COLLABORATION AGREEMENT

Exhibit 10.4

 

COLLABORATION AGREEMENT

 

This Agreement is entered into as of June 14, 2005 by and between SEATTLE GENETICS, INC., a Delaware corporation, having its principal place of business at 21823 30th Drive S.E., Bothell, Washington 98021 (hereinafter referred to as “SGI”), and PSMA DEVELOPMENT COMPANY LLC, a Delaware limited liability corporation, having its principal place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591 (hereinafter referred to as “Licensee”).

 

WITNESSETH

 

WHEREAS, SGI Controls (as defined below) intellectual property rights relating to certain technology useful for linking certain proprietary [***] to other molecules, such as antibodies, capable of directing such [***] to specific tissues and/or cells;

 

WHEREAS, Licensee Controls intellectual property rights relating to the Designated Antigen (as defined below), and is currently conducting research and development relating to Antibodies (as defined below) that bind to the Designated Antigen pursuant to a Research Collaboration Agreement dated [***], as amended (the “Research Collaboration Agreement”); and

 

WHEREAS, Licensee wishes to acquire from SGI, and SGI wishes to grant to Licensee, an exclusive, worldwide license under SGI patent rights and know-how related to SGI’s proprietary [***] for use in conjunction with such Antibodies for the development, commercialization, manufacture, marketing and sale of Licensed Products (as defined below).

 

NOW, THEREFORE, in consideration of the mutual covenants and obligations set forth herein, the Parties hereto, intending to be legally bound, agree as follows:

 

ARTICLE 1

 

DEFINITIONS AND INTERPRETATION

 

1.1 Definitions: For the purposes of this Agreement the following words and phrases shall have the following meanings:

 

1.1.1 “AAA” has the meaning set forth in Section 19.3.4.

 

1.1.2 “ADC” or “Antibody-Drug Conjugate” means an Antibody [***] and that contains, uses or is made using SGI Technology.

 

1.1.3 “ADC Access Fee” has the meaning set forth in Section 6.1.1.

 

1.1.4 “Adverse Drug Experience” shall mean any “adverse experience” as defined or contemplated by 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

 

1.1.5 “Affiliate” of a Party means any corporation or other business entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with a Party. As used herein, the term “control” means the direct or indirect ownership of [***] or more of the stock having the right to vote for directors thereof or the ability to otherwise control the management thereof. For purposes of clarification, each of

 

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Progenics Pharmaceuticals, Inc. (“Progenics”) and Cytogen Corporation (“Cytogen”) shall be deemed an Affiliate of Licensee so long as their respective [***].

 

1.1.6 “Agreement” means this agreement, all duly executed amendments and supplements to this Agreement and all schedules to this Agreement, including the following:

 

Schedule A - Research Plan.

 

Schedule B - SGI Patents.

 

Schedule C - SGI In-Licenses.

 

1.1.7 “Antibody” or “Antibodies” means any molecule that binds specifically to an Antigen, including, but not limited to, [***].

 

1.1.8 “Antigen” means any molecule that will induce an [***], including but not limited to a [***].

 

1.1.9 “[***]” means the SGI Technology licensed to SGI under the BMS Agreement (as defined in the definition of “SGI In-Licenses”).

 

1.1.10 “Breaching Party” has the meaning set forth in Section 13.3.

 

1.1.11 “Calendar Quarter” means any of the three-month periods beginning January 1, April 1, July 1 and October 1 in any year.

 

1.1.12 “Combination Product” means any Licensed Product that contains, in [***], and (b) [***].

 

1.1.13 “Commercially Reasonable Efforts” means, with respect to a Party, the efforts and resources typically used by biotechnology companies similar in size and scope to such Party to perform the obligation at issue; in each case with respect to a product or potential product of similar nature at a similar stage in its development or product life and of similar market potential, in view of conditions prevailing at the time, and evaluated taking into account all relevant factors, including without limitation, the mechanism of action, efficacy, safety, the anticipated regulatory authority approved labeling, the competitiveness of alternative products that are in the marketplace or under development, the patent and other proprietary position of the product, the likelihood of Regulatory Approval, the profitability of the product and other technical, scientific, legal, medical, marketing and competitive factors.

 

1.1.14 “Confidential Information” has the meaning set forth in Section 8.1.

