VIVUS,INC. (NASDAQ:VVUS) Files An 8-K Entry into a Material Definitive Agreement

ME Staff 8-k
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VIVUS,INC. (NASDAQ:VVUS) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry into a Material Definitive Agreement

On June29, 2017, VIVUS,Inc., or the Company, entered into a Settlement Agreement and a License Agreement with Actavis Laboratoris FL,Inc., or Actavis. The Settlement Agreement resolves the action for patent infringement brought by the Company in the U.S. District Court for the District of New Jersey (Civil Action No.14-3786 (SRC)(CLW)(consolidated)) in response to Actavis’ filing of an Abbreivated New Drug Application, or ANDA, seeking to market and sell generic versions of Qsymia® (phentermine and topiramate extended-release) capsules CIV prior to the expiration of U.S. Patents 7,056,890; 7,553,818; 7,659,256; 7,674,776; 8,580,298; 8,580,299; 8,895,057; 8,895,058; 9,011,905; and 9,011,906, collectively referred to as the Asserted Patents. Under the License Agreement, Actavis was granted a non-exclusive license to manufacture and sell generic versions of Qsymia described in its ANDA filing in the United States as of the date that is the earlier of December1, 2024 or the date determined by certain triggering events. Additionally, VIVUS will receive royalty payments on the sale of the generic versions of Qsymia should Actavis be entitled to sell them prior to December1, 2024. 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 (including the License Agreement) will be submitted to the U.S. Federal Trade Commission and U.S. Department of Justice.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits.

ExhibitNo.

Description

99.1

Press Release issued by VIVUS,Inc. dated July5, 2017.


VIVUS INC Exhibit
EX-99.1 2 a17-16884_1ex99d1.htm EX-99.1 Exhibit 99.1     VIVUS Announces Settlement with Actavis on Qsymia® Patent Litigation   CAMPBELL,…
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About VIVUS,INC. (NASDAQ:VVUS)

VIVUS, Inc. is a biopharmaceutical company. The Company operates in the development and commercialization of therapeutic products segment. It provides over two therapies approved by the Food and Drug Association (FDA), which include Qsymia (phentermine and topiramate extended-release) for chronic weight management and STENDRA (avanafil) for erectile dysfunction (ED). The Company has completed the Phase II studies of Qsymia for the indication of Obstructive Sleep Apnea (OSA) and diabetes. Its Qsymia is available in over 40,000 certified retail pharmacies across the country. Its STENDRA is also approved by the European Commission (EC), under the name, SPEDRA, for the treatment of ED in the Europe. The United States Food and Drug Association approved a Supplemental New Drug Application (sNDA) for STENDRA. STENDRA is indicated to be taken approximately 15 minutes before sexual activity.