Common use of Determination of Deficiency Clause in Contracts

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have [***] business days to advise Zogenix by notice in writing that it disagrees with the contents of such Deficiency Notice. If Zogenix and Patheon fail to agree within [***] business days after Patheon’s notice to Zogenix as to whether any Products identified in the Deficiency Notice deviate from the Manufacturing Requirements, then the parties shall mutually select an independent third party to evaluate if the Products deviate from the Manufacturing Requirements. Such evaluation shall be binding on the parties, and if such evaluation certifies that any Products deviate from the Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this Agreement, Zogenix may reject those Products in the manner contemplated by Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a). If such evaluation does not so certify in respect of any such Products, then Zogenix shall be deemed to have accepted delivery of such Products on the fortieth day after delivery and Zogenix shall be responsible for payment for the services provided by the independent third party. For any Product rejected by Zogenix, whether the rejection is accepted by Patheon or is found not to conform by the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out herein.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall Hovione will have [***] * business days from Hovione’s receipt of the Deficiency Notice (the “Response Date”) to advise Zogenix by notice Client in writing that (a) it disagrees in good faith with the contents of such Deficiency Notice, or (b) that despite using good faith efforts, additional time will be required to assess the Deficiency Notice (either, a “Response Notice”). In the case of a Response Notice identifying that additional time is required, the Response Notice shall specify how much additional time is reasonably required by Hovione, which shall not be more than * business days unless Hovione specifically identifies issues that cannot be properly addressed within such * period, and the Response Date will be deemed extended by such period. If Zogenix Hovione does not respond to the Deficiency Notice within the Response Date the Deficiency Notice will be deemed accepted by Hovione. If Client and Patheon Hovione fail to agree within [***] * business days after PatheonClient’s notice to Zogenix receipt of a Response Notice from Hovione as to whether any Products identified in the Deficiency Notice deviate from Product satisfies the Manufacturing Requirements, Standards then the parties shall Parties will promptly mutually select an independent third party laboratory that meets the requirements of cGMP, if Product analysis is required, and an independent Third Party expert with manufacturing expertise, as appropriate, if any other evaluation is required, in either case, of recognized standing in the industry (each such laboratory or expert to be referred to as, an “Independent Expert”), to evaluate a representative sample of Product, using a review of Batch Records and the testing methods described in the Product Specifications, to determine if the Products deviate Product is nonconforming from the relevant Product Specifications or to otherwise determine whether Product meets the Manufacturing RequirementsStandards. Consent to the appointment of such Independent Expert shall not be unreasonably withheld or delayed by either Party. Such evaluation shall will be binding on the partiesParties absent manifest error, and if such evaluation certifies that the Product is nonconforming from any Products deviate from Product Specifications or otherwise does not meet the Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this AgreementStandards, Zogenix Client may reject those Products in the manner contemplated by Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of said Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits as set forth in Section 9.2(a)6.6. If such evaluation does not so certify reveals that the Product in respect of any such Products, question complies with the Product Specifications and meets the other Manufacturing Standards then Zogenix shall Client will be deemed to have accepted delivery of such Products on Product upon the fortieth day after delivery Independent Expert issuing its opinion. The fees and Zogenix expenses of the Independent Expert incurred in making such determination shall be responsible for payment for the services provided paid by the independent third party. For any Product rejected by Zogenix, whether Party against whom the rejection determination is accepted by Patheon or is found not to conform by the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out hereinmade.