Common use of Acceptance of Product Clause in Contracts

Acceptance of Product. (i) ETON may examine and test Product as it sees fit and may reject Product provided hereunder by LM if such Product is defective for any reason, adulterated or misbranded in any manner, or otherwise poses a threat of harm to the public (including, without limitation, by failing to meet the requirements of this Agreement, the Quality Agreement, any Applicable Law, the Specifications or the NDA/ANDA’s requirements) (collectively, a “Product Defect”); provided, however that ETON shall give written notice to LM of its rejection of any Product hereunder, together with appropriate documentation for its decision (a “Rejection Notice”), within fifteen (15) days after ETON’s receipt of shipment of such Product. The Rejection Notice shall specify the grounds for rejection. If such Rejection Notice is not received within fifteen (15) days after ETON’s receipt of any Product, such Product shall be deemed to be accepted by ETON. However, any Product Defect that would not be discoverable upon a reasonable inspection of a Product (a “Hidden Defect”) will not be deemed accepted by ETON at any time. As soon as possible but not exceeding the shelf life of any Product, if either Party becomes aware of a Hidden Defect in such Product, it will, within five (5) business days of becoming aware of such Hidden Defect, notify the other Party in writing about all Product involved (a “Hidden Defect Rejection Notice”). At ETON’s discretion, any Product subject to a Hidden Defect shall be deemed rejected as of the date of any such Hidden Defect Rejection Notice. (ii) LM may dispute a Rejection Notice or Hidden Defect Rejection Notice by providing written notice to ETON of the dispute within fifteen (15) days after receipt of such Rejection Notice or Hidden Defect Rejection Notice (as applicable), which notice from LM shall specify, in reasonable detail, the grounds for the dispute. (iii) If a Rejection Notice or Hidden Defect Rejection Notice for any Product is not disputed by LM as set forth in this section or if, in the event of a rejection dispute between the Parties, the contract laboratory referred to below gives a decision in favor of ETON, then: a. ETON may withhold all payment for the rejected Product; b. Where payment for the rejected Product has been made, LM will promptly issue a full credit or pay a full refund (as selected by ETON) to ETON for the rejected Product; c. LM will promptly pay to ETON any and all reasonable out-of- pocket costs and expenses resulting from the Product Defect, Hidden Defect or Product rejection, including but not limited to customer failure- to-supply penalties and destruction costs; and d. LM will promptly supply ETON with conforming Product in replacement of the rejected Product. (iv) If there is a dispute between the Parties with respect to the rejection of Product, the Parties will first seek to amicably resolve the dispute among themselves. If, after thirty (30) days, the Parties believe that the dispute cannot be amicably resolved, then the Parties shall mutually agree on a contract laboratory to conduct further testing of rejected Product in or order for the laboratory to determine whether the rejected Product meets the requirements for rejection set forth in this section. The Party whose conclusions are not borne out by the laboratory shall bear the cost of such testing. If the contract laboratory gives a decision in favor of LM, ETON shall promptly pay for the Product subject to the dispute, if such payment had not earlier been made; if the contract laboratory gives a decision in favor of ETON, LM shall immediately perform its obligations pursuant to this section. The decision of the contract laboratory, to the extent dispositive of a Product rejection dispute between the Parties, shall be binding upon the Parties with respect to such rejection dispute.

Acceptance of Product. (i1) ETON Eton may examine and test Product as it sees fit and may reject Product provided hereunder by LM if ANXXXXXX xf such Product is defective for any reason, adulterated or misbranded in any manner, or otherwise poses a threat of harm to the public (including, without limitation, by failing to meet the requirements of this Agreement, the Quality AgreementAgreement , any Applicable Law, the Specifications or the NDA/ANDA’s requirements) (collectively, a “Product Defect”); provided, however that ETON Eton shall give written notice to LM of ANXXXXXX xf its rejection of any Product hereunder, together with appropriate documentation for its decision (a “Rejection Notice”), within fifteen (15) days after ETONEton’s receipt of shipment of such Product. The Rejection Notice shall specify the grounds for rejection. If such Rejection Notice is not received within fifteen (15) days after ETONEton’s receipt of any Product, such Product shall be deemed to be accepted by ETONEton. However, any Product Defect that would not be discoverable upon a reasonable inspection of a Product (a “Hidden Defect”) will not be deemed accepted by ETON Eton at any time. As soon as possible but not exceeding the shelf life of any Product, if either Party becomes aware of a Hidden Defect in such Product, it will, within five (5) business days of becoming aware of such Hidden Defect, notify the other Party in writing about all Product involved (a “Hidden Defect Rejection Notice”). At ETONEton’s discretion, any Product subject to a Hidden Defect shall be deemed rejected as of the date of any such Hidden Defect Rejection Notice. (ii2) LM may ANXXXXXX xay dispute a Rejection Notice or Hidden Defect Rejection Notice by providing written notice to ETON Eton of the dispute within fifteen (15) days after receipt of such Rejection Notice or Hidden Defect Rejection Notice (as applicable), which notice from LM shall ANXXXXXX xhall specify, in reasonable detail, the grounds for the dispute. (iii3) If a Rejection Notice or Hidden Defect Rejection Notice for any Product is not disputed by LM as ANXXXXXX xs set forth in this section Section 6.3(2) above or if, in the event of a rejection dispute between the Parties, the contract laboratory referred to in Section 6.3(4) below