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Item 8.01 Other Events.
On February 24, 2023, Intercept Pharmaceuticals, Inc. (the “Company”) and its subsidiary Intercept Pharma Europe Limited (“IPEL”) (collectively, “Intercept”) entered into two separate settlement agreements with (1) Apotex Inc. and Apotex Corp. (collectively, “Apotex”) and (2) MSN Pharmaceuticals, Inc. and MSN Laboratories Private Limited (collectively, “MSN”) resolving the previously disclosed patent litigations concerning the submissions by Apotex and MSN of Abbreviated New Drug Applications (“ANDAs”) seeking approval to market generic versions of Ocaliva® (obeticholic acid) 5 mg and 10 mg tablets prior to expiration of the Company’s Orange Book listed patents.
Under the terms of the agreements, Intercept granted Apotex and MSN non-exclusive, non-sublicensable, non-transferable, royalty-free licenses to commercialize their generic versions of Ocaliva in the United States commencing, respectively, on September 1, 2031, and January 1, 2032, or in each case earlier under certain circumstances. The parties will file the settlement agreements with the Federal Trade Commission and the Department of Justice pursuant to applicable law.
As a result of these settlements, and previously disclosed settlements with other generic drug manufacturers, the Company has fully resolved the patent infringement case in the United States District Court for the District of Delaware that was scheduled for trial on February 27, 2023, and the case has been terminated by the Court. Similar patent litigation previously disclosed by the Company against another ANDA filer seeking approval to market generic Ocaliva remains pending, with trial scheduled for July 22, 2024.
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.
|INTERCEPT PHARMACEUTICALS, INC.|
|By:||/s/ Rocco Venezia|
|Title:||Chief Accounting Officer|
|Date: February 27, 2023|