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have [***] business days * to advise Zogenix Santarus by notice in writing that it disagrees with the contents of such Deficiency Notice. If Zogenix Santarus and Patheon fail to agree within [***] business days * after the Santarus' receipt of Patheon’s 's notice to Zogenix as to whether any Finished Products identified in the Deficiency Notice deviate from the Patheon Manufacturing RequirementsResponsibilities, then the parties Parties shall mutually select an independent third party laboratory to evaluate if the Finished Products deviate from the Patheon Manufacturing RequirementsResponsibilities. Such evaluation shall be binding on the partiesParties, and if such evaluation certifies that any Finished Products deviate from the Patheon Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this AgreementResponsibilities, Zogenix Santarus may reject those Finished Products in the manner contemplated by in this Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)3.5. If such evaluation does not so certify in respect of any such Finished Products, then Zogenix Santarus shall be deemed to have accepted delivery of such Finished Products on the fortieth *** day after delivery and Zogenix (or, in the case of any defects not reasonably susceptible to discovery upon receipt by visual inspection of the Finished Product, including those requiring laboratory analysis, on the *** day after discovery thereof by Santarus, but in no event after the expiration date of the Finished Product). The expenses of such testing shall be responsible for payment for the services provided by the independent third party. For any Product rejected by Zogenix, whether the rejection is accepted borne by Patheon or if the non-conformity with the Patheon Manufacturing Responsibilities is found not to conform confirmed, and otherwise by the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out hereinSantarus.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall will have [***] business ten days to advise Zogenix Client by notice in writing that it disagrees with the contents of such the Deficiency Notice. Should Patheon fail to object to the Deficiency Notice on a timely basis, Patheon will be deemed to have accepted and agreed with the Deficiency Notice. If Zogenix Client and Patheon fail to agree within [***] business ten days after Patheon’s any Patheon notice to Zogenix Client objecting to a Deficiency Notice as to whether any Products identified in the Deficiency Notice deviate from the Manufacturing RequirementsSpecifications, cGMPs, Applicable Laws or other warranties or requirements set forth herein, then the parties shall will mutually select an independent third party laboratory that is properly qualified to evaluate if make the relevant determination to determine whether the Products deviate from the Manufacturing RequirementsSpecifications, cGMPs, Applicable Laws or other warranties or requirements set forth herein. Such evaluation shall The determination of the independent laboratory will be binding on the parties, and if such evaluation certifies . If the independent laboratory determines that any Products deviate from the Manufacturing Requirements due to Patheon’s acts Specifications, cGMPs, Applicable Laws, or omissions constituting a material breach of this Agreementother warranties or requirements set forth herein, Zogenix Client may reject those Products in the manner contemplated by in this Section 5.10(c) 6.1 and Patheon shall will be responsible for the payment for cost of the work performed by evaluation. If the independent third party. In additionlaboratory finds that none of the Products deviates from the Specifications, at Zogenix’ requestcGMPs, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a). If such evaluation does not so certify in respect of any such ProductsApplicable Laws or other warranties or requirements set forth herein, then Zogenix shall (i) Client will be deemed to have accepted delivery of such the Products on the fortieth 40th day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the 40th day after discovery thereof by Client), (ii) the invoice for the Product will be deemed to be dated as of the date when the finding is made, and Zogenix shall (iii) Client will be responsible for payment for the services provided by the independent third party. For any Product rejected by Zogenix, whether the rejection is accepted by Patheon or is found not to conform by the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction cost of the rejected Product subject to the limitations set out hereinevaluation.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon Manufacturer shall have [***] business days to advise Zogenix Santarus by notice in writing that it disagrees with the contents of such Deficiency Notice. If Zogenix Santarus and Patheon Manufacturer fail to agree within [***] business days after Patheonthe Santarus’ receipt of Manufacturer’s notice to Zogenix as to whether any Finished Products identified in the Deficiency Notice deviate from the Manufacturer Manufacturing RequirementsResponsibilities, then the parties Parties shall mutually select an independent third party laboratory to evaluate if the Finished Products deviate from the Manufacturer Manufacturing RequirementsResponsibilities. Such evaluation shall be binding on the partiesParties, and if such evaluation certifies that any Finished Products deviate from the Manufacturer Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this AgreementResponsibilities, Zogenix Santarus may reject those Finished Products in the manner contemplated by in this Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)3.5. If such evaluation does not so certify in respect of any such Finished Products, then Zogenix Santarus shall be deemed to have accepted delivery of such Finished Products on the fortieth [***] day after delivery and Zogenix (or, in the case of any defects not reasonably susceptible to discovery upon receipt by visual inspection of the Finished Product, including those requiring laboratory analysis, on the [***] day after discovery thereof by Santarus). The expenses of such testing shall be responsible for payment for borne by Manufacturer if the services provided non-conformity with the Manufacturer Manufacturing Responsibilities is confirmed, and otherwise by the independent third party. For any Product rejected by Zogenix, whether the rejection is accepted by Patheon or is found not to conform by the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out hereinSantarus.