Common use of Acceptance and Rejection of Product Clause in Contracts

Acceptance and Rejection of Product. (a) GT MED TECH may reject any Product delivered under this Agreement that does not comply with the warranties set forth in Section 10.2(a) (in all cases, a “Defective Product”) by giving written notice of such Defective Product to Isoray within seventy two (72) hours after receipt of the Product shipment, which notice shall specify in reasonable detail the grounds for such rejection. (b) GT MED TECH shall return Defective Products to Isoray at Isoray’s expense using Isoray’s then-standard return material authorization (“RMA”) procedures. Exhibit D describes Isoray’s RMA procedures as of the Effective Date, and Isoray shall provide GT MED TECH with written notice of any modifications to such RMA procedures. Subject to Section 4.3(c), Isoray shall replace any returned Defective Products as quickly as possible, and GT MED TECH shall pay Isoray for such replacement Product in accordance with Section 4.1, or in the event that GT MED TECH has already paid for the returned Defective Products, Isoray shall replace such Defective Products at its own expense. (c) If Isoray disagrees with GT MED TECH’s determination that certain units of Product are Defective Product, the Parties will first use good faith efforts to settle such dispute within thirty (30) days of GT MED TECH’s notice of such alleged defects. If the Parties are unable to resolve such dispute within this thirty (30) day period, such Product shall be submitted to a mutually acceptable Third Party testing service. Such Third Party testing service shall determine whether such Product meets the Specifications, and the Parties agree that such testing service’s determination shall be final and binding on the Parties. The Party against whom the Third Party laboratory rules shall bear all costs of the Third Party testing. (d) A warranty from the manufacturer is in place for the collagen products which states that it shall be in compliance with the collagen product specifications. If it is determined that the collagen product does not meet acceptance criteria during visual inspection, a non-comformance report (NCR) shall be initiated and the collagen product lot shall be quarantined as appropriate. During this time, the collagen product shall remain in the sealed packaging. GT MED TECH shall be notified within 24 hours in order to determine how to best handle the non-conforming collagen product and Isoray will work with GT MED TECH in order to appropriately return product back to the manufacturer.

Acceptance and Rejection of Product. (a) GT MED TECH MedImmune may reject any Product delivered under this Agreement that quality control sample or batch delivery which does not comply conform with the warranties set forth in Section 10.2(a) (in all cases, a “Defective Product”) by giving written Packaging Specifications or with applicable documentation or other requirements. Any such notice of such Defective Product to Isoray within seventy two (72) hours after receipt of rejection shall be in writing and shall indicate the Product shipment, which notice shall specify in reasonable detail the grounds reasons for such rejection. (b) GT MED TECH shall return Defective Products In order to Isoray at Isoray’s expense using Isoray’s then-standard return material authorization reject or put on hold delivery of Product based on testing of a quality control sample, MedImmune must give written notice to Cardinal Health of MedImmune's rejection of any delivery (“RMA”i) procedures. Exhibit D describes Isoray’s RMA procedures as within (CONFIDENTIAL TREATMENT REQUESTED) following receipt of notification of lot rejection by the FDA, or (ii) within (CONFIDENTIAL TREATMENT REQUESTED) after receipt of the Effective Dateapplicable quality control sample, whichever is later (the "Acceptance Period"). If no such notice of rejection/hold is received during such time period, MedImmune shall be deemed to have accepted such quality control sample upon the expiration of the Acceptance Period, and Isoray Cardinal Health shall provide GT MED TECH with written notice be authorized to make delivery of any modifications to such RMA procedures. Subject to Section 4.3(c), Isoray shall replace any returned Defective Products as quickly as possible, and GT MED TECH shall pay Isoray for such replacement Product in accordance with Section 4.1, or in the event that GT MED TECH has already paid for the returned Defective Products, Isoray shall replace such Defective Products at its own expenseProduct. (c) After notice of rejection/hold is given, MedImmune shall cooperate with Cardinal Health in determining whether rejection is necessary or justified and, in situations in which the type of damage so warrants, provide Cardinal Health with the allegedly non-conforming Product for Cardinal Health evaluation. Cardinal Health will evaluate the cause for such non-compliance. Cardinal Health shall notify MedImmune as promptly as reasonably possible whether it accepts MedImmune's basis for any rejection. If Isoray Cardinal Health disagrees with GT MED TECH’s MedImmune's determination that certain units of Product are Defective Product, does not meet the Parties will first use good faith efforts to settle such dispute within thirty (30) days of GT MED TECH’s notice of such alleged defects. If the Parties are unable to resolve such dispute within this thirty (30) day periodPackaging Specifications, such Product shall be submitted to a mutually acceptable Third Party testing servicethird party laboratory. Such Third Party testing service third party laboratory shall determine whether such Product meets the Specifications, Packaging Specifications and the Parties agree that such testing service’s laboratory's determination shall be final and binding on the Partiesdeterminative. The Party against whom the Third Party laboratory third party tester rules shall bear all costs of the Third Party third party testing. (d) A warranty from . Whether or not Cardinal Health accepts MedImmune's basis for rejection, promptly on receipt of a notice of rejection/hold of Product, Cardinal