Company: IPHYF
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001598599-25-000042
Chunk: 153

Company: Innate Pharma SA
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 153
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 in revising the approved labeling to add new safety information; imposing post-market studies or clinical trials to assess new safety risks; or imposing distribution or other restrictions under a REMS program. Other potential consequences include, among other things:

• restrictions on the marketing or manufacturing of the product, suspension of the approval, or complete withdrawal of the product from the market or product recalls;

• fines, warning letters or holds on post-approval clinical trials;

• refusal of the FDA to approve pending applications or supplements to approved BLAs, or suspension or revocation of product license approvals;

• product seizure or detention, or refusal to permit the import or export of products; and

• injunctions or the imposition of civil or criminal penalties.

In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (PDMA) and its implementing regulations, as well as the Drug Supply Chain Security Act (DSCSA), which respectively regulate the distribution and tracing of prescription drug samples at the federal level and set floor and ceiling standards for the regulation of wholesale distributors by the states. PDMA, its implementing regulations and state laws limit the distribution of prescription pharmaceutical product samples, and DSCSA imposes requirements to ensure accountability during distribution and to identify and remove counterfeit and other illegitimate products from the market, each among other objectives.

The FDA strictly regulates labels/labeling, advertising and promotion of prescription drugs that are placed on the market. The FDA-required labeling sets forth the conditions of use under which the licensed biologics has been shown to meet the relevant standard for marketing and provides directions and information on how to use the product safely and effectively under those conditions. Licensed biologics

may be promoted only for the approved indications and in accordance with the provisions of the approved label, including information consistent with the FDA required labeling and not otherwise false or misleading. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. A company that is found to have improperly promoted off-label uses may be subject to significant liability.

Patent term restoration and extension in the United States

A patent claiming a new biologic product may be eligible for a limited patent term extension under the Hatch-Waxman Act, which permits a patent restoration of up to five years for patent term lost during product development and the FDA regulatory review period. A regulatory review period consists of two periods of time: a testing phase and an approval phase. The restoration period granted on a patent covering a product is calculated as one-half the testing phase (the time between the