Everly Well, Inc.

Consent for Services

Last Modified: September 30, 2019

Introduction

This consent form (“Consent”) reviews the benefits, risks and limitations of you, as the person who has created a user account (referred to as “you” or “your”), utilizing the Services provided by Everly Well, Inc. (referred to as “EverlyWell”, “we”, “us” or “our”). It also explains how your information and sample(s) will be used after performance of the Services. Your sample(s) will not be processed unless you confirm that you have read and understood the contents of this form.

By clicking on the box, you indicate that this Consent is a binding agreement and that you have read and understood the following terms. Capitalized terms used but not defined in this Consent have the meaning given to them in our other policies.

By clicking your acceptance, you have chosen to use our Services and have given your informed consent to have your biological sample(s) tested for biomarkers and/or genes. Biological samples shall consist solely of human fluids and/or tissue samples, depending on the test purchased, that are intended to be analyzed for the individual’s sole use, and not for any other purpose, including but not limited to research, publications, commercial uses, or any other purpose other than to inform the purchaser’s health and/or wellness.

Voluntary Participation

Our Services are offered and available to users who are 18 years of age or older and are residents of the United States. Your use of EverlyWell’s Services is voluntary. It is your choice whether to utilize our Services or not. Prior to signing this Consent, you may wish to speak with a genetic counselor or your healthcare provider for further guidance about our Services.

Procedures and Protocol for EverlyWell Tests

When you create your Account, we will collect some information from you. We cannot perform the Services without collecting information from you but we will only collect information that will assist us in providing the Services that you have requested. In order for the Services to be provided as intended, you must provide accurate and correct information. Failure to provide required information or to execute required documents may result in your sample(s) not being tested.

All requests for non-genomic tests will be reviewed by a licensed physician (“Health Consultant”) affiliated with a company that we have partnered with to provide review and authorization of testing, review of lab results, prescriptions and counseling where applicable. Non-genomic test Services will not be provided to you if a Health Consultant does not authorize your request and order the applicable test(s). Requests for genomic tests do not require review by a Health Consultant. If your Services include both a non-genomic test and a genomic test, and a Health Consultant does not authorize the non-genomic test, the request for the accompanying genomic test will be canceled. We will refund the applicable fees for such canceled tests.

You will collect the biological sample(s) (i.e., blood, saliva, or urine) that will be provided to and tested by one of our designated testing laboratory partners (“Lab”). You will send the sample(s) directly to the Lab where your sample(s) will be tested for a number of biomarkers (including but not limited to vitamins, minerals, metabolites and hormones) and, if selected and purchased by you, genes that may inform your health choices.

The results of your test(s) will be made available to you through our Site. In the event we determine that a biological sample is not suitable for testing due to the content of the sample or because we believe the sample to have been submitted in violation of this Consent or the User Agreement, we reserve the right to withhold the results and to not provide a refund. We will determine and establish normal ranges for all tests in conjunction with our laboratory partners based on their validation and proficiency testing procedures. If your results are clinically significant or have a critical value that falls outside of our established normal ranges by at least a certain amount, a Health Consultant will make reasonable efforts to contact you.

Benefits

Utilizing our Services to discover what your genes and biomarkers say about you can help you gain a better perspective on your health and how your body functions. You may use this information to make more informed health care decisions and choices. A summary of the potential benefits of our tests is included below.

Product Name

Potential Benefits Include Learning More Information About:

Cholesterol & Lipids

Your current cholesterol and lipid levels, which are associated with cardiac and other health conditions.

Heart Health

Your current cholesterol and lipids levels, plus HbA1c and hs-CRP.

Food Sensitivity

Your body’s IgG levels for many foods common in Western diets. These biomarkers are related to your body’s sensitivities to certain foods. These are not allergy tests.

Food Sensitivity Expansion

Your body’s IgG levels for 88 foods common in Western diets. These biomarkers are related to your body’s sensitivities to certain foods. These are not allergy tests.

HbA1c

Your body’s ability to control glucose levels.

Heavy Metals

The current levels of a variety of heavy metals in your body.

Men’s Health Test

A broad set of hormones and other biomarkers associated with male health, including testosterone.

Metabolism

Biomarkers that reflect your body’s metabolism (ability to efficiently translate food into energy).

STD Test - Male & STD Test - Female

Whether you test positive for a range of common sexually transmitted diseases, including HIV/AIDS

Chlamydia and Gonorrhea

Part of our single marker STD suite, this test evaluates only Chlamydia and Gonorrhea infections.

