Common use of INSTITUTION OBLIGATIONS AND RESPONSIBILITIES Clause in Contracts

INSTITUTION OBLIGATIONS AND RESPONSIBILITIES. If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the institution must notify the CRG as soon as is practical; the Institution must consult with the CRG and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and if a replacement cannot be found who is acceptable to both parties, the CRG may require recruitment into the Study by the Institution to cease, and the CRG may terminate this Agreement in accordance with clause 14.4. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (4), (8), (10), (11), (13), or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it, its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, 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 CRG as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the CRG’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the CRG that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the CRG (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product(s), Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring and scheduled audit visits in accordance with the GCP Guideline 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 CRG, Regulatory Authority, Reviewing HREC or any third party designated by the CRG. Any such access is 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 may require. 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 Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Protocol, the Investigational Product(s), and their 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. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of the CRG. The Institution agrees to notify the CRG before destroying any Study Materials. The Institution will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the CRG, unless prevented from doing so by law. The Institution will provide the CRG 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 or Study Site. This includes execution of any documents reasonably requested by the CRG in connection with the requirements of a Regulatory Authority or the CRG as a result of such an audit. Any costs resulting from such audit shall be borne equally by the parties, unless the cost has resulted solely from an act or omission of a party, in which case that party will bear the total costs. The Institution shall obtain approval, in writing, from the CRG for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. CRG OBLIGATIONS AND RESPONSIBILITIES Prior to the Agreement being executed, the CRG or its designate 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 that is reasonably available to the CRG and required to justify the nature, scope and duration of the Study. The CRG will act as sponsor of the Study for the purposes of the TGA's CTN Scheme or CTX Scheme (or any successor scheme). The CRG is responsible for preparing and submitting all documents required by the TGA to file an application for initiating and conducting the Study. The CRG will implement and maintain quality assurance and quality control systems 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. The CRG will register the Study on the appropriate clinical trials registry. The CRG will designate appropriately qualified personnel to advise on Study-related medical questions or problems. The CRG will, as soon as it becomes aware, 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. The CRG 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. The CRG 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. To assist the Institution to comply with clause 8, the CRG will provide the Institution with adequate information and all necessary product accountability forms.

INSTITUTION OBLIGATIONS AND RESPONSIBILITIES. If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the institution must notify the CRG as soon as is practical; the Institution must consult with the CRG Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and if a replacement cannot be found who is acceptable to both parties, the CRG Sponsor may require recruitment into the Study by the Institution to cease, and or move the CRG may terminate this Agreement in accordance with clause 14.4Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (45), (8), (10), (11), (13), ) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that that, to the best of its knowledge, it, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies and bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority for debarmentAuthority. Furthermore, the Institution shall notify the CRG Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the CRGSponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the CRG Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the CRG Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product(s)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, the Institution will allow regular monitoring and scheduled audit visits in accordance with the GCP Guideline 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 CRGSponsor, Regulatory Authority, Reviewing HREC or any third party designated by the CRGSponsor. Any such access is to take place at times mutually agreed agreed, during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. 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 Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Protocol, the Investigational Product(s), and their Study 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. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of the CRGSponsor. The Institution agrees to notify the CRG Sponsor before destroying any Study MaterialsMaterials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the CRGSponsor, unless prevented from doing so by law. The Institution will provide the CRG Sponsor 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 or Study Site. This includes execution of any documents reasonably requested by the CRG Sponsor in connection with the requirements of a Regulatory Authority or the CRG Sponsor as a result of such an audit. Any costs resulting from such audit shall The cost will be borne equally by the parties, Sponsor unless such rectification is due to the cost has resulted solely from an act default of the Institution or omission of a party, in which case that party will bear the total costsPrincipal Investigator. The Institution shall obtain approval, in writing, from the CRG Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. CRG SPONSOR OBLIGATIONS AND RESPONSIBILITIES Prior to the Agreement being executed, the CRG or its designate Sponsor must provide the Principal Investigator, and and, through the Principal Investigator Investigator, the Institution and the Reviewing HREC, with all current and relevant information regarding the Investigational Product that is as reasonably available to the CRG and required to justify the nature, scope and duration of the Study. The CRG will act as sponsor of the Study for the purposes of the TGA's CTN Scheme or CTX Scheme (or any successor scheme). The CRG is responsible for preparing and submitting all documents required by the TGA to file an application for initiating and conducting the Study. The CRG 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 22.1. The CRG will register the Study on the appropriate clinical trials registry. The CRG Sponsor will designate appropriately qualified personnel to advise on Study-related medical questions or problems. The CRG will, as soon as it becomes aware, 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 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. The CRG 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. The CRG Sponsor will cooperate with the Institution and/or the Responsible Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the CRG Sponsor will provide the Institution with adequate information and all necessary product Investigational Product accountability forms. 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. 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. 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.

