definiens: means all external costs, including external product development costs, incurred by [COMPANY] andSchering - Plough after the Effective Date in connection with the clinicaldevelopment ( including pre - clinical, toxicology, pharmacology andpharmacodynamic studies and clinical trials, except as limited by the lastsentence of this definition ) and clinical support of regulatory filings withrespect to the Product . also includes the cost ofgoods for material used in clinical trials, which cost will be calculated basedon [COMPANY] 's Cost of Goods Sold, or, if [COMPANY] contracts with a third partyfor manufacture of the Product, will be the actual cost paid by [COMPANY] to thatthird party . also includes such costs of thedevelopment of improvements of manufacturing and control processes as areincurred after the Product has received a first EMEA Approval . All internalcosts of [COMPANY] or Schering - Plough, including but not limited to salaries, payroll taxes, bonuses and benefits incurred with respect to their employees andoffice, administration and overhead expenses, are specifically excluded from thedefinition of unless otherwise agreed by theparties . Excluded from are costs incurred withrespect to clinical trials or other studies undertaken solely to supportapplications for Regulatory Approval outside the Territory