Acceptance; Rejection. If, after performing such testing MannKind determines and informs AFP in writing that any Product delivered is a Non-conforming Product, MannKind shall so notify AFP in writing within forty-five (45) days from receipt of the shipment. In the event that AFP agrees that the Product is Non-conforming Product, MannKind may, at its option, return such Non-conforming Product to AFP or request replacement of the Non-conforming Product at AFP’s sole cost and at the earliest possible timeframe that is commercially reasonable. If MannKind exercises such return rights, MannKind shall return any such Non-conforming Product in accordance with AFP’s then current return procedures, and AFP shall replace such Non-conforming Product. If AFP does not replace such Non-conforming Product so as to remedy any reported non-conformity within forty-five (45) days after such non-conformity is reported to AFP, then MannKind may reject such Non-conforming Product by providing prompt written notice of such rejection to AFP. In the event of such rejection of any Non-conforming Product, AFP shall promptly credit or refund the net purchase price paid by MannKind. MannKind may charge AFP for all costs of shipment of Non-conforming Product and for the cover costs of the Product. If MannKind does not notify AFP that any Product is a Non-conforming Product during the forty-five (45) day period following delivery of such Product at MannKind’s designated facility, or does not reject any Non-conforming Product in accordance with the procedure described above, such Product shall be deemed to have been accepted by MannKind. Acceptance or deemed acceptance under this § 5.4 shall not limit AFP’s warranty obligations or MannKind’s warranty rights under § 7.2. In the event of a discrepancy between MannKind and AFP as to whether the Product is Non-conforming Product or there otherwise exists a dispute between the Parties over the extent to which such non-conformity is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and analyses on samples of the Product that allegedly is Non-conforming. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules.
Appears in 3 contracts
Sources: Supply Agreement (Mannkind Corp), Supply Agreement, Supply Agreement (Mannkind Corp)
Acceptance; Rejection. If, after performing such testing MannKind determines Eisai or the Designated Distributor (or in either case its authorized representative) shall perform a reasonable and informs AFP in writing that customary visual inspection of all Batches of Product delivered by Arena and shall report to Arena any Product delivered that is a reasonably discernible upon such visual inspection not to conform to the warranty set forth in Section 12.1 (“Non-conforming Conforming Product, MannKind ”) within 20 days of receipt by Eisai or the Designated Distributor. Eisai or the Designated Distributor shall so notify AFP in writing report to Arena Non-Conforming Product with hidden defects within forty-five (45) 30 days from receipt of Eisai’s discovery of the shipment. In same; provided that if Eisai fails to notify Arena of a hidden defect in any Product by the event that AFP agrees that earlier of two years after the delivery of such Product is Non-conforming Productor expiration or termination of this Agreement, MannKind may, at its option, return Eisai shall no longer have the right to reject such Non-conforming Product to AFP or request replacement of the Non-conforming Product at AFP’s sole cost and at the earliest possible timeframe that is commercially reasonable. If MannKind exercises such return rights, MannKind shall return any such Non-conforming Product in accordance with AFP’s then current return procedures, and AFP shall replace such Non-conforming Product. If AFP does A defect is hidden if it could not replace such Non-conforming Product so as to remedy any reported non-conformity within forty-five (45) days after such non-conformity is reported to AFP, then MannKind may reject such Non-conforming Product reasonably have been discovered by providing prompt written notice of such rejection to AFP. In the event of such rejection of any Non-conforming Product, AFP shall promptly credit or refund the net purchase price paid by MannKind. MannKind may charge AFP for all costs of shipment of Non-conforming Product a reasonable and for the cover costs customary visual inspection upon receipt of the Product. If MannKind does not notify AFP that any Product is a found to be Non-conforming Conforming Product during and is reported by Eisai or the fortyDesignated Distributor to Arena in the above time frame, then Arena shall, at Eisai’s request and option (to be exercised by Eisai promptly), either: (a) replace such Non-five Conforming Product at no additional charge to Eisai; (45b) day period following refund to Eisai the Product Purchase Price paid (if already paid) to Arena for such Non-Conforming Product or cancel the applicable Purchase Order if not paid; or (c) credit Eisai’s account in an amount equal to the Product Purchase Price paid (if already paid) for such Non-Conforming Product, and in any case ((a), (b) or (c)) Arena shall reimburse all shipping, insurance and customs charges for the Non-Conforming Product from the point of delivery in Switzerland to the destination in the Territory of the original shipment, subject to receipt of invoice; provided that if the Non-Conforming Product is reported to Arena at a time at which Arena would not be able to commence and complete manufacture of replacement