Terms and Conditions

1. ACCEPTANCE OF TERMS

By purchasing PBME Topical™ products from Future Medical Products™, you acknowledge that you have read, understood, and agree to be bound by these Terms and Conditions. These terms constitute a legally binding agreement between you ("Purchaser," "Customer," or "You") and Future Medical Products™ ("Company," "We," "Us," or "Our"). If you do not agree to these terms, do not purchase or use our products.

2. PROFESSIONAL USE REQUIREMENTS

2.1 Licensed Healthcare Professionals Only

PBME Topical™ is exclusively intended for use by or under the supervision of licensed healthcare professionals including but not limited to:

• Licensed physicians (MD, DO)
• Nurse practitioners with appropriate scope of practice
• Physician assistants under physician supervision
• Licensed aestheticians working under medical supervision
• Other healthcare professionals as permitted by state law

2.2 Verification Requirements

Prior to purchase, customers must provide:

• Valid professional license number
• State of licensure
• DEA number (if applicable)
• Medical facility affiliation
• Professional liability insurance information
• Business license (if applicable)

2.3 Scope of Practice

Purchasers represent and warrant that their use of PBME Topical™ falls within their professional scope of practice as defined by their state licensing board and that they maintain all necessary permits, licenses, and insurance required for the administration of biological products.

3. PRODUCT SPECIFICATIONS AND DESCRIPTION

3.1 Product Composition

PBME Topical™ contains:

• Greater than 50 billion exosomes per 5mL vial
• Exosomes derived from human bone marrow mesenchymal stem cells (MSCs)
• Over 1000 growth factors including VEGF, HGF, bFGF, PDGF-AA, TGFb3
• 800+ proteins, 1000+ peptides, 373 lipids
• Preservative-free formulation
• Particle size approximately 70nm ± 6.2nm

3.2 Manufacturing Standards

• Manufactured in ISO 14644-1 level 7 cleanroom facilities
• Produced under current Good Manufacturing Practices (cGMP)
• Sterility tested per USP <71> standards
• Each batch tested for endotoxins, mycoplasma, and sterility
• Certificate of Analysis available upon request

3.3 Intended Use

4. REGULATORY COMPLIANCE AND DISCLAIMERS

4.1 FDA Status

4.2 Biological Product Regulations

This product contains human-derived biological material. All donors are screened and tested in accordance with 21 CFR Part 1271 and determined to be eligible donors free from risk factors for relevant communicable diseases including:

• HIV-1 and HIV-2
• Hepatitis B and C
• Human T-lymphotropic virus (HTLV-I and HTLV-II)
• Syphilis
• West Nile virus
• Zika virus
• Cytomegalovirus
• Trypanosoma cruzi

4.3 Off-Label Use

Any use of this product for indications, dosages, or applications not explicitly stated in the product documentation constitutes off-label use. Healthcare providers using this product off-label do so at their own professional judgment and assume all associated risks and liabilities.

5. ORDERING AND PAYMENT TERMS

5.1 Order Placement

Orders may be placed through our website, by phone, or by email. All orders are subject to acceptance by Future Medical Products™. We reserve the right to refuse any order for any reason, including but not limited to verification failures or regulatory restrictions.

5.2 Pricing

• Prices are listed in US dollars
• Prices subject to change without notice
• Orders are processed at the price in effect at time of order placement
• Volume discounts may be available for qualified facilities

5.3 Payment Methods

• Credit/debit cards processed through Stripe
• ACH transfers for established accounts
• Net 30 terms available for qualified institutions (subject to credit approval)
• Purchase orders accepted from verified medical facilities

5.4 Taxes

Purchaser is responsible for all applicable federal, state, and local taxes. Tax-exempt organizations must provide valid exemption certificates.

