What changed in this filing

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Item 3. Legal Proceedings

2022-03-29 compared with 2021-03-30 · 138 added, 96 removed, 2 unchanged (99% of the section changed)

September 9, 2014, we filed in the District Court of Mannheim, Germany a patent infringement action against TauroPharm GmbH and

Tauro-Implant GmbH as well as their respective CEOs, referred to as the Defendants, claiming infringement of our European Patent

EP 1 814 562 B1, which was granted by the EPO on January 8, 2014, or the Prosl European Patent.

The Prosl European Patent covers

a low dose heparin catheter lock solution for maintaining patency and preventing infection in a hemodialysis catheter.

action, we claim that the Defendants infringe on the Prosl European Patent by manufacturing and distributing catheter locking

solutions to the extent they are covered by the claims of the Prosl European Patent.

We believe that our patent is sound and are

seeking injunctive relief and raising claims for information, rendering of accounts, calling back, destruction and damages.

TauroPharm has filed an opposition with the EPO against the Prosl European Patent alleging that it lacks novelty and inventive

Legal Proceedings

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-cv014020-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.

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.

The complaint names as defendants the Company, Khoso Baluch, Matthew David, Phoebe Mounts, John L.

Robert Cook, Janet Dillione, Alan W.

Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F.

Costa, and Greg Duncan, as well as two underwriters

of the Company’s secondary stock offering, B.

Riley Securities, Inc.

and Needham & Company, LLC.

The purported bases for these

claims are alleged misstatements and omissions in connection with the NDA submitted to the FDA for DefenCath, and the subsequent notification

by the FDA that the NDA could not be approved in its present form.

The lead plaintiff purports to assert the Exchange Act claims on behalf

of persons that purchased or otherwise acquired shares of our securities between October 16, 2019, and September 6, 2021, and purports

to assert the Securities Act claims on behalf of persons that purchased shares of our securities pursuant or traceable to a secondary

offering of stock that commenced on November 27, 2020.

We intend to vigorously contest such claims and filed a motion to dismiss the current

complaint in full, with prejudice, on February 21, 2022.

As of this filing, the current schedule set by the Court requires us and the

other defendants to refile their motion to dismiss on March 28, 2022, requires the lead plaintiff to file an opposition to our motion

to dismiss on or before April 27, 2022 and requires that we file a reply on or before May 27, 2022.

On or about October 13, 2021, a purported shareholder,

derivatively and on our behalf, 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.

2:21-cv-18493-JXN-LDW.

The complaint names as defendants Khoso Baluch,

Janet Dillione, Alan W.

Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F.

Costa, Greg Duncan, Matthew David, and Phoebe Mounts, along

with us as Nominal Defendant.

The complaint alleges breaches of fiduciary duties, abuse of control, and waste of corporate assets

against the defendants and a claim for contribution for purported violations of Sections 10(b) and 21D of the Exchange Act against certain

We intend to vigorously contest such claims.

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 described in the foregoing paragraph is pending.

The stay may be terminated before the motion to dismiss is resolved according to certain circumstances described in the stipulation available

on the Court’s public docket.

On September 9, 2014, we filed in the District

Court of Mannheim, Germany a patent infringement action against TauroPharm GmbH and Tauro-Implant GmbH as well as their respective CEOs,

referred to as the Defendants claiming infringement of our European Patent EP 1 814 562 B1, which was granted by the EPO on January 8,

2014, or the Prosl European Patent.

The Prosl European Patent covers a low dose heparin catheter lock solution for maintaining patency

and preventing infection in a hemodialysis catheter.

In this action, we claim that the Defendants infringe on the Prosl European Patent

by manufacturing and distributing catheter locking solutions to the extent they are covered by the claims of the Prosl European Patent.

We believe that our patent is sound and are seeking injunctive relief and raising claims for information, rendering of accounts, calling

back, destruction and damages.

Separately, TauroPharm has filed an opposition with the EPO against the Prosl European Patent alleging

that it lacks novelty and inventive step.

We cannot predict the ultimate outcome of either of these related matters.

At present, the EPO has revoked the Prosl European

Patent as invalid, and we have filed an appeal, which is currently pending.

the same complaint against the same Defendants, we also alleged an infringement (requesting the same remedies) of NDP’s

utility model DE 20 2005 022 124 U1, referred to as the Utility Model, which we believe is fundamentally identical to the Prosl

European Patent in its main aspects and claims.

The Court separated the two proceedings and the Prosl European Patent and the

Utility Model claims were tried separately.

TauroPharm has filed a cancellation action against the Utility Model before the German

Patent and Trademark Office, or German PTO based on the similar arguments as those in the opposition against the Prosl European

Court issued its decisions on May 8, 2015, staying both proceedings.

In its decisions, the Court found that the commercialization

by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and

the Utility Model and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its

product in Germany.

