Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1173

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1173
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implement the tasks necessary to commercialize its products, which would have a negative impact on Renovaro Cube’s or BioSymetrics’
business and result of operations.

Renovaro
Cube’s or BioSymetrics’ employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct
or other improper activities, including noncompliance with regulatory standards and requirements.

Renovaro
Cube and BioSymetrics are exposed to the risk of fraud, misconduct, or other illegal activity by its employees, independent contractors,
consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and negligent conduct that
fails to comply with the rules and regulations of the Centers for Medicare & Medicaid Services (the “CMS”), the FDA, the
EMA, the MRHA and other comparable regulatory authorities; provide true, complete and accurate information to such regulatory authorities;
comply with manufacturing and clinical laboratory standards; comply with healthcare fraud and abuse laws in the United Kingdom, Europe,
Canada, and, in the future, the United States and similar fraudulent misconduct laws; or report financial information or data accurately
or to disclose unauthorized activities to Renovaro Cube or BioSymetrics. 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,

44

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 and BioSymetrics have each 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 taken to detect and prevent this activity may not be effective in controlling unknown
or unmanaged risks or losses or in protecting each entity from governmental investigations or other actions or lawsuits stemming from
a failure to be in compliance with