Validation Batches definition

Validation Batches for a dosage form shall mean those batches manufactured by Catalytica during the course of the Validation Activities.

Validation Batches means Batches of API submitted by Raylo to Eyetech for validation of the 15mM Process pursuant to the Quality Agreement.

Validation Batches means the batches used to validate Supplier’s Product manufacturing process and has the meaning set forth in Section 3.11.

Examples of Validation Batches in a sentence

• Lonza shall manufacture and deliver Process Validation Batches as mutually agreed by Parties sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documents.

• All such regulatory support activities are excluded from the Price of Process Validation Batches, shall be approved by the Customer in advance, and shall be paid for by the Customer at the Price set out in the applicable Project Plan.

• All process validation activities are excluded from the Price of Process Validation Batches shall be approved by the Customer in advance and shall be paid for by the Customer at the Price set out in the applicable Project Plan.

• It is understood and agreed that the prices set forth in Appendix C with respect to Technology Transfer Activities or Validation Activities are contingent on the successful manufacture of Product Validation Batches (as defined in Section 5.C. below) and Submission Batches (as defined in Appendix C) in accordance with the Specifications as part of the Technology Transfer Activities or Validation Activities.

• Equateq shall ship such Commercial Validation Batches in accordance with, and within [***] of the issuance of, the Purchase Order.

More Definitions of Validation Batches

Validation Batches means each Batch of Product manufactured by Cardinal Health which is necessary to support the validation portion of Client’s NDA or ANDA submission to the FDA.

Validation Batches means each Batch of Product manufactured by Catalent that is necessary to support the validation portion of Client’s NDA or ANDA submission to the FDA. PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS.

Validation Batches means the Process Validation of Product listed under Schedule A or Development Products Process Validation prepared to demonstrate, that under normal and defined conditions and ranges of specified operating parameters, the desired commercial scale and process produces acceptable Product or Development Products that are intended to be used to support approval with a Regulatory Authority and for use as the initial Batches to be sold commercially after approval.

Validation Batches means Initial Products, which, for clarity shall include both doses, manufactured in connection with the validation of the manufacturing process for such products as required by Applicable Law or Regulatory Authority.

Validation Batches means the first three (3) Production Batches manufactured consecutively according to the approved Validation Protocol.

Validation Batches means the batches of AD32 Manufactured by Sicor for use by Anthra in satisfying Product validation requirements in connection with applications for Health Registrations in the United States and the European Union.

Validation Batches means a specified number of consecutive Batches, as agreed in the validation protocol, that have been processed in accordance with the Manufacturing Standards and such Validation Batch will be intended to be commercializable unless specified otherwise in the relevant validation protocol or SOW (defined below) for such Validation Batch.