INFORMED CONSENT TO PARTICIPATE IN COLOR IDEAS

What is Color Ideas?

Employees of Color Genomics, Inc. (“Color”) have lots of good ideas about things we can learn from our genes or features that might be useful, but no way to implement them and/or receive feedback. Color Ideas is a way for Color employees to conduct internal testing using DNA samples and sequencing data provided by Color employees who have consented to participate in Color Ideas. DNA is the genetic material that determines such things as hair color, eye color or other more complex traits. The DNA samples and sequencing data collected for Color Ideas will be used to create, test, and validate experimental laboratory processes to identify variants in specific regions of the genome.

Tests developed and performed as part of a Color Ideas project will not require a physician order, because the testing performed is not intended to provide any clinical, medical, diagnostic, prophylactic, or otherwise actionable data or results. By agreeing to this consent, you acknowledge and agree that the data and results generated or used in Color Ideas projects may under no circumstances be used in your medical care. Color hereby expressly disclaims any liability for any such unpermitted use for any clinical, medical, diagnostic, or prophylactic use or application.

The intended impact of Color Ideas is to decrease development time and foster creativity. Color Ideas is only available to full-time employees of Color. Contractors, consultants, and part-time employees are not eligible to participate or share or access data generated through Color Ideas.

What happens if I do not want to participate in Color Ideas?

There will be no penalty or detriment to your employment status if you choose not to participate in Color Ideas. Color Ideas does not provide any clinically or medically actionable results to you or your physician. Therefore, if you choose not to participate in Color Ideas, there are no relevant alternative procedures or tests.

What happens if I say “Yes”, but I change my mind later?

Your participation in Color Ideas is voluntary. Your refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. You may withdraw your consent at any time and discontinue participation without penalty. However, note that if you choose to withdraw from Color Ideas after having submitted your sample and/or information for use or analysis in one or more Color Ideas projects, data that has already been collected, used, or analyzed in such Color Ideas project(s) may not be removed from the Color Ideas database.

Will it cost me anything to participate in Color Ideas?

There will be no charge for you to participate in Color Ideas.

What will happen to you?

Participation in Color Ideas requires your prior submission of a biological sample to Color for testing. We must be able to associate you with the DNA sequencing data generated from such prior testing in order for you to participate in Color Ideas. If we cannot associate such sample and data with you, or the sample and/or data are otherwise not viable, we reserve the right to decline your participation in Color Ideas. You acknowledge and agree that Color will not, and is not required to, collect another DNA sample from you or re-sequence your data in order to accommodate your desire to participate in Color Ideas.

We will not provide the results of your DNA testing to any physician or genetic counselor for analysis or interpretation. If you decide that you want to pursue follow-up testing in the future based on results reported for Color Ideas, it will be at your expense.

The information collected by studying your DNA sample, along with many other samples, may help Color to develop new commercial products, such as ancestry and wellness tests. However, you acknowledge and understand that such development efforts may never be successful, or may take many years to complete, and may continue after your employment relationship with Color has ended. Your data and results may be retained indefinitely by Color.

Your privacy is very important to us and we will use commercially reasonable efforts to protect it. Despite all of the measures that we will use, we cannot guarantee that your identity will never become known. Federal regulations (called the Health Insurance Portability and Accountability Act, or “HIPAA”) give you certain rights related to your personal health information. These include the right to know who will be able to get the information and why they may be able to get it. By signing this agreement, you are specifically authorizing Color to obtain certain personal health information and genetic data about you and to use, store or disclose such information and/or data. The results of testing on your sample may be submitted to certain federal or state regulatory authorities as part of a regulatory filing or submission, or as part of a technical data file.

If you decide to participate in Color Ideas, your previously submitted sample and/or sequencing data will be accessed and used for Color Ideas project(s). Such samples and sequencing data may be linked to your name and identity by Color. Color will keep your records for Color Ideas confidential as permitted by law. However, if we are required to do so by applicable law or regulation, we will disclose confidential information about you.

The data will be stored on Color’s secure database. Color implements certain physical, managerial, and technical safeguards that are designed to protect the integrity and security of your information. In order to protect your confidentiality as a participant in Color Ideas, all of your data on our servers is encrypted when it is at rest or in transit. All personal data (genetic or otherwise) is encrypted with AES-256 when it is stored on our servers, and is always transmitted over SSL. Internally, strict guidelines and access controls ensure that your data is protected. These precautions can significantly reduce or eliminate the risk of your data being released to unauthorized parties. We cannot, however, ensure or warrant the security of any information you transmit to us or store as part of the Color Ideas project(s), and you do so at your own risk. We also cannot guarantee that such information may not be accessed, disclosed, altered, or destroyed by a breach of any of our physical, technical, or managerial safeguards. You agree that Color is not liable for the unauthorized release of your results or personal information, unless such release was the result of gross negligence or willful misconduct on the part of Color. In the event of a data breach, we intend to comply with all federal and state reporting requirements.

