Common use of Development Batches Clause in Contracts

Development Batches. Each batch of Supplies produced under this Agreement will be considered to be a “Development Batch” until manufacturing, testing and storage methods and processes have been validated or qualified in accordance with industry standards (including production of at least [* * *] consecutive batches of Supplies that meet the applicable specifications). The term “Development Batch” shall include any batch manufactured following (A) a Change Order, or (B) a scale-up in the manufacturing process to produce greater quantities of Supplies, until Catalent has manufactured at least [* * *] consecutive batches of Supplies meeting the new specifications. Client shall be responsible for the cost of each Development Batch, even if such batch fails to meet the specifications therefor, unless Catalent was grossly negligent in the manufacture of the out-of-specification batch. Catalent and Client shall cooperate in good faith to resolve any problems causing the out-of-specification batch.