definiens: means ( a ) the development of an undesirable medic al condition or the deterioration of a pre - existing medical condition i n a patient or clinical investigation subject durin g or following exposure to or use of a Licensed Product, whether or not considered causally related to such Licensed Product, ( b ) the exacerbation in a patient or clinical investigation subject of any pre - exist ing condition occurring during or following exposure to or use of a Licensed Product, or ( c ) any other adv erse experience or adverse drug experience ( as described in the FDA ’s Investigational New Drug safety reporting and NDA post - marketing reporting regulati ons, 21 C.F.R. § § 312.32 and 314.80, respectively, and any applicable corresponding regulations outsid e the United States, in each case as may be amended from time to time ), of a patient or clinical invest igation subject occurring during or following expos ure to or Portions of this Exhibit, indicated by the mark were omitted and have been filed separately w ith the Securities and Exchange Commission pursuant to the Registrant ’s application requesting confidential tr eatment pursuant to Rule 24b-2 of the Securities Exchange A ct of 1934, as amended