Validation Batch definition

Validation Batch means a batch of Product, data from which is used to demonstrate the efficacy of the manufacturing process, the reproducibility of Product quality, Product stability, and other parameters which may be required by regulatory authorities in order to grant approval of the manufacturing process and Product quality.

Validation Batch has the meaning provided in Section 4.2 of this Agreement.

Validation Batch means a batch or lot produced from a validation run. Each Validation Batch is intended to produce Product that is commercially saleable when contained in a finished Paratek Product.

Examples of Validation Batch in a sentence

• Activity 8: Validation Reports 20 working days after completion of Validation Batch #3, or 20 days from date requested by RADIUS Activity 9: Validation Stability Stability study to start within one month of batch purification and continue according to protocol Activity 10: DMF Filing Within 40 working days of date requested by RADIUS, but not earlier than 3.5 months after the end of the Validation Campaign.

• ACP will complete Validation Batch #1, Validation Batch #2 and Validation Batch #3 for one indication as described in Exhibit A to the Master Service Agreement entered into by parties as of January 28, 2015 as of the Effective Date.

• In the event that Anthra shall give Sicor such notice, then Anthra shall make payment for such Validation Batch within thirty days after receipt by Anthra of notice, if any, from the Testing Laboratory that the Validation Batch is conforming.

• In the event of a Validation Batch failure due to Curia's gross negligence or willful misconduct, Indivior shall have, in its sole discretion, the right to either (i) have Curia re-make the relevant Validation Batch at no further cost to Indivior (provided Indivior pays for the conforming replacement services solely in the event Indivior has not already paid for the non-conforming services) or (ii) to have Curia credit to Indivior the amount paid by Indivior for such failed Validation Batch.

• In the event that Anthra determines that any Validation Batch does not conform to the Specifications or the CMC, Anthra shall give Sicor notice of its rejection thereof (including a sample from the batch analyzed) within forty-five (45) days after receipt of such Validation Batch.

More Definitions of Validation Batch

Validation Batch means a full GMP batch of a specific batch size that shall prove that the Process in use delivers batches of releasable quality in full accordance with specifications.

Validation Batch means a Batch that requires testing and documentation beyond what is required per this Agreement.

Validation Batch means a batch of saleable product manufactured prior to NDA approval to confirm that the process set forth in the NDA is reproducible at commercial scale, and which meets FDA requirements for a validation process.

Validation Batch means a batch of Product, data from which is used to demonstrate the efficacy of the manufacturing process, the reproducibility of Product quality, Product stability, and other parameters which may be required by regulatory authorities in order to grant approval of the manufacturing process and Product quality. "Writing" and "Written" mean transmission of information by means of black or blue ink applied by hand or machine to paper by the sender and signed and dated by the sender. The definition expressly excludes information sent by facsimile or electronic mail (e-mail) by means of the internet unless otherwise authorised by the Parties. "Year" means the period of 12 (twelve) months from the date of this Agreement and each subsequent consecutive period of 12 (twelve) months during the period of this Agreement.

Validation Batch means a batch of approximately 580 kg of API, but in no event less than 450 kg of API, produced pursuant to Section 3.8 and the Validation Protocol.

Validation Batch means a batch of PRODUCT (a) that (i) conforms to the parameters described in the validation protocol as agreed in writing between the parties, (ii) is manufactured according to cGMP, as applicable, (iii) is validated in accordance with the ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (the “ICH Guidance”) (including, without limitation, that such batch, together with two other such sequential batches of PRODUCT, demonstrates reproducibility of the commercial manufacturing process for PRODUCT), (iv) supports the NDA (or other filing for Regulatory Approval) for PRODUCT, (v) may be used to complete the consistency, comparability and stability studies for PRODUCT in connection with any such filing, and (vi) meets Specifications; or (b) supports a filing for Regulatory Approval of the implementation of a subsequent process or equipment change with respect to the commercial manufacture of PRODUCT. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Validation Batch means any one of each of three (3) consecutive batches of API or dosage form which conform to the critical parameters described in the process and which are Manufactured according to the Manufacturing process.