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.
Sample 1Sample 2
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;
Sample 1Sample 2
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;
Sample 1

Examples of Defective Batch in a sentence

  • 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.

  • The Chair also drew the attention of GE.1 to the newly established group for the development of a complimentary set of Message Design Rules covering Version 4 (batch and interactive) of the Syntax.

  • 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.

  • If a Batch is a Defective Batch for any reason [***], [***] shall be [***] responsible for all costs associated with replacing such Defective Batch and [***] bear [***] responsibility for costs associated with the transportation, testing and disposal (as applicable) of any such rejected Defective Batch.

  • Risk of loss for all Released API or Defective Batch shall transfer to Nuvelo after delivery of the Released API or Defective Batch to the Nuvelo-approved shipper by Avecia, except with respect to any loss resulting from a failure of Avecia to properly package and label the API for shipment.

  • OXB shall complete such replacement as soon as reasonably practicable following investigation of the cause of the defect and the implementation of appropriate measures to remove such cause and the Parties shall, within [***] of the Delivery Date of the Defective Batch, agree in good faith on a revised Delivery Date for such replacement of the Defective Batch based on the next available Manufacturing Slot.

  • Avecia will package the Released API or Defective Batch in validated containers under validated shipping conditions.

  • If Client believes that a Batch Delivered by OXB is a Defective Batch and provides timely notification in accordance with clause 6.7(a), OXB shall promptly conduct an investigation with the aim of determining: (x) whether the Batch is a Defective Batch and (y) the cause of the defect.

  • All charges shall commence from the Date of Acceptance of the Service at a Location except that: (a) Tail Circuit charges shall commence from the date of installation of the Tail Circuit at a Location by the TO; (b) any Software license fees shall commence from the date of delivery of the Software to Customer.

  • As set forth in Article VIII 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.


More Definitions of Defective Batch

Defective Batch means
Sample 1

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 has the meaning set forth in Section 12.1A.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • 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 any com- ponent that is intended to furnish pharmacological activity or other di- rect effect in the diagnosis, cure, miti- gation, treatment, or prevention of dis- ease, or to affect the structure or any function of the body of humans. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

  • 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.

  • Major Defect means a condition that exists on a ground ambulance vehicle that requires the Department or the certificate holder to place the ground ambulance vehicle out-of-service.

  • 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. §

  • 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 or location of which was lawful prior to the adoption, revision or amendment of a zoning ordinance, but which fails to conform to the requirements of the zoning district in which it is located by reasons of such adoption, revision or amendment.

  • District specification means the specifications followed by the State Govt. in the area where the work is to be executed.