Common use of Acceptance/Rejection; Interim Replacement Clause in Contracts

Acceptance/Rejection; Interim Replacement. (a) IsoRay or its designated customer shall have the right to reject any shipment of Deliverables made to it under this Agreement that does not meet the Specifications and applicable Manufacturing Standards in any material respects when received by it or its designee at such destination. All claims by IsoRay of non-conforming Deliverables shall be deemed waived unless made by IsoRay in writing and received by Oncura within 10 days of IsoRay's receipt or that of its designee of the Deliverable. (b) All claims of non-conforming Deliverables shall be accompanied by the allegedly non-conforming Deliverable. Oncura shall promptly undertake its own analysis, in accordance with the Testing Methods, of such Deliverable after receiving such claim from IsoRay or its designed Customer. If, after its own analysis, Oncura does not confirm such non-conformity, the Parties agree to submit the disputed Deliverable to an independent testing laboratory, to be agreed upon by the Parties, for testing in accordance with the Testing Methods. Notwithstanding Section 12.13, the findings of such laboratory shall be binding on the Parties, absent manifest error. Expenses of such independent testing shall be borne by either Oncura or IsoRay, with Oncura bearing all such expenses if the Deliverable is found to be non-conforming, and IsoRay bearing all such expenses if the Deliverable is found to be conforming. In the event that any Deliverable shipment or batch thereof is ultimately agreed or found not to meet the Specifications and/or applicable Manufacturing Standards, Oncura agrees to replace such shipment or batch with conforming Deliverables and pay for all reasonable out of pocket expenses incurred by IsoRay and its designee in connection with shipping and/or storing such replacement Deliverables and storing the non-conforming Deliverables. Such replacement shipment of Deliverables shall be treated as a new, additional shipment of Deliverables (that will be separately invoiced by Oncura) for all purposes, including measuring its conformity to the Specifications and applicable Manufacturing Standards, and IsoRay's payment for such additional shipment. In the event that any Deliverables shipment or batch thereof is ultimately agreed or found to meet the Specifications and applicable Manufacturing Standards, IsoRay shall accept and pay for such shipment or batch in accordance with Section 5.6. (c) Upon Oncura's receipt of a claim that a shipment or batch thereof of Deliverables does not meet the Specifications and/or applicable Manufacturing Standards, Oncura shall use commercially reasonable efforts to replace such shipment or batch thereof with an additional shipment of Deliverables that does conform to such standards as soon as practicable.

Acceptance/Rejection; Interim Replacement. (a) IsoRay or Endo and its designated customer designees shall have the right to reject any shipment of Deliverables Product, Finished Product or Implanters made to it under this Agreement that does not meet the Specifications and or applicable Manufacturing Standards in any material respects when received inspected by it or Endo to verify its designee at conformity to the Specifications, applicable Manufacturing Standards and applicable purchase order; provided that such destination. All claims by IsoRay Endo of non-conforming Deliverables Product, Finished Product or Implanters shall be deemed waived unless made by IsoRay Endo in writing and received by Oncura DURECT within 10 days a [* * *] period of IsoRay's receipt or that of its designee of the DeliverableEndo discovering same. (b) All claims Any notice delivered pursuant to Section 8.8(a) shall specify the reasons for the rejection. After notice of rejection is received by DURECT, Endo shall cooperate with DURECT in determining whether rejection is justified. DURECT shall notify Endo as soon as reasonably possible, but not later than [* * *] after receipt of the notice from Endo, whether it accepts Endo’s basis for rejection. If DURECT accepts Endo’s determination that the Products, Finished Product or Implanters are non-conforming, then