definiens: shall mean, in every case : ( i ) outside direct costs ( e.g. CMO costs ), ( ii ) internal costs including Allocable Overhead, and ( iii ) the costs to a Party, however denominated, of securing from a Third Party other than BTG intellectual property rights necessary or useful for the implementation of the API Specifications and methods or Final Product Specifications and methods, in each case only to the extent incurred by a Party pursuant to an approved API Development Plan ( and budget ) or Final Product Development Plan ( and budget ), as required to develop and/or obtain the authorization andlor ability to manufacture, formulate or fill a Product in commercial quantities according to either the API Specifications or the Final Product Specifications . shall include, without limitation, the costs of process development, scale - up and recovery ( including plant costs ) and the preparation of related documentation, and shall further include the costs directly associated with the initial qualification lots produced and used for the benefit of both Parties . shall, however, exclude qualification lots produced and used solely for the benefit of one Party, and shall further exclude the cost of material produced and supplied for commercial use . In addition to the foregoing, ' Process Development Costs " shall further exclude costs incurred by either Party either prior to the Effective Date or subsequent to the date on which the final form of API Specifications ( with respect to API ) or the final form of Final Product Specifications ( with respect to Final Product ) have been established by the Parties, or at any time to the extent such costs are not reflected in an approved API Development Plan ( and budget ) or Final Product Development Plan ( and budget )