Clinical Trial Research Agreement

Transcription

1 Agreement Drafting note: No changes should be made to the body of this agreement. Any additional provisions or amendments to the body of the agreement must be made by including Special Conditions in Schedule 7. Clinical Trial Research Agreement [Insert Institution name] JDRF Australia

2 Contents Table of contents 1 Definitions 2 2 The study Conduct of Study Deviation from Protocol for safety reasons Other changes to Protocol Study timetable Principal Investigator Role of Principal Investigator Liability for Principal Investigator Obligations and responsibilities Institution obligations and responsibilities Replacement of Principal Investigator Institution to perform Professional qualifications Conflicts and compliance Security Audit Resources for Study Study Materials Oversight of Reviewing HREC Regulatory Authorities Approval for Public Relations Information regarding Investigational Product Institution as Sponsor Quality control and data capture Adverse event reporting Investigational product 12 6 Payment of Funds Milestones GST Deferral or reduction of payments Payment of Funds only Use of Funds Reporting Interim reports Final Report Other reporting Post-End Date reporting Network 16 9 Funding Agreement Copy of Funding Agreement provided Institution s undertakings Version November 2014 Clinical Trial Research Agreement Contents 1

3 Contents 9.3 Pass-through provisions pursuant to Funding Agreement Conflicts of interest Confidentiality Privacy Liability and insurance Publications Acknowledgement Study results and intellectual property Term and termination Disputes Assignment Subcontracting Force majeure Conflict Notices Form of Notice How Notice must be given and when Notice is received Notice must not be given by electronic communication General Governing law and jurisdiction Invalidity and enforceability Waiver Variation Further action to be taken at each party s own expense Entire agreement No reliance Counterparts Relationship of the parties Interpretation Interpretation of inclusive expressions Business Day Agreement components Special Conditions 28 Schedule 1 Notice details 29 Schedule 2 Key information 30 Version November 2014 Clinical Trial Research Agreement Contents 2

4 Contents Schedule 3 Payments 31 Schedule 4 Research Proposal 32 Schedule 5 Protocol 33 Schedule 6 Funding Agreement 34 Schedule 7 Special conditions 65 Signing page 66 Version November 2014 Clinical Trial Research Agreement Contents 3

5 Clinical Trial Research Agreement Date [insert date] Between the parties Institution [insert name] ABN [insert #] of [insert address] JDRF JDRF Australia ABN of Level 4, Chandos Street, St Leonards NSW 2065 Recitals 1 JDRF funds clinical research to positively impact the lives of people with type 1 diabetes in Australia, and has been awarded funds from the Commonwealth of Australia, as represented by the Australian Research Council, and other sources to fund such clinical research. 2 JDRF sought research proposals for funding by JDRF, and the Principal Investigator, supported by the Institution, submitted to JDRF a research proposal for the Study and requesting certain funding. JDRF agrees to provide funding for the Study on the terms of this agreement. 3 The Medicines Australia Clinical Trial Research Agreement for Collaborative or Cooperative Research Group Studies Standard Form has been used as a guide in the drafting of this agreement. 4 The Institution, through the Principal Investigator, is responsible for the conduct of the Study at the Study Site(s). 5 The Study will be conducted on the terms of this agreement. 6 The parties acknowledge that the Study will be conducted in the spirit of cooperation and collaboration. The parties agree as follows: Version November 2014 Clinical Trial Research Agreement page 1

6 1 Definitions The meanings of the terms used in this agreement are set out below. Term Meaning Adverse Event has the meaning given in the TGA document Access to Unapproved Therapeutic Goods Clinical Trials in Australia (October 2004) or replacement. Background IP of a party means information, techniques, know-how, software and materials (regardless of the form or medium in which they are disclosed or stored) that are provided by or on behalf of that party to the other for use in the Study (whether before or after the date of this agreement) or used by that other party in conducting the Study, and all Intellectual Property in them, but excludes the Study Materials. Biological Samples any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study. Business Day a day on which banks are open for business in Sydney, Australia, excluding a Saturday, Sunday or public holiday in that city. Case Report Form a printed, optical or electronic document or database designed to record all of the information, which is required by the Protocol to be reported on each Study Participant. Commencement Date the Commencement Date set out in Schedule 2. Confidential Information in respect of the Institution: (1) all information relating to the Institution s past, existing or future business, operations, administration or strategic plans; and (2) all information otherwise disclosed by or on behalf of the Institution and is designated as confidential or is of a confidential nature; in respect of JDRF: (1) all information relating to JDRF s past, existing or future business, operations, administration or strategic plans; and Version November 2014 Clinical Trial Research Agreement page 2

7 1 Definitions Term Meaning (c) (2) all information otherwise disclosed by or on behalf of JDRF and is designated as confidential or is of a confidential nature; and in respect of each party, the terms of this agreement, but excluding Personal Information, which is subject to other provisions of this agreement. End Date the End Date set out in Schedule 2, or such other date agreed in writing by the parties. Essential Documents documents which individually and collectively permit evaluation of the conduct of the Study and the quality of the data produced. Final Report has the meaning given in clause 7.2. Final Report Date the Final Report Date set out in Schedule 2. Funds the funds set out in Schedule 3. GCP Guideline the Committee for Proprietary Medicinal Products (CPMP)/International Conference on Harmonisation (ICH) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted with annotation by the TGA, or its replacement. Government Agency any government or governmental, administrative, monetary, fiscal or judicial body, department, commission, authority, tribunal, agency or entity in any part of the world. GST the Goods and Services Tax payable under a GST Law. GST Law the same as in A New Tax System (Goods and Services Tax) Act 1999 (Cth) as amended from time to time, and any regulations made pursuant to that Act. Intellectual Property all present and future industrial and intellectual property rights, including: inventions, patents, copyright, trade business, company or domain names, rights in relation to circuit layouts, plant breeders rights, registered designs, registered and unregistered trade marks, know how, trade secrets and the Version November 2014 Clinical Trial Research Agreement page 3