DURECT shall replace such shipment or batch with conforming Product, Finished Product or Implanters and pay for all reasonable out-of-pocket expenses incurred by Endo and DURECT in connection with shipping and/or storing such replacement Product, Finished Product or Implanters and storing the non-conforming Deliverables shall be accompanied by the allegedly non-conforming DeliverableProduct, Finished Product or Implanters. Oncura shall promptly undertake its own analysis, in accordance with the Testing Methods, of such Deliverable after receiving such claim from IsoRay or its designed Customer. If, after its own analysis, Oncura If DURECT does not confirm such non-conformityaccept Endo’s determination that the Products, the Parties agree to submit the disputed Deliverable to an independent testing laboratory, to be agreed upon by the Parties, for testing in accordance with the Testing Methods. Notwithstanding Section 12.13, the findings of such laboratory shall be binding on the Parties, absent manifest error. Expenses of such independent testing shall be borne by either Oncura Finished Products or IsoRay, with Oncura bearing all such expenses if the Deliverable is found to be Implanters are non-conforming, and IsoRay bearing all such expenses if Endo does not accept DURECT’s conclusion, then DURECT and Endo shall jointly select an independent Third Party expert to test the Deliverable is found Product, Finished Product and/or Implanter and determine whether they conform to be conforming. In the event that any Deliverable shipment or batch thereof is ultimately agreed or found not to meet the Specifications and/or Specifications, applicable Manufacturing StandardsStandards and applicable purchase order. The Parties agree that such Third Party’s determination shall be final and binding. The Party against whom the Third Party expert rules shall bear the costs of the Third Party testing. If the Third Party expert rules that the Product, Oncura Finished Product or Implanter conform to the Specifications, the applicable Manufacturing Standard and applicable purchase order, then Endo shall purchase the Product, Finished Product or Implanter at the agreed upon price. If the Third Party rules that the Product, Finished Product or Implanters do not conform to the Specifications, the applicable Manufacturing Standard or applicable purchase order, then DURECT agrees to replace such shipment or batch with conforming Deliverables Product, Finished Product or Implanters (unless it has already done so pursuant to Section 8.8(c)) and pay for all reasonable out of out-of-pocket expenses incurred by IsoRay Endo and its designee DURECT in connection with shipping and/or storing such replacement Deliverables Product, Finished Product or Implanters and storing the non-conforming DeliverablesProduct, Finished Product or Implanters. Such replacement shipment of Deliverables Product, Finished Product or Implanters shall be treated as a new, additional shipment of Deliverables Product, Finished Product or Implanters (that will be separately invoiced by OncuraDURECT if the Product, Finished Product or Implanters being replaced has not been paid for by Endo) for all purposes, including measuring its conformity to the Specifications Specifications, applicable Manufacturing Standards and applicable Manufacturing Standardspurchase order, and IsoRay's Endo’s payment for such additional shipment. Endo shall return any such rejected shipment to DURECT if so instructed by DURECT, at DURECT’s expense. In the event that any Deliverables Product, Finished Product or Implanters shipment or batch thereof is ultimately agreed or found to meet the Specifications Specifications, applicable Manufacturing Standards and applicable Manufacturing Standardspurchase order, IsoRay Endo shall accept and pay for such shipment or batch in accordance with Section 5.68.6(b). (c) Upon Oncura's receipt of a claim that a shipment or batch thereof of Deliverables does not meet the Specifications and/or applicable Manufacturing Standards, Oncura shall use commercially reasonable efforts to replace such shipment or batch thereof with an additional shipment of Deliverables that does conform to such standards as soon as practicable.

