On April 4, 2023, or the Effective Date, Eagle Pharmaceuticals, Inc., or the Company, entered into a definitive settlement agreement, or the Settlement Agreement, with Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc., or collectively, Dr. Reddy’s, relating to the Company’s product BENDEKA (rapidly infused bendamustine hydrochloride), or the Company Product (Filing, 8-K, Eagle Pharmaceuticals, APR 10, 2023, View Source [SID1234629903]). This settlement resolves patent litigation (subject to U.S. Federal Trade Commission and U.S. Department of Justice review) brought by the Company, and its marketing partners Teva Pharmaceuticals International GmbH and Cephalon, LLC, or collectively, Teva, relating to the alleged infringement of Orange Book listed United States Patent Nos. 11,103,483 and 9,572,887, or the Patents-In-Suit, with respect to Dr. Reddy’s 505(b)(2) New Drug Application, or NDA, No. 215668, submitted to the U.S. Food and Drug Administration, or FDA, seeking approval for the manufacture and sale in the United States of bendamustine hydrochloride injection solution in a 100 mg/4 mL (25 mg/mL) dosage strength for intravenous infusion over ten (10) minutes from a 50 ML infusion bag and used for the treatment of chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, or the Dr. Reddy’s Product. The Settlement Agreement includes customary representations, warranties and agreements by the parties and the following terms:
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Settlement of Patent Infringement and Antitrust Lawsuits and Antitrust Review
Within five days after the Effective Date, the parties to the litigation, or the Parties, will file a joint motion to dismiss all claims, defenses and counterclaims with prejudice in relation to litigation, or the Patent Infringement Lawsuit, concerning the alleged infringement by Dr. Reddy’s of the Patents-In-Suit, resulting from the filing by Dr. Reddy’s of NDA, No. 215668, and the related certification pursuant to 21 U.S.C. § 355(b)(2)(A)(iv).
In addition, within ten business days after the Effective Date, the Parties will submit the Settlement Agreement to the U.S. Federal Trade Commission and U.S. Department of Justice for federal antitrust review.
Mutual Release and Covenant Not to Sue
The Parties each release the counterparty or counterparties from any and all claims relating to (i) the Dr. Reddy’s Product and the Dr. Reddy’s NDA or its filing, (ii) the Patents-In-Suit or (iii) the Patent Infringement Lawsuit.
The Company and Teva and their respective affiliates also covenant not to sue, assert any claim or otherwise participate in any action or proceeding against, Dr. Reddy’s or its affiliates, for infringement of the Patents-In-Suit or any other patents owned or controlled by the Company or Teva now or in the future, subject to certain exceptions.
Limited License
The Company and Teva grant to Dr. Reddy’s and its affiliates a non-exclusive and revocable license under the Patents-In-Suit, including any corrections, extensions, reissues or reexaminations, to manufacture, have manufactured, use, sell, offer to sell, and import the Dr. Reddy’s Product in the United States beginning on the License Effective Date of November 17, 2027 (subject to FDA approval), or earlier under certain circumstances.
The foregoing description of the Settlement Agreement is not intended to be complete and is qualified in its entirety by reference to the full text of the Settlement Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K.