Mutual Representations and Warranties and Covenants. As of the Effective Date, each of Relypsa and Sanofi hereby represents, warrants and covenants to the other Party that: (a) it is a corporation or entity duly organized and validly existing under the laws of the State or other jurisdiction of its incorporation or formation; (b) the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and does not require any shareholder action or approval; (c) it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder and this Agreement constitutes and when executed shall constitute, its legal, valid and binding obligation, enforceable in accordance with its terms, except as may be limited by bankruptcy and equitable principles limiting specific performance; (d) the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and shall not conflict with or result in a breach of any of the terms and provisions of or constitute a default under: (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; and (e) during the Term, it and its Affiliates shall comply with Applicable Law in connection with its activities hereunder. EXECUTION VERSION (f) Each Party represents, warrants and covenants that such Party has not entered into, and will not during the Term enter into, any agreements with any Third Party that conflicts with the rights granted to the other Party, or would prevent such Party from performing its obligations, pursuant to this Agreement in any material respect. (g) Each Party represents to the other that neither it nor its employees or contractors performing services with respect to the Product are currently excluded, debarred, suspended or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs, or has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. 1320a-7(a) and that could reasonably result in such Party or individual being excluded, debarred, suspended or otherwise declared ineligible. Each Party further represents that it has policies to screen all prospective employees and contractors prior to engaging their services and determine whether any existing employee or contractor becomes excluded, debarred, suspended or otherwise declared ineligible. Each Party has policies and procedures in effect that require, and it shall otherwise require, all employees and contractors to immediately disclose to such Party any action or event that could reasonably result in such employee or contractor becoming so excluded, debarred, suspended or otherwise declared ineligible. In addition, each Party shall maintain during the Term a compliance program designed to prevent and detect violations of Applicable Laws in connection with this Agreement, including such violations relating to their respective activities hereunder, which program shall be designed in a manner consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003 by the HHS Office of Inspector General. Further, each Party agrees that it will cause its respective PSRs performing activities in the Territory with respect to the Product to act in accordance with industry standards, including the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals and the American Medical Association’s Guidelines on Gifts to Physicians (in each case, including any updated therefor), and in a professional, ethical and lawful manner generally consistent with the manner in which such Party promotes other products in the Territory.
Appears in 1 contract
Samples: Detailing Agreement
Mutual Representations and Warranties and Covenants. As Each Party hereby represents and warrants as of the Effective DateSigning Date and, each of Relypsa and Sanofi hereby representswhere denoted below, warrants and covenants to the other Party thatas follows:
(a) it It is a company or corporation or entity duly organized organized, validly existing, and validly existing in good standing under the laws of the State or other jurisdiction of in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its incorporation or formation;property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement.
(b) It has the executionfull corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, including the right to grant the licenses granted by it hereunder. It has taken all necessary corporate action on its part required to authorize the execution and delivery and performance of this Agreement by such Party and the performance of its obligations hereunder. This Agreement has been duly authorized by all requisite corporate action executed and does not require any shareholder action or approval;
(c) it has the power and authority delivered on behalf of such Party, and, subject to execute and deliver this Agreement and to perform its obligations hereunder and this Agreement Section 17.16, constitutes and when executed shall constitute, its a legal, valid valid, and binding obligation, obligation of such Party that is enforceable against it in accordance with its terms, except as may be limited by bankruptcy and equitable principles limiting specific performance;.
(dc) the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does It is not and shall not conflict with or result in a breach of party to any of the terms and provisions of or constitute a default under: (i) a loan agreement, guarantyor, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) to the provisions best of its charter or operative documents or bylaws; or (iii) any knowledge, outstanding order, writ, injunction judgment or decree of any court or governmental authority entered against Governmental Authority that would prevent it from granting the rights granted to the other Party under this Agreement or by which any performing its obligations under this Agreement.
(d) In the course of the Development of Therapeutics and Products, such Party has not used prior to the Signing Date, and shall not use during the Term, to the best of its property knowledge, any employee, agent or independent contractor who has been debarred by any Governmental Authority, or, to the best of such Party’s knowledge, is bound; andthe subject of debarment proceedings by a Governmental Authority.
(e) during the Term, it and its Affiliates shall comply with Applicable Law in connection with its activities hereunder. EXECUTION VERSION
(f) Each Party represents, warrants and covenants that such Party It has not entered intoprior to the Signing Date, and will not during the Term enter intoTerm, grant any agreements with right to any Third Party that conflicts would conflict with the rights granted to the other Party hereunder.
