definiens: shall mean, with respect to any experience or reaction, one which is fatal or life threatening, results in persistent or significant disability, requires inpatient hospitalization or prolongation of existing inpatient hospitalization, is a congenital anomaly, cancer, or the result of an overdose, or EXECUTION COpy \\\8A·6304810001 • 164791 v3 Exhibit 2.02 Unredacted Version with redactions highlighted is another important medical event ( even if not life - threatening, resulting in death, or requiring hospitalization ) if, based upon appropriate medical judgments, such medical event may jeopardize the patient 's or subject 's health or may require medical or surgical intervention to prevent one of the other outcomes listed previously ; and shall mean, with respect to any condition or development, one which is not listed in the then - current FDA - approved labeling for the Supplied Products, and includes those experiences or reactions that show a significant increase in incidence or severity over what appears on the labeling for the Supplied Products, or in NDA trials, or that reflect or suggest a failure of the Supplied Products to achieve claimed activity