definiens: means the costs and expenses that are incurred by either party or their Affiliates in the research and development of a Development Candidate after selection of the first Development Candidate in accordance with an applicable Development Plan and associated Budget approved by the Joint Development Committee, including ( without duplication ) the sum of : ( a ) the aggregate costs incurred by [COMPANY] and Cypress for Development FTEs performing research and development of any Development Candidate for purposes of registration in the Field in the Shared Territory or performing further development activities required by any governmental authority with respect to Approved Product in the Field in the Shared Territory after Regulatory Approval in order to maintain Regulatory Approval, in each case at the Development FTE Rate ; ( b ) the aggregate fees and expenses paid by [COMPANY] and Cypress to outside consultants and counsel in respect of filing, prosecution and maintenance of Cypress Patents, [COMPANY] Patents and Joint Patents with respect to the Development Candidate in the Shared Territory prior to the Date of First Commercial Sale of such Development Candidate ; ( el the aggregate payments made by [COMPANY] and Cypress to Third Parties as milestone payments upon the occurrence of research and development milestone events with respect to Development Candidates in the Field in the Shared Territory ; ( d ) Clinical Supply Costs ; ( el the actual payments made by [COMPANY] and Cypress to Third Parties to apply for Regulatory Approval ; and ( f ) the aggregate payments made by [COMPANY] and Cypress to Third Parties for performing research and development of any Development Candidate for purposes of registration in the Shared Territory, including, without limitation, the cost of studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of a Development Candidate necessary or desirable for the purpose of obtaining and/or maintaining Regulatory Approval of a Development Candidate in the Shared Territory ; costs ( and related fees ) for preparing, SUbmitting, reviewing or developing data or information for the purpose of submission to a governmental authority to obtain and/or maintain Regulatory Approval of a Development Candidate in the Shared Territory ; and manufacturing process development and scale - up for a Development Candidate in bulk and finished form for the Shared Territory for purposes of conducting studies necessary to obtain and/or maintain Regulatory Approval of Development Candidates in the Shared Territory . In addition, Development Expenses include, but are not 6