definiens: means all activities that relate to ( a ) obtaining, maintaining or expanding RegulatoryApproval of a Product for one or more indications or ( b ) developing the process for the manufacture of clinical andcommercial quantities of drug substance or drug Product . This includes : ( i ) preclinical and non - clinical testing, toxicology and Clinical Trials ; ( ii ) preparation, submission, review, statistical analysis, report writing and developmentof data or information for the purpose of submission to a Governmental Authority to obtain, maintain and/or expandRegulatory Approval of a Product, and outside counsel regulatory legal services related thereto ; and ( iii ) manufacturingprocess development and scale - up for drug substance and drug product, test method development, packagingdevelopment, stability testing, qualification and validation, production of drug substance and drug product, in bulk forpreclinical and clinical studies, and related quality assurance technical support activities ; provided, however, thatDevelopment shall exclude Commercialization