Compliance with Laws, Regulations and Guidelines. A. The Investigator will perform the Study in conformance (i) with the Protocols, (ii) with all applicable laws and regulations, including laws and regulations governing the performance of clinical studies and (iii) with all applicable standards, regulations or guidelines for good clinical practice (“GCP”) and ethical conduct in connection with clinical studies, including those of the Institution and HMO.
Compliance with Laws, Regulations and Guidelines. Each Party agrees to comply with Law with respect to the development and commercialization of the Licensed Products in the Licensee Indications in the Territory. Neither Party shall be required to undertake any activity relating to the commercialization of a Licensed Product in the Territory that it believes, in good faith, may violate any Law.
Compliance with Laws, Regulations and Guidelines. Institution and Personnel shall comply with all applicable laws, regulations and guidelines, including but not limited to the (a) regulations and guidance governing the protection of human subjects, including, but not limited to, the Declaration of Helsinki, (b) regulations and guidance governing the conduct of clinical research, specifically including, but not limited to, GCP Guidelines developed by the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceutics for Human Use, (c) laws and regulations governing the purchase and sale of securities in a company while in possession of material, non-public information about that company and (d) any applicable anti-corruption or anti-kickback legislation (collectively, “Applicable Laws”). Additionally, Institution and Personnel shall comply with generally accepted professional clinical and research standards of care. 2.3.
Compliance with Laws, Regulations and Guidelines. Each Party agrees to comply with Law with respect to the development and commercialization of the Licensed Product in the Licensee Indications in the Territory.
Compliance with Laws, Regulations and Guidelines governing the performance of clinical studies and (iii) with all applicable standards, regulations or guidelines for good clinical practice (“GCP”) and ethical conduct in connection with clinical studies, including those of the Institution and HMO.
Compliance with Laws, Regulations and Guidelines. (a) Bayer agrees to comply with all Drug Laws of such countries in the Territory where it is selling or manufacturing Licensed Products and in all material respects to conform its practices and procedures with, as applicable, the European Federation of Pharmaceutical Industries Associations and the equivalent thereof, if any, in each Region or Major Country outside of Europe, as the same may be amended from time to time, with respect to the Commercialization of Licensed Product in the Bayer Territory.
Compliance with Laws, Regulations and Guidelines. Bayer agrees to comply with all Bayer Territory Drug Laws and in all material respects to conform its practices and procedures with, as applicable, the European Federation of Pharmaceutical Industries Associations and the equivalent thereof in each country in the Bayer Territory, as the same may be amended from time to time, with respect to the Commercialization of Licensed Product in the Bayer Territory. Nuvelo agrees to comply with all US Drug Laws and in all material respects to conform its practices and procedures with applicable industry guidelines and codes with respect to Commercialization of Licensed Product in the Nuvelo Territory, including without limitation the PhRMA Code on Interactions with Healthcare Professionals. Each Party will conduct its business operations and cause each of its employees, representatives and agents to refrain from activities that such Party knows or reasonably should know would undermine the good will or reputation of the other Party or the Licensed Product. Neither Party will undertake any activity relating to the Commercialization of Licensed Product that it believes, in good faith, may violate any law or regulations. Each Party will promptly notify the other Party of and provide to the other Party a copy of any correspondence or other reports with respect to the Commercialization of Licensed Product submitted to or received by Bayer from the IFPMA or equivalent organizations in the Bayer Territory. Bayer will in all material respects conform its practices and procedures relating to educating the medical community in the Bayer Territory with respect to Licensed Product to any applicable EMEA regulations or guidelines, as the same may be amended from time to time, and, as applicable, equivalent guidelines throughout the Bayer Territory.
Compliance with Laws, Regulations and Guidelines. Each Party agrees to comply with all applicable laws, rules and regulations (e.g., the FD&C Act, the PHS Act, the U.S. Foreign Corrupt Practices Act and any amendments thereto and the regulations promulgated thereunder, and the equivalent laws, rules and regulations in the Territory) and in all material respects to conform its practices and procedures with, as applicable, the Pharmaceutical Research and Manufacturers of America ("PhRMA") Code of Pharmaceutical Marketing Practices and the [***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Compliance with Laws, Regulations and Guidelines. Each Party agrees to comply with Law with respect to the development and commercialization of Dmab in the Territory. Neither Party shall be required to undertake any activity relating to the commercialization of Dmab in the Territory that it believes, in good faith, may violate any Law.
Compliance with Laws, Regulations and Guidelines. Each Party agrees to comply with all applicable laws, rules and regulations (e.g., the FD&C Act, the PHS Act, the U.S. Foreign Corrupt Practices Act and any amendments thereto and the regulations promulgated thereunder, and the equivalent laws, rules and regulations in the Territory) and in all material respects to conform its practices and procedures with, as applicable, the Pharmaceutical Research and Manufacturers of America ("PhRMA") Code of Pharmaceutical Marketing Practices and the American Medical Association ("AMA") Guidelines on Gifts to Physicians from Industry, as the same may be amended from time to time, and equivalent guidelines in the Territory with respect to the Commercialization of Collaboration Products. Each Party shall conduct its business operations and cause each of its employees, representatives and agents to do nothing which such Party knows or reasonably should know would jeopardize the good will or reputation of the other
