Common use of Non-Conforming Product Clause in Contracts

Non-Conforming Product. If Cardinal Health agrees that 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 gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOW, Cardinal Health shall, within […***…] after receiving the non-conforming Batch, at its option and sole expense, either (i) re-perform the Services and replace the entire Delivery containing the non-conforming Batch with conforming Product in accordance with this Agreement, or (ii) refund to Xencor all payments made by Xencor for the Delivery containing the non-conforming Batch. If Cardinal Health in good faith does not agree with Xencor’s determination that the rejected Batch is a non-conforming Batch, then after reasonable efforts to resolve the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party may submit a sample of such Batch to […***…] or another mutually agreed upon independent third party laboratory to determine whether the Batch has been properly rejected under Section 3.7. The independent laboratory’s determination shall be final and binding 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 in writing, the costs associated with testing and review by the independent laboratory shall be borne by (i) Cardinal Health, if the non-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 (ii) Xencor, if the non-conforming Batch is not the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the 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 that a Batch rejected by Xencor pursuant with Client’s determination, Client shall not be responsible to Section 3.7 is non-conforming pay for such batch (the “Defective Product”), and such non-conformity is determined to be the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOW, Cardinal Health shall, within […***…] after receiving the at Reliant’s option, either (A) replace any Batch of non-conforming Batch, at its option and sole expense, either (i) re-perform the Services and replace the entire Delivery containing the non-conforming Batch with conforming Product in accordance with this AgreementProduct, or (iiB) refund to Xencor all credit any payments made by Xencor Reliant for the Delivery containing the non-conforming such Batch. If Cardinal Health in good faith does not agree with XencorReliant’s determination that such Product fails to meet the rejected Batch is a non-conforming Batchwarranty set forth in Section 13.1, then after reasonable efforts to resolve the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party may submit the Parties shall cause a sample of such Batch to […***…] or another mutually agreed upon acceptable independent third party laboratory to determine whether review records, test data and to perform comparative tests and/or analyses on the Batch has been properly rejected under Section 3.7Manufacturing Sample. The results of the independent laboratory’s determination review shall be final and binding 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 14.9binding. 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-conforming Batch is the result of Cardinal Health’s gross negligenceprevailing 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, willful misconduct or breach of this AgreementSUBJECT TO THE LIMITATIONS IN ARTICLE 15.1, the Quality Agreement or the applicable SOWSHALL 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, or (ii) Xencor, if the non-conforming Batch is not the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWEXPRESS OR IMPLIED.

Non-Conforming Product. If Reliant notifies Cardinal Health during the Review Period that the Sample does not conform to the warranty set forth in Section 13.1 and Cardinal Health agrees that a Batch rejected by Xencor pursuant with Client’s determination, Client shall not be responsible to Section 3.7 is non-conforming pay for such batch (the “Defective Product”), and such non-conformity is determined to be the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOW, Cardinal Health shall, within […***…] after receiving the at Reliant’s option, either (A) replace any Batch of non-conforming Batch, at its option and sole expense, either (i) re-perform the Services and replace the entire Delivery containing the non-conforming Batch with conforming Product in accordance with this AgreementProduct, or (iiB) refund to Xencor all credit any payments made by Xencor Reliant for the Delivery containing the non-conforming such Batch. If Cardinal Health in good faith does not agree with XencorReliant’s determination that such Product fails to meet the rejected Batch is a non-conforming Batchwarranty set forth in Section 13.1, then after reasonable efforts to resolve the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party may submit the parties shall cause a sample of such Batch to […***…] or another mutually agreed upon acceptable independent third party laboratory to determine whether review records, test data and to perform comparative tests and/or analyses on the Batch has been properly rejected under Section 3.7Sample. The results of the independent laboratory’s determination review shall be final and binding 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 14.9binding. Unless otherwise agreed to by the 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-conforming Batch is the result of Cardinal Health’s gross negligenceprevailing 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, willful misconduct or breach of this AgreementSUBJECT TO THE LIMITATIONS IN ARTICLE 15.1, the Quality Agreement or the applicable SOWSHALL BE RELIANT’S SOLE AND EXCLUSIVE REMEDY (WITHOUT PREJUDICE TO ANY 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, or (ii) Xencor, if the non-conforming Batch is not the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWEXPRESS OR IMPLIED.

