Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 41

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 41
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 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 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