Mirion Technologies (55I0) Risk Analysis

Our business operations are subject to extensive regulation by various federal, state, and local governmental agencies in the United States and other countries in which we conduct business. These regulations pertain to areas such as radioactive material handling, antitrust, environmental, health and occupational safety, food and drug, medical device and other applicable healthcare and laboratory regulations, import and export controls, and labor and employment regulations. Noncompliance may result in investigations, sanctions, prosecution, enforcement actions by governments or claims from other third parties, damages, fines, civil and criminal penalties, settlements, injunctions or debarment from government contracting or subcontracting. Separately, compliance with anti-corruption laws, including the U.S. Foreign Corrupt Practices Act (FCPA) and the U.K. Bribery Act, is critical as we operate globally including through third parties, agents, or other business partners whose misconduct could be imputed to us. While we require that they operate in compliance with our policies and procedures, there is no guarantee they will be fully effective, and violations could occur, for which we may be held responsible. Further, the interpretation and enforcement of government regulations in the U.S. has been subject to unpredictable changes. For example, a presidential executive order issued in February 2025 ordered a 180-day FCPA enforcement pause. This has created additional uncertainty regarding how the FCPA will be enforced, in particular with respect to international operations, and it may also have the effect of increasing competitive pressures within our industries.

Many of our products are subject to complex and continuously evolving trade controls the violations of which can result in penalties, including fines, debarment from export privileges, and the loss of authorizations needed to conduct our business. Trade wars and sanctions and export controls imposed against Russia, China or other countries or specific parties in those countries where we do business could materially and adversely impact our business, results of operations and financial condition. If we become subject to audits, investigations, or other actions with respect to these matters, we could become subject to significant penalties or be prevented from selling our products and services in other countries. For more information, see "Risks Related to Our Business and Industry-The military conflict between Russia and Ukraine and the sanctions imposed as a result have adversely affected and may further adversely affect our business, results of operations, and financial condition."

The Price-Anderson Act, supports the nuclear services industry by offering financial protection through nuclear liability insurance and broad indemnification for third-party public liability claims arising from a nuclear accident occurring at any commercial NPP in the United States. If the nuclear liability and indemnification authority in the United States or other countries is eliminated or adversely modified in the future, our business could be materially and adversely affected if the owners and operators of NPPs cancel or delay plans to build new plants or curtail the operations of existing plants. Although it is unlikely that the nuclear liability financial protection authority under the Price-Anderson Act would be completely abolished, some aspects of the Act could be changed during future reauthorizations and if the owners and operators of NPPs cancel or delay plans to build new plants or curtail the operations of existing plants as a result of such modifications our business could be adversely affected.

The FDA regulates virtually all aspects of a medical device design, development, testing, manufacturing, labeling, storage, record keeping, adverse event reporting, sale, promotion, distribution and shipping. Additionally, international marketing of these products requires approvals from international counterparts of the FDA, which can be a time consuming and uncertain process. We can offer no assurance that devices or their modifications will be approved or cleared by the FDA or international agencies in a timely manner or at all. Even with regulatory clearances or approvals, significant limitations on the products, indicated uses may be imposed. We must also comply with medical device reporting regulations and cGMP in the United States and ISO 13485 certification internationally to maintain clearances. Post-market the FDA and Federal Trade Commission also oversee advertising and promotion of our products to ensure compliance with regulatory clearances and prevent false or misleading claims. The FDA requires that device manufacturers determine if modifications to approved products require new approvals, though the FDA can review these decisions. We cannot ensure that the FDA will agree with our decisions not to seek approvals or clearances or that new approvals will be obtained timely fashion, if at all. Additionally FDA regulations and similar international regulations necessitate product recalls for significant deficiencies or defects in design, manufacture or labeling, which can be voluntary or mandated. Recalls, whether voluntary or mandated, can result from component failures, manufacturing errors or design defects, and can lead to significant expenses, negative publicity, harm to reputation and adverse effects on our business, financial condition and operating results. In these circumstances, we may also be subject to significant enforcement action. If any of these events were to occur, our ability to introduce new or enhanced products would be adversely affected, which in turn would also harm our future growth. The recent cuts in staff at the FDA's Center for Devices and Radiological Health may result in the FDA taking longer to review applications which could cause significant delays in regulatory approvals resulting in longer timelines to bring new medical devices to market for certain products in our Medical segment. We expect the effects of these uncertainties to impact our orders and sales in the near term, and adversely impact our business, results of operations and financial condition, although we are unable to predict the exact duration or magnitude of the impact.

Our operations are subject to numerous laws and regulations that affect our interactions with healthcare providers, particularly in sales, marketing and promotional activities. These laws limit financial arrangements with customers, potential customers, marketing consultants and other service providers, impacting how we structure our sales offerings, including discount practices, customer support, product loans, education and training programs, physician consulting, research grants and other service arrangements. Additionally, federal and state "false claims" laws generally prohibit the knowing filing or causing the filing of a false claim, or the knowing use of false statements to obtain payment from government payers. We are also subject to federal and state physician self-referral laws and laws protecting the confidentiality of certain patient health information such as the Health Insurance Portability and Accountability Act ("HIPAA"). Non-compliance with HIPAA can lead to civil and criminal liabilities, adverse publicity, and harm our business and financial condition and impair our ability to attract new customers. The Physician Payments Sunshine Act requires annual reporting of payments to U.S. licensed physicians and teaching hospitals as well as physician ownership of such applicable manufacturer's equity, with non-compliance resulting in monetary penalties. Similar state and foreign laws also apply, and violations could lead to civil monetary penalties and adversely impact our reputation and business, results of operations and financial condition.