Document:

EX-10.63

   

  DocuSign Envelope ID: EA350C36-E900-4606-87D9-B0A4B2C2E752

  Roche Draft 1/6/2021

  Exhibit 10.63

   

  SEVENTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT

   

  This SEVENTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT

  (this “Seventh Amendment”) is made and entered into as of January 5, 2022 (the “Seventh Amendment Effective Date”) between Sarepta Therapeutics Three LLC, a limited liability company organized and existing under the laws of the State of Delaware, United States of America, with its principal offices at 215 First Street, Cambridge, MA, 02142 (“Sarepta”) and F. Hoffmann-La Roche Ltd, a company organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, 4070 Basel, Switzerland (“Roche”). Sarepta and Roche may be referred to herein individually as a “Party” and collectively as the “Parties.”

   

  WHEREAS, Sarepta and Roche entered into that certain License, Collaboration, and Option Agreement

  dated December 21, 2019 (the “Original Agreement”); and

   

  WHEREAS, the Parties desire to make certain amendments to the Original Agreement;

   

  NOW, THEREFORE, in consideration of the promises and covenants contained in this Amendment, and intending to be legally bound, the Parties hereby agree as follows:

   

  1.Interpretation. Capitalized terms not defined in this Seventh Amendment have the meanings given such terms in the Original Agreement. References to Sections and Schedules herein will be to Sections and Schedules of the Original Agreement, except as otherwise noted.

   

  2.Amendments.

   

  Section 4.1 is hereby deleted in its entirety and replaced with the following:

   

  As between the Parties and in accordance with this Agreement, (a) Sarepta will be the Party that performs all Development activities set forth in the Joint Global Development Plan for the Licensed Products and all Development activities for all Option Products worldwide, unless agreed otherwise by the Parties and (b) Roche will be the Party that performs all Development activities set forth in the Roche Territory Development Plan for the Licensed Products. Each Party will conduct all Development activities for which it is responsible under this Agreement in a good scientific manner, in accordance with GLP and GCP, as applicable, and in compliance with Professional Requirements and Applicable Law.

   

  3.Effect on Original Agreement. Except as specifically amended by this Amendment, the Original Agreement will remain in full force and effect and is hereby ratified and confirmed. Each future reference to the Original Agreement will refer to the Original Agreement as amended by this Amendment. To the extent a conflict arises between the terms of the Original Agreement and this Amendment, the terms of this Amendment shall prevail but only to the extent necessary to accomplish their intended purpose.

   

  4.Incorporation. Article 17 of the Original Agreement is hereby incorporated mutatis mutandis into this Amendment.

   

  5.Binding Effect. This Seventh Amendment will be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns.

   

   

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  87006015_2

  

   

  DocuSign Envelope ID: EA350C36-E900-4606-87D9-B0A4B2C2E752

  Roche Draft 1/6/2021

   

   

  6.Authority. As of the Seventh Amendment Effective Date, each Party hereby represents and warrants that (a) it has the power and authority to execute and deliver this Seventh Amendment, (b) the execution, delivery, and performance of this Seventh Amendment by it has been duly authorized by all requisite corporate action, and (c) this Seventh Amendment has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, and binding obligation of such Party and is enforceable against it in accordance with its terms.

   

  7.Governing Law. This Seventh Amendment and all amendments, modifications, alterations, or supplements hereto, and the rights of the Parties, will be construed under and governed by the laws of the State of New York, United States, exclusive of its conflicts of laws principles.

   

  8.Amendments. This Seventh Amendment may not be modified or amended, except by another agreement in writing executed by duly authorized signatories of each Party.

   

  9.Counterparts. This Seventh Amendment may be executed in two or more counterparts, all of which taken together will be regarded as one and the same instrument. Each Party may execute this Seventh Amendment in AdobeTM Portable Document Format (PDF) sent by electronic mail.  PDF signatures of authorized signatories of the Parties will be deemed to be original signatures, will be valid and binding upon the Parties, and, upon delivery, will constitute due execution of this Seventh Amendment.

   

  [Signatures Follow]

   

   

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  87006015_2

  

   

  DocuSign Envelope ID: EA350C36-E900-4606-87D9-B0A4B2C2E752

   

   

  IN WITNESS WHEREOF, the Parties have executed this Seventh Amendment to License, Collaboration, and Option Agreement through their duly authorized representatives.

   

    

    

  		
	Sarepta Therapeutics Three, LLC
  
	  

	By: /s/ Adam Hopkin
	  

	Name: Adam Hopkin
	  

	Title: Manager
	  

	  
	  

	F. Hoffmann-La Roche Ltd
  
	  

	By: /s/ Claire Steers
	  

	Name: Claire Steers
	  

	Title: Global Alliance Director
  
	  

	By: /s/ Franziska Baechler
	  

	Name: Franziska Baechler
	  

	Title: Attorney-at-Law
	  

   

   

  [Signature Page To Seventh Amendment To License, Collaboration, and Option Agreement]EX-10.64

   

  DocuSign Envelope ID: 118F1C3C-AB1A-4635-B0F9-E8EBF3E1D40D

   

   

  Exhibit 10.64

   

  EIGHTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT

   

  This EIGHTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT (this

  “Eighth Amendment”) is made and entered into as of January 28, 2022 (the “Eighth Amendment Effective Date”) between Sarepta Therapeutics Three LLC, a limited liability company organized and existing under the laws of the State of Delaware, United States of America, with its principal offices at 215 First Street, Cambridge, MA, 02142 (“Sarepta”) and F. Hoffmann-La Roche Ltd, a company organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, 4070 Basel, Switzerland (“Roche”). Sarepta and Roche may be referred to herein individually as a “Party” and collectively as the “Parties.”

