Common use of Conduct of the Project Clause in Contracts

Conduct of the Project. The Parties agree: that they have each received a copy of the Application and agree that the roles, budget, contributions and program of research of each of the Parties in relation to the Project are set out accurately in the Application and this Agreement; to each carry out their roles, responsibilities and program of research and provide their Project Contributions as set out in this Agreement and in the Application or as varied from time to time with the prior approval of the Parties and Health (if required); to act in a manner that is consistent with, and enables the Eligible Organisation to give effect to, all of the Eligible Organisation’s obligations under the Funding Agreement; to conduct the Project in accordance with the NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals); to carry out the Project in an ethical, responsible, diligent and competent manner; to ensure that the Project is performed and completed within the Funding Period unless otherwise varied by the Funding Body having given reasonable advance written notice to the Eligible Organisation; to ensure that their Specified Personnel perform the Project in accordance with the Application and this Agreement; to implement sound research governance procedures in respect of the Project, including cooperation in complying with the procedures for notification of Misconduct in accordance with the Misconduct Policy and notification and management of breaches of the Australian Code for the Responsible Conduct of Research (2018) and associated Guide to Managing and Investigating Breaches of the Australian Code for the Responsible Conduct of Research (2018), as amended from time to time, and as specified in clause 17 of the Funding Agreement, including advising all Specified Personnel that their Personal Information may be disclosed to Health; to cooperate with each other in relation to any allegations of Misconduct or Research Misconduct; that any Institutional Approval, including statements of compliance and/or ethics clearance necessary for the performance of a Research Activity, where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until Institutional Approvals have been granted; that any requirements applicable to working or contact with a Vulnerable Person or interaction with Children necessary for the performance of a Research Activity (including under the National Principles for Child Safe Organisations), where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until these requirements have been met, in accordance with Sections H.1 and H.2 of Attachment 1 to the Schedule; to comply with the requirements of the Australian Privacy Principles under the Privacy Act 1988 (Cth) in relation to the use, collection, storage and security or disclosure of any personal and/or health information collected or used during the Project, and the Guidelines approved under Section 95A of the Privacy Act 1988 (2014) and the Guidelines under Section 95 of the Privacy Act 1988 (2014); to the extent that any Party is a Data Controller and another Party or Parties are a Data Processor (as those terms are defined under the EU Data Protection Legislation) in carrying out their roles, responsibilities and program of research under this Agreement, the Parties shall comply with all applicable requirements of the EU Data Protection Legislation in addition to their obligations under clause 2.1(l) and the Parties may enter into a separate legal agreement in respect of the processing of Personal Data subject to EU Data Protection Legislation; to maintain appropriate records of their involvement in the Project in accordance with clause 9 of the Funding Agreement; to cooperate with each other in providing information that the Eligible Organisation requires to compile the Reports required under clause 10 of the Funding Agreement and Section H.3 of Attachment 1 to the Schedule, in relation to the Project; to provide the Commonwealth with access specified in clause 12 of the Funding Agreement; that any Assets purchased with the Funds will be dealt with in accordance with clause 14 of the Funding Agreement; to use the MRFF logo and acknowledge the Funding from Health and include other acknowledgements consistently with the requirements of clause 21 of the Funding Agreement and Section H.4 of Attachment 1 to the Schedule. The Participating Institutions agree to notify the Eligible Organisation about any planned launch or media event relating to the Project to enable the Eligible Organisation to provide a reasonable opportunity for the Health Minister or their representative to attend; that Health is entitled to use information relating to the Project in accordance with clause 22 of the Funding Agreement; to notify the Eligible Organisation if any of the circumstances set out in clause 31.4 of the Funding Agreement arises; and to comply with any applicable statutes, regulations, by-laws and requirements of the Commonwealth and any State, Territory or local authority. Each Party agrees to: carry out its role in the Study (and ensure that any third parties it engages to undertake the Study agree to carry out their roles in the Study) in accordance with: the Protocol; any relevant Commonwealth and State or Territory laws and any requirements of Regulatory Authorities; the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted by the Therapeutic Goods Administration; the NHMRC National Statement on Ethical Conduct in Human Research (2007) – updated May 2015 or its replacement, and any other relevant NHMRC publication or guideline that relates to human research; 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 any reasonable direction given by the Sponsor of the Study, where the Party is not the Sponsor of the Study, in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements, including any condition of a Responsible HREC; keep all Biological Samples which are the subject or outcome of the Study in appropriate storage conditions in areas accessible only to authorised personnel; maintain complete and current records (including data and reports) in relation to its performance of the Study; and ensure that records are retained and preserved for at least 15 years from completion of the Project where the Project includes a Study/Clinical Trial and otherwise for 5 years after the end of the Funding Agreement, and in accordance with any other regulatory requirements. The Sponsor of the Study agrees to enter into an agreement with each Study Site which governs the conduct of the Study at the Study Site and which enables the obligations under this Agreement to be met, including in relation to Intellectual Property in Study Materials. In the case of medicines, the Medicines Australia Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form (Medicines Australia CTRA) or substantially similar terms would fulfil this requirement. Where the Sponsor of the Study is not a Party, the Party subcontracting with the Sponsor of the Study agrees to pass on this requirement. Each Party agrees that, if any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Sponsor of the Study may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Sponsor of the Study must notify the (other) Parties and the Responsible HREC of the facts and circumstance giving rise to the requirement for the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the deviation is implemented. Each Party agrees that it is liable for its acts and omissions in relation to the conduct of the Study and must maintain such insurance policies as are reasonably available and necessary to provide indemnity to that Party in relation to any liability which it may incur in conducting the Study or performing its obligations under this Agreement. In carrying out the Project and using and managing the Funds, each Participating Institution agrees: to, and ensure that its Specified Personnel, abide by the terms and conditions of the Funding Agreement, the Funding Policy and any Funding Conditions that apply to the Project, and all applicable NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals) to the extent that they relate to Participating Institutions; not to in any way impede or prevent the Eligible Organisation from complying with any of its obligations under the Funding Agreement; to do all things reasonably required to assist the Eligible Organisation to meet its obligations under the Funding Agreement including reporting, compliance and financial management obligations relating to the Funding; and to require any subcontractor to comply with the applicable obligations of the Participating Institution under this Agreement and, where the subcontractor contributes to or creates Project outputs, to enter into a written subcontract with that subcontractor on terms consistent with this Agreement, including Intellectual Property obligations, any applicable requirements relating to working or contact with a Vulnerable Person or interaction with Children and, where applicable, EU Data Protection Legislation obligations.

