Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 148

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 148
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 in addition to other potentially applicable federal and state laws. In addition, product manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practices, or cGMP, requirements and adherence to commitments made in the NDA or foreign marketing application. If a regulatory authority discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured or disagrees with the promotion, marketing or labeling of that product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If NLS fails to comply with applicable regulatory requirements, a regulatory authority may: •issue an untitled letter or warning letter that we are in violation of the law; •seek an injunction or impose administrative, civil or criminal penalties or monetary fines; •suspend or withdraw regulatory approval; •suspend any ongoing clinical trials; •refuse to approve pending applications or supplements to applications; •restrict the marketing or manufacturing of the product; •seize or detain the products or require the withdrawal of the product from the market; •refuse to permit the import or export of the products; or •refuse to allow NLS to enter into supply contracts, including government contracts. Any government investigation of alleged violations of law could require it to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit its ability to commercialize its product candidates and adversely affect its business, financial condition, results of operations and prospects. The FDA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses. If any of its product candidates are approved and NLS is found to have improperly promoted off -labeluses of those products, NLS may become subject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, if approved. In particular, while the FDA 37 permits the dissemination of truthful and non -misleadinginformation about an approved product, a manufacturer may not promote a product for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. If NLS is found to have promoted such off -labeluses, NLS may become subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off