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have [*** * *] business days to advise Zogenix Santarus by notice in writing that it disagrees with the contents of such Deficiency Notice. If Zogenix Santarus and Patheon fail to agree within [*** * *] business days after Santarus’ receipt of Patheon’s notice to Zogenix as to whether any Products Finished Product identified in the Deficiency Notice deviate deviates from the Patheon Manufacturing RequirementsResponsibilities, then the parties Parties shall mutually select an independent third party laboratory to evaluate if the Products deviate Finished Product deviates from the Patheon Manufacturing RequirementsResponsibilities. Such evaluation shall be binding on the partiesParties, and if such evaluation certifies that any Products deviate Finished Product deviates from the Patheon Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this AgreementResponsibilities, Zogenix Santarus may reject those Products such Finished Product in the manner contemplated by in this Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)3.5. If such evaluation does not so certify in respect of any such ProductsFinished Product, then Zogenix Santarus shall be deemed to have accepted delivery of such Products Finished Product on the fortieth [* * *] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt by visual inspection of the Finished Product, including those requiring laboratory analysis, on the [* * *] day after discovery thereof by Santarus, but in no event after the expiration date of the *** Certain information on this page has been omitted and Zogenix filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Finished Product). The expenses of such testing shall be responsible for payment for the services provided by the independent third party. For any Product rejected by Zogenix, whether the rejection is accepted borne by Patheon or if the non-conformity with the Patheon Manufacturing Responsibilities is found not to conform confirmed, and otherwise by the independent third party due to Patheon’s acts or omissions constituting Santarus. The Parties mutually agree that they shall resolve all determinations of deficiencies as quickly as possible, and in any event, within [* * *] days of a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out hereinDeficiency Notice.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon Manufacturer shall have [***] business days to advise Zogenix Santarus by notice in writing that it disagrees with the contents of such Deficiency Notice. If Zogenix Santarus and Patheon Manufacturer fail to agree within [***] business days after Patheon’s the Santarus' receipt of Manufacturer's notice to Zogenix as to whether any Finished Products identified in the Deficiency Notice deviate from the Manufacturer Manufacturing RequirementsResponsibilities, then the parties Parties shall mutually select an independent third party laboratory to evaluate if the Finished Products deviate from the Manufacturer Manufacturing RequirementsResponsibilities. Such evaluation shall be binding on the partiesParties, and if such evaluation certifies that any Finished Products deviate from the Manufacturer Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this AgreementResponsibilities, Zogenix Santarus may reject those Finished Products in the manner contemplated by in this Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)3.5. If such evaluation does not so certify in respect of any such Finished Products, then Zogenix Santarus shall be deemed to have accepted delivery of such Finished Products on the fortieth [***] day after delivery and Zogenix (or, in the case of any defects not reasonably susceptible to discovery upon receipt by visual inspection of the Finished Product, including those requiring laboratory analysis, on the [***] day after discovery thereof by Santarus). The expenses of such testing shall be responsible for payment for borne by Manufacturer if the services provided non-conformity with the Manufacturer Manufacturing Responsibilities is confirmed, and otherwise by the independent third party. For any Product rejected by Zogenix, whether the rejection is accepted by Patheon or is found not to conform by the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out hereinSantarus.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have [***] business days to advise Zogenix Santarus by notice in writing that it disagrees with the contents of such Deficiency Notice. If Zogenix Santarus and Patheon fail to agree within [***] business days after the Santarus’ receipt of Patheon’s notice to Zogenix as to whether any Finished Products identified in the Deficiency Notice deviate from the Patheon Manufacturing RequirementsResponsibilities, then the parties Parties shall mutually select an independent third party laboratory to evaluate if the Finished Products deviate from the Patheon Manufacturing RequirementsResponsibilities. Such evaluation shall be binding on the partiesParties, and if such evaluation certifies that any Finished Products deviate from the Patheon Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this AgreementResponsibilities, Zogenix Santarus may reject those Finished Products in the manner contemplated by in this Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)3.5. If such evaluation does not so certify in respect of any such Finished Products, then Zogenix Santarus shall be deemed to have accepted delivery of such Finished Products on the fortieth [***] day after delivery and Zogenix (or, in the case of any defects not reasonably susceptible to discovery upon receipt by visual inspection of the Finished Product, including those requiring laboratory analysis, on the [***] day after discovery thereof by Santarus, but in no event after the expiration date of the Finished Product). The expenses of such testing shall be responsible for payment for the services provided by the independent third party. For any Product rejected by Zogenix, whether the rejection is accepted borne by Patheon or if the non-conformity with the Patheon Manufacturing Responsibilities is found not to conform confirmed, and otherwise by the independent third party due to Patheon’s acts or omissions constituting Santarus. The Parties mutually agree that they shall resolve all determinations of deficiencies as quickly as possible, and in any event, within [***] days of a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out hereinDeficiency Notice.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have [***] business days to advise Zogenix Gilead by notice in writing that whether it disagrees with the contents of such Deficiency Notice. If Zogenix Gilead and Patheon fail to agree within [***] business days after Patheon’s notice to Zogenix Gilead as to whether any Products Drug Product identified in the Deficiency Notice deviate deviates from the Manufacturing Requirementsapplicable Specifications or cGMPs, then the parties Parties shall mutually select an independent third party laboratory to evaluate if the Products deviate such Drug Product deviates from the Manufacturing Requirementsapplicable Specifications or cGMPs. A sample of such Drug Product shall be submitted to the independent laboratory and such independent laboratory shall determine within [*] days of receipt of the relevant sample (to the extent within the control of the Parties) whether such Drug Product meets the applicable Specifications and cGMPs. Such evaluation shall be binding on the parties, Parties and if such evaluation certifies that any Products deviate Drug Product deviates from the Manufacturing Requirements due to Patheon’s acts Specifications or omissions constituting a material breach of this AgreementcGMPs, Zogenix Gilead may reject those Products that Drug Product in the manner contemplated by Section 5.10(c5.4(d) and Patheon shall be responsible and, at Gilead’s option, receive either a credit or a refund (to the extent previously paid by Gilead) for the payment amount that it was invoiced by Patheon for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)such shipment. If such evaluation does not so certify in respect of any such ProductsDrug Product, then Zogenix Gilead shall be deemed to have accepted delivery of such Products on the fortieth day after delivery and Zogenix shall be responsible for payment for the services provided Drug Product upon receipt by the independent third party. For any Product rejected by Zogenix, whether Parties of the rejection is accepted by Patheon or is found not to conform by final determination in writing from the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon laboratory. The Party against whom the independent laboratory rules shall be responsible for bear all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out hereintesting.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall have [***] business days to advise Zogenix by notice in writing that it disagrees with the contents of such Deficiency Notice. If Zogenix and Patheon fail to agree within [***] business days after Patheon’s 's notice to Zogenix as to whether any Products identified in the Deficiency Notice deviate from the Manufacturing Requirements, then the parties Parties shall mutually select an independent third party to evaluate if the Products deviate from the Manufacturing Requirements. Such evaluation shall be binding on the partiesParties, and if such evaluation certifies that any Products deviate from the Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this Agreement, or Patheon does not disagree with the Deficiency Notice, Zogenix may reject those Products in the manner contemplated by Section 5.10(c) or 5.10 (d) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a). If such evaluation does not so certify in respect of any such Products, then Zogenix shall be deemed to have accepted delivery of such Products on the fortieth day after delivery and Zogenix shall be responsible for payment for the services provided by the independent third party. For any Product rejected by Zogenix, whether the rejection is accepted by Patheon or is found not to conform by the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out herein.

Determination of Deficiency. (i) Upon receipt of a Deficiency Notice, Patheon Impax shall have [***] business days fifteen (15) Business Days to advise Zogenix GSK by notice in writing that it Impax disagrees with the contents of such Deficiency Notice. If Zogenix Should Impax provide such a notice of disagreement, Impax’s most senior quality assurance officer and Patheon fail GSK’s Quality Head, Contract Manufacturing Quality, or such other persons as they may designate in writing, shall confer to agree within [***] business days after Patheon’s notice review samples and/or batch records, as appropriate to Zogenix as to determine whether any Products identified in the Deficiency Notice deviate from the Manufacturing RequirementsSpecifications, then the parties shall mutually select an independent third party Quality Agreement, cGMPs or Laws. If the Parties are unable to evaluate if resolve whether any Products identified in the Products Deficiency Notice deviate from the Manufacturing RequirementsSpecifications, the Quality Agreement, cGMPs or Laws, Impax and GSK shall conduct an investigation pursuant to Section 6.5 and the Quality Agreement. Such evaluation If as a result of such investigation Impax and GSK resolve that the Products in question: (A) deviates from the Specifications (other than due and to the extent the deviation is caused by occurrences after the title to such Product passes to GSK pursuant to Section 2.6), (B) were not Manufactured in accordance with cGMPs, Laws or the Quality Agreement, or (C) is nonconforming due to the failure of a Impax-supplied Material or any Materials purchased by Impax, then GSK shall be binding on entitled to reject the partiesProducts, and if the cost of the investigation shall be borne by Impax. If as a result of such evaluation certifies investigation Impax and GSK resolve that any the Products deviate from in question: (X) meet the Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this Specifications; (Y) were Manufactured in accordance with the Quality Agreement, Zogenix may reject those Products in cGMPs and Laws, and (Z) the manner contemplated nonconformity of the Product is caused by occurrences after the title to such Product passes to GSK pursuant to Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a). If such evaluation does not so certify in respect of any such Products2.6, then Zogenix GSK shall thereafter be deemed to have accepted delivery of such Products on Products, and the fortieth day after delivery and Zogenix cost of such investigation shall be responsible for payment for borne by GSK. (ii) If, after completion of an investigation pursuant to the services provided Quality Agreement and this Supply Agreement, GSK and Impax fail to resolve whether any Products identified in the Deficiency Notice deviate from the Specifications, the Quality Agreement, cGMPs or Laws, then the Parties shall mutually select an independent laboratory to evaluate if the Products in question deviate from the Specifications, the Quality Agreement, cGMPs or Laws. If the independent laboratory’s evaluation certifies that the Products in question: (A) deviate from the Specifications (other than and to the extent caused by occurrences after the title to such Product passes to GSK pursuant to Section 2.6), (B) were not Manufactured in accordance with cGMPs, Laws or the Quality Agreement, or (C) is nonconforming due to the failure of a Impax-supplied Material or any Materials purchased by Impax, then GSK shall be entitled to reject the Products, and the cost of the testing, evaluation by the independent third partylaboratory shall be borne by Impax. For any If the independent laboratory’s evaluation certifies that the Products in question: (X) meet the Specifications; (Y) were Manufactured in accordance with the Quality Agreement, cGMPs or Laws, or (Z) the nonconformity is caused by occurrences after the title to such Product rejected by Zogenixpasses to GSK pursuant to Section 2.6, whether then GSK shall thereafter be deemed to have accepted delivery of such Products, and the rejection is accepted by Patheon or is found not to conform cost of the testing and evaluation by the independent third party due laboratory shall be borne by GSK. (iii) In the event that the independent laboratory cannot determine that the failure of Product to Patheon’s acts or omissions constituting a material breach of this meet Specifications, the Quality Agreement, Patheon cGMPs or Laws could be attributed to either Party, per Section 6.2(d)(ii) above, Impax shall be responsible invoice GSK for all reasonable direct costs relating to return or destruction fifty percent (50%) of the rejected Transfer Price for such Product subject to unless otherwise mutually agreed by both Parties in writing. Impax and GSK shall share equally the limitations set out hereincost of the testing and evaluation by the independent laboratory.