Conduct of the Project. The Parties agree: that they have each received a copy of the Application and agree that the roles, budget, contributions and program of research of each of the Parties in relation to the Project are set out accurately in the Application and this Agreement; to each carry out their roles, responsibilities and program of research and provide their Project Contributions as set out in this Agreement and in the Application or as varied from time to time with the prior approval of the Parties and Health the NHMRC (if required); to act in a manner that is consistent with, and enables the Eligible Organisation Administering Institution to give effect to, all of the Eligible OrganisationAdministering Institution’s obligations under the Funding NHMRC Agreement; to conduct the Project in accordance with the NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals); to carry out the Project in an ethical, responsible, diligent and competent manner; to ensure that the Project is performed and completed within the Funding Period unless otherwise varied by the Funding Body NHMRC having given reasonable advance written notice to the Eligible OrganisationAdministering Institution; to ensure that their Specified Personnel perform the Project in accordance with the Application and this Agreement; to implement sound research governance procedures in respect of the Project, Project including cooperation in complying with the procedures for notification of Misconduct in accordance with the NHMRC’s Misconduct Policy and notification and management of breaches of the Australian Code for the Responsible Conduct of Research (2018) and associated Guide to Managing and Investigating Breaches of the Australian Code for the Responsible Conduct of Research (20182007), as amended from time to time, and as specified in clause 17 of the Funding Agreement, including advising all Specified Personnel that their Personal Information may be disclosed to Health; to cooperate with each other in relation to any allegations of Misconduct or Research Misconduct; that any Institutional Approval, including statements of compliance and/or ethics clearance necessary for the performance of a Research Activity, Activity where applicable, applicable must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until Institutional Approvals have been granted; that any requirements applicable to working or contact with a Vulnerable Person or interaction with Children necessary for the performance of a Research Activity (including under the National Principles for Child Safe Organisations), where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until these requirements have been met, in accordance with Sections H.1 and H.2 of Attachment 1 to the Schedule; to comply with the requirements of Privacy Xxx 0000 (Cth) and the Australian Privacy Principles under the Privacy that Act 1988 (Cth) in relation to the use, collection, storage and security or disclosure of any personal and/or health information collected or used during the Project, and the Guidelines approved under Section 95A of the Privacy Act 1988 (2014) and the Guidelines under Section 95 of the Privacy Act 1988 (2014); to the extent that any Party is a Data Controller and another Party or Parties are a Data Processor (as those terms are defined under the EU Data Protection Legislation) in carrying out their roles, responsibilities and program of research under this Agreement, the Parties shall comply with all applicable requirements of the EU Data Protection Legislation in addition to their obligations under clause 2.1(l) and the Parties may enter into a separate legal agreement in respect of the processing of Personal Data subject to EU Data Protection Legislation; to maintain appropriate records of their involvement in the Project in accordance with clause 9 8 of the NHMRC Funding Agreement; to cooperate with each other in providing information that the Eligible Organisation Administering Institution requires to compile the Reports required under clause 10 9 of the NHMRC Funding Agreement and Section H.3 of Attachment 1 to the Schedule, in relation to the Project; to provide the Commonwealth with access specified in clause 12 11 of the NHMRC Funding Agreement; that any Assets purchased with the Funds will be dealt with in accordance with clause 14 13 of the NHMRC Funding Agreement; to use the MRFF NHMRC logo and acknowledge the Funding from Health and include other acknowledgements consistently with the requirements of clause 21 20 of the NHMRC Funding Agreement and Section H.4 of Attachment 1 to the Schedule. The Participating Institutions agree to notify the Eligible Organisation about any planned launch or media event relating to the Project to enable the Eligible Organisation to provide a reasonable opportunity for the Health Minister or their representative to attendAgreement; that Health the NHMRC is entitled to use information relating to the Project in accordance with clause 22 21 of the NHMRC Funding Agreement; to notify the Eligible Organisation each other if any of the circumstances set out in clause 31.4 30.4 of the NHMRC Funding Agreement arisesarise; to give effect to clauses 36 and 37 of the NHMRC Funding Agreement if those clauses apply to the Project; and to comply with any applicable statutesstatues, regulations, by-laws and requirements of the Commonwealth and any State, Territory or local authority. Each Party agrees to: carry out its role in the Study (and ensure that any third parties it engages to undertake the Study agree to carry out their roles in the Study) in accordance with: the Protocol; any relevant Commonwealth and State or Territory laws and any requirements of Regulatory Authorities; the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted by the Therapeutic Goods Administration; the NHMRC National Statement on Ethical Conduct in Human Research (2007) – updated May 2015 or its replacement, and any other relevant NHMRC publication or guideline that relates to human research; 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 any reasonable direction given by the Sponsor of the Study, where the Party is not the Sponsor of the Study, in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements, including any condition of a Responsible HREC; keep all Biological Samples which are the subject or outcome of the Study in appropriate storage conditions in areas accessible only to authorised personnel; maintain complete and current records (including data and reports) in relation to its performance of the Study; and ensure that records are retained and preserved for at least 15 years from completion of the Project where the Project includes a Study/Clinical Trial and otherwise for 5 years after the end of the Funding Agreement, and in accordance with any other regulatory requirements. The Sponsor of the Study agrees to enter into an agreement with each Study Site which governs the conduct of the Study at the Study Site and which enables the obligations under this Agreement to be met, including in relation to Intellectual Property in Study Materials. In the case of medicines, the Medicines Australia Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form (Medicines Australia CTRA) or substantially similar terms would fulfil this requirement. Where the Sponsor of the Study is not a Party, the Party subcontracting with the Sponsor of the Study agrees to pass on this requirement. Each Party agrees that, if any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Sponsor of the Study may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Sponsor of the Study must notify the (other) Parties and the Responsible HREC of the facts and circumstance giving rise to the requirement for the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the deviation is implemented. Each Party agrees that it is liable for its acts and omissions in relation to the conduct of the Study and must maintain such insurance policies as are reasonably available and necessary to provide indemnity to that Party in relation to any liability which it may incur in conducting the Study or performing its obligations under this Agreement. In carrying out the Project and using and managing the Funds, each Participating Institution agrees: to, and ensure that its Specified Personnel, abide by the terms and conditions of the NHMRC Funding Agreement, the NHMRC Funding Policy and any Funding Conditions that apply to the Project, and all applicable NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals) to the extent that they relate to Participating Institutions; not to in any way impede or prevent the Eligible Organisation Administering Institution from complying with any of its obligations under the NHMRC Funding Agreement; and to do all things reasonably required to assist the Eligible Organisation Administering Institution to meet its obligations under the NHMRC Funding Agreement including reporting, compliance and financial management obligations relating to the Funding; and to require any subcontractor to comply with the applicable obligations of the Participating Institution under this Agreement and, where the subcontractor contributes to or creates Project outputs, to enter into a written subcontract with that subcontractor on terms consistent with this Agreement, including Intellectual Property obligations, any applicable requirements relating to working or contact with a Vulnerable Person or interaction with Children and, where applicable, EU Data Protection Legislation obligations.

