Common use of Non-Conforming Product Clause in Contracts

Non-Conforming Product. (a) In the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. (ai) Licensee shall inspect all shipments of Product promptly upon receipt, and shall notify Exelixis in writing in reasonable detail within [ * ] of receipt if Licensee is rejecting any Product that fails to conform to Exelixis’ warranties set forth in Sections 8.2(a) or 8.2(b). All Product not rejected within such [ * ] period will be deemed accepted. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (ii) If Licensee notifies Exelixis of any nonconformity of any Product in accordance with Section 2.5(b)(i), Exelixis shall have the right to inspect the Product in question and Licensee shall cooperate with Exelixis’ inspection, including providing Exelixis with samples of the Product in question for testing upon request. If Exelixis agrees with such notice of nonconformity, Exelixis shall, at its discretion and expense, either: (i) replace such Product, at no additional expense to Licensee, as soon as reasonably practicable after receipt of notification of such nonconformity or (ii) refund any portion of the applicable Transfer Price that has already been paid. (iii) In the event Patheon discovers that Exelixis disagrees with Licensee that a potential Non-Conforming Product prior does not conform to Exelixis’ warranties set forth in Sections 8.2(a) or 8.2(b), or considers that the defect was caused by occurrences after the delivery of the Product to Licensee, it may require a sample of the allegedly nonconforming Product to be delivered to a mutually acceptable independent testing laboratory for testing or, in the case of a dispute concerning compliance with GMP, an independent consultant for evaluation. Except in the case of manifest error, the determination of the laboratory or consultant as to whether the Product is nonconforming will be final and binding on the Parties. The fees and expenses of such laboratory testing or consultant, as the case may be, shall be borne entirely by the Party against whom such laboratory’s or consultant’s determination is made. If, as the case may be, such determination is against Exelixis, then Exelixis shall either refund the Transfer Price paid by Licensee for such Product or replace such Product, at no additional cost to FlexionLicensee, Patheon shall provide written notice to Flexion as soon as practicable describing reasonably possible, but in detail no event later than [ * ] if replacement Product stock is available, or if replacement Product stock is unavailable at such time, as soon as reasonably practical after it becomes available. If, as the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubtcase may be, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or determination is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day periodagainst Licensee, then the delivery will such Product shall be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day periodLicensee. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. (a) In the event Patheon discovers a potential Non-Conforming Product prior to delivery Within [*****] of such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause Chiesi’s receipt of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of an order for the Product. Flexion shall within , Chiesi may reject any such order or portion thereof that (i) […***…] days after delivery thereof by Patheon does not conform to the warranty under Section 8.1 above, including to the Specifications, or (ii) is based on any claimed shortage in quantity, provided that such non-conformity in (i) above is not due to any failure by Chiesi, its Affiliates, agents or representatives to ship, handle, maintain, or store the Product as required under the Specifications. Kamada shall reasonably assist Chiesi in performing any such testing by providing to Chiesi any necessary technical information to accomplish such testing by Chiesi. Chiesi shall notify Kamada in writing within such […***…**] days after Flexion discovers period of its rejection of any order or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date portion thereof of the Product)Product delivered by Kamada, give Patheon which notice of any Non-Conforming Product (including a sample rejection must contain the reason for such rejection; provided, however, that this limitation shall not apply to hidden defects in the Product. In the case of such Non-Conforming Producthidden defects, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable Chiesi shall have […***…**] day period, then days from the delivery will be deemed date it becomes aware or reasonably should have become aware of any hidden defect to have been accepted by Flexion on reject any order of the Product in accordance with applicable terms and conditions hereof. […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day periodConfidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine In the cause event of such Non-Conforming Product (including by undertaking an appropriate evaluation the rejection of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes under this Section 8.2, or any other nonconformity or defect which the Parties mutually agree is a Non-Conforming proper basis for rejection, and if such rejection is appropriately made by Chiesi, Kamada shall use its Best Reasonable Efforts to replace the rejected Product or make up the shortage at its expense within […***…**] of the notice of such rejection or shortage, and in any case as soon as reasonably possible after receiving such notice, at no additional cost to Chiesi (including shipping and transportation costs), and Kamada shall make arrangements with Chiesi for the return or disposal of any rejected Product, such return shipping or disposal charges to be paid by Kamada. (c) In the event of a conflict regarding whether or not the Product conforms to the warranty under Section 8.1 above, including to the Specifications at the time of delivery, and Chiesi and Kamada are unable to resolve such conflict after a good faith attempt by both Parties to resolve such matter in a period of [*****] days after either discovery the conflict arises, a sample of the Non-Conforming Product shall be submitted by Chiesi to an independent laboratory reasonably acceptable to both Parties for testing against the Specifications or other defect and the test results obtained by such laboratory shall be final and controlling for purposes of this Agreement. If the Parties are unable to agree upon such independent laboratory in a period of [*****] days after the conflict arises, such independent laboratory shall be selected by the President of the ICC. The fees and expenses of such laboratory testing shall be borne entirely by the Party against whom such laboratory’s findings are made. In the event the independent laboratory test results indicate that the Product in question did not meet the Specifications or is otherwise defective, Kamada shall use its Best Reasonable Efforts to replace the rejected Product at no additional cost to Chiesi within [*****] days after receipt of such Deficiency Notice from Flexionresults if replacement Product stock is available, and in any case as applicablesoon as reasonably possible after receipt of such independent laboratory test. Such notification In the event the independent laboratory test results indicate that the rejected Product in question meets the Specifications, then Chiesi shall include Patheon’s good faith determination pay all additional shipping and transportation costs, incurred by Kamada as a result of the cause conflict as well as the cost of the NonProducts to the extent that such Products have not been previously paid for by Chiesi, and shall accept and pay for the previously rejected Product in accordance with all applicable provisions hereunder. (d) Without derogating from Section 4.2(e) and from any obligations that Kamada may have under this Agreement with respect to Third Party Claims, the foregoing shall be Chiesi’s sole and exclusive remedy with respect to non-Conforming Productconforming Products or shortages, and all other remedies at law or in equity shall not be available to Chiesi. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.

