definiens: means all Development costs [ * * * ] that are directly related and reasonably allocableto Development of Cancer Product [ * * * ] for the purposes of seeking Regulatory Approval of a Co - Developed Product [ * * * ] and incurred [ * * * ], and, to the extent meeting the foregoing criteria, including the following to the extent the activitiesdescribed below were not previously conducted in connection with the Development of the Licensed Product:(a ) the FTE and direct out - of - pocket costs incurred in connection with the planning and conduct of Clinical Trials;(b ) [ * * * ] ; ( c ) development of the manufacturing process for such Cancer Product and any components thereof ( [ * * * ] ), as wellas, to the extent not included in the Manufacturing Cost of [ * * * ] Cancer Product used in Clinical Trials, [ * * * ], and [ * * * ] ofpermitted Third Party contract manufacturers;(d ) Manufacturing Costs for ( i ) Cancer Product for use in Clinical Trials and [ * * * ] in support thereof and ( ii ) themanufacture, purchase or packaging of comparators or placebo for use in Clinical Trials ( with the manufacturing costs forcomparators or placebo to be determined in the same manner as Manufacturing Costs are determined for such Cancer Product),as well as the direct costs and expenses of disposal of drugs and other supplies used in such Clinical Trials [ * * * ] ; ( e ) [ * * * ] arising out of Development activities for the Cancer Product [ * * * ] and for which [ * * * ] ; ( f ) recruitment initiatives for Clinical Trials ; and(g ) conducting advisory board meetings or other consultant programs, the purpose of which is to obtain advice andfeedback related to the Development of a Cancer Product [ * * * ]