Product prior to the expiration of the Term, Eisai shall not have the right to elect that Arena replace such Non-Conforming Product. Arena shall reimburse Eisai for the reasonable and verifiable costs incurred by Eisai or the Designated Distributor in properly disposing of or shipping to Arena (as instructed by Arena) such Non-Conforming Product, subject to receipt of invoice. Any notice given under this Section 6.5 shall specify the reason why such Product at MannKind’s designated facility, was found to be Non-Conforming Product. If Eisai or the applicable Designated Distributor does not reject report any Non-conforming Product in accordance with the procedure described above, such Product shall be deemed to have been accepted by MannKind. Acceptance defect or deemed acceptance under this § 5.4 shall not limit AFP’s warranty obligations or MannKind’s warranty rights under § 7.2. In the event of a discrepancy between MannKind and AFP as to whether the Product is Non-conforming Product or there otherwise exists a dispute between the Parties over the extent to which such non-conformity is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and analyses on samples of the any Product that allegedly is Non-conforming. Such independent laboratory shall be mutually agreed could reasonably have been discovered by a reasonable and customary visual inspection upon receipt within 20 days of receipt by Eisai or the Parties. The independent laboratory’s results shall be in writing Designated Distributor or any hidden defect within 30 days after discovery thereof and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules.within the
Appears in 2 contracts
Sources: Supply Agreement (Arena Pharmaceuticals Inc), Supply Agreement (Arena Pharmaceuticals Inc)
Acceptance; Rejection. If, after performing such testing MannKind determines and informs AFP in writing that any Product delivered is a Non-conforming Product, MannKind All goods tendered shall so notify AFP in writing be inspected by Buyer within forty-five ten (45) days from receipt of the shipment. In the event that AFP agrees that the Product is Non-conforming Product, MannKind may, at its option, return such Non-conforming Product to AFP or request replacement of the Non-conforming Product at AFP’s sole cost and at the earliest possible timeframe that is commercially reasonable. If MannKind exercises such return rights, MannKind shall return any such Non-conforming Product in accordance with AFP’s then current return procedures, and AFP shall replace such Non-conforming Product. If AFP does not replace such Non-conforming Product so as to remedy any reported non-conformity within forty-five (4510) days after such non-conformity is reported to AFPreceipt and, then MannKind may reject such Non-conforming Product by providing prompt written unless a notice of rejections has been sent by Buyer to Whole Alternative within such rejection to AFP. In the event of such rejection of any Non-conforming Productten day period, AFP shall promptly credit or refund the net purchase price paid by MannKind. MannKind may charge AFP for all costs of shipment of Non-conforming Product and for the cover costs of the Product. If MannKind does not notify AFP that any Product is a Non-conforming Product during the forty-five (45) day period following delivery of such Product at MannKind’s designated facility, or does not reject any Non-conforming Product in accordance with the procedure described above, such Product Buyer shall be deemed to have been irrevocably accepted the goods. Goods which are rejected or the subject of any claim be promptly set aside by MannKindBuyer in safe storage for inspection by Whole Alternative. Acceptance or deemed acceptance under this § 5.4 WHOLE ALTERNATIVE’S LIABILTY, IF ANY, INCLUDING CLAIMS FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY, SHALL BE LIMITED TO EITHER THE REPLACEMENT OF THE GOODS OR THE RETURN OF THE PURCHASE PRICE PAID, AT WHOLE ALTERNATIVE’S OPTION. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES. Buyer shall not limit AFP’s warranty obligations or MannKind’s warranty rights under § 7.2. In deduct from the event price the amount of a discrepancy between MannKind and AFP as to whether the Product is Non-conforming Product or there otherwise exists a dispute between the Parties over the extent to which any claim unless Whole Alternative allows such non-conformity is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and analyses on samples of the Product that allegedly is Non-conforming. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties claim in writing. WARRANTIES: Whole Alternative warrants that the goods sold hereunder are of merchantable quality and that Whole Alternative can convey the title to the goods free of any security interest or other lien. ▇▇▇▇▇ agrees to hold Whole Alternative harmless against any claims of infringement of any U.S. patent, trademark, or copyright on the costs associated with such testing and review shall be borne goods arising from compliance by Whole Alternativewith specifications furnished by Buyer. Whole Alternative further warrants that the Party against whom the independent laboratory rulesgoods are fit for ordinary purposes only. WHOLE ALTERNATIVE MAKES NO WARRANTY AS TO THE FITNESS OF THE GOODS FOR ANY PARTICULAR PURPOSE OR THE RESULTS TO BE OBTAINED FROM THEIR USE BY BUYER EITHER ALONE OR IN COMBINATION WITH OTHER SUBSTANCES. WHOLE ALTERNATIVE MAKES NO OTHER REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO THE GOODS.
