definiens: shall mean, with respect to a DevelopmentCandidate and Drug Products derived therefrom, expenses and other costs, including Regulatory Expenses ( except for the maintenance of RegulatoryApprovals ), incurred by or on behalf of a party in connection with the worldwidedevelopment of such Development Candidate and Drug Products derived therefrom inaccordance with the Development Program, including without limitation the costsof clinical trials, the preparation, collation and/or validation of data fromsuch clinical trials and the preparation of medical writing as will make theresults of such clinical trials an element of one or more Registration Filings;provided, that Development Costs shall include the cost of Phase IIIB clinicaltrials and Phase IV clinical trials only if and to the extent they are intendedto support indications beyond the respective initial indications ( as agreed uponby the parties ) for the Drug Products, to support expanded labeling for the DrugProducts, or to satisfy requirements imposed by governmental regulatoryauthorities in connection with Regulatory Approvals for the Products