Company: NCEL
Filing Date: 2025-02-05
Form Type: F-3
Source: 0001213900-25-010223
Chunk: 96

Company: NewcelX Ltd.
Filing Date: 2025-02-05
Form: F-3
Chunk 96
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 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.

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