Common use of Non-Conforming Product Clause in Contracts

Non-Conforming Product. If any Product does not meet the Product Specifications set forth in Schedule B or in the Quality Agreement set forth in Schedule C as determined by CEPHALON's testing and inspection of the Product, then solely at its option CEPHALON may, as its sole remedy, either (i) demand that CATALYTICA remanufacture or repackage (as appropriate) said Product at no charge to CEPHALON and pay all round-trip shipping charges to and from the destination of the original shipment as well as pay for that portion of the acquisition cost of the Active Ingredients and other materials supplied by CEPHALON to CATALYTICA hereunder which are used in such nonconforming Product and which are lost or otherwise rendered unusable as a result of CATALYTICA's producing non-conforming Product, or (ii) be relieved of any obligation to pay CATALYTICA the toll fees otherwise payable for the manufacture of said Product, and CATALYTICA shall reimburse CEPHALON for the reasonable costs incurred by CEPHALON in properly disposing of the Product, as well as that portion of the acquisition cost of the Active Ingredients and other materials supplied by CEPHALON to CATALYTICA hereunder which are used in such nonconforming Product. Any notice given hereunder shall specify the manner in which the Product fails to conform to the purchase order therefor or fails to meet such warranty or the Specifications. If it is determined that the nonconformity (a) is due to damage to the Product (i) caused by CEPHALON or its agents or (ii) which occurs subsequent to delivery of such Product to the carrier at the point of origin, or (b) results from Active Ingredients or other materials supplied by CEPHALON, CATALYTICA shall have no liability to CEPHALON with respect thereto and CEPHALON shall pay for such Product in accordance with the terms of this Agreement. Nothing herein shall be construed to limit CATALYTICA's obligations established in Section 6.1 hereof.

Non-Conforming Product. SM may reject any batch of Product that does not conform to the Manufacturing Standards, subject to the terms of this Section. Within *** after SM’s receipt of Product and batch documents, SM shall inspect the Product and notify EDT whether it will accept or reject the Product. No inspection under this Section shall relieve EDT of its obligations and warranties under this Agreement. If SM rejects all or any part of any shipment of Product, the procedures to be followed are: (a) SM shall submit to EDT in writing any claim that Product does not conform with the Specifications or Manufacturing Standards (including conformance to cGMPs), accompanied by a report of SM’s analysis (which analysis shall be conducted in good faith) and a sample of the Product at issue, explaining in reasonable detail the basis on which the allegedly nonconforming Product does not meet the Product Specifications set forth in Schedule B or Manufacturing Standards. Until any dispute concerning nonconformance is resolved pursuant to (b) (ii) below, ***. Only those tests listed in the Quality Agreement set forth in Schedule C as determined by CEPHALON's testing and inspection Specifications may be used to demonstrate nonconformance of Product from the Specifications. (b) EDT shall conduct its own analysis of the ProductSample in good faith within *** after the receipt by EDT of the report and Sample from SM, then solely at its option CEPHALON may, as its sole remedy, either and provide the results to SM. (i) demand that CATALYTICA remanufacture or repackage (as appropriate) said Product at no charge to CEPHALON and pay all round-trip shipping charges to and from the destination If after EDT’s own analysis of the original shipment Sample EDT agrees with the claim of nonconformity, SM shall promptly inform EDT if SM wishes to have EDT replace the nonconforming Product with conforming Product. If SM wishes to receive such replacement Product, EDT shall provide such replacement as well soon as reasonably practicable thereafter, in which case SM shall be obligated to pay only for such replacement Product. SM shall not be obligated to pay for that portion of the acquisition cost of nonconforming Product, and EDT shall: (A) credit SM for the Active Ingredients and other materials supplied amount paid by CEPHALON SM to CATALYTICA hereunder which are used in EDT for the nonconforming Product if SM has already paid for such nonconforming Product or *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and which are lost or otherwise rendered unusable as a result of CATALYTICA's producing non-conforming filed separately with the Commission. (B) cancel its invoice to SM for such nonconforming Product if SM has not yet paid for such nonconforming Product, or and SM shall not be obligated to pay such canceled invoiced amount. (ii) be relieved If, after its own analysis, EDT does not agree with the claim of any