Non-Conforming Product. (a) In the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period.
(b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.
Non-Conforming Product. If Reliant notifies Cardinal Health during the Review Period that the Manufacturing Sample does not conform to the warranty set forth in Section 13.1 and Cardinal Health agrees with Client’s determination, Client shall not be responsible to pay for such batch (the “Defective Product”), and Cardinal Health shall, at Reliant’s option, either (A) replace any Batch of non-conforming Product, or (B) credit any payments made by Reliant for such Batch. If Cardinal Health does not agree with Reliant’s determination that such Product fails to meet the warranty set forth in Section 13.1, then after reasonable efforts to resolve the disagreement, the Parties shall cause a mutually acceptable independent third party to review records, test data and to perform comparative tests and/or analyses on the Manufacturing Sample. The results of the independent review shall be final and binding. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the non-prevailing Party. THE OBLIGATION OF CARDINAL HEALTH TO (A) REPLACE DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY RELIANT FOR DEFECTIVE PRODUCT AND (B) REIMBURSE RELIANT FOR API LOST IN THE DEFECTIVE BATCH, SUBJECT TO THE LIMITATIONS IN ARTICLE 15.1, SHALL BE RELIANT’S SOLE AND EXCLUSIVE REMEDY (WITHOUT PREJUDICE TO ANY INDEMNIFICATION OBLIGATIONS UNDER SECTION 14.1 OR THE OBLIGATIONS OF SECTION 10.6 (RECALL)) UNDER THIS ARTICLE FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.
Non-Conforming Product. 14.1 Diaxonhit shall be deemed to have waived all claims for damage, defects and shortage relating to the Product supplied by XDx or the Designee unless such claims are notified to XDx in writing within fifteen (15) Working Days after delivery to Diaxonhit of the relevant shipment of Product; provided that in the event of a defect in the Product that could not reasonably have been detected by a customary inspection on delivery, Diaxonhit shall be deemed to have waived all claims for damage, defects and shortage related thereto unless such claims are notified to XDx within fifteen (15) Working Days of discovering such defect but not later than six (6) months from the date of delivery.
14.2 In the event of a dispute between the Parties as to any claimed shortage, damage or defect in the Product (including whether any such shortage, damage or defect occurred before or after delivery) that cannot be resolved within thirty (30) days of the claim being notified to XDx pursuant to clause 14.1, Diaxonhit and XDx shall within a further seven (7) days submit the batch of Product concerned to an independent expert to be mutually agreed between the Parties (the “Independent Expert”) who shall examine the Product concerned. The decision of the Independent Expert shall be binding upon the Parties and the costs of the Independent Expert shall be borne wholly by the Party against whom the Independent Expert decides.
14.3 Following a claim from Diaxonhit pursuant to clause 14.1, XDx shall, in the event that XDx accepts Diaxonhit’s claim as valid or in the event that the Independent Expert supports Diaxonhit’s claim, at XDx’s sole option, replace free of charge any damaged or defective Product or to give Diaxonhit credit for such Product. Any Product which is agreed or determined to be damaged or defective shall (at XDx’s option) be either returned to XDx or destroyed as specified by XDx, at XDx’s reasonable expense.
14.4 Subject to clause 22.1, in respect of claims for damage, defects or shortage referred to in clause 14.1, the remedies set out in clause 14.3 shall be Diaxonhit’s sole remedy; provided that this clause 14.4 shall not limit XDx’s obligations pursuant to clause 19.2(C) and 19.2 (D). Notwithstanding anything herein to the contrary, XDx shall have no liability for damage or defects to Product occurring after delivery thereof pursuant to clause 10.
Non-Conforming Product. Xxxx shall inspect the Products that are delivered by Corium pursuant to this Agreement according to Xxxx’x standard inspection guidelines, prior to their distribution and sale by Xxxx or sublicensees or distributors. If a shipment of Products, or any portion thereof, is adulterated, damaged, defective or otherwise non-conforming, then Xxxx shall have the right to reject such shipment, or the portion thereof that fails to so conform, as the case may be, upon written notice to Corium, specifying the grounds for such rejection, within [*] following the date on which Xxxx receives from Corium the invoice relating to such shipment of Products. If no notice of rejection is given by Xxxx within such [*] period or with respect to a shipment of Products, then such shipment shall be deemed to have been accepted; provided, however, that any failure to provide a notice of rejection by Xxxx shall not be deemed to be an acceptance in the event that any reason for rejection exists that could not be discovered during a reasonable inspection of such shipment. In the event of any such rejection[*]. If Corium agrees with Xxxx’x claim, [*]. If Xxxx and Corium are unable to resolve their differences, then either Xxxx or Corium may refer the matter to a certified analytical firm of international reputation independent of and acceptable to both Parties for final analysis using a sample from such shipment provided by Xxxx, which shall be binding on Xxxx and Corium. The fees and disbursements of such firm shall be paid by the Party whose contention is rejected by the firm.
Non-Conforming Product. SM may reject any batch of Product that does not conform to the Manufacturing Standards, subject to the terms of this Section. Within *** after SM’s receipt of Product and batch documents, SM shall inspect the Product and notify EDT whether it will accept or reject the Product. No inspection under this Section shall relieve EDT of its obligations and warranties under this Agreement. If SM rejects all or any part of any shipment of Product, the procedures to be followed are:
(a) SM shall submit to EDT in writing any claim that Product does not conform with the Specifications or Manufacturing Standards (including conformance to cGMPs), accompanied by a report of SM’s analysis (which analysis shall be conducted in good faith) and a sample of the Product at issue, explaining in reasonable detail the basis on which the allegedly nonconforming Product does not meet the Specifications or Manufacturing Standards. Until any dispute concerning nonconformance is resolved pursuant to (b) (ii) below, ***. Only those tests listed in the Specifications may be used to demonstrate nonconformance of Product from the Specifications.
