TranslateTerms of Service
Legal terms and conditions governing the use of Akesoe Biologics LLC tissue processing and distribution services for healthcare professionals and medical facilities.
Effective Date: July 10, 2026
Company Information & Legal Contact
Akesoe Biologics LLC ("Company," "we," "us," or "our") is a limited liability company organized under the laws of Florida, specializing in tissue processing and distribution services. We operate as an FDA-registered tissue establishment and maintain compliance with all applicable federal and state regulations governing tissue establishments.
1341 Sundial Point, Winter Springs, FL 32708
Acceptance of Terms
By accessing our services, placing orders, or engaging in any business relationship with Akesoe Biologics LLC, you ("Customer," "you," or "your") agree to be bound by these Terms of Service and all applicable laws and regulations. If you do not agree with any part of these terms, you must discontinue use of our services immediately.
IMPORTANT: These services are intended exclusively for qualified healthcare professionals and licensed medical facilities. By accepting these terms, you represent and warrant that you meet all professional and regulatory requirements to legally receive and utilize human tissue products.
Services Description
Akesoe Biologics LLC provides specialized tissue processing and distribution services, including but not limited to:
Living Birth Tissue Processing
- Amniotic membrane processing and preparation
- Placental tissue processing services
- Umbilical cord derived tissue products
- Quality control and sterility assurance
- Tissue characterization and documentation
Distribution Services
- Distribution to qualified facilities
- Cold chain logistics and temperature monitoring
- Regulatory documentation and certificates
- Traceability and chain of custody maintenance
- Customer support and information
Medical Applications
Our processed tissue products are intended for homologous use as barrier membranes as determined by qualified healthcare providers within their scope of practice.
Customer Eligibility Requirements
Our services are exclusively available to qualified healthcare professionals and licensed medical facilities. To be eligible for our services, customers must meet the following requirements:
Healthcare Professionals
- Valid medical license in good standing
- Board certification in relevant specialty (where applicable)
- Demonstrated training and competency in tissue handling
- Compliance with applicable state and federal regulations
Medical Facilities
- Current licensing and accreditation as required by jurisdiction
- Appropriate storage and handling capabilities
- Quality management systems in place
- Compliance with FDA regulations for tissue establishments (where applicable)
International Customers
- Valid import permits and regulatory approvals
- Compliance with local laws and regulations
- Demonstrated ability to maintain cold chain requirements
- English language capability for regulatory communication
Ordering & Purchasing Terms
Current Direct Sales Process
- Orders must be placed through authorized representatives
- Written purchase orders required for all transactions
- Minimum order quantities may apply
- Lead times vary based on product availability and processing requirements
- All orders subject to verification of customer credentials
Future Online Ordering Platform
- Secure online portal for qualified customers
- Real-time inventory and availability tracking
- Automated order processing and confirmation
- Digital documentation and certificate delivery
- Integration with customer management systems
Payment Terms
- Net 30 payment terms for established accounts
- Credit applications required for new customers
- International orders may require letters of credit or advance payment
- Late payment fees may apply per credit agreement
- All prices subject to change with 30-day notice
Product Information & Quality Standards
Quality Assurance Standards
All tissue products processed and distributed by Akesoe Biologics LLC are processed in accordance with applicable regulatory standards and FDA regulations.
- Compliance with 21 CFR Part 1271 and current Good Tissue Practices (cGTP)
- Comprehensive donor screening and testing protocols
- Validated processing procedures with documented controls
- Sterility assurance and bioburden testing
- Complete traceability from donor to end user
- Temperature monitoring throughout cold chain
Product Specifications
- Detailed product documentation provided
- Certificate of analysis for each lot
- Storage and handling instructions
- Expiration dating and shelf life information
- Product information and specifications
Regulatory Documentation
- FDA establishment registration certificates
- Product listing documentation
- International export certificates
- Good Tissue Practice (GTP) compliance records
- Third-party testing and validation reports
Shipping & Delivery Terms
Domestic Shipping (United States)
- Overnight or expedited shipping required for all tissue products
- Temperature-controlled packaging with monitoring devices
- Delivery confirmation and signature required
- Business day delivery only (Monday-Friday)
- Emergency weekend delivery available upon request
International Shipping
- Export documentation and permits required
- Customer responsible for import permits and duties
- Cold chain maintenance throughout transit
- Specialized international shipping partners
- Additional lead time for regulatory clearance
Risk of Loss Transfer
Risk of loss and title to products pass to Customer upon delivery to the carrier at our facility. Customer is responsible for filing claims with carrier for damaged or lost shipments. Temperature excursions during transit may void product warranty and are subject to carrier insurance coverage.
