Privacy Statement

Overview
This website (the “Site”) is owned and operated by Rare Disease Therapeutics (“RDT”). We recognize the importance of privacy to you and are firmly committed to protecting your privacy when you visit the Site. As a result, we have instituted this website privacy policy (“Privacy Statement”), which applies only to the operation of the Site. RDT is providing this notice to explain how we collect, use, disclose and protect the personal information that we collect from you in connection with your use of the Site. This Privacy Statement applies only to the use and collection of data collected by this Site and does not apply to any other data collected by us online or offline.

In general, you may visit the Site and view its content while remaining anonymous by not providing any personal information. By using the Site, you agree to the terms of this Privacy Statement and, if you provide us your personal information, you consent to the collection, use and disclosure of your information as described in this Privacy Statement. If you do not agree with this policy, please do not provide us any information and do not use the Site.

As used in this Privacy Statement, “we” includes RDT, its parents, subsidiaries, affiliates, and any third-party vendors we hire to assist in the administration of the Site, the collection, cataloging and/or analysis of data, and/or the processing or handling of any visitor transactions. These vendors are required to maintain the confidentiality of the user information and are prohibited from using it for any purpose other than as described in this Privacy Statement.

Registering with RDT
In order to use certain services provided on or through the Site, you may need to register with us, which will entail your disclosure and transmission of certain information about you. In connection with your registration, or at any time after registering, you may “opt-out” or unsubscribe from receiving any communications from us by following the unsubscribe instructions on the registration page, the Site or in any email you receive from us.

Information We Collect
If you register with us, we shall collect certain personal information provided by you, which includes your name, address, telephone number, e-mail address, and certain other personal, professional and demographic information about you.

Our Site may also collect non-identifiable information that becomes available to us as a result of your visit to our Site. This information includes, for example, your IP address (a number automatically assigned to your computer when you visit the Site, and which is logged by our servers), your Internet Service Provider (“ISP”), your web browser, the type of operating system, the domain name of the website which links you to our Site, the pages you visited, the average time spent on the Site, and the products searched for on the Site.

Because we are very interested in the successful dissemination of information through the Site, we will review visitor trends recorded on certain log files. In connection with such log files, analysis software will be used to generate reports that will allow us to determine how we can enhance your experience with our Site. This information will not be used to ascertain your identity or the substance of what you are viewing. The log files may be purged periodically, in our discretion, to maximize space on the server.

Collection of Personally Identifying Information from or about Children
RDT does not knowingly collect or solicit personal information from anyone under the age of 13 or knowingly allow such persons to register. If you are under 13, please do not attempt to register or send any information about yourself to us, including your name, address, telephone number, or email address. No one under age 13 may provide any personal information to RDT. In the event that we learn that we have collected personal information from a child under age 13 without verification of parental consent, we will delete that information as quickly as possible. If you believe that we might have any information from or about a child under 13, please contact us at web@raretx.com.

 

Use and Disclosure of Your Personal Information
The information we learn from visitors helps us personalize and improve the Site and services that we offer through the Site. We use your information to respond to your requests for information and to generate and maintain mailing lists.

We may also use your personal information for the following purposes:

• establishment and maintenance of our relationship with you;
• responding to your requests and inquiries;
• meeting legal, regulatory, insurance, security and processing requirements; and
• otherwise with your consent.

We will not share or sell personal information with unaffiliated third parties (including marketers), except as set forth in this Privacy Statement, unless we have clearly requested and obtained your explicit consent.

 

Other Uses
In addition, we may share your personally identifying information with any third-party, without your consent or approval and without notice to you, (i) as permitted or required by law, (ii) to protect and defend the rights of RDT and its employees or any other user of the Site, (iii) as incident to a corporate sale, merger, reorganization, dissolution, bankruptcy or similar event, (iv) under circumstances we believe reasonably necessary to protect the personal safety of our employees, users of the Site, or the public, (v) to disclose information that is necessary to identify, contact or bring legal action against someone who may be violating our published policies, (vi) to operate the Site properly, or (vii) as is otherwise described in this Privacy Statement.

 

Cookies
We from time to time use cookies on our Site. Cookies are small text files that your web browser leaves on your hard drive to recognize you as a repeat user of our Site, track your use of our Site and target advertising. This allows for personalization of certain aspects of your visit to our Site.

