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Kit Order Terms and Conditions

Effective Date: July 1, 2023


These Kit Order Terms and Conditions ("Kit Terms") govern the purchase and processing of whole genome sequencing (WGS) kits from Mosaic Biodata Inc. ("Mosaic," "we," "us," or "our"). By purchasing a kit, you ("Customer," "you," or "your") agree to these Kit Terms, our Terms of Service, Privacy Policy, and Genetic Data Consent Notice.


Service Description


What We Provide:

  • Whole Genome Sequencing (WGS) using advanced Next Generation Sequencing technology (Complete Genomics T7 with DNBSEQ™ or equivalent)

  • Coverage of approximately 3 billion nucleotides at an average of 30x depth

  • Pseudonymized VCF file aligned to GRCh38/hg38 reference genome

  • Access to genetic data through your Mosaic account

Additional Services (Coming Soon):

We are developing the capability for users to upload VCF files from third-party genetic testing providers, including:

  • Whole genome sequencing from other laboratories

  • 23andMe, AncestryDNA, Nebula Genomics, and similar services

  • Clinical genetic testing results (VCF format)

When available:

  • Separate terms and pricing will apply.

  • File format and quality requirements will be specified.

  • Not all VCF files may be compatible with our analysis algorithms.

  • A 30-day advance notice will be provided before launch

Lifestyle Reports: Lifestyle reports (nutrition, fitness, sleep, hormones, athletics) are purchased separately or as part of bundled packages. These Kit Terms govern only the purchase and processing of the WGS kit.

Non-Medical Use and Limitations: This service provides whole genome sequencing data for informational and research purposes only. It does not provide, and should not be used for:

  • Medical diagnosis, prognosis, or treatment recommendations

  • Clinical genetic testing or medical decision-making

  • Pharmacogenomic prescribing information

  • Reproductive, fertility, or prenatal counseling

  • Mental health assessment or psychological evaluation

  • Prediction or diagnosis of disease or medical conditions

Always consult a qualified healthcare professional or genetic counselor for medical interpretation of genetic information or to make informed health-related decisions about your health.

Sequencing Coverage Limitations: Our sequencing does not analyze all genomic regions. Some regions have low or no coverage, including centromeres, highly repetitive sequences, complex structural variants, and portions of the Y chromosome and mitochondrial DNA. Not all variant types (rare variants, structural variations, copy number variations, epigenetic modifications) may be detected or included in your VCF file.


Kit Purchase


What's Included:

  • DNA collection kit with saliva collection tube and stabilization solution

  • Detailed collection instructions

  • Prepaid return shipping label (U.S. customers only)

  • Laboratory processing by a CLIA-certified laboratory partner

  • VCF file delivery to your Mosaic account

Payment Terms:

  • All prices in USD

  • Payment processed via a PCI-compliant payment processor

  • Applicable sales tax added at checkout based on shipping address.

  • Payment method securely stored for future transactions

Shipping:

  • United States: Free standard shipping (1-2 business days); prepaid return shipping label included

  • International: Customer is responsible for all shipping costs (delivery and return), customs clearance, import permits, duties, taxes, and VAT

Kit Activation and Registration


Activation Requirements: You must activate your kit online at https://mosaicbio.io/activate before or immediately after returning your sample. Activation:

  • Links the kit number to your Mosaic account

  • Requires completion of the Genetic Data Consent Notice

  • Must occur within 30 days of laboratory receipt, or the sample will be destroyed with no data generated and no refund issued.

Account Requirements:

  • Must be 18+ years old or have parental/guardian consent

  • Required information: Name, email, date of birth, shipping address

  • You confirm the sample is your own DNA, or you have legal authorization to submit it.

  • You confirm that providing samples complies with export laws in your country.

Sample Collection and Return


Collection Instructions:

  • Provide approximately 2mL of saliva in the provided collection tube.

  • Do not eat, drink, smoke, or chew gum for 30 minutes before collection.

  • Add stabilization solution and seal the tube properly, following the kit instructions.

  • Store at room temperature after collection.

