Rejection and Cure. Customer shall notify Albemarle within one hundred twenty (120) days of Albemarle’s shipment of any batch of Product if it believes that the batch was damaged, defective or did not conform to the Specifications or Applicable Law. In addition to any remedy available to Customer under Sections 2.5.2(c), 2.10 or 6.1.2, Customer’s remedy under this Section 3.5 against Albemarle for any failure to supply a batch of conforming Product is expressly limited to one of the following (as may be elected by Customer at its sole option): (i) Albemarle will provide a replacement batch of conforming Product to Customer at no additional cost and on a schedule acceptable to Customer and reimburse Customer for the shipping and micronization costs, if any, incurred by Customer for the non-conforming batch, or (ii) refund within 10 business days to the Customer the full aggregate Price for such non-conforming batch of Product, plus shipping and micronization costs, if any, incurred by the Customer with respect to such non-conforming batch of Product. This limitation shall apply to all claims with respect to non-conforming Product under this Section 3.5, whether stated in contract, warranty, tort, strict liability, infringement of third party rights or any other legal or equitable claim whatsoever. If Albemarle disputes the above referenced notice of rejection with respect to non-conforming Product, the Parties will each retest the rejected Product within thirty (30) days of Albemarle’s notice of dispute. If the Parties, after retesting the rejected Product continue to have conflicting test results, the matter shall be referred to a laboratory selected by Customer from the list included on Exhibit H (or other mutually agreed upon laboratory) to perform tests on representative samples from the rejected portion of the shipment. The results of such tests will be binding upon Customer and Albemarle. If the laboratory determines that the Product was non-conforming, Albemarle will pay for all laboratory charges; if the laboratory determines that Customer rejected the Product in error, then Customer will pay for all laboratory charges. Rejected Product will be returned to Albemarle or disposed of at Albemarle’s expense in accordance with Albemarle’s instructions, in which case Customer will deliver to Albemarle an appropriate certificate of destruction. If Albemarle requests, Customer will make its personnel available on a reasonable basis to work with Albemarle in order to assist Albemarle in determining the reason for the non-conformity and in developing remedial measures.
Appears in 1 contract
Samples: Commercial Manufacturing Agreement (Siga Technologies Inc)
Rejection and Cure. Customer shall notify Albemarle within one hundred twenty (120) days of Albemarle’s If a shipment of Clinical Trial Products or any batch of Product if it believes that the batch was damaged, defective or did not portion thereof (i) fails to conform to the Specifications or Applicable Law. In addition to any remedy available to Customer under Sections 2.5.2(c)applicable Product Specifications, 2.10 or 6.1.2, Customer’s remedy under this Section 3.5 against Albemarle for any failure to supply a batch of conforming Product is expressly limited to one of the following (as may be elected by Customer at its sole option):
(i) Albemarle will provide a replacement batch of conforming Product to Customer at no additional cost and on a schedule acceptable to Customer and reimburse Customer for the shipping and micronization costs, if any, incurred by Customer for the non-conforming batch, or
(ii) refund within 10 business days to the Customer the full aggregate Price for such non-conforming batch of Productwas not Processed in accordance with applicable laws or regulations or GMP, plus shipping and micronization costs, if any, incurred by the Customer or (iii) is delivered with respect to such non-conforming batch of Product. This limitation shall apply to all claims with respect to non-conforming Product under this Section 3.5, whether stated in contract, warranty, tort, strict liability, infringement of third party rights a material shortage or any other legal overage of Clinical Trial Products, then CTI shall have the right to reject such nonconforming shipment of Clinical Trial Products or equitable claim whatsoeverthe nonconforming portion thereof, as the case may be. If Albemarle disputes the above referenced CTI shall give written notice to Hercon of its rejection with respect to non-conforming Producthereunder, the Parties will each retest the rejected Product within thirty (30) days after CTI’s receipt of Albemarlesuch shipment, specifying the grounds for such rejection; provided, however, that in the event such defect is latent or was not obvious and could not be readily discovered from a physical inspection of the Clinical Trial Products shipment, CTI may give written notice to Hercon of its rejection of such shipment within sixty (60) days after CTI's discovery of such non-conformance. The nonconforming shipment of Clinical Trial Products, or the nonconforming portion thereof, shall be held for Hercon’s disposition, or shall be returned to Hercon, in each case at Hercon’s expense, as directed by Hercon. Hercon shall use its commercially reasonable efforts to replace each nonconforming shipment of Clinical Trial Products, or the nonconforming portion thereof, with conforming Clinical Trial Products as soon as reasonably practicable after receipt of notice of dispute. If rejection thereof, and in any event shall do so within ninety (90) days after the Parties, after retesting the rejected Product continue to have conflicting test results, the matter receipt of replacement Nitroglycerin Adhesive