definiens: or means all activities relating to obtaining RegulatoryApproval for a product and all manufacturing activities undertaken prior to Commercialization that arenecessary for Regulatory Approval and for Commercial launch of such product, including withoutlimitation those activities reasonably required for development of CMC processes and the scale - up ofmanufacturing processes or equipment in preparation for commercial supply of such product . This includes, for example, ( a ) preclinical testing, toxicology, formulation, Clinical Studies, and regulatory affairs requiredfor Regulatory Approval and ( b ) manufacturing process development for commercial supply of bulk andfinished forms of products and components thereof, as applicable, production of clinical supply of bulk andfinished forms of products and components thereof, and manufacturing and quality assurance technicalsupport activities prior to the commencement of Commercialization of such product that are necessary forRegulatory Approval and for Commercial launch of such product