definiens: shall mean an adverse event in the market for the Product outside the reasonable control of Prometheus, including the ( i ) marketing in the Territory of an alternative formulation of the Substance approved by the FDA in accordance with the FD&C Act Section 505(b)(2 ), ( ii ) sale in the Territory of no n - negligible quantities of the Product illegally i m ported from outside the Territory, ( iii ) occurrence of adv erse publicity ( or * * * Certain information on this page has been omitte d and filed separately with the Securities and Exch ange Commission . Confidential treatment has been request ed with respect to the omitted portions . 45 publication or release of adverse information by th e FDA or [COMPANY] ) related to the safety or efficacy of the Product, and/or ( iv ) any regulat ion by a Governmental Authority or other change in Law adversely affecting the Product