CorMedix Inc. Commitments Disclosure

Note 9 - Commitments and Contingencies:

 

Contingency Matters

 

In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv-14020 (D.N.J.)

 

On October 13, 2021, the United States District Court for the District of New Jersey consolidated into In re CorMedix Inc. Securities Litigation, Case No. 2:21-cv 14020-JXN-CLW, two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively, and appointed lead counsel and lead plaintiff, a purported stockholder of the Company. The lead plaintiff filed a consolidated amended class action complaint on December 14, 2021, alleging violations of Sections 10(b) and 20(a) of the Exchange Act, along with Rule 10b-5 promulgated thereunder, and Sections 11 and 15 of the Securities Act of 1933.

 

On October 10, 2022, the lead plaintiff filed a second amended consolidated complaint that superseded the original complaints in In re CorMedix Securities Litigation. On March 21, 2024, the Court denied Defendants’ motion to dismiss without prejudice and granted Lead Plaintiff leave to amend the complaint.

 

On April 22, 2024, the Lead Plaintiff filed a third amended consolidated complaint that superseded the second amended consolidated complaint. In the third amended complaint, the Lead Plaintiff seeks to represent a class of shareholders who purchased or otherwise acquired CorMedix securities between October 16, 2019 and August 8, 2022, inclusive. The third amended complaint names as defendants the Company and six (6) current and former officers of CorMedix, namely Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, John L. Armstrong, and Joseph Todisco (the “Officer Defendants” and collectively with CorMedix, the “CorMedix Defendants”). The third amended complaint alleges that the CorMedix Defendants violated Section 10(b) of the Exchange Act (and Rule 10b-5) and that the Officer Defendants violated Section 20(a). In general, the purported bases for these claims are allegedly false and misleading statements and omissions related to the NDA submissions to the FDA for DefenCath, subsequent complete response letters, as well as communications from the FDA related and directed to the Company’s contract manufacturing organization and heparin supplier. The Company filed its motion to dismiss the third amended complaint on June 6, 2024. The motion to dismiss was fully briefed on August 21, 2024.

 

On August 19, 2025, the Court issued a revised opinion and order, denying the CorMedix Defendants’ motion to dismiss the third amended complaint. Since then, the case has proceeded to discovery.

 

On August 26, 2025, the parties proposed a revised Pretrial Scheduling Order, which the Court so-ordered on August 27, 2025. Among other things, the Scheduling Order provides for the (i) substantial completion of document production by January 27, 2026; (ii) completion of fact discovery by June 25, 2026; and (iii) completion of expert discovery by December 28, 2026.

 

The parties participated in a mediation before Michelle Yoshida, Esq. of Phillips ADR on November 18, 2025, which did not result in a settlement.

 

On December 1, 2025, in response to, among other things, the death of an Officer Defendant, Lead Plaintiff filed an Unopposed Motion for Leave to Amend the complaint, which the Court granted on December 17, 2025. The CorMedix Defendants filed their answer to the Fourth Amended Consolidated Class Action Complaint on January 2, 2026.

 

In re CorMedix Inc. Derivative Litigation, Case No. 2:21-cv-18493-JXN-LDW (D.N.J.)

 

On or about October 13, 2021, a purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled Voter v. Baluch, et al., Case No. 2:21-cv-18493-JXN-LDW (the “Derivative Litigation”). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Greg Duncan, Matthew David, Phoebe Mounts and Joseph Todisco, along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duty, abuse of control, and waste of corporate assets against the individual defendants, and a claim for contribution for purported violations of Sections 10(b) and 21D of the Exchange Act against certain defendants. On January 21, 2022, pursuant to a stipulation between the parties, the Court entered an order staying the case while the motion to dismiss the class action lawsuit was pending.

