definiens: means the rights and interests in and to all issued patents and pending patent applications, including without limitation, all provisional applications, substitutions, continuations, continuations - in - part, divisions, and renewals, all letters patent granted thereon, and all patents - of - addition, reissues, reexaminations and extensions or restorations ~y existing or future extension or restoration mechanisms, and all supplementary protection certificates, together with any foreign counterparts thereof in the, Territory . ' 1.46 '' Person '' or ' Person " means any individual, firm, corporation, partnership, limited liability company, trust, unincorporated organization or other entity or a government agency or ' political subdivision thereto, and shall include any successor ( by mergeror otherwise ) of such Person . means a controlled clinical trial designed to evaluate " clinical efficacy and safety of a Licensed Product as well as to obtain an indication of the dosage regimen required, as more fuUydescribed in 21 C.F.R. § 312.21(b )