(f) The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder do not conflict with, violate, breach, or would prevent constitute a default, or require any consent not already obtained under any contractual obligation or, to the best of such Party’s knowledge, court or administrative order by which such Party from performing its obligations, pursuant to this Agreement in any material respectis bound.
(g) Each It (or its Affiliates) has and, during the Term will have, enforceable written agreements with all of its (or its Affiliates) employees who receive Confidential Information under this Agreement assigning to such Party represents to the other that neither it nor (or its employees or contractors performing services with respect to the Product are currently excluded, debarred, suspended or otherwise ineligible to participate Affiliates) ownership of all intellectual property rights created in the Federal health care programs or in Federal procurement or nonprocurement programscourse of their employment, or has been convicted unless such employees are obliged by Applicable Law to assign ownership of a criminal offense that falls within the ambit of 42 U.S.C. 1320a-7(a) and that could reasonably result in all such intellectual property rights to such Party or individual being excluded, debarred, suspended or otherwise declared ineligible. Each Party further represents that it has policies to screen ownership of all prospective employees and contractors prior to engaging their services and determine whether any existing employee or contractor becomes excluded, debarred, suspended or otherwise declared ineligible. Each Party has policies and procedures in effect that require, and it shall otherwise require, all employees and contractors to immediately disclose to such Party any action or event that could reasonably result in intellectual property rights are automatically assigned by Applicable Law (including cases where such employee or contractor becoming so excluded, debarred, suspended or otherwise declared ineligible. In addition, each Party shall maintain during the Term a compliance program designed to prevent and detect violations of Applicable Laws in connection with this Agreement, including such violations relating to their respective activities hereunder, which program shall be designed in a manner consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003 by the HHS Office of Inspector General. Further, each Party agrees that it will cause its respective PSRs performing activities in the Territory with respect automatic assignment is subject to the Product to act relevant Party (or its Affiliates) claiming such intellectual property right in accordance with industry standards, including the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals and the American Medical Association’s Guidelines on Gifts to Physicians (in each case, including any updated thereforApplicable Law), and in a professional, ethical and lawful manner generally consistent with the manner in which such Party promotes other products in the Territory.
Appears in 1 contract
Mutual Representations and Warranties and Covenants. As Each of Histogenics and MEDINET represents and warrants to the other Party, as of the Effective Date, each of Relypsa and Sanofi hereby representscovenants, warrants and covenants to the other Party that:
(a) it such Party is a corporation or an entity duly organized and organized, validly existing and in good standing under the laws of the State state or other jurisdiction country (as applicable) of its incorporation organization, is qualified to do business and is in good standing as a foreign entity in each jurisdiction in which the conduct of its business or formationthe ownership of its properties requires such qualification and failure to have such would prevent it from performing its obligations under this Agreement, and has full power and authority to enter into this Agreement and to carry out the provisions hereof;
(b) such Party is duly authorized, by all requisite action, to execute and deliver this Agreement and the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and does not require any shareholder action or approval, and the Person executing this Agreement on behalf of such Party is duly authorized to do so by all requisite action;
(c) it no consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any Governmental Authority is required on the part of such Party in connection with the valid execution, delivery and performance of this Agreement;
(d) such Party has not employed (and, to the power best of its knowledge, has not used a contractor or consultant that has employed) and authority in the future shall not employ (or, to execute the best of its knowledge, use any contractor or consultant that employs, provided that, such Party may reasonably rely on a representation made by such contractor or consultant) any Person debarred pursuant to Section 306 of the United States Federal Food, Drug, and deliver Cosmetic Act (or subject to a similar sanction of a foreign Governmental Authority), or any Person that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of a foreign Governmental Authority), in the conduct of its activities under this Agreement and such Party agrees to perform inform the other Party in writing promptly if it or any such Person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of its obligations hereunder and or its Affiliates’ knowledge, is threatened, relating to the debarment or conviction of it or any such Person performing services hereunder;
(e) this Agreement constitutes is a legal and when executed shall constitute, its legal, valid obligation binding upon such Party and binding obligation, enforceable in accordance with its terms, terms except as enforceability may be limited by bankruptcy (i) bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the enforcement of creditors’ rights; and (ii) equitable principles limiting specific performanceof general applicability;
(df) the execution, delivery and performance by such Party it of this Agreement and its compliance with the terms and provisions hereof of this Agreement does not and shall not conflict with or result in a breach of any of the terms GDSVF&H\ ****Certain information has been omitted and provisions of or constitute a default under: (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; and
(e) during the Term, it and its Affiliates shall comply with Applicable Law in connection with its activities hereunder. EXECUTION VERSION
(f) Each Party represents, warrants and covenants that such Party has not entered into, and will not during the Term enter into, any agreements with any Third Party that conflicts filed separately with the rights granted to the other Party, or would prevent such Party from performing its obligations, pursuant to this Agreement in any material respect.