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon Mylan shall have [***] business days * to advise Zogenix Somaxon by notice in writing that it disagrees with the contents of such Deficiency Notice. If Zogenix Somaxon and Patheon Mylan fail to agree within [***] business days * after PatheonMylan’s notice to Zogenix Somaxon as to whether any Products identified in the Deficiency Notice deviate from the Manufacturing RequirementsSpecifications or Applicable Laws, including cGMPs, then the parties shall mutually select an independent third party laboratory within five days from the parties’ failure to agree, which independent laboratory shall evaluate if the Products deviate from the Manufacturing RequirementsSpecifications or Applicable Laws, including cGMPs. The parties shall cause the independent laboratory to conduct its evaluation as promptly as practicable, and in any event within *** from the date of selection of the laboratory. Such evaluation shall be binding on the parties, and if such evaluation certifies that any Products deviate from the Manufacturing Requirements due to Patheon’s acts Specifications or omissions constituting a material breach of this AgreementApplicable Laws, Zogenix including cGMPs, Somaxon may reject those Products in the manner contemplated by in this Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)6.1. If such evaluation does not so certify in respect of any such Products, then Zogenix Somaxon shall be deemed to have accepted delivery of such Products on the fortieth day after delivery and Zogenix shall be responsible for payment for date the services provided evaluation is delivered by the independent third partylaboratory to the parties. For any Product rejected The expenses of such testing shall be borne by ZogenixMylan if the non-conformity with the Specifications or Applicable Laws, whether the rejection including cGMPs, is accepted by Patheon or is found not to conform confirmed by the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreementlaboratory, Patheon shall be responsible for all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out hereinand otherwise by Somaxon.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon (i) NPI shall immediately endeavour to agree whether or not the delivery in question complies with the Product Warranty, (ii) NPI shall be entitled at all reasonable times to inspect and/or analyze the relevant Products, and (iii) NPI will have [***] business twenty (20) days to advise Zogenix CUSTOMER by notice in writing that it disagrees with or questions the contents of such the Deficiency Notice. If Zogenix CUSTOMER and Patheon NPI fail to agree within [***] business twenty (20) days after PatheonNPI’s notice to Zogenix CUSTOMER as to whether any Products identified in the Deficiency Notice deviate from the Manufacturing RequirementsProduct Warranty, then the parties shall Parties will mutually select an independent third party laboratory to evaluate if the Products deviate from the Manufacturing RequirementsProduct Warranty (“Independent Laboratory”). Such The Independent Laboratory must meet the requirements of cGMP, be of recognized standing in the industry, and consent to the appointment of such Independent Laboratory will not be unreasonably withheld or delayed by either Party. The decision of the Independent Laboratory regarding the Products in dispute shall, except for fraud or manifest error, be final and binding on the Parties. The Independent Laboratory will act as an expert and not as an arbitrator and (unless the Independent Laboratory otherwise determines) its fees shall be borne by the Party against whom the Independent Laboratory’s decision is given. This evaluation shall will be binding on the partiesParties, and if such the evaluation certifies that any Products deviate from the Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this AgreementProduct Warranty, Zogenix CUSTOMER may reject those Products in the manner contemplated by Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)Products. If such the evaluation does not so certify in respect of that any such ProductsProduct(s) deviate from the Product Warranty, then Zogenix shall CUSTOMER will be deemed to have accepted delivery of such the Products on the fortieth 65th day after delivery and Zogenix shall be responsible for payment for (or, in the services provided by the independent third party. For case of any Product rejected by Zogenix, whether the rejection is accepted by Patheon or is found deviations not reasonably susceptible to conform by the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction discovery upon receipt of the rejected Product subject to Products, on the limitations set out herein65th day after discovery thereof by CUSTOMER, but in no event after the expiration date of the Product).

