definiens: means : [ ( i ) if API is manufactured by [COMPANY], the direct labor and materials costs plus the overhead reasonably allocable to the manufacture of Active Pharmaceutical Ingredient calculated in line with u.s . GAAP consistently applied on the basis of a unit consisting of 1.58 mg of API, or ( ii ) if API is purchased by [COMPANY] from a Third Party, at the price charged to [COMPANY] by a Third Party contract manufacturer for the manufacture and supply of API, FCA ( Incoterms 2000 ), Biochemie, Kundl, Austria ( the ), plus [COMPANY] ' overhead reasonably allocable to quality assurance and quality control of that API ( including required release testing ) as more fully described in the Quality Agreement, calculated in line with U.S. GAAP consistently applied, which overhead shall not exceed 50 percent of the Basic Cost . Cost of Goods shall be subject to audit by [COMPANY] as provided in Section 10.8(b ), below . ] 1.9 means : ( a ) all activities relating to obtaining and/or maintaining Regulatory Approval of the Original Product in the Territory with an Acceptable Label including, without limitation, clinical trials and the preparation, submission, review and development of data or other information related thereto ( ) ; ( b ) Phase IV clinical trials supporting pre - launch and commercialization of the Product but not contributing to obtaining and/or maintaining Marketing Authorization Applications of the Original Product and any New Product in the Territory, and excluding the Health Outcomes Study ( ) ; ( c ) all activities relating to obtaining and/or maintaining Marketing Authorization of a New Product in the Territory, including Phase III clinical trials and the preparation, submission, review and development of data or other information related thereto but excluding pre - clinical, Phase I and Phase II clinical development ( ) ; and ( d ) design and conduct of the Health Outcomes Study