Common use of Quality Assurance Acceptance Clause in Contracts

Quality Assurance Acceptance. (a) Eurand represents, covenants and warrants to Impax that: (i) all Impax Authorized Generic Product hereunder shall be produced in accordance with cGMP, and Applicable Laws, rules and regulations and that none of the Impax Authorized Generic Product supplied hereunder shall be adulterated or misbranded as defined by Applicable Law; and ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. (ii) all shipments of Impax Authorized Generic Product supplied hereunder shall at the time of delivery, meet the specifications set forth in Anesta’s NDA (including expiration dating). (b) Eurand will use commercially reasonable efforts to maintain throughout the term of this Agreement all permits, licenses, registrations and other forms of governmental authorization and approval required in order for Eurand to perform its obligations hereunder in accordance with all Applicable Laws. (c) to Eurand’s knowledge upon due investigation, as of the Effective Date the manufacture or marketing of the Impax Authorized Generic Products in the Territory pursuant to this Agreement does not infringe, misappropriate or otherwise conflict with any intellectual property rights of any Third Party. (d) Eurand shall perform all quality control tests and other inspections required by applicable cGMP standards and Anesta’s NDA and shall furnish to Impax a certificate of analysis together with each lot of Impax Authorized Generic Product shipped to Impax. Eurand will also provide Impax with Material Safety Data Sheets (hereinafter “MSDS”) for the Impax Authorized Generic Products, and updates of same as necessary, but in no event will Eurand provide any specifications and/or quality control standards under the NDA beyond those necessary for Impax to conduct the testing specified in subparagraph 4.3(f). (e) Anesta will promptly notify Impax of any request from the FDA to change Impax Authorized Generic Product specifications or labeling and will notify Impax of any changes in specifications. ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. (f) Impax shall conduct, at its own expense, such tests as it deems necessary to determine the compliance of the Impax Authorized Generic Product with the requirements of Section 4.3(a). Impax shall notify Eurand and Anesta within thirty (30) days of its receipt of each shipment of the Impax Authorized Generic Product of any non-compliance of the Impax Authorized Generic Product with the requirements of Section 4.3(a) revealed by such testing, and with respect to any latent defect, within ten (10) days of becoming aware of such defect and provide documents alleged to support any such contention. (g) Subject to the provisions of Section 4.3(h), Eurand shall replace, at its own expense, including all freight costs, any Impax Authorized Generic Product that does not meet the requirements of Section 4.3(a) upon delivery (including shelf life dating). (h) If, no more than 30 days following the timely delivery of a notice by Impax pursuant to the provisions of Section 4.3(f), Impax and Eurand do not agree that any lot or lots of the Impax Authorized Generic Product referred to in the notice meets the requirements of Section 4.3(a), that lot or those lots of the Impax Authorized Generic Product shall be tested for such compliance, within thirty (30) days after notice of the defect is delivered to Eurand, by a disinterested Third Party expert selected by the mutual agreement of Impax and Eurand. The decision of such Third Party expert with respect to the question of compliance shall be binding upon Impax and Eurand for the purposes of Section 4.3(g) of this Agreement. The costs of such testing shall be borne by Eurand if such lot or lots ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. are found not to meet the requirements of Section 4.3(a) and by Impax in all other circumstances. (i) Impax represents, covenants and warrants to Eurand that all Impax Authorized Generic Product marketed by Impax will be packaged, labeled, stored, shipped and handled in accordance with cGMP, Anesta’s NDA, and all Applicable Laws.

