Pre-Validation Batches Sample Clauses
Pre-Validation Batches. Client shall be responsible for the full cost of each Batch produced under this Agreement at the theoretical quantities when priced on a per-unit basis (including Clinical Stage Batches and Batches necessary to support the validation portion of Client’s submissions for Product approvals by Regulatory Authorities and any Batch manufactured following (a) a change in Specifications or (b) a scale-up in the manufacturing process to produce greater quantities of Product), even if the Batch fails to meet the Specifications (and in such case, Client shall also be responsible for the cost of destroying the out-of-Specification Batch and its components), until all manufacturing, testing and storage methods and processes have been validated in accordance with industry standards (including production of at least three (3) consecutive cGMP Batches of each strength and packaging configuration that meet the then-applicable Specifications); provided, that the foregoing shall not apply to the extent such failure to meet the Specifications would not have occurred but for Cambrex’s Fault, in which case Cambrex will be responsible for such costs. Cambrex and Client shall cooperate in good faith to determine and resolve any problems causing the out-of-Specification Batch. 86274635_42
Pre-Validation Batches. Client shall be responsible for the cost of each Batch produced under this Agreement (including Batches necessary to support the validation portion of Client’s submissions for Product approvals by Regulatory Authorities and any Batch manufactured following (a) a change in Specifications or (b) a scale-up in the manufacturing process to produce greater quantities of Product), even if the Batch fails to meet the Specifications, until all manufacturing, testing and storage methods and processes have been validated in accordance with industry standards (including production of at least [***] Batches of each strength that meet the then-applicable Specifications); provided, that the foregoing shall not apply to the extent Halo was grossly negligent, engaged in willful misconduct, or violated cGMPs (to the extent applicable) in the manufacturing of the out-of-Specification Batch. In cases where Halo is responsible for an out-of-Specification Batch pursuant to the foregoing proviso, Halo will also be responsible for the cost of destroying the out-of-Specification Batch and its components. In all other cases, Client will be responsible for the cost of destroying the out-of-Specification Batch and its components. Halo and Client shall cooperate in good faith to determine and resolve any problems causing the out-of-Specification Batch.
Pre-Validation Batches. [***] shall order by written request to ▇▇▇▇▇▇▇, and ▇▇▇▇▇▇▇ shall Manufacture, any pre-validation Batches [***]. [***] shall be responsible for the cost of each pre-validation Batch produced under this Agreement and requested in writing by [***], and any Batch Manufactured following: [***]; provided, that the foregoing shall not apply to the extent [***]. ▇▇▇▇▇▇▇ and Sol-Gel shall cooperate in good faith to determine and resolve any problems [***].