Termination Agreement, by and between the Registrant and Aventis, Inc. dated July 17, 2019

EX-10.1 2 myok-ex101_145.htm EX-10.1 myok-ex101_145.htm

Execution Version

Exhibit 10.1

TERMINATION AGREEMENT

This TERMINATION AGREEMENT (“Agreement”) dated as of JULY 17,2019 (the “Effective Date”), is made and entered into by and between MYOKARDIA, INC., a Delaware corporation having an address at 333 Allerton Avenue, South San Francisco, CA 94080, (“MyoKardia”) and AVENTIS, INC., a Pennsylvania corporation (“Sanofi”).

WITNESSETH:

WHEREAS, MyoKardia and Sanofi have been parties to a License and Collaboration Agreement of August 1,2014 (the “Collaboration Agreement”) which has been terminated by Sanofi pursuant to a termination notice dated December 31,2018, with termination of the entire Collaboration Agreement being effective on April 1,2019 (the “Collaboration Agreement Termination Date”); and

WHEREAS, in connection with such termination, the Parties desire to clarify or amend certain rights and obligations of the parties surviving termination of the Collaboration Agreement, on the terms and conditions set forth in this Agreement.

NOW THEREFORE, in consideration of the representations, warranties, covenants and agreements set forth herein and for good and valuable consideration, the adequacy of which is hereby acknowledged, Sanofi and MyoKardia hereby agree as follows:

ARTICLE 1
LICENSE TO MYOKARDIA

Section 1.1Sanofi Licensed Technology: Technology Transfer. Upon the terms and subject to the conditions of this Agreement, in amendment to Section 12.3(b)(i) and 12.3(b)(ii) of the Collaboration Agreement, Sanofi hereby grants to MyoKardia an exclusive, worldwide, fully paid-up and royalty-free, perpetual and irrevocable license with the right to grant sublicenses under the Sanofi Licensed Technology to Develop, Commercialize and Manufacture the Products in the Field. Sanofi shall transfer to MyoKardia the information, data and know-how pertaining to Sanofi’s activities in relation to the Programs and the development and manufacturing of Program Compounds (the “Sanofi Licensed Technology”), including the information, data and know-how as listed in Schedule 1.1 attached hereto, in electronic format. Any additional technology transfer activities will be further memorialized into a detailed technology transfer plan developed and approved by both MyoKardia and Sanofi. The Parties agree to complete all technology transfer activities by December 31, 2019.

Section 1.2Sanofi Retained Rights. Any rights not expressly granted to MyoKardia under the provisions of this Agreement shall be retained by Sanofi. Without limiting the foregoing, Sanofi retains the right to use the Sanofi Licensed Technology to research, have researched, develop, have developed, make, have made, use, have used, sell, offer for sale, have

 

 

1

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

sold, imported and have imported, for any and all purposes, both alone and together with any Third Party, any product that is not a Product.

Section 1.3Termination of Non-Compete Restrictions. The Parties hereby agree that the non-compete restrictions on the Parties pursuant to Section 3.7 of the Collaboration Agreement are hereby terminated as of December 31, 2018 with respect to the DCM1 MOA and HCM2 MOA and, as of the Collaboration Agreement Termination Effective Date, with respect to the HCM1 MOA.

ARTICLE 2
PAID-UP LICENSE FEE & OTHER PAYMENTS BY MYOKARDIA

Section 2.1Paid-Up License Fee. In consideration of Sanofi releasing MyoKardia from its royalty payment obligations on Net Sales of HCM1 Products set forth in Section 9.6(c) of the Collaboration Agreement, MyoKardia shall pay to Sanofi a non-refundable and non-creditable, amount of Eighty Millions US Dollars ($80,000,000.00) net of any broker’s, financial advisor’s or other similar fees or commissions (the “Paid-Up License Fee”) in accordance with Section 2.2 and Section 2.5 of this Agreement.

Section 2.2Payment of Paid-Up License Fee.

(a)Initial Payment. Within five (5) days of the Effective Date hereof, MyoKardia shall pay an amount equal to the Paid-Up License Fee, less Thirty Million US Dollars ($30,000,000) to Sanofi by wire transfer of immediately available United States funds on the bank account designated below

 

Important / Note in wire: For Credit to Aventis Inc.

(b)Balance Payment: Escrow.

 

 

2

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

(c)Failure to Make Initial Payment and Deposit Escrow Amount. MyoKardia’s failure to make the Initial Payment and deposit the Escrow Amount in accordance with Sections 2.2(a) and 2.2(b) respectively, shall grant Sanofi the right to (i) terminate the Parties’ rights and obligations set forth in Article 2 of this Agreement upon written notice to MyoKardia with immediate effect (it being understood that upon such termination, MyoKardia’s royalty payments obligations under section 9.6(c) of the Collaboration Agreement shall be reinstated and (ii) assign, convey, transfer or encumber all or any portion of its ownership rights to the royalty payments to be made by MyoKardia to Sanofi as set forth in Section 9.6 of the Collaboration Agreement.

Section 2.3DCM1 Raw Material Inventory; Drug Substance Batches. Within five (5) days of the Effective Date, MyoKardia shall pay to Sanofi a total and non-refundable amount of [***], for the sale by Sanofi to MyoKardia of DCM1(MYK-491) raw material drug substance and intermediates batches described, and meeting the specifications detailed, in Schedule 2.3 hereto. Such sale by Sanofi and purchase by MyoKardia shall be made EXW, Location of Inventory (Incoterms 2010) as further defined in such schedule, unless otherwise agreed in writing by the Parties.

Section 2.4Reimbursement of Other Pre-Clinical Expenses. Within five (5) days of the Effective Date, MyoKardia shall pay to Sanofi a total and non-refundable amount of [***] in reimbursement of the 2019 costs and expenses incurred by Sanofi in connection with the DCM1 Program pre-clinical activities listed in Schedule 2.4 hereto.

Section 2.5Wire Instructions: Interest on Late Payments.

(a)MyoKardia shall provide Sanofi with a copy of wire instructions documenting payment of the various amounts payable to Sanofi hereunder.

(b)In the event Sanofi does not receive payment of any sum due to it on or before the due date therefor, then MyoKardia shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of three hundred (300) basis points above the London Interbank Offered Rate for deposits in Dollars having a maturity of one (1)

 

 

3

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

month published by the British Bankers’ Association, as adjusted from time to time on the first London business day of each month, such interest to run from the date on which payment of such sum became due until payment thereof in full together with such interest.

ARTICLE 3
CONTINUED DEVELOPMENT & MANUFACTURING ACTIVITIES

Section 3.1Continued Development And Manufacturing Activities. At the request of MyoKardia, Sanofi or any of its Affiliates will perform the development and manufacturing services further detailed in Schedule 3.1 (the “Services”), at MyoKardia’s costs in accordance with Section 12.3(g)(v) of the Collaboration Agreement. The Services by Sanofi and its Affiliates shall be memorialized by appropriate work order and performed in accordance with all applicable laws and regulations (including cGMP where applicable), and the provisions of (i) the Quality Agreement ref. QA_MYO-SANOFI_V2.0 with an effective date of 04 May 2017 (ii) the terms and conditions described in Schedule 3.1 and (iii) the Technical Conditions Agreement ref. MP-TC-204 with effective date 09- Aug-2018. For clarity, the parties agree that the applicable provisions of the Collaboration Agreement specified in Schedule 3.1 shall survive termination of the Collaboration Agreement and apply to the performance of the Services.

ARTICLE 4
NO WARRANTIES

IT IS HEREBY ACKNOWLEDGED BY MYOKARDIA THAT EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT OR PURSUANT TO ARTICLE 3 ABOVE, ANY MATERIAL, RECORD AND INFORMATION PROVIDED BY SANOFI UNDER THE COLLABORATION AGREEMENT AND HEREUNDER ARE SUPPLIED “AS IS” AND SANOFI MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

ARTICLE 5
REPRESENTATIONS AND WARRANTIES

Section 5.1MyoKardia’s Representations and Warranties. MyoKardia represents and warrants to Sanofi that as of the date hereof:

(a)Existence; Good Standing. MyoKardia is a Delaware corporation duly organized, validly existing and in good standing under the laws of the State of Delaware.

(b)Authorization. MyoKardia has the requisite right, power and authority to execute, deliver and perform its obligations under this Agreement. The execution, delivery and performance of this Agreement, and the consummation of the transactions contemplated hereby, have been duly authorized by all necessary action on the part of MyoKardia.

 

 

4

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

(c)Enforceability. This Agreement has been duly executed and delivered by an authorized signatory of MyoKardia and constitutes the valid and binding obligation of MyoKardia, enforceable against MyoKardia in accordance with its terms.

