definiens: means with respect to a Product, the costs and expenses that are actually incurred by or on behalf of a Party and sp ecifically and directly attributable to the Develop ment of such Product . of a Party with respec t to the Product shall include, without duplication : ( a ) the FTE Costs of the Party or its Affiliates wi th respect to such Development ; ( b ) all Out - of - Pocket Costs incurred by the Party o r its Affiliates, including payments made to Third Parties, with respect to such Develop ment ( except to the extent that such costs have bee n included in FTE Costs ), including the costs and exp enses of conducting Clinical Trials ; ( c ) Regulatory Expenses other than Regulatory Maint enance Costs ; ( d ) the cost of contract research organizations ; ( e ) Manufacturing Costs for clinical supply, includ ing : ( i ) costs of packaging of drug products and distrib ution of drug products used in Clinical Trials ; ( ii ) expenses incurred to purchase or package compa rator drugs ; ( iii ) costs and expenses of disposal of clinical sa mples ; and ( iv ) costs and expenses incurred in scaling up Manu facturing activities related to pre - clinical or clinical supply, including formulation development activities ; ( f ) Manufacturing Scale - Up Costs ; and ( g ) Third Party License Costs