Hepatitis C

Part of our single marker STD suite, this test evaluates Hepatitis C exposure.

Trichomoniasis

Part of our single marker STD suite, this test evaluates Trichomonas infection.

HIV

Part of our single marker STD suite, this test evaluates HIV exposure.

HPV Test - Female

This test detects the presence of 14 high risk HPV genotypes.

Sleep and Stress Test

Hormones and other biomarkers associated with sleep quality and stress.

Testosterone Test

Your current level of testosterone, which is commonly known as the male sex hormone.

Thyroid Test

The current function of your thyroid, which is related to a number of health conditions.

Vitamin D

Your body’s current level of Vitamin D. Low levels of Vitamin D are associated with a range of health conditions.

Vitamin D & Inflammation

Your Vitamin D and CRP levels.

Women’s Health

Hormones associated with reproductive potential and women’s health.

Women’s Fertility

Hormones that influence normal ovarian function.

Ovarian Reserve

A hormone (FSH) associated with the number and quality of a woman’s eggs.

Perimenopause

Current levels of hormones that change before menopause.

Post-menopause

Current levels of ovarian hormones after menopause.

Folic Acid

Your body's current level of Vitamin B9.

B Vitamins

Your body's current level of vitamins B6, B9, and B12.

Lyme Disease

This test detects the presence of antibodies associated with exposure to three common bacteria that cause Lyme Disease.

More information about the specific benefits of our tests and Services are available on our Site.

Risks

In order to utilize our Services, you must collect the appropriate biological sample(s) for the test(s). Some of our tests require a urine sample or a saliva sample; there are no risks associated with collecting urine or saliva samples using the containers provided in our test kit(s). Some of our tests require the collection of a blood sample. Although the risks and discomforts associated with a blood draw are very low, you might be at risk for excessive bleeding, fainting, feeling light-headed, bruising, hematoma (blood accumulating under the skin), or infection (a slight risk any time the skin is broken). If you have a history of excessive bleeding or fainting while having blood work done, we advise avoiding our tests that require self blood collection.

Disclosing certain information may make you uncomfortable. Our Services include genetic and biomarker tests that may reveal sensitive information about your health. You may learn about a trait that is mostly genetic and not largely affected or controllable by your behaviors. Genetic testing may also reveal incidental, unsought information (e.g., non-paternity, or that someone with your genotype may have a higher than average chance of developing a specific condition or disease). This information may be distressing.

Genetic information that you share with others could be used against your interests. Currently very few business or insurance companies request genetic information, but this could change in the future. While the Genetic Information Nondiscrimination Act of 2008 (GINA) generally prohibits health insurance companies, group health plans, and most employers from discriminating against you based on your genetic information, GINA does not cover companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not protect you against discrimination if you have already been diagnosed with the genetic disease.

Genetic information that you choose to share with your physician or other healthcare providers may become part of your medical record and through that route may be accessible to other healthcare providers and/or insurance companies in the future. Information that you share with family, friends or employers may also be used against your interests. Even if you share genetic information that has no or limited meaning today, that information could have greater meaning in the future as new discoveries are made.

EverlyWell, or the Health Consultant who reviews your results, may advise you to have a follow-up visit with your doctor after reviewing the results of your test. As a result, you may learn about health conditions and problems or potential health risks that you were not aware of before you utilized our Services. You may experience stress, anxiety, or emotional or physical discomfort when you learn about health problems or potential health problems. There may also be additional risks of utilizing our Services that are currently unforeseeable.

Limitations

OUR SERVICES DO NOT PROVIDE MEDICAL ADVICE. The information and content provided, including but not limited to text, graphics, images, videos, and other material contained in the Services, are for informational purposes only and are not intended as a substitute for professional medical advice, help, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you have regarding your medical care, and never disregard professional medical advice or delay seeking it because of something you have read on or via our Site. Nothing contained in the Services is intended to constitute a medical diagnosis or treatment. Reliance on any information appearing in the Services, including but not limited to information provided by EverlyWell or by other users of the Services, is solely at your own risk. By clicking your acceptance, you understand and agree that your results are not intended to be used for any diagnostic purposes and are not a substitute for professional medical advice. You understand that our Services are for information and educational use only; EverlyWell does not provide medical services, diagnosis, treatment, or advice.

