Changes to Production Strains Sample Clauses

The "Changes to Production Strains" clause governs how modifications to the biological strains used in manufacturing a product are managed and approved. Typically, this clause outlines the process for notifying, reviewing, and obtaining consent from relevant parties before implementing any changes to the strains, such as genetic modifications or switching to a different strain for production. Its core function is to ensure product consistency, regulatory compliance, and mutual agreement, thereby minimizing risks associated with unapproved or unilateral changes to critical production materials.
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.
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Related to Changes to Production Strains

  • Project Scope The physical scope of the Project shall be limited to only those capital improvements as described in Appendix A of this Agreement. In the event that circumstances require a change in such physical scope, the change must be approved by the District Committee, recorded in the District Committee's official meeting minutes, and provided to the OPWC Director for the execution of an amendment to this Agreement.

  • MSAA Indicator Technical Specification Document This Agreement shall be interpreted with reference to the MSAA Indicator Technical Specifications document.

  • Technical Specifications The purpose of the Technical Specifications (TS), is to define the technical characteristics of the Goods and Related Services required by the Procuring Entity. The Procuring Entity shall prepare the detailed TS consider that:

  • Development Schedule The Project shall substantially comply with the specific timetables and triggers for action set forth in Article 5 of this Agreement. The parties acknowledge that, as provided in G.S. 160A-400.25(b), the failure to meet a commencement or completion date shall not, in and of itself, constitute a material breach of this Agreement pursuant to G.S. 160A-400.27 but must be judged based upon the totality of the circumstances.

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.