Amgen 2009 Annual Report Download - page 68

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 regu-
lations 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 gain or maintain 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 you that we, our employees, our consultants or our con-
tractors 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 these
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, with-
drawal 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 ad-
verse 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.
In connection with our continuous process improvement activities, we evaluate our processes and proce-
dures in order to identify opportunities to achieve greater efficiencies in how we conduct our business in order to
reduce costs. In particular, we evaluate our manufacturing practices and related processes to increase production
yields and/or success rates as well as capacity utilization to gain increased cost efficiencies. 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 charges and/or the
recognition of other related charges. The recognition of such charges, if any, could have a material and adverse
affect on our results of operations.
Item 1B. UNRESOLVED STAFF COMMENTS
None.
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