Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 61

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 61
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subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from government funded healthcare
programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. Exclusion, suspension and debarment
from government funded healthcare programs would significantly impact our ability to commercialize, sell or distribute any product.
If any of the physicians or other providers or entities with whom we expect to do business are found not to be in compliance with
applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded
healthcare programs.

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Changes in laws or regulations relating to data protection, or any actual or perceived failure by us to comply with such laws and regulations or our privacy policies, could materially and adversely affect our business or could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.

We expect to receive health
information and other highly sensitive or confidential information and data of patients and other third parties (e.g., healthcare providers
who refer GelrinC to patients), which we expect to compile and analyze. Collection and use of this data might raise privacy and data protection
concerns, which could negatively impact our business. There are numerous federal, state and international laws and regulations regarding
privacy, data protection, information security, and the collection, storing, sharing, use, processing, transfer, disclosure, and protection
of personal information and other data, and the scope of such laws and regulations may change, be subject to differing interpretations,
and may be inconsistent among countries and regions we intend to operate in (e.g., the United States, the 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