definiens: means costs and expenses of Manufacturing a New C ollaboration Compound or a Product which is either : ( a ) supplied to a Party by a Third Party ; or ( b ) Manufactured d irectly by a Party or its Affiliate, in each case to the exten t such costs are directly and reasonably allocable to the Development or Commercialization of such New Collab oration Compound or Product in the Territory, as fu rther described below and in accordance with GAAP . Manufa cturing Costs shall be ( i ) included in Commercializ ation Costs as ( A ) Product is sold, ( B ) Product is distri buted as Samples or ( C ) incurred or accrued by the Manufacturing Party in connection with write - offs o f inventory, or ( ii ) Development Costs as such cost s are incurred, as the case may be . In the event that a P arty performs any of its Manufacturing and supply o bligations through one or more Affiliates, any inter - company a mounts or fees paid for any such services or Produc t or any intermediate used therein by such Party shall not b e included in calculating Manufacturing Costs and o nly those costs directly incurred by such Affiliate shall be so included . To the extent that any Manufacturing C osts apply to both the Profit Share Region for a Joint Product and the Royalty Region for a Unilateral Product, s uch costs shall be reasonably allocated between the Profit Sh are Region and the Royalty Region by the JSC based on the market size in the respective regions