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, including : all cli nical activities, testing and studies of such Licen sed Product ; safety, tolerability and pharmacological studies co nducted in connection with the Clinical Trials of s uch Licensed Product ; distribution of such Licensed Product for use in Clinical Trials ( including placebos and comp arators ) ; statistical analyses ; the preparation, filing and p rosecution of any application for Regulatory Approv al for such Licensed Product ; development activities directed t o label expansion ( including prescribing informatio n ) or obtaining Regulatory Approval for one or more addit ional indications following initial Regulatory Appr oval ; development activities conducted after receipt of R egulatory Approval that are required, recommended o r requested in writing by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining a Regulatory Approval ; Licensed Product - related med ical affairs ; pharmacoeconomic studies relating to the indication for which the applicable Licensed Produc t is being developed ; in each case above, including investigatoror institution - sponsored studies for wh ich a Party is providing material or assistance or otherwise has written obligations to such investigator or institu tion ; and all regulatory activities related to any of the foregoing ; provided, however, that Development shall exclude Commercialization and manufacturing activities ( including manufacturing activities related to Development )