definiens: or means all development activities for any LicensedProduct that are directed to obtaining Marketing Approval(s ) of such Licensed Product and to support appropriateusage for such Licensed Product in the Field, including : all research, non - clinical, preclinical and clinicalactivities, testing and studies of such Licensed Product ; toxicology, pharmacokinetic, pharmacodynamic, drug - drug interaction, safety, tolerability and pharmacological studies ; distribution of such Licensed Product for use inClinical Trials ( including placebos and comparators ) ; statistical analyses ; and the preparation, filing andprosecution of any IND or BLA for such Licensed Product ; development activities directed to label expansion(including prescribing information ) and/or obtaining Marketing Approval for one or more additional Indicationsfollowing initial Marketing Approval ; development activities conducted after receipt of Marketing Approval that arerequired or requested in writing by a Regulatory Authority as a condition of, or in connection with, obtaining ormaintaining a Marketing Approval ; and pharmacoeconomic studies relating to the Indication for which theapplicable Licensed Product is being developed ; in each case above, including investigator- and/or institution - sponsored studies for which a Party is providing material or assistance or otherwise has written obligations tosuch investigator and/or institution ; and all regulatory activities related to any of the foregoing ; provided, however, that Development shall exclude * * * INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED . ALL SUCHOMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED