definiens: shall mean ( x ) for a nonmarketed -29- 30 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 pathoph ysiologically related to an event listed in the labelling but differs from the event because of increased frequency or greater severity or specificity . Each Party further shall immediately notify the other of any information received regarding any threaten ed or pending action by an agency which may affect the safety and efficacy claims of a 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 government agency or take other action that it deems to be appropriate or required by applicable law or regulation