8 1 Definitions Term Meaning right to have confidential information kept confidential, and any and all other rights to intellectual property which may subsist anywhere in the world; and any application for or right to apply for registration of any of those rights. Interim Report has the meaning given in clause 7.1. Interim Report Date each Interim Report Date in respect of each interim reporting interval set out in Schedule 2. Investigational Product where relevant, the medicine(s), trial interventions or device(s) being trialled or tested in the Study and includes any placebo. Investigator s Brochure is a compilation of the clinical and non-clinical data on the Investigational Product(s) which are relevant to the Study of the Investigational Product in humans. IP Policies JDRF s: Australian Type 1 Diabetes Clinical Research Network Intellectual Property, Commercialisation and Royalties Policy; and Australian Type 1 Diabetes Clinical Research Network Data Sharing and Biosample Sharing Policy, published on the Website as at the date of this agreement. Milestone each milestone and all actions required to achieve it, set out in Schedule 3. Milestone Date in respect of a Milestone, the date for achievement of that Milestone set out in Schedule 3, or such other date agreed in writing by the parties. Milestone Payment the milestone payment set out in Schedule 3 in respect of a Milestone. Multi-centre Study a Study conducted by several investigators according to a single protocol at more than one study site. Version November 2014 Clinical Trial Research Agreement page 4

9 1 Definitions Term Meaning Network the Type 1 Diabetes Clinical Research Network (or T1DCRN), comprising a network of collaborating clinical research sites across Australia funded by JDRF, with funding from the Commonwealth of Australia as represented by the Australian Research Council under the Special Research Initiative for Type 1 Juvenile Diabetes to commence in 2014 to expand the network. Network Charter the Network Charter published on the Website at the date of this agreement. Network Policy for Conflicts of Interest JDRF s Network Policy for Conflicts of Interest, which includes a form of certification at the end of the policy, published on the Website. NHMRC the National Health and Medical Research Council of the Commonwealth of Australia. Personal Information has the same meaning as in the Privacy Act 1988 (Cth). Personnel employees, agents, contractors and authorised representatives, and includes, in the case of the Institution, the Principal Investigator and other investigators and students involved in the conduct of the Study. Principal Investigator the person responsible for the conduct of the Study at the Study Site as described in Schedule 2. Protocol the protocol set out in Schedule 5, which describes the objective(s), design, methodology, statistical considerations and organisation of the Study, and subject to clause 2.3, as amended from time to time, as agreed by the parties, and most recently approved by the Reviewing HREC. Publish to publish by way of a paper, article, manuscript, report, poster, internet posting, presentation, slides, abstract, outline, video, instruction material or other disclosure of the Study Materials, in printed, electronic, oral or other form. Publication has a corresponding meaning. Regulatory Authority any body which has jurisdiction over the conduct of the Study at the Study Site and includes the TGA, and any overseas regulatory authorities who may audit or require to be audited, any part of the Study or Study Materials. Version November 2014 Clinical Trial Research Agreement page 5

10 1 Definitions Term Meaning Relevant Privacy Laws the Privacy Act 1988 (Cth) and any other legislation, code or guideline which applies in the jurisdiction in which the Study Site is located and which relates to the protection of Personal Information. Research Proposal the research proposal submitted by the Institution (represented by the Principal Investigator), including amendments (if any) following discussions between the Institution and JDRF, in the form approved by JDRF and set out in Schedule 4. Reviewing HREC the Human Research Ethics Committee reviewing the Study on behalf of the Institution as described in Schedule 2. Serious Adverse Event has the meaning given in the TGA document Access to Unapproved Therapeutic Goods Clinical Trials in Australia (October 2004) or its replacement. Special Conditions the special conditions in Schedule 7, if any. Study the investigation to be conducted in accordance with the Research Proposal and the Protocol. Study Completion all Milestones have been achieved and all Study follow-up requirements under this Agreement have been met; and the Final Report has been provided to JDRF in accordance with clause 7.2. Study Materials all the materials and information created for the Study or required to be submitted to JDRF including all data, results, Biological Samples, Publications, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, knowhow and the like, whether patentable or not relating to the Study which are discovered or developed as a result of the Study, but excluding the Institution s ordinary patient records. Study Participant a person recruited to participate in the Study. Study Site the location(s) where the Study is actually conducted as set out in Schedule 2. TGA the Therapeutic Goods Administration, part of the Australian government Department of Health, or any successor body. Version November 2014 Clinical Trial Research Agreement page 6

11 2 The study Term Meaning Website JDRF s website in respect of the Network at 2 The study 2.1 Conduct of Study The Institution must comply with, and conduct the Study in accordance with the Research Proposal and the Protocol and any conditions of the Reviewing HREC. In addition the Institution must comply with the following, as applicable: any requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities; the requirements of the TGA in Access to Unapproved Therapeutic Goods Clinical Trials in Australia (October 2004) or its replacement and any other TGA publication or guideline that relates to clinical trials, or other such regulations or guidances governing the conduct of clinical research in the jurisdiction of the Study; (c) (d) the GCP Guideline; the principles that have their origins in the Declaration of Helsinki adopted by the World Medical Association in October 1996 (as accepted by the Australian Government); (e) the NHMRC National Statement on Ethical Conduct in Human Research (2007) or replacement, and any other relevant NHMRC publication or guideline that relates or may relate to clinical trial; (f) (g) any Study-specific and standard operating procedures provided by JDRF prior to the commencement of the Study; and any reasonable direction given by JDRF in order to ensure the safe conduct of the Study and compliance with applicable regulatory requirements. 2.2 Deviation from Protocol for safety reasons If any issue relating to the safety of Study Participants arises which requires a deviation from the Protocol, the Institution through the Principal Investigator may immediately make such a deviation without breaching any obligations under this agreement. If there is a need for such a deviation the Institution must notify JDRF and the Reviewing HREC of the facts and circumstance causing the deviation as soon as is reasonably practical, but in any event no later than 5 working days after the change is implemented. 2.3 Other changes to Protocol The parties acknowledge that the Protocol must be approved by the Reviewing HREC. From time to time the Principal Investigator, supported by the Institution, may propose a change to the Protocol. Any such change: Version November 2014 Clinical Trial Research Agreement page 7

