“The Parties in the above-captioned Actions, have agreed to terms and conditions representing a negotiated settlement and have set forth those terms and conditions in a Settlement Agreement (the “Settlement Agreement”). Now the Parties, by their respective undersigned attorneys, hereby stipulate and consent to entry of a Stipulation and Order in these Actions as follows: IT IS this ___ day of _________, 2025: ORDERED, ADJUDGED AND DECREED as follows: 1. This District Court has jurisdiction over the subject matter of the above Actions and has personal jurisdiction over the parties. 2. As used in this Stipulation and Order, (i) the term “Norwich Product” shall mean the generic 40 milligram and 80 milligram generic baloxovir marboxil tablet drug products sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 217449 in the form, subject to amendments as FDA might require, as tentatively approved by FDA on September 13, 2023, and does not include any new or different dosage form, route of Case 1:23-cv-00161-MN Document 123 Filed 07/23/25 Page 1 of 4 PageID #: 2551 2 administration, dosage strength, or active ingredient(s); and (ii) the term “Affiliate” shall mean, with respect to a Party, any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with such Party. For purposes of this definition, “control” means (a) ownership, directly or through one or more intermediaries, of (i) fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or (ii) fifty percent (50%) or more of the equity interests in the case of any other type of legal entity or status as a general partner in any partnership, or (b) any other arrangement whereby an entity or person has the right to elect a majority of the board of directors or equivalent governing body of a corporation or other entity or the right to direct the management and policies of a corporation or other entity. 3. Except as specifically authorized pursuant to the Settlement Agreement, Defendants and any of their Affiliates, successors and assigns, and all other persons in active concert or participation with any of them, are enjoined from manufacturing, using, offering to sell, or selling within the United States, or importing into the United States, the Norwich Product until the earlier of (a) the Entry Date as defined in the Settlement Agreement, or (b) the expiration date of the latest-expiring of United States Patent Numbers 8,927,710, 8,987,441, 9,815,835, 10,392,406, 10,633,397, 10,759,814, 11,261,198, 11,306,106 and 12,064,438 (the “Asserted Patents”), including any extensions or exclusivities and pediatric exclusivities. 4. For purposes of these Actions with respect to the Norwich Product only, Defendants admit that, unless and until the Asserted Patents are held invalid or unenforceable and in the absence of a license or other authorization from Plaintiffs, (a) the submission of ANDA No. 217449 to the FDA for the purpose of obtaining regulatory approval to engage in the commercial manufacture, use, and/or sale of the Norwich Product within the United States Case 1:23-cv-00161-MN Document 123 Filed 07/23/25 Page 2 of 4 PageID #: 2552 3 before the expiration of the Asserted Patents was an act of infringement of the Asserted Patents under 35 U.S.C. § 271(e)(2)(A), and (b) the Asserted Patents would be infringed by the unlicensed manufacture, use, sale, offer to sell, importation or distribution of the Norwich Product in or for the United States. Nothing set forth herein shall prevent Defendants from maintaining their Paragraph IV certifications to the Asserted Patents pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) or pursuant to 21 C.F.R. § 314.94(a)(12). Each Party acknowledges and agrees that the 30- month stay under 21 U.S.C. § 355(j)(5)(B)(iii) with respect to approval of Norwich’s ANDA No. 217449 for the Norwich Product is hereby terminated. 5. This Stipulation and Order is without prejudice to any claim, defense, or counterclaim in any possible future action regarding a product other than the Norwich Product. 6. Compliance with this Stipulation and Order may be enforced by Plaintiffs and Defendants, and their successors in interest, or assigns, as permitted by the terms of the Settlement Agreement. 7. This District Court retains jurisdiction over Plaintiffs and Defendants to enforce or supervise performance under this Stipulation and Order. 8. All other claims, counterclaims, affirmative defenses and demands in these actions are hereby dismissed without prejudice and without costs, disbursements or attorneys’ fees to any party. 9. The Clerk of the Court is directed to enter this Stipulation and Order forthwith in these Actions.”