However, the Court declined to issue an injunction in favor of us that would preclude the continued commercialization

by TauroPharm based upon its finding that there is a sufficient likelihood that the EPO, in the case of the Prosl European Patent,

or the German PTO, in the case of the Utility Model, may find that such patent or utility model is invalid.

Specifically, the

Court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art.

the District Court determined that it will defer any consideration of the request by us for injunctive and other relief until

such time as the EPO or the German PTO made a final decision on the underlying validity of the Prosl European Patent and the Utility

opposition proceeding against the Prosl European Patent before the EPO is ongoing.

Oral proceedings before the Opposition Division

at the EPO were held on November 25, 2015, at which the three-judge patent examiner panel considered arguments related to the

validity of the Prosl European Patent.

The hearing was adjourned due to the fact that the panel was of the view that Claus Herdeis,

one of the managing directors of TauroPharm, had to be heard as a witness in a further hearing in order to close some gaps in

the documentation presented by TauroPharm as regards the publication of prior art.

German PTO held a hearing in the validity proceedings relating to the Utility Model on June 29, 2016, at which the panel affirmed

its preliminary finding that the Utility Model was invalid based upon prior publication of a reference to the benefits that may

be associated with adding heparin to a taurolidine based solution.

At present, the

EPO has revoked the Prosl European Patent as invalid, and we have filed an appeal, which is currently pending.

In the same complaint against the same Defendants,

we also alleged an infringement (requesting the same remedies) of NDP’s utility model DE 20 2005 022 124 U1, referred to as the

Utility Model, which we believe is fundamentally identical to the Prosl European Patent in its main aspects and claims.

The Court separated

the two proceedings and the Prosl European Patent and the Utility Model claims were tried separately.

TauroPharm has filed a cancellation

action against the Utility Model before the German Patent and Trademark Office, or German PTO based on the similar arguments as those

in the opposition against the Prosl European Patent.

The Court issued its decisions on May 8, 2015,

staying both proceedings.

In its decisions, the Court found that the commercialization by TauroPharm in Germany of its TauroLock catheter

lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and the Utility Model and further that there is no prior use

right that would allow TauroPharm to continue to make, use or sell its product in Germany.

However, the Court declined to issue an injunction

in favor of us that would preclude the continued commercialization by TauroPharm based upon its finding that there is a sufficient likelihood

that the EPO, in the case of the Prosl European Patent, or the German PTO, in the case of the Utility Model, may find that such patent

or utility model is invalid.

Specifically, the Court noted the possible publication of certain instructions for product use that may

be deemed to constitute prior art.

As such, the District Court determined that it will defer any consideration of the request by us for

injunctive and other relief until such time as the EPO or the German PTO made a final decision on the underlying validity of the Prosl

European Patent and the Utility Model.

The opposition proceeding against the Prosl European

Patent before the EPO is ongoing.

Oral proceedings before the Opposition Division at the EPO were held on November 25, 2015, at which

the three-judge patent examiner panel considered arguments related to the validity of the Prosl European Patent.

The hearing was adjourned

due to the fact that the panel was of the view that Claus Herdeis, one of the managing directors of TauroPharm, had to be heard as a

witness in a further hearing in order to close some gaps in the documentation presented by TauroPharm as regards the publication of prior

The German PTO held a hearing in the validity

proceedings relating to the Utility Model on June 29, 2016, at which the panel affirmed its preliminary finding that the Utility Model

was invalid based upon prior publication of a reference to the benefits that may be associated with adding heparin to a taurolidine based

We filed an appeal against the ruling on September 7, 2016.

An oral hearing was held on September 17, 2019 in which the German Federal Patent Court affirmed the first instance decision that

the Utility Model was invalid.

The decision has only a declaratory effect, as the Utility Model had expired in November 2015.

On April 28, 2020, we filed a withdrawal of the complaint on the German utility model, thereby waiving our claims on these proceedings.

During the year ended December 31, 2020, costs in connection with the utility model infringement proceedings of approximately

$30,000 was reimbursed to TauroPharm .

November 22, 2017, the EPO in Munich, Germany held a further oral hearing in this matter.

At the hearing, the panel held that

the Prosl European Patent would be invalidated because it did not meet the requirements of novelty based on a technical aspect

of the European intellectual property law.

We disagree with this decision and have appealed the decision.

We continue to believe

that the Prosl European Patent is indeed novel and that its validity should be maintained.

There can be no assurance that we will

prevail in this matter.

In addition, the ongoing Unfair Competition litigation against TauroPharm is not affected and will continue.

January 16, 2015, we filed a complaint against TauroPharm GmbH and its managing directors in the District Court of Cologne, Germany.

In the complaint, we allege violation of the German Unfair Competition Act by TauroPharm for the unauthorized use of our proprietary

information obtained in confidence by TauroPharm.

