Common use of Additional Representations, Warranties and Covenants of Licensee Clause in Contracts

Additional Representations, Warranties and Covenants of Licensee. In addition to the representations, warranties and covenants made by Licensee elsewhere in this Agreement, Licensee hereby represents, warrants and covenants as of the Effective Date that (i) Licensee will implement and comply with corporate policies so that all Exploitation of the Licensed Product by or on behalf of Licensee or its Affiliates in the Field in the Territory will be conducted in accordance with applicable Laws and Regulations. (ii) Neither Licensee nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensee, its Affiliates, their respective officers, and any person or entity engaged by Licensee or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge of Licensee, its Affiliates or any such person or entity engaged by Licensee or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensee agrees to notify Licensor in writing promptly if Licensee or its Affiliates, or any of their respective officers, or any person or entity used by Licensee or its Affiliates under this Agreement, is subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensee, its Affiliates or any such person or entity engaged by Licensee or its Affiliates, is threatened. - 52 - of - 75 - (iii) As of the Effective Date, to Licensee’s knowledge, Licensee and its Affiliates have the financial and organizational capabilities and experience to perform Licensee’s obligations under this Agreement and Licensee and its Affiliates will maintain financial and organizational capabilities to perform Licensee’s obligations under this Agreement. (iv) Licensee will grant sublicenses to the Licensor Technology in strict compliance with the provisions set forth in Section 2.5.

Additional Representations, Warranties and Covenants of Licensee. In addition to the representations, warranties Licensee represents and covenants made by Licensee elsewhere in this Agreement, Licensee hereby represents, warrants and covenants as of the Effective Date and covenants to Takeda that: (ia) Licensee will implement has not been debarred by the FDA (and comply with corporate policies so that all Exploitation is not subject to any similar sanction of the Licensed Product by or on behalf of Licensee or its Affiliates other Regulatory Authorities in the Field in the Territory will be conducted in accordance with applicable Laws and Regulations. (ii) Neither Licensee nor any of its Affiliates has been Debarred and, in the course of its research, development or manufacture of products, Licensee, its Affiliates, their respective officersTerritory), and is not subject to any person such debarment or entity engaged similar sanction by any such Regulatory Authority, and Licensee or its Affiliates, have has not used, and during the Term will not use engage, in performing any activities pursuant to capacity, in connection with this Agreement, any person or entity Person who is or either has been Debarred debarred by the FDA such a Regulatory Authority, or equivalent regulatory authorities or who, to the best knowledge of Licensee, its Affiliates or any such person or entity engaged by Licensee or its Affiliates, is the subject of Debarment proceedings by a conviction described in Section 306 of the FDA or equivalent regulatory authoritiesFFDCA. Licensee agrees to notify Licensor shall inform Takeda in writing promptly if Licensee or its Affiliates, it or any of their respective officers, or any person or entity used Person engaged by Licensee or its Affiliates who is performing services under this Agreement, Agreement is debarred or is the subject to any of a conviction described in Section 306 of the foregoingFFDCA, or if any action, suit, claim, investigationinvestigation or legal or administrative proceeding is pending or, or proceeding to Licensee’s Knowledge, is threatened, relating to the foregoing is pending, debarment or to the best knowledge conviction of Licensee, its Affiliates Licensee or any such person Person performing services hereunder. (b) To the extent permissible under Applicable Law, all employees of Licensee or entity engaged its Affiliates performing activities under this Agreement shall be under an obligation to assign all right, title and interest in and to their inventions and other know-how, whether or not patentable, and intellectual property rights therein, to Licensee or its Affiliate(s) as the sole owner thereof. Takeda shall have no obligation to contribute to any remuneration of any inventor employed or previously employed by Licensee or any of its Affiliates in respect of any such inventions, Information and discoveries and intellectual property rights therein that are so assigned to Licensee or its Affiliate(s). Licensee will pay all such remuneration, if any, due to such inventors with respect to such inventions and other know-how and intellectual property rights therein. (c) In performing its obligations under this Agreement, or any ancillary agreements (if any), Licensee shall, and shall cause its Affiliates and sublicensees to, comply with (i) all Applicable Law, including any applicable anti-corruption or anti-bribery laws or regulation, of any Governmental Authority with jurisdiction over the activities performed by Licensee or its AffiliatesAffiliates or sublicensees in furtherance of such obligations, is threatened. - 52 - and (ii) standard pharmaceutical industry accepted guidelines regarding promotional materials, including Pharmaceutical Research and Manufacturers of - 75 - America (iiiPhRMA) As of the Effective Date, to Licensee’s knowledge, Licensee and its Affiliates have the financial and organizational capabilities and experience to perform Licensee’s obligations under this Agreement and Licensee and its Affiliates will maintain financial and organizational capabilities to perform Licensee’s obligations under this Agreementguidelines. (iv) Licensee will grant sublicenses to the Licensor Technology in strict compliance with the provisions set forth in Section 2.5.

Additional Representations, Warranties and Covenants of Licensee. In addition to the representations, warranties and covenants made by Licensee elsewhere in this Agreement, Licensee hereby represents, warrants and covenants (as applicable) to Amarin that: (a) As of the Effective Date that (i) Date, Licensee will implement is solvent and comply with corporate policies so that has the ability to pay and perform all Exploitation of the Licensed Product by or on behalf of Licensee or its Affiliates in the Field in the Territory will be conducted in accordance with applicable Laws obligations as and Regulationswhen such obligations become due, including payment obligations and other obligations under this Agreement. (iib) Neither Licensee nor any As of its Affiliates has been Debarred and, in the course of its research, development or manufacture of productsEffective Date, Licensee, ’s compensation programs for its Affiliates, their respective officers, and any person or entity engaged by Licensee or its Affiliates, have not usedSales Representatives do not, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity who is or has been Debarred by the FDA or equivalent regulatory authorities or who, with respect to the best knowledge Product, provide financial incentives for the promotion, sales, and marketing in violation of any Applicable Laws or any professional requirements. (c) During the Term, Licensee’s medical, regulatory or legal teams will review all training materials and programs prior to use by Licensee to ensure that such training materials and programs are in accordance with the Commercialization Plan and the Regulatory Approvals and in compliance with Applicable Laws. (d) During the Term, all Product used in Development Activities or Commercialized, by, or under authority of, Licensee: (i) shall be handled, stored and shipped by Licensee, its Affiliates in accordance with the applicable Product Specifications; (ii) shall be handled, stored and shipped by Licensee in compliance with all Applicable Laws, including GMPs; and (iii) shall, during the time such Product is under the care or Control of Licensee or any such person or entity engaged by Licensee or of its Affiliates, is not cause the subject Product to be adulterated or misbranded within the meaning of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensee agrees to notify Licensor in writing promptly if Licensee or its Affiliates, or any of their respective officers, or any person or entity used by Licensee or its Affiliates under this Agreement, is subject to any of the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensee, its Affiliates or any such person or entity engaged by Licensee or its Affiliates, is threatened. - 52 - of - 75 -Applicable Laws. (iiie) As of the Effective Date, no claim or demand of any Person has been asserted in writing to Licensee arising out of Licensee’s knowledgedevelopment, Licensee and its Affiliates have the financial and organizational capabilities and experience regulatory or commercialization activities with respect to any other products that would reasonably be expected to adversely affect Licensee’s ability to perform Licensee’s obligations under this Agreement and Licensee and any of its Affiliates will maintain financial and organizational capabilities to perform Licensee’s obligations under this Agreement, and no investigations are pending or, to the knowledge of Licensee, threatened relating to such activities. (ivf) As of the Effective Date, Licensee will grant sublicenses has complied with all Applicable Laws, in all material respects. (g) As of the Effective Date, Licensee has obtained assignments from the inventors of all inventorship rights relating to the Licensor Technology in strict compliance with Licensee Patents which are owned by Licensee, 57 and, to the provisions set forth in Section 2.5knowledge of Licensee, all such assignments of inventorship rights relating to such Licensee Patents are valid and enforceable.

Additional Representations, Warranties and Covenants of Licensee. In addition to the representations, warranties and covenants made by Licensee elsewhere in this Agreement, Licensee hereby represents, warrants and covenants covenant to Licensor that as of the Effective Date thator during such period specifically referenced herein: a) Licensee, together with its Affiliates, contractors, Sublicensees and distributors, has or will have the necessary resources and expertise, including relevant approvals and licenses (ior the resources to acquire the expertise) Licensee will implement to perform its obligations hereunder, including to use best efforts to Develop and comply with corporate policies so that all Exploitation of Commercialize the Compound and Licensed Product by or on behalf of Licensee or its Affiliates Products in the Field in the Territory will be conducted in accordance with applicable Laws and Regulations.Territory; (iib) Neither Licensee nor any of its Affiliates has been Debarred and, in the course of performing its research, development obligations or manufacture of products, Licensee, exercising its Affiliates, their respective officers, and any person or entity engaged by Licensee or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to rights under this Agreement, Licensee shall, and shall cause its Affiliates and Related Licensee Parties to (i) comply with the Development Plan, all agreements referenced herein and all Applicable Laws, including as applicable, cGMP, GCP, GLP and GSP standards; and (ii) ensure that its distributors, suppliers and manufacturers, if any, comply with Applicable Laws in respect of the Development, Manufacture and Commercialization of the Licensed Products; c) neither Licensee nor any person employee, agent or entity Subcontractor of Licensee involved in or who is or will be involved in the Development, Manufacture and/or Commercialization of the Licensed Products has been Debarred debarred or disqualified under Subsection (a) or (b) of Section 306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 335a) or is otherwise the subject of any pending or threatened debarment or disqualification proceedings or other notice of non-compliance or enforcement action by the FDA any Regulatory Authority; (ii) Licensee shall not employ or equivalent regulatory authorities engage any Person who has been debarred or whodisqualified by any Regulatory Authority, or, to the best knowledge of Licensee, its Affiliates or any such person or entity engaged by Licensee or its Affiliates’s Knowledge, is the subject of Debarment any pending or threatened debarment, disqualification or enforcement proceedings by a Regulatory Authority; and (iii) no Person on any of the FDA or equivalent regulatory authorities. clinical investigator enforcement lists will participate in the performance of any activities hereunder; d) Licensee acknowledges and agrees that (i) it has been furnished the materials relating to notify Licensor the Licensed Technology that it has requested; (ii) it has completed to its satisfaction an independent investigation of the Licensed Technology that it has requested; and (iii) in writing promptly if Licensee or making its Affiliates, or any of their respective officers, or any person or entity used by Licensee or its Affiliates under decision to enter into this Agreement, is subject and to any consummate the transactions contemplated hereby, it has relied solely on the results of its own independent investigation and analysis and the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best knowledge of Licensee, its Affiliates or any such person or entity engaged by Licensee or its Affiliates, is threatened. - 52 - of - 75 - (iii) As of the Effective Date, to Licensee’s knowledge, Licensee representations and its Affiliates have the financial and organizational capabilities and experience to perform Licensee’s obligations under this Agreement and Licensee and its Affiliates will maintain financial and organizational capabilities to perform Licensee’s obligations under this Agreement. (iv) Licensee will grant sublicenses to the Licensor Technology in strict compliance with the provisions warranties set forth in Section 2.5Sections 10.1 and 10.