 

1.1.15 “Control” means, with respect to any information or intellectual property right, possession by a Party of the ability to grant the right to access or use, or to grant a license or a sublicense to, such information or intellectual property right without violating the terms of any agreement or other arrangement with any Third Party. In the case of an Antigen, such Antigen will be deemed to be Controlled by Licensee if Licensee Controls [***].

 

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1.1.16 “Cost of Goods” shall mean with respect to Drug Conjugation Materials or ADCs supplied to Licensee by SGI: (a) for manufacturing activities performed by Third Parties, SGI’s reasonably documented out-of-pocket costs actually incurred in such manufacture and supply of Drug Conjugation Materials or ADCs, as well as SGI’s reasonable internal costs incurred in supporting the Third Party manufacturing relationship, including without limitation [***]; and (b) for manufacturing activities performed by SGI or its Affiliates, the consolidated fully burdened cost of manufacturing such Drug Conjugation Materials or ADCs, which shall mean costs of the following as such costs are actually incurred by SGI or its Affiliates: [***], and as determined in accordance with GAAP as consistently applied by SGI.

 

1.1.17 “Designated Antigen” means the PSMA Antigen having a GenBank Accession No. [***].

 

1.1.18 “Disclosing Party” has the meaning set forth in Section 8.1.

 

1.1.19 “Drug Conjugation Materials” means the [***] and certain [***], as well as other compounds that are useful in attaching such compounds to [***]. Drug Conjugation Materials shall also include SGI Inventions to the foregoing, and shall also include any additional [***] compound or other compounds that are useful in attaching compounds to Antibodies and that are included in New Technologies that the Parties agree to include under this Agreement pursuant to Section 3.3.

 

1.1.20 “Effective Date” means the date set forth in the first line of this Agreement.

 

1.1.21 “Events of Force Majeure” has the meaning set forth in Article 15.

 

1.1.22 “Exclusive License” has the meaning set forth in Section 3.1.

 

1.1.23 “Exclusive License Renewal Fee” has the meaning set forth in Section 6.2.

 

1.1.24 “Existing Third Party Royalties” has the meaning set forth in Section 6.4.3.

 

1.1.25 “Extended Research Program Term” has the meaning set forth in Section 2.2.

 

1.1.26 “FD&C Act” means the federal Food, Drug & Cosmetic Act, as amended.

 

1.1.27 “FDA” means the United States Food and Drug Administration and its subdivisions, and any successor agency thereto.

 

1.1.28 “Field” means the [***].

 

1.1.29 “First Commercial Sale” means, in each country of the Territory, the first commercial sale of a Licensed Product by Licensee, its Affiliates or Sublicensees to a Third Party following, if required by law, Regulatory Approval and, when Regulatory Approval is not

 

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required by law, the first commercial sale in that country, in each case for use or consumption of such Licensed Product in such country by the general public.

 

1.1.30 “Former Designated Antigen” has the meaning set forth in Section 3.6.

 

1.1.31 “FTE” means a full time equivalent person year, based upon a total of [***].

 

1.1.32 “GAAP” means generally accepted accounting principles in the United States.

 

1.1.33 “Generic Version” means, with respect to a Licensed Product in a [***] and (ii) a [***].

 

1.1.34 “Good Clinical Practices” means the standards, practices and procedures set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA, any successor agency and, as applicable, the equivalent thereof in jurisdictions outside the United States.

 

1.1.35 “Good Laboratory Practices” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards in jurisdictions outside the United States.

 

1.1.36 “Good Manufacturing Practices” means the then-current good manufacturing practices required by the FDA and set forth in the U.S. Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder, for the manufacturing and testing of pharmaceutical materials, and any other laws or regulations applicable to the manufacturing and testing of pharmaceutical materials in jurisdictions outside the United States.

 

1.1.37 “IND” means (a) an Investigational New Drug Application filed with the FDA or its equivalent in any country outside the United States where a regulatory filing is required or obtained to conduct a clinical trial; or (b) with respect to any country where a regulatory filing is not required or obtained to conduct a clinical trial, the first enrollment of a patient in the first trial involving the first use of a Licensed Product in humans.

 

1.1.38 “Indemnitee” has the meaning set forth in Section 14.3.1.

 

1.1.39 “Indemnitor” has the meaning set forth in Section 14.3.1.

