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 Xxx Xxxxx Xxxxxx Xxxxx,
Xxxxxxxx Xxxx, XX 00000-0000 ("AMGEN") and INTERMUNE, INC., a Delaware
corporation having its principal place of business at 0000 Xxxxxxxx Xxxx.,
Xxxxxxxx, XX 00000 ("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.
***Confidential Treatment Requested
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.
***Confidential Treatment Requested
(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 provided in subsection (d)
above, and [***] acknowledges that any such power of attorney
will make [***] agent an attorney-in-fact for [***] with respect
to the matter specified in the power of attorney or other
instrument, but will not create an attorney/client relationship
between Amgen and InterMune or [***].
(f) Upon the first issuance of the PEG-Trademark, Amgen shall
automatically be deemed to have granted to InterMune the
exclusive [***] license, with the right to grant sublicenses
(subject to InterMune's compliance with Section 2.5 of the
Agreement), under the entire right, title and interest in and to
the PEG Trademark, solely to use and display the PEG Trademark in
connection with PEG-Infergen Products in the Territory during the
Term. InterMune shall have the right to select, and use and
display with PEG-Infergen Products such Trademarks, consistent
with any reasonable quality standards that Amgen may prescribe
for use and display of the Trademarks.
(g) The PEG-Trademark will be deemed part of the Amgen Trademarks for
purposes of Section 8.3 of the Agreement.
(h) InterMune hereby agrees that in consideration of the rights
granted by Amgen to InterMune to prosecute, maintain and use the
PEG Trademark under the
***Confidential Treatment Requested
Agreement, InterMune shall be responsible for any [***] of
InterMune, its counsel and any Third Parties that act on
InterMune's behalf, which [***] of the PEG Trademark in any way,
whether arising out of the prosecution, maintenance, use or
failure to do any of the foregoing in accordance with standards
common to the biopharmaceutical industry, and upon the expiration
or termination of InterMune's license to use the Amgen
Trademarks, shall [***] Amgen the [***] to such [***].
D. Section 2.7(b) of the Original Agreement is hereby deleted in its
entirety.
E. Section 2.10 of the Original Agreement is hereby deleted in its
entirety and replaced with the following:
2.10 COVENANTS.
(a) Amgen hereby covenants that it and its Affiliates and
assignees, (each a "Covenantor") shall not xxx (or xxxxx rights
to others to licensees to xxx) InterMune, its assignees,
Affiliates and Sublicensees (each, an "InterMune Party") for
infringement of any CNTS Claim, in each case for such InterMune
Party's activities in the Territory and during the period of
InterMune's licenses under Sections 2.2, 2.3 and 2.4. For the
purposes of this Section 2.10(a), a "CNTS Claim" shall mean [***]
in each case [***]. Notwithstanding the foregoing, "CNTS Claim"
excludes [***] not otherwise licensed to InterMune by Amgen as of
the Amendment Effective Date, and technologies for developing or
making any of the foregoing (each, a "CNTS Excluded Claim") and
[***].
(b) Amgen hereby covenants that [***] rights to sell (and such
other rights as may be offered [***] Licensed Products in any
[***] Amgen shall offer to InterMune in writing an opportunity to
accept such rights as [***] makes available subject to the same
terms and conditions upon which such rights are provided to
Amgen. Upon InterMune's written acceptance of such offer, the
Parties will execute an amendment to the Agreement to include
such rights, terms and conditions.
F. The following shall be added to the Original Agreement as a new
Section 3.7:
3.7 DEVELOPMENT OF COMBINATION THERAPIES
(a) Amgen hereby grants to InterMune a non-exclusive, [***]
sublicenseable (solely as permitted under Section 2.5 of the
Agreement) license under any Patent claim owned or Controlled by
Amgen, which claims one or more methods for [***] with a [***] an
Amgen Product, solely to the extent such method was reduced to
practice as the result of a Combination Trial, solely to
research, develop, use, manufacture, have manufactured, sell,
***Confidential Treatment Requested
offer for sale, import, export and/or otherwise exploit Licensed
Products to [***] in [***] in any country in which InterMune has
the right to research, develop, use, manufacture, have
manufactured, sell, offer for sale, import, export and/or
otherwise exploit Licensed Products.
(b) To the extent that Amgen creates or obtains data arising out
of a Combination Trial (the "STUDY DATA"), Amgen will use [***]
to provide the Study Data to InterMune in summary format, as the
Study Data become available. The summary format of Study Data
must be reasonably sufficient for InterMune to evaluate [***] and
[***] and make informed decisions regarding [***] with Licensed
Products. Study Data shall be deemed to be Amgen's Confidential
Information and therefore subject to the obligations of non-use
and non-disclosure set forth in Article 12 [***].