Return Deadlines:

  • Return kit within 180 days of purchase or before kit expiration date (whichever comes first)

  • Kits received after the deadline will not be processed.

  • No extensions available for expired kits

Sample Quality Requirements: For successful processing, samples must have:

  • Sufficient saliva volume (approximately 2mL)

  • No contamination from food particles, blood, or other substances

  • Proper storage and timely return per instructions

Laboratory Processing


Processing Facility:

  • CLIA-certified laboratory partner

  • Federally regulated under Clinical Laboratory Improvement Amendments (CLIA)

  • Secure chain of custody and sample tracking protocols

  • Quality management and quality control systems

Data Flow:

User → Mosaic → Laboratory Partner → Mosaic → User

The laboratory partner:

  • Receives saliva sample with kit number only (no personal identifiers)

  • Performs whole genome sequencing using Next Generation Sequencing technology

  • Generates a pseudonymized VCF file aligned to the GRCh38/hg38 reference genome

  • Transmits VCF file to Mosaic via encrypted API

  • Destroys the physical sample immediately after successful sequencing

  • Does not retain genetic data or personal information

Processing Timeline:

  • 4-6 weeks from laboratory sample receipt to data availability

  • Timeline not guaranteed and may vary based on laboratory capacity, sample quality, or technical issues.

  • No refunds issued for processing delays

  • Real-time progress tracking is available in your account dashboard

Processing Stages:

  1. Sample received at the laboratory

  2. DNA extraction and quality assessment

  3. Whole genome sequencing

  4. Bioinformatics analysis and variant calling.

  5. VCF file generation and quality control

  6. Data delivery to your Mosaic account

Data Delivery:

  • VCF file delivered to secure Mosaic account

  • Email notification when results are ready

  • 24/7 access to data once delivered

Sample Destruction: Physical samples are destroyed immediately after successful processing using approved biomedical waste disposal procedures. No physical samples are retained.

Data Storage, Security, and Compliance

Storage Infrastructure:

  • Location: All genetic data is stored in the United States data centers

  • SOC 2 Type II certified cloud infrastructure

  • No data storage in foreign jurisdictions

  • Access is restricted from foreign adversary entities

Security Measures:

  • Encryption: AES-256 at rest, TLS 1.3 in transit

  • Access Controls: Multi-factor authentication, role-based permissions

  • Monitoring: 24/7 security monitoring and intrusion detection

  • Audits: Regular third-party security assessments

Regulatory Compliance:

Federal Requirements:

  • CLIA: Sequencing performed by CLIA-certified laboratory partner

  • GINA: Compliance with Genetic Information Nondiscrimination Act

  • In alignment with U.S. government policies regarding bulk sensitive data transfers, including anticipated regulations from the Department of Justice and the Department of the Treasury regarding countries of concern

State Requirements:

  • California Genetic Information Privacy Act (GIPA)

  • In alignment with the Texas genetic privacy legislation under consideration

  • Compliance with applicable state consumer protection and genetic privacy laws

International Requirements:

  • GDPR (EU/UK): Article 9 special category data protection

  • PIPEDA (Canada): Personal information protection standards

  • LGPD (Brazil): Sensitive data handling requirements

  • Compliance with local laws where services are offered

Prohibited Access:

We prohibit access to genetic data by entities or persons from countries designated as foreign adversaries by the U.S. government, including but not limited to:

  • People's Republic of China

  • Russian Federation

  • Islamic Republic of Iran

  • Democratic People's Republic of Korea (North Korea)

  • Republic of Cuba

  • Any entity or person subject to the jurisdiction of these countries

International Data Transfers:

For International Users: Your data is transferred to and stored in the United States. We implement appropriate safeguards for international data protection compliance:

EU/UK Residents (GDPR):

  • Standard Contractual Clauses (SCCs) with cloud infrastructure providers

  • Right to detailed information about safeguards (contact support@mosaicbio.io)

  • Right to object to international transfers.

  • Right to lodge a complaint with your supervisory authority.

