Terms & Conditions of Use

These Terms and Conditions of Use ("Terms") govern your access to and use of the CollagenDirect website (collagendirect.health) and Provider Portal (collectively, the "Platform"). CollagenDirect ("we," "us," "our," or "Company") provides this Platform to facilitate wound care product ordering, delivery, and support for patients, healthcare providers, physicians, practice managers, and medical facilities.

By accessing or using the Platform, you agree to be bound by these Terms. If you do not agree to these Terms, do not use the Platform.

1. Definitions

• "Patient" means an individual receiving wound care products ordered by a healthcare provider through the Platform.
• "Provider" or "Physician" means a licensed medical doctor, nurse practitioner, physician assistant, or other licensed healthcare professional authorized to prescribe wound care products.
• "Practice" means a medical practice, clinic, healthcare facility, practice manager, or DME supplier using the Provider Portal.
• "Products" means collagen wound dressings, therapies, and related wound care supplies offered through the Platform.
• "MD DME" means MD DME, LLC, a Texas limited liability company and licensed DME supplier that fulfills and ships Products.
• "PHI" means Protected Health Information as defined by HIPAA.

2. Acceptance of Terms

For Patients

When your healthcare provider orders Products for you through the Platform, you agree to these Terms. Your provider has represented to us that they have your authorization to order Products on your behalf and share your information with us.

For Physicians and Practices

By registering for a Provider Portal account, you accept these Terms and agree to comply with all applicable laws, regulations, and professional standards. You represent that you have the authority to bind your practice or facility to these Terms.

3. Platform Services

CollagenDirect Provides:

• Technology Platform: A secure website and Provider Portal for ordering, tracking, and managing wound care products
• Order Management: Tools to create, submit, and track product orders
• Patient Management: Systems to store patient information, clinical documentation, and treatment records (PHI)
• Communication Tools: Email, SMS, and AI-powered support for patients and providers
• Educational Resources: Clinical guides, product information, and training materials
• Customer Support: Assistance via phone, email, and chat

CollagenDirect Does NOT:

• Manufacture, dispense, ship, or bill for Products (these functions are performed by MD DME)
• Provide medical advice, diagnoses, or treatment recommendations
• Act as a Covered Entity under HIPAA (your healthcare provider is the Covered Entity)
• Guarantee insurance reimbursement or assume financial responsibility for claims
• Replace the physician-patient relationship

4. User Accounts and Access

Account Registration

To use the Provider Portal, you must register and create an account. You agree to:

• Provide accurate, current, and complete registration information
• Maintain and promptly update your account information
• Maintain the confidentiality of your username and password
• Notify us immediately of any unauthorized access or security breach
• Be responsible for all activity under your account

Credential Verification

We verify professional credentials including NPI numbers, medical licenses, DEA registrations, and DME licenses. You authorize us to:

• Verify your credentials with NPPES, state medical boards, and other authorities
• Conduct periodic re-verification to ensure ongoing compliance
• Suspend or terminate your account if credentials expire, are suspended, or become invalid

Account Termination

We reserve the right to suspend or terminate your account immediately if:

• You violate these Terms or applicable laws
• Your professional license is suspended, revoked, or restricted
• We suspect fraudulent activity, abuse, or misuse of the Platform
• You provide false or misleading information
• Your account has been inactive for 12+ months

5. User Responsibilities

For Patients

You agree to:

• Provide accurate contact and delivery information to your healthcare provider
• Follow product usage instructions provided by your healthcare provider and MD DME
• Contact your healthcare provider (not CollagenDirect) for medical questions or concerns
• Report adverse events or product issues to your provider and/or MD DME
• Pay any applicable co-pays, deductibles, or out-of-pocket costs

For Physicians

You agree to:

• Medical Necessity: Only order Products that are medically necessary and appropriate for your patient's condition
• Patient Authorization: Obtain appropriate authorization from patients to share their PHI with CollagenDirect and MD DME
• Standard Written Orders: Provide complete and accurate Standard Written Orders (SWOs) and clinical documentation
• Coding and Billing: Ensure accurate diagnosis codes (ICD-10) and HCPCS codes
• License Compliance: Maintain current, valid medical licenses and practice within your scope of practice
• Patient Monitoring: Monitor patient outcomes and adjust treatment as clinically appropriate
• Record Keeping: Maintain complete medical records for all patients receiving Products
• Fraud Prevention: Comply with all federal and state laws regarding healthcare fraud, waste, and abuse

For Practices

You agree to:

• Physician Management: Ensure only authorized, licensed physicians use the Platform
• Payment Obligations: Pay all invoices promptly according to the MD DME Product and Services Agreement
• License Maintenance: Maintain current DME licenses, accreditations, and business registrations (if applicable)
• Compliance Programs: Implement and maintain compliance programs to prevent fraud and abuse
• Audit Cooperation: Cooperate with payer audits and provide requested documentation
• Accurate Billing: Submit accurate claims to payers with proper documentation

6. Prohibited Uses

You may NOT use the Platform to:

