1. Purpose
Contributor agrees to make available to Prahsys certain patient data solely for use in training, validating, testing, and improving the PrognosiX dental imaging enhancement software as part of Prahsys's FDA 510(k) regulatory submission process and related regulatory compliance activities. This Agreement governs such contribution, the use of the data, and the rights and responsibilities of each party.
2. Scope of Contribution and Access Rights
Contributor will allow authorized Prahsys personnel to access, extract, and process patient imaging and associated metadata from Contributor's systems for the above purpose. The parties may also agree to remote or electronic transfer of such data, subject to security procedures that comply with HIPAA requirements and industry standards for healthcare data transfer, which shall be documented in writing before any data transfer occurs. Contributor agrees to contribute a total of one hundred (100) dental imaging exams meeting Prahsys's quality and format requirements no later than September 14, 2025. The contributed exams shall include a representative mix of anatomical views, including but not limited to upper and lower dental arches, anterior and posterior regions, and bitewing and periapical images.
3. License Grant and Data Rights
Contributor hereby grants to Prahsys a non-exclusive, worldwide, royalty-free, irrevocable
- Use, copy, store, process, modify, and analyze the contributed data;
- De-identify such data in accordance with HIPAA standards (45 C.F.R. § 164.514);
- Use the de-identified data solely for training, validating, and improving the PrognosiX product for regulatory purposes;
- Include results of such use in FDA filings and related internal documentation.
Prahsys shall not use the data or derivatives thereof for any third-party licensing unrelated to the FDA 510(k) application and subsequent regulatory compliance activities, unless Contributor provides separate written consent. Such consent shall not be unreasonably withheld.
4. HIPAA Compliance and Existing BAA
This Agreement is made in conjunction with a Business Associate Agreement ("BAA") previously or contemporaneously herewith executed between the parties, which governs the access, handling, and protection of any Protected Health Information ("PHI") involved in this data contribution. If no BAA exists at the time of execution of this Agreement, the parties shall execute a BAA before any PHI is transferred. To the extent the contributed data contains PHI, the terms of the BAA shall apply.
- It is permitted under HIPAA and/or applicable law to contribute this data for the stated research and development purpose;
- It has obtained any required consents or authorizations, or qualifies for a regulatory exception, and shall maintain documentation of such consents, authorizations, or applicable exceptions.
5. No Transfer of Ownership
This Agreement does not transfer ownership of the original data or underlying patient records. However, Prahsys shall exclusively own all right, title, and interest in any models, algorithms, software enhancements, improvements, modifications, or derivative works developed using or derived from the contributed data, subject to the license and restrictions
6. Warranties, Representations and Covenants
Contributor represents and warrants that:
- It has the legal authority to contribute the data;
- The data will be contributed free of claims, liens, encumbrances or restrictions from third parties, including but not limited to claims from patients, other healthcare providers, or technology vendors;
- To the best of its knowledge, the data is accurate and not intentionally altered or fabricated.
Prahsys represents and warrants that:
- It will use the contributed data only as permitted herein;
- It will comply with applicable privacy, security, and data protection laws.
7. Term, Termination and Post-Termination Rights
This Agreement shall continue in effect until:
- The 510(k)-submission process for PrognosiX is concluded and all related regulatory requirements are satisfied, or
- Either party terminates it upon 30 days’ written notice, provided that such termination shall not affect Prahsys’s rights to continue using previously contributed data in accordance with this Agreement.
Upon termination, Prahsys will delete any unneeded raw contributed data unless required or advisable to retain it under regulatory documentation standards or applicable laws. De-identified data may be retained indefinitely.
8. Confidentiality
Each party agrees to maintain the confidentiality of the other's non-public information obtained in the course of performance, including but not limited to data handling procedures, patient record access, internal methodologies, and AI training techniques, for a period of five (5) years following termination of this Agreement. This obligation shall survive any termination or expiration of this Agreement.
9. Indemnification and Limitation of Liability
Each party shall indemnify, defend, and hold harmless the other party and its officers, directors, employees, and agents for claims arising from the indemnifying party's use or misuse of the data. IN NO EVENT SHALL PRAHSYS BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES. Contributor shall indemnify, defend, and hold harmless Prahsys from any third-party claims arising from Contributor's breach of this Agreement, its misrepresentation of authority to contribute the data, or any claim that the contributed data infringes third-party rights.
10. Miscellaneous
(a) Governing Law: This Agreement shall be governed by the laws of the State of Texas. Venue and Jurisdiction: The parties agree that any legal proceeding arising under this Agreement shall be brought exclusively in the state or federal courts located in Montgomery County, Texas. Each party hereby irrevocably submits to the personal jurisdiction of such
(b) Entire Agreement: This is the entire agreement between the parties with respect to the subject matter and supersedes prior agreements.
(c) Amendments: Must be in writing and signed by both parties. No modification or waiver of any provision shall be binding unless executed in writing by the party against whom such modification or waiver is sought to be enforced.
(d) Counterparts: May be signed electronically and in counterparts.
IN WITNESS WHEREOF, the parties have executed this Agreement by their duly authorized representatives.