EX-10.1


   

  EXHIBIT 10.1

   

  FIFTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT

   

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

  “Fifth Amendment”) is made and entered into as of August 31, 2021 (the “Fifth 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, and June 23, 2021 (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 Amendment, and intending to be legally bound, the Parties hereby agree as follows:

   

  1.Interpretation. Capitalized terms not defined in this Fifth 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)November 30, 2021, 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)November 30, 2021, 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 terms for the commercial-grade supply of such Licensed Product by Sarepta to Roche in 


   

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  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 Fifth 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 Fifth Amendment. To the extent a conflict arises between the terms of the Original Agreement and this Fifth Amendment, the terms of this Fifth 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 Fifth 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 Fifth Amendment Effective Date, each Party hereby represents and warrants that


  (a) it has the power and authority to execute and deliver this Fifth Amendment, (b) the execution, delivery, and performance of this Fifth Amendment by it has been duly authorized by all requisite corporate action, and (c) this Fifth 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 Fifth 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 Fifth Amendment may not be modified or amended, except by another agreement in writing executed by duly authorized signatories of each Party.


   

  9.Counterparts. This Fifth 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 Fifth 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 Fifth Amendment.


   

  [Signatures Follow]

   

   

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  IN WITNESS WHEREOF, the Parties have executed this Fifth 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/ Barbara Schroeder de Castro Lopes
Name: Barbara Schroeder de Castro Lopes
Title: Authorized Signatory

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

   

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

   

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