Non-Conforming Product. Connetics may reject any shipment of Product that does not conform to the Manufacturing Standards, subject to the terms of this Section and the Quality Agreement. Except with respect to "hidden defects," within ten (a10) In business days after APG's internal release of Product, Connetics shall inspect the event Patheon discovers a potential NonProduct and notify APG whether it will accept or reject the Product. If Connetics does not notify APG of the non-Conforming Product prior to delivery conformity of such Product, the Product shall be deemed to Flexionmeet the Specifications, Patheon except for hidden defects. No inspection under this Section shall relieve APG of its obligations and warranties under this Agreement. If Connetics rejects all or any part of any shipment of Product, the procedures to be followed are: (i) Connetics shall submit to APG in writing any claim that Product does not conform with the Specifications or cGMPs, accompanied by a report of Connetics' 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 Specifications. Once nonconformance is confirmed and fault is determined to belong with APG pursuant to the provisions of this SECTION 3.11(b), Connetics shall not be obligated to pay for such nonconforming shipment of Product. Only those tests listed in the Specifications may be used to demonstrate nonconformance of Product. (ii) APG shall conduct its own analysis of the sample in good faith within thirty (30) days after the receipt by APG of the report and sample from Connetics, and provide the results to Connetics. (A) If after APG's own analysis of the sample APG agrees with the claim of nonconformity, Connetics shall promptly inform APG if Connetics wishes to have APG replace the nonconforming Product with conforming Product. If Connetics wishes to receive such replacement Product, APG shall provide written notice to Flexion such replacement as soon as reasonably practicable describing thereafter, in detail the Non-Conforming Product and the potential cause of which case Connetics shall be obligated to pay only for such Non-Conforming replacement Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will Connetics shall not be obliged obligated to perform any testing of pay for the nonconforming Product. Flexion shall within , and APG shall: (i1) […***…] days after delivery thereof credit Connetics for the amount paid by Patheon Connetics to APG for the nonconforming Product if Connetics has already paid for such nonconforming Product or (ii2) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could cancel its invoice to Connetics for such nonconforming Product if Connetics has not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of yet paid for such Non-Conforming nonconforming Product, if applicable) (a “Deficiency Notice”). Subject and Connetics shall not be obligated to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within pay such applicable […***…] day periodcanceled invoiced amount. (bB) Patheon If, after its own analysis, APG does not agree with the claim of nonconformity or determines that Connetics is responsible for the nonconformity, such Product shall conduct be tested for conformance with the applicable Specifications 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 determining whether such Product may be rightfully rejected. (iii) After a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its final determination regarding whether that the Product constitutes a Non-Conforming shipment is nonconforming, and if APG is responsible for the nonconformity, Connetics shall return or destroy it at APG's request and cost in the most cost effective and environmentally safe and appropriate manner available, consistent with federal, state and local laws and regulations. (iv) If conforming Product within […***…] days after either discovery supplied under this Agreement becomes nonconforming or unsuitable at no fault of APG, Connetics will remain obligated to pay APG for such Product. At APG's request, Connetics shall return such unsuitable Product to APG. Otherwise, Connetics shall destroy it in the Non-Conforming Product or receipt of such Deficiency Notice from Flexionmost environmentally safe and appropriate manner available, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Productconsistent with federal, state and local laws and regulations.

Non-Conforming Product. (ai) In Kissei shall inspect all shipments of the event Patheon discovers a potential Non-Conforming Product prior promptly upon receipt, and shall notify Rigel in writing in reasonable detail within ** of receipt if Kissei is rejecting any Product that fails to conform to ▇▇▇▇▇’▇ warranties set forth in Sections 8.2(a) or 8.2(b). All Product not rejected within such ** period will be deemed accepted. (ii) If Kissei notifies Rigel of any nonconformity of any Product in accordance with Section 2.5(a)(i), Rigel shall have the right to inspect the Product in question and Kissei shall cooperate with ▇▇▇▇▇’▇ inspection, including providing Rigel with samples of the Product in question for testing upon request. If Rigel agrees with such notice of nonconformity and that such nonconformity was not caused by occurrences after the delivery of such the Product to FlexionKissei, Patheon shall provide written notice to Flexion Rigel shall, at its discretion and expense, either: (A) replace such Product, ** as soon as reasonably practicable describing in detail the Non-Conforming Product and the potential cause after receipt of notification of such Non-Conforming nonconformity or (B) refund any portion of the applicable amount that has already been paid for such Product. Flexion ; provided, however, that if Rigel is required to make a payment to any contract manufacturer (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited is not entitled to a visual inspection of the shipment-ready packaged Products (and associated shipping documentationrefund from such contract manufacturer) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such rootnon-cause analysis. Patheon conforming Product caused by Kissei or while under Kissei’s control, Kissei shall notify Flexion in writing be required to pay Rigel under this Supply Agreement with respect to such non-conforming Product unless and until Rigel is relieved of its payment obligation (or is refunded its payment) for such non-conforming Product under its agreements with such contract manufacturers. (iii) In the event that ▇▇▇▇▇ disagrees with Kissei that the Product does not conform to ▇▇▇▇▇’▇ warranties set forth in Section 8.2(a) or 8.2(b), as applicable, or considers that the defect was caused by occurrences after the delivery of the Product to Kissei, it may require a sample of the allegedly nonconforming Product to be delivered to a mutually acceptable independent testing laboratory for testing or, in the case of a dispute concerning compliance with GMP, an independent consultant for evaluation. Except in the case of manifest error, the determination regarding of the laboratory or consultant as to whether the Product constitutes a Non-Conforming is nonconforming will be final and binding on the Parties. The fees and expenses of such laboratory testing or consultant, as the case may be, shall be borne entirely by the Party against whom such laboratory’s or consultant’s determination is made. If, as the case may be, such determination is against Kissei, then such Product within […***…] days after shall be deemed accepted by Kissei. If, as the case may be, such determination is against Rigel, then Rigel shall, subject to the instruction of Kissei, either discovery refund any portion of the Non-Conforming applicable amount that has already been paid by Kissei for such Product or receipt of replace such Deficiency Notice from FlexionProduct, at no additional cost to Kissei, as soon as reasonably possible, but in no event later than ** if replacement the Product stock is available, or if replacement the Product stock is unavailable at such time, as soon as reasonably practical after it becomes available; provided, however, that if Rigel is required to make a payment to any contract manufacturer (or is not entitled to a refund from such contract manufacturer) in connection with any such non-conforming Product caused by Kissei or while under Kissei’s control, Kissei shall be required to pay Rigel under this Supply Agreement with respect to such non-conforming Product unless and until Rigel is relieved of its payment obligation (or is refunded its payment) for such non-conforming Product under its agreements with such contract manufacturers. (iv) In the case of 2.5 (a) (ii) or (iii), Kissei shall have a right to request Rigel to supply the additional Product or its placebo (if applicable. Such notification shall include Patheon’s good faith determination ), so as not to cause any delays of the cause of Development and Commercial activities, provided that any additional supply is discussed and agreed upon at the Non-Conforming ProductJSC.

