Nonconforming API Sample Clauses
Nonconforming API. Within [***] from the date SAFC delivers API (including all release documentation) to Company or to a third party designated by Company, Company shall have the right to inspect and test the API to determine whether such API at the time of delivery did not meet the representations, warranties or covenants specified in Section 6.2(b) (collectively the “API Requirements”). Any claim by Company that API does not conform to the API Requirements shall be made in writing to SAFC within such [***] period and shall be accompanied by a detailed report of analysis prepared by or on behalf of Company. Notwithstanding the foregoing, if a defect in the API is a Latent Defect, then such [***] time period shall not apply; provided that Company shall have the obligation to provide such notification to SAFC in writing within [***] after Company’s discovery of such Latent Defect (or within [***] after Company is notified in writing by a third party of such Latent Defect, if later) but in no case later than [***] after the date SAFC delivers API (including all release documentation) to Company or to a third party designated by Company; provided, however, that if SAFC receives stability data that establishes a shelf life of greater than or equal to [***] from the date of Manufacture of the API, then the notification period for a Latent Defect shall be no later than [***] from the date of Manufacture of the API.
Nonconforming API. Par may reject any shipment of API as defective if the API does not conform to Biocon’s obligations under Section 6.1 and/or the Biocon’s product warranties set forth Section 9.2 or which is adulterated or misbranded within the meaning of the Act. In order to reject a shipment, Par must: (i) give notice to Biocon of Par’s intent to reject such shipment together with a written indication of the reasons for such possible rejection within forty five (45) days after delivery of the API to Par, or in the case of latent defects, within forty-five (45) days after the date that Par discovers the defect and (ii) as promptly as reasonably possible thereafter, provide Biocon with notice of final rejection (a “Rejection Notice”) and the full basis therefore. If no such notice of intent to reject is timely received by the Biocon, Par shall be deemed to have accepted such delivery of API.
6.4.1 Par’s tests results or basis for the Rejection Notice shall be conclusive unless Biocon notifies Par in writing within thirty (30) days of receipt of Par’s Rejection Notice that Biocon disagrees with such test results or basis for rejection (“Objection Notice”). If Par and Biocon fail within ten (10) days after delivery of an Objection Notice to agree as to whether the API identified in the Rejection Notice is defective, representative samples of the batch of API in question shall be submitted to a mutually acceptable independent laboratory or consultant (if not a laboratory issue) for analysis for review. The results of such evaluation shall be binding upon the Parties. The Party that is determined to have been incorrect in its determination of whether the API should be rejected shall pay the costs of any such evaluation. If the fees of the independent laboratory or consultant are due in advance, then Biocon shall pay such fees; provided, however, that promptly after the independent laboratory or consultant completes its evaluation, Par shall the reimburse the Biocon such fees if Par was incorrect in its determination.
6.4.2 If any shipment is rejected by Par, Par’s duty to pay all amounts payable to Biocon in respect to the rejected API shall be suspended unless and until there is a determination by an independent laboratory or consultant in support of Biocon’s Objection Notice in accordance with Section 6.2.1.
6.4.3 Whether or not Biocon accepts Par’s basis for its notice of rejection, Biocon shall use reasonable efforts, at Par’s request, to provide replacement API, which sha...