Appears in 1 contract
Sources: Credit Agreement
Acceptance; Rejection. If, after performing such testing MannKind determines and informs AFP in writing that any Product delivered is a Non-conforming Product, MannKind shall so notify AFP in writing within forty-five Within thirty (4530) days from the date of receipt of each shipment of the shipmentProduct, and prior to releasing such Product for sale to customers, Enzon shall conduct (i) a visual inspection of the Product for defects or damages; (ii) an inspection of all associated quality assurance documents, including, without limitation, the certificate of analysis; and (iii) random testing of Units of Product which shall be done in accordance with the test procedures established by Skye from time to time (the “Testing Methods”). In Enzon shall have the event that AFP agrees right to return any Product to the extent Enzon determines that the Product is Non-conforming Product, MannKind may, at its option, return fails to conform with the Product Specifications following such Non-conforming Product to AFP inspection. All or request replacement any part of the Non-conforming Product at AFPany shipment may be held for Skye’s sole cost disposition and at Skye’s expense if found to be not in conformance with the earliest possible timeframe that is commercially reasonable. If MannKind exercises such return rightsProduct Specifications.
5.6.1 All Product delivered to Enzon hereunder shall be deemed to materially conform with the Product Specifications unless Skye receives from Enzon written notice, MannKind shall return any such Non-conforming Product in accordance with AFP’s then current return procedures, and AFP shall replace such Non-conforming Product. If AFP does not replace such Non-conforming Product so as to remedy any reported non-conformity within forty-five later than thirty (4530) days after Enzon’s receipt of a given shipment, specifying the shipment, purchase order number and the exact nature of the failure of such shipment to conform, along with reasonable evidence of such non-conformity is reported (including a sample of the Product from the shipment analyzed); provided, however, that Enzon’s failure to AFP, then MannKind may advise Skye in a timely manner that a shipment of the Product does not conform to the Product Specifications shall not prejudice Enzon’s right to reject such Nonor revoke acceptance of the Product if the defect or other non-conforming Product condition which justifies rejection or revocation could not have been detected by providing prompt written notice Enzon’s inspection undertaken pursuant to Section 5.6.
5.6.2 If at any time Enzon does not accept, or revokes its acceptance of, all or any part of such rejection to AFP. In the event of such rejection of any Non-conforming Product, AFP shall promptly credit or refund the net purchase price paid by MannKind. MannKind may charge AFP for all costs of a shipment of Non-conforming Product and for the cover costs of the Product, then the Parties shall have sixty (60) days from the date of Skye’s receipt of Enzon’s notification to resolve any dispute regarding whether all or any part of such shipment of the Product conforms with the Product Specifications. If MannKind does Disputes between the Parties as to whether all or any part of a shipment rejected by Enzon conforms with the Product Specifications not notify AFP that any Product is a Non-conforming Product during resolved in the forty-five sixty (4560) day period following delivery of such Product at MannKind’s designated facility, or does not reject any Non-conforming Product in accordance with the procedure described above, such Product shall be deemed to have been accepted resolved by MannKind. Acceptance or deemed acceptance under this § 5.4 shall not limit AFP’s warranty obligations or MannKind’s warranty rights under § 7.2. In the event of a discrepancy between MannKind and AFP as to whether the Product is Non-conforming Product or there otherwise exists a dispute between the Parties over the extent to which such non-conformity is attributable to a given Party, the Parties shall cause an independent cGMP testing laboratory promptly or consultant acceptable to review records, test data both Enzon and perform comparative tests and analyses on samples Skye (the “Laboratory”). The determination of the Laboratory with respect to all or part of any shipment of Product that allegedly is Non-conforming. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest errorupon the Parties. Unless otherwise agreed to by The fees and expenses of the Parties in writing, the costs associated with Laboratory making such testing and review determination shall be borne paid by the Party against whom which the independent laboratory rulesdetermination is made.
Appears in 1 contract
Sources: Supply and Distribution Agreement (Pacira Pharmaceuticals, Inc.)