• Order Products for patients without medical necessity or valid clinical indications
• Submit fraudulent orders or false information
• Share your account credentials with unauthorized individuals
• Access or attempt to access accounts or data belonging to others
• Use automated tools (bots, scrapers, etc.) to access the Platform without permission
• Introduce viruses, malware, or other harmful code
• Reverse engineer, decompile, or disassemble Platform software
• Use the Platform in any way that violates HIPAA, Medicare/Medicaid regulations, or other laws
• Harass, abuse, or harm patients, staff, or other users
• Impersonate another person or entity
• Attempt to overwhelm or disrupt Platform servers or infrastructure
• Remove or alter copyright, trademark, or proprietary notices

7. Intellectual Property

CollagenDirect Ownership

The Platform, including all content, features, functionality, software, code, designs, graphics, logos, trademarks, and user interfaces, is owned by CollagenDirect and protected by U.S. and international copyright, trademark, patent, and other intellectual property laws.

You are granted a limited, non-exclusive, non-transferable, revocable license to access and use the Platform solely for its intended purposes. You may not:

• Copy, reproduce, distribute, or create derivative works from Platform content
• Use CollagenDirect trademarks or logos without written permission
• Frame or mirror any part of the Platform on another website
• Use the Platform or its content for commercial purposes outside of ordering Products

User Content

You retain ownership of content you submit to the Platform (patient data, clinical documentation, etc.). By submitting content, you grant CollagenDirect a worldwide, royalty-free license to use, store, process, and transmit your content solely to provide Platform services and comply with legal obligations.

8. HIPAA and Data Privacy

Business Associate Relationship

CollagenDirect acts as a Business Associate under HIPAA. Our HIPAA obligations are governed by the Business Associate Agreement (BAA), which is incorporated into these Terms by reference. In case of conflict between these Terms and the BAA, the BAA controls for PHI matters.

Your Obligations

As a Covered Entity or Business Associate, you agree to:

• Obtain necessary patient authorizations before sharing PHI
• Use the Platform in compliance with HIPAA Privacy and Security Rules
• Notify us immediately of any suspected privacy or security incidents
• Cooperate with breach investigations and notifications
• Maintain appropriate safeguards when accessing PHI

Privacy Policy

Our collection, use, and disclosure of personal information is governed by our Privacy Policy, which is incorporated into these Terms.

9. Third-Party Services

The Platform integrates with third-party services including:

• MD DME: Product fulfillment, shipping, and (when applicable) billing services. Separate terms apply (see MD DME Product and Services Agreement).
• Payment Processors: Stripe, PayPal, or other payment gateways (subject to their terms)
• Shipping Carriers: UPS, FedEx, USPS (subject to their terms)
• Communication Platforms: Twilio (SMS), SendGrid (email), AI service providers

We are not responsible for the actions, content, or services of third parties. Your use of third-party services is at your own risk and subject to their terms.

10. Disclaimers

No Medical Advice

THE PLATFORM DOES NOT PROVIDE MEDICAL ADVICE. Content on the Platform (including product descriptions, clinical guides, and educational materials) is for informational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. Always consult with qualified healthcare professionals regarding medical decisions.

Platform Availability

THE PLATFORM IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND. We do not guarantee that the Platform will be:

• Available without interruption, delay, or errors
• Secure from unauthorized access, viruses, or other harmful components
• Free from bugs, errors, or inaccuracies
• Compatible with all devices, browsers, or operating systems

Disclaimer of Warranties

TO THE MAXIMUM EXTENT PERMITTED BY LAW, WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING:

• Warranties of merchantability, fitness for a particular purpose, and non-infringement
• Warranties regarding accuracy, reliability, or completeness of Platform content
• Warranties that the Platform will meet your requirements or expectations
• Warranties regarding third-party services, products, or content

No Guarantee of Reimbursement

WE DO NOT GUARANTEE INSURANCE REIMBURSEMENT. Reimbursement decisions are made by payers based on coverage policies, medical necessity determinations, and documentation. Physicians and practices are solely responsible for ensuring reimbursement eligibility and defending claims.

11. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW:

COLLAGENDIRECT, ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, AND AFFILIATES SHALL NOT BE LIABLE FOR:

• Indirect, incidental, consequential, special, exemplary, or punitive damages
• Lost profits, lost revenue, lost data, or business interruption
• Personal injury or property damage arising from your use of the Platform
• Medical malpractice or patient harm resulting from treatment decisions
• Denied insurance claims or reimbursement issues
• Actions or omissions of MD DME, shipping carriers, or other third parties
• Unauthorized access to or alteration of your data
• Errors, omissions, or inaccuracies in Platform content

TOTAL LIABILITY CAP: Our total liability to you for all claims arising from your use of the Platform shall not exceed the greater of (a) $100 or (b) the amount you paid to CollagenDirect (if any) in the 12 months preceding the claim.

Some states do not allow exclusion of implied warranties or limitation of liability for incidental or consequential damages. In such states, our liability is limited to the maximum extent permitted by law.

