Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 27

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 27
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, which has resulted in several Congressional inquiries and proposed bills designed to, among other things, bring more
transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program
reimbursement methodologies for drug products. Individual states in the United States have also become increasingly active in implementing
regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions
on certain product access and marketing cost disclosure and transparency measures, and, in some cases, proposing to encourage importation
from other countries and bulk purchasing. We cannot predict what healthcare reform initiatives may be adopted in the future.

We also are subject to various
federal, state, and local laws, regulations, and recommendations relating to safe working conditions, laboratory and manufacturing practices,
the experimental use of animals, and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds
and infectious disease agents, used in connection with our research. The extent of government regulation that might result from any future
legislation or administrative action cannot be accurately predicted.

Renovaro
Cube’s AI-guided diagnostic platform operates within a highly regulated environment, particularly as it involves health data
and medical diagnostics. As a Software as a Medical Device (SaMD), the platform will require compliance with various regional regulations,
including but not limited to the U.S. Food and Drug Administration (FDA) guidelines and European Union Medical Device Regulation (MDR).
Our regulatory strategy involves a meticulous development process, adhering to international standards such as for quality management
systems. Key elements include rigorous clinical validation, cybersecurity, data privacy (in compliance with HIPAA and GDPR), and quality
control to ensure patient safety and diagnostic accuracy. Post-market surveillance and continuous improvement will be integral to maintaining
compliance and effectiveness as we aim for global commercialization. Given the rapidly evolving regulatory landscape for AI-driven diagnostics,
Renovaro Cube remains committed to working closely with regulatory bodies to navigate the approval processes and to address ethical considerations,
ensuring that our products meet the highest standards of safety and efficacy.

Foreign Corrupt Practices Act

Our business activities may be
subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations, or rules of other
countries in which we operate. The FCPA generally prohibits offering, promising, giving, or authorizing others to give anything of value,
either directly or indirectly, to a non-U.S. government official to influence official action, or otherwise