definiens: or shall mean ( a ) activities directly and specificallyrelating to the pre - clinical and clinical drug development of a Licensed Product, including, without limitation, test method development, stability testing with respect to Licensed Productmanufactured by or on behalf of Aventis ( for clarity, other than Product supplied by Regeneronpursuant to the Supply Agreement ), assay development, toxicology, formulation, qualityassurance / quality control development, technology transfer, statistical analysis, processdevelopment, pharmacokinetic studies, Clinical Trials ( including research to design ClinicalTrials and develop target product profiles ), regulatory affairs, drug safety surveillance activities, and Approvals, ( b ) any other research and development activities with respect to a LicensedProduct and ( c ) any pre - launch marketing activities ( including, without limitation, market researchand analysis, and health economics ) performed prior to First Commercial Sale of such LicensedProduct