AMENDMENT AGREEMENT First Amendment to the Manufacturing and Supply Agreement
Exhibit 10.2
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.
AMENDMENT AGREEMENT
First Amendment to the Manufacturing and Supply Agreement
This Amendment Agreement (this “Amendment Agreement”) is between Flexion Therapeutics, Inc., having its principal office at 00 Xxxx Xxxx, Xxxxxxxxxx XX, XXX (“Flexion”) and Patheon UK Limited, having a principal place of business at Xxxxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxx, Xxxxxxxxx XX00XX, Xxxxxx Xxxxxxx (“Patheon”) (collectively, “Parties”; individually, “Party”). This Amendment Agreement is dated 8 May 2019 (the “Amendment Effective Date”).
WHEREAS, Flexion and Patheon entered into a Manufacturing and Supply Agreement (“Manufacturing and Supply Agreement”) on 31 July 2015, pursuant to which Patheon provides manufacturing services for Flexion’s FX006 drug product (ZILRETTA) (an extended-release formulation of triamcinolone acetonide).
WHEREAS, the Parties have agreed to initiate construction of the area referred to as the Phase III manufacturing suite at Patheon’s facility and to incur certain capital expenditures to facilitate the manufacture of Flexion’s product in this manufacturing suite.
NOW, THEREFORE, in consideration of the foregoing and the mutual promises, covenants and agreements set forth below and in the Manufacturing and Supply Agreement, and for other good and valuable consideration, the receipt and sufficiency of which the Parties hereby acknowledge, the Parties hereto, intending to be legally bound, do hereby agree as follows:
1.Definitions
Defined terms in this Amendment Agreement shall have the same meaning as those in the Manufacturing and Supply Agreement as applicable unless otherwise indicated.
2.Amendments
The Manufacturing and Supply Agreement shall be amended such that the following Schedules or parts of Schedules to the Manufacturing and Supply Agreement shall be replaced as set out in the Exhibits attached to this Amendment Agreement.
Schedule 2.9 (Equipment)
Phase III and Combined Phases I, II and III of Schedule 1.60 (Footprint)
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The amendments to the Manufacturing and Supply Agreement set forth herein shall be effective as of the Amendment Effective Date.
4.Integration
Except for the sections of the Manufacturing and Supply Agreement specifically amended hereunder, all terms and conditions of the Manufacturing and Supply Agreement remain and shall remain in full force and effect. This Amendment Agreement shall hereafter be incorporated into and deemed part of the Manufacturing and Supply Agreement and any future reference to the Manufacturing and Supply Agreement shall include the terms and conditions of this Amendment Agreement.
5.Governing Law and Jurisdiction
This Amendment Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the laws that govern the Manufacturing and Supply Agreement, and the Parties submit to the jurisdiction and dispute resolution provisions as set forth in the Manufacturing and Supply Agreement.
IN WITNESS WHEREOF, the Parties have caused this Amendment Agreement to be executed by their duly authorized representatives, effective as of the date of the last signature.
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FLEXION THERAPEUTICS, INC.
/s/ Xxxxxxx X. Xxxxxxx, M.D. |
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PATHEON UK LTD.
/s/ Xxxx Xxxxxxxx |
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Signature
Xxxxxxx X. Xxxxxxx, M.D. |
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Signature
Xxxx Xxxxxxxx |
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Name
CEO |
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Name
Director |
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Title
May 9, 2019 |
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Title
May 12, 2019 |
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Date |
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Date |
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Exhibit 1 of the Amendment Agreement
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Exhibit 2 of the Amendment Agreement
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