Manufacturing Start Date definition
Examples of Manufacturing Start Date in a sentence
Notwithstanding anything to the contrary herein, the Manufacturing Start Date and the outside date for Supplier Release are firm.
Cancellation of any orders of Drug Product of a Passage Bio Product shall be subject to the same cancellation fees below; provided that no such cancellation fees shall apply for any such orders of Drug Product cancelled prior to the date that is [*] ([*]) days prior to the Manufacturing Start Date for the cancelled Batch of Drug Product.
Client will pay PCT, as applicable, a monthly Room 1 fee (the “Room 1 Fee”) in the amount of (i) $*** from and including the month in which the Room 1 Initial Services Start Date occurs through but excluding the month in which the Room 1 Product Manufacturing Start Date occurs and (ii) $*** from and including the month in which the Room 1 Product Manufacturing Start Date occurs through the month in which the Termination Date occurs.
Cancellation of any orders of Drug Product of a Passage Bio Product shall be subject to the same cancellation fees below; provided that no such cancellation fees shall apply for any such orders of Drug Product cancelled prior to the date that is [*] days prior to the Manufacturing Start Date for the cancelled Batch of Drug Product.
Supplier agrees to use its Commercially Reasonable Efforts to start the Manufacture of the Batch by the Manufacturing Start Date, complete the Manufacture of the Product Deliverable, enable shipment of the Product ActiveUS 167576635v.1 Execution Version Deliverable to [**], and provide the Customer with the analytical results of the Product Deliverable by the dates set forth in Schedule A.
Notwithstanding this Section 9(d)(i) to the contrary, if the Room 1 Product Manufacturing Start Date has occurred, neither Party shall cause the Termination Date (as defined in the Agreement) to occur prior to the *** following the *** of the *** day of the month following the month in which the Room 1 Product Manufacturing Start Date has occurred.
The Parties agree and acknowledge that Manufacture of the Product by CBMG China for clinical or commercial purposes shall be subject to a written quality assurance agreement (the “Quality Agreement”) which the Parties shall enter into prior to the commencement of clinical Manufacture or the Manufacturing Start Date, as applicable, in accordance with this Agreement.
The Parties will negotiate in good faith and enter into the Quality Agreement prior to the Manufacturing Start Date.
If the Parties are unable to agree on a Quality Agreement prior to the Manufacturing Start Date, then Healeon shall Manufacture Products in accordance with its past practices.
Effective as of the [***] Manufacturing Start Date, all references to the Insulet/Flex Materials Supplier Agreement in the Original Agreement are hereby deleted and replaced with “Amgen/Insulet/[***] Materials Supplier Agreement” (as defined in the Business Continuity and License Agreement between [***], Amgen, and Insulet dated November 18, 2021).