Establishes the core legal terms governing use of Braincare software and related services
Defines licensing, data rights, confidentiality, and compliance obligations
Sets liability allocation, warranties, and general commercial terms
Serves as the governing agreement for all incorporated exhibits
This Master Agreement is incorporated by reference into any Braincare quotation, order form, or similar ordering document that references this agreement or the agreements.brain4.care website.
Governing law: State of Delaware
Liability framework: limited as specified in the agreement
PHI handling: governed by Exhibit A (Business Associate Agreement), where applicable
Term and termination: as set forth in the agreement
Order of precedence: Master controls over exhibits unless stated otherwise
(Public Standard Form)
Version: 1.0
Effective Date: 01/01/2026
This Master Software as a Service Agreement (“Agreement”) is entered into by and between Braincare USA Corp., a Delaware corporation (“Company”), and the healthcare organization identified in a quotation, order form, or purchase order that references this Agreement (“Client”).
This Agreement is published as a standard form for incorporation by reference and governs Client’s access to and use of Company’s software platform and related services.
“SaMD” means Software as a Medical Device as defined by the U.S. Food and Drug Administration.
“Platform” means Company’s cloud-based software system used to receive, process, store, and present data generated by the Braincare system.
“Sensor Kit” means Company’s non-invasive intracranial monitoring device and respective accessories.
“Mobile App” means the software application that connects the Sensor to the Platform.
“PHI” means Protected Health Information as defined under HIPAA.
“Services” means access to and use of the Platform, Mobile App, and related support services as described in this Agreement and applicable Exhibits.
2.1 Scope
Company provides Client with access to its FDA-cleared SaMD platform, the B4C System, consisting of the Mobile App, cloud-based Platform, analytics, reporting, and support services in accordance with this Agreement and the Service Level Agreement (“SLA”).
No services are provided other than those expressly stated in this Agreement or an applicable Exhibit.
2.2 Regulatory Status
The Braincare system is an FDA-cleared Software as a Medical Device and must be used strictly in accordance with FDA-cleared labeling and instructions for use. Any off-label use is solely at Client’s discretion and risk.
2.3 No Clinical Decision-Making
The Services provide clinical decision-support information only. Company does not practice medicine, provide medical advice, or make treatment decisions. All clinical decisions and patient care remain solely the responsibility of Client and its licensed clinicians.
This Agreement is incorporated by reference into any Company quotation, order form, or Client purchase order that references this Agreement (each, an “Order Document”).
3.2 Acceptance
Client’s issuance of a purchase order, execution of a quotation or order form, or use of the Services constitutes Client’s acceptance of this Agreement and all incorporated Exhibits.
3.3 Order of Precedence
In the event of conflict, the following order of precedence applies:
(i) the applicable Order Document;
(ii) this Agreement;
(iii) the Exhibits; and
(iv) any Client purchase order terms (commercial details only).
Any additional or conflicting terms in a Client purchase order, vendor portal, or similar document are rejected and shall be void and of no effect.
4.1 Authorized Use
Client shall:
Use the Services only for lawful clinical purposes;
Ensure use solely by trained and authorized personnel;
Comply with all applicable laws, regulations, and internal policies.
4.2 Security Responsibilities
Client is responsible for user access management, credential security, and the security of its own networks, devices, and systems. Company is not responsible for security incidents arising from Client-managed environments or credentials.
5.1 PHI Handling
PHI handling is governed exclusively by the Business Associate Agreement (“BAA”), if applicable. Unless expressly authorized in writing, Company does not access identifiable PHI and processes data in encrypted or de-identified form.
5.2 Data Ownership
Client retains all rights in its PHI. Company retains all rights in the Platform, software, analytics, and any de-identified or aggregated data used to operate, maintain, and improve the Services.
Company retains all intellectual property rights in and to the Platform, Mobile App, Sensor, and related technology. Client is granted a limited, non-exclusive, non-transferable, revocable license to use the Services during the applicable term, subject to this Agreement.
Client shall not reverse engineer, decompile, modify, or create derivative works of the Services.
Service availability, support response times, and remedies are governed exclusively by the SLA (Exhibit B). Service credits, if any, constitute Client’s sole and exclusive monetary remedy for service performance issues.
Fees are as set forth in the applicable Order Document. Unless otherwise stated:
Fees are non-cancellable and non-refundable once ordered;
Invoices are payable net thirty (30) days;
Fees exclude taxes, duties, and shipping charges.
To the maximum extent permitted by law:
Company’s total aggregate liability under this Agreement shall not exceed the fees paid by Client during the twelve (12) months preceding the event giving rise to the claim.
Neither Party shall be liable for indirect, incidental, special, or consequential damages.
The Services are not a substitute for clinical judgment or care.
Each Party shall indemnify the other for third-party claims arising from its gross negligence, willful misconduct, or violation of law. Client shall indemnify Company for claims arising from misuse of the Services or non-compliant clinical use.
This Agreement remains in effect for the term specified in the applicable Order Document. Either Party may terminate for material breach not cured within thirty (30) days after written notice. Upon termination, Client shall cease use of the Services.
This Agreement is governed by the laws of the State of Delaware, without regard to conflict-of-law principles. Any dispute shall be resolved by binding arbitration in Delaware, except that either Party may seek injunctive relief.
13.1 Entire Agreement
This Agreement, together with the Exhibits and Order Documents, constitutes the entire agreement between the Parties regarding the Services and supersedes all prior or contemporaneous communications.
13.2 Amendments; Waiver
Any amendment must be in writing and signed by both Parties. No waiver is effective unless in writing.
13.3 Severability
If any provision is held unenforceable, the remainder shall remain in effect.
13.4 Assignment
Neither Party may assign this Agreement without prior written consent, except in connection with a merger, acquisition, or sale of substantially all assets.
13.5 Independent Contractors
The Parties are independent contractors.
13.6 Force Majeure
Neither Party is liable for failure to perform due to events beyond its reasonable control.
13.7 Notices
Notices shall be provided in writing using the contact information in the applicable Order Document.
13.8 Public Version; Version Control
This Agreement is published as a standard form for incorporation by reference. The version and effective date stated above apply to Orders accepted on or after the Effective Date. Orders accepted prior to that date remain governed by the version in effect at the time of acceptance. Any fully executed agreement between the Parties that expressly supersedes this Agreement shall control.
13.9 Interpretation
Headings are for convenience only. “Including” means “including without limitation.”
Exhibit A – Business Associate Agreement
Exhibit B – Service Level Agreement
Exhibit C – Equipment Lease Agreement (if applicable)
Exhibit D – Equipment Purchase Agreement (if applicable)
Exhibit E-1 – Data Security & Cloud and Tablet Administration Addendum (optional delegations inside)
Exhibit E-2 – Clinical Operations & Device Management Addendum (optional delegations inside)
If the parties have executed a written agreement that expressly supersedes this standard form, that executed agreement controls.