Acceptance; Rejection. If, after performing such testing MannKind determines and informs AFP in writing that any Product delivered is a Non-conforming Product, MannKind shall so notify AFP in writing within forty-five (45) days from receipt No later than the first day of the shipmentmonth preceding the Initial Shipment Month, the parties shall establish notification procedures for Product rejections and claims for breach of the Product Warranty. In Such notification procedures (rather than the event provisions of Section 15.5 hereof) shall apply to all notices and communications required or permitted under this Section 5.2 or under Section 5.3 or Section 5.5, and the terms “notice” and “notify” (and similar terms) as used in this Section 5.2 or in Section 5.3 or Section 5.5 shall be deemed to refer to notification in accordance with such notification procedures. Siemens is entitled to reject any shipment of Product that AFP agrees fails to conform to the Product Warranty at the time of Delivery, provided that Siemens has first taken reasonable steps to confirm that the failure to conform to the Product is Non-conforming Product, MannKind may, at its option, return such Non-conforming Product Warranty did not result from Siemens or the carrier’s failure to AFP handle or request replacement of the Non-conforming Product at AFP’s sole cost and at the earliest possible timeframe that is commercially reasonable. If MannKind exercises such return rights, MannKind shall return any such Non-conforming transport Product in accordance with AFP’s then current return proceduresSection 4.9 and the Specifications and has provided UBI with written certification that Siemens has taken such steps. In order to reject a shipment of Product (or any portion thereof), and AFP shall replace such Non-conforming Product. If AFP does not replace such Non-conforming Product so as to remedy any reported non-conformity within forty-five (45) days after such non-conformity is reported to AFP, then MannKind may reject such Non-conforming Product by providing prompt Siemens must give written notice to UBI of such Siemens’s rejection to AFP. In the event of such rejection of any Non-conforming Product, AFP shall promptly credit or refund the net purchase price paid by MannKind. MannKind may charge AFP for all costs of shipment of Non-conforming Product and for the cover costs of the Product. If MannKind does not notify AFP that any Product is a Non-conforming Product during the forty-five (45) day period following delivery of such Product at MannKindwithin *[REDACTED] after Delivery, which notice shall specify Siemens’s designated facilityreason(s) for rejection. If no such notice of rejection is received within *[REDACTED] after Delivery, or does not reject any Non-conforming Product in accordance with the procedure described above, such Product Siemens shall be deemed to have been accepted by MannKindsuch shipment. Acceptance (For the avoidance of doubt, notwithstanding Siemens’ acceptance or deemed acceptance under this § 5.4 of any shipment of Product, Siemens shall not limit AFP’s warranty obligations or MannKind’s warranty have the rights under § 7.2. In the event of a discrepancy between MannKind and AFP as remedies set forth in Section 5.3 with respect to whether the Product is Non-conforming Product or there otherwise exists a dispute between the Parties over the extent to which such non-conformity is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and analyses on samples claims for breach of the Product that allegedly is Non-conformingWarranty.) Within *[REDACTED] of receiving any notice of rejection from Siemens, UBI will respond stating whether (a) it accepts the rejection or (b) it disputes the rejection, in which case the parties will refer such dispute to a mutually acceptable independent third party laboratory. Such independent laboratory shall be mutually agreed upon by analyze the Partiesapplicable Product and shall determine whether such Product conformed or did not conform to the Product Warranty. The independent parties agree that such laboratory’s results shall be in writing and determination shall be final and binding save for manifest errorupon the parties. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party The party against whom the independent laboratory rulesrules shall bear the costs of analysis by such independent laboratory, and if such laboratory determines that Siemens’ rejection of Product was incorrect, Siemens will pay for both the initially rejected and replacement Product. Product rejected by Siemens will be returned to UBI at UBI’s request and expense. Within *[REDACTED] of receipt of any notice of rejection, UBI shall supply replacement Product at no additional cost.
