COLLABORATION AND LICENSE AGREEMENT

Exhibit 10.1

COLLABORATION AND LICENSE AGREEMENT

This Agreement is entered into as of January 7, 2007 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 :

AGENSYS, INC. , a California corporation, having its principal place of business at 1545 17th Street, Santa Monica, CA 90404

(hereinafter referred to as “ Agensys ”).

WITNESSETH

WHEREAS , SGI owns or controls intellectual property rights relating to technology useful for linking proprietary cytotoxins to other molecules such as antibodies capable of directing such cytotoxins to specific tissues and/or cells;

WHEREAS , Agensys is currently conducting research and development programs to discover antigens that may have activity in certain disease-related pathways, and to develop antibodies that bind to those antigens;

WHEREAS , the Parties have created and conducted initial characterization work regarding ADCs (as defined below) to [***] pursuant to the terms and subject to the conditions of the Initial Agreement (as defined below);

WHEREAS , Agensys wishes to obtain, and SGI wishes to grant, options to exclusive research licenses under SGI’s patent rights and know-how related to SGI’s proprietary cytotoxin and linker technology to up to [***] (as defined below) for use in conjunction with Agensys’ antibodies and options to exclusive commercial licenses to three (3) of such Designated Antigens; and

WHEREAS , the Parties desire to establish a collaboration to utilize SGI’s proprietary cytotoxin and linker technology for use in conjunction with certain of the Agensys’ antibodies and to develop and commercialize such antibodies for diagnostic, prophylactic and therapeutic uses.

CONFIDENTIAL

Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

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

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

“ AAA ” has the meaning set forth in Section 23.3.4.

“ [***] ” [***] .

“ ADC ” or “ Antibody-Drug Conjugate ” means an antibody that is linked to a cytotoxin or cytostatic agent (generally, “cytotoxins”) and that contains, uses or is made using SGI Technology.

“ ADC Product Candidate ” means each ADC comprising an Antibody targeted to a Designated Antigen to which Agensys has a Research License under Section 10.1.1 and which has not yet been designated as a Collaboration Product or Unilateral Product hereunder.

“ ADC Research Program ” means the research conducted pursuant to Article 3.

“ ADC Research Program Term ” means the term of the ADC Research Program set forth in Section 3.2.

“ Adverse Event ” means any unfavorable and unintended medical occurrence in a human patient or subject who is administered a Product, including any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Product, whether or not considered related to such Product.

“ 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 in this definition of Affiliate, 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.

“ Agensys ADC Know-How ” means all Program Inventions developed by Agensys using SGI Technology, and that are necessary or useful for identifying, developing, making, using or selling ADC Product Candidates, Agensys Products or Agensys Licensed Products that specifically bind to any Designated Antigen or Exclusive Antigen.

“ Agensys ADC Patents ” means all patent applications and patents that are Controlled by Agensys that claim Agensys ADC Know-How and/or ADC Product Candidates (to the extent SGI consents to the filing of such patent applications with respect to ADC Product Candidates in accordance with Section 10.1).

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“ Agensys Collaboration Know-How ” means any and all technical information, processes, formulae, data, inventions, methods, know-how and trade secrets, that relate to Collaboration Inventions made by or assigned to Agensys under Section 15.1.3(a).

“ Agensys Collaboration Patents ” means Patents that claim Collaboration Inventions made by or assigned to Agensys pursuant to Section 15.1.3(a).

“ Agensys Collaboration Technology ” means the Agensys Collaboration Know-How and the Agensys Collaboration Patents.

“ Agensys In-Licenses ” means the agreements between Agensys and the indicated Third Parties listed on Schedule E , as amended from time to time by Agensys.

“ Agensys Independent Know-How ” means all technical information, processes, formulae, data, inventions, methods, know-how and trade secrets Controlled by Agensys that are (a) used by Agensys in the ADC Research Program, or (b) used by Agensys in the Development or Commercialization Program, including technical information, processes, formulae, data, inventions, methods, know-how and trade secrets that relate to (x) the composition, method of using or method of making an Exclusive Antigen, Designated Antigen or Collaboration Antigen, or (y) the composition, method of using or method of making an Antibody that binds specifically to an Exclusive Antigen, Designated Antigen or Collaboration Antigen. For purposes of clarity, Program Inventions and Collaboration Inventions shall not be deemed to be Agensys Independent Know-How.

“ Agensys Independent Patents ” means all patent applications and patents that claim Agensys Independent Know-How and/or Agensys Materials.

“ Agensys Independent Technology ” means the Agensys Independent Know-How, Agensys ADC Know-How, Agensys Independent Patents and Agensys ADC Patents.

“ Agensys Licensed Product ” means any and all products containing an ADC comprised of an Antibody that binds specifically to an Exclusive Antigen, that was never a Collaboration Antigen hereunder, and that is attached to a cytotoxin or cytostatic agent included in the Drug Conjugation Materials: (a) the manufacture, use, sale, offer for sale or import of which would infringe a Valid Patent Claim of an SGI Patent if not for the licenses granted in this Agreement; or (b) which utilize, incorporate, are derived from or are made using SGI Know-How.

“ Agensys Materials ” means any tangible chemical, biological or physical materials (including but not limited to Antibodies but excluding Products and ADC Product Candidates) that are furnished by or on behalf of Agensys to SGI in connection with this Agreement.

“ Agensys Product ” has the meaning set forth in Section 5.9.1.

“ Agensys Sublicensee ” shall have the meaning set forth in Section 10.1.3.

 

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“ Agensys Technology ” means the Agensys Independent Technology and the Agensys Collaboration Technology.

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

 

“ [***] ” means that certain Antigen designated by Agensys as [***] and as conjugated by SGI under the Initial Agreement.

“ Antibody” or “Antibodies ” means any antibody, or fragment thereof, that binds specifically to an Antigen.

“ Antigen ” means a protein [***] , that are [***] by Agensys and for which the [***] and as set forth in [***] .

“ Applicable Law ” means any law or statute, any rule or regulation issued by a government authority (including courts and Regulatory Authorities) and any judicial, governmental, or administrative order, judgment, decree or ruling, in each case as applicable to the subject matter and the parties at issue.

“ Approved Subcontractor ” means a subcontractor engaged by a Party that has been approved by the JSC to perform specific obligations of the subcontracting Party.

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

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“ Breaching Party ” has the meaning set forth in Section 17.5.

