Informed Consent

Summary

This Informed Consent document summarizes the benefits, limitations, and risks of undergoing blood and clinical data analysis arranged by Newera Aesthetics LLC ("Newera"), presently marketed as "Newera Cancer Screening" (referred to in this document as "the Test"), to assess protein biomarkers associated with the potential likelihood of having one or more types of cancer. It also describes how your blood specimen and health information may be used after the Test is performed.

About the Test

The Test measures a panel of protein biomarkers that circulate in the blood and may combine those measurements with certain clinical factors to assess the likelihood that an individual may have cancer. Where Newera or its partners use scoring or informatics tools, results may be generated by comparing the results from the individual being tested with reference data from others similarly tested. Your ordering clinician reviews the laboratory results (and any related score or flags) with you.

Potential Benefits of the Test

If the test results show a higher than normal likelihood of cancer and are followed up by other diagnostic tests such as imaging, you might detect early-stage cancer that could be potentially treated more effectively. Furthermore, since published studies have demonstrated that the levels of some of the biomarkers in the Test often rise as certain cancers grow (e.g. ovarian, pancreatic, colon), your initial test may serve as a baseline to improve the predictive ability of future tests.

Also, by participating (optionally) in our ongoing Research & Development (see below) your test results and sample could contribute to the early detection of cancer for others.

Potential Limitations and Risks of the Test

The Test is intended to identify abnormally high levels of certain biomarkers (tumor antigens) known to be associated with several cancer types but also some benign conditions. Moreover, no currently available test measures all known cancer biomarkers and the best detection biomarkers may yet be discovered and validated.

Analysis of results is based on currently available information in clinical databases and the medical literature, as well as laboratory methods and any algorithms or informatics that may be subject to change. New information may replace or add to the information that was used to analyze your results. Based on this new information and/or modifications to methods or informatics, you understand and agree that Newera and/or its laboratory partners may, where appropriate under their procedures, amend or modify your Test report, which may result in a change in reported values, flags, score, or cancer likelihood assessment. Newera may attempt to notify you of any material amendments or modifications. You hereby waive claims against Newera for any amendment or modification of the Test Report, or failure to do the same, except those resulting from Newera's proven gross negligence or willful misconduct, as limited by applicable law.

You understand that Newera is neither qualified nor licensed to provide individual medical interpretations of test results nor to offer advice as to what follow-up procedures might benefit particular persons who obtain this Test, except through licensed clinicians involved in your order. Newera may from time to time provide general guidance on its website and may also introduce or make available to healthcare professionals expert opinions on protein biomarker tests. You understand, however, that accurate cancer detection, especially at early stages, is exceedingly difficult, complex, biologically variable, and imperfect and can often result in unnecessary follow-up (false positives) and missed cancers (false negatives). In addition, if you have certain benign or chronic conditions, provide incorrect or incomplete information on the Health Questionnaire, or have a tumor that does not produce antigens at levels that assays or analyzers can reliably detect, these conditions will likely alter the accuracy of the results.

The Test is NOT a definitive test for cancer. The only definitive test for any cancer is an analysis of biopsied tissue by a qualified pathologist. It is not uncommon to have high biomarker levels and/or a higher algorithm-derived or clinician-flagged result but not have any cancer. Some individuals might have inflammatory or other diseases which could result in a false-positive result as determined by the Test.

Low Test scores or results within reference ranges should not be used to rule out the presence of cancer. Because the Test does not have 100% sensitivity, you may receive a false negative result even if you do have cancer.

No single, easy-to-administer tool, including this Test, reliably detects all early-stage cancers. Newera expressly disclaims any liability for false positives or false negatives due to any of the aforementioned factors, without limitation, and you expressly waive any claims against Newera except those which result from the proven gross negligence or willful misconduct on the part of Newera.

Other sources of error, while rare, include sample mix-up, poor sample quality or contamination, shipping issues, and laboratory errors. Newera and its partners implement safeguards to avoid technical errors, but as with all medical tests, there is nevertheless always a very slight chance of incorrect or inaccurate results due to laboratory error.