obligation to pay CATALYTICA the toll fees otherwise payable nonconformity or determines that SM is responsible for the manufacture nonconformity, such Product shall be tested for conformance with the applicable Specifications or Manufacturing Standards by an independent third party testing laboratory mutually acceptable to both parties. The independent analysis shall be binding on both Parties solely for the purpose of said Productdetermining whether such Product may be rightfully rejected. (c) After a final determination that the Product shipment is nonconforming, and CATALYTICA shall reimburse CEPHALON if EDT is responsible for the reasonable costs incurred by CEPHALON nonconformity, SM shall return or destroy it at EDT’s request and cost in properly disposing of the Productmost cost effective and environmentally safe and appropriate manner available, as well as that portion of the acquisition cost of the Active Ingredients consistent with federal, state and other materials supplied by CEPHALON to CATALYTICA hereunder which are used in such nonconforming Product. Any notice given hereunder shall specify the manner in which the Product fails to conform to the purchase order therefor or fails to meet such warranty or the Specifications. If it is determined that the nonconformity (a) is due to damage to the Product (i) caused by CEPHALON or its agents or (ii) which occurs subsequent to delivery of such Product to the carrier at the point of origin, or (b) results from Active Ingredients or other materials supplied by CEPHALON, CATALYTICA shall have no liability to CEPHALON with respect thereto local laws and CEPHALON shall pay for such Product in accordance with the terms of this Agreement. Nothing herein shall be construed to limit CATALYTICA's obligations established in Section 6.1 hereofregulations.

Non-Conforming Product. If (i) Except as expressly set forth herein to the contrary, Progenics may (before or after any payment therefor) reject all or any portion of a shipment of Product does not meet that is found to contain Non-conforming Product. Progenics shall give written notice to INIS, specifying the grounds for such rejection and providing a sample of such allegedly Non- conforming Product. Once declared to be Non-conforming Product Specifications in accordance with this Section 5.3(b), subject to final determination of the cGMP expert as set forth in Schedule B subsection (iii) below, such Product shall be deemed to be the property of INIS (including all risk of loss), and Progenics shall not be obligated to make any payment therefor. (ii) As promptly as practicable, but in any case within no more than thirty (30) days, after receipt of any shipment of Product, Progenics shall, or in shall cause its agent to, assess the Quality Agreement set forth in Schedule C as determined by CEPHALON's testing quantity and inspection visually inspect the quality of such Product to determine conformity of the Productshipment of Product with the applicable Purchase Order and identify any readily observable damage or defects and promptly notify INIS of any shortage or any such readily observable defect. If Progenics elects to undertake testing of any shipment of Product hereunder for conformity to the applicable Specifications, then solely at its option CEPHALON maysuch testing shall be undertaken within five (5) days, as its sole remedyand Progenics shall notify INIS of the results thereof in writing promptly upon completion of such testing. Notwithstanding the foregoing or anything to the contrary in this Agreement, either (i) demand that CATALYTICA remanufacture or repackage (Progenics may reject Product as appropriate) said Product at no charge to CEPHALON and pay all round-trip shipping charges to and from the destination of the original shipment as well as pay for that portion of the acquisition cost of the Active Ingredients and other materials supplied by CEPHALON to CATALYTICA hereunder which are used in such nonconforming Product and which are lost or otherwise rendered unusable as a result of CATALYTICA's producing nonNon-conforming Product, or (ii) be relieved Product on the basis of any obligation to pay CATALYTICA latent defect (which, in the toll fees otherwise payable for the manufacture of said Product, and CATALYTICA shall reimburse CEPHALON for the reasonable costs incurred by CEPHALON in properly disposing case that Progenics undertakes testing of the Product, as well as that portion of described above, is not readily discoverable through such testing) by written notice to INIS within thirty (30) days from the acquisition cost of the Active Ingredients date such defect was actually discovered, and other materials supplied by CEPHALON to CATALYTICA hereunder which are used in such nonconforming Product. Any notice given hereunder shall specify the manner in which the Product fails to conform to the purchase order therefor or fails to meet such warranty or the