EXCLUSIVE LICENSE AND ASSET PURCHASE AGREEMENT
Exhibit 10.1
Execution Copy
EXCLUSIVE LICENSE AND ASSET PURCHASE AGREEMENT
THIS EXCLUSIVE LICENSE AND ASSET PURCHASE AGREEMENT (this “Agreement”) is made effective as of May 23, 2017 (the “Effective Date”) by and between Debiopharm International, S.A., a Swiss limited company (“Debiopharm”) having a place of business at Forum “après-demain,” Xxxxxx Xxxxxxxx 0-0, Xxxx Xxxxxxx 0000, XX-0000 Xxxxxxxx, Xxxxxxxxxxx, and ImmunoGen, Inc., a Massachusetts corporation (“ImmunoGen”) having a place of business at 000 Xxxxxx Xxxxxx, Xxxxxxx, XX 00000-0000, U.S.A. ImmunoGen and Debiopharm are sometimes each hereinafter referred to as a “Party” and collectively as the “Parties”.
WHEREAS, the Parties desire to transfer ImmunoGen’s anti-CD37 antibody-drug conjugate program (the “Program”) to Debiopharm on the terms and subject to the conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the mutual representations, warranties and agreements contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
ARTICLE 1
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Whenever used in this Agreement with an initial capital letter, the terms defined in this ARTICLE 1 shall have the meanings specified.
1.1 “Acquired Assets” has the meaning set forth in Section 3.1. |
1.2 “Acquired CD37 Antibody” means an Antibody having a sequence that is identified or disclosed in the Patent Rights included in the Acquired Intellectual Property. |
1.3 “Acquired Contracts” has the meaning set forth in Section 3.1(b). |
1.4 “Acquired Intellectual Property” has the meaning set forth in Section 3.1(d). |
1.5 “Acquisition Date” has the meaning set forth in Section 2.2. |
1.6 “Affiliate” means with respect to a Party, an entity that, directly or indirectly through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. In this definition, “control” means: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors; and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such entities. |
1.8 “Agreement” has the meaning set forth in the preamble. |
1.9 “Ancillary Agreements” means the Xxxx of Sale, the Assignment and Assumption Agreement, and the IP Assignment Agreement, in the forms of Exhibit A, Exhibit B, and Exhibit C, respectively, and the Technology Transfer Plan and the Clinical Regulatory Transfer Plan. |
1.10 “Anti-Trust Laws” means the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, and any approvals or filings required under, and compliance with other applicable requirements of any non-U.S. Laws intended to prohibit, restrict or regulate actions or transactions having the purpose or effect of monopolization, restraint of trade, harm to competition or effectuating foreign investment. |
1.11 “Antibody” means a polypeptide that Targets an antigen, which polypeptide comprises: (a) one or more immunoglobulin variable domains; or (b) fragments, variants, modifications or derivatives of such immunoglobulin variable domains irrespective of origin or source, including but not limited to antigen binding portions including Fab, Fab’, F(ab’)2, Fv, dAb and CDR fragments, single chain antibodies (scFv), chimeric antibodies, monospecific antibodies, bispecific antibodies, multi-specific antibodies, diabodies and other polypeptides, any of which contain at least a portion of an immunoglobulin that is sufficient to confer specific antigen binding to the polypeptide; and (c) in each case (a) and (b) above, humanized or fully human versions thereof. |
1.12 “Assignment and Assumption Agreement” has the meaning set forth in Section 4.2(a)(ii). |
1.13 “Assumed Liabilities” has the meaning set forth in Section 3.3. |
1.14 “Bankruptcy Code” has the meaning set forth in Section 2.4. |
1.15 “Business Day” means any day other than a Saturday, Sunday or other day on which banking institutions in Boston, Massachusetts or Lausanne, Switzerland are required to be closed or are actually closed with legal authorization. |
1.16 “Xxxx of Sale” has the meaning set forth in Section 4.2(a)(i). |
1.17 “Calendar Year” means a period of time commencing on January 1 and ending on the following December 31. |
1.18 “CD37” means the antigen described by UniProtKB/Swiss Prot accession number P11049, and all fragments, mutations and splice variants thereof. |
1.20 “[***]” has the meaning set forth in [***]. |
1.21 “cGMP” means all good manufacturing practices as defined under Title 21 of the United States Code of Federal Regulations or the corresponding applicable Legal Requirements of the European Union. |
1.22 “Claim Notice” means written notification which contains (a) a description of the Damages incurred or reasonably expected to be incurred by the Indemnified Party and the claimed amount of such Damages, to the extent then known, (b) a statement that the Indemnified Party is entitled to |
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.
indemnification under ARTICLE 8 for such Damages and a reasonable explanation of the basis therefor, and (c) a demand for payment in the amount of such Damages. |
1.23 “Clinical Regulatory Transfer Plan” has the meaning set forth in Section 7.1(b). |
1.24 “Commercially Reasonable Efforts” means exerting such efforts and employing such resources on a consistent basis as would normally be exerted or employed by a biopharmaceutical entity with expertise in developing similar products for a product of similar market potential, profit potential and strategic value at a similar stage of its product life, taking into account the competitiveness of the relevant marketplace, the patent, intellectual property and development positions of Third Parties, the applicable regulatory situation, the commercial viability of the product and other relevant development and commercialization factors based upon then-prevailing conditions, and as if Debiopharm is not developing a product competitive to a Licensed Product, and excluding from consideration any financial obligation of Debiopharm to ImmunoGen. |
1.25 “Confidential Information” means, subject to the exclusions set forth in Section 7.4(a), any and all confidential or proprietary information or material that, at any time before, on or after the Effective Date, has been or is provided or communicated to a Party by or on behalf of the other Party pursuant to or in connection with the transactions contemplated hereby, and any discussions or negotiations with respect thereto. |
1.26 “Contingent Payment” has the meaning set forth in Section 4.1(b). |
1.27 “Consent” has the meaning set forth in Section 4.3(a) |
1.28 “Contract” means any agreement, contract or similar instrument, arrangement or commitment, whether oral or written. |
1.29 “Control” or “Controlled” means, with respect to an item or right and a Person, the possession, whether by ownership or license (in each case other than pursuant to this Agreement), by such Person of the right to grant a license to or under each such item or right as provided in this Agreement without violating any agreement or other arrangement with any Third Party. |
1.30 “CPR” has the meaning set forth in Section 9.16. |
1.31 “Damages” has the meaning set forth in Section 8.2. |
1.32 “Dispute” means the dispute resulting if the Indemnifying Party disputes its liability for all or part of the claimed amount of Damages. |
1.33 “Debiopharm” has the meaning set forth in the preamble. |
1.34 “Effective Date” has the meaning set forth in the preamble. |
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.
1.36 “Excluded Assets” has the meaning set forth in Section 3.2. |
1.37 “Excluded Liabilities” has the meaning set forth in Section 3.4 |
1.38 “FDA” means the U.S. Food and Drug Administration, or any successor entity thereto. |
1.39 “Field” means all pharmaceutical, therapeutic, prophylactic, prognostic and diagnostic uses in humans and/or animals. |
1.41 “FTE Rate” means a rate of [***] per FTE per Calendar Year (pro-rated for the period beginning on the Effective Date and ending at the end of [***], and if applicable, thereafter [***] or [***] by the [***] or [***] in [***] as of [***] of the [***]the [***] of the [***]; the [***] to [***] on [***], if applicable. The FTE Rate is [***] and will [***] and [***] and [***] and [***] and [***] including [***] from [***] of [***] as they may [***]. |
1.42 “Governmental Authorization” means any approval, consent, license, permit, waiver, registration or other authorization issued, granted, given, made available or otherwise required by any Governmental Entity or pursuant to law. |
1.43 “Governmental Entity” means any federal, state, local, foreign, international or multinational entity or authority exercising executive, legislative, judicial, regulatory, administrative or taxing functions of or pertaining to government. |
1.44 “Governmental Order” means any judgment, injunction, writ, order, ruling, award or decree by any Governmental Entity or arbitrator. |
1.45 “IMGN529” has the meaning set forth in Section 1.63. |
1.46 “ImmunoGen” has the meaning set forth in the preamble. |
1.47 “ImmunoGen Acquirer” has the meaning set forth in Section 7.5(b). |
1.48 “Initiation” or “Initiate” means, with respect to the Phase III Trial of a Licensed Product, the date that the first human subject is dosed in such clinical trial. |
1.49 “Infringement” has the meaning set forth in Section 7.7(b). |
1.50 “Intellectual Property” means all intellectual property and industrial property rights of any kind or nature throughout the world, including all (a) Patent Rights; (b) registered and unregistered marks, trade names, trade dress rights, logos, taglines, slogans, Internet domain names, web addresses, and other indicia of origin, together with the goodwill associated with any of the foregoing, and all applications, registrations, extensions and renewals thereof; (c) all works of authorship and any and all other registered and unregistered copyrights and copyrightable works, and all applications, registrations, extensions, and renewals thereof; (d) Know-How; (e) all rights in the foregoing and in other similar intangible assets; and (f) all applications and registrations for the foregoing. |
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.
