Common use of Changes to Production Strains Clause in Contracts

Changes to Production Strains. The Parties recognize that it may be necessary or desirable to make changes with respect to the production strain for a Compound for purposes of complying with any regulatory request or requirement, or for purposes of improving the production of such Compound. In the case where BMS desires that Ambrx work with BMS to make a change to the host strain or the expression vector for any production strain for a Compound, BMS shall notify Ambrx of such desire in writing. Following such notification, the Parties shall agree through the JRC (or if the JRC is not constituted, through the Alliance Managers) upon a work plan for such production strain change setting forth the activities, timelines and budget (including projected Third Party Costs to be incurred by Ambrx and the level of Ambrx FTE effort to be devoted to such activities) for such work (such work being the “Production Strain Work” and such plan being the “Production Strain Work Plan”). BMS shall reimburse Ambrx on a rolling calendar quarter basis for Ambrx’s documented Third Party Costs and FTE costs (at the FTE Rate) incurred in the performance of any Production Strain Work in accordance with the applicable Production Strain Work Plan, provided that such Third Party Costs and FTE costs (i.e., the level of FTE effort) shall be in accordance with the approved Production Strain Work Plan (or an amendment thereto or as otherwise approved in writing by BMS in advance of being incurred). Any such Production Strain Work shall be overseen by the JRC or a subcommittee of the JRC formed for such purpose. Ambrx shall transfer to BMS any production strains generated for a Compound, and such production strains shall be deemed Ambrx Materials for all purposes under this Agreement, for use by BMS solely in accordance with and subject to the terms and conditions of this Agreement.

Appears in 8 contracts

Samples: Collaboration and License Agreement (Ambrx Biopharma Inc.), Collaboration and License Agreement (Ambrx Biopharma Inc.), Collaboration and License Agreement (Ambrx Biopharma Inc.)

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Changes to Production Strains. The Parties recognize that it may be necessary or desirable to make changes with respect to the production strain for a Compound Collaboration Antibody for purposes of complying with any regulatory request or requirement, or for purposes of improving the production of such CompoundCollaboration Antibody. In the case where BMS desires that Ambrx work with BMS to make a change be made to the host strain or the expression vector for any production strain for a CompoundCollaboration Antibody, BMS shall notify Ambrx Alder of such desire in writing. Following As soon as practicable after Alder receives such notification, except as provided in the next sentence, the Parties shall agree through the JRC (or if the JRC is not constituted, through the Alliance Managers) JMC upon a work plan for such production strain change setting forth the activities, timelines and budget (including projected Third Party Costs to be incurred by Ambrx and the level of Ambrx FTE effort to be devoted to such activities) [***] for such work (such work being the “Production Strain Work” and such plan being the “Production Strain Work Plan”). Notwithstanding the foregoing, where BMS proposes that changes be made to the production strain for a Co-Developed Product or Cancer Product, no such changes shall be made unless and until Alder also agrees as to such changes and the Parties agree to such Production Strain Work. As between the Parties, Alder shall be the Party responsible for the conduct of any Production Strain Work. BMS shall reimburse Ambrx Alder on a rolling calendar quarter basis for AmbrxAlder’s documented Third Party Costs out-of-pocket costs and FTE costs (at the FTE Rate) incurred in the performance of any Production Strain Work in accordance with the applicable Production Strain Work Plan, provided that such Third Party Costs out-of-pocket costs and FTE costs (i.e., the level of FTE effort) shall be in accordance with the approved Production Strain Work Plan (or an amendment thereto or as otherwise approved in writing by BMS in advance of being incurred). Any such Production Strain Work shall be overseen by the JRC JMC or a subcommittee of the JRC JMC formed for such purpose. Ambrx Alder shall transfer to BMS any production strains generated for a CompoundCollaboration Antibody, and such production strains shall be deemed Ambrx Alder Materials for all purposes under this Agreement, for use by BMS solely in accordance with and subject to the terms and conditions of this Agreement.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Alder Biopharmaceuticals Inc), Collaboration and License Agreement (Alder Biopharmaceuticals Inc)

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Changes to Production Strains. The Parties recognize that it may be necessary or desirable during the Term to make changes with respect to the production strain for a Compound for purposes of complying with any regulatory request or requirement, or for purposes of improving the production of such Compound; provided that Ambrx shall have no obligation to assist BMS with respect to any such changes pursuant to this Section 6.6 unless BMS requests such changes during the Research Term or during a period of two (2) years after the end of the Research Term. In the case where BMS desires that Ambrx work with BMS to make such a change to the host strain or the expression vector for any production strain for a Compound, BMS shall notify Ambrx of such desire in writing. Following such notification, the Parties shall agree through the JRC (or if the JRC is not constituted, through the Alliance Managers) upon a work plan for such production strain change setting forth the activities, timelines and budget (including projected Third Party Costs to be incurred by Ambrx and the level of Ambrx FTE effort to be devoted to such activities) for such work (such work being the “Production Strain Work” and such plan being the “Production Strain Work Plan”). BMS shall reimburse Ambrx on a rolling calendar quarter Calendar Quarter basis for Ambrx’s documented Third Party Costs and FTE costs (at the FTE Rate) incurred in the performance of any Production Strain Work in accordance with the applicable Production Strain Work Plan, provided that such Third Party Costs and FTE costs (i.e., the level of FTE effort) shall be in accordance with the approved Production Strain Work Plan (or an amendment thereto or as otherwise approved in writing by BMS in advance of being incurred). Any such Production Strain Work shall be overseen by the JRC (which may be reconstituted as necessary for such purpose) or a subcommittee of the JRC formed for such purpose. Ambrx shall transfer to BMS any production strains generated for a Compound, and such production strains shall be deemed Ambrx Materials for all purposes under this Agreement, for use by BMS solely in accordance with and subject to the terms and conditions of this Agreement.

Appears in 2 contracts

Samples: Collaboration and Exclusive License Agreement (Ambrx Inc), Collaboration and Exclusive License Agreement (Ambrx Inc)

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