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

“ Calendar Year ” means (a) with respect to the first Calendar Year, the period beginning on the Effective Date and ending on December 31, 2007 (the “ First Calendar Year ”), and (b) with respect to each subsequent Calendar Year, the twelve (12) month period beginning on the day following the end of the First Calendar Year and each succeeding twelve (12) month period thereafter, as applicable; except that the last Calendar Year shall end upon the expiration or termination of this Agreement.

“ Change in Control ” has the meaning set forth in Article 20.

“ Claims ” has the meaning set forth in Section 18.1.

“ Clinical Trials ” mean any one of Phase I Clinical Trials, Phase II Clinical Trials, or Phase III Clinical Trials.

“ Collaboration Accounting Policies ” means the accounting policies as agreed to by the Parties and implemented by the JSC to be used in determining Development Costs and Product Profit, which will be, in all material respects, consistent with GAAP and any applicable regulations in the United States.

“Collaboration Antigen” means the Initial Collaboration Antigen, the Second Collaboration Antigen and any other Antigen so designated pursuant to Sections 4.5.2 or 9.7.

“ Collaboration Invention ” means any process, formulae, method, chemical compound, biological or physical material (including ADCs and Collaboration Products), invention, technology, know-how, trade secret or data conceived or reduced to practice by either Party or jointly by both Parties in the conduct of the activities under the Development Program or Commercialization Program or pursuant to the Parties activities under the Collaboration Program. Collaboration Inventions shall not include Program Inventions.

“ Collaboration Product ” means the Initial Collaboration Product and the Second Collaboration Product or any other Collaboration Product so designated pursuant to Section 9.7 or Section 4.5.2.

“ Collaboration Product Inventions ” has the meaning set forth in Section 15.1.3(c).

“ Collaboration Product Trademark ” has the meaning set forth in Section 8.8.

 

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“ Collaboration Program ” means the collaborative research, development, manufacturing, Regulatory Approval and Commercialization activities undertaken pursuant to any Development and Commercialization Plan(s) under this Agreement.

“ Collaboration Sublicensee ” means any Third Party to whom a Party has, or the Parties have, granted the right to develop, sell, distribute or otherwise Commercialize a Collaboration Product, in each case pursuant to a Third Party Collaboration Agreement or as otherwise proposed by the JSC and approved by the written consent of the Parties.

“ Collaboration Technology ” means the Agensys Collaboration Technology, the SGI Collaboration Technology and the Joint Collaboration Technology.

“ Combination Product ” means (a) with respect to any Agensys Licensed Product, a product that contains, in addition to an ADC, one or more other ingredients that (i) are not included within Drug Conjugation Technology, and (ii) have independent biologic or chemical activity as a therapeutic agent when present alone, and (b) with respect to any other Unilateral Product or Collaboration Product, a product that contains or is sold together in combination with one or more active ingredients or products.

“ Commercialization ” or “ Commercialize ” means, with respect to a Collaboration Product, any and all activities to establish and maintain commercial sales for such Collaboration Product which are undertaken pursuant to a Commercialization Plan. These activities shall include: (a) the pre-launch marketing and launch activities for a Collaboration Product, (b) the marketing, promotion, distribution, offering for sale and selling of a Collaboration Product, (c) importing and exporting a Collaboration Product for commercial sale, (d) conducting Phase III-B Studies and Phase IV Studies with respect to such Collaboration Product and (e) manufacturing Collaboration Product for commercial sale (except for scale-up activities prior to First Commercial Sale, which shall be considered Development activities), including inventory build to support the launch and making manufacturing improvements after launch; in each case in accordance with the applicable Commercialization Plan. When used as a verb, “Commercialize” means to engage in Commercialization.

“ Commercialization Expenses ” shall mean (a) [***], (b) [***], (c) [***], (d) [***], (e) [***] (to the extent not deducted in [***]), (f) [***], (g) [***] (to the extent not included in [***]), (h) [***], and (i) other costs as mutually agreed by the Parties, all allocated to such Collaboration Product and calculated in accordance with the Collaboration Accounting Policies, consistently applied.

“ Commercialization Plan ” means the commercialization plan to be prepared and approved by the JSC from time to time and the related budget to be prepared and approved by the JSC for each Calendar Year during which it is anticipated that Commercialization activities will occur hereunder, to be updated as necessary during each Calendar Year, setting forth, among other things, a master plan for the Commercialization of Collaboration Products as well as each Party’s responsibilities in connection therewith.

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“ Commercialization Program ” means the collaborative commercialization activities undertaken by the Parties with respect to Collaboration Products as set forth in Article 8.

“ Commercially Reasonable Efforts ” means, (a) with respect to the efforts to be expended by a Party to accomplish a particular objective, the good-faith and diligent efforts that such Party would normally use to accomplish a similar objective under similar circumstances, and (b) with respect to the research, development or Commercialization of a Collaboration Product, an Agensys Product or a SGI Product, such efforts as are [***] , taking into account commercially relevant factors such as (as applicable) stage of development, product life, market potential and regulatory issues. Commercially Reasonable Efforts shall be determined on a [***] and [***] for a particular Collaboration Product, Agensys Product or SGI Product, and it is anticipated that the level of effort may be different for different markets, and may change over time, reflecting changes in the status of such Product and the market(s) involved. Without limiting the forgoing, Commercially Reasonable Efforts with respect to a Collaboration Product, an Agensys or a SGI Product requires that the relevant Party: (a)  [***] , and (b)  [***] .

“ Confidential Information ” has the meaning set forth in Section 14.1.

“ 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 as provided for herein without violating (a) the terms of any agreement with any Third Party or (b) any Applicable Law. In the case of an Antigen, such Antigen will be deemed to be Controlled by Agensys if Agensys Controls (in accordance with the foregoing sentence) a [***] , or [***] , and/or [***] , at the time such Antigen is [***] a Designated Antigen under Section 3.5 of this Agreement.

“ Co-Promote ” or “ Co-Promotion ” mean use of the respective sales forces of the Parties or their Affiliates to jointly promote a Collaboration Product, where “promote” means the process of direct contact between the respective sales forces and persons or entities who are able to purchase or influence the purchase of such Collaboration Product in accordance with and as further defined in Schedule I and the Co-Promotion Agreement.

“ Co-Promotion Agreement ” has the meaning set forth in Schedule I.

