definiens: or means, together with all correlative meanings, pre - clinical studies ( otherthan those specified in Section 1.105 ) and clinical drug development activities, conducted before or after obtainingRegulatory Approval that are reasonably related to or leading to the clinical development, preparation, and submissionof data and information to a Regulatory Authority for the 3 * * * Text Omitted and Filed Separately with the Securities and Exchange Commission Confidential TreatmentRequested Under 17 C.F.R. Sections 200.80(b)(4 ) and 230.406 purpose of obtaining, supporting or expanding Regulatory Approval or to the appropriate body for obtaining, supportingor expanding pricing and reimbursement approval, including without limitation, all activities related to [ … * * * … ] ( including [ … * * * … ] ), 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 the services of outsideadvisors and consultants in connection therewith ) . Development expressly excludes ( a ) Research,(b ) Commercialization and ( c ) the Manufacture and accumulation of commercial inventory of a product