Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 126

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 126
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 obligation to pay to the government, including by knowingly retaining an overpayment. Payments in violation of the Anti-Kickback Statute can also form the basis for FCA liability.
The FCA has been subject to heightened enforcement activity as a result of whistleblowers (called “relators”) who file complaints in the name of the United States (and if applicable, particular states), and who may receive up to 30% of total government recoveries. FCA violators may be liable for treble damages, mandatory penalties, loss of licensing and exclusion from federal and state healthcare programs. Such penalties could have a material adverse effect on our business. Also, these measures may be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that could require us to make changes in our operations or incur substantial defense and settlement expenses. Even unsuccessful challenges by regulatory authorities or relators could result in reputational harm and the incurring of substantial costs. Most states have adopted similar state false claims laws, which could lead to significant additional penalties.
We also are subject to certain United States and foreign laws and regulations concerning the conduct of our foreign operations, including the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, German anti-corruption laws and other anti-bribery laws and laws pertaining to the accuracy of our internal books and records, which have been the focus of increasing enforcement activity globally in recent years.

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The “PPS Act” (Physician Payments Sunshine Act) imposes reporting and disclosure requirements for biologic, drug and device manufacturers with regard to payments or other transfers of value made to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, certified nurse-midwives, teaching hospitals, manufacturers and for GPOs (group purchasing organizations), with regard to practitioner and teaching hospital ownership interests in the reporting entity. CMS publishes information from these reports on a publicly available website, including amounts transferred and practitioner and teaching hospital identities. The PPS Act preempts similar state reporting laws, although we or our subsidiaries may also be required to report under certain state transparency laws that address circumstances not covered by the PPS Act, and some of these state laws, as well as the federal law, can be ambiguous. We are also subject to foreign regulations requiring transparency of certain interactions between suppliers and their customers.
Other Health Care Regulation
In the United States, pricing concerns have led to heightened scrutiny and ongoing governmental efforts to increase transparency around healthcare and pharmaceutical drugs costs. For example