definiens: shall mean all direct and indirect expenses incurred which shall be allocated in a fair and equitable manner in conformance with United States generally accepted accounting principles [ ], consistently applied with those established with respect to other products, and shall include : ( a ) the arms - length transfer price to [COMPANY] for Compounds and clinical supplies manufactured by a third party including [COMPANY] 's expenses incurred in connection with such third party manufacture ; such [COMPANY] expenses include, but are not limited to, those relating to existing or acquired equipment ( current procedures for such equipment allocations shall be provided within thirty ( 30 ) days ofthe Effective Date and upon any amendment of such procedures thereafter ), technology transfer, scale - up, validation, quality control and quality assurance testing, stability testing, storage, regulatory filings, shipping and import / export servIces ; ( b ) all expenses for Compounds and clinical supplies inanufactured by [COMPANY] including, but not limited to, existing and acquired equipment ( current procedures for such equipment allocations shall be provided within thirty ( 30 ) days of the Effective Date and upon any amendment of such procedures thereafter ), technology transfer, scale - up, validation, quality control and qua : lity assurance testing, stability testing, storage, regulatory filings, shipping and import / export services ; and ( c ) all incremental expenses incurred by or op . behalf of Cephalonin the US Program at the written request of Schwarz Pharma which are not otherwise required for regulatory or commercial purposes under the US Program but which specifically support Schwarz Pharma 's CEPHALON - SCHW ARZ PHARMA AGREEMENT 2 Development Program