Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 47

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 47
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 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 such laws. If any such actions are instituted against Renovaro Cube or BioSymetrics, and either is
not successful in defending itself or asserting its rights, those actions could have a significant impact on each’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 or BioSymetrics that either was not in violation of these laws, Renovaro Cube or BioSymetrics may be faced with negative publicity,
incur significant expenses defending its actions and have to divert significant management resources from other matters.

Risks Related To Our Business Operations

Our business plan may lead
to the initiation of one or more product development programs