On or about January 13, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled DeSalvo v. Costa, et al., Case No. 2:23-cv-00150-JXN-CLW. The complaint names as defendants Paulo F. Costa, Janet D. Dillione, Greg Duncan, Alan Dunton, Myron Kaplan, Steven Lefkowitz, Joseph Todisco, Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, and John L. Armstrong, along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duty and unjust enrichment against the individual defendants.

 

On or about January 25, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District Court for the District of New Jersey, in a case entitled Scullion v. Baluch, et al., Case No. 2:23-cv-00406-ES-ESK. The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Gregory Duncan, Matthew David, and Phoebe Mounts, along with the Company as Nominal Defendant. The complaint alleges breaches of fiduciary duty.

 

On or about April 18, 2023, the Court entered an order consolidating the above-mentioned shareholder derivative complaints for all purposes, including pretrial proceedings, trial and appeal. The consolidated derivative action is entitled, In re CorMedix Inc. Derivative Litigation, C.A. No. 2:21-cv-18493-JXN-LDW. The provisions of the Order to Stay that was previously entered in the Voter litigation on January 21, 2022 applied to the consolidated derivative action.

 

On August 19, 2025, the Court issued a revised opinion and order denying the CorMedix Defendants’ motion to dismiss the third amended complaint in the securities litigation. On November 10, 2025, the derivative plaintiffs filed a verified consolidated shareholder derivative complaint (the “Consolidated Complaint”), which alleges that during the relevant period (October 16, 2019 – August 8, 2022), the Individual Defendants, made or caused to be made materially false and misleading statements regarding CorMedix’s business and operations, specifically relating to purported manufacturing deficiencies during the Relevant Period that the Individual Defendants knew or should have known would impact the FDA approval of the developmental drug “DefenCath” prior to its ultimate approval by the FDA.

 

The Consolidated Complaint asserts claims for breach of fiduciary duty and unjust enrichment.  On this basis, the Consolidated Complaint seeks unspecified damages and corporate governance reforms.

 

On November 18, 2025, the parties participated in a mediation before Michelle Yoshida, Esq. of Phillips ADR.  On December 20, 2025, the parties signed a binding settlement term sheet. On January 19, 2026, the parties executed a binding stipulation of settlement, which, if approved, would resolve the case. 

 

The plaintiffs in a new and separate action––the Jhoe action (discussed below)––filed a motion to intervene and stay this case on December 18, 2025.  On January 6, 2026, the plaintiffs filed their opposition to the motion to intervene and stay.  The Jhoe plaintiff filed his reply on January 13, 2026. That motion remains pending and will be decided on the papers.

 

On January 19, 2026, the plaintiffs filed their Unopposed Motion for Preliminary Approval of Settlement (“Preliminary Approval Motion”).  Following an exchange of letters, on February 3, 2026, the Jhoe plaintiff filed his purported opposition to the Preliminary Approval Motion raising, among other things, various objections to the proposed settlement. On February 10, 2026, the plaintiffs filed their reply in further support of preliminary approval of the proposed settlement, in which Defendants joined and advanced additional arguments in favor of preliminary approval. The Preliminary Approval Motion remains pending and will be decided on the papers. 

 

Raval v. Baluch, Case No. UNN-L-003721-25 (N.J. Super Ct. Law Div.)

 

On or about September 26, 2025, a purported shareholder, derivatively and on behalf of CorMedix, filed a shareholder derivative complaint in the Law Division of the Union County Superior Court of New Jersey, in a case entitled, Raval v. Baluch, et al., Case No. UNN-L-003721-25 (N.J. Super Ct. Law Div.) (the “State Derivative Litigation”). The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Gregory Duncan, Matthew David, and Phoebe Mounts, along with CorMedix as Nominal Defendant. The complaint alleges breaches of fiduciary duty, waste of corporate assets, and abuse of control against the defendants and contains similar allegations to the previously-filed consolidated derivative complaint pending in federal court. The Raval complaint seeks unspecified money damages, governance reforms, and costs and expenses. On October 22, 2025, the parties filed a proposed Stipulation and Consent Order, which the Court entered on the same day. The Stipulation and Consent Order provided that Plaintiff would have until December 4, 2025 to file an amended complaint or designate the complaint as operative. On December 4, 2025, Plaintiff filed a notice with the Court designating its September 26, 2025 complaint as the operative complaint.