12 3 Principal Investigator must not be implemented before approval by the Reviewing HREC except where the modification is either necessary to eliminate an immediate hazard to Study Participants and subject to clause 2.2 or involves only logistical or administrative aspects of the trial; and must be notified to and approved by JDRF. If the modification will affect the cost or other aspects of the Study, the parties may, in connection with that approval, agree any change to this agreement. 2.4 Study timetable The Institution must achieve: each Milestone by the Milestone Date in respect of that Milestone; and Study Completion by the End Date. 3 Principal Investigator 3.1 Role of Principal Investigator The Institution has authorised the Principal Investigator as the person responsible on a day to day basis for the conduct of the Study at the Study Site. The Principal Investigator does not have authority on behalf of the Institution to amend this agreement or the Protocol. 3.2 Liability for Principal Investigator For the purpose of this agreement only, and as between JDRF and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Subject to clause 4.1, the Institution warrants that the Principal Investigator is its employee. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. 3.3 Obligations and responsibilities Without limiting any other obligations the Institution has under this agreement or at law, the Institution is responsible for ensuring that the Principal Investigator: (c) thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), as described in the Protocol, Investigator s Brochure, information relating to the Investigational Product and any information sources provided by JDRF; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to JDRF; conducts the Study according to the Protocol without changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by JDRF and the Institution and approved in accordance with clause 3.3(d); Version November 2014 Clinical Trial Research Agreement page 8

13 4 Institution obligations and responsibilities (d) (e) (f) (g) (h) (i) (j) (k) (l) (m) (n) (o) (p) ensures that any amendments to the Protocol are approved by the Reviewing HREC and JDRF prior to implementation of the amendment; as soon as is practical advises JDRF if the Responsible HREC alters its approval of the Study; obtains prior written approval from JDRF and the Responsible HREC of any proposed advertisements to be used for the purpose of Study Participant recruitment in the Study; provides JDRF with evidence of the Principal Investigator s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants in accordance with the Research Proposal and the Protocol; is available when a clinical research representative of JDRF visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies JDRF, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the Protocol, and relevant ethical and regulatory guidelines, and in the case of the Institution and the Reviewing HREC with their policies and procedures; completes Case Report Forms in accordance with the Research Proposal and the Protocol, and before Study Completion. The Principal Investigator will ensure that Study Participants identifying information are removed from all records being transferred to JDRF; provides regular written progress and final reports to JDRF in relation to the Study as required by this agreement; completes and returns to JDRF as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by JDRF, the Institution and the Reviewing HREC; and is aware of and complies with the IP Policies, including in relation to data sharing and biosample sharing. 4 Institution obligations and responsibilities 4.1 Replacement of Principal Investigator If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must notify JDRF as soon as is practical; Version November 2014 Clinical Trial Research Agreement page 9

14 4 Institution obligations and responsibilities (c) the Institution must consult with JDRF 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, JDRF may require recruitment into the Study by the Institution to cease, and JDRF may terminate this agreement in accordance with clause 17(d). 4.2 Institution to perform If the Principal Investigator fails to carry out those obligations specified in clause 3.3, 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. 4.3 Professional qualifications 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, 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 JDRF as soon as practical after it becomes aware of any such disqualification, disbarment or ban. 4.4 Conflicts and compliance The Institution will not engage in any conduct on JDRF s behalf or in relation to the Study 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 JDRF 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 JDRF (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. 4.5 Security 4.6 Audit The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product(s), Essential Documents, Study records and reports, Study Materials and any other Study-related materials held or located at the Study Site. Subject to clause 11, the Institution must 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 Version November 2014 Clinical Trial Research Agreement page 10

15 4 Institution obligations and responsibilities Study-related materials and its Personnel as soon as is reasonably possible upon request by JDRF, Regulatory Authority, Reviewing HREC or any third party designated by JDRF. 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. 4.7 Resources for Study The Institution will make available adequate facilities, equipment and any other resources of the Institution reasonably required to safely follow the Protocol and carry out the Study. 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. 4.8 Study Materials 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 the End Date and must ensure that no Study Materials are destroyed before the expiration of this time period without the written approval of JDRF. The Institution agrees to notify JDRF before destroying any Study Materials. 4.9 Oversight of Reviewing HREC The Institution will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct Regulatory Authorities If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify JDRF, unless prevented from doing so by law. The Institution must take all reasonable steps to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site Approval for Public Relations The Institution shall obtain approval, in writing, from JDRF 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: (c) law; any policy, guideline or direction of any Government Agency; or any Regulatory Authority, Version November 2014 Clinical Trial Research Agreement page 11

16 5 Investigational product 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 Information regarding Investigational Product Prior to this Agreement being executed, the Institution must provide JDRF, and through the Principal Investigator the Reviewing HREC, with all current and relevant information regarding the Investigational Product that is reasonably available to the Institution and required to justify the nature, scope and duration of the Study Institution as Sponsor The Institution will act as sponsor of the Study for the purposes of the TGA's CTN Scheme or CTX Scheme (or any successor scheme). The Institution is responsible for preparing and submitting all documents required by the TGA to file an application for initiating and conducting the Study. The Institution will register the Study on the Australian New Zealand Clinical Trials Registry at or such other appropriate clinical trials registry agreed with JDRF Quality control and data capture The Institution 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 and reporting referred to in clause 7. The Institution will designate appropriately qualified personnel to advise on Study-related medical questions or problems Adverse event reporting (c) The Institution will, as soon as it becomes aware, advise JDRF 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 Institution will notify the TGA of any Adverse Events (including Serious Adverse Events), in accordance with all applicable laws and TGA guidelines, 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, and the Institution must also notify JDRF of such Adverse Events. The Institution will cooperate with the TGA, JDRF and the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. 5 Investigational product The Institution must: Version November 2014 Clinical Trial Research Agreement page 12

