Mutual Covenants. Each Party hereby covenants to the other Party that: 7.3.1 all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) of such Party or its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof; 7.3.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products; 7.3.3 Neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authority), (ii) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement; 7.3.4 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and 7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements.
Appears in 6 contracts
Samples: Collaboration and Option Agreement (Globeimmune Inc), Collaboration and Option Agreement (Globeimmune Inc), Collaboration and Option Agreement (Globeimmune Inc)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 10.3.1 all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) employees of such Party or its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 10.3.2 such Party shall (a) perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws and regulations of the country and the state and local government wherein such activities are conducted, and ; (b) with respect to the care, handling and use in research Research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, with current best practices for comparable-sized pharmaceutical companies for the proper care, handling and also use of animals in Research and Development activities, and with the standards “3R Principles” (reducing the number of animals used, replacing animals with non-animal methods whenever possible and refining the research techniques used), subject to the other Party’s reasonable right of inspection; and (c) promptly and in good faith undertake reasonable corrective steps and measures to remedy the pharmaceutical industry for situation to the Development, Commercialization, and manufacture extent that any significant deficiencies are identified as a result of pharmaceutical productssuch inspection;
7.3.3 10.3.3 Neither Party shall employ (or, to the best of its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory AuthorityAuthorities in the Territory), (ii) or, to the best of its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable Regulatory AuthorityAuthorities in the Territory), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;
7.3.4 10.3.4 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that which would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 10.3.5 Each Party shall perform its obligations disclose to the other Party all material data and exercise its rights hereunder in compliance with information, and all applicable material legal correspondence to or from any Regulatory Authority, relating to any and regulatory requirementsall Collaboration Compounds Developed and/or Commercialized under this Agreement.
Appears in 3 contracts
Samples: Research and Development Collaboration, Option, and License Agreement, Research and Development Collaboration, Option, and License Agreement (OncoMed Pharmaceuticals Inc), Research and Development Collaboration, Option, and License Agreement (OncoMed Pharmaceuticals Inc)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 (a) all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) employees of such Party or its Affiliates or Third Party subcontractors or, in the case of Celgene, its Sublicensees, working under this Agreement shall will be under appropriate confidentiality provisions at least as protective as those contained in this Agreement and the obligation to (i) assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 thereof or (ii) grant such Party shall perform its activities pursuant an exclusive, sublicensable license, under such inventions and discoveries to this Agreement in compliance with GLP, GCP, develop and GMP, commercialize any Licensed Compounds or Licensed Products; in each case as applicable under the Laws of the country (i) and the state and local government wherein such activities are conducted(ii), and that is consistent with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical productsthis Agreement;
7.3.3 Neither Party shall employ (or, b) to its knowledge, shall such Party will not (i) employ or use, nor hire or use any contractor or consultant that employs) employs or uses, any individual or entity (i) entity, including a clinical investigator, institution or institutional review board, debarred or disqualified by the FDA (or subject to a similar sanction of EMEA by any Regulatory Authority outside the United States) or other applicable Regulatory Authority), (ii) employ any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable by any Regulatory AuthorityAuthority outside the United States), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, of subclauses (i) and (ii) in the conduct of its activities under this Agreement;
7.3.4 Neither (c) neither Party nor any of its Affiliates shall, during the Term, grant any right or license to any Third Party relating to in any of the intellectual property rights it Controls that licensed to the other Party hereunder which would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each (d) such Party and its Affiliates shall perform its obligations and exercise its rights hereunder activities pursuant to this Agreement in compliance (and shall ensure compliance by any of its subcontractors) in all material respects with all Laws, including GCP, GLP and GMP as applicable material legal and regulatory requirementswith respect to the development activities hereunder.
Appears in 2 contracts
Samples: License Agreement (Forma Therapeutics Holdings, Inc.,), License Agreement (Forma Therapeutics Holdings, Inc.,)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 (a) all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) employees of such Party or its Affiliates or Third Party subcontractors working under this Agreement shall will be under appropriate confidentiality provisions at least as protective as those contained in this Agreement, and, to the extent permitted under applicable Law, the obligation to assign all right, title title, and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractorsb) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall such Party will not (i) employ or use, nor hire or use any contractor or consultant that employs) employs or uses, any individual or entity (i) entity, including a clinical investigator, institution, or institutional review board that has been debarred or disqualified by the FDA (or subject to a similar sanction of EMEA by any Regulatory Authority outside the United States) or other applicable Regulatory Authority), (ii) employ any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable by any Regulatory AuthorityAuthority outside the United States), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, of subclauses (i) and (ii) of this Section in the conduct of its activities under this Agreement;
7.3.4 Neither (c) neither such Party nor any of its Affiliates shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it owns or Controls that which would conflict or interfere with any of the rights or licenses granted to the other Party hereunderunder this Agreement; and
7.3.5 Each (d) such Party and its Affiliates shall perform its obligations and exercise its rights hereunder pursuant to this Agreement in compliance (and shall ensure compliance by any of its subcontractors) in all material respects with all applicable material legal Laws, including GCP, GLP, and regulatory requirementsGMP, as applicable, and with respect to the research, Development, Manufacturing, and Commercialization activities under this Agreement.
Appears in 2 contracts
Samples: Collaborative Development and Commercialization Agreement, Collaborative Development and Commercialization Agreement (Histogen Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 (a) all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) employees of such Party or its Affiliates or Third Party subcontractors working under this Agreement shall Agreement, or any Development & Commercialization Agreement, as applicable, will be under appropriate confidentiality provisions at least as protective as those contained in this Agreement, or any Development & Commercialization Agreement, as applicable, and, to the extent permitted under applicable Law, the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractorsb) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall such Party will not (i) employ or use, nor hire or use any contractor or consultant that employs) employs or uses, any individual or entity (i) entity, including a clinical investigator, institution or institutional review board, debarred or disqualified by the FDA (or subject to a similar sanction of EMEA by any Regulatory Authority outside the United States) or other applicable Regulatory Authority), (ii) employ any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable by any Regulatory AuthorityAuthority outside the United States), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, of subclauses (i) and (ii) in the conduct of its activities under this Agreement or any Development & Commercialization Agreement, as applicable;
7.3.4 Neither (c) neither such Party nor any of its Affiliates shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it owns or Controls that which would conflict or interfere with any of the rights or licenses granted to the other Party hereunder or under any Development & Commercialization Agreement;
(d) such Party and its Affiliates shall perform their activities pursuant to this Agreement or any Development & Commercialization Agreement, as applicable, in compliance (and shall ensure compliance by any of its subcontractors) in all material respects with all applicable Laws, including GCP, GLP and GMP, as applicable, and with respect to the Development, Manufacturing and Commercialization activities hereunder;
(e) the Parties agree and acknowledge that (A) the terms of this Agreement and (B) the terms of the License Agreement are not intended to give rise to, and shall not be treated by the Parties as giving rise to, in whole or in part, a partnership for U.S. federal (or applicable state or local) income tax purposes, or for any other purposes, except as expressly provided in the Co-Development and Co-Commercialization Agreements. No Party shall take any position, or cause or permit any of its Affiliates, to take any position inconsistent with this Section 9.3.1(e) for such purposes (including with respect to filing U.S. federal income tax returns and in the course of any audit, review or litigation), unless otherwise required by applicable Law; and
7.3.5 Each (f) notwithstanding anything to the contrary in this Agreement, the License Agreements or the Co-Development and Co-Commercialization Agreements, including the use therein of the term “option” (or any derivation thereof), the Parties agree and acknowledge that the Opt-In Rights are not intended to be treated, and shall not be treated by the Parties, as options for U.S. federal (or applicable state or local) income tax purposes, and no Party shall perform take any position, or cause or permit any of its obligations Affiliates to take any position, inconsistent with this Section 9.3.1(f) for tax purposes (including with respect to filing U.S. federal income tax returns and exercise its rights hereunder in compliance with all the course of any audit, review or litigation), unless otherwise required by applicable material legal and regulatory requirementsLaw.
