Defective Batch definition

Defective Batch means a Batch, other than a Batch produced in a process verification, pre-engineering or engineering Batch (or the first cGMP Batch if Customer elects not to perform an engineering Batch), which cannot be released or which does not meet the Specifications.
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Defective Batch means any CGMP Batch that (i) does not conform to the Specifications or (ii) was not Manufactured in accordance with the Quality Agreement or Applicable Law;
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Defective Batch means any Batch that (i) is terminated after the IM Date and before completion, (ii) does not conform to the Specifications, and / or (iii) was not Manufactured in accordance with cGMP, the Quality Agreement or Applicable Law;
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Examples of Defective Batch in a sentence

  • Gallus shall not be responsible for any loss of a Batch in crude or purified form unless it is a Defective Batch caused by a Gallus Failure.

  • For each Failed or Defective Batch subject to Section 8.6(b)(iv), Passage Bio shall be responsible for both [*].

  • The Quality Team will discuss the Batch Dispute in good faith to attempt to reach agreement on: (i) whether a Batch is a Defective Batch and, if so, what course of action shall be taken to address it; and (ii) whether or not a Defective Batch resulted from or arose out of an Avecia Default.

  • Any testing which Passage Bio elects to perform shall not relieve Catalent from its obligations to comply with the terms of this Agreement, including its obligations with respect to any Batch that is determined to be a Defective Batch.

  • If a dispute arises amongst the Quality Team relating to whether or not a Batch of the API is a Defective Batch, or whether or not a Defective Batch results from or arises out of an Avecia Default (each of the preceding a “Batch Dispute”), such Batch Dispute shall be resolved as follows.

  • Such referral shall be solely for the purpose of establishing whether or not the applicable Batch is a Defective Batch and whether or not any Defective Batch results from or arises out of an Avecia Default.

  • Whichever Party failed to accurately assess whether the Batch was or was not a Defective Batch, or whether or not a Defective Batch resulted from or arose out of an Avecia Default, shall bear the full cost and expense associated with the hiring and performance of the independent experts and/or laboratory.

  • The fees of the Testing Laboratory shall be paid by Client unless Batch is a Defective Batch which is not caused by a defect in Client Materials or Client Confidential Information or otherwise by Client, in which case the fees shall be paid by OXB.

  • Except with respect to OXB obligations of confidentiality and indemnification obligations or OXB’s gross negligence or wilful misconduct, Client agrees that its sole remedy with respect to a Defective Batch is as set forth in clause 6.8 and Client hereby waives all other remedies at law or in equity regarding such Defective Batch.

  • In the event AGC cannot commence the manufacture of a replacement single Batch within such [***] days period or within [***] days after the end of a campaign if the Defective Batch was part of a campaign, [***].


More Definitions of Defective Batch

Defective Batch means (a) A Batch that has not been produced in accordance with the Quality Agreement; or (b) A Batch that, upon Delivery, does not meet Specifications or was not Processed according to Applicable Laws or any such other material requirement agreed upon by the Parties in writing.
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Related to Defective Batch

  • Defective Product has the meaning set forth in Section 5.2.

  • Nonconformance as used in this clause means a condition of any hardware, software, material, or service/workmanship in which one or more characteristics do not conform to requirements.

  • Defective Goods means Goods of an inferior quality or which are otherwise inconsistent with this Contract.

  • Nonconforming sign means a sign or sign structure, other than a nonstandard sign or a sign that is erected and maintained in a business area along a scenic byway prior to the designation as a scenic byway, that satisfies 1 of the following:

  • Defective Work means (a) Work that is unsatisfactory, deficient or damaged, does not conform to the Contract Documents, or does not meet the requirements of any inspection, test or approval, or (b) Work associated with punch list items that the Contractor fails to complete within a reasonable time after issuance of the punch list by the Project Manager.