cover the potentially significant losses that may result from a security incident or breach or that the insurer will not deny coverage of any future claim.
Our operations as a global company subject us to various risks, and our failure to manage these risks could adverselyaffect our business, results of operations, cash flows, financial condition and/or prospects.
We face significantoperational risks as a result of doing business globally, such as:
| | | fluctuations in currency exchange rates (in particular, U.S. dollars, Euros and Danish kroner); |
| | | potentially adverse tax consequences, including the complexities of foreign value-added tax systems, taxinefficiencies related to our corporate structure, and potential restrictions on the repatriation of earnings; |
| | | export restrictions, trade regulations and foreign tax laws; |
| | | customs clearance and shipping delays; |
| | | the burdens of complying with a wide variety of foreign laws and different legal standards; and |
| | | increased financial accounting and reporting burdens and complexities. |
If one or more of these risks are realized, it could have a material adverse effect on our business, results of operations,cash flows, financial condition and/or prospects.
We or the third parties upon whom we depend may be adverselyaffected by earthquakes, fires or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
If earthquakes, fires, other natural disasters, terrorism and similar unforeseen events beyond our control prevent us fromusing all or a significant portion of our headquarters or other facilities, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. We do not have a disaster recovery or businesscontinuity plan in place and may incur substantial expenses as a result of the absence or limited nature of our internal or third-party service provider disaster recovery and business continuity plans, which, particularly when taken together withour lack of earthquake insurance, could have a material adverse effect on our business. Furthermore, integral parties in our supply chain are operating from single sites, increasing their vulnerability to natural disasters or other sudden,unforeseen and severe adverse events. If such an event were to affect our supply chain, it could have a material adverse effect on our ability to conduct our clinical trials, our development plans and business.
We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and othertrade laws and regulations. We can face serious consequences for violations.
U.S. and foreign anti-corruption,anti-money laundering, export control, sanctions, and other trade laws and regulations (collectively, Trade Laws) prohibit, among other things, companies and their employees, agents, CROs, legal counsel, accountants, consultants, contractors, andother partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Lawscan result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. We have direct or indirectinteractions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We also expect to continue our non-U.S. activities, which mayincrease over time. We expect to rely on third parties for research, preclinical studies, and clinical trials and/or to obtain necessary permits, licenses, patent registrations, and other marketing approvals. We can be held liable for the corrupt orother illegal activities of our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such activities.
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