definiens: shall mean a human clinical trial conducted with respect to a Product : ( a ) after [ the First Commercial Sale of such Product in the country in which such trial is being conducted ] ; ( b ) within the [ parameters of the Regulatory Approval for the Product in such country ] ; and ( c ) intended as [ part of a to support market uptake, acceptance and differentiation of such Product ] . Phase IV studies may include, for example, [ investigator - sponsored clinical trials of a Product for which financial or in - kind support is provided by [COMPANY], epidemiological studies, modeling and pharmacoeconomic studies ], and the like . Phase IV studies shall not include any human clinical trials : ( i ) [ required or requested by a Regulatory Authority as a condition of, or in connection with, obtaining Regulatory Approval for the Product in such country ] ; and/or ( ii ) from which [ any Data generated is or will be filed with any Regulatory Authority ] for the purposes of : [ ( A ) obtaining Marketing Approval for the Product in any country ; ( B ) obtaining Marketing Approval for an additional indication for the Product in any country ; ] or [ ( C ) otherwise obtaining approval from a Regulatory Authority to modify the labeling of the Product ; ] provided that in the case of paragraph ( ii ), [ such Data may be filed with a Regulatory Authority solely for safety monitoring purposes, as required by the applicable Regulatory Authority, where such trial was not requested or required by a Regulatory Authority ]