definiens: means all pre - clinical and clinical activities performed by or on behalf of either Party with respect toLicensed Compounds or Licensed Products in the Field in the Territory in an indication, or for the purpose of obtainingRegulatory Approval with respect to such indication, from the Effective Date until Regulatory Approval of such LicensedCompounds or Licensed Products is obtained for the indication being studied, including : ( a ) identification and early pre - clinical testing of Licensed Compounds ; ( b ) toxicology, regulatory affairs, pre - clinical studies and clinical trials in accordancewith the GLPs, GCPs and GMPs or other designated quality standards and Applicable Laws ; and ( c ) all Manufacturingactivities ( until such time as Manufacturing of Commercial Supplies commences ) relating to developing the ability toManufacture Licensed Product, including process and formulation development, process validation, manufacturing scale - up, manufacturing and analytical development, and quality assurance and quality control . When used as a verb, meansto engage in Development