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Privacy

CorMedix Privacy Statement

The following outlines CorMedix’s Privacy Statement regarding your use of our website, www.DefenCath.com (the “Website”). CorMedix is aware of our visitors’ concern for privacy when using this Website. We want our Website visitors to know what information we collect about them and how they can limit the use of individually identifiable information beyond the purposes for which they first provided it. This Privacy Statement applies solely to the information that we collect through this Website. This Privacy Statement does not address personal information that you provide to us in other contexts (e.g., through a business relationship not handled through the Website).

Acceptance of this Privacy Statement

Please be sure to read this entire Privacy Statement before using or submitting information to this Website. By using this Website, you agree with the terms of this Privacy Statement. Whenever you submit information via this Website, you consent to the collection, use, and disclosure of that information in accordance with this Privacy Statement. Your use of this Website is also subject to the Terms of Use for this Website, which is incorporated herein by reference.

Data We Collect and How We Use It

Personal Information

If you request information through www.DefenCath.com, we may collect personally identifiable information that may include your name, occupation, address, zip code, phone number, email address, survey information, Website registrations, dates of interactions with the Website and its content (e.g., registration date or date unsubscribed), or any other information that might reasonably be used to identify you individually (“Personal Information”). The Personal Information you provide is considered private and confidential. It may be collected by a third-party vendor that acts as a hosting service for our Website. This information may also be retained by an outside vendor for storage purposes.

We may also collect information obtained from you on registration forms used to process your requests for services and information, such as contact information (name, address, zip code, email address), password, username or code, age, date of birth, gender, ethnicity, medical condition, occupation, and transaction dates (e.g., registration date or date unsubscribed) (“Registration Information”). This Registration Information may also be gathered if you register for certain services via fax or mail. We may use this information to send you a welcoming email to verify your username and password, Website updates, special offers, notices regarding relevant medical conditions and treatment, or other information that is responsive to the data that you provide to us. Additionally, we may refer to your Personal Information and/or your Registration Information to better understand your needs, to improve our Website and our services, or to send updates or notices about our company and the products we offer that we think may be of interest to you.

We may also combine the Personal Information and/or Registration Information you provide with other generally or publicly available information to help us identify visitors’ preferences or interests. We may use the information to improve the content of our Website or our products and services. In addition, we may sell, rent, or otherwise share with unaffiliated entities any Personal Information and/or Registration Information we collect.

Non-Personally Identifiable Information

Our web server captures the Internet Protocol (IP) addresses of each connection to our Website and the specific web pages on our Website visited during that connection. An IP address is a number assigned to your computer by your internet service provider so you can access the Internet. An IP address is generally considered to be non-personally identifiable information because it changes periodically when you connect to the Internet. IP addresses may be used to diagnose problems with our server, report aggregate information, determine the fastest route for your computer to use in connecting to the Website, determine your general location, and administer and improve the Website. The IP address and related information that are collected are stored in the server log files and shared with third-party vendors that assist CorMedix with operating its Website. We may also use this information to help improve our Website and our services by better understanding our audience. We may also collect non-personally identifiable information in aggregate form to track data (e.g., the total number of visitors to each page of our Website) and the website from which the user came, if any. We may use this information, which remains in aggregate form, to understand how our visitors use our Websites so that we may make them better.

How We Disclose Personal Information

CorMedix may sell, rent, license, or trade your Personal Information that we collect to unaffiliated entities. Such unaffiliated entities may use your Personal Information for their marketing purposes.

Disclosures to Third Parties Assisting In Our Operations

CorMedix may share your Personal Information under confidentiality agreements with other companies that work with, or on behalf of, CorMedix to provide products and services. These companies may use your Personal Information to assist CorMedix in its operations. These companies may also have independent rights to use your Personal Information for their marketing purposes.

Disclosures Under Special Circumstances

We may provide information about you to respond to subpoenas, court orders, legal process, or governmental regulations, or to establish or exercise our legal rights or defend against legal claims. We believe it is necessary to share information in order to investigate, prevent, or take action regarding illegal activities, suspected fraud, situations involving potential threats to the physical safety of any person, or as otherwise required by law. In such circumstances, we will take appropriate measures to ensure that the requester understands the sensitive nature of the Personal Information that they may receive.