gives a decision in favor of ETONEton, then: a. ETON (a) Eton may withhold all payment for the rejected Product; b. Where (b) where payment for the rejected Product has been made, LM will ANXXXXXX xill promptly issue a full credit or pay a full refund (as selected by ETON) to ETON for the rejected Product; c. LM will (c) ANXXXXXX xill promptly pay to ETON any and all reasonable out-of- pocket costs and expenses resulting from the Product Defect, Hidden Defect or Product rejection, including but not limited to customer failure- to-supply penalties and destruction costs; and d. LM will (d) ANXXXXXX xill promptly supply ETON with conforming Product in replacement of the rejected Product. (iv4) If there is a dispute between the Parties with respect to the rejection of Product, the Parties will first seek to amicably resolve the dispute among themselves. If, after thirty (30) days, the Parties believe that the dispute cannot be amicably resolved, then the Parties shall mutually agree on a contract laboratory to conduct further testing of rejected Product in or order for the laboratory to determine whether the rejected Product meets the requirements for rejection set forth in this sectionSection 6.3(1). The Party whose conclusions are not borne out by the laboratory shall bear the cost of such testing. If the contract laboratory gives a decision in favor of LMANXXXXXX, ETON Eton shall promptly pay for the Product subject to the dispute, if such payment had not earlier been made; if the contract laboratory gives a decision in favor of ETONEton, LM shall ANXXXXXX xhall immediately perform its obligations pursuant to this sectionSection 6.3(3). The decision of the contract laboratory, to the extent dispositive of a Product rejection dispute between the Parties, shall be binding upon the Parties with respect to such rejection dispute; any other or further disputes between the Parties with respect to Product conformance with Specifications, other representations and warranties made by a Party herein, or other matters will be addressed in accordance with Sections 9.1, 9.2, 9.3, and 11.2.

Acceptance of Product. 17.1 The Purchaser or its relevant Affiliate shall not be entitled to reject any Delivery of Product except in accordance with this clause 17 (iAcceptance of Product) ETON may examine or as set out in the Quality Agreement. For the avoidance of doubt, if the Purchaser or its relevant Affiliate fails to check the Product or notify the Supplier (or the Nominated Supplier) within the agreed timeframes set out in clause 17.3 and test Product as it sees fit and may reject Product provided hereunder by LM if such Product is defective for any reason, adulterated or misbranded in any manner, or otherwise poses a threat of harm to the public (including, without limitation, by failing to meet the requirements of this Agreement, the Quality Agreement, any Applicable Law, the Specifications or the NDA/ANDA’s requirements) (collectively, a “Product Defect”); provided, however that ETON shall give written notice to LM of its rejection of any Product hereunder, together with appropriate documentation for its decision (a “Rejection Notice”), within fifteen (15) days after ETON’s receipt of shipment of such Product. The Rejection Notice shall specify the grounds for rejection. If such Rejection Notice is not received within fifteen (15) days after ETON’s receipt of any Product, such Product Purchaser shall be deemed to be have accepted by ETONthe relevant Delivery of Product. HoweverWithout limiting the foregoing, the Supplier shall inform the Purchaser as soon as reasonably practicable and in any Product Defect that would not be discoverable upon event within forty-eight (48) hours if a reasonable inspection of Delivery is delayed or stopped for any reason. In such event, the Parties shall work together to agree on a Product plan (a “Hidden Defect”each acting reasonably and in good faith) will not be deemed accepted by ETON at any time. As to ensure the Delivery takes place as soon as possible thereafter and the Supplier shall implement such plan. 17.2 Subject only to clauses 36 (Warranties) and 37 (Indemnity and Liability) and any termination rights under clause 40 (Duration and Termination), the remedies prescribed under this clause 17 (Acceptance of Product) shall be the sole and exclusive remedies of the Purchaser or its relevant Affiliate in relation to the quantity of Product Delivered under this Agreement and/or non-compliant, damaged or Defective Product Delivered. 17.3 The Purchaser or its Affiliate shall visually inspect (but not exceeding be required to open the shelf life of any Productpackaging of) the Product Delivered for variances and Defects and shall notify the Supplier (or, if either Party becomes aware of a Hidden Defect directed by the Supplier, the Nominated Supplier and/or Permitted Subcontractor) in such Product, it will, within five (5) business days of becoming aware of such Hidden Defect, notify the other Party in writing about all Product involved (a “Hidden Defect Rejection Notice”). At ETON’s discretion, any Product subject to a Hidden Defect shall be deemed rejected as of the date of any such Hidden Defect Rejection Notice.writing: (iiA) LM may dispute a Rejection Notice or Hidden Defect Rejection Notice by providing written notice to ETON of the dispute within fifteen (15) days after receipt of such Rejection Notice or Hidden Defect Rejection Notice (as applicable), which notice from LM shall specify, in reasonable detail, the grounds for the dispute. (iii) If a Rejection Notice or Hidden Defect Rejection Notice for any Product is not disputed by LM as set forth in this section or if, in the event of a rejection dispute between the Parties, the contract laboratory referred to below gives a decision in favor of ETON, then: a. ETON may withhold all payment for the rejected Product; b. Where payment for the rejected Product has been made, LM will promptly issue a full credit or pay a full refund (as selected by ETON) to ETON for the rejected Product; c. LM will promptly pay to ETON any and all reasonable out-of- pocket costs and expenses resulting from the Product Defect, Hidden Defect or Product