice, (c) will be conducted in a such a manner to minimize, to the extent reasonably possible, the period of examination and in no case shall such period exceed [***], and (d) will be conducted by the minimum number of Sanofi employees as necessary to provide requisite subject matter expertise and conduct the review in the allotted timeframe, each of whom shall have appropriate experience in the Development of small molecule compounds and candidates; provided, that if any examination by Sanofi under this Section 3.7.3 reveals any material discrepancy, Kymera will permit Sanofi to conduct additional examination of pertinent books and records for Calendar Years ending not more than [***] before the date of the written notice, during a period limited to minimize the days of examination as much as possible and in no case more than [***]. Sanofi will be provided access to such books and records at

44


CONFIDENTIAL

 

Kymera’s facility or facilities where such books and records are normally kept and such examination will be conducted during Kymera’s normal business hours. Upon completion of the examination, Sanofi will provide Kymera and the JRDC a written report disclosing the reason(s) for the difference between the relevant report provided by Kymera and the results and data that should have been generated and the activities that should have been conducted by Kymera during the relevant time. The costs and fees of any examination conducted by Sanofi under this Section 3.7.3 will be borne by Sanofi.

Article 4
SANOFI PARTICIPATION ELECTION RIGHT

4.1 Sanofi Participation Election Right. On a Collaboration Target-by-Collaboration Target basis, during the Research Term, Kymera hereby grants to Sanofi an exclusive right, exercisable in Sanofi’s sole discretion, to continue, in collaboration with Kymera as specified herein, the Research, Development, Manufacture and Commercialization of Collaboration Candidates and Licensed Products Directed Against such Collaboration Target (each a “Sanofi Participation Election Right”).

4.1.1 Participation Data Package. Except in the case of a Phase 2 Trigger Point, on a Collaboration Target-by-Collaboration Target basis, within [***] after the Trigger Point for a given Collaboration Target, Kymera will provide Sanofi with the Participation Data Package with respect to such Collaboration Target, and Sanofi will use such Participation Data Package (and any additional information provided by Kymera pursuant to this Article 4) solely to determine whether to exercise the corresponding Sanofi Participation Election Right with respect to such Collaboration Target. Additionally, Kymera will make all data within the Participation Data Package for such Collaboration Target available to Sanofi through an electronic data room. [***] For clarity, Kymera will not be required to provide Sanofi with the Participation Data Package in the event of a Phase 2 Trigger Point.

4.2 Incomplete Participation Data Package. On a Collaboration Target-by-Collaboration Target basis, if such Participation Data Package for a given Collaboration Target is incomplete, Sanofi may notify Kymera of the incomplete status of such Participation Data Package in writing including any items that, in Sanofi’s reasonable determination made in good faith, should have been included in the Participation Data Package but were not included therein within [***] after receipt thereof. Following receipt of such notice, Kymera will promptly deliver to Sanofi the additional information requested by Sanofi to complete such Participation Data Package. For clarity, delivery of such incomplete Participation Data Package will not trigger the [***] period after which the Sanofi Participation Election Deadline would occur pursuant to Section 4.3, but such [***] period after which the Sanofi Participation Election Deadline would occur pursuant to Section 4.3 will thereafter be triggered on the date of Sanofi’s receipt of the additional information requested by Sanofi to complete such Participation Data Package.

4.2.1 Due Diligence Following Participation Data Package. On a Collaboration Target-by-Collaboration Target basis, following the date of delivery of the Participation Data Package for a given Collaboration Target, to assist Sanofi in conducting thorough due diligence to decide whether to exercise the corresponding Sanofi Participation

45


CONFIDENTIAL

 

Election Right with respect to such Collaboration Target, Kymera will afford to Sanofi and its representatives reasonable access during normal business hours to Kymera’s personnel, records and data, offices, laboratories, and manufacturing and supplier sites that Sanofi may reasonably request regarding such Collaboration Target and Collaboration Candidates and Licensed Products Directed Against such Collaboration Target; provided that such obligation to supply such records, data and information will be limited to those records, data and information then available to Kymera and will be subject to customary and reasonable due diligence procedures to preserve the confidential nature of any such information.

4.3 Exercise of Participation Election Right. On a Collaboration Target-by-Collaboration Target basis, during the Research Term, Sanofi will have the right, in its sole discretion, to exercise the Sanofi Participation Election Right (each such exercise, the “Sanofi Participation Election Right Exercise”) for a given Collaboration Target by delivering to Kymera written notice of such exercise (each such notice, the “Sanofi Participation Election Right Exercise Notice”) within [***] after either the date of delivery of the Participation Data Package with respect to such Collaboration Target or the date of the Phase 2 Trigger Point, as applicable (the end of such [***] period, the “Sanofi Participation Election Deadline”). If Sanofi provides the Sanofi Participation Election Right Exercise Notice prior to the Sanofi Participation Election Deadline with respect to such Collaboration Target, then the date of receipt of such Sanofi Participation Election Right Exercise Notice will be the “Sanofi Participation Election Effective Date” with respect to such Collaboration Target.

4.4 No Participation Election Right Exercise. On a Collaboration Target-by-Collaboration Target basis, if Sanofi declines to exercise its Sanofi Participation Election Right or fails to provide a Sanofi Participation Election Right Exercise Notice in accordance with Section 4.3 with respect to a Collaboration Target, in each case, prior to the Sanofi Participation Election Deadline for such Sanofi Participation Election Right, then (a) the Sanofi Participation Election Right will expire and be of no further force or effect with respect to such Collaboration Target, (b) such Collaboration Target will no longer be a Collaboration Target and this Agreement will automatically terminate with respect to such Collaboration Target in accordance with Section 15.2.1 with such Collaboration Target becoming a Terminated Target, and (c) except as set forth in Section 5.6.7, Kymera will retain all right, title and interest in and to such Collaboration Target, including with respect to all Collaboration Compounds, Collaboration Candidates and Licensed Products Directed Against such Collaboration Target. For the avoidance of doubt, [***].

Article 5
DEVELOPMENT AFTER SANOFI PARTICIPATION ELECTION

5.1 Generally. On a Collaboration Target-by-Collaboration Target basis, during the Sanofi Participation Term (if any) with respect to a Collaboration Target and subject to Kymera’s obligations under Sections 2.4, 2.5 and 5.2 and the Kymera Opt-In Right, Sanofi will be solely responsible for all further Research and Development of Collaboration Candidates and Licensed Products (but not, for clarity, Excluded Compounds) Directed Against such Collaboration Target in the Field (but not, for clarity, in the Excluded Field) in the Territory in accordance with the terms and conditions of this Agreement. For clarity, [***].

46


CONFIDENTIAL

 

5.2 Transfer. To the extent not already completed pursuant to Section 3.7.2:

5.2.1 On a Collaboration Target-by-Collaboration Target basis, Kymera will promptly (but no later than [***]) following the Sanofi Participation Election Effective Date with respect to a Collaboration Target (if any), transfer to Sanofi or its designated Affiliate a copy of all Licensed Know-How and Regulatory Filings (if applicable) related to Collaboration Candidates and Licensed Products Directed Against such Collaboration Target in its possession or control as of such Sanofi Participation Election Effective Date, including any documentation (whether held in paper or electronic format) or similar removable media (including e-mails, documents, spreadsheets, copies of standard operating procedures or technical specifications); provided that any documentation transferred electronically will be in an electronic format reasonably acceptable to Sanofi.

5.2.2 During the Sanofi Participation Term (if any), on a Collaboration Target-by-Collaboration Target basis, (a) Kymera shall disclose to Sanofi on a [***] basis any Licensed Know-How created, generated, invented or developed by or on behalf of Kymera under this Agreement and not previously transferred to Sanofi pursuant to Section 5.2.1, and (b) in the event that Sanofi or Kymera reasonably believes additional Licensed Know-How is necessary for the continued Research, Development or Commercialization of the Collaboration Candidates or Licensed Products Directed Against such Collaboration Target, Sanofi may reasonably request a copy of such additional Licensed Know-How from Kymera. Sanofi and Kymera will discuss in good faith and Kymera will transfer to Sanofi a copy of such additional Licensed Know-How in Kymera’s possession or control, including any documentation (whether held in paper or electronic format) or similar removable media (including e-mails, documents, spreadsheets, copies of standard operating procedures or technical specifications), following mutual agreement by the Parties; provided that any documentation transferred electronically will be in an electronic format reasonably acceptable to Sanofi.

5.2.3 To assist with the transfer of Licensed Know-How (excluding CMC) under this Section 5.2 and Sanofi’s exploitation thereof in accordance with the terms of this Agreement, for [***] after the Sanofi Participation Election Effective Date with respect to a Collaboration Target (if any), Kymera will make its personnel reasonably available to Sanofi during normal business hours to transfer such Licensed Know-How to Sanofi and respond to Sanofi’s reasonable inquiries with respect thereto; provided that if Kymera fails to timely and fully complete the technology transfer set forth in Section 5.2.1, the JRDC will agree on a reasonable extension of time during which Kymera will make its personnel reasonably available. Following such [***] period with respect to such Collaboration Target (as it may be extended by the JRDC), upon Sanofi’s request, Kymera will make up to [***] of its personnel that worked on the applicable Collaboration Target reasonably available to Sanofi during normal business hours at a mutually agreeable date and time to transfer such Licensed Know-How (excluding CMC) to Sanofi and respond to Sanofi’s reasonable inquiries with respect thereto, provided that, following such period with respect to a Collaboration Target, such assistance with respect to such Collaboration Target will not exceed [***] of time provided by Kymera employees unless otherwise agreed by Kymera. All assistance provided pursuant to this Section 5.2.3 will be at [***] sole cost and expense; provided that, [***].

47


CONFIDENTIAL

 

5.2.4 [***].

5.2.5 On a Collaboration Target-by-Collaboration Target basis, at Sanofi’s reasonable request following the Sanofi Participation Election Effective Date with respect to a Collaboration Target (if any), Kymera will use Commercially Reasonable Efforts to facilitate the establishment of a business relationship between Sanofi and any Approved Third Party Contractor that Kymera has engaged in the Research or Development activities of Collaboration Candidates or Licensed Products Directed Against the applicable Collaboration Target, including by facilitating introductions with such Approved Third Party Contractors, and use Commercially Reasonable Efforts to assign to Sanofi any agreements with any such Approved Third Party Contractor that are exclusively related to such Collaboration Target in the Field.

5.2.6 On a Collaboration Target-by-Collaboration Target basis, if the Sanofi Participation Election Right was triggered by a Trigger End Date for such Collaboration Target, the following additional provisions will apply:

(a) If Kymera is performing ongoing Research activities under the relevant Research Plan, then Kymera will, at Sanofi’s election, either (i) complete those Research activities remaining under the relevant Research Plan at Sanofi’s expense, or (ii) transfer such activities to Sanofi, which such transfer will include any support necessary for Sanofi to complete the remainder of such activities without unnecessary delay in timelines or unnecessary incremental expense.

(b) If Kymera is performing ongoing Development activities under the Early Development Plan, then Kymera will (i) with respect to Clinical Trials, complete those Clinical Trials ongoing as of the Sanofi Participation Election Effective Date at Sanofi’s expense, and (ii) with respect to Pre-Clinical Development activities, (A) if such activities can be completed within [***] after the Sanofi Participation Election Effective Date, complete such activities, or (B) if such activities cannot be completed within [***] after the Sanofi Participation Election Effective Date, transfer such activities to Sanofi, which transfer will include any transfer support necessary for Sanofi to complete the remainder of the Early Development Plan without unnecessary delay in timelines or unnecessary incremental expense.

(c) Sanofi will reimburse Kymera for all reasonable and documented [***] incurred by or on behalf of Kymera or its Affiliates in the performance of its obligations in this Section 5.2.6.

5.3 Late Development Plan.

5.3.1 During the Sanofi Participation Term (if any), on a Collaboration Target-by-Collaboration Target basis, Sanofi will Research and Develop Collaboration Candidates and Licensed Products Directed Against such Collaboration Target in the Field in the Territory in accordance with a written plan (the “Late Development Plan”) that [***]. An initial draft of the Late Development Plan is attached as Schedule 5.3.1.

5.3.2 Sanofi will promptly (but no later than [***]) following the Sanofi Participation Election Effective Date with respect to a Collaboration Target (if any) prepare,

48


CONFIDENTIAL

 

in consultation with Kymera through the JSC, an updated Late Development Plan for JSC review and approval in accordance with Section 5.3.3.

5.3.3 During the Opt-In Period, on a Collaboration Target-by-Collaboration Target basis:

(a) The Late Development Plan will contain a plan for Development activities to be undertaken by the Parties until [***] (the “U.S. Development Activities”), which plan will include an anticipated [***] budget of U.S. Development Costs for all activities conducted by the Parties in connection therewith (the “U.S. Development Budget”). On or before [***] during the Opt-In Period, Sanofi will provide to the JSC the then-current Late Development Plan (if any) for the Opt-In Products Directed Against such Collaboration Target, which will include a rolling [***] year U.S. Development Budget. The [***] of the initial U.S. Development Budget will be binding, and [***] of the U.S. Development Budget will be binding only to the extent that Sanofi provides such budget to Kymera after it has completed all necessary internal approvals, otherwise such [***] in such initial U.S. Development Budget will be non-binding. Subsequent Calendar Years of the U.S. Development Budget will be non-binding. The U.S. Development Budget, and each update thereto, will be prepared by the Parties based on each Party’s good faith estimation, consistent with its standard internal practices, of the probable Development activities to be conducted during the relevant U.S. Development Budget period for the United States, and based on and consistent with the documents and information related to the Licensed Products prepared by such Party for its internal use and reference in the budgeting process. Upon request by a Party, the JSC will discuss the appropriate level of detail to include in the U.S. Development Budget for the applicable Development activities to be performed during the period covered by such U.S. Development Budget.

(b) The Parties will (i) review the Late Development Plan at least annually during the period covered by such Late Development Plan for the purpose of considering appropriate amendments thereto to be proposed to the JSC and (ii) then no later than [***] of the then-current Calendar Year beginning with the first full Calendar Year of the Late Development Plan, provide the JSC with a proposed updated Late Development Plan for the JSC’s review and discussion.

(c) Annual updates to the U.S. Development Budget will contain a proposed U.S. Development Budget covering [***], in accordance with the requirements set forth in this Section 5.3.3. The annual updates to the U.S. Development Budget for the United States will further contain any proposed Development activities that were not previously included as Development activities in the then-current Late Development Plan (including any new Indications).

