definiens: shall mean anexperience which ( a ) results in the death, a persistent or significant incapacity or substantial disruption of the ability toconduct normal life functions, in - patient hospitalization or prolongation of hospitalization, or ( b ) is a congenital anomaly, theresult of an overdose or life threatening ( only if unrelated to primary disease ) ; and shall mean ( x ) for anonmarketed Product, an experience that is not identified in nature, severity or frequency in the current clinical investigator’sconfidential information brochure, and ( y ) for a marketed product, an event which is not listed in the current labeling for suchproduct, and includes an event that may be symptomatically and pathophysiologically related to an experience listed in thelabeling but differs from the event because of increased frequency or greater severity or specificity . Each party further shallimmediately notify the other party of any information received regarding any threatened or pending action by an agency thatmay affect the safety and efficacy claims of the Product . Upon receipt of any such information, the parties shall consult witheach other in an effort to arrive at a mutually acceptable procedure for taking appropriate action ; provided, however, thatnothing contained herein shall restrict either party ’s right to make a timely report of such matter to any government agency ortake other action that it deems to be appropriate or required by applicable law, regulation or court order