PPQ Batch(es) definition

PPQ Batch(es) means Batches designated as process performance qualification Batches that are produced in compliance with cGMP with the intent to show reproducibility of the Manufacturing Process and are required to complete process validation studies (the number of such PPQ Batches shall be as agreed between the Parties but shall be no less than […***…]), and which shall be regarded as being part of the Services;
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PPQ Batch(es) means those process performance qualification Batches used to: (a) demonstrate and document the consistency and reproducibility of a Manufacturing Process at a Facility; (b) establish the comparability of the applicable Product Manufactured at such Facility to Product manufactured by Biogen or another Third Party as required by the Regulatory Authorities; and (c) support Regulatory Approval of both such Facility and such Manufacturing Process at such Facility. Each PPQ Batch is intended to produce Product that is or expected to be (following Regulatory Approval) commercially saleable.
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PPQ Batch(es) means the manufacture of any Product(s) as a registration batch or validation batch under this Agreement.
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Examples of PPQ Batch(es) in a sentence

  • Vaxcyte shall begin holding safety stock starting immediately after successful DS PPQ Batches are available and Facility regulatory approval by the FDA.

  • Lonza’s payment obligation in Section 9.4.1 shall not go into effect until after successful manufacture and release of DS PPQ Batches.

  • Vir will notify WuXi Biologics by [***] if Vir elects to Manufacture all PPQ Batches in 2020 and shall designate which Campaign batches shall be PPQ Batches.

  • The price of the Media Fills, Engineering Run(s), PPQ Batches, and commercial batches produced at risk will be [*] in the month that they were manufactured, and Company will be responsible for the balance each month.

  • The Quality Agreement must be executed by the Parties prior to Supplier initiating production of the PPQ Batches.

  • The Repurposing Fee shall be fully credited to (or, at Vaxcyte’s request, paid back to) Vaxcyte on an annual, straight-line basis, starting on the first anniversary of the completion of PPQ Batches and ending on the tenth (10th) anniversary thereof, subject to Section 18.4.2.

  • For clarity, no scale-up or process characterization activities are included in the PPQ Batches.

  • E.4.5.1 Reassignment of continuing staff within the school including teachers with employment rights returning to the school from leave of absence, and teachers returning to the District from leaves of absence as specified in Articles A.8.0 and G.16.

  • VIR will pay additional charges of up to but not exceeding [***] for a total for all PPQ Batches [***].

  • Supplier will commence with commercially reasonable efforts to move immediately from Engineering Runs to Media Fills and PPQ Batches to minimize downtime except where required by Batch Record or testing instructions to wait for results.