Information gathered from cookies in this way is only used on an aggregate basis. Unless a visitor specifically provides their identity to us, e.g., by registering at our Site, providing information through an online form or sending us correspondence from the Site, we will not know who the identification of individual visitors. We may use cookies to store preferences; record session information; develop information about Site visitors’ preferences and interests; record past activity at a website in order to provide better service when you return to our Site; or customize web page content based on information you voluntarily provide.

You can disable cookies using your Internet browser settings. Please consult your browsers’ help function for information on how to disable cookies. Note that if you disable cookies, certain features of our Site may not function properly.

Links
Our Site may contain links to other websites. Please recognize that we do not control these third party websites and this Privacy Statement will not apply to those websites. You should consult each applicable privacy policy before using another linked website.

 

Security
We have security measures in place to protect against the loss, misuse, and alteration of the information under our control. While we strive to ensure the integrity and security of our network and systems, we cannot guarantee that our security measures will prevent third-parties from intercepting information. You should not assume or expect that any communication that you transmit to us (such as personally identifiable or other data, questions or answers, comments, or suggestions) is confidential. RDT shall not be liable or responsible if any information about you is intercepted and used by an unintended recipient.

 

Access, Correction and Contacting Us
If you have questions about anything contained in this Privacy Statement, including how your personal information is used, if you wish to correct or change any information about you that we may have collected, or if you wish to opt-out of receiving any communications from us, you may contact us at web@raretx.com.

 

Privacy Statement Changes
This Privacy Statement may be revised from time to time by us in our sole discretion. Any changes will be effective upon posting of the revisions at this address. We may post changes or modifications to referenced policies and guidelines without your approval, and may determine whether and when any such changes apply to you. Your use of the Site following our posting of any changes will constitute your acceptance of such changes. Should you not wish to be bound by the modified Privacy Statement, do not use the Site.

 

This Privacy Statement was last revised on and is effective as of January 30, 2023.

 

Terms of Use

This website has been developed for U.S. audience only as a service of Rare Disease Therapeutics (“RDT”). By accessing and using this website (the “Web Site”), you agree to be bound by the Terms of Use (hereinafter, the “Terms” or “Agreement”) in effect at the time of each such access or other use. You also acknowledge that RDT may, from time to time, in its sole discretion and without notification to you, change these Terms. You should review the Terms each time you visit or use the Web Site. If you do not agree to these Terms, do not use the Web Site. Like any other service, in spite of our best efforts, the information in this Web Site may become out of date over time. As used in these Terms of Use, “we” includes RDT, its parents, subsidiaries, affiliates, and any third-party vendors we hire to assist in the administration of the Web Site, the collection, cataloging and/or analysis of data, and/or the processing or handling of any visitor transactions.

License and Access to the Web Site
No person under the age of eighteen (18) is authorized to access or use this Web Site. User access to, and use of, the Web Site is subject to all applicable international, federal, state and local laws and regulations. Use of this Web Site is void where prohibited. By using this Web Site, you represent and warrant that you are eighteen (18) years of age and that you have the right, authority and capacity to enter into this Agreement and abide by the Terms.

RDT grants you a limited, non-transferable license to access and use for non-commercial purposes the Web Site. Such limited license shall enable you to use the Web Site for informational purposes. This license shall not include any resale or commercial use of the Web Site or its contents; any derivative use of the Web Site or its contents; or any use of data mining, robots, or similar data gathering and extraction tools. You may not frame or utilize framing techniques to enclose any trademark, logo, or other proprietary information (including images, text, page layout, or form) of RDT or our affiliates without our prior express written consent.

RDT accepts no liability for the accuracy or completeness or use of, nor any obligation to update, the information contained on this Web Site. We make no guarantees regarding the availability of the Web Site. Furthermore, we reserve the right, within our sole discretion, to discontinue the Web Site. You agree that we will not be liable to you for any such discontinuance or modification of the Web Site. Any rights not expressly granted by these Terms are reserved by us.

You are under no obligation to use or continue to use the Web Site and may temporarily or permanently cease using the Web Site without notice to RDT. Any use of the Web Site, or any portion thereof, in violation of the foregoing shall constitute a violation of these Terms and may result in, among other things, termination or suspension of your rights to use the Web Site or any portion thereof.