Acceptance/Rejection; Interim Replacement. (a) IsoRay or Endo and its designated customer designees shall have the right to reject any shipment of Deliverables Product, Finished Product or Implanters made to it under this Agreement that does not meet the Specifications and or applicable Manufacturing Standards in any material respects when received inspected by it or Endo to verify its designee at conformity to the Specifications, applicable Manufacturing Standards and applicable purchase order; provided that such destination. All claims by IsoRay Endo of non-conforming Deliverables Product, Finished Product or Implanters shall be deemed waived unless made by IsoRay Endo in writing and received by Oncura DURECT within 10 days a *** period of IsoRay's receipt or that of its designee of the DeliverableEndo discovering same. (b) All claims Any notice delivered pursuant to Section 8.8(a) shall specify the reasons for the rejection. After notice of rejection is received by DURECT, Endo shall cooperate with DURECT in determining whether rejection is justified. DURECT shall notify Endo as soon as reasonably possible, but not later than *** after receipt of the notice from Endo, whether it accepts Endo's basis for rejection. If DURECT accepts Endo's determination that the Products, Finished Product or Implanters are non-conforming, then DURECT shall replace such shipment or batch with conforming Product, Finished Product or Implanters and pay for all reasonable out-of-pocket expenses incurred by Endo and DURECT in connection with shipping and/or storing such replacement Product, Finished Product or Implanters and storing the non-conforming Deliverables shall be accompanied by the allegedly non-conforming DeliverableProduct, Finished Product or Implanters. Oncura shall promptly undertake its own analysis, in accordance with the Testing Methods, of such Deliverable after receiving such claim from IsoRay or its designed Customer. If, after its own analysis, Oncura If DURECT does not confirm such non-conformityaccept Endo's determination that the Products, the Parties agree to submit the disputed Deliverable to an independent testing laboratory, to be agreed upon by the Parties, for testing in accordance with the Testing Methods. Notwithstanding Section 12.13, the findings of such laboratory shall be binding on the Parties, absent manifest error. Expenses of such independent testing shall be borne by either Oncura Finished Products or IsoRay, with Oncura bearing all such expenses if the Deliverable is found to be Implanters are non-conforming, and IsoRay bearing all such expenses if Endo does not accept DURECT's conclusion, then DURECT and Endo shall jointly select an independent Third Party expert to test the Deliverable is found Product, Finished Product and/or Implanter and determine whether they conform to be conforming. In the event that any Deliverable shipment or batch thereof is ultimately agreed or found not to meet the Specifications and/or Specifications, applicable Manufacturing StandardsStandards and applicable purchase order. The Parties agree that such Third Party's determination shall be final and binding. The Party against whom the Third Party expert rules shall bear the costs of the Third Party testing. If the Third Party expert rules that the Product, Oncura Finished Product or Implanter conform to the Specifications, the applicable Manufacturing Standard and applicable purchase order, then Endo shall purchase the Product, Finished Product or Implanter at the agreed upon price. If the Third Party rules that the Product, Finished Product or Implanters do not conform to the Specifications, the applicable Manufacturing Standard or applicable purchase order, then DURECT agrees to replace such shipment or batch with conforming Deliverables Product, Finished Product or Implanters (unless it has already done so pursuant to Section 8.8(c)) and pay for all reasonable out of out-of-pocket expenses incurred by IsoRay Endo and its designee DURECT in connection with shipping and/or storing such replacement Deliverables Product, Finished Product or Implanters and storing the non-conforming DeliverablesProduct, Finished Product or Implanters. Such replacement shipment of Deliverables Product, Finished Product or Implanters shall be treated as a new, additional shipment of Deliverables Product, Finished Product or Implanters (that will be separately invoiced by OncuraDURECT if the Product, Finished Product or Implanters being replaced has not been paid for by Endo) for all purposes, including measuring its conformity to the Specifications Specifications, applicable Manufacturing Standards and applicable Manufacturing Standardspurchase order, and IsoRayEndo's payment for such additional shipment. Endo shall return any such rejected shipment to DURECT if so instructed by DURECT, at DURECT's expense. In the event that any Deliverables Product, Finished Product or Implanters shipment or batch thereof is ultimately agreed or found to meet the Specifications Specifications, applicable Manufacturing Standards and applicable Manufacturing Standardspurchase order, IsoRay Endo shall accept and pay for such shipment or batch in accordance with Section 5.68.6(b). (c) Upon OncuraDURECT's receipt of a claim that a shipment or batch thereof of Deliverables Product, Finished Product or Implanters does not meet the Specifications and/or applicable Manufacturing Standards, Oncura DURECT shall use commercially reasonable efforts to replace such shipment or batch thereof with an additional shipment of Deliverables Product that does conform to such standards standards, as soon as reasonably practicable; provided that such replacement shall not constitute an acceptance by DURECT that such Product, Finished Product or Implanter are non-conforming. (d) DURECT shall maintain in inventory as safety stock Product, Finished Product and Implanters, and all components thereof, and Endo shall maintain in inventory as safety stock Product, Finished Product and Implanters, as is reasonable and customary in the pharmaceutical industry for product manufacturers and marketers, respectively.