Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 23

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 23
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 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 we fail 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 us to enter into supply contracts, including government contracts.  

Any government investigation
of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity.
The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and adversely affect
our 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 our product
candidates are approved and we are found to have improperly promoted off-label uses of those products, we 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 permits the dissemination of truthful and non-misleading
information 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 we are found to have promoted such off-label
uses, we may become subject to significant liability. The federal government has levied large civil and criminal fines against
companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion.
The FDA has also requested that companies enter into consent decrees, corporate integrity agreements or permanent injunctions under
which specified promotional conduct must be changed or curtailed. If we cannot successfully manage the promotion of our product