1.51 “Inventories” has the meaning set forth in Section 3.1(a). |
1.52 “[***]” and [***] between [***] and [***] dated [***]. |
1.53 “Indemnified Party” has the meaning set forth in Section 8.4(a). |
1.54 “Indemnifying Party” has the meaning set forth in Section 8.4(a). |
1.56 “Know-How” means, collectively, all inventions, discoveries, improvements, trade secrets and proprietary methods or materials, whether or not patentable, including sequences, data, technical information, designs, models, plans, designs, formulations, assays, processes, procedures, methods, techniques, know-how, reports and results (including negative results). |
1.57 “Knowledge” of ImmunoGen means the actual knowledge of any of the following ImmunoGen employees: (a) any [***], and (b) any [***]. |
1.58 “Legal Requirement” means any federal, state, local, municipal, foreign, international, multinational or other constitution, law, ordinance, principle of common law, code, regulation, statute or treaty. |
1.59 “Liability” means any liability or obligation whether accrued, absolute, contingent, unliquidated or otherwise, whether due or to become due, whether known or unknown, and regardless of when asserted. |
1.61 “Licensed Patent Rights” means any and all Patent Rights that (a) are [***] for Debiopharm to develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, register, have registered, package, have packaged, label, have labeled, distribute, have distributed, import, have imported or otherwise exploit or have exploited the Licensed Products in the Field and the Territory, and (b) are, on the Effective Date, or thereafter become, [***] Controlled by ImmunoGen or any of its Affiliates. |
1.62 “Licensed Intellectual Property” means all Licensed Patent Rights and Licensed Know-How. |
1.63 “Licensed Product” means any product that incorporates, contains or is comprised of (a) the pharmaceutical product known as naratuximab emtansine (“IMGN529”) or (b) any SMCC-DM1 Conjugate of any other Acquired CD37 Antibody. |
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.
commenced, brought, conducted or heard by or before, or otherwise involving, any Governmental Entity or arbitrator or mediator. |
1.65 “Marketing Approval” means, with respect to a Licensed Product in a country or region, approval by the applicable Governmental Entity of an application for approval to market and sell such Licensed Product in such country or region. |
1.66 “Material Adverse Effect” means any material adverse change, event, circumstance or development with respect to, or material adverse effect on, the [***], including with respect to the [***]; provided, however, that, the following shall not be deemed to constitute a Material Adverse Effect unless they have a materially disproportionate effect on the subject Party as compared to any of the other companies in the industry in which such Party operates: (a) changes in general economic conditions or markets, generally, or affecting the industry in which such Party operates; (b) acts of war or terrorism; (c) acts of any governmental entity or changes in political conditions; (d) changes in legal, tax or regulatory laws, rules or conditions; or (e) failure to meet plans, estimates or projections. |
1.67 “MAY Compound” means any and all maytansinoid compounds (including maytansinol, ansamitocins, DM1 and DM4), whether produced by a botanical source, natural fermentation, chemical synthesis or otherwise, and shall include all variants, fragments or derivatives of any of the foregoing, in each case owned or Controlled by ImmunoGen or any of its Affiliates. |
1.68 “Non-Assignable Right” has the meaning set forth in Section 4.3(a). |
1.69 “Organizational Documents” has the meaning set forth in Section 5.1 with respect to ImmunoGen, and Section 6.1 with respect to Debiopharm. |
1.70 “[***]” means the [***]. |
1.71 “Party” and “Parties” have the meanings set forth in the preamble. |
1.72 “Patent Rights” means the rights and interests in and to any and all issued patents and pending patent applications (including inventor’s certificates, applications for inventor’s certificates, statutory invention registrations, applications for statutory invention registrations, utility models and any foreign counterparts thereof) 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, extensions or restorations by existing or future extension or restoration mechanisms, including patent term extension, supplementary protection certificates or the equivalent, 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. |
1.73 “Permitted Recipient” has the meaning set forth in Section 7.4(a). |
1.74 “Person” means any individual, corporation (including any non-profit corporation), general or limited partnership, limited liability company, joint venture, estate, trust, association, organization, labor union, Governmental Entity or other entity. |
1.75 “Phase III Trial” means, with respect to the United States, the third phase of human clinical trials of a product, which are large-scale trials designed to gain evidence of efficacy and safety in a number of human subjects sufficient to support registration for such Licensed Product with the United |
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.
States Food and Drug Administration, as described in 21 C.F.R. §312.21(c), as may be amended, or, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction. “Phase III Trial” also includes any other clinical study in humans prospectively designed as a pivotal study to demonstrate whether the product is safe and effective for use in the indication under investigation in a manner sufficient to file a drug approval application for such indication in the United States or with the European Medicines Agency or any successor entity thereto, whether or not such trial is called a “Phase III” trial. Without limiting the generality of the foregoing, a clinical study will be deemed to be a “Phase III Trial” if such study has been designated by the sponsor as a Phase III clinical trial on xxx.xxxxxxxxxxxxxx.xxx (or any successor website maintained by the U.S. National Institutes of Health or any successor agency of the U.S. government). |
1.76 “Program” has the meaning set forth in the preamble. |
1.77 “Regulatory Documentation” means any and all applications, registrations, licenses, authorizations and approvals (including all Governmental Authorizations), and non-clinical and clinical study authorization applications or notifications (including all supporting files, writings, data, correspondence, studies and reports) prepared for submission to a Governmental Entity or research ethics committee with a view to the granting of any Governmental Authorizations, and any correspondence to or with the FDA or any other Governmental Entity (including minutes and official contact reports relating to any communications therewith), and all data contained in any of the foregoing, including regulatory drug lists, advertising and promotion documents, adverse event files, complaint files and manufacturing records. |
1.79 “Return” means any return, declaration, report, estimate, information return or statement pertaining to any Taxes, including any schedule or attachment thereto, and including any amendment thereof. |
1.80 “SMCC-DM1 Conjugate” means a conjugate comprising the chemical linker, N-succinimidyl 4-(maleimidomethyl) cyclohexanecarboxylate (SMCC) and the cytotoxic agent, N(2’)-deacetyl-N(2’)-(3-mercapto-1-oxopropyl)-maytansine (DM1). |
1.81 “Sublicensee” means an entity to which Debiopharm grants a sublicense under Debiopharm’s rights under Section 2.3. |
1.82 “Substantial Completion,” has the meaning set forth in the Technology Transfer Plan with respect thereto, or the Clinical Regulatory Transfer Plan with respect thereto, as applicable. |
1.83 “Target” means, when used as a verb to describe the relationship between a molecule and an antigen, that the molecule’s primary intended mechanism of action functions such that it specifically binds to the antigen (or a portion thereof). |
1.84 “Taxes” means (i) all taxes, charges, fees, levies or other assessments, including all net income, gross income, gross receipts, sales, use, ad valorem, transfer, unclaimed property, escheat, franchise, profits, license, withholding, payroll, employment, social security, unemployment, excise, estimated, severance, stamp, occupation, property or other taxes, customs duties, fees, assessments or |
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.
