definiens: or or means all development activities for any Licensed C ompound or Licensed Product that are directed to obtaining Regulatory Approval(s ) of such Licensed Product and to support appropriate usage for such Licensed Product, includ ing : all research, non - clinic al, preclinical and clinical activities, testing and studies of such Licensed Co mpound or Licensed Product ; toxicology, pharmacokin etic, pharmacodynamic, drug- drug interaction, safety, tolerability and pharmaco logical studies of such Licensed Compound or L icensed Product ; sourcing and distribution of such Licensed Product for use in Clinical Trials ( including placebos and comparators ) ; statistical a nalyses ; the preparation, filing and prosecution of Regulatory Documents for such Licensed Compound or License d Product ; with respect to Development conducted by [COMPANY] pursuant to the Global Strategy, or by Lic ensee under the Development Plan, development activ ities directed to label expansion ( including prescribing information ) or obtaining Regulatory Approval for one ( 1 ) or more additional Indications following initial Regul atory Approval ; development activities conducted af ter receipt of Regulatory Approval that are required or request ed in writing by a Regulatory Authority as a condit ion of, or in connection with, obtaining or maintaining a Regulatory Approva l ; and pharmacoeconomic studies relating to the Indication for which the applicable Licensed Pr oduct is being developed ; in each case above, inclu ding investigator- or 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 ( including Manufacturing related to Development )