VIVUS,INC. (NASDAQ:VVUS) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry into a Material Definitive Agreement.
The information contained in Item 1.02 below is hereby
incorporated by reference.
Item1.02. Termination of a Material Definitive
On December11, 2013, VIVUS,Inc., or VIVUS or the Company, entered
into a license and commercialization agreement, or the License
Agreement, with Sanofi, and a supply agreement, or the Supply
Agreement, with Sanofi Winthrop Industrie, a wholly owned
subsidiary of Sanofi. The Supply Agreement terminated in
accordance with its terms on June30, 2015. On March23, 2017, the
Company and Sanofi entered into the Termination, Rights Reversion
and Transition Services Agreement, or the Transition Agreement,
effective February28, 2017. Under the Transition Agreement,
effective upon the thirtieth (30th) day following February28,
2017, the License Agreement will terminate for all countries in
the Sanofi Territory (as defined below) as a termination by
Sanofi for convenience notwithstanding any notice requirements
contained in the License Agreement. In addition, under the
Transition Agreement, Sanofi will provide the Company with
certain transition services in support of ongoing regulatory
approval efforts while the Company seeks to obtain a new
commercial partner or partners for the Sanofi Territory. The
Company will pay certain transition service fees to Sanofi as
part of the Transition Agreement.
Under the terms of the License Agreement, Sanofi received an
exclusive license to commercialize and promote VIVUS drug
avanafil for therapeutic use in humans in Africa, the Middle
East, Turkey and the Commonwealth of Independent States,
including Russia, or the Sanofi Territory. Under the terms of the
Supply Agreement, VIVUS agreed to supply Sanofi Winthrop
Industrie with avanafil tablets until June30, 2015, or in the
event the obligations of Mitsubishi Tanabe Pharma Corporation, or
MTPC, to supply avanafil tablets to VIVUS were amended to extend
beyond June30, 2015 then until the expiration of the MTPC supply
obligations as amended.
As previously reported on Form8-K, on July31, 2013, VIVUS entered
into a Commercial Supply Agreement with Sanofi Chimie, a wholly
owned subsidiary of Sanofi, to which Sanofi Chimie will
manufacture and supply the active pharmaceutical ingredient for
VIVUS drug avanafil. Further, as previously reported on Form8-K,
on November18, 2013, VIVUS entered into a Manufacturing and
Supply Agreement with Sanofi Winthrop Industrie, a wholly owned
subsidiary of Sanofi, to which Sanofi Winthrop Industrie will
manufacture and supply the tablets for VIVUS drug avanafil. The
Transition Agreement does not affect the terms of these
manufacturing and supply agreements.
Certain statements in this Current Report on Form8-K are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as anticipate, believe,
forecast, estimate, expect, intend, likely, may, plan, potential,
predict, opportunity and should, among others. There are a number
of factors that could cause actual events to differ materially
from those indicated by such forward-looking statements. The
Company does not undertake an obligation to update or revise any
forward-looking statements. Investors should read the risk
factors set forth in the Companys Form10-K for the year ended
December31, 2016 as filed on March8, 2017, and periodic reports
filed with the Securities and Exchange Commission.
Item 7.01. Regulation FD
In a press release issued on March27, 2017, VIVUS announced the
termination of the License Agreement with Sanofi and the entry
into the Transition Agreement with Sanofi. A copy of the press
release is attached hereto as Exhibit99.1 and is incorporated
herein by reference.
The information in Item 7.01 of this Form8-K and the exhibit
attached hereto shall not be deemed filed for purposes of
Section18 of the Securities Exchange Act of 1934, as amended (the
Exchange Act), or otherwise subject to the liabilities of that
Section, or incorporated by reference into any of the Companys
filings under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific
reference in any such filing.
Item9.01. Financial Statements and
Press Release issued by VIVUS,Inc. dated March27, 2017.
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. VIVUS, INC. (NASDAQ:VVUS) Recent Trading Information
VIVUS, INC. (NASDAQ:VVUS) closed its last trading session 00.00 at 1.10 with 181,208 shares trading hands.