Company: OFIX
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0000950170-25-026066
Chunk: 147

Company: Orthofix Medical Inc.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1A
Chunk 147
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 approvals; 

•changes in, or uncertainties relating to, foreign rules and regulations that may impact our ability to sell our products, perform services or repatriate profits to the U.S.; 

•tariffs, trade barriers, export regulations, and other regulatory and contractual limitations that may adversely impact our ability to sell our products in certain foreign markets, the scope and consequences of which are subject to changing agendas of political, business, and environmental groups;

•consequences from changes in tax or customs laws; 

•fluctuations in foreign currency exchange rates; 

•limitations on or increase of withholding and other taxes on remittances and other payments by foreign subsidiaries or joint ventures; 

•differing multiple payor reimbursement regimes, government payors, or patient self-pay systems; 

•differing labor laws and standards; 

•an inability, or reduced ability, to protect our intellectual property, including any effect of compulsory licensing imposed by government action;

•availability of government subsidies or other incentives that benefit competitors in their local markets that are not available to us; and 

•having to comply with various U.S. and international laws, including the FCPA and anti-money laundering laws, and violation by our independent sales representatives or distributors of such laws. 

44

Risks Related to our Intellectual Property

We depend on our ability to protect our intellectual property and proprietary rights, but we may not be able to maintain the confidentiality of these assets or assure their protection. 

Our success depends, in large part, on our ability to protect our current and future technologies and products and to defend our intellectual property rights. If we fail to protect our intellectual property adequately, competitors may manufacture and market products that are similar to, or that compete directly with, our products. Numerous patents covering our technologies have been issued to us and we have filed, and expect to continue to file, patent applications seeking to protect newly developed technologies and products in various countries, including the U.S. Some patent applications in the U.S. are maintained in secrecy until the patent is issued. Because the publication of discoveries tends to follow their actual discovery by several months, we may not be the first to invent or file patent applications on any of our discoveries. Further, there is a substantial backlog of patent applications at the U.S. Patent and Trademark Office, and the approval or rejection of patent applications may take several years. Patents may not be issued with respect to any of our patent applications and existing or future patents issued to or licensed by us and may not provide