Additional Representations, Warranties and Covenants of Licensee. In addition to the representations, warranties Licensee represents and covenants made by Licensee elsewhere in this Agreement, Licensee hereby represents, warrants and covenants as of the Effective Date and covenants to Takeda that: (ia) Licensee will implement has not been debarred by the FDA, and comply with corporate policies so that all Exploitation of the Licensed Product is not subject to any such debarment or similar sanction by or on behalf of Licensee or its Affiliates any other Regulatory Authorities in the Field in the Territory will be conducted in accordance with applicable Laws Territory, and Regulations. (ii) Neither neither Licensee nor any of its Affiliates has been Debarred andused, or will engage, in any capacity, in connection with this Agreement, any Person who either has been debarred by such a Regulatory Authority, or is the course subject of its research, development a conviction described in Section 306 of the FFDCA. Licensee shall inform Takeda in writing promptly if it or manufacture of products, Licensee, its Affiliates, their respective officers, and any person or entity Person engaged by Licensee or its Affiliates, have not used, and during the Term will not use in performing any activities pursuant to this Agreement, any person or entity Affiliates who is performing activities under this Agreement is debarred or has been Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge of Licensee, its Affiliates or any such person or entity engaged by Licensee or its Affiliates, is the subject of Debarment proceedings by the FDA or equivalent regulatory authorities. Licensee agrees to notify Licensor a conviction described in writing promptly if Licensee or its Affiliates, or any of their respective officers, or any person or entity used by Licensee or its Affiliates under this Agreement, is subject to any Section 306 of the foregoingFFDCA, or if any action, suit, claim, investigationinvestigation or legal or administrative proceeding is pending or, or proceeding to Licensee’s Knowledge, is threatened, relating to the foregoing is pending, debarment or to the best knowledge conviction of Licensee, its Affiliates Licensee or any such person Person performing activities hereunder. (b) To the extent permissible under Applicable Law, all employees of Licensee or entity engaged its Affiliates performing activities under this Agreement shall be under an obligation to assign all right, title and interest in and to their inventions and other know-how, whether or not patentable, and intellectual property rights therein, to Licensee or its Affiliate(s) as the sole owner thereof. Takeda shall have no obligation to contribute to any remuneration of any inventor employed or previously employed by Licensee or any of its Affiliates in respect of any such inventions, Information and discoveries and intellectual property rights therein that are so assigned to Licensee or its Affiliate(s). Licensee will pay all such remuneration, if any, due to such inventors with respect to such inventions and other know-how and intellectual property rights therein. (c) In performing its obligations under this Agreement, or any ancillary agreements (if any), Licensee shall, and shall cause its Affiliates to, comply with all Applicable Law, including any applicable anti-corruption or anti-bribery laws or regulation, of any Governmental Authority with jurisdiction over the activities performed by Licensee or its Affiliates, is threatened. - 52 - Affiliates in furtherance of - 75 - (iii) As of the Effective Date, to Licensee’s knowledge, Licensee and its Affiliates have the financial and organizational capabilities and experience to perform Licensee’s obligations under this Agreement and Licensee and its Affiliates will maintain financial and organizational capabilities to perform Licensee’s obligations under this Agreementsuch obligations. (iv) Licensee will grant sublicenses to the Licensor Technology in strict compliance with the provisions set forth in Section 2.5.