Privacy Statement

ARTICLE I
INTRODUCTION

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1.1 Purpose. 

This Initial Express Consent is intended to inform you regarding Quoiden’s collection, use, and disclosure of your genetic information.

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1.2 Quoiden’s Mission. ‍

Quoiden began with one family’s mission to prevent unnecessary deaths and improve the quality of life for those living with an ornithine transcarbamylase (“OTC”) deficiency. Quoiden’s goal is to educate individuals about the risks of OTC and connect impacted families with educational resources, DNA testing, and Research opportunities. We created Quoiden to identify OTC deficiencies, so that no one lives a life of painful undiagnosed symptoms and possible death without support.

1.3 Primary Purpose. ‍

Quoiden’s primary purpose is to identify OTC deficient individuals and connect them to resources, including Research and DNA testing, to help advance treatment and knowledge about this rare genetic disorder.

1.4 Overview. ‍

Based on just one OTC deficient family member, Quoiden uses the power of genealogy to identify family members near and far who are at risk for OTC deficiencies. Our website provides a space for you to input your known family tree. Then, working with Quoiden professionals, Quoiden will help you identify individuals within your family who are at risk for OTC deficiencies. Next, Quoiden provides direct-to-consumer genetic testing to confirm OTC deficiencies. By working alongside professional genetic counselors, Quoiden provides you with the resources to not only confirm an OTC deficiency, but also learn how to live with the diagnosis. For those who wish to advance research about OTC deficiencies, Quoiden offers Research opportunities for customers. Quoiden Research works to advance the future of OTC treatment so the next generation of our families may live more comfortably than our ancestors.

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1.5 Services. ‍

Services include Quoiden’s products, software, services, and website (including but not limited to text, graphics, images, and other material and information) as accessed from time to time by you, regardless if the use is in connection with an account or not (collectively, the “Services”).

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ARTICLE II
WHAT IS INFORMATION?

2.1 Two Types of Information.

At Quoiden, there are two types Information: Personal Information and Research Information.

2.2 Categories of Information.‍

Information is a general term referring to both Personal Information and Research Information. Both types of Information can be either:

(a) Individual-Level Information: Information about a single individual, such as their genotypes, diseases or other traits or characteristics; or

(b) De-Identified Information: Information that has been stripped of identifying data, such as name and contact information, so that an individual cannot reasonably be identified.

2.3 Personal Information. ‍

Personal Information includes:

(a) Registration Information: Information you provide during account registration or when purchasing the Services, such as a name, user ID, password, date of birth, billing address, shipping address, payment information (e.g., credit card), account authentication information, or Contact Information.

(i) Contact Information. Includes your:

1) Full Name;

2) Email Address;

3) Phone Number; and

4) Mailing Address.

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(b) Genetic Information: Information regarding your genotype (e.g., the As, Ts, Cs, and Gs at particular locations in your DNA). Genetic Information includes the Quoiden genetic data and reports provided to you as part of our Services.

(c) Sample Information: Information regarding any sample, such as a saliva sample, that you submit for processing to be analyzed to provide you with Genetic Information, laboratory values or other data provided through our Services.

(d) Self-Reported Information: Information you provide to Quoiden including your gender, age, disease conditions, health-related information, traits, ethnicity, family history, data you authorize us to use for Research, or anything else you provide to us within our Services.

(e) Biometric Information: Certain Self-Reported Information you provide to us or our service providers to verify your identity using biological characteristics.

(f) User Content: Information, data, text, software, music, audio, photographs, graphics, video, messages, or other materials, other than Genetic Information and Self-Reported Information, generated by users of Quoiden Services and transmitted, whether publicly or privately, to or through Quoiden.

(g) Web-Behavior Information: Information on how you use our Services or about the way your devices use our Services is collected through log files, cookies, web beacons, and similar technologies (e.g., device information, device identifiers, IP address, browser type, location, domains, page views). For more detail on how we collect and use Web-Behavior Information, please see our Cookie Policy.

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2.4 Research Information.‍

Research Information contains less data than Personal Information. These limits are to protect your private information.

(a) Research Information includes:

(i) Genetic Information;

(ii) Self-Reported Information; and

(iii) Web-Behavior Information.

(b) Research Information does NOT include:

(i) Registration Information;

(ii) Sample Information;o9

(iii) User Content; or

(iv) Biometric Information.

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2.5 Aggregate Information.

