definiens: shall mean FTE Costs and Out - of - Pocket Expenses incurred by Ci dara and itsAffiliates in the conduct of the Research Plan Activities, incl uding:(a ) FTE Costs and Out - of - Pocket Expenses incurred for CMC Developme nt;20 ( b ) with respect to non - clinical and clinical research and drug Development activities ( including ClinicalTrials ), the Manufacturing Cost of Clinical Supply for a Compound and Product and other drugs, biological product s ordevices used in such Clinical Trials ( including FTE Costs and O ut - of - Pocket Expenses to purchase or package Third Partydrugs, biological products and devices ) and FTE Costs and Out -of - Pocket Expenses for disposal of clinical samples ; ( c ) with respect to regulatory activities for a Compound and Product, FTE Costs and Out - of - PocketExpenses incurred in connection with regulatory ﬁlings ( includ ing INDs and Marketing Approval Applications ), RegulatoryApprovals and meetings with Regulatory Authorities ; and(d ) any other FTE Costs and Out - of - Pocket Expenses incurred that ar e expressly included in the ResearchBudget