Non-Conforming Product. If Cardinal Health agrees that a Batch rejected by Xencor pursuant 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 3.7 is non-conforming 5.1. Advancis will use validated methods to test Product. Advancis will notify Lilly in writing promptly, and such non-conformity is determined to be the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOW, Cardinal Health shall, within in any event not later than […***…] after receiving receipt thereof at an Advancis distribution center if it rejects any Product delivered to it because such Product failed to meet the non-conforming BatchSpecifications. If Advancis rejects any such Product Lilly and Advancis will conduct a joint investigation to determine the cause. Lilly shall have the right, at its option request and sole at its expense, either (i) re-perform the Services 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 entire Delivery containing 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 non-conforming Batch with conforming Purchase Price of such nonconforming Product but will pay Lilly the Purchase Price for the replacement Product in accordance with this AgreementSection 2.3; provided, or (ii) refund however, that to Xencor all payments made by Xencor the extent Advancis previously paid for the Delivery containing the non-conforming Batch. If Cardinal Health in good faith does not agree with Xencor’s determination that the rejected Batch is a non-conforming Batch, then after reasonable efforts to resolve the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party may submit a sample of such Batch to […***…] or another mutually agreed upon independent third party laboratory to determine whether the Batch has been Product it properly rejected under Section 3.7. The independent laboratory’s determination shall be final and binding 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 this Section 5.3(a), Advancis will receive a credit against the terms of Purchase Price for replacement Product. Product properly rejected in accordance with this Section 14.9. Unless otherwise agreed 5.3(a) will not be applied to by the parties in writingapplicable Purchase Maximums, the costs associated with testing and review by the independent laboratory shall be borne by (i) Cardinal Health, if the non-conforming Batch is the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWpurchase obligation set forth in Section 2.2, or (ii) Xencor, if the non-conforming Batch is not the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWbut replacement Product will be so applied.

Non-Conforming Product. If Cardinal Health agrees that a Batch rejected by Xencor pursuant to Section 3.7 is non-conforming and such non-conformity is determined to NEOSAN will be the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOW, Cardinal Health shall, within […***…] after receiving the non-conforming Batchentitled, at its option 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, either (i) re-perform 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 Services and replace Purchase Price of such nonconforming Product but will pay Lilly the entire Delivery containing Purchase Price for the non-conforming Batch with conforming replacement Product in accordance with this AgreementSection 2.3, or (ii) refund above; provided, however, that to Xencor all payments made by Xencor the extent NEOSAN previously paid for the Delivery containing the non-conforming Batch. If Cardinal Health in good faith does not agree with Xencor’s determination that the rejected Batch is a non-conforming Batch, then after reasonable efforts to resolve the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party may submit a sample of such Batch to […***…] or another mutually agreed upon independent third party laboratory to determine whether the Batch has been Product it properly rejected under Section 3.7. The independent laboratory’s determination shall be final and binding 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 this Section 5.3(a), NEOSAN will receive a credit against the terms of Purchase Price for replacement Product. Product properly rejected in accordance with this Section 14.9. Unless otherwise agreed 5.3(a) will not be applied to by the parties in writingapplicable Purchase Maximums, Purchase Minimums, the costs associated with testing and review by purchase obligation set forth in Section 2.2, or the independent laboratory shall minimum purchase or maximum supply obligations set forth in Section 4.4(a); but replacement Product will be borne by (i) Cardinal Healthapplied to the applicable Purchase Maximums, if the non-conforming Batch is the result of Cardinal Health’s gross negligence, willful misconduct or breach of this AgreementPurchase Minimums, the Quality Agreement purchase obligations set forth in Section 2.2, and the minimum purchase or the applicable SOW, or (ii) Xencor, if the non-conforming Batch is not the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWmaximum supply obligations set forth in Section 4.4(a).

Non-Conforming Product. If Reliant notifies Cardinal Health during the Review Period that the Sample does not conform to the warranty set forth in Section 13.1 and Cardinal Health agrees that a Batch rejected by Xencor pursuant with Client’s determination, Client shall not be responsible to Section 3.7 is non-conforming pay for such batch (the “Defective Product”), and such non-conformity is determined to be the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOW, Cardinal Health shall, within […***…] after receiving the at Reliant’s option, either (A) replace any Batch of non-conforming Batch, at its option and sole expense, either (i) re-perform the Services and replace the entire Delivery containing the non-conforming Batch with conforming Product in accordance with this AgreementProduct, or (iiB) refund to Xencor all credit any payments made by Xencor Reliant for the Delivery containing the non-conforming such Batch. If Cardinal Health in good faith does not agree with XencorReliant’s determination that such Product fails to meet the rejected Batch is a non-conforming Batchwarranty set forth in Section 13.1, then after reasonable efforts to resolve the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party may submit the parties shall cause a sample of such Batch to […***…] or another mutually agreed upon acceptable independent third party laboratory to determine whether review records, test data and to perform comparative tests and/or analyses on the Batch has been properly rejected under Section 3.7Sample. The results of the independent laboratory’s determination review shall be final and binding 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 14.9binding. Unless otherwise agreed to by the 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-conforming Batch is the result of Cardinal Health’s gross negligenceprevailing 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, willful misconduct or breach of this AgreementSUBJECT TO THE LIMITATIONS IN ARTICLE 15.1, the Quality Agreement or the applicable SOWSHALL 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, or (ii) Xencor, if the non-conforming Batch is not the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWEXPRESS OR IMPLIED.

