In the future, there may continue to be
additional proposals relating to the reform of the United States healthcare system, some of which could further limit the prices
we are able to charge for our products candidates, or the amounts of reimbursement available for our product candidates. If future
legislation were to impose direct governmental price controls and access restrictions, it could have a significant adverse impact
on our business. Managed care organizations, as well as Medicaid and other government agencies, continue to seek price discounts.
Some states have implemented, and other states are considering, price controls or patient access constraints under the Medicaid
program, and some states are considering price-control regimes that would apply to broader segments of their populations that are
not Medicaid-eligible. Due to the volatility in the current economic and market dynamics, we are unable to predict the impact of
any unforeseen or unknown legislative, regulatory, payor or policy actions, which may include cost containment and healthcare reform
measures. Such policy actions could have a material adverse impact on our profitability.
Moreover, the recently enacted federal
Drug Supply Chain Security Act imposes new obligations on manufacturers of pharmaceutical products, among others, related to product
tracking and tracing. Among the requirements of this new federal legislation, manufacturers will be required to provide certain
information regarding the drug product to individuals and entities to which product ownership is transferred, label drug product
with a product identifier, and keep certain records regarding the drug product. Further, under this new legislation, manufacturers
will have drug product investigation, quarantine, disposition, and notification responsibilities related to counterfeit, diverted,
stolen, and intentionally adulterated products, as well as products that are the subject of fraudulent transactions or which are
otherwise unfit for distribution such that they would be reasonably likely to result in serious health consequences or death.
Physician Payment Sunshine
The Physician Payment Sunshine Act requires
most pharmaceutical manufacturers to report annually to the Secretary of HHS any and all financial arrangements, payments, or other
transfers of value made by that entity to physicians and teaching hospitals. The payment information is made publicly available
in a searchable format on a CMS website. Over the next several years, we will need to dedicate significant resources to establish
and maintain systems and processes in order to comply with these regulations. Failure to comply with the reporting requirements
can result in significant civil monetary penalties. Similar laws have been enacted or are under consideration in foreign jurisdictions,
including France which has adopted the Loi Bertrand, or French Sunshine Act, which became effective in 2013.
Environmental, Health and Safety Laws
We are subject to numerous environmental,
health and safety laws and regulations and permitting requirements, including those governing laboratory procedures, decontamination
activities and the handling, transportation, use, remediation, storage, treatment, and disposal of hazardous materials and wastes.
Our operations involve the use of hazardous and flammable materials, and the risk of injury, contamination or noncompliance with
environmental, health and safety requirements cannot be eliminated. Although compliance with such laws and regulations and permitting
requirements has not had a material effect on our capital expenditures, earnings or competitive position, environmental, health
and safety laws and regulations and permitting requirements have tended to become increasingly stringent and, to the extent legal
or regulatory changes occur in the future, they could result in, among other things, increased costs to us or the impairment of
our research, development or production efforts.
We are a Swiss stock corporation (société
anonyme) organized under the laws of Switzerland. We were formed as a Swiss limited liability company (société
à responsabilité limitée) on February 13, 2003 with our registered office and domicile in Basel, Switzerland.
We converted to a Swiss stock corporation (société anonyme) under the laws of Switzerland on August 25, 2003.
Our Swiss enterprise identification number is CHE-109.878.825. Prior to our initial public offering, we were a privately owned
company. Our domicile and registered office is in Ecublens, near Lausanne, Canton of Vaud, Switzerland. Our registered and principal
executive offices are located at EPFL Innovation Park, Building B, 1015 Lausanne, Switzerland, our general telephone number is
(41) 21 345 91 21 and our internet address is www.acimmune.com.
We did not have any subsidiaries as of
December 31, 2018.