HEXVIX PRODUCT

HEXVIX PRODUCT. Means the pharmaceutical formulation containing [C.I.] substantially in the form approved by the Swedish Medical Products Agency (Lakemedelsverket) (as the reference member state under the European Union mutual recognition procedure) under marketing authorization number 19227 as of the Effective Date for sale in European Union under the trademark "HEXVIX," including any supplements to such approvals changing the manufacturer of (a) such formulation or (b) any component thereof.