By signing this consent, you acknowledge and agree that the tests and services developed, implemented, and tested through Color Ideas are experimental and are not validated for any research, clinical, diagnostic, or prophylactic purposes. The data and results generated from such tests may be inaccurate, false, unreliable, or otherwise misleading. You agree that you will not rely on or otherwise use or distribute such data or results for any clinical, medical, diagnostic, or prophylactic purpose.

Despite all efforts to keep the results of Color Ideas and your testing information confidential, there remains the possibility that there may be social, economic (e.g., insurance, employment), psychological (related to mind or emotions) and other unforeseen risks associated with collecting DNA. For example, some people may find it upsetting to learn that they have certain traits or ancestry that may also impact relatives and children.

Testing developed and performed in connection with Color Ideas projects are deemed to be experimental tests that are not validated. Results from such projects may not always be accurate, exact, reliable, or reproducible. They should not and cannot be used to make a diagnosis or prediction about your health. You acknowledge that Color, through the Color Ideas project(s), does not provide medical services, diagnosis, treatment, or advice. Nothing contained in Color Ideas or made available through Color Ideas is intended to constitute the practice of medicine or the provision of medical care or to otherwise create a patient-medical provider relationship between Color and a Color Ideas participant.

It is possible that the experimental testing and any results generated in connection thereto could possibly identify a medical problem that is unrelated to the purpose of Color Ideas and that you did not know about before. Color expressly disclaims any liability for any inaccurate, incorrect, incomplete, false, or misleading results or information resulting from any Color Ideas testing, and by participating in Color Ideas, you expressly waive any claims against Color with respect thereto.

Color has no control over the privacy of your results after they are made available to you, and you are solely responsible for protecting and safeguarding your results after you receive them. Color will not provide any interpretation of the test results nor provide any genetic counseling or physician review in connection with such results. If you decide, at your expense, to undergo clinical genetic testing in the future, the costs of such testing shall be your sole responsibility, and the applicable risks of receiving genetic test results will be discussed with you at that time with your healthcare provider.

The results of the testing used for Color Ideas will be kept confidential to the fullest extent possible while in Color’s possession or control. If this confidentiality were broken, a third party could learn something about you that you would not want them to know (i.e., name, address, or other personal information you do not want them to have). Because changes in genes or proteins may affect the outcome of a disease, or may affect or influence one’s health, information as to your risk for a hereditary disorder may be of interest to employers or insurance companies in determining future health risks, and could be used in a discriminatory fashion. Federal and State laws provide some protection against employment or health insurance discrimination based on genetic findings. The Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:

• Health insurance companies and group health plans may not request your genetic information that we get from Color Ideas projects.
• Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
• Employers with 15 or more employees (including Color) may not use your genetic information that we get from Color Ideas projects when making a decision to hire, promote, or fire you or when setting the terms of your employment.

These protections do not extend to life insurance, disability insurance, or long-term care insurance.

Color does not expect results from Color Ideas to provide information that could affect you in any way or cause you any discrimination. You may request withdrawal of your samples from Color Ideas at any time, at which time the samples will be destroyed in accordance with Color’s routine protocols. However, data that is generated from your sample will not be destroyed and shall be retained in accordance with Color’s protocols.

You may not receive any direct benefit from taking part in Color Ideas. However, your participation in Color Ideas may help us improve laboratory technologies and processes to better analyze genetic variants and develop new commercial product and service offerings. The data and results obtained through Color Ideas may also be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified.

You will not be paid or compensated for your participation in Color Ideas, and you and/or your health plan/insurance will not be billed for tests and procedures that are performed as part of Color Ideas projects.

By signing this consent, you agree that your sample and any data associated with such sample will be owned by Color. If a commercial product or service is developed from Color Ideas, the commercial product will be owned by Color or its designee. By taking part in Color Ideas, you agree that Color is free to apply for and use intellectual property (including patents) relating to any inventions arising from Color Ideas projects, for example, ancestry and wellness products and services. If there are any patent or commercial uses of your DNA data (apart from commercial testing that you have authorized), identifiers that would link it to you will be destroyed (for example, your name, address, phone number, and social security number).

There are no plans to provide any financial compensation (money) or financial benefit or other benefit to you for such commercialization, and you will not profit financially from any products or services developed from your participation in Color Ideas. Your only compensation for your participation is described above in this informed consent.

If you later decide that you do not want the specimen and/or data already collected from you to be used in future Color Ideas projects, you may tell us and we will use our best efforts to stop any further use of your specimen and/or data in such projects. However, in some cases, it may be impossible to locate and stop such future development work once the materials and/or data already have been shared with other investigators or partners.

Color does not expect that any injury will result from your participation in Color Ideas. However, if you are injured as a direct result of your participation in a Color Ideas project, you will receive medical treatment. You and/or your health plan/insurance will be billed for this treatment. Color will not pay for this treatment. There are no plans to offer any type of payment for injury. However, by signing this form you have not given up any of your legal rights.

If you have questions, concerns, or complaints about your rights as a participant or Color Ideas in general, please feel free to contact support@color.com.