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.
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|CONFIDENTIAL || ||EXECUTION VERSION|
LETTER OF INTENT
BETWEEN Vir Biotechnology, Inc.
AND WUXI BIOLOGICS (HONG KONG) LIMITED
This Letter of Intent (LOI) confirms the recent discussions between Vir Biotechnology, Inc. (Vir) and WuXi Biologics (Hong Kong) Limited (WuXi Biologics) whereby Vir reserves some capacity in WuXi Biologicss bulk drug substance facility referred to as Manufacturing #2 (the Capacity Reservation) and retains WuXi Biologics to perform certain development and/or manufacturing services (the Services) regarding Virs VIR-7831 SARS-Cov-2 mAb (also referred to as WBP2275 within WuXi Biologics) (the Initial Product) or any backup SARS CoV-2 mAb product that Vir may specify from time to time (collectively, the Initial Product and any backup product specified by Vir, the Product).
WuXi Biologics and Vir may each be referred to in this LOI as a Party and collectively as the Parties. This LOI is a binding contractual obligation of the Parties as of the last signature date below by both Parties (the LOI Effective Date). Any capitalized terms used herein but not defined shall be as defined in the Development and Manufacturing Collaboration Agreement between the Parties effective as of February 25, 2020. The Parties do hereby agree as follows:
|1. || |
Definitive Agreement. Additional terms and conditions related to the Services and the rights and obligations of each Party related thereto will be specified in a commercial manufacturing and supply agreement (the Commercial MSA) and commercial quality agreement (the Commercial QAG). This LOI does not obligate either Party to enter into the Commercial MSA, the terms of which remain subject to discussion and approval by each Party. Notwithstanding the foregoing, the Parties shall use their respective commercially reasonable efforts to negotiate and enter into the Commercial MSA before July 30, 2020. The terms agreed upon in this LOI shall be incorporated into the Commercial MSA.
|2. || |
Section 2. Capacity Reservation. As of the LOI Execution Date, (a) Vir will purchase a firm and binding capacity reservation at WuXi Biologicss Manufacturing #2 bulk drug substance facility (the Facility) to Manufacture [***] in accordance with the Manufacturing schedule and parameters in Appendix 1, and (b) WuXi Biologics will schedule such capacity reservation.
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Campaign. WuXi Biologics will Manufacture [***] (the Campaign) in accordance with the Manufacturing schedule and parameters in Appendix 1.
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[***]. At Virs sole discretion, at any time prior to [***], Vir may request that WuXi Biologics [***]. If Vir elects to [***], the Parties will mutually agree on the timing and scheduling of [***].
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PPQ Batches. Vir will designate [***] batches from the Campaign that will be used to Manufacture process performance qualification batches (PPQ Batches) intended (a) [***] and (b) [***] . Vir will notify WuXi Biologics by [***] if Vir elects to Manufacture all PPQ Batches in 2020 and shall designate which Campaign batches shall be PPQ Batches. [***].