Amgen 2009 Annual Report Download - page 43

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 commerci-
alize and sell any of our product candidates or existing products for new indications.”)
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 Eu-
rope and in Canada, Australia, Mexico, Hong Kong and India (see “Item 2. Properties”).
In addition to product candidates and marketed products generated from our internal R&D efforts, we ac-
quire companies, acquire and license certain product and technology rights and establish R&D collaborations
with third parties, which enhance our strategic position within our industry by strengthening and diversifying our
R&D capabilities, product pipeline and marketed product base. These licenses and collaboration agreements
generally provide for non-refundable, upfront license fees, R&D and commercial performance milestone pay-
ments, cost sharing, royalty payments and/or profit sharing. (See “Business Relationships” and Note 3,
“Acquisitions” to the Consolidated Financial Statements.)
Some of our competitors are actively engaged in R&D in areas where we have products or where we are de-
veloping 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 cer-
tain clinical trials. The competitive marketplace for our product candidates is significantly dependent upon the
timing of entry into the market. Early entry may have important advantages in gaining product acceptance, con-
tributing to the product’s eventual success and profitability. Accordingly, we expect that in some cases, the
relative speed with which we can develop products, complete clinical testing, receive regulatory approval and
supply commercial quantities of the product to the market is expected to be important to our competitive posi-
tion.
Various public and privately owned companies, research organizations, academic institutions and gov-
ernmental agencies conduct a significant amount of R&D in the biotechnology industry. We face competition in
pursuing collaborative arrangements and licensing or acquisition activities from other pharmaceutical and bio-
technology companies that also seek to license or acquire technologies, product candidates or marketed products
from these entities. Accordingly, we may have difficulty entering into collaborative arrangements and licensing
or acquiring technologies, product candidates and marketed products on acceptable terms.
See “Government Regulation — Clinical Development” for a discussion of the government regulation over
clinical development.
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