(d) In addition to the annual updates, either Party, through its representatives on the JSC, may propose amendments to any Late Development Plan at any time until such time as no further Development activities are occurring or expected to occur under such Late Development Plan, including amendments to add Development activities to such Late Development Plan (including new Indications). In addition, at least [***], Sanofi will prepare an updated Late Development Plan (including an updated U.S. Development Budget) for JSC review in accordance with Section 9.1.2.

49


CONFIDENTIAL

 

(e) Subject to Section 9.9.2(b)(ii), during the applicable Opt-In Period, no annual update or material amendment to the Late Development Plan will be effective unless and until approved by the JSC.

(f) Subject to Section 9.9.2(b)(ii), during the applicable Opt-In Period, any additional amendments to the Late Development Plan will be subject to JSC approval in accordance with Sections 5.3 and 9.1.2. In the event of any inconsistency between the Late Development Plan and this Agreement, the terms of this Agreement will prevail.

5.4 Diligence. On a Collaboration Target-by-Collaboration Target basis, during the Sanofi Participation Term, Sanofi will (a) [***], and (b) use Commercially Reasonable Efforts to (i) Develop and (ii) seek Marketing Approval for, in each case ((i)-(ii)), at least one (1) Licensed Product Directed Against such Collaboration Target in at least one (1) Indication in the Field in [***].

5.5 Backup Degraders.

5.5.1 If, [***], Kymera will, upon Sanofi’s written request [***], perform additional Research activities, including to identify and synthesize Backup Degraders (“Backup Research”), in accordance with this Section 5.5; provided that Sanofi will not have a right to request such Backup Research with respect to a Collaboration Target after the first Marketing Approval of a Licensed Product Directed Against such Collaboration Target.

5.5.2 Prior to Kymera commencing any Backup Research for such Collaboration Target, Kymera will notify Sanofi of any Reversion Compounds which are subject to any Pre-Existing Restrictions, and the Parties will mutually agree (such agreement not to be unreasonably withheld, conditioned or delayed) upon a reasonable written plan for such Backup Research (the “Backup Research Plan”), which will include [***] (the “Backup Research Budget”). Sanofi may only include in the Backup Research Plan any Reversion Compounds which are not subject to Pre-Existing Restrictions at the time the Backup Research Plan is prepared; thereafter, any such Reversion Compound will no longer be classified as a “Reversion Compound” and instead will be classified as a “Collaboration Compound” under the Backup Research Plan.

5.5.3 During the Backup Research Term, either Party may, at any time, propose updates or amendments to any Backup Research Plan, which updates or amendments will only become effective by mutual agreement of the Parties.

5.5.4 Following the Parties’ agreement on a Backup Research Plan, during the Backup Research Term, Kymera, directly or through its Affiliates or Subcontractors, will use diligent efforts to perform the Backup Research in accordance with such Backup Research Plan, in a professional and timely manner and in accordance with all Applicable Laws.

5.5.5 Sanofi will reimburse Kymera in accordance with Section 11.6.3 for Kymera’s [***] actually incurred by or on behalf of Kymera or its Affiliates (a) during the Backup Research Term, (b) in accordance with the Backup Research Budget, and (c) in

50


CONFIDENTIAL

 

connection with conducting Backup Research activities under this Section 5.5 in accordance with the Backup Research Plan.

5.5.6 [***].

5.5.7 During the Backup Research Term, Kymera will use the screening assays in accordance with the procedures set forth in the Backup Research Plan to determine whether a given Degrader that is Researched under this Section 5.5 satisfies the Screening Criteria or the Backup Degrader Criteria. All Degraders that meet the Screening Criteria during the Backup Research Term will be Collaboration Compounds under this Agreement, subject to the reversion rights set forth in Section 5.6. Notwithstanding anything herein to the contrary, any Degraders that are Researched by or on behalf of Kymera under this Section 5.5 that do not meet the Screening Criteria will be classified as Excluded Compounds, unless [***].

5.5.8 During the Backup Research Term, Kymera will furnish to the JRDC, within [***], an update on Kymera’s progress under the Backup Research Plan for the applicable Collaboration Target during the relevant Calendar Quarter, including a summary of any results and data generated by Kymera under such Backup Research Plan and an overview of the resources (including an overview of FTEs used by such Party for such Backup Research activities) allocated to activities under such Backup Research Plan during the relevant Calendar Quarter. Kymera will provide the JRDC with such other information, results and data with respect to the Backup Research activities under the Backup Research Plan as any member of the JRDC may reasonably request that are in Kymera’s possession or control. Kymera will provide Sanofi a reasonable opportunity via the JRDC to discuss and provide input with respect to Kymera’s Backup Research activities under the Backup Research Plan, including with respect to the prioritization of Backup Research activities.

5.5.9 In addition to, and without limiting, the reporting requirements in Section 5.5.8, during the Backup Research Term, Kymera will furnish to the JRDC, within [***], a written report on Kymera’s Backup Research activities with respect to Collaboration Compounds that are Researched under Section 5.5.5 and have the potential to be classified as Backup Degraders. Such reports will [***].

5.5.10 During the Backup Research Term, within [***] after Kymera reasonably believes that it has identified a Collaboration Compound that satisfies all of the Backup Degrader Criteria, Kymera will present a written report to Sanofi that identifies such Collaboration Compound [***]. Sanofi may, in its discretion and through the JRDC, request any other information, results or data with respect to such Collaboration Compound as set forth more fully in Section 5.9.2. Within [***] after the delivery of such report (or such longer period of time as may be reasonably determined by the JRDC, but in no event longer than [***]), the JRDC will (a) meet, discuss and review the report and associated data, results and information and (b) determine whether such Collaboration Compound satisfies the Backup Degrader Criteria. If the JRDC determines that such Collaboration Compound satisfies the Backup Degrader Criteria, then such Collaboration Compound will be classified as a “Backup Degrader” under this Agreement. If the JRDC does not believe that such Collaboration Compound satisfies the Backup Degrader Criteria, then Kymera will use diligent efforts to

51


CONFIDENTIAL

 

conduct additional Research activities during the remainder of the Backup Research Term in accordance with the Backup Research Plan, and thereafter present a report to the JRDC as and to the extent applicable in this Section 5.5.10. In the event that the JRDC does not agree on whether such Collaboration Compound satisfies the Backup Degrader Criteria, then such dispute will be resolved in accordance with Section 9.9.2(b). Notwithstanding the foregoing, Sanofi may determine, in its sole discretion, that a Collaboration Compound that satisfies at least certain of the Backup Degrader Criteria during the Backup Research Term will be selected as a “Backup Degrader” notwithstanding that it does not satisfy all of the Backup Degrader Criteria. Any selection of a Collaboration Compound as a Backup Degrader by the JRDC, by the R&D Expert in accordance with Section 9.9.2(b), or by Sanofi pursuant to the preceding sentence, will be recorded in the minutes of the JRDC.

5.5.11 In the event that Sanofi has provided written notice to Kymera (including via the JRDC) that [***], then, within [***] of the date of receipt of such written notice, Kymera will permit Sanofi to examine the relevant books and records of Kymera and its Affiliates, as may be reasonably necessary to verify the Backup Research updates and progress reports submitted by Kymera in accordance with this Section 5.5; provided that such examination will be subject to customary and reasonable due diligence procedures to preserve the confidential nature of any books or records. An examination by Sanofi under this Section 5.5.11 (a) will occur not more than [***], (b) will be limited to the pertinent books and records for any Calendar Year ending not more than [***] before the date of the written notice, (c) will be conducted in such a manner to minimize, to the extent reasonably possible, the period of examination and in no case shall such period exceed [***], and (d) will be conducted by the minimum number of Sanofi employees as necessary to provide requisite subject matter expertise and conduct the review in the allotted timeframe, each of whom shall have appropriate experience in the Research of small molecule compounds and candidates; provided, that if any examination by Sanofi under this Section 5.5.11 reveals any material discrepancy, Kymera will permit Sanofi to conduct additional examination of pertinent books and records for Calendar Years ending not more than [***] before the date of the written notice, during a period limited to minimize the days of examination as much as possible and in no case more than an additional [***]. Sanofi will be provided access to such books and records at Kymera’s facility or facilities where such books and records are normally kept and such examination will be conducted during Kymera’s normal business hours. Upon completion of the examination, Sanofi will provide Kymera and the JRDC a written report disclosing the reason(s) for the difference between the relevant report provided by Kymera and the results and data that should have been generated and the activities that should have been conducted by Kymera during the relevant time. The costs and fees of any examination conducted by Sanofi under this Section 5.5.11 will be borne by Sanofi.

5.5.12 Notwithstanding anything herein to the contrary, in no event will Kymera be required to conduct any Development activities for any Backup Degraders.

5.6 Reversion Compounds.

5.6.1 Effective as of the effective date of expiration of the First Additional Degrader Research Term, all Collaboration Compounds and Collaboration Candidates Directed Against Collaboration Target 1, that were Researched by or on behalf of Kymera

52


CONFIDENTIAL

 

under Section 2.4 but are (a) [***], or (b) [***], will, in each case ((a)-(b)) cease to be Collaboration Compounds, Collaboration Candidates or Licensed Products and will be classified as “Reversion Compounds” as of such date [***].

5.6.2 Effective as of the effective date of expiration of the Second Additional Degrader Research Term, all Collaboration Compounds and Collaboration Candidates Directed Against Collaboration Target 1 that were Researched by or on behalf of Kymera under Section 2.5 but are (a) [***], or (b) [***], will, in each case ((a)-(b)) cease to be Collaboration Compounds, Collaboration Candidates or Licensed Products and will be classified as “Reversion Compounds” as of such date [***].

5.6.3 Effective as of the expiration of the Backup Research Term (if any), all Collaboration Compounds and Collaboration Candidates Directed Against Collaboration Target 1 that were Researched by or on behalf of Kymera under Section 5.5 but are (a) [***], or (b) [***], will, in each case ((a)-(b)) cease to be Collaboration Compounds, Collaboration Candidates or Licensed Products and will be classified as “Reversion Compounds” as of such date.

5.6.4 Each of the applicable dates for reversion referenced in Sections 5.6.1, 5.6.2 and 5.6.3 will be referred to in this Agreement as the applicable “Reversion Date”.

5.6.5 In addition to the foregoing, if at any time prior to the applicable Reversion Dates, [***], then the Parties will promptly meet and discuss the same in good faith through the JRDC and JPC. In the event that both Parties, through the JRDC and JPC working together, agree to proceed with an early reversion of any such Collaboration Compounds or Collaboration Candidates to Kymera, then the JRDC will identify the applicable Collaboration Compounds or Collaboration Candidates as “Reversion Compounds” and the applicable “Reversion Date” in the minutes of the JRDC.

5.6.6 From and after each applicable Reversion Date, subject to Section 5.5.2, (a) Kymera will retain all right, title and interest in and to all corresponding Reversion Compounds, (b) Sanofi’s licenses and rights under this Agreement will terminate with respect to all corresponding Reversion Compounds, and (c) Kymera will grant a license to Sanofi with respect to the corresponding Reversion Compound Data in accordance with Section 10.1.4.

5.6.7 Notwithstanding anything to the contrary, and for the avoidance of doubt, [***].

5.7 Kymera Opt-In Right.

5.7.1 Subject to the remainder of this Section 5.7, on a Collaboration Target-by-Collaboration Target basis, Sanofi hereby grants to Kymera an exclusive option, exercisable in Kymera’s sole discretion one (1) time per Collaboration Target, to fund fifty percent (50%) of the U.S. Development Costs for Opt-In Products Directed Against a given Collaboration Target in the Field in the United States and share equally (50:50) in the Net Profits and Net Losses of Commercializing Opt-In Products Directed Against such

53


CONFIDENTIAL

 

Collaboration Target in the Field in the United States (collectively, the “Kymera Opt-In Right”).

5.7.2 On a Collaboration Target-by-Collaboration Target basis, on the later of (a) the date that is reasonably anticipated to be [***] of a Licensed Product Directed Against the relevant Collaboration Target or (b) [***] after the Sanofi Participation Election Effective Date, Sanofi will provide Kymera with the Opt-In Data Package with respect to such Collaboration Target, and Kymera will use such Opt-In Data Package (and any additional information provided by Sanofi pursuant to this Section 5.7) solely to determine whether to exercise the corresponding Kymera Opt-In Right with respect to such Collaboration Target. Additionally, Sanofi will make all material data within the Opt-In Data Package for a Collaboration Target available to Kymera through an electronic data room. Notwithstanding anything herein to the contrary, Sanofi shall not be permitted to [***].

5.7.3 On a Collaboration Target-by-Collaboration Target basis, if such Opt-In Data Package for a given Collaboration Target is incomplete, Kymera may notify Sanofi of the incomplete status of such Opt-In Data Package in writing including any items that, in Kymera’s reasonable determination made in good faith, should have been included in the Opt-In Data Package but were not included therein within [***] after receipt thereof. Following receipt of such notice, Sanofi will promptly deliver to Kymera the additional information requested by Kymera to complete such Opt-In Data Package. For clarity, delivery of such incomplete Opt-In Data Package will not trigger the [***] period after which the Kymera Opt-In Deadline would occur pursuant to Section 5.7.5, but such [***] period after which the Kymera Opt-In Deadline would occur pursuant to Section 5.7.5 will thereafter be triggered on the date of Kymera’s receipt of the additional information requested by Kymera to complete such Opt-In Data Package (such date of receipt in no event to exceed the [***] period described above).

5.7.4 Following delivery of the complete Opt-In Data Package, and prior to the Kymera Opt-In Deadline, Kymera will be entitled to request, through the Alliance Managers and with reasonable advanced notice, [***].

5.7.5 On a Collaboration Target-by-Collaboration Target basis, Kymera will have the right, in its sole discretion, to exercise the Kymera Opt-In Right for a given Collaboration Target by delivering to Sanofi the following within [***] after the delivery of the Opt-In Data Package with respect to such Collaboration Target (the end of such [***] period, the “Kymera Opt-In Deadline”): (a) written notice of exercise (each such notice, the “Kymera Opt-In Exercise Notice”) and (b) reasonable documentation demonstrating that Kymera has enough cash to cover its allocation of costs and expenses according to the proposed budget for the first year of Development and Commercialization of Licensed Products contemplated by the relevant Opt-In Data Package, and a reasonable plan to cover its allocation of costs and expenses according to the proposed budget for the subsequent [***] of Development and Commercialization of Licensed Products contemplated by the relevant Opt-In Data Package.

