definiens: shall mean an eKperience which ( a ) results in the death, permanent or substantial disability~ in - patient hospitalization or prolongation of hospitalization, or ( b ) is a congenital anomaly, cancer, the result of an overdose Of life threatening ( only if unrelated to primary disease ) ; and shall mean ( x ) for a nonmarketed product, an experience that is not identified in nature, severity or frequency in the current clinieal investigator 's confidential infurmation brochure, and ( y ) for a marketed product, an event which is not listed in the current labeling for such product, and includes an event that may be symptomatically and pathopbysiologically related to an experience listed in the labeling but differs from the event because of increased frequency or greater severity or specificity . Each party further shall promptly notify the other party of any information received regarding any threatened or pending action by an agency that may affect the safety and efficacy claims of a Product Upon receipt of any sucb information, tbe parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action ; provided, however, that nothing contained herein shall restrict either party 's right to make a timely report of such matter to any govellUDent agency or take other action that it deems to be appropriate or required by applicable law, regulation or court order