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You should carefully consider the risk factors discussed below, together with all the other information included in this Form 10-K, in evaluating us and our ordinary shares.
−Removed: If any of the risks below actually occurs, our business, financial condition, results of operations and cash flows could be materially and adversely affected.
+Added: If any of the risks below actually occur, our business, financial condition, results of operations and cash flows could be materially and adversely affected.
Any such adverse effect may cause the trading price of our ordinary shares to decline, and as a result, you could lose all or part of your investment in us.
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export duties and quotas;
−Removed: imposition of, or changes in, tariffs, sanctions, trade restrictions, and trade relations including but not limited to those associated with the United States-Mexico-Canada Agreement ("USMCA") which replaced the North American Free Trade Agreement ("NAFTA"), other free trade agreements, and the exit of the United Kingdom from the European Union;
−Removed: unexpected changes in regulatory requirements;
+Added: imposition of, or escalations or changes in, tariffs, sanctions, trade restrictions, and trade relations including but not limited to those associated with the United States-Mexico-Canada Agreement ("USMCA") which replaced the North American Free Trade Agreement ("NAFTA"), other free trade agreements, and the exit of the United Kingdom from the European Union;
+Added: new or unexpected changes in regulatory requirements;
certification requirements;
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political and economic instability;
−Removed: geopolitical tensions;
−Removed: and preference for locally produced products.
+Added: geopolitical tensions and increased geopolitical volatility;
+Added: geopolitical trends towards nationalism and protectionism;
+Added: changing perceptions of U.S.-based companies;
+Added: preference for locally produced products;
+Added: and global economic uncertainty and long-term changes in global trade.
These factors could have a material adverse impact on our ability to increase or maintain our international sales.
Our sales and operations may be adversely affected by supply chain disruptions due to political unrest, terrorist acts, and national and international conflicts.
−Removed: Our sales and operations are subject to a number of risks, including political and economic instability and geopolitical tensions, which could have a material adverse impact on our ability to increase or maintain our international sales and operations.
+Added: Our sales and operations are subject to a number of risks, including political and economic instability, geopolitical tensions, and increased geopolitical volatility, which could have a material adverse impact on our ability to increase or maintain our international sales and operations.
National and international conflicts such as war, border closures, civil disturbances and terrorist acts, including Russia's invasion of Ukraine and the ongoing conflict in the Middle East, may increase the likelihood of already strained supply interruptions and further hinder our ability to access the materials and energy we need to manufacture our products.
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The effects of global climate change or other unexpected events, including global health crises, may disrupt our operations and have a negative impact on our business.
−Removed: The effects of global climate change, such as extreme weather conditions and natural disasters occurring more frequently or with more intense effects, or the occurrence of unexpected events including wildfires, tornadoes, hurricanes, earthquakes, floods, tsunamis and other severe hazards or global health crises, such as the outbreak of Ebola or the global COVID-19 pandemic, or other actual or threatened epidemic, pandemic, outbreak and spread of a communicable disease or virus, in the countries where we operate or sell products and provide services, could adversely affect our operations and financial performance.
+Added: The effects of global climate change, such as extreme weather conditions and natural disasters occurring more frequently or with more intense effects, or the occurrence of unexpected events including floods, extreme wind, wildfires, tornadoes, hurricanes, earthquakes, tsunamis and other severe hazards or global health crises, such as the outbreak of Ebola or the global COVID-19 pandemic, or other actual or threatened epidemic, pandemic, outbreak and spread of a communicable disease or virus, in the countries where we operate or sell products and provide services, could adversely affect our operations and financial performance.
Extreme weather, natural disasters, power outages, global health crises or other unexpected events could disrupt our operations by impacting the availability and cost of materials needed for manufacturing, causing physical damage and partial or complete closure of our manufacturing sites or distribution centers, loss of human capital, temporary or long-term disruption in the manufacturing and supply of products and services and disruption in our ability to deliver products and services to customers.
These events and disruptions could also adversely affect our customers’ and suppliers’ financial condition or ability to operate, resulting in reduced customer demand, delays in payments received or supply chain disruptions.