Non-Conforming Product. (a) In the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to FlexionPacira, Patheon shall provide written notice to Flexion Pacira as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion Pacira (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping [**] - Indicates certain information has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the redacted portions. documentation) and Flexion Pacira will not be obliged obligated to perform any testing of the Product. Flexion Pacira shall within (i) […***…] days after delivery thereof by Patheon (or (ii) within […***…] days after Flexion Pacira discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion Should Pacira fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion Pacira on the […***…] day after delivery or discovery, as applicable. Patheon shall will have no liability under whether pursuant to this Section 2.8 2.8, Section 3.11 or Section 3.13 or otherwise for any Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion Pacira shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion Pacira in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] thirty (30) days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from FlexionPacira, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. (a) In the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period.. *** Certain Confidential Information Omitted - 18 - (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. (a) In the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to FlexionPacira, Patheon shall provide written notice to Flexion Pacira as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion Pacira (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion Pacira will not be obliged obligated to perform any testing of the Product. Flexion Pacira shall within (i) […***…] days after delivery thereof by Patheon (or (ii) within […***…] days after Flexion ▇▇▇▇▇▇ discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion Should Pacira fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion Pacira on the […***…] day after delivery or discovery, as applicable. Patheon shall will have no liability under whether pursuant to this Section 2.8 2.8, Section 3.11 or Section 3.13 or otherwise for any Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion Pacira shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion Pacira in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] thirty (30) days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from FlexionPacira, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. (a) In the event Patheon discovers that Medtronic determines that any of the Products shipped to it fails to comply with the then current Specifications or fails to satisfy the representations and warranties of Supplier herein (each such Product, a potential Non-Conforming Product prior to delivery of such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such “Non-Conforming Product. Flexion ”), Medtronic shall, except as in the case of any Latent Defect (or its shipping carrier) will perform a customary inspection of as defined below), report the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited same to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall Supplier within (i) […***…] 30 days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Productto Medtronic and, if applicable) (a “Deficiency Notice”)requested in writing by Supplier, furnish such written evidence or other documentation as Supplier reasonably may deem appropriate in connection therewith. Subject Any Products not rejected by Medtronic by written notice to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice Supplier within the applicable […***…] such 30-day period, then the delivery will period shall be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under Medtronic for purposes of this Section 2.8 for Nonconforming 5.3; provided, however, Medtronic will not be deemed to have accepted any Product for which whose nonconformity making such Product a Non-Conforming Product is not reasonably apparent from a visual inspection of such Product as packaged by Supplier, without performing any tests on or measurements or other analysis of such Product (a “Latent Defect”). Medtronic shall give written notice to Supplier of such Latent Defect within 10 days after Medtronic actually became aware of such Latent Defect. Supplier shall promptly notify Medtronic in writing if it has not received a Deficiency Notice within such applicable […***…] day periodreason to believe that any Products delivered hereunder are Non-Conforming Products. (b) Patheon shall conduct a root-cause analysis to verify Any dispute in connection with whether a Product constitutes is a Non-Conforming Product andshall be resolved by an independent third party laboratory selected by the parties and the findings of such independent laboratory shall be binding on the parties, absent manifest error. The cost of such independent third party laboratory shall be borne by the party adversely affected by such finding; provided however, that if foundthe parties cannot agree on the independent third party laboratory, to determine then said dispute shall be resolved in accordance with Section 10.15 hereof. (c) All costs involved in the cause disposal, sale, return, storage, or replacement of Non-Conforming Products shall be paid by Supplier. Medtronic shall handle the disposal of such Non-Conforming Product (including Products in accordance with Supplier’s instructions, so as to minimize to the extent reasonably practicable any such costs, and Medtronic’s reasonable out-of-pocket handling charges shall be paid for by undertaking an appropriate evaluation of a Supplier. Supplier will promptly replace any such Non-Conforming Product sampleat its own expense on the same shipping terms as the original shipment or issue a credit note to Medtronic for such shipment including shipping charges, as applicable)customs and duties paid by Supplier. Flexion shall provide reasonable cooperation For purposes of this Section 5.3 only, the exclusive remedy of Medtronic with respect to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery Products not yet sold, transferred or otherwise disposed of the Non-Conforming Product by Medtronic will be replacement or receipt of such Deficiency Notice from Flexioncredit, as applicable. Such notification shall include Patheonat Medtronic’s good faith determination of the cause of the Non-Conforming Productoption.

Non-Conforming Product. (a) In the event If Patheon discovers a potential Non-Conforming Product prior to before delivery of such the Product to FlexionClient, Patheon shall will suspend any planned release or delivery of the Products in accordance with the Quality Agreement and provide written notice to Flexion Client as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such for the Non-Conforming Product. Flexion . (b) Client (or its shipping carrierdesignee) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such This inspection will be limited [***] to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion Client (or its designee) will not be obliged obligated to perform any testing of the Product. Flexion shall within Client will (i) within […***…] days after delivery thereof receipt by Patheon Client (or its designee) of a shipment of Product or (ii) within […***…] days after Flexion Client (or its designee) discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such the Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail If Client fails to give Patheon the Deficiency Notice within the expiry of the applicable […***…] day notice period, then the delivery will be deemed considered to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicableClient. Patheon shall will have no liability whether under this Section 2.8 2.8, Section 3.12 or Section 3.14 or otherwise for Nonconforming any Non-Conforming Product for which it has not received a Deficiency Notice within such the expiry of the applicable notice period. […***…] day periodCertain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (bc) Following receipt of a Deficiency Notice Patheon shall will conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such for the Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall Client will provide reasonable cooperation to Patheon in connection with any such the root-cause analysis. The payment obligation in relation to the Product Fee for the Product will be suspended pending resolution of the issue. Patheon shall will notify Flexion Client in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such the Deficiency Notice from FlexionClient, as applicable. Such This notification shall will include Patheon’s good faith determination of the cause of the Non-Conforming Product if the notification indicates Patheon agrees that the Product constitutes Non-Conforming Product. At Client’s request and following the issue of a Purchase Order from Client, Patheon will [***] deliver a replacement delivery of the Product to Client as soon as practicable after receipt of the Deficiency Notice (subject to Client supplying Patheon with Client-Supplied Materials, if required for the replacement delivery) in order to ensure continuity of supply, and Client will pay Patheon for the delivery in accordance with this Agreement.

Non-Conforming Product. (ai) Purchaser or its designee shall perform the acceptance tests set forth in the Specifications after each delivery of Product hereunder; provided however, that neither a failure to conduct such acceptance testing nor any such acceptance testing results that indicate Product conformity shall have any bearing on any of Manufacturer’s representations, warranties or Manufacturing obligations. In the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to Flexionthat Purchaser determines, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion within thirty (or its shipping carrier30) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon Manufacturer (or within fourteen (ii14) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity any non-conformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Productsuch acceptance testing), that any Product supplied by Manufacturer does not conform to the warranties set forth in Sections 2.2(f)(i), (ii) or (vi), then Purchaser shall give Patheon notice Manufacturer Notice of rejection of non-conforming Product. Purchaser shall set forth in each such notification the basis for such rejection, including any Non-Conforming Product testing or inspection results. Manufacturer shall undertake appropriate evaluation and shall notify Purchaser whether it has confirmed such nonconformity within thirty (including a sample 30) days after receipt of such Non-Conforming Product, if applicable) (a “Deficiency Notice”)Notice from Purchaser. Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which If Manufacturer notifies Purchaser that it has not received confirmed such nonconformity, the Parties shall submit the dispute to an independent testing laboratory or other appropriate expert mutually acceptable to the Parties (the “Testing Laboratory”) for evaluation. Both Parties shall cooperate with the Testing Laboratory’s reasonable requests for assistance in connection with its evaluation hereunder. The findings of the Testing Laboratory shall be binding on the Parties, absent manifest error. The expenses of the Testing Laboratory shall be borne by Manufacturer if the testing confirms the non-conformity and otherwise by Purchaser. If the Testing Laboratory or Manufacturer confirms that Product does not conform to the warranties set forth in Sections 2.2(f)(i), (ii) or (vi), and Purchaser either returns such non-conforming Product to Manufacturer or provides to Manufacturer written Notice with documentation to the effect that such non-conforming Product has been destroyed in accordance with applicable Law, upon mutual agreement of the Parties, Manufacturer promptly shall (i) supply Purchaser with a Deficiency Notice within conforming quantity of Product at Manufacturer’s expense; or (ii) reimburse Purchaser for the Purchase Price paid by Purchaser with respect to such applicable […***…] day periodnon- conforming Product if already paid. In addition, the Parties shall mutually agree as to the reimbursement by Manufacturer of any actual out-of-pocket costs incurred by Purchaser with respect to such non-conforming Product, including costs of recalls, field alerts, field corrections and market withdrawals of Product, including associated retrieval of Product, returns of Product, destruction of Product, replacement of Product, and fees and penalties owed to Third Parties. (bii) Patheon If at any time Manufacturer discovers that any Product delivered hereunder does not conform to the warranties set forth in Section 2.2(f), Manufacturer shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product andpromptly, if found, to determine the cause of such Non-Conforming Product and in no event more than three (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] 3) days after either Manufacturer’s discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexionthereof, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Productnotify Purchaser thereof in writing.