(g) Each Party represents to the other that neither it nor its employees or contractors performing services Commission. Confidential treatment has been requested with respect to the Product are currently excluded, debarred, suspended or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs, or has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. 1320a-7(a) and that could reasonably result in such Party or individual being excluded, debarred, suspended or otherwise declared ineligibleomitted portions. Each Party further represents that it has policies to screen all prospective employees and contractors prior to engaging their services and determine whether any existing employee or contractor becomes excluded, debarred, suspended or otherwise declared ineligible. Each Party has policies and procedures in effect that require, and it shall otherwise require, all employees and contractors to immediately disclose to such Party any action or event that could reasonably result in such employee or contractor becoming so excluded, debarred, suspended or otherwise declared ineligible. In addition, each Party shall maintain during the Term a compliance program designed to prevent and detect violations of Applicable Laws in connection with this Agreement, including such violations relating to their respective activities hereunder, which program shall be designed in a manner consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003 by the HHS Office of Inspector General. Further, each Party agrees that it will cause its respective PSRs performing activities in the Territory with respect to the Product to act in accordance with industry standards, including the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals and the American Medical Association’s Guidelines on Gifts to Physicians (in each case, including any updated therefor), and in a professional, ethical and lawful manner generally consistent with the manner in which such Party promotes other products in the Territory.US-DOCS\97178923.5
Appears in 1 contract
Samples: License and Commercialization Agreement (Histogenics Corp)
Mutual Representations and Warranties and Covenants. As of the Effective Date, each of Relypsa and Sanofi hereby represents, warrants and covenants to the other Party that:
(a) it is a corporation or entity duly organized and validly existing under the laws of the State or other jurisdiction of its incorporation or formation;
(b) the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and does not require any shareholder action or approval;
(c) it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder and this Agreement constitutes and when executed shall constitute, its legal, valid and binding obligation, enforceable in accordance with its terms, except as may be limited by bankruptcy and equitable principles limiting specific performance;
(d) the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and shall not conflict with or result in a breach of any of the terms and provisions of or constitute a default under: (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; and
(e) during the Term, it and its Affiliates shall comply with Applicable Law in connection with its activities hereunder. EXECUTION VERSION
(f) Each Party represents, warrants and covenants that such Party has not entered into, and will not during the Term enter into, any agreements with any Third Party that conflicts with the rights granted to the other Party, or would prevent such Party from performing its obligations, pursuant to this Agreement in any material respect.
(g) Each Party represents to the other that neither it nor its employees or contractors performing services with respect to the Product are currently excluded, debarred, suspended or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs, or has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. 1320a-7(a) and that could reasonably result in such Party or individual being excluded, debarred, suspended or otherwise declared ineligible. Each Party further represents that it has policies to screen all prospective employees and contractors prior to engaging their services and determine whether any existing employee or contractor becomes excluded, debarred, suspended or otherwise declared ineligible. Each Party has policies and procedures in effect that require, and it shall otherwise require, all employees and contractors to immediately disclose to such Party any action or event that could reasonably result in such employee or contractor becoming so excluded, debarred, suspended or otherwise declared ineligible. In addition, each Party shall maintain during the Term a compliance program designed to prevent and detect violations of Applicable Laws in connection with this Agreement, including such violations relating to their respective activities hereunder, which program shall be designed in a manner consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003 by the HHS Office of Inspector General. Further, each Party agrees that it will cause its respective PSRs performing activities in the Territory with respect to the Product to act in accordance with industry standards, including the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals and the American Medical Association’s Guidelines on Gifts to Physicians (in each case, including any updated therefor), and in a professional, ethical and lawful manner generally consistent with the manner in which such Party promotes other products in the Territory.