Appears in 2 contracts
Samples: Master Research and Collaboration Agreement (Vividion Therapeutics, Inc.), Master Research and Collaboration Agreement (Vividion Therapeutics, Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7a) All employees of such Party or its Affiliates working under this Agreement shall will be under confidentiality obligations consistent with Article XI and the obligation to assign all right, title and interest in and to their inventions and discoveriesdiscoveries arising in the performance of such work, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 (b) To its knowledge, such Party will not (i) employ or use any contractor or consultant that employs any individual or entity debarred or disqualified by the FDA (or subject to a similar sanction by any Regulatory Authority outside the United States) or, (ii) employ any individual who or entity that is the subject of an FDA debarment or disqualification investigation or proceeding (or similar proceeding by any Regulatory Authority outside the United States), in each of clauses (i) and (ii) in the conduct of its activities under this Agreement;
(c) Such Party shall perform its activities pursuant to this Agreement in compliance in all material respects with GLP, GCP, and GMPapplicable Laws;
(d) Each Party will, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of performing its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authority), (ii) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities obligations under this Agreement, comply in all material respects with all applicable FDA and other current international regulatory requirements and standards, including FDA’s current Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices, and comparable foreign regulatory standards, and other applicable rules, regulations and requirements;
7.3.4 (e) Neither Party shall, during the Term, grant any right or license to any Third Party or take any other action, or permit any action to be taken, relating to any of the intellectual property rights it owns or Controls that as of the Effective Date or thereafter which would conflict with, or interfere with limit the scope of, any of the rights or licenses granted or to be granted to the other Party hereunder; and
7.3.5 Each (f) Neither Party shall perform its obligations and exercise its permit any agreement (including, with respect to MERRIMACK, the 2005 License Agreement) or arrangement under which such Party owns or otherwise Controls (other than pursuant to this Agreement) Licensed Technology to be modified or terminated (in whole or in part) in a manner that adversely affects the other Party’s rights hereunder in compliance with all applicable material legal and regulatory requirementsunder this Agreement without the other Party’s prior written consent.
Appears in 2 contracts
Samples: Assignment, Sublicense and Collaboration Agreement (Merrimack Pharmaceuticals Inc), Assignment, Sublicense and Collaboration Agreement (Merrimack Pharmaceuticals Inc)
Mutual Covenants. Each Party hereby covenants to the other Party thatthat during the Term:
7.3.1 all employees, agents, consultants, contactors, (a) All employees and subcontractors (as provided in Section 3.2.7) officers of such Party or its Affiliates working under this Agreement shall will be under the obligation to assign all right, title and interest in and to their inventions and discoveriesInventions, whether or not patentable, if any, to such Party as the sole owner thereof;, and under the obligation to maintain as confidential the Confidential Information of such Party.
7.3.2 such (b) Such Party shall will perform its activities pursuant to this Agreement in compliance with GLP, GCP, good clinical practices and GMPgood manufacturing practices, in each case as applicable under the Applicable Laws and regulations of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, development and manufacture commercialization of pharmaceutical products;.
7.3.3 Neither (c) Such Party shall will not employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable a Regulatory Authority), (ii) or, to its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable a Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;, and each contractor or consultant used by such Party in connection with the conduct of clinical trials under this Agreement will be subject to a covenant that is the same or substantially the same as the foregoing covenant.
7.3.4 Neither (d) Such Party shall, during will not practice or exploit the Term, intellectual property licensed to such Party under this Agreement except to the extent expressly permitted under the terms and conditions of this Agreement.
(e) Such Party will not grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that which would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements.
Appears in 2 contracts
Samples: License Agreement (Cerecor Inc.), Clinical Development and Option Agreement (Cerecor Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:: [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
7.3.1 8.3.1 all employeesemployees of such Party or its Affiliates, and all agents, consultants, contactors, contractors and subcontractors (as provided in Section 3.2.74.4) of such Party or its Affiliates working performing any research activities under this Agreement a research plan under a Project shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 8.3.2 such Party shall perform its obligations and activities pursuant to this Agreement in compliance with Applicable Law and industry standards, including, without limitation, GLP, GCP, GCP and GMP, in each case as applicable under the Laws Applicable Law of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all LawsApplicable Law, and also with the standards in the pharmaceutical industry for the Development, Commercialization, development and manufacture of pharmaceutical products, and (b) with individuals who are appropriately trained and qualified;
7.3.3 Neither 8.3.3 neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (ia) debarred by the FDA (or subject to a similar sanction of EMEA or any other applicable Regulatory Authority), (iib) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or any other applicable Regulatory Authority), or (iiic) has been charged with or convicted under any Applicable Law of the United States Law for conduct relating to the development or approvaldevelopment, approval or otherwise relating to the regulation of any Licensed Product product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;; and
7.3.4 Neither 8.3.4 neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property Intellectual Property rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements.
Appears in 1 contract
Samples: Platform Technology Transfer, Collaboration and License Agreement (Codexis Inc)
Mutual Covenants. Each Party hereby represents, warrants, and covenants (as applicable) to the other Party thatas follows, during the Term:
7.3.1 all employees, agents, consultants, contactors(a) It, and subcontractors (as provided in Section 3.2.7) of such Party or its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by Person acting for or on behalf of such Partyits behalf, shall at all times comply with all Applicable Laws and all applicable contractual obligations with respect to the receipt, collection, compilation, use, storage, processing, sharing, safeguarding, security (technical, physical and administrative), disposal, destruction, disclosure, or transfer (including cross- border) of Personal Information in connection with this Agreement, including providing any notice, obtaining any consent and/or prior authorization, and conducting any assessment required under Applicable Laws, with respect thereto; provided, however, that such Party’s obligations to provide notice or obtain consents or prior authorizations with respect to Personal Information shall be limited to the receipt, collection, compilation, use, storage, processing, sharing, safeguarding, security (technical, physical and administrative), disposal, destruction, disclosure, or transfer (including cross- border) of Personal Information by each of the Parties and their respective Affiliates;
(b) Each Party covenants to the other Party that in the course of performing its obligations or exercising its rights under this Agreement, it shall, and shall ensure compliance cause its Affiliates, Sublicensees (in the case of AKP) and VectivBio Product Sublicensees (in the case of VectivBio) to, comply with all ancillary agreements contemplated hereunder, all Applicable Laws, including as applicable, GMP, GCP, GLP, and GSP standards, and shall not employ or engage any party who has been debarred by any of its subcontractors) with all LawsRegulatory Authority, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its such Party’s knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authority), (ii) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable proceedings by a Regulatory Authority).
(c) Each Party shall comply, or and shall ensure that its employees, agents, and independent contractors (iiiincluding subcontractors) has been charged comply, with or convicted all Applicable Laws in the exercise of its rights and performance of its obligations under United States Law for this Agreement and all ancillary agreements contemplated hereunder. Without limiting the foregoing, each Party shall, at its sole expense, obtain and maintain during the Term all certifications, credentials, authorizations, licenses, and permits necessary to conduct that portion of its business relating to the development or approvalDevelopment, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992Manufacture (as applicable), in each case, in the conduct of its activities under this Agreement;
7.3.4 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any and Commercialization of the intellectual property rights it Controls that would conflict or interfere Product, and to comply with any the Anti-Corruption Laws, good business ethics, and its ethics and other corporate policies, and to abide by the spirit of the rights or licenses granted to the other Party’s applicable ethics and compliance guidelines which may be provided by such other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirementsfrom time to time.
Appears in 1 contract
Samples: Development and Commercialization Agreement (VectivBio Holding AG)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 (a) all employees, agents, consultants, contactors, employees and subcontractors (as provided in Section 3.2.7) Third Party contractors of such Party or any of its Affiliates or sublicensees working under this Agreement shall will be under appropriate confidentiality provisions at least as protective as those contained in this Agreement, and, to the extent permitted under applicable Law, the obligation to assign all right, title and interest in and to their inventions all Know-How made, invented, created, designed, conceived, produced, reduced to practice or otherwise developed by such employees and discoveriesThird Party contractors, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 (b) to such Party’s knowledge, such Party shall perform its activities pursuant to this Agreement in compliance with GLPwill not (i) employ or use, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by nor hire or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) employs or uses, any individual or entity (i) entity, including a clinical investigator, institution or institutional review board, debarred or disqualified by the FDA (or subject to a similar sanction of EMEA by any Regulatory Authority outside the United States) or other applicable Regulatory Authority), (ii) who employ any individual or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable by any Regulatory AuthorityAuthority outside the United States), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, of subclauses (i) and (ii) in the conduct of its activities under this Agreement;
7.3.4 Neither (c) neither such Party nor any of its Affiliates shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it owns or Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder;
(d) such Party and its Affiliates shall perform their activities pursuant to this Agreement in compliance (and shall ensure compliance by its contractors and Sublicensees) in all material respects with all applicable Laws, including GCP, GLP and GMP, as applicable; Table of Contents
(e) the Parties agree and acknowledge that the terms of this Agreement are not intended to give rise to, and shall not be treated by the Parties as giving rise to, in whole or in part, a partnership for U.S. federal (or applicable state or local) income tax purposes, or for any other purposes. No Party shall take any position, or cause or permit any of its Affiliates to take any position, inconsistent with this Section 12.3.1(e) for such purposes (including with respect to filing U.S. federal income tax returns and in the course of any audit, review or litigation), unless otherwise required by applicable Law; and
7.3.5 Each (f) notwithstanding anything to the contrary in this Agreement, including the use of the term “option” (or any derivation thereof), the Parties agree and acknowledge that the Options are not intended to be treated, and shall not be treated by the Parties, as options for U.S. federal (or applicable state or local) income tax purposes, and no Party shall perform take any position, or cause or permit any of its obligations Affiliates to take any position, inconsistent with this Section 12.3.1(f) for tax purposes (including with respect to filing U.S. federal income tax returns and exercise its rights hereunder in compliance with all the course of any audit, review or litigation), unless otherwise required by applicable material legal and regulatory requirementsLaw.
