definiens: means, with respect to a particular Product ( and the Licensed Compound contained therein),all development activities ( including non - clinical studies and Clinical Trials and regulatory activities ) conducted by theParties in support of ( a ) obtaining, maintaining or expanding Regulatory Approval of a Product for one or more indications inthe Joint Development Territory, and/or ( b ) commercialization or Medical Affairs Activities of or for such Product in the JointDevelopment Territory . The Development Program shall include research, clinical development ( including Phase IV ClinicalTrials, pharmacovigilance programs and outcome studies ), manufacturing process development, and regulatory andregistration activities, all as required for or directly in support of the foregoing activities for the benefit of any country in theJoint Development Territory . For clarity, the Development Program commences ( i ) in the case of the Lead Product, on theEffective Date, and ( ii ) in the case of any other Product, on the date that such Product becomes the subject of an IND, andcontinues in each case ( ( i ) and ( ii ) ) through Regulatory Approval and commercialization of such Product ( or termination of alldevelopment activities with respect to such Product )