definiens: means [COMPANY] ’s fully - loaded costs related to the Development of ( andobtaining Regulatory Approval from the EMA for ) the Licensed Product, excluding Patent Costs, and including any ( a)direct, out - of - pocket costs and expenses, including clinical or medical grants, clinical laboratory fees, positivecontrols and the cost of pre - clinical and clinical studies conducted and services provided by contract researchorganizations, and ( b ) the conduct of clinical studies, including costs and expenses associated with datamanagement, statistical designs and studies, document preparation and any and all other costs and expensesassociated with preparing and submitting regulatory filings, obtaining ( including, solely with respect to approvalsgranted upon specific conditions requiring the conduct of specified additional required studies to maintain suchgranted Regulatory Approval, maintaining ) Regulatory Approval for the Licensed Product, and the conduct of theclinical Development program for the Licensed Product, including as set out in the Development Plan [ * * * ]