LONI | IDEAS Data Use Agreement

This Data Use Agreement for Images and Clinical Data - IDEAS Study (the "Agreement") is effective as of the date of acceptance and submission of this form below (the "Effective Date"), by and between the American College of Radiology (hereinafter "ACR"), the University of Southern California ("USC") on behalf of its Laboratory of Neuro Imaging (hereinafter "LONI"), and the individual submitting this form (hereinafter "Requestor"). Each of ACR, LONI, and Requestor will be referenced herein individually as a "Party" or collectively, the "Parties".

WHEREAS, ACR is a scientific, educational, and charitable organization engaged in conducting clinical research for the future of radiology and to further patient quality care, and is serving as the Sponsor and operations center for the IDEAS Study.;

WHEREAS, LONI houses the Image and Data Archive (IDA), a secure online resource for archiving, exploring and sharing neuroscience data;

WHEREAS, ACR has contracted with USC ("Coded Data Use Agreement" dated June 23, 2021, and the "Global Alzheimer's Association Interactive Network Collaborative Agreement" dated April 22, 2020) to allow access to certain images and clinical data as part of ACRIN 7155 trial ("IDEAS Study") through LONI;

WHEREAS, Requestor desires access to IDEAS Study images and clinical data to be used in support of Requestor activities for the purpose of scientific investigation, teaching, or the planning of clinical research studies;

WHEREAS, LONI will provide images and clinical data collected as part of the IDEAS Study to Requestor.

NOW, THEREFORE, the Parties agree as follows:

Requestor Obligations,. LONI will provide Requestor with access to selected images and/or clinical data collected as part of the IDEAS Study as identified by Requestor. No additional images or clinical data will be provided to Requestor. The images and clinical data provided to Requestor will be used in support of Requestor activities for the purpose of the scientific investigation, teaching, or the planning of clinical research studies as described in Requestor's initial request (the "Purpose"). Neither Requestor nor any third party in receipt of the images and clinical data shall use the images and clinical data for any other purpose. Nothing herein shall be construed to give permission to Requestor to re-sell the data.

Patient identifiers have been removed from all clinical and imaging data before delivery to Requestor. Clinical data will be provided to the Requestor in a table format (i.e., Excel or similar file type).
Requestor may only share the images and clinical data provided with a third party in furtherance of the Purpose set forth this Section. Requestor will require that any third party who is approved to receive the images and/or clinical data is bound by written terms substantially similar to the confidentiality requirements in Section 2 of this Agreement.

Confidentiality. As used in this Agreement, the term "Confidential Information" will mean all confidential or proprietary information, of one Party (the "Disclosing Party"), including but not limited to information related to the research & development, manufacturing, clinical development, know-how, technology, intellectual property, biological substances, strategy, business plan, marketing and sales, or trade secrets of the Disclosing Party, to which the obligations of the other Party (the "Recipient") under this Agreement will apply according to this Section 2. Confidential Information that is not marked as "confidential" will be considered confidential if the information is of a type or nature that a reasonable person, in the context of the disclosure, would understand it to be confidential. Confidential Information may only be used to the extent necessary to support the Purpose and no other use is authorized. The Recipient will disclose or deliver Confidential Information only to persons within its organization who have a need to know the same in the course of performance of their duties and who are bound either by a written agreement to protect the confidentiality thereof or by virtue of their employment status with Recipient are required to comply with the terms of this Agreement. Recipient will notify the Disclosing Party promptly of its knowledge of any unauthorized use or disclosure of Confidential Information.
For a period of five (5) years from the Effective Date, the Recipient will maintain such Confidential Information as confidential and will not disclose it to any third party or utilize it for its own benefit or the benefit of any third party. It will be understood, however, that such obligations of confidentiality and nondisclosure will not apply to disclosed Confidential Information which:
1. becomes publicly available through no wrongful act or omission of the Recipient;
2. is learned from a third party without obligation of confidentiality and which said third party is legally entitled to disclose;
3. is already known to Recipient prior to receipt from the Disclosing Party, as shown by prior written record; or
4. is required by applicable law to be disclosed to national, local or other lawful authority. Recipient will immediately notify Disclosing Party of such request.
The Recipient agrees that the Disclosing Party is and will remain the exclusive owner of all Confidential Information and all patent, copyright, trade secret, trademark and other intellectual property rights contained therein. No license or conveyance of any such rights to the Recipient is granted or implied under this Agreement.
Publications Requirements. All publications must include acknowledgement of ACR, ALZ, and use of the IDEAS data. Acknowledgement language should state, Imaging Dementia - Evidence for Amyloid Scanning (IDEAS) study (NCT# 02420756) evaluated the clinical utility of amyloid PET in Medicare beneficiaries with MCI or dementia meeting Appropriate Use Criteria for amyloid PET. The IDEAS study was funded by the Alzheimer's Association, the American College of Radiology, Avid Radiopharmaceuticals Inc (a wholly owned subsidiary of Eli Lilly and Company), General Electric Healthcare, and Life Molecular Imaging (formerly Piramal Imaging). The Centers for Medicare & Medicaid Services provided coverage for amyloid PET scans under coverage with evidence development. Publications should be submitted to IDEAS-ResearchPub@acr.org upon publication.
Governing Law. This Agreement is subject to and will be interpreted according to the laws of the Commonwealth of Pennsylvania.
Warranties. ACR specifically disclaims all express or implied warranties, including the warranties of merchantability and fitness for a particular purpose. Requestor assumes full responsibility for its use of the images and clinical data received from ACR, and assumes all risks associated with its use of such images and clinical data.
RECIPIENT ACKNOWLEDGES AND AGREES THAT RECIPIENT IS RECEIVING THE CLINICAL DATA AND IMAGES IN AN "AS-IS" CONDITION WITHOUT ANY WARRANTIES, REPRESENTATIONS, OR GUARANTEES, EITHER EXPRESSED OR IMPLIED, OF ANY NATURE WHATSOEVER FROM OR ON BEHALF OF ACR, INCLUDING WITHOUT LIMITATION, THOSE OF FITNESS FOR A PARTICULAR PURPOSE AND USE.
No Third Party Rights. Nothing in this Agreement will give rise to any rights in any person or entity that is not a Party to this Agreement.