   

  WHEREAS, Sarepta and Roche entered into that certain License, Collaboration, and Option Agreement executed on December 21, 2019 and effective as of February 4, 2020 and amended October 23, 2020,

  October 28, 2020, February 4, 2021, June 23, 2021, August 31, 2021, November 30, 2021, and January 5, 2022 (the “Original Agreement”); and

   

  WHEREAS, the Parties desire to make certain further amendments to the Original Agreement;

   

  NOW, THEREFORE, in consideration of the promises and covenants contained in this Eighth Amendment, and intending to be legally bound, the Parties hereby agree as follows:

   

  1.Interpretation. Capitalized terms not defined in this Eighth Amendment have the meanings given such terms in the Original Agreement. References to Sections and Schedules herein will be to Sections and Schedules of the Original Agreement, except as otherwise noted.

   

  2.Amendments.

   

  a.Section 8.6.1 shall be deleted and replaced by the following:

   

  Development Supply Agreement.  Unless otherwise agreed by the Parties, no later than

  (a)March 31, 2022, with regards to the Lead Product, and (b) no later than nine months following the effective date of exercise of the Option with regards to every other Licensed Product to which this Article 8 (Manufacturing and Supply) applies in accordance with Section 8.1, (or such other time as agreed by each Party), the Parties will negotiate in good faith and enter into a supply agreement on reasonable and customary terms for the supply of such Licensed Product by Sarepta to Roche in the Roche Territory at the Supply Price (the “Development Supply Agreement”), and a related quality agreement, which agreements will govern the terms and conditions of the Manufacturing of such Licensed Product for Development purposes. The Parties may choose to combine into a single agreement the Development Supply Agreement and the Commercial Supply Agreement for a Licensed Product.

   

  b.Section 8.6.2 shall be deleted and replaced by the following:

   

  Commercial Supply Agreement.  Unless otherwise agreed by the Parties, no later   than

  (a)March 31, 2022, with regards to the Lead Product, and (b) no later than twelve (12) months following the effective date of the Option Exercise with regards to every other Licensed Product to which this Article 8 (Manufacturing and Supply) applies in accordance with Section 8.1, (or such other time as agreed by each Party), the Parties will negotiate in good faith and enter into a commercial supply agreement on reasonable and customary 

   

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  DocuSign Envelope ID: 118F1C3C-AB1A-4635-B0F9-E8EBF3E1D40D

  terms for the commercial-grade supply of such Licensed Product by Sarepta to

   

   

  Roche in the Roche Territory at the Supply Price (the “Commercial Supply Agreement” and together with the Development Supply Agreement, the “Supply Agreements”), and a related quality agreement, which agreements will govern the terms and conditions of the Manufacturing and supply of such Licensed Product for Commercialization purposes. As noted above, the Parties may choose to combine into a single agreement the Development Supply Agreement and the Commercial Supply Agreement for a Licensed Product,

  3.Effect on Original Agreement. Except as specifically amended by this Eighth Amendment, the Original Agreement will remain in full force and effect and is hereby ratified and confirmed. Each future reference to the Original Agreement will refer to the Original Agreement as amended by this Eighth Amendment. To the extent a conflict arises between the terms of the Original Agreement and this Eighth Amendment, the terms of this Eighth Amendment shall prevail but only to the extent necessary to accomplish their intended purpose.

   

  4.Incorporation. Article 17 of the Original Agreement is hereby incorporated mutatis mutandis into this Amendment.

   

  5.Binding Effect. This Eighth Amendment will be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns.

   

  6.Authority. As of the Eighth Amendment Effective Date, each Party hereby represents and warrants that

  (a) it has the power and authority to execute and deliver this Eighth Amendment, (b) the execution, delivery, and performance of this Eighth Amendment by it has been duly authorized by all requisite corporate action, and (c) this Eighth Amendment has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, and binding obligation of such Party and is enforceable against it in accordance with its terms.

   

  7.Governing Law. This Eighth Amendment and all amendments, modifications, alterations, or supplements hereto, and the rights of the Parties, will be construed under and governed by the laws of the State of New York, United States, exclusive of its conflicts of laws principles.

   

  8.Amendments. This Eighth Amendment may not be modified or amended, except by another agreement in writing executed by duly authorized signatories of each Party.

   

  9.Counterparts. This Eighth Amendment may be executed in two or more counterparts, all of which taken together will be regarded as one and the same instrument. Each Party may execute this Eighth Amendment in AdobeTM Portable Document Format (PDF) sent by electronic mail. PDF signatures of authorized signatories of the Parties will be deemed to be original signatures, will be valid and binding upon the Parties, and, upon delivery, will constitute due execution of this Eighth Amendment.

   

  [Signatures Follow]

   

   

  2

  

   

  DocuSign Envelope ID: 118F1C3C-AB1A-4635-B0F9-E8EBF3E1D40D

   

   

  IN WITNESS WHEREOF, the Parties have executed this Eighth Amendment to License, Collaboration, and Option Agreement through their duly authorized representatives.

   

  	
	Sarepta Therapeutics Three, LLC
  

	By: /s/ Adam Hopkin

	Name: Adam Hopkin

	Title: Manager

	  

	F. Hoffmann-La Roche Ltd
  

	By: /s/ Claire Steers

	Name: Claire Steers

	Title: Global Alliance Director
  

	By: /s/ Franziska Baechler

	Name: Franziska Baechler

	Title: Attorney-at-Law

   

   

   

   

  [Signature Page To Eighth Amendment To License, Collaboration, and Option Agreement]

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