Item 1.01. Entry into a Material Definitive Agreement.
On January 14, 2022, Vanda Pharmaceuticals Inc. ("Vanda") announced that it has
entered into a License Agreement (the "License Agreement") with MSN
Pharmaceuticals Inc., MSN Laboratories Private Limited (together "MSN") and
Impax Laboratories LLC ("Impax") settling Vanda's patent infringement litigation
against MSN (the "Litigation") in the U.S. District Court for the District of
Delaware (the "Court"). In the Litigation, Vanda alleges that MSN's Abbreviated
New Drug Application ("ANDA") seeking approval to market generic versions of
HETLIOZ® (tasimelteon) in the U.S. infringes certain U.S. patents owned by Vanda
that cover HETLIOZ®.
In accordance with legal requirements, Vanda and MSN 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 MSN 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 tasimelteon-related
infringement claims against MSN and Impax 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 MSN from making, using, selling, offering for sale, or importing into
the U.S., the tasimelteon products that are the subject of MSN's ANDA except
pursuant to a license from Vanda, and enjoining MSN from inducing or
contributing to such infringement by others except pursuant to such a license
from Vanda.
Under the License Agreement, Vanda granted MSN and Impax a non-exclusive license
to manufacture and commercialize in the U.S. MSN's generic versions of the
HETLIOZ® Products (as defined in the License Agreement) after the Trigger Date
(as defined below).
Under the License Agreement, the "Trigger Date" is March 13, 2035, unless prior
to that date Vanda obtains pediatric exclusivity for HETLIOZ®, in which case the
Trigger Date will be July 27, 2035; however, MSN and Impax may be able to enter
the market earlier under certain circumstances. Such circumstances relate to the
resolution of any other third party HETLIOZ® patent litigation and the entry of
certain other third-party generic versions of HETLIOZ®, among other events.
Vanda also agreed that if it enters into any similar agreements with other
parties with respect to generic versions of HETLIOZ® that allow such other
parties the right to sell generic versions of HETLIOZ® earlier than the date on
which MSN and Impax are first permitted to sell MSN's generic version of
HETLIOZ® under the License Agreement, then MSN and Impax 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 Vanda's Quarterly Report on Form 10-Q
for the fiscal quarter ending March 31, 2022.
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.
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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Press release of Vanda Pharmaceuticals Inc. dated January 14,
2022.
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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