Company: DAWN
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0000950170-25-026654
Chunk: 169

Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1A
Chunk 169
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requirements, and later discovery of previously unknown adverse events or other problems with our products, manufacturers or manufacturing processes, may yield various results, including: 

•litigation involving patients taking our products; 

•restrictions on such products, manufacturers or manufacturing processes; 

•restrictions on the labeling or marketing of a product; 

•restrictions on product distribution or use; 

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

•warning or untitled letters; 

•withdrawal of the products from the market; 

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

•voluntary or mandatory recall of products; 

•fines, restitution or disgorgement of profits or revenues; 

•suspension or withdrawal of marketing authorizations; 

•damage to relationships with any potential collaborators; 

•unfavorable media coverage and damage to our reputation; 

•refusal to permit the import or export of our products; 

•product seizure; or 

•injunctions or the imposition of civil or criminal penalties. 

Non-compliance by us or any future collaborator with regulatory requirements, including safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population can also result in significant financial penalties. Further, if any of these actions were to occur, we may have to discontinue the commercialization of our product, OJEMDA, and product candidates, limit our sales and marketing efforts, conduct further post-approval studies and/or discontinue or change any other ongoing clinical studies, which in turn could result in significant expense and delay and/or limit our ability to generate sales revenues.

Our failure to obtain marketing authorization in foreign jurisdictions would prevent OJEMDA and our product candidates from being marketed in those jurisdictions, and any approval we are granted for our product candidates in the United States would not assure approval of product candidates in foreign jurisdictions.

In order to market and sell our products in any jurisdiction outside the United States, we must obtain separate marketing authorizations and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. Further, FDA approval of OJEMDA does not guarantee approval in jurisdictions outside of the United States. The marketing authorization process outside the United States generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States, it is required that the