definiens: means all applicable laws, rules, regulations and guidelines that may apply to the development, marketing, manufacturing or sale of the Licensed Product or the performance of either Party ’s obligations under thisAgreement, including but not limited to all laws, regulations and guidelines governing the import, export, development, marketing, distribution and sale of the Licensed Product in the Territory, to the extent relevant, all Good ManufacturingPractices or Good Clinical Practices standards or guidelines promulgated by the FDA, other Competent Authorities, or theInternational Conference on Harmonization, and all laws, rules, regulations, and guidelines applicable to the manufacture, use, shipment, handling, sale, marketing, and distribution of fentanyl as a Schedule II controlled substance under the UnitedStates ’ Controlled Substances Act and any similar foreign laws, rules, and regulations, and trade association guidelines(including but not limited to, with respect to all of the foregoing, those which apply to the handling of narcotics ), whereapplicable