12. Indemnification

You agree to indemnify, defend, and hold harmless CollagenDirect, MD DME, and their respective officers, directors, employees, agents, and affiliates from and against any and all claims, liabilities, damages, losses, costs, and expenses (including reasonable attorneys' fees) arising out of or related to:

• Your use or misuse of the Platform
• Your violation of these Terms or applicable laws
• Your violation of the rights of any third party, including patients
• Clinical decisions, medical necessity determinations, or treatment provided to your patients
• Inaccurate or incomplete information you provide
• Billing and coding activities, including denied or recouped claims
• Breach of confidentiality, HIPAA violations, or privacy incidents you cause

13. Compliance with Laws

You agree to comply with all applicable federal, state, and local laws, regulations, and professional standards, including but not limited to:

• HIPAA: Health Insurance Portability and Accountability Act
• Medicare/Medicaid Regulations: 42 CFR, Social Security Act, CMS rules
• Anti-Kickback Statute: 42 U.S.C. § 1320a-7b(b)
• Stark Law: 42 U.S.C. § 1395nn
• False Claims Act: 31 U.S.C. §§ 3729–3733
• TCPA: Telephone Consumer Protection Act
• CAN-SPAM Act: Email marketing regulations
• State Medical Practice Acts: Professional licensing and scope of practice
• State Consumer Protection Laws: Including CCPA, CPRA, and other privacy laws

14. Dispute Resolution

Informal Resolution

Before filing a lawsuit, you agree to contact us at legal@collagendirect.health to attempt informal resolution. We will work in good faith to resolve disputes amicably.

Arbitration Agreement

Except for disputes that may be brought in small claims court, any dispute arising from these Terms or your use of the Platform shall be resolved by binding arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association (AAA).

Key arbitration terms:

• Arbitration will be conducted in Texas (or mutually agreed location)
• One arbitrator will be selected per AAA rules
• The arbitrator's decision is final and binding
• Each party bears its own costs and attorneys' fees (unless awarded by arbitrator)
• Arbitration is confidential

Class Action Waiver

YOU AGREE THAT DISPUTES MUST BE BROUGHT INDIVIDUALLY AND NOT AS PART OF A CLASS ACTION, COLLECTIVE ACTION, OR REPRESENTATIVE PROCEEDING. You waive the right to participate in class arbitrations or class lawsuits.

Exceptions

Either party may seek injunctive or equitable relief in court to prevent irreparable harm (e.g., intellectual property violations, security breaches).

Opt-Out

You may opt out of the arbitration agreement by sending written notice to legal@collagendirect.health within 30 days of first accepting these Terms. Opt-out does not affect other provisions of these Terms.

15. Governing Law and Jurisdiction

These Terms are governed by the laws of the State of Texas, without regard to conflict of law principles. Any disputes not subject to arbitration shall be brought exclusively in the state or federal courts located in Texas, and you consent to the jurisdiction of such courts.

16. Modification of Terms

We may update these Terms from time to time. When we make material changes:

• We will post the updated Terms with a new "Last Updated" date
• We will notify registered users via email or Platform notification
• Continued use of the Platform after changes take effect constitutes acceptance

If you do not agree to updated Terms, you must stop using the Platform. For material changes affecting existing agreements (e.g., payment terms), we may require affirmative consent.

17. Severability

If any provision of these Terms is found to be invalid, illegal, or unenforceable, the remaining provisions will continue in full force and effect. The invalid provision will be modified to the minimum extent necessary to make it enforceable.

18. Waiver

Our failure to enforce any provision of these Terms does not constitute a waiver of that provision or our right to enforce it in the future. Waivers must be in writing to be effective.

19. Assignment

You may not assign or transfer these Terms or your account without our written consent. We may assign these Terms in connection with a merger, acquisition, or sale of assets. These Terms bind and benefit the parties and their permitted successors and assigns.

20. Entire Agreement

These Terms, together with our Privacy Policy, Electronic Communications Policy, HIPAA Business Associate Agreement, and MD DME Product and Services Agreement (if applicable), constitute the entire agreement between you and CollagenDirect regarding the Platform and supersede all prior agreements and understandings.

21. Survival

Provisions that by their nature should survive termination of these Terms shall survive, including: ownership provisions, disclaimers, limitations of liability, indemnification, dispute resolution, and governing law.

22. Contact Information

For questions, concerns, or notices regarding these Terms:

CollagenDirect Legal Department
Email: legal@collagendirect.health
Phone: 1-800-XXX-XXXX
Mail: 8080 N Central Expressway, Dallas, TX 75206
Business Hours: Monday–Friday, 9 AM – 5 PM Central Time

---

BY ACCESSING OR USING THE COLLAGENDIRECT PLATFORM, YOU ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD, AND AGREE TO BE BOUND BY THESE TERMS AND CONDITIONS OF USE.

CollagenDirect™ is a trademark of CollagenDirect, Inc. All rights reserved.