definiens: shall mean the aggregate amount of the following costs incurred in preclinical development, clinical development and regulatory approval of a DEVELOPMENT PRODUCT for a country of the CO - PROMOTION TERRITORY in which BTl has elected to co - promote such DEVELOPMENT PRODUCT detennined in a reasonable manner consistent with SANDOZ ' internal cost accounting methods and in accordance with ~ generally accepted accounting principles, including but not limited to : ( i ) direct labor ( salaries,-wages and employee benefits ) ; ( ii ) materials and supplies ; ( iii ) depreciation, repairs and maintenance and other operating costs of machineD ' and equipment utilized in preclinical and clinical development and regulatory approval ; ( iv ) Building operating costs assigned to the development area ; ( v ) overhead incurred in clinical and preclinical development, and regulatory approval including development administration ; and ( vi ) payments made to third parties or for services in connection with preclinical and Glinical development and regulatory approval