definiens: shall mean ( x ) for a non - marketed product, an experience that is not identified in nature, severity or frequency in the current clinical investigator 's confidential information brochure, and ( y ) for a marketed product, an experience which is not listed in the current labeling for such product, and includes an event that may be symptomatically and pathophysiologic ally related to an event listed in the labeling but differs from the event because of increased frequency or greater severity or specificity . Each party shall further notify the other immediately of any information received regarding any threatened or pending action by any regulatory authority which may affect the safety and efficacy claims of the Product . Upon receipt of any such information, the 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 be construed as restricting either party 's right to make a timely report of such matter to any regulatory authority or take other action that it deems to be appropriate or required by applicable law or regulation