Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 99

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 99
---
 promote their product for Kadimastem’s targeted indications or uses for which it may obtain
patents, physicians may recommend that patients use these products off-label, or patients may do so themselves. Although off-label use
may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to
prevent or prosecute.

<div align='center'>67</div>

There is no certainty that its pending or future patent applications will result in the issuance of patents.

Kadimastem’s success
depends in part on its ability to obtain and defend patent and other intellectual property rights that are important to the commercialization
of its products and product candidates. The degree of patent protection that will be afforded to its products and processes in the U.S.
and in other important markets remains uncertain and is dependent upon the scope of protection decided upon by the patent offices, courts,
administrative bodies and lawmakers in these countries. Kadimastem can provide no assurance that it will successfully obtain or preserve
patent protection for the technologies incorporated into its products and processes, or that the protection obtained will be of sufficient
breadth and degree to protect its commercial interests in all countries where it conducts business. If Kadimastem cannot prevent others
from exploiting its inventions, it will not derive the benefit from them that it currently expects. Furthermore, Kadimastem can provide
no assurance that its products will not infringe patents or other intellectual property rights held by third parties.

In Europe, for example, there
is uncertainty about the eligibility of human embryonic stem cell subject matter for patent protection. The European Patent Convention,
or EPC, prohibits the granting of European patents for inventions that concern “uses of human embryos for industrial or commercial
purposes.” A recent decision at the Court of Justice of the European Union interpreted parthenogenetically produced human embryonic
stem cells as patentable subject matter. Consequently, the European Patent Office now recognizes that human pluripotent stem cells (including
human embryonic stem cells) can be created without a destructive use of human embryos as of June 5, 2003, and patent applications relating
to human embryonic stem cell subject matter with a filing and priority date after this date are no longer automatically excluded from
patentability under Article 53 (a) EPC and Rule 28(c) EPC.

Even if Kadimastem is issued patents, because the patent positions of pharmaceutical and/or biotech products are complex and uncertain,