definiens: means an Abbreviated New Drug Application, as defined in the United States Food, Drug and . Cosmetic Act, as amended, and applicable PDA rules and regulations . 1.6 means the actual net price paid per kilo by CIMA to its .t\ctive Ingredient supplier ( the ) plus 11.11 % of the AI Price ( to reflect a ninety percent ( 90 % ) price yield factor ), plus 10 % of the AI Price ( to cover all related expenses " including handling and testing ) . the sum of Which is divided by 100,000 ( to reflect lOmg Active Ingredient per tablet ) . For example, assuming CJMA 's cost of Active Ingredient is $ 3000 . the API Per Tablet Cost would be $ 0.0363 « $ 3000 + 333.33 + $ 300 = $ 3,633.33 ) + 100,000 = $ 0.0363 ) per tablet, 1.7 means CIMA 's manufacturing costs for Finished Product based on a four hundred twenty ( 420 ) kilogram batch size comprised of raw materials ( including packaging, but excluding Active Ingredient ), direct labor, and overhead costs allocable to such Finished Product, ' as determined in accordance with United States generally accepted accounting practices consistently applied