definiens: means any and all laws, rules and regulations applicable to the performance of theServices in the country in which ( a ) Services are performed, or ( b ) a regulatory filing including results ofServices is intended to be filed . Regulations shall include, without limitation, and where and when applicable;(i ) the United States Food, Drug, and Cosmetic Act, as amended and any and all rules, regulations andguidance promulgated thereunder, ( ii ) all applicable European Union, national and local laws, standards andguidelines, ( iii ) any and all rules and regulations of the Regulatory Agency or any other federal or stategovernment agency related to the conduct of clinical research studies, and ( iv ) any applicable guidelinespromulgated by the International Conference on Harmonization, including without limitation, the ICHHarmonized Tripartite Guidelines for Good Manufacturing Practice, ( v ) cGMP, and ( vi ) cGLP