5.7.6 On a Collaboration Target-by-Collaboration Target basis, if Kymera provides a Kymera Opt-In Exercise Notice for a given Collaboration Target in accordance

54


CONFIDENTIAL

 

with Section 5.7.5, then (a) Kymera will have exercised the Kymera Opt-In Right with respect to such Collaboration Target, and (b) the date of receipt of such Kymera Opt-In Exercise Notice will be the “Kymera Opt-In Effective Date” with respect to such Collaboration Target.

5.7.7 On a Collaboration Target-by-Collaboration Target basis, if Kymera fails to provide a Kymera Opt-In Exercise Notice in accordance with Section 5.7.5 with respect to a Collaboration Target prior to the Kymera Opt-In Deadline for such Kymera Opt-In Right, the Kymera Opt-In Right will expire and be of no further force or effect with respect to such Collaboration Target.

5.7.8 On a Collaboration Target-by-Collaboration Target basis, if Kymera exercises the Kymera Opt-In Right with respect to a Collaboration Target, the Parties will negotiate in good faith the terms of a cost and profit sharing agreement which will include the terms set forth on Exhibits A and C (the “Cost/Profit Sharing Agreement”), within [***] of Sanofi’s receipt of the Kymera Opt-In Exercise Notice with respect to such Collaboration Target provided that the terms of Exhibits A and C shall govern until such Cost/Profit Sharing Agreement is executed.

5.7.9 On a Collaboration Target-by-Collaboration Target basis, the Cost/Profit Sharing Agreement will provide that each of Kymera and Sanofi will be entitled to and bear fifty percent (50%) of all Net Profits and Net Losses incurred in each Calendar Quarter that the Cost/Profit Sharing Agreement is in effect with respect to all Opt-In Products being sold in the United States by or on behalf of the Parties or their Affiliates or (sub)licensees, pursuant to the terms of Exhibit C (the “Cost/Profit Share”). On a Collaboration Target-by-Collaboration Target basis, the Cost/Profit Share will commence on the Kymera Opt-In Effective Date and immediately terminate on the earliest to occur of (w) [***] of Kymera providing written notice that is terminating the Cost/Profit Share (the “Opt-Out Right”), (x) [***] (the “Opt-In Period”). If the Opt-In Period for a Collaboration Target terminates pursuant to clauses (w) or (x) in the immediately preceding sentence, then the Royalty Term will apply with respect to such Collaboration Target.

5.7.10 If Kymera fails to pay amounts owed under the Opt-In Period for U.S. Development Costs or the Cost/Profit Share (the “Funding Failure”), then, subject to the cure period set forth in the Cost/Profit Sharing Agreement, Sanofi will be entitled, in its sole discretion, to [***]. The remedies set forth in this Section 5.7.10 will be Sanofi’s sole and exclusive remedy with respect to such Funding Failure.

5.7.11 Notwithstanding anything to the contrary:

(a) if the Opt-In Period terminates pursuant to clause (w) of Section 5.7.9, then the Co-Promote Period will terminate on the [***]; provided that if [***];

(b) if the Opt-In Period terminates pursuant to clauses (x) or (z) of Section 5.7.9, then the Co-Promote Period will terminate on the [***] (the “Co-Promotion Wind-Down Period”); provided that, if [***]; and

55


CONFIDENTIAL

 

(c) if the Opt-In Period terminates pursuant to clause (y) of Section 5.7.9, then the Co-Promote Period will terminate on the effective date of termination of the Opt-In Period.

5.7.12 For clarity, the terms of this Section 5.7 are on a Collaboration Target-by-Collaboration Target basis, and the application of such terms for a given Collaboration Target have no effect on the other Collaboration Target.

5.8 Development Costs.

5.8.1 On a Collaboration Target-by-Collaboration Target basis, unless and until Kymera exercises the Kymera Opt-In Right for a given Collaboration Target, during the Sanofi Participation Term with respect to such Collaboration Target, Sanofi will be solely responsible for all costs and expenses incurred in connection with the Development of Collaboration Compounds, Collaboration Candidates and Licensed Products Directed Against such Collaboration Target in the Field in the Territory.

5.8.2 On a Collaboration Target-by-Collaboration Target basis, if Kymera exercises the Kymera Opt-In Right for a given Collaboration Target, then during the applicable Opt-In Period, (a) the Parties will share all U.S. Development Costs for all Development activities for Opt-In Products Directed Against such Collaboration Target in the Field in the United States in accordance with the applicable Cost/Profit Sharing Agreement, and (b) Sanofi will be solely responsible for all costs and expenses incurred in connection with the Development of Collaboration Compounds, Collaboration Candidates and Licensed Products Directed Against such Collaboration Target in the Field in the Rest of the World.

5.9 Records; Reporting.

5.9.1 Each Party will maintain, and [***] to maintain, records of the Development activities under this Agreement in sufficient detail and in good scientific manner appropriate for scientific, patent and regulatory purposes, which will be complete and accurate in all material respects and will fully and properly reflect all work done, data and developments made, and results achieved.

5.9.2 Each Party will furnish to the JSC, (a) prior to any Kymera Opt-In Effective Date, on a semi-annual basis, to the extent applicable to such Party, and (b) during the applicable Opt-In Period, within [***], to the extent applicable to such Party, in each case ((a)-(b)), an update on such Party’s progress under the Late Development Plan for the applicable Collaboration Target during the relevant period, including a summary of any results and data generated by such Party under such Late Development Plan and an overview of the resources (including an overview of FTEs used by such Party for such Development activities), allocated to activities under such Late Development Plan during the relevant period. Such Party will provide the JSC with such other material information, results and data with respect to the Development activities under the Late Development Plan as any member of the JSC may reasonably request that are in such Party’s possession or control. In the event Kymera is a Reporting Company, Sanofi will provide Kymera such information regarding its Development activities under the Late Development Plan that is necessary for Kymera to

56


CONFIDENTIAL

 

comply with Applicable Law (including the rules and regulations promulgated by the United States Securities and Exchange Commission).

5.9.3 On a Collaboration Target-by-Collaboration Target basis, [***].

Article 6
Commercialization

6.1 General. Subject to the terms and conditions set forth in this Agreement, on a Collaboration Target-by-Collaboration Target basis, during the Sanofi Participation Term, the Parties will conduct Commercialization activities for the Licensed Products Directed Against such Collaboration Target in the Field in the Territory as further set forth in this Article 6. On a Collaboration Target-by-Collaboration Target basis, during the Sanofi Participation Term, Sanofi will be solely responsible for all Commercialization activities relating to the Licensed Products Directed Against such Collaboration Target in the Field in the Territory, including the booking of all sales of such Licensed Products, subject to Kymera’s right to perform certain Co-Promotion activities (with Sanofi) in the Field in the United States for Opt-In Products Directed Against such Collaboration Target as specified in Section 6.3.

6.2 Kymera Co-Promote Right. Subject to the remainder of this Section 6.2 and Exhibit B, on a Collaboration Target-by-Collaboration Target basis, Sanofi hereby grants to Kymera an exclusive option, exercisable in Kymera’s sole discretion one (1) time per Collaboration Target, to conduct between [***] and [***] of all Co-Promotion activities for Opt-In Products Directed Against such Collaboration Target in the Field in the United States (the “Kymera Co-Promote Right”); provided that such Kymera Co-Promote Right will expire immediately with respect to such Collaboration Target if Kymera did not exercise the Kymera Opt-In Right prior to the corresponding Kymera Opt-In Deadline or the corresponding Cost/Profit Share has been terminated.

6.2.1 On a Collaboration Target-by-Collaboration Target basis, on or about the date is reasonably anticipated to be [***], Sanofi will provide Kymera with the Co-Commercialization Plan with respect to such Collaboration Target, and Kymera will use such Co-Commercialization Plan (and any additional information provided by Sanofi pursuant to this Section 6.2) solely to determine whether to exercise the corresponding Kymera Co-Promote Right with respect to such Collaboration Target. Additionally, Sanofi will make all material data within the Co-Commercialization Plan for a Collaboration Target available to Kymera through an electronic data room.

6.2.2 On a Collaboration Target-by-Collaboration Target basis, if such Co-Commercialization Plan for a given Collaboration Target is incomplete with respect to related Co-Promotion activities, Kymera may notify Sanofi of the incomplete status of such Co-Commercialization Plan in writing including any items that, in Kymera’s reasonable determination made in good faith, should have been included in the Co-Commercialization Plan but were not included therein within [***] after receipt thereof. [***]. For clarity, delivery of such incomplete Co-Commercialization Plan will not trigger the [***] period after which the Kymera Co-Promote Right Deadline would occur pursuant to Section 6.2.4, but such [***] period after which the Kymera Co-Promote Right Deadline would occur pursuant

57


CONFIDENTIAL

 

to Section 6.2.4 will thereafter be triggered on the date of Kymera’s receipt of the additional information requested by Kymera to complete such Co-Commercialization Plan.

6.2.3 Following delivery of the complete Co-Commercialization Plan, and prior to the Kymera Co-Promote Right Deadline, Kymera will be entitled to request, through the Alliance Managers and with reasonable advanced notice, [***].

6.2.4 On a Collaboration Target-by-Collaboration Target basis, Kymera will have the right, in its sole discretion, to exercise the Kymera Co-Promote Right for a given Collaboration Target by delivering to Sanofi the following within [***] after the delivery of the Co-Commercialization Plan with respect to such Collaboration Target (the end of such [***] period, the “Kymera Co-Promote Right Deadline”): (a) written notice of exercise (each such notice, the “Kymera Co-Promote Right Exercise Notice”) and (b) reasonable documentation demonstrating that Kymera has (i) the necessary sales force in place to Co-Promote the Licensed Products Directed Against such Collaboration Target in the Field in the United States or (ii) a plan reasonably designed to build such sales force to Co-Promote the Licensed Products Licensed Products Directed Against such Collaboration Target in the Field in the United States at least [***] before the anticipated First Commercial Sale of the first Licensed Product Directed Against such Collaboration Target in the Field in the United States; provided that, Kymera will not be entitled to use in such sales force any field personnel who are responsible for promoting Collaboration Target 1 Degraders in the Excluded Field.

6.2.5 On a Collaboration Target-by-Collaboration Target basis, if Kymera provides a Kymera Co-Promote Right Exercise Notice for a given Collaboration Target in accordance with Section 6.2.4, then (a) Kymera will have exercised the Kymera Co-Promote Right with respect to such Collaboration Target, and (b) the date of such Kymera Co-Promote Right Exercise Notice will be the “Kymera Co-Promote Effective Date” with respect to such Collaboration Target.

6.2.6 On a Collaboration Target-by-Collaboration Target basis, if Kymera fails to provide a Kymera Co-Promote Right Exercise Notice in accordance with Section 6.2.4 with respect to a Collaboration Target prior to the Kymera Co-Promote Right Deadline for such Kymera Co-Promote Right, the Kymera Co-Promote Right will expire and be of no further force or effect with respect to such Collaboration Target.

6.2.7 On a Collaboration Target-by-Collaboration Target basis, if Kymera exercises the Kymera Co-Promote Right with respect to a Collaboration Target, the Parties will negotiate in good faith the terms of a definitive Co-Promotion Agreement covering the Co-Promotion activities for Licensed Products Directed Against such Collaboration Target in the Field in the United States which will include the terms set forth on Exhibit B (the “Co-Promotion Agreement”), within [***] of Sanofi’s receipt of the Kymera Co-Promote Exercise Notice with respect to such Collaboration Target; provided that, the terms of Exhibit B shall govern until such Co-Promotion Agreement is executed.

6.2.8 For clarity, the terms of this Section 6.2 are on a Collaboration Target-by-Collaboration Target basis, and the application of such terms for a given Collaboration Target have no effect on the other Collaboration Target.

58


CONFIDENTIAL

 

6.3 Co-Commercialization Plan. On a Collaboration Target-by-Collaboration Target basis, but only during the Co-Promote Period:

6.3.1 The Commercialization of the Opt-In Products Directed Against such Collaboration Target in the United States will be conducted pursuant to the Co-Commercialization Plan, which will at a minimum include a reasonably detailed plan for the Commercialization of the Opt-In Products Directed Against such Collaboration Target in the United States. At least [***] prior to the anticipated date of First Commercial Sale of the first Opt-In Product Directed Against such Collaboration Target in the United States (or such other time as may be mutually agreed by the Parties), Sanofi will prepare, in consultation with Kymera via the JCC, a proposed initial Co-Commercialization Plan for the JCC’s review, discussion and approval. The JCC will endeavor to approve the initial Co-Commercialization Plan at least [***] prior to anticipated date of First Commercial Sale of an Opt-In Product Directed Against such Collaboration Target in the United States. The initial Co-Commercialization Plan for a given Collaboration Target will not be effective unless and until approved by the JCC.

6.3.2 On a Collaboration Target-by-Collaboration Target basis, the Co-Commercialization Plan for a given Collaboration Target will contain a [***] rolling budget for the probable Allowed Expenses for the Commercialization activities to be performed for the United States during the then-current Calendar Year (broken down by Calendar Quarter) and the [***] of the Co-Commercialization Plan, and will be updated by Sanofi annually on a rolling [***] period basis. Such initial Co-Commercialization Plan will include a budget for the then-current Calendar Year commencing as of the date of such initial Co-Commercialization Plan and ending [***] of such Calendar Year and [***] thereafter [***] (each such budget, a “Co-Commercialization Budget”). The [***] of the initial Co-Commercialization Budget will be binding. [***]. The initial Co-Commercialization Budget for the Co-Commercialization Plan, and each update thereto, will be prepared by Sanofi based on Sanofi’s good faith estimation, consistent with its standard internal practices, of the probable Commercialization activities to be conducted in the United States during the relevant Co-Commercialization Budget period, and based on and consistent with the documents and information related to the Opt-In Products Directed Against such Collaboration Target prepared by Sanofi for its internal use and reference in the budgeting process. Upon request by a Party, the JCC will discuss the appropriate level of detail to include in a Co-Commercialization Budget for the applicable Commercialization activities to be performed during the period covered by such Co-Commercialization Budget.

6.3.3 On a Collaboration Target-by-Collaboration Target basis, Sanofi, in consultation with Kymera via the JCC, will (a) review the Co-Commercialization Plan for a given Collaboration Target at least annually for the purpose of considering appropriate amendments thereto to be proposed to the JCC and (b) then no later than [***] of the then-current Calendar Year beginning with the first full Calendar Year of the initial Co-Commercialization Plan, provide the JCC with a proposed updated Co-Commercialization Plan for the JCC’s review, discussion and approval. The JCC will endeavor to approve such updated Co-Commercialization Plan for such Collaboration Target no later than [***] of the then-current Calendar Year. Annual updates to the Co-Commercialization Budget for such Collaboration Target will contain a proposed Co-Commercialization Budget covering (i) the

59


CONFIDENTIAL

 

next Calendar Year, broken down by Calendar Quarter, and (ii) each of the [***], in each case ((i) and (ii)), in accordance with the requirements set forth in Section 6.3.2. In addition to the annual update, either Party, through its representatives on the JCC, may propose amendments to the Co-Commercialization Plan for such Collaboration Target at any time. No update or amendment to the Co-Commercialization Plan for such Collaboration Target will be effective unless and until approved by the JCC.

