• you agree that you have read and understood the terms of this Agreement;
• you agree to be legally bound by this Agreement; and
• where you are accessing the AIBL Data in your capacity as an employee of an organisation/institution, the organisation/institution is legally bound by the terms of this Agreement. You warrant that you have the full authority and consent of your organisation/institution to bind it to the terms of this Agreement.

• notices of employees in your organisation that will be accessing the AIBL Data;
• notice of the details of the AIBL Data analysis proposed;
• disclosure of abstracts and manuscripts using AIBL Data to the AIBL Parties prior to submission for publication.

1. You may access and use the AIBL Data only for the purpose of scientific investigation, teaching or the planning of clinical studies and for no other purpose. Under no circumstances are you permitted to use the AIBL Data for commercial purposes.
2. You will receive access to de-identified AIBL Data and you must not attempt to establish the identity of, or attempt to contact, any of the AIBL subjects used to generate the AIBL Data.
3. Except as expressly permitted by this Agreement, you must not disclose or make available the AIBL Data to any other person.
4. Where you are accessing the AIBL Data as an employee of an organisation/institute that is bound by the Agreement, you may disclose the AIBL Data to other employees within your organisation/institute if:
   1. you make that employee aware of the terms of this Agreement;
   2. the relevant employee agrees to comply with the terms of this Agreement;
   3. the organisation/institution consents to that employee having access to the AIBL Data; and
   4. you provide the AIBL Parties with notice of the employees within your organisation/institute to whom the AIBL Data is to be disclosed to.
5. You must notify the AIBL Parties in advance of any proposed analysis that you are planning to do with the AIBL Data.
6. You agree to accurately and promptly provide the AIBL Parties with notice of the information required in clauses 4 and 5.
7. If requested, you must promptly and accurately provide the AIBL Parties with updated information relating to clauses 4 and 5.
8. You must comply with any rules and regulations imposed by your organisation/institution and its review board in requesting, accessing and using the AIBL Data, and you warrant that you have the required authority and all necessary consents to bind the organisation/institution to this Agreement and to access and use the AIBL Data in the manner proposed.
9. You acknowledge and agree that:
   1. while the AIBL Parties have taken care to ensure the accuracy of the AIBL Data, the AIBL Parties provide no representation as to the accuracy, reliability, completeness, suitability or usefulness of the AIBL Data, or its fitness for any purpose, and the AIBL Data is provided to you "as is";
   2. the AIBL Data may be preliminary in nature and the results may change as new methods of analysis are implemented;
   3. the AIBL Data is not all of the data that has been collected and generated by the AIBL Parties pursuant to the various AIBL research projects and is only a subset of that data;
   4. you will review the limitations of the AIBL Data prior to using them for scientific purposes;
   5. where you make use of any AIBL Data, given that all or part of the AIBL Data may be preliminary in nature, you must note the version and date of the AIBL Data that has been accessed and refer to this in your manuscript or abstract. You are also responsible for checking whether the AIBL Data has been updated prior to submission of any material for publication; and
   6. to the extent permitted by law, the AIBL Parties disclaim all liability to you and your organisation/institution for any loss, expense or damage (including consequential loss or damage) suffered or incurred by any person, whether directly or indirectly, in connection with the access and use of the AIBL Data.
10. You must keep any AIBL Data in your possession or control, whether in electronic form or otherwise, safe and secure from unauthorised access and you must implement appropriate administrative, physical and technical safeguards to prevent unauthorised access, use or disclosure of the AIBL Data.
11. You must notify the AIBL Parties of any use or disclosure of the AIBL Data which is not permitted by this Agreement which you become aware of within 5 days of becoming aware of such use or disclosure.
12. You agree that failure to abide by any of the terms of this Agreement results in the automatic termination of this Agreement.
13. On expiry or termination of this Agreement for any reason:
    1. all rights granted to you under this document immediately cease; and
    2. you must permanently destroy, and certify the destruction of, any copies of the AIBL Data in your possession, custody or control. This does not apply to that part of the AIBL Data that has been published by you in accordance with clause 14 or as otherwise required by applicable law.

14. You must submit all presentations, abstracts and manuscripts containing or referring to any AIBL Data to the AIBL Management Committee prior to submission to a journal or making any public communication. This review will not be a scientific review, but is intended to ensure that clauses 15-16 below are correctly implemented. The AIBL Management Committee will maintain confidentiality of the submitted materials and will complete its review within 2 weeks. If the AIBL Management Committee does not respond within this period, and provided that the submitted document complies with clauses 15-16 (and all other terms of this Agreement), you may proceed to publish the abstract/manuscript.
15. If you publish abstracts which refer to or use any part of the AIBL Data:
    1. you must cite the AIBL Parties as the source of the AIBL Data and as follows:

       "Data used in the preparation of this article was obtained from the Australian Imaging Biomarkers and Lifestyle flagship study of ageing (AIBL). See www.aibl.csiro.au for further details."

    2. you do not need to include reference to the AIBL Parties in the authorship line of the abstract; and
    3. you must upload the published abstracts onto the ADNI Website for registered users to see either after they are accepted or after they are presented.
16. If you publish manuscripts which refer to or use any part of the AIBL Data, you must:
    1. on the author line of the manuscript, after the named authors, include the phrase "and the Australian Imaging Biomarkers and Lifestyle flagship study of ageing*" with the asterisk referring to the following statement and list of names:

       *Data used in the preparation of this article was obtained from the Australian Imaging Biomarkers and Lifestyle flagship study of ageing (AIBL) funded by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) which was made available at the ADNI database (www.loni.usc.edu/ADNI). The AIBL researchers contributed data but did not participate in analysis or writing of this report. AIBL researchers are listed at www.aibl.csiro.au.

    2. include the following in the methods section of your manuscripts in order to accurately acknowledge AIBL Data gathering by the AIBL personnel:

       "Data was collected by the AIBL study group. AIBL study methodology has been reported previously (Ellis et al. 2009)"

17. If you believe you do not have space to include the full required acknowledgements pursuant to clause 15 or 16, you must obtain the prior written consent of the AIBL Parties to do so. You can request consent by sending a notice to the AIBL Management Committee (you must specify the proposed shortened acknowledgment wording in that notice).

18. You agree that in relation to the AIBL Data and any copies, updates, new releases, modifications and alterations, whether made by the AIBL Parties, you or any third party (the "AIBL materials"):
    1. the AIBL Parties hold, or will hold, any and all Intellectual Property Rights in and to the AIBL materials;
    2. there is no transfer of title or ownership of the AIBL materials to you;
    3. no Intellectual Property Rights in the AIBL materials are held or will be held by you; and
    4. you will not challenge the validity of the AIBL Parties' ownership of and Intellectual Property Rights in and to the AIBL materials.
19. The AIBL Data is confidential information of the AIBL Parties and you agree to keep the AIBL Data confidential and to not disclose the AIBL Data to any person, except as expressly permitted by this Agreement.
20. Notwithstanding clause 19:
    1. any part of the AIBL Data which is in the public domain (other than due to a breach of confidentiality or this Agreement) is not confidential information of the AIBL Parties (Published AIBL Data) and clause 19 does not apply to the Published AIBL Data; and
    2. all restrictions (other than clause 19) on your rights to access and use the AIBL Data specified in this Agreement apply to the Published AIBL Data.
21. You are responsible for ensuring that the access and use of the AIBL Data and the exercise of your rights under this Agreement does not breach any Australian law or regulation or any laws and regulations outside of Australia which are applicable to you or your organisation/institution (including, without limitation, all applicable privacy and data protection laws (including the Privacy Act 1988 (Cth)).
22. All implied terms, conditions and warranties which otherwise might apply to, or arise out of, this Agreement are excluded other than:
    1. terms expressly specified in this Agreement; and
    2. terms, conditions and warranties which by law cannot lawfully be excluded or modified by agreement including those under Part V of the Trade Practices Act 1974 (Cth) (other than implied by section 69 of that Act) and corresponding provisions of state legislation.
23. Where a party is liable for a breach of a term, condition or warranty described in clause 22 (ii), that party's liability is, to the fullest extent permitted by law, limited to any one or more of the following (as determined by the liable party):
    1. in relation to goods, replacing or repairing the goods or payment of the costs of doing so; or
    2. in relation to services, re-supply of the services or payment of the cost of having the services re-supplied.
24. This Agreement is governed by and is to be construed in accordance with the laws applicable in the State of Victoria, Australia. Each party to this Agreement irrevocably and unconditionally submits to the exclusive jurisdiction of the courts exercising jurisdiction in the State of Victoria (including the Federal Court of Australia) and any courts which have jurisdiction to hear appeals from any of those courts and waive any right to object to any proceedings being brought in those courts.
25. A single or partial exercise or waiver by a party of a right relating to this Agreement does not prevent any other exercise of that right or the exercise of any other right. A right relating to this Agreement may only be waived in writing signed by the party or parties waiving the right.
26. This Agreement may only be varied or replaced by a document executed by the parties.
27. You must not assign or deal with any right under this Agreement without the prior written consent of the AIBL Parties. The AIBL Parties may assign or deal with any right under this Agreement without consent or notice to you.
28. Clauses 9(i), 9(vi), 13, 18, 19, 20(i), 22, 24, 28, and 29 will remain in full force and effect and survive the termination or expiry of this Agreement.
29. You must promptly at your own cost do all things (including executing all documents) necessary or required by the AIBL Parties to give full effect to this Agreement.
30. An obligation of two or more persons binds them jointly and severally.

