definiens: means ( a ) all laws, ordinances, rules, directives and regulations applicable to the Products, the Project or this Agr eement, including without limitation applicable loc al laws and regulations in each country in the [COMPANY] Territo ry, ( b ) applicable regulations and guidelines of th e FDA and other Regulatory Authorities and the ICH guidelines ; ( c ) as applicable to the particular activities pe rformed, Good Manufacturing Practices, Good Laboratory Pract ices and Good Clinical Practices promulgated by the FDA and other Regulatory Authorities or the ICH ; and ( d ) all applicable industry and trade standards, incl uding the applicable standards of the International Organizat ion for Standardization ( ISO ) . 1.4 means [COMPANY] ’s proprietary amikacin antibiotic ( including the 70 mg / ml formulation ) based on [COMPANY] ’s proprietary sustained release l iposomal technology for inhalation