Amgen 2007 Annual Report Download - page 41

our products could adversely impact or disrupt our commercial manufacturing of our products or could result in a
mandated withdrawal of our products from the market. (See “Item 1A. Risk Factors — We rely on single third-
party suppliers for some of our raw materials, medical devices and components; if these third parties fail to
supply these items, we may be unable to supply our products.”)
Joint Ventures and Business Relationships
From time to time, we may enter into joint ventures and other business relationships to provide additional
development, manufacturing and marketing capabilities. In addition to our internal R&D efforts, we have ac-
quired certain product rights and have established R&D collaborations to enhance our R&D capabilities and
internally developed product pipeline. Our R&D collaborations generally consist of non-refundable, upfront li-
cense fees, R&D and commercial performance milestones, cost sharing, royalties and/or profit sharing.
Additionally, these collaborations may include manufacturing and co-promotion arrangements. Our collaboration
agreements with third parties are performed on a “best efforts” basis with no guarantee of either technological or
commercial success.
Kirin Holdings Company, Limited
We formed KA, a 50-50 joint venture with Kirin in 1984. KA develops and commercializes certain of our
and Kirin’s product rights, which have been transferred to this joint venture. KA has given exclusive licenses to
us to manufacture and market: (i) darbepoetin alfa in the United States, all European countries, Canada, Austral-
ia, New Zealand, Mexico, all Central and South American countries and certain countries in Central Asia, North
Africa and the Middle East, (ii) pegfilgrastim and G-CSF in the United States, Europe, Canada, Australia and
New Zealand and (iii) recombinant human erythropoietin in the United States. We currently market darbepoetin
alfa, pegfilgrastim, G-CSF and recombinant human erythropoietin under the brand names Aranesp®, Neulasta®,
NEUPOGEN®and EPOGEN®, respectively.
KA has also given exclusive licenses to Kirin to manufacture and market: (i) darbepoetin alfa in Japan, the
People’s Republic of China (“China”), Taiwan, Korea and certain other countries in Southeast Asia,
(ii) pegfilgrastim and G-CSF in Japan, Taiwan and Korea and (iii) recombinant human erythropoietin in Japan.
Kirin markets G-CSF and recombinant human erythropoietin in China under a separate agreement with KA. Kir-
in markets its G-CSF product in its respective territories under the trademark GRAN®. Kirin markets its
recombinant human erythropoietin product in Japan under the trademark ESPO®. Kirin received manufacturing
and marketing approval for darbepoetin alfa in Japan under the brand name NESP®on April 18, 2007.
KA has licensed to J&J rights to recombinant human erythropoietin in certain geographic areas of the world
outside the United States, China and Japan (see “- Johnson & Johnson”). Under its agreement with KA, J&J pays
a royalty to KA based on sales. KA has also licensed to Roche rights to pegfilgrastim and G-CSF in certain geo-
graphic areas of the world.
During 2005 certain of our and Kirin’s product rights related to AMG 531 were transferred to KA. In return,
KA has given us and Kirin exclusive licenses to manufacture and market AMG 531 in certain territories.
In connection with our various license agreements with KA, we pay KA royalties based on product sales. In
addition, we also receive payment from KA for conducting certain R&D activities on their behalf (see Note 4,
“Related party transactions” to the Consolidated Financial Statements).
Johnson & Johnson
We granted J&J a license to commercialize recombinant human erythropoietin as a human therapeutic in the
United States in all markets other than dialysis. All recombinant human erythropoietin sold by J&J in the United
States is manufactured by us and sold by J&J under the trademark PROCRIT®(Epoetin alfa). PROCRIT®brand
Epoetin alfa is identical to EPOGEN®brand Epoetin alfa, which is manufactured and sold by us in the U.S.
dialysis market. Pursuant to the license agreement with J&J, we earn a 10% royalty on net sales of PROCRIT®
by J&J in the United States.
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