definiens: means : ( a ) a human clinical trial of a compound or product that would satisfy therequirements of U.S. 21 C.F.R. Part 312.21(c ) or corresponding foreign regulations or ( b ) a human clinical trial of acompound or product that is intended to : ( i ) establish that the compound or product is safe and eﬃcacious for its intendeduse ; ( ii ) deﬁne contraindications, warnings, precautions, and adverse reactions that are associated with the compound orproduct in the dosage range to be prescribed ; and ( iii ) support Regulatory Approval for such compound or product ( whetherconditional or ﬁnal ), but may not include the data that may be necessary to support the Pricing Approvals ; or ( c ) a humanclinical trial similar to a human clinical trial described in sub - clause ( a ) prescribed by the relevant Regulatory Authorities in acountry other than the United States