External Factor

External Factor. Means the occurrence of one or more of the following with respect to a Licensed Product; provided that such occurrence was not caused by any negligence, misconduct, violation of applicable laws, or failure to act by Licensee: (a) any change imposed by a regulatory agency which is new or unanticipated and requires Licensee's compliance; (b) the primary endpoint in any clinical study is not achieved; (c) adverse changes occur in applicable laws relating to the development or marketing of the... Licensed Product; or (d) an event of force majeure occurs as set forth in Section 15.12. View More