Item 1.01. Entry into a Material Definitive Agreement.
License and Commercialization Agreement
On July 5, 2013, VIVUS, Inc. (the “Company”) entered into a license and commercialization agreement (the “License Agreement”) and a supply agreement (the “Supply Agreement”) with the Menarini Group through its subsidiary Berlin-Chemie AG (“Menarini”).
Under the terms of the License Agreement, Menarini received an exclusive license to commercialize and promote VIVUS’s drug SPEDRA™ (avanafil) for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand. Additionally, VIVUS has agreed to transfer to Menarini ownership of the European Union marketing authorization for SPEDRA for the treatment of erectile dysfunction, which was granted by the European Commission in June 2013. Each party agreed not to develop, commercialize, or in-license any other product that operates as phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction for a limited time period, subject to certain exceptions.
VIVUS will receive upfront payments and various approval and sales milestones, plus royalties on SPEDRA sales. Within the first year, VIVUS expects to receive approximately €39 million (or approximately $51 million at current exchange rates) including upfront payments totaling €16 million (or approximately $21 million at current exchange rates). Menarini will also reimburse VIVUS for payments made to cover various obligations to Mitsubishi-Tanabe Pharmaceutical Corporation during the term of the License Agreement. The License Agreement will terminate on a country-by-country basis in the relevant territories upon the latest to occur of the following: the expiration of the last-to-expire valid VIVUS patent covering SPEDRA; the expiration of data protection covering SPEDRA; or ten (10) years after the SPEDRA product launch. In addition, Menarini may terminate the License Agreement if certain additional regulatory obligations are imposed on SPEDRA, the Company may terminate the License Agreement if Menarini challenges the VIVUS patents covering SPEDRA or if Menarini commits certain legal violations. Either party may terminate the License Agreement for the other party’s uncured material breach or bankruptcy.
Under the terms of the Supply Agreement, VIVUS will supply Menarini with STENDRA drug product until December 31, 2018 at the latest. Menarini also has the right to manufacture STENDRA independently, provided that it continues to satisfy certain minimum purchase obligations to VIVUS. Following the expiration of the Supply Agreement, Menarini will be responsible for its own supply of STENDRA. Either party may terminate the Supply Agreement for the other party’s uncured material breach or bankruptcy, or upon the termination of the License Agreement.
Item 7.01. Regulation FD Disclosure
In a press release issued on July 9, 2013, the Company announced its entry into the License Agreement and the Supply Agreement. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Form 8-K and the exhibits attached hereto shall not be deemed “filed” for purposes of Section 18 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 Registrant’s 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.