Quality Assurance Acceptance. (a) Eurand represents, covenants and warrants to Impax that: (i) all Impax Authorized Generic Product hereunder shall be produced in accordance with cGMP, and Applicable Laws, rules and regulations and that none of the Impax Authorized Generic Product supplied hereunder shall be adulterated or misbranded as defined by Applicable Law; and ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.and (ii) all shipments of Impax Authorized Generic Product supplied hereunder shall at the time of delivery, meet the specifications set forth in Anesta’s NDA (including expiration dating). (b) Eurand will use commercially reasonable efforts to maintain throughout the term of this Agreement all permits, licenses, registrations and other forms of governmental authorization and approval required in order for Eurand to perform its obligations hereunder in accordance with all Applicable Laws. (c) to Eurand’s knowledge upon due investigation, as of the Effective Date the manufacture or marketing of the Impax Authorized Generic Products in the Territory pursuant to this Agreement does not infringe, misappropriate or otherwise conflict with any intellectual property rights of any Third Party. (d) Eurand shall perform all quality control tests and other inspections required by applicable cGMP standards and Anesta’s NDA and shall furnish to Impax a certificate of analysis together with each lot of Impax Authorized Generic Product shipped to Impax. Eurand will also provide Impax with Material Safety Data Sheets (hereinafter “MSDS”) for the Impax Authorized Generic Products, and updates of same as necessary, but in no event will Eurand provide any specifications and/or quality control standards under the NDA beyond those necessary for Impax to conduct the testing specified in subparagraph 4.3(f). (e) Anesta will promptly notify Impax of any request from the FDA to change Impax Authorized Generic Product specifications or labeling and will notify Impax of any changes in specifications. ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. (f) Impax shall conduct, at its own expense, such tests as it deems necessary to determine the compliance of the Impax Authorized Generic Product with the requirements of Section 4.3(a). Impax shall notify Eurand and Anesta within thirty (30) days of its receipt of each shipment of the Impax Authorized Generic Product of any non-compliance of the Impax Authorized Generic Product with the requirements of Section 4.3(a) revealed by such testing, and with respect to any latent defect, within ten (10) days of becoming aware of such defect and provide documents alleged to support any such contention. (g) Subject to the provisions of Section 4.3(h), Eurand shall replace, at its own expense, including all freight costs, any Impax Authorized Generic Product that does not meet the requirements of Section 4.3(a) upon delivery (including shelf life dating). (h) If, no more than 30 days following the timely delivery of a notice by Impax pursuant to the provisions of Section 4.3(f), Impax and Eurand do not agree that any lot or lots of the Impax Authorized Generic Product referred to in the notice meets the requirements of Section 4.3(a), that lot or those lots of the Impax Authorized Generic Product shall be tested for such compliance, within thirty (30) days after notice of the defect is delivered to Eurand, by a disinterested Third Party expert selected by the mutual agreement of Impax and Eurand. The decision of such Third Party expert with respect to the question of compliance shall be binding upon Impax and Eurand for the purposes of Section 4.3(g) of this Agreement. The costs of such testing shall be borne by Eurand if such lot or lots ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. are found not to meet the requirements of Section 4.3(a) and by Impax in all other circumstances. (i) Impax represents, covenants and warrants to Eurand that all Impax Authorized Generic Product marketed by Impax will be packaged, labeled, stored, shipped and handled in accordance with cGMP, Anesta’s NDA, and all Applicable Laws.

