Common use of Obligations and Responsibilities Clause in Contracts

Obligations and Responsibilities. (1) Prior to the Agreement being executed, the Sponsor will provide the Principal Investigator, and through the Principal Investigator the Institution and the Responsible HREC, with all current and relevant information regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. (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. (3) The Sponsor will designate appropriately qualified personnel to advise on Study-related medical questions or problems. (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) 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 Subjects. (6) The Sponsor will cooperate with the Institution and/or the Responsible HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. (7) To assist the Institution to comply with clause 8, the Sponsor will provide the Institution with adequate information and all necessary product accountability forms. (8) The Sponsor will provide indemnity to the Institution and members of the Responsible 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. (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. (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 currency of insurance, as requested by the Institution from time to time.

Obligations and Responsibilities. (1) Prior to the Agreement being executed, the Sponsor will provide the Principal Investigator, and through the Principal Investigator Investigator, the Institution and the Responsible HREC, with the Clinical Investigator’s Brochure and all current and relevant information information, including the Instructions for use, regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. (2) The Sponsor will must 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. (3) The Sponsor will must designate appropriately qualified personnel to advise on Study-related medical questions or problems. (4) The Sponsor will must 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) The Sponsor will must 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 Subjects. (6) The Sponsor will must cooperate with the Institution and/or the Responsible HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. (7) To assist the Institution to comply with clause 8, the Sponsor will must provide the Institution with adequate information and all necessary product accountability forms. (8) The Sponsor will must provide indemnity to the Institution and members of the Responsible HREC against claims arising from the Study on the terms and conditions set out in the relevant Medicines Medical Technology Association of Australia Form of Indemnity for Clinical Trials Investigations as set out in Schedule 3. (9) The Sponsor will comply with the Medicines Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored Trial clinical investigation as specified in Schedule 5. (10) The Sponsor will must 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 currency of insurance, as requested by the Institution from time to time.

Obligations and Responsibilities. (1) Prior to the Agreement being executed, the Sponsor will provide the Principal Investigator, and through the Principal Investigator Investigator, the Institution and the Responsible HREC, with the Clinical Investigator’s Brochure and all current and relevant information information, including the Instructions for use, regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. (2) The Sponsor will must 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. (3) The Sponsor will must designate appropriately qualified personnel to advise on Study-related medical questions or problems. (4) The Sponsor will must 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) The Sponsor will must 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 Subjects. (6) The Sponsor will must cooperate with the Institution and/or the Responsible HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. (7) To assist the Institution to comply with clause 8, the Sponsor will must provide the Institution with adequate information and all necessary product accountability forms. (8) The Sponsor will must provide indemnity to the Institution and members of the Responsible HREC against claims arising from the Study on the terms and conditions set out in the relevant Medicines Medical Technology Association of Australia Form of Indemnity for Clinical Trials Investigations as set out in Schedule 3.3.‌ (9) The Sponsor will comply with the Medicines Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored Trial clinical investigation as specified in Schedule 5.5.‌‌‌ (10) The Sponsor will must 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 currency of insurance, as requested by the Institution from time to time.