definiens: means ( a ) FTE Costs and other costs actually incur red by Hutchison or its Affiliates or [COMPANY] or its Affiliates, as appli cable ( such Party or Affiliate, the for the purposes of this Article 1.22 ), that are ( i ) specif ically identifiable or allocable to Development of a Product, ( ii ) reasonably incurred by the Incurring Party and ( iii ) that result from activities specifically ass igned to the Incurring Party in accordance with this Agreement o r the applicable Development Plan ; provided that no costs incurred by [COMPANY] or its Affiliates shall be deemed Development Costs unless such costs are incurred i n Subsequent Development and are approved in advance by the JSC and ( b ) the COGS of the clinical supply of Product for Phase II / III clinical trials and Phase III clinical trials, such COGS to be Subsequent Dev elopment Costs