 

1.1.40 “Initial Research Program Term” has the meaning set forth in Section 2.2.

 

1.1.41 “Initiation” means, with respect to a human clinical trial, the dosing of the first patient with a Licensed Product pursuant to the clinical protocol for the specified clinical trial.

 

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1.1.42 “Inventions” means any patentable or non-patentable inventions, discoveries or other know-how discovered, created or developed and Controlled by either Party that arise out of activities conducted under this Agreement or the Research Collaboration Agreement; provided that Inventions shall not include any [***].

 

1.1.43 “Joint Inventions” has the meaning set forth in Section 9.1.2(c).

 

1.1.44 “Joint Patents” has the meaning set forth in Section 9.2.2.

 

1.1.45 “Licensed Product” means any and all products containing an ADC comprised of an Antibody that binds to the Designated Antigen.

 

1.1.46 “Licensee” has the meaning set forth in the first paragraph of this Agreement. Each reference to “Licensee” shall, where appropriate, be deemed to include applicable “Sublicensees”.

 

1.1.47 “Licensee ADC Know-How” means all technical information, processes, formulae, data, inventions, methods, chemical compounds, biological or physical materials, know-how and trade secrets Controlled by Licensee, in each case that are not in the public domain, that are developed by Licensee using SGI Technology, and that relate to or are useful in identifying, developing, making, using or selling [***].

 

1.1.48 “Licensee ADC Patents” means all patent applications and patents that are Controlled by Licensee that claim inventions made using SGI Technology, which inventions are for identifying, developing, making, using or selling [***].

 

1.1.49 “Licensee Know-How” means all technical information, processes, formulae, data, inventions, methods, chemical compounds, biological or physical materials, know-how and trade secrets Controlled by Licensee, in each case that are not in the public domain, that relate to or are useful in (a) [***] or (b) [***].

 

1.1.50 “Licensee Indemnified Parties” has the meaning set forth in Section 14.2.

 

1.1.51 “Licensee Invention Patents” has the meaning set forth in Section 9.3.3.

 

1.1.52 “Licensee Inventions” has the meaning set forth in Section 9.1.2(a).

 

1.1.53 “Licensee Patents” means all patent applications and patents that are Controlled by Licensee that claim (a) [***], or (b) [***].

 

1.1.54 “Losses” has the meaning set forth in Section 14.1.

 

1.1.55 “Net Sales” means, as to each calendar quarter, the gross invoiced sales prices charged for all Licensed Products sold by or for Licensee, its Affiliates and Sublicensees to independent Third Parties during such quarter, [***] with respect to sales of Licensed Products:

 

(a)

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(b)

[***];

 

(c)

[***]; and

 

(d)

[***].

 

All of the foregoing [***] shall be determined in accordance with GAAP. In the event that Licensee, its Affiliates or Sublicensees make any adjustments to such [***] have been reported pursuant to this Agreement, the adjustments shall be reported and reconciled in the next report and payment of any royalties due.

 

In the event a Licensed Product is sold as part of a [***] during the applicable royalty reporting period, by the [***] in each case during the applicable royalty reporting period or, if sales of the Licensed Product [***] did not occur in such period or country, then in the most recent royalty reporting period in which [***] Licensed Product occurred in such country or if no such sales have occurred in such country, the [***] during the applicable royalty period. In the event that such [***].

 

1.1.56 “New Technologies” means any [***] (i) that are [***] Controlled by SGI, or (ii) that are first developed by SGI after the Effective Date and that are [***], including but not limited to the chemical compositions and the methods useful for [***].

 

1.1.57 “Notice of Dispute” has the meaning set forth in Section 19.3.1.

 

1.1.58 “Parties” means Licensee and SGI, and “Party” means either of them.

 

1.1.59 “Person” means a natural person, a partnership, a corporation, an association, a joint stock company, a limited liability company, a trust, a joint venture or an unincorporated organization.

 

1.1.60 “Personnel Fees” has the meaning set forth in Section 6.1.2.

 

1.1.61 “Phase I Clinical Trial” means a human clinical trial, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients.

 

1.1.62 “Phase II Clinical Trial” means a controlled dose clinical trial prospectively designed to evaluate the efficacy and safety of a candidate drug in the targeted patient population and to define the optimal dosing regimen.