−Removed: Further, these events and disruptions could increase insurance and other operating costs, including impacting our decisions regarding construction of new facilities to select areas less prone to climate change risks and natural disasters, which could result in indirect financial risks passed through the supply chain or other price modifications to our products and services.
+Added: Further, these events and
+Added: disruptions could increase insurance and other operating costs, including impacting our decisions regarding construction of new facilities to select areas less prone to climate-related events and natural disasters, which could result in indirect financial risks passed through the supply chain or other price modifications to our products and services.
We may be subject to risks relating to our information technology and operational technology systems.
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Disruptions or breaches of our information systems could adversely affect us.
−Removed: Despite our implementation of cybersecurity measures which have focused on prevention (including a robust cybersecurity employee education program to train our employees on email and password security, recognizing phishing and related topics on a regular basis), mitigation, resilience and recovery, our network and products, including access solutions, may be vulnerable to cybersecurity attacks, computer viruses, malicious codes, malware, ransomware, phishing, social engineering, denial of service, hacking, break-ins and similar disruptions, including through use of emerging technologies, such as artificial intelligence and machine learning.
−Removed: Cybersecurity attacks and intrusion efforts are continuous and evolving, and in certain cases they have been successful at the most robust institutions.
+Added: Despite our implementation of cybersecurity measures which have focused on prevention (including a robust cybersecurity employee education program to train our employees on email and password security, recognizing phishing and related topics on a regular basis), mitigation, resilience and recovery, our network and products, including access solutions, may be vulnerable to cybersecurity attacks, computer viruses, malicious codes, malware, ransomware, phishing, social engineering, denial of service, hacking, break-ins and similar disruptions, including through use of emerging technologies, such as artificial intelligence ("AI") and machine learning.
+Added: Cybersecurity attacks and intrusion efforts are continuous and constantly evolving, making it more difficult to successfully defend against them or to implement adequate preventative measures, and in certain cases they have been successful at the most robust institutions.
+Added: Geopolitical tensions or conflicts may further heighten the risk of cybersecurity attacks.
+Added: Further, the emergence and maturation of AI capabilities may lead to new or more sophisticated methods of attack, including fraud or phishing attempts that rely upon "deep fake" impersonation technology or other forms of generative technology that may increase the efficiency or effectiveness of cybersecurity attacks.
+Added: AI is also increasingly being used by malicious actors to create more targeted cybersecurity attacks and spread disinformation.
The scope and severity of risks that cyber threats present have increased dramatically and include, but are not limited to, malicious software, attempts to gain unauthorized access to data or premises, exploiting weaknesses related to vendors or other third parties that could be exploited to attack our systems, denials of service and other electronic security breaches that could lead to disruptions in systems, unauthorized release of confidential or otherwise protected information and corruption of data.
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We also face increasing and evolving disclosure obligations related to cybersecurity events.
−Removed: Despite rigorous processes, we may not adequately meet all our existing or future disclosure obligations and/or having our disclosures misinterpreted.
+Added: Despite rigorous processes, we may not adequately meet all our existing or future disclosure obligations and/or we may have our disclosures misinterpreted.
Determining whether a cybersecurity incident is notifiable or reportable may not be straightforward and any such mandatory disclosures could lead to negative publicity, loss of customer confidence in the effectiveness of our security measures, diversion of management's attention and governmental investigations.
−Removed: Our daily business operations also require us to collect and/or retain sensitive data such as intellectual property, proprietary business information and data related to customers, employees, suppliers and business partners within our networking infrastructure including data from individuals subject to the European Union's General Data Protection Regulation, that is subject to privacy and security laws, regulations and/or customer-imposed controls.
+Added: Our daily business operations also require us to collect and/or retain sensitive data such as intellectual property, proprietary business information and data related to customers, employees, suppliers and business partners within our networking infrastructure including data from individuals subject to the European Union's General Data Protection Regulation, that is subject
+Added: to privacy and security laws, regulations and/or customer-imposed controls.
