definiens: shall mean the fully allocated cost to manufacture PRODUCT determined in a reasonable manner cons istent with MEDIMMUNE 's normal internal accounting practices and in ac cordance with generally accepted accounting principles ( ) which includes but is not limited to : ( i ) direct labor ( salaries, wages and employee benefits ) ; ( ii ) direct materials ; ( iii ) operating costs o f building and equipment used in connection with the manufacture of PRO DUCT, ( iv ) allocated depreciation and repairs and maintenance ; ( v ) quality and in - process control ; ( vi ) an allocation of overhead costs incurred in connection with the manufacturing of PRODUCT, including : raw material supply and manufacturing administration and management ; m aterials management, storage and handling ; and manufacturing and em ployee training ; ( vii ) any charges for obsolescence, out of dat e product, spoilage, scrap or rework costs ; and ( viii ) the cost of packaging and labeling, if applicable