Informed Consent

Genomic Data Interpretation Services Agreement

This Genomic Data Interpretation Services Agreement (the “Agreement”) is entered into by and between MoodNote LLC, (“MoodNote”) a Nevada corporation, and You or Your. MoodNote and You may each be referred to individually as a “Party” and collectively as the “Parties.”

Background

MoodNote is a data analysis, interpretation and education company dedicated to improving healthcare by making its proprietary genomic data interpretation tools, analytics and clinical decision support technology available to individual consumers, physicians, researchers and others.

You are an individual interested in submitting your genomic data for genomic analysis, bioinformatics analysis and interpretation.

Agreement

In consideration of the mutual promises described below, the Parties agree as follows:

1. Services. Upon request and during the Term of this Agreement, MoodNote will provide You with certain genomic data interpretation services (“Services”) in accordance with the terms of this Agreement. You may request Services by providing MoodNote with a signed consent form and a genomic data as a fastq, bam, vcf or other file format that meets MoodNote’s current data processing guidelines. MoodNote will perform your submitted data interpretation services using established procedures for such analyses and certain proprietary algorithms. Data interpretation results will be made available to you through an innovate genome viewing tool known as Genomic Avatar.

2. Fees and Invoices. MoodNote will bill you for Services provided to you.  You agree to pay MoodNote $195 for each DNA dataset interpretation ordered under this Agreement. This fee does not include any applicable State or Federal taxes, which are Your responsibility. Pricing of repeated interpretations must be mutually agreed upon in writing between the Parties. Invoices under this Agreement are due and payable prior to the generation and release of an electronic report by MoodNote. The fee listed above does not include any applicable server fees, internet fees or any other software or hardware (e.g. a computer or an ipad, etc.) costs that may be required for MoodNote to function properly, and that you may incur.

3. Health Care Responsibility. MoodNote is not a health care company and does not provide any medical or other health care services. Our genomic data interpretation process is fully automated with only a minimal human input for styling and organizing the report.

1. 1. Any decisions related to healthcare and treatment choices should be based on the independent judgment of the treating health care provider and should consider all information related to the patient, including without limitation, the patient and family history, direct physical examination and pertinent laboratory, psychological and other tests. Your health care provider is solely responsible for health care that may be provided or not provided to you. You agree that:
      1. MoodNote does not recommend, endorse, or make any representations about the efficacy or appropriateness of any therapy, tests, procedures, or treatments described in any report or information made available to you;
      2. Reports and information provided by MoodNote should be reviewed by a treating health care provider who is responsible for decisions regarding Your care;
      3. You are solely responsible for Your use of reports and information made available to You by MoodNote via Genomic Avatar. Interpretations provided by MoodNote are also subject to any notes, explanations, limitations, and disclaimers included in the reports.

Terms & Conditions, Privacy

Scope

By using the Service you accept Terms and Conditions. Please read them carefully. MoodNote provides you with a software application for browsing your genome. It enables Your access to your personal genetic data through a simple interface and straightforward graphic presentation of data. MoodNote uses proprietary algorithms to stratify and annotate your genomic data with health information available from publicly accessible databases.

Disclaimer

MoodNote and MoodNote’s web browser  are not medical devices. Information that is accessible through this website is not intended to diagnose, prevent or treat any disease or condition. MoodNote’s annotation of DNA variants is intended for educational and informational purposes only. Only a trained and duly licensed health care professional, after having conducted a thorough and direct examination, can diagnose or treat an emotional, psychological, psychiatric, neurological, genetic or medical condition. If you have any concerns about your health, please contact a qualified health care professional who is duly licensed in your jurisdiction. If you feel suicidal or have a medical emergency, please call 911 or proceed to the nearest emergency room.

Risks

1. 1. There are risks of using genomic data interpretation services provided by MoodNote. You may learn information about yourself that you did not anticipate. You may discover things about yourself that may trouble you and that you may not have the ability to control or change. These outcomes could have social, legal, economic and psychological implications.
   2.  Interpretations of DNA variants made by MoodNote may be erroneous, ambiguous or incorrect.
   3. There is a small chance that your data may be lost, damaged or intercepted by third parties during their transmission through the internet.
   4. You should not change your health behaviors on the basis of the information obtained from MoodNote. If you have concerns or questions about what you learn through MoodNote, you should seek guidance from your genomics-competent health care provider.
   5. MoodNote’s interpretation of your genomic data is based on thousands of research papers published in peer-reviewed medical and scientific journals conducted by parties outside of the control of MoodNote LLC. Not all research studies are accurate, it is not possible to review them all, and they may not disclose all information.
   6. Future research may change today’s interpretation of DNA variants and future research may show today’s research to be incomplete or inaccurate. Because interpretations provided by MoodNote rely on these published studies, some interpretations may not be applicable to you.
   7. If you share your DNA data with others, these data may be used against your interests. DNA variant interpretations shared with your health care providers may become part of your medical record. Through that path it may become accessible to other health care providers, health care provider organizations such as HMOs, PPOs, other private or government organizations, and insurance companies. DNA data that you share with family, friends may no longer be under your control. Even if you share your DNA data that today have no or only a limited meaning, these data may have greater meaning in the future.