The known risks of a venous blood draw are discomfort as the needle is inserted, bleeding, and bruising. Infection from a blood draw is rare but may happen. If you are uncomfortable at the sight of blood you may feel light-headed or faint. Risks will be minimized by having the blood drawn by a trained medical professional when a mobile or in-person draw is used. If you use an at-home upper-arm or capillary collection kit, risks include discomfort, bruising, incomplete sample collection, or need to redraw; follow kit instructions carefully.

There is a risk of loss of confidentiality about your personal and medical information.

About Our Laboratory

Testing is performed by a clinical testing laboratory partner (or partners) that meets the certification requirements for high complexity testing as set forth under the Clinical Laboratory Improvement Amendments (CLIA) as administered by the U.S. Department of Health & Human Services, and any applicable state laboratory licenses. Newera arranges the customer experience, ordering logistics, and support, and may not itself operate the laboratory that analyzes your specimen.

Blood Sample & Health Information Collection, Transport, and Testing

A physician or other qualified healthcare provider will review your information, and if they agree that the Test is appropriate for you, will order the Test on your behalf and receive the results and go over them with you. If you don't have a physician or your physician does not wish to order the Test, we will work with you to identify an independent, qualified medical practitioner or telemedicine provider who can help you with ordering and interpretation of the test results, subject to state rules and eligibility.

You will also be asked to complete and submit an electronic (or paper) Health Questionnaire to provide information about your current health status, disease history, and family history. This information from individuals like you may help improve how clinical factors and benign conditions that might also elevate biomarkers are accounted for. Complete and accurate information on the Health Questionnaire will help improve the Test over time for you and other consumers. The Health Questionnaire will be maintained by Newera and/or its partners in confidence according to our Privacy Policy.

A blood sample will be collected either (a) by a phlebotomist from a vein in your arm (mobile or other arranged draw), in a manner similar to a routine check-up, or (b) via an at-home upper-arm / capillary collection kit according to kit instructions. Specimen volume depends on the panel and method (often one or more small tubes or kit devices). The specimen will be transported to the partner laboratory using recommended handling processes. Unused serum or specimen may be frozen and stored for future research and development, for example of new or alternative biomarkers, unless you direct us otherwise (see Research & Development below), and subject to laboratory policies and applicable law.

Medical Follow-up Based on Test Results

Upon completion of the Test, you are requesting that your results be made available to you and your provider as specified in your order form. By agreeing to this Informed Consent, you also agree that your biomarker values, health questionnaire, and results can be shared with your ordering provider, and with any healthcare provider that you or your ordering provider designates. You also agree that Newera may communicate with you about your order, results, account details, and other Test logistics and procedures.

Having one or more biomarkers above the cut-off or having a score or clinical assessment suggesting a higher than average likelihood of having cancer does not necessarily mean that you actually have cancer since many benign conditions can also raise biomarker levels. These results are intended to prompt a timely engagement between you and your healthcare providers about possible follow-up testing. This may include repeat testing of one or more biomarkers over time, an imaging test, or referral to a medical specialist.

On the other hand, even if all biomarkers are below their cut-offs or results suggest only an average likelihood of cancer, that does not rule out the possibility of having cancer. In no event should you consider this Test to be a substitute or replacement for routine cancer screening tests recommended in the guidelines of leading medical organizations including mammograms, colonoscopies, and Pap smears / HPV testing.

By signing this Informed Consent, you understand and agree that your results must be reviewed with qualified medical personnel of your choosing and that you should not make medical decisions without consulting one or more healthcare providers. Newera does not provide medical services, diagnosis, treatment planning, or individualized advice except through the licensed clinicians involved in your order.

Follow-up information about whether or not you have developed cancer may be collected. This information can be important to help demonstrate the accuracy of the Test and to make improvements. For those deemed at lower concern, follow-up may be collected about one year after reporting the test results. For those deemed at higher concern, follow-up may be sooner (e.g. 1-2 months after reporting). In all cases, the decision to receive follow-up testing (e.g. CT scans, ultrasound, etc.) or not will be yours alone in consultation with the medical professionals that you choose.

Privacy and Data Security

Your privacy and preserving the confidentiality of your health information is a very high priority for Newera. Details about Newera's policies governing patient privacy and health information, including patient rights regarding such information, can be found in the Privacy Policy on the Newera Cancer Screening website, or will be made available upon request by emailing nathan.shalom@neweraaesthetics.com. Newera intends to comply with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (as amended) regarding protected health information and personally identifiable information when Newera or its partners act as covered entities or business associates.

