EX-10.1 2 a11-26542_1ex10d1.htm EX-10.1
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`Page 1 of 28
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`Exhibit 10.1
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`LICENSE AGREEMENT
`
`This License Agreement (“Agreement”) is made effective as of May 2, 2000 (the “Effective Date”) by and between
`GENENTECH, INC., a Delaware corporation having its principal business office at 1 DNA Way, South San Francisco,
`California 94080 (“GENENTECH”), and IMMUNOGEN, INC., a Massachusetts corporation with its principal place of
`business at 333 Providence Highway, Norwood, Massachusetts 02062 (“IMMUNOGEN”). GENENTECH and
`IMMUNOGEN are each hereafter referred to individually as a “Party” and together as the “Parties”.
`
`WHEREAS, GENENTECH is the owner of or otherwise controls certain rights in proprietary technology and know-how
`relating to anti-HER2 antibodies and other HER-2 binding proteins; and
`
`WHEREAS, IMMUNOGEN is the owner of or otherwise controls certain rights in proprietary technology and know-how
`relating to or otherwise useful in the conjugation of maytansine derivatives such as DM1 to binding proteins;
`
`WHEREAS, pursuant to an MTA (as defined below), IMMUNOGEN performed certain work using a biologic materials
`of GENENTECH to create a conjugated compound, which work under the MTA is part of what is covered by this
`Agreement; and
`
`WHEREAS, on the terms and conditions set forth herein, GENENTECH desires to obtain from IMMUNOGEN, and
`IMMUNOGEN desires to grant to GENENTECH, the rights set forth herein, including a license under IMMUNOGEN’S
`technology and/or intellectual property rights to develop and commercialize one or more Licensed Products (as defined
`below).
`
`NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable
`consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereby agree as follows:
`
`1. DEFINITIONS
`
`Whenever used in the Agreement with an initial capital letter, the terms defined in this Section 1 shall have the meanings
`specified.
`
`1.1. “ADVERSE EVENT” shall mean any untoward medical occurrence in a patient or subject who is administered a
`Licensed Product, whether or not considered related to the
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
`
`Licensed Product, including, without limitation, any undesirable sign (including abnormal laboratory findings of clinical
`concern), symptom or disease temporally associated with the use of such Licensed Product.
`
`1.2. “AFFILIATE” shall mean any corporation, firm, limited liability company, partnership or other entity which directly
`or indirectly controls or is controlled by or is under common control with a Party to this Agreement. For purposes of this
`Section 1.2, “control” means ownership, directly or indirectly through one or more Affiliates, of fifty percent (50%) or
`more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%)
`or more of the equity interests in the case of any other type of legal entity, or status as a general partner in the case of any
`partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or
`equivalent governing body or management of a corporation or other entity.
`
`1.3. “AGREEMENT” shall mean this License Agreement between the Parties, dated as of the Effective Date, including
`any exhibits, schedules or other attachments hereto and incorporated herein, as any of the foregoing may be validly
`amended from time to time. In the event of any inconsistency between the terms of this Agreement and the terms of any
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`exhibits, schedules or other attachments incorporated herein, the terms of this Agreement shall govern unless the Parties
`expressly agree otherwise in writing.
`
`1.4. “ALLOCABLE OVERHEAD” shall mean overhead costs incurred by IMMUNOGEN attributable to
`IMMUNOGEN’s [*] functions which are allocated to company departments based on [*] or [*] or another [*] method, and
`shall include the [*] as defined hereinbelow. For purposes of any given calculation of “Allocable Overhead” hereunder,
`the [*] of the total amount of Allocable Overhead (as calculated before the inclusion of any such fee). However,
`“Allocable Overhead” [*]
`
`1.5. “ANTI-HER2 ANTIBODY” shall mean [*].
`
`1.6. “BLA” shall mean a biologics license application (as defined in Title 21 of the United States Code of Federal
`Regulations, as amended from time to time) filed with the FDA seeking Regulatory Approval to market and sell any
`Licensed Product in the United States for a particular indication within the Field.
`
`1.7. “CLINICAL MATERIALS” shall mean (a) supplies of ansamitocin P-3, and/or any other MAY Compound as
`manufactured in accordance with all applicable GMPs and other legal requirements and all applicable Specifications for
`such MAY Compound for use in human
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
`
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`clinical testing, and (b) supplies of any Licensed Product as manufactured in accordance with all applicable GMPs and
`other legal requirements and all applicable Specifications for such Licensed Product for use in human clinical testing of
`any Licensed Product.
