Conduct of Activities. (a) In the performance of its obligations under this Agreement, it will comply, and will cause its and its Affiliates’ employees and contractors to comply, with all Applicable Laws and will obtain and maintain all licenses, permits, approvals and other authorizations applicable to it in order to enable it to perform its respective obligations hereunder. (b) It (i) will ensure that its personnel receive appropriate training on the Anti-Corruption Laws, (ii) will provide, at the other Party’s request, a certification in a form reasonably satisfactory to such other Party, as to its compliance with the foregoing clause (i), and (iii) agrees, on behalf of itself, its Affiliates, and its and their officers, directors, employees, agents, representatives, consultants, and (sub)contractors (together with such Party, the “Party Representatives”) that, in connection with the performance of its obligations hereunder or the Exploitation of the Licensed Compounds or the Licensed Products, the Party Representatives will comply with Jazz’s anti-corruption policy as set forth at xxx.xxxxxxxxxxxxxxxxxxx.xxx and will not, directly or indirectly, solicit, receive or agree to accept any payment of money or anything else of value in violation of Anti-Corruption Laws or pay, offer or promise to pay, or authorize the payment of any money, or give, offer or promise to give, or authorize the giving of anything else of value, to: i. any Government Official in order to influence official action; ii. any Government Official (A) to influence such Person to act in breach of a duty of good faith, impartiality or trust (“Acting Improperly”), (B) to reward such Person for Acting Improperly, or (C) where such Person would be Acting Improperly by receiving the money or other thing of value; iii. any Person while knowing or having reason to believe that all or any portion of the money or other thing of value will be paid, offered, promised or given to, or will otherwise benefit, a Government Official in order to influence official action for or against either Party in connection with the matters that are the subject of this Agreement; or iv. any other Person to secure an improper advantage. It is the intent of the Parties that no payments or transfer of value will be made which have the purpose or effect of public or commercial bribery, acceptance of or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining or retaining business. This clause will not, however, prohibit ordinary and customary business entertainment or the giving of business mementos of nominal value in connection with a Party’s performance under this Agreement to the extent otherwise permitted by the Anti-Corruption Laws and this Agreement. In the event that during the Term either Party or its Affiliates fail to comply with the covenants set forth in this Section 11.1.7(b), such Party will promptly notify the other Party thereof in writing and, whether or not such notice is provided, such other Party may make any disclosure to Governmental Authorities or otherwise as it determines is appropriate in its sole discretion. (c) As to all matters contained in this Agreement, it will conduct the activities allocated to it in compliance in all material respects with all Applicable Laws and in accordance with good scientific, clinical, laboratory and manufacturing practices and applicable industry ethical codes, applicable under the laws and regulations of the country in which such activities are conducted.
Appears in 3 contracts
Samples: Collaboration and License Agreement (Codiak BioSciences, Inc.), Collaboration and License Agreement (Codiak BioSciences, Inc.), Collaboration and License Agreement (Codiak BioSciences, Inc.)
Conduct of Activities. As to all matters contained in this Agreement, each Party shall conduct the activities allocated to it in compliance in all material respects with all Applicable Laws and in accordance with generally accepted scientific standards, good clinical and manufacturing practices and applicable industry ethical codes, applicable under the laws and regulations of the country in which such activities are conducted or of the country in which a Regulatory Filing is made. Without limiting the foregoing, each Party agrees as follows:
(a) In the performance of its obligations under this Agreement, it will comply, such Party shall comply and will shall cause its and its Affiliates’ employees and contractors to comply, comply with all Applicable Laws Laws, and will shall obtain and maintain all licenses, permits, approvals and other authorizations applicable to it in order to enable it to perform its respective obligations hereunder.