Appears in 1 contract
Samples: Collaboration and License Agreement (Repare Therapeutics Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 all employees, agents, consultants, contactors, and subcontractors (as provided a) in Section 3.2.7) the course of such Party performing its obligations or exercising its Affiliates working rights under this Agreement shall be under Agreement, the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such covenanting Party shall perform its activities pursuant to this Agreement in compliance comply with GLPall Applicable Laws, including, as applicable, GMP, GCP, and GMPGLP standards and the Antitrust Laws, and shall not employ or engage any Person who has been debarred by any Regulatory Authority or is the subject of debarment proceedings by a Regulatory Authority;
(b) the covenanting Party and its Affiliates will only engage Clinical Trial sites that conduct all Clinical Trials in each case compliance with Applicable Laws, including GCP and the ICH Guidelines, and are approved by the applicable Regulatory Authority;
(c) the covenanting Party shall (i) comply with all Applicable Laws in relation to data protection, privacy, or restrictions on, or requirements in respect of, the processing of Personal Data of any kind, including the Health Insurance Portability and Accountability Act, General Data Protection Regulation (Regulation (EU) 2016/679) (GDPR), and any equivalent Applicable Law in any other jurisdiction (as applicable under the Laws any of the country and the state and local government wherein such activities are conductedforegoing may be amended from time to time, and collectively, “Data Protection Laws”), with respect to the carecollection, handling and use, transfer, storage, destruction, aggregation or other use of subject health information or other Personal Data (as defined in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all the applicable Data Protection Laws, and also collectively, “Personal Data”) in connection with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authority), this Agreement; (ii) who is implement appropriate and reasonable security processes and controls in connection with its activities under or in connection with this Agreement so as to protect the subject security and privacy of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable Regulatory Authority), or Personal Data in accordance with Data Protection Laws; and (iii) has been charged take such steps as necessary to comply with or convicted under United States Law for conduct relating Data Protection Laws to the development or approval, or otherwise relating permit such Party to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;
7.3.4 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted disclose Personal Data to the other Party hereunderand to permit the other Party to use and disclose such Personal Data for its own purposes in accordance with this Agreement; andand [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
7.3.5 Each (d) the covenanting Party shall perform and its obligations and exercise its rights hereunder Affiliates’ will not use any employees or contractors in compliance with all applicable material legal and regulatory requirementsthe Development, manufacture or Commercialization of any Royalty Product who are debarred, disqualified, or subject to any similar sanction by any Regulatory Authority or become the subject of any investigation or proceeding, which may result in debarment, disqualification or any similar sanction by any Regulatory Authority.
Appears in 1 contract
Samples: License Agreement (Seagen Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 7.4.1 all employees, agentsofficers, consultants, contactorscontractors, and subcontractors (as provided in Section 3.2.7) consultants of such Party or its Affiliates working under this Agreement shall be under the obligation execute agreements requiring assignment to assign such Party of all right, title and interest in and to their inventions and discoveriesdiscoveries invented or otherwise discovered or generated during the course of and as a result of their association with such Party, whether or not patentable, if any, to such Party as the sole owner thereof, or, if any of such Party’s employees, officers, contractors, and consultants shall not have executed such an agreement, assignment by such employee, officer, contractor, and consultant of such inventions to such Party shall occur by operation of Law or other legal requirements;
7.3.2 7.4.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws Law and regulations of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all LawsLaw, and also with the standards in the pharmaceutical industry for the Development, Commercialization, Development and manufacture Commercialization of pharmaceutical products;
7.3.3 Neither 7.4.3 neither Party shall employ (or, to the best of its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory AuthorityEMA), (ii) or, to the best of its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable Regulatory AuthorityEMA), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;
7.3.4 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each 7.4.4 such Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirementsLaw;
7.4.5 such Party shall not engage in any activities that use the other Party’s intellectual property rights licensed to such Party hereunder in a manner that is outside the scope of the license rights granted to it hereunder; and
7.4.6 such Party shall not knowingly infringe the intellectual property rights of any Third Party in connection with its activities pursuant to this Agreement.
Appears in 1 contract
Samples: Collaboration and Option Agreement (OncoMed Pharmaceuticals Inc)
Mutual Covenants. Each In addition to any covenants made by the Parties elsewhere in this Agreement, each Party hereby covenants to the other Party that:
7.3.1 (a) (i) all employees, agents, consultants, contactorspatient authorizations and consents required under Applicable Laws (in connection with any applicable clinical study) permit the granting of access of Data that such Party is required to provide to the other Party pursuant to Section 5.6, and subcontractors (as provided ii) it will comply with Applicable Laws in Section 3.2.7) transferring personal and other Data in connection with the granting of access of Data that such Party is required to provide to the other Party pursuant to Section 5.6. Each Party will obtain all the necessary authorizations, consents and approvals in order for such Party to grant access to its Data with the other Party, including obtaining the necessary patient authorizations and consents, and obtaining the necessary approvals from and completing all necessary filing procedures with the applicable Governmental Authorities in the Territory and within the Retained Territory (to the extent required to preserve Licensee’s position in the Territory);
(b) it will not knowingly, during the Term, employ or use the services of any person who is debarred or disqualified in connection with activities relating to the Licensed Compound or Licensed Products; and in the event that it becomes aware of the debarment or disqualification or threatened debarment or disqualification of any person providing services to it with respect to any activities relating to the Licensed Compound or Licensed Products, it will immediately notify the other Party in writing and it will cease employing, contracting with, or retaining any such person to perform any services relating to the Licensed Compound or Licensed Products;
(c) it shall conduct, and shall cause its Affiliates working Affiliates, subcontractors, Sublicensees (in case of Licensee) or sublicensees (in case of Duality) to conduct all activities under this Agreement shall be under (including, as set forth in the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and Development Plan(s) with respect to the care, handling and use Licensed Products in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure the Field in the Territory) in compliance by any of its subcontractors) with all Applicable Laws, and also any Regulatory Authority and Governmental Authority health care programs having jurisdiction, each as may be amended from time to time;
(d) it shall conduct its obligations with respect to Development of Licensed Products in the Territory in adherence with the standards Development Plan as may be amended from time to time;
(e) it shall comply, and ensure that shall use commercially reasonable efforts to cause its Affiliates, subcontractors and Sublicensees (in case of Licensee) or sublicensees (in case of Duality) to comply with and commit to uphold the ABC Terms in the pharmaceutical industry for the Development, Commercialization, and manufacture performance of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authority), (ii) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;
7.3.4 Neither (f) it shall have (and shall ensure its Affiliates and (sub)licensees, and subcontractors as applicable, have), at all times, a reasonably sufficient number of suitably qualified personnel to allow the Party shall(or its Affiliates,sublicensees or subcontractors, during the Termas applicable) to conduct, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all Development timeframes set out in the applicable material legal Development Plans and regulatory requirementsGXPs, any Clinical Trials that the Party is required to conduct with respect to the Licensed Products in its territory, or in the other Party’s territory as permitted under this Agreement; and
(g) it shall not induce or solicit, or attempt to induce or solicit, any employees of the other Party or any of its Affiliates to leave the employment of, or to terminate his/her employment, services or engagement with, the other Party or its applicable Affiliate, or enter into any employment or services agreement or arrangement with such Party or any of its Affiliates.
Appears in 1 contract
Mutual Covenants. (a) HSR Act Filings; Reasonable Efforts; Notification.
(i) Each Party hereby covenants of Parent and the Company shall (A) make or cause to be made the other Party that:
7.3.1 all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) filings required of such Party party or any of its Affiliates working under this Agreement shall be subsidiaries or affiliates under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and HSR Act with respect to the caretransactions contemplated hereby as promptly as practicable and in any event within five business days after the date of this Agreement, handling (B) cooperate with the other party in connection with any such filing and use in research and Development activities hereunder connection with resolving any investigation or other inquiry of any non-human animals such agency or other Governmental Authority under any Foreign Antitrust Laws with respect to any such filing or any such transaction. Each party shall use all reasonable efforts to furnish to each other all information required for any application or other filing to be made pursuant to any Applicable Laws in connection with the Merger and the other transactions contemplated by this Agreement. Each party shall promptly inform the other party of any communication with, and any proposed understanding, undertaking, or agreement with, any Governmental Authority regarding any such filings or any such transaction. Neither party shall independently participate in any formal meeting with any Governmental Authority in respect of any such filings, investigation, or other inquiry without giving the other party prior notice of the meeting and, to the extent permitted by such Governmental Authority, the opportunity to attend and/or participate. The parties hereto will consult and cooperate with one another in connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any party hereto in connection with proceedings under or relating to the HSR Act or other Antitrust Laws.
