definiens: of a Licensed Product means all Out - of - Pocket Costs and Expenses for work requiredfor Development of such Licensed Product, other than amounts related solely to Development of such LicensedProduct in the ROW ( including preclinical, clinical, regulatory and manufacturing activities ), in each case only to theextent provided for in an approved Development Plan or otherwise approved in advance by the Joint DevelopmentCommittee or Joint Steering Committee . Development Costs shall consist of:1.35.1 Out - of - Pocket Costs and Expenses incurred ( a ) to a Third Party, in connection with all Developmentactivities performed in accordance with the Development Plan ; ( b ) in connection with regulatory submissions ; or ( c ) forprocess development of the manufacturing process for the Licensed Product;1.35.2 the Out - of - Pocket Costs and Expenses of clinical supplies for such Clinical Studies or activities asagreed in the Development Plan, which costs shall consist of : ( a ) the Out - of - Pocket Costs and Expenses incurred inpurchasing clinical and pre - clinical supplies, including the Named Compound, utilized in Development, ( b ) Out - of - Pocket Costs and Expenses incurred in purchasing comparator drug(s ) and in packaging comparator drug(s ) and / orthe Named Products, and ( c ) shipping clinical supplies to centers or disposal of clinical supplies ; and1.35.3 such other Out - of - Pocket Costs and Expenses as the Parties may agree upon in writing from time totime