Business Transfers

We may share your Personal Information with other business entities in connection with the sale, assignment, merger, or other transfer of all or a portion of CorMedix’s business to such business entity. We will require any such successor business entity to honor the terms of this Privacy Statement.

Children’s Privacy Protection

Under Age 13

CorMedix understands the importance of protecting children’s privacy in the interactive online world. The Website is not designed for, or intentionally targeted at, children under 13 years of age. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. No one under the age of 13 should submit any Personal Information to CorMedix or the Website.

Under Age 18

Minors under 18 years of age may have the Personal Information that they have provided to CorMedix through the Website deleted by sending an email requesting deletion to privacy@cormedix.com. Please note that, while we make reasonable efforts to comply with such requests, deletion of your personal information does not ensure complete and comprehensive removal of that data from all systems.

How You Can Control and Update Data About You

Updating Contact Information

We want to be sure that we keep only the most accurate and up-to-date information about you in our records. Therefore, whenever you believe that your contact information needs to be updated, you can contact us using the information provided below under “Questions” to correct or update your contact information. You may choose at any time to remove your name, telephone number and postal and email addresses from the list we use to send notices or updates and elect not to receive correspondence from us by contacting us.

Data Integrity and Security

We take reasonable steps to protect your Personal Information as you transmit your information from your computer to our Website and to protect your information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. All information transmitted to this Website is secure to the extent possible using existing technology. You should keep in mind, however, that no Internet transmission or Website is ever 100% secure or error free. In particular, email sent to or from this Website may not be secure, and you should therefore take special care in deciding what information you send to us via email. While CorMedix has endeavored to create a secure and reliable Website for users, the confidentiality of any communication or material transmitted to/from the Website or via email cannot be guaranteed. Moreover, where you use passwords, ID numbers, or other special access features on this Website, it is your responsibility to safeguard them.

Cookies

We use “cookies,” a standard technology that is used by many websites. A cookie is a small piece of data that is sent from a web server to a web browser and stored locally on the user’s machine. The cookie is stored on the user’s machine but is not an executable program. Cookies are managed by your browser. They enable us to track each time you revisit our site. If you do not want us to be able to track your visits to our site, you can disable cookies by turning them off in your browser. You may also opt out of cookies being used on your web browser by adjusting the cookie settings for this Website via the cookie opt-out banner. Our cookies do not acquire any Personal Information. We use cookies to gather general traffic pattern and site usage information. We believe this allows us to continually improve our site for our users. CorMedix may sell, trade, lease, or reveal information that is obtained through cookies on your computer to a third party.

Response to “Do Not Track” Signals

Some Internet browsers include the ability to transmit “Do Not Track” signals. Since uniform standards for “Do Not Track” signals have not yet been adopted, CorMedix does not process or respond to “Do Not Track” signals.

Links

This Website may provide links to other websites as a service to our visitors. These are websites that we believe may have helpful information. However, we do not endorse, and are not responsible for, the content of third-party websites. Nor does CorMedix have any control over information you may choose to provide to those websites.

The Privacy Statement described here does not apply to third-party websites, even if they are linked to CorMedix’s Website. Other websites you visit may have their own privacy policies or no policy at all. Other websites might use Personal Information differently than our policy permits. We strongly encourage you to review the privacy policies of any website before providing any personal information.

Changes to this Privacy Statement

This Privacy Statement may be revised from time to time as we add new features and services, as laws change, and as industry privacy and security best practices evolve. We display an effective date on the policy in the upper right corner of this Privacy Statement so that it will be easier for you to know when there has been a change. If we make any change to this Privacy Statement regarding use or disclosure of Personal Information, we will provide advance notice on the Website. Small changes or changes that do not significantly affect individual privacy interests may be made at any time and without prior notice.

Questions

Questions about the CorMedix Privacy Statement may be directed to:CorMedix Inc.300 Connell Drive Suite 4200 Berkeley Heights, NJ TEL +1 908-517-9500 FAX +1 908-375-8272 EMAIL privacy@cormedix.com

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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