definiens: means any country within the European Union as of the Closing Date, and Norway, Switzerland and Iceland, in which the approval for marketing of a vaccine product [ ( 1 ) is based on the filing with the appropriate government health regulatory authorities a marketing approval application including a copy, summary of, or a reference to, a marketing approval from a non - European country ( not an EMEA approval ), ( 2 ) requires no additional clinical studies, and ( 3 ) for which the marketing approval costs are less than 25,000 Euro . ] 1.18 '' Mastel means the [ Hansenula polymorpha yeast ] strain, designated as [ YU305, ] that exists as master cell banks designated as [ MCBOOl - xx, MCB002 - xx, et seq ., ] and working cell banks designated as [ WCBOOl - xx et seq,, ] as such cell line is described and referred to in the following IND filed with the FDA : [ BB - IND 12692 . ] This strain is referred to between the Parties as the [ ] strain, 1.19 means all granted patents, including utility models and certificates of invention, and reissues, reexaminations, supplementary protection certificates, extensions, and term restorations thereof, and patent applications, including any continuations, continuations - in - parts, divisionals thereof, and the like