charges of any kind whatsoever, including all interest and penalties thereon, and additions to tax or additional amounts imposed by any Governmental Entity, any Liability for the payment of any amounts of the type described in clause (i) of this sentence as a result of being a member of a consolidated, combined, unitary or similar group for any Tax period, and (iii) any Liability for the payment of any amounts of the type described in clause (i) or (ii) of this sentence as a result of being a transferee of or successor to any Person or as a result of any express or implied obligation to indemnify any other Person, by contract or otherwise. |
1.85 “Technology Transfer Plan” has the meaning set forth in Section 7.1(a). |
1.87 “Third Party” means any entity other than ImmunoGen or Debiopharm or their respective Affiliates. |
1.88 “Third Party Action” means any suit or proceeding by a Third Party for which indemnification is sought by an Indemnified Party under ARTICLE 8. |
1.89 “Transfer Taxes” has the meaning set forth in Section 7.8. |
1.90 “Upfront Payment” has the meaning set forth in Section 4.1(a). |
ARTICLE 2
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2.1 License Grant to Debiopharm. Subject to the terms and conditions of this Agreement, ImmunoGen and its Affiliates (subject to Section 2.2 below) grants to Debiopharm an exclusive, perpetual, irrevocable, royalty-free license, with the right to grant sublicenses subject to Section 2.3, under and to use the Licensed Intellectual Property to develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, register, have registered, package, have packaged, label, have labeled, distribute, have distribute, import, have imported and otherwise exploit and have exploited Licensed Products in the Field in the Territory. |
2.2 Exceptions. The license grant set forth in Section 2.1 excludes the following Intellectual Property: (a) Intellectual Property owned or Controlled by an [***] such Person became [***]; and (b) Intellectual Property that [***] owned or Controlled by the [***] (excluding [***] as of [***] other than [***]. |
2.3 Sublicenses. Debiopharm will be entitled to grant sublicenses of its rights under Section 2.1 to its Affiliates and to Third Parties, provided, that: (a) each such sublicense will be consistent with the terms and conditions of this Agreement; (b) Debiopharm will provide ImmunoGen with the identity of each such Sublicensee with rights to commercialize any Licensed Product [***]; and (c) Debiopharm will not be relieved of its obligations (including any obligations delegated to its Affiliates or Sublicensees) under this Agreement. |
2.4 U.S. Bankruptcy Code. All licenses granted under or pursuant to this Agreement by ImmunoGen to Debiopharm are, and will otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that Debiopharm, as a licensee |
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.
of such rights under this Agreement, will retain and may fully exercise all of its rights and elections under the Bankruptcy Code and comparable Legal Requirements outside of the United States. |
2.5 No Implied Licenses or Rights. Except as expressly set forth in this Agreement, neither Party grants any licenses under its intellectual property rights to the other Party. |
ARTICLE 3
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3.1 Purchase and Sale of Acquired Assets. Subject to the terms and conditions of this Agreement, ImmunoGen agrees to sell or assign to Debiopharm, and Debiopharm agrees to buy or assume from ImmunoGen, free and clear of all Encumbrances, all of ImmunoGen’s and its Affiliates’ right, title and interest in and to the following assets (the “Acquired Assets”) (but excluding the Excluded Assets): |
(b) the Contracts pertaining to the Program to which ImmunoGen or any of its Affiliates is a party that are listed on Schedule 3.1(b) (the “Acquired Contracts”), subject to Section 4.3; |
(e) any and all claims, suits, demands, causes of action, rights of recovery or rights of set-off of whatever kind or description of ImmunoGen or any of its Affiliates against any Person to the extent relating to the Acquired Assets or Assumed Liabilities, to the extent assignable; and |
3.2 Excluded Assets. Notwithstanding anything to the contrary contained herein or in any Ancillary Agreement, any item not explicitly identified as an Acquired Asset in Section 3.1 and the related Schedules hereto shall be excluded from the Acquired Assets (the “Excluded Assets”) and will be retained by ImmunoGen and remain the property of ImmunoGen following the Effective Date. For the avoidance of doubt, Excluded Assets include (a) the [***] listed on Schedule 3.2, and (b) [***]. |
3.3 Assumed Liabilities. Debiopharm agrees to assume and to pay, perform and discharge all Liabilities of ImmunoGen arising on or after the Effective Date under the Acquired Contracts (other than any Liabilities under the Acquired Contracts arising from, or accruing or relating to any of the covenants, |
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.
obligations, representations, warranties or other provisions of any Acquired Contract that relates to periods prior to the Effective Date) (the “Assumed Liabilities”), subject to Section 5.8. |
3.4 Excluded Liabilities. The parties specifically acknowledge that Debiopharm is not agreeing to assume any Liability of ImmunoGen, except the Assumed Liabilities, whether related to the Acquired Assets or otherwise (the “Excluded Liabilities”), which Excluded Liabilities include (a) any liabilities under the agreements listed in Schedule 3.2, (b) patent and other legal costs and fees relating to the Acquired Intellectual Property that have become due or accrue, arise from or relate to periods prior to the Effective Date, and (c) any Liability for (i) Taxes of ImmunoGen (or any stockholder or Affiliate of ImmunoGen) or, with respect to a taxable period or portion thereof ending prior to the Effective Date, relating to the Acquired Assets, (ii) Taxes that arise out of the consummation of the transactions contemplated hereby, except as otherwise provided in Section 4.1(d) and Section 7.9 or (iii) other Taxes of ImmunoGen (or any stockholder or Affiliate of ImmunoGen) of any kind or description (including any Liability for Taxes of ImmunoGen (or any stockholder or Affiliate of the ImmunoGen) that becomes a Liability of Debiopharm under any common law doctrine of de facto merger or transferee or successor liability or otherwise by operation of contract or Law. |
ARTICLE 4
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4.1 Payments to ImmunoGen. In consideration of the rights granted to Debiopharm under ARTICLE 2 and the purchase or assignment of the Acquired Assets under ARTICLE 3 (the “Aggregate Consideration”), Debiopharm hereby agrees to assume the Assumed Liabilities and to pay ImmunoGen as follows: |
(a) Upfront Payment. Debiopharm shall pay to ImmunoGen an upfront payment (the “Upfront Payment”) in the amount of Twenty-Five Million U.S. Dollars (US$25,000,000), payable on the Effective Date by wire transfer of immediately available funds to an account designated in writing by ImmunoGen; and |
(b) Contingent Payment. As additional consideration for the rights granted to Debiopharm under ARTICLE 2 and for the purchase or assignment of the Acquired Assets under ARTICLE 3, following the completion or achievement of each milestone in the schedule below, Debiopharm shall pay to ImmunoGen the amount associated with such milestone (each, a “Contingent Payment”) by wire transfer of immediately available funds to an account designated in writing by ImmunoGen. |
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.
If the milestone event described in (2) above occurs prior to the milestone event described in (3) above, then the milestone described in (3) above shall thereafter not be payable. If the milestone described in (3) above occurs prior to the milestone event described in (2) above, then the milestone described in (2) above shall thereafter not be payable.
(a) Notifications. Debiopharm shall provide ImmunoGen with prompt written notice of the occurrence of any event giving rise to an obligation to make a Contingent Payment to ImmunoGen under Section 4.1(b), which shall in any event be no later than [***] after the occurrence of such event. Upon achievement of each milestone event, ImmunoGen shall issue an invoice to Debiopharm for the applicable Contingent Payment, and Debiopharm shall pay the applicable Contingent Payment within [***] of the date of receipt of such invoice. |
3.2 Deliveries. |
(a) ImmunoGen. On the Effective Date, ImmunoGen shall have delivered to Debiopharm: |
(ii) an assignment of Acquired Assets that are intangible rights and property (including Contracts) in the form of Exhibit B, duly executed by ImmunoGen (the “Assignment and Assumption Agreement”); |
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.