Conduct of the Project. The Parties agree: that they have each received a copy of the Application and agree that the roles, budget, contributions and program of research of each of the Parties in relation to the Project are set out accurately in the Application and this Agreement; to each carry out their roles, responsibilities and program of research and provide their Project Contributions as set out in this Agreement and in the Application or as varied from time to time with the prior approval of the Parties (and Health (the NHMRC if required); to act in a manner that is consistent with, and enables the Eligible Organisation to give effect to, all of the Eligible Organisation’s obligations under the Funding Agreement; to conduct the Project in accordance with the NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals)Guidelines; to carry out the Project in an ethical, responsible, diligent and competent manner; to ensure that the Project is performed and completed within the Funding Period unless otherwise varied by the Funding Body NHMRC having given reasonable advance written notice to the Eligible OrganisationMH; to ensure that their Specified Personnel perform the Project in accordance with the Application and this Agreement; to implement sound research governance procedures carry out their obligations in respect of the Project, including cooperation in complying with the procedures for notification of Misconduct Project in accordance with the Misconduct Policy National Statement on Ethical Conduct in Human Research 2007 and The Australian Code for Responsible Conduct of Research 2007 (as varied or replaced by the National Health & Medical Research Council, the Australian Research Council and Universities Australia) including procedures for the notification and management of breaches of the Australian Code for the Responsible Conduct same or instances of Research (2018) and associated Guide to Managing and Investigating Breaches of Misconduct as required by the Australian Code for the Responsible Conduct of Research (2018), as amended from time to time, and as specified in clause 17 of the NHMRC Funding Agreement, including advising all Specified Personnel that their Personal Information may be disclosed to Health; to cooperate co-operate with each other in relation to any allegations of Misconduct or Research Misconduct; that any Institutional Approvalthat, including statements if the approval of compliance an appropriate ethics and/or ethics clearance necessary biosafety committee (or similar) is required for the performance of a Research ActivityProject, where applicable, must MH will be obtained prior to the commencement of responsible for obtaining that Research Activity approval but no research work will commence and any associated no Funding must not will be expended until Institutional Approvals have that approval has been granted; that any requirements applicable to working or contact with a Vulnerable Person or interaction with Children necessary for the performance of a Research Activity (including under the National Principles for Child Safe Organisations), where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until these requirements have been met, in accordance with Sections H.1 and H.2 of Attachment 1 to the Schedule; to comply with the requirements of the Australian Privacy Principles under the Privacy Act 1988 (CthC’th) and the National Privacy Principles under that Act in relation to the use, collection, storage and security or disclosure of any personal and/or health information collected or used during the Project, and the Guidelines approved under Section 95A of the Privacy Act 1988 (2014) and the Guidelines under Section 95 of the Privacy Act 1988 (2014); to the extent that any Party is a Data Controller and another Party or Parties are a Data Processor (as those terms are defined under the EU Data Protection Legislation) in carrying out their roles, responsibilities and program of research under this Agreement, the Parties shall comply with all applicable requirements of the EU Data Protection Legislation in addition to their obligations under clause 2.1(l) and the Parties may enter into a separate legal agreement in respect of the processing of Personal Data subject to EU Data Protection Legislation; to maintain appropriate records of their involvement in the Project in accordance with clause 9 8 of the NHMRC Funding Agreement; to cooperate co-operate with each other in providing information that the Eligible Organisation MH requires to compile provide in compiling the Reports required under clause 10 9 of the NHMRC Funding Agreement and Section H.3 of Attachment 1 to the Schedule, in relation to the Project; to provide the Commonwealth with access specified in clause 12 11 of the NHMRC Funding Agreement; that any Assets purchased with the Funds will be dealt with in accordance with clause 14 13 of the NHMRC Funding Agreement; to use the MRFF NHRMC logo and acknowledge the Funding from Health and include other acknowledgements consistently with the requirements of clause 21 20 of the NHMRC Funding Agreement and Section H.4 of Attachment 1 to the Schedule. The Participating Institutions agree to notify the Eligible Organisation about any planned launch or media event relating to the Project to enable the Eligible Organisation to provide a reasonable opportunity for the Health Minister or their representative to attendAgreement; that Health the NHMRC is entitled to use information relating to the Project in accordance with clause 22 21 of the NHMRC Funding Agreement; to notify the Eligible Organisation each other if any of the circumstances set out in clause 31.4 30.4 of the NHMRC Funding Agreement arisesarise; to give effect to clauses 36 and 37 of the NHMRC Funding Agreement if those clauses apply to the Project; and to comply with any applicable statutesstatues, regulations, by-laws and requirements of the Commonwealth and any State, Territory or local authority. Each Party agrees to: carry out its role in the Study (and ensure that any third parties it engages to undertake the Study agree to carry out their roles in the Study) in accordance with: the Protocol; any relevant Commonwealth and State or Territory laws and any requirements of Regulatory Authorities; the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted by the Therapeutic Goods Administration; the NHMRC National Statement on Ethical Conduct in Human Research (2007) – updated May 2015 or its replacement, and any other relevant NHMRC publication or guideline that relates to human research; 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 any reasonable direction given by the Sponsor of the Study, where the Party is not the Sponsor of the Study, in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements, including any condition of a Responsible HREC; keep all Biological Samples which are the subject or outcome of the Study in appropriate storage conditions in areas accessible only to authorised personnel; maintain complete and current records (including data and reports) in relation to its performance of the Study; and ensure that records are retained and preserved for at least 15 years from completion of the Project where the Project includes a Study/Clinical Trial and otherwise for 5 years after the end of the Funding Agreement, and in accordance with any other regulatory requirements. The Sponsor of the Study agrees to enter into an agreement with each Study Site which governs the conduct of the Study at the Study Site and which enables the obligations under this Agreement to be met, including in relation to Intellectual Property in Study Materials. In the case of medicines, the Medicines Australia Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form (Medicines Australia CTRA) or substantially similar terms would fulfil this requirement. Where the Sponsor of the Study is not a Party, the Party subcontracting with the Sponsor of the Study agrees to pass on this requirement. Each Party agrees that, if any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Sponsor of the Study may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Sponsor of the Study must notify the (other) Parties and the Responsible HREC of the facts and circumstance giving rise to the requirement for the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the deviation is implemented. Each Party agrees that it is liable for its acts and omissions in relation to the conduct of the Study and must maintain such insurance policies as are reasonably available and necessary to provide indemnity to that Party in relation to any liability which it may incur in conducting the Study or performing its obligations under this Agreement. In carrying out the Project and using and managing the Funds, each Participating Institution agrees: to, and ensure that its Specified Personnel, abide by the terms and conditions of the NHMRC Funding Agreement, the Funding Policy and any Funding Conditions that apply to the Project, and all applicable NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals) to the extent that they relate to Participating Institutions; not to in any way impede or prevent the Eligible Organisation MH from complying with any of its obligations under the NHMRC Funding Agreement; and to do all things reasonably required to assist the Eligible Organisation MH to meet its obligations under the NHMRC Funding Agreement including reporting, compliance and financial management obligations relating to the Funding; and to require any subcontractor to comply with the applicable obligations of the Participating Institution under this Agreement and, where the subcontractor contributes to or creates Project outputs, to enter into a written subcontract with that subcontractor on terms consistent with this Agreement, including Intellectual Property obligations, any applicable requirements relating to working or contact with a Vulnerable Person or interaction with Children and, where applicable, EU Data Protection Legislation obligations.

Conduct of the Project. The Parties agree: that the conduct and management of the Project and the Funding must at all times be in accordance with the Linkage Program Funding Agreement and Funding Rules; that they have each received a copy of the Application Proposal and agree that the roles, budget, roles and contributions and program of research of each of the Parties in relation to the Project are set out accurately in the Application Proposal and this Agreement; that in the event of any inconsistency between the terms and conditions of this Agreement and the Linkage Program Funding Agreement, the Parties agree to amend the terms and conditions of this Agreement to the extent of such inconsistency; to each carry out their roles, responsibilities and program of research roles and provide their Project Cash Contributions and In-Kind Contributions as set out in this Agreement and in the Application or as varied from time to time with the prior approval of the Parties and Health (if required); to act in a manner that is consistent with, and enables the Eligible Organisation to give effect to, all of the Eligible Organisation’s obligations under the Funding Agreement; to conduct the Project in accordance with the NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals); to carry out the Project in an ethical, responsible, diligent and competent manner; to ensure that the Project is performed and completed within the Funding Period unless otherwise varied by the Funding Body having given reasonable advance written notice to the Eligible Organisation; to ensure that their Specified Personnel perform the Project in accordance with the Application Proposal and this Agreement; that the Project must conform to implement sound research governance procedures the principles outlined in respect of the Project, including cooperation in complying with the procedures for notification of Misconduct in accordance with the Misconduct Policy following and notification and management of breaches of the their successor documents (where applicable): NHMRC/ARC/UA Australian Code for the Responsible Conduct of Research (2018) and associated Guide to Managing and Investigating Breaches of the Australian Code for the Responsible Conduct of Research (20182007), ; as amended from time to time, and as specified in clause 17 of the Funding Agreement, including advising all Specified Personnel that their Personal Information may be disclosed to Health; to cooperate with each other in relation to any allegations of Misconduct or Research Misconduct; that any Institutional Approval, including statements of compliance and/or ethics clearance necessary for the performance of a Research Activity, where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until Institutional Approvals have been granted; that any requirements applicable to working or contact with a Vulnerable Person or interaction with Children necessary for the performance of a Research Activity (including under the National Principles for Child Safe Organisations), where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until these requirements have been met, in accordance with Sections H.1 and H.2 of Attachment 1 to the Schedule; to comply with the requirements of the Australian Privacy Principles under the Privacy Act 1988 (Cth) in relation to the use, collection, storage and security or disclosure of any personal and/or health information collected or used during the Project, and the Guidelines approved under Section 95A of the Privacy Act 1988 (2014) and the Guidelines under Section 95 of the Privacy Act 1988 (2014); to the extent that any Party is a Data Controller and another Party or Parties are a Data Processor (as those terms are defined under the EU Data Protection Legislation) in carrying out their roles, responsibilities and program of research under this Agreement, the Parties shall comply with all applicable requirements of the EU Data Protection Legislation in addition to their obligations under clause 2.1(l) and the Parties may enter into a separate legal agreement in respect of the processing of Personal Data subject to EU Data Protection Legislation; to maintain appropriate records of their involvement in the Project in accordance with clause 9 of the Funding Agreement; to cooperate with each other in providing information that the Eligible Organisation requires to compile the Reports required under clause 10 of the Funding Agreement and Section H.3 of Attachment 1 to the Schedule, in relation to the Project; to provide the Commonwealth with access specified in clause 12 of the Funding Agreement; that any Assets purchased with the Funds will be dealt with in accordance with clause 14 of the Funding Agreement; to use the MRFF logo and acknowledge the Funding from Health and include other acknowledgements consistently with the requirements of clause 21 of the Funding Agreement and Section H.4 of Attachment 1 to the Schedule. The Participating Institutions agree to notify the Eligible Organisation about any planned launch or media event relating to the Project to enable the Eligible Organisation to provide a reasonable opportunity for the Health Minister or their representative to attend; that Health is entitled to use information relating to the Project in accordance with clause 22 of the Funding Agreement; to notify the Eligible Organisation if any of the circumstances set out in clause 31.4 of the Funding Agreement arises; and to comply with any applicable statutes, regulations, by-laws and requirements of the Commonwealth and any State, Territory or local authority. Each Party agrees to: carry out its role in the Study (and ensure that any third parties it engages to undertake the Study agree to carry out their roles in the Study) in accordance with: the Protocol; any relevant Commonwealth and State or Territory laws and any requirements of Regulatory Authorities; the Note for Guidance on Good Clinical Practice (CPMPNHMRC/ICH/135/95) as adopted by the Therapeutic Goods Administration; the NHMRC ARC/UA National Statement on Ethical Conduct in Human Research (2007, updated 2015); as applicable, NHMRC Values and Ethics – Guidelines for Ethical conduct in Aboriginal and Xxxxxx Xxxxxx Islander Health Research (2003); as applicable, Australian Institute of Aboriginal and Xxxxxx Strait Islander Studies (AIATSIS) – updated May 2015 or its replacementGuidelines for Ethical Research in Australian Indigenous Studies (2012); as applicable, Australia Council for the Arts Indigenous Cultural Protocols for producing Indigenous Music; Writing; Visual Arts; Media Arts; and any other relevant NHMRC publication or guideline that relates to human researchPerforming Arts (2007); as applicable, the principles that have their origins in Australian Code for the Declaration care and use of Helsinki adopted animals for scientific purposes (2013) endorsed by the World Medical Association in October 1996 (as accepted by NHMRC, the Australian Government); ARC, the Commonwealth Scientific and Industrial Research Organisation and UA provided that if there is any reasonable direction given by conflict between a successor document and its predecessor, then the Sponsor successor document prevails to the extent of any inconsistency. All Parties shall at all times comply with the Studyrequirements of all applicable laws including the Disability Discrimination Xxx 0000 and the Racial Discrimination Act 1975 and shall not treat any person or group of people less favourably than another on the grounds of race, where the Party is not the Sponsor colour, religion, ethnicity, sex, age, disability, nationality, marital status or sexual orientation. The Administering Organisation and each Other Eligible Organisation acknowledge and agree that they are each responsible for notification of the Study, in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements, including any condition of a Responsible HREC; keep all Biological Samples which are the subject or outcome of the Study in appropriate storage conditions in areas accessible only to authorised personnel; maintain complete and current records (including data and reports) in relation to its performance of the Study; and ensure that records are retained and preserved for at least 15 years from completion of the Project where the Project includes a Study/Clinical Trial and otherwise for 5 years after the end of the Funding Agreement, and research integrity matters in accordance with any other regulatory requirements. The Sponsor the ARC Research Integrity and Research Misconduct Policy, and investigation and management of breaches of the Study agrees to enter into an agreement with each Study Site which governs NHMRC/ARC/UA Australian Code for the conduct Responsible Conduct of the Study at the Study Site and which enables the obligations under this Agreement to be met, including Research (2007) in relation to Intellectual Property in Study Materials. In the case of medicines, the Medicines Australia Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form (Medicines Australia CTRA) or substantially similar terms would fulfil this requirement. Where the Sponsor of the Study is not a Party, the Party subcontracting accordance with the Sponsor of the Study agrees to pass on this requirementCode. Each Party agrees that, if any issue relating to is responsible for the safety investigation and management of Study Participants arises which requires a deviation from the Protocol, the Sponsor breaches of the Study Code in accordance with the Code. The Collaborating Organisations agree not to do or omit to do anything that may immediately make such a deviation without breaching any cause the Administering Organisation to be in breach of the Administering Organisations obligations under this Agreementthe Linkage Program Funding Agreement and Funding Rules. If there is a need for such a deviation the Sponsor of the Study must notify the (other) Parties and the Responsible HREC of the facts and circumstance giving rise The Collaborating Organisations agree to the requirement for the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the deviation is implemented. Each Party agrees that it is liable for its acts and omissions in relation to the conduct of the Study and must maintain such insurance policies as are reasonably available and necessary to provide indemnity to that Party in relation to any liability which it may incur in conducting the Study or performing its obligations under this Agreement. In carrying out the Project and using and managing the Funds, each Participating Institution agrees: to, and ensure that its Specified Personnel, abide by the terms and conditions of the Linkage Program Funding Agreement, the Agreement and Funding Policy Rules and any Funding Conditions that apply to the Project, and all applicable NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals) to the extent that they relate to Participating Institutions; not to in any way impede or prevent the Eligible Organisation from complying with any of its obligations under the Funding Agreement; to do all things reasonably required to assist enable the Eligible Administering Organisation to meet its obligations under the Linkage Program Funding Agreement including reportingand the Funding Rules, compliance including, without limitation, reporting and financial management obligations relating to of the Funding, Cash Contributions and In-kind Contributions; compliance with the ARC Open Access Policy to satisfy the requirements of clause 22.4 and clause 22.5 of the Linkage Program Funding Agreement; and to require any subcontractor to comply compliance with the applicable obligations ARC Research Integrity and Research Misconduct Policy to satisfy the requirements of clause 34.1 and 34.2 of the Participating Institution Linkage Program Funding Agreement. The Parties will cooperate with each other with respect to any allegations of Research Misconduct in respect of the Project. A Collaborating Organisation must notify the Administering Organisation if findings of Research Misconduct are made against any of its personnel or Students involved in the conduct of the Project and the Administering Organisation will make all notifications required under this Agreement andthe ARC Research Integrity and Research Misconduct Policy. The Parties acknowledge that research work is of its nature uncertain, where and that particular outcomes and results from the subcontractor contributes to or creates Project outputs, to enter into a written subcontract with that subcontractor on terms consistent with this Agreement, including Intellectual Property obligations, any applicable requirements relating to working or contact with a Vulnerable Person or interaction with Children and, where applicable, EU Data Protection Legislation obligationscannot be guaranteed.