  • Right to delete data at any time

Other Jurisdictions:

  • Compliance with PIPEDA (Canada), LGPD (Brazil), and applicable local laws

  • Appropriate legal mechanisms for data transfers

  • Enhanced security measures for cross-border data protection

Reprocessing and Refund Policy


Non-Refundable Purchase: All kit purchases are final and non-refundable, except as specified below.


Sample Processing Failures: If your sample fails processing due to insufficient DNA quantity, poor DNA quality, or contamination:


First Failure: Automatic reprocessing using the remaining sample at no charge

Second Failure: Refund of kit purchase price minus $20 processing fee

After receiving a refund, you may purchase a new kit if you wish to attempt testing again. The $20 processing fee covers laboratory handling, quality assessment, and administrative costs.


No Refunds Provided For:

  • Unactivated kits (not activated within 30 days of lab receipt)

  • Expired kits (returned after 180-day deadline or expiration date)

  • Processing delays regardless of duration

  • Change of mind after sample submission

  • Dissatisfaction with VCF file content or coverage

  • Customer-caused sample quality issues (contamination, insufficient volume, improper storage)

Refund Processing:

  • Approved refunds processed within 5-10 business days

  • Refunded to the original payment method

  • Written confirmation provided upon completion

Data Ownership and Access Rights


Your Ownership

You retain complete ownership of your genetic data. We process and store it only as authorized in our Privacy Policy and Genetic Data Consent Notice.

Initial Free Access Period

You receive 30 days of free data storage and access beginning when your VCF file results become available in your account. During this period, you may:

  • View your VCF file and reports unlimited times.

  • Download your VCF file.

  • Share or export your data to third-party services

  • Request permanent deletion at any time.

Continued Access Options After Free Period

IMPORTANT: After your initial 30-day free period ends, you have three options:

Option 1: Monthly Storage Subscription (Automatically Renewing)

Service: $5.00 per month (plus applicable taxes) for:

  • Secure cloud storage of your VCF file

  • Unlimited VCF downloads and viewing

  • Continuous access to all reports

  • 24/7 account access

Automatic Renewal: This subscription will automatically renew each month and charge your payment method until you cancel. You can cancel at any time through your account settings or by emailing support@mosaicbio.io with no penalties or fees.

Complete Terms: For full details about automatic renewal, cancellation procedures, billing, your rights, and all subscription terms, see our separate Data Storage Subscription Terms document, which you will review and consent to before enrolling in the subscription service.

Option 2: Archive (No Cost)

If you choose not to maintain a storage subscription:

  • Reports remain viewable at no cost through your account.

  • The VCF file is automatically archived and cannot be downloaded or viewed.

  • You will receive an email notification 5 days before archiving.

  • Archived data remains securely stored but is inaccessible until it is unarchived.

  • You may request permanent deletion of archived data at any time

Option 3: Unarchiving (One-Time Fee)

To access archived VCF files, pay a $10 unarchiving fee (per unarchiving event):

  • Restores full access to your VCF file for 30 days

  • Allows unlimited viewing and downloading during the 30-day active period

  • Does not require a storage subscription during the 30-day active period

  • Can be repeated as needed (each unarchiving provides another 30-day active period)

Data Portability Rights

You may download your VCF file in industry-standard, machine-readable formats during any active access period (free 30 days, subscription period, or unarchived period). We strongly recommend downloading and storing your own backup copy during the initial 30-day free period.

Data Deletion Rights

You may request permanent deletion of your genetic data (VCF file and reports) at any time, regardless of subscription or archive status:

  • Deletion Request: Submit via account settings or email support@mosaicbio.io

  • Processing Timeline: Completed within 30 days with written confirmation

  • Irreversible: Deletion is permanent and cannot be undone.