The parties attended a mediation before Michelle Yoshida, Esq. of Phillips ADR on November 18, 2025.  On December 20, 2025, the parties signed a binding settlement term sheet.  On January 5, 2026, the parties filed a Stipulation and Consent Order Staying Action staying the case pending approval of the settlement in the federal derivative action, which the court entered on the same day. On January 19, 2026, the parties signed a stipulation of settlement. This action will be dismissed in the event that the proposed settlement is approved by the court in the federal derivative action.

 

Jhoe v. Todisco, et al., C.A. No. 2025-1367-PAF (Del. Ch.)

 

On November 24, 2025, an action was initiated under seal by Robert Jhoe, a purported shareholder of the Company, asserting claims derivatively and on behalf of CorMedix.  A public version of the complaint was filed on December 1, 2025.  The complaint names as defendants Khoso Baluch, Janet D. Dillione, Alan W. Dunton, Robert Cook, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, Greg Duncan, Matthew David, Phoebe Mounts, John L. Armstrong, and Joseph Todisco, along with the Company as Nominal Defendant.

 

The complaint asserts claims for breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment, and waste.  Mr. Jhoe made a books-and-records demand on CorMedix pursuant to Section 220 of the Delaware General Corporation Law prior to initiating this action, and the complaint purports to quote and cite board-level materials in support of Mr. Jhoe’s claims.  It seeks unspecified damages and costs along with certain governance reforms.

 

On December 29, 2025, the defendants moved to stay or dismiss this action, pending approval of the settlement in the federal derivative action.  On January 15, 2026, the parties filed a Stipulation and Proposed Order Governing the Briefing Schedule for the Motion to Dismiss or Stay, which the court so-ordered the following day.  Per the Stipulation, Defendants filed their Opening Brief on February 16, 2026. Further, Plaintiff’s Opposition Brief is due on March 18, 2026 and Defendants’ Reply is due on April 2, 2026.

 

On February 27, 2026, the parties filed a stipulation and proposed order to stay this case––including the Motion to Dismiss or Stay––pending decisions by the court in the New Jersey derivative case on two motions: (i) Mr. Jhoe’s Motion to Intervene and (ii) the plaintiffs’ Motion for Preliminary Approval of Settlement, which Mr. Jhoe opposes. The stipulation, which the court so-ordered on March 2, 2026, further provides that following the New Jersey court’s decisions on these motions, the parties in the Jhoe case will confer regarding appropriate next steps and update the court accordingly.

 

Melinta Legal Proceedings

 

Melinta markets MINOCIN, which is indicated for the treatment of certain bacterial infections. Melinta holds Orange Book listed patents for MINOCIN, including two formulation patents (patents 11,944,634 and 12,161,656) issued in 2024.

 

In 2020, Nexus Pharmaceuticals (“Nexus”) filed an Abbreviated New Drug Application (“ANDA”) with Paragraph IV (“PIV”) certification against the only Orange Book listed patents at the time, specifically patents ‘802 and ‘105 (“Minocin Treatment Patents”), on the alleged basis that the Minocin Treatment Patents were invalid and, in the alternative, that its ANDA did not infringe.

 

 Melinta filed suit against Nexus in the US District Court for the Northern District of Illinois (the “Court”), asserting that the Minocin Treatment Patents were valid and accordingly, Nexus’s ANDA for its generic version of MINOCIN infringed these patents.  In November 2024, the Court found that the Minocin Treatment Patents are valid, enforceable and infringed and issued a permanent injunction against the Nexus ANDA as part of that decision. Nexus subsequently filed an appeal with the U.S. Court of Appeals for the Federal Circuit. The appeal is ongoing. 

