definiens: means ( i ) expenses relatod to Clinical Trill planning, materials, clinical sile reeMting, training and pll1icipatioll, monitoring of clinical sites, dal : a analysis and data quality aswrancc, preparing documents for initial Ii Uingx for Regulal(l(1 Authorily SllbmiS$ion ( including . but 001 limited to, & II fees paid to clinicli investigators and patients ) ; ( ii ) expenses related to planning . managing, carrying out, an.a.Iyt.lns and preparing rcPQrU of pre - clinicailtudics ncccs ~ ary to submit as part of initial regulatory marketing application s ; ( iii ) travel expenscs related 10 planning meetings, clinical development or regulatory 5ubmissio!l5 ; lind ( iv ) a reasonable allocation of eacb of overhead associated with the conduct of.ruch activities md general Blld aliministrnli'o!e ell : penses . shall not include any othcrcosts incWTed to conduct ~ucll trials outliide oCthe Development PIM refam : ! to in Exhibit A. The geDCnJ and ~inistrlllive expense ~ponenl referred to in eilUse ( iv ) ofmi ! definition shall not CJ[cced c : venty - five percent ( 25~ of the total of all expenses relating to a Clinical Tri ; ; !