Appears in 1 contract
Acceptance; Rejection. If, after performing such testing MannKind determines and informs AFP in writing that any Product delivered is a Non-conforming Product, MannKind shall so notify AFP in writing within forty-five (45) days from receipt of the shipment. In the event that AFP agrees any Drug Substance delivered to Apellis or any Apellis designated location fails to conform to the Drug Substance warranties set forth in Section 8.2, Apellis may reject such shipment by providing Bachem written notice within [**] of the shipment of the Drug Substance. Apellis will have the right to test any quantity of the Drug Substance delivered by Bachem in order to verify that such quantity satisfies the Product Specifications but will not have any obligation to do so unless required by Applicable Law. Any notice of rejection by Apellis shall specify the nonconformity. If there is Non-conforming Productno dispute between the Parties relating to the existence of the nonconformity, MannKind any quantity of the Drug Substance supplied by Bachem does not conform to the Drug Substance warranties set forth in Section 8.2, Bachem may, at its optionApellis’s election and Bachem’s agreement, return such Non-conforming Product to AFP reprocess or request replacement of rework the Non-conforming Product at AFP’s sole cost and at the earliest possible timeframe that is commercially reasonablerejected Drug Substance. If MannKind exercises such return rightsreprocessing or reworking is not otherwise feasible, MannKind Bachem shall return any such Non-conforming Product in accordance with AFP’s then current return procedures, and AFP shall promptly (i) replace such Non-conforming Product. If AFP does not replace such Non-conforming Product so as to remedy any reported non-conformity within forty-five nonconforming Drug Substance in a timely manner at no additional cost, or (45ii) days after such non-conformity is reported to AFP, then MannKind may reject such Non-conforming Product by providing prompt written notice of such rejection to AFP. In the event of such rejection of any Non-conforming Product, AFP shall promptly credit Apellis’ account for or refund the net purchase price paid by MannKindinvoiced for such nonconforming Drug Substance. MannKind may charge AFP for all costs of shipment of Non-conforming Product and for Any dispute between the cover costs of Parties regarding whether Drug Substance fails to conform to the Product. If MannKind does not notify AFP that any Product is a Non-conforming Product during the forty-five (45) day period following delivery of such Product at MannKind’s designated facility, or does not reject any Non-conforming Product Drug Substance warranties set forth in Section 8.2 shall be resolved in accordance with the procedure described aboveset forth in Section 3.7. Apellis retains the right to determine the disposition of any and all Drug Substance Manufactured under this Agreement; provided, however, that Bachem shall have the right to offer for sale to Apellis any excess or nonconforming Drug Substance Manufactured hereunder; provided, further, however, that any such Product excess or nonconforming Drug Substance not offered to Apellis or not purchased by Apellis shall be deemed promptly and properly destroyed by Bachem. Nothing in this Section 3.6 shall limit the rights of Apellis to have been accepted by MannKind. Acceptance seek damages or deemed otherwise exercise its rights to remedies after acceptance under this § 5.4 shall not limit AFP’s warranty obligations or MannKind’s warranty rights under § 7.2. In of Drug Substance that fails to conform to the event Drug Substance warranties set forth in Section 8.2 if the nonconformity is a Latent Defect, provided that Apellis provides Bachem with prompt notice of a discrepancy between MannKind such Latent Defect after discovery thereof and AFP as prior to whether the Product is Non-conforming Product or there otherwise exists a dispute between the Parties over the extent to which stated expiration date of such non-conformity is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and analyses on samples of the Product that allegedly is Non-conforming. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rulesDrug Substance.
Appears in 1 contract
Sources: Commercial Supply Agreement (Apellis Pharmaceuticals, Inc.)
Acceptance; Rejection. If, after performing such testing MannKind determines and informs AFP in writing that any Product delivered is a Non-conforming Product, MannKind All goods tendered shall so notify AFP in writing be inspected by Buyer within forty-five ten (45) days from receipt of the shipment. In the event that AFP agrees that the Product is Non-conforming Product, MannKind may, at its option, return such Non-conforming Product to AFP or request replacement of the Non-conforming Product at AFP’s sole cost and at the earliest possible timeframe that is commercially reasonable. If MannKind exercises such return rights, MannKind shall return any such Non-conforming Product in accordance with AFP’s then current return procedures, and AFP shall replace such Non-conforming Product. If AFP does not replace such Non-conforming Product so as to remedy any reported non-conformity within forty-five (4510) days after such non-conformity is reported to AFPreceipt and, then MannKind may reject such Non-conforming Product by providing prompt written unless a notice of rejections has been sent by Buyer to ▇▇▇▇▇▇▇ Seed within such rejection to AFP. In the event of such rejection of any Non-conforming Productten day period, AFP shall promptly credit or refund the net purchase price paid by MannKind. MannKind may charge AFP for all costs of shipment of Non-conforming Product and for the cover costs of the Product. If MannKind does not notify AFP that any Product is a Non-conforming Product during the forty-five (45) day period following delivery of such Product at MannKind’s designated facility, or does not reject any Non-conforming Product in accordance with the procedure described above, such Product Buyer shall be deemed to have been irrevocably accepted the goods. Goods which are rejected or the subject of any claim be promptly set aside by MannKindBuyer in safe storage for inspection by ▇▇▇▇▇▇▇ Seed. Acceptance or deemed acceptance under this § 5.4 ▇▇▇▇▇▇▇ SEED’S LIABILTY, IF ANY, INCLUDING CLAIMS FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY, SHALL BE LIMITED TO EITHER THE REPLACEMENT OF THE GOODS OR THE RETURN OF THE PURCHASE PRICE PAID, AT ▇▇▇▇▇▇▇ SEED’S OPTION. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES. Buyer shall not limit AFP’s warranty obligations or MannKind’s warranty rights under § 7.2. In deduct from the event price the amount of a discrepancy between MannKind and AFP as to whether the Product is Non-conforming Product or there otherwise exists a dispute between the Parties over the extent to which any claim unless ▇▇▇▇▇▇▇ Seed allows such non-conformity is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and analyses on samples of the Product that allegedly is Non-conforming. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties claim in writing. WARRANTIES: ▇▇▇▇▇▇▇ Seed warrants that the goods sold hereunder are of merchantable quality and that ▇▇▇▇▇▇▇ Seed can convey the title to the goods free of any security interest or other lien. Buyer agrees to hold ▇▇▇▇▇▇▇ Seed harmless against any claims of infringement of any U.S. patent, trademark, or copyright on the costs associated goods arising from compliance by ▇▇▇▇▇▇▇ Seed with such testing and review shall be borne specifications furnished by Buyer. ▇▇▇▇▇▇▇ Seed further warrants that the Party against whom the independent laboratory rulesgoods are fit for ordinary purposes only. ▇▇▇▇▇▇▇ SEED MAKES NO WARRANTY AS TO THE FITNESS OF THE GOODS FOR ANY PARTICULAR PURPOSE OR THE RESULTS TO BE OBTAINED FROM THEIR USE BY BUYER EITHER ALONE OR IN COMBINATION WITH OTHER SUBSTANCES. ▇▇▇▇▇▇▇ SEED MAKES NO OTHER REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO THE GOODS.
Appears in 1 contract
Sources: Credit Agreement
Acceptance; Rejection. If, after performing such testing MannKind determines and informs AFP in writing that any Product delivered is a Non-conforming Product, MannKind shall so notify AFP in writing within forty-five (45) days from receipt of the shipment. In the event that AFP agrees that the Product is Non-conforming Product, MannKind may, at its option, return such Non-conforming Product to AFP or request replacement of the Non-conforming Product at AFP’s sole cost and at the earliest possible timeframe that is commercially reasonable. If MannKind exercises such return rights, MannKind shall return any such Non-conforming Product in accordance with AFP’s then current return procedures, and AFP shall replace such Non-conforming Product. If AFP does not replace such Non-conforming Product so as to remedy any reported non-conformity within forty-five (45) days after such non-conformity is reported to AFP, then MannKind may reject such Non-conforming Product by providing prompt written notice of such rejection to AFP. In the event of such rejection of any Non-conforming Product, AFP shall promptly credit or refund the net purchase price paid by MannKind. MannKind may charge AFP for all costs of shipment of Non-conforming Product and for the cover costs of the Product. If MannKind does not notify AFP that any Product is a Non-conforming Product during the forty-five (45) day period following delivery of such Product at MannKind’s designated facility, or does not reject any Non-conforming Product in accordance with the procedure described above, such Product shall be deemed to have been accepted by MannKind. Acceptance or deemed acceptance under this § 5.4 shall not limit AFP’s warranty obligations or MannKind’s warranty rights under § 7.2. In the event of a discrepancy between MannKind and AFP as to whether the Product is Non-conforming Product or there otherwise exists a dispute between the Parties over the extent to which such non-conformity is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and analyses on samples of the Product that allegedly is Non-conforming. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 1 contract
Acceptance; Rejection. If, after performing such testing MannKind determines Roivant (or its authorized representative) shall perform a reasonable and informs AFP customary visual inspection in writing that any accordance with its quality policies of a statistical sampling of Finished Product delivered by Arena and shall report to Arena any Finished Product that is a reasonably discernible upon such visual inspection not to conform to the Product Warranty (“Non-conforming Conforming Finished Product, MannKind ”) within [***] days of receipt by Roivant. Roivant shall so notify AFP in writing report to Arena Non-Conforming Finished Product with hidden defects within forty-five (45) [***] days from of Roivant’s discovery of the same. A defect is hidden if it could not reasonably have been discovered by a reasonable and customary visual inspection upon receipt of the shipmentFinished Product. In the event that AFP agrees that the If any Finished Product is found to be Non-conforming ProductConforming Finished Product and is reported by Roivant to Arena in the above time frame, MannKind maythen Arena shall, at its optionRoivant’s request and option (to be exercised by Roivant promptly), return such Non-either: (a) (i) if conforming safety stock of Finished Product to AFP or request replacement of the Non-conforming Product at AFP’s sole cost and at the earliest possible timeframe that is commercially reasonable. If MannKind exercises such return rightsavailable, MannKind shall return any such Non-conforming Product in accordance with AFP’s then current return procedures, and AFP shall replace such Non-Conforming Finished Product