Quality Assurance Acceptance. (a) Eurand 6.1 Shire represents, covenants and warrants to Impax that: (ia) all Impax Authorized Generic AG Product hereunder shall be produced in accordance with cGMP, cGMP and other Applicable Laws, rules and regulations and that none of the Impax Authorized Generic AG Product supplied hereunder shall be adulterated or misbranded as defined by Applicable Law; and ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.Act; (iib) all shipments of Impax Authorized Generic AG Product supplied hereunder shall at the time of delivery, meet the specifications and quality control standards set forth in AnestaShire’s NDA (including expiration dating).NDA; (bc) Eurand Shire or a Shire Affiliate will use commercially reasonable efforts Commercially Reasonable Efforts to maintain throughout the term of this Agreement all permits, licenses, registrations and other forms of governmental authorization and approval required in order for Eurand Shire to perform its obligations hereunder in accordance with all Applicable Laws.; (cd) to EurandShire’s knowledge upon due investigation, as of the Original Effective Date Date, the manufacture Manufacture or marketing Marketing of the Impax Authorized Generic AG Products in the Territory pursuant to this Agreement does not infringe, misappropriate or otherwise conflict with any intellectual property rights of any Third Party; (e) Shire or a Shire Affiliate owns and possesses all right, title and interest in the Shire NDA; and (f) Shire has the right to grant all of the rights and licenses granted herein to Impax under the Adderall XR Intellectual Property, and it is not under any obligation to any Third Party that conflicts with the terms of this Agreement. 6.2 Impax AG Products shall (di) Eurand have a shelf life of at least [***] months from the date of Manufacture and (ii) conform to Shire’s NDA. 6.3 All AG Products will be in finished dosage form, filled, Packaged and Labeled for commercial sale in accordance with the terms and conditions of this Agreement, the Quality Agreement, and Applicable Laws. 6.4 Shire shall perform all quality control tests and other inspections required by applicable cGMP standards and AnestaShire’s NDA and shall furnish to Impax a certificate of analysis together with each lot of Impax Authorized Generic AG Product shipped to Impax. Eurand Shire will also provide Impax with Material Safety Data Sheets (hereinafter “MSDS”) as required by Law for the Impax Authorized Generic AG Products, and updates of same as necessary, but in no event will Eurand provide any specifications and/or quality control standards under the NDA beyond those necessary for Impax to conduct the testing specified in subparagraph 4.3(f). (e) Anesta 6.5 Shire will promptly notify Impax of any request from the FDA to change Impax Authorized Generic AG Product specifications or labeling Labeling and will notify Impax of any changes in specifications. ** Portions of the Exhibit have been omitted and have been filed separately pursuant No such change which requires FDA approval will be implemented prior to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amendedobtaining such Impax approval. (f) 6.6 Impax shall conduct, at its own expense, such tests as it deems necessary to determine the compliance of the Impax Authorized Generic AG Product with the requirements of Section 4.3(a)Sections 6. Impax shall notify Eurand and Anesta within thirty (30) days of its receipt of each shipment of the Impax Authorized Generic Product of any non1(a-compliance of the Impax Authorized Generic Product with the requirements of Section 4.3(a) revealed by such testing, and with respect to any latent defect, within ten (10) days of becoming aware of such defect and provide documents alleged to support any such contention. (g) Subject to the provisions of Section 4.3(hb), Eurand shall replace, at its own expense, including all freight costs, any Impax Authorized Generic Product that does not meet the requirements of Section 4.3(a) upon delivery (including shelf life dating)6. 2 and 6. (h) If, no more than 30 days following the timely delivery of a notice by Impax pursuant to the provisions of Section 4.3(f), Impax and Eurand do not agree that any lot or lots of the Impax Authorized Generic Product referred to in the notice meets the requirements of Section 4.3(a), that lot or those lots of the Impax Authorized Generic Product shall be tested for such compliance, within thirty (30) days after notice of the defect is delivered to Eurand, by a disinterested Third Party expert selected by the mutual agreement of Impax and Eurand. The decision of such Third Party expert with respect to the question of compliance shall be binding upon Impax and Eurand for the purposes of Section 4.3(g) of this Agreement. The costs of such testing shall be borne by Eurand if such lot or lots ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. are found not to meet the requirements of Section 4.3(a) and by Impax in all other circumstances. (i) Impax represents, covenants and warrants to Eurand that all Impax Authorized Generic Product marketed by Impax will be packaged, labeled, stored, shipped and handled in accordance with cGMP, Anesta’s NDA, and all Applicable Laws.