Privacy

MoodNote will not share your data with third parties except for your designed health care provider (physician, counselor, genetic coach or other person) whom you explicitly designate to share these results with. MoodNote LLC will never sell or otherwise communicate information about your DNA data to third parties without your explicit authorization, nor shall we share it with law enforcement unless compelled to do so by a court order. However, it is important to understand that using MoodNote Services involves transmission of your genetic data through internet and therefore complete privacy cannot be guaranteed. Further, MoodNote may use Google (www.google.com, www.appsheet.com) servers for its operation of which we have no control.

MoodNote LLC employs robust security measures to protect against unauthorized access to or unauthorized alteration, disclosure, or destruction of stored data. Our security program includes regular reviews of our security measures and systems. All genomic data in MoodNote’s possession are stored on encrypted drives with no connection to internet. As with any security system, we cannot guarantee that our systems can never be breached. Except as described in this document, external parties will not be given any of your information without your written and explicit consent, or when required to comply with legal requirements under the applicable laws. If we are legally compelled to provide this information, we will attempt to notify you before providing your information to external parties unless such notification is prohibited by law.

Intellectual Property

Except to the extent expressly stated otherwise, this Agreement does not grant either Party a license to or any right in the other Party’s intellectual property.

Copyright

All MoodNote application design, texts, images, graphics, other content, and any part or arrangements thereof, as well as all proprietary software, algorithms, pipelines or other features used on the website and/or application are the property of MoodNote LLC or are used by MoodNote LLC under license. Any use of materials on this application including their reproduction, modification, distribution, reverse engineering or republication without the prior written consent of MoodNote LLC is strictly prohibited.

The original works incorporated into MoodNote services are either proprietary works or works in public domain and where appropriate we provide citations to such works acknowledging the intellectual contribution of their authors, publishers or academic institutions of origin. If you are a valid copyright holder for a work used in part on Genomic Avatar, and you believe that such use violates your copyright, please send us a DMCA takedown notice via e-mail at info(at)mygenesdirect.com.

No Warranty

MoodNote LLC makes no representation as to the validity, reliability or accuracy of genomic data interpretation.  Reports provided by MoodNote may contain typographical errors, errors in coding and other unknown errors, which may result in incorrect interpretations. The scoring ranges and normative values provided are averages and estimates, which may not be applicable to everyone. Only direct, personal evaluation by a health care professional can provide you with an accurate assessment and diagnosis of or treatment for your symptoms. By using MoodNote Services, You agree and accept the data interpretation as is, with no warranty, express or implied or fitness of use. MoodNote LLC makes no guarantee about the reliability, accuracy, or timeliness of the service or the results obtained from the service. You understand that You are responsible for determining that the service offered meets your needs.

WE PROVIDE THE SERVICE “AS-IS,” “WITH ALL FAULTS,” AND “AS AVAILABLE.” YOU BEAR THE RISK OF USING IT. TO THE MAXIMUM EXTENT PERMITTED BY LAW, MOODNOTE LLC GIVES NO EXPRESS WARRANTIES, GUARANTEES, OR CONDITIONS. YOU MAY HAVE ADDITIONAL RIGHTS UNDER YOUR LOCAL LAWS THAT THIS AGREEMENT CANNOT CHANGE. TO THE EXTENT PERMITTED BY LAW, WE EXCLUDE ANY IMPLIED WARRANTIES OR CONDITIONS INCLUDING THOSE OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, WORKMANLIKE EFFORT, NON-INFRINGEMENT, AND SATISFACTORY QUALITY.

Contact

For any questions, comments, or suggestions, please contact MoodNote LLC at PO BOX 9287, NEWPORT BEACH, CA 92658, USA.

Whole Exome Sequencing Data Analysis and Interpretation

Informed Consent

I hereby acknowledge my consent to have my DNA data analyzed and results of this analysis reported to me by MoodNote LLC. I understand the following:

RISKS:

1. I may learn genetic information about myself or my family members that is not related to the medical
concern for which this test is ordered. This information might reveal:

• Genetic risks for diseases that may develop later in life
• Diseases unrelated to the primary reason for ordering or requesting the test
• Diseases that do not have current treatment.

2. Learning this information might cause anxiety and psychological distress, which may include alteration of self-image, experiences of feelings of guilt, familial distress related to identification of other family members who might be at risk, difficulty obtaining life and/or disability insurance, and detection of misattributed parentage. There could be other, unknown and unexpected consequences as well.