within [***] days or (ii) if conforming Product. If AFP does safety stock of Finished Product is not available, use Commercially Reasonable Efforts to replace such Non-conforming Conforming Finished Product so as soon as reasonably practicable, and at no additional charge to remedy Roivant; (b) refund within [***] days to Roivant Product Purchase Price paid (if already paid) to Arena for such Non-Conforming Finished Product or cancel the applicable Purchase Order if not paid; or (c) credit Roivant’s account within [***] days in an amount equal to Product Purchase Price paid for such Non-Conforming Finished Product, and in any reported case ((a), (b) or (c)) Arena shall reimburse all shipping, insurance, taxes, import licensure and customs charges (in each case that are non-refundable) for the Non-Conforming Finished Product from the point of delivery [***] to the destination of the original shipment, subject to receipt of invoice. Arena shall reimburse Roivant for the reasonable costs incurred by Roivant in properly disposing of or shipping to Arena (as instructed by Arena) such Non-Conforming Finished Product, subject to receipt of invoice. Any notice given under this Section 6.9 shall specify the reason why such Finished Product was found to be Non-Conforming Finished Product. If Roivant does not report any defect or non-conformity of any Finished Product that could reasonably have been discovered by a reasonable and customary visual inspection upon receipt as described above within forty-five (45) [***] days of receipt by Roivant or any hidden defect within [***] days after such non-conformity is reported to AFPdiscovery thereof, then MannKind may reject such Non-conforming Product by providing prompt written notice of such rejection to AFP. In the event of such rejection of any Non-conforming Product, AFP shall promptly credit or refund the net purchase price paid by MannKind. MannKind may charge AFP for all costs of shipment of Non-conforming Product and for the cover costs of the Product. If MannKind does not notify AFP that any Product is a Non-conforming Product during the forty-five (45) day period following delivery of such Product at MannKind’s designated facility, or does not reject any Non-conforming Product in accordance with the procedure described above, such Product Roivant shall be deemed to have been accepted by MannKind. Acceptance or deemed acceptance under this § 5.4 shall not limit AFP’s warranty obligations or MannKind’s warranty rights under § 7.2. In the event of a discrepancy between MannKind and AFP as to whether the Product is Non-conforming Product or there otherwise exists a dispute between the Parties over the extent to which such non-conformity is attributable to a given Party, the Parties shall cause an independent laboratory promptly to review records, test data and perform comparative tests and analyses on samples of the Product that allegedly is Non-conforming. Such independent laboratory shall be mutually agreed upon by the Parties. The independent laboratory’s results shall be in writing and shall be final and binding save for manifest error. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rulesFinished Product.
Appears in 1 contract
Sources: Development, Marketing and Supply Agreement (Axovant Sciences Ltd.)
Acceptance; Rejection. If(a) ▇▇▇▇▇▇▇▇ (or its agent) shall inspect at ▇▇▇▇▇▇▇▇’▇ discretion (based minimally on physical inspection and review of the Certificate of Analysis provided by UPM pursuant to Section 3.5) the Drug Product following Delivery for any Deficiency. If Madrigal claims that a shipment of Drug Product did not, at the time of Delivery, meet the representations, and warranties specified in Section 8.2 (a “Deficiency”), ▇▇▇▇▇▇▇▇ shall notify UPM based on the foregoing inspection within thirty (30) days after performing receipt of such testing MannKind determines Drug Product at ▇▇▇▇▇▇▇▇’▇ (or its designee’s) site, which notice shall provide the quantities affected, the basis for the claim and informs AFP other information reasonably necessary for UPM to assess the claim. If ▇▇▇▇▇▇▇▇ fails to notify UPM in writing that any Product delivered is of a Non-conforming Product, MannKind shall so notify AFP in writing claimed Deficiency within forty-five thirty (4530) days from after receipt of the shipment. In the event that AFP agrees that the Product is Non-conforming Drug Product, MannKind may, at its option, return such Non-conforming Drug Product to AFP or request replacement of the Non-conforming Product at AFP’s sole cost and at the earliest possible timeframe that is commercially reasonable. If MannKind exercises such return rights, MannKind shall return any such Non-conforming Product in accordance with AFP’s then current return procedures, and AFP shall replace such Non-conforming Product. If AFP does not replace such Non-conforming Product so as to remedy any reported non-conformity within forty-five (45) days after such non-conformity is reported to AFP, then MannKind may reject such Non-conforming Product by providing prompt written notice of such rejection to AFP. In the event of such rejection of any Non-conforming Product, AFP shall promptly credit or refund the net purchase price paid by MannKind. MannKind may charge AFP for all costs of shipment of Non-conforming Product and for the cover costs of the Product. If MannKind does not notify AFP that any Product is a Non-conforming Product during the forty-five (45) day period following delivery of such Product at MannKind’s designated facility, or does not reject any Non-conforming Product in accordance with the procedure described above, such Product shall will be deemed to have been accepted by MannKind. Acceptance or deemed acceptance under this § 5.4 shall not limit AFP’s warranty obligations or MannKind’s warranty rights under § 7.2. In the event of a discrepancy between MannKind and AFP as ▇▇▇▇▇▇▇▇, subject to whether the Product Section 3.7(d).