17 6 Payment of Funds (1) ensure that all Investigational Product is used strictly according to the Protocol and is not used for any other purposes, unless agreed in writing by JDRF and the Reviewing HREC; (2) provide a written explanation accounting for any missing Investigational Product; (3) not charge a Study Participant or third party payer for Investigational Product; and (4) keep all Investigational Product under appropriate storage conditions as specified in the Protocol in a secured area accessible only to authorised Personnel, and that complete and current records are maintained for all received, dispensed and returned Investigational Product. On termination of this agreement, the Institution must promptly return or destroy any unused Investigational Product(s) in accordance with applicable law and as requested by the supplier of that Investigational Product(s). 6 Payment of Funds 6.1 Milestones 6.2 GST Subject to the Institution complying with this agreement and achieving the Milestones, JDRF will pay the Institution the Funds in instalments, by paying each Milestone Payment following achievement of the relevant Milestone to JDRF s reasonable satisfaction and within 20 Business Days of receipt of the Institution s invoice for that Milestone Payment (whichever is later). (c) The amounts set out in Schedule 3 do not include GST. At the time of payment, JDRF must pay to the Institution any amount of GST that the Institution is required to pay in addition to the amounts set out in Schedule 3, and in accordance with GST Law. Payments will be made by JDRF upon receipt of a valid tax invoice JDRF and the Institution each warrant that they are registered under GST Law. Tax invoices must identify supplies for which GST is payable. 6.3 Deferral or reduction of payments JDRF may, at its discretion, defer, reduce or not make a payment of any part of the Funds: (1) where it forms the reasonable opinion that the full payment of the Funds is not required by the Institution to complete the Project, including in relation to any changes in the scope of the Study; (2) until the Institution performs any of its obligations or activities to achieve a Milestone that are required to be completed up to the date when the applicable Funds are due to be paid; or (3) if the Study ceases. Version November 2014 Clinical Trial Research Agreement page 13

18 7 Reporting The Institution acknowledges and agrees that if JDRF reasonably considers it may not have sufficient funds to allocate to pay any part of the Funds when due, JDRF may defer payment of that part of the Funds, by notice to the Institution, until such time as it does have sufficient funds. 6.4 Payment of Funds only Other than as expressly provided in this clause 6, JDRF is not obliged to make any payments in connection with the Study. Without limitation, JDRF is not responsible to the Institution or to any Institution Personnel for remuneration, annual leave, sick leave, long service leave, public holidays, redundancy payments, superannuation, employmentrelated taxes or any other similar benefits and payments under any law or industrial instrument. 6.5 Use of Funds The Institution must: (c) (d) (e) only use the Funds for the purpose of the Study and for no other purpose; only expend the Funds in accordance with this agreement, including any budget or expenses set out in the Research Proposal; keep clear, accurate and stand-alone records and accounts in relation to the Funds, including expenditure against the budget in respect of the Study, and allow such records and accounts to be inspected by JDRF or its representative upon notice; repay to JDRF any Funds which were not expended in accordance with this agreement or which are unspent on completion of the Study or earlier termination, within 15 days of JDRF s notice; and not receive funding from a third party which duplicates the Funds. 7 Reporting 7.1 Interim reports Within 10 days after each Interim Report Date the Institution must provide to JDRF a written interim report on progress of the Study as at that Interim Report Date (Interim Report). The Interim Report must be in the form of the interim reporting template required by JDRF from time to time, and must include: (1) the extent to which the objectives of the Study and the Research Proposal have been met; (2) whether the objectives set out in the Research Proposal are being achieved, and if not, why not; (3) relevant Publications in relation to the Study; (4) a copy of documented Study Materials and a description of undocumented Study Materials produced to the Interim Report Date; (5) reporting on compliance with the IP Policies (including data and biosample sharing) in respect of the Study to the Interim Report Date; Version November 2014 Clinical Trial Research Agreement page 14

19 7 Reporting 7.2 Final Report (6) an accounting of costs expended, costs committed and costs to complete the Study, as against Funds received or to be received from JDRF; (7) progress made against the goals and key deliverables identified in the Research Proposal, including Study Participant recruitment status; and (8) difficulties or delays experienced in progressing activities identified in the Research Proposal. Within 40 days after the Final Report Date, the Institution must provide to JDRF a written final report on the Study (Final Report). The Final Report must be in the form of the final reporting template required by JDRF, and must include: (1) a comprehensive report on actual performance against the objectives set out in the Research Proposal; (2) a comprehensive report on whether the objectives set out in the Research Proposal were achieved, and if not, why not; (3) relevant Publications in relation to the Study; (4) if available on Study Completion, a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator in relation to the Study; (5) a complete copy of the documented Study Material and a description of the undocumented Study Material; (6) reporting on compliance with the IP Policies (including submission of the final Data Sharing Plan as required by the Data Sharing and Biosample Sharing Policy) in respect of the Study; (7) in respect of total Funds under this agreement, an accounting of Funds received from JDRF against Funds expended in respect of the Study in accordance with this agreement, including any unspent Funds; (8) progress made against the goals and key deliverables identified in the Research Proposal, including Study Participant recruitment status; and (9) difficulties or delays experienced in progressing activities identified in the Research Proposal. 7.3 Other reporting (c) The Institution must submit all documents required to be submitted under this deed in the form or method of delivery as JDRF notifies to the Institution from time to time. The Institution must promptly provide any other report reasonably requested by JDRF from time to time, including to enable JDRF to report to or respond to information requests from the Commonwealth in relation to the Study, the Network or the Funding Agreement. The Institution must in respect of all reports, including Interim Reports and the Final Report: Version November 2014 Clinical Trial Research Agreement page 15

20 8 Network (1) ensure that information included in its reports is not false or misleading; and (2) address any aspect of its reports which JDRF reasonably considers unsatisfactory and resubmit such reports within the time requested by JDRF. 7.4 Post-End Date reporting If the Study is part of an ongoing study which continues after the End Date, the Institution agrees to: (c) keep JDRF informed of major developments in relation to the study; provide copies to JDRF of publications and the final analyses in relation to the study; and provide a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator in relation to the study. 8 Network The Institution acknowledges that the Study is part of the Network, and the Institution must procure that the Principal Investigator: (c) (d) does not recruit from the same target population of potential Study Participants for any other study unless prior approval is obtained from JDRF; participates in Network events such as workshops and annual meetings, as reasonably requested by JDRF. If the Principal Investigator is unable to attend, the Institution must procure that a senior representative involved with the Study attends such events; performs such other Network activities reasonably requested by JDRF, such as reviewing research proposals, participating on ad hoc committees and other relevant activities; and otherwise complies with the Network Charter. 9 Funding Agreement 9.1 Copy of Funding Agreement provided A copy of the Funding Agreement between the Commonwealth of Australia as represented by the Australian Research Council (ARC) and Juvenile Diabetes Research Foundation Australia regarding funding for Special Research Initiative in Type 1 Juvenile Diabetes to commence in 2014 dated 20 June 2014 (Funding Agreement), with Schedule A and Schedule C redacted, is attached as Schedule 6 to this agreement. 9.2 Institution s undertakings The Institution undertakes: Version November 2014 Clinical Trial Research Agreement page 16

