definiens: means, 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 is another important Wt -13- 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 . Distributor acknowledges that it must promptly inform Cipher of all ADE ’s of which Distributor is notiﬁed or of which it otherwise becomes aware so that Cipher may fulﬁll its obligations under Section 4.1(a ) for ADE reporting to the Regulatory Authority within the time limits required by applicable Law . The roles and responsibilities of each Party in respect of ADE ’s shall be specified in the Technical Agreement attached as Schedule E. Cipher shall provide to Distributor a copy of any periodic safety update reports that are prepared for the Product by it and are submitted to the Regulatory Authority