rejection, including but not limited to customer failure- to-supply penalties and destruction costs; and d. LM will promptly supply ETON with conforming Product in replacement of the rejected Product. (iv) If there is a dispute between the Parties with respect to the rejection of Product, the Parties will first seek to amicably resolve the dispute among themselves. If, after thirty (30) daysdays of Delivery if there is an apparent Defect in the Product (in which case the Purchaser or its relevant Affiliate shall submit a sample of the allegedly Defective Product with such notice); (B) within thirty (30) days of Delivery if there is any shortfall below or excess above the Delivery tolerance agreed in clause 9.1; (C) within thirty (30) days of Delivery if there are any other Defects or non-compliance, whether or not this includes any quality or actual Defect; or (D) during the relevant Product’s Minimum Remaining Shelf Life within thirty (30) days of discovery of a Defect if there is a Latent Defect. 17.4 Complaints in connection with the Product will be handled in accordance with this Agreement and the Quality Agreement. 17.5 If the Purchaser or its Affiliate notifies the Supplier, the Nominated Supplier and/or the Permitted Subcontractor of a Product which is (or is alleged to be) damaged or Defective (including any Latent Defects) under clause 17.3 or under the Quality Agreement, the Purchaser or its Affiliate shall store, at Supplier’s expense, the Product concerned in quarantine in accordance with the Supplier’s, the Nominated Supplier’s or the Permitted Subcontractor’s reasonable instructions and give the Supplier, the Nominated Supplier and/or the Permitted Subcontractor reasonable opportunity to inspect and analyse the Product concerned. On the Supplier’s request, the Purchaser shall return the Product concerned to the Supplier (or, if so directed by the Supplier, the Nominated Supplier or Permitted Subcontractor), at Supplier’s expense, but the Purchaser and/or its Affiliate shall be entitled to retain a sample for testing. For the avoidance of doubt, any Product Actions resulting from any notifications made by the Purchaser or its Affiliate to the Supplier, the Nominated Supplier and/or the Permitted Subcontractor pursuant to this clause 17 (Acceptance of Product) shall be dealt with in accordance with clause 29 (Product Action). 17.6 If the Purchaser or its Affiliate notifies the Supplier, the Nominated Supplier and/or the Permitted Subcontractor under clause 17.3 or under the Quality Agreement, the Parties believe shall promptly endeavour to agree whether or not the Product in question is damaged or Defective, or if there was a shortfall or excess of Product on Delivery or a delay in Delivery of Product. If no agreement is reached within twenty (20) days of the Purchaser’s (or its Affiliate’s) notice under clause 17.3 or under the Quality Agreement the matter shall be determined by an Independent Expert and the decision of the Independent Expert shall be final and binding on the Parties. The Independent Expert’s fees shall be borne by the Party against whom the Independent Expert’s decision is given. 17.7 To the extent that the dispute cannot be amicably resolvedSupplier agrees or the Independent Expert finds in favour of the Purchaser, then the Parties Supplier shall mutually agree either: (A) use its Commercially Reasonable Efforts to replace or procure the replacement of the Product(s) referable to the Delivery in question on a contract laboratory timeframe to conduct further testing of rejected be agreed between the Parties on a Product-by-Product basis, each acting reasonably and in good faith; or (B) at the Purchaser’s election (acting reasonably), or order where it is not reasonably practicable for the laboratory Supplier to determine whether replace or procure the replacement of the Product(s) referable to the Delivery in question within a timeframe acceptable to the Purchaser (and meet any reasonable associated transportation costs), refund the Purchaser for the Supply Price of such Delivery (if already paid); and (C) in either case, the Purchaser shall be entitled to recover costs in accordance with clause 9.3(C), and the Supplier shall, at its option, either promptly collect at its own expense any damaged or Defective Product from the Purchaser or its Affiliate or reimburse the Purchaser’s Group for any reasonable costs incurred in its disposal of such Product or in shipping such Product to the Supplier. For the avoidance of doubt, the Purchaser shall have no obligation to pay the Supplier for any Product agreed or found to be damaged or Defective in accordance with this clause 17 (Acceptance of Product) unless such damaged or Defective Product is replaced free of charge pursuant to clause 17.7(A) and the Supplier shall reimburse the Purchaser for any amounts already paid for such Product where such Product is to be refunded and not replaced. 17.8 If the Parties agree, or the Independent Expert finds, that a Delivery of Product complied with the Specification at the time of Delivery and was Manufactured in accordance with cGMP and the Quality Standards, or that there was no shortfall in the volumes Delivered, the Purchaser shall pay for such Delivery in accordance with this Agreement. 17.9 The Parties agree that this clause 17 shall not place a requirement on the Supplier to rework or reprocess rejected Product meets the requirements for rejection set forth Defective Products unless such activity has been expressly approved and authorised in this section. The Party whose conclusions are not borne out writing by the laboratory shall bear Purchaser in accordance with the cost of such testing. If the contract laboratory gives a decision in favor of LM, ETON shall promptly pay for the Product subject to the dispute, if such payment had not earlier been made; if the contract laboratory gives a decision in favor of ETON, LM shall immediately perform its obligations pursuant to this section. The decision of the contract laboratory, to the extent dispositive of a Product rejection dispute between the Parties, shall be binding upon the Parties with respect to such rejection disputeQuality Agreement.

