definiens: means any natural perwn, corporation, gcnc;:al partnership, limited partnership, limited liability company, joint venture, proprietorship or other dejure entit ), organized under the Laws uf any jurisdiction L24 means, with respect to the United States . wcll - controlled clinical trials in [, uman subjects, including clinical trials conducted in patienl'i with a condition, and designed to evaluate clinical activity ( including h-:.lt not limited to . pertinent pharmacodynamic effects or biomarker I ~ J C ~ lftdcr.thll : n;<tt : T)(,'l1 t ! ' flqUBstcd, 17078.33 - 447941 vI 4 rcspol1;;e < ;) and safety tQr a Licensed Product for one or more indica / ions, as well as to obtain an indication of the dosage regimen requiTed, as more fully defined in 21 C.E' . R