31. In this Agreement:
    • "ADNI" means the Alzheimer's Disease Neuroimaging Initiative.
    • "ADNI Website" means the ADNI website located at www.loni.usc.edu/ADNI.
    • "Agreement" means all of the terms of this document, including the Agreement Details and the General Conditions sections.
    • "AIBL" has the meaning set out in the Agreement Details section.
    • "AIBL Data" has the meaning set out in the Agreement Details section.
    • "AIBL Management Committee" means a committee of AIBL consisting of various scientists and representatives from the AIBL Parties which are responsible for the management of AIBL.
    • "AIBL Parties" means, collectively, the following organisations:
      1. Commonwealth Scientific and Industrial Research Organisation, acting through its Division of Molecular and Health Technologies and Division of Manufacturing and Materials Technology, located at Limestone Avenue, Campbell, ACT, Australia;
      2. The University of Melbourne, a body politic and corporate pursuant to the provisions of the Melbourne University Act 1958, acting through its School of Chemistry, located at Parkville, Victoria, Australia;
      3. Neurosciences Australia Ltd, an Australian public company limited by Guarantee, located at Level 2, 161 Barry Street, Carlton South, Victoria, Australia;
      4. Mental Health Research Institute of Victoria, an Australian public company limited by Guarantee, located at 155 Oak Street Parkville, Victoria, Australia; and
      5. Edith Cowan University, located at 100 Joondalup Drive, Joondalup, Western Australia, Australia.
    • "Intellectual Property Rights" means all intellectual property rights including any rights in copyright (including future copyright), trade marks, patents, designs, semiconductor and circuit layout rights, rights in databases, rights in relation to confidential information and trade secrets, know how, manner of manufacture, formulas, inventions and get up, whether arising by operation of law, equity or by statute, and whether registered or not and whether registrable or not, but excludes non-assignable moral rights or similar non-assignable personal rights of authors and producers.
    • "you" and "your" means:
      1. the person who has been notified of and accepted the terms of this Agreement by agreeing to proceed to access and use the AIBL Data; and
      2. where the person in sub-paragraph (i) of this definition is accessing the AIBL Data as an employee of an organisation/institution, that organisation/institution.
32. Unless expressed to the contrary, in this Agreement:
    1. "includes" means includes without limitation;
    2. no rule of construction will apply to a clause to the disadvantage of a party merely because that party put forward the clause or would otherwise benefit from it;
    3. headings are used for convenience only and do not affect the interpretation of this Agreement; and
    4. a reference to a person includes a partnership, joint venture, unincorporated association, corporation and a government or statutory body or authority.