(b) It (i) will ensure that its personnel receive appropriate training on the Anti-Corruption LawsSuch Party and, (ii) will provide, at the other Party’s request, a certification in a form reasonably satisfactory to such other Party, as to its compliance with the foregoing clause (i), and (iii) agrees, on behalf of itselfknowledge, its Affiliates, and its Affiliates’ employees and their officers, directors, employees, agents, representatives, consultants, and (sub)contractors (together with such Party, the “Party Representatives”) thatcontractors shall not, in connection with the performance of its their respective obligations hereunder or the Exploitation of the Licensed Compounds or the Licensed Products, the Party Representatives will comply with Jazz’s anti-corruption policy as set forth at xxx.xxxxxxxxxxxxxxxxxxx.xxx and will notunder this Agreement, directly or indirectlyindirectly through Third Parties, solicit, receive or agree to accept any payment of money or anything else of value in violation of Anti-Corruption Laws or pay, promise or offer or promise to pay, or authorize the payment of of, any money, money or give, give any promise or offer or promise to give, or authorize the giving of anything else of value, to:
i. any Government value to a Public Official in order to influence official action;
ii. any Government Official (A) to influence such Person to act in breach of a duty of good faith, impartiality or trust (“Acting Improperly”), (B) to reward such Entity or other Person for Acting Improperlypurpose of obtaining or retaining business for or with, or directing business to, any Person, including either Party (C) where it being understood that such Person would be Acting Improperly by receiving the money Party, and to its knowledge, its and its Affiliates’ employees and contractors, has not directly or indirectly promised, offered or provided any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other thing of value;
iii. any Person while knowing illegal or having reason unethical benefit to believe that all a Public Official or Entity or any portion of the money or other thing of value will be paid, offered, promised or given to, or will otherwise benefit, a Government Official in order to influence official action for or against either Party person in connection with the matters that are the subject performance of such Party’s obligations under this Agreement; or
iv. , and shall not, directly or indirectly, engage in any other Person to secure an improper advantage. It is the intent of the Parties that no payments or transfer of value will be made which have the purpose or effect of public or commercial bribery, acceptance of or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining or retaining business. This clause will not, however, prohibit ordinary and customary business entertainment or the giving of business mementos of nominal value in connection with a Party’s performance under this Agreement to the extent otherwise permitted by the Anti-Corruption Laws and this Agreement. In the event that during the Term either Party or its Affiliates fail to comply with the covenants set forth in this Section 11.1.7(bforegoing), such Party will promptly notify the other Party thereof in writing and, whether or not such notice is provided, such other Party may make any disclosure to Governmental Authorities or otherwise as it determines is appropriate in its sole discretion.
(c) As to all matters contained Such Party and its Affiliates, and their respective employees and contractors, in connection with the performance of their respective obligations under this Agreement, it will conduct shall not violate, and shall not cause the activities allocated other Party or such other Party’s Indemnitees to it be in compliance in all material respects with all violation of the FCPA, Export Control Laws, the federal health care program anti-kickback statute, the public contracts anti-kickback act, any state anti-kickback law, the Health Insurance Portability and Accountability Act (“HIPAA”), set forth at 42 U.S.C. sec. 1320d-2, the federal civil False Claims Act (or any state equivalent), federal or state “sunshine”/aggregate spend reporting laws, government price reporting laws, consumer protection and unfair trade practices laws, or any other Applicable Laws, rules or regulations or otherwise cause any reputational harm to such other Party.
(d) Such Party shall immediately notify the other Party if such Party has any information or suspicion that there may be a violation of the FCPA, Export Control Laws, the federal health care program anti-kickback statute, the public contracts anti-kickback act, any state anti-kickback law, HIPAA, the federal civil False Claims Act (or any state equivalent), federal or state “sunshine”/aggregate spend reporting laws, government price reporting laws, consumer protection and unfair trade practices laws, or any other Applicable Laws in connection with the performance of this Agreement or the development, manufacture or commercialization of Product.
(e) In connection with the performance of its obligations under this Agreement, such Party shall comply and shall cause its and its Affiliates’ employees and contractors to comply with such Party’s own anti-corruption and anti-bribery policy, a copy of which has been provided or made available to the other Party.
(f) The other Party will have the right, upon reasonable prior written notice and during such Party’s regular business hours and without undue interference with business operations, to audit such Party’s books and records in accordance with good scientific, clinical, laboratory and manufacturing practices and applicable industry ethical codes, applicable under the laws and regulations event that a reasonably suspected violation of any of the country representations, warranties or covenants in which this Section 16.4 needs to be investigated (including without limitation, any Governmental Authority-identified deficiency.
(g) Each Party agrees that, in connection with any inspection or audit by a Governmental Authority relating to any activities contemplated under this Agreement, such activities are conductedParty shall: (i) respond promptly and courteously to the inspectors/auditors; (ii) use its reasonable best efforts to notify the other Party of such inspection/audit with sufficient time to permit the other Party to obtain a protective or similar order with respect to such Party’s Confidential Information; (iii) use its reasonable best efforts to disclose the minimum of the other Party’s Confidential Information necessary to comply with the request whether a protective order is obtained; and (iv) assert any applicable protections (such as exemption from freedom of information act disclosure, as may be applicable) with respect to disclosed information.
(h) In the event that such Party has violated or been suspected of violating any of the representations, warranties or covenants in this Section 16.4, such Party will cause its or its Affiliates’ personnel or others working under its direction or control to submit to periodic training that such Party will provide on anti-corruption and/or “fraud and abuse” law compliance.
(i) Such Party will, at the other Party’s request, annually certify to such other Party in writing such party’s compliance, in connection with the performance of such Party’s obligations under this Agreement, with the representations, warranties or covenants in Section 16.4.
(j) Such Party shall have the right to suspend or terminate this Agreement in their entirety where there is a credible finding, after a reasonable investigation, that the other Party, in connection with performance of such other Party’s obligations under this Agreement, has violated any Applicable Laws.