6.4 Commercialization Activities in the United States.

6.4.1 On a Collaboration Target-by-Collaboration Target basis, during the applicable Co-Promote Period, for each Opt-In Product Directed Against such Collaboration Target in the United States, Sanofi will be solely responsible for all Commercialization activities for each Opt-In Product Directed Against such Collaboration Target in the Field in the United States, including handling all returns, recalls, order processing, invoicing and collection, booking of sales, inventory and receivables, and managed and government pricing programs, other than Kymera’s Co-Promotion activities with respect to such Opt-In Product Directed Against such Collaboration Target as set forth in the Co-Promotion Agreement. Kymera will not accept orders for any Opt-In Product Directed Against such Collaboration Target or make sales for its own account or for Sanofi’s account, and if Kymera receives any order for an Opt-In Product Directed Against such Collaboration Target in the United States, then it will refer such orders to Sanofi for acceptance or rejection.

6.4.2 On a Collaboration Target-by-Collaboration Target basis, if Kymera does not exercise the Kymera Co-Promote Right with respect to a given Collaboration Target (or thereafter exercises the corresponding Kymera Co-Promote Opt-Out Right for such Collaboration Target), then Sanofi will be solely responsible for all Commercialization activities for each Licensed Product Directed Against such Collaboration Target in the Field in the United States, including development and implementation of a promotional strategy, handling all returns, recalls, order processing, invoicing and collection, booking of sales, inventory and receivables, and managed and government pricing programs.

6.5 Commercialization Activities in the Rest of World. On a Collaboration Target-by-Collaboration Target basis, Sanofi will be solely responsible for all Commercialization activities for each Licensed Product Directed Against such Collaboration Target in the Field in the Rest of World including development and implementation of a promotional strategy, handling all returns, recalls, order processing, invoicing and collection, booking of sales, inventory and receivables, and managed and government pricing programs.

6.6 No Commercialization Activities in the Excluded Field. For clarity, in no event will any of the Commercialization activities under this Agreement be conducted in the Excluded Field.

6.7 Diligence.

6.7.1 On a Collaboration Target-by-Collaboration Target basis, during the applicable Co-Promote Period (if any), Kymera will use diligent efforts to perform its Co-Promotion activities for the Opt-In Products Directed Against such Collaboration Target in

60


CONFIDENTIAL

 

the Field in the United States in accordance with the Co-Commercialization Plan and the Co-Promotion Agreement for such Collaboration Target.

6.7.2 On a Collaboration Target-by-Collaboration Target basis, Sanofi will use diligent efforts to perform its Commercialization activities for the Opt-In Products Directed Against such Collaboration Target in the Field in the United States in accordance with the Co-Commercialization Plan and the Co-Promotion Agreement (if any) for such Collaboration Target.

6.7.3 On a Collaboration Target-by-Collaboration Target basis, during the Sanofi Participation Term for a given Collaboration Target, [***].

6.8 Reports. During the Co-Promote Period (if any):

6.8.1 On a Collaboration Target-by-Collaboration Target basis, [***], each Party will provide to the JCC during the applicable Co-Promote Period (if any), a summary of material Commercialization activities undertaken by or on behalf of such Party in the Field in the Territory during such Calendar Quarter with respect to Licensed Products Directed Against such Collaboration Target, and an overview of the resources, including an overview of FTEs, allocated to activities under the Co-Commercialization Plan during the relevant Calendar Quarter. Such Party will provide the JCC with such other information with respect to the Commercialization activities as any member of the JCC may reasonably request that are in such Party’s Control. Each Party will maintain records relating to its sales force and account management. Kymera’s obligations under this Section 6.8.1 will only apply during the Co-Promote Period for a particular Collaboration Target.

6.8.2 Sanofi will be responsible for the creation, preparation, production, reproduction, review (medical, legal, and regulatory), and filing with the applicable Regulatory Authorities, of promotional materials relating to each Licensed Product in the Field in the Territory. All such promotional materials will be compliant with Applicable Law. Unless prohibited under Applicable Law, Sanofi will include a reference in such promotional materials to such Licensed Product as being marketed by Sanofi and Kymera in the Field in the Territory. Sanofi will own all rights, title, and interest, in and to any and all promotional materials for any Licensed Product in the Field in the Territory.

6.8.3 On a Collaboration Target-by-Collaboration Target basis, [***].

6.9 Advertising and Promotional Materials.

6.9.1 Sanofi, in its reasonable discretion, will lead and develop (and thereafter modify and update) a branding strategy (including positioning, messages, logo, colors, and other visual branding elements) (a “Branding Strategy”) for each Licensed Product in the Field in the Territory. During the Research Term, Kymera, in its reasonable discretion, will lead and develop the International Nonproprietary Name (INN) submission request process for Licensed Products Directed Against Collaboration Target 1; provided that (i) Kymera shall provide a draft of the INN submission to Sanofi prior to its submission, (ii) Sanofi shall have [***] to review such submission and provide comments to Kymera and (iii) Kymera shall consider any such comments provided by Sanofi in good faith; provided further

61


CONFIDENTIAL

 

that, in the event that Applicable Law requires Sanofi to be the filing party for such INN submission, Kymera shall continue to lead and develop the INN submission request process, and Sanofi shall be responsible for filing the INN. During the Sanofi Participation Term (if any), Sanofi, in its reasonable discretion, will lead and develop the INN submission request process for Licensed Products Directed Against Collaboration Target 1; provided that, (i) Sanofi shall provide such INN submission to Kymera prior to its submission, (ii) Kymera shall have [***] to review such submission and provide comments to Sanofi and (iii) Sanofi shall consider any such comments provided by Kymera in good faith.

6.9.2 Sanofi will be responsible for the creation, preparation, production, reproduction, review (medical, legal, and regulatory), and filing with the applicable Regulatory Authorities, of Promotional Materials relating to each Licensed Product. All such Promotional Materials will be compliant with Applicable Law. During the Co-Promote Period and in respect of materials for the U.S., (i) all Promotional Materials will be consistent in all material respects with the Co-Commercialization Plan for such Licensed Product and (ii) unless prohibited under Applicable Law, Sanofi will include a reference in such Promotional Materials to such Licensed Product as being marketed by Sanofi and Kymera in the approved Indication in the Field in the Territory. Sanofi will own all rights, title, and interest, in and to any and all Promotional Materials for any Licensed Product.

6.9.3 Sanofi will develop and approve packaging and labeling for each Licensed Product, which in all cases will be in accordance with Applicable Law. During the Co-Promote Period, such activities further will be consistent with the Co-Commercialization Plan.

6.9.4 Sanofi will have the sole right to determine and own the trademarks used in connection with the Development, Manufacture and Commercialization of the Licensed Products on a worldwide basis. Subject to any pre-existing trademarks a Party may have, neither Party will, directly or indirectly: (a) use in their respective businesses, any trademark that is confusingly similar to, misleading, or deceptive with respect to or that dilutes any trademark for a Licensed Product; and (b) do any act which endangers, destroys, or similarly affects, in any material respect, the value of the goodwill pertaining to the trademarks for any Licensed Product. Each Party agrees to conform to the customary industry standards for the protection of trademarks for Licensed Products and such guidelines of Sanofi with respect to manner of use (in the case of Kymera, as provided in writing by Sanofi) of the trademarks for Licensed Products. Without limiting any pre-existing trademarks a Party may have, neither Party will, directly or indirectly, attack, dispute, or contest the validity of or ownership of such trademark anywhere in the Territory or any registrations issued or issuing with respect thereto.

6.10 Sales and Distribution. Notwithstanding anything to the contrary contained in this Agreement, Sanofi and its Affiliates will, as between the Parties, have the sole right to book sales, warehouse and distribute Licensed Products in the Field in the Territory.

6.11 Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with a Licensed Product in the Field in the Territory, Sanofi will, as between the Parties, have the sole

62


CONFIDENTIAL

 

right to decide whether to conduct a recall and the manner in which any such recall will be conducted. Without limiting any indemnification obligation Kymera may have under this Agreement, (a) during the applicable Opt-In Period, [***], (b) during any time other than the applicable Opt-In Period, [***], and (c) [***].

6.12 Pricing Approvals and Combination Product Decisions. For all Licensed Products, Sanofi will exclusively control without coordination by the JCC (a) all Price Approvals and (b) all decisions with respect to Commercialization of such Licensed Products as Combination Products. Kymera will provide Sanofi with reasonable assistance and cooperation with respect to obtaining pricing and reimbursement approvals for all such Licensed Products, at Sanofi’s request and expense, subject to the Cost/Profit Share, if applicable.

6.13 Subcontracts. Subject to any applicable Cost/Profit Sharing Agreement or Co-Promote Agreement, each Party will be entitled to utilize the services of Third Parties to perform Commercialization activities under this Agreement, provided that (a) such Party will require that such Third Party perform its obligations in a manner consistent with the terms of this Agreement, (b) if such Party is Kymera, (i) Sanofi will have the right to conduct customary reviews and audits of Kymera and its Affiliates and (ii) Kymera will use diligent efforts to obtain for Sanofi the right to conduct customary reviews and audits of its Approved Third Party Contractors, in each case ((i) and (ii)), upon [***] prior written notice, to confirm such Parties’ compliance with the Co-Promotion Agreement and (c) such Party will remain at all times fully liable for its responsibilities. Each Party will require that any such Third Party agreement entered into by such Party pursuant to this Section 6.13 [***]. For clarity, [***]. In each agreement with a Third Party that relates solely to Collaboration Compounds, Collaboration Candidates or Licensed Products, the subcontracting Party will use Commercially Reasonable Efforts to require that such agreement is freely assignable.

Article 7
Regulatory Matters

7.1 Regulatory Lead Responsibilities. Subject to Section 6.12, on a Collaboration Target-by-Collaboration Target basis, the Regulatory Lead will be solely responsible for all regulatory matters in the Territory relating to the Collaboration Candidates and Licensed Products Directed Against such Collaboration Target for which such Party is the Regulatory Lead. The Regulatory Lead will own all INDs, NDAs, Marketing Approvals, Regulatory Filings, Price Approvals and related regulatory documents in the Territory with respect to such Collaboration Candidates and Licensed Products Directed Against such Collaboration Target, including any drug master files maintained by such Regulatory Lead solely with respect thereto in the Territory. The role of Regulatory Lead may transition from one Party to the other Party as contemplated by the definition of such term, and the Parties will document such transition in writing. On a Collaboration Target-by-Collaboration Target basis, the Regulatory Lead will be the sole point of contact with Regulatory Authorities with respect to the Collaboration Candidates and Licensed Products Directed Against such Collaboration Target.

7.2 Assignment of Regulatory Filings. To the extent not already completed pursuant to Section 3.1.1(e), On a Collaboration Target-by-Collaboration Target basis, within [***] following Sanofi Participation Election Effective Date for a given Collaboration Target (if any),

63


CONFIDENTIAL

 

Kymera will transfer and assign to Sanofi Kymera’s entire right, title, and interest in and to all INDs, other Regulatory Filings, and other regulatory documentation in the Territory with respect to all Collaboration Candidates and Licensed Products Directed Against such Collaboration Target that is in the possession and control of Kymera, excluding any drug master files maintained by Kymera or a Third Party solely with respect thereto.

7.3 Communications with Regulatory Authorities.

7.3.1 On a Collaboration Target-by-Collaboration Target basis, (a) Kymera, as Regulatory Lead, with respect to Material Communications with a Regulatory Authority in the Territory, and (b) Sanofi, as Regulatory Lead prior to and during the Opt-In Period, with respect to Material Communications with a Regulatory Authority in the Major Market Countries, as applicable, will:

(a) provide the JSC (or a Committee or Subcommittee to which the JSC has delegated responsibility) for its review and discussion with a brief description in English of the principal issues raised in each Material Communication with Regulatory Authorities with respect to any Collaboration Candidates or Licensed Products Directed Against such Collaboration Target for which such Party is the Regulatory Lead, including any communications with a Regulatory Authority with respect to any audit or inspection of such Party or any of its Affiliates or Subcontractors conducted by a Regulatory Authority and related findings thereunder to the extent such audit or inspection relates to the activities conducted under this Agreement;

(b) provide such descriptions of such Material Communications to the JSC as part of the quarterly updates regarding Development and Commercialization activities with respect to such Collaboration Target, if related to any Collaboration Candidates or Licensed Products Directed Against such Collaboration Target (except, solely with respect to the U.S., within [***] after receipt thereof), if related to any Collaboration Candidates or Licensed Products Directed Against such Collaboration Target; and

(c) allow the other Party a reasonable opportunity to review and comment on such Regulatory Lead’s proposed response to such Material Communication in advance of the transmission of such response, and the Regulatory Lead will reasonably consider all comments timely provided by such other Party in connection therewith; provided that Sanofi will not be obligated to provide Kymera the right to review or comment on Sanofi’s proposed response to a Material Communication to a Major Market Country other than the U.S., even during the Opt-In Period.

7.3.2 Subject to Section 7.3.1, Sanofi, as Regulatory Lead, will keep Kymera reasonably informed of its progress with Regulatory Authorities with respect to Collaboration Candidates and Licensed Products pursuant to the Late Development Plan and JSC as part of the quarterly updates regarding Development and Commercialization activities with respect to such Collaboration Candidates and Licensed Products.

7.4 Regulatory Meetings. On a Collaboration Target-by-Collaboration Target basis, (a) Kymera, as Regulatory Lead, with respect to meetings with a Governmental Authority in the Territory, and (b) Sanofi, as Regulatory Lead both prior to and during the Opt-In Period, with

64


CONFIDENTIAL

 

respect to meetings with a Governmental Authority in the U.S., as applicable, will provide the other Party with reasonable advance notice of all meetings with Governmental Authorities pertaining to any Collaboration Candidates or Licensed Products Directed Against such Collaboration Target for which such Party is the Regulatory Lead, or with as much advance notice as practicable under the circumstances. To the extent permitted by the applicable Government Authority, the non-Regulatory Lead may have up to [***] attend all such meetings.

