Common use of Non-Conforming Product Clause in Contracts

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. 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 Clientthat a Batch rejected by Xencor pursuant to Section 3.7 is non-conforming and such non-conformity is determined to be the result of Cardinal Health’s determinationgross negligence, Client shall not be responsible to pay for such batch (willful misconduct or breach of this Agreement, the “Defective Product”)Quality Agreement or the applicable SOW, and Cardinal Health shall, within […***…] after receiving the non-conforming Batch, at Reliant’s optionits option and sole expense, either (Ai) re-perform the Services and replace any Batch of the entire Delivery containing the non-conforming ProductBatch with conforming Product in accordance with this Agreement, or (Bii) credit any refund to Xencor all payments made by Reliant Xencor for such the Delivery containing the non-conforming Batch. If Cardinal Health in good faith does not agree with ReliantXencor’s determination that such Product fails to meet the warranty set forth in Section 13.1rejected Batch is a non-conforming Batch, then after reasonable efforts to resolve the disagreement, the Parties shall cause not to exceed […***…] following such Batch’s rejection by Xencor, either party may submit a sample of such Batch to […***…] or another mutually acceptable agreed upon independent third party laboratory to review records, test data and to perform comparative tests and/or analyses on determine whether the Manufacturing SampleBatch has been properly rejected under Section 3.7. The results of the independent review laboratory’s determination shall be final and bindingbinding on both parties. If the independent laboratory determines that the Batch has been properly rejected under Section 3.7, but the parties do not agree on whether or not such failure is the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement; the Quality Agreement or the applicable SOW, the parties shall submit such dispute to arbitration in accordance with the terms of Section 14.9. Unless otherwise agreed to by the Parties parties in writing, the costs associated with such testing and review by the independent laboratory shall be borne by (i) Cardinal Health, if the non-prevailing Party. THE OBLIGATION OF CARDINAL HEALTH TO conforming Batch is the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOW, or (Aii) 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 BATCHXencor, SUBJECT TO THE LIMITATIONS IN ARTICLE 15.1if the non-conforming Batch is not the result of Cardinal Health’s gross negligence, 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 WARRANTYwillful misconduct or breach of this Agreement, EXPRESS OR IMPLIEDthe Quality Agreement or the applicable SOW.

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 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 parties in writing, the costs associated with such testing and review shall be borne by the non-prevailing Partyparty. 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 INDEMINIFICATION 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. Upon receiving a written request from DAS, SP will rework or, if necessary, remanufacture a new Product lot to replace any Non-conforming Product lot. If Reliant notifies Cardinal Health during the Review Period SP agrees that the Manufacturing Sample Product in question is Non-conforming Product as a result of an error or omission by SP, it shall promptly pay to DAS the Reimbursement Amount. At DAS' option, (i) SP shall be relieved of any obligation to deliver any substitute Product with respect to the Non-conforming Product lot, or (ii) SP shall use best efforts to replace the Non-conforming Product with substitute Product that conforms with the Specifications and any other requirements of this Agreement as soon as reasonably possible, in which case DAS shall pay SP for the substitute Product in accordance with the Pricing Appendix and this Agreement. SP shall dispose of any Non-conforming Product which is the result of an error or omission of SP at its own expense. DAS shall pay for disposal of all Non-conforming [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Product which is not due to the error or omission of SP, and which occurs after the Product is surrendered by SP for shipping to DAS or its representatives. 4.1 If SP does not agree that the Product is Non-conforming Product as a result of an error or omission by SP, the parties shall timely consult with each other and attempt to resolve the discrepancies. If the parties cannot resolve the discrepancies in a timely manner, they shall promptly nominate an independent, reputable laboratory, which shall carry out appropriate analyses with respect to such Product to determine if it conforms to the Specifications. If the results conclude that the Product conformed to the Specifications, DAS will be responsible for all amounts owed to the laboratory and shall not be entitled to the Reimbursement Amount. If the results conclude that the Product did not conform to the warranty set forth in Section 13.1 and Cardinal Health agrees with Client’s determinationSpecifications, Client as a result of an error or omission by SP, SP shall not be responsible for all amounts owed to Laboratory and shall promptly pay for such batch (DAS 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 IMPLIEDReimbursement Amount.

