Sample Business Contracts

License and Commercialization Agreement [Amendment No. 3] - Amgen Inc. and InterMune Inc.

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"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.


     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

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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.

          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

          1.54 "AMGEN PRODUCT" shall mean any product owned or Controlled by
          Amgen, other than a Licensed Product or a Directly Competitive

          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

          (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

          (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

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               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

     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:


               (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,

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               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

     G.   The following shall be added to the Original Agreement as new Section

          (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

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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.

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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


                                  ATTACHMENT 1

                                    EXHIBIT G

                            AMGEN FOREIGN PEG PATENTS


                                    EXHIBIT G


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