(iii) assignments of the Acquired Intellectual Property rights, duly executed by ImmunoGen in the form of Exhibit C (the “IP Assignment Agreement”); |
(iv) documentation that is described in the Clinical Regulatory Transfer Plan for submission to the applicable Governmental Entity by Debiopharm in order to transfer to Debiopharm each Acquired Governmental Authorization, in a form reasonably acceptable to Debiopharm; |
(v) documentation associated with the Acquired Assets included in Schedules 3.1(a) though 3.1(f), which will be deemed to have been delivered to Debiopharm upon ImmunoGen providing Debiopharm with updated access codes as may be necessary for Debiopharm to be able to continue to access, download and print such information located at: [***] ; and until [***] or such longer period as the Parties may agree in writing, ImmunoGen shall: (i) keep such access available, and (ii) maintain the materials located on such site as they are on the Effective Date, and for the avoidance of doubt, without any additions, deletions or changes thereto; |
(vi) an invoice for the Upfront Payment; and |
(vii) other instruments of transfer reasonably requested by Debiopharm, duly executed by ImmunoGen. |
(b) Debiopharm. On the Effective Date, Debiopharm shall have delivered to ImmunoGen: |
(i) the Upfront Payment; |
(iii) documentation that is described in the Clinical Regulatory Transfer Plan for submission to the applicable Governmental Entity by Debiopharm in order for Debiopharm to assume all of ImmunoGen’s obligations under each Acquired Governmental Authorization, in a form reasonably acceptable to ImmunoGen. |
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.
(i) Debiopharm shall cooperate with ImmunoGen’s efforts to obtain, and shall agree to, [***] with ImmunoGen and the Third Parties thereto, whether such Acquired Contracts are assigned as of the Effective Date or subject to assignment thereafter under Section 4.3(a), if agreed to by ImmunoGen and the applicable Third Parties [***]. Debiopharm shall not be required to [***] or make any [***] in order to [***], and Debiopharm shall not be [***]; and |
(ii) at Debiopharm’s request, ImmunoGen shall use commercially reasonable efforts, at no further cost to either Party, to transfer the statements of work identified on Schedule 4.3(c)(ii) to Debiopharm; and |
(iii) ImmunoGen shall use commercially reasonable efforts to [***] in accordance with [***] until [***], and, at Debiopharm’s written request on or before [***], to [***] to Debiopharm (or its designated [***])[***], provided that ImmunoGen shall not be required to [***] unless and until [***] identified in [***] and, upon obtaining such [***], ImmunoGen agrees to [***] to Debiopharm, [***]; provided that, subject to any representations or warranties as of the Effective Date, or covenants expressly set forth in this subsection, ImmunoGen shall have no liability to Debiopharm for the [***] at the time of [***] and disclaims all implied warranties; and |
(iv) If requested in writing by Debiopharm on or before [***], ImmunoGen agrees to authorize the [***] to [***] to Debiopharm, provided that [***], such [***] provides [***] with a [***] or [***] provides [***] with [***], in each case reasonably satisfactory to [***], relating to [***], there is [***], and [***] shall have [***] for the [***] from and after the Effective Date and disclaims all implied warranties. For the avoidance of doubt, the Parties acknowledge that the [***], the [***] and [***] are neither an Acquired Assets nor part of the Licensed Intellectual Property; and |
(v) ImmunoGen shall [***], and, at Debiopharm’s written request on or before [***], to [***], payment [***], up to the [***] for the [***] identified on such schedule, and pursuant to the services agreement referenced in Section 7.1(d) below; and |
(vi) With respect to the [***] identified in Sections 5, 6 and 7 of Schedule 3.1(a): |
(A) that were obtained from [***], ImmunoGen agrees to [***], each such [***] to Debiopharm upon Debiopharm providing evidence reasonably satisfactory to ImmunoGen that Debiopharm has become the sponsor of such study. Debiopharm agrees that each such [***], as provided by ImmunoGen to Debiopharm prior to the Effective Date, and in accordance with applicable Legal Requirements. In addition, for the [***], Debiopharm agrees to [***]; and |
(B) that were obtained [***], ImmunoGen will [***] to determine [***] following the Effective Date [***], and upon its reasonable determination that [***], it |
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.
will, at Debiopharm’s written election on or before [***],[***] to Debiopharm and such [***] shall become part of the Acquired Assets; and Debiopharm agrees that each such [***]. In the event that a [***], ImmunoGen shall inform Debiopharm and the Parties will discuss how to [***]. ImmunoGen confirms that it [***] and that it will [***] until the earliest of (x) [***] Debiopharm, (y) Debiopharm’s decision not to have them [***], and (z) [***]; and |
(i) ImmunoGen shall [***] to [***] in the [***], and, on or before such date, Debiopharm shall, at its expense, cause such materials to be removed from the premises of ImmunoGen; and |
(ii) With respect to any Acquired Assets in the possession of a Third Party or ImmunoGen on the Effective Date that will continue to be stored by such Third Party or ImmunoGen pursuant to the terms of this Agreement or the services agreement contemplated by Section 7.1(d) for a period of time following the Effective Date, ImmunoGen shall [***] to continue to have such assets stored (by such Third Party or ImmunoGen, as the case may be) in the same manner as such assets are stored on the Effective Date, provided that ImmunoGen shall have no liability to Debiopharm for the condition of such assets and it disclaims all implied warranties. Notwithstanding anything else to the contrary, to the extent any Third Party continues to store any Acquired Assets, then Debiopharm shall reimburse ImmunoGen, payment [***], for any and all Third Party costs associated therewith including storage and maintenance from the Effective Date until the earlier of (x) Debiopharm has notified ImmunoGen in writing of its decision to take possession, or not take possession, of such asset as the case may be, or (y) the occurrence of any applicable deadline that is specifically set forth in this Agreement with respect to such asset. Notwithstanding anything in this Agreement to the contrary, ImmunoGen shall not be required to store [***] past [***]. |
(d) Capitalized terms used in this Section 4.3(d), but not otherwise defined in this Agreement shall have the meanings ascribed to them in the [***]. ImmunoGen shall provide Debiopharm with a copy of any [***] relating solely to IMGN529 that are received by ImmunoGen pursuant to the [***]; provided, that (i) [***] consents to such disclosure to Debiopharm and (ii) Debiopharm agrees with ImmunoGen and [***] to treat such [***] and any other Confidential Information of [***] as confidential, consistent with the confidentiality and non-use obligations pertaining to [***] Confidential Information as set forth in the [***]. Subject to the preceding sentence, ImmunoGen shall provide Debiopharm with a copy of any [***] by [***] received by ImmunoGen pursuant to [***] within [***] days of receipt by ImmunoGen thereof. If Debiopharm notifies ImmunoGen within [***] days of its receipt of said copy of the [***] pursuant to the preceding sentence, that Debiopharm [***] or any Confidential Information of Debiopharm in such [***] that [***], then ImmunoGen will [***] to notify [***] of such [***] or Confidential Information, as the case may be within the [***] notice period set forth in [***]. ImmunoGen shall promptly notify Debiopharm of any disclosure by [***] to ImmunoGen of any [***]. Any such [***] that is [***] shall be [***], subject to the terms of the [***]. If Debiopharm notifies ImmunoGen in writing that Debiopharm desires ImmunoGen to [***], then ImmunoGen will [***] within the [***]. However, if such [***], then ImmunoGen and Debiopharm will discuss in good faith and must mutually agree upon the strategy and terms under which [***]. For the sake of clarity, for any notifications of ImmunoGen to Debiopharm hereabove mentioned, ImmunoGen shall indicate to Debiopharm the notification period set forth in the [***] enabling Debiopharm to respond to ImmunoGen before the expiration of the [***]. |
(e) Capitalized terms used in this Section 4.3(e), but not otherwise defined in this Agreement shall have the meanings ascribed to them in the [***]. ImmunoGen has provided Debiopharm with a copy of any [***] relating solely to IMGN529 that were received by ImmunoGen pursuant to the |
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.
