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License and Supply Agreement with Toray Industries | 12 Months Ended
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Dec. 31, 2025
License and Supply Agreement with Toray Industries [Abstract] |
LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES | 3. LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES The Company depends on Toray’s intellectual property for the Symphony cartridges upon which the Symphony platform relies. On October 6, 2020, the Company entered into a License and Supply Agreement (the “License Agreement”) with Toray, providing the Company with an exclusive global license (excluding Japan) to use Toray’s patents and know-how related to the Symphony detection cartridges for manufacturing, marketing and sale of the products (as defined in the License Agreement). In exchange for the license, the Company committed to make two payments of $120,000 each to Toray, both of which were made in 2021. In addition, following the first sale of the cartridges after regulatory clearance, the Company is obligated to make royalty payments to Toray based on the net sales of the cartridges for the period that any underlying patents exist or ten years after the first sale. Following the first sale after obtaining regulatory clearance, the Company will make minimum annual royalty payments of $60,000 for the first year and $100,000 for each year thereafter, which shall be creditable against any royalties owed to Toray in such calendar year. On October 23, 2023, the Company and Toray entered into an Amended and Restated License Agreement (the “New Toray License Agreement”) and a Master Supply Agreement (the “New Toray Supply Agreement”). Under the New Toray License Agreement, the Company continues to license from Toray intellectual property rights needed to manufacture single-use test cartridges, and the Company has received the right to sublicense certain Toray intellectual property to Sanyoseiko in connection with Sanyoseiko’s ongoing agreement with the Company to manufacture the Company’s Symphony analyzers and cartridges (including in connection with the Company’s clinical trials). In addition, the New Toray License Agreement provided for the transfer of certain technology related to the cartridges to Sanyoseiko. The royalty payment percentage payable by the Company to Toray was reduced under the New Toray License Agreement from 15% to 7.5% (or less in certain circumstances) of net sales of certain cartridges for a term of 10 years. A 50% reduction in the royalty rate applies upon expiry of applicable Toray patents on a product-by-product and country-by-country basis. The New Toray License Agreement contemplates that applicable royalty payment obligations from the Company to Toray for other products will be determined separately by the parties in the future. On July 23, 2025, the Company entered into an amendment (the “Amendment”) to the New Toray License Agreement and the New Toray Supply Agreement with Toray. The Amendment provided that the deadline under the New Toray License Agreement for the Company to establish an alternative manufacturing site for the Company’s Symphony cartridges would be extended from October 23, 2025 to October 23, 2026, and the Company has agreed to use its best efforts to establish the site by such date. The Amendment confirms that Toray has provided to the Company all applicable know-how required under the New Toray License Agreement and is not under any further obligation to provide know-how or technical assistance to the Company. Pursuant to the Amendment, the Company paid $71,212 to Toray for a final supply of certain chip components prior to the expiration of the New Toray Supply Agreement, which occurred on October 23, 2025. There were no sales of or revenues from the cartridges during the years ended December 31, 2025 and 2024. The Company has begun cartridge manufacturing process redevelopment through Sanyoseiko, a third-party contractor who is managing such redevelopment. Such redevelopment is intended to address several technical challenges to bring Symphony to a level consistent with necessary performance and quality requirements. After the cartridge manufacturing process redevelopment is completed, the Company plans to have the manufacturing process occur at Sanyoseiko, a FDA-registered CMO, including for verification and validation testing and commercial manufacturing. The manufacturing site will be established by the Company without Toray’s technical assistance. If Toray were to assert that the Company has not used its best efforts to establish the cartridge manufacturing site by October 2026, they could seek to terminate the license agreement as early as November 2026. If Toray were to be successful in terminating the license agreement, the Company would lose access to certain technology required to produce the cartridges that the Symphony system relies on to function, which would likely result in a material adverse effect on the Company’s commercialization efforts. At December 31, 2025 and 2024, there were no amounts accrued related to the New Toray License Agreement or the License Agreement.

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