Acceptance upon Delivery. Grünenthal shall be under no obligation to accept any shipment of Product for which AcelRx has not provided a Certificate of Analysis or a Certificate of Conformance, as applicable. Grünenthal shall inspect all shipments of the Product promptly upon receipt, and Grünenthal may reject any shipment of the Product which is nonconforming. In order to reject delivery of a shipment of the Product, Grünenthal must give written notice to AcelRx of Grünenthal’s rejection of any delivery [ * ] after receipt of such delivery or with regard to [ * ]. If no such notice of rejection is received, Grünenthal shall be deemed to have accepted such Product on the [ * ] after delivery, subject to later detection of hidden defects. For clarity, a [ * ]. (i) After timely notice of rejection is received by AcelRx, Grünenthal shall cooperate with AcelRx in determining whether rejection is appropriate or justified. AcelRx [ * ] = 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. will evaluate process issues and other reasons for any alleged nonconformity. AcelRx shall notify Grünenthal as promptly as reasonably possible whether it accepts Grünenthal’s basis for any rejection, however not later than [ * ] after the respective notification. If AcelRx agrees with Grünenthal’s determination that the rejected Product does not meet the Specifications, promptly on receipt of a notice of rejection of a shipment of Product and no later than [ * ] after receipt of such notice, AcelRx shall use commercially reasonable efforts to replace such rejected Product with conforming Product. If AcelRx disagrees with Grünenthal’s determination that certain Product is nonconforming, (x) promptly on receipt of a notice of rejection of a shipment of Product and no later than [ * ] after receipt of such notice, at Grünenthal’s request, AcelRx shall use commercially reasonable efforts at Grünenthal’s request to replace such rejected Product and (y) the rejected Product shall be submitted to a mutually acceptable Third Party laboratory in the Territory, which shall determine whether such Product is nonconforming. The Parties agree that such Third Party laboratory’s determination shall be final and binding on the Parties. The Party against whom the Third Party laboratory rules shall bear the reasonable costs of the Third Party testing. If the Third Party laboratory rules that the Product in question meets Specifications, Grünenthal shall purchase that batch at the agreed-upon price, irrespective of whether AcelRx has provided replacement Product, provided that in such event Grünenthal shall also pay for any replacement Product delivered if not previously paid. Otherwise the replacement delivery shall be at no charge to Grünenthal. (ii) Grünenthal shall not destroy any rejected Product until it receives written notification from AcelRx that AcelRx does not dispute that the rejected Product fails to meet Specifications. At AcelRx’s election and upon instruction from AcelRx, Grünenthal shall either (a) destroy the Product received in the rejected delivery promptly at AcelRx’s cost and provide AcelRx with certification of such destruction, or (b) return such Product to AcelRx at AcelRx’s cost
Appears in 3 contracts
Samples: Manufacture and Supply Agreement, Manufacture and Supply Agreement (Acelrx Pharmaceuticals Inc), Manufacture and Supply Agreement (Acelrx Pharmaceuticals Inc)
Acceptance upon Delivery. Grünenthal Jaguar shall be under no obligation to accept any shipment of Product Crofelemer Animal API for which AcelRx Glenmark has not provided a Certificate of Analysis or a Certificate of Conformance, as applicable. Grünenthal Jaguar shall inspect all shipments of the Product Crofelemer Animal API promptly upon receipt, and Grünenthal Jaguar may reject any shipment of the Product Crofelemer Animal API which is nonconformingnonconforming to the Specifications. In order to reject delivery of a shipment of the ProductCrofelemer Animal API, Grünenthal Jaguar must give written notice to AcelRx Glenmark of GrünenthalJaguar’s rejection of any delivery [ * ] thirty (30) days after receipt of such delivery or with regard to [ * ]delivery. If no such notice of rejection is received, Grünenthal Jaguar shall be deemed to have accepted such Product Crofelemer Animal API on the [ * ] thirtieth (30th) day after delivery, subject to later detection of hidden defects. For clarity, a [ * ]defects which in no event shall be more than twelve (12) months after the delivery of Crofelemer Animal API by Glenmark.
