Common use of Validation Batches Clause in Contracts

Validation Batches. Each batch of Product manufactured as part of the Validation Activities will be considered to be an "Experimental Batch" until BLP has manufactured [*] that meets the Specifications applicable to such Product upon which such consecutive batches shall be considered "Validation Batches." ISTA shall pay to BLP the Product price set forth in Appendix A for each Experimental Batch manufactured as part of the Validation Activities; provided that if any such Experimental Batch does not meet the Specifications due to BLP's negligence, the failure of BLP's Processing equipment, or BLP's failure to adhere to the batch records, validation protocols or other similar documentation, BLP shall, at its own expense, manufacture additional Experimental Batches of Product until the successful completion of a total of [*] which meet the Specifications. BLP shall not be responsible for any batch failures directly caused by Product formulation, container compatibility and testing methods developed or provided by ISTA to BLP hereunder. ISTA may, at its own expense, request BLP to manufacture additional batches of Product attributed to such failures. BLP and ISTA shall cooperate in good faith to resolve any problems causing any out-of-Specification batch. It is understood and agreed that the Validation Batches will, upon ISTA's receipt of written FDA approval of the Product, be sold as commercial Product.