Zoetis Inc.

The sale of animal health products is governed by the laws and regulations specific to each jurisdiction in which we market our products. To maintain compliance with these regulatory requirements, we have established processes, systems, and dedicated resources with end-to-end involvement from product concept to launch and maintenance in the market. Our regulatory function actively engages in dialogue with various global agencies regarding their requirements, policies, and guidance documents that relate to animal health products.

United States

United States Food and Drug Administration (FDA). The regulatory body that is responsible for the regulation of animal health pharmaceuticals in the U.S. is the Center for Veterinary Medicine (CVM), housed within the FDA. Generally, manufacturers of animal health pharmaceuticals must show their products to be safe, effective and produced by a consistent method of manufacture as defined under the Federal Food, Drug and Cosmetic Act. The FDA's basis for approving an animal drug application is documented in a Freedom of Information (FOI) Summary. Post-approval monitoring of products is required by law, with reports being provided to CVM's Office of Surveillance and Compliance. Reports of product quality defects, adverse events or unexpected results are submitted in accordance with the legal and agency requirements.

CVM also has regulatory oversight of medical devices (including certainin vitro diagnostics) intended for animal use and can take appropriate regulatory action if an animal device is misbranded or adulterated. Importantly, however, CVM exercises enforcement discretion and does not require pre-market review of animal medical devices. Animal medical device labeling should not be false or misleading, and such products must be adequately labeled for their intended use(s). But, there is no specific FDA regulation reflecting such requirements at this time.

As a result of our acquisition of Abaxis, our product portfolio includes human medical devices, specifically humanin vitro diagnostics, which are subject to regulation in the U.S. by the FDA's Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic Act and its implementing medical device regulations (21 CFR Chapter I, Subchapter H), including the Quality Management System Regulation, and the Center for Medicaid & Medicare Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 and its implementing regulations (42 CFR Part 493). Post-market surveillance is required, with reports provided to the FDA in accordance with agency requirements.

United States Department of Agriculture (USDA). The regulatory body in the U.S. for veterinary biological products is the USDA. The USDA's Center for Veterinary Biologics (CVB) is responsible for the regulation of animal health vaccines, including certain immunotherapeutics and certain diagnostic products. In December 2024, the CVB and CVM published a charter that details how the two agencies work together to determine the appropriate agency to regulate the small number of animal biologicals for which jurisdiction may be unclear. This is in addition to a 2013 Memorandum of Understanding (MOU) that outlines which animal biologicals each agency would regulate.

Manufacturers of animal health biological products must show their products to be pure, safe, effective and produced by a consistent method of manufacture as defined under the Virus-Serum-Toxin Act (VSTA) and its implementing regulations (9 CFR Chapter I, Subchapter E). Post-license monitoring of products is required. Reports of product quality defects, adverse events or unexpected results are submitted in accordance with agency requirements.

Environmental Protection Agency (EPA). The main regulatory body in the U.S. for veterinary pesticides is the EPA. The EPA's Office of Pesticide Programs is responsible for the regulation of pesticide products applied topically to animals. The EPA and FDA determine regulatory oversight of pesticides and animal drugs based on an MOU between the two agencies signed in 1971 and revised in 1973. In February 2023, the EPA and FDA released a whitepaper that outlined potential approaches for updating the agencies' oversight of such animal health products.

Currently, manufacturers of animal health pesticides must show their products, when used according to specifications, will not cause “unreasonable adverse effects to man or the environment” as stated in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and its implementing regulations. Within the U.S., pesticide products that are registered by the EPA (including review and approval of product labeling) must also be registered by individual state pesticide authorities before distribution in that state. Post-approval monitoring of products is required, with reports provided to the EPA and some state regulatory agencies.

Anti Bribery, Anti Corruption. The U.S. Foreign Corrupt Practices Act (FCPA) prohibits U.S. corporations and their representatives from offering, promising, authorizing or making payments to any foreign government official, government staff member, political party or political candidate to obtain or retain business abroad. The scope of the FCPA includes interactions with certain animal healthcare professionals in many countries. Other countries have enacted similar anti-corruption laws and/or regulations.

Foreign Trade Controls. Zoetis is also subject to foreign trade controls administered by certain U.S. government agencies, including the Bureau of Industry and Security within the Commerce Department, Customs and Border Protection within the Department of Homeland Security and the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC). As a global animal health company, we conduct business in multiple jurisdictions throughout the world. This includes supplying medicines and medical products for use in, and the shipment of goods to, Iran and Russia, and conducting related activities, in accordance with a general license and specific licenses issued by OFAC and EU Member States and in line with our corporate policies.

