Common use of THE STUDY Clause in Contracts

THE STUDY. The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable: any requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities; the requirements of the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (October 2004) or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidance governing the conduct of clinical research in the jurisdiction of the Study; the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); and the NHMRC National Statement on Ethical Conduct in Human Research (2007) or its replacement, and any other relevant NHMRC publication or guideline that relates to clinical trials. If any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Institution through the Principal Investigator may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Institution must notify the Sponsor and the Reviewing HREC of the facts and circumstance causing the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the change is implemented. From time to time, the Sponsor may modify the Protocol by written notice to the Institution and Principal Investigator. Except where the modification is necessary to eliminate an immediate hazard to Study Participants, or involves only logistical or administrative aspects of the trial, any modification may not be implemented before approval by the Reviewing HREC. If the parties determine that a modification will affect the cost of the Study, the parties shall amend Schedule 2 as agreed between them. PRINCIPAL INVESTIGATOR Role of Principal Investigator The Institution has authorised the Principal Investigator as the person responsible on a day-to-day basis for the conduct of the Study. The Principal Investigator does not have authority on behalf of the Institution to amend this Agreement or the Protocol.

THE STUDY. The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable: any requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities; the requirements of the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (October 2004) or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidance governing the conduct of clinical research in the jurisdiction of the Study; the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); and the NHMRC National Statement on Ethical Conduct in Human Research (2007) or its replacement, and any other relevant NHMRC publication or guideline that relates to clinical trials. If any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Institution through the Principal Investigator may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Institution must notify the Sponsor and the Reviewing HREC of the facts and circumstance causing the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the change is implemented. From time to time, the Sponsor may modify the Protocol by written notice to the Institution and Principal Investigator. Except where the modification is necessary to eliminate an immediate hazard to Study Participants, or involves only logistical or administrative aspects of the trial, any modification may not be implemented before approval by the Reviewing HREC. If the parties determine that a modification will affect the cost of the Study, the parties shall amend Schedule 2 as agreed between them. PRINCIPAL INVESTIGATOR Role of Principal Investigator The Institution has authorised the Principal Investigator as the person responsible on a day-to-day basis for the conduct of the Study. The Principal Investigator does not have authority on behalf of the Institution to amend this Agreement or the Protocol.INVESTIGATOR

THE STUDY. The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable: any requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities; the requirements Joint TGA - Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance (PMS) studies or its replacement; the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (October 2004) document 'Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by Drug Safety and Evaluation Branch' or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidance governing the conduct of clinical research in the jurisdiction of the Studyreplacement; the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); and the NHMRC National Statement on Ethical Conduct in Human Research (2007) or its replacement, and any other relevant NHMRC publication or guideline that relates to clinical trials. If any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Institution through the Principal Investigator may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Institution must notify the Sponsor and the Reviewing HREC of the facts and circumstance causing the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the change is implemented. From time to time, the Sponsor may modify the Protocol by written notice to the Institution and Principal Investigator. Except where the modification is necessary to eliminate an immediate hazard to Study Participants, or involves only logistical or administrative aspects of the trial, any modification may not be implemented before approval by the Reviewing HREC. If the parties determine that a modification will affect the cost of the Study, the parties shall amend Schedule 2 as agreed between them. PRINCIPAL INVESTIGATOR Role of Principal Investigator The Institution has authorised the Principal Investigator as the person responsible on a day-to-day basis for the conduct of the Study. The Principal Investigator does not have authority on behalf of the Institution to amend this Agreement or the Protocol.INVESTIGATOR

THE STUDY. The parties must comply with, and conduct the Study in accordance with, the Protocol and any conditions of the Reviewing HREC. In addition the parties must comply with the following, as applicable: any requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities; the requirements of the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials in Australia (October 2004) or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidance governing the conduct of clinical research in the jurisdiction of the Study; the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); and the NHMRC National Statement on Ethical Conduct in Human Research (2007) or its replacement, and any other relevant NHMRC publication or guideline that relates to clinical trials. If any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Institution through the Principal Investigator may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Institution must notify the Local Sponsor and the Reviewing HREC of the facts and circumstance causing the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the change is implemented. From time to time, the Local Sponsor may modify the Protocol by written notice to the Institution and Principal Investigator. Except where the modification is necessary to eliminate an immediate hazard to Study Participants, or involves only logistical or administrative aspects of the trial, any modification may not be implemented before approval by the Reviewing HREC. If the parties determine that a modification will affect the cost of the Study, the parties shall amend Schedule 2 as agreed between them. PRINCIPAL INVESTIGATOR Role of Principal Investigator The Institution has authorised the Principal Investigator as the person responsible on a day-to-day basis for the conduct of the Study. The Principal Investigator does not have authority on behalf of the Institution to amend this Agreement or the Protocol.INVESTIGATOR