Drug Substance Inventory Sample Clauses

Drug Substance Inventory. In relation to Drug Substance Inventory, Company may choose to (A) have all or a portion of the Drug Substance Inventory transferred to Company or any Third Party designated by Company (and not converted into drug product), or (B) request Licensor to convert all or a portion of the Drug Substance Inventory into drug product and transfer such drug product to Company or any Third Party designated by Company. In case of (A), the provisions set forth in sub-paragraph i. shall apply mutatis mutandis. In case of (B), the following shall apply: Licensor will manufacture and supply to Company up to [***] ([***]) batches of drug product with a batch size of [***] ([***]) liters for clinical use, to be delivered in bulk packaging, using and limited to the Drug Substance Inventory or portion thereof, and there shall be no additional cost to Company for such Drug Substance Inventory. Batch size shall be as requested by Company, whereby Company may choose between (aa) [***] ([***]) to (bb) [***] ([***]) liter batch. In addition, [***] ([***]) aseptic process simulation (“APS”) per calendar year and within the interval between biannual shutdowns shall be required to be performed prior to drug product manufacture. For clarity, an APS will need to be performed following each manufacturing suite shutdown, before the subsequent drug product batch manufacture. The Parties will work together in good faith to optimize drug product manufacture scheduling. Licensor will deliver the drug product batches according to the same attributes (including but not limited to strength, formulation, batch size and container closure system) as Licensor’s current process. The drug product will be released by Licensor for use in Phase I/II clinical trials, or for clinical trials for which additional Phase III release procedures are required following completion of additional Phase III release procedure studies subject to Section 3.1e)v. Delivery will be [***] Company’s manufacturing or storage site. Title to the Drug Product shall transfer to Company simultaneously with risk transfer according to the aforementioned Incoterms. Any change to the manufacturing process or outcome required by the Company will need to be agreed in advance and Company will bear the cost for its implementation. Within [***] ([***]) days of the Effective Date and every [***] ([***]) months thereafter, Company shall provide Licensor with an updated rolling forecast with the number of batches to be manufactured in the fol...