SURGEBRIGHT INC. – GENERAL TERMS AND CONDITIONS OF SALE, CONSIGNMENT, AND INSTRUMENT USE
Effective Date: October 1st 2025
Issued by: Surgebright Inc., 4949 S Syracuse St, Suite 550, Denver, CO 80237
Governing Law: State of Colorado, United States
1. DEFINITIONS
„Surgebright“ refers to Surgebright Inc., the seller, consignor, or lender of the products.
„Customer“ refers to the hospital, surgery center, healthcare facility, or purchasing entity receiving the products.
„Products“ refers to human allografts and surgical instruments supplied by Surgebright.
„Consigned Products“ are allografts provided without upfront payment for use upon implantation.
„Loaned Instruments“ are surgical tools temporarily provided for procedures.
„Effective Date“ refers to the date noted above.
2. APPLICABILITY
These Terms govern all transactions between Surgebright and the Customer, including sales, consignments, and instrument loans. These Terms supersede any conflicting terms in Customer’s purchase orders unless explicitly accepted in writing by Surgebright.
3. PRODUCT OFFERING & OWNERSHIP
Products may be:
- Sold, transferring full ownership upon payment.
- Consigned, retaining ownership by Surgebright until documented use.
- Loaned, requiring return after the agreed procedure timeframe.
Ownership of all consigned and loaned items remains with Surgebright unless stated otherwise in writing.
4. USE & RISK ASSUMPTION
Surgebright supplies surgical materials only and does not practice medicine. Product selection, surgical technique, and patient care decisions lie solely with the attending physician or healthcare provider.
Customer assumes all risk associated with the handling and use of Products. No guarantee is made regarding clinical outcomes. Off-label use is not authorized.
5. CONSIGNMENT & LOANED INVENTORY OBLIGATIONS
For consigned Products and loaned instruments, Customer agrees to:
- Maintain secure and compliant storage at approved locations.
- Limit use to authorized procedures and locations.
- Notify Surgebright of implant use within five (5) business days.
- Return instruments within seven (7) business days post-use or upon written request.
- Allow reasonable audit and reconciliation of inventory by Surgebright.
- Customer is financially responsible for loss, damage, or misuse beyond normal wear.
6. STORAGE, HANDLING & TRACEABILITY
Customer shall handle and store allografts per Surgebright’s specifications and applicable regulatory requirements, including FDA regulations (21 CFR Part 1271) and AATB Standards for Tissue Banking.
Customer is responsible for:
- Implant tracking and documentation,
- Maintaining records for traceability in compliance with regulatory retention periods,
- Promptly reporting adverse events involving Products to Surgebright.
7. ORDERING, INVOICING & PAYMENT TERMS
Products sold or implanted from consignment shall be invoiced at current list or contracted pricing. Payment is due within thirty (30) calendar days of invoice date (“Net 30”).
Late payments may incur:
A finance charge of 1.5% per month (or the maximum allowed by law), suspension of further deliveries or services, referral for collection at Customer’s expense.
8. RETURNS & RECALLS
Returns of unused, sealed, and unexpired Products are permitted under Surgebright’s then-current Return Policy.
In the event of a product recall, Surgebright shall bear all associated costs. Customer agrees to:
- Comply with all recall instructions,
- Assist in retrieval and documentation,
- Not use affected Products after recall notification.
Damaged Packaging and Opened Boxes:
If Products are returned with damaged cartons or opened packaging, they will be evaluated by Surgebright upon receipt. Provided the Product is intact and the sterile barrier is uncompromised, it may be relabeled and returned to inventory. If relabeling is required due to Customer handling, Surgebright reserves the right to charge the associated relabeling costs. If the sterile packaging has been breached, the graft will be deemed non-usable and Surgebright may invoice the Customer for the full cost of the Product.
9. WARRANTIES
Surgebright warrants that Products meet applicable specifications at the time of delivery. This warranty is:
Limited to replacement or credit at Surgebright’s option,
Void if Products are misused, altered, or improperly stored.
No other warranties, express or implied, including merchantability or fitness for a particular purpose are made. No agent or distributor is authorized to alter this warranty.
10. LIMITATION OF LIABILITY
To the fullest extent permitted by law:
Surgebright shall not be liable for indirect, incidental, punitive, or consequential damages.Maximum liability shall not exceed the amount paid for the Product in question. No liability shall be assumed for delay, misuse, off-label use, or third-party handling.
11. INDEMNIFICATION
Customer agrees to indemnify, defend, and hold harmless Surgebright from any claims, liabilities, losses, damages, or costs (including attorneys’ fees) arising from:
- Improper use or handling of Products,
- Breach of these Terms,
- Violation of applicable laws,
- Off-label or unauthorized use of Products.
12. INSURANCE
Customer shall maintain general and professional liability insurance, consistent with industry standards, adequate to cover claims related to the use of Products. Proof of insurance shall be provided upon request.
13. COMPLIANCE WITH LAWS & REGULATIONS
Customer shall comply with all applicable:
- FDA regulations,
- HIPAA and state privacy laws,
- Laws related to the handling of human tissue and surgical instruments.
- Customer shall not export, re-export, or transfer Products contrary to U.S. law.
14. CONFIDENTIALITY & DATA PROTECTION
Customer agrees to keep confidential all non-public information received from Surgebright, including but not limited to:
- Pricing,
- Technical documentation,
- Product specifications.
- No Customer shall use Surgebright’s name, trademarks, or branding without prior written consent.
- All patient information exchanged with Surgebright must be anonymized or comply with HIPAA standards.
15. TERMINATION
Either party may terminate this agreement at any time with thirty (30) days’ written notice, unless a longer term is contractually agreed.
Upon termination:
- All consigned inventory must be returned or invoiced,
- Outstanding balances remain payable,
- Obligations relating to confidentiality, traceability, indemnification, and liability shall survive.
16. GOVERNING LAW & DISPUTE RESOLUTION
These Terms are governed by the laws of the State of Colorado, without regard to conflict-of-law principles.
All disputes shall be exclusively resolved in the federal or state courts located in Denver, Colorado.
17. FORCE MAJEURE
Surgebright shall not be liable for delay or non-performance caused by events beyond its reasonable control, including but not limited to:
Natural disasters, Labor strikes, Government actions, Supply chain disruptions, Acts of war or terrorism.
Obligations suspended due to force majeure shall resume upon resolution of the event.
18. GENERAL PROVISIONS
Entire Agreement: These Terms represent the entire understanding and supersede all prior agreements related to the subject matter.
- No Waiver: Failure to enforce any right shall not constitute a waiver.
- Severability: If any provision is held unenforceable, the remainder remains valid.
- Assignment: Customer may not assign rights or obligations without prior written consent.
- Headings: Section headings are for convenience only and do not affect interpretation.