Non-Conforming Product. (a) In ViroPharma reserves the event Patheon discovers a potential Non-Conforming right to reject Product prior that does not conform to delivery of such the Product to Flexion, Patheon shall Specifications. ViroPharma will provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming that Product and the potential cause has been rejected within [***] days of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing receipt of the Product. Flexion shall , or within (i) […***…] days of discovery of the non-conformity, should it not be evident upon reasonable inspection at the time of delivery. Within [***] days after delivery thereof by Patheon receipt of such rejection, Alpharma will have the right to inspect such Product at ViroPharma’s facility and, whether or (ii) not it conducts such an inspection, Alpharma shall determine within […***…] days after Flexion discovers or receipt of ViroPharma’s written notice whether the Product at issue is informed of a discovery of nonconformity non-conforming, following which determination: (1) If Alpharma has determined that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date rejected Product is non-conforming, it shall accept return of the Product and, at Alpharma’s discretion, either (1) replace the non-conforming Product with new Product meeting the Product Specifications as quickly as possible, or (2) refund the purchase price paid by ViroPharma and ViroPharma’s shipping costs, within [***] days after receipt of ViroPharma’s rejection notice. If Alpharma chooses not to so replace the non-conforming Product, ViroPharma shall have the right to obtain substitute product from another supplier. If ViroPharma exercises that right, it shall so notify Alpharma and shall provide Alpharma with the invoice covering the replacement product. Provided that the reason that the Product was non-conforming is caused by Alpharma, upon receipt of which invoice, Alpharma will reimburse ViroPharma for the difference between ViroPharma’s contract price with Alpharma under this Agreement and the actual cost of the cover product purchased by ViroPharma to replace the non-conforming Product provided that Alpharma shall not, in any event, owe ViroPharma a payment under this subsection (d)(1) which exceeds [***]% of the contract price under this Agreement for the returned non-conforming Product. Any non-conforming Product for which Alpharma elects to issue a refund will be credited against all of ViroPharma’s purchase requirements under Section 9(a) and 14(a) of this Agreement. (2) If Alpharma has determined that the rejected Product conforms to the Product Specifications and if the parties, after good faith discussion for a period of [***] days between their senior managements, are unable to resolve the issue of conformity, then the issue shall be referred to an independent third party expert (“Mediator”) agreeable to both parties for final resolution. If the parties are unable to agree on a [***] Indicates material that has been omitted and for which confidential treatment has been requested. All such omitted material has been filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. Mediator, then each party shall appoint an expert, and the two experts shall jointly appoint a Mediator to finally resolve the issue of conformity. Pending the Mediator’s award, ViroPharma shall have the rights set forth in the preceding subsection 26(d)(1), give Patheon notice subject to reimbursement of any NonAlpharma if the Mediator determines that the rejected Product met Product Specifications. (3) As from the [***] Product Qualification Date, regardless whether or not Alpharma agrees that the rejected Product is non-Conforming conforming, if the rejection of the Product (results in an urgent need for replacement Product for ViroPharma, ViroPharma shall be entitled to request that Alpharma supplies an additional quantity of Product substantially identical to the Product rejected by ViroPharma, such request to include indication of the desired delivery date. Alpharma will use commercially reasonable efforts to supply such quantity of Product to ViroPharma within the requested delivery date, but shall not be obligated to do so. The Product shall be supplied in accordance with the terms and conditions, including a sample pricing and delivery, of such Nonthis Agreement. The remedies set forth in this subparagraph 26(d) shall be ViroPharma’s sole remedies for Product that ViroPharma has rejected as non-Conforming Productconforming, except, if applicable, the remedies set forth in Sections 26(b) and (a “Deficiency Notice”f). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. (ai) In Kissei shall inspect all shipments of Product promptly upon receipt, and shall notify Rigel in writing in reasonable detail within [*] of receipt if Kissei is rejecting any Product that fails to conform to Rigel’s warranties set forth in Sections ‎8.2(a) or ‎8.2(b). All Product not rejected within such [*] period will be deemed accepted. (ii) If Kissei notifies Rigel of any nonconformity of any Product in accordance with Section 2.5(a)‎(i), Rigel shall have the event Patheon discovers a potential Non-Conforming right to inspect the Product prior to in question and Kissei shall cooperate with Rigel’s inspection, including providing Rigel with samples of the Product in question for testing upon request. If Rigel agrees with such notice of nonconformity and that such nonconformity was not caused by occurrences after the delivery of such the Product to FlexionKissei, Patheon shall provide written notice to Flexion Rigel shall, at its discretion and expense, either: (A) replace such Product, [*], as soon as reasonably practicable describing in detail the Non-Conforming Product and the potential cause after receipt of notification of such Non-Conforming nonconformity or (B) refund any portion of the applicable amount that has already been paid for such Product. Flexion ; provided, however, that if Rigel is required to make a payment to any contract manufacturer (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited is not entitled to a visual inspection of the shipment-ready packaged Products (and associated shipping documentationrefund from such contract manufacturer) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such rootnon-cause analysis. Patheon conforming Product caused by Kissei or while under Kissei’s control, Kissei shall notify Flexion in writing be required to pay Rigel under this Supply Agreement with respect to such non-conforming Product unless and until Rigel is relieved of its payment obligation (or is refunded its payment) for such non-conforming Product under its agreements with such contract manufacturers. (iii) In the event that Rigel disagrees with Kissei that a Product does not conform to Rigel’s warranties set forth in Section ‎8.2(a) or ‎8.2(b), as applicable, or considers that the defect was caused by occurrences after the delivery of the Product to Kissei, it may require a sample of the allegedly nonconforming Product to be delivered to a mutually acceptable independent testing laboratory for testing or, in the case of a dispute concerning compliance with GMP, an independent consultant for evaluation. Except in the case of manifest error, the determination regarding of the laboratory or consultant as to whether the Product constitutes a Non-Conforming is nonconforming will be final and binding on the Parties. The fees and expenses of such laboratory testing or consultant, as the case may be, shall be borne entirely by the Party against whom such laboratory’s or consultant’s determination is made. If, as the case may be, such determination is against Kissei, then such Product within […***…] days after shall be deemed accepted by Kissei. If, as the case may be, such determination is against Rigel, then Rigel shall, subject to the instruction of Kissei, either discovery refund any portion of the Non-Conforming applicable amount that has already been paid by Kissei for such Product or receipt of replace such Deficiency Notice from FlexionProduct, at no additional cost to Kissei, as applicable. Such notification soon as reasonably possible, but in no event later than [*] if replacement Drug Product stock is available, or if replacement Drug Product stock is unavailable at such time, as soon as reasonably practical after it becomes available; provided, however, that if Rigel is required to make a payment to any contract manufacturer (or is not entitled to a refund from such contract manufacturer) in connection with any such non-conforming Product caused by Kissei or while under Kissei’s control, Kissei shall include Patheon’s good faith determination be required to pay Rigel under this Supply Agreement with respect to such non-conforming Product unless and until Rigel is relieved of the cause of the Nonits payment obligation (or is refunded its payment) for such non-Conforming Productconforming Product under its agreements with such contract manufacturers.

