CRITICAL PRODUCT CLASSIFICATION AND GUIDANCE FOR USE

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BY USING ENLISENSE SERVICES, YOU ACKNOWLEDGE AND AGREE TO THE FOLLOWING CRITICAL CLASSIFICATIONS

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1.1 Product Portfolio

EnLiSense provides the following devices and services (collectively, "Products" or "Devices"):

- IBD AWARE® - Inflammatory biomarker monitoring system

- SWEAT AWARE® - Sweat analysis and wellness tracking software and associated applications, platforms, and data analytics services

- CORTITM  - Cortisol and stress biomarker monitoring system

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1.2 Dual Classification Framework

A. GENERAL WELLNESS USE (Consumer Application)

Primary Intended Use: EnLiSense Devices are intended for general wellness purposes in healthy individuals, including:

- Health awareness and lifestyle insights

- Fitness tracking and optimization

- Wellness monitoring and personal health data collection

- Stress management and lifestyle coaching

- Educational purposes regarding personal biomarkers

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Regulatory Status: These devices are NOT FDA-cleared or FDA-approved medical devices when used for general wellness purposes.

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Explicit Limitations:

- NOT intended to diagnose, treat, cure, prevent, or mitigate any disease

- NOT intended to replace medical devices or professional medical advice

- NOT evaluated by the FDA for safety or effectiveness in treating medical conditions

- NOT suitable for making medical decisions without healthcare professional consultation

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​B. INVESTIGATIONAL MEDICAL USE (Clinical/Research Application)

**Secondary Intended Use:** Medical applications of EnLiSense Devices, including monitoring, managing, or diagnosing medical conditions, are:

- **INVESTIGATIONAL ONLY**

- **NOT FDA-CLEARED OR APPROVED**

- **REQUIRE QUALIFIED HEALTHCARE PROFESSIONAL SUPERVISION**

- **MUST BE CONDUCTED WITHIN APPROVED CLINICAL OR RESEARCH SETTINGS**

 

Mandatory Requirements for Medical Use:

1. Active supervision by licensed healthcare professionals

2. Institutional Review Board (IRB) approval where applicable

3. Signed informed consent documentation

4. Compliance with Good Clinical Practice (GCP) guidelines

5. Adherence to applicable research protocols

6. Appropriate regulatory oversight and reporting

 

1.3 Biomarker References Are Not Medical Claims

Any references to biomarkers, health conditions, diseases, or medical applications within our Services:

- Reflect ongoing research and development goals

- Are provided for educational and informational purposes only

- Have NOT been evaluated or approved by the FDA

- Do NOT constitute medical claims or clinical recommendations

- Should NOT be relied upon for medical decision-making

 

1.4 User Category Selection and Binding Effect

Upon registration, you must accurately identify your intended use category:

- **Consumer/Wellness User:** Subject to General Wellness Use terms

- **Clinical Research Participant:** Subject to separate Informed Consent and Study Protocol

- **Healthcare Professional/Researcher:** Subject to additional professional use agreements

 

False representation of use category constitutes material breach of these Terms and may result in immediate termination and legal action.

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FDA REGULATORY STATUS AND DISCLAIMERS

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2.1 FDA Evaluation Status

**CRITICAL NOTICE:** The EnLiSense Devices (IBD AWARE®, SWEAT AWARE®, and CORTITM) and the information, data, and insights they provide have NOT been evaluated by the United States Food and Drug Administration (FDA).

 

2.2 Non-Medical Device Classification

These Products are NOT FDA-cleared, FDA-approved, or FDA-authorized as medical devices. They do NOT meet the definition of a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act when used for general wellness purposes.

2.3 Explicit Non-Medical Purpose Statement EnLiSense Products are NOT intended to:

- Diagnose any disease or medical condition - Treat any disease or medical condition

- Cure any disease or medical condition

- Prevent any disease or medical condition

- Mitigate any disease or medical condition

- Assess, monitor, or screen for medical conditions outside of approved clinical research protocols

 

2.4 Claims Limitation

Any statements regarding:

- Product efficacy - Health benefits

- Biomarker interpretation

- Correlation with health outcomes

- Research findings Are based on limited preliminary research, are not conclusive, and should NOT be considered FDA-validated claims.

 

2.5 Regulatory Guidance Compliance

Users should consult the FDA's guidance documents on mobile medical applications and general wellness products, including:

- "Policy for Device Software Functions and Mobile Medical Applications" (2022)

- "General Wellness: Policy for Low-Risk Devices" (2019)

- Other applicable FDA guidance documents

 

2.6 International Regulatory Status

For users outside the United States:

- Products may not be approved by your local regulatory authority

- You are responsible for compliance with local medical device regulations

- Import, use, and distribution may be restricted in your jurisdiction

 

ACCEPTANCE OF TERMS AND ELIGIBILITY

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3.1 Binding Agreement

By accessing, downloading, installing, registering for, or using any EnLiSense Services, you ("User," "you," or "your") acknowledge that you have read, understood, and agree to be legally bound by these Terms and Conditions ("Terms," "Agreement," or "Terms and Conditions") and our Privacy Policy, which is incorporated herein by reference.

 

3.2 Agreement to Terms Constitutes Acceptance

Your acceptance may be indicated by:

- Clicking "I Agree," "Accept," "Sign Up," or similar buttons

- Creating an account

- Downloading or installing our mobile applications

- Using any EnLiSense Device - Accessing any EnLiSense Service **IF YOU DO NOT AGREE TO THESE TERMS, DO NOT USE OUR SERVICES.**

 

3.3 Eligibility Requirements

Age Requirements:

- **General Wellness Users:** Must be at least 18 years of age or the age of majority in your jurisdiction, whichever is higher

- **Research Participants:** Age requirements specified in study-specific informed consent

- **Minors:** Use by individuals under 18 is prohibited except in approved IRB-supervised research with parental/guardian consent.

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Legal Capacity:

- Must be legally capable of entering into binding contracts

- Must have authority to bind any entity on whose behalf you are acting

- Must not be legally prohibited from receiving or using the Services ####

 

Geographic Restrictions:

- Services may not be available in all jurisdictions

- Use may be restricted by local laws, regulations, or export controls

- You are responsible for compliance with applicable local laws 

 

3.4 No Representation Regarding Accuracy

You represent and warrant that:

- All information provided during registration is accurate, current, and complete

- You will maintain and update such information to keep it accurate

- You are not impersonating any person or entity

- You have the legal right to use any payment methods provided

Providing false information constitutes material breach and grounds for immediate termination.**

 

3.5 Entity Users

If you are using Services on behalf of an organization, company, or other legal entity:

- You represent that you have authority to bind that entity to these Terms

- Both you and the entity are bound by these Terms

- References to "you" include both you and the entity ###

 

3.6 Changes to Terms

EnLiSense reserves the right to modify, amend, or update these Terms at any time, with or without notice, at our sole discretion. Changes are effective immediately upon posting to our website or Services.

 

*Your Responsibility:**

- Check Terms periodically for updates

- Continued use after changes constitutes acceptance

- If you disagree with changes, you must immediately cease use

 

**We are NOT obligated to provide individual notice of changes.**

 

3.7 Entire Agreement

These Terms, together with:

- Our Privacy Policy

- Any study-specific informed consent forms

- Product-specific terms and conditions

- Any additional legal notices or policies

 

Constitute the entire agreement between you and EnLiSense regarding your use of the Services, superseding all prior or contemporaneous communications, proposals, and agreements.

 

DEFINITIONS​

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For purposes of these Terms, the following definitions apply:

**"Company," "EnLiSense," "we," "us," or "our"** means EnLiSense and its affiliate companies, subsidiaries, affiliates, officers, directors, employees, agents, licensors, and suppliers.

**"User," "you," or "your"** means the individual or entity accessing or using the Services.

**"Services"** means all software, mobile applications, devices, products, websites, platforms, data analytics, and services provided by EnLiSense, collectively.

**"Devices" or "Products"** means IBD AWARE®, SWEAT AWARE®, CORTITM, and any other hardware devices provided by EnLiSense.

**"Personal Data" or "Personal Information"** means information that can identify you as an individual, as further defined in our Privacy Policy.

**"Health Data"** means biometric data, biomarker readings, wellness information, and health-related data collected through the Devices.

**"General Wellness Use"** means use of Devices for fitness, lifestyle, stress management, and general health awareness purposes, not for medical purposes.

**"Investigational Medical Use"** means use of Devices in clinical research, medical studies, or disease monitoring under healthcare professional supervision.

**"Informed Consent"** means a document signed by research participants that meets ethical and regulatory requirements for human subjects research. *

*"Healthcare Professional"** means a licensed physician, nurse practitioner, or other qualified medical professional authorized to provide medical care in their jurisdiction.

**"IRB"** means Institutional Review Board, an ethics committee that reviews and approves human subjects research.

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GENERAL WELLNESS USE - CONSUMER APPLICATIONS

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5.1 Scope of General Wellness Use

When using EnLiSense Devices for general wellness purposes, you acknowledge and agree that:

Permitted Uses:

- Personal health awareness and education

- Fitness tracking and performance optimization

- Stress management and lifestyle insights

- Sleep quality monitoring and improvement

- Nutritional and hydration awareness

- Personal biomarker trend observation

- Wellness goal setting and tracking

Prohibited Uses:

- Making medical diagnoses

- Determining treatment plans

- Monitoring active disease states

- Replacing prescribed medical devices

- Making medication decisions

- Managing chronic medical conditions

- Any use that requires FDA clearance

 

5.2 No Medical Purpose or Advice

You explicitly acknowledge that for general wellness use:

- Devices provide information for educational and awareness purposes ONLY

- Data and insights are NOT medical advice

- Results should NOT guide medical decisions

- Professional medical consultation is required for health concerns

- Devices do NOT detect, diagnose, or predict disease

 

5.3 Data Interpretation Limitations

Biomarker readings and health data provided through the Services:

- May vary due to numerous factors unrelated to health status

- Require context and professional interpretation for medical significance

- Are not validated for clinical decision-making

- Should not be used to self-diagnose or self-treat

- May not be accurate or reliable for all individuals

 

5.4 Lifestyle and Wellness Education

Information provided about:

- Biomarkers and their general functions

- Lifestyle factors affecting health

- General wellness principles

- Health optimization strategies

Is for educational purposes only and does not constitute personalized medical advice.