  • Legal Retention: Limited data may be retained for legal/regulatory compliance (transaction records, tax documentation)

Data Retention

  • Active/Subscribed Data: Retained indefinitely while subscription is active or during free/unarchived periods

  • Archived Data: Retained securely until you request deletion or restart subscription

  • After Deletion Request: Genetic data will be permanently deleted within 30 days

  • Transaction Records: Retained for 7 years for tax and regulatory compliance (separate from genetic data)

Sequencing Technology and Limitations


Technology Used:

  • Next Generation Sequencing (Complete Genomics T7 with DNBSEQ™ or equivalent platforms)

  • Average 30x genome coverage

  • Alignment to GRCh38/hg38 reference genome

  • Industry-standard bioinformatics pipelines for variant calling.

Technical Limitations:

Coverage Gaps: The following genomic regions may have low or no coverage:

  • Centromeric regions and heterochromatin

  • Highly repetitive sequences and tandem repeats.

  • Complex structural variants and inversions

  • Segmental duplications and pseudogenes

  • Portions of the Y chromosome and mitochondrial DNA

Variant Detection Limitations:

  • No-Call Regions: Areas where sequencing data doesn't meet quality thresholds

  • Rare Variants: Many rare genetic variants may not be detected

  • Structural Variations: Large insertions, deletions, or rearrangements may be missed

  • Copy Number Variations: Changes in gene copy number may not be detected

  • Epigenetic Modifications: DNA methylation and other epigenetic changes are not analyzed.

Analysis Limitations:

  • Reference Genome Bias: Analysis based on reference genomes that may not represent all populations

  • Algorithm Constraints: Bioinformatics tools have inherent accuracy limitations

  • Population Bias: Most genetic research is conducted on European ancestry populations

  • Complex Inheritance: Difficulty analyzing complex genetic interactions (epistasis)

Scientific Evolution:

  • Genetic science is continually evolving; interpretations may change as research advances.

  • Variant annotations are updated regularly in genetic databases.

  • Discoveries may change the understanding of variant effects.

  • Most genetic variants have small effect sizes for complex traits

Risks and Important Considerations


Privacy and Security Risks:

  • Data Permanence: Genetic data cannot be changed and has lifelong implications

  • Re-identification: Even pseudonymized genetic data carries potential re-identification risks

  • Family Privacy: Your genetic data reveals information about biological relatives who have not consented

  • Future Unknown Uses: Unknown future applications of genetic data may pose unforeseen privacy risks

  • Third-Party Exposure: Sharing data with third parties increases privacy exposure

For complete information about risks, see our Genetic Data Consent Notice.

Discrimination and Legal Risks:

The Genetic Information Nondiscrimination Act (GINA) provides federal employment and health insurance protections, but does NOT cover:

  • Life insurance

  • Disability insurance

  • Long-term care insurance

State and international protections vary. See our Genetic Data Consent Notice for complete details.

Your Responsibilities:

  • Consider potential emotional impact before testing.

  • Understand that genetic information does not determine health outcomes.

  • Review third-party privacy policies carefully before sharing VCF data.

  • Consult healthcare professionals or genetic counselors for medical interpretation.

  • Consider implications for biological family members.

Third-Party Data Sharing


Your Right to Share: You may download your VCF file and share it with third-party applications for additional analysis, interpretation, or research purposes.

Critical Limitations:

No Control: Once shared, we cannot control how third parties use, store, or protect your genetic data

Independent Policies: Third-party services operate under their own privacy policies, terms of service, and security standards that may differ significantly from ours

Your Responsibility: You are solely responsible for:

  • Reviewing third-party privacy policies and terms before sharing

  • Understanding how third parties will use your data

  • Accepting risks associated with third-party data handling

  • Consequences of third-party data breaches or misuse

Data Recovery: Genetic data shared with third parties cannot be retrieved or deleted by us

Revocable Access: You can revoke third-party access to your Mosaic account anytime, but this does not affect data already shared

No Liability: We are not liable for third-party data handling practices, security breaches, commercial use, or any other third-party actions involving your genetic data

Recommendation: Only share genetic data with trusted, reputable services after carefully reviewing their data handling practices and considering long-term privacy implications.