Non-Conforming Product. (a) In ▇▇▇▇▇ will be entitled, but not obliged, at its cost and expense and using the event Patheon discovers a potential Non-Conforming Product prior to delivery of test methods set forth in the sNDAs or other applicable cGMP test methods used by Lilly at the time such Product was manufactured, to Flexion, Patheon shall provide written notice test any and all Product delivered to Flexion as soon as practicable describing in detail it hereunder to determine whether such Product complies with the Non-Conforming Product and the potential cause of such Non-Conforming Specifications. ▇▇▇▇▇ will use validated methods to test Product. Flexion ▇▇▇▇▇ will notify Lilly in writing promptly, and in any event not later than forty-five (or its shipping carrier45) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof if it rejects any Product delivered to it because such Product failed to meet the Specifications. Any notice of rejection by Patheon or ▇▇▇▇▇ shall be accompanied by a reasonably detailed statement of its reasons for rejection and a report of any pertinent analysis performed by ▇▇▇▇▇ on the allegedly nonconforming product, together with the methods and procedures used. Lilly shall notify ▇▇▇▇▇ as promptly as reasonably possible, but in any event within forty-five (ii45) within […***…] business days after Flexion discovers or is informed receipt of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon such notice of rejection, whether it accepts Galen's assertions of non-conformity. If ▇▇▇▇▇ rejects any Non-Conforming such Product (including a sample of it will, at Lilly's request, provide Lilly with the opportunity to conduct its own tests on such Non-Conforming rejected Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice Product not rejected within the applicable […***…] forty-five (45) day period, then the delivery period will be deemed accepted and, without in any way limiting Lilly's indemnity obligations set forth in Section 11.1, will constitute a waiver of any claims ▇▇▇▇▇ may have against Lilly with respect to have been accepted the purchase price for such shipment; subject, however, to Galen's right to reject any Product for Latent Defects discovered by Flexion on ▇▇▇▇▇ and promptly reported to Lilly. Lilly will use commercially reasonable efforts to replace the […***…] day after delivery or discoveryproperly rejected Product with Product which meets the Specifications within a commercially reasonable time and will deliver such replacement Product, as at Lilly's sole cost and expense, to ▇▇▇▇▇. In addition, Lilly will, at Lilly's sole cost and expense, arrange for all such rejected Product to be picked up promptly and, where applicable, destroyed in accordance with all Applicable Laws. Patheon shall have no liability under Product properly rejected in accordance with this Section 2.8 for Nonconforming 5.3(a) will not be applied to the applicable Purchase Maximums, Purchase Minimums, the purchase obligation set forth in Section 2.2, or the minimum purchase or maximum supply obligations set forth in Section 4.4(a); but replacement Product for which it has not received a Deficiency Notice within such will be applied to the applicable […***…] day periodPurchase Maximums, Purchase Minimums, the purchase obligations set forth in Section 2.2, and the minimum purchase or maximum supply obligations set forth in Section 4.4(a). (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. (a) In ViroPharma reserves the event Patheon discovers a potential Non-Conforming right to reject Product prior that does not conform to delivery of such the Product to Flexion, Patheon shall Specifications. ViroPharma will provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming that Product and the potential cause has been rejected within [***] days of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing receipt of the Product. Flexion shall , or within (i) […***…] [***] Indicates material that has been omitted and for which confidential treatment has been requested. All such omitted material has been filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. days of discovery of the non-conformity, should it not be evident upon reasonable inspection at the time of delivery. Within [***] days after delivery thereof by Patheon receipt of such rejection, Alpharma will have the right to inspect such Product at ViroPharma’s facility and, whether or (ii) not it conducts such an inspection, Alpharma shall determine within […***…] days after Flexion discovers or receipt of ViroPharma’s written notice whether the Product at issue is informed of a discovery of nonconformity non-conforming, following which determination: (1) If Alpharma has determined that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date rejected Product is non-conforming, it shall accept return of the Product)Product and, give Patheon notice of any Nonat Alpharma’s discretion, either (1) replace the non-Conforming conforming Product with new Product meeting the Product Specifications as quickly as possible, or (including a sample of such Non-Conforming Product2) refund the purchase price paid by ViroPharma and ViroPharma’s shipping costs, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day perioddays after receipt of ViroPharma’s rejection notice. If Alpharma chooses not to so replace the non-conforming Product, ViroPharma shall have the right to obtain substitute product from another supplier. If ViroPharma exercises that right, it shall so notify Alpharma and shall provide Alpharma with the invoice covering the replacement product. Provided that the reason that the Product was non-conforming is caused by Alpharma, upon receipt of which invoice, Alpharma will reimburse ViroPharma for the difference between ViroPharma’s contract price with Alpharma under this Agreement and the actual cost of the cover product purchased by ViroPharma to replace the non-conforming Product provided that Alpharma shall not, in any event, owe ViroPharma a payment under this subsection (d)(1) which exceeds [***] of the contract price under this Agreement for the returned non-conforming Product. Any non-conforming Product for which Alpharma elects to issue a refund will reduce the Minimum Order ViroPharma is required to purchase from Alpharma under this Agreement, and shall be counted toward ViroPharma’s purchase requirements under Section 9(a) above. (2) If Alpharma has determined that the rejected Product conforms to the Product Specifications and if the parties, after good faith discussion for a period of [***] days between their senior managements, are unable to resolve the issue of conformity, then the delivery will issue shall be deemed referred to have been accepted by Flexion an independent third party expert (“Mediator”) agreeable to both parties for final resolution. If the parties are unable to agree on a Mediator, then each party shall appoint an expert, and the […***…] day after delivery or discoverytwo experts shall jointly appoint a Mediator to finally resolve the issue of conformity. Pending the Mediator’s award, as applicable. Patheon ViroPharma shall have no liability under the rights set forth in the preceding subsection 26(d)(1), subject to reimbursement of Alpharma if the Mediator determines that the rejected Product met Product Specifications. The remedies set forth in this Section 2.8 subparagraph 26(d) shall be ViroPharma’s sole remedies for Nonconforming Product for which it that ViroPharma has not received a Deficiency Notice within such applicable […***…] day periodrejected as non-conforming. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. (a) In Durata shall have the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail right but not the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged obligation to perform any testing tests to check the conformity to the Specifications of the Productany Product supplied hereunder. Flexion Durata shall notify Gnosis of any non-conformity within (i) […***…] days Business Days after delivery thereof receipt of the Product in the event of a defect discovered by Patheon Durata through the use of approved testing methods and procedures as referred in the Specifications and in the Quality Agreement or (ii) within […**] Business Days after Durata’s confirmation of the non-conforming status of the Product in the event of a defect (hidden or otherwise) which was not discoverable through the use of such testing methods and procedures, and shall provide reasonable evidence thereof. Durata shall have the right to notify any non-conformity to Gnosis within a maximum period of [*…*] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by from the customary inspection on Product delivery (but not after otherwise the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will shall be deemed to have been unconditionally accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day periodDurata. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product andGnosis will, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery Business Days of the Non-Conforming Product or receipt of such Deficiency Notice a notification from FlexionDurata, as applicable. Such notification shall include Patheon’s good faith determination notify Durata in writing whether Gnosis agrees to such non-conformity. (c) Gnosis will replace any non-conforming quantity of Product free of charge for Durata, including all shipping costs, within the shortest feasible time period and in no event later than [**] days from (i) the receipt of the cause notification referred to in Section 3.5(a) or, (ii) if there is a disagreement between the parties as to the non-conformity, from the date on which the independent expert laboratory referred to in Section 3.5(d) will have established the non-conformity of such Product and made the results of the Nontests showing such non-Conforming conformity known to the Parties. The non-conforming quantity of Product will be returned to Gnosis, at Gnosis’ costs. (d) Should Gnosis disagree on the non-conformity of a batch of Product, the Parties will, within [**] Business Days of such Gnosis’ notification, appoint an independent expert laboratory (appointed by mutual agreement between the Parties, which agreement shall not be unreasonably withheld, conditioned or delayed) who shall determine whether such Product is non-conforming. In the absence of manifest error, the independent expert laboratory’s decision shall be conclusive and binding on the Parties. The cost of such analysis will be borne by the Party in error.