 

1.1.63 “Phase III Clinical Trial” means a controlled, and usually multi-center, clinical trial, involving patients with the disease or condition of interest to obtain sufficient efficacy and safety data to support Regulatory Approval of a candidate drug.

 

1.1.64 “Publication” has the meaning set forth in Section 8.5.

 

1.1.65 “Receiving Party” has the meaning set forth in Section 8.1.

 

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1.1.66 “Regulatory Approval” means final regulatory approval (including, where applicable, pricing approval in the event that actual sales do not take place before such approval) required to market a Licensed Product for a disease or condition in accordance with the applicable laws and regulations of a given country. In the United States, its territories and possessions, Regulatory Approval means approval of a New Drug Application (“NDA”), Biologics License Application (“BLA”) or an equivalent by the FDA.

 

1.1.67 “[***]” has the meaning set forth in Section 3.6.

 

1.1.68 “Replacement Antigen Fee” has the meaning set forth in Section 3.6.

 

1.1.69 “Reports” has the meaning set forth in Section 7.1.1.

 

1.1.70 “Research Fees” has the meaning set forth in Section 6.1.2.

 

1.1.71 “Research Fees Report” has the meaning set forth in Section 6.1.2.

 

1.1.72 “Research Plan” means the plan for the Research Program agreed upon by the Parties and attached hereto as Schedule A.

 

1.1.73 “Research Program” means the research program conducted pursuant to Article 2.

 

1.1.74 “Research Program Term” means the term of the Research Program set forth in Section 2.2.

 

1.1.75 “Royalty Term” means, on a Licensed Product-by-Licensed Product and country-by-country basis, the later to occur of: (a) the tenth anniversary of the date of First Commercial Sale of the Licensed Product in such country; or (b) the expiration of the last to expire Valid Patent Claim that would be infringed by the sale of the Licensed Product in such country, if not for the licenses granted hereunder.

 

1.1.76 “Serious Adverse Drug Experience” shall mean any Adverse Drug Experience that is fatal or life-threatening, is permanently disabling, requires in-patient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability or incapacity, or is a congenital anomaly, or overdose, or other event which would constitute a “serious” adverse experience pursuant to the terms of 21 C.F.R. § 312.32 or 21 C.F.R. §314.80.

 

1.1.77 “SGI Indemnified Parties” has the meaning set forth in Section 14.1.

 

1.1.78 “SGI In-Licenses” means the following agreements between SGI and the indicated Third Parties: (a) [***].

 

1.1.79 “SGI Inventions” has the meaning set forth in Section 9.1.2(b).

 

1.1.80 “SGI Know-How” means all technical information, processes, formulae, data, inventions, methods, chemical compounds, biological or physical materials, know-how and

 

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trade secrets Controlled by SGI, in each case that are not in the public domain, that relate to or are useful in the discovery, research, development, manufacture or use of Drug Conjugation Materials or ADCs for purposes of the offer and sale of Licensed Products in the Field, including but not limited to the chemical compositions and the methods useful for attaching the Drug Conjugation Materials to Antibodies. SGI Know-How shall exclude any [***].

 

1.1.81 “SGI Patents” means:

 

(a) any patents and patent applications listed in Schedule B to this Agreement (each, an “Existing SGI Patent”), which shall be amended from time to time to add any other patents and patent applications which shall be included as SGI Patents;

 

(b) any patents and patent applications covering SGI Know-How or SGI Inventions and, solely to the extent the parties so agree pursuant to [***], and Schedule B to this Agreement shall be amended from time to time to add patents or patent applications that arise from any of the foregoing;

 

(c) any future patents issued from any patent applications referred to above and any future patents issued from any continuation, continuation-in-part (to the extent Controlled by SGI), divisional or provisional of any of the foregoing patent applications or any patent applications from which the foregoing patents issued; and

 

(d) any reissues, reexaminations, confirmations, renewals, registrations, substitutions, extensions, or counterparts of any of the foregoing.

 

1.1.82 “SGI Technology” means the SGI Patents, the Drug Conjugation Materials, the SGI Know-How, SGI’s rights in the Joint Inventions and the SGI Inventions. For purposes of clarification, SGI Technology shall include, without limitation, the technology comprising [***] in each case as set forth on Schedule B, or as may otherwise be identified as an SGI In-License pursuant to Section 1.1.78.