Specifications. If it is determined that the nonconformity (aii) is due to damage INIS’ warranties with respect to the Product and otherwise hereunder shall remain in effect notwithstanding any failure by Progenics to reject Product supplied hereunder. Any such notice shall describe in reasonable detail the defect or non-conformity and shall include samples of the Product being rejected and, if available, copies of written reports relating to tests, studies or investigations performed by or on behalf of Progenics on the Product being rejected. (iiii) caused If INIS in good faith disputes Progenics’ rejection of all or part of any shipment of Product, and such dispute is not resolved by CEPHALON or its agents or mutual agreement of the Parties within thirty (ii30) which occurs subsequent days of Progenics’ notice of rejection, such dispute shall be referred to delivery an independent, cGMP expert organization of recognized repute within the pharmaceutical industry reasonably acceptable to, and appointed by, both INIS and Progenics, for final assessment of product quality and acceptability. Such organization shall act as an expert and not as an arbitrator. The results of such Product to the carrier at the point of origin, or (b) results from Active Ingredients or other materials supplied by CEPHALON, CATALYTICA shall have no liability to CEPHALON with respect thereto and CEPHALON shall pay for such Product in accordance with the terms of this Agreement. Nothing herein assessment shall be construed to limit CATALYTICA's obligations established in Section 6.1 hereofbinding on Progenics and INIS and cannot be the subject of any appeal. The expense of hiring and fees and disbursements of such organization shall be paid by the Party whose position is rejected by such expert organization.

Non-Conforming Product. If any [1] Confidential treatment has been requested for the language which has been omitted. All such omitted material has been filed separately with the SEC. (a) The Bulk Product and Finished Product supplied by Genentech to Connetics hereunder shall be in conformance with the Specifications. Non-conformance of Bulk Product and Finished Product shall be proved by establishing non-conformity of the Bulk Product or Finished Product delivered as compared to the Specifications. Any claim by Connetics of non-conforming Bulk Product or Finished Product must be submitted to Genentech, in writing, within thirty (30) days after the delivery of Bulk Product or Finished Product and the accompanying Certificate of Analysis to Connetics, accompanied by a report of Connetics' analysis (which analysis shall be conducted in good faith) and a sample of the Bulk Product or Finished Product at issue, explaining in reasonable detail the basis on which the allegedly non-conforming Bulk Product or Finished Product does not meet the Product Specifications set forth in Schedule B or Specifications. Only those tests listed in the Quality Agreement set forth in Schedule C as determined by CEPHALONSpecifications may be used to demonstrate non-conformance of Bulk Product or Finished Product. (b) If after Genentech's testing and inspection own analysis of the sample (which shall be conducted in good faith and completed within thirty (30) days after the receipt by Genentech of the report and sample from Connetics, and the results of which shall be provided to Connetics) Genentech agrees with the claim of non-conformity, Connetics shall promptly inform Genentech if it wishes to have Genentech replace the non-conforming Bulk Product or Finished Product with conforming Bulk Product or Finished Product. If Connetics wishes to receive such replacement Bulk Product or Finished Product, then solely at its option CEPHALON mayGenentech shall provide such replacement as soon as reasonably practicable thereafter, as its sole remedyin which case Connetics shall be obligated to pay only for such replacement Bulk Product or Finished Product. Connetics shall not be obligated to pay for the nonconforming Bulk Product or Finished Product, either and Genentech shall: (i) demand that CATALYTICA remanufacture or repackage (as appropriate) said Product at no charge to CEPHALON and pay all round-trip shipping charges to and from credit Connetics for the destination of amount paid by Connetics for the original shipment as well as pay for that portion of the acquisition cost of the Active Ingredients and other materials supplied by CEPHALON to CATALYTICA hereunder which are used in such nonconforming Product and which are lost or otherwise rendered unusable as a result of CATALYTICA's producing non-conforming Product, Bulk Product or Finished Product if Connetics has already paid for such non-conforming Bulk Product or Finished Product or (ii) be relieved of any obligation cancel its invoice to pay CATALYTICA the toll fees otherwise payable Connetics for the manufacture of said such non-conforming Bulk Product or Finished Product