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Terms of Use

Welcome to our Website, www.DefenCath.com (the “Website”). CorMedix Inc. (“CorMedix”) owns, controls, and maintains this site for your information and education and as a service to the Internet community. By accessing information or materials on this Website, you acknowledge certain of our intellectual property rights and you accept, without limitation or qualification, that you are bound by the Terms of Use set forth below that supersede any other agreement between you and CorMedix covering our Website or the contents of the Website. We reserve the right to change these Terms of Use from time to time at our sole discretion and without notice, and such changes shall become effective when posted on the Website.

The product information provided on our Website is intended for residents of the United States.

ATTENTION: PLEASE READ THESE TERMS OF USE CAREFULLY BEFORE USING THIS WEBSITE. BY USING THIS WEBSITE, INCLUDING ANY SERVICES PROVIDED ON OR THROUGH THIS WEBSITE (WWW.DEFENCATH.COM), YOU INDICATE THAT YOU ACCEPT, WITHOUT LIMITATION OR QUALIFICATION, THESE TERMS OF USE. IF YOU DO NOT ACCEPT THESE TERMS OF USE, DO NOT USE THIS WEBSITE.

Limited License

All contents on our Website, including, but not limited to, pictures, illustrations, designs, icons, text, audio clips, and video clips (collectively, the “Site Content”), and all intellectual property rights therein, are owned, controlled, or licensed by CorMedix, our affiliates or partners, or other individuals or organizations and are protected by copyright. You may view and make a reasonable number of copies of materials made available on the public portions of our Website solely for non-commercial, personal, and informational purposes. You may not publicly distribute information or materials made available on the Website, and no use of the Website or the information therein is authorized other than the use expressly described in these Terms of Use. Any copy you make of this material or information shall retain all copyright and other proprietary notices in the same form and manner as the original. Except as specified above, nothing contained in this Website shall be construed as conferring by implication, estoppel, or otherwise, any license or right under any copyright, patent, trademark, or other intellectual property right of CorMedix or any third party. No other use of the information is authorized without the express written permission of CorMedix or the copyright owner. All other rights reserved.

User-Provided Ideas

CorMedix does not accept or consider unsolicited ideas submitted through, or in connection with, the Website. Notwithstanding the foregoing, you agree that any feedback, information, suggestions, ideas, or materials (e.g., text, photographs, caricatures, illustrations, designs, icons, articles, audio clips, videoclips, and other materials) you submit through, or in connection with, this Website (each, an “idea”) will not be subject to any use or disclosure restrictions and will be considered non-confidential by us. By providing ideas to us, you agree that we shall have, at no charge, a non-exclusive, transferable, royalty-free, perpetual, irrevocable, worldwide right and license to reproduce distribute, display, perform, and create derivative works of such ideas and to use, make, offer for sale, sell, and import products containing or based on such ideas. We shall be free to use and disseminate such ideas on an unrestricted basis for any purpose. In addition, we do not control ideas posted or otherwise transmitted via this Website by others and we do not guarantee the accuracy, integrity, or quality of such ideas. Any communications you send to this Website or otherwise to CorMedix by electronic mail, with the exception of personally identifiable information as defined in the CorMedix Privacy Statement on this Website, shall be deemed to be non-confidential.

Notice; Electronic Communications

When you visit the Website, submit information through it, or send emails to CorMedix, you are communicating with us electronically. You consent to receive communications from us electronically. We will communicate with you by email or by posting notices on the Website. You agree that all agreements, notices, disclosures, and other communications that we provide to you electronically satisfy any legal requirement that such communications be in writing.

Privacy

Our policies concerning the use of your personal information are set forth in the CorMedix Privacy Statement on this Website and incorporated by reference herein. By using this Website, submitting information through it, or using the services provided by or through this Website (“services”), you agree to waive and release CorMedix from any claim or liability in connection with the collection, use, or disclosure of information, including your personal information, consistent with the CorMedix Privacy Statement on this Website.

Medical Advice

The Site Content is provided for informational purposes only and should not be construed as medical, legal, financial, investment, or other professional advice or opinion. We do not offer personalized medical advice or patient-specific treatment advice. Only your doctor or other healthcare professional can determine if a product described on this Website is appropriate for you. Use of this Website is not a substitute for a call or visit to, or consultation with, your physician or a healthcare professional. You should not rely on this Website or any other service offered by or through this Website for medical diagnosis or treatment.

YOU SHOULD NEVER DISREGARD OR DELAY SEEKING MEDICAL ADVICE BECAUSE OF SOMETHING THAT YOU HAVE SEEN OR HEARD ON THIS WEBSITE. PLEASE CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTHCARE PROFESSIONAL, BEFORE USING ANY PRODUCT DISCUSSED ON THIS WEBSITE.