Aggregate Information is not Personal Information because Aggregate Information does not contain information about, nor can it reasonably be linked to, a specific individual. Aggregate Information is information about a group of people, such as an analysis or evaluation of a group. Aggregate Information describes the group as a whole in such a way that no specific individual may be reasonably identified. For example, the number of Quoiden customers with a specific OTC variant is Aggregate Information

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ARTICLE III
HOW WE COLLECT YOUR INFORMATION

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3.1 How We Collect Information.

Quoiden collects Information from the following sources:

(a) You: We collect information you provide to us when you request or purchase Services or information from us (including authorizations to share data with us from another entity, like lab test results and other medical information), register with us (including when you link your account on a third-party site or platform with your Quoiden account, such as via Google or Apple), participate in forums or other activities on our sites, features, and applications, respond to surveys, visit our physical properties, call our Customer Care support line, or otherwise interact with us using one or more devices. You may provide information in a variety of ways, including by typing or using voice commands.

(b) Family Members: Direct Customers may provide the Contact Information for family members who they want to include in their family tree.

(c) Service Providers: We may collect information through service providers who use a variety of technologies and tools, such as cookies, analytics tools, software development kits, application program interfaces, web beacons, pixels, and tags when you visit, use or interact with our Services.

(d) Other Third Parties: We may receive information about you from other users, individuals, our corporate affiliates, or other third parties. For example, if someone gifts you a Subscription, invites you to view their Quoiden Report, or otherwise refers you to Quoiden, we may collect information about you.

(e) Quoiden: We may infer new information from other data we collect, including using automated means to generate information about your likely preferences or other characteristics. For example, we use your Genetic Information to predict certain health predispositions, or we may infer your location (such as city, state, and country) based on your IP address.

ARTICLE IV
HOW WE USE YOUR INFORMATION

4.1 Use. ‍

Quoiden will never release your Individual-Level Information to any third party without asking for and receiving your explicit authorization to do so. We use your information to:

(a) Provide our Services. This includes developing, operating, improving, providing, maintaining and safeguarding our Services, such as developing new product tools and features. These activities may also include, among other things, opening your account, enabling purchases, Indirect Customer outreach, processing payments, operating our business, billing, accounting, preventing fraud, and enabling, enhancing, and improving your use of our Services, such as our website and mobile applications, or our internal operations.

(b) Analyze and measure trends and usage of the Services. Good services and products mean there is a lot of testing, measuring, and analysis to deliver improvements and the most up-to-date and accurate data. This means we’re constantly working on identifying improvements to our Services. We also use information about how you use and interact with our reports, features and other elements on our Services to perform these research and development activities. For example, this can include activities like data analysis to develop new or improve existing products and services, and performing quality control activities.

(c) Communicate with you, including customer support. Communication may also include sharing information about our Services or other offers or information we think may be relevant to you. We use your information to respond to messages you send us, such as Customer Care questions, or to share information about our Services or other offers or information we think may be relevant to you, like policy changes, or security Updates.

(d) Conduct surveys or polls, and obtain testimonials or stories about you. We value your feedback and may send you surveys, polls, or requests for testimonials, which we use to improve and optimize our Services. It’s your choice to provide us with your feedback, stories or other information.

(e) Personalize, contextualize and market our Services to you. Rest assured,we will not use your Genetic Information for personalized or targeted marketing and/or advertising without your explicit consent. We do use your information to help contextualize our Services and provide relevant content based on how you interact with our Services. We may also use your information, such as Web-Behavior Information, to help us provide you with relevant advertisements or marketing. You can learn more in our Cookie Policy.

(f) Provide cross-context behavioral or targeted advertising. Just like many websites and services, Quoiden may provide cross-context behavioral and targeted advertising to you. This helps us show relevant ads to people who may be interested in Quoiden’s Services. When you browse our websites or interact with our Services online and across different websites, cookies and other tracking technologies collect information, such as Web-Behavior Information, to provide you with cross-context behavioral advertising or targeted advertising.

(g) Advance OTC Research, if you choose to participate. Participating in Quoiden’s Research is entirely optional.

(h) Enhance the safety, integrity, and security of our Services. This includes prevention of fraud and other unauthorized or illegal activities on our Services. We take security and the trust you place in us seriously. We implement physical, technical and administrative measures to prevent unauthorized access or disclosure of your information. To make these features work, we use your information, like when we email you in connection with two-factor authentication or when we authenticate a URL or link on our website, to ensure it’s safe.

(i) Enforce, investigate, and report conduct violating our Terms of Service or other policies. We believe everyone deserves a safe place to discover and understand OTC deficiencies, which means we need to keep our platform a safe place for all. We use information to monitor, detect, prevent, investigate and mitigate any suspected or actual fraud, prohibited or illegal behaviors on our Services, to combat spam, and other behaviors or actions that break the promises we outline in our Terms of Service.