 

Additionally, in February 2025, Melinta received a PIV certification for all four Orange Book listed patents from Gland Pharma (“Gland”) on the alleged basis that the patents were invalid, and in the alternative that its ANDA did not infringe these patents. Melinta filed a suit against Gland in the same Court in April 2025. The case is ongoing.

 

Commitments

 

License and Assignment Agreement

 

In 2008, the Company entered into a License and Assignment Agreement (the ND License Agreement) with ND Partners, LLP (NDP). Pursuant to the ND License Agreement, NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications (the NDP Technology). As consideration in part for the rights to the NDP Technology, upon execution of the ND License Agreement, the Company paid NDP an initial licensing fee of $0.3 million and granted NDP a 5% equity interest in the Company, consisting of 7,996 shares of the Company’s common stock.

Under the ND License Agreement, the Company is required to make cash and equity payments to NDP upon the achievement of certain milestones. Under the ND License Agreement, the maximum aggregate amount of cash payments due upon achievement of applicable milestones was $2.5 million, with the balance being $2 million as of March 31, 2025. The initial licensing fee of $0.3 million, the fair value of the 5% equity interest (7,996 shares of the Company’s common stock) and an additional $0.5 million, as a result of the achievement of one milestone, were recognized on the Company’s statement of operations in R&D in prior periods, as the related milestones were achieved by the Company prior to the FDA approval. During the year ended December 31, 2024, the Company determined it was probable that the net sales milestones would be achieved in future periods and, as a result, the Company recorded a license intangible asset of $2 million and a license agreement liability of $2 million, which was included within accrued expenses in the Company’s consolidated balance sheet as of December 31, 2024. In May 2025, the Company paid the final milestone liability in the aggregate amount of $2 million.

   

The ND License Agreement will expire on a country-by-country basis upon the earlier of (i) the expiration of the last patent claim under the ND License Agreement in a given country, or (ii) the payment of all milestone payments. Upon the expiration of the ND License Agreement in each country, the Company will have an irrevocable, perpetual, fully paid-up, royalty-free exclusive license to the NDP Technology in such country.

 

Melinta Commitments

 

Melinta is party to several license agreements, under which it will be required to make payments based on the achievement of agreed-upon milestones or circumstances. As of December 31, 2025, Melinta was not obligated to make any of the future payments discussed below.

 

Wakunaga Pharmaceutical Co., Ltd. In May 2006, Wakunaga and Melinta executed a license agreement under which Melinta acquired rights to certain patents, patent applications, and other intellectual property related to BAXDELA. Melinta is obligated to pay royalties to Wakunaga on sales of BAXDELA. Under the license, Melinta has the right to grant sublicenses, although Wakunaga is entitled to a substantial portion of non-royalty income received from a sublicense of the Wakunaga technology. Wakunaga has certain termination rights, should Melinta fail to perform its obligations under the agreement, it becomes subject to bankruptcy or similar events, or Melinta’s business is transferred or sold and the successor requires us to terminate a substantial part of its development activities under the agreement. Melinta has the right to terminate the license for cause upon six months’ written notice to Wakunaga. Unless earlier terminated, the license agreement will continue in effect on a country-by-country and product-by-product basis until Melinta is no longer required to pay any royalties, which is the later of the date the manufacture, use or sale of a licensed product in a country is no longer covered by a valid patent claim, or a specified number of years following the first commercial sale in such country.

