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 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 Licensee shall inspect all shipments of Product promptly upon receipt, and replace the entire Delivery containing the non-conforming Batch with conforming shall notify Exelixis in writing in reasonable detail within [ * ] of receipt if Licensee is rejecting any Product that fails to conform to Exelixis’ warranties set forth in Sections 8.2(a) or 8.2(b). All Product not rejected within such [ * ] period will be deemed accepted. (ii) If Licensee notifies Exelixis of any nonconformity of any Product in accordance with this AgreementSection 2.5(b)(i), Exelixis shall have the right to inspect the Product in question and Licensee shall cooperate with Exelixis’ inspection, including providing Exelixis with samples of the Product in question for testing upon request. If Exelixis agrees with such notice of nonconformity, Exelixis shall, at its discretion and expense, either: (i) replace such Product, at no additional expense to Licensee, as soon as reasonably practicable after receipt of notification of such nonconformity or (ii) refund to Xencor all payments made by Xencor for any portion of the Delivery containing applicable Transfer Price that has already been paid. (iii) In the non-conforming Batch. If Cardinal Health in good faith event that Exelixis disagrees with Licensee that a Product does not agree with Xencor’s determination conform to Exelixis’ warranties set forth in Sections 8.2(a) or 8.2(b), or considers that [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. the rejected Batch is a non-conforming Batchdefect was caused by occurrences after the delivery of the Product to Licensee, then after reasonable efforts to resolve the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party it may submit require a sample of such Batch the allegedly nonconforming Product to […***…] be delivered to a mutually acceptable independent testing laboratory for testing or, in the case of a dispute concerning compliance with GMP, an independent consultant for evaluation. Except in the case of manifest error, the determination of the laboratory or another mutually agreed upon independent third party laboratory consultant as to determine whether the Batch has been properly rejected under Section 3.7. The independent laboratory’s determination shall Product is nonconforming will be final and binding on both partiesthe Parties. If The fees and expenses of such laboratory testing or consultant, as the independent laboratory determines that the Batch has been properly rejected under Section 3.7case may be, 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 entirely by (i) Cardinal Healththe Party against whom such laboratory’s or consultant’s determination is made. If, as the case may be, such determination is against Exelixis, then Exelixis shall either refund the Transfer Price paid by Licensee for such Product or replace such Product, at no additional cost to Licensee, as soon as reasonably possible, but in no event later than [ * ] if the non-conforming Batch replacement Product stock is the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWavailable, or (ii) Xencorif replacement Product stock is unavailable at such time, if as soon as reasonably practical after it becomes available. If, as the non-conforming Batch case may be, such determination is not the result of Cardinal Health’s gross negligenceagainst Licensee, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWthen such Product shall be deemed accepted by Licensee.

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 Licensee shall inspect all shipments of Product promptly upon receipt, and replace the entire Delivery containing the non-conforming Batch with conforming shall notify Exelixis in writing in reasonable detail within [ * ] of receipt if Licensee is rejecting any Product that fails to conform to Exelixis’ warranties set forth in Sections 8.2(a) or 8.2(b). All Product not rejected within such [ * ] period will be deemed accepted. (ii) If Licensee notifies Exelixis of any nonconformity of any Product in accordance with this AgreementSection 2.5(b)(i), Exelixis shall have the right to inspect the Product in question and Licensee shall cooperate with Exelixis’ inspection, including providing Exelixis with samples of the Product in question for testing upon request. If Exelixis agrees with such notice of nonconformity, Exelixis shall, at its discretion and expense, either: (i) replace such Product, at no additional expense to Licensee, as soon as reasonably practicable after receipt of notification of such nonconformity or (ii) refund to Xencor all payments made by Xencor for any portion of the Delivery containing applicable Transfer Price that has already been paid. (iii) In the non-conforming Batch. If Cardinal Health in good faith event that Exelixis disagrees with Licensee that a Product does not agree with Xencor’s determination conform to Exelixis’ warranties set forth in Sections 8.2(a) or 8.2(b), or considers that the rejected Batch is a non-conforming Batchdefect was caused by occurrences after the delivery of the Product to Licensee, then after reasonable efforts to resolve the disagreement, not to exceed […***…] following such Batch’s rejection by Xencor, either party it may submit require a sample of such Batch the allegedly nonconforming Product to […***…] be delivered to a mutually acceptable independent testing laboratory for testing or, in the case of a dispute concerning compliance with GMP, an independent consultant for evaluation. Except in the case of manifest error, the determination of the laboratory or another mutually agreed upon independent third party laboratory consultant as to determine whether the Batch has been properly rejected under Section 3.7. The independent laboratory’s determination shall Product is nonconforming will be final and binding on both partiesthe Parties. If The fees and expenses of such laboratory testing or consultant, as the independent laboratory determines that the Batch has been properly rejected under Section 3.7case may be, 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 entirely by (i) Cardinal Healththe Party against whom such laboratory’s or consultant’s determination is made. If, as the case may be, such determination is against Exelixis, then Exelixis shall either refund the Transfer Price paid by Licensee for such Product or replace such Product, at no additional cost to Licensee, as soon as reasonably possible, but in no event later than [ * ] if the non-conforming Batch replacement Product stock is the result of Cardinal Health’s gross negligence, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWavailable, or (ii) Xencorif replacement Product stock is unavailable at such time, if as soon as reasonably practical after it becomes available. If, as the non-conforming Batch case may be, such determination is not the result of Cardinal Health’s gross negligenceagainst Licensee, willful misconduct or breach of this Agreement, the Quality Agreement or the applicable SOWthen such Product shall be deemed accepted by Licensee.