(d)No Conflicts. The execution, delivery and performance by MyoKardia of this Agreement do not (i) contravene or conflict with the organizational documents of MyoKardia, (ii) contravene or conflict with or constitute a default under any material provision of any law binding upon or applicable to MyoKardia or (iii) contravene or conflict with or constitute a default under any material contract or other material agreement or Judgment binding upon or applicable to MyoKardia.

(e)Consents. No consent, approval, license, order, authorization, registration, declaration or filing with or of any Governmental Entity or other Person is required to be done or obtained by MyoKardia in connection with (i) the execution and delivery by MyoKardia of this Agreement, (ii) the performance by MyoKardia of its obligations under this Agreement, or (iii) the consummation by MyoKardia of any of the transactions contemplated by this Agreement.

(f)Payments. MyoKardia has sufficient cash to satisfy its payment obligations hereunder as such obligations become due in accordance with this Agreement. MyoKardia acknowledges that its obligations under this Agreement are not contingent on obtaining financing.

(g)No Reliance. MyoKardia has undertaken such investigation and has evaluated such documents and information as it has deemed necessary to enable it to make an informed and intelligent decision with respect to the execution, delivery and performance of this Agreement. MyoKardia acknowledges that none of Sanofi or any of its Affiliate or representatives makes any representation or warranty with respect to any other information or documents made available to MyoKardia or its representatives with respect to the Products.

Section 5.2Sanofi’s Representations and Warranties. Sanofi represents and warrants to MyoKardia that as of the date hereof:

(a)Existence; Good Standing. Sanofi is a Pennsylvania corporation duly incorporated, validly existing and in good standing under the laws of the State of Pennsylvania.

(b)Authorization. Sanofi has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement. The execution, delivery and performance of this Agreement, and the consummation of the transactions contemplated hereby, have been duly authorized by all necessary corporate action on the part of Sanofi.

(c)Enforceability. This Agreement has been duly executed and delivered by an authorized managing director or officer of Sanofi and constitutes the valid and binding obligation of Sanofi, enforceable against Sanofi in accordance with its terms.

 

 

5

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

(d)No Conflicts. The execution, delivery and performance by Sanofi of this Agreement do not (i) contravene or conflict with the organizational documents of Sanofi, (ii) contravene or conflict with or constitute a default under any material provision of any law binding upon or applicable to Sanofi or (iii) contravene or conflict with or constitute a default under any material contract or other material agreement or Judgment binding upon or applicable to Sanofi.

(e)Consents. No consent, approval, license, order, authorization, registration, declaration or filing with or of any Governmental Entity or other Person is required to be done or obtained by Sanofi in connection with (i) the execution and delivery by Sanofi of this Agreement, (ii) the performance by Sanofi of its obligations under this Agreement, or (iii) the consummation by Sanofi of any of the transactions contemplated by this Agreement.

(f)No Prior Transfer. Sanofi has not assigned and has not in any way conveyed, transferred or encumbered all or any portion of its ownership rights to the royalty payments to be made by MyoKardia to Sanofi as set forth in Section 9.6 of the Collaboration Agreement.

ARTICLE 6
INDEMNIFICATION

Section 6.1Indemnification by Sanofi. Sanofi shall indemnify, defend and hold harmless MyoKardia, its Affiliates and their respective officers, directors, agents and employees from and against any Third Party Claims and Losses arising therefrom under or related to this Agreement against any of them to the extent resulting from Sanofi’s breach of this Agreement.

Section 6.2Indemnification by MyoKardia. MyoKardia shall indemnify, defend and hold harmless Sanofi, its Affiliates and their respective officers, directors, agents and employees from and against any Third Party Claims and Losses arising therefrom under or related to this Agreement against any of them to the extent resulting from MyoKardia’s breach of this Agreement.

Section 6.3Indemnification Procedure. The terms and conditions of Section 14.3 of the Collaboration Agreement shall govern all indemnification claims pursuant to this Article 6 and are incorporated herein by reference.

