definiens: means reasonable expenses and other costs, including external regulatory expenses, directlyincurred by or on behalf of a Party in connection with the Development activities to be undertaken by the Parties inaccordance with the approved Development Plan and Development Budget, including, without limitation, the external costsof clinical trials, the preparation, collation and/or validation of data from such clinical trials and the preparation of medicalwriting and publishing, but excluding any Indirect Costs and any costs of external fees related to the filing of RegulatoryMaterials . Without limitation of the generality of the foregoing, Development Costs shall include:(a ) all Out - of - Pocket Costs incurred by the Parties or their Affiliates;(b ) the cost of clinical supply, including without limitation ( i ) costs of clinical supplies of Product, ( ii ) expensesincurred to purchase and/or package comparator drugs, and ( iii ) costs and expenses of disposal of clinical samples ; and(c ) the costs of consultation and pre - submission meetings with Regulatory Authorities, including any costs relatedto pharmacovigilance, to the extent such costs are to be considered Development Costs in accordance with theDevelopment Plan