(ii) Each of Parent and the Company shall use all reasonable efforts to resolve such Partyobjections, shall at all times comply if any, as may be asserted by the Federal Trade Commission or the Department of Justice (and shall ensure compliance either, an "HSR --- Authority") or any Governmental Authority with respect to the transactions ---------- contemplated by this Agreement under the HSR Act, the Xxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the Federal Trade Commission Act, as amended, any of its subcontractors) with all Foreign Antitrust Laws, and also with any other federal, state or foreign statutes, rules, regulations, orders, decrees, administrative or judicial doctrines or other laws that are designed to prohibit, restrict or regulate actions having the standards in purpose or effect of monopolization or restraint of trade (collectively, "Antitrust --------- Laws"); provided, however, that neither Parent nor the pharmaceutical industry for the DevelopmentCompany, Commercializationnor any of ----- ----------------- their respective affiliates, and manufacture shall be required, as a result of pharmaceutical products;
7.3.3 Neither Party shall employ (orthis Section 5.1(a)(ii), to propose or agree to accept any undertaking or condition, to enter into any consent decree, to make any divestiture or accept any operational restriction, or take or commit to take any action that could reasonably be expected to limit (A) the freedom of action of Parent or its knowledgesubsidiaries or affiliates with respect to operation of, shall not use or Parent's or its subsidiaries' or affiliates' ability to retain, the Company or any contractor business, product lines or consultant that employs) any individual or entity (i) debarred by assets of the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authority), (ii) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable Regulatory Authority)Company, or (iiiB) has been charged with the ability to retain, own or convicted under United States Law for conduct relating to operate any portion of the development businesses, product lines or approvalassets, of the Parent or its subsidiaries or alter or restrict in any way the business or commercial practices of the Company, the Parent, or otherwise relating either of their subsidiaries or affiliates. Parent shall be entitled to the regulation of direct any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;
7.3.4 Neither Party shall, during the Term, grant proceedings or negotiations with any right or license to any Third Party Governmental Authority relating to any of the intellectual property foregoing described in this paragraph (ii) or to the matters described in paragraph (i) of this Section 5.1(a), provided that it shall afford the Company -------- a reasonable opportunity to participate therein, and provided, further, that -------- ------- nothing in this sentence shall affect the parties' rights it Controls and obligations contained in the third, fourth and fifth sentences of Section 5.1(a)(i). Notwithstanding the foregoing or any other provision of this Agreement, nothing in this Section 5.1(a) shall limit a party's right to terminate this Agreement pursuant to Section 7.1, so long as such party has up to then complied in all material respects with its obligations under this Section 5.1(a). Each of Parent and the Company shall use all reasonable efforts to take such action as may be required to cause the expiration or early termination of the notice period under the HSR Act or other Antitrust Laws with respect to such transactions as promptly as possible after the execution of this Agreement.
(iii) Each of the parties shall use all reasonable efforts to take, or cause to be taken, all actions, and to do, or cause to be done, and to assist and cooperate with the other parties in doing, all things necessary, proper or advisable to consummate and make effective, in the most expeditious manner practicable, the Merger and the other transactions contemplated by this Agreement, including (A) the obtaining of all other necessary actions or nonactions, waivers, consents, licenses, permits, authorizations, orders and approvals from Governmental Authorities and the making of all other necessary registrations and filings (including other filings with Governmental Authorities, if any), subject to the limitations of Section 5.1(a)(ii), (B) the obtaining of all consents, approvals or waivers from third parties related to or required in connection with the Merger that would conflict are necessary to consummate the Merger and the transactions contemplated by this Agreement or interfere with required to prevent a Material Adverse Effect on Parent or the Company from occurring prior to or after the Effective Time, (C) the preparation of the Joint Proxy Statement, the Prospectus and the Registration Statement, (D) the taking of all action necessary to ensure that the Merger constitutes a reorganization within the meaning of Section 368(a) of the Code and (E) the execution and delivery of any additional instruments necessary to consummate the transactions contemplated by, and to fully carry out the purposes of, this Agreement.
(iv) Notwithstanding anything to the contrary in this Agreement, neither Parent nor the Company shall be required to (i) hold separate (including by trust or otherwise) or divest any of their respective businesses or assets or (ii) waive any of the rights or licenses granted conditions to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder Merger set forth in compliance with all applicable material legal and regulatory requirementsArticle VI of this Agreement as they apply to such party.
Appears in 1 contract
Samples: Merger Agreement (Intersil Corp/De)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 9.3.1 all employeesemployees of such Party or its Affiliates, and all agents, consultants, contactors, contractors and subcontractors (as provided in Section 3.2.74.3) of such Party or its Affiliates working performing any activities under this Agreement a research plan under a Technology Transfer Project (including, in the case of Codexis, any Additional Services) shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 9.3.2 such Party shall perform its obligations and activities pursuant to under this Agreement (including, in the case of Codexis, the Additional Services) in compliance with Applicable Law and industry standards, including, without limitation, GLP, GCP, GCP and GMP, in each case as applicable under the Laws Applicable Law of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all LawsApplicable Law, and also with the standards in the pharmaceutical industry for the Development, Commercialization, development and manufacture of pharmaceutical products, and (b) with individuals who are appropriately trained and qualified;
7.3.3 Neither 9.3.3 with specific regard to each Party’s performance of their respective obligations to the other Party under this Agreement, neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (ia) debarred by the FDA (or subject to a similar sanction of EMEA or any other applicable Regulatory Authority), (iib) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or any other applicable Regulatory Authority), or (iiic) has been charged with or convicted under any Applicable Law of the United States Law for conduct relating to the development or approvaldevelopment, approval or otherwise relating to the regulation of any Licensed Product product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;; and
7.3.4 Neither 9.3.4 neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights Intellectual Property Rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations . [***] Certain information in this document has been omitted and exercise its rights hereunder in compliance filed separately with all applicable material legal the Securities and regulatory requirements.Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Execution Version
Appears in 1 contract
Samples: Platform Technology Transfer and License Agreement (Codexis Inc)
Mutual Covenants. Each Party hereby of the Company and Holdings covenants and agrees that, with respect to the Programs and any other Party thatrights and obligations set forth in the Operative Documents, it shall:
7.3.1 (a) perform all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) of such Party or its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities obligations pursuant to this Agreement in material compliance with GLPwith: (i) all applicable federal and state laws, GCPstatutes, rules, regulations and orders (including all applicable approval and qualification requirements thereunder), including, without limitation, the Federal Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto; (ii) all applicable good clinical practices and guidelines; (iii) all applicable standard operating procedures; (iv) all applicable Protocols; and (v) the provisions of this Agreement;
(b) keep complete, proper and separate books of record and account, including a record of all costs and expenses incurred, all charges made, all credits made and received, and GMP, all income derived in each case as applicable under connection with the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any operation of its subcontractors) business, all in accordance with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical productsGAAP;
7.3.3 Neither Party shall (c) not employ (or, to the best of its knowledgeKnowledge, shall not use any contractor or consultant who is or that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or any other applicable Regulatory Authority), (ii) or, to the best of its Knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or any other applicable Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of the Programs;
(d) promptly deliver to the other, upon receipt thereof, notice of all actions, suits, investigations, litigation and proceedings before any Governmental Authority, which would reasonably be expected to affect such Party’s ability to perform its activities obligations under this Agreement;
7.3.4 Neither Party shall(e) upon its acquiring Knowledge of (i) any breach by it of any representation, during the Termwarranty, grant covenant or any right other term or license condition of this Agreement or (ii) any other event or development, in each case that is, or is reasonably expected to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted be, materially adverse to the other Party hereunderwith respect to any Program, such Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Party shall promptly notify the other Party in writing within [ * ] ([ * ]) Business Days of acquiring such Knowledge; provided, that the failure to provide such notice shall not impair or otherwise be deemed a waiver of any rights any Party may have arising from such breach, event or development and that notice under this Section 9.1(e) shall not be deemed an admission by the Party providing such notice of any breach of any of the Operative Documents; and
7.3.5 Each (f) with reasonable promptness, deliver to the other Party shall such data and information relating to the ability of such Party to perform its obligations hereunder as from time to time may be reasonably requested by the other Party (subject to the maintenance of the confidentiality of any such information by the receiving Party). For the avoidance of doubt, this Section 9.1(f) includes the Company’s obligations to provide financial and exercise other necessary information in respect of such Programs to Holdings to enable Holdings to fulfill its rights hereunder in compliance with all applicable material legal and regulatory requirementsobligations to the Company under Section 5(d) of the Purchase Option Agreement.