Conduct of the Project. The Parties agree: that they have each received a copy of the Application and agree that the roles, budget, contributions and program of research of each of the Parties in relation to the Project are set out accurately in the Application and this Agreement; to each carry out their roles, responsibilities and program of research and provide their Project Contributions as set out in this Agreement and in the Application or as varied from time to time with the prior approval of the Parties and Health the NHMRC (if required); to act in a manner that is consistent with, and enables the Eligible Organisation Administering Institution to give effect to, all of the Eligible OrganisationAdministering Institution’s obligations under the Funding NHMRC Agreement; to conduct the Project in accordance with the NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals); to carry out the Project in an ethical, responsible, diligent and competent manner; to ensure that the Project is performed and completed within the Funding Period unless otherwise varied by the Funding Body NHMRC having given reasonable advance written notice to the Eligible OrganisationAdministering Institution; to ensure that their Specified Personnel perform the Project in accordance with the Application and this Agreement; to implement sound research governance procedures in respect of the Project, including cooperation in complying with the procedures for notification of Misconduct in accordance with the NHMRC’s Misconduct Policy and notification and management of breaches of the Australian Code for the Responsible Conduct of Research (2018) and associated Guide to Managing and Investigating Breaches of the Australian Code for the Responsible Conduct of Research (20182007), as amended from time to time, and as specified in clause 17 of the Funding Agreement, including advising all Specified Personnel that their Personal Information may be disclosed to Health; to cooperate with each other in relation to any allegations of Misconduct or Research Misconduct; that any Institutional Approval, including statements of compliance and/or ethics clearance necessary for the performance of a Research Activity, Activity where applicable, applicable must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until Institutional Approvals have been granted; that any requirements applicable to working or contact with a Vulnerable Person or interaction with Children necessary for the performance of a Research Activity (including under the National Principles for Child Safe Organisations), where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until these requirements have been met, in accordance with Sections H.1 and H.2 of Attachment 1 to the Schedule; to comply with the requirements of the Privacy Xxx 0000 (Cth) and the Australian Privacy Principles under the Privacy that Act 1988 (Cth) in relation to the use, collection, storage and security or disclosure of any personal and/or health information collected or used during the Project, and including the Guidelines approved under Section 95A of the Privacy Act 1988 Xxx 0000 (2014) and the Guidelines under Section 95 of the Privacy Act 1988 Xxx 0000 (2014); to the extent that any Party is a Data Controller and another Party or Parties are a Data Processor (as those terms are defined under the EU Data Protection Legislation) in carrying out their roles, responsibilities and program of research under this Agreement, the Parties shall comply with all applicable requirements of the EU Data Protection Legislation in addition to their obligations under clause 2.1(l) and the Parties may enter into a separate legal agreement in respect of the processing of Personal Data subject to EU Data Protection Legislation; to maintain appropriate records of their involvement in the Project in accordance with clause 9 8 of the NHMRC Funding Agreement; to cooperate with each other in providing information that the Eligible Organisation Administering Institution requires to compile the Reports required under clause 10 9 of the NHMRC Funding Agreement and Section H.3 of Attachment 1 to the Schedule, in relation to the Project; to provide the Commonwealth with access specified in clause 12 11 of the NHMRC Funding Agreement; that any Assets purchased with the Funds will be dealt with in accordance with clause 14 13 of the NHMRC Funding Agreement; to use the MRFF NHMRC logo and acknowledge the Funding from Health and include other acknowledgements consistently with the requirements of clause 21 20 of the NHMRC Funding Agreement and Section H.4 of Attachment 1 to the Schedule. The Participating Institutions agree to notify the Eligible Organisation about any planned launch or media event relating to the Project to enable the Eligible Organisation to provide a reasonable opportunity for the Health Minister or their representative to attendAgreement; that Health the NHMRC is entitled to use information relating to the Project in accordance with clause 22 21 of the NHMRC Funding Agreement; to notify the Eligible Organisation Administering Institution if any of the circumstances set out in clause 31.4 30.4 of the NHMRC Funding Agreement arises; to give effect to clauses 36 and 37 of the NHMRC Funding Agreement if those clauses apply to the Project; and to comply with any applicable statutesstatues, regulations, by-laws and requirements of the Commonwealth and any State, Territory or local authority. Each Party agrees to: carry out its role in the Study (and ensure that any third parties it engages to undertake the Study agree to carry out their roles in the Study) in accordance with: the Protocol; any relevant Commonwealth and State or Territory laws and any requirements of Regulatory Authorities; the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted by the Therapeutic Goods Administration; the NHMRC National Statement on Ethical Conduct in Human Research (2007) – updated May 2015 or its replacement, and any other relevant NHMRC publication or guideline that relates to human research; 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 any reasonable direction given by the Sponsor of the Study, where the Party is not the Sponsor of the Study, in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements, including any condition of a Responsible HREC; keep all Biological Samples which are the subject or outcome of the Study in appropriate storage conditions in areas accessible only to authorised personnel; maintain complete and current records (including data and reports) in relation to its performance of the Study; and ensure that records are retained and preserved for at least 15 years from completion of the Project where the Project includes a Study/Clinical Trial and otherwise for 5 years after the end of the Funding Agreement, and in accordance with any other regulatory requirements. The Sponsor of the Study agrees to enter into an agreement with each Study Site which governs the conduct of the Study at the Study Site and which enables the obligations under this Agreement to be met, including in relation to Intellectual Property in Study Materials. In the case of medicines, the Medicines Australia Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form (Medicines Australia CTRA) or substantially similar terms would fulfil this requirement. Where the Sponsor of the Study is not a Party, the Party subcontracting with the Sponsor of the Study agrees to pass on this requirement. Each Party agrees that, if any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Sponsor of the Study may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Sponsor of the Study must notify the (other) Parties and the Responsible HREC of the facts and circumstance giving rise to the requirement for the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the deviation is implemented. Each Party agrees that it is liable for its acts and omissions in relation to the conduct of the Study and must maintain such insurance policies as are reasonably available and necessary to provide indemnity to that Party in relation to any liability which it may incur in conducting the Study or performing its obligations under this Agreement. In carrying out the Project and using and managing the Funds, each Participating Institution agrees: to, and ensure that its Specified Personnel, abide by the terms and conditions of the NHMRC Funding Agreement, the NHMRC Funding Policy and any Funding Conditions that apply to the Project, and all applicable NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals) to the extent that they relate to Participating Institutions; not to in any way impede or prevent the Eligible Organisation Administering Institution from complying with any of its obligations under the NHMRC Funding Agreement; and to do all things reasonably required to assist the Eligible Organisation Administering Institution to meet its obligations under the NHMRC Funding Agreement including reporting, compliance and financial management obligations relating to the Funding; and Funding and, to require any subcontractor to comply with the applicable obligations of the Participating Institution under this Agreement and, where the subcontractor contributes to or creates Project outputs, to enter into a written subcontract with that subcontractor on terms consistent with this Agreement, including Intellectual Property obligations, any applicable requirements relating to working or contact with a Vulnerable Person or interaction with Children and, where applicable, EU Data Protection Legislation obligations.