1. I will receive access to de-identified data and will not attempt to establish the identity of, or attempt to contact any of the ADNI participants.
2. I will not attempt to make direct contact with ADNI PIs or staff at sites concerning the specific results of individual subjects.
3. I will not further disclose these data beyond the uses outlined in this agreement and my data use application. I understand that redistribution of individual participant-level data in any manner is prohibited. Reports and publication of summary (not participant-level) data are allowed.
4. I will not utilize AI tools, especially (but not exclusively) those with public-facing interfaces that do not offer guarantees regarding the containment of data inputs for ADNI data, recognizing that the use of AI tools, including generative and analytical models, poses a potential risk of inadvertent data sharing due to the nature of how these tools process information and may lead to data being sent, saved, viewed, or used in unforeseen ways by parties not covered by the DUA, which is a direct violation of this agreement. See Appendix A for additional AI tool concerns, restrictions, and guidance.
5. I will not disclose any participant-level raw or derived datasets beyond the uses outlined in this agreement. Derived datasets containing participant-level data that I create and that I anticipate will benefit the scientific community, will be submitted to the ADNI study PI (Dr. Michael Weiner) using the format described in Derived Data Submission Form (available in the ADNI repository). The study PI will determine whether my data may be distributed through the ADNI-LONI and/or other NIA-designated data repository. I understand derived datasets should only be shared through the ADNI-LONI and/or other NIA-designated data repository.
6. I will require anyone on my team (i.e. in my lab or company) who utilizes these data to comply with this Data Use Agreement. I understand that I am not allowed to distribute ADNI data outside of my team, only the ADNI study website operated by LONI-IDA can distribute data.
7. I will accurately provide the requested information for persons who will use these data and the analyses that are planned using these data.
8. I will respond promptly and accurately to annual requests to update information about my use of ADNI data.
9. I will comply with any rules and regulations imposed by my institution and its institutional review board in requesting these data.
   

1. I will cite ADNI as the source of data and the ADNI funding sources in the abstract as space allows.
2. For abstracts, you are not required to cite ADNI in the authorship line.

1. On the by-line of the manuscript, after the named authors, I will include ADNI as an author by using the phrase "for the Alzheimer's Disease Neuroimaging Initiative*" with the asterisk referring to the following statement and list of names:

   *Data used in preparation of this article were obtained from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database (adni.loni.usc.edu). As such, the investigators within the ADNI contributed to the design and implementation of ADNI and/or provided data but did not participate in analysis or writing of this report. A complete listing of ADNI investigators can be found at: http://adni.loni.usc.edu/wp-content/uploads/how_to_apply/ADNI_Acknowledgement_List.pdf

   [For manuscripts that use metabolomics data generated by the Alzheimer's Disease Metabolomics Consortium (ADMC) in the by-line of the manuscript, after the named authors, I will include the phrase "for the Alzheimer's Disease Metabolomics Consortium**" with the double asterisk referring to the following statement and list of names:

   **Data used in preparation of this article were generated by the Alzheimer's Disease Metabolomics Consortium (ADMC). As such, the investigators within the ADMC provided data but did not participate in analysis or writing of this report. A complete listing of ADMC investigators can be found at: https://sites.duke.edu/adnimetab/team/]

2. I will include language similar to the following in the Methods section of my manuscripts in order to accurately acknowledge data gathering by the ADNI personnel. Depending upon the length and focus of the article, it may be appropriate to include more or less than the example below. However, inclusion of some variation of the language shown below is mandatory.

   Data used in the preparation of this article were obtained from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database (adni.loni.usc.edu). The ADNI was launched in 2003 as a public-private partnership, led by Principal Investigator Michael W. Weiner, MD. The original goal of ADNI was to test whether serial magnetic resonance imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and neuropsychological assessment can be combined to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). The current goals include validating biomarkers for clinical trials, improving the generalizability of ADNI data by increasing diversity in the participant cohort, and to provide data concerning the diagnosis and progression of Alzheimer's disease to the scientific community. For up-to-date information, see adni.loni.usc.edu.

