Company: KROS
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001664710-25-000018
Chunk: 303

Company: Keros Therapeutics, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 303
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 foreign countries and may also conduct certain future clinical trials outside of the United States. Additionally, while we have not taken any steps to enter into any non-U.S. markets, we may do so in the future. Accordingly, we are subject to risks related to operating in foreign countries, including: 

▪different standards of care in various countries that could complicate the evaluation of our product candidates; 

▪different United States and foreign drug import and export rules; 

▪reduced protection for intellectual property rights in certain countries; 

▪unexpected changes in tariffs, trade barriers and regulatory requirements; 

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

▪compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad; 

▪compliance with the FCPA and other anti-corruption and anti-bribery laws; 

▪foreign taxes, including withholding of payroll taxes; 

▪foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; 

▪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; 

▪different payor reimbursement regimes, governmental payors or patient self-pay systems and price controls; 

▪potential liability resulting from development work conducted by foreign partners; 

▪business interruptions resulting from natural disasters, outbreaks of contagious diseases and other public health crises, or geopolitical actions, including war and terrorism, or systems failure including cybersecurity breaches; and 

▪compliance with evolving and expansive foreign regulatory requirements, including data privacy laws (such as the GDPR).

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Additionally, in connection with the ongoing war between Russia and Ukraine, the U.S. government and EU countries have imposed enhanced export controls on certain products and sanctions on certain industry sectors and parties in Russia. The U.S. government has also indicated it will consider imposing additional sanctions and other similar measures in the near future. Although we do not currently conduct any clinical trials in Russia or Ukraine, further escalation of geopolitical tensions could have a broader impact that expands into other markets where we do business or conduct certain research and development operations, which could adversely affect our business, our supply chain for our product candidates, our collaborators or our ability to carry out our clinical trials.

We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control