(j) Comply with our legal, licensing, and regulatory obligations. We may use your information to comply with applicable legal, licensing and regulatory obligations. For example, we may use your Information to investigate if unlawful content was posted on our website, or if we need to defend ourselves against legal claims. If legally required,we may also need to share your Information to comply with a law enforcement request. We are prepared to use all legal measures to resist any and all law enforcement requests in order to protect the privacy of our customers.

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ARTICLE V
HOW WE DISCLOSE YOUR INFORMATIOn

5.1 Who We Share Information With:

(a) Service providers: Our service providers and contractors help us provide our Services and act on our behalf to get things done. We implement procedures and maintain contractual terms with each service provider and contractor to protect the confidentiality and security of your Information. For example, some of the things we use service providers and contractors to help us with include: order fulfillment and shipping; processing and analyzing your samples; sample storage; customer care support; cloud storage, IT, and security; marketing and analytics; and more.

(b) Your sharing choices: You may direct us to share your Information with friends, family members, doctors or other healthcare professionals, and/or any other individuals or entities who may or may not be using our Services, including through third party services such as social networks and third-party apps that connect to our Services. If you share your Information with a third party, they may use your Information differently than we do under this Initial Disclosure. Please make such choices carefully and review the privacy policies of all other third parties involved.

(c) Commonly owned entities, affiliates and change of ownership: If we are involved in a bankruptcy, merger, acquisition, reorganization, or sale of assets, your Information may be accessed, sold or transferred as part of that transaction and this Initial Disclosure will apply to your Information as transferred to the new entity. We may also disclose Information about you to our corporate affiliates to help operate our services and our affiliates’ services.

(d) Third parties related to law, harm, and the public interest: Quoiden will not provide Information to law enforcement unless required by law to comply with a valid court order, subpoena, or search warrant. We require all law enforcement inquiries to follow a valid legal process, such as a court order or search warrant, and are prepared to exhaust available legal remedies to protect customer privacy. If we are compelled to disclose your Information to law enforcement, we will try our best to provide you with prior notice, unless we are prohibited from doing so under the law. Quoiden will preserve and disclose any and all Information if required to do so by law or in the good faith belief that such preservation or disclosure is reasonably necessary to:

(i) comply with legal or regulatory process (such as a judicial proceeding, court order, or government inquiry) or obligations that Quoiden may owe pursuant to ethical and other professional rules, laws, and regulations;

(ii) enforce the Quoiden Terms of Service and other policies;

(iii) respond to claims that any content violates the rights of third parties; or

(iv) protect the rights, property, or personal safety of Quoiden, its employees, officers, directors, contractors or other personnel, its users, and the public. Nothing in this Privacy Statement is intended to limit any legal defenses or objections that you may have to a third party’s, including a government’s, request to disclose your Information.

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5.2 Who We DO NOT Share With. 

Quoiden will not voluntarily share your Information with:

(a) Public databases;

(b) Insurance companies or employers; or

(c) Law enforcement, absent a valid court order, subpoena, or search warrant.

ARTICLE VI
RESEARCH

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6.1 The Purpose of Research. ‍

The purpose of Research is to make new discoveries about OTC deficiencies.

6.2 Opt-In Program.

Quoiden has an opt-in Research program, meaning that for eligible customers, taking part in Quoiden Research is completely voluntary. We do not use your Information for Research unless you explicitly consent to participate. Refer to the Main Research Consent for Information to help you make an informed choice about participating. This Article will discuss the key points about Quoiden Research and how Research uses Research Information. You can change your mind any time. Customers never need to participate in Research to use Quoiden. Nothing changes about your core Quoiden experience if you do not participate in Research.

6.3 Quoiden Research. ‍

“Research” means research activities performed by Quoiden, either independently or by third parties, and overseen by an independent ethics review board (also called an Institutional Review Board or “IRB”). Research may be sponsored by, conducted on behalf of, conducted by, or in collaboration with third parties, including non-profit foundations, academic institutions or pharmaceutical companies.

6.4 Researchers.‍

Quoiden shall carefully select researchers, including non-profit foundations, academic institutions or pharmaceutical companies, who may access the Database for legitimate, secure, OTC research (the “Researchers”).

6.5 Opportunities.

Currently, Quoiden offers two Research opportunities:

(a) The Database. The Database includes only the De-Identified Research Information about Database Customers and Clinical Trial Customers. Here, select Researchers may analyze your De-Identified data as a collective set alongside others to study OTC deficiencies.

