Amgen 2010 Annual Report Download - page 49

violate the anti-kickback statute. We seek to comply with the safe harbors wherever possible. Due to the breadth of
the statutory provisions and the absence of guidance in the form of regulations or court decisions addressing some of
our practices, it is possible that our practices might be challenged under anti-kickback or similar laws. False claims
laws prohibit knowingly and willingly presenting, or causing to be presented for payment to third-party payers
(including Medicare and Medicaid), claims for reimbursed drugs or services that are false or fraudulent, claims for
items or services not provided as claimed or claims for medically unnecessary items or services. Our activities
related to the sale and marketing of our products may be subject to scrutiny under these laws. Violations of fraud and
abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as
well as the possibility of exclusion from federal healthcare programs (including Medicare and Medicaid). If the
government were to allege against or convict us of violating those laws or if we entered into a settlement with the
government, there could be a material adverse effect on our business, including our stock price. Our activities could
be subject to challenge for the reasons discussed above and due to the broad scope of those laws and the increasing
attention being given to them by law enforcement authorities.
We are also subject to regulation under the Occupational Safety and Health Act, the Toxic Substances Control
Act, the Resource Conservation and Recovery Act and other current and potential future federal, state or local laws,
rules and/or regulations. Our R&D activities involve the controlled use of hazardous materials, chemicals,
biological materials and various radioactive compounds. We believe our procedures comply with the standards
prescribed by federal, state or local laws, rules and/or regulations; however, the risk of injury or accidental
contamination cannot be completely eliminated. While we are not required to do so, we strive to conduct our
research and manufacturing activities in a manner that meets the intents and purposes of the National Institutes of
Health Guidelines for Recombinant DNA Research.
Additionally, the U.S. Foreign Corrupt Practices Act (“FCPA”) prohibits U.S. corporations and their repre-
sentatives from offering, promising, authorizing or making payments to any foreign government official, gov-
ernment staff member, political party or political candidate in an attempt to obtain or retain business abroad. The
scope of the FCPA includes interactions with certain healthcare professionals in many countries.
Our present and future business has been and will continue to be subject to various other U.S. and foreign laws,
rules and/or regulations.
Research and Development and Selected Product Candidates
Our vision is to deliver therapeutics that can make a meaningful difference in patients’ lives. Therefore, we
focus our R&D on novel human therapeutics for the treatment of grievous illness in the areas of oncology,
hematology, inflammation, bone, nephrology, cardiovascular and general medicine, which includes neurology. We
take a modality-independent approach to R&D — that is, we identify targets, and then choose the modality best
suited to address a specific target. As such, our discovery research programs may yield targets that lead to the
development of human therapeutics delivered as large molecules (such as proteins, antibodies and peptibodies) or
small molecules.
We have major R&D centers in several locations throughout the United States and in the United Kingdom, as
well as smaller research centers in Canada and Germany, and smaller development facilities throughout Europe and
in Canada, Australia, Mexico, Hong Kong and India. (See Item 2. Properties.)
To execute our clinical trial programs, we need to maintain an effective development organization and
associated R&D support organizations. We conduct clinical trial activities with both our internal staff and third-
party contract clinical trial service providers. In order to increase the number of patients available for enrollment for
our clinical trials, we have and will continue to open clinical sites and enroll patients in a number of geographic
locations. (See Item 1A. Risk Factors — We must conduct clinical trials in humans before we can commercialize
and sell any of our product candidates or existing products for new indications.)
Some of our competitors are actively engaged in R&D in areas where we have products or where we are
developing product candidates or new indications for existing products. For example, we compete with other
clinical trials for eligible patients, which may limit the number of available patients who meet the criteria for certain
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