6. SHIPPING, DELIVERY, AND STORAGE

6.1 Shipping Methods

• Products ship via FedEx Priority Overnight or UPS Next Day Air
• Cold chain packaging with temperature monitoring included
• Signature required upon delivery
• Shipping available to US addresses only (international shipping requires special arrangements)

6.2 Delivery Requirements

• Someone must be present to accept delivery
• Products must be immediately unpacked and refrigerated upon receipt
• Temperature indicators must be checked immediately
• Any temperature excursions must be reported within 2 hours of delivery

6.3 Storage Requirements

6.4 Shipping Damage

Claims for shipping damage must be made within 24 hours of delivery with photographic documentation of:

• Damaged packaging
• Temperature indicator status
• Product condition
• Shipping label and tracking information

7. RETURN AND REFUND POLICY

7.1 General Policy

Due to the temperature-sensitive biological nature of PBME Topical™, returns are extremely limited. Products cannot be returned once they have left our cold chain custody except in specific circumstances outlined below.

7.2 Eligible Returns

Returns may be considered only for:

• Products damaged during shipping (with documentation)
• Wrong product shipped
• Temperature excursion during shipping (indicator shows breach)
• Manufacturing defects discovered upon receipt

7.3 Return Process

To initiate a return:

1. Contact customer service within 24 hours of delivery
2. Provide order number and detailed reason for return
3. Submit photographic evidence as requested
4. Receive Return Merchandise Authorization (RMA) number
5. Do not return products without RMA

7.4 Refund Processing

Approved refunds will be processed within 10 business days of approval. Refunds will be issued to the original payment method. Shipping charges are non-refundable unless error was on our part.

8. WARRANTIES AND LIMITATIONS OF LIABILITY

8.1 Limited Warranty

Future Medical Products™ warrants that PBME Topical™:

• Meets the specifications listed in the Certificate of Analysis
• Has been manufactured according to cGMP standards
• Has been properly stored and shipped in our custody

8.2 Disclaimer of Warranties

8.3 Limitation of Liability

8.4 Maximum Liability

Our maximum liability for any claim related to the product shall not exceed the purchase price paid for the specific product giving rise to the claim.

9. INDEMNIFICATION

9.1 Customer Indemnification

Customer agrees to indemnify, defend, and hold harmless Future Medical Products™, its officers, directors, employees, agents, and affiliates from and against any and all claims, damages, losses, costs, and expenses (including reasonable attorneys' fees) arising from:

• Customer's use, handling, storage, or administration of the product
• Customer's breach of these terms
• Customer's violation of applicable laws or regulations
• Claims by Customer's patients or third parties

9.2 Procedure

We will notify Customer of any claim subject to indemnification. Customer shall have the right to control the defense with counsel of its choosing, subject to our reasonable approval.

10. INSURANCE REQUIREMENTS

10.1 Professional Liability Coverage

Customers must maintain professional liability insurance with minimum coverage of:

• $1,000,000 per occurrence
• $3,000,000 aggregate
• Coverage for administration of biological products

10.2 General Liability

Customers must maintain general liability insurance with minimum coverage of $1,000,000 per occurrence.

10.3 Proof of Insurance

We reserve the right to request proof of insurance at any time. Failure to maintain required insurance may result in termination of purchasing privileges.

11. RECORD KEEPING AND TRACEABILITY

11.1 Customer Records

Customers must maintain records for each use of PBME Topical™ including:

• Patient identifier
• Date of administration
• Lot number used
• Administering practitioner
• Any adverse events

11.2 Retention Period

Records must be retained for minimum of 7 years or as required by state law, whichever is longer.

11.3 Traceability

Customers must cooperate with any product tracing requirements, recalls, or investigations.

12. ADVERSE EVENT REPORTING

12.1 Reporting Requirements

Any adverse events potentially related to PBME Topical™ must be reported within 24 hours to:

• Future Medical Products: safety@futuremedicalproducts.com
• Phone: (888) 927-6270
• FDA MedWatch as required by law

12.2 Information Required

Reports must include:

• Patient demographics (age, gender)
• Description of event
• Temporal relationship to product use
• Lot number
• Concomitant products/procedures
• Event outcome

13. INTELLECTUAL PROPERTY

13.1 Ownership

All intellectual property rights in PBME Topical™, including trademarks, trade secrets, and proprietary processes, remain the exclusive property of Future Medical Products™.

