definiens: means any human clinical study, or other test or s tudy with respect to a Licensed Product for an indication that ( a ) is cond ucted solely in support of pricing or reimbursement for such Licensed Product in a country or ( b ) is not require d to obtain or maintain Initial Regulatory Approval for such Licensed Product for such indication and is conduct ed within the scope of the labeling for such Licens ed Product ( for clarity, any human clinical study that is inte nded to expand the labeling for a Licensed Product shall be a Clinical Trial and shall not be a Post Approval Stu dy ) . Subject to the foregoing, Post Approval Studie s may include epidemiological studies, modeling and pharm acoeconomic studies, post - marketing surveillance st udies, investigator sponsored studies, and health economic s studies . For clarity, Post Approval Studies shall not include any tests or studies that are required or recommend ed for a Licensed Product by the Regulatory Authori ties as a condition to obtaining, or as a requirement of main taining, an Initial Regulatory Approval for such Li censed Product for an indication