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 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 parties in writing, the costs associated with such testing and review shall be borne by the non-prevailing Partyparty. 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. Subject to Elan’s rights under Clause 6 of the Elan Supply Agreement and the rights of the Second Source (as defined in the Elan Supply Agreement) under any Acorda Supply Agreement, including the mechanisms and time frames for the resolution of any disputes: (i) Within (A) [*****] after delivery of an order of Product to Licensee or (B) [*****] of Licensee’s discovery of an issue with Product following Licensee’s acceptance of Product which issue cannot be ascertained by reviewing the Documentation or the exercise of reasonable diligence (including the performance of the routine testing protocol to be agreed in the Quality Agreement) by Licensee upon receipt of such Product (such issue, a “Latent Defect”), Licensee shall notify Acorda in writing if such Product does not comply with the Specifications at the time of delivery to Licensee and shall provide Acorda with reasonable details of the alleged non-conformance and supporting evidence and upon Acorda’s request permit Acorda to re-test the Product. Licensee shall only make such claims in good faith. If Reliant notifies Cardinal Health during Licensee does not make a claim within such [*****] period, Licensee shall be deemed to have accepted the Review Period Product. (ii) If Acorda does not agree with the substantiating evidence provided by Licensee, Acorda shall provide Licensee with a written notice of such disagreement within twenty-five (25) days of receipt of Licensee’s notice of non-conformance, responding to Licensee’s claim. The Parties shall use Commercially Reasonable Efforts to resolve such disagreement within ten (10) days of Licensee’s receipt of notice from Acorda of such disagreement. In the event of an unresolved dispute as to (A) conformity of the Product with Specifications; or (B) whether defects in the Product are attributable to the negligent acts or omissions of Acorda or its Third Party manufacturers of Product, the Parties shall, within thirty (30) days after expiration of such ten (10) day period, appoint a mutually acceptable independent laboratory to undertake the relevant testing and its findings shall be conclusive and binding upon the Parties. All costs relating to this process shall be borne solely by the Party whose testing was in error. (iii) If the Parties agree or the independent laboratory’s analysis confirms that Licensee’s complaint was valid, Acorda shall use Commercially Reasonable Efforts to supply to Licensee, as promptly as reasonably practicable, the remaining quantity of the Product conforming to the relevant Specifications. If Licensee has already paid for the conforming quantity of Product Acorda initially failed to supply, then such additional or replacement quantity shall be provided by Acorda at no additional cost to Licensee; otherwise, Acorda shall invoice Licensee for such conforming Product in accordance with Section 6.2. (iv) Any nonconforming Product shall either be destroyed by Licensee or returned to Acorda for destruction by Acorda, according to Acorda’s instructions. In the event that the Manufacturing Sample does not conform nonconformity was solely due to the warranty set forth in Section 13.1 a fault of Licensee, then Licensee shall bear all costs of such destruction or return and Cardinal Health agrees with Client’s determination, Client Licensee shall not be responsible entitled to pay for such batch (any credit as to 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 ; in the event that such Product fails the nonconformity was solely due to meet the warranty set forth in Section 13.1a fault of Acorda, then after reasonable efforts to resolve the disagreementAcorda shall bear all costs of such destruction or return; and otherwise, 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. equally share such costs. (v) The results of the independent review Product shelf-life shall be final and binding. Unless otherwise agreed to by as set forth in the Parties Technical Agreement (as defined 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 (RECALLElan Supply Agreement)) UNDER THIS ARTICLE FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.

Non-Conforming Product. Advancis 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 and the labeling requirements of Section 5.1. Advancis will use validated methods to test Product. Advancis will notify Lilly in writing promptly, and in any event not later than [***] after receipt thereof at an Advancis distribution center if it rejects any Product delivered to it because such Product failed to meet the Specifications. If Reliant notifies Cardinal Health during Advancis rejects any such Product Lilly and Advancis will conduct a joint investigation to determine the Review Period cause. Lilly shall have the right, at its request and at its expense, the opportunity to conduct its own tests on such rejected Product. Product not rejected within [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. the [***] period will be deemed accepted and will constitute a waiver of any claims Advancis may have against Lilly with respect to payment for such shipment subject, however, to Advancis’ right to reject any Product for Latent Defects discovered by Advancis and promptly reported to Lilly after such stipulated period has expired. Lilly will use commercially reasonable efforts to replace any properly 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 Advancis. 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. Advancis 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; provided, however, that the Manufacturing Sample does not conform to the warranty extent Advancis previously paid for Product it properly rejected in accordance with this Section 5.3(a), Advancis 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, or the purchase obligation set forth in Section 13.1 and Cardinal Health agrees with Client’s determination2.2, Client shall not but replacement Product will 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 IMPLIEDso applied.

Non-Conforming Product. If Reliant notifies Cardinal Health during 8.3.1 FIRST HORIZON shall inspect each shipment of PRODUCT received hereunder as soon as practicable following receipt thereof. FIRST HORIZON shall be deemed to have accepted delivery of the Review Period that PRODUCT in good order and condition, unless FIRST HORIZON has notified BAYER in writing of any short delivery or nonconformity in respect of a shipment of PRODUCT with thirty (30) days following receipt of same. Notwithstanding the Manufacturing Sample does foregoing, in the case of any nonconformity which is not conform to the warranty set forth in Section 13.1 and Cardinal Health agrees readily apparent or discoverable upon reasonable inspection within such thirty (30) day period, any claim of nonconformity with Client’s determination, Client respect thereto shall not be responsible deemed waived and delivery of the PRODUCT shall not be deemed to pay for have been accepted if FIRST HORIZON notifies BAYER as soon as practicable, but no later than fifteen (15) days, following the date on which FIRST HORIZON learns of such batch (nonconformity. 8.3.2 Any claim of nonconformity hereunder shall be accompanied by a report of analysis of the “Defective Product”)allegedly nonconforming PRODUCT, and Cardinal Health which report shall be prepared by or on behalf of FIRST HORIZON. If, after analyzing a sample of such PRODUCT, BAYER, confirms FIRST HORIZON's claim of nonconformity, BAYER shall, replace the nonconforming PRODUCT with conforming PRODUCT at Reliant’s optionBAYER's expense. Pursuant to written directions from BAYER, FIRST HORIZON shall either (A) replace any Batch of non-conforming Productreturn the nonconfirming PRODUCT to BAYER, or (B) credit any payments made by Reliant for such Batchdestroy same, in each case, at BAYER's expense. If Cardinal Health BAYER's analysis 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 disagreementconfirm FIRST HORIZON's claim of nonconformity, the Parties PARTIES shall cause commence good faith discussions with a view to resolving the issue. In the event the issue cannot be resolved within thirty (30) days following the start of such discussions, a sample of the PRODUCT in dispute shall be submitted to an independent laboratory, mutually acceptable independent third party to review recordsaccepted by the PARTIES, test data and to perform comparative tests and/or analyses on the Manufacturing Samplefor testing. The results of such testing shall be binding upon the PARTY. The PARTY whose assertion as to the PRODUCT in question was not borne out by the results of the testing by the independent review laboratory shall be final bear all costs relating to such testing. 8.3.3 Notwithstanding anything to the contrary contained in this Article 8, BAYER's warranties and bindingindemnification obligations hereunder for latent defects of PRODUCTS shall survive the failure by FIRST HORIZON to reject any shipment of PRODUCT. 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.[***] - CONFIDENTIAL TREATMENT REQUESTED

Non-Conforming Product. If Reliant notifies Cardinal Health during Bulk Product supplied hereunder shall be produced by Solvay in accordance with applicable laws and regulations and Good Manufacturing Practices, to meet the Review Period that Specification. COR may reject any shipment of Bulk Product which is (a) not conforming with the Manufacturing Sample does not conform to Specification or (b) adulterated or misbranded within the warranty set forth in Section 13.1 meaning of the United States Federal Food, Drug 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 Cosmetic Act. Any notice of rejection of non-conforming ProductBulk Product must be submitted to Solvay within [*] after shipment, or accompanied by a report of analysis (Bincluding a product sample from the lot analyzed) credit any payments made by Reliant for such Batchprepared according to the Specification. If Cardinal Health no such notice of rejection of non-conforming Bulk Product is received, COR shall be deemed to have accepted such delivery of Bulk Product. After notice of rejection of non-conforming Bulk Product is given, COR shall cooperate with Solvay in determining whether rejection is necessary or justified. Solvay shall notify COR as promptly as reasonably possible whether or not it accepts COR's basis for any rejection. If Solvay disagrees with COR's determination that certain Bulk Product does not agree with Reliant’s determination that such Product fails to meet the warranty set forth in Section 13.1Specification, then after reasonable efforts such Bulk Product shall be submitted to resolve the disagreement, the Parties shall cause a mutually acceptable independent third party to review records, test data laboratory; the fees and to perform comparative tests and/or analyses on expenses of such laboratory testing shall be borne entirely by the Manufacturing SampleParty against whom such findings are made. The results of Such third party laboratory shall determine whether such Bulk Product meets the independent review Specifications and the Parties agree that such laboratory's determination shall be final and bindingdeterminative. Unless otherwise Whether or not Solvay accepts COR's basis for rejection, promptly on receipt of a notice of rejection of non-conforming Bulk Product, Solvay shall, at COR's request, use its best efforts to replace such rejected Bulk Product. Bulk Product can only be reprocessed in accordance with validated reprocessing procedures described in the drug master file, as 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 IMPLIEDParties.