definiens: means for all studies or activities performed in accordance with a Clinical DevelopmentPlan for any Product in the Territory, the following : ( a ) All out - of - pocket costs and expenses incurred ( i. e., paid to ThirdParties or accrued therefor ) by the applicable Party or Parties or any of their permitted designees including, without limitation, the costs of clinical trial insurance, ( b ) the costs of internal personnel engaged in the performance of such studies or activities, which costs shall be determined based on FTE costing or such other basis as may be agreed by the Parties, if relevant, and ( c)the costs of Clinical Supplies for such studies or activities, which costs shall include ( i ) the Clinical Supply Price, ( ii ) out - of - pocket costs and expenses incurred in purchasing comparator drug and in packaging comparator drug and/or such Product, asapplicable, shipping Clinical Supplies to centers, or disposal of Clinical Supplies, and ( iii ) actual costs of packaging ClinicalSamples and comparator drug, as applicable, if done by a Party . Notwithstanding the foregoing, Clinical Development Costsshall not include any costs or expenses incurred in connection with manufacturing process development and validation, manufacturing scale - up, stability testing, or quality assurance / quality control development