We allege that TauroPharm is improperly and unfairly using our proprietary information

relating to the composition and manufacture of Neutrolin, in the manufacture and sale of TauroPharm’s products TauroLockTM,

TauroLock-HEP100 and TauroLock-HEP500.

We seek a cease and desist order against TauroPharm from continuing to manufacture and

sell any product containing taurolidine (the API of Neutrolin) and citric acid in addition to possible other components, damages

for any sales in the past and the removal of all such products from the market.

An initial hearing in the District Court of Cologne,

Germany was held on November 19, 2015 to consider our claims.

On January 14, 2016, the Court issued an interim decision in the

form of a court order outlining several issues of concern that relate primarily to the court’s interest in clarifying the

facts and reviewing any and all available documentation, in particular with regard to the question which specific know-how was

provided to TauroPharm by whom and when.

A further oral hearing in this matter was held on November 15, 2016.

In this hearing,

the Court heard arguments from CorMedix and TauroPharm concerning the allegations of unfair competition.

On March 7, 2017, the

Court issued another interim decision in the form of a court order outlining again several issues relating to the argumentation

of both sides in the proceedings.

Both parties have submitted further writs in this matter and the Court had scheduled a further

hearing for May 8, 2018.

After having been rescheduled several times, the hearing took place on November 20, 2018.

was rendered by the Court on December 11, 2018, dismissing the complaint in its entirety.

However, we intend to continue to pursue

this matter, and still believe firmly that our claims are well-founded.

We have therefore appealed in January 2019 and filed our

grounds of appeal in March 2019.

An oral hearing was held on September 6, 2019 in which our legal counsel brought forward further

arguments for the fact that the manufacturing process of the respective catheter locking solution is indeed protectable as a trade

In view of these new arguments, the Court issued an evidentiary order on September 27, 2019 ordering an expert opinion.

The expert opinion was not in our favor, but we have filed a response to the expert opinion in reaction to which the Court asked

the expert to supplement his opinion to address the issues brought forward in our submission.

In the supplementary expert opinion,

the expert confirmed his view.

We have filed another response and an oral hearing has been scheduled for February 5, 2021 but

was postponed to June 18, 2021 due to the COVID-19 situation in Germany.

Safety Disclosures

An oral hearing was held on September 17, 2019 in which the German

Federal Patent Court affirmed the first instance decision that the Utility Model was invalid.

The decision has only a declaratory effect,

as the Utility Model had expired in November 2015.

On April 28, 2020, we filed a withdrawal of the complaint on the German utility model,

thereby waiving our claims on these proceedings.

On November 22, 2017, the EPO in Munich, Germany

held a further oral hearing in this matter.

At the hearing, the panel held that the Prosl European Patent would be invalidated because

it did not meet the requirements of novelty based on a technical aspect of the European intellectual property law.

We disagree with this

decision and have appealed the decision.

We continue to believe that the Prosl European Patent is indeed novel and that its validity

should be maintained.

There can be no assurance that we will prevail in this matter.

On January 16, 2015, we filed a complaint against

TauroPharm GmbH and its managing directors in the District Court of Cologne, Germany.

In the complaint, we allege violation of the German

Unfair Competition Act by TauroPharm and that TauroPharm is improperly and unfairly using our proprietary information relating to the

composition and manufacture of Neutrolin, in the manufacture and sale of TauroPharm’s products TauroLockTM, TauroLock-HEP100 and

TauroLock-HEP500.

We sought a cease and desist order against TauroPharm from continuing to manufacture and sell any product containing

taurolidine (the API of Neutrolin) and citric acid in addition to possible other components, damages for any sales in the past and the

removal of all such products from the market.

Hearings in this matter were held in the District Court of Cologne, Germany on November

19, 2015, on November 15, 2016 and on November 20, 2018.

A decision was rendered by the Court on December 11, 2018, dismissing the complaint

in its entirety.

We appealed in January 2019.

An oral hearing was held on September 6, 2019.

In view of new arguments brought forward

in this hearing, the Court issued an evidentiary order on September 27, 2019 ordering an expert opinion.

The expert opinion was not in

In a supplementary expert opinion submitted after we had brought forward arguments against the first expert opinion, the expert

confirmed his view.

In an oral hearing held on June 18, 2021, the Court only heard from the expert, and the Court as well as both parties

asked further questions to the expert around his expert opinion.

At the end of the hearing and internal deliberation among the panel of

judges, the Court indicated that it would dismiss our complaint if we did not withdraw the appeal.

As there were no advantages to further

pursuing the matter in view of the Court’s statements, we withdrew the appeal and the proceedings are therefore now closed.

requested an increase of the value in dispute determined by the Court in order to receive a higher reimbursement of costs (as this is

based on the value in dispute under German law) but the request was rejected in view of arguments brought forward against it by our legal

We will have to reimburse costs in the amount of approximately $41,000 plus interest to TauroPharm.

Mine Safety Disclosures

Not applicable.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 3. Legal Proceedings