Despite our efforts to protect such data, the loss or breach of such data due to various causes including material security breaches, catastrophic events, extreme weather, natural disasters, power outages, system failures, computer viruses, improper data handling, programming errors, unauthorized access and employee error or malfeasance could result in wide reaching negative impacts to our business, and as such, the ongoing maintenance and security of this information is pertinent to the success of our business operations and our strategic goals.
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Global economic conditions may adversely affect our business, operating results and financial condition.
−Removed: Unfavorable changes in economic conditions, including inflation, monetary policies, recession, changes in tariffs and trade relations amongst international trading partners, or other changes in economic conditions, may adversely impact the markets in which we operate.
+Added: Unfavorable changes and instability in economic conditions, including inflation, monetary policies, recession, changes in tariffs and trade relations amongst international trading partners, geopolitical tensions and increased geopolitical volatility, or other changes in economic conditions, may adversely impact the markets in which we operate.
These conditions may make it extremely difficult for our customers, our vendors and us to accurately forecast and plan future business activities, and they could cause U.S.
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Interest payable in accordance with our five-year senior secured revolving credit agreement (the "Credit Agreement") is based on a fluctuating rate.
−Removed: In light of potential fluctuations, including interest rate increases which may continue, we are exposed to risk resulting from adverse changes in interest rates.
−Removed: Further, due to the cessation of the London Interbank Offered Rate (“LIBOR”), we have entered into financial transactions such as credit agreements that use the Secured Overnight Financing Rate (“SOFR”) as interest rate benchmarks.
−Removed: SOFR is calculated differently from LIBOR and has inherent differences which could give rise to uncertainties, including the limited historical data and volatility in the benchmark rates.
−Removed: The full effects of the transition to SOFR or other rates remain uncertain.
+Added: In light of potential fluctuations, including interest rate increases, we are exposed to risk resulting from adverse changes in interest rates.
+Added: In addition, certain of our financial transactions such as our credit agreement have, or in the future could have, interest rates that are tied to reference rates such as the Secured Overnight Financing Rate (“SOFR”).
+Added: The volatility and availability of such reference rates, including the use of alternative reference rates, are outside of our control and the consequences are not entirely predictable.
We may not be able to successfully consummate and manage acquisition, joint venture and divestiture activities which could have an impact on our results.
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As we continue to add capabilities to quickly move the appropriate amount of inventory at optimal operational costs through our entire supply chain, operating our fulfillment network becomes more complex and challenging.
−Removed: If our fulfillment network does not operate properly, if a vendor fails to deliver on its commitments, or if common carriers have difficulty providing capacity to meet demands for their services, we could experience inventory shortages, delivery delays or increased delivery costs, which could lead to lost sales and decreased guest confidence, and adversely affect our results of operations.
+Added: If our fulfillment network does not operate properly, if a vendor fails to deliver on its commitments, or if common carriers have difficulty providing capacity to meet demands for their services, we could experience inventory shortages, delivery delays or increased delivery costs, which could lead to lost sales and decreased customer confidence, and adversely affect our results of operations.
A large portion of our raw materials are sourced, directly or indirectly, from outside the U.S.
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and countries from which we source raw materials could require us to take certain actions, including for example raising prices on products we sell and seeking alternative sources of supply from vendors in other countries with whom we have less familiarity, which could adversely affect our reputation, sales, and our results of operations.
−Removed: Political or financial instability, geopolitical tensions, currency fluctuations, the outbreak of pandemics or other illnesses (such as the COVID-19 pandemic), labor unrest, transport capacity and costs, port security, weather conditions, natural disasters, or other events that could alter or suspend our operations, slow or disrupt port activities, or affect foreign trade are beyond our control and could materially disrupt our supply of raw materials, increase our costs, and/or adversely affect our results of operations.
+Added: Political or economic instability, geopolitical tensions and volatility, currency fluctuations, the outbreak of pandemics or other illnesses (such as the COVID-19 pandemic), labor unrest, transport capacity and costs, port security, weather conditions, natural disasters, or other events that could alter or suspend our operations, slow or disrupt port activities, or affect foreign trade are beyond our control and could materially disrupt our supply of raw materials, increase our costs, and/or adversely affect our results of operations.