Acceptance of Product. 17.1 The Purchaser or its relevant Affiliate shall not be entitled to reject any Delivery of Product except in accordance with this clause 17 (iAcceptance of Product) ETON may examine or as set out in the Quality Agreement. For the avoidance of doubt, if the Purchaser or its relevant Affiliate fails to check the Product or notify the Supplier (or the Nominated Supplier) within the agreed timeframes set out in clause 17.3 and test Product as it sees fit and may reject Product provided hereunder by LM if such Product is defective for any reason, adulterated or misbranded in any manner, or otherwise poses a threat of harm to the public (including, without limitation, by failing to meet the requirements of this Agreement, the Quality Agreement, any Applicable Law, the Specifications or the NDA/ANDA’s requirements) (collectively, a “Product Defect”); provided, however that ETON shall give written notice to LM of its rejection of any Product hereunder, together with appropriate documentation for its decision (a “Rejection Notice”), within fifteen (15) days after ETON’s receipt of shipment of such Product. The Rejection Notice shall specify the grounds for rejection. If such Rejection Notice is not received within fifteen (15) days after ETON’s receipt of any Product, such Product Purchaser shall be deemed to be have accepted by ETONthe relevant Delivery of Product. HoweverWithout limiting the foregoing, the Supplier shall inform the Purchaser as soon as reasonably practicable and in any Product Defect that would not be discoverable upon event within forty-eight (48) hours if a reasonable inspection of Delivery is delayed or stopped for any reason. In such event, the Parties shall work together to agree on a Product plan (a “Hidden Defect”each acting reasonably and in good faith) will not be deemed accepted by ETON at any time. As to ensure the Delivery takes place as soon as possible thereafter and the Supplier shall implement such plan. 17.2 Subject only to clauses 36 (Warranties) and 37 (Indemnity and Liability) and any termination rights under clause 40 (Duration and Termination), the remedies prescribed under this clause 17 (Acceptance of Product) shall be the sole and exclusive remedies of the Purchaser or its relevant Affiliate in relation to the quantity of Product Delivered under this Agreement and/or non-compliant, damaged or Defective Product Delivered. 17.3 The Purchaser or its Affiliate shall visually inspect (but not exceeding be required to open the shelf life of any Productpackaging of) the Product Delivered for variances and Defects and shall notify the Supplier (or, if either Party becomes aware of a Hidden Defect directed by the Supplier, the Nominated Supplier and/or Permitted Subcontractor) in such Product, it will, within five (5) business days of becoming aware of such Hidden Defect, notify the other Party in writing about all Product involved (a “Hidden Defect Rejection Notice”). At ETON’s discretion, any Product subject to a Hidden Defect shall be deemed rejected as of the date of any such Hidden Defect Rejection Notice.writing: (iiA) LM may dispute a Rejection Notice or Hidden Defect Rejection Notice by providing written notice to ETON of the dispute within fifteen (15) days after receipt of such Rejection Notice or Hidden Defect Rejection Notice (as applicable), which notice from LM shall specify, in reasonable detail, the grounds for the dispute. (iii) If a Rejection Notice or Hidden Defect Rejection Notice for any Product is not disputed by LM as set forth in this section or if, in the event of a rejection dispute between the Parties, the contract laboratory referred to below gives a decision in favor of ETON, then: a. ETON may withhold all payment for the rejected Product; b. Where payment for the rejected Product has been made, LM will promptly issue a full credit or pay a full refund (as selected by ETON) to ETON for the rejected Product; c. LM will promptly pay to ETON any and all reasonable out-of- pocket costs and expenses resulting from the Product Defect, Hidden Defect or Product rejection, including but not limited to customer failure- to-supply penalties and destruction costs; and d. LM will promptly supply ETON with conforming Product in replacement of the rejected Product. (iv) If there is a dispute between the Parties with respect to the rejection of Product, the Parties will first seek to amicably resolve the dispute among themselves. If, after thirty (30) daysdays of Delivery if there is an apparent Defect in the Product (in which case the Purchaser or its relevant Affiliate shall submit a sample of the allegedly Defective Product with such notice); (B) within thirty (30) days of Delivery if there is any shortfall below or excess above the Delivery tolerance agreed in clause 9.1; (C) within thirty (30) days of Delivery if there are any other Defects or non-compliance, whether or not this includes any quality or actual Defect; or (D) during the relevant Product’s Minimum Remaining Shelf Life within thirty (30) days of discovery of a Defect if there is a Latent Defect. 