`
`1.8. “COMBINATION PRODUCT” shall mean any Licensed Product that contains, in addition to any conjugate of any
`Anti-HER2 Antibody with any MAY Compound, one or more other ingredients that has biologic activity as a therapeutic
`agent when present alone.
`
`1.9. “COMPETING PRODUCT” shall have the meaning set forth in Section 2.1(b).
`
`1.10. “CONFIDENTIAL INFORMATION” shall have the meaning set forth in Section 5.1.
`
`1.11. “CONTROL” or “CONTROLLED” shall mean, with respect to any Patent Rights or Technology (including, without
`limitation, any MAY Compound, Anti-HER2 Antibody or other proprietary biologic material covered under this
`Agreement), the possession by a Party of the ability to grant a license or sublicense of such patent rights, know-how or
`other intellectual property and the rights thereto or to supply such compounds or materials as provided for in this
`Agreement without violating the terms of any arrangement or agreement between such Party and any Third Party.
`
`1.12. “DEVELOPMENT” and “DEVELOP” shall mean, with respect to any Licensed Product, all activities with respect
`to such Licensed Product relating to research and development in connection with seeking, obtaining and/or maintaining
`any Regulatory Approval for such Licensed Product in the Field in the Territory, including without limitation, all pre-
`clinical research and development activities, all human clinical studies, all activities relating to developing the ability to
`manufacture any Licensed Product or any component thereof (including, without limitation, process development work),
`and all other activities relating to seeking, obtaining and/or maintaining any Regulatory Approvals from the FDA and/or
`any Foreign Regulatory Authority.
`
`1.13. “DRUG APPROVAL APPLICATION” shall mean any application for Regulatory Approval (including pricing and
`reimbursement approvals) required prior to any commercial sale or use of a Licensed Product in any country or
`jurisdiction in the Territory, including, without limitation, (a) any BLA, NDA or MAA filed with the FDA or any Foreign
`Regulatory Authority, and (b) any equivalent application filed with any Foreign Regulatory Authority for Regulatory
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`Approval (including pricing and reimbursement approvals) required prior to any commercial sale or use of a Licensed
`Product in any country or jurisdiction in the Territory.
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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`1.14. “EFFECTIVE DATE” shall mean the date first written above in the introductory paragraph to this Agreement.
`
`1.15. “EXTENDED INDICATIONS” shall mean any and all human uses for the indications of [*]. However, “Extended
`Indications” shall not include any human therapeutic use for the indication of metastatic breast cancer.
`
`1.16. “FDA” shall mean the United States Food and Drug Administration and any successor agency or authority thereto.
`
`1.17. “FIELD” shall mean any and all human uses, including, without limitation, for the indication of metastatic breast
`cancer and/or any Extended Indications.
`
`1.18. “FIRST COMMERCIAL SALE” shall mean the date of the first commercial sale (other than for purposes of
`obtaining Regulatory Approval) of a Licensed Product by or on behalf of GENENTECH or any Sublicensee.
`
`1.19. “FOREIGN REGULATORY AUTHORITIES” shall mean any applicable supranational, national, federal, state or
`local regulatory agency, department, bureau or other governmental entity of any country or jurisdiction in the Territory
`(other than the FDA in the United States), having responsibility in such country or jurisdiction for any Regulatory
`Approvals of any kind in such country or jurisdiction, and any successor agency or authority thereto.
`
`1.20. “FULLY BURDENED MANUFACTURING COST” shall mean, with respect to any Preclinical Materials or
`Clinical Materials produced by IMMUNOGEN for GENENTECH under this Agreement, the sum of the following
`components: (a) the costs of goods produced, as determined by IMMUNOGEN in accordance with generally accepted
`accounting principles in the United States, consistently applied, including, without limitation, direct labor, material and
`product testing costs of such Preclinical Materials or Clinical Materials; (b) any Third Party royalty costs directly allocable
`to the manufacture or use of such Preclinical Materials or Clinical Materials; (c) all Allocable Overhead on the cost of
`goods under clause (a) above; and (d) any other costs borne by IMMUNOGEN, for the transport, customs clearance, duty,
`insurance and/or storage of such Preclinical Materials or Clinical Materials.
