Common use of Determination of Deficiency Clause in Contracts

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have ten days to advise Client by notice in writing that it disagrees with the contents of 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 Client and Patheon fail to agree within ten days after any Patheon notice to Client objecting to a Deficiency Notice as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth herein, then the parties will mutually select an independent laboratory that is properly qualified to make the relevant determination to determine whether the Products deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth herein. The determination of the independent laboratory will be binding on the parties. If the independent laboratory determines that any Products deviate from the Specifications, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the independent laboratory finds that none of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth herein, then (i) Client will be deemed to have accepted delivery of the Products on the 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 (iii) Client will be responsible for the cost of the evaluation.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will shall have ten [***] business days to advise Client Zogenix by notice in writing that it disagrees with the contents of 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 such Deficiency Notice. If Client Zogenix and Patheon fail to agree within ten [***] business days after any Patheon Patheon’s notice to Client objecting to a Deficiency Notice Zogenix as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinManufacturing Requirements, then the parties will shall mutually select an independent laboratory that is properly qualified third party to make the relevant determination to determine whether evaluate if the Products deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinManufacturing Requirements. The determination of the independent laboratory will Such evaluation shall be binding on the parties. If the independent laboratory determines , and if such evaluation certifies that any Products deviate from the SpecificationsManufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this Agreement, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Client Zogenix may reject those Products in the manner contemplated in this by Section 6.1 5.10(c) and Patheon will 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 of to Zogenix and will be liable to Zogenix in amounts not to exceed the evaluationlimits in Section 9.2(a). If the independent laboratory finds that none such evaluation does not so certify in respect of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinany such Products, then (i) Client will Zogenix shall be deemed to have accepted delivery of the such Products on the 40th fortieth 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 (iii) Client will Zogenix shall be responsible for payment for the cost 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 evaluationrejected Product subject to the limitations set out herein.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will shall have ten days *** to advise Client Santarus by notice in writing that it disagrees with the contents of 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 such Deficiency Notice. If Client Santarus and Patheon fail to agree within ten days *** after any Patheon the Santarus' receipt of Patheon's notice to Client objecting to a Deficiency Notice as to whether any Finished Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinPatheon Manufacturing Responsibilities, then the parties will Parties shall mutually select an independent laboratory that is properly qualified to make evaluate if the relevant determination to determine whether the Finished Products deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinPatheon Manufacturing Responsibilities. The determination of the independent laboratory will Such evaluation shall be binding on the parties. If the independent laboratory determines Parties, and if such evaluation certifies that any Finished Products deviate from the SpecificationsPatheon Manufacturing Responsibilities, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Client Santarus may reject those Finished Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation3.5. If the independent laboratory finds that none such evaluation does not so certify in respect of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinany such Finished Products, then (i) Client will Santarus shall be deemed to have accepted delivery of the such Finished Products on the 40th *** 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 40th *** day after discovery thereof by Client)Santarus, (ii) but in no event after the invoice for the Product will be deemed to be dated as expiration date of the date when Finished Product). The expenses of such testing shall be borne by Patheon if the finding non-conformity with the Patheon Manufacturing Responsibilities is madeconfirmed, and (iii) Client will be responsible for the cost of the evaluationotherwise by Santarus.