3. I will acknowledge funding by the ADNI in the support acknowledgement section of the manuscript using language similar to the following:

   Data collection and sharing for the Alzheimer's Disease Neuroimaging Initiative (ADNI) is funded by the National Institute on Aging (National Institutes of Health Grant U19AG024904). The grantee organization is the Northern California Institute for Research and Education. In the past, ADNI has also received funding from the National Institute of Biomedical Imaging and Bioengineering, the Canadian Institutes of Health Research, and private sector contributions through the Foundation for the National Institutes of Health (FNIH) including generous contributions from the following: AbbVie, Alzheimer's Association; Alzheimer's Drug Discovery Foundation; Araclon Biotech; BioClinica, Inc.; Biogen; Bristol-Myers Squibb Company; CereSpir, Inc.; Cogstate; Eisai Inc.; Elan Pharmaceuticals, Inc.; Eli Lilly and Company; EuroImmun; F. Hoffmann-La Roche Ltd and its affiliated company Genentech, Inc.; Fujirebio; GE Healthcare; IXICO Ltd.; Janssen Alzheimer Immunotherapy Research & Development, LLC.; Johnson & Johnson Pharmaceutical Research & Development LLC.; Lumosity; Lundbeck; Merck & Co., Inc.; Meso Scale Diagnostics, LLC.; NeuroRx Research; Neurotrack Technologies; Novartis Pharmaceuticals Corporation; Pfizer Inc.; Piramal Imaging; Servier; Takeda Pharmaceutical Company; and Transition Therapeutics.

   [Note: For manuscripts that use metabolomics data generated by the Alzheimer's Disease Metabolomics Consortium (ADMC) I will include the following language: Data collection and sharing for this project was funded by the Alzheimer's Disease Metabolomics Consortium (National Institute on Aging R01AG046171, RF1AG051550 and 3U01AG024904-09S4).]

   [Note: For manuscripts that use ADNI whole genome sequencing data generated by the ADSP, I will include the following language: Data generation and sharing for this project was funded, in part, by the Alzheimer's Disease Sequencing Project. For details on how to acknowledge ADSP Data Sets including ADNI see: https://dss.niagads.org/datasets/ng00067/#dataset-acknowledgement]

   [Note: For manuscripts that use multiomics data generated by CLEAR-AD, I will include the following language: Data generation and sharing for this project was funded, in part, by "Centrally-linked longitudinal peripheral biomarkers of AD in multi-ethnic populations" (National Institute on Aging U19 AG074879). See CLEAR-AD.org for further details.]

4. I will submit all manuscripts to the ADNI Data and Publications Committee (DPC) prior to submitting them to a journal. This review will not be a scientific review, but it is intended to ensure that the items above are correctly implemented. The DPC will maintain confidentiality of the manuscript and will complete its review within 2 weeks. The DPC can be reached by logging into your LONI-IDA account: 1) click "My Account" in the upper right corner 2) click the "Update" button in the Project line for ADNI; 3) On the ADNI User Account Update page, select "Publication Update" tab; 4) Enter and upload your publication information; 5) Email your manuscript to the DPC at: EDRAKE@BWH.HARVARD.EDU. Note: in the event that a journal requires a Conflict of Interest form because ADNI is listed on the author line of the manuscript, the DPC will provide one on request.
5. I will ensure that Investigators who utilize ADNI data use appropriate administrative, physical, and technical safeguards to prevent the use or disclosure of the data other than as provided for by this Agreement.
6. I will report any use or disclosure of the data not provided for by this Agreement of which I become aware within 15 days of becoming aware of such use or disclosure.

IMPORTANT NOTE: It is the policy of the Alzheimer's Disease Neuroimaging Initiative to make analyzed data available to investigators as quickly as possible. However, data analysis for this project is expected to take years as methods for analysis of these datasets evolve. Therefore, I understand that any processed data that I download might be preliminary and that results may change as new methods of analysis are implemented. I will familiarize myself with the analysis methods so that I am aware of the limitations of these data prior to using them for scientific purposes.

Finally, because "preliminary data" will be posted on the database, in the event that I download data from the ADNI database for the purposes of analysis and future presentation/publication in the form of abstracts and/or manuscripts, I will note the version (download date) of the data I download and provide this information in any Methods section (if publishing), and I will check the database to determine if updated data has been provided prior to submission of any material for publication.

ADNI maintains the right to modify terms of this agreement and may do so by posting notice of such modifications on this page: https://adni.loni.usc.edu/news-publications/. Any modification made is effective immediately upon posting the modification (unless otherwise stated). You should visit this page periodically to review the current use agreement terms.

Prohibited use of AI Tools: This ADNI Data Use Agreement explicitly prohibits any individual who has obtained ADNI data from sharing raw data, specifically participant-specific data, with any other individual or entity, in any forum, in any medium. For a variety of reasons, including the important need to protect the privacy of research participants, all data must be directly released to requesting individuals from our ADNI LONI website.

