Research Use Only (RUO) Software and Device Use Agreement
This Research Use Only (“RUO”) Software and Device Use Agreement (“Agreement”) is entered into by and between NeuroField (“Company”), and the undersigned institution or individual (“User”).
This Agreement governs access to and use of the AI Profiler and Protocol Generator, NeuroField64, NeuroField Analysis Suite software Neurofeedback Module, and associated neurostimulation devices, including but not limited to the NeuroField Genesis, Q21 and Photon devices (collectively, the “Products”).
1. Purpose and Regulatory Status
1.1 Research Use Only Designation
The Products are provided FOR RESEARCH USE ONLY and are intended solely for non-clinical, investigational, educational, or exploratory research purposes. The Products are not intended for use in the diagnosis, treatment, mitigation, cure, or prevention of any disease or medical condition.
1.2 No FDA Clearance or Approval
The Products have not been cleared or approved by the U.S. Food and Drug Administration (FDA) for clinical use. No representations are made regarding safety or effectiveness for any clinical or therapeutic purpose.
1.3 Regulatory Basis
This Agreement is intended to align with applicable FDA guidance regarding Research Use Only products, including but not limited to labeling and use limitations under 21 CFR Parts 801 and 812, as applicable.
2. Permitted Use
2.1 The User may use the Products solely for:
- Basic scientific research
- Exploratory neurophysiological investigation
- Method development
- Educational or training demonstrations
2.2 All use must be conducted in accordance with:
- This Agreement
- Applicable federal, state, and local laws and regulations
- Institutional policies and procedures
3. Prohibited Use
The User shall not:
- Use the Products for any clinical, diagnostic, or therapeutic purpose.
- Use the Products in human subjects research intended to influence clinical decision-making or patient care.
- Promote, advertise, or represent the Products as safe or effective for clinical use.
- Modify, reverse engineer, decompile, or create derivative works of the software, except as expressly permitted in writing by the Company.
- Use the Products in a manner inconsistent with FDA Research Use Only requirements.
4. Human Subjects Research
4.1 Institutional Responsibility
If the User conducts research involving human subjects, the User is solely responsible for:
- Obtaining Institutional Review Board (IRB) or ethics committee approval, if required
- Ensuring informed consent is obtained
- Determining whether an Investigational Device Exemption (IDE) or other regulatory authorization is required
4.2 No Clinical Claims
Data generated using the Products may not be used to support clinical claims, marketing claims, or regulatory submissions without prior written authorization from the Company and appropriate regulatory clearance.
5. User Qualifications
The User represents and warrants that:
- They possess appropriate training and expertise to operate the Products safely
- They understand the experimental nature of the Products
- They will supervise all use of the Products
6. Data and Results
6.1 Ownership
User retains ownership of research data generated through use of the Products.
6.2 Acknowledgment
Publications or presentations arising from use of the Products shall acknowledge NeuroField and state that the Products were used for research purposes only.
6.3 No Warranty on Results
The Company makes no representations regarding the validity, accuracy, or reproducibility of research results.
7. Disclaimer of Warranties
THE PRODUCTS ARE PROVIDED “AS IS” AND “AS AVAILABLE” WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.
8. Limitation of Liability
TO THE MAXIMUM EXTENT PERMITTED BY LAW, THE COMPANY SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR PUNITIVE DAMAGES ARISING OUT OF OR RELATED TO USE OF THE PRODUCTS.
9. Indemnification
The User agrees to indemnify, defend, and hold harmless the Company, its officers, employees, and affiliates from any claims, damages, or liabilities arising from the User’s use of the Products, including but not limited to regulatory violations or misuse.
10. Term and Termination
- This Agreement is effective upon execution and continues until terminated.
- The Company may terminate this Agreement immediately upon breach.
- Upon termination, the User shall discontinue all use of the Products.
11. Governing Law
This Agreement shall be governed by and construed in accordance with the laws of the State in which the Company is incorporated, without regard to conflict of laws principles.
12. Entire Agreement
This Agreement constitutes the entire agreement between the parties regarding the subject matter herein and supersedes all prior agreements or understandings.
RESEARCH USE ONLY – NOT FOR CLINICAL USE