Theravance Biopharma : Material Event - Form 8-K

Item 8.01 Other Events

On December 26, 2023, Theravance Biopharma R&D IP, LLC, Theravance Biopharma US, Inc. and Theravance Biopharma Ireland Limited, subsidiaries of the Registrant Theravance Biopharma, Inc. (together, "Theravance"), and Mylan Ireland Limited and Mylan Specialty L.P. (together, "Mylan"), entered into a Settlement Agreement (the "Settlement Agreement") with Accord Healthcare, Inc. ("Accord", and together with Theravance and Mylan, the "parties") relating to Theravance and Mylan's YUPELRI^® (revefenacin) inhalation solution.A Theravance entity owns and Mylan is the exclusive sub-licensee of United States Patent Nos. 8,541,451; 9,765,028; 10,550,081; 11,008,289; 11,484,531; 11,691,948; 8,017,783; 9,249,099; 10,100,013; 11,649,209; 8,754,225; and 9,035,061 (the "Patents-in-Suit").

The Settlement Agreement resolves ongoing patent litigation brought by Theravance and Mylan against Accord pursuant to the Hatch-Waxman Act based on Accord's filing of an abbreviated new drug application ("ANDA") seeking approval to market a generic version of YUPELRI^® (revefenacin) inhalation solution prior to expiration of the Patents-in-Suit.

Under the Settlement Agreement, Theravance and Mylan granted Accord a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Accord's generic version of YUPELRI^® (revefenacin) inhalation solution in the United States on or after the Licensed Launch Date of April 23, 2039, subject to certain exceptions as is customary in these type of agreements.

As required by law, the settlement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

The patent litigation previously disclosed by the Company remains pending against five other ANDA filers: Cipla Limited; Eugia Pharma Specialities Ltd.; Lupin Inc.; Mankind Pharma Ltd.; and Orbicular Pharmaceutical Technologies Private Limited, along with certain affiliates.