SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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|Item 1.01.||Entry into a Material Definitive Agreement.|
On May 20, 2021, Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) entered into a Commercial Supply Agreement with Catalent Pharma Solutions, LLC (the “Agreement”), with an effective date of May 12, 2021, that defines each party’s responsibilities with respect to the processing, validation and maintenance services for the bulk pharmaceutical product containing Viloxazine HCL (“API”), which is Qelbree™ extended release capsules (the “Product”). The Company entered into the Agreement in connection with the final approval of the Product by the U.S. Food and Drug Administration, which was received on April 2, 2021, and the commercial launch of the Product, which occurred on May 24, 2021.
Under the Agreement, the parties agreed that Catalent Pharma Solutions, LLC will manufacture at its facility, in accordance with mutually agreed upon specifications and current good manufacturing practices, commercial quantities of the Product worldwide, except for countries targeted by the comprehensive sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States. Supernus will be responsible for providing, at no cost to Catalent Pharma Solutions, LLC, API and other materials required in connection with the manufacture of the Product, and Catalent Pharma Solutions, LLC will be responsible for procuring all raw materials, supplies, components and packaging necessary for the compounding, filling or tableting, encapsulating, producing and bulk packaging (but not secondary or retail packaging) of Product in accordance with the specifications.
The Agreement will continue until December 31, 2026, unless earlier terminated, and will automatically be extended for successive two year periods until one party gives notice to the other party.
The foregoing description of the terms of the Agreement is only a summary, does not purport to be complete and is qualified in its entirety by reference to the Agreement, which the Company intends to file as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2021. Unless otherwise defined herein, the capitalized terms used above shall have the same meaning ascribed to them in the Agreement.
|Item 9.01||Financial Statements and Exhibits.|
Exhibit 104 – The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|SUPERNUS PHARMACEUTICALS, INC.|
|DATED: May 26, 2021||By:||/s/ James P. Kelly|
|James P. Kelly|
|Executive Vice-President and Chief Financial Officer|