Account Registration
In order to access certain portions of the Web Site, you may be required to register and create an account (“Account”) with RDT. Information gathered through the registration process and any other information related to your Account will be subject to these Terms as well as to our Privacy Statement. You represent and warrant that you are at least 18 years old and that all information provided by you when creating your Account is true, accurate and complete and that you will maintain, at all times, true, accurate and complete information related to your Account. Information related to your Account should be maintained by you in a confidential manner, as you are solely responsible for the usage of your Account by any third parties with respect to the Web Site. It is your responsibility to advise us if you are aware of any unauthorized access to your Account or if your Account information has been made available by you to third-parties in a manner that may result in unauthorized usage of the Account. In our sole and absolute discretion, we may terminate your Account for any reason (including for reasons related to unlawful or unauthorized usage) and we are under no obligation to retain a record of your Account or any data or information that you may have stored by means of the Account.

Restrictions on Your Use
All content within the Web Site and any materials made available on these pages for downloading, if any, are the property of RDT and/or its affiliates or other third parties. The Web Site and portions of the Web Site are protected by copyright and trademark laws. This Agreement does not grant any license to modify or alter the materials on the Web Site that are viewed, downloaded or otherwise accessed by you. You shall keep intact all proprietary notices, including copyright notices, contained on any downloadable materials. You shall be solely liable for any damages resulting from any infringement of copyright, trademark, or other proprietary right, or any and all harm resulting from your use of the Web Site.

To the extent applicable, when accessing the Web Site, you are required to use the security procedures currently or hereafter maintained by us to confirm that only authorized users have access to certain information provided at, or contained in, the Web Site. You are prohibited from utilizing alter-egos or other disguised identities when accessing the Web Site. All forms of indirect and ‘spoofed’ access are strictly prohibited.

Do not submit, post or otherwise transmit via the Web Site information that is proprietary or confidential of third parties (whether by law or by contract) or that you otherwise do not have the legal right to use. Any information, content or other material, including, but not limited to, any feedback, data, answers, questions, comments, suggestions, plans, ideas, user reviews or the like, which you send to us will be treated as being non-confidential and non-proprietary. We assume no obligation to protect confidential or proprietary information (other than those outlined in our Privacy Statement) from disclosure.

Intellectual Property Ownership
Any and all intellectual property rights associated with the Web Site, including, without limitation, any inventive concepts, know-how, publicity rights, trademarks, trade-dress, trade secrets, copyrights and patents (“Intellectual Property”) are the sole property of RDT, or third parties. Except as otherwise expressly authorized by these Terms, you may not copy, reproduce, modify, lease, loan, sell, create derivative works from, upload, transmit, or distribute the Intellectual Property of the Web Site in any way without the express written consent of RDT or the express written consent of the appropriate third party, as applicable. Except as provided herein, RDT does not grant to you any express or implied rights to RDT or any third party’s Intellectual Property.

Privacy Policy
Any personal information or other information about you collected by RDT through, or in connection with, this Web Site is subject to our Privacy Statement. The RDT Privacy Statement is incorporated into the terms of this Agreement by this reference. As indicated in these Terms, this Web Site is designed for adults of legal age (18 years and over). For questions about our online privacy policy for children please refer to the Privacy Statement.

Links
This Web Site may provide or include links to other world wide web sites or resources. While RDT attempts to provide links only to third-party websites that comply with all applicable laws and regulations and RDT’s standards, please understand that the content on these third-party websites is subject to change without notice to RDT. Because we have no control over such sites and resources, you acknowledge and agree that RDT is not responsible for the availability of such external sites, or resources, and does not endorse and is not responsible or liable for any content, advertising, products or other materials on or available from such sites or resources. YOU FURTHER ACKNOWLEDGE AND AGREE THAT RDT SHALL NOT BE RESPONSIBLE OR LIABLE, DIRECTLY OR INDIRECTLY, FOR ANY DAMAGE OR LOSS CAUSED OR ALLEGED TO BE CAUSED BY OR IN CONNECTION WITH USE OF OR RELIANCE ON ANY SUCH CONTENT, GOODS, OR SITES AVAILABLE ON OR THROUGH ANY SUCH SITE OR RESOURCE.

RDT prohibits caching of any portion of the Web Site and any unauthorized hypertext links to the Web Site. We reserve the right to disable any unauthorized links or frames. If you desire to provide a hyperlink from your website to the Web Site, you must contact RDT to discuss mutually agreeable terms for such hyperlink.

