60 • challenges enforcing our contractua t l and intellectua t l property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States; • difficulties in compliance with non-U.S. laws and regulations; • changes in non-U.S. regulations and customs, tariffs and trade barriers; • changes in non-U.S. currency exchange rates and currency controls; • changes in a specific f country’s or region’s political or economic environment; • trade protection measures, import or export licensing requirements or other restrictive actions by U.S. or non-U.S. governments; • negative consequences from changes in tax laws; • compliance with tax, employment, immigration and labor a laws for employees living or traveling abroad; • workforce uncertainty in countries where labor a unrest is more common than in the United States; • difficulties associated with staffi f ng and managing international operations, including differing labor a relations; • potential liabi a lity under the FCPA or comparable foreign laws; and • business interrupt u ions resulting from geo-political actions, including war and terrorism or natural disasters. Other international, geo-political, and macroeconomic events could also have an adverse impact on our business. The United States and certain other countries may impose significant sanctions, trade restrictions, and other retaliatory r actions in response to these events. While we cannot predict the broader consequences of these types of events, the conflic f t and retaliatory r and counter-retaliatory r actions could materially adversely affe f ct global trade, currency exchange rates, inflation, regional economies, and the global economy, which in turn may increase our costs, disrupt r our suppl u y chain, or otherwise adversely affe f ct our business, financial condition, and results of operations. In addition, increasing inflation rates and the responses by central banking authorities to control such inflation have contributed to uncertainty and volatility in U.S. and global markets. Rising inflation rates in the United States have begun to affe f ct businesses across many industries, including ours, by increasing costs of operations such as labor a . These and other risks associated with our planned international operations may materially adversely affe f ct our business, financial condition, and ability to attain profita f bl a e operations. Our busine i ss couldl be materially l and adverse r ly affe f cted t in the future by the effe f ctst of dise i ase outbreaks,s epidem d ics and pandemics, as well as the busine i ss or operations of our manufa u cturers, r CROs or othe t r third parties with i whom we conduct busine i ss. Our business could be materially and adversely affe f cted by health epidemics in regions where we have concentrations of clinical trial sites or other business operations and could cause significant disrupt r ion in the operations of third-party manufac f turers and CROs upon whom we rely. In addition, our current and future clinical trials may be materially and adversely affe f cted by health epidemics in the future. Site initiation and patient enrollment may be further delayed due to prioritization of hospital resources toward health epidemics. Some patients may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt u healthcare services. Our ability to recrui r t and retain patients and principal investigators and site stafff who, as healthcare providers, may have heightened exposure during health epidemics, and may adversely impact our clinical trial operations. Kodiak stafff and/or our CRO partners may not be able to travel to study t sites, impacting further site initiations and in-person monitoring of study t data quality. Other Kodiak vendors on whom we depend, such as suppl u y chain and logistics partners and our image reading centers may be disrupt r ed, and our operations could be affe f cted. Our clinical studi t es enroll patients who have underlying risk factors such as advanced age, hypertension and/or diabetes which could lead to higher than expected study t discontinuation rates and/or missed visit rates if these patients are adversely affe f cted by health epidemics. To date, we continue to see low levels of patient missed visits.
Kodiak: 2023 Annual Report Page 69 Page 71