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Annex B: Appendix

Form of Indemnity for Clinical Studies

To: [Name and address of sponsoring company] (“the Sponsor”)

From: [Name and address of Health Authority/Health Board/NHS Trust] (“the Authority”)

Re: Clinical Study No [ ] with [name of product]

1. It is proposed that the Authority should agree to participate in the above sponsored study (“the
Study”) involving [patients of the Authority] [non-patient volunteers] (“the Subjects”) to be
conducted by [name of investigator(s)] (“the Investigator”) in accordance with the protocol
annexed, as amended from time to time with the agreement of the Sponsor and the Investigator
(“the Protocol”). The Sponsor confirms that it is a term of its agreement with the Investigator that
the Investigator shall obtain all necessary approvals of the applicable Local Research Ethics
Committee and shall resolve with the Authority any issues of a revenue nature.

2. The Authority agrees to participate by allowing the Study to be undertaken on its premises
utilising such facilities, personnel and equipment as the
Investigator may reasonably need for the purpose of the Study.

3. In consideration of such participation by the Authority, and subject to paragraph 4 below, the
Sponsor indemnifies and holds harmless the Authority and its employees and agents against all
claims and proceedings (to include any settlements or ex-gratia payments made with the consent
of the parties hereto and reasonable legal and expert costs and expenses) made or brought
(whether successfully or otherwise):

(a) by or on behalf of Subjects taking part in the Study (or their dependants) against the
Authority or any of its employees or agents for personal injury (including death) to
Subjects arising out of or relating to the administration of the product(s) under
investigation or any clinical intervention or procedure provided for or required by the
Protocol to which the Subjects would not have been exposed but for their participation in
the Study.

(b) by the Authority, its employees or agents or by or on behalf of a Subject for a declaration
concerning the treatment of a Subject who has
suffered such personal injury.

4. The above indemnity by the Sponsor shall not apply to any such claim or proceeding:

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