definiens: means the aggregate amount of costs incuned by [COMPANY] in development of MTI03, including Commercial Process development and regulatOlY filing costs, as determined in a reasonable manner consistent with [COMPANY] 's normal internal cost accounting practices and in accordance with generally accepted accounting principles, consisting o. _ .1 ' . : .. ( i!'fe ~ t, labor, ( salaIies " wages . a ~ d employee benefit~ ( ii)ji:~]eria.l .... S ........ an.d . supplies ; ( mcludmg Chmcal Tnal Matenal ) used m research and developme!S ( lll){i;verhead charges ; ~t.t . ".~.'bU.ta ... ble .. ~o, developme .. nt . _ ( but excludin, g any C ? .... rp .. orate administra ~ iv, e expens~ .. in ~ luding Il ~ cated bmldmi and 6ql;J1pment operating costs ; allocated depreClatIoj ' and Cifepan"i/ and giaintenan<1, ( iv)tf}ay ~ ents made to a Third Party for services in connection with research and developmenj 1.15 means the development plan for a Licensed Product, as approved pursuant to Section 2 and as may be amended pursuant to the tenns of this Agreement 1.16 means the European Medicines Evaluation Agency and any successor agency thereof 1.17 means the United States Food and Drug Administration and any successor agency thereof 1.18 means the equivalent of a total ofll - l ~ J ) hour ~ er year of scientific or technical work on or directly related to the execution or implementation of a Research Plan or a Development Plan or other tasks to be performed under this Agreement, canied out by a qualified employee of a Party, except to the extent included inmJi1ty .,;Burdened ManufactuIinq Costs, Scientific or technical work includes performing research, experimental laboratory work, developing manufacturing processes for Licensed Product, conducting pre - clinical and clinical development of Licensed Product, recording and writing up results, reviewing literature and references, holding scientific discussions, and attending conferences in the relevant field