Appears in 1 contract
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 all employees, agents, consultants, contactors, and subcontractors that during the Term: (as provided in Section 3.2.7a) of such Party or and its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall will perform its activities pursuant to this Agreement (including without limitation any activities set forth in the Co-Promotion and Medical Affairs Plan and the deployment of its Field Force) in compliance with GLP, GCP, (and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling will contractually require and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure commercially reasonable efforts to enforce compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by this Agreement (including the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory AuthorityCo-Promotion and Medical Affairs Plan), (ii) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other all Applicable Law, including applicable Regulatory Authority)industry ethical codes, or and (iii) has been charged with respect to Sanofi, any applicable Sanofi policies or convicted procedures or, with respect to Provention, any applicable Provention policies or procedures; (b) will not employ, or otherwise use in any capacity, the services of any Person suspended, proposed for debarment or debarred under United States Law for conduct relating to the development or approvallaw, including under 21 U.S.C. § 335a, or any foreign equivalent thereof, or is otherwise relating ineligible to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992participate in federal healthcare programs, in each case, in with respect to the conduct performance of its activities under this Agreement;
7.3.4 Neither hereunder; (c) such Party shallwill not enter into any agreement, during the Termcontract, grant any right commitment or license other arrangement that could reasonably be expected to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder or otherwise prevent the other Party from exercising the rights granted to it hereunder; and
7.3.5 Each (d) such Party shall will not knowingly misappropriate any trade secret of a Third Party in connection with the performance of its activities hereunder; and (e) such Party will maintain all permits, licenses, registrations and other forms of authorizations and approvals from any Governmental Authority (including, with respect to Provention, once a Regulatory Approval is obtained for the Product in the Field in the Territory, such Regulatory Approval) necessary or required to be obtained or maintained by such Party in order for such Party to execute and deliver this Agreement and to perform its obligations and exercise its rights hereunder in compliance a manner which complies with all applicable material legal and regulatory requirementsApplicable Law.
Appears in 1 contract
Mutual Covenants. Each Party hereby covenants to the other Party thatthat during the Term:
7.3.1 all employees, agents, consultants, contactors, (a) All employees and subcontractors (as provided in Section 3.2.7) officers of such Party or its Affiliates working under this Agreement shall will be under the obligation to assign all right, title and interest in and to their inventions and discoveriesInventions, whether or not patentable, if any, to such Party as the sole owner thereof;, and under the obligation to maintain as confidential the Confidential Information of such Party.
7.3.2 such (b) Such Party shall will perform its activities pursuant to this Agreement in compliance with GLP, GCP, good clinical practices and GMPgood manufacturing practices, in each case as applicable under the Applicable Laws and regulations of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, development and manufacture commercialization of pharmaceutical products;.
7.3.3 Neither (c) Such Party shall will not employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable a Regulatory Authority), (ii) or, to its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable a Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;, and each contractor or consultant used by such Party in connection with the conduct of clinical trials under this Agreement will be subject to a covenant that is the same or substantially the same as the foregoing covenant. ***** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information.
7.3.4 Neither (d) Such Party shall, during will not practice or exploit the Term, intellectual property licensed to such Party under this Agreement except to the extent expressly permitted under the terms and conditions of this Agreement.
(e) Such Party will not grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that which would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements.
Appears in 1 contract
Samples: Clinical Development and Option Agreement (Medgenics, Inc.)
Mutual Covenants. (a) Reasonable Efforts; Notification.
(i) Each Party hereby covenants to of Parent and the Company shall act in good faith and reasonably cooperate with the other Party that:
7.3.1 all employeesparty in connection with resolving any investigation or other inquiry of any such agency or other Governmental Authority under any Antitrust Laws with respect to any such filing or any such transaction. To the extent not prohibited by Applicable Laws, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) of such Party or its Affiliates working under each party to this Agreement shall use all reasonable efforts to furnish to each other all information required for any application or other filing to be under made pursuant to any Applicable Laws in connection with the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities pursuant transactions contemplated by this Agreement. Each party to this Agreement in compliance with GLP, GCPshall give the other parties to this Agreement reasonable prior notice of any communication with, and GMPany proposed understanding, undertaking, or agreement with, any Governmental Authority regarding any such filings or any such transaction. None of the parties to this Agreement shall independently participate in any meeting, or engage in any substantive conversation, with any Governmental Authority in respect of any such filings, investigation, or other inquiry without giving the other parties to this Agreement prior notice of the meeting and, to the extent permitted by such Governmental Authority, the opportunity to attend and/or participate. The parties to this Agreement will consult and cooperate with one another, in each case as applicable under the Laws of the country connection with any analyses, appearances, presentations, memoranda, briefs, arguments, opinions and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals proposals made or submitted by or on behalf of any party to this Agreement in connection with proceedings under or relating to the HSR Act or other Antitrust Laws. The parties acknowledge that the applicable waiting periods under the HSR Act have expired or been terminated.
(ii) Subject to Section 6.1(a)(iv) of this Agreement, each of Parent and the Company shall use all reasonable efforts to resolve such Partyobjections, shall at all times comply (and shall ensure compliance if any, as may be asserted by any of its subcontractors) Governmental Authority with all Lawsrespect to the transactions contemplated by this Agreement, under the HSR Act, the Xxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the Federal Trade Commission Act, as amended, and also any other United States federal or state or foreign statues, rules, regulations, orders, decrees, administrative or judicial doctrines or other laws that are designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade (collectively, "ANTITRUST LAWS"). In connection therewith and subject to Section 6.1(a)(iv) of this Agreement, if any Action is instituted (or threatened to be instituted) challenging any transactions contemplated by this Agreement as inconsistent with or violative of any Antitrust Law, each of Parent and the Company shall cooperate and use all reasonable efforts vigorously to contest and resist such Action, and to have vacated, lifted, reversed, or overturned any Order whether temporary, preliminary or permanent, that is in effect and that prohibits, prevents, delays or restricts consummation of the transactions contemplated by this Agreement, including by vigorously pursuing all available avenues of administrative and judicial appeal and all available legislative action, unless Parent determines that litigation is not in its best interests. Subject to Section 6.1(a)(iv) of this Agreement, each of Parent and the Company shall use all reasonable efforts to take such action as may be required to cause the expiration of the notice periods under applicable Antitrust Laws with respect to the transactions contemplated by this Agreement as promptly as possible after the execution of this Agreement.
(iii) Subject to Section 6.1(a)(iv) of this Agreement, each of the parties to this Agreement agrees to use all reasonable efforts to take, or cause to be taken, all actions, and to do, or cause to be done, and to assist and cooperate with the standards other parties to this Agreement in doing, all things necessary, proper or advisable to consummate and make effective, in the pharmaceutical industry for most expeditious manner practicable, the Developmenttransactions contemplated by this Agreement, Commercializationincluding (A) the obtaining of all other necessary actions or nonactions, waivers, consents, licenses, permits, authorizations, orders and manufacture approvals from Governmental Authorities and the making of pharmaceutical products;
7.3.3 Neither Party shall employ all other necessary registrations and filings (orincluding other filings with Governmental Authorities, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authorityif any), (iiB) who is the subject obtaining of an FDA debarment investigation all consents, approvals or proceeding waivers from third parties related to or required in connection with the Offer and the Merger that are necessary to consummate the transactions contemplated by this Agreement or required to prevent a Material Adverse Effect on Parent or the Company from occurring prior to or after the Effective Time, (or similar proceeding of EMEA or other applicable Regulatory Authority), or (iiiC) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;
7.3.4 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any preparation of the intellectual property rights it Controls that would conflict or interfere with any of Proxy/Information Statement (if required) (D) the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations execution and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements.delivery of
Appears in 1 contract
Samples: Merger Agreement (Omnicare Inc)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 9.3.1 all employeesemployees of such Party or its Affiliates, and all agents, consultants, contactors, contractors and subcontractors (as provided in Section 3.2.74.3) of such Party or its Affiliates working performing any activities under this Agreement a research plan under a Technology Transfer Project (including, in the case of Codexis, any Additional Services) shall be under the obligation to assign all right, title and Execution Version interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 9.3.2 such Party shall perform its obligations and activities pursuant to under this Agreement (including, in the case of Codexis, the Additional Services) in compliance with Applicable Law and industry standards, including, without limitation, GLP, GCP, GCP and GMP, in each case as applicable under the Laws Applicable Law of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all LawsApplicable Law, and also with the standards in the pharmaceutical industry for the Development, Commercialization, development and manufacture of pharmaceutical products, and (b) with individuals who are appropriately trained and qualified;
7.3.3 Neither 9.3.3 with specific regard to each Party’s performance of their respective obligations to the other Party under this Agreement, neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (ia) debarred by the FDA (or subject to a similar sanction of EMEA or any other applicable Regulatory Authority), (iib) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or any other applicable Regulatory Authority), or (iiic) has been charged with or convicted under any Applicable Law of the United States Law for conduct relating to the development or approvaldevelopment, approval or otherwise relating to the regulation of any Licensed Product product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;; and
7.3.4 Neither 9.3.4 neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights Intellectual Property Rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements.
Appears in 1 contract
Samples: Platform Technology Transfer and License Agreement (Codexis, Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 9.2.1 all employeesemployees of such Party or its Affiliates, and all agents, consultants, contactors, consultants and subcontractors (as provided in Section 3.2.7) of such Party or its Affiliates working under performing any activities arising out of this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveriesdiscoveries directly related to any Collaboration Products, whether or not patentablePatentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party 9.2.2 it shall perform its obligations and activities pursuant to this Agreement in compliance with all Applicable Law and industry standards, including, without limitation, GLP, GCP, GCP and GMP, in each case as applicable under the Laws Applicable Law of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party 9.2.3 it shall not employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (ia) debarred by the FDA United States Food and Drug Administration (or subject to a similar sanction of EMEA or any other applicable Regulatory Authority), ) or (iib) who is the subject of an FDA United States Food and Drug Administration debarment investigation or proceeding (or similar proceeding of EMEA or any other applicable Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;
7.3.4 Neither 9.2.4 it shall not knowingly infringe the intellectual property rights of any Third Party shall, in connection with its activities pursuant to this Agreement; and
9.2.5 during the Term, grant for any right or license Collaboration Compound for which such Party is obligated to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted to pay the other Party royalties hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements, it will not undergo Pre-Clinical Development of, Clinical Development of, Manufacture, Commercialize or otherwise distribute any product containing such Collaboration Compound other than the Collaboration Products.
Appears in 1 contract
Samples: Exclusive License and Collaboration Agreement (EPIRUS Biopharmaceuticals, Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) of such Party or its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also connection with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authority), (ii) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct performance of its activities under this Agreement:
(a) neither such Party nor any of its Affiliates will, (or any of their respective employees and consultants (including CMOs) directly or indirectly through Affiliates or Third Parties, pay, promise, or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including such Party and its Affiliates, nor will such Party or any of its Affiliates (or any of their respective employees and consultants (including CMOs) directly or indirectly promise, offer, or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift, or hospitality or other illegal or unethical benefit to a public official or entity or any other Person;
7.3.4 Neither (b) neither such Party shall, during the Term, grant any right or license to any Third Party relating to nor any of the intellectual property rights it Controls that would conflict its Affiliates (or interfere with any of their respective employees and consultants or CMOs), in connection with the exercise of such Party’s rights or licenses granted to performance of such Party’s obligations under this Agreement, shall cause the other Party hereunderto be in violation of Anti-Corruption Laws or Export Control Laws;
(c) such Party shall immediately notify the other Party if such Party has any information that there is or is likely to be a violation of Anti-Corruption Laws or Export Control Laws in connection with the exercise of such Party’s rights or performance of such Party’s obligations under this Agreement; and
7.3.5 Each (d) each Party shall perform undertake due diligence activities appropriate to its obligations activities under this Agreement in accordance with applicable Anti-Corruption Laws and exercise its rights hereunder related guidance, including guidance issued by the U.S. Department of Justice Criminal Division (entitled “Evaluation of Corporate Compliance Programs”) concerning the FCPA, and issued by the U.K. Ministry of Justice concerning the UK Xxxxxxx Xxx 0000, such activities to include the conduct of appropriate due diligence in compliance relation to Third Party contractors, and shall to the extent permitted by Applicable Law, reasonably collaborate with all applicable material legal and regulatory requirementsthe other Party to ensure such compliance.
Appears in 1 contract
Samples: Supply Agreement (Valneva SE)
Mutual Covenants. Each Party hereby covenants to the other Party thatthat during the CDOA Term:
7.3.1 (a) all employees, agents, consultants, contactors, employees and subcontractors (as provided in Section 3.2.7) officers of such Party or its Affiliates working under this Agreement shall will be under the obligation to assign all right, title and interest in and to their inventions and discoveriesInventions, whether or not patentable, if any, to such Party as the sole owner thereof, and under the obligation to maintain as confidential the Confidential Information of such Party;
7.3.2 (b) such Party shall will perform its activities pursuant to this Agreement in compliance with GLP, GCP, good clinical practices and GMPgood manufacturing practices, in each case as applicable under the Applicable Laws and regulations of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, development and manufacture commercialization of pharmaceutical products;
7.3.3 Neither (c) neither Party shall will employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable a Regulatory Authority), (ii) or, to its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable a Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;, and each contractor or consultant used by a Party in connection with the conduct of clinical trials under this Agreement will be subject to a covenant that is the same or substantially the same as the foregoing covenant; ***** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information.
7.3.4 Neither (d) neither Party shallwill, during the CDOA Term, practice or exploit the intellectual property licensed to such Party under this Agreement except to the extent expressly permitted under the terms and conditions of this Agreement; and
(e) neither Party will, during the CDOA Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that which would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements.
Appears in 1 contract
Samples: Clinical Development and Option Agreement (Medgenics, Inc.)
Mutual Covenants. Each Party hereby of Eiger and RRD covenants and agrees that, with respect to the Programs and any other Party thatrights and obligations set forth herein, it shall:
7.3.1 A. perform all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) of such Party or its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities obligations pursuant to this Agreement in material compliance with GLPwith: (i) all applicable international, GCPfederal and state laws, statutes, rules, regulations and GMPorders (including all applicable approval and qualification requirements thereunder), in each case as applicable under including, without limitation, the Laws of the country Federal Food, Drug and Cosmetic Act and the state regulations promulgated pursuant thereto; (ii) all applicable good clinical practices and local government wherein such activities are conducted, guidelines; (iii) all applicable standard operating procedures; (iv) all applicable protocols; (v) the provisions of this Agreement and Project Agreements and (vi) with respect to RRD, RRD shall perform the care, handling and use Services in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply a professional manner;
B. not employ (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant who is or that employs) any individual or entity (i) debarred by the FDA Food and Drug Administration (“FDA”) (or subject to a similar sanction of EMEA or any other applicable Regulatory Authorityregulatory authority), (ii) or, to the best of its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or any other applicable Regulatory Authorityregulatory authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities the Programs; and with respect to RRD, RRD shall promptly notify Eiger in the event any RRD employee, contractor or consultant is under or threated to be under investigation by the FDA or is subject to debarment by the FDA during the term of this Agreement;
7.3.4 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted C. promptly deliver to the other Party hereunder; and
7.3.5 Each Party shall other, upon receipt thereof, notice of all actions, suits, investigations, litigation and proceedings before any governmental authority, which would reasonably be expected to affect such Party’s ability to perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirementsunder this Agreement.
Appears in 1 contract
Samples: Product Development Agreement (Eiger BioPharmaceuticals, Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) 8.2.1 All employees of such Party or its Affiliates and working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 8.2.2 Such Party shall not employ (or, to the best of its knowledge without further duty of inquiry, shall not use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA), in the conduct of its activities under the Development Plan;
8.2.3 The Development activities allocated to such Party in the Development Plan shall be performed by qualified personnel in a professional manner;
8.2.4 Such Party shall (a) perform its activities pursuant to this Agreement in compliance with GLPall applicable federal, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conductedlaws, regulations and ordinances, including but not limited to the FD&C Act and the regulations promulgated thereunder, and including, but not limited to, to the extent applicable, good laboratory and clinical practices and cGMP and other applicable industry standards, and (b) with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Lawsapplicable federal, state and also with the standards in the pharmaceutical industry for the Developmentlocal laws, Commercialization, regulations and manufacture of pharmaceutical productsordinances;
7.3.3 Neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authority), (ii) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;
7.3.4 8.2.5 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that which would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 8.2.6 Each Party shall perform its obligations and exercise its rights hereunder will notify the other Party in compliance with all applicable writing promptly in the event that it has actual knowledge of the material legal and regulatory requirementsbreach of any covenant under this Section 8.2 or the material breach of any representation or warranty provided by either Party under Section 8.1.
Appears in 1 contract
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 9.4.1 all employeesemployees of such Party or its Affiliates, and all agents, consultants, contactors, contractors and subcontractors (as provided in Section 3.2.74.2) of such Party or its Affiliates working performing any activities under this Agreement a research plan under a Technology Transfer Project (including, in the case of Codexis, any Additional Services) shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 9.4.2 such Party shall perform its obligations and activities pursuant to under this Agreement (including, in the case of Codexis, the Additional Services) in compliance with Applicable Law and industry standards, including, without limitation, GLP, GCP, GCP and GMP, in each case as applicable under the Laws Applicable Law of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all LawsApplicable Law, and also with the standards in the pharmaceutical industry for the Development, Commercialization, development and manufacture of pharmaceutical products, and (b) with individuals who are appropriately trained and qualified;
7.3.3 Neither 9.4.3 with specific regard to each Party’s performance of their respective obligations to the other Party under this Agreement, neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (ia) debarred by the FDA (or subject to a similar sanction of EMEA or any other applicable Regulatory Authority), (iib) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or any other applicable Regulatory Authority), or (iiic) has been charged with or convicted under any Applicable Law of the United States Law for conduct relating to the development or approvaldevelopment, approval or otherwise relating to the regulation of any Licensed Product product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;; and
7.3.4 Neither 9.4.4 neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights Intellectual Property Rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements.
