Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 49

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 49
---
 to facilitate civil claims in respect of harm caused by AI and to include
AI-enabled products within the scope of the European Union’s existing product liability regime. If enacted, this regulatory framework
is expected to have a material impact on the way AI is regulated in the European Union, and together with developing guidance and/or decisions
in this area, may affect Renovaro Cube’s use of AI and its ability to provide and to improve its services, require additional compliance
measures and changes to its operations and processes, result in increased compliance costs and potential increases in civil claims against
Renovaro Cube, and could adversely affect its business, operations and financial condition.

On October
30, 2023, the Biden administration issued an Executive Order on the Safe, Secure and Trustworthy Development and Use of AI, emphasizing
the need for transparency, accountability, and fairness in the development and use of AI, including in the healthcare industry. The order
seeks to balance fostering innovation with addressing risks associated with AI by providing eight guiding principles and priorities, such
as ensuring that consumers are protected from fraud, discrimination, and privacy risks related to AI. The order also calls for future
regulations from various agencies, such as the Department of Commerce (to draft guidance for detecting and authenticating AI content)
and the Federal Trade Commission (to ensure fair competition and reduce consumer harm). In alignment with the order, other agencies have
published guidance. Other jurisdictions may decide to adopt similar or more restrictive legislation that may render the use of such technologies
challenging.

The FTC
has issued a report expressing a concern regarding AI and bias across industry sectors, including in the healthcare space, and has suggested
that such bias could lead to unfair and deceptive practices, among other concerns. Any changes to our ability to use AI or concerns about
bias could require us to modify our products and services or could have other negative financial impact on our business.

These
compliance obligations may make it harder for us to conduct our business using AI, lead to regulatory fines or penalties, require us to
change our product offerings or business practices, or prevent or limit our use of AI. If we cannot use AI, or if our use of AI is restricted,
our business may be less efficient, or we may be at a competitive disadvantage. Though we have taken steps to be thoughtful in our development,
training, and implementation of machine learning, including taking steps to comply with the laws and frameworks discussed above, our machine
learning-related processing could pose certain risks to