Batch or Batches definition

Batch or Batches means a certain quantity of raw materials and excipients, packaging materials or finished AB-106 Products having the intended homogeneous quality and characters which are manufactured in a process or processes; in order to complete certain manufacturing operations, it may be necessary to divide a Batch into several lots, which may then be combined into a homogeneous Batch. In case of continuous manufacturing, a Batch must correspond to a defined quantity of the products manufactured having the intended homogeneous characters. The Batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.
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Examples of Batch or Batches in a sentence

  • In the case of a Deficiency Notice, payments will be due within […***…] days following receipt of a replacement Batch or Batches that are not subject to a Deficiency Notice.

  • If API is lost or damaged in processing as a result of ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇’▇ negligent acts or omissions, ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ will process a replacement Batch (or Batches if applicable) at no additional cost to Auxilium for that number of Batches for which API was lost or damaged as its sole liability and Auxilium’s sole remedy (except that Auxilium shall provide replacement API at Auxilium’s expense).

  • For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned, it shall be deemed not Catalent Defective Processing and Client shall be responsible to pay Catalent for such Batch or Batches in accordance with the provisions of this Agreement.

  • If INYX does not accept the claim or UCB disagrees then an independent laboratory mutually agreed by the parties (or failing agreement the Medicines and Healthcare Products Regulatory Agency Laboratory in Edinburgh) shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute.

  • For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned after resort to Section 5.2 (C), it shall be deemed not Catalent Defective Processing and Client shall be responsible to pay for the Batch or Batches at issue.

  • If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute.

  • Iroko shall be responsible to pay for the Batch or Batches if Product is not Defective Product or there is no Catalent Defective Processing after resort to Section 5.3 (should resort to Section 5.3 be necessary).

  • For the purposes of clarity, such third party determination of conformance of the Product to Patheon Manufacturing Requirements shall be solely for the purpose of determining whether the Manufacturing Fee for a given Batch or Batches, as applicable, shall be payable by Genelabs to Patheon.

  • If the Parties disagree as to whether a Batch or Batches is/are Nonconforming Product, the Parties shall cause a mutually agreeable independent third party to review records and test data and to perform comparative tests and/or analyses on samples of the alleged Nonconforming Product.

  • Further, approval by Genelabs to ship a given Batch or Batches of Product prior to completion of testing shall have no bearing whatsoever on Genelabs' later refusal to do the same with a future Batch or Batches.