(c) For purposes of clarification, the Parties acknowledge that a
clinical trial or set of clinical trials not originally deemed a
Combination Trial may at a later point in time become a
Combination Trial. By way of example, with respect to a clinical
trial that is not initially a Combination Trial because the
product used in combination with an Amgen Product in such trial
is not commercialized for an indication for which a Licensed
Product is approved, a Licensed Product may [***] for an [***]
for which such product is [***] thereby causing such product to
be [***] in that [***] and, in turn, rendering [***] and such
trial a Combination Trial. The Parties agree that at the point in
time a clinical trial becomes a Combination Trial, such event
shall effect the grant of rights to InterMune by Amgen provided
in this Section 3.7. In addition, for purposes of Section 6.4,
the Parties agree that at the point in time [***] such event
could [***] in accordance with the terms set forth in Section
6.4.
G. The following shall be added to the Original Agreement as new Section
6.3(d):
(d) InterMune shall pay to Amgen milestone payments as set forth in
this Section 6.3(d) within [***] days after the first achievement
of the corresponding milestone for a PEG-Infergen Product. No
milestone payment shall be payable more than once, no matter how
many times achieved by a single Amgen PEG-Infergen Product or
multiple Amgen PEG-Infergen Products. Such milestone payments
shall be nonrefundable and noncreditable against royalties
payable pursuant to Sections 6.4 and 6.7, and any other fees,
milestone payments or other payments due Amgen under this
Agreement.
MILESTONE EVENT MILESTONE PAYMENT AMOUNT
--------------- ------------------------
1. [***] [***]
***Confidential Treatment Requested
MILESTONE EVENT MILESTONE PAYMENT AMOUNT
--------------- ------------------------
2. [***] [***]
H. The following shall be added to the Original Agreement at the end of
Section 6.4:
"Notwithstanding the foregoing, the Royalty described in this
Section 6.4 shall (i) be automatically [***] percent [***] on a
country-by-country basis, if at all, upon Amgen's first sale
after the Amendment Effective Date of any Directly Competitive
Product in such country and (ii) be automatically [***] percent
[***] with respect to all countries within the Territory upon the
[***] by Amgen, independently or with a Third Party, of [***]
from a [***] that [***] with [***] of the [***] of [***] Amgen's
[***] product or second generation [***] product."
I. A new Exhibit G shall be added to the Original Agreement, which
Exhibit G shall be the form attached hereto as ATTACHMENT 1.
2. Entire Agreement. This Amendment No. Three is intended by the Parties to
amend the Original Agreement only to the extent of the specific amendments set
forth above. This Amendment No. Three, and the Original Agreement (collectively,
the "TRANSACTION AGREEMENTS") set forth the complete, final and exclusive
agreement with respect to their subject matter and all the covenants, promises,
agreements, warranties, representations, conditions and understandings between
the Parties hereto with respect to such subject matter and supersede and
terminate all prior agreements and understandings between the Parties with
respect to such subject matter. There are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or
written, between the Parties other than as are set forth in the Transaction
Agreements. No subsequent alteration, amendment, change or addition to this
Amendment No. Three shall be binding upon the Parties unless reduced to writing
and signed by an authorized officer of each Party.
3. Counterparts. This Amendment No. Three may be executed in two (2)
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
4. Representation and Warranty. Amgen hereby represents and warrants to
InterMune that, as of the Amendment Effective Date, Amgen has no current plan to
(a) acquire a company with a Directly Competitive Product currently marketed in
the Territory and (b) clinically develop a novel Directly Competitive Product,
except to the extent that Amgen may engage in clinical testing of a Directly
Competitive Product(s) in combination with one or more Amgen Products.
***Confidential Treatment Requested
IN WITNESS WHEREOF, the Parties have executed this Amendment No. Three in
duplicate originals by their duly authorized representatives as of the Amendment
Effective Date.
AMGEN INC. INTERMUNE, INC.
BY: /s/ X.X. Xxxxxxxx BY: /s/ Xxxxxx Xxxxx
--------------------------------- ------------------------------------
NAME: Xxxxxx X. Xxxxxxxx NAME: Xxxxxx X. Xxxxx
TITLE: Vice President, Law TITLE: President and CEO
DATE: 1/13/2005 DATE: 1/12/05
ATTACHMENT 1
EXHIBIT G
AMGEN FOREIGN PEG PATENTS
EXHIBIT G
[***]
***Confidential Treatment Requested
