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

Additional Representations, Warranties and Covenants of Licensee. Licensee represents and warrants as of the Effective Date and covenants to Takeda that: (a) Licensee has not been debarred by the FDA (and is not subject to any similar sanction of other Regulatory Authorities in the Territory), and is not subject to any such debarment or similar sanction by any such Regulatory Authority, and Licensee has not used, and will not engage, in any capacity, in connection with this Agreement, any Person who either has been debarred by such a Regulatory Authority, or is the subject of a conviction described in Section 306 of the FFDCA. Licensee shall inform Takeda in writing promptly if it or any Person engaged by Licensee who is performing services under this Agreement is debarred or is the subject of a conviction described in Section 306 of the FFDCA, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to Licensee’s Knowledge, is threatened, relating to the debarment or conviction of Licensee or any such Person performing services hereunder. (b) To the extent permissible under Applicable Law, all employees of Licensee or 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 Affiliates or sublicensees in furtherance of such obligations, and (ii) standard pharmaceutical industry accepted guidelines regarding promotional materials, including Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines.

Additional Representations, Warranties and Covenants of Licensee. In addition to the representations, warranties and covenants made by Licensee represents elsewhere in this Agreement, Licensee hereby represents, warrants and warrants covenants as of the Effective Date and covenants to Takeda that: (ai) Licensee has not been debarred will implement and comply with corporate policies so that all Exploitation of the Licensed Product by the FDA (and is not subject to any similar sanction or on behalf of other Regulatory Authorities Licensee or its Affiliates in the Territory)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 is not subject to any such debarment person or similar sanction entity engaged by any such Regulatory AuthorityLicensee or its Affiliates, and Licensee has have not used, and during the Term will not engage, use in performing any capacity, in connection with activities pursuant to this Agreement, any Person person or entity who either is or has been debarred Debarred by the FDA or equivalent regulatory authorities or who, to the best knowledge of Licensee, its Affiliates or any such a Regulatory Authorityperson or entity engaged by Licensee or its Affiliates, or is the subject of a conviction described in Section 306 of Debarment proceedings by the FFDCAFDA or equivalent regulatory authorities. Licensee shall inform Takeda agrees to notify Licensor in writing promptly if it Licensee or its Affiliates, or any Person engaged of their respective officers, or any person or entity used by Licensee who is performing services or its Affiliates under this Agreement Agreement, is debarred or is the subject of a conviction described in Section 306 to any of the FFDCAforegoing, or if any action, suit, claim, investigation investigation, or legal proceeding relating to the foregoing is pending, or administrative proceeding to the best knowledge of Licensee, its Affiliates or any such person or entity engaged by Licensee or its Affiliates, is pending orthreatened. - 52 - of - 75 - (iii) As of the Effective Date, to Licensee’s Knowledgeknowledge, is threatened, relating to the debarment or conviction of Licensee or any such Person performing services hereunder. (b) To the extent permissible under Applicable Law, all employees of Licensee or and its Affiliates performing activities have the financial and organizational capabilities and experience to perform Licensee’s obligations under this Agreement shall be under an obligation to assign all right, title and interest in Licensee 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 will maintain financial and discoveries and intellectual property rights therein that are so assigned organizational capabilities 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 perform Licensee’s obligations under this Agreement, or any ancillary agreements . (if any), iv) Licensee shall, and shall cause its Affiliates and sublicensees to, comply will grant sublicenses to the Licensor Technology in strict compliance 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 Affiliates or sublicensees provisions set forth in furtherance of such obligations, and (ii) standard pharmaceutical industry accepted guidelines regarding promotional materials, including Pharmaceutical Research and Manufacturers of America (PhRMA) guidelinesSection 2.5.

Additional Representations, Warranties and Covenants of Licensee. Licensee represents and warrants as of the Effective Date and covenants to Takeda that: (a) Licensee has not been debarred by the FDA (and is not subject to any similar sanction of other Regulatory Authorities in the Territory)FDA, and is not subject to any such debarment or similar sanction by any such other Regulatory AuthorityAuthorities in the Territory, and neither Licensee nor any of its Affiliates has not used, and or will not engage, in any capacity, in connection with this Agreement, any Person who either has been debarred by such a Regulatory Authority, or is the subject of a conviction described in Section 306 of the FFDCA. Licensee shall inform Takeda in writing promptly if it or any Person engaged by Licensee or its Affiliates who is performing services activities under this Agreement is debarred or is the subject of a conviction described in Section 306 of the FFDCA, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to Licensee’s Knowledge, is threatened, relating to the debarment or conviction of Licensee or any such Person performing services activities hereunder. (b) To the extent permissible under Applicable Law, all employees of Licensee or 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 Affiliates or sublicensees in furtherance of such obligations, and (ii) standard pharmaceutical industry accepted guidelines regarding promotional materials, including Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines.