21 10 Conflicts of interest not to impede or prevent JDRF from complying with any of its obligations under the Funding Agreement; and to abide by the terms of the Funding Agreement in respect of the Study. 9.3 Pass-through provisions pursuant to Funding Agreement (c) The Institution acknowledges that the Study is an aspect of the Project referred to in the Funding Agreement. The Institution agrees that: (1) JDRF has all rights of the ARC; and (2) the Institution will comply with the obligations of the Administering Organisation (that is, JDRF), in the Funding Agreement in relation to the Study and the conduct of the Study by the Institution, as terms of this agreement. Without limiting clause 9.3: (1) the Institution will indemnify JDRF, its officers, employees and agents against any liability, loss, damage, costs and expenses arising from any claim, suit, demand, action or proceedings by any person (Loss): (A) (B) where such Loss was caused by a breach of this agreement by the Institution or any wilful, unlawful or negligent act or omission of the Institution, its employees, agents or subcontractors (including the Principal Investigator) in connection with this agreement. The Institution s liability to indemnify under this clause 9.3 shall be reduced proportionately to the extent that any act or omission of JDRF or its employees or agents contributed to the loss or liability; or in respect of any infringement (or alleged infringement) of Intellectual Property rights by the Institution, its employees, agents or subcontractors (including the Principal Investigator) in the course of, or incidental to, performing the Study or the use by JDRF or the ARC of reports provided by the Institution under this agreement. Loss includes any Loss claimed by the ARC from JDRF under the Funding Agreement in respect of such matters; (2) JDRF shall have additional rights to terminate this agreement that the ARC has to terminate the Funding Agreement (with the necessary changes); (3) JDRF may suspend funding under this agreement or terminate this agreement if funding is suspended under the Funding Agreement or the Funding Agreement is terminated; (4) JDRF is liable only for amounts due and payable for work performed up to the date of suspension or termination in accordance with this agreement; and (5) JDRF may vary and recover funding under this agreement in the same terms as the Commonwealth s right to vary and recover funding under the Funding Agreement. The Institution agrees that if JDRF is required to provide or do anything at the reasonable request of the ARC under the Funding Agreement which relates (in Version November 2014 Clinical Trial Research Agreement page 17

22 10 Conflicts of interest whole or in part) to the Study, the Institution will provide or do anything that JDRF reasonably requests to fulfil that ARC request. 10 Conflicts of interest (c) In addition to clause 4.4, the Institution must notify JDRF of any and all conflicts of interest that it or its Personnel involved in the Study have, which may potentially influence or appear to influence the research or activities related to the Study: (1) prior to signing the Agreement for those conflicts of interest which exist at that time; and (2) for any such conflicts which arise during the term of this agreement, immediately upon becoming aware of them. Without limiting clause 10, before this agreement is signed by JDRF: (1) the Institution and the Principal Investigator must sign the form of declaration titled Written Evidence for the Special Research Initiative in Type 1 Juvenile Diabetes available on the Website; and (2) the other Personnel must sign the certification in the Network Policy for Conflicts of Interest. Without limiting clause 9, the Institution: (1) warrants it has in place prior to signing this agreement established and documented processes for managing actual or potential conflicts of interest which comply with the requirements of the Funding Agreement (Institution COI Policy); and (2) must comply, and must ensure its Personnel comply, with the Institution COI Policy, in relation to the Research Proposal and the Study. 11 Confidentiality Subject to clauses 11 and 11(d), each Party must not, and must ensure their Personnel do not, use or disclose any Confidential Information of the other party, other than where and only to the extent that such use or disclosure is necessary for the performance of the Study, the exercise of it rights or the performance of its obligations under this agreement. The Institution may use or disclose JDRF Confidential Information in any of the following circumstances: (1) for the purposes of complying with the Institution s internal complaint procedures, accident reporting procedures, quality assurance activities, disciplinary procedures or any applicable policy in relation to patient safety, Adverse Events and/or reportable incidents; (2) for the purposes of disclosing any material risks identified during the Study or subsequent to it, to Study Participants, Principal Investigators, medical practitioners administering treatment to Study Participants, Responsible HRECs and Regulatory Authorities; Version November 2014 Clinical Trial Research Agreement page 18

23 11 Confidentiality (c) (d) (e) (f) (3) for the purposes of complying with the requirements of any Regulatory Authority; (4) to enable the Reviewing HREC to monitor the Study; (5) where JDRF consents in writing to the disclosure; (6) as part of a publication issued under the provisions of clause 14; (7) where release of the Confidential Information is required by law, with notice as soon as reasonably practical to JDRF, and subject to the Institution upon request providing reasonable assistance to enable JDRF to obtain a protective order or other remedy to resist disclosure or ensure confidential treatment for any required disclosure (8) for the purposes of legal advice; and (9) disclosure to the Institution s insurer. Where Confidential Information is disclosed in accordance with clause 11(1) or 11(2), the Confidential Information must only be used in connection with the legitimate purposes of the Institution, and only disclosed to those who have a need to know it for such purposes and are obligated to keep the information confidential. JDRF may use or disclose Institution Confidential Information in any of the following circumstances: (1) for the purposes of complying with the requirements of any Regulatory Authority or the Funding Agreement; (2) where the Institution consents in writing to the disclosure; (3) as part of a publication issued under the provisions of clause 14; (4) where release of the Confidential Information is required by law, with notice as soon as reasonably practical to the Institution, and subject to JDRF upon request providing reasonable assistance to enable the Institution to obtain a protective order or other remedy to resist disclosure or ensure confidential treatment for any required disclosure; (5) for the purposes of legal advice; (6) disclosure to JDRF s insurer; or (7) where consistent with the IP Policies or to the extent reasonably necessary to enable JDRF to exercise rights in the Study Materials licensed to JDRF. Each party is responsible for ensuring that its Personnel are aware of that party s obligations in respect of Confidential Information in this clause 11, and are bound in similar terms to keep such information confidential, but is not responsible if those Personnel deliberately and intentionally fail to observe those restrictions. Information will not be Confidential Information or subject to the provisions of this clause 11 where: (1) the information has been independently received from a third party who is free to disclose it; (2) the information is in or has entered the public domain other than as a result of a breach of this agreement; Version November 2014 Clinical Trial Research Agreement page 19