The use of AI tools, including generative and analytical models, pose a genuine risk of inadvertent data sharing due to the nature of how AI tools process, store, and regenerate information. AI tools, including but not limited to those with public-facing interfaces, such as OpenAI's ChatGPT, usually do not offer guarantees regarding the containment of data inputs. Any data input into a prompt or output generated from a prompt could result with proprietary data infringed, sent, saved, viewed, misinterpreted, or used in unforeseen public ways. As a result, the use of such AI tools which may release ADNI participant level data to others, is in direct violation of ADNI Data Use Agreement policies.

However, an important exception to the above stated prohibition would be AI tools, including generative and analytical models, which explicitly prevent sharing data with others. Such AI tools may be developed and internally trained by individual research groups or academic institutions, and strictly used for the individual research group or academic institution provided that "sharing" data beyond the tool is strictly prohibited. Therefore, ADNI data may be analyzed using AI tools which provide guarantees that all data is safeguarded, contained, and will not be released to others.

Note that this amendment does not impose any new restrictions on the use of ADNI data, but is intended for clarification on item #3 in the DUA (above): "I will not further disclose these data beyond the uses outlined in this agreement and my data use application and understand that redistribution of data in any manner is prohibited."

As of the writing of this Appendix the term "Artificial Intelligence" or "AI" means a broad range of technologies and tools that can generate and regenerate content in various mediums including text, images, videos, and audio, based on the content or data input to generate output in any medium response. The recent commercialization of these AI tools represents a significant challenge in maintaining the privacy of participants in the ADNI study, and of participants in human subjects' research in general. Uploading ADNI data to a third-party platform that is not explicitly in compliance with the prohibition and restrictions on redistribution of ADNI data set forth herein is a clear violation of this Agreement.

ADNI requires investigators to adhere to the following terms when deciding whether a project utilizing these tools is in compliance with the terms of this Agreement:

• Computational resources

• The application of any statistical or other analytic methods to ADNI data - whether branded as 'AI' and "AI Tool" or otherwise - should not be performed using computational or AI resources owned by third parties who engage in the long-term retention of user content that is either shared with other parties or used in the training of public-facing models, such activity could include the contents of the ADNI data set. This includes the use of third-party platforms for inference (e.g. the inclusion of ADNI data as part of an input or 'prompt' for a generative language model), training (including both the training of foundations model and the fine-tuning of pre-trained models via transfer learning or some other process), prediction, or any other task that could result] in ADNI data being retained, shared, regenerated or otherwise by entities that are not in compliance with the DUA.
• Some commercial entities may offer an 'opt-out' clause in the terms of use for their models, allowing users to decline the right of the entity to retain the data for training and other purposes. This does not constitute sufficient protection, and under no circumstances should this be viewed as an acceptable safeguard for sharing ADNI data with these third parties.
• Investigators making use of remote computational resources such as Microsoft Azure, Google Cloud, Amazon Web Services, Runpod, or other computational services for the purposes of training AI models must take care to review the terms of use for the service to ensure that their workflow is secure.

• Public release of models trained using ADNI data

• The use of ADNI data in training models is both permitted and encouraged, provided that the process is carried out in compliance with the DUA as outlined above. However, investigators who intend on making the weights of a trained model publicly available should consider whether the model could be used to easily reconstruct parts of the ADNI data set. ADNI prohibits release of participant level data, even if it is sufficiently processed or altered and lack ADNI subject codes. See Term (3) above "I understand that redistribution of individual participant-level data in any manner is prohibited". All participant level data generated by ADNI can only be released by the LONI-IDA website. Individual investigators who have generated participant level data based on ADNI data can request for their data to be shared by contacting Dr. Weiner at michael.weiner@ucsf.edu.
• This precaution is particularly important in the case of large language models and other highly overparameterized generative models. Numerous studies have demonstrated that it is possible to extract training examples from these large and complex models, and investigators should keep this fact in mind.

I understand that failure to abide by these guidelines will result in the termination of my privileges to access ADNI data. Furthermore, ADNI reserves the right to pursue damages for actions which violate ADNI guidelines.