 

1.1.83 “Sublicensees” means any person or entity that is granted a sublicense under the SGI Technology by Licensee or its Affiliates in accordance with the terms of this Agreement.

 

1.1.84 “Supply Fees” has the meaning set forth in Section 5.3.

 

1.1.85 “Term” has the meaning set forth in Article 13.

 

1.1.86 “Territory” means all countries in the world.

 

1.1.87 “Third Party” means any person or entity other than Licensee, SGI and their respective Affiliates.

 

1.1.88 “Third Party Claim” has the meaning set forth in Section 14.1.

 

1.1.89 “Valid Patent Claim” means a claim (a) of any issued and unexpired SGI Patent (as applicable) which has not been revoked or held unenforceable or invalid by a decision

 

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of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (b) of any patent application contained in the SGI Patents (as applicable) which shall not have been pending on or after the [***] of the date of issuance of a first patent office communication during examination of the first application related thereto (in the relevant country), and shall not have been earlier cancelled, withdrawn or abandoned, and, on a country-by-country basis, which is enforceable on the operative date of inquiry by virtue of applicable law in such country.

 

1.2 Certain Rules of Interpretation in this Agreement and the Schedules.

 

1.2.1 Unless otherwise specified, all references to monetary amounts are to United States of America currency (U.S. Dollars);

 

1.2.2 The preamble to this Agreement and the descriptive headings of Articles and Sections are inserted solely for convenience of reference and are not intended as complete or accurate descriptions of the content of this Agreement or of such Articles or Sections;

 

1.2.3 The use of words in the singular or plural, or with a particular gender, shall not limit the scope or exclude the application of any provision of this Agreement to such person or persons or circumstances as the context otherwise permits;

 

1.2.4 The words “include” and “including” have the inclusive meaning frequently identified with the phrases “without limitation” and “but not limited to”;

 

1.2.5 Unless otherwise specified, time periods within or following which any payment is to be made or act is to be done shall be calculated by excluding the day on which the period commences and including the day on which the period ends and by extending the period to the next business day following if the last day of the period is not a business day in the jurisdiction of the Party to make such payment or do such act; and

 

1.2.6 Whenever any payment is to be made or action to be taken under this Agreement is required to be made or taken on a day other than a business day, such payment shall be made or action taken on the next business day following such day to make such payment or do such act.

 

ARTICLE 2

 

RESEARCH PROGRAM

 

2.1 Objective and Conduct of the Research Program. Licensee intends to conduct a Research Program, with SGI’s support, to evaluate ADCs for commercial development under this Agreement. Licensee acknowledges that, in addition to the licenses to the SGI Patents granted hereunder, the SGI Know-How transferred to Licensee under this Agreement contains valuable information that is critical to Licensee’s development of ADCs hereunder. SGI’s research activities hereunder which are designated by Licensee to be used in support of regulatory filings will be performed in a good scientific manner, consistent with Good

 

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Laboratory Practices. SGI shall deliver to Licensee a report summarizing the results of such research activities within [***] of the end of any calendar quarter in which such research activities were conducted.

 

2.2 Term of the Research Program. The initial term of the Research Program shall be for a period of [***] after the Effective Date (the “Initial Research Program Term”), [***]; provided, however, that, upon notice and payment to SGI of [***], Licensee may renew (prior to the end of Initial Research Program Term) the Research Program for an [***] (the “Extended Research Program Term”, and together with the Initial Research Program Term, the “Research Program Term”).

 

2.3 SGI Preparation of ADCs. SGI will prepare, in accordance with the procedures set forth in the Research Plan, such research quantities of ADCs as may be reasonably requested by Licensee using Antibodies supplied by Licensee to SGI and Drug Conjugation Materials manufactured by SGI, or by or on behalf of Licensee, and shall deliver the resulting ADCs to Licensee in accordance with the reasonable timelines requested by Licensee (or as otherwise set forth in the Research Plan). SGI will also provide Licensee, in accordance with Article 4 and the Research Plan, with [***]. All such Drug Conjugation Materials provided by SGI to Licensee hereunder will be deemed Confidential Information of SGI pursuant to Article 8.

 

2.4 Payment. Licensee shall pay SGI the amounts set forth in Section 6.1.2 for any research efforts or other assistance provided by SGI pursuant to Section 2.3.