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon Hovione will have ten * business days from Hovione’s receipt of the Deficiency Notice (the “Response Date”) to advise Client by notice 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”). Should Patheon fail to object 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 Hovione does not respond to the Deficiency Notice on a timely basis, Patheon within the Response Date the Deficiency Notice will be deemed to have accepted and agreed with the Deficiency Noticeby Hovione. If Client and Patheon Hovione fail to agree within ten * business days after any Patheon notice to Client objecting to Client’s receipt of a Deficiency Response Notice from Hovione as to whether any Products identified in the Deficiency Notice deviate from Product satisfies the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth herein, Manufacturing Standards then the parties Parties will promptly mutually select an independent laboratory that meets the requirements of cGMP, if Product analysis is properly qualified 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 make 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 Product is nonconforming from the relevant determination Product Specifications or to otherwise determine whether Product meets the Products deviate from Manufacturing Standards. Consent to the Specifications, cGMPs, Applicable Laws appointment of such Independent Expert shall not be unreasonably withheld or other warranties or requirements set forth hereindelayed by either Party. The determination of the independent laboratory Such evaluation will be binding on the parties. If Parties absent manifest error, and if such evaluation certifies that the independent laboratory determines that Product is nonconforming from any Products deviate from Product Specifications or otherwise does not meet the Specifications, cGMPs, Applicable Laws, or other warranties or requirements set forth hereinManufacturing Standards, Client may reject those Products said Product as set forth in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation6.6. If such evaluation reveals that the independent laboratory finds that none of Product in question complies with the Products deviates from Product Specifications and meets the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth herein, Manufacturing Standards then (i) Client will be deemed to have accepted delivery of such Product upon the Products on the 40th day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt Independent Expert issuing its opinion. The fees and expenses of the Product, on Independent Expert incurred in making such determination shall be paid by the 40th day after discovery thereof by Client), (ii) Party against whom the invoice for the Product will be deemed to be dated as of the date when the finding determination is made, and (iii) Client will be responsible for the cost of the evaluation.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will Manufacturer shall have ten days [***] to advise Client Santarus by notice in writing that it disagrees with the contents of 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 such Deficiency Notice. If Client Santarus and Patheon Manufacturer fail to agree within ten days [***] after any Patheon the Santarus’ receipt of Manufacturer’s notice to Client objecting to a Deficiency Notice as to whether any Finished Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinManufacturer Manufacturing Responsibilities, then the parties will Parties shall mutually select an independent laboratory that is properly qualified to make evaluate if the relevant determination to determine whether the Finished Products deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinManufacturer Manufacturing Responsibilities. The determination of the independent laboratory will Such evaluation shall be binding on the parties. If the independent laboratory determines Parties, and if such evaluation certifies that any Finished Products deviate from the SpecificationsManufacturer Manufacturing Responsibilities, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Client Santarus may reject those Finished Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation3.5. If the independent laboratory finds that none such evaluation does not so certify in respect of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinany such Finished Products, then (i) Client will Santarus shall be deemed to have accepted delivery of the such Finished Products on the 40th [***] 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 40th [***] day after discovery thereof by ClientSantarus), (ii) . The expenses of such testing shall be borne by Manufacturer if the invoice for non-conformity with the Product will be deemed to be dated as of the date when the finding Manufacturer Manufacturing Responsibilities is madeconfirmed, and (iii) Client will be responsible for the cost of the evaluationotherwise by Santarus.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have ten [***] days to advise Client by notice in writing that it disagrees with the contents of 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 Client and Patheon fail to agree within ten [***] days after any Patheon Patheon’s notice to Client objecting to a Deficiency Notice as to whether any Products Product identified in the Deficiency Notice deviate was not manufactured in accordance with or deviates from (except for properly documented and approved deviations) the Specifications, cGMPscGMP, or Applicable Laws or other warranties or requirements set forth hereinLaws, then the parties will mutually select an independent laboratory that is properly qualified of reputable standing reasonably acceptable to make each party to evaluate the relevant determination to determine whether the Products deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinProduct. The determination of the independent laboratory This evaluation will be binding on the partiesparties in respect of this Section 6 in the absence of manifest bias or error. If the independent laboratory determines evaluation certifies that any Products deviate Product was not manufactured in accordance with or deviates from (except for properly documented and approved deviations) the Specifications, cGMPs, cGMPs or Applicable Laws, or other warranties or requirements set forth herein, then such Product shall be deemed to be rejected by Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the independent laboratory finds that none of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinevaluation does not so certify, then (i) Client will be deemed to have accepted delivery of the Products Product on the 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 [***] dayafter discovery thereof by Client, but not after the expiration date of the Product), (ii) the invoice for the Product will be deemed to be dated as of the date when the finding is made, and (iii) Client will be responsible for the cost of the evaluation. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

