Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 48

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 48
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 products in a timely manner, or at all.

In addition, if Renovaro Cube’s products labelled as “For Research
Use Only. Not for use in diagnostic procedures,” or RUO, are used, or could be used, for the diagnosis of disease, the regulatory
requirements related to marketing, selling, and supporting such products could change or be uncertain, even if such use by Renovaro Cube’s
customers is without its consent. If the FDA or other regulatory agencies assert that any of Renovaro Cube’s RUO products are subject
to regulatory clearance or approval, Renovaro Cube’s business, financial condition, and results of operations could be adversely affected.

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Regulatory and legislative developments on the use of AI and machine learning could adversely affect Renovaro Cube’s use of such technologies in its platform and other products.

As with
many technological innovations, artificial intelligence presents risks and challenges that could affect its adoption, and therefore our
business. Uncertainty in the legal regulatory regime relating to AI may require significant resources to modify and maintain business
practices to comply with U.S. and non-U.S. laws, the nature of which cannot be determined at this time. It is possible that new laws and
regulations will be adopted in the United Kingdom, the European Union, the United States and/or other foreign jurisdictions, or that existing
laws and regulations may be interpreted in ways that would affect the operation of Renovaro Cube’s AI platform and data analytics
and the way in which Renovaro Cube uses AI and machine learning technology. Further, the cost to comply with such laws or regulations
could be significant and would increase Renovaro Cube’s operating expenses, which could adversely affect its business, financial
condition and results of operations.

For example,
in Europe, on April 21, 2021, the European Commission proposed a regulation seeking to establish a comprehensive, risk-based governance
framework for AI in the European Union market. The proposed legislation is intended to apply to companies that develop, use and/ or provide
AI in the European Union and includes requirements around transparency, conformity assessments and monitoring, risk assessments, human
oversight, security and accuracy, and proposes fines for breach of up to 6% of worldwide annual turnover. In addition, on September 28,
2022, the European Commission proposed the AI Liability Directive and the revised Product Liability Directive seeking to establish a harmonized
civil liability regime for AI in the European Union in order