International Customers


Service Availability: Services available in select countries worldwide, subject to:

  • Compliance with local genetic testing regulations

  • Compliance with biological sample import/export restrictions

  • Compliance with local data protection laws

  • No prohibition on genetic testing services in the customer's jurisdiction

Customer Responsibilities:

Legal Compliance:

  • You confirm that genetic testing is legal in your country.

  • You confirm that providing samples complies with export laws in your country.

  • You are responsible for obtaining any required permits or approvals

Shipping and Customs:

  • You pay all international shipping costs (delivery and return)

  • You are responsible for all customs clearance fees, import duties, taxes, and VAT.

  • You ensure samples clear customs in both the origin and destination countries.

  • You accept responsibility for any shipment delays or customs issues

Processing Considerations:

  • International samples may experience additional processing delays.

  • Some countries may require special documentation or permits.

  • Regulatory requirements may affect service availability or features

Limitation of Liability


Maximum Liability: Our total liability for any claims arising from these Kit Terms is limited to the amount you paid for the WGS kit.

Excluded Damages: To the maximum extent permitted by law, we are not liable for:

  • Indirect, incidental, special, consequential, or punitive damages

  • Lost profits, revenue, or business opportunities

  • Emotional distress, psychological harm, or mental anguish

  • Loss of data or information (except as required by law)

  • Third-party claims arising from your sharing of genetic data

  • Processing delays, service interruptions, or force majeure events

  • Accuracy, completeness, or interpretation of sequencing results

  • Medical decisions or health outcomes based on genetic data

Disclaimer of Warranties: Services provided "AS IS" and "AS AVAILABLE" without warranties of any kind, express or implied, including:

  • No warranty of merchantability or fitness for a particular purpose

  • No warranty regarding accuracy, reliability, or completeness of results

  • No warranty of uninterrupted or error-free service

  • No warranty regarding specific sequencing coverage or variant detection

  • No warranty regarding compatibility with third-party services

Essential Purpose: These limitations apply even if any limited remedy fails of its essential purpose.

Jurisdictional Variations: Some jurisdictions do not permit the limitation of certain warranties or damages. In such jurisdictions, our liability is limited to the maximum extent permitted by law.


Modifications to Terms


Notice of Changes: We reserve the right to modify these Kit Terms to reflect changes in law, technology, or business practices. We will provide notice as follows:

  • Material Changes: 30 days' advance notice via email to the registered address

  • Minor Changes: 7-day notice for clarifications or non-material updates

  • Price Changes: 60 days' advance notice for price increases

  • Legal Requirements: Immediate implementation when required by law or regulation

Material changes include: changes to refund policy, data handling practices, processing procedures, limitation of liability, or dispute resolution.

Your Options:

  • Accept Changes: Continuing to use services constitutes acceptance.

  • Reject Changes: Cancel pending orders before the effective date.

  • Request Refund: Request a refund for prepaid services before the effective date (if materially adverse)

Existing Orders: Orders placed before the effective date of changes will be processed under the terms in effect at the time of purchase, where feasible.


Dispute Resolution


Disputes related to kit orders are subject to the dispute resolution procedures in our Terms of Service, including:

  • 60-day informal resolution period

  • Binding arbitration administered by JAMS

  • Individual claims only (no class actions)

  • Texas venue for non-arbitrated disputes

Contact Information


Customer Support:

  • Email: support@mosaicbio.io (Include "Kit Order" in subject line)

  • Response Time: 24-48 hours for standard inquiries; 4-8 hours for urgent issues

  • Support Hours: Monday-Friday, 9:00 AM - 6:00 PM Central Time

Mailing Address:

Mosaic Biodata Inc. Attn: Kit Orders 919 Congress Ave, Suite 525 Austin, TX 78701 United States

Corporate Information:

  • Incorporated: Delaware, United States

  • Principal Place of Business: Texas, United States

Entire Agreement

These Kit Terms, together with our Terms of Service, Privacy Policy, Genetic Data Consent Notice, and other referenced policies, constitute the complete agreement between you and Mosaic regarding the purchase and processing of WGS kits.

By purchasing a WGS kit, you acknowledge that you have read, understood, and agree to these Kit Order Terms and Conditions.

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