INSTITUTION OBLIGATIONS AND RESPONSIBILITIES. If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the institution must notify the CRG as soon as is practical; the Institution must consult with the CRG and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and if a replacement cannot be found who is acceptable to both parties, the CRG may require recruitment into the Study by the Institution to cease, and the CRG may terminate this Agreement in accordance with clause 14.4. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (4), (8), (10), (11), (13), or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it, its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, 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 CRG as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the CRG’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the CRG that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the CRG (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product(s), Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring and scheduled audit visits in accordance with the GCP Guideline 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 CRG, Regulatory Authority, Reviewing HREC or any third party designated by the CRG. Any such access is 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 may require. 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 Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Protocol, the Investigational Product(s), and their 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. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of the CRG. The Institution agrees to notify the CRG before destroying any Study Materials. The Institution will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the CRG, unless prevented from doing so by law. The Institution will provide the CRG 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 or Study Site. This includes execution of any documents reasonably requested by the CRG in connection with the requirements of a Regulatory Authority or the CRG as a result of such an audit. Any costs resulting from such audit shall be borne equally by the parties, unless the cost has resulted solely from an act or omission of a party, in which case that party will bear the total costs. The Institution shall obtain approval, in writing, from the CRG for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. CRG OBLIGATIONS AND RESPONSIBILITIES Prior to the Agreement being executed, the CRG or its designate 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 that is reasonably available to the CRG and required to justify the nature, scope and duration of the Study. The CRG will act as sponsor of the Study for the purposes of the TGA's CTN Scheme or CTX Scheme (or any successor scheme). The CRG is responsible for preparing and submitting all documents required by the TGA to file an application for initiating and conducting the Study. The CRG will implement and maintain quality assurance and quality control systems 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. The CRG will register the Study on the appropriate clinical trials registry. The CRG will designate appropriately qualified personnel to advise on Study-related medical questions or problems. The CRG will, as soon as it becomes aware, 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. The CRG 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. The CRG 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. To assist the Institution to comply with clause 8, the CRG will provide the Institution with adequate information and all necessary product accountability forms.

INSTITUTION OBLIGATIONS AND RESPONSIBILITIES. If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the institution must notify the CRG as soon as is practical; the Institution must consult with the CRG Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and if a replacement cannot be found who is acceptable to both parties, the CRG Sponsor may require recruitment into the Study by the Institution to cease, and or move the CRG may terminate this Agreement in accordance with clause 14.4Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (45), (8), (10), (11), (13), ) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that that, to the best of its knowledge, it, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies and bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority for debarmentAuthority. Furthermore, the Institution shall notify the CRG Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the CRGSponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the CRG Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the CRG Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product(s)Study 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, the Institution will allow regular monitoring and scheduled audit visits in accordance with the GCP Guideline 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 CRGSponsor, Regulatory Authority, Reviewing HREC or any third party designated by the CRGSponsor. Any such access is 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 may require. 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 Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Protocol, the Investigational Study Product(s), and their 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. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Protocol, information relating to the Investigational Study Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of the CRGSponsor. The Institution agrees to notify the CRG Sponsor before destroying any Study MaterialsMaterials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the CRGSponsor, unless prevented from doing so by law. The Institution will provide the CRG Sponsor 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 or Study Site. This includes execution of any documents reasonably requested by the CRG Sponsor in connection with the requirements of a Regulatory Authority or the CRG Sponsor as a result of such an audit. Any costs resulting from such audit shall The cost will be borne equally by the parties, Sponsor unless such rectification is due to the cost has resulted solely from an act default of the Institution or omission of a party, in which case that party will bear the total costsPrincipal Investigator. The Institution shall obtain approval, in writing, from the CRG Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) Study Product before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. CRG SPONSOR OBLIGATIONS AND RESPONSIBILITIES Prior to the Agreement being executed, the CRG or its designate Sponsor must provide the Principal Investigator, and and, through the Principal Investigator Investigator, the Institution and the Reviewing HREC, with all current and relevant information regarding the Investigational Study Product that is as reasonably available to the CRG and required to justify the nature, scope and duration of the Study. The CRG will act as sponsor of the Study for the purposes of the TGA's CTN Scheme or CTX Scheme (or any successor scheme). The CRG is responsible for preparing and submitting all documents required by the TGA to file an application for initiating and conducting the Study. The CRG 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 22.1. The CRG will register the Study on the appropriate clinical trials registry. The CRG Sponsor will designate appropriately qualified personnel to advise on Study-related medical questions or problems. The CRG will, as soon as it becomes aware, Sponsor will monitor the application of the Study Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator Investigator, and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Study Product from any other market for safety reasons. The CRG 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. The CRG Sponsor will cooperate with the Institution and/or the Responsible Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the CRG Sponsor will provide the Institution with adequate information and all necessary product Study Product accountability forms. The Sponsor indemnifies the Institution against any claim or proceeding that is made, threatened or commenced, and any cost, liability, loss, damage or expense (including reasonable legal and other professional costs on a full indemnity basis) (Liability) that the Institution incurs or suffers, as a result of: a negligent or wrongful act or omission of the Sponsor; or a breach of Relevant Privacy Laws by the Sponsor; However, the Sponsor is not required to indemnify the Institution to the extent that the Liability results directly from a negligent or wrongful act or omission of the Institution, or its Personnel, a breach of this Agreement or a failure to follow the Protocol. The Sponsor must maintain at all times policies of insurance in relation to its business against such risks as are normally insured by prudent companies carrying on a similar business and to cover all claims or damages for which it may be liable under this Agreement or as is reasonably required by the Institution from time to time. The Sponsor must, within a reasonable time of a written request to do so, deliver to the Institution evidence satisfactory to the Institution that it has an appropriate and current insurance policy (or policies).

