Failed Batches. If any Batch of Product fails solely because of defects or other non-conformities existing at the time of delivery to DSM in the API supplied by a Designated Vendor, then AMAG shall be obligated to pay DSM a failed Batch fee computed [***] of the Purchase Price of the quantities that would have been produced in the failed Batch but for the Designated Vendor caused defect of the API. DSM shall not proceed with manufacture of any Batch of Product in which DSM reasonably suspects defective or non-conforming API without AMAG’s written authorization.
Failed Batches. If any Batch fails because of a defect in API or Excipients supplied by OMEROS or an Unapproved Vendor that was not and could not reasonably have been detected by DSM by inspecting and testing as provided for in Section 4.2.1 herein, then OMEROS shall be obligated to pay DSM a fee equal to [†] of the Product Price of the quantities that would have been produced in the failed Batch (based on the Expected Yield) but for the non-conformities in the API or Excipients. Upon OMEROS’ payment of such fee, the quantities † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION that would have been produced shall be deducted from the Firm Purchase Commitment and credited against the Requirements Obligation.
Failed Batches. If any Batch of Product fails solely because of defects or other non-conformities in API or Raw Materials supplied by a Designated Vendor, [ *** ].
Failed Batches. Vaxcyte may reject a Batch if the Batch does not meet or comply with the Specifications, cGMPs, the Quality Agreement or is not in accordance with this CMSA. In the event Lonza believes a Batch has been incorrectly rejected, Lonza may test a Batch sample and provide a report on the testing conditions and testing results for such Batch sample to Vaxcyte. In the event Lonza’s test results show the Failed Batch meets Specifications, the Quality Agreement and GMP or there continues to be a dispute between the Parties over either (a) whether such Batch constituted a Failed Batch or (b) with respect to a Batch which the Parties agree is a Failed Batch, the extent to which such failure is attributable to a given Party, the Parties shall cause an independent laboratory to promptly review records, test data and perform comparative tests and/or analyses on samples of the Failed Batch. Such independent laboratory shall be mutually agreed upon by the Parties and shall be located in either the United States or the European Union. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules.
Failed Batches. ImmunoGen shall bear the responsibility for a failed Batch Run if such failure is attributable to the [ * ] or [ * ] of ImmunoGen. The foregoing notwithstanding, the [ * ] that there may be [ * ] not [ * ] to [ * ] . [ * ] of [ * ] shall take place according to the [ * ] in [ * ], in which the [ * ] to the [ * ] of [ * ].
Failed Batches. If any Batch of Product fails because of defects or other non-conformities in Excipients and such Excipients were supplied by a Designated Vendor, then Onyx shall be obligated to pay DSM a failed Batch fee computed as [*] of the Purchase Price of the quantities that would have been produced in the failed Batch but for the defect of the Excipients. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Failed Batches. ImmunoGen shall bear the responsibility for a failed Batch Run if such failure is attributable to the negligence or misconduct of ImmunoGen. The foregoing notwithstanding, the Parties acknowledge that there may be Batch Run failures not attributable to either Party. Cost sharing of such failed batches shall take place according to the table in Schedule C, in which the success rate improves according to the number of batches produced.
Failed Batches. If FCDI, during the Manufacturing Phase, fails to manufacture a Batch that meets the Release Specifications, and/or a Batch is not manufactured under GMP, FCDI shall notify Century in writing of such non-conformity as soon as reasonably practicable and thereafter FCDI shall use its commercially reasonable efforts to manufacture a replacement Batch according to GMP Procedures, which conforms to the Release Specifications. In the event that FCDI performs a Run according to the GMP Procedures but nevertheless fails to manufacture a replacement Batch which conforms to the Release Specifications, FCDI shall have no further responsibility or liability, and CENTURY shall have no further rights and remedies, with respect to such non-conforming Product except as may be expressly otherwise provided in Article 7.7. The responsibility for the cost and expense of the replacement Batch will be as set forth in Article 7.7.
