Exhibit 10.16
“ [
* ]” = confidential portions of this document that
have been omitted and have been separately
filed with the Securities and Exchange Commission pursuant to an
application for confidential
treatment under Rule 24b-2 under the Securities Exchange Act
of 1934, as amended.
AMENDMENT NO. 3 TO AMENDED AND RESTATED
PROMOTION AGREEMENT
This Amendment
No. 3 (this “ Amendment ”), entered into as
of this 19 th day of April, 2005 and effective as of the
1 st
day of January, 2005 (the “
Effective Date ”), is made by and among Wyeth, a
Delaware corporation (formerly American Home Products Corporation,
“ Wyeth ”), Amgen Inc., a Delaware corporation
(“ Amgen ”), and Immunex Corporation, a
Washington corporation and wholly-owned subsidiary of Amgen
(“ Immunex ”) and amends the Amended and
Restated Promotion Agreement dated as of December 16, 2001
which became effective on July 15, 2002, as amended by
Amendment No. 1 to Collaboration and Global Supply Agreement,
Amended and Restated Promotion Agreement, and TNFR License and
Development Agreement effective as of July 8, 2003 among
Wyeth, Amgen and Immunex and by Amendment No. 2 to
Collaboration and Global Supply Agreement and Amended and Restated
Promotion Agreement effective as of April 20, 2004 among
Wyeth, Amgen and Immunex (as amended, the “ Promotion
Agreement ”).
Recitals
WHEREAS, Wyeth,
Amgen and Immunex entered into the Promotion Agreement pursuant to
which the parties set forth certain terms and conditions relating
to the promotion of Enbrel in the United States and Canada;
and
WHEREAS, the
parties wish to amend certain portions of the Promotion Agreement
to agree to share costs for certain full time equivalents employed
by Wyeth and Amgen performing medical affairs functions pursuant to
the terms and conditions of the Promotion Agreement, all on the
terms and conditions set forth in this Amendment.
Agreement
NOW, THEREFORE, in
consideration of the mutual covenants, promises, and agreements
contained herein, and intending to be legally bound hereby, as of
the Effective Date, Immunex, Wyeth and Amgen agree as
follows:
Article 1
Promotion Agreement
1.1
Capitalized Terms and Amendment . All capitalized terms used
in this Article 1 but not otherwise defined in this Amendment
shall have the meanings assigned to them in the Promotion
Agreement. Wyeth, Amgen and Immunex hereby amend the Promotion
Agreement as follows in this Article 1.
1.2
Medical Affairs FTEs . A new Section 1.35a shall be
inserted into the Promotion Agreement as follows:
1.35a. “
Medical Affairs FTE ” shall mean a total of
[ * ] employee hours
per year of work relating to (a) medical strategic
consultation, scientific strategic consultation, medical review of
promotional materials, medical review of publication planning, and
medical work on clinical trial design; (b) responses to
medical inquiries; and (c) implementation and execution of
clinical programs, including, without limitation, managing contract
research organizations, collecting and analyzing clinical trial
data, collecting safety information, managing investigator
relationships, and collating information into manuscripts,
abstracts, poste
