Commitments and Contingencies |
9 Months Ended |
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Sep. 30, 2026 | |
| Commitments and Contingencies. | |
| Commitments and Contingencies | Note 12. Commitments and Contingencies
Indemnification Agreements
The Company maintains indemnification agreements with its directors and officers that may require it to indemnify them against liabilities that arise by reason of their status or service as directors or officers, except as prohibited by applicable law.
Clinical Trial Agreements
The Company contracted with various universities, hospitals, and medical practices to conduct an early feasibility clinical study of Orion which was completed in March 2025, a Phase 1 study of NPM-115 (LIBERATE-1) which was completed in August 2025, and a Phase 1 study of NPM-139 (SLIM-1) which was fully enrolled with all participants dosed in August 2026.
Payments are based on procedures performed for each subject and are charged to clinical and regulatory expense as incurred. Total amounts expensed during the three months ended September 30, 2026 and 2025 were $539,000 and $0, respectively, and during the nine months ended September 30, 2026 and 2025 were $765,000 and $35,000, respectively.
Litigation, Claims and Assessments
The Company is party to litigation arising in the ordinary course of business. It is the Company’s opinion that the outcome of such matters will not have a material effect on its results of operations, however, the results of litigation and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact because of defense and settlement costs, diversion of management resources and other factors.
Pixium
One opposition filed by Pixium Vision SA (“Pixium”) was pending in the European Patent Office (“EPO”) challenging the validity of a European patent owned by Cortigent. The Company decided to allow the patent to be abandoned by the EPO, which occurred in February 2025. As a result, this opposition is no longer pending. While this abandonment could impact the Company’s ability to protect Cortigent’s neurostimulation technology in Europe related to this patent, the Company does not believe that it will have a material effect on its ability to manufacture and sell its products, or otherwise have a material effect on Cortigent’s operations.
As described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, the Company had entered into a Memorandum of Understanding (“MOU”) for a proposed business combination with Pixium. In response to a press release by Pixium dated March 24, 2021, and subsequent communications between the Company and Pixium, the Company’s Board of Directors determined that the business combination with Pixium was not in the best interest of its stockholders. On April 1, 2021, the Company gave notice to Pixium that it was terminating the MOU between the parties and seeking an amicable resolution of termination amounts that may be due, however no assurance can be given that an amicable resolution will be reached. The Company accrued $1,000,000 of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021 and remitted that amount to Pixium in April 2021. Pixium indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000 payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, and currently claims damages of approximately €5.1 million or about $5.6 million. The Company believes it has fulfilled its obligations to Pixium with the liquidated damages payment of $1,000,000.
On December 8, 2022, the Company received notice that the Paris Commercial Court had rendered its judgment, including finding that the Company’s termination of the MOU was not valid. In the judgment, the Company was ordered to pay to Pixium the amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid, a net amount payable of approximately €1,552,220. We recorded a charge of $1,675,000 for the year ended December 31, 2022, related to this matter but plan to continue our appeal against the preliminary judgment. On May 24, 2023, the Company filed an appeal against the judgment from the Paris Commercial Court except in so far as such prior judgment dismissed (i) Pixium’s claim for the Company to pay it a sum of €480,693 relating to the alleged time spent by its teams, (ii) Pixium’s application to order the Company to pay it a sum of €1,500,000 in respect to alleged loss of opportunity and (iii) deducted the sum of $1,000,000 that the Company already paid Pixium and which Pixium retained converted into euros at the date of the judgment.
Thereafter Pixium filed its brief with Paris Court of Appeal and filed a cross-appeal on January 18, 2024. Meanwhile, the Company received notice that the Paris Commercial Court had opened safeguard proceedings against Pixium by judgment dated October 9, 2023, then in its judgment dated November 13, 2023, converted safeguard proceedings into receivership, and in its judgment dated January 31, 2024, converted Pixium’s receivership proceedings to liquidation proceedings, the transfer plan being rejected. As a result, Pixium’s liquidator intervened on behalf of Pixium in the pending proceedings before the Paris Court of Appeal and filed its brief on March 21, 2024.
The Company filed its brief in reply with the Paris Court of Appeal on April 17, 2024. Proceedings before the Paris Court of Appeal are pending. In parallel, because the Company has failed to enforce the judgment, Pixium requested the pre-trial judge to strike out the Company's appeal for failure to enforce the judgment. The hearing took place on June 4, 2024 and on October 23, 2024, the pre-trial judge issued his order, striking out Vivani's appeal for failure to enforce the decision. As of September 30, 2026, the Company adjusted the litigation accrual to $1.79 million to reflect the amount paid on October 1, 2026, with the resulting foreign currency adjustment recognized within other income, net in the condensed consolidated statements of operations. On October 1, 2026, the Company paid the remaining balance of $1,790,000 to reinstate the case on the court's docket and prevent the appeal proceeding from lapsing. On November 2, 2026, the correspondent before the Paris Court of Appeal confirmed that the Conseiller de la mise en état had reinstated the appeal, and that the case will now proceed on the merits, as no objection was raised by the liquidator.
On January 26, 2024, Oppenheimer & Co. Inc. (“Oppenheimer”) filed a complaint asserting breach of contract and other claims against the Company and a party unrelated to the Company with respect to this matter, ThinkEquity LLC (the “Third Party”), arising from a placement agent agreement dated November 5, 2020, executed by and between the Company and Pixium in connection with a proposed business combination transaction with Pixium. The complaint, filed in the Supreme Court of the State of New York, County of New York, Index No. 650421/2024, seeks recovery of no less than $1,625,000 in damages, plus costs and fees. On April 3, 2024, the Company filed a motion to dismiss the complaint. On May 3, 2024, the Third Party filed its own motion to dismiss. On June 12, 2025, the Court granted the Company’s motion in part and denied it in part, dismissing all claims except the first cause of action for breach of contract (the “Claim”), and the Court dismissed the complaint as against the Third Party. Oppenheimer and the Company are now commencing discovery on the Claim, which seeks the monetary damages referenced above. Each of the Company and Oppenheimer have filed notices of appeal. The Company has defenses to the Claim and intends to defend itself vigorously, but there can be no assurance as to the outcome of the litigation. |