Common use of Rejection and Cure Clause in Contracts

Rejection and Cure. If a shipment of Clinical Trial Products or any portion thereof (i) fails to conform to the applicable Product Specifications, (ii) was not Processed in accordance with applicable laws or regulations or GMP, or (iii) is delivered with a material shortage or any overage of Clinical Trial Products, then CTI shall have the right to reject such nonconforming shipment of Clinical Trial Products or the nonconforming portion thereof, as the case may be. CTI shall give written notice to Hercon of its rejection hereunder, within thirty (30) days after CTI’s receipt of such 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 rejection thereof, and in any event shall do so within ninety (90) days after the receipt of replacement Nitroglycerin Adhesive Mixture which shall be 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 sample of such Clinical Trial Products, together with mutually agreed upon questions, 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") obtained by such laboratory shall be final and binding upon the parties save for manifest error on the face of the laboratory’s report. The 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 laboratory testing, and all additional shipping and transportation costs incurred as a result of the dispute, shall be borne entirely by the party against whom such laboratory findings are made. In the event the Test Results indicate that the Clinical Trial Products in question do not conform to the Product Specifications, Hercon shall replace such Clinical Trial Products with conforming Clinical Trial Products in accordance with this 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, including, without limitation, costs for shipping, disposal, storage or cover, if applicable, of the nonconforming Clinical Trial Products.

Rejection and Cure. If a shipment of Clinical Trial Products Product or any portion thereof (i) fails to conform to the applicable Product Specificationscontains a Defect, (ii) was not Processed in accordance with applicable laws or regulations or GMP, or (iii) is delivered with a material shortage or any overage of Clinical Trial Products, then CTI Columbia shall have the right to reject such nonconforming Defective shipment of Clinical Trial Products Product or the nonconforming portion thereof, as the case may be. CTI shall give upon written notice to Hercon Fleet of its rejection hereunder, to be given within thirty (30) days after CTIColumbia’s receipt discovery of such shipmentDefect, 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 . After receipt of such shipment within sixty (60) days after CTI's discovery notice from Columbia, Fleet shall be permitted to analyze any Product rejected by Columbia regarding such Defect, at Fleet’s sole cost and expense, and to present its findings with respect to such 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 non-conformancelaboratory shall be binding. The nonconforming If the shipment of Clinical Trial ProductsProduct in question is determined to contain a Defect, or the nonconforming portion thereof, such Product shall be held for Hercon’s dispositionProduct Disposition, or shall be returned to HerconFleet, in each case at HerconFleet’s expense, as directed by HerconColumbia. Hercon Fleet shall use its commercially reasonable efforts to replace each nonconforming Defective shipment of Clinical Trial ProductsProduct, or the nonconforming portion thereof, with conforming Clinical Trial Products as soon as reasonably practicable after Product within thirty (30) days of the later of receipt of notice of rejection thereof, and in any event shall do so within ninety (90) days after the or expedited receipt of replacement Nitroglycerin Adhesive Mixture which out of stock raw materials, if any. Fleet shall be ordered no later than thirty bear one hundred percent (30100%) days after receipt of notice all costs including cost of rejection thereofdestruction of all rejected Product resulting from the fault or negligence of Fleet. In Columbia shall bear one hundred percent (100%) of all costs including cost of destruction of all rejected Product resulting from the event fault or negligence of a dispute regarding any non-conforming Clinical Trial Products which CTI and Hercon are unable to resolve, a sample of such Clinical Trial Products, together with mutually agreed upon questions, Columbia. Fleet shall be submitted by CTI to an independent laboratory reasonably acceptable to both parties for testing against the destroy rejected Product Specifications, and the test results ("Test Results") obtained by such laboratory shall be final and binding upon the parties save for manifest error on the face of the laboratory’s report. The 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 laboratory testing, and all additional shipping and transportation costs incurred as a result of the dispute, shall be borne entirely by the party against whom such laboratory findings are made. In the event the Test Results indicate that the Clinical Trial Products in question do not conform to the Product Specifications, Hercon shall replace such Clinical Trial Products with conforming Clinical Trial Products in accordance with this Section. Hercon all Applicable Laws, and shall reimburse CTI indemnify Columbia for all reasonable out-of-pocket charges that CTI incurred as a result of any liability, costs or expenses, including attorney’s fees and court costs, relating to any nonconforming Clinical Trial Productsa failure to dispose of such Product in accordance with Applicable Law, including, without limitation, costs for shipping, disposal, storage or cover, if applicable, and shall provide all manifests and other applicable evidence of the nonconforming Clinical Trial Productsproper destruction as may be required by Applicable Law.

