Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 28

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 28
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 the technologies in a manner that is
different from their customary commercial uses. The quality of materials can be critical to the performance of a drug delivery technology,
so a reliable source that provides a consistent supply of materials is important. Materials or components needed for our drug delivery
technologies may be difficult to obtain on commercially reasonable terms, particularly when relatively small quantities are required or
if the materials traditionally have not been used in pharmaceutical products.

Our reliance on these third-party
suppliers also subjects us to other risks that could harm our business, including:

| ● | we are not currently a major customer of many of our suppliers, and these suppliers may therefore give other customers’ needs higher priority than ours;                                               |
| ● | we may not be able to obtain an adequate supply in a timely manner or on commercially reasonable terms;                                                                                                |
| ● | our suppliers, especially new suppliers, may make errors in manufacturing that could negatively affect the efficacy or safety of our products or cause delays in shipment;                             |
| ● | we may have difficulty locating and qualifying alternative suppliers;                                                                                                                                  |
| ● | switching components or suppliers may require product redesign and possibly submission to the FDA or other similar foreign regulatory agencies, which could impede or delay our commercial activities; |
| ● | one or more of our suppliers may be unwilling or unable to supply components of our products;                                                                                                          |
| ● | the occurrence of a fire, natural disaster or other catastrophe impacting one or more of our suppliers may affect their ability to deliver products to us in a timely manner; and                      |
| ● | our suppliers may encounter financial or other business hardships unrelated to our demand, which could inhibit their ability to fulfill our orders and meet our requirements.                          |

We may not be able to quickly
establish additional or alternative suppliers, if necessary, in part because we may need to undertake additional activities to establish
such suppliers as required by the regulatory approval process. Any interruption or delay in obtaining products from our third-party suppliers,
or our inability to obtain products from qualified alternate sources at acceptable prices in a timely manner, could impair our ability
to meet the demand of our customers and cause them to switch to competing products. Given our reliance on certain suppliers, we may be
susceptible to supply shortages whilst looking for alternate suppliers.

We may not be able to replace our current manufacturing capabilities in a timely manner.

If our manufacturing facility
suffers any type of prolonged interruption, whether caused by regulator action, equipment failure, critical facility services (such as
water purification, clean