 

5.5 When to Seek Professional Care

You agree to immediately consult a healthcare professional if you:

- Experience concerning symptoms

- Have questions about your health status

- Observe unusual or unexpected readings

- Have pre-existing medical conditions

- Are pregnant or nursing

- Are taking medications

- Experience adverse reactions

 

5.6 Emergency Situations

CRITICAL: EnLiSense Services are NOT designed for emergency use. In case of medical emergency:

- Call 911 (US) or local emergency services immediately

- Do NOT rely on Device data for emergency decisions

- Seek immediate in-person medical care

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INVESTIGATIONAL MEDICAL USE - CLINICAL AND RESEARCH APPLICATIONS

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6.1 Investigational Status

Medical applications of EnLiSense Devices are **INVESTIGATIONAL ONLY** and:

- Are NOT approved or cleared by any regulatory authority for medical use

- Carry unknown risks and uncertain benefits

- Require rigorous scientific evaluation

- Must comply with research ethics standards

- Are subject to regulatory oversight ###

 

6.2 Mandatory Healthcare Professional Supervision

Medical use of Devices REQUIRES:

Qualified Supervision:

- Licensed healthcare professional oversight

- Active clinical monitoring and interpretation

- Professional medical judgment for all decisions

- Access to appropriate medical facilities

- Emergency response capabilities

 

Professional Responsibilities:

Healthcare professionals using EnLiSense Devices for medical purposes acknowledge:

- They bear full responsibility for clinical interpretation

- They maintain appropriate clinical oversight

- They ensure patient safety and informed consent

- They comply with applicable medical practice standards

- They report adverse events appropriately

 

6.3 Clinical Research Requirements

IRB Approval: All medical research use must have:

- Appropriate IRB or ethics committee approval

- Documented study protocol

- Risk-benefit assessment

- Data safety monitoring plan (where applicable)

- Regulatory compliance documentation

 

Informed Consent Process:

Research participants must:

- Receive and review study

-specific informed consent

- Understand investigational nature of use

- Acknowledge risks and uncertainties

- Provide voluntary written consent

- Have opportunity to ask questions

 

**These Terms do NOT constitute informed consent for research participation.**

 

6.4 Study-Specific Terms

Research participants are subject to:

- Study-specific informed consent documents

- Research protocol requirements

- Additional terms governing data use

- Institutional policies and procedures

 

**In case of conflict between these Terms and study-specific informed consent, the informed consent controls.**

 

6.5 No Guarantee of Medical Benefit

You acknowledge that investigational medical use:

- May provide no medical benefit

- Carries uncertain and unknown risks

- Is experimental in nature

- May require discontinuation if safety concerns arise

- Should not replace standard medical care

 

6.6 Adverse Event Reporting

Healthcare professionals and research participants must immediately report:

- Serious adverse events

- Device malfunctions

- Unexpected risks

- Safety concerns

- Protocol deviations

Contact: safety@enlisense.com within 24 hours of awareness

 

6.7 Regulatory Compliance

Medical use must comply with:

- FDA regulations (21 CFR Parts 812, 50, 56)

- ICH Good Clinical Practice (GCP) guidelines

- Declaration of Helsinki principles

- Local research ethics requirements

- HIPAA and privacy regulations

- Applicable state and federal laws

 

6.8 Investigational Device Exemption (IDE)

Where applicable, medical studies may be conducted under:

- FDA Investigational Device Exemption

- IRB-approved protocols

- Regulatory oversight and monitoring

- Sponsor responsibilities and obligations

 

Participants in IDE studies receive separate informed consent describing the investigational nature of use.

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MEDICAL DISCLAIMERS AND LIMITATIONS

 

7.1 No Physician-Patient Relationship​

Use of EnLiSense Services does NOT create a physician-patient relationship or professional healthcare relationship between you and:
- EnLiSense or its affiliates
- Any healthcare professionals providing content
- Any employees or agents of EnLiSense
- Any third-party service providers

 

7.2 Not a Substitute for Professional Medical Care​

YOU EXPRESSLY ACKNOWLEDGE:
- Services do NOT replace professional medical advice, diagnosis, or treatment
- Healthcare provider consultation is essential for medical concerns
- Device data should NOT be used to self-diagnose or self-treat
- Professional medical judgment supersedes Device information
- Delaying or avoiding medical care based on Device data may be harmful

 

7.3 Consultation Mandate

You MUST consult qualified healthcare providers regarding:
- Any medical symptoms or concerns
- Questions about health status or test results
- Treatment decisions or medication changes
- Management of chronic conditions
- Pregnancy or nursing-related health matters
- Interpretation of biomarker data for medical purposes
- Any health changes or unexpected readings

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7.4 Accuracy and Reliability Limitations
EnLiSense makes NO warranties or representations regarding:
- Accuracy of Device readings or measurements
- Reliability of data under all conditions
- Completeness of information provided
- Suitability for any particular individual
- Freedom from errors or interruptions
- Correlation between readings and health status

