Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 7

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 7
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 but our business strategy
incorporates potentially significant international expansion, particularly in anticipation of approval of our product candidates. We
may plan to maintain sales representatives and conduct physician and patient association outreach activities, as well as clinical
trials, outside of the United States, Switzerland and Europe. If Quilience and/or Nolazol or any of our other product candidates are
approved for commercialization outside the United States, Switzerland, or the EU, we will likely enter into agreements with third
parties to market the drugs in these additional global territories. We expect that we will be subject to additional risks related to
entering into or maintaining international business relationships, including:

  different regulatory requirements for drug approvals in foreign countries;  

  differing United States and foreign drug import and export rules, tariffs and other trade barriers;  

  reduced protection for intellectual property rights in foreign countries;  

  failure by us to obtain regulatory approvals for the use of our products in various countries;  

  different reimbursement systems;  

  economic weakness, including inflation, or political instability in particular foreign economies and markets;  

  multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental ap...  

  complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;  

  financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure ...  

  workforce uncertainty in countries where labor unrest is more common than in the United States;  

  production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;                                                                                    
  regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the U. S. Foreign Corrupt Practices Act...  

  business interruptions resulting from cyber-attacks, geo-political actions, including war (such as the Russia-Ukraine war and Israel’s multi-front war) and terrorism, or natural disasters inclu...  

  potential liability resulting from development work conducted by these distributors; and  

  business interruptions resulting from a local or worldwide pandemic, such as COVID-19, geopolitical actions, including war and terrorism, or natural disasters.  

Any of these factors could
significantly harm our future international expansion and operations and, consequently, our results of operations.

Even if any of our product candidates receives
marketing approval, it may fail to achieve the