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Monday, February 01, 2021 10:58:57 AM
Item 1.01 Entry Into a Material Definitive Agreement.
As previously disclosed, Adamas Pharma, LLC, a wholly-owned subsidiary of Adamas Pharmaceuticals, Inc. (the “Company”) is involved in a lawsuit against Zydus Worldwide DMCC and Zydus Pharmaceuticals (USA), Inc. (collectively “Zydus”) in the United States District Court for the District of New Jersey alleging infringement of the Company’s patents by Zydus. On January 30, 2021, the Company entered into a definitive agreement (the “Definitive Agreement”) with Zydus pursuant to which the parties agreed to end the lawsuit and dismiss it without prejudice. Pursuant to the Definitive Agreement, the Company grants a license to make, use, sell, offer to sell and import a generic version of GOCOVRI® (amantadine) extended release capsules, effective as of March 4, 2030, or earlier in certain circumstances typical for such agreements. In addition, the Definitive Agreement contains provisions that may accelerate the license date, including if unit sales of GOCOVRI in the 12-month period ending July 31, 2025 or any subsequent 12-month period decline by a specified percentage below GOCOVRI unit sales in the year ended December 31, 2019.
The Definitive Agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice. The Company expects to file the Definitive Agreement as an exhibit to its Quarterly Report on Form 10-Q for the quarter ending March 31, 2021.
Zydus Pharmaceuticals
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