Additional Representations, Warranties and Covenants of Licensee. Licensee represents represents, warrants and warrants covenant to Licensor that as of the Effective Date and covenants to Takeda thator during such period specifically referenced herein: (a) Licensee Licensee, together with its Affiliates, contractors, Sublicensees and distributors, has not been debarred by or will have the FDA necessary resources and expertise, including relevant approvals and licenses (or the resources to acquire the expertise) to perform its obligations hereunder, including to use best efforts to Develop and is not subject to any similar sanction of other Regulatory Authorities Commercialize the Compound and Licensed Products in the Field in the Territory), and is not subject to any such debarment or similar sanction by any such Regulatory Authority, and Licensee has not used, and will not engage, in any capacity, in connection with this Agreement, any Person who either has been debarred by such a Regulatory Authority, or is the subject of a conviction described in Section 306 of the FFDCA. Licensee shall inform Takeda in writing promptly if it or any Person engaged by Licensee who is performing services under this Agreement is debarred or is the subject of a conviction described in Section 306 of the FFDCA, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to Licensee’s Knowledge, is threatened, relating to the debarment or conviction of Licensee or any such Person performing services hereunder.; (b) To in the extent permissible under Applicable Law, all employees course of Licensee or 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 or exercising its rights under this Agreement, or any ancillary agreements (if any), Licensee shall, and shall cause its Affiliates and sublicensees to, comply with Related Licensee Parties to (i) comply with the Development Plan, all agreements referenced herein and all Applicable LawLaws, including any applicable anti-corruption or anti-bribery laws or regulationas applicable, of any Governmental Authority with jurisdiction over the activities performed by Licensee or its Affiliates or sublicensees in furtherance of such obligationscGMP, GCP, GLP and GSP standards; and (ii) standard pharmaceutical industry accepted guidelines regarding promotional materialsensure that its distributors, including Pharmaceutical Research suppliers and Manufacturers manufacturers, if any, comply with Applicable Laws in respect of America the Development, Manufacture and Commercialization of the Licensed Products; c) neither Licensee nor any employee, agent or Subcontractor of Licensee involved in or who will be involved in the Development, Manufacture and/or Commercialization of the Licensed Products has been debarred or disqualified under Subsection (PhRMAa) guidelinesor (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 any Regulatory Authority; (ii) Licensee shall not employ or engage any Person who has been debarred or disqualified by any Regulatory Authority, or, to Licensee’s Knowledge, is the subject of any pending or threatened debarment, disqualification or enforcement proceedings by a Regulatory Authority; and (iii) no Person on any of the FDA 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 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 making its decision to enter into this Agreement, and to consummate the transactions contemplated hereby, it has relied solely on the results of its own independent investigation and analysis and the representations and warranties set forth in Sections 10.1 and 10.

Additional Representations, Warranties and Covenants of Licensee. Licensee represents and hereby represents, warrants as of the Effective Date and covenants (as applicable) to Takeda Amarin that: (a) As of the Effective Date, Licensee is solvent and has not been debarred by the FDA (ability to pay and is not subject to any similar sanction perform all of its obligations as and when such obligations become due, including payment obligations and other Regulatory Authorities in the Territory), and is not subject to any such debarment or similar sanction by any such Regulatory Authority, and Licensee has not used, and will not engage, in any capacity, in connection with obligations under this Agreement, any Person who either has been debarred by such a Regulatory Authority, or is the subject of a conviction described in Section 306 of the FFDCA. Licensee shall inform Takeda in writing promptly if it or any Person engaged by Licensee who is performing services under this Agreement is debarred or is the subject of a conviction described in Section 306 of the FFDCA, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to Licensee’s Knowledge, is threatened, relating to the debarment or conviction of Licensee or any such Person performing services hereunder. (b) To As of the extent permissible under Effective Date, Licensee’s compensation programs for its Sales Representatives do not, and during the Term will not with respect to the Product, provide financial incentives for the promotion, sales, and marketing in violation of any Applicable LawLaws 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 employees of Licensee Product used in Development Activities or its Affiliates performing activities Commercialized, by, or under this Agreement authority of, Licensee: (i) shall be handled, stored and shipped by Licensee, 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 an obligation to assign all right, title and interest in and to their inventions and other know-how, whether the care 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 Control of any inventor employed or previously employed by Licensee or any of its Affiliates in respect Affiliates, not cause the Product to be adulterated or misbranded within the meaning of Applicable Laws. (e) As of the Effective Date, no claim or demand of any such inventions, Information and discoveries and intellectual property rights therein that are so assigned Person has been asserted in writing to Licensee arising out of Licensee’s development, regulatory or its Affiliate(s). Licensee will pay all such remuneration, if any, due to such inventors commercialization activities with respect to such inventions and any other know-how and intellectual property rights therein. (c) In performing products that would reasonably be expected to adversely affect Licensee’s ability to perform any of its obligations under this Agreement, or any ancillary agreements and no investigations are pending or, to the knowledge of Licensee, threatened relating to such activities. (if any)f) As of the Effective Date, Licensee shall, and shall cause its Affiliates and sublicensees to, comply has complied with (i) all Applicable LawLaws, including any applicable anti-corruption or anti-bribery laws or regulationin all material respects. (g) As of the Effective Date, Licensee has obtained assignments from the inventors of any Governmental Authority with jurisdiction over all inventorship rights relating to the activities performed Licensee Patents which are owned by Licensee, 57 and, to the knowledge of Licensee, all such assignments of inventorship rights relating to such Licensee or its Affiliates or sublicensees in furtherance of such obligations, Patents are valid and (ii) standard pharmaceutical industry accepted guidelines regarding promotional materials, including Pharmaceutical Research and Manufacturers of America (PhRMA) guidelinesenforceable.