Failed Batch definition

Failed Batch means any cGMP Batch that fails to conform with the Specifications and/or is not manufactured in accordance with cGMP and/or the Quality Agreement.
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Failed Batch is defined in Section 10.4 (Batch Failure).
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Failed Batch means any batch of Product Manufactured by Regeneron or the Third Party Fill/Finish Provider that fails to generate adequate yields of Product or fails to meet quality requirements, including failure to Manufacture any Product in compliance with Specifications or applicable Good Practices, in each case which were not released by Regeneron. If a Failed Batch does not result from the gross negligence, recklessness, bad faith or intentional wrongful acts, or omissions committed by Regeneron or its Affiliates (or their respective agents, contractors, representatives or other persons or entities working on their behalf), then, to the extent such Failed Batch was Manufactured, in whole or in part to fulfill Kiniksa’s Firm Order, the costs of the Failed Batch (or a pro rata allocation thereof if the Failed Batch was not Manufactured solely to fulfill Kiniksa’s Firm Order) will be included as Manufacturing Costs of Product as set forth in the LA (in the definition of Manufacturing Costs), otherwise KINIKSA shall not be responsible for the costs of such Failed Batch.
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Examples of Failed Batch in a sentence

  • If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications, then the Steering Committee shall decide in its sole discretion, [***].

  • Lonza shall not be responsible for the cost of Raw Materials or Customer Materials consumed in any Failed Batch except to the extent set forth in this Clause 7.3.3.

  • The compensation is capped at [***]% of the price of that Failed Batch.

  • Customer acknowledges and agrees that its [***] with respect to a Failed Batch that is a Lonza Responsibility is [***].

  • Absent fraud or manifest error of the External Party, the determination of the External Party as to whether or not such Product is a Nonconforming Product and the cause of any Failed Batch or Nonconforming Product will be binding upon the Parties (absent manifest error or bad faith on the part of the External Party) for purposes of determining financial liability hereunder.

  • Without prejudice to the indemnities set out in Section 14.1.1 (Provider Indemnification), the remedies under this Section 10.6 (Remedies) shall be Senti’s sole remedies and Provider’s sole liability in connection with any Failed Batch or Nonconforming Product.

  • The Parties agree that with respect to meeting the quality and safety specifications of a Batch, a Batch that does not meet the Specifications will be deemed a Failed Batch.

  • If any replacement cGMP Batch provided as replacement for a Failed Batch also fails to conform to the Specifications due to Lonza’s Responsibility, then the Steering Committee shall decide in its sole discretion, if Lonza shall either replace such cGMP Batch or refund the amounts paid by Customer for such cGMP Batch.

  • Customer acknowledges and agrees that its sole remedy with respect to a Failed Batch that is a Lonza Responsibility is as set forth in this Clause 7.3.3, and in furtherance thereof, Customer hereby waives all other remedies at law or in equity regarding the foregoing claims.

  • Customer acknowledges and agrees that [***] with respect to a Failed Batch that is a Lonza Responsibility [***].


More Definitions of Failed Batch

Failed Batch shall have the meaning set out in Clause 7.4.3.
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Failed Batch means [***].
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Failed Batch means any Batch (a) which does not conform to the requirements of the Specifications, or (b) fails to meet a cGMP requirement, or (c) was not Processed in accordance with the Master Production Record as allowed by cGMP, such that identity, purity, strength or potency is compromised.
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Related to Failed Batch