Exhibit 10.97


 


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.


 










[ 
*  ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


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.


 










[ 
*  ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


(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


 










[ 
*  ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


 


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 sue (or grant rights to others to licensees to sue) 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,


 










[ 
*  ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


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.  [ * ]

  	
   

  	
  [ * ]

  	
   

  



 










[ 
*  ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


	
  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.


 










[ 
*  ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


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/ T.D. Zindrick

  	
   

  	
  By:

  	
  /s/ Daniel Welch

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  Thomas D. Zindrick

  	
   

  	
  Name:

  	
  Daniel G. Welch

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Vice President, Law

  	
   

  	
  Title:

  	
  President and CEO

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  1/13/2005

  	
   

  	
  Date:

  	
  1/12/05

  	
   

  



 










[  *  ] =
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT
OF 1934, AS AMENDED.


 





















 


Attachment
1


 


Exhibit G


 


AMGEN FOREIGN PEG PATENTS


 










[ 
*  ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


Exhibit G


 


[ * ]


 










[ 
*  ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.