Outside the United States / Global

EU. The European Medicines Agency (EMA) is the centralized medicines regulatory agency of the EU. The agency is responsible for the scientific evaluation of medicines developed by healthcare companies seeking centralized approval for use in the EU. The agency has a distinct veterinary review section. The Committee for Veterinary Medicinal Products (CVMP) is responsible for scientific and technical review of the submissions for innovative pharmaceuticals, biopharmaceuticals and vaccines. After the CVMP issues a positive opinion on the approvability of a product, the European Commission reviews the opinion and, if they agree with the CVMP, they grant the product market authorization. Once granted by the European Commission, a centralized marketing authorization is valid in all EU and European Economic Area-European Free Trade Association

10 | states. The centralized procedure is mandatory for certain types of products, such as those developed by means of recombinant DNA technology or novel therapeutic veterinary medicinal products. Products (other than those covered by the mandatory scope of the centralized procedure) can also be registered in the EU via the decentralized or the mutual recognition routes under the supervision of the Co-ordination Group for Mutual Recognition and Decentralized Procedures for Veterinary Medicinal Products (CMDv). This co-ordination group is composed of one representative per member state from each national regulatory agency, including Norway, Iceland and Liechtenstein. A series of Regulations (including the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)), Directives, Guidelines and EU Pharmacopeia Monographs provide the requirements for product approval in the EU. In general, these requirements are similar to those in the U.S., requiring demonstrated evidence of, safety, efficacy, and quality/consistency of manufacturing processes. We are also subject to the EU General Data Protection Regulation (GDPR) that requires us to meet enhanced requirements regarding the handling of personal data, including its use, protection and the rights of data subjects to request correction or deletion of their personal data.

Currently, there is no EU-specific Regulation regarding veterinary medical devices or veterinary in vitro diagnostics. In Europe, such animal health products are reviewed by national agencies based on national requirements, where such requirements exist. The EU-specific regulation regarding humanin vitro diagnostics is the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746) (IVDR).

United Kingdom. The making, updating and enforcing of U.K. legislation for veterinary medicinal products is the responsibility of the U.K.’s Veterinary Medicines Directorate (VMD).

China. The Ministry of Agriculture and Rural Affairs (MARA), a ministerial-level component of the State Council, drafts and implements policies related to agriculture, rural areas and rural residents, and regulates crop farming, animal husbandry, fisheries, agriculture mechanization and the quality of agriculture products. MARA is also the regulatory body responsible for the regulation and supervision of pharmaceuticals and biologicals for animal use. Regulatory requirements in China have become increasingly stringent, with MARA issuing new regulations and changes to the regulatory review process.

Brazil. The Ministry of Agriculture, Livestock and Food Supply (MAPA) is the regulatory body in Brazil that is responsible for the regulation and control of pharmaceuticals, biologicals and medicated feed additives for animal use. MAPA's regulatory activities are conducted through the Secretary of Agricultural Defense and its Livestock Products Inspection Department. In addition, regulatory activities are conducted at a local level through the Federal Agriculture Superintendence. These activities include the inspection and licensing of both manufacturing and commercial establishments for veterinary products, as well as the submission, review and approval of pharmaceuticals, biologicals, and medicated feed additives. MAPA is one of the most active regulatory agencies in Latin America, having permanent seats at several international animal health forums, such as Codex Alimentarius, World Organization for Animal Health and Committee of Veterinary Medicines for the Americas. MAPA was also invited to be a Latin American representative at meetings of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). Several normative instructions issued by MAPA have set regulatory trends in Latin America.

Australia. The Australian Pesticides and Veterinary Medicines Authority (APVMA) is an Australian government statutory authority established in 1993 to centralize the registration of all agricultural and veterinary products for the Australian marketplace. Previously each State and Territory government had its own system of registration. The APVMA assesses applications from companies and individuals seeking registration or a permit so they can supply their product to the marketplace. Applications undergo rigorous assessment using the expertise of the APVMA's scientific staff and drawing on the technical knowledge of other relevant scientific organizations, Commonwealth government departments and state agriculture departments. If the product works as intended and the scientific data confirms that when used as directed on the product label it will have no harmful or unintended effects on people, animals, the environment or international trade, the APVMA will register the product. As well as registering new agricultural and veterinary products, the APVMA receives and reviews adverse event information which may be submitted by registrants or members of the public. The APVMA also reviews registered products when particular concerns are raised about their safety and effectiveness. The review of a product may result in confirmation of its registration, or it may see registration continue with some changes to the way the product can be used. In some cases the review may result in the registration of a product being canceled and the product taken off the market.