[***]. ImmunoGen shall provide Debiopharm with a copy of any [***] by [***] received by ImmunoGen pursuant to [***] within [***] days of receipt by ImmunoGen thereof. If Debiopharm notifies ImmunoGen within [***] days of its receipt of said copy of the [***] pursuant to the preceding sentence, that Debiopharm [***] or any Confidential Information of Debiopharm in such [***] that [***], then ImmunoGen will [***] to notify [***] of such [***] or Confidential Information, as the case may be within the [***] notice period set forth in [***]. |
2.4 Further Assurances. On and after the Effective Date, and without further consideration, Debiopharm and ImmunoGen will take all appropriate action, and execute any documents, instruments or conveyances of any kind, that may be reasonably requested by the other party to carry out any of the provisions of this Agreement. Additionally, and without limiting the generality of the foregoing, if, after the Effective Date, either Party identifies (a) Acquired Assets not previously transferred to Debiopharm or (b) Licensed Know-How not previously transferred or otherwise made available to Debiopharm, which Licensed Know-How is reasonably necessary for Debiopharm to develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, register, have registered, package, have packaged, label, have labeled, distribute, have distributed, import, have imported or otherwise exploit or have exploited the Licensed Products in the Field and the Territory, then ImmunoGen shall take appropriate action, and execute such documents, licenses, instruments or conveyances, that may be reasonably requested to transfer such Acquired Assets or transfer or otherwise make available such assets or Licensed Know-How to Debiopharm. The Parties acknowledge that the immediately preceding sentence is subject to the conditions set forth in Sections 4.3(a), (b), and (c). |
ImmunoGen represents and warrants to Debiopharm that, as of the Effective Date and except as set forth in the Disclosure Letter, the following representations and warranties are true and correct.
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.
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.
licensee of the Licensed Intellectual Property, free and clear of all Encumbrances, except, with respect to the Licensed Intellectual Property, any Encumbrances which do not conflict with or limit Debiopharm’s rights under ARTICLE 2 of this Agreement; (b) neither ImmunoGen nor any of its Affiliates is, and has not been, bound by any policies or agreements under which the Acquired Assets have been or will be assigned to anyone other than Debiopharm; (c) ImmunoGen and each of its Affiliates has the right to sell and transfer to Debiopharm good, clear record and title to the Acquired Assets, free and clear of all Encumbrances of any kind; and (d) upon execution and delivery to Debiopharm of this Agreement, Debiopharm will become the sole, true and lawful owner of, and receive good and marketable title to, the Acquired Assets, free and clear of all Encumbrances. Except for the property, plant, equipment and other general operating assets of ImmunoGen, the Acquired Assets and the Licensed Intellectual Property constitute all of the assets and properties owned or Controlled by ImmunoGen or any of its Affiliates necessary or useful for the development, manufacture and commercialization of Licensed Product in its form as of the Effective Date. |
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.
such action. ImmunoGen and each of its Affiliates is, and at all times has been, in material compliance with all applicable Legal Requirements with respect to Licensed Product and the other Acquired Assets, and the research, development, manufacture and use of Licensed Product, except where failure to do so would not have a Material Adverse Effect. Neither ImmunoGen nor any of its Affiliates has been served with or received any written search warrant, subpoena, civil investigative demand or contract letter from any Governmental Entity pertaining to Licensed Product or any of the other Acquired Assets or with respect to the research, development, manufacture or use of Licensed Product. The only Regulatory Documentation related to Licensed Product in ImmunoGen’s possession or Control relates to IMGN529. ImmunoGen has provided to Debiopharm a complete copy of the Investigational New Drug application in the United States and the Clinical Trial Applications in EU and in Switzerland (including all communication with FDA, AFMPS and SwissMedic pertaining to the relevant Investigational New Drug application or Clinical Trial Application, as the case may be) has been provided to Debiopharm. |
5.12 Debarment. None of ImmunoGen or any of its Affiliates or, any of their respective officers, employees or agents, or any Person involved in the manufacture or development of IMGN529, has been debarred under applicable law, including, 21 U.S.C. §335a, or excluded from participation in government programs, including 42 U.S.C. §1320a-7. None of ImmunoGen or any of its Affiliates, or to ImmunoGen’s Knowledge, any of their respective officers, employees or agents, or any Person involved in the manufacture or development of Licensed Product has been charged or convicted of any crime or engaged in any conduct that would reasonably be expected to result, in debarment under applicable law, including, 21 U.S.C. §335a, or exclusion from participation in government programs, including 42 U.S.C. §1320a-7. No claims, actions or proceedings or, to ImmunoGen’s Knowledge, investigations, that would reasonably be expected to result in such a debarment or exclusion of ImmunoGen or any of its Affiliates are pending or, to ImmunoGen’s Knowledge, threatened, against ImmunoGen or any of its Affiliates, to ImmunoGen’s Knowledge, any of their respective officers, employees or agents or any Person involved in the manufacture or development of Licensed Product. |
5.13 Affiliates. Set forth on Schedule 5.13 is a list of all Affiliates of ImmunoGen. None of ImmunoGen’s Affiliates are, or has been, involved in the research, development or commercialization of Licensed Product. |
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.
to Section 7.7, ImmunoGen to enforce the Licensed Intellectual Property against any Person. [***] The Acquired Intellectual Property is not subject to any obligation to make payment, or the obligation to grant rights, to any Person in exchange. Neither ImmunoGen nor any of its Affiliates is bound by, or party to, any Contract that would prevent, prohibit or otherwise interfere with the ability of Debiopharm to use or otherwise exploit (I) the Acquired Intellectual Property or (II) the Licensed Intellectual Property pursuant to the terms of Section 2.1. |
(b) [***] |
(c) [***] There are no claims, challenges, oppositions, nullity actions, interferences, inter-partes reexaminations, inter-partes reviews, post-grant reviews, derivation proceedings or other proceedings pending or, to ImmunoGen’s Knowledge, threatened, involving the patents or patent applications within the Acquired Intellectual Property or the Licensed Intellectual Property. [***] ImmunoGen and its Affiliates have taken commercially reasonable actions to maintain and protect each item of the Acquired Intellectual Property. All application, registration, maintenance and renewal fees in respect of the Acquired Intellectual Property have been paid and to ImmunoGen’s knowledge, all necessary documents and certificates have been filed with the relevant agencies for the purpose of maintaining such Acquired Intellectual Property. |
5.17 Disclaimer. Except as expressly set forth in this Agreement, nothing in this Agreement is or will be construed as a warranty or representation by ImmunoGen (a) as to the validity or scope of any patent application or patent within the Acquired Intellectual Property or the Licensed Patent Rights, or (b) that anything made, used, sold or otherwise disposed through the use or practice of the Acquired Assets or any license granted under this Agreement is or will be free from infringement of any Third Party Intellectual Property. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, IMMUNOGEN DOES NOT MAKE ANY REPRESENTATION OR EXTEND ANY WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT, AND HEREBY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF TITLE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. |
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.
