definiens: or means all activities that relate to obtaining, maintaining or expanding Regulatory Approval of a Product and tosupporting appropriate usage for such Product in the 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 purpose of submission to agovernmental authority to obtain, maintain and/or expand Regulatory Approval of a Product ( including contacts with Regulatory Authorities ), andoutside counsel regulatory legal services related thereto ; provided, however, that Development shall exclude Commercialization and manufacturingactivities ( including manufacturing activities related to Development ) . For clarity, Development shall include Phase 4 Clinical Trials that are required orrequested in writing by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining Regulatory Approval ( whether the trial iscommenced prior to or after receipt of such Regulatory Approval )