(b) Clinical Trial Outreach. If you opt-in to the Database, you may also choose to be contacted for consideration in clinical trials to advance OTC research. Opting into clinical trial outreach does not commit you to joining a clinical trial, it only allows Quoiden to communicate with you regarding those opportunities.

6.6 Levels of Consent.‍

All Research consents occur within either the (1) Main Research Consent form or (2) Study-Specific Agreements. A customer interested in Research may choose between three levels of consent. This process is designed to ensure you stay in control of your information and understand what uses are permitted.

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(a) DATABASE CUSTOMERS

(i) Who? Database Customers are those who consent to being included on the Database, but do not consent to outreach for clinical trials.

(ii) What Type of Research Information? Only De-Identified Research Information.

(iii) Which Consent Form Do I Sign? You may opt-in within the Main Research Consent form.
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(b) OUTREACH CUSTOMERS

(i) Who? Outreach Customers are those who not only consent to being included on the Database, but also welcome communications from Quoiden regarding opportunities to participate in a clinical trial.

(ii) What Type of Research Information? Only De-Identified Research Information. All outreach shall be coordinated through Quoiden. Your contact information as an Outreach Customer shall never be shared with the Researcher.

(iii) Which Consent Form Do I Sign? You may opt-in within the Main Research Consent form.

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(c) CLINICAL CUSTOMERS

(i) Who? Clinical Trial Customers are former Outreach Customers who are: 1) Selected by Researchers to participate in a clinical trial; and 2) Consent to participate within a Study-Specific Agreement.

(ii) What Type of Information? 1) Individual-Level Research Information; and 2) Contact Information.

(iii) Which Consent Form Do I Sign? The Study-Specific Agreement. This is a separate express consent form which will explain the specific opportunity and the details of the clinical trial. This gives you a chance to learn about the opportunity before you consent. We will not share Individual-Level Research Information or Contact Information without your separate express consent within the Study-Specific Agreement. You are currently reading the Main Research Consent form. Nothing within this Agreement shall bind you to becoming a participant in a clinical trial. Nothing in this Agreement permits Quoiden to share your Individual-Level Research Information or Contact Information with a Researcher, that consent may only be granted within the separateStudy-Specific Agreement.

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6.7 Eligibility. ‍

Anyone is eligible to participate in Research. However, Quoiden reserves the right to not include your De-Identified Research Information in the Database based on its sole discretion, including the needs of the Researchers.

6.8 Protection of Your Information During Research. ‍

Research is conducted with information that has been stripped of your identifying Registration Information. You can read more about protections for your data in the Main Research Consent.

6.9 Study-Specific Agreement. ‍

The Study-Specific Agreement is a separate express consent form, but like the Main Research Consent, you can withdraw consent anytime. You must review the Study-Specific Agreement for details.

6.10 Summary.

Database Customer:
Consent Form: Main Research Consent Form

Type of Information Shared:  De-Identified Research Information

Use of Information : Quoiden’s Database

Outreach Customer:  

Consent Form: Main Research Consent

Type of Information: De-Identified Research Information

Use of Information: Quoiden’s Database, Permitting Clinical Trial Outreach

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Clinical Trial: 

Consent Form: Customer Study-Specific Agreement

Type of Information: Individual Level Research, Information and Contact Information 

Use of information: Direct Coordination with Researcher for Clinical Trial

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ARTICLE VII
PRIVACY STATEMENT

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7.1 Privacy. ‍

This Section applies to all websites owned and operated by Quoiden, LLC. including [website here] and any other websites, pages, features, or content we own or operate, and to your use of the Quoiden mobile app and any related Services.

7.2 Your Privacy Settings and Controls. ‍

We do not make choices on your behalf for the privacy settings described below. Below are the types of controls you have in your Account Settings and we’ve listed what it means to opt-out or to opt-in:

(a) Viewing your health reports:

(i) Opt-out: No, I do not want to receive my health reports.

(ii) Opt-in: Yes, I do want to receive OTC Genetic Health Risk and OTC Carrier Status reports, as well as other reports if available.

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(b) Sharing features:

(i) Opt-out: No, I do not want to share my information with genetic relatives or other users.

(ii) Opt-in: Yes, I want to be able to share my information so I can discover genetic relatives or connect with others.

(c) Communications preferences:

(i) Opt-out: Please don’t contact me for promotional purposes. In addition to changing your preferences via Account Settings or your device, you can also click the “unsubscribe” button at the bottom of promotional email communications.

