Company: NOTV
Filing Date: 2025-12-05
Form Type: 10-K
Source: 0001628280-25-055483
Chunk: 122

Company: Inotiv, Inc.
Filing Date: 2025-12-05
Form: 10-K
Item: Item 1
Chunk 122
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 against us, and we are not successful in defending ourselves, those actions could have a material impact on our business.

For further information on these and other actions, see Note 15 - Contingencies and Commitments to the consolidated financial statements contained in Part II, Item 8. 

Changes in government regulation or practices relating to the pharmaceutical, biotechnology and medical device industries could reduce demand for our services and products.

Governmental agencies throughout the world, but particularly in the United States, strictly regulate the drug development process. Our business depends on helping clients navigate complex drug development regulations. While new or stricter regulations can increase demand for our services, changes such as relaxed regulatory requirements, expedited drug approvals, or rules that make our services less competitive could reduce the demand for our products and services. 

For example, the FDA Modernization Act 2.0, passed in December 2022, removed certain references to animal testing in the FDCA to facilitate the broader acceptance of alternatives to animal testing. In April 2025, the FDA published a roadmap to reduce animal testing in preclinical safety studies with scientifically validated new approach methodologies. It is unpredictable whether and when any changes related to animal testing alternatives will occur, and a shift away from animal research could negatively impact our business, operations, or financial condition if we are unable to implement acceptable alternatives, or if they do not deliver comparable financial results, even if implemented.

If we fail to comply with data privacy and security laws and regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected. 

Many U.S. and foreign jurisdictions have passed, or are currently contemplating, a variety of data privacy and cyber and data security laws and regulations. For example, U.S. Department of Health and Human Services regulations under the HIPAA demand compliance with patient privacy and confidentiality requirements. We are also subject to federal, state and international data privacy and security laws and regulations that govern the collection, use, disclosure, transfer, storage, location, disposal and protection of health-related and other personal information, including that of employees. In addition to U.S. federal laws and regulations, a number of U.S. states have also enacted data privacy and security laws and regulations that govern the collection, use, disclosure, transfer, storage, disposal, and protection of personal information. Internationally, virtually every jurisdiction in which we operate has established its own data privacy and security legal framework with which we must comply. 

The legislative and regulatory framework for privacy and data protection issues worldwide is rapidly evolving