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Factors affecting accuracy may include:
- Individual biological variation
- Environmental conditions
- Device placement and usage
- Technical limitations
- User error or misuse
- Interference from other factors

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7.5 Interpretation Limitations
Device readings and data:
- Require professional clinical context for interpretation
- May not reflect actual health status
- Can be affected by numerous non-disease factors
- Are not diagnostic indicators
- Should not be interpreted as medical results

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7.6 Individual Variability
You acknowledge that:
- Biomarker levels vary significantly between individuals
- "Normal" ranges may not apply to all users
- Personal baselines differ
- Results may not be clinically significant
- Professional interpretation is essential

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7.7 No Specific Outcome Guarantee
EnLiSense does NOT guarantee that use of Services will:
- Improve your health status
- Prevent disease or illness
- Detect health problems
- Provide accurate predictions
- Lead to any particular health outcome

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7.8 Pre-Existing Conditions
If you have pre-existing medical conditions, you MUST:
- Consult your healthcare provider before use
- Follow medical advice over Device data
- Continue prescribed treatments and monitoring
- Report Device use to treating physicians
- Seek immediate care for symptom changes

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7.9 Pregnancy and Nursing
Pregnant or nursing individuals:
- MUST consult healthcare providers before use
- Should not rely on Device data for pregnancy-related decisions
- Must seek immediate care for any concerning symptoms
- Acknowledge insufficient data on safety during pregnancy

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7.10 Drug and Device Interactions
Device accuracy may be affected by:
- Prescription medications
- Over-the-counter drugs
- Supplements and vitamins
- Other wearable devices
- Medical implants
- Skin conditions or treatments

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Consult your healthcare provider regarding potential interactions.

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If our platform allows for user-generated content, you agree not to post content that:

• Is defamatory, obscene, or discriminatory

• Violates any intellectual property rights

• Contains any form of advertising or solicitation

 

ASSUMPTION OF RISK AND USER ACKNOWLEDGMENTS

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8.1 Voluntary Use and Risk Acceptance
BY USING ENLISENSE SERVICES, YOU VOLUNTARILY ASSUME ALL RISKS associated with such use, including but not limited to:​

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Technical Risks:
- Device malfunction or inaccuracy
- Software errors or bugs
- Data transmission failures
- Connectivity issues
- Technical limitations

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Health-Related Risks:
- Reliance on inaccurate or misleading data
- Delayed medical care due to false reassurance
- Anxiety from misinterpreted results
- Skin irritation or allergic reactions
- Physical injury from device use

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Data and Privacy Risks:
- Data breaches or unauthorized access
- Loss of confidentiality
- Misuse of personal information
- Third-party data sharing

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Financial Risks:
- Costs of device and services
- Charges for unnecessary medical care
- Costs from device malfunction

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8.2 Express Acknowledgments
You expressly acknowledge and agree that:

1. **No FDA Clearance:** Devices are not FDA-cleared or approved for any medical purpose

2. **Investigational Nature:** Medical applications are experimental and unproven

3. **Limited Evidence:** Claims are based on limited research and are not conclusive

4. **No Medical Supervision:** General wellness use occurs without medical oversight

5. **Personal Responsibility:** You are solely responsible for health decisions

6. **Data Limitations:** Device data may be inaccurate, incomplete, or misleading

7. **No Emergency Use:** Services are unsuitable for emergency situations

8. **Professional Consultation Required:** Medical advice from qualified professionals is essential

9. **Variation in Results:** Individual results and experiences will vary

10. **Continuous Development:** Products are subject to ongoing development and changes

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8.3 Informed Decision-Making
You confirm that:
- You have read and understood all limitations and disclaimers
- You have had opportunity to ask questions
- You understand the investigational nature of medical use
- You accept uncertainty regarding accuracy and reliability
- You will not make medical decisions based solely on Device data
- You understand the importance of professional medical consultation

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8.4 Feature and Capability Changes
You acknowledge that:
- Product features and capabilities may change as development continues
- New features may be added or removed
- Accuracy and functionality may improve or change over time
- We may discontinue certain features or services
- Updates may affect device performance

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8.5 No Guarantees or Warranties
You understand that EnLiSense provides Services:
- "AS IS" and "AS AVAILABLE"
- Without warranties of any kind, express or implied
- Without guarantee of accuracy or reliability
- Without guarantee of fitness for any particular purpose
- Subject to all limitations stated in these Terms

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8.6 Release of Liability
TO THE MAXIMUM EXTENT PERMITTED BY LAW, you release, waive, and forever discharge EnLiSense and its affiliates from any and all claims, liabilities, damages, or losses arising from your use of the Services, including:
- Health outcomes or adverse events
- Reliance on Device data
- Medical decisions made based on Services
- Technical failures or inaccuracies
- Any other use or misuse of Services

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This release applies even if EnLiSense has been advised of the possibility of such damages.

