definiens: means, with respect to any experience or reaction, one which is fatal or life threatening, results in persistent or signi ﬁcant 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 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 . The roles and responsibilities of each Party in respect of ADE ’s shall be speci ﬁed in the Technical Agreement attached as Schedule E. Cipher shall provide to Distributor for its review and comment and draft of any periodic safety update reports that it prepares for the Product Marketed outside the Territory and intends to submit to the Regulatory Authority . Cipher will incorporate Distributor‘s comments to such reports, to the extent reasonable, prior to ﬁling with the Regulatory Authority