definiens: or means, together with all correlative meanings, all research and pre / non - clinical and clinical drugdevelopment activities, conducted before or after obtaining Regulatory Approval that are reasonably related to or leading tothe development, preparation, and submission of data and information to a Regulatory Authority for the purpose of obtaining, supporting, maintaining or expanding Regulatory Approval or to the appropriate Governmental Authority for obtaining, supporting, maintaining or expanding pricing and reimbursement approval, including without limitation, all activities related toChemistry, Manufacturing and Controls ( CMC ), preclinical testing, assay development and validation, in vivo testing, biomarker development and validation, toxicology, pharmacokinetic proﬁling, optimizing, design and conduct of Clinical Trialsand any other clinical trials or studies, regulatory aﬀairs, statistical analysis, report writing, and regulatory ﬁling creation andsubmission ( including the services of outside advisors and consultants in connection therewith )