Determination of Deficiency. (i) Upon receipt of a Deficiency Notice, Patheon will Impax shall have ten days fifteen (15) Business Days to advise Client GSK by notice in writing that it Impax disagrees with the contents of the such Deficiency Notice. Should Patheon fail Impax provide such a notice of disagreement, Impax’s most senior quality assurance officer and GSK’s Quality Head, Contract Manufacturing Quality, or such other persons as they may designate in writing, shall confer to object review samples and/or batch records, as appropriate to the Deficiency Notice on a timely basis, Patheon will be deemed to have accepted and agreed with the Deficiency Notice. If Client and Patheon fail to agree within ten days after any Patheon notice to Client objecting to a Deficiency Notice as to determine whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPsthe Quality Agreement, Applicable Laws cGMPs or other warranties or requirements set forth herein, then Laws. If the parties will mutually select an independent laboratory that is properly qualified Parties are unable to make resolve whether any Products identified in the relevant determination to determine whether the Products Deficiency Notice deviate from the Specifications, the Quality Agreement, cGMPs or Laws, Impax and GSK shall conduct an investigation pursuant to Section 6.5 and the Quality Agreement. 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, Applicable Laws or other warranties or requirements set forth herein. The determination of the independent laboratory will be binding on the parties. If the independent laboratory determines that any Products deviate from the Specifications, cGMPs, Applicable LawsQuality Agreement, or other warranties (C) is nonconforming due to the failure of a Impax-supplied Material or requirements set forth hereinany Materials purchased by Impax, Client may then GSK shall be entitled to reject those Products in the manner contemplated in this Section 6.1 Products, and Patheon will be responsible for the cost of the evaluationinvestigation shall be borne by Impax. If as a result of such investigation Impax and GSK resolve that the independent laboratory finds that none Products in question: (X) meet the Specifications; (Y) were Manufactured in accordance with the Quality Agreement, cGMPs and Laws, and (Z) the nonconformity of the Products deviates from Product is caused by occurrences after the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereintitle to such Product passes to GSK pursuant to Section 2.6, then (i) Client will GSK shall thereafter be deemed to have accepted delivery of the Products on the 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 madesuch Products, and (iii) Client will be responsible for the cost of the evaluationsuch investigation shall be borne by GSK.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will shall have ten [* * *] days to advise Client Santarus by notice in writing that it disagrees with the contents of 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 such Deficiency Notice. If Client Santarus and Patheon fail to agree within ten [* * *] days after any Patheon Santarus’ receipt of Patheon’s notice to Client objecting to a Deficiency Notice as to whether any Products Finished Product identified in the Deficiency Notice deviate deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinPatheon Manufacturing Responsibilities, then the parties will Parties shall mutually select an independent laboratory that is properly qualified to make evaluate if the relevant determination to determine whether the Products deviate Finished Product deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinPatheon Manufacturing Responsibilities. The determination of the independent laboratory will Such evaluation shall be binding on the parties. If the independent laboratory determines Parties, and if such evaluation certifies that any Products deviate Finished Product deviates from the SpecificationsPatheon Manufacturing Responsibilities, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Client Santarus may reject those Products such Finished Product in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation3.5. If the independent laboratory finds that none such evaluation does not so certify in respect of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinany such Finished Product, then (i) Client will Santarus shall be deemed to have accepted delivery of the Products such Finished Product on the 40th [* * *] 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 40th [* * *] day after discovery thereof by Client)Santarus, (ii) but in no event after the invoice for the Product will be deemed to be dated as expiration date of the date when *** Certain information on this page has been omitted and filed separately with the finding Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Finished Product). The expenses of such testing shall be borne by Patheon if the non-conformity with the Patheon Manufacturing Responsibilities is madeconfirmed, and (iii) Client will be responsible for the cost otherwise by Santarus. The Parties mutually agree that they shall resolve all determinations of the evaluationdeficiencies as quickly as possible, and in any event, within [* * *] days of a Deficiency Notice.