definiens: means with respect to a given Calendar Year with respect to an Agreement Product inany country, that during such Calendar Year, * * * have received Regulatory Approval to sell in such country aBiosimilar Biologic Product, such Biosimilar Biologic Product shall be commercially available in suchcountry and such Biosimilar Biologic Product shall have, in the aggregate, * * * or more market share of theaggregate of such Agreement Product and Biosimilar Biologic Product ( based on data provided by IMSInternational, or if such data is not available, such other reliable data source as reasonably determined byPfizer and agreed by [COMPANY] ( such agreement not to be unreasonably withheld ) ) as measured by sales . Inthe event IMS International data ( or such other agreed data source ) is not sufficient to determine thepercentage market share for each country in the EU, the percent market share for the EU countries for whichdata is not available will be deemed to be the average percent market share for those EU countries in whichthe data is available . A product shall be a with respect to an AgreementProduct if such product ( 1 ) has been licensed as a biosimilar or interchangeable product by FDA pursuant toSection 351(k ) of the Public Health Service Act ( 42 U.S.C. 262(k ) ), as may be amended, or any subsequent orsuperseding law, stature or regulation, ( 2 ) has been licensed as a similar biological medicinal product byEMEA pursuant to Directive 2001/83 / EC, as may be amended, or any subsequent or superseding law, statureor regulation, or ( 3 ) has otherwise achieved analogous Regulatory Marketing Approval from anotherapplicable Regulatory Authority