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon shall will have [***] business days to advise Zogenix PGx by notice in writing that it disagrees with the contents of such the Deficiency Notice. If Zogenix PGx and Patheon fail to agree within [***] business days after Patheon’s notice to Zogenix PGx as to whether any Products identified in the Deficiency Notice deviate from the Manufacturing RequirementsSpecifications, cGMPs, or Applicable Laws, then the parties shall will mutually select an independent third party laboratory or quality assurance consultant, as applicable, to evaluate if the Products deviate from the Manufacturing RequirementsSpecifications, cGMPs, or Applicable Laws. Such This evaluation shall will be binding on the parties, and if such . If the evaluation certifies that any Products deviate from the Manufacturing Requirements due to Patheon’s acts Specifications, cGMPs, or omissions constituting a material breach of this AgreementApplicable Laws, Zogenix PGx may reject those Products in the manner contemplated by in this Section 5.10(c) 6.1 and Patheon shall will be responsible for the payment for cost of the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)evaluation. If such the evaluation does not so certify in respect for any of any such the Products, then Zogenix shall PGx will be deemed to have accepted delivery of such the Products on the fortieth [*] day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the [*] day after discovery thereof by PGx, but not after the expiration date of the Product) and Zogenix shall PGx will be responsible for payment for the services provided by the independent third party. For any Product rejected by Zogenix, whether the rejection is accepted by Patheon or is found not to conform by the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction cost of the rejected Product subject to the limitations set out hereinevaluation.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon Supplier shall have [***] business days to advise Zogenix Santarus by notice in writing that it disagrees with the contents of such Deficiency Notice. If Zogenix Santarus and Patheon Supplier fail to agree within [***] business days after PatheonSantarus’ receipt of Supplier’s notice to Zogenix as to whether any Products Finished Bulk Product identified in the Deficiency Notice deviate deviates from the Supplier Manufacturing RequirementsResponsibilities, then the parties Parties shall mutually select an independent third party laboratory to evaluate if the Products deviate Finished Bulk Product deviates from the Supplier Manufacturing RequirementsResponsibilities. No product testing outside of the approved methods and procedures identified in the Quality Agreement or product NDA shall be performed by the Supplier, Manufacturer or any Third Party test laboratory without concurrence by both Parties. Such evaluation shall be binding on the partiesParties, and if such evaluation certifies that any Products deviate Finished Bulk Product deviates from the Supplier Manufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this AgreementResponsibilities, Zogenix Santarus may reject those Products such Finished Bulk Product in the manner contemplated by in this Section 5.10(c) and Patheon shall be responsible for the payment for the work performed by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a replacement batch of Product at no additional cost to Zogenix and will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)3.5. If such evaluation does not so certify in respect of any such ProductsFinished Bulk Product, then Zogenix Santarus shall be deemed to have accepted delivery of such Products Finished Bulk Product on the fortieth [***] day after delivery and Zogenix (or, in the case of any defects not reasonably susceptible to discovery upon receipt by visual inspection of the Finished Bulk Product, including those requiring laboratory analysis, on the [***] day after discovery thereof by Santarus). The expenses of such testing shall be responsible for payment for borne by Supplier if the services provided non-conformity with the Supplier Manufacturing Responsibilities is confirmed, and otherwise by the independent third partySantarus. For The Parties mutually agree that they shall resolve all determinations of deficiencies as quickly as possible, and in any Product rejected by Zogenixevent, whether the rejection is accepted by Patheon or is found not to conform by the independent third party due to Patheon’s acts or omissions constituting within [***] days of a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction of the rejected Product subject to the limitations set out hereinDeficiency Notice.

