Common use of SPONSOR OBLIGATIONS AND RESPONSIBILITIES Clause in Contracts

SPONSOR OBLIGATIONS AND RESPONSIBILITIES. 5.1 Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and, through the Principal Investigator, the Institution and the Reviewing HREC, with all current and relevant information regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. 5.2 The Sponsor will implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. 5.3 The Sponsor will designate appropriately qualified personnel to advise on Study-related medical questions or problems. 5.4 The Sponsor will monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator, and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. 5.5 The Sponsor will notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. 5.6 The Sponsor will cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. 5.7 To assist the Institution to comply with clause 8, the Sponsor will provide the Institution with adequate information and all necessary Investigational Product accountability forms. 5.8 The Sponsor will provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medicines Australia Form of Indemnity for Clinical Trials as set out in Schedule 3. 5.9 The Sponsor will comply with the Medicines Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored Trial as specified in Schedule 5. 5.10 The Sponsor will maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

SPONSOR OBLIGATIONS AND RESPONSIBILITIES. 5.1 Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and, through the Principal Investigator, the Institution and the Reviewing HREC, with all current and relevant information regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. 5.2 The Sponsor will implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. 5.3 The Sponsor will designate appropriately qualified personnel to advise on Study-Study- related medical questions or problems. 5.4 The Sponsor will monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator, and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. 5.5 The Sponsor will notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. 5.6 The Sponsor will cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. 5.7 To assist the Institution to comply with clause 8, the Sponsor will provide the Institution with adequate information and all necessary Investigational Product accountability forms. 5.8 The Sponsor will provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medicines Australia Form of Indemnity for Clinical Trials as set out in Schedule 3. 5.9 The Sponsor will comply with the Medicines Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored Trial as specified in Schedule 5. 5.10 The Sponsor will maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

SPONSOR OBLIGATIONS AND RESPONSIBILITIES. 5.1 Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and, through the Principal Investigator, the Institution and the Reviewing HREC, with all current and relevant information regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. 5.2 The Sponsor will implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. 5.3 The Sponsor will designate appropriately qualified personnel to advise on Study-Study- related medical questions or problems. 5.4 The Sponsor will monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator, and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. 5.5 The Sponsor will notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. 5.6 The Sponsor will cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. 5.7 To assist the Institution to comply with clause 8, the Sponsor will provide the Institution with adequate information and all necessary Investigational Product accountability forms. 5.8 The Sponsor will provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medicines Australia Form of Indemnity for Clinical Trials as set out in Schedule 3. 5.9 The Sponsor will comply with the Medicines Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored Trial as specified in Schedule 5.. Please ensure payee and amount details are correct within schedule 2 5.10 The Sponsor will maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

SPONSOR OBLIGATIONS AND RESPONSIBILITIES. 5.1 Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and, through the Principal Investigator, the Institution and the Reviewing HREC, with all current and relevant information regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. 5.2 The Sponsor will implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. 5.3 The Sponsor will designate appropriately qualified personnel to advise on Study-Study- related medical questions or problems. 5.4 The Sponsor will monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator, and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. 5.5 The Sponsor will notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. 5.6 The Sponsor will cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. 5.7 To assist the Institution to comply with clause 8, the Sponsor will provide the Institution with adequate information and all necessary Investigational Product accountability forms. 5.8 The Sponsor will provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medicines Australia Form of Indemnity for Clinical Trials as set out in Schedule 3. . 5.9 The Sponsor will comply with the Medicines Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored Trial as specified in Schedule 55.‌ Please ensure payee and amount details are correct within schedule 2 and” in accordance to current Ministry of Health (OHMR) fee policy”. To facilitate post approval invoice payment. 5.10 The Sponsor will maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.