EverlyWell does not warrant the accuracy, completeness, timeliness or usefulness of the opinions, content, services or other information provided through the Services or on the Internet generally. EverlyWell and its affiliates, licensors, and suppliers have no control over and accept no responsibility for your compliance with the laws applicable to your state of residence.

EverlyWell implements several safeguards to avoid technical errors, but as with all medical tests, there is a chance of a false positive or a false negative result. A false positive result means a genetic mutation or biomarker was detected, which is not in fact present. A false negative result means the test failed to identify a genetic mutation or biomarker that is in fact present. Other sources of error include sample mix-up, poor sample quality or contamination, inherent DNA sequence properties, and technical errors in the laboratory. Some biological factors, such as a history of bone marrow transplants or recent blood transfusions may limit the accuracy of the results or prevent the Services from being completed.

Genetic result interpretation is based on currently available information in the medical literature and scientific databases. The field of genetics is constantly changing and our understanding of genetics and biomarkers is evolving. New information may replace or add to the information that we used to interpret your results. We are not obligated to notify you if there is a new understanding of genetics or biomarkers that might result in a change to the interpretation of your results. We reserve the right to contact you, at our option, in the future.

Retention and Use of Your Information

We are subject to multiple laws on the retention of data. Accordingly, we retain any information collected about you for as long as we are required to maintain it for regulatory and compliance purposes or for a legal or business necessity.

You will send your biological sample(s) directly to the Lab that will conduct the test. EverlyWell has no obligations or liability regarding the retention of your sample(s). You understand that by providing any sample, having your sample processed, accessing your results, or providing information to us, you acquire no rights in any research or commercial products that may be developed by EverlyWell or its collaborating partners. You specifically understand that you will not receive compensation for any research or commercial products that include or result from your sample or information.

Your information and test results may be stored in a repository and used for validation, educational, and/or research purposes. By clicking your acceptance of this Consent, you acknowledge and agree that EverlyWell may de-identify the genetic information that is obtained from our Services and that we may aggregate this information with de-identified genetic information from other users. De-identification means that the personally identifiable information associated with your genetic information will be removed. (1) You understand that we would not disclose, sell and otherwise commercialize genetic information but (2) You understand that we may disclose, sell and otherwise commercialize de-identified non-genetic information / User Content without restriction.

We may incorporate different or additional technologies to test or analyze data in the future. We may, at our sole discretion, choose to test or analyze your data using such technologies. We are not obligated to notify you if we chose to conduct different or additional testing or analysis on your data. Your purchase of our Services does not automatically include any such different or additional technologies. You may have to pay additional fees in order to receive Services using any future or additional technologies or features.

Confidentiality

The Genetic Information Nondiscrimination Act of 2008 (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. Be aware that there are currently no United States federal laws that prohibit genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance, which may be governed by state law. GINA also does not protect you against discrimination if you have already been diagnosed with the genetic disease. You acknowledge that there are limitations to the protections afforded by this law and that the law and its protections may change in the future.

By clicking your acceptance of this Consent, you acknowledge that you have read and understand our Privacy Policy and HIPAA Privacy Authorization. You agree the EverlyWell is not liable for the unauthorized release of your results or information unless such unauthorized release was the result of gross negligence or willful misconduct on the part of EverlyWell.

Withdrawal of Consent

Your use of EverlyWell’s Services is voluntary. You may choose to withdraw your Consent or to stop using EverlyWell’s Services at any time. Such requests to should be sent to us by email at [email protected] or in writing at Everly Well Inc., 823 Congress Ave, Austin, TX 78701.

Please note that while any changes you make will be reflected in our databases within a reasonable period of time, we may retain your information in the ordinary course of business, for the satisfaction of our legal obligations, or where we otherwise reasonably believe that we have a legitimate reason to do so. Information that has already been de-identified, anonymized, or aggregated may not be retrievable or traced back for destruction, deletion, or amendment.

Legal Agreement

You give permission for EverlyWell, its representatives, affiliates, staff, agents, and designees to perform the requested Services on the sample(s) you provide and to disclose your information and results in accordance with our Privacy Policy and your HIPAA Privacy Authorization. You are not an insurance company or an employer attempting to obtain information about an insured person or an employee.

Contacting EverlyWell

If you have questions or comments about our Services or this Consent, please contact us by email at [email protected] , by phone at (512) 309-5588, by fax at (512) 857-0981, or in writing at Everly Well Inc., 823 Congress Ave, Austin, TX 78701.