definiens: shall mean ( i ) a human clinical study conducted in any country that would satisfy the requirements of 21 CFR312.21(b ) and that is designed or intended to explore a variety of doses, dose response and duration of effect to generate initial evidence ofclinical safety and activity in a target patient population, or ( ii ) an equivalent clinical study required by a Regulatory Authority in a jurisdictionoutside of the United States . For clarity, the Parties acknowledge and agree that Licensee ’s proof of concept study “ A Phase 1/2a SingleDose and 28- day Parallel Group, Double Blind, Vehicle - Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream0.5 % and 0.15 % in Adults with Mild to Moderate Chronic Plaque Psoriasis ” ( NCT03392168 ), shall be excluded from the definition of Phase IIStudy and shall not be considered a Phase II Study for purposes of this Agreement