Appears in 1 contract
Samples: Platform Technology Transfer and License Agreement (Codexis, Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 all employees, agents, consultants, contactors, 10.4.1 All employees and subcontractors (as provided in Section 3.2.7) independent contractors of such Party or its Affiliates and working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such 10.4.2 Such Party shall not employ (or, to the best of its knowledge without further duty of inquiry, shall not use any contractor or consultant that employs) any Person debarred by the FDA (or subject to a similar sanction of EMA or other regulatory agency), or, to the best of its knowledge without further duty of inquiry, any Person which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA or other regulatory agency), in the conduct of its activities hereunder; and
10.4.3 Such Party shall, except as otherwise specified in this Agreement or Research Plan, perform its activities pursuant to this Agreement in compliance with GLPgood laboratory (cGLP), GCP, clinical (cGCP) and GMPmanufacturing (cGMP) practices and other applicable ICH guidelines, in each case as applicable under the Laws laws and regulations of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Lawsapplicable federal, state and local laws, regulations and ordinances, and also with the standards [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. most current best practices in the pharmaceutical industry for the Developmentproper care, Commercializationhandling and use of animals in pharmaceutical research and Development activities, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authority), (ii) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;
7.3.4 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirementsParty’s reasonable right of inspection.
Appears in 1 contract
Samples: Research and Development Option and License Agreement (Anacor Pharmaceuticals Inc)
Mutual Covenants. Each Party hereby covenants of Dipexium and RRD covenant and agree that, with respect to the Programs and any other Party thatrights and obligations set forth herein, it shall:
7.3.1 A. perform all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) of such Party or its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities obligations pursuant to this Agreement in material compliance with GLPwith: (i) all applicable international, GCPfederal and state laws, statutes, rules, regulations and GMPorders (including all applicable approval and qualification requirements thereunder), in each case as applicable under including, without limitation, the Laws of the country Federal Food, Drug and Cosmetic Act and the state regulations promulgated pursuant thereto; (ii) all applicable good clinical practices and local government wherein such activities are conducted, guidelines; (iii) all applicable standard operating procedures; (iv) all applicable Protocols; (v) the provisions of this Agreement and Project Agreements and (vi) with respect to RRD, RRD shall perform the care, handling Services in a professional and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical productsworkmanlike manner;
7.3.3 Neither Party shall B. not employ (or, to the best of its knowledge, shall not use any contractor or consultant who is or that employs) any individual or entity (i) debarred by the FDA Food and Drug Administration (uFDA”) (or subject to a similar sanction of EMEA or any other applicable Regulatory Authorityregulatory authority), (ii) or, to the best of its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or any other applicable Regulatory Authorityregulatory authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of the Programs;
C. promptly deliver to the other, upon receipt thereof, notice of all actions, suits, investigations, litigation and proceedings before any governmental authority, which would reasonably be expected to affect such Party’s ability to perform its activities obligations under this Agreement;
7.3.4 Neither Party shall. Upon its acquiring knowledge of (i) any possible breach by it of any representation, during the Termwarranty, grant covenant or any right other term or license condition of this Agreement or (ii) any other event or development in each case that may, or may be reasonably expected to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted be, materially adverse to the other Party hereunder; and
7.3.5 Each with respect to any Program, such Party shall perform its obligations promptly notify the other Party in writing within three (3) business days of acquiring such knowledge; provided, that the failure to provide such notice shall not impair or otherwise be deemed a waiver of any rights any Party may have arising from such breach, event or development and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirementsthat notice under this Section shall not be deemed an admission by the Party providing such notice of any breach of this Agreement.
Appears in 1 contract
Samples: Product Development Agreement (Dipexium Pharmaceuticals, LLC)
Mutual Covenants. Each Party hereby covenants to the other Party thatthat during the Term:
7.3.1 all employees, agents, consultants, contactors, (a) All employees and subcontractors (as provided in Section 3.2.7) officers of such Party or its Affiliates working under this Agreement shall will be under the obligation to assign all right, title and interest in and to their inventions and discoveriesInventions, whether or not patentable, if any, to such Party as the sole owner thereof;, and under the obligation to maintain as confidential the Confidential Information of such Party.
7.3.2 such (b) Such Party shall will perform its activities pursuant to this Agreement in compliance with GLP, GCP, good clinical practices and GMPgood manufacturing practices, in each case as applicable under the Applicable Laws and regulations of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, development and manufacture commercialization of pharmaceutical products;.
7.3.3 Neither (c) Such Party shall will not employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable a Regulatory Authority), (ii) or, to its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable a Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;, and each contractor or consultant used by such Party in connection with the conduct of clinical trials under this Agreement will be subject to a covenant that is the same or substantially the same as the foregoing covenant.
7.3.4 Neither (d) Such Party shall, during will not practice or exploit the Term, intellectual property licensed to such Party under this Agreement except to the extent expressly permitted under the terms and conditions of this Agreement.
(e) Such Party will not grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that which would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations . ***** Confidential Information has been omitted and exercise its rights hereunder in compliance filed separately with all applicable material legal the Securities and regulatory requirementsExchange Commission. Confidential treatment has been requested with respect to this omitted information.
Appears in 1 contract
Samples: Clinical Development and Option Agreement (Medgenics, Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 (a) all employees, agents, consultants, contactors, and subcontractors (as provided in Section 3.2.7) employees of such Party or its Affiliates or Third Party subcontractors working under this Agreement, any Development & Commercialization Agreement shall or the [***]SM Agreement, as applicable, will be under appropriate confidentiality provisions at least as protective as those contained in this Agreement, any Development & Commercialization Agreement or the [***]SM Agreement, as applicable, and, subject to Section 2.4.1, the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractorsb) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical products;
7.3.3 Neither Party shall employ (or, to its knowledge, shall such Party will not (i) employ or use, nor hire or use any contractor or consultant that employs) employs or uses, any individual or entity (i) entity, including a clinical investigator, institution or institutional review board, debarred or disqualified by the FDA (or subject to a similar sanction of EMEA by any Regulatory Authority outside the United States) or other applicable Regulatory Authority), (ii) employ any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable by any Regulatory AuthorityAuthority outside the United States), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, of subclauses (i) and (ii) in the conduct of its activities under this Agreement, any Development & Commercialization Agreement or the [***]SM Agreement, as applicable;
7.3.4 Neither (c) neither Party nor any of its Affiliates shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it owns or Controls that which would conflict or interfere with any of the rights or licenses granted to the other Party hereunderhereunder or under any Development & Commercialization Agreement or the [***]SM Agreement; and
7.3.5 Each (d) such Party and its Affiliates shall perform its obligations and exercise its rights hereunder activities pursuant to this Agreement, any Development & Commercialization Agreement or the [***]SM Agreement, as applicable, in compliance (and shall ensure compliance by any of its subcontractors) in all material respects with all applicable material legal Laws, including GCP, GLP and regulatory requirementsGMP as applicable and with respect to the research and development activities hereunder;
(e) Celgene and OncoMed agree and acknowledge that [***]; and
(f) Celgene and OncoMed agree and acknowledge that [***]. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Appears in 1 contract
Samples: Master Research and Collaboration Agreement (OncoMed Pharmaceuticals Inc)
Mutual Covenants. Each Party hereby covenants to the other Party that, except as expressly permitted under this Agreement:
7.3.1 all employees, agents, consultants, contactors7.3.1. such Party will, and subcontractors will require its Affiliates and Subcontractors to, materially comply with Applicable Law and accepted pharmaceutical industry business practices in conducting its activities hereunder, including (as provided in Section 3.2.7a) to the extent applicable, the FD&C Act, the Anti-Kickback Statute (42 U.S.C. 1320a-7b), Civil Monetary Penalty Statute (42 U.S.C. 1320a-7a), the False Claims Act (31 U.S.C. 3729 et seq.), comparable state statutes, the regulations promulgated under all such statutes and the regulations issued by the FDA, consistent with the ‘Compliance Program Guidance for Pharmaceutical Manufacturers’ published by the Office of Inspector General, U.S. Department of Health and Human Services, (b) the applicable laws and regulations of the countries where it operates, including anti-bribery and anti-corruption laws, accounting and record keeping laws and laws relating to interactions with healthcare professionals or healthcare providers and Government Officials and (c) where appropriate GMP, GCP and GLP (or similar standards);
7.3.2. all employees and Subcontractors of such Party performing Research Activities or its Affiliates working under this Agreement shall Additional Research Activities hereunder on behalf of such Party will be under the obligation obligated to assign all right, title and interest in and to their any inventions and discoveriesCreated by them, whether or not patentable, if any, to such Party as the sole owner thereof;
; provided that (a) in the case of Vertex, this Section 7.3.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and apply only with respect to inventions included in the careCompany System Know-How and (b) in the case of Subcontractors, handling such assignment obligation shall apply only to the extent such inventions are included in the Company System Know-How or Vertex System Know-How and, with respect to any other inventions Created by Subcontractors, Company will use Commercially Reasonable Efforts to obtain such assignment obligation and, if after using such Commercially Reasonable Efforts, Company is not able to obtain such assignment obligation, then Company shall have the right to instead obtain an exclusive license under such inventions for purposes of researching, developing, manufacturing and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply commercializing [**] (and shall ensure compliance agents contained in such products) so that such inventions are Controlled by any of its subcontractors) with all Laws, Company and also with the standards included in the pharmaceutical industry for the Development, Commercialization, Licensed Technology and manufacture of pharmaceutical productsexclusively licensed to Vertex under this Agreement;
7.3.3 Neither 7.3.3. such Party shall employ (orwill not engage directly or indirectly, to its knowledge, shall not use in any contractor or consultant that employs) capacity in connection with this Agreement any individual or entity (i) Person who either has been debarred by the FDA (or subject to a similar sanction of EMEA or other applicable Regulatory Authority)FDA, (ii) who is the subject of an FDA debarment investigation a conviction described in Section 306 of the FD&C Act or proceeding (or is subject to any such similar proceeding of EMEA or other sanction;
7.3.4. such Party will be, will cause its Affiliates to be, in material compliance with all applicable Regulatory Authority)economics sanctions, or (iii) has been charged import, and export control laws, regulations, and orders;
7.3.5. such Party will not, and will cause its Affiliates not to, engage with or convicted under United States Law for conduct relating to the development or approvalengage in any transaction, or otherwise relating to deal with, any country or Person targeted by the regulation of United States, Europe or other relevant economic sanctions laws in connection with any Licensed Product activities contemplated under the Generic Drug Enforcement Act of 1992this Agreement, in each case, in the conduct of its activities under this Agreement;
7.3.4 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunderexcept as permitted by Applicable Law; and
7.3.5 Each 7.3.6. such Party shall perform will be, as between the Parties, solely responsible to ensure Compliance in all material respects by it and its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirementsAffiliates.
