definiens: shall mean the costs and expenses incurred by or on behalf of a Party or itsAffiliates in connection with the Development of Licensed Compounds or Licensed Products in the Field, includingwithout limitation ( a ) costs of each Party ’s or its Affiliates ’ employees supporting such efforts ( calculated as the FTECosts ), ( b ) all out - of - pocket costs of procuring services, products or materials used in the Development of LicensedCompounds or Licensed Products in the Field, ( c ) any amounts paid to clinical research organizations or other ThirdParties engaged to conduct Development activities and ( d ) amounts paid to Third Party contractors to supplyLicensed Compounds or Licensed Products for Development . shall include without limitation allcosts of toxicological, pharmacokinetic, metabolical studies, Clinical Trials, the preparation, collation and/or validationof data from such studies and the preparation of medical writing and publishing, which include expenses for datamanagement, statistical designs and studies, document preparation, and other administrative expenses associatedwith the clinical testing program or post - marketing studies required or necessary to maintain product approvals, development of quality assurance and quality control procedures and protocols, formulation development and othernonclinical and preclinical studies for Licensed Compounds or Licensed Products . For the avoidance of doubt, shall not include any costs of procuring capital equipment used in Development