 

2.5 Disclaimer. EXCEPT AS MAY BE OTHERWISE PROVIDED IN ARTICLE 12, NEITHER PARTY MAKES ANY REPRESENTATION OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, REGARDING THE DRUG CONJUGATION MATERIALS, ANTIBODIES, ANTIGENS, ADCs OR LICENSED PRODUCTS, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR USE OR PURPOSE.

 

ARTICLE 3

 

EXCLUSIVE LICENSE

 

3.1 Exclusive License Grant. Upon payment of the ADC Access Fee set forth in Section 6.1.1, subject to the terms and conditions of this Agreement, SGI shall be automatically deemed to grant to Licensee a worldwide, exclusive (even as to SGI), royalty-bearing license under the SGI Technology, with the right to sublicense as permitted in Section 3.2, to discover, research, develop, make, have made, import, have imported and use, Licensed Products in the Field and Drug Conjugation Materials for the offer and sale of Licensed Products in the Field in the Territory (the “Exclusive License”). The Exclusive License shall continue for the Royalty Term, unless earlier terminated pursuant to Article 13, subject to payment of applicable milestones, royalties and the Exclusive License Renewal Fees set forth in Section 6.2.

 

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3.2 Rights to Sublicense.

 

3.2.1 Licensee shall have the right to grant sublicenses of the rights granted to Licensee pursuant to this Agreement to any Affiliate or any Third Party, subject to the restrictions contained in this Section 3.2 and the requirements of Section 3.4. Licensee shall not have the right to sublicense the SGI Technology outside the scope of the license granted in Section 3.1, including to develop further Drug Conjugation Materials on a stand alone basis or to create ADCs that include or are based upon any Antibodies that do not bind to the Designated Antigen or Replacement Antigen, if any.

 

3.2.2 Licensee agrees that it shall have responsibility to make payments to SGI for the achievement of any milestones set forth in Section 6.5 by its Sublicensee(s), and to pay royalties on Net Sales of any Licensed Products by any such Sublicensee(s) pursuant to Section 6.3 (subject to reduction in accordance with Section 6.4). In addition, Licensee shall be responsible for the compliance by its Sublicensee(s) with all terms of this Agreement applicable to Licensee (including all terms of this Agreement identified as applicable to such Sublicensee(s)). Licensee shall also require any such Sublicensee(s) to agree in writing to keep books and records and permit SGI to review the information concerning such books and records in accordance with Section 7.2.

 

3.2.3 Licensee shall notify SGI of each sublicense granted to Affiliates or Third Parties and shall provide SGI with the name and address of each Sublicensee and a description of the rights granted and the territory covered by each Sublicensee.

 

3.3 [***]. The Exclusive License shall extend to [***] as follows: SGI shall promptly notify Licensee of any [***] to which it obtains rights (with the right to grant sublicenses thereunder) during the Term by providing to Licensee a [***], including all [***] under which Licensee would be able to access such [***]. If Licensee is interested in practicing such [***], the Parties shall discuss in good faith modifications to this Agreement to reflect the terms governing Licensee’s access to any [***] pursuant to this Agreement, which shall include without limitation Licensee’s agreement to [***]; provided, however, that in no event shall the costs to Licensee associated with Licensee’s use of such [***] exceed the amount of any [***].

 

3.4 Compliance with the SGI In-Licenses.

 

3.4.1 Licensee, its Affiliates and Sublicensees shall comply with all obligations, covenants and conditions of the SGI In-Licenses listed in Schedule C (unless such obligations, conditions or covenants have been redacted by SGI in the version of SGI In-License delivered to Licensee), and any amendments thereto following written disclosure thereof to Licensee, to the extent (i) expressly applicable to sublicensees under such SGI In-Licenses, and (ii) technology included within such SGI In-License is being utilized in the Research Program or is incorporated into a Licensed Product. Licensee shall be entitled to all rights expressly provided sublicensees under the terms of the SGI In-Licenses, including but not limited to the rights provided under [***]. The Parties agree that BMS is a Third Party beneficiary to this Agreement to the extent SGI Technology includes BMS Technology. SGI shall use best efforts to include in each SGI In-License executed after the Effective Date a provision requiring the licensor of such rights to treat Licensee as a direct licensee under the terms of such SGI In-License in the event that such SGI In-License is terminated; provided that Licensee is then in compliance with the terms of such SGI In-License.

