Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 62

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 62
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 EU and Israel),
or conflict with other laws and regulations. The regulatory framework for privacy and data protection worldwide is, and is likely to
remain for the foreseeable future, uncertain and complex, and this or other actual or alleged obligations may be interpreted and applied
in a manner that we may not anticipate or that is inconsistent from one jurisdiction to another and may conflict with other rules or
practices including ours. Further, any significant change to applicable laws, regulations, or industry practices regarding the collection,
use, retention, security, or disclosure of data, or their interpretation, or any changes regarding the manner in which the consent of
relevant users for the collection, use, retention, or disclosure of such data must be obtained, could increase our costs and require
us to modify our services and candidate products, possibly in a material manner, which we may be unable to complete, and may limit our
ability to store and process patients’ data or develop new services and features.

In particular, we will be
subject to U.S. data protection laws and regulations (i.e., laws and regulations that address privacy and data security) at both the
federal and state levels. The legislative and regulatory landscape for data protection continues to evolve, and in recent years there
has been an increasing focus on privacy and data security issues. Numerous federal and state laws, including state data breach notification
laws, state health information privacy laws, and federal and state consumer protection laws, govern the collection, use, and disclosure
of health-related and other personal information. 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