IMPORTANT SAFETY INFORMATION:

Terms and Conditions of Use

Terms of Use

Effective Date: June 14, 2021

These Terms of Use (“Terms of Use” or “Terms”) describe the rules for visitors to this QOL Medical LLC (“we”, “us”, “our”, or “QOL Medical”) website (“Website”). Access to and use of our Website is subject to these Terms and all applicable laws. By using our Website, you agree to these Terms and all other rules, policies, and procedures without limitation or qualification. If you do not agree to the Terms, do not access or otherwise use any of our Website.

About QOL Medical

QOL Medical is formed under the laws of the State of Delaware with its headquarter offices located at 3405 Ocean Dr., Vero Beach, FL 32963.

Medical Disclaimer

THIS WEBSITE DOES NOT PROVIDE MEDICAL ADVICE OR PROFESSIONAL ADVICE. Nothing contained within the Website is intended to constitute as medical advice, instruction for medical diagnosis, or instruction for treatment. Any information provided through the Website should be considered to be hypothetical, and not be considered complete, nor should it be relied upon to suggest a course of treatment for any particular individual. Information received from the Website should not be relied upon for personal, medical, legal, technical, or financial decisions. QOL Medical does not, through the Website or otherwise, directly or indirectly practice medicine, render medical advice, or provide medical services. After reviewing the Website and before taking any action related to any content on the Website, you are expected to make a reasonable investigation into, and consider the potential consequences of, any such action. This includes, but is not limited to, talking to your doctor to determine the best course of treatment for your individual condition. If you obtain any information through the Website, you use such information at your own risk.

This website contains information about products and therapies that may not be approved, cleared, or authorized in your geography. You may see information about products or therapies that are not available in your country.

IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY, CALL YOUR DOCTOR OR 911 (OR OTHER APPLICABLE EMERGENCY NUMBER) IMMEDIATELY.

General Disclaimer

Although we have attempted to provide accurate information on our Website, we assume no responsibility for, and do not guarantee, the accuracy, effectiveness, and suitability of any information contained on this Website. This information is presented “AS IS” and may include technical inaccuracies or errors. We may change the information provided on our Website at any time, without notice.

QOL Medical Copyrights and Trademarks

You agree to abide by all copyright notices, trademark rules, information, and restrictions contained in our Website, and you won’t use, copy, reproduce, modify, translate, publish, broadcast, transmit, distribute, perform, upload, display, license, sell, commercialize or otherwise exploit for any purpose any of our Website (i) without the prior consent of the owner or (ii) in a way that violates someone else’s (including QOL Medical) rights. You won’t modify, publish, transmit, participate in the transfer or sale of, reproduce (except as expressly provided in this Section), create derivative works based on, or otherwise exploit any of the Website. Subject to these Terms, you may e-mail, download, or print copies of materials on this website for personal, noncommercial use or for purposes of using our Website only.

Product names and services on this Website belong to us and are protected by the United States and foreign trademark laws. Use of these trademarks or service marks without express written consent is strictly prohibited.

Title to materials remains with us or with the authors of the materials contained on this Website. All rights not expressly granted are reserved.

Use of materials or trademarks on this Website in a manner not clearly allowed by these Terms constitutes a violation of your agreement with us and may be in violation of copyright, trademark, and other laws. If this is the case, we will automatically revoke your permission to use this Website.

Your Privacy

These Terms, and any personally identifiable information in electronic communications to our Website, are additionally governed by our Privacy Policy.

User Submissions

Anything you post, upload, share, store, or otherwise provide through our Website, including any feedback, comments, ideas, inventions, concepts, techniques or know-how disclosed therein, is your “User Submission” and will be treated as non-confidential and non-proprietary. You are solely responsible for all User Submissions you contribute to the Website. You represent that all User Submissions submitted by you are accurate, complete, up-to-date, and in compliance with all applicable laws, rules and regulations. All such information becomes the property of QOL Medical or its affiliates and may be used, without compensation to you, for any purpose whatsoever, including disclosure to third parties and/or developing, manufacturing and/or marketing products or services.