“ Cost of Goods ” shall mean:

(a) with respect to Drug Conjugation Materials and ADC Product Candidates supplied to Agensys pursuant to the ADC Research Program:

(i) [***] ; and

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(ii) [***].

(b) with respect to Unilateral Products or a component thereof supplied pursuant to Section 6.3.2 (the “ Goods ”), [***] . Direct costs will include [***] . Indirect costs identifiable to the production effort will include, [***] . Notwithstanding anything in this Agreement to the contrary, Cost of Goods will [***] .

(c) with respect to Collaboration Products, [***] of such Collaboration Product, [***] . Direct costs will include [***] . Indirect costs identifiable to the production effort will include, [***] . Notwithstanding anything to the contrary, [***] .

The above (a) – (c) shall only include costs incurred by either Party prior to the Effective Date to the extent such costs ( [***] ) [***] .

“ Designated Antigen ” means each of the [***] Antigens designated as such and set forth in Schedule C in accordance with Section 3.5 of this Agreement, but excluding any Collaboration Antigen.

“ Designated Antigen Research Plan ” means the research activities, schedule and budget for each Designated Antigen under the ADC Research Program to be agreed upon by the Parties and appended to this Agreement as Schedule D after the Effective Date and revised as needed from to time by the Parties. An outline Designated Antigen Research Plan is attached hereto as Schedule A .

“ Development ” or “ Develop ” means, with respect to Collaboration Products, any and all preclinical and clinical drug development activities and manufacturing activities undertaken pursuant to the Initial Collaboration Product Plan or an Manufacturing, Preclinical and Clinical Development Plan in order develop a Collaboration Product up to and including obtaining Regulatory Approval for such Collaboration Product for an indication and to perform manufacturing scale up to enable commercial scale manufacturing prior to launch (except that inventory build shall be considered a Commercialization activity). These activities shall include preclinical research, stability testing, toxicology testing, formulation activities, reformulation activities, process development, manufacturing scale-up activities, development stage manufacturing, quality assurance/quality control development, clinical studies (including Phase III Studies, other than Phase III-B Studies) and other activities to obtain the applicable Regulatory Approvals; in each case in accordance with the applicable Initial Collaboration Product Plan or Manufacturing, Preclinical and Clinical Development Plan, as applicable. When used as a verb, “Develop” means to engage in Development.

“ Development Costs ” means, with respect to the Collaboration Program, the actual direct and indirect costs incurred by a Party from the Effective Date identifiable to the Collaboration Program in support of: (a) the research, development, and clinical studies required to support development and registration for a Collaboration Product; (b) the manufacture and validation of pilot and scale up lots; and (c) the application for Regulatory Approval (if any is required), including software for system operation and/or data analysis, calculated in accordance with the Collaboration

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Accounting Policies, consistently applied. The actual costs will include the direct and indirect costs of conducting research, development, and clinical activities with respect to the Collaboration Program. Direct costs will include [***] . Indirect costs identifiable to the research and development effort will include, [***] in support of the research and development process, including [***] .

“ Development Program ” means the collaborative development activities undertaken by the Parties with respect to Collaboration Products as described in Article 4 and Article 5.

“ Direct Marketing Expenses ” shall mean the following costs incurred by the Parties or its Affiliates in the marketing and promotion of the Collaboration Product: (i)  [***] , (ii)  [***] , (iii)  [***] and (iv)  [***] or other study (including pharmacovigilence programs and outcome studies) that the JSC considers necessary or economically justifiable. For the avoidance of doubt, Direct Marketing Expenses shall [***] .

“ DMF ” means (i) a Drug Master File filed with the FDA (and any foreign counterpart of a U.S. Drug Master File) and (ii) all supplements and amendments that may be filed with respect to thereto.

“ Drug Conjugation Materials ” means the compounds monomethyl Auristatin E and monomethyl Auristatin F and certain variants, derivatives, analogues and salts thereof, as well as compounds that are useful in attaching such compounds to Antibodies, in each case to the extent included in or covered by the SGI Technology. Drug Conjugation Materials shall also include Improvements to Drug Conjugation Materials and any additional cytotoxic or cytostatic compounds that are included in New Technologies and that the Parties agree to include under this Agreement pursuant to Section 10.4.2. For the avoidance of doubt, Drug Conjugation Materials do not include ADC Product Candidates.

“ Drug Conjugation Technology ” means chemical compositions and methods, including methods of manufacture, that are Controlled by SGI and that are useful to attach cytotoxins or cytostatic compounds to Antibodies, including the composition and methods of making and using cytotoxic or cytostatic compounds, as well as compositions and methods useful for attaching the foregoing cytotoxic or cytostatic compounds to Antibodies.

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

“ EMEA ” means the European Medicines Agency and any successor agency(ies) thereto.

“ Events of Force Majeure ” has the meaning set forth in Article 19.

“ Exclusive Antigen ” means collectively, the First Exclusive Antigen, the Second Exclusive Antigen and the Third Exclusive Antigen, but specifically excluding any Collaboration Antigen.

“ Exclusive License ” has the meaning set forth in Section 10.1.2.

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“ FDA ” means the United States Food and Drug Administration, and any successor agency(ies) thereto.

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

“ Field ” means the treatment and diagnosis of conditions and diseases [***]; provided that, with respect to the [***], the [***].

“ Financial Statement ” means a financial statement in a form as may be reasonably agreed upon by the Parties from time to time in accordance with the terms of this Agreement and consistent with the Collaboration Accounting Policies.

“ First Commercial Sale ” means, in each country of the Territory, the first commercial sale of a Product by a Party, its Affiliates or Sublicensees to a Third Party (other than a sublicensee) following, if required by law, Regulatory Approval and, when Regulatory Approval is not required by law, the first commercial sale in that country, in each case for use or consumption of such Product in such country by the general public. Sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.

“ First Exclusive Antigen ” means the first Designated Antigen for which Agensys obtains an Exclusive License pursuant to Section 10.1.2 of this Agreement, as set forth in Schedule C in accordance with Section 3.5 of this Agreement.

“ Full Time Equivalent ” or “ FTE ” means the equivalent of full-time work of a person, carried out by one or more employees of the Parties, who devotes a portion of his or her full time, consisting of [***] , in support of any of the activities contemplated hereunder during any period of [***] .

“ GAAP ” means generally accepted accounting principles in the United States or equivalent International Financial Reporting Standards outside the United States.