`
`1.21. “GENENTECH” shall mean Genentech, Inc., a Delaware corporation, and its successors and permitted assigns under
`this Agreement.
`
`1.22. “GENENTECH PRODUCT” shall have the meaning set forth in Section 2.1(b).
`
`1.23. “GLPS” shall mean all good laboratory practices under Title 21 of the United States Code of Federal Regulations, as
`amended from time to time.
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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`1.24. “GMPS” shall mean all good manufacturing practices under Title 21 of the United States Code of Federal
`Regulations, as amended from time to time.
`
`1.25. “HER2 PRODUCT” shall have the meaning set forth in Section 2.3(b).
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`1.26. “IMMUNOGEN” shall mean ImmunoGen, Inc., a Massachusetts corporation, and its successors and permitted
`assigns under this Agreement.
`
`1.27. “IMPROVEMENT” shall mean any enhancement, improvement or modification created or identified by
`GENENTECH under this Agreement or by IMMUNOGEN under this Agreement or otherwise, to the extent covered by or
`under the Licensed Patent Rights or the Licensed Technology.
`
`1.28. “IND” shall mean an investigational new drug application (as defined in Title 21 of the United States Code of
`Federal Regulations, as amended from time to time) filed or to be filed with the FDA with regard to any Licensed Product.
`
`1.29. “IND ACCEPTANCE” shall mean the expiration of thirty (30) days following receipt by GENENTECH of a notice
`from the FDA to GENENTECH (or its Sublicensee) that the FDA has received an IND for a Licensed Product filed by
`GENENTECH (or its Sublicensee) for the purpose of obtaining approval or authority to commence human clinical trials in
`the United States with such Licensed Product; PROVIDED, HOWEVER, that if the FDA puts a clinical hold on the IND
`during such thirty (30) day period, the term “IND Acceptance” shall mean that date during the term of this Agreement
`when GENENTECH (or its Sublicensee) receives written confirmation from the FDA that the clinical hold has been
`removed and that GENENTECH (or its Sublicensee) has the approval or authority to commence human clinical trials of
`such Licensed Product under such IND in the United States. Notwithstanding anything set forth herein, “IND Acceptance”
`shall not be deemed to have occurred in any circumstances where GENENTECH (or its Sublicensee) withdraws any IND
`filed with the FDA for a Licensed Product at any time prior to the commencement of human clinical trials with such
`Licensed Product in the United States.
`
`1.30. “INDEMNITEES” and “INDEMNIFYING PARTY” shall have the meanings set forth in Section 9.
`
`1.31. “JOINT PROCESS DEVELOPMENT COMMITTEE” or “JPDC” shall mean the committee with representatives of
`each Party established as set forth in Section 3.4.
`
`1.32 “LICENSED PATENT RIGHTS” shall mean any and all Patent Rights in the Field in the Territory which are
`Controlled by IMMUNOGEN as of the Effective Date (including
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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`IMMUNOGEN’s interest in any such Patent Rights conceived or reduced to practice or arising from any work under the
`MTA) or become Controlled by IMMUNOGEN during the Term, to the extent that any of the foregoing is necessary or
`useful for the Development, manufacture, use, import, export or sale of any Licensed Product (or any component thereof)
`or any Improvement in the Field in the Territory. The Licensed Patent Rights as of the Effective Date include, without
`limitation, the patents and patent applications set forth in SCHEDULE I attached hereto and incorporated herein.
`SCHEDULE I shall be updated by IMMUNOGEN by written notice to GENENTECH on a semi-annual basis during the
`term of this Agreement, beginning six (6) months after the Effective Date, to include any Licensed Patent Rights that have
`arisen in the period since the Effective Date or since the last update to SCHEDULE I. If IMMUNOGEN fails to update
`SCHEDULE I on a timely basis as provided herein, IMMUNOGEN shall update SCHEDULE I within thirty (30) days
`after any written request from GENENTECH to do so.
`
`1.33 “LICENSED PRODUCT” shall mean any product containing any conjugate of any Anti-HER2 Antibody with any
`MAY Compound, and shall include, without limitation, any formulation thereof (including, without limitation, any
`lyophilized, liquid, sustained release or aerosolized formulation). “Licensed Product” shall also include any and all
`Combination Products (if any) and any HER2 Product.