Third Party Websites

This Website may contain links to websites operated by other parties. These linked websites are not under our control, and we are not responsible for the content available on any other websites linked to this Website which are not affiliated with QOL Medical. Such links do not imply our endorsement of material on any other website and we disclaim all liability with regard to your access to such linked websites. We provide links to other websites as a convenience to users, and access to any other websites linked to this Website is at your own risk.

Third Party Content

Certain content from third parties may be made available as part of our Website. We do not endorse or guarantee the accuracy or completeness of this content.

Additional Policies

In addition to these Terms of Use, the Privacy Policy, you may be subject to additional terms that may apply when you access particular services or materials on certain areas in this Website, such as when you follow a link from this Website. Please read our Privacy Policy to learn how we protect and use information that we gather through this website.

Compliance with Laws

You agree to comply with all applicable laws, statutes, ordinances and regulations regarding your use of our Website. We may, in our sole discretion, report actual or perceived violations of law to law enforcement or other appropriate authorities. If we become aware, through a complaint or otherwise, of any potential or suspected violation of these Terms of Use, we may (but are not obligated to): conduct an investigation to determine the nature and extent of the suspected violation and the appropriate enforcement action, during which investigation we may suspend access to our Website to any user being investigated and/or remove any material from our servers. You agree to cooperate fully with any such investigation. You acknowledge that violations of these Terms of Use could subject you to criminal or civil penalties.

Violations

We reserve the right to seek all remedies available at law and in equity for violations of these Terms of Use, including the right to block access from a particular Internet address to our Website.

NO WARRANTIES.

ALL CONTENT ON THIS WEBSITE IS PROVIDED TO YOU ON AN “AS IS,” “AS AVAILABLE” BASIS. QOL MEDICAL AND ITS LICENSORS, SUPPLIERS, PARTNERS, PARENT, SUBSIDIARIES OR AFFILIATED ENTITIES, AND EACH OF THEIR RESPECTIVE OFFICERS, DIRECTORS, MEMBERS, EMPLOYEES, CONSULTANTS, CONTRACT EMPLOYEES, REPRESENTATIVES AND AGENTS, AND EACH OF THEIR RESPECTIVE SUCCESSORS AND ASSIGNS (QOL MEDICAL AND ALL SUCH PARTIES TOGETHER, THE “QOL MEDICAL PARTIES”) HEREBY DISCLAIM ALL WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. THE QOL MEDICAL PARTIES MAKE NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE.

THE QOL MEDICAL PARTIES MAKE NO REPRESENTATIONS OR WARRANTIES THAT USE OF THIS WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. YOU ARE RESPONSIBLE FOR TAKING ALL PRECAUTIONS NECESSARY TO ENSURE THAT ANY CONTENT YOU MAY OBTAIN FROM THIS WEBSITE IS FREE OF VIRUSES AND ANY OTHER POTENTIALLY DESTRUCTIVE COMPUTER CODE.

Some jurisdictions do not allow limitations on implied warranties, so one or more of the above limitations may not apply to you.

LIMITATION OF LIABILITY.

TO THE FULLEST EXTENT ALLOWED BY APPLICABLE LAW, YOU AGREE THAT NEITHER ANY QOL MEDICAL PARTY NOR ANY OTHER PERSON OR COMPANY ASSOCIATED WITH QOL MEDICAL SHALL BE LIABLE FOR ANY DAMAGE RESULTING FROM YOUR USE OR INABILITY TO USE THIS WEBSITE OR THE MATERIALS ON THIS WEBSITE. THIS PROTECTION COVERS CLAIMS BASED ON WARRANTY, CONTRACT, TORT, STRICT LIABILITY, AND ANY OTHER LEGAL THEORY. THIS PROTECTION COVERS ALL LOSSES INCLUDING, WITHOUT LIMITATION, DIRECT OR INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, AND PUNITIVE DAMAGES, PERSONAL INJURY/WRONGFUL DEATH, LOST PROFITS, OR DAMAGES RESULTING FROM LOST DATA OR BUSINESS INTERRUPTION. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL OR CERTAIN OTHER DAMAGES, SO THE ABOVE LIMITATION AND EXCLUSIONS MAY NOT APPLY TO YOU.

