This document outlines the standard legal protections and operational terms for the procurement of human corneal tissue. It is designed to prioritize the limitation of liability for the supplying institution.

The Bank is currently registered as an Eye Specifi c Tissue Bank with the Director General Health, South Africa and a Member of South African Tissue Bank Association (SATIBA) fulfi lling all Lawful requirements for a Tissue Bank as stated in the law of South Africa.

These terms and conditions apply to all human corneal tissue (“Tissue”) supplied by The Bank to the Recipient. By accepting the delivery of the Tissue, the Recipient agrees to be bound by these terms.

The Bank performs screening and testing in accordance with applicable regulatory standards. However:

• The Tissue is provided “AS IS” and “WITH ALL FAULTS.”
• The Bank makes no warranties, express or implied, including but not limited to any implied warranties of merchantability, fitness for a particular purpose, or the biological viability of the tissue post-transplant.

The Recipient expressly agrees that The Bank shall not be held liable for any damages—direct, indirect, incidental, or consequential—arising from the use of the Tissue.

A. Tissue Degradation and Damage

The Bank is not responsible for degradation once Tissue has left its facility. This includes damage during:

• Third-party transit or shipping.
• Improper storage or handling at the Recipient’s facility.
  – Required storage conditions:
  – Fridge line products: 4°C – 8°C
  – Frozen products: Lower than -10°C
• Natural biological rejection or failure of integration.

B. Surgical Error and Clinical Outcome

The Bank is a supplier of biological material only. The Bank assumes no liability for: surgeon negligence; infection, primary graft failure, or loss of sight; or complications arising from the Recipient’s failure to follow protocols.

The Recipient agrees to indemnify, defend, and hold harmless The Bank and its offi cers, directors and employees from any claims, lawsuits, or losses (including attorney fees) brought by third parties (including the patient / end-user) resulting from the use of the Tissue.

The Recipient is responsible for maintaining accurate records of the Tissue’s use.

• Adverse Events: Any suspected tissue-transmitted disease or adverse reaction must be reported to The Bank within 24 hours of discovery.
• Documentation: The Recipient must return all required transplant record forms to The Bank to ensure regulatory compliance.

This agreement shall be governed by the laws of the jurisdiction in which The Bank is registered. Any disputes shall be resolved in the courts of said jurisdiction.

This tissue was recovered via a voluntary donation and no profit was made on the tissue itself in accordance with Chapter 8 of the National Health Act 61 of 2003, which prohibits the sale of human biological material for profit.

In accordance with the Protection of Personal Information Act, No. 4 of 2013 (“POPIA”), both The Bank and the Recipient agree to the following:

8.1 Role of the Parties:

The Bank is the Responsible Party for the personal information it collects to facilitate tissue supply. The Recipient, in providing patient outcomes or adverse event reports back to The Bank, acts as an Operator or a joint Responsible Party and agrees to process all such information in strict accordance with POPIA.

8.2 Purpose of Collection:

The Bank collects and processes personal information (including names, professional registration numbers, and contact details) for the following specifi c purposes:

• To verify the professional standing of the Recipient.
• To maintain a legally mandated “Chain of Custody” and traceability from donor to recipient.
• To comply with the National Health Act regarding human tissue records.

8.3 Processing of Special Personal Information (Donor Data):

The Recipient acknowledges that they may receive de-identifi ed health information regarding the donor. The Recipient agrees:

• To treat all donor-related information as strictly confi dential.
• Not to attempt to re-identify any donor.
• To ensure that only authorized medical staff have access to these records.

8.4 Data Security & Breach Notification:

The Bank implements appropriate technical and organizational measures to secure data. In the event of a suspected data breach (unauthorized access to personal information), The Bank will notify the Information Regulator and the aff ected Data Subjects as soon as reasonably possible, as required by Section 22 of POPIA.

All donor information is strictly confidential and intended solely for clinical evaluation purposes.

Note: Fees charged represent a reimbursement for recovery, processing, and distribution services and do not constitute a “sale” of the tissue.