Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 178

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 178
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tariffs and trade barriers; •regulations related to customs and import/export matters; •longer payment cycles and challenges in collecting accounts receivable; •tax issues, including but not limited to tax law changes and variations in tax; •currency fluctuations and exchange controls; •rates of inflation; •cultural and language differences; •employment regulations; •trade restrictions including limitations on imports or exports of components or assembled products, unilaterally or bilaterally; •trade sanctions and related regulatory enforcement actions and other proceedings; •potential trade wars; •increased scrutiny by the media and other third parties of labor practices within our industry (including but not limited to working conditions) which may result in allegations of violations, more stringent and burdensome labor laws and regulations and inconsistency in the enforcement and interpretation of such laws and regulations, higher labor costs, and/or loss of revenues if our customers become dissatisfied with our labor practices and diminish or terminate their relationship with us; •imposition of restrictions on currency conversion or the transfer of funds; •expropriation of private entities; •ineffective legal protection of our intellectual property rights in certain countries; •crime, strikes, riots, civil disturbances, terrorist attacks, natural disasters and wars; •deterioration of political relations with the United States; and •government appropriations of assets. We may not be able to adequately address these additional risks. If we were unable to do so, our operations might suffer, which may adversely impact our results of operations and financial condition. 95 Even if we obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential. In order to market any products outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval procedures vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking foreign regulatory approvals could result in significant delays, difficulties and costs for us and may require additional preclinical studies or clinical trials which would be costly and time -consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our products in those countries. Satisfying these and other regulatory requirements is costly, time -consuming, uncertain and subject