24 12 Privacy (3) the party already knew the information, the prior knowledge of which it can document by prior written records; or (4) the party independently develops, discovers or arrives at the information without use, reference to, or reliance upon, the Confidential Information. 12 Privacy Each party must ensure that any Personal Information of Study Participants or Personnel it obtains or holds as a result of the conduct of the Study is collected, stored, used and disclosed by it in accordance with the Relevant Privacy Laws. Each party will promptly report to the other party any unauthorised access to, use or disclosure of Personal Information of Study Participants (Incident) of which it becomes aware, and will work with the other party to take reasonable steps to remedy the Incident. 13 Liability and insurance (c) Each party is liable for its acts and omissions in relation to the conduct of the Study. Each party must maintain such insurances as are reasonably available and necessary to provide indemnity to it in relation to any liability which it may incur in conducting the Study or performing its obligations under this agreement. The Institution satisfies the requirements of clause 13 if it is entitled to indemnity under a program or scheme of insurance or indemnity that is arranged by a State or Territory of the Commonwealth of Australia. 14 Publications (c) The Institution, its personnel and the Principal Investigator must not Publish or present any aspect of the Study without the prior written approval of JDRF, such approval not to be unreasonably withheld. However, the Institution may use and present any information concerning the Study for the purposes of internal training, education, evaluation or discussion without the consent of JDRF. JDRF acknowledges that the Institution may periodically wish to distribute information releases and announcements regarding the progress of research, including this Study. The Institution agrees that they will not release such written or oral material regarding the Study to the news media or a third party without the prior written approval of JDRF, such approval not to be unreasonably withheld. The parties agree that publications or presentations of any of the results from the Study will take into account the co-operative nature of the conduct of the Study and the overall objective of increasing public knowledge and shall be in accordance with accepted scientific practice, academic standards and customs and in accordance with the Protocol and with any more specific Version November 2014 Clinical Trial Research Agreement page 20

25 15 Acknowledgement publication/presentation guidelines developed during the course of the Study, including the following: (1) if the Study is a Multi-centre Study, the results from a single centre must not be Published before the Publication of results from all centres; and (2) individuals making a substantial contribution to the Study will be recognised with co-authorship in the publication of results from the Study, unless they elect not to be recognised. 15 Acknowledgement The Institution must acknowledge, and ensure that its Personnel acknowledge, the financial and other support provided by JDRF and the Commonwealth of Australia in any publications, presentations, promotional or advertising materials, public announcements or activities by it or on its behalf in relation to the Study, including after the End Date, in the following form: This research was supported by JDRF Australia, the recipient of the Australian Research Council Special Research Initiative in Type 1 Juvenile Diabetes, or such other acknowledgement notified by JDRF from time to time. 16 Study results and intellectual property (c) (d) (e) (f) JDRF grants to the Institution the right to use the Background IP of JDRF as required to carry out the Study and perform this agreement. Except for this right, neither the Institution nor any of its Personnel acquires any right or interest in any Intellectual Property provided by or on behalf of JDRF. In order to carry out the Study, the Institution may use Intellectual Property which is part of the Institution s Background IP. Any such Background IP remains the sole property of the Institution. The Institution grants to JDRF a non-exclusive, perpetual, royalty free licence to use (including the right to sublicense) the Institution s Background IP solely for the purpose of for any noncommercial use of the Study Materials. Intellectual Property in the Study Materials will be owned by the Institution upon creation. The Institution grants to JDRF a non-exclusive, perpetual, royalty-free licence to use (including the right to sub-license) the Intellectual Property in the Study Materials for any non-commercial purpose. The Institution agrees to comply with the IP Policies with respect to the Study and the Study Materials. The Institution represents and warrants to JDRF that: (1) nothing done by the Institution in carrying out the Study will infringe the Intellectual Property rights of any person; and (2) the Institution is entitled to grant the rights to Intellectual Property under this agreement and exercise of the rights granted to JDRF will not infringe the Intellectual Property rights of any person. Version November 2014 Clinical Trial Research Agreement page 21

26 17 Term and termination (g) The Institution must promptly disclose and communicate in writing to JDRF full particulars of any Intellectual Property that the Institution or Principal Investigator make, discover or conceive in the course of the Study that is directly related to the Study Materials. 17 Term and termination (c) (d) (e) (f) (g) This agreement commences on the Commencement Date and continues until the End Date, unless terminated earlier in accordance with its terms. In the ordinary course of events this agreement terminates on Study Completion. A party may terminate this agreement with 30 days prior written notice or such shorter time period as is reasonably required in the circumstances if the other party: (1) is in breach of any obligations under the Agreement or the Protocol (including without just cause to meet a timeframe) and fails to remedy such breach where it is capable of remedy within 30 days of a written notice from the terminating party specifying the breach and requiring its remedy; (2) is insolvent; or (3) assigns this agreement to a person in breach of clause 19. In addition to clause 17, a party may terminate this agreement immediately by written notice to the other party if it believes on reasonable grounds that: (1) continuing the Study poses an unacceptable risk to the rights, interests, safety or well-being of Study Participants; and (2) terminating this agreement is the most appropriate way to respond to that risk. JDRF may terminate this agreement immediately by giving notice if the Principal Investigator leaves the institution and an acceptable replacement cannot be found in accordance with clause 4.1. JDRF may terminate this agreement by notice to the Institution if the Institution fails to achieve a Milestone by the Milestone Date in respect that Milestone or fails to achieve Study Completion by the End Date. JDRF may terminate this agreement with 30 days prior written notice to the Institution. In the event of such early termination, JDRF will pay the Institution for all amounts due and payable in accordance with Schedule 3 up to the date of termination. In the event of termination, the Institution must: (1) promptly initiate all appropriate action to close the Study and, subject to any applicable retention requirements imposed by law, return to JDRF (or destroy if requested by JDRF, and provide evidence of such destruction) and other materials received from JDRF before Study Completion; (2) take all appropriate action to close out the Study Site in a timely manner; and (3) comply with any post-study requirements of the Reviewing HREC. Version November 2014 Clinical Trial Research Agreement page 22

