Note 19 - Commitments and Contingencies |
6 Months Ended |
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Jun. 30, 2026 | |
| Notes to Financial Statements | |
| Commitments and Contingencies Disclosure [Text Block] |
Note 19 – Commitments and Contingencies
In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of June 30, 2026 and December 31, 2025. The Company does not anticipate recognizing any significant losses relating to these arrangements.
On April 2, 2024, the Company 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 to the FDA seeking approval to manufacture, use, or sell a generic version of Jelmyto in the United States prior to the expiration of such patents. The Company 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, the Company entered into a settlement and license agreement (the “Agreement”) with Teva, resolving this litigation. Under the Agreement, the Company has agreed to grant Teva a non-exclusive license to sell its generic version of Jelmyto 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.
Leases
See Note 11 for further discussion regarding lease commitments.
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