definiens: or means all activities that relate to ( a ) obtaining, maintaining or expandingRegulatory Approval of a Product and to supporting appropriate usage for such Product, for one or more indications inthe Field . This includes : ( i ) preclinical / nonclinical research and testing, toxicology, and Clinical Trials ; and(ii ) preparation, submission, review, and development of data or information and Regulatory Materials for the purposeof submission to a governmental authority to obtain, maintain and/or expand Regulatory Approval of a Product(including contacts with Regulatory Authorities ), and outside counsel regulatory legal services related thereto;provided, however, that Development shall exclude Commercialization and manufacturing activities ( includingmanufacturing activities related to Development ) . For clarity, Development shall include Phase 4 Clinical Trials thatare required or requested in writing by a Regulatory Authority as a condition of, or in connection with, obtaining ormaintaining Regulatory Approval ( whether the trial is commenced prior to or after receipt of such Regulatory Approval )