Rejection and Cure. Upon Elutia or its customers’ use of Product, Elutia or its customers shall perform an initial physical inspection of such Product and review any related documentation. If a shipment batch of Clinical Trial Products Product (including without limitation any documentation related thereto) fails, in whole or any portion thereof (i) fails in part, to conform to the applicable Product Specifications, (ii) was not Processed in accordance with applicable laws then Elutia or regulations or GMP, or (iii) is delivered with a material shortage or any overage of Clinical Trial Products, then CTI its customers shall have the right to reject the batch which contains such nonconforming portion of the shipment of Clinical Trial Products Product (but, for clarity, not other batches included in such shipment). Elutia or the nonconforming portion thereof, as the case may be. CTI its customers shall give written notice to Hercon Purchaser of its rejection hereunderhereunder as soon as possible, within thirty (30) but in any event no more than [***] days after CTIElutia’s receipt or its customer’s use of such shipmentthe Product (the “Inspection Deadline”), specifying the grounds for such rejection, and if no such notice is received by Purchaser by the Inspection Deadline, Elutia or its customer (as applicable) shall be deemed to have accepted such Product and shall have no right to reject the Product under this Section 3.3; provided, however, 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 event such defect is latent applicable Order) nor (b) any nonconformance attributable to any action or was not obvious and could 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., if related to documentation) to Elutia’s reasonable satisfaction within [***] days of notification. If the nonconformance cannot be readily discovered from a physical inspection cured, Purchaser shall direct the disposition of the Clinical Trial Products shipment, CTI may give written notice to Hercon of nonconforming batch at its rejection of such shipment within sixty (60) days after CTI's discovery of such non-conformanceexpense. 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 Purchaser shall use its commercially reasonable efforts to replace each nonconforming shipment batch of Clinical Trial ProductsProduct with conforming Product. If Elutia or its customer returns nonconforming Product after paying for such nonconforming Product, Purchaser may, in its reasonable discretion (A) offset the 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 reimburse Elutia for any payments made for and expenses incurred in connection with the returned Product. Notwithstanding anything to the contrary in this Agreement, the provisions of this Section 3.3 provide Elutia’s sole remedy for any defect in Product, or failure of Product to meet the nonconforming portion thereofSpecifications, with conforming Clinical Trial Products as soon as to the extent that such defect or failure was reasonably practicable after receipt of notice of rejection thereof, and in discoverable by the Inspection Deadline (any event shall do so within ninety (90) days after the receipt of replacement Nitroglycerin Adhesive Mixture which shall be 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 resolvesuch failure, a sample of such Clinical Trial Products, together with mutually agreed upon questions, 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") obtained by such laboratory shall be final and binding upon the parties save for manifest error on the face of the laboratory’s report. The 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 laboratory testing, and all additional shipping and transportation costs incurred as a result of the dispute, shall be borne entirely by the party against whom such laboratory findings are made. In the event the Test Results indicate that the Clinical Trial Products in question do not conform to the Product Specifications, Hercon shall replace such Clinical Trial Products with conforming Clinical Trial Products in accordance with this 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, including, without limitation, costs for shipping, disposal, storage or cover, if applicable, of the nonconforming Clinical Trial Products“Detectable Nonconformance”).

Rejection and Cure. If a shipment of Clinical Trial Products Product or any portion thereof (i) fails to conform to the applicable Product Specifications, (ii) was not Processed in accordance with applicable laws has a Patent Defect or regulations or GMP, or (iii) is delivered with a material shortage or any overage of Clinical Trial ProductsLatent Defect, then CTI Purchaser shall have the right to reject such nonconforming shipment of Clinical Trial Products Product or the nonconforming portion thereof, as the case may be. CTI , in accordance with the following: 9.1.1 Purchaser shall give written notice to Hercon Seller of its rejection hereunder, within thirty (30) days after CTIPurchaser’s receipt of such shipmentshipment of any Product containing a Patent Defect, 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 . After receipt of such shipment within sixty (60) days after CTI's discovery notice from 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 parties cannot agree on whether the Product in question is nonconforming, 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 definitive results of such non-conformancelaboratory shall be binding. The nonconforming If the shipment of Clinical Trial ProductsProduct in question is determined to be nonconforming, or the such nonconforming portion thereof, Product shall be held for HerconSeller’s disposition, or shall be returned to HerconSeller, in each case at HerconSeller’s expense, as directed by HerconSeller. Hercon Seller shall use its commercially reasonable efforts Commercially Reasonable Efforts to replace each nonconforming shipment of Clinical Trial ProductsProduct, or the nonconforming portion thereof, with conforming Clinical Trial Products Product as soon as reasonably practicable after receipt of notice of rejection thereof, and in any event shall do so within ninety (90) days after the receipt of replacement Nitroglycerin Adhesive Mixture which shall be ordered no later than thirty (30) days after receipt of notice of rejection thereof. In If and to the event extent that the nominated independent laboratory determines that the rejected Product is conforming, 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 dispute regarding Latent Defect in any non-conforming Clinical Trial Products which CTI Product lot, it shall immediately notify the other Party and Hercon are unable to resolvethe batch involved, a sample of such Clinical Trial Products, together with mutually agreed upon questionsat Purchaser’s election, shall be submitted by CTI to an independent laboratory reasonably acceptable to both parties deemed rejected as of the date of such notice. Seller shall refund all moneys paid for testing against the shipment of Product Specifications, involved and the test results ("Test Results") obtained by such laboratory shall reimburse Purchaser for its costs of accepting returns from its customers and shall be final and binding upon the parties save for manifest error on the face of the laboratory’s report. The 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 laboratory testing, and all additional shipping and transportation costs incurred as a result of the dispute, shall be borne entirely by the party against whom such laboratory findings are made. In the event the Test Results indicate that the Clinical Trial Products in question do not conform to the Product Specifications, Hercon shall replace such Clinical Trial Products with conforming Clinical Trial Products in accordance with this Section. Hercon shall reimburse CTI responsible for all reasonable out-of-pocket charges costs reasonably incurred by Purchaser in recalling Product that CTI incurred as a result of or relating to any nonconforming Clinical Trial Products, including, without limitation, costs for shipping, disposal, storage or cover, if applicable, of the nonconforming Clinical Trial Productshave Latent Defects.