Conduct of the Project. The Parties agree: Application of Part B This Part B applies if the schedule specifies that they have each received a copy the Participant is to conduct all or part of the Application and agree that Project. Appointment MLA appoints the roles, budget, contributions and program of research of each of the Parties in relation Participant to the Project are set out accurately in the Application and this Agreement; to each carry out their roles, responsibilities and program of research and provide their Project Contributions as set out in this Agreement and in the Application or as varied from time to time with the prior approval of the Parties and Health (if required); to act in a manner that is consistent with, and enables the Eligible Organisation to give effect to, all of the Eligible Organisation’s obligations under the Funding Agreement; to conduct the Project in accordance with the NHMRC Approved Standards Milestones and Guidelines (the Budget on the terms set out in this Agreement, and the Participant accepts the appointment. Obligations of the Participant Conduct of the Project The Participant must conduct the Project: in accordance with all relevant laws and regulations and any applicable industry standards or guidelines, including obtainingapplicable Ethics Laws; in accordance with the Milestones and the Budget and otherwise in compliance with the requirements set out in the schedule; in accordance with MLA Policies and all reasonable and lawful directions of MLA from time to time concerning the Project; to the best of its skill and ability; and using appropriately qualified, maintaining competent and complying skilled personnel necessary for the proper conduct of the Project. Without limiting the Participant's obligations under this clause 7, the Participant must, in conducting the Project: only apply the Funds and the Assets for the purposes of the Project and in accordance with the Budget and the Milestones; not vary the Project, the Budget or the Milestones without MLA’s prior written consent; not conduct any Institutional Approvals); work under the Project if the Participant is required to obtain approvals or licences under applicable Ethics Laws in order to carry out the Project in an ethicalProject, responsible, diligent until that approval or consent has been obtained; cooperate and competent mannerregularly liaise with MLA and any consultant engaged by MLA; not apply the Funds to ensure that the Project is performed and completed within the Funding Period unless otherwise varied by the Funding Body having given reasonable advance written notice to the Eligible Organisation; to ensure that their Specified Personnel perform the Project in accordance with the Application and this Agreement; to implement sound research governance procedures in respect Agri-Political Activities nor conduct any Agri-Political Activities as part of the Project; and as requested by MLA, including cooperation in complying with the procedures for notification of Misconduct in accordance with the Misconduct Policy and notification and management of breaches provide reasonable details of the Australian Code Participant’s proposed course of action and strategies, for the Responsible Conduct purpose of Research (2018) and associated Guide enabling MLA to Managing and Investigating Breaches of the Australian Code for the Responsible Conduct of Research (2018), as amended from time to time, and as specified in clause 17 of the Funding Agreement, including advising all Specified Personnel that their Personal Information may be disclosed to Health; to cooperate with each other in relation to any allegations of Misconduct or Research Misconduct; that any Institutional Approval, including statements of compliance and/or ethics clearance necessary for review the performance of a Research Activity, where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until Institutional Approvals have been granted; that any requirements applicable to working or contact with a Vulnerable Person or interaction with Children necessary for the performance of a Research Activity (including under the National Principles for Child Safe Organisations), where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until these requirements have been met, in accordance with Sections H.1 and H.2 of Attachment 1 to the Schedule; to comply with the requirements of the Australian Privacy Principles under the Privacy Act 1988 (Cth) in relation to the use, collection, storage and security or disclosure of any personal and/or health information collected or used during the Project, and the Guidelines approved under Section 95A of the Privacy Act 1988 (2014) and the Guidelines under Section 95 of the Privacy Act 1988 (2014); to the extent that any Party is a Data Controller and another Party or Parties are a Data Processor (as those terms are defined under the EU Data Protection Legislation) in carrying out their roles, responsibilities and program of research under this Agreement, the Parties shall comply with all applicable requirements of the EU Data Protection Legislation in addition to their obligations under clause 2.1(l) and the Parties may enter into a separate legal agreement in respect of the processing of Personal Data subject to EU Data Protection Legislation; to maintain appropriate records of their involvement in the Project in accordance with clause 9 of the Funding Agreement; to cooperate with each other in providing information that the Eligible Organisation requires to compile the Reports required under clause 10 of the Funding Agreement and Section H.3 of Attachment 1 to the Schedule, in relation to the Project; to provide the Commonwealth with access specified in clause 12 of the Funding Agreement; that any Assets purchased with the Funds will be dealt with in accordance with clause 14 of the Funding Agreement; to use the MRFF logo and acknowledge the Funding from Health and include other acknowledgements consistently with the requirements of clause 21 of the Funding Agreement and Section H.4 of Attachment 1 to the Schedule. The Participating Institutions agree to notify the Eligible Organisation about any planned launch or media event relating to the Project to enable the Eligible Organisation to provide a reasonable opportunity for the Health Minister or their representative to attend; that Health is entitled to use information relating to the Project in accordance with clause 22 of the Funding Agreement; to notify the Eligible Organisation if any of the circumstances set out in clause 31.4 of the Funding Agreement arises; and to comply with any applicable statutes, regulations, by-laws and requirements of the Commonwealth and any State, Territory or local authority. Each Party agrees to: carry out its role in the Study (and ensure that any third parties it engages to undertake the Study agree to carry out their roles in the Study) in accordance with: the Protocol; any relevant Commonwealth and State or Territory laws and any requirements of Regulatory Authorities; the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted by the Therapeutic Goods Administration; the NHMRC National Statement on Ethical Conduct in Human Research (2007) – updated May 2015 or its replacement, and any other relevant NHMRC publication or guideline that relates to human research; 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 any reasonable direction given by the Sponsor of the Study, where the Party is not the Sponsor of the Study, in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements, including any condition of a Responsible HREC; keep all Biological Samples which are the subject or outcome of the Study in appropriate storage conditions in areas accessible only to authorised personnel; maintain complete and current records (including data and reports) in relation to its performance of the Study; and ensure that records are retained and preserved for at least 15 years from completion of the Project where the Project includes a Study/Clinical Trial and otherwise for 5 years after the end of the Funding Agreement, and in accordance with any other regulatory requirements. The Sponsor of the Study agrees to enter into an agreement with each Study Site which governs the conduct of the Study at the Study Site and which enables the obligations under this Agreement to be met, including in relation to Intellectual Property in Study Materials. In the case of medicines, the Medicines Australia Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form (Medicines Australia CTRA) or substantially similar terms would fulfil this requirement. Where the Sponsor of the Study is not a Party, the Party subcontracting with the Sponsor of the Study agrees to pass on this requirement. Each Party agrees that, if any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Sponsor of the Study may immediately make such a deviation without breaching any Participant’s obligations under this Agreement. If there is a need for such a deviation the Sponsor of the Study must notify the (other) Parties and the Responsible HREC of the facts and circumstance giving rise to the requirement for the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the deviation is implemented. Each Party agrees that it is liable for its acts and omissions in relation to the conduct of the Study and must maintain such insurance policies as are reasonably available and necessary to provide indemnity to that Party in relation to any liability which it may incur in conducting the Study or performing its obligations under this Agreement. In carrying out the Project and using and managing the Funds, each Participating Institution agrees: to, and ensure that its Specified Personnel, abide by the terms and conditions of the Funding Agreement, the Funding Policy and any Funding Conditions that apply to the Project, and all applicable NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals) to the extent that they relate to Participating Institutions; not to in any way impede or prevent the Eligible Organisation from complying with any of its obligations under the Funding Agreement; to do all things reasonably required to assist the Eligible Organisation to meet its obligations under the Funding Agreement including reporting, compliance and financial management obligations relating to the Funding; and to require any subcontractor to comply with the applicable obligations of the Participating Institution under this Agreement and, where the subcontractor contributes to or creates Project outputs, to enter into a written subcontract with that subcontractor on terms consistent with this Agreement, including Intellectual Property obligations, any applicable requirements relating to working or contact with a Vulnerable Person or interaction with Children and, where applicable, EU Data Protection Legislation obligations.

