Exhibit 10.32
`
`Page 1 of 7
`
`EX-10.32 3 exhibit10_32.htm EXHIBIT 10.32
`Amendment to License Agreement for Anti-HER2 Antibodies
`
`Genentech, Inc. (“GENENTECH”) and ImmunoGen, Inc. (“IMMUNOGEN”) are entering into this
`Amendment to License Agreement for Anti-HER2 Antibodies (“Amendment”) as of May 3, 2006
`(the “Amendment Effective Date”).
`
`Background
`
` Genentech and ImmunoGen are parties to the following agreements: that certain License
`Agreement dated as of May 2, 2000, and amendments thereto (the “License Agreement”); that
`certain Heads of Agreement, dated as of May 2, 2000, as amended (as so amended, the “Heads of
`Agreement”); that certain Process Development Heads of Agreement, dated as of June 29, 2001, and
`amendments thereto, including that certain Amendment No.1 dated November 15, 2002 (the “PD
`Heads of Agreement”); that certain Manufacturing and Supply Agreement dated as of January 11,
`2005, and amendments thereto (the “Clinical Supply Agreement”); that certain Development
`Agreement dated as of June 1, 2004, and amendments thereto (the “Development Agreement”); and
`the Quality Services Agreement dated as of June 30, 2005 (the “Quality Services Agreement”) (the
`License Agreement, the Heads of Agreement, the PD Heads of Agreement, the Clinical Supply
`Agreement, the Development Agreement and the Quality Services Agreement, collectively the
`“Existing Agreements”).
`
` GENENTECH and IMMUNOGEN are, as of the Amendment Effective Date, entering into a
`Process Development Agreement (the “Process Development Agreement”), under which
`IMMUNOGEN will develop a commercial-scale conjugation process for certain products that are
`“Licensed Products” under the License Agreement.
`
` In connection with entering into the Process Development Agreement, GENENTECH has
`agreed to increase the milestones and royalties for Licensed Products in certain circumstances, as set
`forth in this Amendment.
`
` GENENTECH and IMMUNOGEN also have agreed to modify the terms of the license
`granted, specifically by revising the definition of “Improvements” and expanding IMMUNOGEN’s
`rights to Improvements.
`
` In consideration of the mutual promises and covenants contained in this Amendment, the
`sufficiency of which consideration is hereby mutually acknowledged, the Parties have agreed as
`follows:
`
`Agreement
`
`1. Definitions. In the License Agreement, the following definitions are modified or added,
`effective as of the Amendment Effective Date.
`(a) Definition of “Improvement.” Section 1.27 (definition of “Improvement”) of the License
`Agreement is hereby deleted in its entirety and replaced with the following:
`Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission
`pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities
`Exchange Act of 1934.
`
`http://www.sec.gov/Archives/edgar/data/855654/000085565406000029/exhibit10_32.htm
`
`1/16/2015
`
`IMMUNOGEN 2263, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Exhibit 10.32
`
`Page 2 of 7
`
`1.27 “Improvement” means: (a) improvements to any MAY Compound, (b) improvements
`to methods of making any MAY Compound, and (c) improvements to the conjugation process
`for making antibody-drug conjugates that include any MAY Compound (including, for example,
`reaction conditions or changes in process that create improvements in the yield of such
`conjugate). “Improvement” excludes any and all of the following items (“GNE Exclusions”):
`(w) any improvement that is specific to any antibody-drug conjugates that bind to an antigen
`that is subject to an exclusive license from ImmunoGen under, or arising from, the Heads of
`Agreement or is subject to an Exclusive Target Option under the Heads of Agreement during the
`period that such exclusive license or Exclusive Target Option remains in effect;
`(x) improvements to [***] [***] [***] or [***] [***], or the [***] of [***] or [***] [***] of the
`foregoing; (y) improvements arising out of Genentech [***] or [***] activities (whether or not
`the associated [***] is licensed to Genentech by ImmunoGen); or (z) the [***] or [***] of [***]
`[***] [***] (i.e., the [***] or [***] of such [***] [***] (e.g., the [***] of [***] or the [***] of
`[***] to [***]) and [***] the manner of [***] such [***] [***]) that binds to an antigen that is
`subject to an exclusive license from ImmunoGen under, or arising from, the Heads of
`Agreement or an antigen that is subject to an Exclusive Target Option under the Heads of
`Agreement, during the period that such exclusive license or Exclusive Target Option remains in
`effect.
`
`(b) Definition of “ImmunoGen Field.” A new Section 1.26A is added as follows:
`
` 1.26A “ImmunoGen Field” means any and all uses other than any use that involves an
`antibody that binds to an antigen that is subject to an exclusive license from ImmunoGen under,
`or arising from, the Heads of Agreement or an antigen that is subject to an Exclusive Target
`Option under the Heads of Agreement, during the period that such exclusive license or
`Exclusive Target Option remains in effect.