“ Good Clinical Practices ” or “ GCP ” means the then-current 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, as applicable.

“ Good Laboratory Practices ” or “ cGLP ” means the then-current standards for laboratory activities for pharmaceuticals, as set forth in the FD&C Act and applicable regulations and guidances promulgated thereunder, including without limitation the Code of Federal Regulations, as amended from time to time.

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“ Good Manufacturing Practices ” or “ cGMP ” means the then-current good manufacturing practices as set forth in the FD&C Act and applicable regulations and guidances promulgated thereunder, including without limitation the Code of Federal Regulations, as amended from time to time, for the manufacturing and testing of pharmaceutical materials.

“ Improvements ” means all patentable or non-patentable inventions, discoveries, or know-how developed by either Party or jointly by the Parties during the Term that utilize, incorporate, are directly derived from, or relate to, the SGI Independent Technology; provided that Improvements shall not include [***] .

“ Information ” has the meaning set forth in Section 14.1.

“ 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 Product in humans.

“ Indemnitee ” has the meaning set forth in Section 18.1.1. The term “ Indemnitee ” may refer to either or both the Agensys Indemnitees and the SGI Indemnitees, as the context may indicate.

“ Indemnitor ” has the meaning set forth in Section 18.3.

“ Independent Patents ” means the Agensys Independent Patents and the SGI Independent Patents.

“ Independent Technology ” means the Agensys Independent Technology and the SGI Independent Technology.

“Indirect Marketing Expenses” means all indirect marketing, promotion and operational expenses incurred by the Parties or its Affiliates for Collaboration Product, which shall be [***] (the “ IME Percentage ”). Such [***] shall be adjusted by the Parties in the event that [***] or more from the IME Percentage currently being used by the Parties. Examples of Indirect Marketing Expenses included in the calculation of the IME Percentage include, but are not limited to, [***] .

“ Initial Agreement ” means the Material Transfer Agreement dated as of February 9, 2004 by and between the Parties, as amended.

“ Initial Collaboration Antigen ” means that certain Antigen designated by Agensys as [***] , the sequence of which is attached as Schedule F .

“ Initial Collaboration Product ” means any and all products containing an ADC comprised of an Antibody that binds specifically to the Initial Collaboration Antigen.

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“ Initial Collaboration Product Plan ” means the research activities, schedule and budget for the Initial Collaboration Product under the Development Program agreed upon by the Parties and appended to this Agreement as Schedule G and updated and revised as needed from time to time by the Parties.

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

“ Internal Expenses ” means all expenses associated with an FTE. The rate per FTE shall include, but shall not be limited to, direct labor (including fringe benefits), [***] . The Parties agree that for a [***] following the execution of this Agreement, the rate per FTE shall be [***] for each Party. Commencing upon the [***] of the Effective Date and upon [***] thereafter, the rate per FTE shall be increased by the percentage increase, if any, in the [***] , All Items, as published by the [***] , for the [***] prior to such anniversary date for which data is available. The initial FTE rate and any applicable annual increases shall be referred to as the “FTE Fees.”

“ IP and Trademark Costs ” means all costs relating to Joint Collaboration Invention Patents and Collaboration Product Trademarks.

“ Joint Collaboration Invention Know-How ” means any and all technical information, processes, formulae, data, inventions, methods, know-how and trade secrets relating to the jointly owned Collaboration Inventions.

“ Joint Collaboration Invention Patents ” means all Patents that claim jointly owned Collaboration Inventions.

“ Joint Collaboration Technology ” means the Joint Collaboration Invention Know-How and the Joint Collaboration Invention Patents.

“ Joint Know-How ” means the Joint Program Invention Know-How and the Joint Collaboration Invention Know-How.

“ Joint Patents ” means the Joint Program Invention Patents and the Joint Collaboration Invention Patents.

“ Joint Program Invention Know-How ” means any and all technical information, processes, formulae, data, inventions, methods, know-how and trade secrets relating to the jointly owned Program Inventions.

“ Joint Program Invention Patents ” has the meaning set forth in Section 15.10.1.

“ Joint Steering Committee ” has the meaning set forth in Section 4.3.1.

“ Lead Regulatory Party ” has the meaning set forth in Section 7.1.

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“ Liabilities ” has the meaning set forth in Section 18.1.1.

“ Major Market Countries ” means the United States, Great Britain, France, Germany, Spain, Italy and Japan.

“ Manufacturing, Preclinical and Clinical Development Plan ” or “ Development Plan ” means manufacturing, preclinical and clinical development plans to be prepared and approved by the JSC from time to time and the related budget to be prepared and approved by the JSC for each Calendar Year during which it is anticipated that Development activities will occur hereunder, to be updated as necessary during each Calendar Year, setting forth, among other things, a master plan for the Development of Collaboration Products as well as each Party’s responsibilities in connection therewith. For the avoidance of doubt, the Initial Collaboration Product Plan shall be considered a Development Plan hereunder.

“ Net Sales ” means the invoiced gross sales by a Party, and their respective Affiliates and Sublicensees (a “ Selling Party ”) for commercial sales of Products to a Third Party (other than a Sublicensee) [***] :

 

(a)

[***] ;

 

(b)

[***] ;

 

(c)

[***] ; and

 

(d)

[***] .

All of the [***] from the gross invoiced sales prices of Products shall be determined in accordance with GAAP. In the event a Selling Party makes any adjustments to such [***] after the associated Net Sales have been reported pursuant to this Agreement, the adjustments shall be reported, reconciled and settled in the next report with appropriate adjustment of payments (including royalties) due.

Sales of Products by and between a Party and its Affiliate, or a Party or a Party’s Affiliate and its respective Sublicensees, are excluded (and not to be calculated as constituting a deductible) from this definition of Net Sales, provided that the final sales of Products by such Affiliates or Sublicensees to Third Parties are included in Net Sales. Transfers of Products for donation, laboratory research and development purposes, testing and/or clinical studies shall be excluded from this definition of Net Sales.

In the event a Product is sold as part of a Combination Product, the Net Sales from the Combination Product, for the purposes of determining payments hereunder, shall be determined by [***] in finished form in the country in which the Combination Product is sold, in each case during the applicable period or, [***] . In the event that such average sale price cannot be determined for the Product, on the one hand, and all other product(s) included in the Combination Product, on the other, Net Sales for the purposes of determining any payments (including royalties) shall be mutually agreed upon by the Parties based on the relative value contributed by each component, such agreement to be negotiated in good faith.