INSTITUTION OBLIGATIONS AND RESPONSIBILITIES. If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the institution must notify the CRG as soon as is practical; the Institution must consult with the CRG Local Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and if a replacement cannot be found who is acceptable to both parties, the CRG Local Sponsor may require recruitment into the Study by the Institution to cease, and or move the CRG may terminate this Agreement in accordance with clause 14.4Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (45), (8), (10), (11), (13), ) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that that, to the best of its knowledge, it, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies and bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority for debarmentAuthority. Furthermore, the Institution shall notify the CRG Local Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the CRG’s Local Sponsor's behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the CRG Local Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the CRG Local Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product(s)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, the Institution will allow regular monitoring and scheduled audit visits in accordance with the GCP Guideline 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 CRGLocal Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the CRGLocal Sponsor. Any such access is 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 may require. 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 Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Protocol, the Investigational Product(s), and their 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. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of the CRGLocal Sponsor. The Institution agrees to notify the CRG Local Sponsor before destroying any Study MaterialsMaterials and agrees to retain the Study Materials for such longer period as reasonably required by the Local Sponsor at the Local Sponsor's expense. The Institution will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the CRGLocal Sponsor, unless prevented from doing so by law. The Institution will provide the CRG Local Sponsor 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 or Study Site. This includes execution of any documents reasonably requested by the CRG Local Sponsor in connection with the requirements of a Regulatory Authority or the CRG Local Sponsor as a result of such an audit. Any costs resulting from such audit shall The cost will be borne equally by the parties, Local Sponsor unless such rectification is due to the cost has resulted solely from an act default of the Institution or omission of a party, in which case that party will bear the total costsPrincipal Investigator. The Institution shall obtain approval, in writing, from the CRG Local Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. CRG LOCAL SPONSOR OBLIGATIONS AND RESPONSIBILITIES RESPONSIBILITIES. Prior to the Agreement being executed, the CRG or its designate Local Sponsor must provide the Principal Investigator, and and, through the Principal Investigator Investigator, the Institution and the Reviewing HREC, with all current and relevant information regarding the Investigational Product that is as reasonably available to the CRG and required to justify the nature, scope and duration of the Study. The CRG will act as sponsor of the Study for the purposes of the TGA's CTN Scheme or CTX Scheme (or any successor scheme). The CRG is responsible for preparing and submitting all documents required by the TGA to file an application for initiating and conducting the Study. The CRG Local 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 22.1. The CRG will register the Study on the appropriate clinical trials registry. The CRG Local Sponsor will designate appropriately qualified personnel to advise on Study-related medical questions or problems. The CRG will, as soon as it becomes aware, Local 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 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. The CRG Local 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. The CRG Local Sponsor will cooperate with the Institution and/or the Responsible Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the CRG Local Sponsor will provide the Institution with adequate information and all necessary product Investigational Product accountability forms. The Local 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. The Local 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. The Local Sponsor will maintain insurance, or ensure that it is a named insured under the Organisation's insurance policy, 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.

