definiens: means the expenses incurred by a Party or for its account by a Third Party ( including capital expenditures made by a Third Party and reimbursed by a Party ) which are generally consistent with a Development Plan and Development Budget and are specifically attributable to the Development of a Collaboration Compound or Collaboration Product ( including royalties paid to a Third Party not otherwise recovered as a Cost of Goods Sold ) . Development Expenses shall include, but are not limited to, the cost of precliQ.ical and clinical studies ( whether conducted internally or by a Third Party, individual investigators or consultants ), toxicological, pharmacokinetic, metabolic, analytical, formulation, and chemical studies, final product scale - up, and qualification and validation batches as 4 required for Pre - Approval Inspection by FDA for the purpose of obtaining Regulatory Approval of a Collaboration Product in the ProfitlLoss Sharing Territory, and costs ( and related fees ) for preparing, submitting, reviewing or developing data or infonnation for the purpose of submission to a governmental authority to obtain and/or maintain Regulatory Approval of a Collaboration Product in the Profit / Loss Sharing Territory