definiens: shall mean agents injected in the cardiovascular system which satisfy both of the following two criteria : ( i ) with respect to any Region : ( a ) the agent has an approved indication for magnetic resonance angiography ; or ( b)~he agent does not have an approveo lnolcatlon tor magnetic reSonance angiography, buteither ( A ) at least thirty percent ( 30 % ) of the units sold in any calendar year are for use in magnetic resonance angiography procedures ; or ( B ) the agent has achieved a market share of at least ten percent ( 10 % ) of all magnetic resonance angiography procedures ; in the case of both ( A ) and ( B ), as determined by reference to Arlington Medical Resources for the United States, and by reference to a mutually agreed upon source for markets outside of the United States ; and ( ii ) the agent possesses some molecular feature ( e.g., plasma protein binding, large molecular size, or unique reduction in renal elimination ) which, as compared to Magnevist, ( x ) increases the MRI signal of blood, and/or ( y ) lengthens the distribution half - life into the interstitiuml The types of agents include, but are not limited to, albumin­binding agents, iron partlcles, or polymeric / cascade molecules with attached chelates