17.4 Complaints in connection with the Product will be handled in accordance with this Agreement and the Quality Agreement. 17.5 If the Purchaser or its Affiliate notifies the Supplier, the Nominated Supplier and/or the Permitted Subcontractor of a Product which is (or is alleged to be) damaged or Defective (including any Latent Defects) under clause 17.3 or under the Quality Agreement, the Purchaser or its Affiliate shall store, at Supplier’s expense, the Product concerned in quarantine in accordance with the Supplier’s, the Nominated Supplier’s or the Permitted Subcontractor’s reasonable instructions and give the Supplier, the Nominated Supplier and/or the Permitted Subcontractor reasonable opportunity to inspect and analyse the Product concerned. On the Supplier’s request, the Purchaser shall return the Product concerned to the Supplier (or, if so directed by the Supplier, the Nominated Supplier or Permitted Subcontractor), at Supplier’s expense, but the Purchaser and/or its Affiliate shall be entitled to retain a sample for testing. For the avoidance of doubt, any Product Actions resulting from any notifications made by the Purchaser or its Affiliate to the Supplier, the Nominated Supplier and/or the Permitted Subcontractor pursuant to this clause 17 (Acceptance of Product) shall be dealt with in accordance with clause 29 (Product Action). 17.6 If the Purchaser or its Affiliate notifies the Supplier, the Nominated Supplier and/or the Permitted Subcontractor under clause 17.3 or under the Quality Agreement, the Parties believe shall promptly endeavour to agree whether or not the Product in question is damaged or Defective, or if there was a shortfall or excess of Product on Delivery or a delay in Delivery of Product. If no agreement is reached within twenty (20) days of the Purchaser’s (or its Affiliate’s) notice under clause 17.3 or under the Quality Agreement the matter shall be determined by an Independent Expert and the decision of the Independent Expert shall be final and binding on the Parties. The Independent Expert’s fees shall be borne by the Party against whom the Independent Expert’s decision is given. 17.7 To the extent that the dispute cannot be amicably resolvedSupplier agrees or the Independent Expert finds in favour of the Purchaser, then the Parties Supplier shall mutually agree either: (A) use its Commercially Reasonable Efforts to replace or procure the replacement of the Product(s) referable to the Delivery in question on a contract laboratory timeframe to conduct further testing of rejected be agreed between the Parties on a Product-by-Product basis, each acting reasonably and in good faith; or (B) at the Purchaser’s election (acting reasonably), or order where it is not reasonably practicable for the laboratory Supplier to determine whether replace or procure the replacement of the Product(s) referable to the Delivery in question within a timeframe acceptable to the Purchaser (and meet any reasonable associated transportation costs), refund the Purchaser for the Supply Price of such Delivery (if already paid); and (C) in either case, the Purchaser shall be entitled to recover costs in accordance with clause 9.3(C) and the Supplier shall, at its option, either promptly collect at its own expense any damaged or Defective Product from the Purchaser or its Affiliate or reimburse the Purchaser’s Group for any reasonable costs incurred in its disposal of such Product or in shipping such Product to the Supplier. For the avoidance of doubt, the Purchaser shall have no obligation to pay the Supplier for any Product agreed or found to be damaged or Defective in accordance with this clause 17 (Acceptance of Product) unless such damaged or Defective Product is replaced free of charge pursuant to clause 17.7(A) and the Supplier shall reimburse the Purchaser for any amounts already paid for such Product where such Product is to be refunded and not replaced. 17.8 If the Parties agree, or the Independent Expert finds, that a Delivery of Product complied with the Specification at the time of Delivery and was Manufactured in accordance with cGMP and the Quality Standards, or that there was no shortfall in the volumes Delivered, the Purchaser shall pay for such Delivery in accordance with this Agreement. 17.9 The Parties agree that this clause 17 shall not place a requirement on the Supplier to rework or reprocess rejected Product meets the requirements for rejection set forth Defective Products unless such activity has been expressly approved and authorised in this section. The Party whose conclusions are not borne out writing by the laboratory shall bear Purchaser in accordance with the cost of such testing. If the contract laboratory gives a decision in favor of LM, ETON shall promptly pay for the Product subject to the dispute, if such payment had not earlier been made; if the contract laboratory gives a decision in favor of ETON, LM shall immediately perform its obligations pursuant to this section. The decision of the contract laboratory, to the extent dispositive of a Product rejection dispute between the Parties, shall be binding upon the Parties with respect to such rejection disputeQuality Agreement.