Newera implements certain physical, managerial, and technical safeguards that are designed to protect the integrity and security of your information. Newera cannot, however, guarantee the security of any information you transmit to Newera or store on Newera websites or systems, and you do so at your own risk. You agree that Newera is not liable for the unauthorized release of your information, results, or medical information unless such release was the result of gross negligence or willful misconduct on the part of Newera. In the event of a data breach, we intend to comply with all applicable federal and state reporting requirements.

By agreeing to this Informed Consent you agree that the laws and regulations of the United States regarding data privacy and collection, use, processing, and storage of patient information shall govern Newera's performance of the Test and handling of your sample and information, even if they may differ from those of your country of residence. You further agree that by providing your sample, you are not violating any export ban or other legal restrictions in your country.

People outside of Newera may need to review your results. Examples include government agencies and other safety monitors (such as the Food and Drug Administration, Institutional Review Boards (IRBs), or the Office for Human Research Protections), and laboratory accreditation or CLIA inspectors. These entities and/or individuals generally have an obligation to protect your health information.

We work to make sure that everyone who needs to see your information keeps it confidential, but we cannot offer a 100% guarantee that your information will not be redisclosed.

Your Blood Specimens and Information for Ongoing Research & Development (Optional)

Unless you decline with written notice to nathan.shalom@neweraaesthetics.com (subject: "Opt out of R&D"), by signing this Informed Consent you acknowledge and agree that Newera and its research collaborators and laboratory partners may de-identify (i.e. remove your name, address, and other information that identifies you) any unused portions of your blood or serum sample (where permitted by the laboratory and law), health information, medical history (e.g., age, tobacco usage, family history of cancer, disease history, etc.), the Test analysis, results, and reports, and clinical outcomes over time (collectively "Clinical Information") and aggregate this with de-identified Clinical Information from other consumers. This Clinical Information may be used by Newera, or a third party under contract with Newera that agrees to be bound by applicable privacy terms, without limitation, for any of the following purposes (collectively "R&D"):

• Future research and development including, without limitation, machine learning, algorithm improvements, and panel improvements
• Validation studies and generation of real-world evidence (RWE) of the Test's accuracy and effectiveness through prospective collection of clinical outcome data after the test results are first reported
• Data generation for regulatory compliance or new submissions or internal quality control
• Integration of Clinical Information and outcomes (i.e. whether cancer is diagnosed after the test) from many individuals for any of the aforementioned purposes
• Comparing possible Test variability between various ethnic and geographic communities and improving methods to account for any such variability discovered
• Evaluating both the health and economic benefits vs. possible harms of the Test
• Improve the Test's ability to correctly pinpoint the specific organs in which cancer may be found while avoiding harm associated with false positives
• Studies to be published in peer-reviewed medical or scientific journals, using such de-identified information, either on its own or in collaboration with academic or commercial third parties

You understand that Test methods and any scoring tools may be developed based on known cancer outcomes after biomarkers were measured for many individuals, and that Newera intends to continue to collect real-world outcome data for ongoing development and improvement. To assist in this regard, you therefore agree to alert us if you are diagnosed with cancer within about one year after taking a Test and to permit your doctors to provide us with information verifying this diagnosis, unless you have opted out of R&D. If the contact information that you have provided changes, or the names of your medical professionals change, you agree to notify us in a timely manner by contacting nathan.shalom@neweraaesthetics.com.

• You will likely be contacted at least 12 months after the performance of the Test to determine if a positive diagnosis of cancer has been received. If your Test results indicate medium or higher concern, follow-up data collection may begin sooner, about 2-3 months after reporting the test results.
• If you choose to have follow-up diagnostic testing for cancer for any reason during the 12-month period after the Test, you may be asked to provide information about the results of any cancer diagnostic testing that you undergo.
• If you have a medium or high-concern result on the Test, Newera's team, clinical partners, or the laboratory medical director may contact you or your doctor to collect information about your health status and the results of follow-up testing by phone, email, or a web-based portal.
• As a participant in this ongoing study aspect, you are agreeing to alert the team if you are diagnosed with cancer at any future date, for at least one year after you received your Test results, unless you opt out. In all cases, the team will likely contact you at the one-year mark to verify whether or not a cancer diagnosis has been received.

