definiens: shall mean ( i ) any finding from tests in laborato ry animals or in vitro that suggests a significant risk for human subjects including repor ts of mutagenicity, teratogenicity or carcinogenici ty and ( ii ) any undesirable, untoward or noxious event or experience associated with the clinical, commer cial or other use or occurring following administration, of the Licensed Products in humans, occurring at a ny dose, whether expected or unexpected and whether or not considered related to or caused by the License d Products, including such an event or experience as occurs in the course of the use of the Licensed Pro ducts in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharm acological or biological therapeutic action of the Licensed Products, and including those events or ex periences that are required to be reported to the regulatory authorities, including the European Medi cines Agency and the FDA under the respective applicable laws, subject to Exhibit 4 12 . CONFIDENTIALITY 12.1 All Confidential Information disclosed or provided by e ither Party to the other Party under or in relation to this Agreement shall be held by the receiving Pa rty in strict confidence . Each Party will use the Confidential Information solely for the purposes se t forth in this Agreement . Each Party will take reasonable precautions to maintain the confidential ity of Confidential Information received from the disclosing Party, such precautions to be at least e qual to those taken by the receiving Party in respe ct of its own confidential proprietary information, but i n no event using less than reasonable care . The rec eiving Party shall promptly notify the disclosing Party up on discovery of any use or disclosure of the disclo sing Party ’s Confidential Information in viol ation of this Agreement and shall take all such act ions as are reasonably necessary to mitigate the unauthorized u se or disclosure of the disclosing Party ’s Confiden tial Information