13.2 Limited License

Purchase grants only the right to use the product as intended. No rights to reverse engineer, analyze, or replicate the product are granted.

14. CONFIDENTIALITY

14.1 Proprietary Information

Product specifications, manufacturing processes, and unpublished clinical data constitute confidential information and shall not be disclosed to third parties.

14.2 Permitted Disclosures

Confidential information may be disclosed only:

• To patients as necessary for informed consent
• To regulatory authorities as required by law
• To professional colleagues on a need-to-know basis

15. DISPUTE RESOLUTION

15.1 Governing Law

These terms are governed by the laws of the State of Missouri, without regard to conflict of law principles.

15.2 Arbitration

Any dispute arising under these terms shall be resolved through binding arbitration under the rules of the American Arbitration Association.

15.3 Venue

Any legal proceedings shall be brought exclusively in St. Louis County, Missouri.

15.4 Attorneys' Fees

The prevailing party in any dispute shall be entitled to recover reasonable attorneys' fees and costs.

PRIVACY POLICY

1. INTRODUCTION

1.1 Our Commitment

Future Medical Products™ ("we," "our," or "us") is committed to protecting the privacy and security of your personal and professional information. This Privacy Policy explains how we collect, use, disclose, and safeguard your information when you purchase PBME Topical™ products or interact with our services.

1.2 Scope

This policy applies to all information collected through:

• Our website (www.purebme.com)
• Phone orders
• Email communications
• Trade shows and professional events
• Third-party platforms authorized to sell our products

1.3 Consent

By providing information to us, you consent to the collection and use of information in accordance with this policy.

2. INFORMATION WE COLLECT

2.1 Professional Information

• Full name and title
• Professional license numbers and state of licensure
• DEA registration number (if applicable)
• Medical specialty and credentials
• Years in practice
• Professional affiliations and memberships

2.2 Business Information

• Practice or facility name
• Business address and shipping addresses
• Business phone and fax numbers
• Business email addresses
• Federal Tax ID or EIN
• Business license numbers

2.3 Financial Information

• Credit card information (processed through Stripe)
• Bank account information (for ACH payments)
• Purchase history and order details
• Credit references (for net terms)
• Tax exemption certificates

3. HOW WE USE YOUR INFORMATION

3.1 Order Processing

• Verify professional credentials
• Process payments
• Fulfill product orders
• Send shipping confirmations
• Provide customer support

3.2 Regulatory Compliance

• Maintain records as required by FDA regulations
• Report adverse events to authorities
• Conduct product recalls if necessary
• Comply with state and federal laws

4. DATA SECURITY

4.1 Technical Safeguards

• SSL/TLS encryption for all data transmission
• Encrypted storage of sensitive information
• Regular security audits and penetration testing
• Multi-factor authentication for system access
• Firewalls and intrusion detection systems

4.2 Administrative Safeguards

• Limited access on need-to-know basis
• Background checks for employees
• Confidentiality agreements
• Regular security training
• Incident response procedures

BIOLOGICAL PRODUCT SAFETY INFORMATION

Donor Screening and Testing

All tissue donors undergo comprehensive screening including:

• Medical history evaluation
• Physical examination
• Behavioral risk assessment
• Laboratory testing for infectious diseases
• Review of relevant medical records

Quality Control

• Each batch undergoes extensive testing
• Certificates of Analysis available
• Sterility testing per USP <71>
• Endotoxin testing per USP <85>
• Mycoplasma testing
• Particle size verification
• Protein quantification

MEDICAL PROFESSIONAL RESPONSIBILITIES

Informed Consent

Healthcare providers must obtain appropriate informed consent including:

• Explanation of exosome therapy
• Potential risks and benefits
• Alternative treatments
• Human-derived nature of product
• Off-label use disclosure (if applicable)

Patient Selection

Providers are responsible for appropriate patient selection considering:

• Contraindications
• Concurrent medications
• Medical history
• Realistic outcome expectations

Documentation

Maintain complete records including:

• Patient consent forms
• Treatment protocols
• Product lot numbers
• Clinical outcomes
• Any adverse events