<PAGE>
EXHIBIT 10.30
***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.
(INTERMUNE (R) LOGO)
December 31, 2004
Thomas D. Zindrick
Vice President, Law
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
RE: AMENDMENT NUMBER 2
TO AMGEN/INTERMUNE LICENSE AND COMMERCIALIZATION
AGREEMENT FOR INFERGEN
Dear Mr. Zindrick:
As you know, Amgen Inc. ("Amgen") and InterMune, Inc. ("InterMune")
are parties
to that certain License and Commercialization Agreement effective
June 15, 2001,
as first amended April 25, 2002 (the "Agreement"). The Parties have
now agreed
to amend the Agreement to provide for the transfer of certain Amgen
technology
for manufacturing Infergen to InterMune and/or InterMune's
contract
manufacturer[***] in accordance with the terms set forth in this
letter
amendment (the "Amendment").
Therefore, for good and valuable consideration, the receipt and
sufficiency of
which is hereby acknowledged, the Parties hereby agree to amend the
Agreement
pursuant to this Amendment as follows:
1. This
Amendment is effective as of the Amendment Effective Date.
Capitalized
terms used herein and not otherwise defined will have the same
meaning as
ascribed thereto in the Agreement.
2. The following
capitalized terms will have the meanings set forth below:
(a)
"Allowed Activities"
means use on and after the Amendment Effective
Date by InterMune, its Affiliates, its assignees and/or its
Authorized
Sublicensees, in accordance with this Amendment, of the
Manufacturing
Process and any improvements thereto developed by InterMune or
[***]
on InterMune's behalf, to develop, manufacture or have manufactured
a
Licensed Product for development, use or sale in the Territory.
(b)
"Amendment Effective
Date" means the date first set forth above.
***Confidential Treatment Requested
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(c)
"Amgen Manufacturing
Improvements" means any improvements to the
Manufacturing Process conceived, created or discovered solely
by
Amgen, its Affiliates or its licensees (other than InterMune)
after
the Amendment Effective Date but prior to the expiration of the
Term
or the earlier termination of the Agreement.
(d)
"Amgen Manufacturing
Patents" means all Patents [***]. Amgen
Manufacturing Patents will be [***] of [***] for all purposes
under
the Agreement.
(e)
"Amgen Manufacturing
Technology" means: (i) the Manufacturing Process;
(ii) all data, documentation, know-how and trade secrets owned
or
Controlled by Amgen relating to the Manufacturing Process to
the
extent actually provided by Amgen to InterMune under Section 6 of
this
Amendment; (iii) the Amgen Manufacturing Patents; and (iv) the
Amgen
Materials. Amgen Manufacturing Technology excludes any
InterMune
Manufacturing Improvements.
(f)
"Amgen Materials"
means the materials set forth in Exhibit 2 hereto
and any other material provided to InterMune and/or [***] by
Amgen
pursuant to Section 6.
(g)
"Authorized
Sublicensee" means a sublicensee of InterMune's rights
pursuant to Section 3 of this Amendment, the sublicense to whom
is
permitted pursuant to Section 3(a) or 3(d) of this Amendment.
(h)
"[***] Affiliate" will
mean an entity that, directly or indirectly,
through one or more intermediaries, controls, is controlled by, or
is
under common control with [***]. For the purposes of this
definition,
control will mean the direct, indirect or indirect ownership of
greater than fifty percent (50%) or, if less than fifty percent
(50%),
the maximum percentage as allowed by applicable law of (i) the
stock
shares entitled to vote for the election of directors or (ii)
ownership interest.
(i)
"CDA" means the
confidentiality and materials transfer agreement
substantially in the form attached hereto as Exhibit 7 hereto to
be
executed by and among InterMune, Amgen and [***] to enable the
technology transfer activities described in Section 6 hereof to
commence.
(j)
"Contract
Manufacturer" means a manufacturer of [***] Licensed Product
[***] and/or [***] Licensed Product, which manufacturer is
[***]
responsible for such manufacture, although it may [***] to
perform
[***] of the [***] Licensed Products.
(k)
"GMP" means current
Good Manufacturing Practices as defined in the
United States Code of Federal Regulations (21 CFR 210 and 211
et
seq.).
(l)
"Infergen BLA" means
the BLA for Infergen and any and all updates and
supplements thereto.