Exclusion of Warranty
RDT MAKES NO WARRANTY OF ANY KIND REGARDING THE WEB SITE AND/OR ANY MATERIALS PROVIDED ON THE WEB SITE, ALL OF WHICH ARE PROVIDED ON AN “AS IS” “AS AVAILABLE” BASIS. RDT DOES NOT WARRANT THE ACCURACY, COMPLETENESS, CURRENCY OR RELIABILITY OF ANY OF THE CONTENT OR DATA FOUND ON THE WEB SITE AND EXPRESSLY DISCLAIMS ALL WARRANTIES, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT, AND THOSE ARISING BY STATUTE OR OTHERWISE IN LAW OR FROM A COURSE OF DEALING OR USAGE OF TRADE. RDT DOES NOT WARRANT THAT THE WEB SITE, ITS SERVERS OR ANY E-MAIL SENT FROM IT ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS.

NEITHER RDT, NOR ITS AFFILIATES, MAKES ANY REPRESENTATIONS, WARRANTIES OR GUARANTEES REGARDING (1) THE OPERATION OR PERFORMANCE OF THE WEB SITE OR SERVICES, OR (2) THE INTERNET GENERALLY.

SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO THE ABOVE EXCLUSIONS MAY NOT APPLY TO YOU. YOU MAY ALSO HAVE OTHER RIGHTS THAT VARY FROM JURISDICTION TO JURISDICTION AND THAT MAY NOT BE LIMITED BY THESE TERM, PROVIDED HOWEVER YOU AGREE AND ACKNOWLEDGE THAT TO THE EXTENT PERMISSIBLE UNDER APPLICABLE LAW, YOU WAIVE ANY SUCH STATUTORY RIGHTS WITH RESPECT TO IMPLIED WARRANTIES.

Limitation of Liability
RDT ASSUMES NO RESPONSIBILITY, AND SHALL NOT BE LIABLE FOR, ANY DAMAGES TO, OR VIRUSES THAT MAY INFECT YOUR COMPUTER EQUIPMENT OR OTHER PROPERTY ON ACCOUNT OF YOUR ACCESS TO, USE OF, OR BROWSING IN THE WEB SITE OR YOUR DOWNLOADING OF ANY MATERIALS, DATA, TEXT, IMAGES, VIDEO OR AUDIO FROM THE WEB SITE. IN NO EVENT SHALL RDT BE LIABLE FOR ANY INJURY, LOSS, CLAIM, DAMAGE, OR ANY SPECIAL, EXEMPLARY, PUNITIVE, DIRECT, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND (INCLUDING, BUT NOT LIMITED TO LOST PROFITS OR LOST SAVINGS), WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY, OR OTHERWISE, WHICH ARISES OUT OF OR IS IN ANY WAY CONNECTED WITH ANY USE OF THE WEB SITE OR CONTENT FOUND THEREIN.

Jurisdictional Issues
Although this Web Site is accessible worldwide, not all information, products or services discussed or referenced herein are available to all persons or in all geographic locations. This Web Site is controlled and operated by RDT from its offices within Franklin, Tennessee, USA and is intended for U.S. audience only; therefore, the product information is intended only for residents of the United States, as other countries have different regulations related to medicines. RDT makes no representation that materials on this Web Site are appropriate or available for use in other locations. Those who choose to access this Web Site from other locations do so on their own initiative and are responsible for compliance with local laws.

Indemnity and Release
By using this Web Site, you agree to indemnify RDT and its parents, subsidiaries, affiliates, and their respective officers, directors, managers and employees and hold them harmless from any and all claims and expenses, including attorneys’ fees, arising from your use of the Web Site. By using the Web Site, you are hereby agreeing to release RDT and its parents, subsidiaries, affiliates, and their respective officers, directors, managers and employees from any and all claims, demands, debts, obligations, damages (actual or consequential), costs and expenses of any kind or nature whatsoever, whether known or unknown, suspected or unsuspected, disclosed or undisclosed, that you may have against them arising out of or in any way related to your use of the Web Site.

Severability and Integration
Unless otherwise specified herein, this Agreement constitutes the entire agreement between you and RDT with respect to this Web Site and supersedes all prior or contemporaneous communications and proposals (whether oral, written, or electronic) between you and RDT with respect to this Web Site. If any part of these Terms is held invalid or unenforceable, that portion shall be construed in a manner consistent with applicable law to reflect, as nearly as possible, the original intentions of the parties and the remaining portion shall remain in full force and effect.

Changes to the Terms
We may periodically modify and supplement these Terms and the notice provided to you will be the updating of these Terms. You are responsible for regularly checking these Terms for revisions. All amended Terms become effective upon our posting to the Web Site, and any use of the Web Site after such revisions have been posted signifies your consent and agreement to the modified Terms

This Agreement was last modified and is effective as of January 30, 2023.