Appears in 1 contract
Samples: Detailing Agreement (Relypsa Inc)
Mutual Representations and Warranties and Covenants. As of the Effective Date, each of Relypsa and Sanofi hereby represents, warrants and covenants to the other Party that:
(a) it is a corporation or entity duly organized and validly existing under the laws of the State or other jurisdiction of its incorporation or formation;
(b) the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and does not require any shareholder action or approval;
(c) it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder and this Agreement constitutes and when executed shall constitute, its legal, valid and binding obligation, enforceable in accordance with its terms, except as may be limited by bankruptcy and equitable principles limiting specific performance;
(d) the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and shall not conflict with or result in a breach of any of the terms and provisions of or constitute a default under: (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; and
(e) during the Term, it and its Affiliates shall comply with Applicable Law in connection with its activities hereunder. EXECUTION VERSION.
(f) Each Party represents, warrants and covenants that such Party has not entered into, and will not during the Term enter into, any agreements with any Third Party that conflicts with the rights granted to the other Party, or would prevent such Party from performing its obligations, pursuant to this Agreement in any material respect.
(g) Each Party represents to the other that neither it nor its employees or contractors performing services with respect to the Product are currently excluded, debarred, suspended or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs, or has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. 1320a-7(a) and that could reasonably result in such Party or individual being excluded, debarred, suspended or otherwise declared ineligible. Each Party further represents that it has policies to screen all prospective employees and contractors prior to engaging their services and determine whether any existing employee or contractor becomes excluded, debarred, suspended or otherwise declared ineligible. Each Party has policies and procedures in [***] 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. EXECUTION VERSION effect that require, and it shall otherwise require, all employees and contractors to immediately disclose to such Party any action or event that could reasonably result in such employee or contractor becoming so excluded, debarred, suspended or otherwise declared ineligible. In addition, each Party shall maintain during the Term a compliance program designed to prevent and detect violations of Applicable Laws in connection with this Agreement, including such violations relating to their respective activities hereunder, which program shall be designed in a manner consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003 by the HHS Office of Inspector General. Further, each Party agrees that it will cause its respective PSRs performing activities in the Territory with respect to the Product to act in accordance with industry standards, including the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals and the American Medical Association’s Guidelines on Gifts to Physicians (in each case, including any updated therefor), and in a professional, ethical and lawful manner generally consistent with the manner in which such Party promotes other products in the Territory.
Appears in 1 contract
Samples: Detailing Agreement
Mutual Representations and Warranties and Covenants. As of the Effective Date, each of Relypsa and Sanofi hereby represents, warrants and covenants to the other Party that:
(a) it is a corporation or entity duly organized and validly existing under the laws of the State or other jurisdiction of its incorporation or formation;
(b) the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and does not require any shareholder action or approval;
(c) it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder and this Agreement constitutes and when executed shall constitute, its legal, valid and binding obligation, enforceable in accordance with its terms, except as may be limited by bankruptcy and equitable principles limiting specific performance;
(d) the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and shall not conflict with or result in a breach of any of the terms and provisions of or constitute a default under: (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; and
(e) during the Term, it and its Affiliates shall comply with Applicable Law in connection with its activities hereunder. EXECUTION VERSION.
(f) Each Party represents, warrants and covenants that such Party has not entered into, and will not during the Term enter into, any agreements with any Third Party that conflicts with the rights granted to the other Party, or would prevent such Party from performing its obligations, pursuant to this Agreement in any material respect.
(g) Each Party represents to the other that neither it nor its employees or contractors performing services with respect to the Product are currently excluded, debarred, suspended or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs, or has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. 1320a-7(a) and that could reasonably result in such Party or individual being excluded, debarred, suspended or otherwise declared ineligible. Each Party further represents that it has policies to screen all prospective employees and contractors prior to engaging their services and determine whether any existing employee or contractor becomes excluded, debarred, suspended or otherwise declared ineligible. Each Party has policies and procedures in effect that require, and it shall otherwise require, all employees and contractors to immediately disclose to such Party any action or event that could reasonably result in such employee or contractor becoming so excluded, debarred, suspended or otherwise declared ineligible. In addition, each Party shall maintain during the Term a compliance program designed to prevent and detect violations of Applicable Laws in connection with this Agreement, including such violations relating to their respective activities hereunder, which program shall be designed in a manner consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers issued in April 2003 by the HHS Office of Inspector General. Further, each Party agrees that it will cause its respective PSRs performing activities in the Territory with respect to the Product to act in accordance with industry standards, including the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals and the American Medical Association’s Guidelines on Gifts to Physicians (in each case, including any updated therefor), and in a professional, ethical and lawful manner generally consistent with the manner in which such Party promotes other products in the Territory.in
Appears in 1 contract
Samples: Detailing Agreement (Relypsa Inc)