Non-Conforming Product. In the event that any Product shall fail to strictly conform with the Specifications, Axxxxx shall reject such Product by giving written notice to NxStage within [ * ] days from the date of receipt of such Products at Axxxxx, or [ * ] of the discovery of any defect that could not be reasonably discovered by Axxxxx during such [ * ] day period following a diligent Product inspection; provided that such notice must, in any event, be provided within the first [ * ] months of the Product’s labelled shelf life when the average annual purchase volume is below [ * ] Units, and [ * ] months of the Product’s labelled shelf life when the average annual purchase volume exceeds [ * ] Units. Any notice given hereunder shall specify the manner in which the Product fails to conform with the Specifications. 5.4.1 If Cardinal Health agrees that it is determined by agreement of the Parties (or in the absence of agreement of the Parties by a Batch rejected mutually acceptable independent testing laboratory or consultant whose fees shall be paid by Xencor pursuant to Section 3.7 is the non-conforming and such prevailing Party) that the non-conformity is determined due to be damage to the result Product (i) caused by Axxxxx or its agents or (ii) which occurs subsequent to delivery of Cardinal Health’s gross negligencesuch Product to the carrier at the point of origin, willful misconduct NxStage shall have no liability to Axxxxx with respect thereto. If the non-conformity is caused by the negligence of NxStage or breach by NxStage of any term of this Agreement, the Quality Agreement or the applicable SOW, Cardinal Health NxStage shall, within […***…] after receiving as Axxxxx’ sole and exclusive remedy, for Product rejected pursuant to this Section 5.4, credit Axxxxx’ account the price invoiced for such non-conforming BatchProduct (including without limitation reimbursement to Axxxxx for the cost of any Fiber Bundles included in such non-conforming Product). If payment for non conforming Product has previously been made by Arbios, at its option and sole expenseAxxxxx’ option, either NxStage shall (i) re-perform pay Axxxxx the Services and replace amount of such credit (including without limitation reimbursement to Axxxxx for the entire Delivery containing the cost of any Fiber Bundles included in such non-conforming Batch Product), (ii) offset the amount thereof (including without limitation reimbursement to Axxxxx for the cost of any Fiber Bundles included in such non-conforming Product) against other amounts then due NxStage hereunder or (iii) replace such non-conforming Product with conforming Product in accordance with this Agreement, or at no additional cost to Arbios (ii) refund including without limitation reimbursement to Xencor all payments made by Xencor Arbios for the Delivery containing the non-conforming Batchcost of any Fiber Bundles needed to make such replacement Product). If Cardinal Health in good faith does For clarity, this section shall not agree with Xencorbe deemed to limit NxStage’s determination that the rejected Batch is a non-conforming Batch, then after reasonable efforts indemnification obligations pursuant 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 SOW11.3.

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.