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. Xxxx shall inspect the Product that is 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 Product, or any portion thereof, is from visual inspection 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 Product. If no notice of rejection is given by Xxxx within such [*] period or with respect to a shipment of Product, 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 which case Xxxx shall have the right to reject the shipment within [*] of the discovery of such latent defect, but in no event later than [*] following the date on which Xxxx receives from Corium the invoice relating to such shipment of Product. For the avoidance of doubt, Xxxx shall have no obligation to inspect any shipment beyond ordinary visual inspection. In the event of any rejection pursuant to this Section 8.8, [*]. 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 *Confidential Treatment Requested.
Non-Conforming Product. Supplier must notify X X Xxxx of any significant Non conformance which affects the product. Concessions can only be granted with Main customer approval and must be signed by X X Xxxx and Supplier. Copy of concession to be held by X X Xxxx and xxxxxxxx. Approval of procedures Any procedures requiring approval will be notified to supplier in PO. Two copies of Procedures must be forwarded to X X Xxxx for approval. After approval signed copy will be returned to Supplier. Approval of processes Any processes requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. NOTE: Supplier must use customer-approved special process sources when notified by X X Xxxx. Details of source/s will be forwarded to Supplier as part of purchasing process. X X Xxxx will visit supplier to approve processes, as appropriate. NOTE: It is a requirement that the supplier notifies X X Xxxx of any process changes which may affect the product/service ordered by X X Xxxx. This is of utmost importance if change affects a Key Characteristic. Approval of Changes Any changes in product and/or process, changes of suppliers, changes of manufacturing facility location, including any approval registrations/certificates i.e. ISO 9001 or AS9100. Where required, XX Xxxx must be informed prior to any change being completed. Approval of equipment Any equipment requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. Approval can be achieved by forwarding machine capability studies as appropriate. Supplier will be notified by X X Xxxx of approval. Certificate of Conformance (C of C) Requirement for C of C will be stated in PO C of C must be signed by Supplier’s Quality representative and state that products/materials have been inspected and or tested and meet X X Xxxx and/or customer specification. Counterfeit product Requirement for assuring traceability of parts and components to their original or authorised manufacturers. XX Xxxx must be informed of any Reporting and quarantining of suspected or detected counterfeit parts which could impact on product conformance Material Test Certificates Requirement for Mill Certificate will be stated in PO. Mill Certificate must be forwarded to X X Xxxx for all metals. Qualifications of personnel Any specific Qualification relating to personnel will be stated in PO. Qualification of personnel will only apply when specified by X X Xxxx Customer. Record Control All records created by and...
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. Where Purchaser asserts that Product is non-conforming for any reason, including for not complying with this Agreement or not meeting an applicable Specification or warranty, prompt notice will be communicated to the Supplier’s SA Contact. The Parties will cooperate to review the situation and undertake reasonable investigation and analysis to determine whether a non-conformance exists and potential root causes or corrective actions. If Purchaser requests additional investigation that exceeds historical service levels it may initiate a request under the appropriate Ancillary Agreement for a project to be opened to conduct the assessment. Any non-conforming Product will be held by Purchaser at Supplier’s risk. At Supplier’s request and cost, Purchaser will either return or properly dispose of non-conforming Product, including any portion thereof that Supplier may require for testing or analysis.
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.
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.
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. (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.
