Company: QTIWW
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001844505-25-000038
Chunk: 36

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 36
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 regulatory approval process in Japan. 

CMSC and QT Imaging have also discussed other potential terms between them. 

Feasibility Agreement with Canon Medical Systems Corporation 

On March 28, 2024, the Company entered into the Feasibility Study Agreement with CMSC. The term of the Feasibility Study Agreement commenced on March 28, 2024 and remained in force until the end of December 2024. In connection with the Feasibility Study Agreement, CMSC initiated studies to evaluate the business, technical, and clinical values of the QT Breast Scanner including the Feasibility Study. CMSC has no right to reverse engineer the QT Breast Scanner and may only modify and disassemble the QT Breast Scanner as necessary to conduct the Feasibility Study.

Under the terms of the Feasibility Study Agreement, QT Imaging provided support for the Feasibility Study as agreed with CMSC from time to time during the term of the Feasibility Study Agreement and used its commercially reasonable efforts to facilitate the Feasibility Study.

All know-how and intellectual property embodied in QT Breast Scanner are owned by QT Imaging and all rights not expressly granted to QT Imaging are reserved.

33

Canon Manufacturing Agreement

On March 28, 2025, the Company entered into a manufacturing agreement (the “Canon Manufacturing Agreement”) with CMSC.  Pursuant to the terms of the Canon Manufacturing Agreement, the Company appoints CMSC as the exclusive manufacture of the QT Breast Scanners to be distributed by NXC Imaging, a wholly-owned subsidiary of CMSU (“NXC”) pursuant to the Amended Distribution Agreement (as defined below).  CMSC’s manufacturing of the QT Breast Scanners shall not include the final testing process for the QT Breast Scanners, and CMSC shall not have any responsibility for the QT Breast Scanner as a manufacturer of medical equipment for FDA purposes.

In order for CMSC to manufacture the QT Breast Scanners, the Company shall sell components to CMSC in a timely manner, in accordance with agreed-upon terms and conditions.  The Company shall cooperate with and support CMSC to allow CMSC to procure components through its own supply chain.  The parties shall negotiate in good faith specific procedures to phase out CMSC’s purchase of components from the Company, with the target date of the fourth quarter of 2025, although this is not a commitment.  The terms for purchasing components (or subassemblies), including components for service, by the Company from CMSC shall be mutually agreed upon by the parties.

The