PPQ Batches Clause Samples
The "PPQ Batches" clause defines the requirements and procedures for Process Performance Qualification (PPQ) batches in a manufacturing or supply agreement. It typically outlines the number of batches to be produced, the standards they must meet, and the documentation required to demonstrate that the manufacturing process consistently yields products meeting quality specifications. For example, the clause may specify that three consecutive PPQ batches must pass all quality tests before commercial production can begin. This clause ensures that both parties agree on the criteria for validating the manufacturing process, thereby reducing the risk of quality issues in commercial supply.
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PPQ Batches. If it is determined that a process performance qualification (“PPQ”) Batch does not meet the Product specifications set forth in the master batch record (“Specifications”) as a result of Service Provider’s failure to follow cGMP, then Service Provider shall, at AstraZeneca’s request and option, and as AstraZeneca’s sole and exclusive remedy (subject to Clause 12.5.5), and as soon as it is commercially practical to do so following receipt of any required materials at Service Provider’s sole cost and expense (excluding, subject to Clause 12.5.1, costs or expenses for AstraZeneca’s Materials including shipping and transport costs), either (i) re-perform such PPQ Batch; or (ii) provide AstraZeneca a credit for the amounts paid by AstraZeneca to Service Provider for such PPQ Batch. If a PPQ Batch fails to meet Specifications for any cause other than Service Provider’s gross negligence, willful misconduct or failure to follow cGMP, then Service Provider shall have no liability to AstraZeneca with respect to such Batch and AstraZeneca shall pay Service Provider for such Batch.
PPQ Batches. Lonza shall manufacture and deliver PPQ Batches sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documents.
PPQ Batches. The Parties agree that Client shall be permitted to utilize PPQ Batches for the Permitted Use, provided that: [****]. If the preceding four (4) conditions have been met, Parties agree that the PPQ Batches shall be governed by the terms and conditions of this CMSA, inclusive of the Permitted Use, but only as it relates to commercial activities. For purposes of clarity, [****] shall govern the PPQ Batches for all activities prior to commercial use of the PPQ Batches.
PPQ Batches. Vir will designate [***] batches from the Campaign that will be used to Manufacture process performance qualification batches (“PPQ Batches”) intended (a) [***] and (b) [***] . 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. [***].
PPQ Batches. As requested by Company and covered in a Work Order, Supplier will produce PPQ Batches to be used in clinical trials in US and ex US. Product can be filled in either [*]or [*]. Assuming that PPQ Batches are run at Full Scale, the cost of the PPQ will be billed to Company at a rate of $[*]/[*]. If a smaller scale Batch is requested by Company, the per vial price will be adjusted appropriately. Under no circumstances will the per Batch price be less than $[*]. Testing, raw materials (excluding [*] and [*]) and Batch Record Documentation will be covered in this pricing. The cost of any required process characterization and/or process validation documentation is not covered in the per [*] pricing and will be agreed upon by the Parties in the relevant Work Order. The price of these [*] will count toward the Monthly Fees covered in Section 10.7. If the PPQ Batch Product is out-of-specification, Company will still be responsible for the price of Batch unless the root cause of the OOS is material and is directly related to Supplier’s failure to follow the manufacturing process or testing instructions that are covered in the agreed upon Batch Records or transferred test methods, respectively. For clarity, no scale-up or process characterization activities are included in the PPQ Batches. Any required scale-up or process characterization activities will be covered and agreed upon in writing by the Parties in a Work Order.