Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-Q/A
Source: 0001731122-25-000250
Chunk: 105

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-Q/A
Chunk 105
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 or report financial information or data accurately or to disclose unauthorized activities
to Renovaro Cube. When Renovaro Cube begins commercializing its products in the United Kingdom and Europe and, in the future, the United
States, its potential exposure under such laws will increase significantly, and its costs associated with compliance with such laws are
also likely to increase. In particular, research, sales, marketing, education and other business arrangements in the healthcare industry
are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices, as well as off-label product
promotion. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, educating, marketing and promotion,
sales and commission, certain customer incentive programs and other business arrangements generally. Activities subject to these laws
also involve the improper use of information obtained in the course of clinical validation, which could result in regulatory sanctions
and cause serious harm to Renovaro Cube’s reputation. Renovaro Cube has adopted a code of business conduct and ethics, but it is
not always possible to identify and deter misconduct by employees and third parties, and the precautions Renovaro Cube takes to detect
and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Renovaro Cube from
governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws. If any such actions
are instituted against Renovaro Cube, and Renovaro Cube is not successful in defending itself or asserting its rights, those actions could
have a significant impact on Renovaro Cube’s business, including the imposition of significant fines or other sanctions. Even if
it is later determined after an action is instituted against Renovaro Cube that Renovaro Cube was not in violation of these laws, Renovaro
Cube may be faced with negative publicity, incur significant expenses defending its actions and have to divert significant management
resources from other matters.

Renovaro Cube’s products, if used for the diagnosis of disease, could be subject to government regulation, and the regulatory approval and maintenance process for such products may be expensive, time-consuming, and uncertain both in timing and in outcome.

Renovaro
Cube’s products are not subject to FDA or other government regulatory clearance or approval if they are not intended to be used
for the diagnosis, treatment or prevention of disease. However, as Renovaro Cube expands its product line to encompass products that are
intended to be used for the