definiens: shall mean ( 3 . ) for a nonmarketed Product, an experience that is not identiﬁed in nature, smrity or frequency in the current clinical investigamr ’s conﬁdential informati ﬂn tChuI'e, and ( y ) for a marketed product, an event which is not listed in the current labeling fur such mod act, and Malaria ; an event than may he symptomatically and pamophysiolugically related to an experience listed in the labeling but differs [ mm the event because of increased frequency or greater severity or speci ﬁcity . Each party further shall immediately notify the other part } ! ofan } ; information received regarding any thmalcncd or pending action : by an agency that may affect the safety and cﬁicacy claims ﬁfth - E Pro - duct . Upon receipt of any such information, the parties shall consult with each other in an cffort to arrive at a mutually acceptable procedure for taking appropriate action ; provided, however . that nothing contained herein shall restrict either party ’s right 10 make a timely report of such matter In any government agency or take other action that it deems to be appropriate or required by applicable law, regulation a ? court order