Final Product Specifications Sample Clauses

Final Product Specifications. As the Parties progress toward the development of the Final Products, the marketing personnel from both Parties, with consultation from the clinical, regulatory and research and development personnel of both Parties, shall work together to develop Product Specifications for the Final Products. The Representatives shall be responsible for approving Product Specifications for such Final Products, which Product Specifications, once approved by the Representatives, may not be amended without the prior written consent of BSC; provided, however, in the event any modifications to the Product Specifications are required by the FDA or other relevant Regulatory Authorities, such modifications to the Plan Specifications may be made by the Company without the consent of _________ “***” indicates redacted confidential information pursuant to a confidential treatment request filed with the SEC.

Final Product Specifications. As the Parties progress toward the development of the Final Products, the marketing personnel from both Parties, with consultation from the clinical, regulatory and research and development personnel of both Parties, shall work together to develop Product Specifications for the Final Products. The JSC shall be responsible for approving Product Specifications for such Final Products, which Product Specifications, once approved by the JSC, shall become part of the R&D Plan and may be updated from time to time by the JSC. If Product Specifications developed by the marketing personnel are not approved by the JSC then the marketing personnel shall be responsible for revising such Product Specifications.

Final Product Specifications. Upon the first submission by Apollon, its Affiliate or a sublicensee of a BLA(PLA) to the United States Food and Drug Administration (USFDA) or equivalent agency in any country in the Territory for approval of the marketing of any Licensed Product, Apollon will furnish Biogen with a detailed specification for such Licensed Product, and thereafter Apollon will promptly furnish Biogen with any modifications or updates of such specification (as so modified or updated, the "Specification").