Item 1.01. Entry into a Material Definitive Agreement.
Manufacturing and Supply Agreement
On November 18, 2013, VIVUS, Inc., or VIVUS, entered into a Manufacturing and Supply Agreement, or the Agreement, effective as of September 1, 2013 with Sanofi Winthrop Industrie, or Sanofi Winthrop, a wholly owned subsidiary of Sanofi. Under the terms of the Agreement, Sanofi Winthrop will manufacture and supply the tablets for VIVUS’ drug avanafil on an exclusive basis in the United States and other territories and on a semi-exclusive basis in Europe, Latin America and other territories. Beginning in 2015, VIVUS must purchase a minimum quantity of tablets each year for its drug avanafil from Sanofi Winthrop.
The Agreement has an initial term commencing on September 1, 2013 and continuing for a period of five years after the date of the first commercial sale, and the Agreement will auto-renew for additional two year periods unless either party makes a timely election not to renew. Either party may terminate the Agreement for the other party’s uncured material breach or bankruptcy or in the event of a persistent force majeure event. In addition, the parties may mutually agree to terminate the Agreement if (i) Sanofi Winthrop is unable to manufacture and deliver the required number of validation batches meeting the specifications within the time period specified in the technology transfer master plan, or (ii) registration of Sanofi Winthrop as the manufacturer and supplier for the tablets for VIVUS’ drug avanafil fails.
As previously reported on Form 8-K, on July 31, 2013, VIVUS entered into a Commercial Supply Agreement with Sanofi Chimie, a wholly owned subsidiary of Sanofi, pursuant to which Sanofi Chimie will manufacture and supply the active pharmaceutical ingredient for VIVUS’ drug avanafil.