(m)
"InterMune
Manufacturing Improvements" means any improvements to the
Manufacturing Process conceived, created or discovered solely
by
InterMune, its
***Confidential Treatment Requested
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Affiliates or its sublicensees (other than Amgen) after the
Amendment
Effective Date but prior to the expiration of the Term or the
earlier
termination of the Agreement.
(n)
"Manufacturing
Process" means the manufacturing process for Infergen
described in the Infergen BLA (i) as it exists as of the
Amendment
Effective Date, e.g., in the CMC section of the BLA and updates to
the
BLA existing as of the Amendment Effective Date (such as annual
reportable information, GMP requirements, etc.), and (ii) as
such
Infergen BLA may be modified by Amgen at any time after the
Amendment
Effective Date until the successful completion of the transfer of
the
Manufacturing Process to [***] (or another Contract Manufacturer,
as
the case may be) as contemplated in this Amendment.
(o)
"Manufacturing
Sublicense" means a sublicense agreement between
InterMune and [***], or other Contract Manufacturer, pursuant to
which
InterMune grants [***] or such other Contract Manufacturer a
sublicense under the license set forth in Section 3 below to
contract
manufacture Licensed Products.
(p)
"Process-Related
Technical Issues" means manufacturing process issues
and analytical testing issues relating solely to the
Manufacturing
Process identified through GMP compliance investigations as
required
by a Regulatory Authority as "Process Related" and does not
include
issues identified as "Equipment Related" or "Human Error
Related."
3. (a)
Pursuant to and
subject to that certain Amendment to License and
Supply Agreement by and between Amgen and [***] dated [***] and
the
License and Supply Agreement by and between Amgen and [***]
dated
[***] as amended [***]
Amgen hereby grants to InterMune during the
Term of the Agreement a non-exclusive license under the Amgen
Manufacturing Technology solely for the purposes of InterMune
granting
a sublicense to [***], to solely develop and contract manufacture
(and
perform all associated activities relating thereto) Licensed
Products,
including without limitation Infergen and PEG-Infergen Product
in
[***] solely for/to InterMune and its Affiliates and Sublicensees
for
[***] InterMune and its Affiliates and Sublicensees in the
Territory
(which sublicense will include the right for [***] to use [***]
Affiliates and subcontractors to perform elements of the [***]
Licensed Products). Upon the prior written consent of [***]
Amgen,
which consent from Amgen [***] will not be unreasonably withheld
or
delayed, InterMune may grant a sublicense under the foregoing
license
to another Contract Manufacturer [***] the identical rights
permitted
to be granted to [***] pursuant to this Section 3(a)).
(b)
Amgen hereby grants to
InterMune a non-exclusive license under the
Amgen Manufacturing Technology solely to manufacture and have
manufactured Licensed Products in the Territory, provided,
however,
that InterMune will not manufacture any Licensed Products or grant
any
rights to any Third Party to manufacture Licensed Products for
InterMune until and
unless Amgen has first granted its consent thereto
pursuant to Section 3(d) below.
***Confidential Treatment Requested
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(c)
Amgen hereby grants to
InterMune a non-exclusive sublicense under the
Existing License Patents solely to import, manufacture and have
manufactured Infergen in the Territory, provided, however, that
InterMune will not manufacture any Infergen or grant any rights to
any
Third Party to manufacture Infergen for InterMune until and
unless
Amgen has first granted its consent thereto pursuant to Section
3(d)
below.
(d)
Prior to manufacturing
or engaging any Contract Manufacturer (other
than [***]) to manufacture any Licensed Product, InterMune
shall
provide to Amgen a written request for such manufacturing along
with a
reasonably detailed description of the manufacturing activities,
the
Contract Manufacturer (if applicable), and upon Amgen's
reasonable
request, any other information that would be helpful to Amgen
in
evaluating the then current capabilities of InterMune or such
Contract
Manufacturer and the extent to which such Contract Manufacturer
(if
applicable) is competitive to Amgen. Within [***] days of
receiving
InterMune's request and such supplemental information as Amgen
requests pursuant to this Section 3(d), Amgen will review such
request
and provide to InterMune its decision about whether to consent to
the
proposed manufacturing activities, which consent will not be
unreasonably withheld. Once Amgen has approved a sublicense to
a
particular Contract Manufacturer, Amgen's further consent will not
be
required for such Contract Manufacturer to use its affiliates
and
subcontractors to perform elements of the manufacturing, filling
and
finishing of Licensed Products.
