Item 1.01.
|
Entry into a Material Definitive Agreement.
|
On December 7, 2016, Vanda
Pharmaceuticals Inc. (Vanda) announced that it has entered into a License Agreement (the License Agreement) with Apotex Inc. and Apotex Corp. (collectively, Apotex) settling Vandas patent infringement
litigation against Apotex (the Litigation) in the U.S. District Court for the District of Delaware (the Court). In the Litigation, Vanda alleges that Apotexs Abbreviated New Drug Application (ANDA) seeking
approval to market generic versions of Fanapt
®
(iloperidone) in the U.S. infringes certain U.S. patents owned by Vanda that cover
Fanapt
®
.
In accordance with legal requirements, Vanda and Apotex have agreed to
submit the License Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Vanda and Apotex have also agreed to file stipulations of dismissal with the Court regarding the Litigation. The License Agreement
provides for a full settlement of the claims that were asserted in the Litigation, and includes a release by Vanda of all iloperidone-related infringement claims against Apotex based on conduct prior to the effective date of the License Agreement.
The License Agreement also provides for the joint submission to the Court, for its approval, of a consent judgment enjoining Apotex from making, using, selling, offering for sale, or importing into the U.S., the iloperidone products that are the
subject of Apotexs ANDA except pursuant to a license from Vanda, and enjoining Apotex from inducing or contributing to such infringement by others except pursuant to such a license from Vanda.
Under the License Agreement, Vanda granted Apotex a non-exclusive license to manufacture and commercialize in the U.S. Apotexs generic
versions of the Fanapt
®
Products (as defined in the License Agreement) after the Trigger Date (as defined below).
Under the License Agreement, the Trigger Date is November 2, 2027, unless prior to that date Vanda obtains pediatric
exclusivity, in which case the Trigger Date will be May 2, 2028; however, Apotex may be able to enter the market earlier under certain circumstances. Such circumstances relate to the resolution of any other third party Fanapt
®
patent litigation and the entry of certain other third party generic versions of Fanapt
®
, among other events.
Vanda also agreed that if it enters into any similar agreements with other parties with respect to generic versions of Fanapt
®
that allow such other parties the right to sell generic versions of Fanapt
®
earlier than the date on which Apotex is first permitted to
sell its generic version of Fanapt
®
under the License Agreement, then Apotex will receive the benefit of such earlier date.
The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the
complete text of the agreement, which will be filed with the U.S. Securities and Exchange Commission (the SEC) as an exhibit to Vandas Annual Report on Form 10-K for the fiscal year ending December 31, 2016.
The press release announcing the entry into the License Agreement and the settlement of the Litigation is furnished as Exhibit 99.1 to
this current report on Form 8-K.
Forward-Looking Statements
This report and the press release furnished hereto as Exhibit 99.1 contain forward-looking statements, including statements regarding the
anticipated results and actions to be taken under the License Agreement, plans to submit the License Agreement for regulatory approval and the potential dismissal of the Litigation. These forward-looking statements are based on managements
expectations and assumptions as of the date of this report and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to risks regarding whether
regulatory authorities challenge the enforceability of or seek to enjoin the entry into the License Agreement, whether the Court will grant orders dismissing the Litigation, whether additional third parties may seek to market generic versions of
Fanapt
®
and the results of any litigation that Vanda files to defend and/or assert its patents against such third parties, and other factors that are described in the Risk Factors
and Managements Discussion and Analysis of Financial Condition and Results of Operations
sections of Vandas annual report on Form 10-K for the fiscal year ended December 31, 2015 and quarterly report on Form 10-Q for the quarter ended September 30, 2016, which are on
file with the SEC and available on the SECs website at www.sec.gov. In addition to the risks described above and in Vandas annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with
the SEC, other unknown or unpredictable factors also could affect Vandas results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have
the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their
entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this report and the press
release is provided only as of the date hereof, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements contained herein after the date hereof, whether as a result of
new information, future events or otherwise.