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INDICATION

XROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years, with sickle cell anemia with recurrent moderate to severe painful crises.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

XROMI is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation.

WARNINGS AND PRECAUTIONS

Myelosuppression
Hydroxyurea causes severe myelosuppression. Do not initiate treatment with XROMI in patients if bone marrow function is markedly depressed. Bone marrow suppression may occur, and leukopenia is generally its first and most common manifestation. Thrombocytopenia and anemia occur less often and are seldom seen without a preceding leukopenia.

Evaluate hematologic status prior to and during treatment with XROMI. Provide supportive care and modify dose or discontinue XROMI as needed. Recovery from myelosuppression is usually rapid when therapy is interrupted.

Hemolytic Anemia
Cases of hemolytic anemia in patients treated with hydroxyurea for myeloproliferative diseases have been reported. In the setting of confirmed diagnosis of hemolytic anemia and in the absence of other causes, discontinue XROMI. Monitor blood counts throughout treatment.

Malignancies
Hydroxyurea is a human carcinogen. In patients receiving long-term hydroxyurea for myeloproliferative disorders (a condition for which XROMI is not approved), secondary leukemia has been reported.

Secondary leukemia has also been reported in patients treated with long-term hydroxyurea for sickle cell anemia. Leukemia has also been reported in patients with sickle cell anemia and no prior history of treatment with hydroxyurea.

All patients using XROMI should be followed up on a long-term basis with regular blood counts to detect development of leukemia.

Skin cancer has also been reported in patients receiving long-term hydroxyurea. Advise protection from sun exposure and monitor for the development of secondary malignancies.

Embryo-Fetal Toxicity
Based on the mechanism of action and findings in animals, XROMI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus.

Advise females of reproductive potential to use effective contraception during and after treatment with XROMI for at least 6 months after therapy. Advise males of reproductive potential to use effective contraception during and after treatment with XROMI for at least 6 months after therapy.

Vasculitic Toxicities
Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. If cutaneous vasculitic ulcers occur, institute treatment and discontinue XROMI.

Live Vaccines
Avoid use of live vaccines in patients taking XROMI as it may potentiate the replication of the virus and/or may increase the adverse reaction of the vaccine because normal defense mechanisms may be suppressed by XROMI. Vaccination with live vaccines in a patient receiving XROMI may result in severe infection. Patient’s antibody response to vaccines may be decreased. Consider consultation with a specialist.

Risks with Concomitant Use of Antiretroviral Drugs
Pancreatitis, hepatotoxicity, and peripheral neuropathy have occurred when hydroxyurea was administered concomitantly with antiretroviral drugs, including didanosine and stavudine.

Macrocytosis
XROMI may cause macrocytosis, which is self-limiting, and is often seen early in the course of treatment. The morphologic change resembles pernicious anemia, but is not related to vitamin B12 or folic acid deficiency. This may mask the diagnosis of pernicious anemia. Prophylactic administration of folic acid is recommended.

Laboratory Test Interference
Interference with uric acid, Urea, or lactic acid assays is possible, rendering falsely elevated results of these in patients treated with hydroxyurea. Hydroxyurea may falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems and may lead to hypoglycemia if sensor glucose results are relied upon to dose insulin.

ADVERSE REACTIONS

Most common adverse reactions (incidence >33%) are neutropenia and thrombocytopenia.

USE IN SPECIFIC POPULATIONS

• Females and Males of Reproductive Potential: XROMI is not approved in males or females of reproductive potential.
• Pediatric Use: Continuous follow-up of the growth of treated children is recommended.
• Renal Impairment: Reduce dosage and closely monitor the hematologic parameters when XROMI is administered to patients with renal impairment who have a creatinine clearance of less than 60mL/min.
• Hepatic Impairment: Close monitoring of hematologic parameters is advised in these patients receiving XROMI.

OVERDOSAGE

Acute mucocutaneous toxicity and neutropenia has been reported in patients receiving hydroxyurea at doses several times above the therapeutic dose. Soreness, violet erythema, oedema on palms and soles followed by scaling of hand and feet, severe generalized hyperpigmentation of the skin and stomatitis have been observed.

 

Please see complete Prescribing Information including BOXED Warning and Patient Information or at www.xromi.com/pi.

To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1-844-472-7389 or by email at safety@raretx.com or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.