definiens: or means, together with all correlative meanings, pre - clinical andclinical drug development activities, conducted before or after obtaining Regulatory Approval that are reasonablyrelated to or leading to the development, preparation, and submission of data and information to a RegulatoryAuthority for the purpose of obtaining, supporting or expanding Regulatory Approval or to the appropriate body forobtaining, supporting or expanding pricing and reimbursement approval, including without limitation, all activitiesrelated to preclinical testing, assay development and validation, in vivo testing, biomarker development and validation, toxicology, pharmacokinetic profiling, design and conduct of Clinical Trials and any other clinical trials or studies, regulatory affairs, statistical analysis, report writing, and regulatory filing creation and submission ( including theservices of outside advisors and consultants in connection therewith ) . Development expressly excludes ( a ) Research,(b ) Commercialization and ( c ) the Manufacture and accumulation of commercial inventory of a product