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LIMITATION OF LIABILITY

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9.1 Maximum Liability Cap
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, THE TOTAL AGGREGATE LIABILITY OF EnLiSense AND ITS AFFILIATES, OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, AND SUPPLIERS (COLLECTIVELY, "ENLISENSE PARTIES") FOR ANY CLAIMS ARISING OUT OF OR RELATED TO YOUR USE OF THE SERVICES SHALL NOT EXCEED THE GREATER OF:
- (a) The total amount paid by you to EnLiSense in the twelve (12) months preceding the claim; OR
- (b) One hundred dollars ($100.00 USD)

 

9.2 Excluded Damages
ENLISENSE PARTIES SHALL NOT BE LIABLE FOR ANY:

Direct Damages:
- Personal injury or death
- Property damage
- Lost profits or revenue
- Cost of substitute goods or services
- Loss of data or information
- Loss of business opportunities

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Indirect and Consequential Damages:
- Indirect, incidental, special, consequential, exemplary, or punitive damages
- Loss of use, goodwill, or reputation
- Emotional distress or mental anguish
- Medical expenses or health-related costs
- Costs of investigation or litigation
- Any other intangible losses

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THIS LIMITATION APPLIES REGARDLESS OF:
- The legal theory (contract, tort, negligence, strict liability, warranty, or otherwise)
- Whether EnLiSense has been advised of the possibility of such damages
- Whether a limited remedy fails of its essential purpose
- Any failure of any exclusive remedy

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9.3 No Liability for Third Parties
EnLiSense is NOT liable for:
- Actions or omissions of healthcare professionals
- Third-party service provider failures
- Actions of research institutions or IRBs
- Unauthorized access by third parties
- Content or services of linked websites
- Third-party data breaches

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9.4 No Liability for Medical Outcomes
EnLiSense is explicitly NOT LIABLE for any health outcomes, medical decisions, or consequences resulting from:
- Use or misuse of Devices or Services
- Reliance on Device data or information
- Delays in seeking medical care
- Misinterpretation of results
- Device inaccuracy or malfunction
- Failure to receive medical advice

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9.5 Force Majeure
EnLiSense shall not be liable for any failure or delay in performance due to circumstances beyond our reasonable control, including:
- Acts of God, natural disasters
- War, terrorism, civil unrest
- Government actions or regulations
- Pandemics or public health emergencies
- Labor strikes or disputes
- Failure of suppliers or vendors
- Telecommunications or internet failures
- Power outages or equipment failures

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9.6 Basis of Bargain
You acknowledge that:
- These liability limitations are essential elements of the agreement
- EnLiSense would not provide Services without these limitations
- Fees charged reflect these allocations of risk
- You have accepted these limitations in exchange for access to Services

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9.7 Jurisdictional Limitations
Some jurisdictions do not allow:
- Limitation of liability for personal injury or death
- Exclusion of implied warranties
- Limitation of incidental or consequential damages

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In such jurisdictions, EnLiSense's liability is limited to the maximum extent permitted by law.

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9.8 Separate Liability
Each provision of this limitation of liability section is separable and independent. If any provision is held invalid or unenforceable, the remaining provisions remain in full effect

 

INDEMNIFICATION

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10.1 Your Indemnification Obligations
You agree to defend, indemnify, and hold harmless EnLiSense Parties from and against any and all third-party claims, actions, demands, liabilities, settlements, judgments, losses, damages, penalties, fines, costs, and expenses (including reasonable attorneys' fees, expert fees, court costs, and litigation expenses) arising out of or related to:

Use of Services:
- Your use or misuse of Devices or Services
- Your reliance on Device data or information
- Health decisions made based on Services
- Any adverse health outcomes
- Delay in seeking medical care

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Breach of Terms:
- Violation of these Terms and Conditions
- Violation of any applicable laws or regulations
- Infringement of third-party rights
- Breach of representations and warranties

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User Content and Conduct:
- Content you submit or transmit
- Your interactions with other users
- Unauthorized use of your account
- Violation of third-party intellectual property rights

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False Representations:
- Misrepresentation of identity or credentials
- False information provided during registration
- Unauthorized use on behalf of another entity
- Fraudulent activity

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10.2 Defense and Settlement
In the event of any claim requiring indemnification:

Notice: EnLiSense will provide prompt written notice of the claim.

 

Your Obligations:
- You agree to assume defense and control of the claim
- You will retain qualified legal counsel
- You will keep EnLiSense informed of proceedings
- You will not settle without EnLiSense's prior written consent

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EnLiSense's Rights:
- We may participate in defense at our expense
- We may assume exclusive defense and control at your expense if you fail to defend adequately
- We have final approval over any settlement affecting our rights

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10.3 Cooperation
You agree to:
- Cooperate fully with EnLiSense's defense efforts
- Provide requested information and documentation
- Make yourself available for depositions and testimony
- Not make any admissions prejudicial to EnLiSense

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10.4 No Admission of Liability
Your indemnification obligations are independent of any liability limitations and do not constitute an admission of liability by EnLiSense.