if Connetics has not yet paid for such non-conforming Bulk Product or Finished Product, and CATALYTICA shall reimburse CEPHALON for the reasonable costs incurred by CEPHALON in properly disposing of the Product, as well as that portion of the acquisition cost of the Active Ingredients and other materials supplied by CEPHALON to CATALYTICA hereunder which are used in such nonconforming Product. Any notice given hereunder shall specify the manner in which the Product fails to conform to the purchase order therefor or fails to meet such warranty or the Specifications. If it is determined that the nonconformity (a) is due to damage to the Product (i) caused by CEPHALON or its agents or (ii) which occurs subsequent to delivery of such Product to the carrier at the point of origin, or (b) results from Active Ingredients or other materials supplied by CEPHALON, CATALYTICA shall have no liability to CEPHALON with respect thereto and CEPHALON shall pay for such Product in accordance with the terms of this Agreement. Nothing herein shall be construed to limit CATALYTICA's obligations established in Section 6.1 hereof.and

Non-Conforming Product. If (a) A Product that does not conform with the applicable Production Standards (as may be in effect from time to time) as at the date of delivery for any reason shall be deemed to be a non-conforming product (“Non-Conforming Product”). AVADEL shall inspect Products delivered and review the certificate of analysis for the Products and report to RPC as to any Non-Conforming Product [***] of its receipt at the AVADEL plant or that of its designee. A Product will be deemed accepted if rejected within such time frame, and AVADEL shall not be entitled to reject such Product provided however that, AVADEL or its designee may nevertheless reject a Product as a Non-Conforming Product if the reason such Product does not meet conform with the applicable Production Standards is a Latent Defect. (b) RPC shall have the right to examine and test any Product Specifications set forth that AVADEL claims to be a Non-Conforming Product and shall notify AVADEL in Schedule B or writing of the results of such examination. Notwithstanding Section 17.15, in the Quality Agreement set forth event the Parties cannot agree as to whether or not any Product is a Non-Conforming Product, the Parties shall designate an independent testing laboratory to determine same, the findings of which shall be binding on the Parties, absent manifest error. Expenses of such laboratory testing shall be borne by the Party whose position is determined to have been in Schedule C as determined by CEPHALON's testing error or if the laboratory cannot place the fault noticed and inspection complained about, then the Parties shall share equally the expenses of the Productlaboratory. (c) In the event that any such Product is ultimately agreed or found to be a Non-Conforming Product by the Parties or, then solely if appropriate, the aforementioned independent testing laboratory, RPC shall use its best efforts to replace such Product as soon as possible at its option CEPHALON may, as its sole remedy, either (i) demand that CATALYTICA remanufacture or repackage (as appropriate) said Product at no charge to CEPHALON and pay all round-trip shipping charges to and from the destination of the original shipment as well as pay for that portion of the acquisition cost of the Active Ingredients and other materials supplied by CEPHALON to CATALYTICA hereunder which are used in such nonconforming Product and which are lost or otherwise rendered unusable as a result of CATALYTICA's producing non-conforming Product, or (ii) be relieved of any obligation to pay CATALYTICA the toll fees otherwise payable for the manufacture of said Product, and CATALYTICA shall reimburse CEPHALON for the reasonable costs incurred by CEPHALON in properly disposing of the ProductRPC’s expense, as well as that portion of the acquisition cost of the Active Ingredients and other materials supplied charges incurred by CEPHALON AVADEL for shipping and/or storage. AVADEL shall not be required to CATALYTICA hereunder which are used in such nonconforming Product. Any notice given hereunder shall specify the manner in which the Product fails to conform to the purchase order therefor or fails to meet such warranty or the Specifications. If it is determined that the nonconformity (a) is due to damage to the Product (i) caused by CEPHALON or its agents or (ii) which occurs subsequent to delivery of such Product to the carrier at the point of origin, or (b) results from Active Ingredients or other materials supplied by CEPHALON, CATALYTICA shall have no liability to CEPHALON with respect thereto and CEPHALON shall pay for such any Product in accordance with the terms of this Agreement. Nothing herein shall that ultimately is agreed or found to be construed to limit CATALYTICA's obligations established in Section 6.1 hereofa Non-Conforming Product.