Appears in 1 contract
Samples: License and Collaboration Agreement (Mannkind Corp)
Conduct of Activities. As to all matters contained in this Agreement, each Party shall conduct the activities allocated to it in compliance in all material respects with all Applicable Laws and in accordance with generally accepted scientific standards, good clinical and manufacturing practices and applicable industry ethical codes, applicable under the laws and regulations of the country in which such activities are conducted or of the country in which a Regulatory Filing is made. Without limiting the foregoing, each Party agrees as follows:
(a) In the performance of its obligations under this Agreement, it will comply, such Party shall comply and will shall cause its and its Affiliates’ employees and contractors to comply, comply with all Applicable Laws Laws, and will shall obtain and maintain all licenses, permits, approvals and other authorizations applicable to it in order to enable it to perform its respective obligations hereunder.
(b) It (i) will ensure that its personnel receive appropriate training on the Anti-Corruption LawsSuch Party and, (ii) will provide, at the other Party’s request, a certification in a form reasonably satisfactory to such other Party, as to its compliance with the foregoing clause (i), and (iii) agrees, on behalf of itselfknowledge, its Affiliates, and its Affiliates’ employees and their officers, directors, employees, agents, representatives, consultants, and (sub)contractors (together with such Party, the “Party Representatives”) thatcontractors shall not, in connection with the performance of its their respective obligations hereunder or the Exploitation of the Licensed Compounds or the Licensed Products, the Party Representatives will comply with Jazz’s anti-corruption policy as set forth at xxx.xxxxxxxxxxxxxxxxxxx.xxx and will notunder this Agreement, directly or indirectlyindirectly through Third Parties, solicit, receive or agree to accept any payment of money or anything else of value in violation of Anti-Corruption Laws or pay, promise or offer or promise to pay, or authorize the payment of of, any money, money or give, give any promise or offer or promise to give, or authorize the giving of anything else of value, to:
i. any Government value to a Public Official in order to influence official action;
ii. any Government Official (A) to influence such Person to act in breach of a duty of good faith, impartiality or trust (“Acting Improperly”), (B) to reward such Entity or other Person for Acting Improperlypurpose of obtaining or retaining business for or with, or directing business to, any Person, including either Party (C) where it being understood that such Person would be Acting Improperly by receiving the money Party, and to its knowledge, its and its Affiliates’ employees and contractors, has not directly or indirectly promised, offered or provided any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other thing of value;
iii. any Person while knowing illegal or having reason unethical benefit to believe that all a Public Official or Entity or any portion of the money or other thing of value will be paid, offered, promised or given to, or will otherwise benefit, a Government Official in order to influence official action for or against either Party person in connection with the matters that are the subject performance of such Party’s obligations under this Agreement; or
iv. , and shall not, directly or indirectly, engage in any other Person to secure an improper advantage. It is the intent of the Parties that no payments or transfer of value will be made which have the purpose or effect of public or commercial bribery, acceptance of or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining or retaining business. This clause will not, however, prohibit ordinary and customary business entertainment or the giving of business mementos of nominal value in connection with a Party’s performance under this Agreement to the extent otherwise permitted by the Anti-Corruption Laws and this Agreement. In the event that during the Term either Party or its Affiliates fail to comply with the covenants set forth in this Section 11.1.7(bforegoing), such Party will promptly notify the other Party thereof in writing and, whether or not such notice is provided, such other Party may make any disclosure to Governmental Authorities or otherwise as it determines is appropriate in its sole discretion.
(c) As to all matters contained Such Party and its Affiliates, and their respective employees and contractors, in connection with the performance of their respective obligations under this Agreement, it will conduct shall not violate, and shall not cause the activities allocated other Party or such other Party’s Indemnitees to it be in compliance in all material respects with all violation of the FCPA, Export Control Laws, the federal health care program anti-kickback statute, the public contracts anti-kickback act, any state anti-kickback law, the Health Insurance Portability and Accountability Act (“HIPAA”), set forth at 42 U.S.C. sec. 1320d-2, the federal civil False Claims Act (or any state equivalent), federal or state “sunshine”/aggregate spend reporting laws, government price reporting laws, consumer protection and unfair trade practices laws, or any other Applicable Laws, rules or regulations or otherwise cause any reputational harm to such other Party.
(d) Such Party shall immediately notify the other Party if such Party has any information or suspicion that there may be a violation of the FCPA, Export Control Laws, the federal health care program anti-kickback statute, the public contracts anti-kickback act, any state anti-kickback law, HIPAA, the federal civil False Claims Act (or any state equivalent), federal or state “sunshine”/aggregate spend reporting laws, government price reporting laws, consumer protection and unfair trade practices laws, or any other Applicable Laws in connection with the performance of this Agreement or the development, manufacture or commercialization of Product.
(e) In connection with the performance of its obligations under this Agreement, such Party shall comply and in accordance with good scientific, clinical, laboratory shall cause its and manufacturing practices and applicable industry ethical codes, applicable under the laws and regulations of the country in which such activities are conducted.its Affiliates’ employees and
Appears in 1 contract
Samples: License and Collaboration Agreement (UNITED THERAPEUTICS Corp)