definiens: or or means all development activities for any Licensed Product that are directed to obtaining Reg ulatory Approval(s ) of such Licensed Product and to support appropriate usage for such Licensed Product in the Field, including : ( a ) all research, non - clinical, p reclinical and clinical activities, testing and studies of such Li censed Product ; toxicology, pharmacokinetic, pharma codynamic, drug - drug interaction, safety, tolerability and pha rmacological studies of such Licensed Product ; ( b ) distribution of such Licensed Product for use in Clinical Trials ( including placebos and comparators ) ; ( c ) statisti cal analyses ; ( d ) the preparation, filing and prosecution of any NDA for such Licensed Product in the Territory, wi th respect to Development activities conducted under the Territor y Development Plan, and the preparation, filing and prosecution of any Biological License Application o r New Drug Application ( each as defined by the FDA ) outside the Territory, with respect to Development activiti es conducted under the Global Development Plan ; ( e ) all development activities directed to label expansion ( including prescribing information ) or obtaining Re gulatory Approval for one or more additional Indications fol lowing initial Regulatory Approval ; ( f ) all develop ment activities conducted after receipt of Regulatory Ap proval that are required or requested in writing by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining a Regulatory Approval ; ( g ) any pharmacoeconomic studies relating to the Indication for which the applicable Licensed Product is being developed ; ( h ) any investigator- or institution - sponsored stud ies ; and ( i ) all regulatory activities related to a ny of the foregoing . For clarity, Development does not includ e manufacture