There have been periodic labor disputes impacting the U.S.
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Adverse intellectual property litigation or claims of infringement against us may become extremely disruptive if the plaintiffs succeed in blocking the trade of our products and services and may have a material adverse effect on our business.
−Removed: We are subject to risks related to corporate social responsibility and reputational matters.
+Added: We are subject to risks related to sustainability and corporate social responsibility and various reputational matters.
Our reputation and the reputation of our brands, including the perception held by our customers, end-users, business partners, investors, other key stakeholders and the communities in which we do business are influenced by various factors.
−Removed: With respect to interest from our stakeholders on Environmental, Social and Governance (“ESG”) practices and disclosure, if we fail, or are perceived to have failed, in any number of ESG matters, such as environmental stewardship, goals regarding our intended reduction of carbon emissions and water usage, workplace conduct and belonging, and support for local communities, or to effectively respond to changes in, or new, legal or regulatory requirements concerning climate change, climate risk reporting, or other sustainability concerns, our reputation or the reputation of our brands may suffer.
+Added: With respect to interest from our stakeholders on our sustainability and corporate social responsibility (including Environmental, Social and Governance ("ESG")) practices and disclosure, if we fail, or are perceived to have failed, in any number of sustainability or corporate social responsibility matters, such as environmental stewardship, goals regarding our intended reduction of carbon emissions and water usage, workplace conduct and belonging, and support for local communities, or to effectively respond to changes in, or new, legal or regulatory requirements concerning climate change, climate risk reporting, or other sustainability concerns, our reputation or the reputation of our brands may suffer.
Such damage to our reputation and the reputation of our brands may negatively impact our business, financial condition and results of operations.
Further, there are an increasing number of anti-ESG legislative initiatives that may conflict with other regulatory requirements or our stakeholders' expectations.
−Removed: In addition, negative or inaccurate postings or comments on social media or networking websites about the Company or our brands could generate adverse publicity that could damage our reputation or the reputation of our brands.
+Added: In addition, negative or inaccurate postings or comments, misinformation, and disinformation across the media landscape, including on social media or networking websites about the Company or our brands could generate adverse publicity that could damage our reputation or the reputation of our brands.
If we are unable to effectively manage real or perceived issues, including concerns about product quality, safety, corporate social responsibility or other matters, sentiments toward the Company or our products could be negatively impacted, and our financial results could suffer.
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federal and state and non-U.S.
−Removed: laws, regulations and policies, including laws related to environmental, health and safety, anti-corruption, export and import compliance, anti-trust and money laundering due to our global operations.
+Added: laws, regulations and policies, including laws related to environmental, health and safety, sustainability, anti-corruption, export and import compliance, anti-trust, money laundering, data privacy, and artificial intelligence due to our global operations.
We cannot provide assurance that our internal controls will always protect us from the improper conduct of our employees, agents and business partners.
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Our operations are subject to regulatory risks and the loss of governmental permits and approvals would materially and adversely affect some of our businesses.
−Removed: operations are subject to a number of laws and regulations, including environmental, health and safety standards.
+Added: operations are subject to a number of laws and regulations, including food and feed regulations, and environmental, health and safety standards.
We have incurred, and will be required to continue to incur, significant expenditures to comply with these laws and regulations.
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While the Company remains confident that the sterilization industry as a whole will take appropriate measures to comply with the latest EPA requirements in a timely manner, there is no assurance that this will consistently be the case.
−Removed: The ID and other requirements may be subject to further review, including additional stakeholder input, and the Company plans on continuing to work with various stakeholders to help ensure the EPA considers all available assessments to appropriately evaluate the risks of EtO.
−Removed: If the ID and other requirements remain unchanged, such requirements will likely result in increased costs and regulatory burdens for EtO users.
+Added: The Company plans on continuing to work with various stakeholders to help ensure the EPA considers all available assessments to appropriately evaluate the risks of EtO.
+Added: If the ID and other requirements remain unchanged, such requirements will likely result in increased costs and regulatory burdens.
Further, additional regulatory requirements associated with the use and emission of EtO may be imposed in the future, both within and outside of the U.S.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.