definiens: or or means all development and regulatory activities for the Licensed Compound or Licensed Products that are directed to obtaining Regulatory Approval(s ) o f such Licensed Product and to support appropriate usage f or such Licensed Product including, but not limited to : all research, non - clinical, preclinical and clinical ac tivities, testing and studies of such Licensed Comp ound or Licensed Product ; toxicology, pharmacokinetic, phar macodynamic, drug - drug interaction, safety, tolerab ility and pharmacological studies of such Licensed Compound o r Licensed Product ; sourcing and distribution of su ch Licensed Product for use in Clinical Trials ( includ ing placebos and comparators ) ; statistical analyses ; the preparation, filing and prosecution of Regulatory D ocuments for such Licensed Compound or Licensed Pro duct ; activities directed to label expansion ( including p rescribing information ) or obtaining Regulatory App roval for one ( 1 ) or more additional Indications following an initial Regulatory Approval for Licensed Products ; activities that are required or requested in writing by a Regu latory Authority as a condition of, or in connectio n with, obtaining, maintaining or expanding a Regulatory A pproval, including but not limited to the conduct o f additional Clinical Trials in the Territory ; and post - Regulato ry Approval product support activities for Licensed Product ( including laboratory and clinical efforts directed toward the further understanding of the safety and efficacity of the Licensed Product ) . For clarity, Development inc ludes phase IV clinical trials and other post - Regul atory Approval clinical trials of Licensed Product