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“ [***] ” means any [***] that either: (a)  [***] or (b)  [***] (x)  [***] existing as of the Effective Date, or (y)  [***] . [***] shall include without limitation [***] other than those included in the Drug Conjugation Materials as of the Effective Date that SGI Controls during the Term.

“ Notice of Dispute ” has the meaning set forth in Section 23.3.1.

“ Opt-In Decision ” has the meaning set forth in Section 4.1.2.

“ Opt-In Period ” has the meaning set forth in Section 4.1.2.

“ Opt-In Right ” has the meaning set forth in Section 4.1.2.

“ Option ” has the meaning set forth in Section 10.1.2.

“ Option Period ” means the period commencing on the Effective Date and continuing until expiration or termination of the Research License Period for each Designated Antigen as set forth in Section 3.2.

“ Patents ” means (a) patent applications filed in the Territory, (b) all patents including supplemental protection certificates that have issued or in the future issue from any of the foregoing, including, without limitation, utility models, design patents and certificates of invention and (c) all divisionals, continuations, continuations-in-part, reissues, re-examination certificates, renewals, extensions or additions to any such patents and patent applications (as applicable).

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

“ Payments to Third Parties ” has the meaning set forth in Section 10.5.2.

“ Phase I Clinical Trial ” means the first administration of a candidate drug in a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).

“ Phase II Clinical Trial ” means a controlled dose human 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 in any country that would satisfy the requirements of 21 CFR 312.21(b).

“ Phase III Clinical Trial ” means a controlled, and usually multi-center, human 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 that would satisfy the requirements of 21 CFR 312.21(c).

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“ Phase III-B Study ” means a clinical study which provides for product support ( i.e. , a clinical trial which is not required for receipt of initial Regulatory Approval but which may be useful in providing additional drug profile data or in seeking a label expansion) commenced before receipt of Regulatory Approval for the indication for which such trial is being conducted.

“ Phase IV Study ” means a post-marketing study to delineate additional information about a pharmaceutical product’s risks, benefits, and optimal use, commenced after receipt of Regulatory Approval in the indication for which such Regulatory Approval was obtained, including a trial that would satisfy the requirements of 21 CFR 312.85.

“ Plans and Budgets ” means the Manufacturing, Preclinical and Clinical Development Plan and the Commercialization Plan.

“ Product ” means a Unilateral Product or a Collaboration Product, as applicable.

“ Product Profit ” means the profits or losses resulting from the Commercialization of Collaboration Products and shall be equal to Net Sales of Collaboration Products less Commercialization Expenses; provided, however that [***] . Product Profit shall also include [***] .

“ Program Invention ” means any process, formula, method, chemical compound, biological or physical material (including ADC Product Candidates, and Unilateral Products), invention, technology, know-how, trade secret or data conceived or reduced to practice by either Party or jointly by both Parties in the conduct of the activities under the ADC Research Program, or in the development or commercialization of Unilateral Products outside of the Collaboration Program and solely in accordance with the licenses and rights set forth under this Agreement and/or under the Initial Agreement only; provided, that Program Inventions shall not include Improvement Inventions to Seattle Genetics Material/Technology (as defined in the Initial Agreement) made pursuant to the Initial Agreement that are not related to a Designated Antigen or an Exclusive Antigen, each of which shall remain governed by the terms of the Initial Agreement. Program Inventions shall not include Collaboration Inventions.

“ Promotional Materials ” has the meaning set forth in Section 8.6.

“ Publication ” has the meaning set forth in Section 14.6.

“ 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 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.

“ Regulatory Authority ” means the FDA, the EMEA , or any comparable national or territorial regulatory entity within the Territory having substantially the same functions.

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“ Research License ” has the meaning set forth in Section 10.1.1.

“ Research License Period ” means, other than as provided in Section 4.5.2, for each Designated Antigen, the earlier of (a)  [***] , or (b)  [***] .

“ Royalty Reports ” has the meaning set forth in Section 11.9.

“ Royalty Term ” means, on a Product-by-Product and country-by-country basis, the period commencing on the First Commercial Sale of a Product and ending upon [***] : (a)  [***] ; or (b) (x) [***] , or (y)  [***] (i)  [***] (A)  [***] , and (B)  [***] .

“Sales Training Expenses” has the meaning sent forth in Schedule I.

“ Second Collaboration Antigen ” means that certain Designated Antigen with respect to which SGI exercises its Opt-In Right pursuant to Section 4.1.2.

“ Second Collaboration Product ” means any and all products containing an ADC comprised of an Antibody that binds specifically to the Second Collaboration Antigen.

“ Second Exclusive Antigen ” means a Designated Antigen, other than the First Exclusive Antigen or the Third Exclusive Antigen, for which Agensys exercises an Option for an Exclusive License pursuant to Section 10.1.2 of this Agreement, as set forth in Schedule C in accordance with Section 3.5 of this Agreement.

“ Serious Adverse Event ” means any Adverse Event occurring at any dose in response to the administration of Product that: (a) results in death or threatens life; (b) results in persistent or significant disability/incapacity; (c) results in or prolongs hospitalization; (d) results in a congenital anomaly or birth defect; or (e) is otherwise medically significant.

“ SGI Collaboration Know-How ” means any and all technical information, processes, formulae, data, inventions, methods, know-how and trade secrets, that relate to Collaboration Inventions made by or assigned to SGI under Section 15.1.3(b).

“ SGI Collaboration Patents ” means Patents that claim the Collaboration Inventions made by or assigned to SGI under Section 15.1.3(b).

“ SGI Collaboration Technology ” means the SGI Collaboration Patents and the SGI Collaboration Know-How.

“ SGI In-Licenses ” means the following agreements between SGI and the indicated Third Parties: (a) the License Agreement between [***] and SGI dated [***] , as amended (the “ [***] ”); (b) the License Agreement between [***] and SGI dated [***] , as amended (the “ [***] ”); and (c) any other license agreement between SGI and a Third Party covering [***] under which Agensys is granted a sublicense under this Agreement as provided in Section 10.4.2.

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“ SGI Independent Know-How ” means any and all technical information, processes, formulae, data, inventions, methods, know-how and trade secrets, that relate to Drug Conjugation Materials or are useful to practice the Drug Conjugation Technology and that have been, or hereafter are during the Term, Controlled by SGI. SGI Independent Know-How shall include Improvements and Program Inventions Controlled by SGI but shall exclude New Technologies unless included pursuant to Section 10.4.2. For purposes of clarity, Collaboration Inventions shall not be deemed to be SGI Independent Know-How.

