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

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

As previously reported on Form8-K, on July31, 2013, VIVUS,Inc., or 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, or API, for VIVUS’ drug avanafil. On December7, 2018, VIVUS entered into Amendment N°1 to the Commercial Supply Agreement with Sanofi Chimie, to which certain amendments were made to the Commercial Supply Agreement, which include: (i)beginning January 1, 2019, Sanofi Chimie will manufacture and supply API for VIVUS’ drug avanafil on an exclusive basis in all countries where VIVUS has the right to sell avanafil; (ii)beginning January1, 2019, the yearly minimum quantities of API that VIVUS must purchase from Sanofi Chimie will be adjusted, as well as adjustments to the associated pricing and payment terms; and (iii)with the initial five year term of the Commercial Supply Agreement expiring on December31, 2018, VIVUS and Sanofi Chimie have agreed to extend the term of the Commercial Supply Agreement until December31, 2023 unless either party makes a timely election to terminate the agreement and that thereafter the Commercial Supply Agreement will auto-renew for successive one year terms unless either party makes a timely election not to renew.

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.

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.