Company: WHWK
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001628280-25-023932
Chunk: 661

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-05-08
Form: 10-Q
Item: Part I, Item 2
Chunk 661
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 Violations of the Federal Food, Drug and Cosmetic Act relating to the promotion of prescription drugs may lead to a number of actions and penalties, including warning letters, cyber letters, or untitled letters, adverse publicity, the requirement for dear-health-care-provider letters or other corrective information, fines and other monetary penalties, civil or criminal prosecution, including False Claims Act liability, restrictions on our operations and other operating requirements through consent decrees or corporate integrity agreements, debarment, exclusion from participation in federal health care programs and refusal of government contracts or future orders under existing contracts, among other consequences.

We will be required to report certain adverse reactions and production problems, if any, to the FDA and comparable foreign regulatory authorities. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. Any new legislation addressing drug safety issues could result in delays in product development or commercialization, or increased costs to assure compliance. In addition, failure to comply with FDA, EMA and other comparable foreign regulatory requirements may have negative consequences, including:

•adverse inspection findings;

•additional warnings or otherwise restrict the product’s indicated use, label, or marketing;

•restrictions on a product, distribution, manufacturers or manufacturing processes;

•issuance of warning letters, safety alerts, dear-healthcare-provider letters, press releases or other communications containing warnings regarding the product that would result in adverse publicity;

•voluntary or mandatory product recalls and publicity requirements or withdrawal of a product from the market;

•suspension or withdrawal of marketing or regulatory approvals or other permits or voluntary;

•product seizures, detentions or import bans;

•total or partial suspension of production;

•imposition of restrictions on operations, including costly new manufacturing requirements;

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•requirement to establish or modify a REMS;

•requirement to conduct post-marketing studies or surveillance;

•restrictions on drug distribution or use;

•requirements to conduct post-marketing studies or clinical trials;

•refusal to approve pending applications or supplements to approved applications that we submit and other delays;

•delays in or the rejection of approvals of additional indications for a product;

•restrictions on our ability to conduct clinical trials, including full or partial clinical holds on, or the suspension or termination of, future trials;

•fines