Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 132

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 132
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 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 other regulatory authorities through their facilities inspection program. Some of its contract manufacturers have never produced a commercially approved pharmaceutical product and therefore have not obtained the requisite regulatory authority approvals to do so. The facilities and quality systems of some or all of its collaborators and third -partycontractors must pass a pre -approvalinspection for compliance with the applicable regulations as a condition of regulatory approval of its product candidates or any of its other potential product candidates. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of its product candidates or its other potential product candidates or the associated quality systems for compliance with the regulations applicable to the activities being conducted. NLS does not control the manufacturing process of, and are completely dependent on, its contract manufacturing partners for compliance with the regulatory requirements. If these facilities do not pass a pre -approvalplant inspection, regulatory approval of the product candidates may not be granted or may be substantially delayed until any violations are corrected to the satisfaction of the regulatory authority, if ever. Moreover, if its contract manufacturers fail to achieve