Disclaimer—Warranty

The Site Content is for your general education only and is not intended to provide advice or guidance or to be used for any commercial purpose. The identification or description of products or services of CorMedix or third parties on the Website is for informational purposes only and does not constitute a representation, warranty, guarantee, endorsement, or recommendation of such products and services. Although we have attempted to provide accurate information on our Website, we assume no responsibility for the accuracy of the Site Content. In particular, we may not update our Website on a daily or other regular basis. As such, the Site Content may be out of date or include omissions or other errors. We may update or change the Site Content at any time without notice.

All Site Content is provided “AS IS” and “AS AVAILABLE” without warranty of any kind. To the maximum extent permitted by law, CorMedix, its affiliates, and its collaborators disclaim all warranties, express or implied, regarding the Website and the Site Content therein, including the implied warranties of merchantability, fitness for a particular purpose, and non-infringement of third-party rights. We make no warranty that this Website will meet your requirements; that this Website will be uninterrupted, timely, secure, or error free; that messages or requests will be delivered; that defects will be corrected; or that this Website is free of viruses or other harmful components.

We make no warranty regarding any goods or services purchased or obtained through this Website or any transactions entered into through this Website. You assume the entire risk as to the results and performance of this Website and any goods or services purchased therefrom.

Indemnification

You agree to indemnify, defend, and hold harmless CorMedix, its officers, directors, employees, agents, licensors, and suppliers from and against all losses, expenses, damages, and costs, including reasonable attorneys’ fees, resulting from any violation of these Terms of Use or any activity related to your Internet account (including negligent or wrongful conduct) by you or any other person accessing the site using your Internet account.

Limitation of Liability

YOUR USE OF THE SITE IS AT YOUR OWN RISK. NEITHER CORMEDIX, NOR ANY OF ITS SUBSIDIARIES, AFFILIATES, OFFICERS, OR DIRECTORS, NOR ANY OF ITS AGENTS OR ANY OTHER PARTY INVOLVED IN CREATING, PRODUCING, OR DELIVERING THE SITE OR ITS CONTENT, ARE LIABLE FOR ANY DIRECT, INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR OTHER DAMAGES ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OF THE SITE, WHETHER BASED ON CONTRACT, TORT, STRICT LIABILITY, OR OTHERWISE, EVEN IF ADVISED OF THE POSSIBILITY OF ANY SUCH DAMAGES. Some states do not permit limitations or exclusions on warranties, so the above limitations may not apply to you.

Use of this Website

You agree not to do any of the following while visiting or using this Website or any services provided by or through this Website:

  • Impersonate or misrepresent your affiliation with any person or entity;
  • Submit personal information belonging to another person;
  • Except as expressly permitted by the rules of this Website, post or transmit any unsolicited advertising, promotional materials, junk mail, spam, or any other form of solicitation on this Website or through the services;
  • Post or transmit any information or material that is defamatory, offensive, indecent, obscene, or unlawful; Post or transmit any information or software that contains a virus, Trojan horse, worm, or other harmful components;
  • Violate any applicable law or regulation, including, without limitation, any local, state, provincial, national, or international law, any export control laws, or any regulations promulgated by any state or federal authority;
  • Access or use password-protected, secure, or non-public areas of this Website without authorization; or Frame, repackage, or otherwise re-distribute any portion of this Website.

CorMedix may, at its sole discretion, take any action we deem necessary, including, but not limited to, termination of access to this Website, if we believe a user’s conduct or content fails to conform to the terms and conditions provided in these Terms of Use or may create liability for CorMedix, our affiliates, partners, suppliers, or other users. CorMedix will not be liable to you or any third party as a result of such termination and modification. The terms and conditions provided in the Terms of Use will survive any such termination and modification.

Links

Our Website may contain hyperlinks to websites owned and/or controlled by other parties. Access to any other website is at your own risk, and we are not responsible for the accuracy or reliability of any information, data, opinions, advice, or statements accessible from these websites, and we do not make any representations or warranties about them. Third-party linked websites and their contents should not be attributed to CorMedix in any manner. We provide these hyperlinks merely as a convenience, and the hyperlinks are not an endorsement of any product, service, individual, or entity.

Reservation of Rights

Any rights not expressly granted in our Website are reserved to us. If any provision of these Terms of Use is held to be invalid or unenforceable, such provision shall be struck and the remaining provisions shall be enforced.

