definiens: means all specifications, methods ; applications, criteria, qualities ; requirements and all other infonnation in connection with the use, handling, distribution, marketing andlor sale of the Product published, promulgated or conveyed by or on behalf of ANESIV A to LPL in any manner whatsoever, including any manual, speciilcation booklet, letter, notice, memorandum or other written from, from time to time, 1.26 . shall mean any adverse experience that result in any of the following outcomes : death ) a life - threatening experience . inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, or a congenital anomalylbirth defect . Important medical events that may not result in death, be life -- threatening or require hospitalization may be considered a Serious Adverse Event when, based upon appropriate medical ANESIVA 's Initials { J .. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT . MARKED BY BRACKETS . IS'F'o'V < TrTH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 248.2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED CONFIDENTIAL 724891 vllHN Page 5 of 21 judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition, 127 . · · SFDA " means the Chinese State Food and Drug Administration