“ SGI Independent Patents ” means:

(a) any patents and patent applications listed in Schedule B to this Agreement, which shall be amended from time to time to reflect any other patents and patent applications;

(b) any patents and patent applications covering Improvements that are not Agensys ADC Patents and, solely to the extent the Parties so agree pursuant to Section 10.4.2, New Technologies, in each case that are Controlled by SGI;

(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), or divisional of any of the foregoing patent applications or any patent applications from which the foregoing patents issued, in each case to the extent Controlled by SGI; and

(d) any reissues, reexaminations, confirmations, renewals, registrations, substitutions, extensions, or counterparts of any of the foregoing, in each case to the extent Controlled by SGI.

“ SGI Independent Technology ” means SGI Independent Patents and SGI Independent Know-How.

“ SGI Materials ” means any tangible chemical, biological or physical materials (excluding Products and ADC Product Candidates) that are furnished by or on behalf of SGI to Agensys in connection with this Agreement.

“ SGI Patents ” means the SGI Independent Patents and the SGI Collaboration Patents.

“ SGI Product ” has the meaning set forth in Section 5.9.1.

“ SGI Technology ” means the SGI Independent Technology and the SGI Collaboration Technology.

“ Sublicensee ” means an Agensys Sublicensee, SGI Sublicensee or a Collaboration Sublicensee, as applicable.

“ Supply Fees ” has the meaning set forth in Section 11.1.2.

 

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“ Term ” has the meaning set forth in Article 17.

“ Territory ” means all countries in the world.

“ Third Exclusive Antigen ” means a Designated Antigen, other than the First Exclusive Antigen or the Second Exclusive Antigen, for which Agensys exercises an Option for an Exclusive License pursuant to Section 10.1.2 of this Agreement, as set forth in Schedule C in accordance with Section 3.5 of this Agreement.

“ Third Party ” means any person or entity other than SGI and its Affiliates, and Agensys and its Affiliates.

“ Third Party Collaboration Agreement ” means any agreement pursuant to which a Third Party is granted rights to commercialize (including to develop and commercialize) one or more Collaboration Products, including development agreements, collaboration agreements, marketing and marketing/distribution agreements, promotion agreements or other similar agreements, in each case in accordance with the provisions of Section 5.9.2.

“ Third Party License Agreement ” has the meaning set forth in Section 10.5.1.

“ Unilateral Product Maintenance Fee ” has the meaning set forth in Section 11.3.

“ Unilateral Product ” means any Agensys Product, Agensys Licensed Product or SGI Product.

“ Valid Patent Claim ” means (a) an unexpired claim of an issued patent which has not been found to be unpatentable, invalid or unenforceable by an unreversed and unappealable decision of a court or other authority in the subject country; or (b) a claim of an application for a patent that has been pending for less than [***] .

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

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

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;

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;

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

The word “day” shall mean a calendar day and the words “business day” shall mean a day other than a Saturday, a Sunday, or any day that is a holiday for the United States Postal Service;

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

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

THE COLLABORATION RELATIONSHIP

Section 2.1 Overview. SGI and Agensys will collaborate to identify ADCs for development and commercialization on the terms set forth herein. Initially, the Parties will jointly develop and commercialize Initial Collaboration Products. In addition, SGI will grant Agensys Research Licenses to [***] , three (3) of which will be convertible by Agensys into Exclusive Licenses and Exclusive Antigens, respectively, pursuant to Section 10.1.2. SGI will generate ADC Product Candidates targeted to each such Antigen, pursuant to the ADC Research Program described in Article 3. SGI will have the right to opt-in to development and commercialization of ADC Product Candidates as set forth in Section 4.1.2. If SGI elects to exercise its right to opt in to development of an ADC targeting any such Antigen, the Parties will jointly develop and commercialize ADCs targeting such Antigen pursuant to the provisions of this Agreement.

Article 3

RESEARCH PROGRAM FOR DESIGNATED ANTIGENS

Section 3.1 Objective and Conduct of the Research Program for Designated Antigens. Agensys intends to conduct research, with SGI’s support, on [***] , to evaluate and select ADCs targeting three (3) Exclusive Antigens for development and commercialization by Agensys as Agensys Licensed Products (the “ ADC Research Program ”), subject to SGI’s Opt-In Right. The Parties shall use Commercially Reasonable Efforts to develop a specific Research Plan for each Designated Antigen within [***] from the date such Antigen is accepted by SGI pursuant to Section 3.5, each of which shall be included in this Agreement under Schedule D . All research work performed by Agensys and SGI hereunder shall be performed in a good scientific manner and in compliance with all Applicable Laws.

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Section 3.2 Term of the ADC Research Program. The term of the ADC Research Program shall commence on the Effective Date and end on the earlier of (a)  [***] , or (b) termination of this Agreement in accordance with Article 17 (the “ ADC Research Program Term ”). The Parties agree to use all Commercially Reasonable Efforts to timely and diligently achieve all aspects of the ADC Research Program.

Section 3.3 Delivery of Drug Conjugation Materials. In support of the ADC Research Program, during the ADC Research Program Term, SGI will deliver Drug Conjugation Materials to Agensys in accordance with the mutually agreed upon times, quantities and specifications included in the Designated Antigen Research Plans to enable Agensys to attach such materials to Agensys’ Antibodies to create ADCs. [***] . All such Drug Conjugation Materials and other information provided by SGI to Agensys hereunder will be deemed Confidential Information of SGI pursuant to Article 14.

Section 3.4 SGI Preparation of ADC Product Candidates. In order to enable Agensys to select three (3) Exclusive Antigens during the ADC Research Program Term, SGI will prepare in accordance with the Designated Antigen Research Plans mutually agreed upon research quantities of ADC Product Candidates using the Drug Conjugation Materials and Agensys Materials [***] .

