Amgen 2010 Annual Report Download - page 74

In addition, Health Technology Assessment organizations, such as NICE in the United Kingdom and the
Canadian Agency for Drugs and Technologies in Health, make reimbursement recommendations to payers in their
jurisdictions based on the clinical effectiveness, cost-effectiveness and service impact of new, emerging and
existing medicines and treatments.
Any recommendations or guidelines that result in decreased use, dosage or reimbursement of our products
could adversely affect our product sales and operating results materially. In addition, the perception by the
investment community or stockholders that such recommendations or guidelines will result in decreased use and
dosage of our products could adversely affect the market price for our common stock.
The commercialization of certain of our product candidates and the marketing of certain of our products is
dependent in part on our partners.
We have entered into agreements with third parties to assist in the commercialization of certain of our product
candidates and the marketing of certain of our products in specified geographic areas. (See Business Relationships.)
Many of these agreements involve the sharing of certain decisions and a division of responsibilities, costs and
benefits. If our partners fail to effectively deliver on their marketing and commercialization commitments to us or if
we and our partners fail to coordinate our efforts effectively, sales of our products may be materially adversely
affected.
Our corporate compliance and risk mitigation programs cannot guarantee that we are in compliance with all
potentially applicable U.S. federal and state regulations and all potentially applicable foreign regulations and/or
that we effectively manage all operational risks.
The development, manufacturing, distribution, pricing, sales, marketing and reimbursement of our products,
together with our general operations, are subject to extensive federal and state regulation in the United States and to
extensive regulation in foreign countries. (See Our current products and products in development cannot be sold if
we do not maintain or gain regulatory approval and Manufacturing difficulties, disruptions or delays could limit
supply of our products and limit our product sales.) While we have developed and instituted a corporate compliance
program, we cannot guarantee that we, our employees, our consultants or our contractors are or will be in
compliance with all potentially applicable U.S. federal and state regulations and/or laws or all potentially applicable
foreign regulations and/or laws. If we or our agents fail to comply with any of those regulations and/or laws, a range
of actions could result, including, but not limited to, the termination of clinical trials, the failure to approve a product
candidate, restrictions on our products or manufacturing processes, withdrawal of our products from the market,
significant fines, exclusion from government healthcare programs or other sanctions or litigation. Additionally,
while we have implemented numerous risk mitigation measures, we cannot guarantee that we will be able to
effectively mitigate all operational risks. If we fail to effectively mitigate all operational risks, our product supply
may be materially adversely affected, which could have a material adverse effect on our product sales and results of
operations.
Continual process improvement efforts may result in the carrying value of certain existing manufacturing
facilities or other assets becoming impaired or other related charges being incurred
Our business continues to face many challenges. In response to these challenges, we have worked and continue
to work to improve cost efficiencies and to reduce discretionary expenditures. As part of those efforts, we undertake
continuous process improvement activities to evaluate our processes and procedures in order to identify oppor-
tunities for achieving greater efficiencies in how we conduct our business. In particular, we evaluate our
manufacturing operations to identify opportunities to increase production yields and/or success rates as well as
capacity utilization. Depending on the timing and outcomes of these process improvement initiatives, the carrying
value of certain manufacturing or other assets may not be fully recoverable and could result in the recognition of
impairment and/or other related charges. The recognition of such charges, if any, could have a material adverse
affect on our results of operations.
58