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USER RESPONSIBILITIES AND PROHIBITED CONDUCT

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11.1 Lawful Use

You agree to use Services only for lawful purposes and in compliance with:
- All applicable local, state, federal, and international laws
- All regulations governing medical devices and health data
- Export control laws and sanctions
- Privacy and data protection laws
- Consumer protection laws

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11.2 Accurate Information
You agree to:
- Provide accurate, current, and complete information during registration
- Maintain and update information to keep it accurate
- Not impersonate any person or entity
- Not provide false or misleading health information
- Not misrepresent your credentials or qualifications

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11.3 Prohibited Uses
You shall NOT:

Unauthorized Medical Use:
- Use Devices for medical diagnosis without professional supervision
- Rely solely on Device data for medical decisions
- Use in clinical settings without proper authorization
- Make treatment decisions without healthcare professional consultation
- Use for emergency medical situations

 

Harmful Activities:
- Engage in fraudulent schemes or scams
- Harass, threaten, or harm other users
- Distribute malware, viruses, or harmful code
- Attempt unauthorized access to systems or accounts
- Interfere with or disrupt Services
- Overload or impair system functionality

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Intellectual Property Violations:
- Reverse engineer, decompile, or disassemble Devices or software
- Copy, modify, or create derivative works without authorization
- Remove or alter proprietary notices or labels
- Use EnLiSense trademarks without permission
- Infringe third-party intellectual property rights

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Data Misuse:
- Extract data through automated scraping or harvesting
- Use data for commercial purposes without authorization
- Share or sell access credentials
- Violate other users' privacy
- Export data in violation of regulations

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Prohibited Content:
- Post defamatory, obscene, or discriminatory content
- Upload malicious or harmful materials
- Share false or misleading information
- Violate intellectual property rights
- Post unsolicited advertising or spam

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11.4 Research Participant Responsibilities
If participating in clinical research, you must:
- Follow study protocol requirements
- Attend scheduled visits and assessments
- Report adverse events promptly
- Use Devices as instructed
- Not share Devices with others
- Maintain confidentiality of study information

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11.5 Healthcare Professional Responsibilities
Healthcare professionals using Services must:
- Maintain appropriate professional standards
- Exercise independent clinical judgment
- Provide adequate patient oversight
- Obtain informed consent for medical use
- Comply with professional licensing requirements
- Report adverse events per regulatory requirements

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11.6 Device Care and Maintenance
You agree to:
- Use Devices according to instructions
- Maintain Devices in good working condition
- Not modify or tamper with Devices
- Store Devices properly when not in use
- Replace components as recommended
- Not expose Devices to extreme conditions

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11.7 Security Obligations
You must:
- Maintain confidentiality of login credentials
- Not share accounts with others
- Use strong, unique passwords
- Enable two-factor authentication if available
- Log out from shared devices
- Report security breaches immediately

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11.8 Adverse Event and Safety Reporting
You must immediately report:
- Device malfunctions or defects
- Unexpected or serious adverse events
- Safety concerns
- Product quality issues
- Injuries related to device use

Report to: PR@enlisense.com or +1-703-349-6950

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11.9 Consequences of Violations
Violation of these responsibilities may result in:
- Immediate termination of account and access
- Legal action and pursuit of damages
- Criminal prosecution where applicable
- Reporting to regulatory authorities
- Permanent ban from Services

 

ACCOUNT MANAGEMENT AND SECURITY

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12.1 Account Creation
To access certain Services, you must create an account by providing:
- Valid email address
- Secure password
- Accurate personal information
- Payment information (for paid services)
- Health and demographic data (as requested)

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12.2 Account Security
You are solely responsible for:
- Maintaining confidentiality of credentials
- All activities under your account
- Unauthorized access resulting from your negligence
- Security of devices used to access Services

 

Immediately notify EnLiSense of any unauthorized access or security breach.

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12.3 Single User Accounts
Accounts are for individual use only:
- Do not share accounts with others
- Do not allow others to use your credentials
- Do not create accounts on behalf of others without authorization
- Devices are assigned to specific users and should not be shared

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12.4 Account Information Accuracy
You must:
- Keep account information current and accurate
- Update information when it changes
- Verify email address and contact information
- Correct inaccurate health data promptly

 

12.5 Account Suspension
EnLiSense may suspend your account if:
- Suspicious activity is detected
- Payment fails or is disputed
- Investigation of Terms violation is ongoing
- Required information is not provided
- Security concerns exist

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12.6 Data Retention After Termination
Upon account termination:
- Some data may be retained for legal or business purposes. EnLiSense retains the rights to all data retention.
- Anonymized data may be retained for research
- You may lose access to all account data
- We are not obligated to provide data copies
- Any particular issues/requests may be considered on a situational basis

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CANCELLATION, REFUND, AND REPLACEMENT POLICY

 

13.1 Cancellation

How to Cancel:
- Contact us via website contact form
- Email: pr@enlisense.com
- Submit cancellation request through account settings

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Effective Date:
- Cancellation effective at end of current billing period
- No partial-month refunds
- Continued access through end of paid period
- No charges after cancellation processed

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13.2 Refund Policy

General Policy:
- **No refunds for canceled orders** as a general rule
- Services are provided throughout paid period even after cancellation
- Partial refunds only in extraordinary circumstances at EnLiSense's sole discretion

​

Extraordinary Circumstances:
Prorated refunds may be considered for:
- Service unavailability for extended periods
- Material change in services affecting usability
- EnLiSense-initiated cancellation
- Duplicate or erroneous charges

​

All refund requests subject to verification and approval.

