Common use of Obligations and Responsibilities Clause in Contracts

Obligations and Responsibilities. If the Principal Investigator leaves the Institution or otherwise ceases to be available, the Institution must consult with the Organisation and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both Parties. If the parties cannot agree on a replacement, either party may terminate this Agreement in accordance with clause 9.3. The Institution will not engage in any conduct on the Organisation’s behalf which is in violation of, or potentially in violation of, any applicable local laws or regulations. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Protocol, provided that any amendments to the Protocol which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Responsible HREC. The Institution will have an adequate number of appropriately qualified Personnel for the foreseen duration of the Research and ensure that such Personnel are adequately informed about the Protocol, Investigational Product(s), and their Research related duties and functions. The Institution will ensure that the Research is subject to the continuing oversight of the Responsible HREC throughout its conduct. PAYMENTS In consideration of the Institution conducting the Research, the Organisation will pay to the Institution as nominated in Schedule 2 in the manner and on the basis of the prices and at the times set out in Schedule 2. The prices set out in Schedule 2 do not include GST. At the time of payment, the Organisation must pay to the Institution any amount of GST that the Institution is required to pay in addition to the prices set out in Schedule 2, and in accordance with GST Law. Payments will be made by the Organisation upon either receipt of a valid tax invoice or a “Recipient Created Tax Invoice” issued by the Organisation, if applicable. the Organisation and the Institution warrant that they are registered under GST Law. Tax invoices must identify supplies for which GST is payable. PUBLICATIONS The Institution, Principal Investigator and other investigators (“Discloser”) involved in the Research have the right to Publish the methods, results of, and conclusions from, the Research. In any Publication referred to in clause 6.1 the Discloser will acknowledge the contribution of the Organisation. RESEARCH RESULTS AND INTELLECTUAL PROPERTY All Intellectual Property created in the course of the Research belongs to the Institution.

Obligations and Responsibilities. If The Institution warrants that to the best of its knowledge, it, its affiliates and any person involved in the conduct of the Study on behalf of or at the behest of the Institution are properly registered with appropriate professional registration bodies and have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority for debarment. Furthermore, the Institution shall notify the Principal Investigator leaves the Institution or otherwise ceases to be available, the Institution must consult with the Organisation and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both Parties. If the parties cannot agree on a replacementpractical after it becomes aware of any such disqualification, either party may terminate this Agreement in accordance with clause 9.3disbarment or ban. The Institution will will: not engage in any conduct on the Organisation’s behalf which is in violation of, or potentially in violation of, any applicable local laws or regulations; provide, for the Principal Investigator’s use, adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site; subject to clause 9.3, allow regular monitoring visits in accordance with the GCP Guideline, access for the purposes of audit and as required by Regulatory Authorities or as specified in the Protocol and permit access to the Essential Documents (including original records), Study records, reports, other Study related materials and its Personnel as soon as is reasonably possible upon request by the Principal Investigator, Regulatory Authority, Reviewing HREC or any third party designated by the Principal Investigator. The Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution will may require; make available adequate facilities, equipment and any other resource of the Institution as agreed with the Principal Investigator and as reasonably required to safely follow the Protocol, provided that any amendments to the Protocol which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Responsible Reviewing HREC. The Institution will ; have an adequate number of appropriately qualified Personnel as agreed with the Principal Investigator for the foreseen duration of the Research Study and ensure that such Personnel are adequately informed about the Protocol, Investigational Product(s), and their Research Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate; ensure that the Research Study is subject to the continuing oversight of the Responsible Reviewing HREC throughout its conduct; if contacted by any Regulatory Authority in connection with the conduct of the Study, immediately notify the Principal Investigator, unless prevented from doing so by law. PAYMENTS In consideration The Institution will use all reasonable efforts to obtain approval for the Principal Investigator to be present at any audit by a Regulatory Authority, and will cooperate with the Regulatory Authority, comply with the legitimate requirements of such an audit, and make appropriate Personnel available to explain and discuss records and documentation related to the Study; and provide the Principal Investigator with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution conducting or Study Site. This includes execution of any documents reasonably requested by the Research, Principal Investigator in connection with the Organisation requirements of a Regulatory Authority as a result of such an audit. The cost will pay be borne by the Principal Investigator unless such rectification is due to the Institution as nominated in Schedule 2 in the manner and on the basis default of the prices and at the times set out in Schedule 2. The prices set out in Schedule 2 do not include GST. At the time of payment, the Organisation must pay to the Institution any amount of GST that the Institution is required to pay in addition to the prices set out in Schedule 2, and in accordance with GST Law. Payments will be made by the Organisation upon either receipt of a valid tax invoice or a “Recipient Created Tax Invoice” issued by the Organisation, if applicable. the Organisation and the Institution warrant that they are registered under GST Law. Tax invoices must identify supplies for which GST is payable. PUBLICATIONS The Institution, Principal Investigator and other investigators (“Discloser”) involved in the Research have the right to Publish the methods, results of, and conclusions from, the Research. In any Publication referred to in clause 6.1 the Discloser will acknowledge the contribution of the Organisation. RESEARCH RESULTS AND INTELLECTUAL PROPERTY All Intellectual Property created in the course of the Research belongs to the Institution.