Acceptance of Product. (i1) ETON Eton may examine and test Product as it sees fit and may reject Product provided hereunder by LM ANDERSEN if such Product is defective for any reason, adulterated or misbranded in any manner, or otherwise poses a threat of harm to the public (including, without limitation, by failing to meet the requirements of this Agreement, the Quality AgreementAgreement , any Applicable Law, the Specifications or the NDA/ANDA’s requirements) (collectively, a “Product Defect”); provided, however that ETON Eton shall give written notice to LM ANDERSEN of its rejection of any Product hereunder, together with appropriate documentation for its decision (a “Rejection Notice”), within fifteen (15) days after ETONEton’s receipt of shipment of such Product. The Rejection Notice shall specify the grounds for rejection. If such Rejection Notice is not received within fifteen (15) days after ETONEton’s receipt of any Product, such Product shall be deemed to be accepted by ETONEton. However, any Product Defect that would not be discoverable upon a reasonable inspection of a Product (a “Hidden Defect”) will not be deemed accepted by ETON Eton at any time. As soon as possible but not exceeding the shelf life of any Product, if either Party becomes aware of a Hidden Defect in such Product, it will, within five (5) business days of becoming aware of such Hidden Defect, notify the other Party in writing about all Product involved (a “Hidden Defect Rejection Notice”). At ETONEton’s discretion, any Product subject to a Hidden Defect shall be deemed rejected as of the date of any such Hidden Defect Rejection Notice. (ii2) LM ANDERSEN may dispute a Rejection Notice or Hidden Defect Rejection Notice by providing written notice to ETON Eton of the dispute within fifteen (15) days after receipt of such Rejection Notice or Hidden Defect Rejection Notice (as applicable), which notice from LM ANDERSEN shall specify, in reasonable detail, the grounds for the dispute. (iii3) If a Rejection Notice or Hidden Defect Rejection Notice for any Product is not disputed by LM ANDERSEN as set forth in this section Section 6.3(2) above or if, in the event of a rejection dispute between the Parties, the contract laboratory referred to in Section 6.3(4) below gives a decision in favor of ETONEton, then: a. ETON (a) Eton may withhold all payment for the rejected Product; b. Where (b) where payment for the rejected Product has been made, LM ANDERSEN will promptly issue a full credit or pay a full refund (as selected by ETON) to ETON for the rejected Product; c. LM (c) ANDERSEN will promptly pay to ETON any and all reasonable out-of- pocket costs and expenses resulting from the Product Defect, Hidden Defect or Product rejection, including but not limited to customer failure- to-supply penalties and destruction costs; and d. LM (d) ANDERSEN will promptly supply ETON with conforming Product in replacement of the rejected Product. (iv4) If there is a dispute between the Parties with respect to the rejection of Product, the Parties will first seek to amicably resolve the dispute among themselves. If, after thirty (30) days, the Parties believe that the dispute cannot be amicably resolved, then the Parties shall mutually agree on a contract laboratory to conduct further testing of rejected Product in or order for the laboratory to determine whether the rejected Product meets the requirements for rejection set forth in this sectionSection 6.3(1). The Party whose conclusions are not borne out by the laboratory shall bear the cost of such testing. If the contract laboratory gives a decision in favor of LMANDERSEN, ETON Eton shall promptly pay for the Product subject to the dispute, if such payment had not earlier been made; if the contract laboratory gives a decision in favor of ETONEton, LM ANDERSEN shall immediately perform its obligations pursuant to this sectionSection 6.3(3). The decision of the contract laboratory, to the extent dispositive of a Product rejection dispute between the Parties, shall be binding upon the Parties with respect to such rejection dispute; any other or further disputes between the Parties with respect to Product conformance with Specifications, other representations and warranties made by a Party herein, or other matters will be addressed in accordance with Sections 9.1, 9.2, 9.3, and 11.2.

Acceptance of Product. Not later than ninety (i) ETON may examine and test Product as it sees fit and may reject Product provided hereunder by LM if such Product is defective for any reason, adulterated or misbranded in any manner, or otherwise poses a threat of harm to the public (including, without limitation, by failing to meet the requirements of this Agreement, the Quality Agreement, any Applicable Law, the Specifications or the NDA/ANDA’s requirements) (collectively, a “Product Defect”); provided, however that ETON shall give written notice to LM of its rejection of any Product hereunder, together with appropriate documentation for its decision (a “Rejection Notice”), within fifteen (15) days after ETON’s receipt of shipment of such Product. The Rejection Notice shall specify the grounds for rejection. If such Rejection Notice is not received within fifteen (15) days after ETON’s receipt of any Product, such Product shall be deemed to be accepted by ETON. However, any Product Defect that would not be discoverable upon a reasonable inspection of a Product (a “Hidden Defect”) will not be deemed accepted by ETON at any time. As soon as possible but not exceeding the shelf life of any Product, if either Party becomes aware of a Hidden Defect in such Product, it will, within five (5) business days of becoming aware of such Hidden Defect, notify the other Party in writing about all Product involved (a “Hidden Defect Rejection Notice”). At ETON’s discretion, any Product subject to a Hidden Defect shall be deemed rejected as of the date of any such Hidden Defect Rejection Notice. (ii) LM may dispute a Rejection Notice or Hidden Defect Rejection Notice by providing written notice to ETON of the dispute within fifteen (1590) days after receipt of Testing Samples for each Lot of Product, AMYLIN shall examine such Rejection Notice Testing Samples for compliance with the Product Specifications, and any damage, defects or Hidden Defect Rejection Notice shortage. If AMYLIN believes that any such Testing Samples do not comply with the Product Specifications or are otherwise deficient, AMYLIN shall promptly, but not later than ninety (as applicable90) days from receipt of such Testing Samples (which period may be extendible should AMYLIN be