You also agree, unless you provide us with written notice to the contrary, that your Clinical Information and the results from any R&D may be shared with third-party collaborators. Such third parties may include government, academic, or commercial third parties. Newera may engage in research with such third parties to develop new tests and inventions or to validate and improve existing technologies or processes. You acknowledge and understand that Newera may receive financial compensation to conduct such research, which may include providing your de-identified data to such third parties.

• You can opt out of R&D by notifying us at nathan.shalom@neweraaesthetics.com (subject: "Opt out of R&D"). However, if you consent and later opt out, Newera cannot exclude any Clinical Information from any R&D that was performed before you opted out.
• You have the right to make inquiries about the status of any of our R&D that utilizes your Clinical Information by contacting nathan.shalom@neweraaesthetics.com to the extent that responding does not require disclosing company confidential information, trade secrets, competitive intelligence, or other proprietary information.
• If any new tests, technologies, processes, or inventions are made as a result of the research activities described above (whether made by Newera or by a third party), you agree that you will not receive any compensation, nor will you have any right, title, and/or interest in or to such new or improved tests, technologies, processes, or inventions.
• Newera may contact you to solicit feedback (including through optional surveys, interviews, or testimonials), and describe new tests and services developed by Newera and its collaborators that may be of interest to you. You can opt out of this marketing communication at any time.
• Where permitted by law, Newera may access information about you contained in state or federal Cancer Registries to enable it to learn of your clinical outcomes after receiving the tests.

Payments for and Commercial Uses of Clinical Information

• As complete consideration for your participation in research & development where applicable, the Test may be provided to you at the purchase price disclosed at checkout (which may reflect promotional pricing). Newera has the right to use any and all unused serum specimens (where permitted), information from the Health Questionnaire, and analysis and calculations (collectively Clinical Information) for commercial purposes including, without limitation, product and algorithm development and improvements and intellectual property development and commercialization, without any additional payments or compensation to you. Newera also has the right to license, market or sell anonymized Clinical Information to any third party that agrees to comply with the confidentiality and privacy provisions herein without additional permissions from or compensation to you.
• Newera is paying the costs of this research & development, including compensation to the research team and product developers where applicable. Your physician or healthcare provider may also be compensated by Newera or its partners for receiving training on clinical use of the Test, explaining the Test and this Consent to you, reviewing Test results with you, following up on health outcomes after you have taken the Test, and conveying related data back in a timely manner.

Consent

I confirm that I have read (or have had read to me), all of the information in this Informed Consent document, and I understand what it says. I have had the opportunity to ask any questions I may have about the Newera Cancer Screening Test and related issues, and any questions so posed have been answered to my satisfaction. I freely and voluntarily consent to undergo this testing, and I specifically acknowledge and consent to at least the following:

• I am the individual providing the blood sample and I am at least 18 years of age, or I am the parent or legal guardian of a minor who is providing the sample for testing.
• I understand that this Test is not intended to diagnose whether I have or will get cancer or any other disease. It is intended to tell me the levels of certain tumor-associated biomarkers and, where applicable, information about the likelihood of having cancer at the time the Test is taken relative to reference data, for review with a clinician.
• I should not make any medical decisions based on these results without speaking to qualified healthcare providers first.
• The procedures involved, the purpose of storing my serum samples, and the strengths and limitations of the Test have all been made clear to me.
• My de-identified blood sample and health information, and results (unless I have requested otherwise), may be added to databases used for regulatory compliance; internal quality control; laboratory validation studies; research and development; and educational purposes.
• My sample and all my related personal information will be transferred to a U.S. CLIA-certified partner laboratory for analysis, use, processing, and storage, and will be subject to the laws, rules, and regulations of the United States.
• If a minor will be tested, I further acknowledge and understand that while report information may be similar for adults and minors, the Test was neither designed nor intended primarily for use with minors, and the consequences of testing minors are relatively new and less understood.

Electronic agreement: Checking "I agree," signing electronically, or completing checkout with consent affirmation has the same effect as a handwritten signature.