definiens: or or means all 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, precl inical and clinical activities, testing and studies of such Licensed Product ; toxicology, pharmacokinetic, pharmacodynamic, drug -drug interaction, safety, tolerability and pharmacological studies of such Licensed Product ; distribution of such Licensed Prod uct for use in Clinical Trials ( including placebos and comparators ) ; statistical analyses ; the preparation, filing and prosecution of any NDA -C for such Licensed Product in the Territory, with respect to Development activities conducted under the Territory Development Plan, and the preparation, filing and prosecution of any Biological License Application or New Drug Application ( each as defined by the FDA ) outside the Territory, with respect to Development activities conducted under the Global Development P lan ; development activities directed to label expansion ( including prescribing information ) or obtaining Regulatory Approval for one or more additional Indications following initial Regulatory Approval ; development activities conducted after receipt of Reg ulatory Approval that are required 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 relating to the Indication for which the applicable Licensed Product is being developed ; in each case above, including investigator - or institution -sponsored studies for which a Party is providing material or assistance or otherwise has written obligations to such investigator or institution ; and all regula tory activities related to any of the foregoing ; provided, however, that Development shall exclude Commercialization and manufacturing activities ( including manufacturing activities related to Development )