definiens: means fixed and variable unreimbursed costs incurred by DEBIOPHARM forits activities regarding the development of the Lead Compound and/or theProduct, calculated in accordance with the Accounting Standards applicableto DEBIOPHARM . Subject to the foregoing sentence, such costs shall include(i ) direct, out - of - pocket external cost, e.g., clinical grants, clinical laboratoryfees, patent and trademark prosecution, maintenance and litigation, and thecost of studies conducted and services provided by contract researchorganizations and individuals, consultants, toxicology contractors, andmanufacturers necessary or useful for the purpose of obtaining a MarketingAuthorization for the Product in any country, ( ii ) amount paid with 5[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT . EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [ * * * ], HAS BEENFILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION . ] respect to the development of the Lead Compound, and/or the Productdirectly relating to pre - clinical and clinical trials, including quality controland quality assurance, ( iii ) costs related to Data management, statisticaldesigns and studies, document preparation and related expenses associatedwith the clinical testing program for a Lead Compound and/or the Product, and ( iv ) cost of labor, raw materials, supplies and other resources directlyconsumed in the conduct of the research, development and manufacture of theLead Compound and/or Product for use in preclinical and clinical trials