Appears in 1 contract
Samples: Strategic Collaboration and License Agreement (Verve Therapeutics, Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party thatthat during the CDOA Term:
7.3.1 (a) all employees, agents, consultants, contactors, employees and subcontractors (as provided in Section 3.2.7) officers of such Party or its Affiliates working under this Agreement shall will be under the obligation to assign all right, title and interest in and to their inventions and discoveriesInventions, whether or not patentable, if any, to such Party as the sole owner thereof, and under the obligation to maintain as confidential the Confidential Information of such Party;
7.3.2 (b) such Party shall will perform its activities pursuant to this Agreement in compliance with GLP, GCP, good clinical practices and GMPgood manufacturing practices, in each case as applicable under the Applicable Laws and regulations of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, Commercialization, development and manufacture commercialization of pharmaceutical products;
7.3.3 Neither (c) neither Party shall will employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (i) debarred by the FDA (or subject to a similar sanction of EMEA or other applicable a Regulatory Authority), (ii) or, to its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable a Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement, and each contractor or consultant used by a Party in connection with the conduct of clinical trials under this Agreement will be subject to a covenant that is the same or substantially the same as the foregoing covenant;
7.3.4 Neither (d) neither Party shallwill, during the CDOA Term, practice or exploit the intellectual property licensed to such Party under this Agreement except to the extent expressly permitted under the terms and conditions of this Agreement; and
(e) neither Party will, during the CDOA Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that which would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements.
Appears in 1 contract
Samples: Clinical Development and Option Agreement (Cerecor Inc.)
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 11.4.1 all employees, agents, consultants, contactors, consultants and subcontractors (as provided in Section 3.2.7) contactors of such Party or its Affiliates working conducting activities under this Agreement shall be under the obligation to assign to such Party or Affiliate all right, title and interest in and to their inventions Inventions Made by such employee, agent, consultant or contractor in the course of conducting activities under this Agreement, and discoveries, whether or not patentable, if any, Know-How pertaining to any such Invention that is Made by such person in the course of conducting such person’s work for such Party as or its Affiliates (it being understood that Section 8.3.1(b) prohibits Curis and its Affiliates from Exploiting ImmuNext Technology, Compounds and Products outside the sole owner thereofscope of or otherwise not in compliance with the licenses, sublicenses and other rights granted to Curis under this Agreement), subject to any exceptions permitted under Section 3.2.5;
7.3.2 11.4.2 such Party shall perform its obligations and conduct its activities pursuant to this Agreement (a) in compliance with all Laws and industry standards, including GLP, GCP, GCP and GMP, in each case as applicable under the Laws of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractorsSubcontractors) with all Laws, and also with the standards in the pharmaceutical industry for the Development, CommercializationDevelopment and Manufacture of pharmaceutical or biological products, and manufacture of pharmaceutical products(b) with individuals who are appropriately trained and qualified;
7.3.3 Neither 11.4.3 neither Party shall employ (or, to its knowledge, shall not use any contractor or consultant that employs) any individual or entity (ia) debarred by the FDA (or subject to a similar sanction of EMEA EMA or other applicable Regulatory Authority), (iib) who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA EMA or other applicable Regulatory Authority), or (iiic) has been charged with or convicted under United States Law for conduct relating to the development or approvaldevelopment, approval or otherwise relating to the regulation of any Licensed Product product under the Generic Drug Enforcement Act of 1992, as amended, in each case, in the conduct of its activities under this Agreement;; and
7.3.4 Neither 11.4.4 neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls that would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and
7.3.5 Each Party shall perform its obligations and exercise its rights hereunder in compliance with all applicable material legal and regulatory requirements.
Appears in 1 contract
Mutual Covenants. Each Party hereby covenants to the other Party that:
7.3.1 all employees, agents, consultants, contactors(a) it will use its commercially reasonable best efforts to conduct, and subcontractors (will cause its contractors to conduct, all preclinical and clinical studies for Amgen Products and Kite Products, as provided in Section 3.2.7) applicable, and manufacturing of such Party or its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;
7.3.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMPproducts, in each case as applicable under accordance with (i) all U.S. Laws and the Laws of the country and the state and local government wherein in which such activities clinical studies are conducted, and with respect to (ii) the careknown or published standards of the FDA and the Regulatory Authority in such country. Neither such Party, handling and use in research and Development activities hereunder of nor any non-human animals by officer, employee or on behalf agent of such Party, shall at all times comply will knowingly make an untrue statement of a material fact to any Regulatory Authority with respect to Amgen Products and Kite Products, as applicable (and shall ensure compliance by whether in any of its subcontractors) with all Lawssubmission to such Regulatory Authority or otherwise), and also neither will knowingly fail to disclose a material fact required to be disclosed to any Regulatory Authority with the standards in the pharmaceutical industry for the Development, Commercialization, and manufacture of pharmaceutical respect to such products;
7.3.3 Neither Party shall employ (orb) it will not knowingly use in connection with any Preclinical Development activities or Program activities hereunder any employee, to its knowledgecontractor, shall not use any contractor investigator or consultant that employs) any individual or entity (i) has been debarred by the FDA (or subject to a similar sanction of EMEA or other applicable a Regulatory Authority), (ii) who or that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA or other applicable a Regulatory Authority), or (iii) has been charged with or convicted under United States Law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, in each case, in the conduct of its activities under this Agreement;
7.3.4 Neither Party shall, during the Term, (c) it will not grant any right or license to any Third Party relating to any of the intellectual property rights it Controls right or license, or enter into any agreement, that would conflict or interfere with any of the licenses and rights or licenses granted to the other Party hereunder;
(d) in connection with its activities hereunder, it shall use its commercially reasonable best efforts to comply with all applicable (i) U.S. Laws prohibiting the re-export, directly or indirectly, of certain controlled U.S.-origin items without a license to parties located in certain countries or appearing on certain U.S. Government lists of restricted parties; (ii) U.S. Laws prohibiting participation in non-U.S. boycotts that the United States does not support; and (iii) U.S. Laws prohibiting the sale of products to parties from any country subject to U.S. economic sanctions or who are identified on related U.S. Government lists of restricted parties; and
7.3.5 (e) as of the Effective Date to and through the expiration or termination of this Agreement, (1) it, and, to the best of its knowledge, its owners, directors, officers, employees, or any agent, representative, subcontractor or other third party acting for or on such its behalf, shall not, directly or indirectly, offer, pay, promise to pay, or authorize such offer, promise or payment, of anything of value, to any Person for the purposes of obtaining or retaining business through any improper advantage in connection with this Agreement, or that would otherwise violate any applicable Laws, rules and regulations concerning or relating to public or commercial bribery or corruption, and (2) that its books, accounts, records and invoices related to this Agreement or related to any work conducted for or on behalf of the other Party are and will be complete and accurate in all material respects. Each Party shall perform its obligations and exercise its rights hereunder in may request from time to time that the other Party complete a compliance with all applicable material legal and regulatory requirementscertification regarding the foregoing.
Appears in 1 contract
Samples: Research Collaboration and License Agreement (Kite Pharma, Inc.)