Debiopharm represents and warrants to ImmunoGen that, as of the Effective Date the following representations and warranties are true and correct:
6.1 Organization; Power and Authority. Debiopharm is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization, and has all necessary power and authority necessary to own, lease and operate its assets and to carry on its business as conducted and proposed to be conducted. Debiopharm has all necessary power and authority to execute, deliver and perform this Agreement and the Ancillary Agreements to which it is a party. Debiopharm is in material compliance with all provisions of its organizational documents and by-laws, each as amended to date (the “Organizational Documents”). |
6.2 Authority; Binding Agreements. The execution, delivery and performance of this Agreement and the Ancillary Agreements to which it is a party by Debiopharm have been duly and validly authorized by all necessary corporate action on behalf of Debiopharm. This Agreement has been duly executed and delivered by Debiopharm and constitutes the valid and binding obligation of Debiopharm, enforceable in accordance with its terms, subject to the extent enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or other laws affecting the enforcement of creditors’ rights generally and by general equitable principles. Each Ancillary Agreement to which Debiopharm is a party, when executed and delivered by Debiopharm, will constitute the valid and binding obligation of Debiopharm, enforceable against Debiopharm in accordance with its terms, subject to the extent enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or other laws affecting the enforcement of creditors’ rights generally and by general equitable principles. |
6.3 Conflicts; Consents. The execution, delivery and performance of this Agreement and the Ancillary Agreements to which Debiopharm is a party will not (a) contravene any material provision of the Organizational Documents of Debiopharm; (b) violate or conflict with any law, Governmental Order or Governmental Authorization, the violation of which would have a Material Adverse Effect; (c) require any authorization, consent, approval, filing, waiver, exemption or other action to be obtained, given or made, as applicable, by Debiopharm, which could reasonably be expected to have a Material Adverse Effect; or (d) violate any order, writ, injunction, decree, statute, rule or regulation applicable to Debiopharm. |
6.4 Litigation. There is no Litigation to which Debiopharm is party which is pending or has been threatened in writing against Debiopharm which in any manner challenges or seeks to prevent, enjoin, alter or delay the transactions contemplated by this Agreement or any of the Ancillary Agreements. There are no material judgments or Governmental Orders outstanding against Debiopharm that could reasonably be expected to affect the transactions contemplated by this Agreement or the Ancillary Agreements. |
6.5 Brokerage. No agent, broker investment banker, firm or other Person acting on behalf, or under the authority, of Debiopharm is or will be entitled to any broker’s or finder’s fee or any other commission or similar fee directly or indirectly from Debiopharm in connection with any of the transactions contemplated hereby. |
6.6 Solvency. Debiopharm is not now insolvent, and will not be rendered insolvent by any of the transactions contemplated by, or the performance of any of the obligations under, this Agreement or the Ancillary Agreements. In addition, immediately after giving effect to the consummation of the transactions |
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.
contemplated hereby, (a) Debiopharm will be able to pay its debts as they become due, (b) Debiopharm will not have unreasonably small capital with which to conduct its present or proposed business, (c) Debiopharm will have assets (calculated at fair market value) that exceed its liabilities, (d) taking into account all pending and threatened litigation, final judgments against Debiopharm in actions for money damages are not reasonably anticipated to be rendered at a time when, or in amounts such that, Debiopharm will be unable to satisfy any such judgments promptly in accordance with their terms (taking into account the maximum probable amount of such judgments in any such actions and the earliest reasonable time at which such judgments might be rendered) as well as all other obligations of Debiopharm and (e) the cash available to Debiopharm, after taking into account all other anticipated uses of the cash, will be sufficient to pay all such debts and judgments promptly in accordance with their terms. |
(b) Clinical Regulatory Transfer Plan. Following the Effective Date, the Parties shall [***] to effect the clinical regulatory transfer plan agreed between the Parties (the “Clinical Regulatory Transfer Plan”) [***]. |
(c) Safety Data Exchange Agreement. Following the Effective Date, (i) ImmunoGen agrees to promptly provide to Debiopharm any safety data or information that it or any of its Affiliates receives relating to Licensed Product, and (ii) the Parties shall [***] to enter into a safety data exchange agreement pursuant to which the Parties will share and protect safety data developed or obtained by them that relates to MAY Compounds. |
(e) Quality Agreement. Following the Effective Date, the Parties shall [***] to enter into a Quality Agreement with respect to the drug product manufactured by ImmunoGen and transferred to Debiopharm, and which Debiopharm will use in clinical trials. |
(f) Access to Additional Data. Following the Effective Date, ImmunoGen will [***] efforts to provide to Debiopharm data, results and information in ImmunoGen’s possession or Control (including, without limitation, information contained in [***]) that has not theretofore been provided pursuant to Section 4, the Technology Transfer Plan or the Clinical Regulatory Transfer Plan (i) [***], or (ii) [***], Debiopharm may request such information, and ImmunoGen will [***] to retrieve such information and provide it to Debiopharm [***]. Such request will [***], as well as [***]. |
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.
(c) If Debiopharm shall transfer, assign, sell, license, convey or dispose of Acquired Assets, or sublicense Licensed Intellectual Property, or rights in or to any of the foregoing (whole or partial), to any Third Party, Debiopharm shall in all cases remain primarily responsible for the payment and other obligations in this Agreement including, without limitation, payment of the Contingent Payments. |
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.
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.
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.
(c) Infringement of Third Party Rights. If any Licensed Product that is manufactured, used or sold by or for Debiopharm becomes the subject of a Third Party’s claim or assertion of infringement of Patent Rights controlled by such Third Party, the Party first having notice of the claim or assertion will promptly notify the other Party in writing, and the Parties will promptly meet to consider in good faith the claim or assertion and the appropriate course of action. Nothing in this Section 7.7(c) will be deemed to relieve either Party of its indemnification obligations under ARTICLE 8. |
(d) Covenant Not to Enforce. In partial consideration for the rights and obligations contained herein, ImmunoGen and its Affiliates agrees not to enforce against Debiopharm, its Affiliates or, Sublicensees any Licensed Patent Rights which Debiopharm or its Affiliates may infringe in practicing the license granted in Section 2.1. |
(e) Covenant Not to Contest or Challenge. Neither ImmunoGen nor any of its Affiliates will contest or challenge, either directly or indirectly through any Third Party, in any patent office, court, or other forum, the validity and enforceability of the Acquired Intellectual Property. |
(f) Patent Marking. Debiopharm agrees to comply with the patent marking statutes in each country in which a Licensed Product is sold by Debiopharm or its Affiliates, licensees or Sublicensees. |
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.
8.1 Survival; Expiration. Notwithstanding any investigation made by or on behalf of any party hereto prior to, on or after the Effective Date, the representations and warranties contained in this Agreement (including the Schedules hereto) and in any Ancillary Agreement shall survive for a period of one (1) year following the Effective Date, except that the representations and warranties contained in Sections 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.14, 5.15, 6.1, 6.2, 6.3, 6.4, 6.5 and 6.6 shall survive for the applicable statute of limitations period. The covenants, agreements and obligations of the parties shall survive until fully performed and discharged, unless otherwise expressly provided herein. Each Party shall give prompt written notice to the other Party of (a) any event, circumstance or condition that constitutes a |
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.
breach of, or makes inaccurate, any representation and warranty of such Party hereunder, or (b) the non-fulfillment of any covenant, agreement or obligation of such Party hereunder. |
8.2 Indemnification by ImmunoGen. ImmunoGen shall indemnify Debiopharm, its Affiliates, its and their respective directors, officers, employees, consultants and agents, and its and their respective successors, heirs and assigns, in respect of, and hold each of them harmless and defend them against, all liabilities, judgments, claims, settlements, losses, damages, fees, Taxes, penalties, obligations and expenses (including reasonable attorneys’ fees and expenses and costs and expenses of investigation) (collectively, “Damages”) incurred or suffered by them resulting from, relating to or constituting: |
(a) any breach of any representation or warranty of ImmunoGen contained in this Agreement or any Ancillary Agreement; or |
(b) any failure to perform any covenant or agreement of ImmunoGen contained in this Agreement or any Ancillary Agreement; or |
(d) with respect to Third Party Actions only, to the extent relating to use of the Acquired Assets or the development or commercialization (including the manufacture, promotion, import, use or sale by any Person) of any Licensed Product by or on behalf of ImmunoGen or its Affiliates, or their respective licensees, contractors, distributors or agents, or their respective heirs, successors or assigns, prior to the Effective Date. |
8.3 Indemnification by Debiopharm. Debiopharm shall indemnify ImmunoGen, its Affiliates, its and their respective directors, officers, employees, consultants and agents, and its and their respective successors, heirs and assigns, in respect of, and hold each of them harmless and defend them against, all Damages incurred or suffered by them thereof resulting from, relating to or constituting: |
(a) any breach of any representation or warranty of Debiopharm contained in this Agreement or any Ancillary Agreement; |
(b) any failure to perform any covenant or agreement of Debiopharm contained in this Agreement or any Ancillary Agreement; or |
(d) with respect to Third Party Actions only, to the extent relating to use of the Acquired Assets or the development or commercialization (including the manufacture, promotion, import, use or sale by any Person) of any Licensed Product by or on behalf of Debiopharm or its Affiliates, or their respective licensees, contractors, distributors or agents, or their respective heirs, successors or assigns, on or after the Effective Date, except to the extent such Third Party Action results from, relates to or constitutes any of the items set forth above in Section 8.2(a) through (d), but including for the avoidance of doubt any such Third Party Actions (including involving a Governmental Entity) relating to any clinical studies referred to in Section 3.1(c) that are performed on or after the Effective Date, including while ImmunoGen remains the nominal sponsor thereunder (other than to the extent such Third Party Action arises from, or accrues or relates to the period prior to the Effective Date). |
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.
