Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 154

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 154
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 If we, or its contract manufacturers are unable to comply with such process validation or other requirements, NLS may be subject to regulatory, civil actions or penalties which could harm its business. NLS purchases finished mazindol, the molecule in both of Quilience and Nolazol, from a single third party, currently under a development agreement with us. In addition, NLS does not have an agreement in place for, but NLS has identified, a secondary fill/finish supplier. There can be no guarantee that NLS will enter into an agreement with such fill/finish supplier or that an effort to enter into such an agreement will be on favorable terms. If NLS needs to identify an additional fill/finish manufacturer, NLS would not be able to do so without delay and likely significant additional costs. 44 Its existing manufacturer and any future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business. In the event of a natural disaster, business failure, strike or other difficulty, such as difficulties involving production yields, quality control and quality assurance, NLS may be unable to replace a third -partymanufacturer in a timely manner and the production of any product candidate or commercialized drug would be interrupted, resulting in delays and additional costs. In addition, because the contract manufacturer of its drug substance is located in the United States, NLS may face difficulties in importing its drug substances into Europe as a result of, among other things, import inspections, incomplete or inaccurate import documentation or defective packaging. NLS and its collaborators and contract manufacturers are subject to significant regulation with respect to manufacturing its product candidates. The manufacturing facilities on which NLS rely may not continue to meet regulatory requirements and have limited capacity. Manufacturers and their facilities are required to comply with extensive regulatory requirements, including ensuring that quality control and manufacturing procedures conform to cGMPs. These cGMP regulations cover all aspects of manufacturing relating to its product candidates. These regulations govern manufacturing processes and procedures (including record keeping) and the implementation and operation of quality systems to control and assure the quality of investigational product candidates and products approved for sale. Poor control of production processes can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of its product candidates that may not be detectable in final product testing. We, its collaborators or its contract manufacturers must supply all necessary documentation in support of an NDA or MAA on a timely basis and must adhere to GLP and cGMP QSR regulations enforced by the FDA and