definiens: or or means all regulatory a nd development activities for any Licensed Product that are directed to obtaining Regulatory Approval(s ) of such Licensed Product and to support appropriate usage for such Licensed Product in the Field, including : all research, non -clinical, preclinical and clinical activities, testing and studies of such Licensed Product ; toxicology, pharmacokinetic, pharmacodynamic, drug -drug interaction, safety, tolerability and pharmacological studies ; distribution of such Licensed Product for use in Clinical Trials ( in cluding placebos and comparators ) ; statistical analyses ; and the preparation, filing and prosecution of any Marketing Approval Applications ( ) for such Licensed Product ; development activities conducted after receipt of Regulatory Approval that are re quired or requested in writing by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining a Regulatory Approval ; and pharmacoeconomic studies for the Licensed Product in the Field ; in each case above, including investigato r- and/or institution -sponsored studies for which a Party is providing material or assistance or otherwise has written obligations to such investigator and/or institution ; and all regulatory activities related to any of the foregoing ; provided, however, th at Development shall exclude Commercialization and manufacturing activities ( including manufacturing activities related to Development )