(a) Third Party Actions. A Person seeking indemnification under Article 8 (the “Indemnified Party”) shall give written notification to the Party from which recovery is sought (the “Indemnifying Party”) of the commencement of any Third Party Action. Such notification shall be given within twenty (20) days after receipt by the Indemnified Party of notice of such Third Party Action, and shall describe in reasonable detail (to the extent known by the Indemnified Party) the facts constituting the basis for such Third Party Action and the amount of the claimed damages; provided, however, that no delay or failure on the part of the Indemnified Party in so notifying the Indemnifying Party shall relieve the Indemnifying Party of any liability or obligation hereunder except to the extent of any damage or liability caused by or arising out of such failure. Within twenty (20) days after delivery of such notification, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such Third Party Action with counsel reasonably satisfactory to the Indemnified Party; provided that (i) the Indemnifying Party may only assume control of such defense if (A) it acknowledges in writing to the Indemnified Party that any damages, fines, costs or other liabilities that may be assessed against the Indemnified Party in connection with such Third Party Action constitute Damages for which the Indemnified Party shall be indemnified pursuant to this ARTICLE 8 and (B) the ad damnum is less than or equal to the amount of Damages for which the Indemnifying Party is liable under this ARTICLE 8 and (ii) the Indemnifying Party may not assume control of the defense of Third Party Action involving criminal liability or in which equitable relief is sought against the Indemnified Party. If the Indemnifying Party does not, or is not permitted under the terms hereof to, so assume control of the defense of a Third Party Action, the Indemnified Party shall control such defense. The non-controlling Party may participate in such defense at its own expense. The controlling Party shall keep the non-controlling Party advised of the status of such Third Party Action and the defense thereof and shall consider in good faith recommendations made by the non-controlling Party with respect thereto. The non-controlling Party shall furnish the controlling Party with such information as it may have with respect to such Third Party Action (including copies of any summons, complaint or other pleading which may have been served on such party and any written claim, demand, invoice, billing or other document evidencing or asserting the same) and shall otherwise cooperate with and assist the controlling Party in the defense of such Third Party Action. The reasonable fees and expenses of counsel to the Indemnified Party with respect to a Third Party Action shall be considered Damages for purposes of this Agreement if the Indemnified Party controls the defense of such Third Party Action pursuant to the terms hereof. The Indemnifying Party shall not agree to any settlement of, or the entry of any judgment arising from, any Third Party Action without the prior written consent of the Indemnified Party, which shall not be unreasonably withheld, conditioned or delayed; provided that the consent of the Indemnified Party shall not be required if the Indemnifying Party agrees in writing to pay any amounts payable pursuant to such settlement or judgment and such settlement or judgment includes a complete release of the Indemnified Party from further liability and has no other adverse effect on the Indemnified Party. The Indemnified Party shall not agree to any settlement of, or the entry of any judgment arising from, any such Third Party Action without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld, conditioned or delayed. |
(b) Other Claims. |
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.
8.5 Limitations. |
(b) Anything contained in this Agreement to the contrary notwithstanding, except for Damages resulting from Third Party Actions indemnifiable under this Agreement, the aggregate liability of a Party for Damages under this ARTICLE 8 for breach of any representation or warranty by such Party contained in Sections [***] shall not exceed [***] of the Aggregate Consideration actually paid to ImmunoGen. |
(c) Notwithstanding anything herein to the contrary, ImmunoGen shall have no liability for Damages arising from a breach of [***], if such breach is the result of the fact that an ImmunoGen agent or a Person involved in the manufacture or development of IMGN529 other than an officer or employee, [***], and ImmunoGen did not [***]. |
(d) EXCEPT FOR EITHER PARTY’S BREACH OF SECTION 7.4 OR IMMUNOGEN’S BREACH OF SECTION 7.5, NEITHER PARTY WILL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR (i) ANY SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL DAMAGES (INCLUDING ANY DAMAGES RESULTING FROM LOSS OF PROFITS, LOSS OF BUSINESS OR LOSS OF GOODWILL), OR (ii) COSTS OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES, EVEN IF EITHER PARTY IS INFORMED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES AND EVEN IF THE REMEDIES PROVIDED FOR IN THIS AGREEMENT FAIL OF THEIR ESSENTIAL PURPOSE. NEITHER PARTY WILL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY PUNITIVE OR EXEMPLARY DAMAGES. For purposes of clarity, an Indemnified Party’s monetary liability under a Third Party Action for such Third Party’s special, incidental, indirect or consequential damages, or for any exemplary or punitive damages payable to such Third Party in connection with such Third Party Claim, shall be deemed to be the direct damages of such Indemnified Party for purposes of this ARTICLE 8. No breach by ImmunoGen hereunder shall permit Debiopharm the right to rescind this Agreement or any of the transactions contemplated hereby. |
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.
(e) No limitation or condition of liability provided in this Section 8.5 shall apply to any Damages resulting from fraud. |
(f) Each Party shall (and shall cause its Affiliates to) [***] to take such actions, and pursue such legal rights and remedies available, in order to mitigate Damages (or potential Damages) for which indemnification is provided to it under this Agreement. |
8.6 Right to Set-Off. Without limiting any other rights or remedies available to Debiopharm, Debiopharm may set-off the amount of any Damages for which indemnification has been finally determined or agreed pursuant to Section 8.4 against any Contingent Payments or other amounts payable by Debiopharm under this Agreement or any of the Ancillary Agreements. If any Contingent Payment becomes due and is not yet paid and Debiopharm submits a Claim Notice or there exists a Third Party Action pursuant to which Debiopharm is entitled to indemnification under Section 8.2, Debiopharm may pay such Contingent Payment, up to the amount of the Damages claimed in the Claim Notice or Third Party Action, into an escrow account pursuant to an escrow agreement reasonably acceptable to the Parties pending resolution of such Claim or Third Party Action. |
ARTICLE 9
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9.1 Entire Agreement; Amendment. This Agreement, the Ancillary Agreements, and the Exhibits attached hereto and thereto set forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties with respect to the subject matter of this Agreement and supersedes and terminates all prior agreements and understandings between the Parties with respect to such subject matter. No subsequent alteration, amendment, change or addition to this Agreement will be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party. |
9.2 Governing Law. This Agreement will be construed in accordance with, and governed in all respects by, the laws of the State of New York (without giving effect to principles of conflicts of laws that would require the application of any other law). The provisions of the United Nations Convention on Contracts for the International Sale of Goods (Vienna 1980) and the Convention on the Limitation Period in the International Sale of Goods (New York 1974), as amended by that certain Protocol, done at Vienna on 11 April 1980, shall not apply to this Agreement or the Ancillary Agreements, or any subject matter hereof or thereof. |
9.3 Notices. Any notice required or permitted to be given under this Agreement will be in writing, will specifically refer to this Agreement and will be deemed to have been sufficiently given for all purposes (a) as documented in a delivery receipt if sent by international express delivery service or (b) upon delivery if delivered personally. Unless otherwise specified in writing, the notice addresses of the Parties will be as described below. |
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.
Xxxxxxx, XX 00000-0000
Attn: Vice President, Business Development
with a copy to:ImmunoGen, Inc.
Xxxxxxx, XX 00000-0000
Attn: Legal Department
For Debiopharm:Debiopharm International, S.A.
Forum “après-demain,”
Chemin Messidor 5-7,
Xxxx Xxxxxxx 0000,
XX-0000 Xxxxxxxx,
Xxxxxxxxxxx
Attention: Chief Executive Officer
with a copy to:Debiopharm International, S.A.
