definiens: means for all studies or activities performed in a ccordance with [COMPANY] 's Development Plan for any Product in the Territory, including the following : ( a ) all out - of - pocket cost s and expenses incurred ( i.e., paid to Third Parties or a ccrued therefor ) by [COMPANY] or any of its permitte d designees, ( b ) the costs of internal personnel engaged in the performance of such studies or activities, and ( c ) the costs of clinical supplies for such studies or activities, w hich costs shall include ( i ) the clinical supply pr ice, ( ii ) out - of - pocket costs and expenses incurred in purchasing co mparator drug and in packaging comparator drug and/ or such Product, as applicable, shipping clinical supp lies to centers, or disposal of clinical supplies, and ( iii ) actual costs of packaging clinical samples and comparator drug, as applicable, if done by a Party