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.

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • As set forth in Section 8 below and following Passage Bio Approval of a Batch and Delivery by Catalent, Passage Bio may later reject the Batch and deem it a Defective Batch if it determines through its own release testing that the Batch does not meet the Product Requirements.

  • Until the shipping conditions have been validated, Avecia will package the Released API or Defective Batch with temperature monitoring devices that are able to function properly during the shipping process, as further set forth in the Quality Agreement.

  • Client agrees that its sole remedy with respect to a Defective Batch is as set forth in clause 6.7 and Client hereby waives all other remedies at law or in equity regarding such Defective Batch.


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.

  • Minor defect means a defect which is not a Major Defect.

  • Nonconformity or “Nonconformities” means any failure or failures of the Software to conform to the requirements of this Contract, including any applicable Documentation.

  • Nonconforming Goods means only the following: (i) product shipped is different than identified in Buyer's purchase order; or (ii) product's label or packaging incorrectly identifies its contents.

  • Defective means, when modifying the work, refers to work that is unsatisfactory, faulty or deficient in that it:

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • Nonconforming lot means a lot that met dimensional requirements of the applicable master program at the time of its establishment but now contains less than the required width, depth or area due to subsequent changes to the master program.

  • Harvest batch means a specifically identified quantity of dried flower or trim, leaves, and other cannabis plant matter that is uniform in strain, harvested at the same time, and, if applicable, cultivated using the same pesticides and other agricultural chemicals, and harvested at the same time.

  • Shipment means a volume of products offered to and accepted by Carrier for transportation.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Purchase Order means the form or format a Customer uses to make a purchase under the Contract (e.g., a formal written purchase order, electronic purchase order, procurement card, contract or other authorized means).

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • Latent Defect means a defect, inherently lying within the material or arising out of design deficiency, which do not manifest themselves and/or was not reasonably discoverable during Defect Liability period.

  • Document Defect As defined in Section 2.03(a).

  • Product Warranty has the meaning set forth in Section 9.3.

  • Nonconforming use means a use of land that:

  • Mentally defective means that a person suffers from a mental disease or defect which renders the person temporarily or permanently incapable of appraising the nature of his or her conduct. S.C. Code Ann. §

  • Service line sample means a one (1) liter sample of water collected in accordance with section 37(b)(3) of this rule that has been standing at least six (6) hours in a service line.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Purchase Order (PO) means a written offer made by a purchaser to a supplier formally stating the terms and conditions of a proposed transaction.

  • Nonconforming structure means a structure the size, dimension

  • Nonconforming zoning condition means a physical improvement on a property that does not conform with current zoning standards.