27 18 Disputes (h) Without limiting the survival of provisions which by their nature are intended to survive termination, the following provisions survive termination of this agreement, clauses 3.3(p), 4.6, 4.8, 4.10, 4.11, 5, 6.5(d), 7.2, 9.3, 11, 12, 13, 14, 15, 16, 16(d), 16(e), 16(f), 17(g), 18, and Disputes (c) (d) (e) No party may commence legal proceedings against another in respect of a dispute arising in relation to this agreement (except for urgent interlocutory relief) unless the parties have complied with this clause and that party has first notified the other party in writing of the dispute and has used all reasonable endeavours to resolve the dispute with the other party within 28 days of the giving of that notice (Initial Period). If the dispute is not resolved within the Initial Period, then the dispute shall be referred within a further 28 days to the Australian Commercial Disputes Centre for mediation or any other agreed venue which conducts mediation. The parties will by agreement appoint a mediator to mediate the dispute in this forum. If the parties cannot agree to a mediator, then the mediator will be nominated by the then current President of the Law Society of the State or Territory in which the Institution is located. Any documents produced for the mediation are to be kept confidential and cannot be used except for the purpose of settling the dispute. Each party must bear its own costs of resolving a dispute under this clause, and unless the parties otherwise agree, the parties to the dispute must bear equally the costs of the mediator. In the event that the dispute is not settled at mediation within 28 days (or such other period as the parties agree in writing) after the appointment of the mediator, or if no mediator is appointed, then within 28 days of the referral of the dispute to mediation, then the parties are free to pursue any other procedures available at law for the resolution of the dispute. Nothing in this clause 18 will prevent a party from seeking injunctive relief where damages may be an inadequate or inappropriate remedy. 19 Assignment A party (the Assigning Party) may assign its rights or novate its rights and obligations under this agreement after obtaining the prior written consent of the other party (the Other Party). The Assigning Party's request for the Other Party's consent to an assignment or novation of this agreement must include: (1) the name and the address of the proposed assignee or novatee; (2) a copy of the proposed deed of assignment or novation; and (3) such other information as the Other Party reasonably requires. Version November 2014 Clinical Trial Research Agreement page 23

28 20 Subcontracting 20 Subcontracting (c) (d) The Institution must not subcontract any of its obligations under this agreement, or any part of the Study, unless expressly permitted by this agreement or JDRF has otherwise approved such subcontracting. JDRF may impose any terms and conditions it considers appropriate in giving any approval under this clause 20. Without limiting clause 20, where the Institution subcontracts the performance of any part of the Study, or otherwise any obligation under this agreement, the Institution must procure that: (1) the subcontractor complies with the terms of this agreement and grants all rights as if the subcontractor were the Institution; and (2) the relevant subcontract with the subcontractor contains all relevant terms of this agreement and does not conflict with or detract from the rights and entitlements of JDRF under this agreement. If requested, the Institution must give JDRF a copy of any subcontract it enters into in relation to the Study. For the avoidance of doubt, this clause 20 applies, without limitation, to any collaborating site which the Institution proposes to engage in respect of the Study. 21 Force majeure If any party is delayed or prevented from the performance of any act required under this agreement by reason of any act of God, act of nature, including any epidemic or outbreak of pandemic disease, fire, act of government or state, war, civil commotion, insurrection, embargo, prevention from or hindrance in obtaining raw material, energy or other supplies, labour disputes of whatever nature or whatever reason beyond the control of the party (a Force Majeure Event), the affected party shall promptly notify the other party in writing, giving details of the Force Majeure Event, the acts affected by the Force Majeure Event and the extent to which they are affected, and performance of such acts shall be excused for the period of such event provided that if such interference lasts for any period in excess of 30 days either party may, by written notice to the other, terminate this agreement. 22 Conflict In the event of any inconsistency between: the Protocol; and other provisions of this agreement, the other provisions of this agreement prevail. Version November 2014 Clinical Trial Research Agreement page 24

29 23 Notices 23 Notices 23.1 Form of Notice A notice, consent, approval or other communication to a party under this agreement (Notice) must be: in writing; and addressed to that party in accordance with the details nominated in Schedule 1 (or any alternative details nominated to the sending party by Notice) How Notice must be given and when Notice is received A Notice must be given by one of the methods set out in the table below. A Notice is regarded as given and received at the time set out in the table below. However, if this means the Notice would be regarded as given and received outside the period between 9.00am and 5.00pm (addressee s time) on a Business Day (business hours period), then the Notice will instead be regarded as given and received at the start of the following business hours period. Method of giving Notice When Notice is regarded as given and received By hand to the nominated address When delivered to the nominated address By pre-paid post to the nominated address At 9.00am (addressee s time) on the second Business Day after the date of posting By fax to the nominated fax number At the time indicated by the sending party s transmission equipment as the time that the fax was sent in its entirety. However, if the recipient party informs the sending party within 4 hours after that time that the fax transmission was illegible or incomplete, then the Notice will not be regarded as given or received. When calculating this 4 hour period, only time within a business hours period is to be included. By to the nominated address When the (including any attachment) comes to the attention of the recipient party or a person acting on its behalf Notice must not be given by electronic communication Notices of breach or termination must not be given by . A Notice must not be given by electronic means of communication (other than fax and in accordance with this clause 23 and subject to clause 23.3). Version November 2014 Clinical Trial Research Agreement page 25