 

CyDex Pharmaceuticals, Inc. In November 2010, Melinta entered into a license and supply agreement with CyDex Pharmaceuticals, Inc. (now a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated, both hereafter referred to as Ligand) under which Melinta obtained an exclusive right, under certain patents and patent applications, to use Ligand’s beta sulfobutyl cyclodextrin, Captisol, in the development and commercialization of a BAXDELA product. In addition, under the terms of the license agreement, Melinta obtained a nonexclusive license to Ligand’s Captisol data package. Melinta is obligated to pay royalties to them based on our sales of BAXDELA. Melinta is obligated to certain diligence requirements and have the right to grant sublicenses to third parties. The license agreement provides for future payments to Ligand upon the achievement of a future commercial milestone, and obligations to make percentage royalty payments in the single digits based on net sales, if any, of the licensed product. Additionally, Melinta has agreed to purchase our requirements of Captisol from Ligand for use in a BAXDELA product, with pricing established pursuant to a tiered pricing schedule. Ligand has certain rights to terminate the agreement following a cure period, should Melinta fail to perform our obligations under the agreement. In addition, Ligand may terminate the agreement immediately if Melinta fails to pay milestones or royalties due under the agreement or if Melinta becomes subject to bankruptcy or similar events. Melinta has the right to terminate the license upon 90 days’ written notice to Ligand. Unless earlier terminated, the agreement will continue in effect until the expiration of our obligation to pay royalties. Such obligation expires, on a country-by-country basis, over a specified number of years following the expiration date of the last valid claim of a licensed product in the country of sale; if there has never been a valid claim of a licensed product in the country of sale, then such number of years after the first sale of the licensed product in such country.

AstraZeneca AB (“AZ”). In connection with the acquisition of Toprol XL, the seller assigned its rights, title, interests and obligations for the Toprol product in the U.S. under the supply and license agreements with AZ to Melinta, as a wholly-owned subsidiary of the Company. AZ is obligated to supply the Toprol product to Melinta in accordance with the supply agreement, and Melinta is obligated to pay royalties based on net sales of the Toprol product.

 

Mundipharma. In July 2022, Melinta entered into a license agreement with Cidara Therapeutics (“REZZAYO License Agreement”) (who in April 2024 sold all of its rights in REZZAYO to Napp Pharmaceutical Group Limited (“Napp”), a member of Mundipharma independent associated companies) to acquire an exclusive license to develop and sell REZZAYO in the U.S. Napp acquired of all assets and rights related to rezafungin globally, including ongoing development and distribution, while commercialization rights to rezafungin in the United States remain licensed to Melinta.

 

As of December 31, 2025, the commitments under the REZZAYO License Agreement  include a regulatory milestone of between $30 million and $40 million upon receipt of the marketing approval for the prophylaxis indication, a number of commercial milestones upon exceeding certain net sales targets, and net sales-based royalties. The agreement additionally stipulates that upon the earlier of thirty-days following the receipt of the marketing approval for the prophylaxis indication or on June 30, 2028, Napp shall assign and transfer to Melinta all rights, title and interest in and to all product filings for the current product in the U.S. Following the first anniversary of the contract effective date, Melinta may terminate this agreement, in its sole discretion, upon 90 days prior written notice; otherwise, this agreement shall expire on the expiration of Melinta’s obligation to pay royalties to Napp when there is no valid claim of the licensed patent rights in the United States.

 

In connection with the purchase of the active pharmaceutical ingredient (API) for VABOMERE, Melinta has committed to API deliveries from the CMO in 2026 with a total cost of €5.9 million, subject to inflation adjustments.

 

Other Commitments

 

In December 2024, the Company entered into a three-year agreement with Syneos Health Commercial Services, LLC (“Syneos”) under which Syneos agreed to provide a dedicated inpatient field sales force to exclusively promote DefenCath to hospitals and health systems. The Company paid an up-front implementation and was obligated to pay a fixed monthly fee.  The Company signed a termination agreement, effective October 1, 2025 whereas the related services to CorMedix were completed on December 31, 2025.  As of December 31, 2025, the Company has a total net obligation of $2.3 million, consisting of $1.3 million of accrued termination fees and $1.6 million of unpaid expenses incurred through Q4 2025, which will be partially offset by a security deposit of $0.6 million. We expect complete settlement to occur in Q1 2026.