Trademarks

“DefenCath®,” the DefenCath logo®, “CorMedix®,” and the CorMedix logo® are registered trademarks of CorMedix Inc. Any use of these trademarks, except as permitted herein, is prohibited and may be in violation of trademark law and other laws. All trademarks, logos, trade names, trade dress, service marks, and products of CorMedix (collectively, “Marks”) displayed on our Website are the property of CorMedix or third parties, are protected in the United States and internationally, and may not be used for advertising or publicity purposes, or to indicate any affiliation with, or endorsement by, CorMedix. These Marks may not be used in whole or in part without the prior written permission of such owners.

Copyright 2024 CorMedix

All content included on the Website, such as text, graphics, logos, button icons, images, audio clips, digital downloads, data compilations, and software, is the property of CorMedix or its content suppliers and protected by United States and international copyright laws. The compilation of all content on the Website is the exclusive property of CorMedix and protected by United States and international copyright laws. All software used on the Website is the property of CorMedix or its software suppliers and protected by United States and international copyright laws. You agree not to change or delete any proprietary notices from materials printed or downloaded from the Website.

Copyright Complaints

CorMedix respects the intellectual property of others. If you believe that your work has been copied in a way that constitutes copyright infringement, please contact us at privacy@cormedix.com.

This Website is for U.S. Audiences Only

Access to and use of this Website is subject to the above Terms of Use. This Website was developed and is maintained by CorMedix. This information is intended only for residents of the United States.

Export Control

Software and other materials downloaded or otherwise made available from the Website may be subject to United States Export Control. The United States Export Control laws prohibit the export of certain technical data and software to certain territories. No software from the Website may be downloaded or exported into: Cuba, Iraq, Libya, North Korea, Iran, Sudan, Syria, or any other country to which the United States has embargoed goods (or to a national or resident thereof); or anyone on the United States Treasury Department’s list of Specially Designated Nationals or the United States Commerce Department’s Table of Deny Orders.

CorMedix does not authorize the downloading or exportation of any software or technical data from the Website to any jurisdiction prohibited by the United States Export Control Laws.

Dispute Resolution and Arbitration

Binding Arbitration

You and CorMedix agree that any legal dispute between you and CorMedix concerning or arising in any way out of these Terms of Use, the Privacy Statement, any purchase from CorMedix, any communications between you and CorMedix, or your participation in any other program or service provided by CorMedix shall be resolved through binding individual arbitration and not in court. The term “dispute” means any dispute, action, claim, or other controversy between you and CorMedix, whether in contract, warranty, tort, statute, regulation, ordinance, or any other legal or equitable basis. “Dispute” will be given the broadest possible meaning allowable under law. You understand and agree that you and CorMedix are waiving the right to sue or go to court to assert or defend your rights. If for any reason, a dispute proceeds or is being adjudicated in court, you and CorMedix both agree to waive any right to a jury trial. You may bring any individual claim in small claims court consistent with the jurisdictional and dollar limits that may apply, as long as it is brought and maintained as an individual claim.

Waiver of Right to Bring Class Action and Representative Claims

You and CorMedix understand and agree that there is no right to a judge or jury in arbitration. You and CorMedix agree that any dispute proceedings will proceed only on an individual basis, and not in a class, joint, consolidated, or representative action of any kind in court or arbitration. You and CorMedix each agree to hereby waive the right to a trial by jury, to assert or participate in any class action lawsuit or class action arbitration, any private attorney general lawsuit or private attorney general arbitration, and any joint, consolidated, or representative proceeding. The arbitrator is empowered to resolve any dispute with the same remedies available in court, including public injunctive relief. The arbitrator shall follow the terms of these Terms of Use.

How Arbitration Works

Each party―you or CorMedix―may initiate arbitration by sending to the other a request in writing with confirmation of receipt. The payment of filing, administrative, and arbitrator’s fees shall be governed by the American Arbitration Association (“AAA”) rules. The arbitration shall be conducted by the AAA pursuant to its Consumer Arbitration Rules (“AAA Rules”), as modified by these Terms of Use, including these arbitration provisions. The AAA Rules are available on the AAA’s website at www.adr.org, or by calling the AAA at (800) 778-7879. The arbitration hearing shall take place in the County of Union, New Jersey, United States of America, or at another mutually agreed upon location, or by video, telephone, or teleconference based on written submissions if the parties so agree.

