definiens: means an oral formulation of the Ticagrelor Compo und that is ( a ) sold, offered for sale or distributed under : ( i ) in the U.S., an ANDA ( as defined in the FFDCA ) th at refers to the AstraZeneca Product as the reference listed dru g, ( ii ) in the EU, a marketing authorization for a generic medicinal product granted in accordance with Articl e 10 of Directive 2001/83 / EC or ( iii ) in any other country or jurisdiction, an equivalent of provisions set forth in clause ( i ) or clause ( ii ) and ( b ) approved in t he applicable country or jurisdiction for at least one of the ind ications for which the AstraZeneca Product is appro ved in such country or jurisdiction . For purposes of this defin ition, references to AstraZeneca Product exclude Ge neric Ticagrelor Products