(i) After timely notice of rejection is received by AcelRxGlenmark, Grünenthal Jaguar shall cooperate with AcelRx Glenmark in determining whether rejection is appropriate or justified. AcelRx [ * ] = 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. Glenmark will evaluate process issues and other reasons for any alleged nonconformitynonconformity to the Specifications. AcelRx Glenmark shall notify Grünenthal Jaguar as promptly as reasonably possible whether it accepts GrünenthalJaguar’s basis for any rejection, however but not later than [ * ] thirty (30) business days after the respective notification. If AcelRx Glenmark agrees with GrünenthalJaguar’s determination that the rejected Product Crofelemer Animal API does not meet the Specifications, promptly on receipt of a notice of rejection of a shipment of Product Crofelemer Animal API and no later than [ * ] 120 Business Days after receipt of such notice, AcelRx Glenmark shall use commercially reasonable efforts to replace such rejected Product Crofelemer Animal API with Crofelemer Animal API conforming ProductCrofelemer Animal API to the Specifications. If AcelRx Glenmark disagrees with GrünenthalJaguar’s determination that certain Product Crofelemer Animal API is nonconformingnonconforming to Specifications, (x) promptly on receipt of a notice of rejection of a shipment of Product and Crofelemer Animal API but no later than [ * ] 120 Business Days after receipt of such notice, at GrünenthalJaguar’s request, AcelRx Glenmark shall use commercially reasonable efforts at GrünenthalJaguar’s request to replace such rejected Product Crofelemer Animal API and (y) the rejected Product Crofelemer Animal API shall be submitted to a mutually acceptable Third Party laboratory in the Territory, which shall determine whether such Product Crofelemer Animal API is nonconformingnonconforming to Specifications. The Parties agree that such Third Party laboratory’s determination shall be final and binding on the PartiesParties absent manifest error. The Party against whom the Third Party laboratory rules shall bear the reasonable costs of the Third Party testing. If the Third Party laboratory rules that the Product Crofelemer Animal API in question meets Specifications, Grünenthal Jaguar shall purchase that batch at the agreed-upon price, irrespective of whether AcelRx Glenmark has provided replacement ProductCrofelemer Animal API, provided that in such event Grünenthal Jaguar shall also pay for any replacement Product Crofelemer Animal API delivered if not previously paid. Otherwise the replacement delivery shall be at no charge to GrünenthalJaguar.
(ii) Grünenthal Jaguar shall not destroy any rejected Product Crofelemer Animal API until it receives written notification from AcelRx Glenmark that AcelRx Glenmark does not dispute that the rejected Product Crofelemer Animal API fails to meet Specifications. At AcelRxGlenmark’s election and upon instruction from AcelRxGlenmark, Grünenthal Jaguar shall either (a) destroy the Product Crofelemer Animal API received in the rejected delivery promptly at AcelRxGlenmark’s cost and provide AcelRx Glenmark with certification of such destruction, or (b) return such Product Crofelemer Animal API to AcelRx Glenmark at AcelRxGlenmark’s cost.
(iii) Notwithstanding any other provisions hereinabove, Glenmark shall have no liability hereunder to the extent any such liability is attributable to (i) failure of Jaguar-Supplied CPL to conform to applicable Specifications as of its time of delivery to Glenmark or (ii) Jaguar-Supplied CPL having been adulterated (as such term is defined in FD&C) prior to the time of delivery to Glenmark.
Appears in 2 contracts
Samples: Manufacture and Supply Agreement, Manufacture and Supply Agreement (Jaguar Animal Health, Inc.)
Acceptance upon Delivery. Grünenthal Napo shall be under no obligation to accept any shipment of Product Crofelemer Final for which AcelRx Glenmark has not provided a Certificate Record of Analysis or a Certificate of ConformanceBatch Record Certificate, as applicable. Grünenthal The receiving agent at the contract formulation facility (the consignee) shall inspect all shipments of the Product Crofelemer Final promptly upon receipt, and Grünenthal Napo may reject any shipment of the Product Crofelemer Final which is nonconformingnonconforming to the Specifications for Crofelemer Final. In order to To reject delivery of a shipment of the ProductCrofelemer Final, Grünenthal Napo must give written notice to AcelRx Glenmark of Grünenthal’s Napo's rejection of any delivery [ * within [****] after receipt of such delivery or with regard to [ * ]delivery. If no such notice of rejection is received, Grünenthal Napo shall be deemed to have accepted such Product Crofelemer Final on the [ * [****] after delivery, subject to later detection of hidden defects. For clarity, a [ * ].Section 3.7C.