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will shall have ten [***] days to advise Client Santarus by notice in writing that it disagrees with the contents of 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 such Deficiency Notice. If Client Santarus and Patheon fail to agree within ten [***] days after any Patheon the Santarus’ receipt of Patheon’s notice to Client objecting to a Deficiency Notice as to whether any Finished Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinPatheon Manufacturing Responsibilities, then the parties will Parties shall mutually select an independent laboratory that is properly qualified to make evaluate if the relevant determination to determine whether the Finished Products deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinPatheon Manufacturing Responsibilities. The determination of the independent laboratory will Such evaluation shall be binding on the parties. If the independent laboratory determines Parties, and if such evaluation certifies that any Finished Products deviate from the SpecificationsPatheon Manufacturing Responsibilities, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Client Santarus may reject those Finished Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation3.5. If the independent laboratory finds that none such evaluation does not so certify in respect of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinany such Finished Products, then (i) Client will Santarus shall be deemed to have accepted delivery of the such Finished Products on the 40th [***] 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 40th [***] day after discovery thereof by Client)Santarus, (ii) but in no event after the invoice for the Product will be deemed to be dated as expiration date of the date when Finished Product). The expenses of such testing shall be borne by Patheon if the finding non-conformity with the Patheon Manufacturing Responsibilities is madeconfirmed, and (iii) Client will be responsible for the cost otherwise by Santarus. The Parties mutually agree that they shall resolve all determinations of the evaluationdeficiencies as quickly as possible, and in any event, within [***] days of a Deficiency Notice.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will shall have ten days [***] to advise Client Zogenix by notice in writing that it disagrees with the contents of 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 such Deficiency Notice. If Client Zogenix and Patheon fail to agree within ten days [***] after any Patheon Patheon's notice to Client objecting to a Deficiency Notice Zogenix as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinManufacturing Requirements, then the parties will Parties shall mutually select an independent laboratory that is properly qualified third party to make the relevant determination to determine whether evaluate if the Products deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinManufacturing Requirements. The determination of the independent laboratory will Such evaluation shall be binding on the parties. If the independent laboratory determines Parties, and if such evaluation certifies that any Products deviate from the Specifications, cGMPs, Applicable LawsManufacturing Requirements due to Patheon’s acts or omissions constituting a material breach of this Agreement, or other warranties or requirements set forth hereinPatheon does not disagree with the Deficiency Notice, Client Zogenix may reject those Products in the manner contemplated in this by Section 6.1 5.10(c) or 5.10 (d) and Patheon will 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 of to Zogenix and will be liable to Zogenix in amounts not to exceed the evaluationlimits in Section 9.2(a). If the independent laboratory finds that none such evaluation does not so certify in respect of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinany such Products, then (i) Client will Zogenix shall be deemed to have accepted delivery of the such Products on the 40th fortieth 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 (iii) Client will Zogenix shall be responsible for payment for the cost 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 evaluationrejected Product subject to the limitations set out herein.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will Mylan shall have ten days *** to advise Client Somaxon by notice in writing that it disagrees with the contents of 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 such Deficiency Notice. If Client Somaxon and Patheon Mylan fail to agree within ten days *** after any Patheon Mylan’s notice to Client objecting to a Deficiency Notice Somaxon as to whether any Products identified in the Deficiency Notice deviate from the SpecificationsSpecifications or Applicable Laws, including cGMPs, Applicable Laws or other warranties or requirements set forth herein, then the parties will shall mutually select an independent laboratory that is properly qualified within five days from the parties’ failure to make the relevant determination to determine whether agree, which independent laboratory shall evaluate if the Products deviate from the SpecificationsSpecifications or Applicable Laws, including cGMPs, Applicable Laws or other warranties or requirements set forth herein. The determination of parties shall cause the independent laboratory will 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. If the independent laboratory determines , and if such evaluation certifies that any Products deviate from the Specifications, cGMPs, Specifications or Applicable Laws, or other warranties or requirements set forth hereinincluding cGMPs, Client Somaxon may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation6.1. If the independent laboratory finds that none such evaluation does not so certify in respect of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinany such Products, then (i) Client will Somaxon shall be deemed to have accepted delivery of the such Products on the 40th day after delivery (ordate the evaluation is delivered by the independent laboratory to the parties. The expenses of such testing shall be borne by Mylan if the non-conformity with the Specifications or Applicable Laws, in including cGMPs, is confirmed by 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 madeindependent laboratory, and (iii) Client will be responsible for the cost of the evaluationotherwise by Somaxon.