Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1631

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1631
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is typically governed by the national anti-bribery laws of European Union Member States, and in respect of the U.K. (which is longer a
member of the European Union), the U.K. Bribery Act 2010. Infringement of these laws could result in substantial fines and imprisonment.
European Union Directive 2001/83/EC, which is the European Union Directive governing medicinal products for human use, further provides
that, where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or
benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine
or pharmacy. This provision has been transposed into the Human Medicines Regulations 2012 and so remains applicable in the UK despite
its departure from the European Union. Payments made to physicians in certain European Union Member States must be publicly disclosed.
Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his
or her competent professional organization and/or the regulatory authorities of the individual European Union Member States. These requirements
are provided in the national laws, industry codes or professional codes of conduct, applicable in the European Union Member States. Failure
to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

The collection, use, disclosure,
transfer, or other processing of personal data regarding individuals in the European Union, including personal health data, is subject
to the European Union General Data Protection Regulation (“GDPR”), which became effective on May 25, 2018, as well as the
United Kingdom’s General Data Protection Regulations (the “UK GDPR”), which, together with the amended UK Data Protection
Act 2018, retains the GDPR in UK national law. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process
personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to
whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards to
protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging
third-party processors. The GDPR also imposes strict rules on the transfer of personal data to countries outside the European Union, including
the United States, and permits data protection authorities to impose large penalties for violations of the GDPR, including potential fines
of up to €20 million