30 24 General 24 General 24.1 Governing law and jurisdiction This agreement is governed by the law in force in New South Wales. Each party irrevocably submits to the non-exclusive jurisdiction of courts exercising jurisdiction in New South Wales Invalidity and enforceability If any provision of this agreement is invalid under the law of any jurisdiction the provision is enforceable in that jurisdiction to the extent that it is not invalid, whether it is in severable terms or not. Clause 24.2 does not apply where enforcement of the provision of this agreement in accordance with clause 24.2 would materially affect the nature or effect of the parties obligations under this agreement Waiver No party to this agreement may rely on the words or conduct of any other party as a waiver of any right unless the waiver is in writing and signed by the party granting the waiver. The meanings of the terms used in this clause 24.3 are set out below. Term Meaning conduct includes delay in the exercise of a right. right any right arising under or in connection with this agreement and includes the right to rely on this clause. waiver includes an election between rights and remedies, and conduct which might otherwise give rise to an estoppel Variation A variation of any term of this agreement must be in writing and signed by the parties Further action to be taken at each party s own expense Each party must, at its own expense, do all things and execute all documents necessary to give full effect to this agreement and the transactions contemplated by it. Version November 2014 Clinical Trial Research Agreement page 26

31 24 General 24.6 Entire agreement This agreement states all the express terms of the agreement between the parties in respect of its subject matter. It supersedes all prior discussions, negotiations, understandings and agreements in respect of its subject matter No reliance Neither party has relied on any statement by the other party not expressly included in this agreement Counterparts (c) This agreement may be executed in any number of counterparts. All counterparts, taken together, constitute one instrument. A party may execute this agreement by signing any counterpart Relationship of the parties Nothing in this agreement gives a party authority to bind any other party in any way. Nothing in this agreement imposes any fiduciary duties on a party in relation to any other party Interpretation In this agreement: (c) (d) (e) (f) (g) (h) (i) (j) Headings and bold type are for convenience only and do not affect the interpretation of this agreement. The singular includes the plural and the plural includes the singular. Words of any gender include all genders. Other parts of speech and grammatical forms of a word or phrase defined in this agreement have a corresponding meaning. An expression importing a person includes any company, partnership, joint venture, association, corporation or other body corporate and any Government Agency as well as an individual. A reference to a clause, party, schedule, attachment or exhibit is a reference to a clause of, and a party, schedule, attachment or exhibit to, this agreement. A reference to any legislation includes all delegated legislation made under it and amendments, consolidations, replacements or re-enactments of any of them. A reference to a document includes all amendments or supplements to, or replacements or novations of, that document. A reference to a party to a document includes that party s successors and permitted assignees. A reference to an agreement other than this agreement includes a deed and any legally enforceable undertaking, agreement, arrangement or understanding, whether or not in writing. Version November 2014 Clinical Trial Research Agreement page 27

32 25 Special Conditions (k) (l) (m) A reference to liquidation or insolvency includes appointment of an administrator, compromise, arrangement, merger, amalgamation, reconstruction, winding-up, dissolution, deregistration, assignment for the benefit of creditors, scheme, composition or arrangement with creditors, insolvency, bankruptcy, or any similar procedure or, where applicable, changes in the constitution of any partnership or person, or death. No provision of this agreement will be construed adversely to a party because that party was responsible for the preparation of this agreement or that provision. A reference to a body, other than a party to this agreement (including an institute, association or authority), whether statutory or not: (1) which ceases to exist; or (2) whose powers or functions are transferred to another body, is a reference to the body which replaces it or which substantially succeeds to its powers or functions Interpretation of inclusive expressions Specifying anything in this agreement after the words include or for example or similar expressions does not limit what else is included Business Day Where the day on or by which any thing is to be done is not a Business Day, that thing must be done on or by the next Business Day Agreement components This agreement includes any schedule. 25 Special Conditions The parties agree to the Special Conditions. To the extent there is any inconsistency between: (1) this agreement other than Schedule 7; and (2) the Special Conditions, the Special Conditions take precedence. Version November 2014 Clinical Trial Research Agreement page 28

33 Schedule 1 Notice details Institution Address Attention Phone Fax [insert name] [insert address] [insert] [insert] [insert] [insert] Institution JDRF Australia Address Level 4, Chandos Street, St Leonards NSW 2065 Attention Phone Fax [insert] [insert] [insert] [insert] Version November 2014 Clinical Trial Research Agreement page 29

34 Schedule 2 Key information Study Name: Study Site/s: Principal Investigator Name: Address: State: P/code: Investigators other than Principal Investigator Reviewing HREC: Interim Report Dates [6 months after the date of this agreement and every 6 months thereafter, until the Final Report Date] Final Report Date [the earliest of [insert date], completion of the Study to the satisfaction of JDRF and termination of this agreement.] Commencement Date End Date Version November 2014 Clinical Trial Research Agreement page 30

35 Schedule 3 Payments Funds [insert] Milestones / Milestone Payments (Funds payment schedule) Milestone Evidence of achievement required Date for achievement of Milestone Milestone Payment [final Protocol with all required approvals including HREC approval] Version November 2014 Clinical Trial Research Agreement page 31

36 Schedule 4 Research Proposal Version November 2014 Clinical Trial Research Agreement page 32

37 Schedule 5 Protocol Full Title: Version Number: Date: / / List of Key attachments: Protocol Version November 2014 Clinical Trial Research Agreement page 33

38 Schedule 6 Funding Agreement Signed copy of the Funding Agreement between the Commonwealth of Australia as represented by the Australian Research Council and Juvenile Diabetes Research Foundation Australia regarding funding for Special Research Initiative in Type 1 Juvenile Diabetes to commence in 2014 (Funding Agreement) dated 20 June 2014 with the Schedules A and C redacted. Version November 2014 Clinical Trial Research Agreement page 34

39 Schedule 6 Funding Agreement Version November 2014 Clinical Trial Research Agreement page 35

40 Schedule 6 Funding Agreement Version November 2014 Clinical Trial Research Agreement page 36

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