definiens: means the cost of purchased materials used in the manufacture or packaging ofthe Product, including costs of Raw Materials, excipients, intermediates and laboratory reagents and consumables, and costs of packaging materials, labels and other printed materials used in the production of Product;(b ) means the personnel cost of employees directly employed in themanufacturing, packaging, quality testing or release of the Product, including basic wages, labor and related payrolltaxes and benefits ; and(c ) means:(i ) Depreciation costs or lease / rental for manufacturing buildings and equipment and costs formaintenance and repair of such buildings and equipment . The depreciation costs shall be allocated using anappropriate methodology . Costs of equipment shall be based on a planned utilization of equipment . Facility andequipment depreciation and/or lease / rental shall be allocated to production proportionate to the usage of theManufacturing facility and equipment for the actual Manufacturing of Product ; 2.(ii ) Allocable Overhead, as such term is defined in Exhibit B to the License Agreement;(iii ) Quality assurance activities;(iv ) Interim transportation, or any related transportation cost including tertiary packaging andstorage of Product, as incurred or spent in connection with this Agreement;(v ) Costs of approved Third Party manufacturers ( such costs will include the actual amount paidincluding the benefit of any price reductions, payment or terms discounts or other reimbursements, such as volumediscounts, that may be applicable to such purchases ) ; and(vi ) Subject to Section 6.4, costs associated with changes of the Product Specifications or theManufacturing Process