Item 1.01
Entry into a Material Definitive Agreement.
On March 6, 2017, Supernus Pharmaceuticals, Inc. (Supernus or the Company) entered into a binding term sheet (the Term Sheet) with Actavis Laboratories, FL, Inc., Actavis Pharma, Inc., and Watson Laboratories, Inc. (collectively, Actavis, now a subsidiary of Teva Pharmaceuticals Industries, Ltd.), to settle ongoing patent litigation regarding Actavis filing of an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of the Companys Trokendi XR® (extended-release topiramate) capsules. The ANDA included a paragraph IV certification seeking approval to engage in the manufacture, use and sale of the Actavis product prior to the expiration of United States Patent Nos. 8,298,576 (the 576 Patent), 8,298,580 (the 580 Patent), 8,663,683 (the 683 Patent), 8,877,248 (the 248 Patent), 8,889,191 (the 191 Patent), and 8,992,989 (the 989 Patent, and together with the 576 Patent, the 580 Patent, the 683 Patent, the 248 Patent, and the 191 Patent, the Patents-in-Suit).
Under the terms of the Term Sheet, the Company and Actavis will enter into settlement and license agreements with respect to Actavis ANDA, and the Company will grant to Actavis and its affiliates a non-exclusive license, beginning on January 1, 2023, or earlier under certain circumstances.
During the term of the license agreement, Actavis will make royalty payments to the Company. The Company retains the right itself or through an affiliate to market an authorized generic product and grant additional licenses under the Patents-in-Suits to third parties.