`
`1.34 “LICENSED TECHNOLOGY” shall mean any and all Technology which relates to the use of any Licensed Product
`in the Field in the Territory which is Controlled by IMMUNOGEN as of the Effective Date (including IMMUNOGEN’s
`interest in any such Technology conceived or reduced to practice or arising from any work under the MTA) or becomes
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`Controlled by IMMUNOGEN during the Term, to the extent that any of the foregoing relates to any Licensed Patent
`Rights or is necessary or useful for the Development, manufacture, use, import, export or sale of any Licensed Product (or
`any component thereof, including any linker) or any unpatented Improvement in the Field in the Territory. The Licensed
`Technology as of the Effective Date includes, without limitation, the materials, information and documentation set forth in
`SCHEDULE II attached hereto and incorporated herein.
`
`1.35 “MAA” shall mean an application filed with the relevant Foreign Regulatory Authorities in Europe seeking
`Regulatory Approval to market and sell any Licensed Product in Europe or any country or territory therein for a particular
`indication within the Field.
`
`1.36 “MAY COMPOUND” shall mean any and all maytansinoid compounds (including, without limitation, maytansine,
`ansamitocin P-3 and DM1), whether produced by a botanical
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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`source, natural fermentation or chemical synthesis, and shall include, without limitation, all variants, fragments or
`derivatives of any of the foregoing, in each case owned or otherwise Controlled by IMMUNOGEN. MAY shall include,
`without limitation, that certain maytansine derivative known as “DM1” whose more specific chemical name is N2’-
`deacetyl-N2’-(3-mercapto-1-oxopropyl)-maytansine.
`
`1.37 “MTA” shall mean that certain Material Transfer Agreement, dated as of March 29, 1999, between the Parties.
`
`1.38 “NDA” shall mean a new drug application (as defined in Title 21 of the United States Code of Federal Regulations,
`as amended from time to time) filed with the FDA seeking Regulatory Approval to market and sell any Licensed Product
`in the United States for a particular indication within the Field.
`
`1.39 “NET SALES” shall mean, as to each calendar quarter during the Term, the gross invoiced sales prices charged for
`all Licensed Products sold by GENENTECH or its Sublicensees to Third Parties throughout the Territory during such
`calendar quarter, less the following amounts incurred or paid by GENENTECH or its Sublicensees during such calendar
`quarter with respect to sales of Licensed Products regardless of the calendar quarter in which such sales were made:
`
`(a) trade, cash and quantity discounts or rebates actually allowed or taken, including discounts or rebates to
`governmental or managed care organizations;
`
`(b) credits or allowances actually given or made for rejection of or return of, and for uncollectible amounts
`on, previously sold Licensed Products or for retroactive price reductions (including Medicare and similar
`types of rebates);
`
`(c) any charges for insurance, freight, and other transportation costs directly related to the delivery of
`Licensed Product to the extent included in the gross invoiced sales price;
`
`(d) any tax, tariff, duty or governmental charge levied on the sales, transfer, transportation or delivery of a
`Licensed Product (including any tax such as a value added or similar tax or government charge) borne by the
`seller thereof, other than franchise or income tax of any kind whatsoever; and
`
`(e) any import or export duties or their equivalent borne by the seller. “Net Sales” shall not include sales or
`transfers between GENENTECH and its Sublicensees, unless the Licensed Product is consumed by the
`Sublicensee.
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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`IPR2014-00676
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`1.40 “PATENT RIGHTS” shall mean the rights and interests in and to any and all issued patents and pending patent
`applications (including inventor’s certificates and utility models) in any country or jurisdiction in the Territory, including
`any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisionals and other
`continuing applications, supplementary protection certificates, renewals, and all letters patent on any of the foregoing, and
`any and all reissues, reexaminations, extensions, confirmations, registrations and patents of addition on any of the
`foregoing.
`
`1.41 “PHASE II CLINICAL STUDY” shall mean, as to a particular Licensed Product for a particular indication, a
`controlled and lawful study in humans of the safety, dose ranging and efficacy of such Licensed Product for such
`indication, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical
`Trial of such Licensed Product for such indication.
`
`1.42 “PHASE III CLINICAL TRIAL” shall mean, as to a particular Licensed Product for a particular indication, a
`controlled and lawful study in humans of the safety and efficacy of such Licensed Product for such indication, which is
`prospectively designed to demonstrate statistically whether such Licensed Product is safe and effective for use in such
`indication in a manner sufficient to file a BLA or NDA to obtain Regulatory Approval to market and sell that Licensed
`Product in the United States for the indication under investigation in such study.