Section 3.5 Availability of Antigens. Agensys shall provide SGI with a confidential written description of each Antigen, including to the extent available, the GenBank accession number and the cDNA and amino acid sequence for each Antigen, which Agensys desires to have accepted as a Designated Antigen for purposes of this Agreement (the “ Proposed Designated Antigen ”). In addition, simultaneous with Agensys’ submission of such information to SGI, Agensys shall notify SGI (a)  [***] , and (b)  [***] . Agensys shall have the ability to nominate Antigens as one of the [***] for a period of [***] from the Effective Date, at which time Agensys shall no longer be able to nominate Antigens as Designated Antigens, provided that, Agensys may only nominate a maximum of [***] Antigens as Designated Antigens hereunder. Within [***] following SGI’s receipt of such written notice with respect to a particular Antigen, (i) SGI shall notify Agensys in writing whether the Exclusive License described in Section 10.1.2 of this Agreement is available with respect to such Antigen, and (ii)  [***] (a “ Notice of Unavailability ”). Schedule C to this Agreement will be amended from time to time to list the Designated Antigens and the First, Second and Third Exclusive Antigens, if applicable. The Parties hereby acknowledge and agree that SGI will accept an Antigen nominated by Agensys as a Designated Antigen unless (a)  [***] , (b)  [***] , or (c)  [***] that have been designated by Agensys as Designated Antigens as of the date of receipt of the written notice from Agensys. The matters described in Sections 3.5(a), 3.5(b) and 3.5(c) shall be the sole reasons for such Antigen to be deemed not available to Agensys under this Section 3.5. Notwithstanding the foregoing, if SGI provides Agensys a Notice of Unavailability, [***] .

Section 3.6 Additional Activities under ADC Research Program. Upon mutual agreement of the Parties, the ADC Research Program may also include the development by SGI of a technology transfer program for the conjugation of cytotoxins to Antibodies, including associated purification and analytics.

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Section 3.7 Payment . Agensys shall pay SGI the amounts set forth in Section 11.1 for any research efforts or other assistance provided by SGI pursuant to the ADC Research Program.

Section 3.8 Supply of Agensys Materials . From time to time during the ADC Research Program Term, Agensys may supply SGI with Agensys Materials for use in the ADC Research Program. Except as provided elsewhere in this Agreement with respect to the development and commercialization of Collaboration Products or SGI Products, SGI hereby agrees that (a) it shall not use Agensys Materials for any purpose other than conducting the Designated Antigen Research Plans; (b) it shall use the Agensys Materials only in compliance with all Applicable Laws; (c) it shall not transfer any Agensys Materials to any Third Party without the prior written consent of Agensys; (d) Agensys shall retain full ownership of all such Agensys Materials; and (e) upon the expiration or termination of this Agreement, SGI shall at the instruction of Agensys either destroy or return any unused Agensys Materials.

Section 3.9 Supply of SGI Materials . From time to time during the ADC Research Program Term, SGI may supply Agensys with SGI Materials for use in the ADC Research Program. Except as provided elsewhere in this Agreement with respect to the development and commercialization of Collaboration Products, Agensys Products or Agensys Licensed Products, Agensys hereby agrees that (a) it shall not use SGI Materials for any purpose other than conducting the Designated Antigen Research Plans; (b) it shall use the SGI Materials only in compliance with all Applicable Laws; (c) it shall not transfer any SGI Materials to any Third Party without the prior written consent of SGI; (d) SGI shall retain full ownership of all such SGI Materials; and (e) upon the expiration or termination of this Agreement, Agensys shall at the instruction of SGI either destroy or return any unused SGI Materials.

Section 3.10 Disclosure of Drug Conjugation Technology . During the ADC Research Program Term, SGI shall (a) disclose to Agensys such SGI Independent Technology as is reasonably useful to enable Agensys to use the Drug Conjugation Materials and Drug Conjugation Technology as provided in the Designated Antigen Research Plan or to practice the Research License and (b) upon Agensys’ reasonable written request and with adequate notice to SGI, make available to Agensys at SGI’s facilities, SGI’s personnel to provide a reasonable amount of technical assistance and/or training to Agensys’ personnel. All such technical assistance and/or training shall be agreed in advance in writing and Agensys shall pay to SGI for such technical assistance and/or training an amount equal to SGI’s Internal Expenses in accordance with Section 11.1 for SGI employees providing such assistance.

Section 3.11 Encumbrance of Designated Antigens . During the ADC Research Program Term, Agensys shall not enter into any Third Party collaboration or license agreement with any Third Party relating to [***] Antigen that has become a Designated Antigen, and/or Antibodies targeted to [***] Antigen, in any oncology indication, other than for research, development or commercialization of any such Antibody solely [***] which have become Designated Antigens pursuant to Section 3.5.

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Article 4

COLLABORATION PRODUCTS

Section 4.1 Designation of Collaboration Products .

4.1.1 Initial Collaboration Product Development . Upon the Effective Date, the Parties will collaborate to identify, develop and commercialize ADCs to the Initial Collaboration Antigen in accordance with the Initial Collaboration Product Plan. The Parties will collaborate to Develop and Commercialize such Initial Collaboration Product in accordance with the Development Program and the Commercialization Program.

4.1.2 Opt-In Regarding Second Collaboration Product .

(a) As long as SGI retains an Opt-In Right hereunder, not later than [***] targeting a Designated Antigen, Agensys will provide SGI with (i)  [***] , (ii)  [***] , (iii)  [***] , (iv)  [***] , and (v)  [***] . In addition, simultaneous with Agensys’ submission of such information to SGI, Agensys shall notify SGI of (a)  [***] , and (b)  [***] .

(b) SGI shall have until [***] after [***] (the “ Opt-In Period ”) to determine whether SGI will elect (the “ Opt-In Right ”) to co-fund the development and commercialization of such ADC Product Candidate and associated Designated Antigen (the “ Opt-In Decision ”).

(c) If SGI exercises its Opt-In Right, SGI shall provide written notice to Agensys of its Opt-In Decision, accompanied by an [***] prior to the expiration of the Opt-In Period. Effective as of the date of such notice, (A) the Designated Antigen to which the ADC Product Candidate is targeted would become the Second Collaboration Antigen and any ADC targeting such Collaboration Antigen would become the Second Collaboration Product, (B) Agensys would grant SGI a co-exclusive license with respect to such Collaboration Antigen and the corresponding antibodies on the same terms as the Initial Collaboration Antigen and Initial Collaboration Product as set forth in Section 10.2.2, (C) the Parties would share equally all further research, development, clinical and commercialization costs for such Second Collaboration Product, subject to oversight of the JSC; and (D)  [***] .