Health shall use reasonable commercial efforts at MedImmune's request to replace such rejected Product. Until such time as the manufacturer is in place for third party tester makes a ruling regarding whether the collagen products which states that it Product meets Packaging Specifications, MedImmune shall be in compliance with bear the collagen product specificationsexpenses of such replacement. If it is determined the third party tester rules that the collagen product Product meets the Packaging Specifications, MedImmune guarantees to purchase that Product and any replacement Product which Cardinal Health has delivered to MedImmune at the price set forth in Section 13.1. In the event the third party tester rules the Product does not meet acceptance criteria during visual inspection, a non-comformance report (NCR) shall be initiated and the collagen product lot shall be quarantined as appropriate. During this timePackaging Specifications, the collagen product provisions of Sections 7.4 and 7.5 shall remain in the sealed packaging. GT MED TECH shall be notified within 24 hours in order to determine how to best handle the non-conforming collagen product and Isoray will work with GT MED TECH in order to appropriately return product back to the manufacturerapply.

Acceptance and Rejection of Product. (a) GT MED TECH MedImmune may reject any Product delivered under this Agreement that quality control sample or batch delivery which does not comply conform with the warranties set forth in Section 10.2(a) (in all cases, a “Defective Product”) by giving written Packaging Specifications or with applicable documentation or other requirements. Any such notice of such Defective Product to Isoray within seventy two (72) hours after receipt of rejection shall be in writing and shall indicate the Product shipment, which notice shall specify in reasonable detail the grounds reasons for such rejection. (b) GT MED TECH shall return Defective Products In order to Isoray at Isorayreject or put on hold delivery of Product based on testing of a quality control sample, MedImmune must give written notice to Cardinal Health of MedImmune’s expense using Isoray’s then-standard return material authorization rejection of any delivery (“RMA”i) procedures. Exhibit D describes Isoray’s RMA procedures as within (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) following receipt of notification of lot rejection by the FDA, or (ii) within (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) after receipt of the Effective Dateapplicable quality control sample, whichever is later (the “Acceptance Period”). If no such notice of rejection/hold is received during such time period, MedImmune shall be deemed to have accepted such quality control sample upon the expiration of the Acceptance Period, and Isoray Cardinal Health shall provide GT MED TECH with written notice be authorized to make delivery of any modifications to such RMA procedures. Subject to Section 4.3(c), Isoray shall replace any returned Defective Products as quickly as possible, and GT MED TECH shall pay Isoray for such replacement Product in accordance with Section 4.1, or in the event that GT MED TECH has already paid for the returned Defective Products, Isoray shall replace such Defective Products at its own expenseProduct. (c) After notice of rejection/hold is given, MedImmune shall cooperate with Cardinal Health in determining whether rejection is necessary or justified and, in situations in which the type of damage so warrants, provide Cardinal Health with the allegedly non-conforming Product for Cardinal Health evaluation. Cardinal Health will evaluate the cause for such non-compliance. Cardinal Health shall notify MedImmune as promptly as reasonably possible whether it accepts MedImmune’s basis for any rejection. If Isoray Cardinal Health disagrees with GT MED TECHMedImmune’s determination that certain units of Product are Defective Product, does not meet the Parties will first use good faith efforts to settle such dispute within thirty (30) days of GT MED TECH’s notice of such alleged defects. If the Parties are unable to resolve such dispute within this thirty (30) day periodPackaging Specifications, such Product shall be submitted to a mutually acceptable Third Party testing servicethird party laboratory. Such Third Party testing service third party laboratory shall determine whether such Product meets the Specifications, Packaging Specifications and the Parties agree that such testing servicelaboratory’s determination shall be final and binding on the Partiesdeterminative. The Party against whom the Third Party laboratory third party tester rules shall bear all costs of the Third Party third party testing. (d) A warranty from . Whether or not Cardinal Health accepts MedImmune’s basis for rejection, promptly on receipt of a notice of rejection/hold of Product, Cardinal Health shall use reasonable commercial efforts at MedImmune’s request to replace such rejected Product. Until such time as the manufacturer is in place for third party tester makes a ruling regarding whether the collagen products which states that it Product meets Packaging Specifications, MedImmune shall be in compliance with bear the collagen product specificationsexpenses of such replacement. If it is determined the third party tester rules that the collagen product Product meets the Packaging Specifications, MedImmune guarantees to purchase that Product and any replacement Product which Cardinal Health has delivered to MedImmune at the price set forth in Section 13.1. In the event the third party tester rules the Product does not meet acceptance criteria during visual inspection, a non-comformance report (NCR) shall be initiated and the collagen product lot shall be quarantined as appropriate. During this timePackaging Specifications, the collagen product provisions of Sections 7.4 and 7.5 shall remain in the sealed packaging. GT MED TECH shall be notified within 24 hours in order to determine how to best handle the non-conforming collagen product and Isoray will work with GT MED TECH in order to appropriately return product back to the manufacturerapply.

Acceptance and Rejection of Product. (a) GT MED TECH PCYC may reject any Product Batch delivered under this Agreement hereunder that does not comply conform with the warranties set forth applicable Master Batch Record, LONZA's standard operating procedures, certificate of analysis, Product Specifications or Packaging Specifications, or documentation or process requirements (collectively, the "Release Criteria") based upon PCYC's testing of the QC Sample in Section 10.2(a) (in all cases, a “Defective Product”) by giving written accordance with the Test Methods and review of the Released Executed Batch Record. Any such notice of rejection shall be in writing and shall indicate the reasons for such Defective Product rejection. Such notice is to Isoray be delivered to LONZA within seventy two (72) hours after [ *** ] from PCYC's receipt of the QC Sample and certificate of analysis or such other period as may be specified in the applicable Product shipmentAppendix (the "Testing Period"). If LONZA does not receive such notice of rejection by the end of the Testing Period, which then PCYC shall be deemed to have accepted such Batch. After notice of rejection is given, PCYC shall specify cooperate with LONZA in reasonable detail establishing the grounds root cause of the rejection and shall deliver to LONZA a sample of the allegedly non-conforming QC Sample for LONZA's evaluation. LONZA will evaluate process issues and other reasons for such non- compliance. LONZA shall notify PCYC as promptly as reasonably possible whether it disputes PCYC's basis for any rejection. , but in any event no later than [ *** ] after its receipt of PCYC's notice of rejection of such non-conforming sample or such other period as may be specified in the applicable Product Appendix (b) GT MED TECH shall return Defective Products to Isoray at Isoray’s expense using Isoray’s then-standard return material authorization (“RMA”) proceduresthe "Response Period"). Exhibit D describes Isoray’s RMA procedures as If PCYC does not receive such notice of dispute by the end of the Effective DateResponse Period, and Isoray then LONZA shall provide GT MED TECH be deemed to agree with written notice PCYC's rejection of any modifications to such RMA proceduresBatch. Subject to Section 4.3(c), Isoray shall replace any returned Defective Products as quickly as possible, and GT MED TECH shall pay Isoray for such replacement Product in accordance with Section 4.1, or in the event that GT MED TECH has already paid for the returned Defective Products, Isoray shall replace such Defective Products at its own expense. (c) If Isoray LONZA disagrees with GT MED TECH’s PCYC's determination that certain units of Product are Defective Producta QC Sample does not meet the Release Criteria, the Parties will first use good faith efforts to settle then such dispute within thirty (30) days of GT MED TECH’s notice of such alleged defects. If the Parties are unable to resolve such dispute within this thirty (30) day period, such Product QC Sample shall be submitted to a mutually acceptable Third Party testing service. Such Third Party testing service shall acceptable, independent third party laboratory to determine whether such Product meets QC Sample conforms to the Specifications, and the Release Criteria. The Parties agree that such testing service’s third party laboratory's determination shall be final and binding on binding. If the Partiesthird party laboratory determines that such QC Sample meets the Release Criteria, then PCYC shall be deemed to have accepted such Batch, and shall pay for such Batch as set forth in Section 5.2. If the third party laboratory determines that such Product does not meet the Release Criteria, then such Batch shall be deemed rightfully rejected, and PCYC shall have no further obligation under this Agreement with respect to such Batch. The Party against whom the Third Party such independent third party laboratory rules shall bear all costs the expenses of the Third Party testing. (d) A warranty from the manufacturer is in place for the collagen products which states that it shall be in compliance such laboratory with the collagen product specificationsrespect to such testing of such Batch. If it is determined that the collagen product does not meet acceptance criteria during visual inspection, a non-comformance report (NCR) shall be initiated and the collagen product lot shall be quarantined as appropriate. During Any Batch accepted by PCYC under this time, the collagen product Agreement shall remain subject to LONZA' warranties in the sealed packaging. GT MED TECH shall be notified within 24 hours in order to determine how to best handle the non-conforming collagen product Sections 8.2 and Isoray will work with GT MED TECH in order to appropriately return product back to the manufacturer8.3.