definiens: or means, with respect to any product, any and all internal and external research or development activities regardingsuch product, including ( a ) research, non - clinical testing and activities, IND - enabling pre - clinical studies and other pre - clinical activities, andClinical Trials, ( b ) test method development and stability testing, process development and formulation development and toxicology, and ( c)preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtainauthorization to conduct Clinical Trials or to obtain Regulatory Approval of such product ( excluding any activities reasonably necessary forobtaining Reimbursement Approval, but not for other elements of the Regulatory Approval ) and interacting with Regulatory Authorities regardingany of the foregoing ; but excluding, in each case, any activities directed to Manufacturing, Medical Affairs, or Commercialization . and will be construed accordingly