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 which Noven elects to utilize to satisfy the FDA requirements regarding validation of its commercial manufacturing process. ***. Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.

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.

• The Commercial Occupancy Fee is payable commencing on January 1st of the year that commercial manufacture of the Product occurs (including manufacture of Validation Batches for commercial sale) and each subsequent January 1st during the term of this Agreement.

• BLP will place each of the Validation Batches into on-going stability studies and will provide interim stability reports to ISTA, as required by cGMP regulations.

• 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.

• 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.

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 Targanta’s NDA or ANDA submission to the FDA.

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.

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

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 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.