definiens: means ( a ) the delivered cost to [COMPANY] of an ANDA Product for use or sale in the Territory if a Third Party is the manufactur er of such ANDA Product, or ( b ) where [COMPANY] is itse lf the manufacturer, the sum of Materials Costs, labor cos ts, Overhead and Freight And Taxes incurred by Impa x to produce such ANDA Product for use or sale in the Te rritory, including the costs of rejected or failed batches of such ANDA Product . As used herein, means [COMPANY] ’s procurement costs for ( i ) raw materia ls ( both active and inactive ingredients ), and ( ii ) pa ckaging, labeling and storing materials, incurred i n connection with the manufacture, testing, labeling, purchasing and distribution of such ANDA Product ; means all indirect costs of manufacturing such ANDA Produ ct including, without limitation, insurance, inspec tion, testing, quality control and quality assurance, dep reciation, maintenance and repair costs, all as det ermined in accordance with the U.S. GAAP, and means all insurance, freight and shipping charges, import taxes and duties and similar taxes and dutie s levied by the United States or other government e ntity with jurisdiction, and port and loading charges, all to the extent not already deducted under Distribution and Sales Costs