Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 56

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 56
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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 or 4% of annual global revenues, whichever is greater; UK GDPR
mirrors such fines under the GDPR. The GDPR also confers a private right of action on data subjects and consumer associations to
lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations
of the GDPR.