Company: NOTV
Filing Date: 2025-12-05
Form Type: 10-K
Source: 0001628280-25-055483
Chunk: 94

Company: Inotiv, Inc.
Filing Date: 2025-12-05
Form: 10-K
Item: Item 1
Chunk 94
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 are held to related and additional FDA expectations, all designed to ensure the quality and integrity of our data and products and to bioresearch monitoring (BIMO), including government inspections and audits related thereto and clinical trial monitoring. These regulations and related expectations include those promulgated under the FDCA, as amended from time to time, and issued by the FDA in guidances for industry (“GFI”), covering good laboratory practice (“GLP”), current good manufacturing practice (“CGMP”), bioequivalence (“BE”), and good clinical practice ("GCP"). These requirements demand rigorous attention to research; development; safety; manufacturing quality control; employee training; detailed documentation; equipment and computer validation; promotion and advertising; careful tracking of changes and routine auditing of compliance. Noncompliance with these standards could result in disqualification of project data collected by the Company, which would substantially impact our ability to meet our obligations to clients, and, in severe cases, discontinuance of selected operations. The products and services we offer to international clients are also subject to foreign regulatory requirements, which vary from country to country.

We are subject to federal, state and foreign healthcare and other regulations, including anti-bribery and anti-corruption laws (such as the U.S. Foreign Corrupt Practices Act of 1977), and could face substantial penalties if we fail to comply with such regulations and laws. In particular, the relationships that we, and third parties that market and/or sell our products, have with purchasers of our products, are subject to scrutiny under various state and federal laws, including those referred to collectively as healthcare fraud and abuse laws.

Our facilities and operations are subject to various federal, state, and local laws and regulations relating to protection of human health and the environment, including those governing the discharge of pollutants into the environment and the storage, handling, use, treatment, disposal, and recycling of hazardous substances and wastes, as well as relating to the humane treatment of animals in our custody, as further described below. Such laws include, without limitation, the Clean Air Act, the Clean Water Act, the Toxic Substances Control Act, the Animal Welfare Act and the Resource Conservation and Recovery Act. As environmental laws and regulations continue to evolve, it is likely we will be subject to increasingly stringent environmental standards in the future, particularly under air and water quality laws and standards related to climate change issues. Environmental laws are complex, change frequently and have tended to become increasingly stringent over time.

As a result of the Resolution Agreement and Plea Agreement, a compliance monitor was