Determination of Deficiency. (i) Upon receipt of a Deficiency Notice, Patheon shall will have [***[ * ] business days to advise Zogenix XenoPort by notice in writing that it Patheon disagrees with the contents of such Deficiency Notice. If Zogenix and Patheon fail to agree within [***] business days after provides such a notice of disagreement, Patheon’s notice most senior quality assurance officer and XenoPort’s Quality Head, External Supply Quality, or any other persons as they may designate in writing, will confer to Zogenix review samples and/or batch records, as appropriate to determine whether any Products identified in the Deficiency Notice deviate from the Manufacturing RequirementsSpecifications, the Quality Agreement, cGMPs or Laws. If the Parties are unable to resolve whether any Products identified in the Deficiency Notice deviate from the Specifications, the Quality Agreement, cGMPs or Laws, Patheon will conduct an investigation pursuant to the Agreement. (ii) If, after completion of an investigation pursuant to this Agreement, XenoPort and Patheon fail to resolve whether any Products identified in the Deficiency Notice deviate from the Specifications, the Quality Agreement, cGMPs or Laws, then the parties shall Parties will mutually select an independent third party laboratory to evaluate if the Products deviate from the Manufacturing RequirementsSpecifications, the Quality Agreement, cGMPs or Laws. Such evaluation shall be binding on If the parties, and if such independent laboratory’s evaluation certifies that any Products deviate the shipment of Products: (A) deviates from the Manufacturing Requirements Specifications, (B) was not manufactured in accordance with cGMPs, Laws or the Quality Agreement, or (C) is nonconforming due to the failure of a Patheon-supplied Material or any Materials purchased by Patheon from Patheon’s acts or omissions constituting a material breach suppliers, then XenoPort will be entitled to reject the Products, and the cost of this Agreementthe testing, Zogenix may reject those Products in the manner contemplated by Section 5.10(c) and Patheon shall be responsible for the payment for the work performed evaluation by the independent third party. In addition, at Zogenix’ request, Patheon shall manufacture a laboratory and replacement batch of Product at no additional cost to Zogenix and XenoPort-provided Materials will be liable to Zogenix in amounts not to exceed the limits in Section 9.2(a)borne by Patheon. If such the independent laboratory’s evaluation does certifies that: (X) the Product shipment meets the Specifications; (Y) Patheon is not so certify in respect found to have failed to comply with the Specifications, the Quality Agreement, cGMPs or Laws, or (Z) the failure of [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. the Product is caused by failure of any such ProductsXenoPort-supplied Materials, then Zogenix shall XenoPort will thereafter be deemed to have accepted delivery of such Products on the fortieth day after delivery Products, and Zogenix shall be responsible for payment for the services provided cost of the testing and evaluation by the independent third party. For laboratory will be borne by XenoPort. (iii) If the independent laboratory cannot determine that the failure of Product to meet Specifications, the Quality Agreement, cGMPs or Laws could be attributed to either Party, per Section 8.4(d)(ii) above: (A) Patheon will [ * ] as per Section [ * ]; (B) [ * ] will absorb the cost of any Product rejected by Zogenix, whether the rejection is accepted [ * ]-supplied Materials; (C) Any [ * ]-supplied Material used by Patheon or is found not to conform by for the independent third party due to Patheon’s acts or omissions constituting a material breach of this Agreement, Patheon shall be responsible for all reasonable direct costs relating to return or destruction manufacture of the rejected Product subject Products under investigation will not be included in the annual yield per Section 4.2; and (D) The Parties will meet to the limitations set out hereindetermine how to proceed.