definiens: or means ( a ) all activities relating to research, non - clinical, preclinical and clinical trials, toxicology testing, statistical analysis, publication and presentation of research and study results and reporting, preparation andsubmission of applications ( including any CMC Information ) for obtaining and maintaining Regulatory Approval of the OriginalProduct, and ( b ) if [COMPANY] exercises an Option, all activities ( both prior to and after [COMPANY] ’s exercise of an Option ) relating to research, non - clinical, preclinical and clinical trials, toxicology testing, statistical analysis, publication and presentation of research and studyresults and reporting, preparation and submission of applications ( including any CMC - related information ) for obtaining andmaintaining Regulatory Approval of the particular Improved Product in question ; provided, however, Develop and Developmentshall not include any activities that involve the Commercialization of a Licensed Product