Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 138

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 138
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 ability to develop, manufacture, market and sell its product candidates without infringing the proprietary rights of third parties. There is considerable intellectual property litigation in the pharmaceutical industry. While no such litigation has been brought against it and NLS has not been held by any court to have infringed a third party’s intellectual property rights, NLS cannot guarantee that its product candidates or use of its product candidates do not infringe third -partypatents. It is also possible that NLS has failed to identify relevant third -partypatents or applications. For example, applications filed before November 29, 2000 and certain applications filed after that date that will not be filed outside the United States remain confidential until patents issue. Patent applications in the United States and elsewhere are published approximately 18 months after the earliest filing, which is referred to as the priority date. Therefore, patent applications covering its product candidates could have been filed by others without its knowledge. Additionally, pending patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover its product candidates. 47 NLS may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to its product candidates, including inter parties review, interference, or derivation proceedings before the U.S. PTO and similar bodies in other countries. Third parties may assert infringement claims against it based on existing intellectual property rights and intellectual property rights that may be granted in the future. If NLS is found to infringe a third party’s intellectual property rights, NLS could be required to obtain a license from such third party to continue developing and marketing its product candidates. However, NLS may not be able to obtain any required license on commercially reasonable terms or at all. Any inability to secure licenses could result in delays in the introduction of its products or lead to prohibition of the manufacture or sale of products by us. Even if NLS was able to obtain a license, it could be non -exclusive, thereby giving its competitors access to the same license. NLS could be forced, including by court order, to cease commercializing the products subject to the infringing intellectual property rights. In addition, NLS could be found liable for monetary damages, including treble damages and attorneys’ fees if NLS is found to have willfully infringed a patent. A finding of infringement could prevent it from commercializing its product candidates or force it to cease some of its business operations, which could materially harm its business. Claims that NLS