definiens: means all activities that relate to ( a ) obtaining, maintaining or expanding Regulatory Approval of aProduct and to support appropriate usage for such Product, for one or more indications, or ( b ) developing the process for themanufacture of clinical and commercial quantities of Product . This includes : ( i ) research, preclinical testing, toxicology, andClinical Trials ; ( ii ) preparation, submission, review, and development of data or information and Regulatory Materials for thepurpose of 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 ; and(iii ) manufacturing process development and scale - up, bulk production and fill / finish work associated with the supply ofProduct for preclinical and clinical studies, and related quality assurance technical support activities ; provided, however, thatDevelopment shall exclude Commercialization, the construction, validation and qualification of commercial manufacturingfacilities, the building of commercial inventory of Product, and the negotiation of pricing / reimbursement for a Product . Forclarity, Development shall include Phase 4 Clinical Trials that are required, requested or advised by a Regulatory Authority asa condition of, or in connection with, obtaining or maintaining an Approval ( whether the trial is commenced prior to or afterreceipt of such Approval ) . has a correlative meaning