Non-Conforming Product. If Cardinal Health agrees that SPA will have a Batch rejected by Xencor period of ten (10) Business Days from the date of its receipt of a shipment of Drug Substance and Drug Product to inspect and reject such shipment for non-conformance with the obligations under this Section 2.3.2 and the warranties of RTU pursuant to Section 3.7 is non9.7 including the Specifications based on SPA’s (or SPA designee’s) normal incoming-conforming and goods inspections procedures, by providing RTU with written notice of rejection for any Product Defect within such non-conformity is determined to be the result period of Cardinal Health’s gross negligence, willful misconduct or breach ten (10) Business Days together with samples of this Agreement, the Quality Agreement or the applicable SOW, Cardinal Health shall, within […***…] after receiving the non-conforming Batchor Drug Substance and Drug Products in the relevant shipment for testing. In the case of Product with Latent Defects, at its option SPA will promptly, and sole expensein no event more than ten (10) Business Days of SPA knowing of any such Latent Defect, either notify RTU of such Latent Defect; provided however, that any Latent Defect must be notified no later than one (i1) re-perform month following the Services expiry date of the applicable Drug Substance and replace the entire Delivery containing Drug Product, together with samples of the non-conforming Batch with conforming Product Drug Substance and Drug Products in accordance with this Agreement, or (ii) refund to Xencor all payments made by Xencor the relevant shipment for the Delivery containing the non-conforming Batchtesting. If Cardinal Health in good faith does not agree with Xencor’s determination RTU determines that such shipment did conform to the rejected Batch is a non-conforming Batchwarranties of RTU for product pursuant to Section 9.7, then after reasonable efforts to resolve the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party may Parties will submit a sample samples of such Batch shipment to […***…] or another a mutually agreed upon acceptable independent third party laboratory to determine whether the Batch has been properly rejected under Section 3.7. The independent laboratory’s determination shall be final and binding on both partiesfor testing. If the such independent laboratory determines that the Batch has been properly rejected under shipment conformed to the warranties of RTU for Drug Substance and Drug Product pursuant to Section 3.79.7 including the Specifications and was not affected by a Product or Latent Defect, but the parties do not agree on whether or not SPA will bear all expenses of shipping and testing by 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 in writing, the costs associated with testing and review by the independent laboratory shall of such shipment samples. If RTU or such independent laboratory confirms that such shipment did not meet the warranties of RTU for product pursuant to Section 9.7 including the Specifications, RTU will, as soon as practicable, give SPA a credit for any amount paid with respect to that portion of the Drug Substance or Drug Product which does not conform and will bear all of SPA’s expenses of returning such Drug Substance or Drug Product to RTU or its nominee. RTU or SPA, as directed by RTU, will dispose of any non-conforming portion of any shipment, at RTU’s expense. The costs of the activities of any such independent laboratory will be borne by (i) Cardinal Healththe Party in error. [*] = Certain confidential information contained in this document, if marked by brackets, is filed with the non-conforming Batch is the result Securities and Exchange Commission pursuant to Rule 24b-2 of Cardinal Health’s gross negligenceThe Securities Exchange Act of 1934, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOW, or (ii) Xencor, if the non-conforming Batch is not the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWas amended.

