Validation Batches definition

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.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedSchedule a Demo

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.

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.

• The Product Maintenance 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.

• 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 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.

Validation Batches means the validation batches of the Product as set out in the Development and Technology Transfer Plan.

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

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 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.