FDA & Regulatory Compliance
Company Compliance Obligations
- Maintain FDA establishment registration as tissue establishment
- Comply with Good Tissue Practice (GTP) regulations
- Report adverse events and reactions as required by 21 CFR 1271.350
- Maintain complete donor eligibility and testing records
- Conduct ongoing quality assurance and process validation
- Submit to FDA inspections and regulatory oversight
Customer Compliance Responsibilities
- Ensure proper storage and handling per product specifications
- Maintain traceability records and chain of custody documentation
- Report adverse events to manufacturer and regulatory authorities
- Use products only for intended medical applications
- Comply with applicable professional practice standards
- Maintain appropriate licensing and facility registrations
International Regulatory Requirements
- Customer responsible for obtaining import permits and approvals
- Compliance with local tissue establishment regulations
- Adherence to country-specific storage and handling requirements
- Local adverse event reporting obligations
- Professional licensing and practice compliance
Limitation of Liability
IMPORTANT LIABILITY LIMITATIONS
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW:
- COMPANY'S TOTAL LIABILITY SHALL NOT EXCEED THE PURCHASE PRICE OF THE SPECIFIC PRODUCT(S) GIVING RISE TO THE CLAIM
- COMPANY SHALL NOT BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES
- COMPANY MAKES NO WARRANTIES BEYOND THOSE EXPRESSLY STATED IN WRITING
- CUSTOMER ASSUMES ALL RISKS ASSOCIATED WITH CLINICAL USE OF PRODUCTS
Product Warranties
Products are processed to meet published specifications at time of shipment. Warranty is voided by improper storage, handling, or use. No warranty is made regarding patient outcomes or clinical results.
Professional Practice
Customer is solely responsible for clinical decisions, patient selection, and medical outcomes. Company provides processed tissue products only and does not provide medical advice or practice medicine.
Regulatory Compliance
Customer is responsible for ensuring compliance with all applicable laws and regulations in their jurisdiction. Company's compliance representations are limited to our processing and distribution operations.
Dispute Resolution & Governing Law
Governing Law
These Terms of Service shall be governed by and construed in accordance with the laws of the State of Florida, without regard to conflict of law principles. The federal and state courts located in Orange County, Florida shall have exclusive jurisdiction over any disputes arising under these terms.
Dispute Resolution Process
- Direct Negotiation: Parties must attempt good faith negotiation for 30 days
- Mediation: If negotiation fails, binding mediation through qualified healthcare mediator
- Arbitration: Final binding arbitration under American Arbitration Association rules
- Court Action: Limited to injunctive relief and enforcement of arbitration awards
International Disputes
- International Commercial Arbitration Court procedures
- English language proceedings
- Florida law governs substantive issues
- Awards enforceable under New York Convention
- Emergency interim relief available through courts
Terms Modifications & Legal Contact
Terms Updates
We reserve the right to modify these Terms of Service at any time. Changes will be effective immediately upon posting to our website. Continued use of our services constitutes acceptance of modified terms. For material changes affecting existing orders, we will provide 30 days advance notice.
Legal Questions & Contact Information
Legal Department
Legal Email
Legal Address
Akesoe Biologics LLC
1341 Sundial Point
Winter Springs, FL 32708
Entire Agreement: These Terms of Service, together with any written agreements signed by both parties, constitute the entire agreement between Customer and Company and supersede all prior negotiations, representations, or agreements.
