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.
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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...
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Related to Nonconforming API

  • Nonconforming Work 5.6.1 Rejection, Removal and Replacement of Nonconforming Work

  • Defective Product If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products. If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.

  • Inspection and Rejection of Nonconforming Goods The Buyer has the right to inspect the Goods on or after the Delivery Date. Buyer, at its sole option, may inspect all or a sample of the Goods, and may reject all or any portion of the Goods if it determines the Goods are nonconforming or defective. If Buyer rejects any portion of the Goods, Buyer has the right, effective upon written notice to Seller, to: (a) rescind the Order in its entirety; (b) accept the Goods at a reasonably reduced price; or (c) reject the Goods and require replacement of the rejected Goods. If Buyer requires replacement of the Goods, Seller shall, at its expense, promptly replace the nonconforming Goods and pay for all related expenses, including, but not limited to, transportation charges for the return of the defective goods and the delivery of replacement Goods. If Seller fails to timely deliver replacement Goods, Buyer may replace them with goods from a third party and charge Seller the cost thereof and terminate this Order for cause pursuant to Section 19. Any inspection or other action by Buyer under this Section shall not reduce or otherwise affect Seller's obligations under the Order, and Buyer shall have the right to conduct further inspections after Seller has carried out its remedial actions.

  • Non-Conforming Product (a) Within [*****] of Chiesi’s receipt of an order for the Product, Chiesi may reject any such order or portion thereof that (i) does not conform to the warranty under Section 8.1 above, including to the Specifications, or (ii) is based on any claimed shortage in quantity, provided that such non-conformity in (i) above is not due to any failure by Chiesi, its Affiliates, agents or representatives to ship, handle, maintain, or store the Product as required under the Specifications. Kamada shall reasonably assist Chiesi in performing any such testing by providing to Chiesi any necessary technical information to accomplish such testing by Chiesi. Chiesi shall notify Kamada in writing within such [*****] period of its rejection of any order or portion thereof of the Product delivered by Kamada, which notice of rejection must contain the reason for such rejection; provided, however, that this limitation shall not apply to hidden defects in the Product. In the case of hidden defects, Chiesi shall have [*****] days from the date it becomes aware or reasonably should have become aware of any hidden defect to reject any order of the Product in accordance with applicable terms and conditions hereof. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) In the event of the rejection of the Product under this Section 8.2, or any other nonconformity or defect which the Parties mutually agree is a proper basis for rejection, and if such rejection is appropriately made by Chiesi, Kamada shall use its Best Reasonable Efforts to replace the rejected Product or make up the shortage at its expense within [*****] of the notice of such rejection or shortage, and in any case as soon as reasonably possible after receiving such notice, at no additional cost to Chiesi (including shipping and transportation costs), and Kamada shall make arrangements with Chiesi for the return or disposal of any rejected Product, such return shipping or disposal charges to be paid by Kamada. (c) In the event of a conflict regarding whether or not the Product conforms to the warranty under Section 8.1 above, including to the Specifications at the time of delivery, and Chiesi and Kamada are unable to resolve such conflict after a good faith attempt by both Parties to resolve such matter in a period of [*****] days after the conflict arises, a sample of the Product shall be submitted by Chiesi to an independent laboratory reasonably acceptable to both Parties for testing against the Specifications or other defect and the test results obtained by such laboratory shall be final and controlling for purposes of this Agreement. If the Parties are unable to agree upon such independent laboratory in a period of [*****] days after the conflict arises, such independent laboratory shall be selected by the President of the ICC. The fees and expenses of such laboratory testing shall be borne entirely by the Party against whom such laboratory’s findings are made. In the event the independent laboratory test results indicate that the Product in question did not meet the Specifications or is otherwise defective, Kamada shall use its Best Reasonable Efforts to replace the rejected Product at no additional cost to Chiesi within [*****] days after receipt of such results if replacement Product stock is available, and in any case as soon as reasonably possible after receipt of such independent laboratory test. In the event the independent laboratory test results indicate that the rejected Product in question meets the Specifications, then Chiesi shall pay all additional shipping and transportation costs, incurred by Kamada as a result of the conflict as well as the cost of the Products to the extent that such Products have not been previously paid for by Chiesi, and shall accept and pay for the previously rejected Product in accordance with all applicable provisions hereunder. (d) Without derogating from Section 4.2(e) and from any obligations that Kamada may have under this Agreement with respect to Third Party Claims, the foregoing shall be Chiesi’s sole and exclusive remedy with respect to non-conforming Products or shortages, and all other remedies at law or in equity shall not be available to Chiesi. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.

  • Defective Products (a) In the event that Nycomed determines that any shipment of Product, at the time of delivery, (i) does not conform to the Product Specifications, (ii) contains misprinted or non-conforming labelling or packaging, or (iii) has been damaged in transit (collectively, "Defective Products"), then Nycomed shall give Anthra notice thereof (including a sample from such shipment) within fifteen days after receipt thereof, if such defects may be ascertained by the exercise of reasonable diligence (which shall include laboratory testing or other chemical analysis as necessary) upon receipt thereof, and otherwise within fifteen days after discovery thereof. If Anthra confirms such defect, it shall promptly so notify Nycomed. If Anthra does not confirm such defect, it shall promptly so notify Nycomed, and the parties shall submit the disputed shipment for testing to an independent testing laboratory that is mutually acceptable to the parties. The findings of the testing laboratory shall be *** CONFIDENTIAL TREATMENT REQUESTED. 18 binding on the parties. The expenses of such testing shall be borne by Anthra if the testing confirms the defect, and otherwise by Nycomed. (b) If any shipment contains Defective Product, for any reason other than the willful or negligent acts or omissions of Nycomed or its customers or agents, Anthra shall credit Nycomed with the costs incurred by Nycomed with respect to all such Defective Product that has not been sold (or has been sold and returned), which costs shall be deemed equal to the sum of any amounts paid on account of such Defective Product pursuant to Section 3.7 and any and all transportation and storage charges incurred by Nycomed in connection with such Defective Product. In addition, at Nycomed's option, (i) Anthra shall be relieved of any obligation to deliver any Product in replacement of such Defective Product, or (ii) Anthra shall replace such Defective Product as soon as possible after Nycomed notifies Anthra of its election of option (ii) of this Section 3.4, in which case Nycomed shall pay to Anthra any unpaid amounts in respect of the replacement Product in accordance with Section 3.7 following delivery of the replacement Product.