Mixture which shall be referred ordered no later than thirty (30) days after receipt of notice of rejection thereof. In the event of a dispute regarding any non-conforming Clinical Trial Products which CTI and Hercon are unable to resolve, a laboratory selected by Customer from the list included on Exhibit H (or other sample of such Clinical Trial Products, together with mutually agreed upon laboratoryquestions, shall be submitted by CTI to an independent laboratory reasonably acceptable to both parties for testing against the Product Specifications, and the test results ("Test Results") to perform tests obtained by such laboratory shall be final and binding upon the parties save for manifest error on representative samples from the rejected portion face of the shipmentlaboratory’s report. The results outside testing laboratory shall be required to enter into written undertakings of confidentiality at least as restrictive as those set forth herein. The fees and expenses of such tests will laboratory testing, and all additional shipping and transportation costs incurred as a result of the dispute, shall be binding upon Customer and Albemarleborne entirely by the party against whom such laboratory findings are made. If In the laboratory determines event the Test Results indicate that the Product was non-conforming, Albemarle will pay for all laboratory charges; if the laboratory determines that Customer rejected Clinical Trial Products in question do not conform to the Product in errorSpecifications, then Customer will pay for all laboratory charges. Rejected Product will be returned to Albemarle or disposed of at Albemarle’s expense Hercon shall replace such Clinical Trial Products with conforming Clinical Trial Products in accordance with Albemarle’s instructionsthis Section. Hercon shall reimburse CTI for all reasonable out-of-pocket charges that CTI incurred as a result of or relating to any nonconforming Clinical Trial Products, in which case Customer will deliver to Albemarle an appropriate certificate including, without limitation, costs for shipping, disposal, storage or cover, if applicable, of destruction. If Albemarle requests, Customer will make its personnel available on a reasonable basis to work with Albemarle in order to assist Albemarle in determining the reason for the non-conformity and in developing remedial measuresnonconforming Clinical Trial Products.
Appears in 1 contract
Samples: Development, Manufacturing and Supply Agreement (Health Chem Corp)
Rejection and Cure. Customer Upon Elutia or its customers’ use of Product, Elutia or its customers shall notify Albemarle within one hundred twenty (120) days perform an initial physical inspection of Albemarle’s shipment of such Product and review any related documentation. If a batch of Product if it believes that the batch was damaged(including without limitation any documentation related thereto) fails, defective in whole or did not in part, to conform to the Specifications applicable Specifications, then Elutia or Applicable Lawits customers shall have the right to reject the batch which contains such nonconforming portion of the shipment of Product (but, for clarity, not other batches included in such shipment). In addition Elutia or its customers shall give written notice to Purchaser of its rejection hereunder as soon as possible, but in any remedy available to Customer under Sections 2.5.2(cevent no more than [***] days after Elutia’s or its customer’s use of the Product (the “Inspection Deadline”), 2.10 specifying the grounds for such rejection, and if no such notice is received by Purchaser by the Inspection Deadline, Elutia or 6.1.2, Customer’s remedy under this Section 3.5 against Albemarle for any failure to supply a batch of conforming Product is expressly limited to one of the following its customer (as may applicable) shall be elected by Customer at its sole option):
(i) Albemarle will provide a replacement batch of conforming deemed to have accepted such Product and shall have no right to Customer at no additional cost and on a schedule acceptable to Customer and reimburse Customer for reject the shipping and micronization costs, if any, incurred by Customer for the non-conforming batch, or
(ii) refund within 10 business days to the Customer the full aggregate Price for such non-conforming batch of Product, plus shipping and micronization costs, if any, incurred by the Customer with respect to such non-conforming batch of Product. This limitation shall apply to all claims with respect to non-conforming Product under this Section 3.53.3; provided that (i) the Inspection Deadline shall in no event be more than [***] days after Elutia or the applicable customer has received such shipment and (ii) neither (a) the expiration of Product (if such Product had not expired at the time it arrived at the shipping destination specified in the applicable Order) nor (b) any nonconformance attributable to any action or omission of Elutia or the applicable customer shall be grounds for rejection. Purchaser shall have the opportunity to cure the nonconformance if possible (e.g., whether stated in contract, warranty, tort, strict liability, infringement of third party rights or any other legal or equitable claim whatsoever. If Albemarle disputes the above referenced notice of rejection with respect if related to non-conforming Product, the Parties will each retest the rejected Product documentation) to Elutia’s reasonable satisfaction within thirty (30) [***] days of Albemarle’s notice of disputenotification. If the Partiesnonconformance cannot be cured, Purchaser shall direct the disposition of the nonconforming batch at its expense. Purchaser shall use commercially reasonable efforts to replace