Governing Law and Other Terms

By accessing the Website, or using any of the CorMedix services, you agree that the Terms of Use, including arbitration provisions, other provisions presented within, and the Privacy Statement, shall be governed by, and interpreted, construed, and enforced in accordance with, the Federal Arbitration Act and federal arbitration law and, to the extent that state law applies to any aspect of these Terms of Use, the applicable law will be the laws of the State of New Jersey without regard to the principle of conflict of laws. The parties agree that any issue concerning the validity of the class/representative action waiver above must be decided by an arbitrator. This Dispute Resolution & Arbitration provision of these Terms of Use survives the termination of your relationship with CorMedix.

Law and Jurisdiction

These Terms of Use and your use of the Website are governed by the laws of the State of New Jersey, without regard to the State of New Jersey’s choice of law provisions. The courts of general jurisdiction located within Berkeley Heights, New Jersey will have exclusive jurisdiction over any and all disputes (i) arising out of, relating to, or concerning these Terms of Use and/or the Website or (ii) in which these Terms of Use and/or the Website are a material fact.

Assignment

CorMedix may assign its rights and duties under these Terms of Use to any party at any time without notice to you.

Questions and Feedback

We welcome your questions, comments, and concerns about the Website. Please send us any and all feedback pertaining to the Website by contacting us at privacy@cormedix.com.

Survival

The provisions of these Terms of Use entitled “Disclaimer—Warranty,” “Indemnification,” “Limitation of Liability,” “Dispute Resolution and Arbitration,” “Law and Jurisdiction,” and “General Provisions” will survive the termination of this Agreement, as that term is defined in the “General Provisions.”

General Provisions

Except as provided in a particular “Legal Notice” on this Website, these Terms of Use, along with the CorMedix Privacy Statement, constitute the entire agreement and understanding between you and CorMedix with respect to use of the Website (the “Agreement”), superseding all prior or contemporaneous communications with CorMedix. These Terms of Use are severable and, in the event any provision is determined to be invalid or unenforceable, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions. A printed version of these Terms of Use shall be admissible in judicial or administrative proceedings based upon or relating to use of the Website to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. The section titles of this Agreement are displayed for convenience only and have no legal effect. Nothing in this Agreement shall be deemed to confer any third-party rights or benefit.

INDICATIONS AND USAGE

LIMITED POPULATION: DefenCath® is indicated to reduce the incidence of catheter‑related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

Limitations of Use

The safety and effectiveness of DefenCath have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.

Important Safety Information

CONTRAINDICATIONS

DefenCath is contraindicated in patients with:

  • Known heparin-induced thrombocytopenia (HIT).
  • Known hypersensitivity to taurolidine, heparin or the citrate excipient (components of DefenCath), or pork products.

WARNINGS AND PRECAUTIONS

  • Heparin-Induced Thrombocytopenia (HIT): HIT was reported in patients using heparin, a component of DefenCath, as a catheter lock solution. If HIT occurs, discontinue DefenCath and institute appropriate supportive measures.
  • Drug Hypersensitivity: Drug hypersensitivity reactions have been reported in patients using heparin, a component of DefenCath, as a catheter lock solution. If a hypersensitivity reaction occurs, discontinue DefenCath and institute appropriate supportive measures.

ADVERSE REACTIONS

The most frequently reported adverse reactions occurring in ≥2% of patients using DefenCath as a CLS were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.

To report SUSPECTED ADVERSE REACTIONS, contact CorMedix Inc at 1-844-424-6345 or FDA at 1-800-FDA-1088 or

.

Important Safety Information

CONTRAINDICATIONS

DefenCath is contraindicated in patients with:

  • Known heparin-induced thrombocytopenia (HIT).
  • Known hypersensitivity to taurolidine, heparin or the citrate excipient (components of DefenCath), or pork products.

WARNINGS AND PRECAUTIONS

  • Heparin-Induced Thrombocytopenia (HIT): HIT was reported in patients using heparin, a component of DefenCath, as a catheter lock solution. If HIT occurs, discontinue DefenCath and institute appropriate supportive measures.
  • Drug Hypersensitivity: Drug hypersensitivity reactions have been reported in patients using heparin, a component of DefenCath, as a catheter lock solution. If a hypersensitivity reaction occurs, discontinue DefenCath and institute appropriate supportive measures.

ADVERSE REACTIONS

The most frequently reported adverse reactions occurring in ≥2% of patients using DefenCath as a CLS were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.

To report SUSPECTED ADVERSE REACTIONS, contact CorMedix Inc at 1-844-424-6345 or FDA at 1-800-FDA-1088 or

.

INDICATIONS AND USAGE

LIMITED POPULATION: DefenCath® is indicated to reduce the incidence of catheter‑related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

Limitations of Use

The safety and effectiveness of DefenCath have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.

Please see the full Prescribing Information.

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