ARTICLE 7
MISCELLANEOUS

Section 7.1Entire Agreement: Survival. The Parties hereby confirm and agree that, except as amended hereby, the provisions of the Collaboration Agreement surviving termination remain in full force and effect and are binding obligations of the Parties hereto. This Agreement and applicable sections/definitions of the Collaboration Agreement, as may be amended hereby, are the entire agreements with respect to the subject matter thereof and supersedes all other

 

 

6

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

agreements and understandings between the Parties with respect to such subject matter. If any provision of this Agreement is or becomes invalid or is ruled invalid by any court of competent jurisdiction or is deemed unenforceable, it is the intention of the Parties that the remainder of this Agreement shall not be affected. Unless explicitly stated, in the event of conflict between this Agreement and the Collaboration Agreement, the Collaboration Agreement shall control. Unless otherwise defined herein, all capitalized terms shall have the meaning set forth in the Collaboration Agreement.

Section 7.2Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as necessary or appropriate in order to carry out the purposes and intent of this Agreement.

Section 7.3Counterparts. This Agreement may be executed in two or more counterparts by original signature, facsimile or PDF files, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

[Remainder of Page Intentionally Left Blank]

 

IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

AVENTIS INC.

/s/ Chan H. Lee
Name: Chan H. Lee
Title: Vice President

MYOKARDIA INC.

/s/ Taylor C. Harris
Name: Taylor C. Harris
Title: CFO

 

 

7

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

 

 

 

 

8

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

Schedule 1.1

Sanofi Licensed Technology

 

 

9

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

 

 

10

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

 

 

 

 

 

11

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

Schedule 2.2

Form of Escrow Agreement

 

 

 

 

12

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

[***]

 

 

13

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

Schedule 2.3

DCM1 Raw Material; Drug Substance Batches

(attached)

 

 

 

 

14

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

 

 

 

 

 

15

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

Schedule 2.4

Sanofi 2019 Pre-Clinical Costs and Expenses

 

 

 

 

 

16

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

Schedule 3.1

Continued Development and Manufacturing Services

Stability Studies

 

Packaging and Labeling Activities

 

Governing Terms and Conditions

(attached)

 

 

 

 

17

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

Schedule 3.1

Development and Manufacturing Services

Governing Terms and Conditions

Definitions.

Unless this Schedule 3.1 expressly provides to the contrary, the terms below, whether used in the singular or plural, have the respective meanings set forth below.

Capitalized terms used in this and not defined in this Schedule 3.1 have the meaning ascribed to them in the Collaboration Agreement. Except as expressly set forth in this Schedule 3.1, any section or Article of the Collaboration Agreement is incorporated into this Schedule 3.1 by reference, then (a) all references in such section or Article to this Agreement are deemed to mean this Schedule 3.1, (b) all references in such section or Article to Effective Date are deemed to mean the Effective Date of this Schedule 3.1; and (c) the word hereunder in such section or Article is deemed to mean hereunder this Schedule 3.1. As used in this attachment,

“Applicable Law” has the meaning ascribed to such term in Section 1.12 of the Collaboration Agreement; provided, however, for purpose of this Schedule 3.1, it also includes cGMP, if applicable.

“Batch” means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch record.

“Batch Documentation” has the meaning set forth below.

“Certificate of Analysis” means a document signed by an authorized representative of Sanofi or one of its Affiliates, describing Specifications for, and testing methods applied to Product, and the results of testing.

“Certificate of Compliance” means a document signed by an authorized representative of Sanofi or one of its Affiliates, certifying that a particular Batch was Manufactured in accordance with Applicable Law, the Quality Agreement and the Specifications.

“cGMP” means current good manufacturing practices and regulations applicable to the Manufacture of Product that are promulgated by any Authority.

“Change Order” has the meaning set forth in Section 1.3.

 

 

18

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

“Confidential Information” has the meaning ascribed to such term in Section 1.31 of the Collaboration Agreement and includes, for clarity, the terms of this Schedule 3.1, and the content of the discussions between the Parties in the negotiation of this Schedule 3.1, including any proposed and/or executed Statements) of Work, and all information and data generated in the performance of the Services.

“Develop” or “Development” has the meaning ascribed to such term in Section 1.46 of the Collaboration Agreement.

“Facility” means the facility(ies) of Sanofi or one of its Affiliates as set forth in the applicable Statement of Work.

“Manufacture” or “Manufacturing” has the meaning ascribed to such term in Section 1.116 of the Collaboration Agreement.

“Services” means the Development, Manufacturing and/or other services described in a Statement of Work entered into MyoKardia and Sanofi or one of its Affiliates.