Quality Assurance Acceptance. (a) Eurand 6.1. Shire represents, covenants and warrants to Impax that: (ia) all Impax Authorized Generic AG Product hereunder shall be produced in accordance with cGMP, cGMP and other Applicable Laws, rules and regulations and that none of the Impax Authorized Generic AG Product supplied hereunder shall be adulterated or misbranded as defined by Applicable Lawthe Act; and ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.and (iib) all shipments of Impax Authorized Generic AG Product supplied hereunder shall at the time of delivery, meet the specifications and quality control standards set forth in AnestaShire’s NDA (including expiration dating)NDA. (bc) Eurand Shire or a Shire Affiliate will use commercially reasonable efforts Commercially Reasonable Efforts to maintain throughout the term of this Agreement all permits, licenses, registrations and other forms of governmental authorization and approval required in order for Eurand Shire to perform its obligations hereunder in accordance with all Applicable applicable Laws. (cd) to EurandShire’s knowledge upon due investigation, as of the Effective Date the manufacture Manufacture or marketing Marketing of the Impax Authorized Generic AG Products in the Territory pursuant to this Agreement does not infringe, misappropriate or otherwise conflict with any intellectual property rights of any Third Party. (de) Eurand Shire or a Shire Affiliate owns and possesses all right, title and interest in the Shire NDA. (f) Shire has the right to grant all of the rights and licenses granted herein to Impax under the Adderall XR Intellectual Property, and it is not under any obligation to any third party that conflicts with the terms of this Agreement. 6.2. Shire shall perform all quality control tests and other inspections required by applicable cGMP standards and AnestaShire’s NDA and shall furnish to Impax a certificate of analysis together with each lot of Impax Authorized Generic AG Product shipped to Impax. Eurand Shire will also provide Impax with Material Safety Data Sheets (hereinafter “MSDS”) as required by Law for the Impax Authorized Generic AG Products, and updates of same as necessary, but in no event will Eurand provide any specifications and/or quality control standards under the NDA beyond those necessary for Impax to conduct the testing specified in subparagraph 4.3(f). (e) Anesta 6.3. Shire will promptly notify Impax of any request from the FDA to change Impax Authorized Generic AG Product specifications or labeling Labeling and will notify Impax of any changes in specifications. ** Portions of the Exhibit have been omitted and have been filed separately pursuant No such change which requires FDA approval will be implemented prior to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amendedobtaining such Impax approval. (f) 6.4. Impax shall conduct, at its own expense, such tests as it deems necessary to determine the compliance of the Impax Authorized Generic AG Product with the requirements of Section 4.3(a)6.1. Impax shall notify Eurand and Anesta Shire within thirty (30) days of its receipt of each shipment of the Impax Authorized Generic AG Product of any non-compliance of the Impax Authorized Generic AG Product with the requirements of Section 4.3(a) 6.1 revealed by such testing. If no notice of non-compliance is delivered to Shire within such thirty (30) day period, and the AG Product so delivered shall be deemed to comply with respect to any latent defect, within ten (10) days of becoming aware of such defect and provide documents alleged to support any such contentionSection 6.1. (g) 6.5. Subject to the provisions of Section 4.3(h)6.6, Eurand Shire shall replace, at its own expense, including all freight costs, any Impax Authorized Generic AG Product that does not meet the requirements of Section 4.3(a) upon delivery (including shelf life dating)6.1. Subject only to the indemnification obligations set forth in Section 12.1, Shire shall have no other obligations to Impax in respect of such AG Product or the representations set forth in Section 6.1. (h) 6.6. If, no more than 30 days following the timely delivery of a notice by Impax pursuant to the provisions of Section 4.3(f)6.4, Impax and Eurand Shire do not agree that any lot or lots of the Impax Authorized Generic AG Product referred to in the notice meets the requirements of Section 4.3(a)6.1, that lot or those lots of the Impax Authorized Generic AG Product shall be tested for such compliance, within thirty (30) days after notice of the defect is delivered to EurandShire, by a disinterested Third Party expert selected by the mutual agreement of Impax and EurandShire. The decision of such Third Party expert with respect to the question of compliance shall be binding upon Impax and Eurand Shire for the purposes of Section 4.3(g) 6.1 of this AgreementAgreement only. The costs of such testing shall be borne by Eurand Shire if such lot or lots ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. are found not to meet the requirements of Section 4.3(a) 6.1 and by Impax in all other circumstancesif those lot or lots are found to meet the requirements of Section 6.1. (i) 6.7. At least once per calendar year following the License Effective Date, Impax will provide Shire with a certificate of a duly authorized officer with regulatory responsibilities to the effect that Impax stores and ships AG Product in accordance with all Applicable Laws and regulations, including cGMP standards. 6.8. Impax represents, covenants and warrants to Eurand Shire that all Impax Authorized Generic Product marketed Marketed by Impax will be packaged, labeled, stored, shipped and handled in accordance with cGMP, Anesta’s NDA, cGMP and all Applicable Laws, rules and regulations and all Impax Product Manufactured by Impax, or for Impax by a Third Party, shall be Manufactured, shipped and handled in accordance with cGMP and all Applicable Laws, rules and regulations and the Impax ANDA.