Non-Conforming Product. If Cardinal Health agrees that a Batch rejected Bulk Product supplied hereunder shall be produced by Xencor pursuant Solvay in accordance with applicable laws and regulations and Good Manufacturing Practices, to Section 3.7 meet the Specification. COR may reject any shipment of Bulk Product which is (a) not conforming with the Specification or (b) adulterated or misbranded within the meaning of the United States Federal Food, Drug and Cosmetic Act. Any notice of rejection of non-conforming and such non-conformity is determined Bulk Product must be submitted to be the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOW, Cardinal Health shall, Solvay within […***…] after receiving shipment, accompanied by a report of analysis (including a product sample from the lot analyzed) prepared according to the Specification. If no such notice of rejection of non-conforming BatchBulk Product is received, at its option and sole expense, either (i) re-perform the Services and replace the entire Delivery containing the COR shall be deemed to have accepted such delivery of Bulk Product. After notice of rejection of non-conforming Batch Bulk Product is given, COR shall cooperate with conforming Product Solvay in accordance with this Agreement, determining whether rejection is necessary or (ii) refund to Xencor all payments made by Xencor justified. Solvay shall notify COR as promptly as reasonably possible whether or not it accepts COR's basis for the Delivery containing the non-conforming Batchany rejection. If Cardinal Health in good faith Solvay disagrees with COR's determination that certain Bulk Product does not agree with Xencor’s determination that meet the rejected Batch is Specification, such Bulk Product shall be submitted to a non-conforming Batch, then after reasonable efforts to resolve mutually acceptable third party laboratory; the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party may submit a sample fees and expenses of such Batch to […***…] or another mutually agreed upon independent laboratory testing shall be borne entirely by the Party against whom such findings are made. Such third party laboratory to shall determine whether such Bulk Product meets the Batch has been properly rejected under Section 3.7. The independent Specifications and the Parties agree that such laboratory’s 's determination shall be final and binding on both partiesdeterminative. If the independent laboratory determines that the Batch has been properly rejected under Section 3.7, but the parties do not agree on whether 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 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 rejected Bulk Product. Bulk Product can only be reprocessed in accordance with validated reprocessing procedures described in the terms of Section 14.9. Unless otherwise drug master file, as agreed to by the parties in writing, the costs associated with testing and review by the independent laboratory shall be borne by (i) Cardinal Health, if the non-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 (ii) Xencor, if the non-conforming Batch is not the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWParties.

Non-Conforming Product. If Cardinal Health agrees that a Batch rejected 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 Xencor 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 12 Certain portions of this Exhibit have been omitted pursuant to Section 3.7 is a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Securities and Exchange Commission. (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-conforming 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 Licensee does not make a claim within such [*****] period, Licensee shall be deemed to have accepted the 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 is determined of the Product with Specifications; or (B) whether defects in the Product are attributable to be the result negligent acts or omissions of Cardinal Health’s gross negligence, willful misconduct Acorda or breach its Third Party manufacturers of this AgreementProduct, the Quality Agreement or the applicable SOW, Cardinal Health Parties shall, within […***…] thirty (30) days after receiving expiration of such ten (10) day period, appoint a mutually acceptable independent laboratory to undertake the non-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 Batchto 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 its option and sole expenseno additional cost to Licensee; otherwise, either (i) re-perform the Services and replace the entire Delivery containing the non-conforming Batch with Acorda shall invoice Licensee for such conforming Product in accordance with this AgreementSection 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 nonconformity was solely due to a fault of Licensee, then Licensee shall bear all costs of such destruction or (ii) refund return and Licensee shall not be entitled to Xencor all payments made by Xencor for the Delivery containing any credit as to the non-conforming Batch. If Cardinal Health Product; in good faith does not agree with Xencor’s determination the event that the rejected Batch is nonconformity was solely due to a non-conforming Batchfault of Acorda, then after reasonable efforts to resolve the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party may submit a sample Acorda shall bear all costs of such Batch to […***…] destruction or another mutually agreed upon independent third party laboratory to determine whether return; and otherwise, the Batch has been properly rejected under Section 3.7Parties shall equally share such costs. (v) The independent laboratory’s determination Product shelf-life shall be final and binding on both partiesas set forth in the Technical Agreement (as defined in the Elan Supply Agreement). 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 (d) THE PROVISIONS HEREIN SHALL BE ACORDA’S EXCLUSIVE LIABILITY AND LICENSEE’S SOLE REMEDY WITH RESPECT TO ACORDA’S FAILURE TO SUPPLY THE ORDERED QUANTITIES OF PRODUCT CONFORMING TO THE SPECIFICATIONS AND THE WARRANTIES HEREUNDER. 13 Certain portions of this Agreement; the Quality Agreement or the applicable SOWExhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, the parties shall submit such dispute to arbitration in accordance which are marked with brackets [ ] and an asterisk*, have been separately filed with the terms of Section 14.9Securities and Exchange Commission. Unless otherwise agreed to by the parties in writing, the costs associated with testing and review by the independent laboratory shall be borne by (i) Cardinal Health, if the non-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 (ii) Xencor, if the non-conforming Batch is not the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOW.5.4