Forum “après-demain,”
Xxxxxx Xxxxxxxx 0-0,
Xxxx Xxxxxxx 0000,
XX-0000 Xxxxxxxx,
Xxxxxxxxxxx
Attention: Director, IP& Legal Affairs
9.4 No Strict Construction. This Agreement has been prepared jointly and will not be strictly construed against either Party. |
9.5 Assignment. Neither Party may assign or transfer this Agreement or any rights or obligations under this Agreement without the prior written consent of the other Party, except that a Party may make such an assignment or transfer without the other Party’s consent (a) to the assigning Party’s Affiliates or (b) to the successor to all or substantially all of the business or assets of such Party (or with respect to Debiopharm only, all or substantially all of the business or assets to which this Agreement relates), whether by merger, sale of stock, sale of assets or other transaction. Any permitted successor or assignee of rights or obligations under this Agreement will, in a writing to the other Party, expressly assume performance of such rights or obligations, but the assigning Party will remain primarily liable and responsible for the performance of all of its obligations under this Agreement and for causing its assignees to act in a manner consistent with this Agreement. Any permitted assignment will be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 9.5 will be null and void. This Agreement shall be binding upon and inure to the benefit of the Parties named herein and their respective successors and permitted assigns. |
9.6 Independent Contractors. It is understood and agreed that the relationship between the Parties is that of independent contractors and that nothing in this Agreement will be construed as authorization for either Party to act as the agent for the other Party. |
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.
9.7 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. |
9.8 Severability. Each provision in this Agreement is independent and severable from the others, and no provision will be rendered unenforceable because any other provision may be invalid or unenforceable in whole or in part. If the scope of any restrictive provision in this Agreement is too broad to permit enforcement to its full extent, then such restriction will be reformed to the maximum extent permitted by law. |
9.9 Headings. The headings for each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section. |
9.10 No Waiver. Any delay in enforcing a Party’s rights under this Agreement, or any waiver as to a particular default or other matter, will not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time. |
9.11 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which will be deemed an original, but all of which together will constitute one (1) and the same instrument. For purposes of executing this Agreement, a facsimile copy of this Agreement, or .pdf copy, including the signature pages, will be deemed an original. |
9.12 Public Announcements. Either Party may make any public disclosure relating to the subject matter of this Agreement that it believes in good faith is required by applicable law, regulation or stock market rule; provided that such Party shall use commercially reasonable efforts to provide the other Party with notice of the contents of each such public disclosure at least ten (10) days prior to issuing such public disclosure, and shall consider in good faith any comments provided by the other Party prior to making such public disclosure. Except as contemplated by the prior sentence, each Party must get the prior approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed, prior to making any public announcement, or issuance of a press release, relating to the transactions contemplated by this Agreement. |
9.13 No Third Party Beneficiaries. Except as set forth in ARTICLE 8 hereof, this Agreement shall not confer any rights or remedies upon any person other than the Parties and their respective successors and permitted assigns. |
9.14 Amendments and Waivers. No amendment of any provision of this Agreement shall be valid unless the same shall be in writing and signed by each of the Parties. No waiver by either Party of any right or remedy hereunder shall be valid unless the same shall be in writing and signed by the Party giving such waiver. No waiver by either Party with respect to any default, misrepresentation, or breach of warranty or covenant hereunder shall be deemed to extend to any prior or subsequent default, misrepresentation, or breach of warranty or covenant hereunder or affect in any way any rights arising by virtue of any prior or subsequent such occurrence. |
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.
9.15 Expenses. Except as set forth in ARTICLE 8, each Party shall bear its own costs and expenses (including legal fees and expenses) incurred in connection with this Agreement and the transactions contemplated hereby. |
9.16 Dispute Resolution. Each Party shall provide the other Party with written notice of any claim of breach under this Agreement or any Ancillary Agreement and such other Party shall have a reasonable period of time (of not less than 30 days) to cure such breach if curable. The Parties recognize that a bona fide dispute as to certain matters may from time to time arise relating to either Party’s rights or obligations hereunder or under the Ancillary Agreement, or otherwise relating to the validity, enforceability or performance of this Agreement or the Ancillary Agreements, including claims for indemnification under this Agreement. In the event of the occurrence of any such dispute, the Parties shall, by written notice to the other Party, have such dispute referred to their respective senior officers designated below, for attempted resolution by good faith negotiations commencing promptly after such notice is received. Said designated senior officials of the Parties are as follows: |
For Debiopharm:Chief Executive Officer; and
For ImmunoGen:Chief Executive Officer.
If the designated senior officials are not able to resolve such dispute within 60 days following delivery of the notice referring the dispute to the Parties’ respective senior officers designated above, then such dispute shall be finally resolved by arbitration in accordance with the International Institute for Conflict Prevention and Resolution (“CPR”) Rules for Administered Arbitration by three independent arbitrators, of whom each Party shall designate one, with the third arbitrator to be designated by the two Party-designated arbitrators. The arbitration shall be governed by the Federal Arbitration Act, 9 U.S.C. §§1 et seq., and judgment upon the award rendered by the arbitrators may be entered by any court having competent jurisdiction thereof. The place of arbitration shall be the Borough of Manhattan, City of New York, New York, and all proceedings shall be conducted in English.
9.17 Equitable Relief; Submission to Jurisdiction. Anything contained in this Agreement to the contrary notwithstanding, if a Party reasonably requires relief on a more expedited basis that would be possible pursuant to the procedures set forth in Section 9.16, such Party may seek a temporary injunction or other equitable relief in a court of competent jurisdiction, without posting a bond, pending the resolution of the Dispute in accordance with Section 9.16. Solely with respect to a Party seeking a temporary injunction or other equitable relief, each Party (a) submits to the jurisdiction of any state or federal court sitting in the Southern District of the State of New York in any such action or proceeding arising out of or relating to this Agreement or the Ancillary Agreements, (b) waives any claim of inconvenient forum or other challenge to venue in such court, (c) agrees not to bring any such action or proceeding arising out of or relating to this Agreement or the Ancillary Agreements in any other court, and (d) waives any right it may have to a trial by jury with respect to any such action or proceeding arising out of or relating to this Agreement or the Ancillary Agreements. The Parties agree that with respect to any arbitration of a Dispute, the arbitrators shall resolve all threshold issues relating to the validity and applicability of the arbitration provisions of this Agreement, contract validity, applicability of statutes of limitations and issue preclusion, and such threshold issues shall not be heard or determined by such court. Each party agrees to accept service of any summons, complaint or other initial pleading made in the manner provided for the giving of notices in this Agreement, provided that nothing in this Section 9.17 shall affect the right of either Party to serve such summons, complaint or other initial pleading in any other manner permitted by law. |
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.
9.18 Interpretation. Words such as “herein,” “hereinafter,” “hereof” and “hereunder” refer to this Agreement as a whole and not merely to a Section or paragraph in which such words appear, unless the context otherwise requires. The singular shall include the plural, and each masculine, feminine and neuter reference shall include and refer also to the others, unless the context otherwise requires. The word “or” is used in the inclusive sense typically associated with the phrase “and/or”, unless the context otherwise requires. The words “include,” “includes” and “including” shall be deemed to be followed by the phrase “without limitation” and shall not be construed to limit any general statement which it follows to the specific or similar items or matters immediately following it irrespective of the use of the phrase “without limitation” or similar phrases in any provision of this Agreement. The word “will” shall be construed to have the same meaning and effect as the word “shall.” All references herein to Articles, Sections, Schedules or Exhibits shall be construed to refer to Articles, Sections, Schedules and Exhibits of this Agreement, and references to this Agreement include all Schedules and Exhibits hereto. |
[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.
IN WITNESS WHEREOF, Debiopharm and ImmunoGen have executed this Exclusive License and Asset Purchase Agreement as of the date first above written
DEBIOPHARM INTERNATIONAL, S.A. By:/s/ Thierry Mauvernay Name: Thierry Mauvernay Title: Delegate of the Board |
By:/s/ Xxxxx Xxxxxxxx Name: Xxxxx Xxxxxxxx Title: Vice President, Business Development |
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.