Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 35

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 35
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 including the duration and severity of the outbreak, and the actions that may be required to contain COVID-19 or treat
its impact. In particular, the extent to which any resurgence of the COVID-19 pandemic may impact our business and financial performance
will depend on future developments, which are highly uncertain and cannot be predicted with confidence.

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Risks Related to Our Reliance on Third Parties

We will rely on third parties to conduct certain elements of our preclinical studies and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates.

We rely upon third-party
vendors, including CROs, to monitor and manage data for our ongoing preclinical studies and clinical trials. If our CROs do not successfully
carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy
of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for
other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for or
successfully commercialize our product candidates. We rely on these CROs for execution of our preclinical studies and clinical trials,
and we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted
in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the vendors and CROs does
not relieve us of our regulatory responsibilities. We and our CROs and other vendors are required to comply with good clinical practice,
or GCP, cGMP, the Helsinki Declaration, the International Conference on Harmonization Guideline for Good Clinical Practice, applicable
European Commission Directives on Clinical Trials, laws and regulations applicable to clinical trials conducted in other territories,
and good laboratory practices, or GLP, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member
States of the European Economic Area, or EEA, and comparable foreign regulatory authorities for all of our product candidates in clinical
development. Regulatory authorities enforce these regulations through periodic inspections of study sponsors, principal investigators,
study sites and other contractors. If we or any of our CROs or vendors fail to comply with applicable regulations, including GCP and
c