definiens: or or means all development activities for any Licensed Compound or Licensed Product that are directed to o btaining Regulatory Approval(s ) of such Licensed Pr oduct and to support appropriate usage for such Licensed Product, including : all research, non - clinical, pre clinical and clinical activities, testing and studies of such Li censed Compound or Licensed Product ; toxicology, pharmacokinetic, pharmacodynamic, drug - drug interac tion, safety, tolerability and pharmacological stud ies of such Licensed Compound or Licensed Product ; sourcin g and distribution of such Licensed Product for use in Clinical Trials ( including placebos and comparators ) ; statistical analyses ; the preparation, filing an d prosecution of Regulatory Documents for such Licensed Compound or Licensed Product ; with respect to Development conducted by [COMPANY] pursuant to the Global Strate gy, or by Licensee under the Development Plan, deve lopment activities directed to label expansion ( including p rescribing information ) or obtaining Regulatory App roval for one ( 1 ) or more additional Indications following in itial Regulatory Approval ; development activities c onducted after receipt of Regulatory Approval that are requi red or requested in writing by a Regulatory Authori ty as a condition of, or in connection with, obtaining or m aintaining a Regulatory Approval ; and pharmacoecono mic studies relating to the Indication for which the ap plicable Licensed Product is being developed ; in ea ch case above, including investigator- or institution - sponsored st udies for which a Party is providing material or as sistance or otherwise has written obligations to such investiga tor or institution ; and all regulatory activities r elated to any of the foregoing ; provided, however, that Development shall exclude Commercialization and Manufacturing ( including Manufacturing related to Development )