7.5 Submissions. On a Collaboration Target-by-Collaboration Target basis, (a) Kymera, as Regulatory Lead, with respect to submissions to a Governmental Authority in the Territory, and (b) Sanofi, as Regulatory Lead prior to and during the Opt-In Period, with respect to meetings with a Governmental Authority in Major Market Countries, as applicable, will provide the non-Regulatory Lead, through the JSC, with written notice of each of the following events with regard to any Collaboration Candidates or Licensed Products Directed Against such Collaboration Target for which such Party is the Regulatory Lead (a) within a reasonable period of time following the occurrence thereof (but in any event no later than [***] thereafter), to the extent notice was not previously provided: [***].

7.6 Pharmacovigilance.

7.6.1 On a Collaboration Target-by-Collaboration Target basis, prior to the Initiation of the first Clinical Trial for a Licensed Product or earlier upon the written request of either Party, the Parties will enter into a pharmacovigilance agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Licensed Products, such as safety data sharing, adverse events reporting and safety profile monitoring with respect to Licensed Products Directed Against such Collaboration Target (the “Pharmacovigilance Agreement”). Such procedures will be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Law. Each Party will be responsible for reporting quality complaints, adverse events and safety data related to the Licensed Products to the applicable Regulatory Authorities in its territory, as well as responding to safety issues and to all requests of Regulatory Authorities related to the Licensed Products in its territory, in each case at its own cost. The initial global safety database will be established by Kymera using its Approved Third Party Contractors, and Kymera will, at Kymera’s sole cost and expense, transfer such global safety database to Sanofi upon Sanofi’s written request reasonably in advance of the desired transfer date, which transfer date will be no later than [***] and in the form requested by Sanofi. Prior to such transfer Kymera shall provide to Sanofi all safety information obtained by Kymera for the Licensed Products prior to Sanofi’s assumption and implementation of the global safety database in accordance with the Pharmacovigilance Agreement. Each Party agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to [***] comply with such obligations. Among other things, the Pharmacovigilance Agreement will provide the right for each Party to cross-reference all relevant safety data of the other Party.

7.6.2 Without limiting the foregoing, (a) if a Material Safety Event occurs during the Sanofi Participation Term, and [***], Sanofi will provide written notice thereof to Kymera (a “Sanofi Material Safety Event Notice”) and (b) if a Party, in accordance with such Party’s internal operating procedures consistently applied across its own pharmaceutical products, determines that a Material Safety Event has occurred with respect to a Clinical Trial

65


CONFIDENTIAL

 

conducted by or on behalf of Kymera under this Agreement, such Party will provide written notice thereof to the other Party (a “Kymera Material Safety Event Notice”). Any such notice issued by a Party under this Section 7.6.2 will include [***].

7.7 Right of Reference. To the extent necessary or useful to exercise Sanofi’s rights under the Exclusive Licenses, Kymera hereby grants, and shall ensure that its Affiliates grant, to Sanofi and its permitted Sublicensees a “right of reference or use” (as that term is defined in 21 C.F.R. §314.3(b), as amended from time to time, and any foreign equivalent thereto), to any drug master files maintained by Kymera or a Third Party solely with respect to all INDs, other Regulatory Filings, and other regulatory documentation in the Territory with respect to all Collaboration Candidates and Licensed Products Directed Against such Collaboration Target that is in the possession and control of Kymera, and Kymera shall provide appropriate notification of Sanofi’s access and reference rights to the applicable Regulatory Authorities requested by Sanofi.

Article 8
Manufacturing

8.1 Technology Transfer.

8.1.1 Transfer Timing.

(a) Under the Original Agreement, Kymera conducted a technology transfer of CMC information for [***] to Sanofi or its designated CMO.

(b) Kymera will conduct a technology transfer of CMC information for the [***] to be completed (i) if such transfer occurs upon the achievement of [***], at least
[***] prior to the anticipated transfer of Development responsibility to Sanofi for the applicable Degrader Directed Against Collaboration Target 1, (ii) if such transfer occurs after the achievement of [***] for the applicable Degrader Directed Against Collaboration Target 1 [***], and (iii) at least [***] prior to the anticipated transfer of Development responsibility to Sanofi for the applicable Degrader Directed Against Collaboration Target 2. Such transfer will be conducted pursuant to a transfer plan to be agreed upon by the Parties and approved by the JMC (the “
CMC Transfer Plan”) in accordance with the timelines set forth in this clause (b).

8.1.2 Process of Transfer to CMO. On a Collaboration Candidate-by-Collaboration Candidate basis, the CMC Transfer Plan will require that Kymera initiate a technology transfer of the relevant CMC information to Sanofi or its designated CMO. Such transfer will include a transfer of Kymera Background Know-How that is necessary for the Manufacture of the relevant Collaboration Candidates. Kymera will make available its personnel on a reasonable basis to consult with Sanofi or such CMO with respect thereto. Except as set forth in the previous sentence, Sanofi will bear the costs of conducting each CMC Transfer Plan. For each Collaboration Candidate, Kymera will not be required to perform technology transfer to more than one (1) CMO for each stage of such the relevant supply chain (i.e., non-GMP starting material, bulk drug substance, bulk drug product and finished product). Promptly after Sanofi’s written request, Kymera will use diligent efforts to assign to Sanofi any manufacturing agreement between Kymera and a CMO that is solely related to the manufacture of relevant Collaboration Candidates. Subject to applicable

66


CONFIDENTIAL

 

confidentiality obligations, Kymera will promptly provide to Sanofi a copy of any such manufacturing agreement and, to the extent permitted by such manufacturing agreement, reasonable access to personnel from such CMO. Such assignment will be subject to the terms and conditions of such agreement, including any required consents of such CMO and Sanofi’s written agreement to assume all the obligations of Kymera under such agreement to be undertaken after such assignment, but Kymera will remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, Sanofi will be solely responsible for contracting with such CMO (and any other CMO to whom a technology transfer has been or will be conducted as set forth in this Section 8.1) for the supply of relevant Collaboration Candidates and Licensed Products and Kymera will have no obligations under such agreement between Sanofi and such CMO.

8.2 Research Term Supply.

8.2.1 On a Collaboration Target-by-Collaboration Target basis, Kymera (through itself, its Affiliates or CMOs) will be solely responsible, [***], for Manufacturing all Collaboration Compounds, Collaboration Candidates and Licensed Products required to conduct Kymera’s activities under the Research Plan or Early Development Plan. Notwithstanding the foregoing, Sanofi (through itself, its Affiliates or CMOs) will be responsible, [***], for (a) the CMC process development of such Collaboration Candidates and Licensed Products Directed Against the relevant Collaboration Target in accordance with the Research Plan or Early Development Plan (as applicable), and (b) Manufacturing all Collaboration Compounds, Collaboration Candidates and Licensed Products required to conduct the Phase 2 Activities or Sanofi’s activities under the Early Development Plan (if any) or Late Development Plan (if any).

8.2.2 Under the Original Agreement, [***]. Sanofi is responsible for completing Manufacturing of [***] using such delivered starting materials at Sanofi’s cost and expense. If Sanofi provides a written notice to Kymera with a request to [***], Kymera will, within [***] of a request from Sanofi, authorize the applicable CMOs to accept orders for starting materials and for Manufacturing of active ingredients from Sanofi, Sanofi may engage the applicable CMOs for such purposes, and all such starting materials and Manufacturing will be obtained at Sanofi’s cost and expense.

8.2.3 Under the Original Agreement, Kymera supplied to Sanofi or its designated CMO quantities of [***] as set forth in the then-current Research Plan to enable Sanofi to execute its comparability protocol as set forth in the Research Plan. To the extent required by Sanofi, the Parties will enter into an agreement that details the quality assurance obligations of each Party.

8.2.4 The JMC, in consultation with the JRDC, will be responsible for monitoring Kymera’s progress under the Early Development Plan to anticipate, and plan for, the transition of Manufacturing activities to Sanofi based on the anticipated Development timelines set forth in the Early Development Plan and the Late Development Plan. With respect to [***].

67


CONFIDENTIAL

 

8.3 Sanofi Participation Term Supply.

8.3.1 On a Collaboration Target-by-Collaboration Target basis, Sanofi (through itself, its Affiliates or CMOs) will be responsible, at its cost and expense, for Manufacturing (including CMC process development) for Sanofi use in the Development and Commercialization of Collaboration Candidates and Licensed Products Directed Against such Collaboration Target.

8.3.2 Notwithstanding Section 8.3.1, on a Collaboration Target-by-Collaboration Target basis, if Kymera exercises the Kymera Opt-In Right with respect to a Collaboration Target, Sanofi’s fully burdened manufacturing cost for all Collaboration Compounds, Collaboration Candidates and Licensed Products Directed Against the relevant Collaboration Target will be shared by the Parties in accordance with the relevant Cost/Profit Sharing Agreement.

8.4 CMOs. Each Party will be entitled to utilize the services of CMOs to perform Manufacturing activities under this Agreement, provided that: (a) such Party will require that each such CMO perform its obligations in a manner consistent with the terms of this Agreement; (b) such Party will remain at all times fully liable for its responsibilities; (c) in the case of Kymera, such CMO(s) (and specified manufacturing site(s)) shall be as set forth on Schedule 8.4 (as such schedule may be updated from time to time solely by prior written agreement of the Parties), provided that for [***], Kymera may continue to use its existing CMO; and (d) in the case of Sanofi, such CMO(s) will be selected in accordance with its internal standard operating procedures for the selection of CMOs. Each Party will require that any such CMO agreement entered into by such Party pursuant to this Section 8.4 entered into after the Original Agreement Execution Date [***]. The subcontracting Party will be solely responsible for direction of and communications with such CMO. In each CMO agreement entered into after the Original Agreement Execution Date that relates solely to Collaboration Compounds, Collaboration Candidates or Licensed Products, the subcontracting Party will use Commercially Reasonable Efforts to require that such agreement is freely assignable.

8.5 cGMP Compliance and QA Audits. Following the Effective Date, when negotiating a CMO agreement for the Manufacture of Collaboration Compounds or Collaboration Candidates, Kymera will use Commercially Reasonable Efforts to obtain the right for Sanofi to, upon no less than [***] advance written notice to Kymera, and subject to the terms of any relevant CMO agreement, have representatives visit the locations at which Manufacturing activities are undertaken by the relevant CMO, in each case, during normal business hours to review and inspect records and reports pertinent to the Manufacture, disposition or transport of Collaboration Compounds or Collaboration Candidates. Such visits will occur no more than [***], except in the case of audits by Sanofi that are required by Applicable Laws. In addition, upon [***] written notice to Kymera, Kymera will permit Sanofi to conduct on-site visits to the relevant Kymera premises during normal business hours to review and inspect such premises, and Kymera’s reports and records, regarding (a) Kymera’s oversight of manufacturing, quality control procedures, release, and (b) the Manufacture, disposition or transport of materials supplied by Kymera to Sanofi, in each case ((a) and (b)) to confirm Kymera’s compliance with Applicable Law; such visits to be subject to customary and reasonable due diligence procedures to preserve the confidentiality of any information obtained by Sanofi. Such visits will (a) occur no more than

68


CONFIDENTIAL

 

[***], (b) will be conducted in such a manner to minimize, to the extent reasonably possible, the period of such visit and in no case shall such period exceed [***], and (c) will be conducted by the minimum number of Sanofi employees as necessary to provide requisite subject matter expertise and conduct the review in the allotted timeframe, each of whom shall have appropriate experience in the Manufacture, quality and cGMP compliance of small molecule compounds and candidates. Upon completion of any such visit, Sanofi will provide Kymera and the JMC of Sanofi’s findings from each such visits. [***].

8.6 Quality Agreements. The Parties will enter into one or more quality agreements to govern the transfer of materials, Collaboration Candidates and Licensed Products contemplated under this Article 8.

Article 9
GOVERNANCE

9.1 Joint Steering Committee.

9.1.1 Formation. Pursuant to the Original Agreement, the Parties established a joint steering committee (the “JSC”) to act as a forum to review, discuss and oversee activities under this Agreement. The JSC will be comprised of [***] from each Party. Each Party’s representatives on the JSC will be of the seniority and experience appropriate in light of the functions and responsibilities of the JSC. In addition, each Party may invite a reasonable number of additional subject matter experts or relevant personnel of such Party to participate in discussions and meetings of the JSC; provided that such individuals will have no decision-making authority. Each Party’s representatives on the JSC and all other individuals attending or participating in discussions and meetings of the JSC on behalf of a Party will be bound under written confidentiality and non-use obligations with respect to information disclosed at such meeting that are no less restrictive than the provisions of Article 16. Each Party may replace its representatives on the JSC at any time by providing notice in writing to the other Party. Each Party will appoint one of its representatives on the JSC to act as a co-chairperson of the JSC. The co-chairpersons of the JSC will be responsible for setting the agenda for meetings of the JSC with input from the other members, and for conducting the meetings of the JSC. The JSC will conduct its responsibilities hereunder in good faith and with reasonable care and diligence.