`
`1.43 “PHASE III EQUIVALENT DECISION” shall mean the date (if any) on which GENENTECH (or its Sublicensee)
`decides, based on notification and input from the FDA, that the data and results generated from the Phase II Clinical
`Studies of a Licensed Product for a particular indication are sufficient, without any Phase III Clinical Trial of such
`Licensed Product for such indication, to support the filing of a BLA or NDA to obtain Regulatory Approval to market and
`sell that Licensed Product in the United States for the indication under investigation.
`
`1.44 “PRECLINICAL MATERIALS” shall mean (a) supplies of ansamitocin P-3, DM1 and/or any other
`MAY Compound as manufactured in accordance with all applicable legal requirements and all applicable Specifications
`for such MAY Compound for use in preclinical testing, and (b) supplies of any Licensed Product as manufactured in
`accordance with all applicable legal requirements and all applicable Specifications for such Licensed Product for use in
`preclinical testing of any Licensed Product.
`
`1.45 “REGULATORY APPROVAL” shall mean any and all approvals (including pricing and reimbursement approvals),
`product and establishment licenses, registrations or authorizations of
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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`any kind of the FDA or any Foreign Regulatory Authority necessary for the development, pre-clinical and/or human
`clinical testing, manufacture, quality testing, supply, use, storage, importation, export, transport, marketing and sale of a
`Licensed Product (or any component thereof) for use in the Field in any country or other jurisdiction in the Territory.
`“Regulatory Approval” shall include, without limitation, any BLA, NDA, MAA or other Drug Approval Application.
`
`1.46 “SPECIFICATIONS” shall mean any specifications agreed upon in writing by the Parties relating to the
`manufacturing and supply of any MAY Compound and/or Licensed Product hereunder.
`
`1.47 “SUBLICENSEE” shall have the meaning set forth in Section 2.2, and “MATERIAL SUBLICENSEE” shall have
`the meaning set forth in Section 3.3.
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`1.48 “TARGET” shall have the meaning set forth in Section 2.1(b).
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`1.49 “TECHNOLOGY” shall mean and include any and all unpatented proprietary ideas, inventions, discoveries,
`Confidential Information, biologic materials, data, results, formulae, designs, specifications, methods, processes,
`formulations, techniques, ideas, know-how, technical information (including, without limitation, structural and
`functional information), process information, pre-clinical information, clinical information, and any and all
`proprietary biological, chemical, pharmacological, toxicological, pre-clinical, clinical, assay, control and
`manufacturing data and materials.
`
`1.50 “TERM” shall mean the period commencing on the Effective Date and continuing until the expiration or termination
`of this Agreement in accordance with the terms hereof (including Section 7).
`
`1.51 “TERRITORY” shall mean all countries and jurisdictions of the world.
`
`1.52 “THIRD PARTY” shall mean any entity other than GENENTECH, IMMUNOGEN and their respective
`Affiliates.
`
`1.53 “THIRD PARTY PAYMENTS” shall have the meaning set forth in Section 4.2.2.
`
`1.54 “VALID CLAIM” shall mean a claim in an issued, unexpired patent within the Licensed Patent Rights that (i) has not
`been finally cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent
`jurisdiction, and (ii) has not been revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court
`or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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`appeal, and (iii) has not been rendered unenforceable through disclaimer or otherwise, and (iv) is not lost through an
`interference proceeding.
`
`2. GRANT OF RIGHTS
`
`2.1. LICENSE GRANTS.
`
`(a) LICENSE TO GENENTECH. IMMUNOGEN hereby grants to GENENTECH an exclusive (even as to
`IMMUNOGEN) royalty-bearing license within the Territory, including the right to grant sublicenses as
`described in Section 2.2 below, under the Licensed Patent Rights and Licensed Technology and
`IMMUNOGEN’s interest in any Improvements, to Develop, have Developed, make, have made, use, have
`used, sell, have sold, offer for sale, import, have imported, export and have exported Licensed Products in the
`Field in the Territory, subject to the other terms and conditions of this Agreement. IMMUNOGEN and
`GENENTECH hereby acknowledge and agree that this Agreement constitutes the worldwide exclusive
`license relating to Licensed Products as to which IMMUNOGEN afforded GENENTECH an exclusive option
`under the MTA.
