Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 135

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 135
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 actively promote their product for its targeted indications or uses for which NLS may obtain patents, physicians may recommend that patients use these products off -label, or patients may do so themselves. Although off -labeluse 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. 45 Because the patent positions of pharmaceutical products are complex and uncertain, NLS cannot predict the scope and extent of patent protection of its issued patents for its product candidates. NLS’s issued patents may not ensure the protection of its 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 products including identical or similar drug products; •if issued patents expire, there would be no protections against competitors making generic equivalents; •there may be prior art of which we are 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 Quilience and Nolazol, or any other product candidates that we seek to commercialize or develop, if any, that will affect NLS’s freedom to operate; •if NLS’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 NLS’s patents; •NLS’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 NLS encounter delays in its development or clinical trials, the period of time during which it could market our products under patent protection would be reduced. Obtaining and maintaining its patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and its 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