9.1.2 Responsibilities. The JSC will be responsible for overseeing the collaboration and approving strategy, plans and budgets with respect to (i) Collaboration Compounds, Collaboration Candidates and Licensed Product activities before the expiration or termination of Kymera’s Opt-In Right with respect to a given Collaboration Target, and (ii) during the applicable Opt-In Period, Collaboration Candidates and Licensed Products activities as to which Kymera has exercised the Kymera Opt-In Right for a given Collaboration Target. Any failure of the Parties to agree on matters within the purview of the JSC as set forth this Section 9.1.2 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.2. Without limiting the first sentence of this Section 9.1.2, the JSC will:

69


CONFIDENTIAL

 

(a) discuss and approve changes to the Screening Criteria, M2 Criteria, Phase 1 Ready Criteria or Phase 2 Ready Criteria;

(b) review, discuss and approve each Late Development Plan;

(c) be responsible for overseeing the Parties’ performance of their respective activities under the Late Development Plan and provide support to each Party with respect to such Party’s activities thereunder;

(d) solely during the applicable Opt-In Period, upon request by a Party, discuss the appropriate level of detail to include in the U.S. Development Budget required for the United States for the applicable Development activities to be performed during the period covered by such U.S. Development Budget for the United States;

(e) solely during the applicable Opt-In Period, review, discuss and approve proposed updates and amendments to each Late Development Plan;

(f) review and discuss reports provided by a Party pursuant to Section 5.9.2;

(g) review and discuss materials provided by a Party pursuant to Section 7.3 or 7.5;

(h) solely with respect to (i) Collaboration Compounds, Collaboration Candidates and Licensed Product activities before expiration or termination of the Kymera Opt-In Right for a given Collaboration Target, and (ii) during the applicable Opt-In Period, Collaboration Candidates and Licensed Products as to which Kymera has exercised the Kymera Opt-In Right for a given Collaboration Target, in each case review, discuss and approve annual budgets and any updates or amendments thereto;

(i) discuss and approve extensions to timelines pursuant to Section 18.2.2;

(j) review and discuss the rationale of obtaining any Potential In-License;

(k) in coordination with the JPC, review and discuss Potential In-Licenses (including related proposed economics);

(l) identify a Party to lead negotiations with the applicable Third Party licensor for any Potential In-License;

(m) on receipt of a substantially finalized draft Potential In-License, determine whether to approve such Potential In-License as a Collaboration In-License Agreement for the applicable Collaboration Target;

(n) solely during the applicable Opt-In Period, review, discuss and agree on the Late Development Budget;

70


CONFIDENTIAL

 

(o) solely during the applicable Opt-In Period, review, discuss and determine whether an overspend is a Permitted U.S. Budget Overrun;

(p) solely during the applicable Opt-In Period, review, discuss and determine whether an U.S. Budget Excession was caused by circumstances within Sanofi’s reasonable control or whether to otherwise approve an U.S. Budget Excession;

(q) solely during the applicable Opt-In Period, review and discuss expense reports with respect to U.S. Development Costs;

(r) review, discuss and approve any decisions or disputes submitted by a Committee to the JSC;

(s) establish, but not delegate decision making authority to, such additional Subcommittees as it deems necessary to achieve the objective and intent of this Agreement; and perform such other duties as are specifically assigned to the JSC under this Agreement or as may be otherwise mutually agreed by the Parties from time to time; and

(t) perform such other functions as are set forth in this Agreement, or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

9.2 Joint Research and Development Committee.

9.2.1 Formation. Pursuant to the Original Agreement, the Parties established a joint research and development committee (the “JRDC”) to act as a forum to review, discuss and oversee research activities under this Agreement on a Collaboration Target-by-Collaboration Target basis prior to the applicable Sanofi Participation Election Effective Date. The JRDC will be comprised of [***] from each Party. Each Party’s representatives on the JRDC will be of the seniority and experience appropriate in light of the functions and responsibilities of the JRDC In addition, each Party may invite a reasonable number of additional subject matter experts or relevant personnel of such Party to participate in discussions and meetings of the JRDC; provided that such individuals will have no decision-making authority. Each Party’s representatives on the JRDC and all other individuals attending or participating in discussions and meetings of the JRDC on behalf of a Party will be bound under written confidentiality and non-use obligations with respect to information disclosed at such meeting that are no less restrictive than the provisions of Article 16. Each Party may replace its representatives on the JRDC at any time by providing notice in writing to the other Party. Until Sanofi’s first exercise of the Sanofi Participation Election Right, Kymera will designate the chairperson of the JRDC; thereafter, Sanofi will designate the chairperson of the JRDC. The chairperson of the JRDC will be responsible for setting the agenda for meetings of the JRDC with input from the other members, and for conducting the meetings of the JRDC. The JRDC will conduct its responsibilities hereunder in good faith and with reasonable care and diligence.

9.2.2 Specific Responsibilities. The JRDC will, subject to the escalation, final decision-making authority and dispute resolution procedures in Section 9.9:

71


CONFIDENTIAL

 

(a) be responsible for overseeing the Parties’ performance of their respective activities under the Research Plan and Early Development Plan and provide support to each Party with respect to such Party’s activities thereunder;

(b) review and discuss (i) each amended Research Plan and Early Development Plan and approve updates or material amendments to the Research Plan and the Early Development Plan and (ii) the Phase 2 Development Plan and approve updates or material amendments to the Phase 2 Development Plan;

(c) discuss and determine whether a Degrader that is Researched under this Agreement meets the Screening Criteria, M2 Criteria, Phase 1 Ready Criteria or Phase 2 Ready Criteria;

(d) review, discuss and approve changes to the Screening Criteria, M2 Criteria, Phase 1 Ready Criteria or Phase 2 Ready Criteria;

(e) discuss and determine whether Successful Completion has been achieved;

(f) review and discuss the list of Degraders provided by Kymera pursuant to Section 2.2.2;

(g) review and discuss reports and data provided by Kymera pursuant to Section 2.4.7 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the First Additional Degrader Criteria;

(h) cause the minutes of the JRDC to reflect any selection of a Degrader as a First Additional Degrader, whether by the JRDC, the R&D Expert in accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 2.4.7;

(i) review, discuss and determine whether a Collaboration Candidate or Licensed Product Directed Against Collaboration Target 2 satisfies the Phase 1 Ready Criteria;

(j) review and discuss reports and data provided by Kymera pursuant to Section 2.5.7 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the Second Additional Degrader Criteria;

(k) cause the minutes of the JRDC to reflect any selection of a Degrader as a Second Additional Degrader, whether by the JRDC or the R&D Expert or by Sanofi in accordance with Section 2.5.7;

(l) review and discuss reports and data provided by Kymera pursuant to Section 2.6.5 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the M2 Criteria;

(m) cause the minutes of the JRDC to reflect any selection of a Collaboration Compound as a Collaboration Candidate, whether by the JRDC or the R&D Expert;

72


CONFIDENTIAL

 

(n) review and discuss information provided by Kymera pursuant to Sections 2.4.5 and 2.5.5 and whether to approve any related overspend as a FAD Permitted Overrun or SAD Permitted Overrun;

(o) review, discuss and approve a FAD Research Budget Excession or SAD Research Budget Excession in accordance with Sections 2.4.5 and 2.5.5, including whether any such FAD Research Budget Excession or SAD Research Budget Excession was in Kymera’s reasonable control;

(p) review, discuss and determine whether Research Activities under Section 2.6.3 should be discontinued;

(q) review and discuss information provided by Kymera pursuant to Section 2.6.4 and whether to approve any related overspend as a Series 2 Permitted Overrun;

(r) review, discuss and approve Series 2 Research Budget Excession in accordance with Section 2.6.4, including whether any such Series 2 Research Budget Excession was in Kymera’s reasonable control;

(s) discuss and approve a transfer of Materials from one Party to the other Party in accordance with Section 2.9 and discuss information provided by a Party with respect to MTA Research Studies;

(t) during the Research Term prior to Sanofi’s exercise of the Sanofi Participation Election Right with respect to Collaboration Target 2, determine the first Indication for which the first IND will be filed with respect to a Licensed Product;

(u) discuss and approve a transfer of Materials from one Party to the other Party in accordance with Section 3.5 and discuss information provided by a Party with respect to MTA Development Studies;

(v) review and discuss reports provided by a Party pursuant to Section 2.11, Section 3.7 or Section 5.5;

(w) to the extent contemplated by Section 5.2.3, review, discussion and approve an extension of time during which Kymera will make its personnel reasonably available;

(x) review and discuss information provided by Kymera pursuant to Section 5.5.6 and whether to approve any related overspend as a Permitted Backup Research Overrun;

(y) review, discuss and determine, in accordance with Section 5.5.6, whether any Backup Research Budget Excession was in Kymera’s reasonable control;

(z) review and discuss reports and data provided by Kymera pursuant to Section 5.5.7 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the Backup Degrader Criteria;

73


CONFIDENTIAL

 

(aa) cause the minutes of the JRDC to reflect any selection of a Degrader as a Backup Degrader, whether by the JRDC, the R&D Expert in accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 5.5.10;

(bb) in coordination with the JPC, review and discuss any requests by Kymera pursuant to Section 5.6.5 regarding a potential reversion of any Collaboration Compounds or Collaboration Candidates Directed Against Collaboration Target 1 that were Researched by or on behalf of Kymera under Section 2.3, 2.4, 2.5 or 5.5 but have not been selected as the First Additional Degraders, Second Additional Degraders or Backup Degraders;

(cc) review and discuss reports provided by Sanofi in accordance with Section 5.9;

(dd) in coordination with the JMC, monitor Kymera’s progress under the Early Development Plan to anticipate, and plan for, the transition of Manufacturing activities to Sanofi based on the anticipated Development timelines set forth in the Early Development Plan and the Late Development Plan;

(ee) in coordination with the JMC, determine whether it is reasonably foreseeable that [***];

(ff) discuss, review and approve, in accordance with Section 10.3.2, grants of Sublicenses by Kymera of any of the licenses granted to Kymera in Section 10.1.3 to additional Third Party contractors other than Approved Third Party Contractors, such approval not to be unreasonably withheld, conditioned or delayed;

(gg) review and discuss information provided by Sanofi pursuant to Exhibit A and whether to approve any related overspend as a Permitted U.S. Budget Overrun;

(hh) review, discuss and determine, in accordance with Section 5.5.6, whether any Research Budget Excession was in Kymera’s reasonable control;

(ii) review, discuss and approve any U.S. Budget Excession in accordance with Exhibit A, including whether any U.S. Budget Excession was in Sanofi’s reasonable control;

(jj) review, discuss and approve additional Third Party contractors as Approved Third Party Contractors;

(kk) determine reasonable expenses pursuant to Section 15.2.4; and

(ll) perform such other functions as are set forth in this Agreement, or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Any failure of the Parties to agree on matters within the purview of the JRDC as set forth in this Section 9.2 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.

74


CONFIDENTIAL

 

 

9.3 Joint Patent Committee.

9.3.1 Formation. Pursuant to the Original Agreement, the Parties established a joint patent committee (the “JPC”) to coordinate the Prosecution and Maintenance and enforcement of [***]. The JPC will be comprised of up to [***] representing each Party. Each Party’s representative(s) on the JPC will be of the seniority and experience appropriate in light of the functions and responsibilities of the JPC. In addition, each Party may invite a reasonable number of additional subject matter experts, outside counsel or relevant personnel of such Party to participate in discussions and meetings of the JPC on an ad-hoc basis. Each Party may replace its representative(s) on the JPC at any time by providing notice in writing to the other Party. The JPC will conduct its responsibilities hereunder in good faith and with reasonable care and diligence.

9.3.2 Specific Responsibilities. The JPC will, subject to the escalation, final decision-making authority and dispute resolution procedures in Section 9.9:

(a) in coordination with the JSC, review and discuss Potential In-Licenses (including related proposed economics);

(b) in coordination with the JRDC, review and discuss any requests by Kymera pursuant to Section 5.6 regarding a potential reversion of any Collaboration Compounds or Collaboration Candidates Directed Against Collaboration Target 1 that were Researched by or on behalf of Kymera under Section 2.3, 2.4, 2.5 or 5.5 but have not been selected as the First Additional Degraders, Second Additional Degraders or Backup Degraders;

(c) review, discuss and determine [***];

(d) coordinate the Prosecution and Maintenance activities under Article 12;

(e) consider matters raised to the JPC pursuant to Section 16.6.3; and

(f) perform such other functions as are set forth in this Agreement, or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Any failure of the Parties to agree on matters within the purview of the JPC as set forth in this Section 9.3.2 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.

 

9.4 Joint Manufacturing Committee.

9.4.1 Formation. Pursuant to the Original Agreement, the Parties established a joint manufacturing committee (the “JMC”) to act as a forum to review, discuss and oversee Manufacturing activities under this Agreement. The JMC will be comprised of [***] from each Party. Each Party’s representatives on the JMC will be of the seniority and experience appropriate in light of the functions and responsibilities of the JMC. In addition,

75


CONFIDENTIAL

 

each Party may invite a reasonable number of additional subject matter experts or relevant personnel of such Party to participate in discussions and meetings of the JMC; provided that such individuals will have no decision-making authority. Each Party’s representatives on the JMC and all other individuals attending or participating in discussions and meetings of the JMC on behalf of a Party will be bound under written confidentiality and non-use obligations with respect to information disclosed at such meeting that are no less restrictive than the provisions of Article 16. Each Party may replace its representatives on the JMC at any time by providing notice in writing to the other Party. Prior to the Sanofi Participation Election Effective Date, each Party will appoint one of its representatives on the JMC to act as a co-chairperson of the JMC; thereafter, Sanofi will designate the chairperson of the JMC. The chairperson of the JMC will be responsible for setting the agenda for meetings of the JMC with input from the other members, and for conducting the meetings of the JMC. The JMC will conduct its responsibilities hereunder in good faith and with reasonable care and diligence.

9.4.2 Specific Responsibilities. The JMC will, subject to the escalation, final decision-making authority and dispute resolution procedures in Section 9.9:

(a) work with the JSC to be responsible for overseeing Manufacturing activities under this Agreement;

(b) review, discuss and approve the CMC Transfer Plans;

(c) determine the timeline for technology transfer of CMC information for a Degrader Directed Against Collaboration Target 1 for which transfer will occur after the achievement of the relevant [***];

(d) in coordination with the JRDC, monitor Kymera’s progress under the Research Plan and the Early Development Plan to anticipate, and plan for, the transition of Manufacturing activities to Sanofi based on the anticipated Development timelines set forth in the Research Plan, the Early Development Plan and the Late Development Plan;

(e) in coordination with the JRDC, (i) determine whether it is reasonably foreseeable that [***];

(f) discuss and approve changes to Schedule 8.4;

(g) discuss, review and oversee the transfer of Manufacturing activities to Sanofi or its CMO(s); and

(h) 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.

Any failure of the Parties to agree on matters within the purview of the JMC as set forth in this Section 9.4 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.

9.5 Joint Transition Team.

76


CONFIDENTIAL

 

9.5.1 Formation. On a Collaboration Target-by-Collaboration Target basis, within [***] after the relevant Sanofi Participation Election Effective Date for such Collaboration Target, the Parties will establish a joint transition team (the “JTT”) to coordinate the transition of the relevant Collaboration Compounds, Collaboration Candidates and Licensed Products Directed Against such Collaboration Target. The JTT will be comprised of [***] from each Party. Without limiting the foregoing, but subject to the escalation, final decision-making authority and dispute resolution procedures in Section 9.9, the JTT will be responsible for (a) finalizing and approving a transition plan, including transition activities that either Party will be obligated to perform under such transition plan and (b) performing such other activities as the Parties agree in writing will be the responsibility of the JTT with respect to such Collaboration Target. Each Party’s representatives on the JTT will be of the seniority and experience appropriate in light of the functions and responsibilities of the JTT. In addition, each Party may invite a reasonable number of additional subject matter experts or relevant personnel of such Party to participate in discussions and meetings of the JTT; provided that such individuals will have no decision-making authority. Each Party’s representatives on the JTT and all other individuals attending or participating in discussions and meetings of the JTT on behalf of a Party will be bound under written confidentiality and non-use obligations with respect to information disclosed at such meeting that are no less restrictive than the provisions of Article 16. Each Party may replace its representatives on the JTT at any time by providing notice in writing to the other Party. Sanofi will designate the chairperson of the JTT. The chairperson of the JTT will be responsible for setting the agenda for meetings of the JTT with input from the other members, and for conducting the meetings of the JTT. The JTT will conduct its responsibilities hereunder in good faith and with reasonable care and diligence. Any failure of the Parties to agree on matters within the purview of the JTT as set forth in this Section 9.5 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.