(i) After timely notice of rejection is received by AcelRx, Grünenthal shall cooperate with AcelRx in determining whether rejection is appropriate or justified. AcelRx [ * ] = 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. will evaluate process issues and other reasons for any alleged nonconformity. AcelRx shall notify Grünenthal as promptly as reasonably possible whether it accepts Grünenthal’s basis for any rejection, however not later than [ * ] after the respective notification. If AcelRx agrees with Grünenthal’s determination that the rejected Product does not meet the Specifications, promptly on receipt of a notice of rejection of a shipment of Product and no later than [ * ] after receipt of such notice, AcelRx Glenmark shall use commercially reasonable efforts to replace such rejected Product Crofelemer Final with Crofelemer Final conforming Productto the Specifications. The replacement Crofelemer Final and the delivery of such replacement Crofelemer Final shall be at no additional cost to Napo or its Affiliates.
(ii) Napo will, at Napo’s sole discretion, either (a) dispose of the rejected Crofelemer Final at Napo’s expense and will provide Glenmark with a copy of the certificate of destruction, or (b) use such rejected Crofelemer Final for research and development purposes. If AcelRx disagrees the Parties fail to agree whether Crofelemer Final conforms with Grünenthal’s determination that certain Product is nonconformingthe terms of this Agreement, (x) promptly on receipt of a notice of rejection of a shipment of Product and no later than [ * ] after receipt of including without limitation to the Quality Agreement, or are defective or not such notice, at Grünenthal’s request, AcelRx shall use commercially reasonable efforts at Grünenthal’s request to replace such rejected Product and (y) the rejected Product matter shall be submitted to a mutually acceptable Third Party finally settled by an independent testing laboratory in as agreed upon by the Territory, which shall determine whether such Product is nonconforming. The Parties agree that such Third Party laboratory’s determination and the decision of the independent testing laboratory shall be final and binding on the Parties. The Party against whom said independent testing laboratory shall act as an expert and not as an arbitrator and the Third Party laboratory rules shall bear the reasonable costs fees of the Third Party testingindependent testing laboratory shall be borne by the losing Party. If Glenmark shall be responsible to pay Napo for the Third Party laboratory rules cost of any CPL associated with Crofelemer Final that has been rejected pursuant to this Section 3.5D. For the Product in question meets Specificationsavoidance of doubt, Grünenthal this shall constitute Napo’s sole remedy for the late delivery of Crofelemer Final due to the Crofelemer Final not being accepted by Napo pursuant to this Section 3.5 and all other rights or remedies available under statute, common law or otherwise are hereby expressly excluded by the Parties. Notwithstanding the foregoing, if any such delivery is rejected due to a non-acceptance by Napo (pursuant to this Section 3.5) and such non-acceptance is caused by any event solely due to any act or omission of Glenmark and Glenmark cannot replace such Crofelemer Final before the end of the Financial Year, such quantity of Crofelemer Final will be used to reduce the quantity of Crofelemer Final that Napo is obligated to purchase that batch at under the agreed-upon price, irrespective of whether AcelRx has provided replacement Product, provided that in Purchase Order for the Financial Year related to such event Grünenthal shall also pay for any replacement Product delivered delivery and if not previously paid. Otherwise promptly remediated by the replacement delivery end of the Financial Year shall be at no charge to Grünenthal.
(ii) Grünenthal shall not destroy any rejected Product until it receives written notification from AcelRx that AcelRx does not dispute that the rejected Product fails to meet Specificationsconsidered an event for purposes of Chronicity. At AcelRx’s election and upon instruction from AcelRx, Grünenthal shall either (a) destroy the Product received in the rejected delivery promptly at AcelRx’s cost and provide AcelRx with certification of such destruction, or (b) return such Product to AcelRx at AcelRx’s cost 9|Page
Appears in 1 contract
Samples: Manufacturing and Supply Agreement (Jaguar Health, Inc.)