The
licenses set forth in this Section 3 are granted [***] or [***]
other
than
as set forth in [***] of the Agreement. Notwithstanding any
sublicensing of InterMune's rights and obligations hereunder to
[***] or
other Authorized Sublicensees, InterMune will remain responsible
for the
full
and complete performance of all of InterMune's obligations and
duties
hereunder and under the Agreement. Nothing herein is intended to
alter the
exclusive rights granted to InterMune by Amgen in Article 2 of
the
Agreement. InterMune's licenses set forth this Section 3 will,
upon
expiration of the Agreement as set forth in Section 13.1
thereof,
automatically convert to being irrevocable and fully-paid.
4. Amgen hereby
covenants that during the period of InterMune's licenses set
forth in Section 3 hereof, neither Amgen, nor any Amgen Affiliate
or
assignee (the "Amgen Covenantors") will sue InterMune, its
Affiliates, its
assignees and/or Authorized Sublicensees for infringement of any
Patent or
know-how owned or Controlled by any Amgen Covenantor (but excluding
the
Amgen Manufacturing Technology), or under which any Amgen
Covenantor has
the
right to sue infringers, solely to the extent InterMune, its
Affiliates, its assignees and/or its Authorized Sublicensees are
performing
Allowed Activities. The covenant in this Section 4 is expressly
subject to
InterMune's and its Affiliates', assignees' and/or sublicensees'
continuous
compliance with all of the terms and conditions of this Amendment
and the
Agreement.
For
the avoidance of doubt, nothing set forth in the Agreement or
this
Amendment will preclude Amgen from using the Amgen Manufacturing
Technology
or
granting a license to the Amgen Manufacturing Technology to a
Third
Party, in each case for: [***].
***Confidential Treatment Requested
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5. Amgen will
provide InterMune and [***] with access to the [***] Infergen
BLA.
InterMune will be the license holder for the Infergen BLA and
any
supplements thereto. As between Amgen and InterMune, [***] for
interacting
with
Regulatory Authorities and for obtaining all necessary
Regulatory
Approvals for the manufacturing of Infergen by [***] for use or
sale in the
Territory.
6. Amgen will
provide support (not to exceed [***] hours for technical
support
and
[***] hours of regulatory support, except as set forth herein
below) to
InterMune as requested by InterMune, as solely limited to the
following:
(a)
assisting InterMune in
developing a plan to transfer the Manufacturing
Process (a preliminary form of transfer plan is attached as Exhibit
4
hereto);
(b) assisting InterMune in the
transfer of the Manufacturing Process to
[***]; and
(c)
providing relevant
manufacturing know-how and documentation set forth
on Exhibit 5 hereto (which Amgen will complete within [***] days
from
the Amendment Effective Date, except for relevant manufacturing
know-how and documentation set forth on Exhibit 5 hereto that
relates
to tasks and processes currently performed at [***] which Amgen
will
complete within [***] days after the Amendment Effective Date;
provided, however, that in the event that InterMune provides
written
notice to Amgen of specific know-how and documentation that relates
to
tasks and processes currently performed at [***] and the reason
that
the same is needed prior to the end of such [***] day [***]
period
then Amgen shall use reasonable efforts to endeavor to provide
the
requested know-how and documentation sooner) and such other
know-how
and documentation necessary to manufacture Infergen as
InterMune
reasonably requests, provided that such know-how and
documentation
exists and Amgen would not have to [***] and that Amgen's
obligation
to deliver such know-how and documentation will be limited to
Amgen's
obligations to provide support under this Section 6, and
further
provided that InterMune hereby acknowledges that [***] may not
have
been [***] Amgen and therefore may [***] to be [***] hereunder.
InterMune acknowledges that Amgen has already expended, but not
yet
invoiced InterMune for, approximately [***] hours of technical
support
expended in [***], which will be deemed deducted from such [***]
hours of
technical support described above. In its sole discretion, Amgen
may
provide additional support beyond the hour limits stated above
upon
InterMune's reasonable request. InterMune and Amgen will each
endeavor to
manage blocks of time for coordinating technical transfer
discussions,
issues and manufacturing site interactions with Amgen and [***] so
as to
minimize [***], in accordance with the preliminary transfer plan
attached
as
Exhibit 4 hereto. Du