9.6 Joint Commercialization Committee.

9.6.1 Formation. The Parties will establish a joint commercialization committee (the “JCC”) at least [***] to act as a forum to review, discuss and oversee Co-Promotion activities for Licensed Products Directed Against Collaboration Targets for which Kymera has exercised the Kymera Opt-In Right. The JCC will be comprised of [***] from each Party. Each Party’s representatives on the JCC will be of the seniority and experience appropriate in light of the functions and responsibilities of the JCC. In addition, each Party may invite a reasonable number of additional subject matter experts or relevant personnel of such Party to participate in discussions and meetings of the JCC; provided that such individuals will have no decision-making authority. Each Party’s representatives on the JCC and all other individuals attending or participating in discussions and meetings of the JCC on behalf of a Party will be bound under written confidentiality and non-use obligations with respect to information disclosed at such meeting that are no less restrictive than the provisions of Article 16. Each Party may replace its representatives on the JCC at any time by providing notice in writing to the other Party. Sanofi will designate the chairperson of the JCC. The chairperson of the JCC will be responsible for setting the agenda for meetings of the JCC with input from the other members, and for conducting the meetings of the JCC. The JCC will conduct its responsibilities hereunder in good faith and with reasonable care and diligence.

77


CONFIDENTIAL

 

9.6.2 Specific Responsibilities. The JCC will, subject to the escalation, final decision-making authority and dispute resolution procedures in Section 9.9:

(a) review, discuss and approve the FTE Rate with respect to Co-Promote activities;

(b) ensure that each Co-Promotion Plan allocates to the Designated Sales Force a pro rata portion of centers of excellence and high prescribing physicians for the Opt-In Product(s);

(c) upon request of a Party, discuss the appropriate level of detail to include in a Co-Commercialization Budget;

(d) review, discuss and approve each proposed Co-Commercialization Plan; while endeavoring to approve each such Co-Commercialization Plan no later than [***] of each relevant Calendar Year;

(e) review, discuss and approve proposed updates or amendments to a Co-Commercialization Plan;

(f) review and discuss reports provided pursuant to Section 6.8 or a Co-Promotion Agreement;

(g) review, discuss and provide comments with respect to any promotional materials for the Co-Promotion of Opt-In Products;

(h) discuss notification from Kymera that Kymera wishes to decrease its then-allocated percentage of Detailing;

(i) oversee the Parties’ joint promotional efforts;

(j) specify which commercial functional area experts (other than managed care) of Sanofi the Designated Sales Force will have access to;

(k) review and discuss the engagement by Sanofi of a commercial advertising agency to be used in connection with Detailing of the Opt-In Products, including the identity of such agency and the material terms of such engagement;

(l) establish the value of secondary position details, consistent with Sanofi’s then-current standard operating procedures;

(m) establish benchmarks for the content and effectiveness of the principal promotional messages that are used by the Parties to promote the relevant Opt-In Product(s);

(n) develop a Corrective Plan in the event market research indicates that a Party’s delivery of the principal promotional messages for an Opt-In Product set forth in the

78


CONFIDENTIAL

 

applicable Co-Promotion Plan is not effective and not conveying the corresponding underlying promotional message;

(o) establish the PDE Cost;

(p) determine the anticipated commercial launch date of each Opt-In Product; and

(q) perform such other functions as are set forth in this Agreement, or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Any failure of the Parties to agree on matters within the purview of the JCC as set forth in this Section 9.6 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.

9.7 Joint Finance Committee.

9.7.1 Formation. Within [***], the Parties will establish a joint finance committee (the “JFC”) to coordinate the financial reporting by the Parties with respect to the funding of U.S. Development Costs for Opt-In Products pursuant to the Cost/Profit Sharing Agreement and to discuss and resolve financial disputes in connection therewith. The JFC will be comprised of [***] from each Party. Each Party’s representatives on the JFC will be of the seniority and experience appropriate in light of the functions and responsibilities of the JFC. In addition, each Party may invite a reasonable number of additional subject matter experts or relevant personnel of such Party to participate in discussions and meetings of the JFC; provided that such individuals will have no decision-making authority. Each Party’s representatives on the JFC and all other individuals attending or participating in discussions and meetings of the JFC on behalf of a Party will be bound under written confidentiality and non-use obligations with respect to information disclosed at such meeting that are no less restrictive than the provisions of Article 16. Each Party may replace its representatives on the JFC at any time by providing notice in writing to the other Party. Sanofi will designate the chairperson of the JFC. The chairperson of the JFC will be responsible for setting the agenda for meetings of the JFC with input from the other members, and for conducting the meetings of the JFC. The JFC will conduct its responsibilities hereunder in good faith and with reasonable care and diligence.

9.7.2 Specific Responsibilities. The JFC will, subject to the escalation, final decision-making authority and dispute resolution procedures in Section 9.9:

(a) facilitate, in coordination with the JSC and JCC, the creation of U.S. Development Budget and Co-Commercialization Budget, including the annual updates thereto;

(b) reconcile financial and accounting matters between the Parties;

(c) initiate and execute an effective and efficient revenue and cost sharing process (cross-charges);

79


CONFIDENTIAL

 

(d) cooperate to ensure that the U.S. Development Budget and Co-Commercialization Budget agreed to for a Calendar Year (or any other given period) can be interpreted for the purposes of both Parties’ internal financial and audit reporting requirements, including each Party’s fiscal year reporting;

(e) monitor the budget, expense and revenue reporting requirements between the Parties related to each Cost/Profit Sharing Agreement to ensure that each Party is able to comply with its respective internal financial and audit reporting requirements and, as appropriate, recommending to the JSC for approval, changes to the reporting requirements under this Agreement; and

(f) undertake such other tasks with respect to the calculation, implementation and reporting for the Parties’ sharing of U.S. Development Costs, Allowable Expenses, Net Profits or Net Losses as the Parties mutually agree.

Any failure of the Parties to agree on matters within the purview of the JFC as set forth in this Section 9.7 will be resolved in accordance with the decision-making and escalation procedures set forth in Section 9.9.

9.8 Meetings; Minutes.

9.8.1 Each Committee will meet in person or by teleconference at least [***] following the formation thereof on such dates and at such times and places as agreed to by the members of the such Committee; provided that (i) at least [***] such meeting of each Committee per Calendar Year will be in person unless the Parties agree otherwise and (ii) the first meeting of the JCC will occur within [***] of the date on which Sanofi proposes the initial Co-Commercialization Plan to the JCC. Each Party will be responsible for its own expenses relating to attendance at, or participation in, Committee meetings. Upon [***] prior written notice, either Party may convene a special meeting of a Committee for the purpose of discussing any urgent matter within the scope of the authority and responsibility of such Committee.

9.8.2 The responsibility for preparing the minutes will alternate between the Alliance Managers or their respective designees on a meeting-by-meeting basis. The Alliance Manager or its designee responsible for the minutes will provide the other Alliance Manager and the members of such Committee with draft written minutes for the Committee’s approval from each meeting within [***] after each such meeting setting forth, among other things, a description, in reasonable detail, of the discussions at the meeting and a list of any actions, decisions, or determinations approved by the Committee. Such minutes will be effective only after being approved by both Parties. If the minutes of any meeting of the Committee are not approved by the Committee (with each Party’s representatives on the Committee collectively having one (1) vote) within [***] after the meeting, the objecting Party will append a notice of objection with the specific details of the objection to the proposed minutes. Should a decision be made by a Committee outside of a meeting, such decision may be made by a written resolution unanimously agreed to by the Parties; notwithstanding anything herein to the contrary, such written agreement may be by email. Notwithstanding the foregoing, no minutes will be prepared for meetings of the JPC.

80


CONFIDENTIAL

 

9.9 Decisions; Disputes.

9.9.1 Decisions and Disputes within Committees other than the JSC. With respect to decisions of all Committees other than the JSC, the representatives of each Party will have collectively one (1) vote on behalf of such Party. For each meeting of such Committee, at least [***] of each Party will constitute a quorum and each Party will use Commercially Reasonable Efforts to have its representative(s) participate in each Committee meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. Each such Committee will attempt to resolve any and all matters before it for decision by consensus. If a Committee other than the JSC is unable to resolve a matter by consensus during a period of [***], then (a) with [***] with respect to all other matters not discussed in the foregoing clauses (a)-(d), such matter(s) will be escalated to the JSC. Any action of any Committee taken pursuant to this Section 9.9 will be recorded in meeting minutes in accordance with Section 9.8.2. Notwithstanding anything to the contrary set forth in this Agreement, without the other Party’s prior written consent, no exercise of a Party’s decision-making authority on any such matters may, without the other Party’s prior written consent, (i) conflict with any of the express terms of this Agreement or any Co-Promotion Agreement or Cost/Profit Sharing Agreement, (ii) impose any requirements that the other Party take or decline to take any action that would result in a violation of any Law or any Collaboration In-License Agreement or (iii) otherwise conflict with this Agreement.

9.9.2 JSC Decisions and Disputes. With respect to decisions of the JSC, the representatives of each Party will have collectively one (1) vote on behalf of such Party. For each meeting of the JSC, at least [***] of each Party will constitute a quorum and each Party will use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting. Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. The JSC will attempt to resolve any and all matters before it for decision by consensus. If a dispute is escalated to the JSC by any Subcommittee, then at the next meeting of the JSC each Party will provide analysis to support its position with respect to the dispute.

(a) If the JSC is unable to reach a consensus with respect to a matter before the JSC within [***], then the dispute will be submitted to a senior executive of each of Kymera and Sanofi to be designated by Kymera and Sanofi, respectively, for resolution.

(b) If such escalated dispute cannot be resolved by the senior executives during a period of [***], then

(i) On a Collaboration Target-by-Collaboration Target basis, prior to the Sanofi Participation Election Effective Date (if any), except as set forth in Article 12, (A) Kymera will have final decision-making authority on all matters, except as to the following matters: [***]; (B) subject to the terms and obligations set forth in Article 8, each Party will have final decision-making authority with respect to matters concerning [***]; and (C) Sanofi shall have final decision making authority on [***].

(ii) On a Collaboration Target-by-Collaboration Target basis, following the Sanofi Participation Election Effective Date (if any), except as set forth in Article

81


CONFIDENTIAL

 

12, Sanofi will have final decision-making authority on all matters, except as to the following matters: [***]. Following the Sanofi Participation Election Effective Date (if any), Sanofi will have final decision making authority with respect to matters concerning [***].

(iii) If the dispute arises out of any of [***] (each of the foregoing, an “Expert Dispute”) the Parties will submit such matter for resolution in accordance with Schedule 9.9.2(b)(iii), and the determination of the R&D Expert will be binding on the Parties. For avoidance of doubt, the Parties will be bound by the determination of such R&D Expert and neither Party nor the JSC will have authority to modify or amend the finding of the R&D Expert.

(iv) If the dispute is related to [***], then the Parties will submit their respective proposals to arbitration in accordance with the provisions set forth on Schedule 9.9.2(b)(iv).

(v) If the dispute is related to the calculation, sharing, or payment of amounts owed with respect to U.S. Development Costs, Allowable Expenses or Net Profits and Net Losses during the Opt-In Period in accordance with this Agreement or the Cost/Profit Sharing Agreement (a “Finance Dispute”), then such dispute will be resolved by “Baseball” arbitration in accordance with the provisions set forth on Schedule 9.9.2(b)(v).

(vi) If the dispute relates to a Party’s request that Kymera suspend or cease Development activities due to a Safety Concern prior to the Sanofi Participation Election Effective Date (if any), Kymera will suspend or cease such Development activities unless and until the Parties mutually agree to re-start such Development activities.

(vii) For all other disputes, a Party may institute dispute resolution procedures pursuant to Section 18.12 (excluding Section 18.12.1).

(c) The JSC will conduct its activities in good faith and will not have the power to (i) amend or modify the Parties’ respective rights and obligations under this Agreement or (ii) resolve any dispute between the Parties regarding such rights and obligations.

(d) Where this Agreement or any Co-Promotion or Cost/Profit Sharing Agreement refers to a decision or determination or similar action by a Committee and the relevant matter is decided pursuant to this Section 9.9, such decision, determination or similar action will be deemed to have been made by the relevant Committee.

9.10 Discontinuation of the Committees. The JSC and JPC will remain in existence throughout the Term, unless the Parties mutually agree to terminate the responsibilities of such Committee with respect to each Collaboration Target. The JRDC will disband and terminate on the effective date of expiration of the latest to expire Sanofi Participation Election with respect to the Collaboration Candidates. The JMC will disband and terminate upon completion of technology transfer pursuant to Section 8.1. The JTT will disband and terminate upon the completion of all transitions of the relevant Collaboration Compounds, Collaboration Candidates and Licensed Products Directed Against each Collaboration Target. The JCC and JFC will disband and terminate on the effective date of termination or expiration of the Opt-In Period or,

82


CONFIDENTIAL

 

with respect to the JCC, termination of Kymera’s Co-Promotion activities pursuant to Section 10.8.3(b) or the Co-Promotion Agreement.

9.11 Establishment of Sub-Committees. Each Committee may establish sub-committees or working groups to interact on a more frequent basis on specific projects and tasks assigned to them by such Committee; provided, that the authority of such sub-committees or working groups will not expand beyond the authority of the applicable Committee. Any such sub-committees or working groups will have no decision-making authority, but will make recommendations to the applicable Committee for its review and approval.

9.12 Alliance Managers.

9.12.1 Appointment. Each Party will appoint a representative of such Party to act as its alliance manager under this Agreement (each, an “Alliance Manager”). Each Party may replace its Alliance Manager at any time upon notice to the other Party. The Alliance Managers as of the Restatement Effective Date will be:

For Sanofi: [***]

For Kymera: [***]

9.12.2 Specific Responsibilities. The Alliance Managers will attend all meetings of each Committee (other than the JPC) but may not be members of any Committee. The Alliance Managers will serve as the primary contact point between the Parties for the purpose of providing each Party with information regarding the other Party’s activities pursuant to this Agreement and will have the following responsibilities:

(a) schedule meetings of each Committee and circulate draft written minutes as provided in Section 9.8;

(b) oversee and facilitate the flow of information and otherwise promote communication, coordination and collaboration between the Parties;

(c) provide a single point of communication for seeking consensus both internally within the respective Party’s organization and between the Parties regarding key strategy and planning issues; and

(d) perform such other functions as requested by the JSC.