`
`2. License to ImmunoGen. Section 2.1(b) of the License Agreement is hereby deleted in its
`entirety and the following is inserted in lieu thereof:
`
`(b) License to IMMUNOGEN. GENENTECH hereby grants to IMMUNOGEN a non-
`exclusive, royalty-free license (i) under GENENTECH’s
`intellectual property interest in Improvements, to develop, make, use, sell, offer for sale, import,
`and export any product that is not a Licensed Product, subject to Section 2.3(b) below and the
`remaining terms of this Section 2.1(b); and (ii) to otherwise exploit Improvements for all uses
`within the ImmunoGen Field, subject to Section 2.3(b) below and the remaining terms of this
`Section 2.1(b). The foregoing license includes the right to sublicense the rights granted under
`this Section 2.1(b) on and after the Amendment Effective Date only if all of the following three
`conditions (i), (ii) and (iii) are met:
`(i) the sublicense is limited to the ImmunoGen Field;
`(ii) the sublicense is granted only in connection with a license to ImmunoGen
`MAY Technology (where “ImmunoGen MAY Technology” means Technology Controlled by
`ImmunoGen and used in the conjugation of MAY Compounds to binding proteins), and the
`rights granted for ImmunoGen MAY Technology are of the same scope (e.g., for the same
`product or technology and within the same field and the same territory) as the rights granted for
`Genentech’s Improvements; and
`Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission
`pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities
`Exchange Act of 1934.
`
`http://www.sec.gov/Archives/edgar/data/855654/000085565406000029/exhibit10_32.htm
`
`1/16/2015
`
`IMMUNOGEN 2263, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Exhibit 10.32
`
`Page 3 of 7
`
`(iii) GENENTECH obtains Substantially Similar Grant Back Rights without
`incurring an obligation to pay any additional consideration (either to IMMUNOGEN or to the
`sublicensee). “Substantially Similar Grant Back Rights” means non-exclusive rights in and to
`that sublicensee’s “improvements” (improvements to MAY Compounds, methods of making
`MAY Compounds, and methods of making antibody-drug conjugates) that are of substantially
`the same scope (e.g., within the same field and the same territory) as the rights granted in and to
`Improvements under this Agreement. (GENENTECH may obtain such rights directly from
`IMMUNOGEN’s sublicensee or indirectly through IMMUNOGEN; if GENENTECH obtains
`such rights from IMMUNOGEN, IMMUNOGEN may have obtained such rights under license
`or by transfer of ownership).
`
`Nothing in this Agreement or the course of dealings between the Parties or usage or
`custom in the industry or trade shall be construed to confer any other rights or licenses to any
`other intellectual property Controlled by either Party or its Affiliates by implication, estoppel or
`otherwise. GENENTECH has no obligation to [***] in any [***] [***] or [***] of [***] [***]
`to [***] or a [***] of [***] with respect to [***]. During the term of the Process Development
`Agreement, IMMUNOGEN may inquire of GENENTECH as to Improvements Controlled by
`GENENTECH, and GENENTECH shall respond by disclosing any such Improvements within
`the ImmunoGen Field.
`
`3. Milestone Payments. Section 4.1.1 of the License Agreement is replaced in its entirety by the
`following:
`
`4.1.1 In consideration of the grant of the license by IMMUNOGEN hereunder, and subject to
`the other terms of this Agreement, GENENTECH will pay IMMUNOGEN the amounts in the
`column titled “milestone payment” within thirty (30) days after the first achievement of each of
`the milestones set forth in the table below. Further, if IMMUNOGEN successfully meets the
`milestones set forth in the Process Development Agreement and if the [***] of the Conjugation
`Process (as defined in the Process Development Agreement) to a [***] is [***] by the end of the
`first [***] [***] of [***] (as the foregoing timeline will be adjusted in accordance with the
`Process Development Agreement), then GENENTECH shall pay IMMUNOGEN the amounts in
`the column titled “additional payment” within thirty (30) days after the first achievement of the
`milestones for which an additional payment applies. Milestone payments and additional
`payments under this Section are nonrefundable and noncreditable, except as expressly provided
`in Section 4.1.2 below.
`
`Milestone
`
`Milestone Payment
`
`Additional
`Payment
`
`$[***] [***]
`
`$2 Million*
`
`$2 Million*
`
`$[***] [***]
`
`Effective Date (of License
`Agreement)
`IND Acceptance for a
`Licensed Product
`[***] of [***] [***] [***]
`[***] [***] [***] [***] for a
`[***] [***]
`[***] of [***] [***] [***]
`[***] in the [***] [***] for a
`[***] [***] or [***] [***]
`
`$[***] [***]
`
`$[***] [***]
`
`http://www.sec.gov/Archives/edgar/data/855654/000085565406000029/exhibit10_32.htm
`
`1/16/2015
`
`IMMUNOGEN 2263, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Exhibit 10.32
`
`Page 4 of 7
`
`[***] [***] for a [***] [***]
`([***] is [***])
`[***] of [***] or [***] by the
`[***] for a [***] [***] for
`[***] of [***] [***] [***]
`[***] of an [***] or other
`[***] [***] [***] in the [***]
`[***] for a [***] [***] for
`[***] of [***] [***] [***]
`[***] of a [***] [***] for a
`[***] [***] in [***] for
`treatment of [***] [***] [***]
`[***] of [***] or [***] by the
`[***] for a [***] [***] [***]
`[***] of [***] or [***] by the
`[***] for [***] [***] [***].