​

13.3 Company-Initiated Cancellation
EnLiSense may cancel subscriptions for:
- Terms violations
- Fraudulent activity
- Failure to pay
- Service discontinuation
- Other business reasons

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13.4 Hardware Defects and Replacements

Replacement Policy:
If you receive defective hardware:
1. Contact us within 30 days of receipt
2. Provide proof of purchase and defect description
3. Follow return instructions provided
4. We will inspect the returned device and provide a response.

​

Eligibility:
- Hardware must be used according to user guidelines
- Defects must be manufacturing-related
- Does NOT cover:
  - Normal wear and tear
  - Misuse or accidents
  - Unauthorized modifications
  - Damage from improper storage
  - Lost or stolen devices

 

Process:
- Submit replacement request to pr@enlisense.com
- Verification of defect
- Return authorization and instructions provided
- Replacement/Repaired unit shipped upon receipt of defective unit

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13.5 No Refunds for Health Outcomes
CRITICAL: No refunds or compensation provided for:
- Dissatisfaction with Device readings
- Lack of expected health improvements
- Adverse health events
- Inaccurate or unexpected results
- Any health-related outcomes

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13.6 Processing Time
- Cancellation: Immediate to 5 business days
- Refunds: 7-14 business days after approval
- Replacements/Repair: Ship within 5-10 business days from Response report

​​

INTELLECTUAL PROPERTY RIGHTS

 

14.1 Ownership of Company IP
All intellectual property related to EnLiSense Services, including but not limited to:
- Devices, sensors, and hardware
- Software, algorithms, and code
- Mobile applications and platforms
- Data analytics and processing methods
- Trademarks, logos, and branding
- Patents and trade secrets
- User manuals and documentation
- Website content and design
- Derivative data and insights

**(Collectively, "Company IP")** are and remain the exclusive property of EnLiSense.

​

14.2 Reserved Rights
EnLiSense retains ALL rights, title, and interest in Company IP, including:
- Copyright in software and content
- Patent rights in inventions and methods
- Trademark rights in brands and logos
- Trade secret protection
- Database rights
- All other intellectual property rights

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14.3 Limited License Grant
Subject to your compliance with these Terms, EnLiSense grants you a limited, non-exclusive, non-transferable, revocable license to:
- Access and use Services for personal use (general wellness) or authorized research use
- Install and use mobile applications on your personal devices
- Use Devices according to instructions
- Access your personal account and data

​

This license does NOT permit:
- Commercial use or resale
- Modification or derivative works
- Reverse engineering or decompilation
- Sublicensing or transfer
- Removal of proprietary notices
- Any use not expressly authorized

​

14.4 Reverse Engineering Prohibition
You are **EXPRESSLY PROHIBITED** from:
- Reverse engineering, decompiling, or disassembling any Company IP
- Attempting to discover source code or algorithms
- Circumventing security or access controls
- Extracting or copying proprietary information
- Creating competing products or services
- Tampering with hardware or software

​

Violation constitutes material breach and may result in criminal prosecution.

​

14.5 Prohibited Uses of Company IP

You SHALL NOT:
- **Commercial Resale:** Resell, rent, or lease Devices or Services
- **Modification:** Alter, adapt, or create derivatives of Company IP
- **Unauthorized Copying:** Reproduce or distribute Company IP
- **Data Harvesting:** Use automated tools to extract data
- **Illegal Activity:** Use for fraudulent or criminal purposes
- **Unauthorized Access:** Attempt to access restricted systems
- **Network Disruption:** Interfere with service operation
- **Impersonation:** Impersonate EnLiSense or misuse branding
- **License Violation:** Use beyond scope of license grant
- **Export Violation:** Export to prohibited countries or entities

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14.6 Data Ownership and Rights

Your Personal Data:
- You retain ownership of your personal information
- You grant EnLiSense license to use data as described in Privacy Policy
- License includes right to aggregate, anonymize, and analyze data

​

Aggregated and Anonymized Data:
- EnLiSense owns all aggregated and anonymized data
- May be used for research, product improvement, and commercial purposes
- No compensation owed for use of aggregated data

​

Research Data:
- Research study participants grant rights as specified in informed consent
- May include broader data use for research purposes

​

14.7 User Content
Any content you submit (feedback, suggestions, ideas):
- Becomes property of EnLiSense
- May be used without compensation or attribution
- Non-confidential and non-proprietary
- May be incorporated into products or services

​

14.8 Trademarks
EnLiSense trademarks and logos:
- Are protected marks owned by EnLiSense
- May not be used without express written permission
- Use in comparative advertising must comply with law
- Misuse may result in legal action

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14.9 Copyright Infringement Claims
If you believe your copyright has been infringed, contact: legal@enlisense.com

Include:
- Identification of copyrighted work
- Location of infringing material
- Your contact information
- Statement of good faith belief
- Statement of accuracy and authority
- Signature