Changes to these Terms of Use

We reserve the right to revise these Terms of Use or any portion of them at any time by updating this posting on our Website, sending you an email, and/or notifying you by some other means. If you use the Services in any way after revisions to the Terms are effective, you are bound by any such revisions. You should periodically visit this page to review the current Terms of Use that apply to your use of our Website.

Other Rules

Provisions that, by their nature, should survive termination of these Terms of Use will survive termination of these Terms of Use. By way of example, all of the following will survive termination: any obligation you have to indemnify us, any limitations on our liability, any terms regarding ownership or intellectual property rights, and any terms regarding disputes between us.

If any provision of these Terms of Use is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of these Terms of Use, which shall remain in full force and effect. No waiver of any of these Terms of Use shall be deemed a further or continuing waiver of such term or condition or any other term or condition.

You agree to indemnify and hold the QOL Medical Parties harmless from and against any and all claims, liabilities, damages (actual and consequential), losses and expenses (including attorneys’ fees) arising from or in any way related to any claims relating to (a) your use of the Website (including any actions taken by a third party using your account), and (b) your violation of these Terms, the Privacy Policy. In the event of such a claim, suit, or action (“Claim”), we will attempt to provide notice of the Claim to the contact information we have for your account (provided that failure to deliver such notice shall not eliminate or reduce your indemnification obligations hereunder).

These Terms of Use are governed by the internal substantive laws of the State of Florida, without respect to its conflict of laws principles, and the federal laws of the United States.

The Terms of Use will be venued exclusively in the courts of the State of Florida located in Indian River County or the federal district court for the Southern District of Florida located in Ft. Pierce, Florida. You hereby irrevocably consent and submit to the personal jurisdiction of said courts for all such purposes. However, we retain the right to bring legal proceedings in any jurisdiction where we believe that infringement of these Terms of Use is taking place or originating.

CONTACT / ADDRESS FOR ALL LEGAL NOTICES
QOL Medical, LLC
Attn: Legal Department
3405 Ocean Dr.
Vero Beach, FL 32963

Important Safety Information for Sucraid® (sacrosidase) Oral Solution

  • Sucraid® may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away.
  • Tell your doctor if you are allergic to, have ever had a reaction to, or have ever had difficulty taking yeast, yeast products, papain, or glycerin (glycerol).
  • Sucraid® does not break down some sugars that come from the digestion of starch. You may need to restrict the amount of starch in your diet. Your doctor will tell you if you should restrict starch in your diet.
  • Tell your doctor if you have diabetes, as your blood glucose levels may change if you begin taking Sucraid®. Your doctor will tell you if your diet or diabetes medicines need to be changed.
  • Some patients treated with Sucraid® may have worse abdominal pain, vomiting, nausea, or diarrhea. Constipation, difficulty sleeping, headache, nervousness, and dehydration have also occurred in patients treated with Sucraid®. Check with your doctor if you notice these or other side effects.
  • Sucraid® has not been tested to see if it works in patients with secondary (acquired) sucrase deficiency.
  • NEVER HEAT SUCRAID® OR PUT IT IN WARM OR HOT BEVERAGES OR INFANT FORMULA. Do not mix Sucraid® with fruit juice or take it with fruit juice. Take Sucraid® as prescribed by your doctor. Normally, half the dose of Sucraid® is taken before a meal or snack and the other half is taken during the meal or snack.
  • Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Indication

Sucraid® (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of Congenital Sucrase-Isomaltase Deficiency (CSID).