`
`$[***] [***]
`
`$[***] [***]
`
`$[***] [***]
`
`$[***] [***]
`
`$[***] [***]
`
`$[***] [***]
`
`Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission
`pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities
`Exchange Act of 1934.
`
`http://www.sec.gov/Archives/edgar/data/855654/000085565406000029/exhibit10_32.htm
`
`1/16/2015
`
`IMMUNOGEN 2263, pg. 4
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Exhibit 10.32
`
`Page 5 of 7
`
`It is hereby acknowledged and agreed that those milestone payments and additional
`payments identified with a * in the table above already have been paid by GENENTECH. It is
`also hereby acknowledged and agreed that any milestone payment shall be made only once, with
`respect to the first achievement of the relevant milestone for the first Licensed Product,
`regardless of how many times a particular Licensed Product achieves such milestones.
`GENENTECH shall notify IMMUNOGEN of the achievement of milestones hereunder as
`provided in Section 3.2(a) above.
`
`4. Royalties. Section 4.2.3 ([***] [***] [***]) of the License Agreement is replaced with the
`following:
`
`4.2.3 [***] [***] [***]. In consideration of the grant of the license by IMMUNOGEN
`hereunder, and subject to the other terms of this Agreement (including the other terms of this
`Section 4):
`
` (a) [***] [***] [***]. Notwithstanding anything set forth in [***] above, the
`[***] [***] set forth therein shall apply, on a [***] and [***] [***], to [***] [***] of [***]
`[***] [***] [***] [***] [***] [***] or its [***], [***] or [***] in [***] [***] would, [***] for
`the [***] under this Agreement, [***] a [***] [***] [***] the [***] [***] [***] (excluding any
`[***] [***] [***] [***] by [***] and [***] and further excluding any [***] [***] in or to [***]
`for which [***] is the [***] or [***] [***]).Subject to the other terms of this Agreement (except
`for Section 4.2.2 above, which shall not apply), on a [***] and [***] [***] where and as of
`when the [***] [***] under Section 4.2.1 [***] [***] [***] as a [***] of this Section 4.2.3 (a),
`GENENTECH shall [***] to IMMUNOGEN a [***] [***] to [***]:
` (i) if the [***] [***] has been [***] [***], in [***] or in [***] [***],
`the [***] [***] (as defined in the Process Development Agreement) following the [***] of the
`[***] [***] the [***] [***] as contemplated by Section 3.2 of the Process Development
`Agreement, then [***] [***] ([***]) of [***] [***] of [***] [***] [***] [***] by [***] and/or
`its [***] in [***] [***]; or
`(ii) if the [***] [***] has not been [***] [***], in [***] or in [***]
`[***], the [***] [***] (as defined in the Process Development Agreement) following the [***]
`of the [***] [***] the [***] [***] as contemplated by Section 3.2 of the Process Development
`Agreement, then [***] [***] ([***]) of [***] [***] of [***] [***] [***] [***] by [***] and/or
`its [***] in [***] [***].
`
`5. Miscellaneous. This Amendment is governed by the substantive rules of the state of
`California. Capitalized terms used and not otherwise defined herein shall have the respective
`meanings ascribed to them in the respective Existing Agreement that is being amended hereby.
`The Existing Agreements remain in full force and effect, as amended by this Amendment.
`References in the Existing Agreements to “Agreement” mean those Existing Agreements as
`amended by the Amendment.
`
`[Signature page follows.]
`Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission
`pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities
`Exchange Act of 1934.
`
`http://www.sec.gov/Archives/edgar/data/855654/000085565406000029/exhibit10_32.htm
`
`1/16/2015
`
`IMMUNOGEN 2263, pg. 5
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Exhibit 10.32
`
`Page 6 of 7
`
`IN WITNESS WHEREOF, the Parties have caused this AMENDMENT TO LICENSE
`AGREEMENT to be duly executed, effective as of the Amendment Effective Date, by their respective
`duly authorized officers.
`
`GENENTECH, INC.
`
`IMMUNOGEN, INC.
`
`By:
`Name:
`Title:
`
`Date:
`
`By:
`Name:
`Title:
`
`Date:
`
`Pauline Jen Ryan
`Senior Vice President
`Corporate Development and
`Operations
`
`Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission
`pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities
`Exchange Act of 1934.
`
`http://www.sec.gov/Archives/edgar/data/855654/000085565406000029/exhibit10_32.htm
`
`1/16/2015
`
`IMMUNOGEN 2263, pg. 6
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Exhibit 10.32
`
`Page 7 of 7
`
`http://www.sec.gov/Archives/edgar/data/855654/000085565406000029/exhibit10_32.htm
`
`1/16/2015
`
`IMMUNOGEN 2263, pg. 7
`Phigenix v. Immunogen
`IPR2014-00676
`
`