each nonconforming batch of Product with conforming Product. If Elutia or its customer returns nonconforming Product after retesting paying for such nonconforming Product, Purchaser may, in its reasonable discretion (A) offset the rejected Product continue fees paid for the returned Product, including the cost of the return, against any yet unpaid invoice received from Purchaser or (B) require Purchaser to have conflicting test resultsreimburse Elutia for any payments made for and expenses incurred in connection with the returned Product. Notwithstanding anything to the contrary in this Agreement, the matter shall be referred provisions of this Section 3.3 provide Elutia’s sole remedy for any defect in Product, or failure of Product to meet the Specifications, to the extent that such defect or failure was reasonably discoverable by the Inspection Deadline (any such failure, a laboratory selected by Customer from the list included on Exhibit H (or other mutually agreed upon laboratory) to perform tests on representative samples from the rejected portion of the shipment. The results of such tests will be binding upon Customer and Albemarle. If the laboratory determines that the Product was non-conforming, Albemarle will pay for all laboratory charges; if the laboratory determines that Customer rejected the Product in error, then Customer will pay for all laboratory charges. Rejected Product will be returned to Albemarle or disposed of at Albemarle’s expense in accordance with Albemarle’s instructions, in which case Customer will deliver to Albemarle an appropriate certificate of destruction. If Albemarle requests, Customer will make its personnel available on a reasonable basis to work with Albemarle in order to assist Albemarle in determining the reason for the non-conformity and in developing remedial measures“Detectable Nonconformance”).
Appears in 1 contract
Samples: Transition Tissue Processing, Supply and Distribution Agreement (Elutia Inc.)
Rejection and Cure. Customer shall notify Albemarle within one hundred twenty (120) days of Albemarle’s If a shipment of Product or any batch portion thereof has a Patent Defect or Latent Defect, then Purchaser shall have the right to reject such nonconforming shipment of Product if it believes that or the batch was damagednonconforming portion thereof, defective or did not conform as the case may be, in accordance with the following:
9.1.1 Purchaser shall give written notice to the Specifications or Applicable Law. In addition to any remedy available to Customer under Sections 2.5.2(c)Seller of its rejection hereunder, 2.10 or 6.1.2, Customer’s remedy under this Section 3.5 against Albemarle for any failure to supply a batch of conforming Product is expressly limited to one of the following (as may be elected by Customer at its sole option):
(i) Albemarle will provide a replacement batch of conforming Product to Customer at no additional cost and on a schedule acceptable to Customer and reimburse Customer for the shipping and micronization costs, if any, incurred by Customer for the non-conforming batch, or
(ii) refund within 10 business days to the Customer the full aggregate Price for such non-conforming batch of Product, plus shipping and micronization costs, if any, incurred by the Customer with respect to such non-conforming batch of Product. This limitation shall apply to all claims with respect to non-conforming Product under this Section 3.5, whether stated in contract, warranty, tort, strict liability, infringement of third party rights or any other legal or equitable claim whatsoever. If Albemarle disputes the above referenced notice of rejection with respect to non-conforming Product, the Parties will each retest the rejected Product within thirty (30) days after Purchaser’s receipt of Albemarle’s shipment of any Product containing a Patent Defect, specifying the grounds for such rejection. After receipt of such notice of disputefrom Purchaser, Seller shall be permitted to analyze any Product rejected by Purchaser for nonconformity, and to present its findings with respect to such Product to Purchaser. If the Partiesparties cannot agree on whether the Product in question is nonconforming, after retesting an independent laboratory, reasonably acceptable to both parties and at a cost equally shared by both parties, shall analyze both Purchaser’s and Seller’s samples of Product in question, and the rejected Product continue to have conflicting test results, the matter shall be referred to a laboratory selected by Customer from the list included on Exhibit H (or other mutually agreed upon laboratory) to perform tests on representative samples from the rejected portion of the shipment. The definitive results of such tests will laboratory shall be binding upon Customer and Albemarlebinding. If the shipment of Product in question is determined to be nonconforming, such nonconforming Product shall be held for Seller’s disposition, or shall be returned to Seller, in each case at Seller’s expense, as directed by Seller. Seller shall use its Commercially Reasonable Efforts to replace each nonconforming shipment of Product, or the nonconforming portion thereof, with conforming Product as soon as reasonably practicable after receipt of notice of rejection thereof, and in any event shall do so within thirty (30) days after receipt of notice of rejection thereof. If and to the extent that the nominated independent laboratory determines that the rejected Product was non-is conforming, Albemarle will pay and to the extent that Seller has replaced such rejected Product with additional Product, then Purchaser shall be responsible for the Delivery Price for both the allegedly nonconforming Product and for the replacement Product.
