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EXHIBIT 10.31
***TEXT OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(B)(4)
AND 240.24B-2.
AMENDMENT NO. THREE TO LICENSE AND COMMERCIALIZATION AGREEMENT
This AMENDMENT NO. THREE TO LICENSE AND COMMERCIALIZATION AGREEMENT
(the
"AMENDMENT NO. THREE") is made effective as of December 31, 2004
(the "AMENDMENT
EFFECTIVE Date"), and is entered into by and between AMGEN INC., a
Delaware
corporation having its principal place of business at One Amgen
Center Drive,
Thousand Oaks, CA 91320-1799 ("AMGEN") and INTERMUNE, INC., a
Delaware
corporation having its principal place of business at 3280 Bayshore
Blvd.,
Brisbane, CA 94005 ("INTERMUNE"). Amgen and InterMune are sometimes
referred to
herein individually as a "PARTY" and collectively as the "PARTIES,"
and
references to "InterMune" and "Amgen" shall include their
respective Affiliates.
All capitalized terms used herein shall have the meaning given to
them in the
Original Agreement (as defined below) unless otherwise defined
herein.
Background
WHEREAS, the Parties entered into that certain License and
Commercialization Agreement effective as of June 15th, 2001, as
subsequently
amended pursuant to that certain Amendment No. One to License
and
Commercialization Agreement dated April 25, 2002 and that certain
Amendment
Number 2 to Amgen/InterMune License and Commercialization Agreement
for Infergen
of even date herewith (collectively the "ORIGINAL AGREEMENT")
pursuant to which
Amgen granted certain rights to InterMune relating to the Licensed
Products; and
WHEREAS, the Parties now desire to amend the Original Agreement to
amend
the scope of certain provisions in that Original Agreement and to
provide terms
under which they will operate in relation to the study and
commercialization of
certain combinations of therapeutic pharmaceuticals, all as set
forth herein.
NOW
THEREFORE, based on the foregoing premises and the mutual covenants
and
obligations set forth below, and for good and valuable
consideration, the
receipt and sufficiency of which the Parties hereby acknowledge,
the Parties
hereby agree as follows:
1.
Amendments.
A.
The following
shall be added to the Original Agreement as a new
Sections 1.50 - 1.56:
1.50 "DEVELOPMENT COLLABORATOR" shall mean a Third Party, which
collaborates with Amgen in the clinical testing and/or
commercialization of a [***] comprising [***] of [***] an Amgen
Product.
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1.51 "AMGEN FOREIGN PEG PATENTS" shall mean [***].
1.52 "ADDITIONAL
TERRITORY" shall mean the geographical region
encompassing the countries in which Amgen obtains rights from [***]
to
grant to InterMune licenses under Patents to commercialize
Licensed
Products pursuant to Section 2.10(b) below.
1.53 "ADDITIONAL TERRITORY AUTHORIZATION APPLICATION" shall mean a
new
drug, biologic or other application, health registration,
marketing
authorization application, common technical document,
regulatory
submission, notice of compliance or equivalent application
(excluding
local and general business licenses and permits) required to be
approved before commercial sale or use of a Licensed Product in
the
Additional Territory (or any single country within the
Additional
Territory) as a pharmaceutical or medicinal product in any
formulation
or dosage form (excluding any pricing and reimbursement
approvals),
together with all subsequent submissions, supplements and
amendments
thereto.
1.54 "AMGEN PRODUCT" shall mean any product owned or Controlled
by
Amgen, other than a Licensed Product or a Directly Competitive
Product.
1.55 "PEG TRADEMARK" shall mean the Trademark "PEG-INFERGEN,"
together
with all goodwill associated therewith, and any renewals,
extensions
or modifications thereto.
1.56 "COMBINATION TRIAL" shall mean a clinical trial (or set of
clinical trials) of [***] an Amgen Product, conducted by or on
behalf
of Amgen or a Development Collaborator (solely to the extent
within
the scope of a collaboration described in Section 1.50).
B.
The following
shall be added to the Original Agreement as new Sections
2.2(e) and (f):
(e) Subject to the
terms and conditions of this Agreement, Amgen
hereby grants to InterMune an exclusive (even as to Amgen)
license, with the right to grant sublicenses (subject to
InterMune's compliance with Section 2.5 of this Agreement),
solely under the Amgen Foreign PEG Patents solely to [***]
PEG-Infergen Products during the Term in the countries listed
[***]; provided, however, that in the event that InterMune does
not, within [***] days of its receipt of Amgen's offer of
rights
extended pursuant to Section 2.10(b) of the Agreement, accept
such offer with respect to any country within the Additional
Territory, then this license and Section 6.3(d) of the
Agreement
shall automatically and immediately terminate with respect to
such country.
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(f) Amgen hereby
represents and warrants that it is not subject to
any obligation that would conflict with its ability to grant
the
license set forth in subsection (e) above.
C.
The following
shall be added to the Original Agreement as new Sections
2.3 (c) - (h):
(c) InterMune hereby
acknowledges that as of the Amendment Effective
Date Amgen has no rights of any kind or nature in the PEG
Trademark.
(d) At [***],
applications for the PEG-Trademark shall be prepared,
filed and prosecuted, and the PEG-Trademark maintained,
worldwide
by third-party intellectual property counsel selected and
retained by [***] provided that such counsel shall be subject
to
[***] not to be unreasonably withheld or delayed. [***] shall
have the [***] for and [***] over such matters and shall [***]
in
filing, prosecuting and maintaining the PEG-Trademark. [***]
will
remain at all times the [***] of the PEG-Trademark, subject to
subsection (e) below. [***] or its counsel shall keep [***]
fully
informed of the filing, prosecuting and maintenance of the
PEG-Trademark, and shall furnish to [***] copies of documents
relevant to any such efforts in advance with sufficient time
for
[***] to review and provide comments on such documents, and
shall
use its reasonable efforts to incorporate [***] comments and
suggestions.
(e) [***] agrees to
provide [***] counsel with such power of attorney
and other instruments as are necessary for [***] to conduct the
preparation, filing and prosecution of applications for, and
maintenance of, the PEG-Trademark as provide
