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Item 8.01 Other Events.
On August 16, 2022, Intercept Pharmaceuticals, Inc. (the “Company”) and its subsidiary Intercept Pharma Europe Limited (“IPEL”) (collectively, “Intercept”) entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively, “Dr. Reddy’s”) resolving the previously disclosed patent litigation concerning the submission by Dr. Reddy’s of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Ocaliva® (obeticholic acid) 5 mg and 10 mg tablets prior to expiration of the Company’s U.S. Patent Nos. RE48,286; 9,238,673; 10,047,117; 10,052,337; 10,174,073; 10,751,349; and 10,758,549.
Under the terms of the agreement, Intercept granted Dr. Reddy’s a non-exclusive, non-sublicensable, non-transferable, royalty-free license to commercialize its generic version of Ocaliva in the United States commencing on October 26, 2035, or earlier under certain circumstances. The parties will file the settlement agreement with the Federal Trade Commission and the Department of Justice pursuant to applicable law and will terminate their pending litigation pursuant to a consent judgment that is subject to court approval. Similar patent litigation previously disclosed by the Company against five other ANDA filers seeking approval to market generic Ocaliva remains pending.
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: August 16, 2022