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will Ethypharm shall have ten (10) business days to advise Client Ampio by notice in writing that it disagrees with the contents of the such Deficiency Notice. Should Patheon Ethypharm fail to object provide Ampio with a response to the such Deficiency Notice on a timely basiswithin the applicable period, Patheon will then the delivery shall be deemed to have accepted and agreed with deviated from the Deficiency NoticeSpecifications upon the expiration of such period. If Client Ethypharm responds to such Deficiency Notice during such period and Patheon Ampio and Ethypharm fail to agree within ten (10) business days after any Patheon notice of the date of Ethypharm’s response to Client objecting to a Deficiency Notice Ampio as to whether any Products Product identified in the Deficiency Notice deviates from the Specifications, the parties shall mutually select an independent laboratory to analyze the Product for compliance with the Specifications. Such analysis shall be binding on the parties, and Ampio may reject such Product if such analysis determines that the Product in question deviates from the Specifications. If such analysis certifies that the Product does not deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth herein, then the parties will mutually select an independent laboratory that is properly qualified to make the relevant determination to determine whether the Products deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth herein. The determination of the independent laboratory will be binding on the parties. If the independent laboratory determines that any Products deviate from the Specifications, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the independent laboratory finds that none of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth herein, then (i) Client will Ampio shall be deemed to have accepted delivery of the Products such Product on the 40th fortieth (40th) day after delivery (or, in the case of any defects Defect not reasonably susceptible to discovery upon receipt of the ProductProduct or Defect discovered after final release by Ampio of the Product in its commercial packaging pursuant to Section 4.7 above, on the 40th fortieth (40th) day after discovery thereof by Client)Ampio, (ii) but in no event after the invoice for the Product will be deemed to be dated as expiration date of the date when the finding is made, and (iii) Client will be responsible for the cost of the evaluationProduct). CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will Supplier shall have ten [***] days to advise Client Santarus by notice in writing that it disagrees with the contents of 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 such Deficiency Notice. If Client Santarus and Patheon Supplier fail to agree within ten [***] days after any Patheon Santarus’ receipt of Supplier’s notice to Client objecting to a Deficiency Notice as to whether any Products Finished Bulk Product identified in the Deficiency Notice deviate deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinSupplier Manufacturing Responsibilities, then the parties will Parties shall mutually select an independent laboratory that is properly qualified to make evaluate if the relevant determination to determine whether the Products deviate Finished Bulk Product deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinSupplier Manufacturing Responsibilities. The determination No product testing outside of the independent 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 will without concurrence by both Parties. Such evaluation shall be binding on the parties. If the independent laboratory determines Parties, and if such evaluation certifies that any Products deviate Finished Bulk Product deviates from the SpecificationsSupplier Manufacturing Responsibilities, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Client Santarus may reject those Products such Finished Bulk Product in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation3.5. If the independent laboratory finds that none such evaluation does not so certify in respect of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinany such Finished Bulk Product, then (i) Client will Santarus shall be deemed to have accepted delivery of the Products such Finished Bulk Product on the 40th [***] day after delivery (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 40th [***] day after discovery thereof by ClientSantarus), (ii) . The expenses of such testing shall be borne by Supplier if the invoice for non-conformity with the Product will be deemed to be dated as of the date when the finding Supplier Manufacturing Responsibilities is madeconfirmed, and (iii) Client will be responsible for the cost otherwise by Santarus. The Parties mutually agree that they shall resolve all determinations of the evaluationdeficiencies as quickly as possible, and in any event, within [***] days of a Deficiency Notice.

