definiens: or or means all development activities for any Licensed Product that are directed to obtaining Regulatory A pproval(s ) of such Licensed Product and to support appropriate usage for such Licensed Product in the Field, inclu ding : all clinical activities, testing and studies of such Licensed Product ; safety, tolerability and pharmacological s tudies conducted in connection with the Clinical Tr ials of such Licensed Product ; distribution of such Licensed Pro duct for use in Clinical Trials ( including placebos and comparators ) ; statistical analyses ; the preparation, filing and prosecution of any application for Reg ulatory Approval for such Licensed Product in the Territory, with respect to Development activities conducted under the Territory Development Plan ; development activities directed to label expansion ( including prescribing information ) or obtaining Regulatory Approval for o ne or more additional Indications following initial Regulatory Approval ; development activities conducted after re ceipt of Regulatory Approval that are required or r equested 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 Pr oduct is being developed ; in each case above, including inve stigator- or institution - sponsored studies for whic h a Party is providing material or assistance or otherwise has w ritten obligations to such investigator or institut ion ; and all regulatory activities related to any of the foregoi ng ; provided, however, that Development shall exclu de Commercialization and manufacturing activities ( inc luding manufacturing activities related to Developm ent )