definiens: means expenses and other costs, including regulatory expenses, incurred by or on behalf of a Partyor its Affiliates in connection with the Development of the Products in accordance with the applicable approved DevelopmentPlan ( including the Development Budget ), in accordance with GAAP ( or other internationally recognized accounting standardused by such Party ), including, without limitation, the costs of clinical trials, the preparation, collection and/or validation ofdata from such clinical trials and the preparation of medical writing and publishing on the data and results obtained from suchclinical trials . Without limiting the generality of the foregoing, Development Costs shall include, to the extent included in thescope set forth above : ( a ) all out - of - pocket costs incurred by the Parties or their Affiliates, including payments made to Third Parties with respectto any of the foregoing ; ( b ) the cost of clinical supply, including without limitation ( i ) costs of manufacturing or procuring clinical supplies, including reasonable costs incurred in connection with the development of the manufacturing process for such clinicalsupplies, but excluding any capital expenditures or qualification or validation expenses relating to any manufacturingfacility, ( ii ) expenses incurred to purchase and/or package placebos and comparator drugs, and ( iii ) costs and expenses ofdisposal of clinical samples ; and ( c ) the costs of Regulatory Filings