able to justify to UCB that an unusual situation arose which made it not possible for AMYLIN to determine whether or not the Testing Samples are in compliance with Product Specifications after receipt of the shipment), which notice notify UCB. The 90-day period referred to in the preceding two sentences shall be reevaluated after 2004 to determine whether or not 90 days is a reasonable period of time. In any case, on or before the end of 2004, AMYLIN agrees to make its reasonable efforts to reduce this 90-day testing period. If UCB is satisfied that the relevant Testing Samples do not comply with the representations and warranties in Paragraph 4.2 (including Product Specifications) or are otherwise deficient, AMYLIN shall dispose of the non-complying Testing Samples as UCB shall lawfully direct and at UCB’s sole cost and expense, and UCB shall upon request from LM AMYLIN, and at AMYLIN’s option, replace the shipment or remedy the deficiency promptly, at UCB’s sole cost and expense. UCB shall specifynot be liable, in reasonable detailhowever, the grounds for the dispute. (iii) If a Rejection Notice or Hidden Defect Rejection Notice for any incidental or consequential damages associated with a non-complying Lot of Product. If UCB should deny that the relevant Lot of Product does not comply with any of the representations and warranties in Paragraph 4.2 (including Product Specifications) or is not disputed otherwise deficient or should admit such non-compliance or deficiency but deny that it is at fault, UCB and AMYLIN may submit documentation regarding the relevant Lot of Product to an independent expert agreed upon by LM the parties, and the decision of this independent expert shall be final and binding upon the parties. The fees of such expert shall be borne by the losing party. Failure of AMYLIN to notify UCB of a claim, non-compliance or deficiency as set forth in under this section or if, in the event of a rejection dispute between the Parties, the contract laboratory referred to below gives a decision in favor of ETON, then: a. ETON may withhold all payment for the rejected Product; b. Where payment for the rejected Product has been made, LM will promptly issue a full credit or pay a full refund (as selected by ETON) to ETON for the rejected Product; c. LM will promptly pay to ETON any and all reasonable out-of- pocket costs and expenses resulting from the Product Defect, Hidden Defect or Product rejection, including but not limited to customer failure- to-supply penalties and destruction costs; and d. LM will promptly supply ETON with conforming Product in replacement of the rejected Product. (iv) If there is a dispute between the Parties with respect to the rejection of Product, the Parties will first seek to amicably resolve the dispute among themselves. If, after thirty (30) days, the Parties believe that the dispute cannot be amicably resolved, then the Parties Agreement shall mutually agree on a contract laboratory to conduct further testing of rejected Product in or order for the laboratory to determine whether the rejected Product meets the requirements for rejection set forth in this section. The Party whose conclusions are not borne out by the laboratory shall bear the cost constitute acceptance of such testing. If the contract laboratory gives a decision in favor Lot of LM, ETON shall promptly pay for the Product subject to the dispute, if such payment had not earlier been made; if the contract laboratory gives a decision in favor of ETON, LM shall immediately perform its obligations pursuant to this sectionParagraph 4.6. The decision Title and risk of the contract laboratory, Product will be transferred to AMYLIN upon delivery of the extent dispositive of Testing Samples and the Commercial Material to a Product rejection dispute between the Parties, shall be binding upon the Parties with respect carrier specified by AMYLIN as referred to such rejection disputein Paragraph 4.4 above.

Acceptance of Product. (a) Principal shall, (i) ETON may examine and test Product as it sees fit and may reject Product provided hereunder in the case of defects which are determinable by LM if such Product is defective for any reasontesting upon receipt in accordance with standard quality control procedures or are otherwise apparent, adulterated or misbranded in any mannerwithin 30 days after Principal receives delivery of shipment of the Product, or otherwise poses a threat (ii) in the case of harm to latent defects, within 30 days from the public (includingdate that Principal should have discovered such defect, without limitation, by failing to meet the requirements notify Manufacturer in writing of this Agreement, the Quality Agreement, any Applicable Law, the Specifications or the NDA/ANDA’s requirements) (collectively, a “Product Defect”); provided, however that ETON shall give written notice to LM of its rejection of any such Product hereunder, together with appropriate documentation for its decision (a “"Rejection Notice”"), on the basis of (A) any non-compliance with the Specifications of all or any part of said shipment or the occurrence of an Out of Trend Event that gives rise to a right of rejection under Section 3.09(f), or (B) failure of any such shipment to conform with any product warranty set forth in Section 5.01, to the extent such non-compliance or failure is not due to the fault of Principal. Failure to provide a possible Rejection Notice to Manufacturer within fifteen (15) days after ETON’s receipt the applicable 30-day period shall constitute acceptance by Principal of shipment of the shipment, and Manufacturer shall have no liability for any deviations for which it has not received notice within such Product30-day period. The Any such possible Rejection Notice shall specify state in reasonable detail (sufficient to enable Manufacturer to identify the grounds nature of the problem for tests or studies to be conducted by or on its behalf or to dispute the same) the reason why Principal believes the Product may not be acceptable to Principal. Principal shall, within five days of the delivery by Principal of any such possible Rejection Notice, provide samples of the Product being rejected, if appropriate, and copies of written reports relating to tests, studies or investigations performed to that date by or on behalf of Principal on the Batch of the Product being rejected. (b) Principal's test results or basis for rejection shall be conclusive unless Manufacturer notifies Principal, within 30 days of receipt by Manufacturer of the Rejection Notice, that it disagrees with such test results or basis for rejection. If such Principal and Manufacturer fail to agree within 10 days after Manufacturer's notice to Principal as to whether any Product identified in the Rejection Notice is not received within fifteen (15) days after ETON’s receipt deviates from the Specifications, representative samples of any Product, such the Batch of the Product in question shall be deemed submitted to be accepted by ETONa mutually acceptable independent laboratory or consultant (if not a laboratory analysis issue) for analysis or review. However, any Product Defect that would not be discoverable upon a reasonable inspection of a Product (a “Hidden Defect”) will not be deemed accepted by ETON at any time. As soon as possible but not exceeding the shelf life of any Product, if either Party becomes aware of a Hidden Defect in such Product, it will, within five (5) business days of becoming aware The results of such Hidden Defect, notify the other Party in writing about all Product involved (a “Hidden Defect Rejection Notice”). At ETON’s discretion, any Product subject to a Hidden Defect shall be deemed rejected as of the date of any such Hidden Defect Rejection Notice. (ii) LM may dispute a Rejection Notice or Hidden Defect Rejection Notice by providing written notice to ETON of the dispute within fifteen (15) days after receipt of such Rejection Notice or Hidden Defect Rejection Notice (as applicable), which notice from LM shall specify, in reasonable detail, the grounds for the dispute. (iii) If a Rejection Notice or Hidden Defect Rejection Notice for any Product is not disputed by LM as set forth in this section or if, in the event of a rejection dispute between the Parties, the contract laboratory referred to below gives a decision in favor of ETON, then: a. ETON may withhold all payment for the rejected Product; b. Where payment for the rejected Product has been made, LM will promptly issue a full credit or pay a full refund (as selected by ETON) to ETON for the rejected Product; c. LM will promptly pay to ETON any and all reasonable out-of- pocket costs and expenses resulting from the Product Defect, Hidden Defect or Product rejection, including but not limited to customer failure- to-supply penalties and destruction costs; and d. LM will promptly supply ETON with conforming Product in replacement of the rejected Product. (iv) If there is a dispute between the Parties with respect to the rejection of Product, the Parties will first seek to amicably resolve the dispute among themselves. If, after thirty (30) days, the Parties believe that the dispute cannot be amicably resolved, then the Parties shall mutually agree on a contract laboratory to conduct further testing of rejected Product in or order for the laboratory to determine whether the rejected Product meets the requirements for rejection set forth in this section. The Party whose conclusions are not borne out by the laboratory shall bear the cost of such testing. If the contract laboratory gives a decision in favor of LM, ETON shall promptly pay for the Product subject to the dispute, if such payment had not earlier been made; if the contract laboratory gives a decision in favor of ETON, LM shall immediately perform its obligations pursuant to this section. The decision of the contract laboratory, to the extent dispositive of a Product rejection dispute between the Parties, evaluation shall be binding upon the Parties with parties. If Manufacturer and Principal determine by agreement or if such evaluation certifies that the Product was properly rejected by Principal, Principal may reject the Product in the manner contemplated by Section 3.09(e). The party that is determined to have been incorrect in its determination of whether the Product should be rejected shall pay the costs of any such evaluation. ***. (c) In the event of a dispute (other than disputes in relation to the matters set out in Section 3.09(b)) between Manufacturer and Principal that is exclusively related to technical aspects of the manufacturing, packaging, labeling, quality control testing, handling, storage or other activities under this Agreement (a "Technical Dispute"), Manufacturer and Principal shall make all reasonable efforts to resolve the dispute by amicable negotiations pursuant to Section 11.02. (d) If any order of the Product is rejected by Principal, Principal's duty to pay all amounts payable to Manufacturer in respect of the rejected Product shall be suspended unless the rejection is rescinded as per Section 3.09(b). If only a portion of an order is rejected, only the duty to pay the amount allocable to such rejection disputeportion shall be suspended. Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. (e) In the event an order or partial order is rejected by Principal pursuant to the provisions of this Section 3.09, Principal shall return to Manufacturer (or, at the election of Manufacturer, destroy and provide evidence of such destruction to Manufacturer) any units of such rejected Product. Manufacturer shall, at Principal's election, (i) credit the original invoice in respect of the rejected Product and re-invoice Principal for the units that were not rejected and offset any reasonable expenses related to the return or destruction against other amounts then due Manufacturer hereunder, or (ii) at Manufacturer's cost and expense, replace such rejected Product with conforming Product as soon as practicable after Manufacturer's receipt of Principal's instructions to deliver replacement Product and credit Principal any reasonable expenses related to the return or destruction of the rejected Product; provided, however, that in either case Manufacturer shall have no liability or obligation to Principal under this Section 3.09(e) if it is determined that any such defect is attributable to the failure by any Person (including Principal) to properly store, transport or care for any unit of such Product after such Product left Manufacturer's possession. (f) If an Out of Trend Event shall occur, Manufacturer and Principal shall commence a review of the relevant data and commence an investigation in accordance with the terms and conditions of the Quality Assurance Agreement. The results of such investigation shall be reviewed by the Steering Committee or its designees and if the Steering Committee or its designees determines that the Out of Trend Event is reasonably expected to result in a recall or other adverse event and Principal decides not to release the Batch that is the subject of the Out of Trend Event, Principal shall be entitled to reject such Product within 30 days of such determination.