 

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3.4.2 SGI shall perform all obligations required to be performed by it under each SGI In-License in accordance with the terms and conditions of each such SGI In-License, and SGI will use its Commercially Reasonable Efforts to maintain each SGI In-License in full force and effect. SGI will not [***]. In the event that SGI receives notice of a material breach of any SGI In-License, SGI shall immediately inform Licensee of receipt of such notice.

 

3.4.3 SGI will not [***] any [***] to an [***] that [***].

 

3.5 Limited License to SGI. Subject to the provisions of this Agreement, Licensee hereby grants to SGI, during the Research Program Term, a non-exclusive, royalty-free, non-sublicenseable (except to the extent that the Research Plan provides for the use of a Third Party subcontractor by SGI) license under the Licensee Patents and Licensee Know-How in the Territory, for the sole purpose of enabling SGI to perform its obligations under Article 2 and the Research Plan.

 

3.6 [***]. At any time during the [***], Licensee shall have the right to [***] subject to and in accordance with the procedures described below and upon payment of [***]. Once the Designated Antigen [***], such Designated Antigen shall be considered the “Former Designated Antigen” and (a) [***] and (b) [***] provided, however, that the terms of this Section 3.6 shall not be deemed to grant to SGI any rights in the Licensee Patents, Licensee Know-How, Licensee Inventions, Licensee Invention Patents, or Joint Inventions, beyond the [***]. For the avoidance of doubt, the grant of this license is not [***]. Thereafter, the [***] shall be considered the Designated Antigen for purposes of this Agreement (except, for the limited purpose of the license provided in [***]) to the extent the Designated Antigen is considered the Former Designated Antigen and this Agreement shall be appropriately amended or modified to establish the [***] as the Designated Antigen. The [***], will have no effect on the intellectual property ownership rights of the parties relating to such Designated Antigen as such rights existed on the date of the replacement. In addition, upon designation of the [***].

 

3.7 Availability of [***]. To determine if an Antigen is available to become the [***], Licensee shall provide SGI with a [***], including to the extent available, the [***], which Licensee desires to [***] for purposes of this Agreement. Within [***], SGI shall notify Licensee in writing whether the Exclusive License is available with respect to such Antigen. If the Exclusive License is available for such Antigen, such Antigen shall [***]. The Parties hereby acknowledge and agree that an Antigen [***] (a) [***] or (b) [***].

 

ARTICLE 4

 

TECHNOLOGY DISCLOSURE

 

As soon as reasonably practicable following the Effective Date, and from time to time during the Term upon the reasonable request of Licensee, SGI shall deliver to Licensee, in such form as may reasonably be requested by Licensee from time to time, the SGI Know-How as is necessary or reasonably useful to enable Licensee to manufacture or have manufactured and use the Drug Conjugation Materials and the ADCs as provided in this Agreement, including, without limitation, available written or electronic information relating to the [***]. During the Term, upon Licensee’s reasonable request, SGI will provide Licensee, or such Affiliate of Licensee as

 

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Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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may be designated by Licensee, with assistance and training regarding the manufacture and/or use of Drug Conjugation Materials and ADCs; provided that if in-person assistance is required, such assistance shall take place upon at least [***] prior written notice to SGI at SGI’s facilities, unless otherwise mutually agreed upon. Licensee shall pay to SGI for such assistance an amount equal to the Personnel Fees in accordance with Section 6.1.2 for SGI employees providing such assistance.

 

ARTICLE 5

 

DEVELOPMENT AND COMMERCIALIZATION; MANUFACTURING

 

5.1 Diligence. Licensee shall use Commercially Reasonable Efforts to develop, commercialize and market Licensed Products. Notwithstanding the foregoing, Licensee shall have [***].

 

5.2 Funding and Progress Reports. Except as set forth herein, as between SGI and Licensee, Licensee shall be solely responsible for funding all costs of the development and commercialization of Licensed Products. Beginning on [***], and annually thereafter within [***] following the [***], Licensee shall provide SGI with a written report summarizing Licensee’s significant activities related to research and development of Licensed Products and status of clinical trials and applications for Regulatory Approval necessary for marketing Licensed Products. Such reports shall be deemed Licensee’s Confidential Information for the purposes of Article 8.

 

5.3 Manufacturing.