Conduct of the Project. The Parties agree: that the management of the Project and the Funding will at all times be in accordance with the DIN Research Agreement; that they have each received a copy of the Application Proposal and agree that the roles, budget, contributions contributions, and program of research of each of the Parties in relation to the Project are set out accurately in the Application Proposal and this Agreementagreement; to each carry out their roles, responsibilities contributions and program of research and provide their Project Contributions as set out in the Proposal and this agreement; perform their obligations under this Agreement in a diligent and competent manner in accordance with the terms of this Agreement and in compliance with all relevant laws and regulations applicable to the Application or as varied from time to time with the prior approval conduct of the Parties and Health (if required)Project; to act in a manner that is consistent with, and enables the Eligible Organisation to give effect to, all of the Eligible Organisation’s obligations under the Funding Agreement; to conduct the Project in accordance with the NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals); each use reasonable endeavours to carry out the Project within any timeframes specified in an ethicalthe Proposal; provide such assistance, responsibleinformation, diligent data, equipment, resources or materials to the other Parties as may be reasonably required to satisfactorily carry out the Project; contribute its respective Specified Personnel to conduct the Project; and competent manner; to ensure that the Project is performed and completed within the Funding Period unless otherwise varied by the Funding Body having given reasonable advance written notice will conform to the Eligible Organisation; to ensure that principles outlined in the following and their Specified Personnel perform the Project in accordance with the Application and this Agreement; to implement sound research governance procedures in respect of the Project, including cooperation in complying with the procedures for notification of Misconduct in accordance with the Misconduct Policy and notification and management of breaches of successor documents (where applicable): the Australian Code for the Responsible Conduct of Research (2018) and associated Guide to Managing and Investigating Breaches of the Australian Code for the Responsible Conduct of Research (20182007), . as amended from time to time, and as specified in clause 17 of the Funding Agreement, including advising all Specified Personnel that their Personal Information may be disclosed to Health; to cooperate with each other in relation to any allegations of Misconduct or Research Misconduct; that any Institutional Approval, including statements of compliance and/or ethics clearance necessary for the performance of a Research Activity, where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until Institutional Approvals have been granted; that any requirements applicable to working or contact with a Vulnerable Person or interaction with Children necessary for the performance of a Research Activity (including under the National Principles for Child Safe Organisations), where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until these requirements have been met, in accordance with Sections H.1 and H.2 of Attachment 1 to the Schedule; to comply with the requirements of the Australian Privacy Principles under the Privacy Act 1988 (Cth) in relation to the use, collection, storage and security or disclosure of any personal and/or health information collected or used during the Project, and the Guidelines approved under Section 95A of the Privacy Act 1988 (2014) and the Guidelines under Section 95 of the Privacy Act 1988 (2014); to the extent that any Party is a Data Controller and another Party or Parties are a Data Processor (as those terms are defined under the EU Data Protection Legislation) in carrying out their roles, responsibilities and program of research under this Agreement, the Parties shall comply with all applicable requirements of the EU Data Protection Legislation in addition to their obligations under clause 2.1(l) and the Parties may enter into a separate legal agreement in respect of the processing of Personal Data subject to EU Data Protection Legislation; to maintain appropriate records of their involvement in the Project in accordance with clause 9 of the Funding Agreement; to cooperate with each other in providing information that the Eligible Organisation requires to compile the Reports required under clause 10 of the Funding Agreement and Section H.3 of Attachment 1 to the Schedule, in relation to the Project; to provide the Commonwealth with access specified in clause 12 of the Funding Agreement; that any Assets purchased with the Funds will be dealt with in accordance with clause 14 of the Funding Agreement; to use the MRFF logo and acknowledge the Funding from Health and include other acknowledgements consistently with the requirements of clause 21 of the Funding Agreement and Section H.4 of Attachment 1 to the Schedule. The Participating Institutions agree to notify the Eligible Organisation about any planned launch or media event relating to the Project to enable the Eligible Organisation to provide a reasonable opportunity for the Health Minister or their representative to attend; that Health is entitled to use information relating to the Project in accordance with clause 22 of the Funding Agreement; to notify the Eligible Organisation if any of the circumstances set out in clause 31.4 of the Funding Agreement arises; and to comply with any applicable statutes, regulations, by-laws and requirements of the Commonwealth and any State, Territory or local authority. Each Party agrees to: carry out its role in the Study (and ensure that any third parties it engages to undertake the Study agree to carry out their roles in the Study) in accordance with: the Protocol; any relevant Commonwealth and State or Territory laws and any requirements of Regulatory Authorities; the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted by the Therapeutic Goods Administration; the NHMRC National Statement on Ethical Conduct in Human Research (2007, updated 2015); as applicable, the Australian Code for the care and use of animals for scientific purposes (2013) – updated May 2015 or its replacement, and any other relevant NHMRC publication or guideline that relates to human research; the principles that have their origins in the Declaration of Helsinki adopted endorsed by the World Medical Association in October 1996 (as accepted by NHMRC, the Australian Government); DIN, the Commonwealth Scientific and any reasonable direction given by Industrial Research Organisation and UA. All Parties shall at all times comply with the Sponsor requirements of the StudyDisability Discrimination Act 1992 and the Racial Discrimination Act 1975 and shall not treat any person or group of people less favourably than another on the grounds of race, where colour, religion, ethnicity, sex, age, disability, nationality, marital status or sexual orientation. The Collaborating Organisation agree not to do or omit to do anything that may cause the Party is not the Sponsor Administering Organisation to be in breach of the Study, in order to ensure Administering Organisation’s obligations under the safe conduct of the Study and compliance with applicable regulatory requirements, including any condition of a Responsible HREC; keep all Biological Samples which are the subject or outcome of the Study in appropriate storage conditions in areas accessible only to authorised personnel; maintain complete and current records (including data and reports) in relation to its performance of the Study; and ensure that records are retained and preserved for at least 15 years from completion of the Project where the Project includes a Study/Clinical Trial and otherwise for 5 years after the end of the Funding DIN Research Agreement, and in accordance with any other regulatory requirements. The Sponsor of the Study agrees Collaborating Organisation agree to enter into an agreement with each Study Site which governs the conduct of the Study at the Study Site and which enables the obligations under this Agreement to be met, including in relation to Intellectual Property in Study Materials. In the case of medicines, the Medicines Australia Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form (Medicines Australia CTRA) or substantially similar terms would fulfil this requirement. Where the Sponsor of the Study is not a Party, the Party subcontracting with the Sponsor of the Study agrees to pass on this requirement. Each Party agrees that, if any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Sponsor of the Study may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Sponsor of the Study must notify the (other) Parties and the Responsible HREC of the facts and circumstance giving rise to the requirement for the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the deviation is implemented. Each Party agrees that it is liable for its acts and omissions in relation to the conduct of the Study and must maintain such insurance policies as are reasonably available and necessary to provide indemnity to that Party in relation to any liability which it may incur in conducting the Study or performing its obligations under this Agreement. In carrying out the Project and using and managing the Funds, each Participating Institution agrees: to, and ensure that its Specified Personnel, abide by the terms and conditions of the Funding Agreement, the Funding Policy DIN Research Agreement and any Funding Conditions that apply to the Project, and all applicable NHMRC Approved Standards and Guidelines (including obtaining, maintaining and complying with any Institutional Approvals) to the extent that they relate to Participating Institutions; not to in any way impede or prevent the Eligible Organisation from complying with any of its obligations under the Funding Agreement; to do all things reasonably required to assist enable the Eligible Administering Organisation to meet its obligations under the Funding DIN Research Agreement including reporting, compliance regarding reporting and financial management of the Funding. If a Party’s Specified Personnel becomes unavailable to complete its obligations under this Agreement, then that Party must: notify the other Parties immediately; and use best endeavours to appoint another person with sufficient skill, qualifications and time to complete that Party’s obligations under this Agreement. Nothing in this Agreement prevents a Party from pursuing other collaborative opportunities with third parties relating to the Funding; and to require any subcontractor to comply with the applicable obligations subject matter of the Participating Institution under this Agreement andProject, where provided always that such collaborative opportunities do not create a conflict of interest in the subcontractor contributes to or creates Project outputs, to enter into a written subcontract with that subcontractor on terms consistent with this Agreement, including Intellectual Property obligations, any applicable requirements relating to working or contact with a Vulnerable Person or interaction with Children and, where applicable, EU Data Protection Legislation obligationsperformance of the Project.

