definiens: means the laws, rules and regulations, including an y rules, regulations, guidelines or other requireme nts of the regulatory authorities applicable to the Initial De velopment or other activities conducted by the Part ies under this Agreement, that may be in effect from time to time in the applicable jurisdiction . means the then - current standards, practices and procedure s promulgated or endorsed by the FDA as set forth i n the guidelines entitled includin g without limitation related regulatory requirements imposed by the FDA and comparable regulatory standards, pra ctices and procedures promulgated by any other applicable regulatory authority, as they may be updated from t ime to time . means the then - current good laboratory practice st andards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards promulgated b y any other applicable regulatory authority, as they may be updated from time to time . means current Good manufacturing practices for the manufacture of prod ucts as are required by applicable regulatory autho rities and Applicable Law . In the United States, GMP will be d efined under the rules and regulations of the FDA, as the same may be amended from time to time