9.1.2 As soon as either Party becomes aware of a Latent Defect in any Product lot, it shall immediately notify the other Party and the batch involved, at Purchaser’s election, shall be deemed rejected as of the date of such notice. Seller shall refund all moneys paid for the shipment of Product involved and shall reimburse Purchaser for its costs of accepting returns from its customers and shall be responsible for all laboratory charges; if the laboratory determines costs reasonably incurred by Purchaser in recalling Product that Customer rejected the Product in error, then Customer will pay for all laboratory charges. Rejected Product will be returned to Albemarle or disposed of at Albemarle’s expense in accordance with Albemarle’s instructions, in which case Customer will deliver to Albemarle an appropriate certificate of destruction. If Albemarle requests, Customer will make its personnel available on a reasonable basis to work with Albemarle in order to assist Albemarle in determining the reason for the non-conformity and in developing remedial measureshave Latent Defects.
Appears in 1 contract
Rejection and Cure. Customer If a shipment of Product or any portion thereof contains a Defect, Columbia shall notify Albemarle have the right to reject such Defective shipment of Product or the portion thereof, upon written notice to Fleet of its rejection hereunder, to be given within one hundred twenty thirty (12030) days after Columbia’s discovery of Albemarlesuch Defect, specifying the grounds for such rejection. After receipt of such notice from Columbia, Fleet shall be permitted to analyze any Product rejected by Columbia regarding such Defect, at Fleet’s shipment of any batch of Product if it believes that the batch was damaged, defective or did not conform to the Specifications or Applicable Law. In addition to any remedy available to Customer under Sections 2.5.2(c), 2.10 or 6.1.2, Customer’s remedy under this Section 3.5 against Albemarle for any failure to supply a batch of conforming Product is expressly limited to one of the following (as may be elected by Customer at its sole option):
(i) Albemarle will provide a replacement batch of conforming Product to Customer at no additional cost and on a schedule acceptable expense, and to Customer and reimburse Customer for the shipping and micronization costs, if any, incurred by Customer for the non-conforming batch, or
(ii) refund within 10 business days to the Customer the full aggregate Price for such non-conforming batch of Product, plus shipping and micronization costs, if any, incurred by the Customer present its findings with respect to such non-conforming batch Product to Columbia. If the parties cannot agree on whether the Product in question contains a Defect, an independent FDA and/or MHRA qualified laboratory, reasonably acceptable to both parties and at a cost equally shared by both parties, shall analyze both Columbia’s and Fleet’s samples of Product in question, and the definitive results of such laboratory shall be binding. If the shipment of Product in question is determined to contain a Defect, such Product shall be held for Product Disposition, or shall be returned to Fleet, in each case at Fleet’s expense, as directed by Columbia. Fleet shall replace each Defective shipment of Product. This limitation shall apply to all claims , or the portion thereof, with respect to non-conforming Product under this Section 3.5, whether stated in contract, warranty, tort, strict liability, infringement of third party rights or any other legal or equitable claim whatsoever. If Albemarle disputes the above referenced notice of rejection with respect to non-conforming Product, the Parties will each retest the rejected Product within thirty (30) days of Albemarle’s the later of receipt of notice of disputerejection or expedited receipt of out of stock raw materials, if any. If the Parties, after retesting the Fleet shall bear one hundred percent (100%) of all costs including cost of destruction of all rejected Product continue to have conflicting test results, the matter shall be referred to a laboratory selected by Customer resulting from the list included on Exhibit H fault or negligence of Fleet. Columbia shall bear one hundred percent (or other mutually agreed upon laboratory100%) to perform tests on representative samples of all costs including cost of destruction of all rejected Product resulting from the fault or negligence of Columbia. Fleet shall destroy rejected portion of the shipment. The results of such tests will be binding upon Customer and Albemarle. If the laboratory determines that the Product was non-conforming, Albemarle will pay for all laboratory charges; if the laboratory determines that Customer rejected the Product in error, then Customer will pay for all laboratory charges. Rejected Product will be returned to Albemarle or disposed of at Albemarle’s expense in accordance with Albemarleall Applicable Laws, and shall indemnify Columbia for any liability, costs or expenses, including attorney’s instructionsfees and court costs, relating to a failure to dispose of such Product in which case Customer will deliver to Albemarle an appropriate certificate accordance with Applicable Law, and shall provide all manifests and other applicable evidence of destruction. If Albemarle requests, Customer will make its personnel available on a reasonable basis to work with Albemarle in order to assist Albemarle in determining the reason for the non-conformity and in developing remedial measuresproper destruction as may be required by Applicable Law.
Appears in 1 contract
Samples: Manufacturing Agreement (Columbia Laboratories Inc)