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have ten *** days to advise Client by notice in writing that whether it disagrees with the contents of 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 Client and Patheon fail to agree within ten *** days after any Patheon Patheon's notice to Client objecting to a Deficiency Notice as to whether any Products identified in the Deficiency Notice fail to conform to the Product Warranties or deviate from the Specifications, cGMPs, or Applicable Laws or other warranties or requirements set forth hereinLaws, then the parties will mutually select an independent laboratory that is properly qualified to make the relevant determination to determine whether evaluate if the Products fail to conform to the Product Warranties or deviate from the Specifications, cGMPs, or Applicable Laws or other warranties or requirements set forth hereinLaws. The determination of the independent laboratory This evaluation will be binding on the parties. If the independent laboratory determines evaluation certifies that any Products fail to conform to the Product Warranties or deviate from the Specifications, cGMPs, or Applicable Laws, or other warranties or requirements set forth herein, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation. If the independent laboratory finds that none evaluation does not so certify for any of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinProducts, then (i) Client will be deemed to have accepted delivery of the Products on the 40th ***th day after delivery (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, on the 40th ***th day after discovery thereof by Client), (ii) but not after the invoice for the Product will be deemed to be dated as expiration date of the date when the finding is made, Product) and (iii) Client will be responsible for the cost of the evaluation. [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

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 ten twenty (20) days to advise Client CUSTOMER by notice in writing that it disagrees with or questions the contents of the Deficiency Notice. Should Patheon fail to object to the Deficiency Notice on a timely basis, Patheon will be deemed to have accepted If CUSTOMER and agreed with the Deficiency Notice. If Client and Patheon NPI fail to agree within ten twenty (20) days after any Patheon NPI’s notice to Client objecting to a Deficiency Notice CUSTOMER as to whether any Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinProduct Warranty, then the parties Parties will mutually select an independent laboratory that is properly qualified to make the relevant determination to determine whether evaluate if the Products deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinProduct Warranty (“Independent Laboratory”). The determination 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 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 will be binding on the parties. If Parties, and if the independent laboratory determines evaluation certifies that any Products deviate from the SpecificationsProduct Warranty, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Client CUSTOMER may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluationProducts. If the independent laboratory finds evaluation does not certify that none of the Products deviates any Product(s) deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinProduct Warranty, then (i) Client CUSTOMER will be deemed to have accepted delivery of the Products on the 40th 65th day after delivery (or, in the case of any defects deviations not reasonably susceptible to discovery upon receipt of the ProductProducts, on the 40th 65th day after discovery thereof by Client)CUSTOMER, (ii) but in no event after the invoice for the Product will be deemed to be dated as expiration date of the date when the finding is made, and (iii) Client will be responsible for the cost of the evaluationProduct).

Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will Manufacturer shall have ten days [***] to advise Client Santarus by notice in writing that it disagrees with the contents of 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 such Deficiency Notice. If Client Santarus and Patheon Manufacturer fail to agree within ten days [***] after any Patheon the Santarus' receipt of Manufacturer's notice to Client objecting to a Deficiency Notice as to whether any Finished Products identified in the Deficiency Notice deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinManufacturer Manufacturing Responsibilities, then the parties will Parties shall mutually select an independent laboratory that is properly qualified to make evaluate if the relevant determination to determine whether the Finished Products deviate from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinManufacturer Manufacturing Responsibilities. The determination of the independent laboratory will Such evaluation shall be binding on the parties. If the independent laboratory determines Parties, and if such evaluation certifies that any Finished Products deviate from the SpecificationsManufacturer Manufacturing Responsibilities, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Client Santarus may reject those Finished Products in the manner contemplated in this Section 6.1 and Patheon will be responsible for the cost of the evaluation3.5. If the independent laboratory finds that none such evaluation does not so certify in respect of the Products deviates from the Specifications, cGMPs, Applicable Laws or other warranties or requirements set forth hereinany such Finished Products, then (i) Client will Santarus shall be deemed to have accepted delivery of the such Finished Products on the 40th [***] 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 40th [***] day after discovery thereof by ClientSantarus), (ii) . The expenses of such testing shall be borne by Manufacturer if the invoice for non-conformity with the Product will be deemed to be dated as of the date when the finding Manufacturer Manufacturing Responsibilities is madeconfirmed, and (iii) Client will be responsible for the cost of the evaluationotherwise by Santarus.