(ii) Opt-in: Yes, you can contact me (such as through email, in-product notifications, or push notifications) for product or promotional purposes.

(d) Research participation:

(i) Opt-out: I don’t want to participate in Quoiden Research. If you experience difficulties changing your consent status in Account Settings, contact Quoiden at [email]. You can change your mind any time about your participation, however any Research involving your data that has already been performed or published prior to your withdrawal from Quoiden Research will not be reversed, undone, or withdrawn.

(ii) Opt-in: Yes, I’d like to participate in Quoiden Research.

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7.3 Access & Download.

You can access and download your Information processed by Quoiden. Please note, if you lose access to your Quoiden account, we require that you submit additional information to verify your identity before providing access or otherwise releasing information to you.

7.4 Correct Information.‍

You can correct your Registration Information and modify Self- Reported Information.

7.5 Third Party Content and Integrations.‍

Our Services may contain third party content, integrations or links to third party websites operated by organizations not affiliated with Quoiden. Through these integrations, you may be providing information to the third party as well as to Quoiden. Since we can only control our own Services, we are not responsible for how those third parties collect or use your information so please review the privacy policies of every third-party service that you visit or use, including those third parties you interact with through our Services.

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7.6 Federal, State, and Region-Specific Information. ‍

You may have specific privacy rights in your state or region. For example, in the United States, residents of California and other states have specific privacy rights. Federal and state laws (including the federal Genetic Information Non-discrimination Act or “GINA”) provide some protection from employer and health insurance discrimination based on your genetics. Learn more.

7.7 Retention of Information. ‍

We retain Information for as long as necessary to provide the Services and fulfill the transactions you have requested, comply with our legal obligations, resolve disputes, enforce our agreements, and other legitimate and lawful business purposes. Because these needs can vary for different data types in the context of different services, actual retention periods can vary significantly based on criteria such as user expectations or consent, the sensitivity of the data, the availability of automated controls that enable users to delete data, and our legal or contractual obligations. Quoiden and/or our contracted genotyping laboratory will retain your Genetic Information, date of birth, and sex as required for compliance with applicable legal obligations, including the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), California Business and Professions Code Section 1265 and College of American Pathologists (CAP) accreditation requirements, even if you chose to delete your account. Quoiden will also retain limited information related to your account and data deletion request, including but not limited to, your email address, account deletion request identifier, communications related to inquiries or complaints and legal agreements for a limited period of time as required by law, contractual obligations, and/or as necessary for the establishment, exercise or defense of legal claims and for audit and compliance purposes.

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ARTICLE VIII
SECURITY

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8.1 Security Measures. ‍

We implement physical, technical, and administrative measures aimed at preventing unauthorized access to or disclosure of your Information. Our team regularly reviews and improves our security practices to help ensure the integrity of our systems and your Information. Please recognize that protecting your Information is also your responsibility. Be mindful of keeping your password and other authentication information safe from third parties, and immediately notify Quoiden of any unauthorized use of your login credentials. Your password is not visible to Quoiden staff, and we encourage you not to share your password with Quoiden or any third parties. Quoiden cannot secure Information that you release on your own or that you request us to release.

8.2 HIPAA Security.‍

Quoiden is not a covered entity under the Health Insurance Portability and Accountability Act (“HIPAA”), and no data provided by you is subject to or protected by HIPAA. However, to uphold Quoiden’s commitment to security, Quoiden optionally attempts to comply with HIPAA security requirements. This means our website includes encryption and professional evaluations for any unauthorized access.

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ARTICLE IX
ACCESS, RETENTION, & DESTRUCTION OF INFORMATION

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9.1 Access. 

You may access a summary of all your Information through your customer account at [website]. Within Account Settings, you may change any of your opt-in preferences.

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9.2 Destruction of Sample. ‍

Quoiden shall destroy your sample within a reasonable time after genetic testing. Quoiden shall not retain your sample for any reason, including additional subsequent testing.

9.3 Delete your Account. ‍

You can delete your Quoiden account within your Account Settings at any time. Upon account deletion, we will automatically opt you out of Research and discard your sample. Keep in mind this process cannot be canceled, undone, withdrawn, or reversed, and your account deletion is subject to retention requirements and certain exceptions.

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ARTICLE X
MISCELLANEOUS

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10.1 Changes. ‍

We may make changes to this Agreement from time to time. We’ll let you know about those changes here or by reaching out to you via email or some other contact method, such as through in-app notification, or on another website page or feature. If you have any questions regarding Quoiden’s Cookie Policy please contact us at [email].