(b) EDT shall conduct its own analysis of the Sample in good faith within *** after the receipt by EDT of the report and Sample from SM, and provide the results to SM.
(i) If after EDT’s own analysis of the Sample EDT agrees with the claim of nonconformity, SM shall promptly inform EDT if SM wishes to have EDT replace the nonconforming Product with conforming Product. If SM wishes to receive such replacement Product, EDT shall provide such replacement as soon as reasonably practicable thereafter, in which case SM shall be obligated to pay only for such replacement Product. SM shall not be obligated to pay for the nonconforming Product, and EDT shall:
(A) credit SM for the amount paid by SM to EDT for the nonconforming Product if SM has already paid for such nonconforming Product or *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
(B) cancel its invoice to SM for such nonconforming Product if SM has not yet paid for such nonconforming Product, and SM shall not be obligated to pay such canceled invoiced amount.
(ii) If, after its own analysis, EDT does not agree with the claim of nonconformity or determines that SM is responsible for the nonconformity, such Product shall be tested for conformance with the applicable Specifications or Manufacturing Standards by an ...
Non-Conforming Product. NEOSAN will be entitled, at its cost and expense and using the test methods set forth in the NDA, to test any and all Product delivered to it hereunder to determine whether such Product complies with the Specifications. NEOSAN will use validated methods to test Product. NEOSAN will notify Lilly in writing promptly, and in any event not later than thirty (30) days after delivery thereof if it rejects any Product delivered to it because such Product failed to meet the Specifications. If NEOSAN rejects any such Product it will, at Lilly's request, provide Lilly with the opportunity to conduct its own tests on such rejected Product. Product not rejected within the thirty (30) day period will be deemed accepted and will constitute a waiver of any claims NEOSAN may have against Lilly with respect to payment for such shipment subject, however, to NEOSAN's right to reject any Product for Latent Defects discovered by NEOSAN and promptly reported to Lilly after such stipulated period has expired. Lilly will use commercially reasonable efforts to replace the rejected Product with Product which meets the Specifications within a commercially reasonable time and will deliver such replacement Product, at Lilly's sole cost and expense, to NEOSAN. In addition, Lilly will, at Lilly's sole cost and expense, arrange for all such rejected Product to be picked up promptly and, where applicable, destroyed in accordance with all Applicable Laws. NEOSAN will have no responsibility to Lilly for the Purchase Price of such nonconforming Product but will pay Lilly the Purchase Price for the replacement Product in accordance with Section 2.3, above; provided, however, that to the extent NEOSAN previously paid for Product it properly rejected in accordance with this Section 5.3(a), NEOSAN will receive a credit against the Purchase Price for replacement Product. Product properly rejected in accordance with this Section 5.3(a) will not be applied to the applicable Purchase Maximums, Purchase Minimums, the purchase obligation set forth in Section 2.2, or the minimum purchase or maximum supply obligations set forth in Section 4.4(a); but replacement Product will be applied to the applicable Purchase Maximums, Purchase Minimums, the purchase obligations set forth in Section 2.2, and the minimum purchase or maximum supply obligations set forth in Section 4.4(a).
Non-Conforming Product. The agreement will contain provisions relating to the determination and replacement of nonconforming product and the use of a Third Party testing laboratory to resolve disputes relating to nonconforming product.
Non-Conforming Product. SBS shall not deliver to Voyager any Product that fails to conform in any respect to the warranty set forth in Section 5.4. In the event that any Product shall fail to pass the quality control testing conducted by SBS, (i) SBS shall notify Voyager thereof within one (1) business day, (ii) SBS shall not release the batch from which such Product was taken, and (iii) the parties shall agree upon appropriate corrective steps to be taken. Voyager, at its option, may investigate the cause of such failure, or require SBS to do so, in which case SBS shall provide Voyager with a written report summarizing the results of the SBS’s investigation, all at the expense of SBS.
Non-Conforming Product. Within thirty (30) days following Delivery of Product and copies of the relevant production batch records in English, including copies of the CoA, CoC, and BSE/TSE certification provided at Delivery, Customer shall determine whether the Product conforms to the Specifications and has been manufactured in material accordance with such batch records. If Customer determines that the Product fails to meet Specification, or was not produced in material accordance with the batch records Customer shall give WuXi written notice within such 30 day period and shall return such Product to WuXi’s premises, at WuXi’s expense, for further analysis. In the absence of such written notice, Product shall be deemed to have been accepted by Customer as meeting Specification and Customer has waived its right to revoke acceptance. If Customer reasonably demonstrates to WuXi that Product returned to WuXi fails to meet Specification or was not manufactured in material accordance with the batch records and that such failure is due to the negligence of WuXi and not due in whole or in part to the inherent property of the Product or Process, or acts or omissions of Customer or any third party after Delivery, WuXi shall at its option either refund that part of the Price that relates to the production of such non-conforming Product, or initiate a manufacturing run within sixty (60) calendar days from the date it was determined that the Product was non-conforming to replace such Product at its own cost and expense.
Non-Conforming Product. If any Supported Product fails to conform, or is alleged in good faith not to conform, to a warranty set forth in Section 3.3, SpinCo shall, at its sole cost and expense and at Parent’s election and sole discretion, either (a) replace such non-conforming Product or (b) refund the purchase price paid for such non-conforming Product by (i) Parent or relevant Service Provider Party if the non-conforming Product has not been sold to a Customer or (ii) the applicable Customer if the non-conforming Product has been sold to such Customer, as applicable, in each case within a reasonable time after the written notification of such non-conformance shall be delivered by Parent to SpinCo.
