Tissue Transfer Agreement

Between the SUPPLIER, RECIPIENT and SPONSOR (if applicable) as described below.

Agreement for the transfer of human tissues / organs for non-commercial, non-therapeutic research, when the Human Tissue Act, 2004 does not immediately apply (eg NRES project specific approval has been obtained or tissues are acellular).

RECIPIENT:
RECIPIENT’S LOCAL INVESTIGATOR:
SUPPLIER:
SUPPLIERS LOCAL INVESTIGATOR:
SPONSOR (if applicable):
Protocol [ref]:
NRES Ethical opinion ref:
STUDY:
MATERIALS:
FORM OF MATERIALS SUPPLY:
PURPOSES:
RECIPIENT’S PREMISES:
  1. The relevant Protocol and Ethicalopinion is attached to this Agreement. If there is any proposed change to the PROTOCOL or ETHICAL OPINION that would have an impact upon the use, storage or otherwise of the MATERIALS, the RECIPIENT’S LOCAL INVESTIGATOR must obtain the written consent of the SUPPLIER’S LOCAL INVESTIGATOR and the SPONSOR. A change in the type of NRES approval from project specific to research tissue bank status will require a new Tissue Transfer Agreement. All agreed changes to the PROTOCOL or ETHICAL OPINION are to be attached by both parties to their copies of this Agreement.
  1. The RECIPIENT agrees to only use the MATERIALS for the PURPOSES and in accordance with the Protocol and Ethical opinion. The MATERIALS are only to be used and stored on the RECIPIENT’S PREMISES.
  1. The SUPPLIER confirms the necessary informed consents of donors/donor’s representatives have been given or ETHICAL OPINION has provided an exemption to the requirement to obtain consent.
  1. The SUPPLIER will deliver the MATERIALS to the RECIPIENT on the agreed delivery date(s) in the FORM OF MATERIALS SUPPLY prescribed above. A copy of the ”Tissue Sample Form” to be supplied by the SUPPLIER will be forwarded with the MATERIALS.
  1. The RECIPIENT agrees to ensure that all persons involved in access or use of the MATERIALS shall be made aware of, and bound by, the terms of this Agreement.
  1. The RECIPIENT agrees not to transfer or distribute any part of the MATERIALS or any extracts, replications, summaries or derivatives thereof to any third party without the prior approval of the SUPPLIER, the SPONSOR and any relevant ethics committee. The RECIPIENT will provide assurance that any such transfer or distribution is within the scope of the relevant consents. Any such transfer or distribution will be subject to a separate material transfer agreement.
  1. MATERIALS cannot be used for any purpose that is commercial or therapeutic. Sponsored academic or clinical research is not for these purposes deemed to be commercial.
  1. The MATERIALS are supplied without warranty as to its properties, merchantable quality or fitness for any particular purposes and without any other warranty whatsoever, expressed or implied.
  1. The RECIPIENT confirms that the LOCAL INVESTIGATOR is suitably qualified and will be responsible for the proper and safe handling, storage, use and disposal of the MATERIALS.
  1. As soon as the STUDY has been completed by the RECIPIENT, the RECIPIENT’s LOCAL INVESTIGATOR shall inform the SUPPLIER. Used MATERIALS may be retained under the terms of this Agreement only for audit and verification purposes relating to the STUDY. Unused MATERIALS will be returned to the SUPPLIER.
  1. On or before expiry of NRES project specific approval (if applicable), unused MATERIALS taken from a diagnostic archive will be returned to the archive. Any other unused MATERIALS and products of the STUDY that contain human cells will be returned to the SUPPLIER and stored in premises licenced by the Human Tissue Authority. The SUPPLIER’s LOCAL INVESTIGATOR agrees to inform the DESIGNATED INDIVIDUAL for research should this situation arise, and to follow all relevant policies and standard operating procedures on the instruction of the Designated Individual.
  1. Subject to the SUPPLIER meeting its commitments under this Agreement, the RECIPIENT agrees to hold harmless the SUPPLIER from any and all claims, suits and liabilities arising from any use by the RECIPIENT of the MATERIALS.
  1. This Agreement may be terminated by a party upon written notice if the other party shall be in material breach of its commitments and not remedied such commitments following thirty days’ written notice of the breach upon termination. Upon request the RECIPIENT shall on termination securely and confidentially either dispose of or return the MATERIALS as directed by the SUPPLIER .
  1. MATERIALS shall be returned to the SUPPLIER or securely and confidentially destroyed where required for ethical reasons by the relevant ethics committee or if the donor withdraws consent.
  1. This Agreement represents the entire understanding of the parties relating to the use of the MATERIALS and supersedes and overrides all other understandings. Variations require the written consent of both parties nominated representatives.
  1. All communications between the parties relating to the substance of this Agreement shall take place through the RECIPIENTS LOCAL INVESTIGATOR and the SUPPLIER'S LOCAL INVESTIGATOR.
  1. This Agreement shall be interpreted in accordance with English Law and be subject to the jurisdiction of the English Courts.
  1. No third party may rely upon the provisions of this Agreement.

Authorised by the LEAD CLINICIAN in the Clinical Unit harvesting or holding the tissues / Authorised by the RECIPIENT’S LOCAL INVESTIGATOR
Clinical Unit: / Designation:
Signature: / Signature:
Name: / Name:
Date: / Date:
Signed for and on behalf of the SUPPLIER / Signed for and on behalf of the RECIPIENT
Signature: / Signature:
Name: / Name:
Designation: / Designation:
Date: / Date:
Signed for and on behalf of the SPONSOR (only if applicable and the SPONSOR is not the SUPPLIER)
Signature:
Name:
Date:

Leeds TTA when HTA does not immediately apply

09.04 2013 v3 Page 1 of 3