​

14.10 Enforcement and Remedies
EnLiSense will vigorously enforce intellectual property rights and may seek:
- Injunctive relief and cease orders
- Monetary damages
- Criminal prosecution where applicable
- Costs and attorneys' fees​

 

SOFTWARE UPDATES AND TECHNICAL REQUIREMENTS

 

15.1 Automatic Updates
Services may include automatic software updates:
- Bug fixes and security patches
- Feature enhancements
- Performance improvements
- Compatibility updates

 

**By using Services, you consent to automatic updates.**

​

15.2 Update Requirements
You are responsible for:
- Installing updates promptly
- Maintaining compatible devices
- Ensuring adequate storage space
- Maintaining internet connectivity for updates

​

Failure to update may result in:
- Reduced functionality
- Security vulnerabilities
- Service incompatibility
- Lack of technical support

​

15.3 Technical Requirements

Compatible Devices:
- Smartphones: iOS 13.0+ or Android 12.0+
- Operating systems: As specified on website
- Bluetooth: 4.0 or higher
- Internet: Wi-Fi or cellular data connection

​

Storage and Performance:
- Adequate storage space for app and data
- Sufficient processing power
- Current operating system version

​

15.4 Beta Features
We may offer beta or experimental features:
- Marked as "beta," "preview," or "experimental"
- May be unstable or incomplete
- Subject to change or removal
- Use at your own risk
- No warranties or guarantees

​

15.5 Service Modifications
EnLiSense reserves the right to:
- Modify or discontinue features
- Change user interface or functionality
- Update algorithms or data processing
- Remove or add integrations

​

**Changes effective immediately upon implementation.**

​

15.6 Backward Compatibility
We do NOT guarantee:
- Support for older device or software versions
- Compatibility with discontinued products
- Access to deprecated features
- Data migration from legacy systems

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DISPUTE RESOLUTION AND GOVERNING LAW

​

16.1 Mandatory Binding Arbitration

**IMPORTANT:** This section contains a binding arbitration clause and class action waiver that affects your legal rights. Read carefully.

​

**Agreement to Arbitrate:**
Any dispute, claim, or controversy arising out of or relating to these Terms or your use of EnLiSense Services shall be resolved through **MANDATORY BINDING ARBITRATION** rather than in court, except as specified in Section 19.2.

​

16.2 Scope of Arbitration
Subject to arbitration:
- Contract disputes
- Tort claims
- Statutory claims
- Disputes regarding these Terms
- Claims related to use of Services
- Intellectual property disputes

​

Not subject to arbitration:
- Small claims court matters (within jurisdictional limits)
- Claims for equitable relief (injunctions)
- Intellectual property enforcement actions

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16.3 Arbitration Procedures

Forum and Rules:
- Conducted under American Arbitration Association (AAA) rules
- Commercial Arbitration Rules apply
- Consumer Arbitration Rules if applicable
- Location: Plano, Texas or mutually agreed location in Texas

 

Process:
1. Notice of dispute sent to other party
2. 30-day negotiation period
3. File arbitration demand with AAA
4. Arbitrator selection per AAA rules
5. Hearing scheduled and conducted
6. Arbitrator issues written decision

​

Costs:
- Filing fees per AAA rules
- Each party bears own attorney fees unless arbitrator awards otherwise
- Arbitrator fees split equally or as determined by arbitrator

 

16.4 Class Action Waiver

**YOU AGREE TO RESOLVE DISPUTES ON AN INDIVIDUAL BASIS ONLY.**

 

You waive the right to:
- Participate in class action lawsuits
- Bring representative actions
- Join consolidated proceedings
- Seek class-wide relief

 

**Each claim must be brought individually.**

​

16.5 Time Limitation for Claims

**Any claim must be filed within ONE (1) YEAR after the claim arises; otherwise, the claim is PERMANENTLY BARRED.**

​

Time begins to run:
- When you knew or should have known of the facts giving rise to the claim
- Not when damages are discovered

 

16.6 Governing Law

Law Applicable:
These Terms are governed by the laws of the **State of Texas, USA**, without regard to:
- Conflict of law principles
- United Nations Convention on Contracts for the International Sale of Goods
- Any other international treaties

​

Jurisdiction:
For matters not subject to arbitration:
- Exclusive jurisdiction: State and federal courts in Collin County, Texas
- You consent to personal jurisdiction in these courts
- You waive any objection to venue

​

16.7 Federal Arbitration Act
The Federal Arbitration Act (FAA) governs the interpretation and enforcement of this arbitration provision.

​

16.8 Opt-Out Right
You may opt out of arbitration by:
- Sending written notice within 30 days of accepting these Terms
- Send to: EnLiSense, 535 Talbert Drive, Suite 205, Plano, TX 75075
- Include name, address, and clear statement of opt-out intent

​

**Opt-out does not affect other Terms provisions.**

​

16.9 Severability of Arbitration Clause
If any part of this arbitration provision is found invalid or unenforceable:
- Class action waiver remains enforceable to maximum extent
- Remaining provisions continue to apply
- Invalid portion severed from Terms

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16.10 Continuation After Termination
Arbitration provisions survive termination of account or Services.​​​