Common use of Failures Prior to Validation and Additional Validation Batches Clause in Contracts

Failures Prior to Validation and Additional Validation Batches. Notwithstanding anything in this Agreement to the contrary, Indivior shall pay for all Validation Batches that fail to meet the Manufacturing Standards in accordance with this Agreement and assume responsibility for all costs, including but not limited to the cost of API or other Indivior Materials, associated with such Validation Batch failures until such time as there exists a Validated Manufacturing Process for the Product, provided, however, that Curia shall be responsible for Validation Batch failures due to Curia's gross negligence or willful misconduct. In the event of a Validation Batch failure due to Curia's gross negligence or willful misconduct, Indivior shall have, in its sole discretion, the right to either (i) have Curia re-make the relevant Validation Batch at no further cost to Indivior (provided Indivior pays for the conforming replacement services solely in the event Indivior has not already paid for the non-conforming services) or (ii) to have Curia credit to Indivior the amount paid by Indivior for such failed Validation Batch. Indivior shall be responsible for supplying, at Indivior's expense, sufficient quantities of API and other Indivior Materials, as necessary for Curia to complete such replacement. The foregoing remedy shall be Indivior's sole and exclusive remedy for any failure of a Validation Batch to conform to the Manufacturing Standards. Indivior acknowledges that a change in Specifications, manufacturing Process or Master Batch Records may require a new Validated Manufacturing Process using the new Specifications, manufacturing Process or Master Batch Records, provided, however, the parties agree that Validation Batches Processed without changes to the Specifications or Process which are required solely for Indivior to make use of a previously validated Process for a Product in a new Territory shall not constitute a need for a new Validated Manufacturing Process and in such circumstances, each such Batch Processed by Curia shall remain subject to the terms of Section 6. In the event that Purchase Orders do not provide a continuity of processing so as to keep Curia's personnel trained on Product, the processing of additional Validation Batches before the next commercial manufacturing run may be necessary at Curia's discretion and, at Indivior's expense.

Failures Prior to Validation and Additional Validation Batches. Notwithstanding anything in this Agreement to the contrary, Indivior shall pay for all Validation Batches that fail to meet the Manufacturing Standards in accordance with this Agreement and assume responsibility for all costs, including but not limited to the cost of API or other Indivior Materials, associated with such Validation Batch failures until such time as there exists a Validated Manufacturing Process for the Product, provided, however, that Curia shall be responsible for Validation Batch failures due to Curia's gross negligence or willful misconduct. In the event of a Validation Batch failure due to Curia's gross negligence or willful misconduct, Indivior shall have, in its sole discretion, the right to either (i) have Curia re-make the relevant Validation Batch at no further cost to Indivior (provided Indivior pays for the conforming replacement services solely in the event Indivior has not already paid for the non-conforming services) or (ii) to have Curia credit to Indivior the amount paid by Indivior for such failed Validation Batch. Indivior shall be responsible for supplying, at Indivior's expense, sufficient quantities of API and other Indivior Indivior Materials, as necessary for Curia to complete such replacement. The foregoing remedy shall be Indivior's sole and exclusive remedy Indivior for any failure of a Validation Batch to conform to the Manufacturing Standards. Indivior acknowledges that a change in Specifications, manufacturing Process or Master Batch Records may require a new Validated Manufacturing Process using the new Specifications, manufacturing Process or Master Batch Records, provided, however, the parties agree that Validation Batches Processed without changes to the Specifications or Process which are required solely for Indivior to make use of a previously validated Process for a Product in a new Territory shall not constitute constitute 9 a need for a new Validated Manufacturing Process and in such circumstances, each such Batch Processed by Curia shall remain subject to the terms of Section Article 6. In the event that Purchase Orders do not provide a continuity of processing so as to keep Curia's personnel Curia nel trained on Product, the processing of additional Validation Batches before the next commercial manufacturing run may be necessary at Curia's discretion and, at Indivior's expenseCuria Indivior .