TGA use only This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <http://www.tga.gov.au/about/tga-information-to.htm>. Deed of undertaking In relation to confidential information and conflict of interest THIS DEED POLL is made on the day of 2014 by: Member name Member address Whereas 1. The Commonwealth of Australia (the “Commonwealth”) as represented by the Department of Health (the “Department”) has nominated a person as a member of the (the “Committee”). 2. The person (the “Member”) has been appointed as a member of the Committee. 3. The Commonwealth requires the Member to undertake to preserve and maintain the confidentiality of information to which the Member will have access by virtue of his or her position on the Committee. 4. The Commonwealth requires the Member to undertake certain actions in relation to the Member’s direct and indirect financial and personal interests. 5. Under the Therapeutic Goods Regulations 1990 the Member has certain obligations of disclosure in relation to the Member’s direct and indirect material personal interests (whether pecuniary or not) in relation to matters considered by the Committee. Now it is hereby agreed as follows: 1. Interpretation 1.1. In this Deed Poll unless the contrary intention appears: “Approved Person” means a person: a. who has been appointed by the Commonwealth to be a member of the Committee; or b. who is an officer of the Department of Health. “Confidential Information” means any information or document made available to the Member by the Department that: a. is by its nature confidential; b. is designated by the Commonwealth as confidential; or PO Box 100 Woden ACT 2606 ABN 40 939 406 804 Phone: 1800 020 653 Fax: 02 6203 1605 Email: info@tga.gov.au www.tga.gov.au Reference/Publication R13/366679 c. the Member knows or ought to know is confidential, but does not include any information which: d. is in the public domain; or e. becomes public knowledge other than by breach of this Deed Poll. “Conflict of interest” includes, but is not limited to, any situation where a person has a direct or indirect material personal interest (whether pecuniary or not) which, taking into account the nature of the Committee’s role, functions and responsibilities, may influence or may appear to influence the independent, fair and proper consideration by the Member of any matter or proposed matter for consideration by the Committee or participation by the Member otherwise in the work of the Committee. “Direct” interest of a person includes, but is not limited to, an interest or a liability held or owned by the person, whether financial or non-financial (for example membership of a particular group or a duty or obligation owed to another person or body, or a political or other belief (including matter of conscience) or a reputational interest). “Indirect” interest of a person includes, but is not limited to, an interest or liability owned or held indirectly by the person (for example through a trust or a partnership) and includes an interest, of which the person is aware, of a person with whom the person is closely associated. 2. Obligations in relation to confidential information 2.1 Except as provided in this clause 2, the Member undertakes to keep secret and confidential all Confidential Information and not to directly or indirectly disclose to any person, other than an Approved Person, any Confidential Information. 2.2 The Member undertakes not to make use of any Confidential Information other than to fulfil their role as a Member of the Committee or where disclosure is required by court order or by statute. 2.3 The Member’s obligations under this clause will not be taken to have been breached where Confidential Information is disclosed by a Member to a person who is not an Approved Person, if the Commonwealth has given prior written consent to disclose such Confidential Information to that person. In giving written consent to the disclosure of Confidential Information, the Commonwealth may impose such reasonable conditions as it thinks fit. 2.4 Where a Member discloses Confidential Information under clause 2.3 the Member must: a. notify the receiving person that the information is Confidential Information; b. not provide the information unless the receiving person agrees to keep the information confidential; and c. comply with any conditions on disclosure imposed by the Commonwealth. 2.5 The Member understands and acknowledges that any unauthorised use or disclosure of Confidential Information may make him or her liable for prosecution under the laws of the Commonwealth including under section 70 of the Crimes Act 1914. 2.6 Nothing in this Clause prevents a Member disclosing information or producing a document where that disclosure or production is required by court order or statute. 3. Return of materials 3.1. The Member undertakes to return all Confidential Information, including any copies held in the Member’s possession (whether in hard copy or electronically, for instance on discs or memory sticks/cards), to the Commonwealth on ceasing to perform his or her duties as a Member of the Committee, and to return to the Commonwealth, or dispose of, all Confidential Information as otherwise directed by the Commonwealth from time to time, at such times and in such manner as directed by the Commonwealth. The Member also undertakes to return to the Commonwealth, or dispose of, material produced by the Member in the performance of his or her duties as a Member of the Committee. Deed of undertaking - In relation to confidential information and conflict of interest (July 2014) For official use only Page 2 of 3 4. Declarations of interest and conflicts of interest Interests declared 4.1 The Member promises that at the date of this Deed Poll, and to the best of his or her knowledge and after making diligent inquiry, he or she does not have any direct or indirect interests which may, given the nature, role and responsibilities of the Committee, constitute or give rise to an actual or potential conflict of interest or the perception of one in relation to the performance of his or her duties as a Member of the Committee, other than the interests declared to the Commonwealth in the Annual declaration of interests form. Ongoing declaration of interests 4.2 If, during his or her period of the membership on the Committee, the Member becomes aware of any direct or indirect interests which may, given the nature, role and responsibilities of the Committee, constitute or give rise to an actual or potential conflict of interest or the perception of one in relation to a specific matter or proposed matter that is to be dealt with by the Committee or otherwise in relation to the performance of his or her duties as a Member of the Committee, the Member undertakes to notify the Commonwealth and the Chair of the Committee in writing of that interest as soon as reasonably practicable. Notification of situation of potential conflict of interest 4.3 If, during the period of the membership on the Committee, the Member becomes aware of any situation where a direct or indirect interest of the Member may give rise to an actual or potential conflict of interest or the perception of one, in relation to a specific matter or proposed matter that is to be dealt with by the Committee, the Member undertakes to comply with his or her obligations as set out in subregulations 42(4) to (7) of the Therapeutic Goods Regulations 1990 to disclose the interest and otherwise take such steps as the Commonwealth may reasonably require to resolve or to otherwise deal with the matter. 5 Survival of undertakings 5.1 The Member acknowledges that the undertakings given in relation to Confidential Information shall continue in force after the expiration or termination of this Deed Poll. 6 Governing law 6.1 This Deed Poll shall be governed by and construed according to the law of the Australian Capital Territory. Executed as a Deed Poll Signed sealed and delivered by: Name of member Signature Date in the presence of: Name of witness Signature Date Deed of undertaking - In relation to confidential information and conflict of interest (July 2014) For official use only Page 3 of 3