Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-Q/A
Source: 0001731122-25-000250
Chunk: 104

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-Q/A
Chunk 104
---
 of other government agencies that
fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions
at the EMA, the MRHA, and, in the future, the FDA and other agencies may also slow the time necessary for new medical devices or modifications
to cleared or approved medical devices to be reviewed and/or approved by necessary government agencies, which would adversely affect Renovaro
Cube’s business.

If Renovaro Cube is sued for product or professional liability, it could face substantial liabilities that exceed its resources.

Renovaro
Cube’s business depends upon its ability to obtain reliable and accurate test results that incorporate rapidly evolving understanding
of how to interpret minute signals detected by Renovaro Cube’s assays as indications of potential presence of disease. Actual or
perceived errors resulting from laboratory or reporting errors, false positive or false negative test results, or the manufacture, design,
or labelling of Renovaro Cube’s products, could subject Renovaro Cube to product liability or professional liability claims. A product
liability or professional liability claim against Renovaro Cube could result in substantial damages and be costly and time-consuming to
defend. Any liability claim brought against Renovaro Cube, with or without merit, could increase its insurance rates or prevent it from
securing insurance coverage in the future. Additionally, any liability lawsuit could damage Renovaro Cube’s reputation or force
it to delay or suspend sales of its products. The occurrence of any of these events could have a material adverse effect on Renovaro Cube’s
business, results of operations, financial condition and prospects.

<div align='center'>56</div>

Renovaro Cube’s 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 is 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 and, in the future, the United
States and similar fraudulent misconduct laws;