Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 35

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 35
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 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
cGMP regulations, the clinical data generated in our clinical studies may be deemed unreliable and the FDA, European Medicines Agency,
or EMA, or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing
applications. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory
approval process.

If any of our relationships
with these third-party CROs or vendors terminate, we may not be able to enter into arrangements with alternative CROs or vendors or do
so on commercially reasonable terms. In addition, our CROs are not our employees, and, except for remedies available to us under our
agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our ongoing clinical programs.
If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need