definiens: shall mean an experienc e which ( a ) results in the death, a persistent or s ignificant incapacity or substantial disruption of the ability to conduct normal life functions, in - patient hospi talization or prolongation of hospitalization, or ( b ) is a congen ital anomaly, the result of an overdose or life thr eatening ( only if unrelated to primary disease ) ; and shall mean ( x ) for a nonmarketed Product, an experi ence 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 event which is not listed in the current labeling for suc h product, and includes an event that may be symptomatically a nd pathophysiologically related to an experience li sted in the labeling but differs from the event because of increased frequency or greater severity or specific ity . Each party further shall immediately notify the other pa rty of any information received regarding any threa tened or pending action by an agency that may affect the saf ety and efficacy claims of the Product . Upon receip t of any such information, the parties shall consult with ea ch other in an effort to arrive at a mutually accep table procedure for taking appropriate action ; provided, however, that nothing contained herein shall restri ct either party ’s right to make a timely report of such matte r to any government agency or take other action tha t it deems to be appropriate or required by applicable law, re gulation or court order . Each party shall take all reasonable steps to protect the confidentiality of any patient health and medical information that it has access to and to comply with applicable state and federal privacy la ws, as such laws apply to such party