INSTITUTION OBLIGATIONS AND RESPONSIBILITIES. If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the institution must notify the CRG as soon as is practical; the Institution must consult with the CRG and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and if a replacement cannot be found who is acceptable to both parties, the CRG may require recruitment into the Study by the Institution to cease, and the CRG may terminate this Agreement in accordance with clause 14.4. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(23.3(1), (32), (4), (8), (10), (11), (13), or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it, its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies and bodies, 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 CRG as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the CRG’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the CRG that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the CRG (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product(s), Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring and scheduled audit visits in accordance with the GCP Guideline 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 CRG, Regulatory Authority, Reviewing HREC or any third party designated by the CRG. Any such access is 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 may require. 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 Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Protocol, the Investigational Product(s), and their 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. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of the CRG. The Institution agrees to notify the CRG before destroying any Study Materials. The Institution will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the CRG, unless prevented from doing so by law. The Institution will provide the CRG 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 or Study Site. This includes execution of any documents reasonably requested by the CRG in connection with the requirements of a Regulatory Authority or the CRG as a result of such an audit. Any costs resulting from such audit shall be borne equally by the parties, unless the cost has resulted solely from an act or omission of a party, in which case that party will bear the total costs. The Institution shall obtain approval, in writing, from the CRG for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. CRG OBLIGATIONS AND RESPONSIBILITIES Prior to the Agreement being executed, the CRG or its designate 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 that is reasonably available to the CRG and required to justify the nature, scope and duration of the Study. The CRG will act as sponsor of the Study for the purposes of the TGA's CTN Scheme or CTX Scheme (or any successor scheme). The CRG is responsible for preparing and submitting all documents required by the TGA to file an application for initiating and conducting the Study. The CRG will implement and maintain quality assurance and quality control systems 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. The CRG will register the Study on the appropriate clinical trials registry. The CRG will designate appropriately qualified personnel to advise on Study-related medical questions or problems. The CRG will, as soon as it becomes aware, 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. The CRG 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. The CRG 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. To assist the Institution to comply with clause 8, the CRG will provide the Institution with adequate information and all necessary product accountability forms.

INSTITUTION OBLIGATIONS AND RESPONSIBILITIES. If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the institution must notify the CRG CRIG as soon as is practical; the Institution must consult with the CRG CRIG and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and if a replacement cannot be found who is acceptable to both parties, the CRG CRIG may require recruitment into the Study by the Institution to cease, and the CRG CRIG may terminate this Agreement in accordance with clause 14.4. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(23.3(1), (32), (4), (8), (10), (11), (13), or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it, its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies and bodies, 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 CRG CRIG as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the CRGCRIG’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the CRG CRIG that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the CRG CRIG (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product(s), Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring and scheduled audit visits in accordance with the GCP Guideline 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 CRGCRIG, Regulatory Authority, Reviewing HREC or any third party designated by the CRGCRIG. Any such access is 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 may require. 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 Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Protocol, the Investigational Product(s), and their 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. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of the CRGCRIG. The Institution agrees to notify the CRG CRIG before destroying any Study Materials. The Institution will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the CRGCRIG, unless prevented from doing so by law. The Institution will provide the CRG CRIG 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 or Study Site. This includes execution of any documents reasonably requested by the CRG CRIG in connection with the requirements of a Regulatory Authority or the CRG CRIG as a result of such an audit. Any costs resulting from such audit shall be borne equally by the parties, unless the cost has resulted solely from an act or omission of a party, in which case that party will bear the total costs. The Institution shall obtain approval, in writing, from the CRG CRIG for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. CRG OBLIGATIONS AND RESPONSIBILITIES Prior to the Agreement being executed, the CRG or its designate 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 that is reasonably available to the CRG and required to justify the nature, scope and duration of the Study. The CRG will act as sponsor of the Study for the purposes of the TGA's CTN Scheme or CTX Scheme (or any successor scheme). The CRG is responsible for preparing and submitting all documents required by the TGA to file an application for initiating and conducting the Study. The CRG will implement and maintain quality assurance and quality control systems 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. The CRG will register the Study on the appropriate clinical trials registry. The CRG will designate appropriately qualified personnel to advise on Study-related medical questions or problems. The CRG will, as soon as it becomes aware, 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. The CRG 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. The CRG 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. To assist the Institution to comply with clause 8, the CRG will provide the Institution with adequate information and all necessary product accountability forms.