Rest of world. Jurisdiction-specific regulatory laws may have provisions that include requirements for certain labeling, safety, efficacy, and manufacturers' quality control procedures (to assure the consistency of the products), as well as company records and reports. In certain regions and jurisdictions, regulatory agencies may generally refer to the FDA, USDA, EMA and other international animal health entities, including the World Organisation for Animal Health and Codex Alimentarius, in establishing standards or regulations for veterinary pharmaceuticals, immunotherapies and vaccines.

Advertising and promotion review. Promotion of regulated animal health products is controlled by laws and regulations in many jurisdictions. These laws and rules generally restrict advertising and promotion to those product claims and uses that have been reviewed and endorsed by the applicable regulatory agency. We conduct a review of promotional materials for compliance with the local and regional requirements in the markets where we sell animal health products.

Data Privacy and Protection Laws. Our business involves the collection, use, and processing of personal data from our customers. The global privacy landscape is rapidly evolving, with countries where we operate introducing and enforcing new privacy and data protection laws and regulations. Compliance with these laws is costly, complex and requires continuous updates to our privacy practices, systems, policies, training and monitoring. Failure to comply with these laws could result in litigation, significant fines, penalties and reputational damage, as well as restrictions on certain activities.

We collect and process personal information of our employees worldwide, which includes sensitive data such as health information, financial data and personal identifiers. We must comply with local labor and data protection laws concerning the privacy of employee information. In some jurisdictions, employee privacy protections are stricter, and any failure to comply with such laws could result in penalties, litigation or damage to our employer brand. Any changes to international data transfer mechanisms, including the invalidation of established frameworks or imposition of new restrictions, could disrupt our ability to transfer data and impede our business operations. See Item 1A. Risk Factors--Risks related to legal matters and regulation--Our operations and reputation may be impacted if we do not comply with complex and continually evolving laws and regulations regarding data privacy, processing, and security and the use of AI.

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We are also subject to an increasingly complex and growing number of laws, regulations, and directive governing cybersecurity, data security, and the protection of information systems. These requirements apply across multiple jurisdictions in the U.S. and internationally. Compliance with these cybersecurity and data security laws and regulations require us to implement and continually enhance technical, administrative and organizational controls, conduct risk assessments and audits, maintain incident detection and response capabilities and provide training and oversight. These requirements may increase operating and compliance costs and require significant investment in systems and technology. Given the evolving and sometimes ambiguous standards in this area, there is a risk that we may not be able to anticipate or fully comply with all applicable requirements. In addition, cybersecurity incidents could result in unauthorized access and disclosure of sensitive or confidential information which could lead to regulatory enforcement and materially and adversely affect our business, financials, business operations, and reputation.

Artificial Intelligence Laws. Our business involves using AI to provide faster, more accurate in-clinic diagnostic results and improve research efficiency and accelerated animal health drug discovery. We also incorporate (and expect to continue incorporating) the use of AI in our operations. We are increasingly subject to a rapidly evolving legal and regulatory environment relating to the development, deployment, and use of AI, machine learning, automated decision-making systems, and related technologies. Governments and regulators in the US and internationally are considering adopting and implementing new laws, regulations, and standards governing AI, including with respect to cybersecurity, intellectual property, consumer protection, privacy, safety, and ethical use. Compliance with existing and future AI-related laws may require us to modify services and internal processes, data practices, and governance framework, and may increase our costs, reduce operational flexibility, delay, limit, and restrict certain uses of AI. See Item 1A. Risk Factors--We use machine learning and AI in various business operations, and inability to successfully monitor and manage its use could result in operational, competitive or reputational harm, regulatory enforcement, and legal liability.

Global policy and guidance

Joint FAO/WHO Expert Committee on Food Additives (JECFA). The Joint FAO/WHO Expert Committee on Food Additives is an international expert scientific committee that is administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). The JECFA provides a risk assessment/safety evaluation of residues of veterinary drugs in animal products, exposure and residue definition and maximum residue limit proposals for veterinary drugs. We work with them to establish acceptable safe levels of residual product in food-producing animals after treatment. This in turn enables the calculation of appropriate withdrawal times for our products prior to an animal entering the food chain.

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). VICH is a trilateral (EU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration. The objectives of the VICH are as follows:

•Establish and implement harmonized technical requirements for the registration of veterinary medicinal products in the VICH regions, which meet high quality, safety and efficacy standards and minimize the use of test animals and costs of product development.

•Provide a basis for wider international harmonization of registration requirements through the VICH Outreach Forum.

•Monitor and maintain existing VICH guidelines, taking particular note of the VICH work program and, where necessary, update these VICH guidelines.

•Ensure efficient processes for maintaining and monitoring consistent interpretation of data requirements following the implementation of VICH guidelines.

•By means of a constructive dialogue between regulatory authorities and industry, provide technical guidance enabling response to significant emerging global issues and science that impact regulatory requirements within the VICH regions.