definiens: means, with respect to the United States, human clinical trials including typically the first phase of clinical trials conducted in relatively small numbers of healthy volunteers or patients with the condition to obtain information on a Product 's safety, tolerability, pharmacological activity, pharmacokinetics, drug metabolism and mechanism of action, as more fully defined in 21 CF.R. § 312.21(a ), as may be amended, and, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction . [ Microdose Studies shall not constitute a Phase I Clinical Trial for payment of the Phase I Clinical Trial Development milestone in Section 8 . 1.2 . ) 1.74 means, with respect to the United States, well­controlled clinical trials in human subjects, including clinical trials conducted in patients with the condition, and designed to evaluate clinical activity ( including but not limited to, pertinent pharmacodynamic effects or biomarker responses ) and safety for a Product for one or more indications, as well as to obtain an indication of the dosage regimen required, as more fully defined in 2 I CF.R. § 312.2 I ( b ), as may be amended, and, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction