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 000 Xxxxx Xxxxxx, Xxxxxxxxx, XX, 00000 (“Sarepta”) and X. Xxxxxxxx-Xx Xxxxx Ltd, a company organized and existing under the laws of Switzerland, with its principal office at Xxxxxxxxxxxxxxxxx 000, 0000 Xxxxx, Xxxxxxxxxxx (“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.
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 Adobe™ 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]
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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.
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Sarepta Therapeutics Three, LLC |
By: /s/ Xxxx Xxxxxx |
Name: Xxxx Xxxxxx |
Title: Manager |
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X. Xxxxxxxx-Xx Xxxxx Ltd |
By: /s/ Xxxxxx Xxxxxx |
Name: Xxxxxx Xxxxxx |
Title: Global Alliance Director |
By: /s/ Xxxxxxxxx Xxxxxxxx |
Name: Xxxxxxxxx Xxxxxxxx |
Title: Attorney-at-Law |
[Signature Page To Eighth Amendment To License, Collaboration, and Option Agreement]
