UroGen Pharma Ltd.

Item 1. Legal Proceedings.

On April 2, 2024, we filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc. (together with Teva Pharmaceuticals, Inc., "Teva"), and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 and 9,950,069 in response to Teva’s submission of an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to manufacture, use, or sell a generic version ofJelmyto in the United States prior to the expiration of such patents. We sought a permanent injunction preventing U.S. market entry of Teva’s generic product prior to the expiration of such patents. By written stipulation dated June 11, 2024, Teva Pharmaceutical Industries, Ltd. was dismissed from the action.

On June 2, 2026, we entered into a settlement and license agreement (the “Agreement”) with Teva, resolving this litigation. Under the Agreement, we have agreed to grant Teva a non-exclusive license to sell its generic version ofJelmyto beginning on September 15, 2030, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur.

On June 3, 2026, the court granted the parties’ Stipulated Dismissal Order, dismissing and closing the civil action. As required by law, the parties submitted the Agreement to the U.S. Federal Trade Commission and U.S. Department of Justice for review.

From time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. We are not currently a party to any material legal proceedings. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.