Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 100

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 100
---
 Kadimastem cannot predict the scope and extent of patent protection for its product candidates.

Any patents that may be issued
to it will not ensure the protection of Kadimastem’s intellectual property for a number of reasons, including without limitation
the following:

| ● | any issued patents may not be broad or strong enough to prevent competition from other drug substances including identical or similar products and technology; |

| ● | if Kadimastem is not issued patents or if issued patents expire, there would be no protections against competitors making generic equivalents; |

| ● | there may be prior art of which Kadimastem is not aware that may affect the validity or enforceability of a patent claim; |

| ● | there may be other patents existing, now or in the future, in the patent landscape for PBI products, or any other product candidates that Kadimastem seeks to commercialize or develop, if any, that will affect Kadimastem’s freedom to operate; |

| ● | if Kadimastem’s patents are challenged, a court could determine that they are not valid or enforceable; |

| ● | a court could determine that a competitor’s technology or product does not infringe Kadimastem’s patents; |

| ● | Kadimastem’s patents could irretrievably lapse due to failure to pay fees or otherwise comply with regulations, or could be subject to compulsory licensing; and |

| ● | if Kadimastem encounters delays in its development or clinical trials, the period of time during which it could market its products under patent protection would be reduced. |

<div align='center'>68</div>

Obtaining and maintaining Kadimastem’s patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and the patent protection could be reduced or eliminated for noncompliance with these requirements.

Periodic maintenance fees
on any issued patent are due to be paid to the U.S. PTO and foreign patent agencies in several stages over the term of the patent. The
U.S. PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and
other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a
late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment
or lapse of the patent or patent application, resulting in partial or complete