NINTH Amendment to License, Collaboration, and Option Agreement
EXHIBIT 10.2
NINTH Amendment to License, Collaboration, and Option Agreement
This NINTH AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT (this “Ninth Amendment”) is made and entered into as of March 23, 2022 (the “Ninth 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, January 5, 2022, and January 28, 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 Ninth Amendment, and intending to be legally bound, the Parties hereby agree as follows:
Development Supply Agreement. Unless otherwise agreed by the Parties, no later than (a) May 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) May 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
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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 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,
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[Signatures Follow]
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IN WITNESS WHEREOF, the Parties have executed this Ninth Amendment to License, Collaboration, and Option Agreement through their duly authorized representatives.
Sarepta Therapeutics Three, LLC
By: /s/ Xxxx Xxxxxx
Name: Xxxx Xxxxxx
Title: Manager
X. Xxxxxxxx-Xx Xxxxx Ltd
By: /s/ Xxxxxx Xxxxxx By: /s/ Xxxxxx Xxxxx
Name: Xxxxxx Xxxxxx Name: Xxxxxx Xxxxx
Title: Global Alliance Director Title: Legal Counsel
[Signature Page To Ninth Amendment To License, Collaboration, and Option Agreement]