Commitments and Contingencies	9 Months Ended
Sep. 30, 2023
Commitments and Contingencies
Commitments and Contingencies	11. Commitments and Contingencies Legal Proceedings In January 2023, the Company received notice from Accord Healthcare, Inc.; Cipla USA, Inc. and Cipla Limited; Eugia Pharma Specialties Ltd.; Lupin Inc.; Mankind Pharma Ltd.; Orbicular Pharmaceutical Technologies Private Limited; and Teva Pharmaceuticals, Inc. (collectively, the “generic companies”), that they have each filed with FDA an abbreviated new drug application (“ANDA”), for a generic version of YUPELRI. The notices from the generic companies each included a paragraph IV certification with respect to five of the Company’s patents listed in FDA’s Orange Book for YUPELRI on the date of the Company’s receipt of the notice. The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI. In February 2023, the Company filed patent infringement suits against the generic companies in federal district courts, including the United States District Court for the District of New Jersey, the U.S. District Court for the District of Delaware, and the U.S. District Court for the Middle District of North Carolina. The suits in Delaware and North Carolina have been dismissed, as all generic companies have agreed to venue in New Jersey. The complaint alleges that by filing the ANDAs, the generic companies have infringed five of the Company’s Orange Book listed patents. The Company is seeking a permanent injunction to prevent the generic companies from introducing a generic version of YUPELRI that would infringe its patents. As a result of this lawsuit, a stay of approval through May 2026 has been imposed by the FDA on the generic companies’ ANDAs pending any adverse court decision. An additional patent covering YUPELRI granted on July 4, 2023 was subsequently listed in FDA’s Orange Book. The Company filed an additional patent infringement suit against all of the above generic companies in the U.S. District Court for the District of New Jersey during August 2023. This suit has been consolidated with the above action. On October 27, 2023, subsidiaries of the Company and Mylan Ireland Limited and Mylan Specialty L.P. (together, “Viatris entities”), entered into a Settlement Agreement (“Settlement Agreement”) with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (together, “Teva”). The Settlement Agreement resolves ongoing patent litigation described above with respect to these parties. Under the Settlement Agreement, the Company and Viatris entities granted Teva a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Teva’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 types 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 against the other generic companies, along with certain affiliates, remains pending.

Commitments and Contingencies

9 Months Ended

Sep. 30, 2023

11. Commitments and Contingencies

Legal Proceedings

In January 2023, the Company received notice from Accord Healthcare, Inc.; Cipla USA, Inc. and Cipla Limited; Eugia Pharma Specialties Ltd.; Lupin Inc.; Mankind Pharma Ltd.; Orbicular Pharmaceutical Technologies Private Limited; and Teva Pharmaceuticals, Inc. (collectively, the “generic companies”), that they have each filed with FDA an abbreviated new drug application (“ANDA”), for a generic version of YUPELRI. The notices from the generic companies each included a paragraph IV certification with respect to five of the Company’s patents listed in FDA’s Orange Book for YUPELRI on the date of the Company’s receipt of the notice. The asserted patents relate generally to polymorphic forms of and a method of treatment using YUPELRI. In February 2023, the Company filed patent infringement suits against the generic companies in federal district courts, including the United States District Court for the District of New Jersey, the U.S. District Court for the District of Delaware, and the U.S. District Court for the Middle District of North Carolina. The suits in Delaware and North Carolina have been dismissed, as all generic companies have agreed to venue in New Jersey. The complaint alleges that by filing the ANDAs, the generic companies have infringed five of the Company’s Orange Book listed patents. The Company is seeking a permanent injunction to prevent the generic companies from introducing a generic version of YUPELRI that would infringe its patents. As a result of this lawsuit, a stay of approval through May 2026 has been imposed by the FDA on the generic companies’ ANDAs pending any adverse court decision. An additional patent covering YUPELRI granted on July 4, 2023 was subsequently listed in FDA’s Orange Book. The Company filed an additional patent infringement suit against all of the above generic

companies in the U.S. District Court for the District of New Jersey during August 2023. This suit has been consolidated with the above action.

On October 27, 2023, subsidiaries of the Company and Mylan Ireland Limited and Mylan Specialty L.P. (together, “Viatris entities”), entered into a Settlement Agreement (“Settlement Agreement”) with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (together, “Teva”). The Settlement Agreement resolves ongoing patent litigation described above with respect to these parties. Under the Settlement Agreement, the Company and Viatris entities granted Teva a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Teva’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 types 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 against the other generic companies, along with certain affiliates, remains pending.