Amendment no. 3 dated February 4, 2021 to the License, Collaboration, and Option Agreement between Sarepta Therapeutics Three, LLC and F. Hoffman-La Roche Ltd, dated December 21, 2019
Exhibit 10.3
THIRD Amendment to License, Collaboration, and Option Agreement
This THIRD AMENDMENT TO LICENSE, COLLABORATION, AND OPTION AGREEMENT (this “Third Amendment”) is made and entered into as of February 4, 2021 (the “Third 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, as amended (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 Third 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. |
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| a. | Section 8.6.1 is hereby deleted in its entirety and replaced with the following: |
Development Supply Agreement. Unless otherwise agreed by the Parties, no later than (a) June 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.
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| b. | Section 8.6.2 is hereby deleted in its entirety and replaced with the following: |
Commercial Supply Agreement. Unless otherwise agreed by the Parties, no later than (a) June 30, 2021, with regards to the Lead Product, and (b) no later than 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 the Roche Territory at the Supply Price (the “Commercial Supply Agreement” and together with
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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 Third 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 Third Amendment. To the extent a conflict arises between the terms of the Original Agreement and this Third Amendment, the terms of this Third 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 Third 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 Third Amendment Effective Date, each Party hereby represents and warrants that (a) it has the power and authority to execute and deliver this Third Amendment, (b) the execution, delivery, and performance of this Third Amendment by it has been duly authorized by all requisite corporate action, and (c) this Third 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 Third 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 Third Amendment may not be modified or amended, except by another agreement in writing executed by duly authorized signatories of each Party. |
| 9. | Counterparts. This Third 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 Third 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 Third Amendment. |
[Signatures Follow]
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IN WITNESS WHEREOF, the Parties have executed this Third Amendment to License, Collaboration, and Option Agreement through their duly authorized representatives.
| Sarepta Therapeutics Three, LLC |
| By: /s/ Ryan Brown |
| Name: Ryan Brown |
| Title: Interim General Counsel |
| F. HOFFMANN-LA ROCHE LTD |
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| By: /s/ Claire Steers | By: /s/ Dr. Franziska Bachler |
| Name: Claire Steers | Name: Dr. Franziska Bachler |
| Title: Global Alliance Director | Title: Legal Counsel |
[Signature Page To Third Amendment To License, Collaboration, and Option Agreement]
