Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 171

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 171
---
 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; •if the combined company 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 the combined company 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 the combined company seeks to commercialize or develop, if any, that will affect Kadimastem’s freedom to operate; •if the combined company’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 the combined company’s patents; •the combined company’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 the combined company 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. Obtaining and maintaining the combined company’s patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and the combined company’s 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