definiens: shall mean the internal costs and direct out - of - pocket costs that are paid or incurred by aParty or any of its Affiliates that are directly attributable or reasonably allocable to the conduct of the Collaboration Trials, but only to the extent consistent with each Collaboration Trial Protocol and the Collaboration Budget . CollaborationExpenses shall be determined and charged as provided in Article 7 . No allocation for management, overhead, supply of IdenixCompound, 435 Compound or 055 Compound, or Third Party License Payments due on either the Idenix Compound or the435 Compound or 055 Compound, to the extent such Third Party License Payments exist, shall be included in CollaborationExpenses . Subject to the foregoing, Collaboration Expenses shall include : ( a ) the FTE Costs and direct out - of - pocket costsincurred in connection with the planning, conduct, statistical analysis and reporting of the Collaboration Trials, including thecost of Collaboration Trial subject recruitment initiatives ; and ( b ) the FTE Costs and direct out - of - pocket costs incurred inconnection with regulatory activities in support of the Collaboration Trials, including filing, maintenance and other feesincurred to Regulatory Authorities, preparation and, in the case of Idenix, assistance as necessary with the preparation ofCollaboration Trial Regulatory Documentation, and regulatory submissions for, and the obtaining and maintenance ofINDs ( if applicable ), including compliance with ongoing reporting requirements of such Regulatory Authorities and adverseevent recordation . For the avoidance of doubt, Collaboration Expenses shall not include expenses incurred as described inArticle 4 ( regarding Manufacturing and supply ), Article 6 ( regarding intellectual property ) or Section 7.3 ( regarding licensesto Third Party Patents )