Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 62

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 62
---
. Failure to comply with such laws and regulations could result in government enforcement
actions and create liability for us (including the imposition of significant civil or criminal penalties), private litigation and/or
adverse publicity that could negatively affect our business. For instance, California enacted the California Consumer Privacy Act, or
the CCPA, on June 28, 2018, which took effect on January 1, 2020. The CCPA creates individual privacy rights for California consumers
and increases the privacy and security obligations of entities handling certain personal data. The CCPA provides for civil penalties
for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. The CCPA
may increase our compliance costs and potential liability, and many similar laws have been proposed at the federal level and in other
states.

In addition, we expect to
obtain health information that are subject to privacy and security requirements under HITECH and its implementing regulations. The Privacy
Standards and Security Standards under HIPAA establish a set of standards for the protection of individually identifiable health information
by health plans, health care clearinghouses and certain health care providers, referred to as Covered Entities, and the business associates
with whom Covered Entities enter into service relationships pursuant to which individually identifiable health information may be exchanged.
Notably, whereas HIPAA previously directly regulated only Covered Entities, HITECH makes certain of HIPAA’s privacy and security
standards also directly applicable to Covered Entities’ business associates. As a result, both Covered Entities and business associates
are now subject to significant civil and criminal penalties for failure to comply with Privacy Standards and Security Standards. As part
of our normal operations, we expect to collect, process and retain personal identifying information regarding patients, including as
a business associate of Covered Entities, so we expect to be subject to HIPAA, including changes implemented through HITECH, and we could
be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information in a manner that is
not authorized or permitted by HIPAA. A data breach affecting sensitive personal information, including health information, also could
result in significant legal and financial exposure and reputational damages that could potentially have an adverse effect on our business.

<div align='center'>42</div>

HIPAA requires Covered Entities
(like many of our potential customers) and business associates, like us, to develop and maintain policies and procedures with respect
to protected health information that is used or disclosed, including the adoption of administrative