3. I do not authorize MoodNote LLC to release information concerning my genetic data interpretation to my insurance or any other third party even if the DNA testing is billed or was billed through my insurance or paid for by any third party.

4. I understand that the US Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits discrimination on the basis of genetic information with respect to health insurance and employment but GINA does not apply to life insurance, disability insurance, or long-term care insurance, which may be governed by state law.

5. I authorize MoodNote LLC to subject my genetic data to bioinformatics, statistical and other types of analysis for identification of any DNA variants, mutations, insertions, deletions, substitutions, frame-shifts and other types of variations, that can be detected by the Whole Exome or Whole Genome Sequencing techniques and identified by analysis tools available to or developed by MoodNote LLC.

6. I understand that MoodNote LLC analysis of my DNA data is limited to DNA analysis as described in (5) and does not include any other analyses. Specifically, MoodNote LLC does not perform any analyses of blood, blood elements, electrolytes, proteins or hormones or any biochemical, pathological or other similar analyses.

LIMITATIONS:

I understand that interpretation of genetic testing data is difficult and there exist many limitations, some of which are listed below:

1. Genetic data interpretation is complex and MoodNote LLC in addition to multiple publicly available data analysis tools has also developed proprietary algorithms designed to avoid errors and improve data interpretation accuracy. Despite these precautions, technical, biological, and systemic errors may occur.

2. The performance characteristics of the proprietary algorithms used by MoodNote LLC for bioinformatics analysis of my DNA data have not been validated. The U.S. Food and Drug Administration (FDA) has not approved these algorithms; however, FDA approval is currently not required for using bioinformatics tools to be better informed about potential causes of a disease symptoms.

3. Accurate interpretation of test results is dependent upon my clinical diagnosis and family medical history, as well as the fact that any reported family relationships are true biological relationships. I understand that in order to improve the accuracy of my data interpretation, I may be asked to fill out a health questionnaire to be provided to MoodNote.

4. This analysis is specific only for the dataset submitted. This analysis may not detect all variants in any of the evaluated genes. There are types of DNA changes that cannot be detected by methods available to MoodNote LLC and a treating physician may determine that further/other DNA testing is necessary in addition to this test.

5. I understand that MoodNote LLC is not a health care company and does not provide any medical or other health care services. Genomic data interpretation and reporting process is automated with only a minimal human input for styling and organizing the report. Any decisions related to my care, my treatments, my health habits or behaviors, my nutritional and dietary resolutions should be based on the independent judgment of the treating healthcare professional. My health care provider is solely responsible for the care that may be provided or not provided to me.

REPORTING

1. I understand that interpretation of my DNA data is based on medical, genetic and population data that is publicly available. As medical knowledge advances and new discoveries are made, interpretation of my data may change. It is possible that re-interpretation of my data could lead to new information about potential medical conditions. Such re-interpretation must be repeated annually or bi-annually. Data re-interpretation may incur additional costs.

2. I understand that interpretation of my DNA data may have clinical or reproductive implications for me or my family members. Interpretation of my DNA data is completely voluntary. I understand that I may wish to obtain professional genetic or other counseling prior to signing this consent form.

3. I understand that there may be DNA variants in my DNA dataset that may be associated with diseases or conditions that may be unrelated to the original reason for which I sought genetic data analysis. Discovery of such variants is oftentimes referred to as “incidental findings”. I understand that MoodNote LLC will report to me the incidental findings that are deemed “medically actionable” by ACMG (American College of Medical Genetics) and listed on their website (https://www.ncbi.nlm.nih.gov/clinvar/docs/acmg/). unless I elect to not have these results reported to me by informing MoodNote LLC in writing to PO BOX 9287, NEWPORT BEACH, CA 92658, USA or, if by email, to info(at)mindinspector.com.

RELEASE OF DATA

I understand and agree that my DNA data with any personally identifiable information (e.g. my name, my medical record number, address etc.) removed (“deidentified data”) may be used for medical research, for secondary analyses and/or for education conducted by MoodNote LLC or its affiliates and assigns. I understand that my deidentified DNA data may be stored indefinitely.

I agree to release my DNA data to MoodNote LLC for interpretation and bioinformatics analysis.

ACKNOWLEDGMENT OF CONSENT:

By signing this Informed Consent for DNA data analysis, I acknowledge that I have read and understand the information as set forth above, and that I have had the opportunity to have any additional questions answered by a physician or other health care professional with knowledge of genetics and genomics. With my signature below, I give my consent or consent on behalf of the person for whom I am a legal guardian:

1. To conduct genetic and bioinformatics analyses of the DNA data;
2. To process these data by MoodNote LLC in accordance with this consent;
3. To be informed about the results of the genetic analysis;
4. I acknowledge my voluntary participation in this data transfer.