(b) If there is Non-conforming Product or there otherwise exists a no dispute between the Parties over relating to the extent existence of the Deficiency, UPM may, at ▇▇▇▇▇▇▇▇’▇ election and UPM’s agreement, reprocess or rework the rejected Drug Product supplied by UPM that does not conform to which the Drug Product representations and warranties set forth in Section 8.2. If reprocessing or reworking is not otherwise feasible, UPM shall, as ▇▇▇▇▇▇▇▇’▇ sole and exclusive remedy for such non-conformity is attributable Deficiency, either promptly (i) replace such nonconforming Drug Product in a timely manner at no additional cost, or (ii) credit ▇▇▇▇▇▇▇▇’▇ account for or refund the price invoiced for such nonconforming Drug Product. UPM shall not be responsible for the replacement cost of the API used in the Manufacture of replacement Drug Product.
(c) If ▇▇▇▇▇▇▇▇ and UPM are unable to agree as to whether such Drug Product contains a given PartyDeficiency, the Parties shall cause cooperate to have the Drug Product in dispute analyzed by an independent testing laboratory promptly to review recordsof recognized repute selected by ▇▇▇▇▇▇▇▇ and approved by UPM, test data and perform comparative tests and analyses on samples of the Product that allegedly is Non-conforming. Such independent laboratory which approval shall not be mutually agreed upon by the Partiesunreasonably withheld. The independent laboratory’s results shall be in writing and of such laboratory testing shall be final and binding save for manifest error. Unless otherwise agreed to by on the Parties in writing, on the costs associated with issue of whether such Drug Product contains a Deficiency. Such testing and review shall be borne by for the Party against whom determination of financial liability only and shall not determine releasability of Drug Product. If the Drug Product is determined to not contain a Deficiency, then ▇▇▇▇▇▇▇▇ shall bear the cost of the independent laboratory rulesDB1/ 138274066.17 testing and pay the Supply Price with respect to the previously rejected Drug Product and any replacement Drug Product Manufactured at its request to replace such previously rejected Drug Product in accordance with this Agreement. If the Drug Product is determined to contain a Deficiency, then UPM shall bear the cost of laboratory testing, and UPM shall, at ▇▇▇▇▇▇▇▇’▇ election and as ▇▇▇▇▇▇▇▇’▇ sole and exclusive remedy for such Deficiency, either replace the rejected Drug Product, at no cost to ▇▇▇▇▇▇▇▇, or refund to ▇▇▇▇▇▇▇▇ the Supply Price paid for such Drug Product plus any applicable delivery charge. UPM shall not be responsible for the replacement cost of the API used in the Manufacture of replacement Drug Product.
(d) Nothing in this Section 3.7 shall limit the rights of ▇▇▇▇▇▇▇▇ to seek damages or otherwise exercise its rights to remedies after acceptance of Drug Product that fails to conform to the Drug Product representations and warranties set forth in Section 8.2 if the Deficiency is a Latent Defect, provided that ▇▇▇▇▇▇▇▇ provides UPM with notice of such Latent Defect promptly after discovery thereof and prior to the stated expiration date of such Drug Product, and provided further that UPM shall not be responsible for the replacement cost of the API used in the Manufacture of any replacement Drug Product.
(e) Madrigal retains the right to determine the disposition of any and all Drug Product Manufactured under this Agreement; provided, however, that UPM shall have the right to offer for sale to ▇▇▇▇▇▇▇▇ any excess or nonconforming Drug Product Manufactured hereunder; provided, further, however, that any such excess or nonconforming Drug Product not offered to Madrigal or not purchased by ▇▇▇▇▇▇▇▇ shall be promptly and properly destroyed by UPM.
Appears in 1 contract
Sources: Commercial Supply Agreement (Madrigal Pharmaceuticals, Inc.)