definiens: or means under this Agreement, with respect to Licensed Products, the developmentactivities conducted before or after obtaining Regulatory Approval that are reasonably related to or leading to the development, preparation andsubmission of data and information to a Regulatory Authority for the purpose of obtaining, supporting or expanding a Regulatory Approval, including but not limited to all activities related to pharmacokinetic proﬁling, design and conduct of pre - clinical development, non - clinicaldevelopment, pre - clinical studies, in vitro studies, Clinical Studies, other studies and scientiﬁc activities ordinarily conducted in thepharmaceutical industry in the DS Territory as a prerequisite to or in connection with a Clinical Study, regulatory aﬀairs, statistical analysis, reportwriting and regulatory ﬁling creation and submission, including Post - Approval Studies, but excluding, for the avoidance of doubt, Commercialization and Manufacturing