Non-Conforming Product. (a) Any Product that does not conform in any material respect with the applicable Production Standards shall be deemed to be a non-conforming product (“Non-Conforming Product”). Purchaser or its designee shall notify Supplier in writing of defects no later than the later of expiry of the shelf-life of the relevant Product after receipt of the relevant Product, and provide reasonable evidence of such defect (including a sample of the Non-Conforming Products); provided, however, that Purchaser shall (i) notify Supplier of any apparent Product defect promptly upon discovery of such defect, and (ii) notify Supplier of any Product defect which would have been reasonably detectable upon inspection within thirty (30) days after receipt of such Product. (b) Supplier shall have the right to examine and test any Product that Purchaser claims to be a Non-Conforming Product. Notwithstanding Article 15, in the event the Parties cannot agree as to whether or not a shipped Product is a Non-Conforming Product, within ten (10) Business Days after the dispute becomes apparent, the Parties shall mutually designate an independent testing laboratory to determine whether the relevant Product is a Non-Conforming Product, the findings of which shall be binding on the Parties, absent manifest error. The independent testing laboratory shall be instructed to complete its analysis within ten (10) Business Days of its appointment by the Parties. All costs and expenses of such laboratory testing shall be borne by the Party whose position is determined to have been in error, or if the laboratory cannot place the fault noticed and complained about, then all costs and expenses of such laboratory testing shall be borne by the Parties equally. (c) Subject to Section 11.04(a), in the event that Purchaser claims any Product is a Non-Conforming Product, Supplier shall use its Commercially Reasonable Efforts to replace, as soon as reasonably practicable, such Product with Product conforming in all material respects with the Production Standards at no additional cost to Purchaser. In the event Patheon discovers that any Product is ultimately agreed or found to be a potential Non-Conforming Product prior pursuant to delivery of this Section 5.08, Purchaser shall not be obligated to pay for such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause of Supplier shall, within thirty (30) days after such agreement or finding, refund any amounts paid by Purchaser for such Non-Conforming Product. Flexion (In the event that any Product is ultimately agreed or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will found not to be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of and if Supplier has replaced such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject then Purchaser shall be obligated to Flexion’s rights under 3.10 pay the Purchase Price for both the original quantity of Product and 3.12, should Flexion fail any additional quantity provided by Supplier to give Patheon replace the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day periodoriginal quantity. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. 4.2.1 Endo shall have a period of [***] from the date of notification that the Product has been [***] to inspect or cause to be inspected Product supplied under this Agreement. Endo and/or its carrier shall complete an initial visual inspection of the Product at the time its freight forwarders pick up Product at Zogenix' or its Contract Manufacturer's warehouse. Endo shall have the right to reject by notice to Zogenix within such [***] any Product that does not conform in all material respects with the Product Specifications or applicable good manufacturing practices in effect at the time of Acceptance of the Purchase Order (a) In such Product thereby having a “Defect” and upon proper rejection, deemed “Defective”). All shipments of Product shall be deemed accepted by Endo unless Zogenix receives written notice of rejection from Endo within such [***] describing the reasons for the rejection in reasonable detail. Once a delivery of Product is accepted or deemed accepted hereunder, Endo shall have no recourse against Zogenix in the event Patheon discovers the Product is subsequently deemed unsuitable for use for any reason, except where the Defect is deemed a potential Non-Conforming Latent Defect or with respect to Short Dated Product. 4.2.2 As soon as either Party becomes aware of any Defect in any Product prior to delivery Batch which either (i) existed at the time of Acceptance but was not discovered at such time or (ii) arose as a result of any condition existing before the expiration of the Residual Shelf Life of the Product, by no fault of Endo or its Affiliates, sublicensees, distributors, wholesalers or its or their customers (each such Defect, a “Latent Defect”), it will promptly notify the other Party of such event (including reasonable details and the Batch involved). If Product accepted by Endo become non-conforming by virtue of the Latent Defect, such Product shall thereafter be deemed rejected and the notification made under this Section 4.2.2 shall constitute a notice of rejection thereof, and Endo may thereafter place the Batch on quality assurance hold pending Zogenix’ investigation and a final resolution of the claimed Latent Defect pursuant to FlexionSection 4.2.4. To the extent Defect or a Latent Defect in a Product resulted from a failure by a Zogenix Contract Manufacturer to abide by the terms of an applicable contract for manufacture or supply of Materials or Products to Zogenix for use in supply of Products to Endo hereunder, Patheon then Endo [***]. 4.2.3 If, after using Commercially Reasonable Efforts for a period of [***], Endo is unable to Commercialize any Batch which was deemed to be Short Dated Product at the time Delivered or Endo’s wholesaler returns any Batch which was deemed to be Short Dated Product at the time Delivered, then to the extent such Short-Dated Product resulted from a failure by a Zogenix Contract Manufacturer to abide by the terms of an applicable contract for manufacture or supply of Materials or Products to Zogenix for use in supply of Products to Endo hereunder, then Endo [***]. After its receipt of a notice of rejection from Endo pursuant to Section 4.2.1 or 4.2.2 above, Zogenix shall provide written notice to Flexion notify Endo as soon as practicable describing reasonably practical whether it accepts Endo’s basis for rejection and Endo shall reasonably cooperate with Zogenix in detail reasonably determining whether such rejection was necessary, permitted or justified. If the Non-Conforming Parties are unable to agree as to whether a shipment of Product supplied by Zogenix or its Contract Manufacturer hereunder is Defective, such question shall be submitted to an independent quality ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. control laboratory mutually agreed upon by the Parties. The findings of such independent laboratory shall be binding upon the Parties. The Cost of the independent quality control laboratory shall be borne by the Party whose results are shown by such laboratory to have been incorrect. 4.2.4 Except as may be required by Applicable Law, Endo may not return or destroy any rejected Product until it receives (i) written notification from Zogenix that Zogenix does not dispute that the Product is subject to a right of rejection pursuant to Section 4.2.1 or 4.2.2 or (ii) it receives written notice from the independent quality control laboratory that the Product was Defective at the time of release or had a Latent Defect. Zogenix will indicate in its notice either that Endo is authorized to destroy the rejected Product or that Zogenix requires return of the rejected Product. Upon written authorization from Zogenix to do so (which authorization shall be deemed an admission that the Batch was properly rejected by Endo), Endo shall promptly destroy the rejected Product and the potential cause provide Zogenix with written certification of such Non-Conforming destruction, or, if the request so states, Endo shall promptly return the rejected Product to Zogenix, in either case at Zogenix Cost, including the Cost of shipment from the Facility to Endo pursuant to the applicable Purchase order. Under no circumstances shall Endo Commercialize any Product which Endo believes is Defective or which Zogenix has informed Endo is Defective until and unless there is a determination by the Parties or the applicable independent laboratory that such Product is not Defective. 