`
`(b) LICENSE TO IMMUNOGEN. [*]
`
`2.2 SUBLICENSES. GENENTECH shall have the right freely to grant sublicenses to all or any portion of its
`rights under the license rights granted pursuant to Section 2.1(a) hereof to any Affiliate or Third Party (in any
`case, a “SUBLICENSEE”); PROVIDED, HOWEVER, that GENENTECH shall remain obligated to ensure
`payment of milestone and royalty obligations as set forth in Section 4.
`
`2.3 IMMUNOGEN RETAINED RIGHTS AND COVENANTS; GENENTECH TECHNOLOGY OR PATENT
`RIGHTS.
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`(a) RETAINED RIGHTS. Subject to the other terms of this Agreement, including, without limitation,
`Section 2.3 (b) hereof, IMMUNOGEN retains the right to use the Licensed Technology and practice the
`Licensed Patent Rights and to use IMMUNOGEN’s interest in all Improvements (i) to perform its work under
`Sections 3.3, 3.4, 3.5 and 3.6 hereof relating to the Joint Process Development Committee and to manufacture
`and supply of Preclinical Materials and Clinical Materials for GENENTECH (and its Sublicensees), (ii) to
`develop, have developed, make, have made, use, have used, sell have sold, offer for sale, import, have
`imported, export and have exported any product that is not a Licensed Product, subject to Section 2.3
`(b) below,
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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`and (iii) to otherwise exploit such Improvements for any and all uses outside of the Field, subject to Section 2.3(b) below.
`
`(b) COVENANTS. [*]
`
`(c) NO RIGHTS TO GENENTECH TECHNOLOGY OR PATENT RIGHTS. Nothing in this Section 2.3 or
`any other provision of this Agreement shall be construed as a grant to IMMUNOGEN of any license or other
`rights with respect to any Technology (including, without limitation, any Confidential Information) or Patent
`Rights owned or Controlled (in whole or in part) by GENENTECH.
`
`3. DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCTS.
`
`3.1 DEVELOPMENT AND COMMERCIALIZATION.
`
`(a) RESPONSIBILITY. On and after the Effective Date, GENENTECH shall have full control and authority
`over all Development and commercialization of Licensed Products in the Field in the Territory, including,
`without limitation, (i) all pre-clinical Development activities (including any pharmaceutical development
`work on formulations or process development relating to any Licensed Product), (ii) all activities related to
`human clinical trials (including any phase I studies, any Phase II Clinical Studies or any Phase III Clinical
`Trials), (iii) all activities relating to manufacture and supply of all Anti-HER2 Antibodies, all
`MAY Compounds (including ansamitocin P-3 and DM1) and all Licensed Products, solely to the extent such
`activities relate to the development and commercialization of Licensed Products (including all required
`process development and scale up work with respect thereto), (iv) all marketing, promotion, sales,
`distribution, import and export activities relating to any Licensed Product (including any post-marketing trials
`or databases and post-marketing safety surveillance), and (v) all activities relating to any regulatory filings,
`registrations, applications and Regulatory Approvals relating to any of the foregoing (including any INDs or
`foreign equivalents, any manufacturing facility validation and/or licensure, any Drug Approval Applications
`and any other Regulatory Approvals). Except as described in the next sentence, GENENTECH shall own all
`data, results and all other information arising from any such activities under this Agreement, including,
`without limitation, all regulatory filings, registrations, applications and Regulatory Approvals relating to
`Licensed Products (including any INDs or foreign equivalents, any Drug Approval Applications and any other
`Regulatory Approvals), and all of the foregoing
`
`Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities
`and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to
`Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
`
`11
`
`http://www.sec.gov/Archives/edgar/data/855654/000110465911059039/a11-26542_1ex10...
`
`1/16/2015
`
`IMMUNOGEN 2262, pg. 8
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Page 9 of 28
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`information, documentation and materials shall be considered Confidential Information and Technology solely owned by
`GENENTECH. IMMUNOGEN shall own all data, results and all other information arising from IMMUNOGEN’s
`activities relating to the manufacture and supply of MAY Compounds (including ansamitocin P-3 and DM1) to
`GENENTECH, and all of the foregoing information, documentation and materials shall be considered Confidential
`Information and Technology solely owned by IMMUNOGEN. All a