Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 64

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 64
---
 may include data hosting, data residency or data localization requirements (which generally require that certain types
of data collected within a certain country be stored and processed within that country), data export restrictions, international transfer
laws (which prohibit or impose conditions upon the transfer of such data from one country to another), or may require companies to implement
privacy or data protection and security policies, enable users to access, correct and delete personal data stored or maintained by such
companies, inform individuals of security breaches that affect their personal data or obtain individuals’ consent to use their
personal data. For example, European legislators adopted the EU’s General Data Protection Regulation (2016/679), or the GDPR, which
became effective on May 25, 2018, and are now in the process of finalizing the ePrivacy Regulation to replace the European ePrivacy Directive
(Directive 2002/58/EC as amended by Directive 2009/136/EC). The GDPR, supplemented by national laws and further implemented through binding
guidance from the European Data Protection Board, imposes more stringent EU data protection requirements and provides for significant
penalties for noncompliance.

Further, the United Kingdom’s
initiating a process to leave the EU has created uncertainty with regard to the regulation of data protection in the United Kingdom.
In particular, the United Kingdom has brought the GDPR into domestic law with the Data Protection Act 2018 which will remain in force,
even if and when the United Kingdom leaves the EU.

Virtually every jurisdiction
in which we expect to operate has established its own data security and privacy legal framework with which we must, and our target customers
will need to, comply, including the rules and regulation mentioned above. We may also need to comply with varying and possibly conflicting
privacy laws and regulations in other jurisdictions. As a result, we could face regulatory actions, including significant fines or penalties,
adverse publicity and possible loss of business.

While we are preparing to
implement various measures intended to enable us to comply with applicable privacy or data protection laws, regulations and contractual
obligations, these measures may not always be effective and do not guarantee compliance. Any failure or perceived failure by us to comply
with our contractual or legal obligations or regulatory requirements relating to privacy, data protection, or information security may
result in governmental investigations or enforcement actions, litigation, claims, or public statements against us by consumer advocacy
groups or others and could result in significant liability, cause our customers, partners or patients to lose trust