Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 54

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 54
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 legislation, thereby potentially extending the term of marketing exclusivity for our product candidates, our business may be harmed.” 

Trademark 

We hold the trademark for T-win® in the European Union (Registered no. 017871048), the United States (Registered no. 5754675), China (Registered no. 33152486), Japan (Registered no. 6107125), and the United Kingdom (Registered no. 00917871048). The trademark for T-win is registered in class 5 (including pharmaceuticals and other preparations for medical purposes) and class 42 (including scientific and/or medical research services). 

We hold the trademark Cylembio® in the United States (Registration no.7699741), the United Kingdom (Registration no. 00003925757) and an International Trademark (Registration no.1759536) which has been granted in the following jurisdictions: Australia, China, European Union, Israel, Japan, New Zealand, and Singapore. The International Trademark is pending in the following jurisdictions: Brazil, Canada, India, Republic of Korea, and Mexico. There is also a pending national application for Cylembio in South Africa (Application no. 2024/06348). The Cylembio trademarks cover pharmaceuticals and related terms in Class 5. 

Government Regulation 

The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, tracking, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of biological products such as those we are developing. We, along with our vendors, collaboration partners, CROs and CMOs, will be required to navigate the various preclinical, clinical, manufacturing and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval of our product candidates. The process of obtaining regulatory approvals of biological products and ensuring subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations requires the expenditure of substantial time and financial resources. 

In the United States, where we are initially focusing our product development, the FDA regulates biologics under the Federal Food, Drugs, and Cosmetics Act, as amended (“FDCA”) and the Public Health Service Act, as amended (“PHSA”) and their implementing regulations. Bi