VIVUS,INC. (NASDAQ:VVUS) Files An 8-K Other EventsItem 8.01. Other Events
On January 3, 2017, VIVUS, Inc., or the Company, entered into a Settlement Agreement with Hetero USA, Inc., Hetero Labs Limited Unit III and Hetero Labs Limited, collectively referred to as Hetero. The Settlement Agreement resolves the lawsuit, brought by the Company in the U.S. District Court for the District of New Jersey (Case No. 16-4560 (KSH)(CLW)) on July 27, 2016, in response to Hetero’s filing of an Abbreviated New Drug Application, or ANDA, seeking to market and sell generic versions of the currently approved doses of STENDRA® (avanafil) tablets prior to the expiration of U.S. Patents 6,656,935 and 7,501,409, collectively referred to as the Asserted Patents. Under the Settlement Agreement, Hetero was granted a license to manufacture and commercialize the generic version of STENDRA described in its ANDA filing in the United States as of the date that is the later of (a) 180 days prior to the expiration of the last to expire of the Asserted Patents or (b) the date that Hetero obtains final approval from the FDA of the Hetero ANDA. The Settlement Agreement provides for a full settlement of all claims that were asserted in the suit, subject to the Court’s acceptance of the stipulation of dismissal. As required by law, the Settlement Agreement will be submitted to the U.S. Federal Trade Commission and U.S. Department of Justice.