definiens: shall mean the costs and expenses associated with Development activities actually incurred by [COMPANY] or [COMPANY] from March 1, 2000 through the later of ( a ) the date of the last Regulatory Approval obtained ( including thereafter costs to maintain or expand such Regulatory Approval ) in the Territory, or ( b ) the date of termination of Development of the final indication for which Regulatory Approval is to be sought in the Territory, provided that, with respect to the Initial Period, only Included Ini tial Period Costs, as defined in Section 4.6(c ), shall be included . The costs and expenses associated with Development activities shall include those costs required to obtain, maintain and/or expand the authorization and/or ability to manufacture, formulat e, fill, ship and/or sell Licensed Product in commercial quantities to Third Parties in the Territory . shall also include, but are not limited to, costs of research or Development, including costs of studies on the toxicological, pharma cological, metabolical or clinical aspects of a Licensed Product conducted internally or by individual investigators or consultants and necessary for the purpose of obtaining, maintaining and/or expanding marketing approval of a Licensed Product, process d evelopment, process improvement and scale -up and recovery costs ( including plant costs ), validation costs, including qualification lots, the manufacture of Clinical Supplies of Licensed Product, costs for preparing, submitting, reviewing or developing data or information for the purpose of submission to a governmental authority to obtain, maintain and/or expand manufacturing and/or marketing approval of a Licensed Product and costs of marketing studies related to Licensed Product