4.2.5 Endo shall not be required to pay any invoice with respect to any shipment of Product properly rejected, returned or destroyed pursuant to this Section 4.2 until replacement thereof with conforming Product. Flexion Notwithstanding the foregoing, Endo shall be obligated to pay in full for any rejected shipment of Product that is subsequently determined not to have been properly rejected pursuant to this Section 4.2 within [***] of such determination, irrespective of whether Endo has already paid Zogenix for a replacement shipment. If Endo pays in full for a shipment of Product and subsequently properly rejects such shipment in accordance with this Section 4.2, Endo shall be entitled, upon confirmation that such shipment or material portion thereof is Defective, to require Zogenix to replace such rejected shipment with non-Defective Product. Endo acknowledges and agrees that the express remedies set forth herein and the indemnification obligations set forth in Section 10.1, shall be Endo’s sole and exclusive remedy, and Zogenix’ sole obligation, with respect to Defective Product, Short Dated Product or otherwise non-conforming Product delivered hereunder. 4.2.6 Endo’s rights of rejection, return, refund and replacement set forth in this Section 4.2 shall not apply to any Product that is Defective due to damage (i) caused by Endo, its Affiliates, sublicensees or its shipping carrierdistributors or their respective employees or agents, including misuse, neglect, improper storage, transportation or use beyond any dating provided or (ii) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For that occurs due to any circumstance arising solely after Delivery (and for the avoidance of doubt, such inspection will be limited if a Defect occurs due in whole or in part to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will circumstance arising before Delivery, this Section 4.2.6 shall not be obliged apply to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Productsuch Defect), give Patheon notice of including any Non-Conforming Product (including a sample of such Non-Conforming Productdamage caused thereafter by accident, if applicable) (a “Deficiency Notice”)fire or other hazard. Subject to Flexion’s rights under 3.10 and 3.12In each case, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon Zogenix shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […or responsibility to Endo with respect thereto. ***…] day periodCertain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. (a) In the event Patheon discovers that any Product shall fail to strictly conform with the Specifications, A▇▇▇▇▇ shall reject such Product by giving written notice to NxStage within [ * ] days from the date of receipt of such Products at A▇▇▇▇▇, or [ * ] of the discovery of any defect that could not be reasonably discovered by A▇▇▇▇▇ during such [ * ] day period following a potential Nondiligent Product inspection; provided that such notice must, in any event, be provided within the first [ * ] months of the Product’s labelled shelf life when the average annual purchase volume is below [ * ] Units, and [ * ] months of the Product’s labelled shelf life when the average annual purchase volume exceeds [ * ] Units. Any notice given hereunder shall specify the manner in which the Product fails to conform with the Specifications. 5.4.1 If it is determined by agreement of the Parties (or in the absence of agreement of the Parties by a mutually acceptable independent testing laboratory or consultant whose fees shall be paid by the non-Conforming prevailing Party) that the non-conformity is due to damage to the Product prior (i) caused by A▇▇▇▇▇ or its agents or (ii) which occurs subsequent to delivery of such Product to Flexionthe carrier at the point of origin, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon NxStage shall have no liability under to A▇▇▇▇▇ with respect thereto. If the non-conformity is caused by the negligence of NxStage or breach by NxStage of any term of this Agreement, NxStage shall, as A▇▇▇▇▇’ sole and exclusive remedy, for Product rejected pursuant to this Section 2.8 5.4, credit A▇▇▇▇▇’ account the price invoiced for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a rootnon-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming conforming Product (including by undertaking an appropriate evaluation without limitation reimbursement to A▇▇▇▇▇ for the cost of a Nonany Fiber Bundles included in such non-Conforming Product sample, as applicableconforming Product). Flexion If payment for non conforming Product has previously been made by Arbios, at A▇▇▇▇▇’ option, NxStage shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether (i) pay A▇▇▇▇▇ the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt amount of such Deficiency Notice from Flexioncredit (including without limitation reimbursement to A▇▇▇▇▇ for the cost of any Fiber Bundles included in such non-conforming Product), as applicable(ii) offset the amount thereof (including without limitation reimbursement to A▇▇▇▇▇ for the cost of any Fiber Bundles included in such non-conforming Product) against other amounts then due NxStage hereunder or (iii) replace such non-conforming Product with conforming Product at no additional cost to Arbios (including without limitation reimbursement to Arbios for the cost of any Fiber Bundles needed to make such replacement Product). Such notification For clarity, this section shall include Patheonnot be deemed to limit NxStage’s good faith determination of the cause of the Non-Conforming Productindemnification obligations pursuant to Section 11.3.

Non-Conforming Product. (a) 4.1. In writing, ▇▇▇▇▇▇▇ Bros. Pty Ltd shall be promptly notified in the event Patheon discovers a potential of nonconforming process, product/material or service occurrence relating to our purchase order requirements. The supplier has no authorisation to make non-conforming product dispositions of “Use as Is” or “Repair” within the supply chain. Arrangements for the approval of supplier nonconforming process, product/material or service shall be as directed by ▇▇▇▇▇▇▇ Bros. Pty Ltd and our Customer/Engineering Authority. 4.2. Non-Conforming Product prior conforming product shipment will seldom be entertained. However, as a minimum, the following will apply:  N o non-conforming or repaired product shall be shipped without obtaining formal approval  Any approval sought for a non-conforming product shall be via a Concession/Deviation/Waiver request submitted to delivery of such Product to Flexionus, Patheon shall provide written notice to Flexion as soon as practicable describing in detail which includes the Non-Conforming Product part number affected (including the engineering revision level), batch/lot affected, quantities and the potential cause of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection description of the Products Manufactured by Patheon non-conforming product and containment actions taken  Where a Concession/Deviation/Waiver has been approved, the Concession/Deviation/Request reference number shall be recorded on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed documentation, including the Authorised Release Note/Certificate of Conformity  The supplier undertakes to have been accepted by Flexion on take containment action for the […***…] day after delivery non-conforming product or discoveryprocess, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of investigate the cause of the Nonnon-Conforming Product.conformance and provide details of the actions taken to prevent recurrence in a timely manner 4.3. Post-delivery, where it becomes apparent that a non-conforming or suspect product has been shipped/delivered, the Supplier shall promptly notify ▇▇▇▇▇▇▇ Bros. Pty Ltd.

Non-Conforming Product. (a) In ViroPharma reserves the event Patheon discovers a potential Non-Conforming right to reject Product prior that does not conform to delivery of such the Product to Flexion, Patheon shall Specifications. ViroPharma will provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming that Product and the potential cause has been rejected within *** days of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing receipt of the Product, or within *** days of discovery of the non-conformity, should it not be evident upon reasonable inspection at the time of delivery. Flexion Within *** days after receipt of such rejection, Xellia will have the right to inspect such Product at ViroPharma’s facility and, whether or not it conducts such an inspection, Xellia shall determine within *** days after receipt of ViroPharma’s written notice whether the Product at issue is non-conforming, following which determination: (i1) […If Xellia has determined that the rejected Product is non-conforming, it shall accept return of the Product and, at Xellia’s discretion, either (1) replace the non-conforming Product with new Product meeting the Product Specifications as quickly as possible, or (2) refund the purchase price paid by ViroPharma and ViroPharma’s shipping costs, within *** days after receipt of ViroPharma’s rejection notice. If Xellia chooses not to so replace the non-conforming Product, ViroPharma shall have the right to obtain substitute product from another supplier. If ViroPharma exercises that right, it shall so notify Xellia and shall provide Xellia with the invoice covering the replacement product. Provided that the reason that the Product was non-conforming is caused by Xellia, upon receipt of which invoice, Xellia will reimburse ViroPharma for the difference between ViroPharma’s contract price with Xellia under this Agreement and the actual cost of the cover product purchased by ViroPharma to replace the non-conforming Product provided that Xellia shall not, in any event, owe ViroPharma a payment under this subsection (d)(1) which exceeds *** percent (***…] days %) of the contract price under this Agreement for the returned non-conforming Product. Any non-conforming Product for which Xellia elects to issue a refund will be credited against all of ViroPharma’s purchase requirements under Section 9(a) and 14(a) of this Agreement. (2) If Xellia has determined that the rejected Product conforms to the Product Specifications and if the parties, after delivery thereof by Patheon or (ii) within […good faith discussion for a period of ***…] * days after Flexion discovers between their senior managements, are unable to resolve the issue of conformity, then the issue shall be referred to an independent third party expert (“Mediator”) agreeable to both parties for final resolution. If the parties are unable to agree on a Mediator, then each party shall appoint an expert, and the two experts shall jointly appoint a Mediator to finally resolve the issue of conformity. Pending the Mediator’s award, ViroPharma shall have the rights set forth in the preceding subsection 26(d)(1), subject to reimbursement of Xellia if the Mediator determines that the rejected Product met Product Specifications. (3) Regardless whether or not Xellia agrees that the rejected Product is informed of a discovery of nonconformity that could not reasonably have been detected by non-conforming, if the customary inspection on delivery (but not after the expiration date rejection of the Product)Product results in an urgent need for replacement Product for ViroPharma, give Patheon notice ViroPharma shall be entitled to request that Xellia supplies an additional quantity of any NonProduct substantially identical to the Product rejected by ViroPharma, such request to include indication of the desired delivery date. Xellia will use commercially reasonable efforts to supply such quantity of Product to ViroPharma within the requested delivery date, but shall not be obligated to do so. The Product shall be supplied in accordance with the terms and conditions, including pricing and delivery, of this Agreement. The remedies set forth in this subparagraph 26(d) shall be ViroPharma’s sole remedies for Product that ViroPharma has rejected as non-Conforming Product (including a sample of such Non-Conforming Productconforming, except, if applicable, the remedies set forth in Sections 26(b) and (a “Deficiency Notice”f). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

Non-Conforming Product. (a) In the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to FlexionClient, Patheon shall suspend any planned release or delivery of such Products in accordance with the Quality Agreement and provide written notice to Flexion Client as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (or its shipping carrierb) Client will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such Such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion Client will not be obliged to perform any testing of the Product. Flexion Client shall within (i) on or before […***…] days after delivery thereof by Patheon or (ii) within on or before […***…] days after Flexion Client discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion Should Client fail to give Patheon the Deficiency Notice within on or before the expiry of the applicable […***…] day notice period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicableClient. Patheon shall will have no liability under whether pursuant to this Section 2.8 2.8, Section 3.12 or Section 3.14 or otherwise for Nonconforming any Non-Conforming Product for which it has not received a Deficiency Notice within such on or before the expiry of the applicable […***…] day notice period. (bc) Following receipt of a Deficiency Notice Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion Client shall provide reasonable cooperation to Patheon in connection with any such root-cause analysisanalysis and the payment obligation in relation to the Product Fee for such Product shall be suspended pending resolution of the issue. Patheon shall notify Flexion Client in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within on or before […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from FlexionClient, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product. At Client’s request and following the issue of a Purchase Order from Client, Patheon will use Commercially Reasonable Efforts to deliver a replacement delivery of the Product to Client as soon as practicable after receipt of the Deficiency Notice (subject to Client supplying Patheon with Client-Supplied Materials, if required) in order to ensure continuity of supply, and Client shall pay Patheon for such delivery in accordance with the terms of this Agreement.

Non-Conforming Product. (a) In Celsion shall have the event Patheon discovers a potential Non-Conforming right, at its sole discretion and at its cost and expense, to inspect and test any and all Product prior delivered to delivery of it hereunder to determine whether such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail complies with the Non-Conforming Product and the potential cause of such Non-Conforming ProductSpecifications. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be Compliance verification may include but is not limited to a visual inspection of the shipmenton-ready packaged Products (site inspections, environmental monitoring program reviews, employee training and associated shipping documentation) methods analysis, batch record reviews, controlled document maintenance assessment, analytical and Flexion physical analysis, among other commonly used means to assess Product Quality. Celsion will not be obliged use validated methods to perform any testing of test the Product. Flexion shall within (i) Celsion will notify Hisun in writing […***…] days after delivery thereof by Patheon if it rejects any Product delivered or to be delivered because such Product failed to meet the Specifications, quality practices (ii) within […***…] days after Flexion discovers GMP), or is informed does provide sufficient documented assurances of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of Quality environment. If Celsion rejects any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 Hisun and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery Celsion will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, joint investigation to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation the defect or system failure. In the event of a Non-Conforming specification failure, Hisun shall have the right, at its request, to conduct its own tests on such rejected Product. Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product not rejected within […***…] days after either discovery will be deemed accepted and will constitute a waiver of any claims Celsion may have against Hisun with respect to payment for such shipment subject, however, to Celsion’s right to reject any Product for Latent Defects discovered by Celsion and return such Product to Hisun with [***]of the Non-Conforming Product or receipt identification of such Deficiency Notice from FlexionLatent Defect by Celsion. Hisun will replace any properly rejected Product with Product which meets the Specifications within a commercially reasonable time and will deliver such replacement Product to Celsion, as at Hisun’s sole cost and expense. In addition, Hisun will, at Hisun’s sole cost and expense, arrange for all such rejected Product to be picked up promptly and, where applicable, destroyed in accordance with all Applicable Laws. Such notification shall include PatheonCelsion will have no responsibility to Hisun for the Purchase Price of such nonconforming Product, but will pay Hisun the Purchase Price for the replacement Product in accordance with Section 3.1 above; provided, however, that to the extent Celsion previously paid for Product it properly rejected in accordance with this Section 4.5.1, Celsion will receive a credit against the Purchase Price for the replacement Product. Product properly rejected in accordance with this Section 4.5 will not be applied to Celsion’s good faith determination of purchase commitment set forth in Section 4.1, but replacement Product will be so applied. ***Text Omitted and Filed Separately with the cause of the Non-Conforming Product.Securities and Exchange Commission. Confidential Treatment Requested Under