definiens: means all laws, ordinances, rules, rulings, direc tives and regulations of any Regulatory Authority that apply to the development, manufacture, processing or commercialization of th e Product or the other activities contemplated under this Agr eement, including ( a ) all applicable federal, state and local laws, rules and regulations ; ( b ) the BPCI Act, the Public Health Service Act and the U.S. Federal Food, Drug and Cosmetic Act ; ( c ) Article 6 of Regulation ( EC ) 726/ 2004 and Article 10(4 ) of Directive 2001/83 / EC ; ( d ) 42 C.F.R., Part 73 and other applicable laws and regul ations relating to toxins, ( e ) regulations, guideli nes and procedural advice of the EMA, the FDA and other Reg ulatory Authorities, including guidelines of the Co mmittee for Medicinal for Human Use ( CHMP ) and ICH ; and ( f ) any applicable equivalents of any of the foregoing in the [COMPANY] Territory