definiens: ) . ( b ) Cost of Goods . means the actual fully - burdened cost of Compound, Non - Commercial Product ( including placebo ) and/or Comme rcial Product shipped . As used herein, the cost of Compound, Non - Commercial Product ( including placebo ) and/or Commercial Product means ( i ) in the case o f products, materials ( including, but not limited to, poloxamer CRL1005 ), reagents and services acquired from Third Parties for use in connection with Manufactur ing and/or supplying Compound, Non - Commercial Produ ct and/or Commercial Product, payments made to such Th ird Parties, and ( ii ) in the case of Manufacturing and supply services performed by [COMPANY] or its Affiliate, the actual unit costs of Manufacture in bulk form or final Manufacturing ( including the costs of any Packaging purchased by [COMPANY], but excluding any costs of Pac kaging and Labeling purchased and provided by [COMPANY] pur suant to Section 7.3, if any, and any costs for whi ch [COMPANY] is reimbursed pursuant to Section 5.2(c ) ), as the c ase may be, plus the variances and other costs spec ifically provided for herein . Actual unit costs shall consis t of direct material and direct labor costs, plus m anufacturing overhead reasonably allocable to such Manufacturing and supply services, of [COMPANY] or its Affiliate, in each case in accordance with reasonable cost accounting metho ds, consistently applied . Direct material costs sha ll include the costs incurred in purchasing materials, includi ng sales and excise taxes imposed thereon and custo ms duty and charges levied by Regulatory Authorities, and a ll costs of packaging components . Direct labor shal l include all actual FTE costs of employees and contractors e ngaged in direct Manufacturing or supply activities and direct quality control and quality assurance activities wh o are directly employed in Manufacturing and supply services