definiens: means, with respect to a particular Separate Indication, the actual and direct costsand expenses reasonably incurred by Onyx and its 10 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separatelywith the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended . Affiliates or for its account, as calculated in accordance with United States generally accepted accounting principlesconsistently applied, that are specifically identifiable or reasonably and consistently allocable to the development of theProduct for such Separate Indication, that are directed to obtaining Drug Approval from the FDA or EMA of the ApprovedProduct for such Separate Indication and that are reasonably commensurate in scope with the Separate Development Programundertaken by Onyx . The Separate Development Costs shall include amounts, without mark - up, that Onyx pays to ThirdParties involved in the conduct of the applicable Separate Development Program, and the internal costs incurred by Onyx andcosts of [COMPANY] for services requested by Onyx in connection with such Separate Development Program . Separate DevelopmentCosts include : ( a ) pre - clinical costs, such as costs for toxicology, pharmacokinetics, pharmacological studies specificallydirected to the Separate Indication ; ( b ) costs of clinical trials of the Product for the Separate Indication, including ethicscommittee fees, investigators ’ fees, investigators ’ meeting costs, hospital fees, fees for clinical research organizations ’ services;(c ) costs of manufacturing or procuring the Product, comparators and placebos, as applicable, for use in development activitiesdirected toward the Separate Indication, as well as the direct costs and expenses of disposal of drugs and other supplies used insuch Separate Development Program ; ( d ) regulatory expenses, including FDA and EMA filing fees, relating to developmentactivities for the purpose of obtaining Drug Approval by the FDA or EMA of the Product for the Separate Indication ; and(e ) other costs and expenses that meet the criteria set forth above . Separate Development Costs shall specifically exclude ( i ) [ * ] and ( ii ) [ * ] . In calculating the Separate Development Costs, Onyx ’s FTE efforts shall be calculated based upon Onyx ’s actualcosts for such FTEs