Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 39

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 39
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 and others are
custom-made components for us. We do not have any control over the availability of raw materials. If we or our manufacturers are unable
to purchase these raw materials on acceptable terms, at sufficient quality levels, or in adequate quantities, if at all, the development
and commercialization of our product candidates or any future product candidates, would be delayed or there would be a shortage in supply,
which would impair our ability to meet our development objectives for our product candidates or generate revenues from the sale of any
approved products.

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We intend to rely on third
party suppliers for these raw materials, which will continue to expose us to manufacturing risks including:

| ● | reduced control for certain aspects of manufacturing activities;                                                                                    |
| ● | termination or nonrenewal of manufacturing and service agreements with third parties in a manner or at a time that is costly or damaging to us; and |

| ● | disruptions to the operations of our third-party manufacturers and service providers caused by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or service provider. |

We require materials from
suppliers that are cGMP compliant. All of our raw material suppliers are cGMP-compliant at the present. If these suppliers do not successfully
carry out their contractual duties or manufacture our raw materials in accordance with regulatory requirements, we will not be able to
submit our NDA as planned or complete, or may be delayed in completing, the clinical trials required for approval of our Gelrin platform
product candidates. In such instances, we may need to locate an appropriate replacement third-party relationship, which may not be readily
available or on acceptable terms, which would cause additional delay or increased expense prior to the approval of our Gelrin platform
product candidates and would thereby have a material adverse effect on our business, financial condition, results of operations and prospects.

Our reliance on third parties requires us to share our trade secrets and intellectual property, which increases the possibility that a competitor will discover them or that our trade secrets and intellectual property will be misappropriated or disclosed.

Because we rely on third parties
to provide us with the materials and services that we use to develop and, if appropriate in the future, manufacture our product candidates
or approved products, we may, at times, share trade secrets and intellectual property with such third parties. We seek to protect our
technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research
agreements, consulting