Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 132

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 132
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. If the combined company
cannot prevent others from exploiting its inventions, it will not derive the benefit from them that it currently expects. Furthermore,
the combined company 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 the combined company will issue
patents, because the patent positions of pharmaceutical and/or biotech products are complex and uncertain, the combined company 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 the combined company’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;  
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  if the combined company is not issued patents or if issued                                     

  there may be prior art of which the combined company is not              
  aware that may affect the validity or enforceability of a patent claim;  
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  there may be other patents existing, now or in the future,                                                                              
  in the patent landscape for PBI products, or any other product candidates that the combined company seeks to commercialize or develop,  
  if any, that will affect Kadimastem’s freedom to operate;                                                                               
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  if the combined company’s patents are challenged, a