“WHEREAS Defendants Apotex Inc. and Apotex Corp. (collectively, the “Apotex Defendants”), MSN Laboratories Private Ltd., MSN Life Sciences Private Ltd., and MSN Pharmaceuticals Inc. (collectively, the “MSN Defendants”) (the Apotex Defendants and the MSN Defendants collectively, the “GENVOYA Defendants”) submitted Abbreviated New Drug Application (“ANDA”) No. 218575 (“the APOTEX GENVOYA ANDA”) seeking approval to manufacture, use, offer for sale, sell, and/or import a generic version of Plaintiff’s GENVOYA® product (the “APOTEX GENVOYA ANDA product”), including a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV); WHEREAS Plaintiff Gilead Sciences, Inc. (“Gilead”) filed a Complaint (C.A. No. 23-774- MN, D.I. 1) alleging that the GENVOYA Defendants’ submission of the APOTEX GENVOYA ANDA infringed U.S. Patent No. 10,039,718 (“the ’718 patent”) under 35 U.S.C. § 271(e)(2)(A), and that the making, using, selling, offering for sale, and/or importing in or into the United States of the APOTEX GENVOYA ANDA product would infringe the ’718 patent under §§ 271(a), (b), (c) and/or (g) (the “GENVOYA Action”); WHEREAS Gilead and the GENVOYA Defendants have determined that good cause exists and wish to narrow the issues in dispute in the GENVOYA Action; WHEREAS the Apotex Defendants, as well as Defendants Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, the “Lupin Defendants”) and the MSN Defendants, have filed ANDAs seeking FDA approval to market a generic version of Janssen Products, L.P.’s SYMTUZA® product; WHEREAS, Gilead, together with Gilead Sciences Ireland UC, Janssen Products, L.P., Janssen Sciences Ireland Unlimited Company (collectively, the “SYMTUZA Plaintiffs”), filed a patent infringement suit on the ’718 patent based on the filing of those ANDAs seeking FDA approval to market a generic version of SYMTUZA®, against: (a) the Apotex Defendants on October 25, 2022 (C.A. No. 22-1399-MN); (b) the Lupin Defendants and the MSN Defendants on November 16, 2021 (C.A. No. 21-1621-MN); and (c) the Lupin Defendants and the MSN Defendants on May 9, 2023 (C.A. No. 23-508-MN), which the Court consolidated on June 26, 2023 (C.A. No. 21-1621-MN, D.I. 128) (the “SYMTUZA Actions”);WHEREAS, in the SYMTUZA Actions, the Lupin Defendants, MSN Defendants, and Apotex Defendants have all stipulated to infringement of, and the Court has entered an order that the Lupin Defendants, MSN Defendants, and Apotex Defendants infringe, claims 1, 4–5, 14–15, 17, 19–20, and 22–23 (the “Asserted Claimed”) of the ’718 patent (C.A. No. 21-1621-MN, D.I. 67 & 128, C.A. No. 22-1338-MN, D.I. 20); WHEREAS, the GENVOYA Action and the SYMTUZA Actions involve the same factual and legal issues relating to the validity of the Asserted Claims of the ’718 patent; WHEREAS, all counsel hereby certify that they have received approval to submit this stipulation and proposed order from their respective clients; NOW, THEREFORE, it is hereby stipulated and agreed as follows, subject to the approval of the Court, that: 1. By submitting the APOTEX GENVOYA ANDA, the GENVOYA Defendants have infringed the Asserted Claims of the ’718 patent under 35 U.S.C. § 271(e)(2)(A). 2. The GENVOYA Defendants’ making, using, selling, offering for sale, and/or importing in or into the United States of the APOTEX GENVOYA ANDA product prior to the expiration date of the ’718 patent (including any extensions and/or additional periods of exclusivity to which Gilead is or will be entitled) would infringe the Asserted Claims of the ’718 patent under 35 U.S.C. §§ 271(a), (b), (c), and/or (g). 3. Gilead asserts only the Asserted Claims of the ’718 patent against the GENVOYA Defendants in the GENVOYA Action, and the GENVOYA Defendants will assert their counterclaims and defenses only against the Asserted Claims of the ’718 patent.Gilead and the GENVOYA Defendants further agree that there will be no further fact or expert discovery in the GENVOYA Action related solely to the issue of infringement by the GENVOYA Defendants of the Asserted Claims of the ’718 patent. 5. If the Court renders a decision that any of the Asserted Claims of the ’718 patent is not invalid, then a final judgment in Gilead’s favor and orders pursuant to 35 U.S.C. § 271(e)(4)(A) and 35 U.S.C. § 271(e)(4)(B) will be entered against the GENVOYA Defendants for any such claim. 6. Gilead and the GENVOYA Defendants agree that this Order is not a final judgment in Gilead’s favor for the ’718 patent, as the GENVOYA Defendants reserve the right to challenge the validity of the Asserted Claims of the ’718 patent. 7. The GENVOYA Action and the SYMTUZA Actions are consolidated for all purposes. All papers shall be filed in the lead action, C.A. No. 21-1621-MN. 9. The GENVOYA Action and the SYMTUZA Actions shall proceed according to the schedule entered in the SYMTUZA Actions (C.A. No. 21-1621-MN, D.I. 128), subject to the following additions: a. Gilead and the GENVOYA Defendants shall serve their initial disclosures pursuant to Federal Rule of Civil Procedure 26(a)(1) by August 18, 2023; b. The GENVOYA Defendants shall adopt the Supplemental Final Invalidity Contentions served on July 7, 2023 in the SYMTUZA Actions; Gilead shall be permitted to respond to such Supplemental Final Invalidity Contentions in its Opening or Rebuttal Expert Reports, as applicable; and The GENVOYA Defendants shall produce to Gilead their GENVOYA ANDA and any and all supplements, amendments or replacements to the same, and any and all correspondence to or from FDA regarding the same; otherwise, there shall be no further fact discovery served by or on the GENVOYA Defendants, absent good cause. 10. Subject to paragraph 11 below, the terms of the Stipulated Protective Order in C.A. No. 21-1621-MN (D.I. 35) shall apply in the consolidated GENVOYA Action and the SYMTUZA Actions. 11. Notwithstanding any statement to the contrary in the Stipulated Protective Order, Gilead and the SYMTUZA Plaintiffs may disclose, summarize, describe, reveal, or otherwise make available, in whole or in part, any confidential information provided by one defendant to the outside counsel of record or experts of another defendant concerning the ’718 patent. 12. Nothing herein is intended to be or shall be construed as a waiver of the parties’ right to seek fees or costs.”