Purchase Orders; Forecasts; Procedures Clause Samples
Purchase Orders; Forecasts; Procedures. 2.4.1 Upon receipt of a Purchase Order from Passage Bio pursuant to this Agreement and/or one or more Passage Bio Supply Agreements and/or Additional Manufacturing and Supply Agreements, Catalent shall Manufacture Batches of Bulk Drug Substance and/or Drug Product at the BWI Facility in accordance with the Product Requirements, cGMPs, the then-current Quality Agreement and any applicable Laws and otherwise in accordance with the applicable supply agreements. The maximum number of Batches of Bulk Drug Substance that can be Manufactured in the Dedicated Clean Room Suite (the “Maximum Annual Batches”) at any time during the Term is [*]. The [*], and the corresponding Maximum Annual Batches, shall be determined by the JSC. The JSC will make an initial determination of the [*] upon the Readiness Determination and the JSC will review the [*] periodically (no less than annually) and make appropriate adjustments thereto.
2.4.2 Purchase Orders shall include orders for Drug Product, however, the Manufacture of Batches of Drug Product shall be performed in accordance [*], which schedule shall generally consist of the Manufacture and Delivery of Batches of Drug Product [*] the Delivery of Batches of Bulk Drug Substance of each Passage Bio Product in a quantity [*] necessary for the Manufacture of one or more Batches of Drug Product.
Purchase Orders; Forecasts; Procedures. 3.4.1 Upon receipt of a Purchase Order from BridgeBio pursuant to a BridgeBio Manufacturing and Supply Agreement and/or one or more Additional Manufacturing and Supply Agreements, Catalent shall Manufacture Batches of BridgeBio Product at the BWI Facility in accordance with the Product Requirements, cGMPs, the then-current Quality Agreement and any applicable Laws and otherwise in accordance with the applicable Definitive Agreement. The maximum number of Batches of BridgeBio Product that can be Manufactured in the Dedicated Clean Room Suite (the “Maximum Batches”) at any time during the Term is based upon the Manufacturing Configuration established for each BridgeBio Product and the maximum number of upstream production runs that can be safely and efficiently completed in the Dedicated Clean Room Suite (the “Maximum Upstream Runs”) during each BMP. The Maximum Upstream Runs, and the corresponding Maximum Batches, shall be determined by the JSC. The JSC will make an initial determination of the Maximum Batches and Maximum Upstream Runs upon the Readiness Determination and the JSC will review the Maximum Upstream Runs periodically (no less than annually) and make appropriate adjustments thereto.
3.4.2 With respect to orders of Batches of the BridgeBio Product and subject to the Maximum Batches, BridgeBio shall provide forecasts of its ordering needs and place with Catalent Purchase Orders for the supply of BridgeBio Products being Manufactured by Catalent pursuant to one or more BridgeBio Manufacturing and Supply Agreement and/or one or more Additional Manufacturing and Supply Agreements.
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(a) Upon receipt of a Purchase Order from Sarepta pursuant to this Agreement, Catalent shall Manufacture Batches of Bulk Drug Substance and/or Drug Product in accordance with the Product Requirements, cGMPs, the then-current Quality Agreement and any applicable Laws and otherwise in accordance with this Agreement. [**]
(b) With respect to orders of Batches of Bulk Drug Substance, Sarepta shall provide forecasts of its ordering needs and, as set forth in Section 5.3(f) below, place with Catalent Purchase Orders for the supply of Bulk Drug Substance of Sarepta Drug Products being Manufactured by Catalent pursuant to this Agreement. Such Purchase Orders shall also include orders for Drug Product as needed.