Conduct of the Project. The Parties agree: that they have each received a copy of the Application and agree that the roles, budget, contributions and program of research of each of the Parties in relation to the Project are set out accurately in the Application and this Agreement; to each carry out their roles, responsibilities and program of research and provide their Project Contributions as set out in this Agreement and in the Application or as varied from time to time with the prior approval of the Parties and Health the NHMRC (if required); to act in a manner that is consistent with, and enables the Eligible Organisation Administering Institution to give effect to, all of the Eligible OrganisationAdministering Institution’s obligations under the Funding NHMRC Agreement; to conduct the Project in accordance with the NHMRC Approved Standards Standards, Guidelines and Guidelines any applicable NHMRC policies (including obtaining, maintaining and complying with any Institutional Approvals); to carry out the Project in an ethical, responsible, diligent and competent manner; to ensure that the Project is performed and completed within the Funding Period unless otherwise varied by the NHMRC in accordance with the NHMRC Funding Body having given reasonable advance written notice to the Eligible OrganisationAgreement; to ensure that their Specified Personnel perform the Project in accordance with the Application and this Agreement; to implement sound research governance procedures in respect of the Project, including cooperation in complying with the procedures for notification of Misconduct in accordance with the Misconduct Policy and notification and management of breaches or potential breaches of the Australian Code for the Responsible Conduct of Research (2018) in accordance with the NHMRC’s Integrity Policy, and associated Guide to Managing and Investigating Breaches of the Australian Code for the Responsible Conduct of Research (2018), as amended from time to time, and as specified in clause 17 of the Funding Agreement, including advising all Specified Personnel that their Personal Information may be disclosed to Health; to cooperate with each other in relation to any complaints or allegations about potential breaches of Misconduct or the Australian Code for the Responsible Conduct of Research (2018), including Research Misconduct; that any Institutional Approval, including statements of compliance and/or ethics clearance necessary for the performance of a Research Activity, Activity where applicable, applicable must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until Institutional Approvals have been granted; that any requirements applicable to working or contact with a Vulnerable Person or interaction with Children necessary for the performance of a Research Activity (including under the National Principles for Child Safe Organisations), where applicable, must be obtained prior to the commencement of that Research Activity and any associated Funding must not be expended until these requirements have been met, in accordance with Sections H.1 and H.2 of Attachment 1 to the Schedule; to comply with the requirements of the Australian Privacy Principles under the Privacy Act 1988 (Cth) and such other relevant laws or regulations prevailing in the jurisdiction in which the Study is being undertaken or in which the Administering Institution or a Participating Institution is located in relation to the use, collection, storage and security or disclosure of any personal and/or health information collected or used during the Project, and the Guidelines approved under Section 95A of the Privacy Act 1988 (2014) and the Guidelines under Section 95 of the Privacy Act 1988 (2014); to the extent that any Party is a Data Controller and another Party or Parties are a Data Processor (as those terms are defined under the EU Data Protection Legislation) in carrying out their roles, responsibilities and program of research under this Agreement, the Parties shall comply with all applicable requirements of the EU Data Protection Legislation in addition Protection; not to their use any form of child labour, bonded labour, forced labour nor other forms of slavery or slavery-like conditions or human trafficking, and to abide by all other obligations under clause 2.1(l) and the Parties may enter into a separate legal agreement in respect of the processing of Personal Data subject to EU Data Protection Legislationany applicable anti-slavery legislation; to maintain appropriate records of their involvement in the Project in accordance with clause 9 8 of the NHMRC Funding Agreement; to cooperate with each other in providing information that the Eligible Organisation Administering Institution requires to compile the Reports required under clause 10 9 of the NHMRC Funding Agreement and Section H.3 of Attachment 1 to the Schedule, in relation to the Project; to provide the Commonwealth with access specified in clause 12 11 of the NHMRC Funding Agreement; that any Assets purchased with the Funds will be dealt with in accordance with clause 14 13 of the NHMRC Funding Agreement; to use the MRFF NHMRC logo and acknowledge the Funding from Health and include other acknowledgements consistently with the requirements of clause 21 20 of the NHMRC Funding Agreement and Section H.4 of Attachment 1 to the Schedule. The Participating Institutions agree to notify the Eligible Organisation about any planned launch or media event relating to the Project to enable the Eligible Organisation to provide a reasonable opportunity for the Health Minister or their representative to attendAgreement; that Health the NHMRC is entitled to use information relating to the Project in accordance with clause 22 21 of the NHMRC Funding Agreement; to notify the Eligible Organisation Administering Institution if any of the circumstances set out in clause 31.4 of the NHMRC Funding Agreement arises; and to comply with any applicable statutes, regulations, by-laws and requirements of the Commonwealth and any State, Territory or local authority. Each Party agrees to: carry out its role in the Study (and ensure that any third parties it engages to undertake the Study agree to carry out their roles in the Study) in accordance with: the Protocol; any relevant Commonwealth and State or Territory laws and any requirements of Regulatory Authorities; the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted by the Therapeutic Goods Administration; the NHMRC National Statement on Ethical Conduct in Human Research (2007) – updated May 2015 2018 or its replacement, and any other relevant NHMRC publication or guideline that relates to human research; 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 any reasonable direction given by the Sponsor of the Study, where the Party is not the Sponsor of the StudySponsor, in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements, including any condition of a Responsible HREC; ensure that any personal information arising from the Study regarding Study Participants or the personnel involved in the Study is collected, stored, used and disclosed in accordance with the Privacy Act 1988 (Cth) and any other legislation, code or guideline which applies to the Party and relates to the protection of personal information; keep all Biological Samples which are the subject or outcome of the Study in appropriate storage conditions in areas accessible only to authorised personnel; maintain complete and current records (including data and reports) in relation to its performance of the Study; that it will not involve in the Project any of its personnel (including any personnel of its subcontractors) who have been found to have engaged in Misconduct related to NHMRC Funding within the last 3 years; and ensure that records are retained and preserved for at least 15 years from completion of the Project where the Project includes a Study/Clinical Trial and otherwise for 5 years after the end of the Funding Agreement, and in accordance with any other regulatory requirementsProject. The Party which is the Sponsor of the Study agrees to (or, where the Sponsor of the Study is not a Party, the Party which takes responsibility for entering into an agreement with the Sponsor of the Study will ensure that the Sponsor of the Study agrees to): ensure that the Study is registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) or equivalent before recruitment of the first Study Participant; and enter into an agreement with each Study Site which governs the conduct of the Study at the Study Site and which enables the obligations under this Agreement to be metwhich, including in relation to Intellectual Property in Study Materials. In the case of medicines, would be substantially in the terms of the Medicines Australia Clinical Trial Research Agreement - Collaborative or Cooperative Research Group (CRG) Studies – Standard Form (Medicines Australia CTRA) or, in the case of medical devices or software as a medical device, would be substantially similar in the terms would fulfil this requirement. Where the Sponsor of the Study is not MTAA CTRA [, including the Schedule 4 Special Terms for clinical trials funded under the NHMRC Funding Agreement, which have been approved for the University of Sydney by the Southern and Eastern Border States (SEBS) - Queensland, New South Wales, Victoria and South Australia, which are attached as Annexure 1 of this Agreement, or in the case of medical devices or software as a Party, medical device will be substantially in the Party subcontracting with the Sponsor terms of the Study agrees to pass on this requirementequivalent MTAA CTRA terms]. Each Party agrees that, if any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Sponsor of the Study may immediately make such a deviation without breaching any obligations under this Agreement. If there is a need for such a deviation the Sponsor of the Study must notify the (other) other Party/Parties and the Responsible Reviewing HREC of the facts and circumstance giving rise to the requirement for the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the deviation is implemented. Each Party agrees that it is liable for its acts and omissions in relation to the conduct of the Study and must maintain such insurance policies as are reasonably available and necessary to provide indemnity to that Party in relation to any liability which it may incur in conducting the Study or performing its obligations under this Agreement. In carrying out the Project and using and managing the Funds, each Participating Institution agrees: to, and ensure that its Specified Personnel, abide by the terms and conditions of the NHMRC Funding Agreement, the NHMRC Funding Policy and any Funding Conditions that apply to the Project, and all applicable NHMRC Approved Standards and Guidelines (including the Grant Guidelines, and obtaining, maintaining and complying with any Institutional Approvals) to the extent that they relate to Participating Institutions; to provide reasonably requested assistance to the Administering Institution for the purposes of enabling the Administering Institution to report to the NHMRC against milestones and performance indicators as required under section 12.2.4 of the Grant Guidelines; not to in any way impede or prevent the Eligible Organisation Administering Institution from complying with any of its obligations under the NHMRC Funding Agreement; and to do all things reasonably required to assist the Eligible Organisation Administering Institution to meet its obligations under the NHMRC Funding Agreement including reporting, compliance and financial management obligations relating to the Funding; and Funding and, to require any subcontractor to comply with the applicable obligations of the Participating Institution under this Agreement and, where the subcontractor contributes to or creates Project outputs, to enter into a written subcontract with that subcontractor on terms consistent with this Agreement, including Intellectual Property obligations, any applicable requirements relating to working or contact with a Vulnerable Person or interaction with Children obligations and, where applicable, EU Data Protection Legislation obligations.