Article 10
LICENSE GRANTS;
EXCLUSIVITY

10.1 License Grants to Sanofi.

10.1.1 Subject to the terms of this Agreement, on a Collaboration Target-by-Collaboration Target basis, during the period commencing on the Original Agreement Execution Date and expiring on the Original Agreement Effective Date, Kymera hereby grants to Sanofi a non-exclusive, non-royalty bearing license, including the right to grant

83


CONFIDENTIAL

 

Sublicenses in accordance with Section 10.3, under the Licensed Technology to perform CMC process development activities and Manufacturing of [***].

10.1.2 Subject to the terms of this Agreement, on a Collaboration Target-by-Collaboration Target basis, during the Research Term, solely to the extent that Sanofi has any Step-In Activities, CMC activities, Manufacturing activities, or other activities under the Research Plan, Early Development Plan and Phase 2 Activities, Kymera hereby grants to Sanofi a non-exclusive, non-royalty bearing license, including the right to grant Sublicenses in accordance with Section 10.3, under the Licensed Technology to perform such Step-In Activities, CMC activities, Manufacturing activities, or other activities under the Research Plan, Early Development Plan or Phase 2 Activities, as applicable.

10.1.3 Subject to the terms of this Agreement, on a Collaboration Target-by-Collaboration Target basis, Kymera hereby grants to Sanofi (a) an exclusive license (even as to Kymera), including the right to grant Sublicenses in accordance with Section 10.3, under the Licensed Technology to Research, Develop and Manufacture Collaboration Compounds, Collaboration Candidates and Licensed Products Directed Against such Collaboration Target in the applicable Field in the Territory, and (b) an exclusive (even as to Kymera) royalty-bearing license under the Licensed Technology to Commercialize Licensed Products Directed Against such Collaboration Target in the applicable Field in the Territory (collectively, the “Exclusive Licenses”); [***], and (ii) such Exclusive Licenses are subject to immediate termination (and without any further action) as set forth in Section 4.4.

10.1.4 [***]

10.2 License Grant to Kymera. Subject to the terms and conditions of this Agreement, including Section 8.1, on a Collaboration Target-by-Collaboration Target basis during the Term, Sanofi hereby grants to Kymera a non-exclusive license under (i) the Sanofi Technology, and (ii) the Exclusive Licenses under Section 10.1.3, each including the right to grant Sublicenses in accordance with Section 10.3, solely to perform Kymera’s obligations under this Agreement. The foregoing license to Kymera and its Affiliates includes, on a Collaboration Target-by-Collaboration Target basis, a license to Kymera and its Affiliates to (a) perform activities under the Research Plan, Early Development Plan and Backup Research Plan for a given Collaboration Target, (b) if Kymera exercises the Kymera Co-Promote Right for a Collaboration Target, to perform Co-Promotion activities for Opt-In Products Directed Against such Collaboration Target in the applicable Field in the United States, and (c) perform Manufacturing activities for Collaboration Compounds, Collaboration Candidates and Licensed Products Directed Against such Collaboration Target as set forth in this Agreement.

10.3 Sublicensing.

10.3.1 By Sanofi.

(a) Sanofi may grant Sublicenses (through multiple tiers) to its Affiliates and Third Party Subcontractors (including CMOs) of any of the licenses granted to Sanofi in Section 10.1 without the prior consent of Kymera.

84


CONFIDENTIAL

 

(b) Subject to Section 10.3.1(c), Sanofi may grant Sublicenses (through multiple tiers) to [***].

(c) [***]. As used herein, “[***]” means [***].

10.3.2 By Kymera. Kymera may grant Sublicenses to its Affiliates and to Approved Third Party Contractors of any of the licenses granted to Kymera in Section 10.2 without the prior consent of Sanofi. In addition, Kymera may grant Sublicenses to additional Third Party contractors [***].

10.3.3 Generally.

(a) Except as expressly set forth in Section 10.3.1 or Section 10.3.2, prior to granting a Sublicense of the licenses granted in Sections 10.1 or 10.2, the sublicensing Party will obtain the prior written consent of the other Party. For clarity, Sanofi has no licenses or other rights with respect the Excluded Compounds except with as expressly provided in Section 10.1.4.

(b) Each such Sublicense will be consistent with, the terms of this Agreement and will require such Sublicensee to comply with all applicable terms of this Agreement. The sublicensing Party will, as soon as reasonably practicable thereafter (and in any event within [***]), provide the other Party with a copy of an executed Sublicense with a Third Party Sublicensee (which copy may be redacted to remove provisions which are not necessary to monitor compliance with this Section 10.3), provided that a Party will have no obligation to provide the other Party with any copy of any Subcontractor agreement. Each Sublicense will contain the following provisions: [***]. Notwithstanding any Sublicense, the Party that grants a Sublicense will remain liable to the other Party for the performance of the granting Party’s obligations hereunder, and will be responsible for all actions and omissions of each Sublicensee of such Party, as if such Sublicensee were such Party hereunder.

10.4 No Implied Licenses. Except as expressly provided in this Agreement, no Party will be deemed by estoppel, implication or otherwise to have granted the other Party any licenses or other right with respect to any intellectual property.

10.5 Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by a Party to the other are and will otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the Bankruptcy Code. The Parties agree that the Parties will retain and may fully exercise all of their rights and elections under the Bankruptcy Code and any foreign equivalent thereto. The Parties further agree that if (x) a bankruptcy proceeding by or against a Party (the “Bankrupt Party”) is commenced under the Bankruptcy Code, (y) this Agreement is rejected as provided in the Bankruptcy Code, and (z) the other Party (the “Non-Bankrupt Party”) elects to retain its rights hereunder as provided in Section 365(n) of the Bankruptcy Code, the Non-Bankrupt Party will be entitled to a complete duplicate of, and complete access to (as the Non-Bankrupt Party deems appropriate), all such intellectual property and all embodiments of such intellectual property. Upon such occurrence, such intellectual property and all embodiments of such intellectual property will be promptly delivered to the Non-Bankrupt Party. The Bankrupt Party

85


CONFIDENTIAL

 

(in any capacity, including debtor-in-possession) and its successors and assigns (including any trustee) agrees not to interfere with the exercise by the Non-Bankrupt Party of its rights and licenses to such intellectual property and such embodiments of intellectual property in accordance with this Agreement, and agrees to assist the Non-Bankrupt Party and its Affiliates in obtaining such intellectual property and such embodiments of intellectual property in the possession or control of Third Parties. The foregoing provisions are without prejudice to any rights the Non-Bankrupt Party may have arising under the Bankruptcy Code or other Applicable Law. As used herein, “Bankruptcy Code” means Title 11, United States Code, as from time to time in effect.

10.6 Exclusivity Covenants.

10.6.1 From and after the Original Agreement Effective Date and [***], on a Collaboration Target-by-Collaboration Target basis, except as expressly permitted under this Agreement, each Party and its Affiliates will not [***].

10.6.2 From and after the Original Agreement Effective Date and [***], for Collaboration Target 1, each Party and its Affiliates will not, itself or through any Affiliate or Third Party [***].

10.6.3 From and after the Original Agreement Effective Date and [***], for Collaboration Target 1 [***].

10.6.4 From and after the Original Agreement Effective Date and [***], with respect to Collaboration Target 1, Kymera and its Affiliates will [***].

10.6.5 The Parties hereby acknowledge and agree that neither Party’s obligations under this Section 10.6 will apply to any activities intended by such Party or any of its Affiliates to ensure its compliance with this Section 10.6 (e.g., using screening assays for compounds). In addition, notwithstanding the foregoing, the rights and licenses granted to the Counterparty pursuant to the Third Party Agreement, and the Counterparty’s practice of such rights and licenses, did not and will not constitute a breach of this Section 10.6.

10.7 Acquisition of Competing Product.

10.7.1 Notwithstanding the provisions of Section 10.6, if a Party or any of its Affiliates (such Party, the “Competing Party”) acquires rights to research, develop, manufacture, or commercialize a product in the applicable Field as the result of a merger, acquisition or combination with or of a Third Party other than a Change of Control of such Party (each, an “Acquisition Transaction”) and, on the date of the closing of such Acquisition Transaction, such product is being researched, developed, manufactured or commercialized and such activities would, but for the provisions of this Section 10.7, constitute a breach of Section 10.6 (such product, a “Competing Product”), the Competing Party or such Affiliate will, within [***] notify the other Party in writing of such acquisition and either:

(a) [***];

(b) [***]; or

86


CONFIDENTIAL

 

(c) [***].

10.7.2 During the discussion period under Section 10.7.1(a), prior to the time of divestiture pursuant to Section 10.7.1(b) or prior to the termination of activities pursuant to Section 10.7.1(c), as applicable, the Competing Party and its Affiliates will [***].

10.8 Change of Control.

10.8.1 Each Party will notify the other Party in writing promptly (and in any event within [***]) following the closing of a Change of Control of such Party (the Party subject to the Change of Control, the “Acquired Party”).

10.8.2 On a Collaboration Target-by-Collaboration Target basis, if, as of the closing of the Change of Control, the acquirer or its Affiliates (other than the Acquired Party and its Preexisting Affiliates) (the “Acquiring Parties”) possess rights to research, develop, manufacture, or commercialize a Competing Product Directed Against a given Collaboration Target in the applicable Field on the closing of the Change of Control transaction, [***].

10.8.3 If the Acquired Party is Kymera and the Acquiring Parties possess rights to research, develop, manufacture, or commercialize a Competing Product in the applicable Field as permitted pursuant to Section 10.8.2 as of the closing of the Change of Control transaction, then:

(a) [***]; and

(b) on a Collaboration Target-by-Collaboration Target basis, Sanofi may, in its sole discretion, within [***].

 

87


CONFIDENTIAL

 

Article 11
FINANCIAL PROVISIONS

11.1 Up-Front Fee. Under the Original Agreement, Sanofi paid Kymera a one-time, non-refundable, non-creditable, up-front fee of One Hundred Fifty Million Dollars ($150,000,000) that is not subject to set-off.

11.2 Milestone Payments.

11.2.1 Early Development Milestones. On a Collaboration Target-by-Collaboration Target basis, Sanofi will pay to Kymera the milestone payments (each an “Early Development Milestone Payment”) set forth in this Section 11.2.1 upon the [***] (each an “Early Development Milestone Event”) with respect to a Licensed Product Directed Against such Collaboration Target, as applicable, in each case, subject to reductions pursuant to Section 11.2.5.

Collaboration Target 1 – Early Development Milestones

Milestone Number

Early Development Milestone Event

Early Development Milestone Payment

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

 

Collaboration Target 2 – Early Development Milestones

Milestone Number

Early Development Milestone Event

Early Development Milestone Payment

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

On a Collaboration Target-by-Collaboration Target basis, each of the Early Development Milestone Payments [***]. Further, in no event will the Early Development Milestone Payments with respect to [***] exceed [***], will the Early Development Milestone Payments with respect to [***] exceed [***], nor will the total Early Development Milestone Payments exceed [***].

88


CONFIDENTIAL

 

11.2.2 Pre-POC Milestones. On a Collaboration Target-by-Collaboration Target basis, Sanofi will pay to Kymera the milestone payments (each a “Pre-POC Milestone Payment”) set forth in this Section 11.2.2 upon the [***] (each a “Pre-POC Milestone Event”) with respect to a Licensed Product Directed Against such Collaboration Target in each case, subject to reductions pursuant to Section 11.2.5. Each of the Pre-POC Milestone Payments for each Collaboration Target is payable [***], and no such Pre-POC Milestone Payment will be payable for [***]. Further, for the avoidance of doubt, with respect to [***], the Pre-POC Milestone Payments will be paid [***] under one of the following Sections 11.2.2(a)(i), 11.2.2(a)(ii) or 11.2.2(a)(iii) based on the nature of [***].

(a) Pre-POC Milestones for [***].

 

(i) If the first Clinical Trial for a Licensed Product [***] conducted after the Initiation of the Kymera Existing Phase 1 Clinical Trial (A) does not contain [***] and (B) is a [***], then the following Pre-POC Milestone Payments shall be paid.

Milestone Event

Pre-POC Milestone Event

Pre-POC Milestone Payment

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

 

(ii) If the first Clinical Trial for a Licensed Product [***] conducted after the Initiation of the Kymera Existing Phase 1 Clinical Trial (A) does contain [***] and (B) is a [***], then the following Pre-POC Milestone Payments shall be paid.

 

First person dosed in the first [***] that does contain [***]

(Column 1)

First person dosed in a second [***] that does contain [***]

(Column 2)

First person dosed in the first [***] that does not contain [***]

(Column 3)

[***]

(Row 1)

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

89


CONFIDENTIAL

 

(iii) If the [***] (A) does contain [***] and (B) is any type of [***], then the following Pre-POC Milestone Payments shall be paid.

Milestone Event

Pre-POC Milestone Event

Pre-POC Milestone Payment

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

 

(iv) The maximum payment for the Pre-POC Milestone Event 1 for [***] shall be: (a) [***] or (b) [***].

(v) In no event will the Pre-POC Milestone Payments associated with [***].

(b) Pre-POC Milestones for [***].

 

[***] – Pre-POC Milestones

Milestone Number

Pre-POC Milestone Event

Pre-POC Milestone Payment

[***]

[***]

[***]

 

(i) In no event will the Pre-POC Milestone Payments with respect to [***] exceed [***], nor will the [***].

(c) Additional Provisions.

(i) For [***]. By way of example, [***]. As an alternative example, [***].

(ii) For the avoidance of doubt, (I) [***].

(iii) [***].

11.2.3 Post-POC Milestones. On a Collaboration Target-by-Collaboration Target basis, to the extent indicated below, on a Licensed Product-by-Licensed Product basis, Sanofi will pay to Kymera the milestone payments (each a “Post-POC Milestone Payment”, and together with the Early Development Milestone Payments and the Pre-POC Milestone Payments, the “Development Milestone Payments”) set forth in this Section 11.2.3 upon the [***] (each a “Post-POC Milestone Event”, and together with the Early Development Milestone Events and the Pre-POC Milestone Events, the “Development

90


CONFIDENTIAL

 

Milestone Events”) with respect to a Licensed Product Directed Against each Collaboration Target, in each case, subject to reductions forth in this Section 11.2.3 or Section 11.2.5.

Collaboration Target 1 – Post-POC Milestones

Milestone Number

Post-POC Milestone Event

Column A: [***]

Column B: [***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]