“Specifications” means the list of tests, references to any analytical procedures and appropriate acceptance criteria which are numerical limits, ranges or other criteria for tests described in order to establish a set of criteria to which Product at any stage of Manufacture should conform to be considered acceptable for its intended use that are agreed to in writing by the Parties, as such specifications are amended or supplemented from time to time by MyoKardia and Sanofi or one of its Affiliates in writing.

“Statement of Work” means a written Statement of Work referencing this Schedule 3.1, substantially in the form attached hereto as Appendix A, for the performance of Services by Sanofi or one of its Affiliates under this Schedule 3.1.

“Technical Protocol” means the technical document agreed by the Parties, and incorporated into the applicable Statement of Work, before the start of Service(s) describing the manufacturing processes to be performed by Sanofi, related time frame, testing and control procedures/in-process controls, and the agreed Specifications.

1.Statement of Work and Performance of Services.

 

 

19

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

 

 

20

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

(i)Sanofi or one of its Affiliates will keep complete and accurate records (including, but not limited to Batch Documentation, development campaign reports, reports for process development, formulation development and analytical development activities, as well as analytical method and process validation, protocols, Certificate of Compliance, validated reports, accounts, notes, raw data, and all information and results obtained from the performance of the Services and all other mandatory documents required for filing purposes) of all work done by it under this Schedule 3.1, in form and substance as specified in the applicable Statement of Work, the applicable Quality Agreement, and this Schedule 3.1 (collectively, the “Records”).

(ii)Records will be transferred by Sanofi or one of its Affiliates to MyoKardia. It is understood between the Parties that promptly upon request by MyoKardia, raw data will be transferred by Sanofi or one of its Affiliates to MyoKardia to the extent necessary for regulatory purposes (especially in case of specific requirements from Authorities) or for MyoKardia to fulfill its obligations under cGMP and/or Applicable Law. Sanofi or one of its Affiliates will cooperate in good faith with MyoKardia in the carrying out by MyoKardia of regulatory activities. Sanofi or one of its Affiliates will not transfer, deliver or otherwise provide any such Records to any party other than MyoKardia, without the prior written approval of MyoKardia.

(iii)Records will be available at reasonable times for inspection, examination and copying by or on behalf of MyoKardia. All original Records of the Development and Manufacturing of Product under this Schedule 3.1 will be retained and archived by Sanofi or one of its Affiliates in accordance with the Collaboration Agreement.

2.Testing and Acceptance Process.

 

 

21

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

 

 

22

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

3Compensation for the Services

4.Confidential Information; Use of Names

 

 

23

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

5.Indemnification; Liability; Insurance

NOTHING IN THIS SECTION IS INTENDED TO LIMIT OR SHALL LIMIT (I) THE LIABILITY OF EITHER PARTY FOR DEATH OR PERSONAL INJURY CAUSED BY THE OTHER PARTY, ITS AFFILIATES OR THEIR RESPECTIVE EMPLOYEES, REPRESENTATIVES OR AGENTS IN THE PERFORMANCE OF THEIR OBLIGATIONS UNDER THIS SCHEDULE 3.1 OR ANY STATEMENT OF WORK, (II) THE FRAUD OR FRAUDULENT MISREPRESENTATION BY A PARTY OR ANY OF ITS AFFILIATES OR BY THEIR RESPECTIVE EMPLOYEES, REPRESENTATIVES OR AGENTS IN THE PERFORMANCE OF THEIR OBLIGATIONS UNDER THIS SCHEDULE 3.1: OR (III) ANY MATTER FOR WHICH IT WOULD BE ILLEGAL TO EXCLUDE OR LIMIT THE LIABILITY OF A PARTY PURSUANT TO APPLICABLE REGULATIONS.

IT IS EXPRESSLY AGREED THAT SANOFI’s LIABILITY UNDER EACH STATEMENT OF WORK TOWARDS MYOKARDIA FOR ANY MYOKARDIA MATERIAL LOSS SHALL NOT EXCEED FORTY (40)% OF THE PRICE PAID BY MYOKARDIA TO PURCHASE SUCH MYOKARDIA MATERIAL.

IN ALL CASES, THE MAXIMUM AGGREGATED SANOFI’ LIABILITY TOWARDS MYOKARDIA UNDER THIS SCHEDULE 3.1 SHALL NOT EXCEED FIVE HUNDRED THOUSAND EUROS (500.000 €).

 

 

24

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.

  

 

 

---

Execution Version

Exhibit 10.1

6.Term, Termination and Effects of Termination.

 

 

 

25

[***] Certain information in this exhibit has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.