definiens: .S.QYJ : ified Regulatory Requirements " means ( i ) applicable cGMPs and all olher applicable laws, rules, regulations, guidelines or requirements of the FDA, the EMEA, the ICB, and Switzerland ; ( ii ) commencing at such time as MERCK is conducting any Clinical Trial in Japan, Australia or any Added Regulatory Jurisdiction, the applicable cGMPs and all other applicable laws, rules, regulations, guidelines or requirements of Japan, Australia or such Added Regulatory Jurisdiction, as appropriate, pertaining to the use of Clinical Product in a Clinical Trial in such jurisdiction ; and ( iii ) commencing at such time as MERCK is selling MERCK Product in Japan, Australia or any Added Regulatory Jurisdiction, the applicable cGMPs and all other applicable laws, rules, regulations, guidelines or requirements of Japan, Australia or such Added Regulatory Jurisdiction, as appropriate, pertaining to the sale of MERCK Product in such jurisdiction