(d) If SGI does not notify Agensys of its decision to exercise its Opt-In Right with respect to a Designated Antigen during the Opt-In Period, then contingent upon Agensys’ obtaining an Exclusive License pursuant to Section 10.1.2, (A) such Antigen would become an Exclusive Antigen and ADCs targeting such Exclusive Antigen would become Agensys Licensed Products, (B) Agensys would retain the Exclusive License to develop such Agensys Licensed Products on its own and would be obligated to pay SGI the fees, milestones and royalties set forth in Article 11 below and (3) SGI would maintain its Opt-In Right with respect to additional Antigens submitted pursuant to the process set forth in this Section 4.1.2.

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(e) If the [***] .

(f) SGI agrees that the information listed in Section 4.1.2(a) shall be Confidential Information of Agensys and to hold in strict confidence all information disclosed to it in accordance with Article 14, shall be used by SGI solely for the purpose of making the Opt-In Decision, and shall return all such materials to Agensys (and shall not keep any copies of such materials) not later than [***] after providing notice of its decision not to exercise its Opt-In Right.

4.1.3 Exclusion for [***]. Notwithstanding the provisions of Section 4.1.2, in the event that Agensys decides to [***] . Upon such notice by Agensys, Agensys shall exercise its right to [***] with respect to [***] pursuant to Section 10.1.2 and, contingent upon such exercise by Agensys, [***] shall become an [***] hereunder and [***] shall become [***] hereunder. For the avoidance of doubt, Agensys may not [***] , unless it (a) provides SGI the notice provided for in this Section 4.1.3, and (b) exercises [***] with respect to [***] hereunder.

Section 4.2 Payments for Collaboration Products . The Parties will make the following payments for each Collaboration Product:

4.2.1 Initial Payments with Respect to the Second Collaboration Product . Within [***] of SGI’s exercise of its Opt-In Right under Section 4.1.2 only, SGI shall pay to Agensys a [***] ; provided that the total amount of such [***] . For the avoidance of doubt, all payments owed or paid by [***] up to and including the [***] for such Collaboration Product shall be [***] and in no event shall [***] .

4.2.2 Reimbursement of Development Costs . The Parties shall reimburse each other for Development Costs incurred after the Effective Date with respect to all Collaboration Products as set forth in Section 12.2 below.

Section 4.3 Management of Collaboration . The activities of the Parties with respect to research, development and commercialization of Collaboration Products shall be overseen by a Joint Steering Committee as set forth in this Section 4.3.

4.3.1 Establishment of Joint Steering Committee . Upon the Effective Date, the Parties will establish a joint steering committee (“ Joint Steering Committee ” or “ JSC ”) to provide oversight for the research, development and commercialization undertaken pursuant to this Agreement for Collaboration Products during the Term. The Joint Steering Committee will be composed of [***] representatives from each Party. The representatives of each Party to the JSC as of the Effective Date are listed on Schedule H . Either Party may change its representatives to the JSC upon prior written notice to the other Party in accordance with this Agreement. It is anticipated that the membership of the JSC may change over time in accordance with the development stage of the Collaboration Product(s). Each Party shall insure that the representatives named by such Party

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for membership on the JSC have the requisite seniority level and expertise to oversee the activities of the collaboration during the Term. Any member of the Joint Steering Committee may designate a substitute of at least equal seniority and a similar level of expertise to attend and perform the functions of that member at any meeting of the Joint Steering Committee.

4.3.2 Responsibilities . The JSC shall be responsible for the following functions:

(a) supplementing, updating and amending, to the extent required, the Initial Collaboration Product Plan within [***] after the Effective Date;

(b) reviewing, coordinating and monitoring the activities and progress of the Parties in implementing the Initial Collaboration Product Plan, and ensuring each Party’s compliance therewith;

(c) establishing, reviewing, coordinating and monitoring the activities and progress of the Parties in implementing a Development Plan for each Collaboration Product, and ensuring each Party’s compliance therewith;

(d) establishing the Plans and Budgets for each Collaboration Product, and reviewing, coordinating and monitoring each Party’s compliance therewith;

(e) establishing the goals and strategy for the manufacture and development of Collaboration Products, including regulatory strategies;

(f) approving protocols for, and prioritization of, Clinical Trials and indications for Collaboration Products;

(g) establishing the Commercialization Plans for each Collaboration Product and reviewing, coordinating and monitoring each Party’s compliance therewith;

(h) establishing the goals and strategy for the commercialization of Collaboration Products;

(i) overseeing the Parties activities with respect to Collaboration Inventions as set forth in this Agreement;

(j) establishing and overseeing subcommittees responsible for development and/or commercialization of Collaboration Products hereunder; and

(k) performing such other functions as are specifically designated to the JSC in this Agreement or otherwise as agreed upon by the Parties.

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4.3.3 Meetings . The Joint Steering Committee shall meet not less than [***] on such dates and at such times as agreed to by SGI and Agensys, with all scheduled meetings to alternate between Seattle, Washington and Santa Monica, California, or at such other locations as determined by the Joint Steering Committee. Upon the determination of the Joint Steering Committee, any such meeting may be conducted by conference telephone or videoconference; provided, however, that not less than [***] shall be in person. Telephonic and videoconference meetings shall be [***] of each Party are in attendance or participating in the meeting. Each Party may permit such non-voting observers visitors to attend meetings of the Joint Steering Committee as the Joint Steering Committee determines. Each Party shall be responsible for its own costs in connection with the meetings of the Joint Steering Committee.

4.3.4 Decisions; Actions Without Meeting . Any approval, determination or other action of the Joint Steering Committee shall require [***] of the Joint Steering Committee, with each Party’s representatives [***] . Action that may be taken at a meeting of the Joint Steering Committee also may be taken without a meeting if a written consent setting forth the action so taken is agreed in writing [***] .

4.3.5 Authority . It shall be conclusively presumed that each voting member of the Joint Steering Committee has the authority and approval of such member’s respective senior management in casting the vote described in Section 4.3.4 on matters as described in this Article 4. Notwithstanding the creation of the Joint Steering Committee, each Party to this Agreement shall retain the rights, powers and discretion granted to it hereunder, and the Joint Steering Committee shall not be delegated or vested with any such rights, powers or discretion unless such delegation or vesting is expressly provided for herein or the Parties expressly so agree in writing. The Joint Steering Committee shall not have power to amend or modify this Agreement, to change the time any payment is due from one Party to another, or to impose additional economic burdens on either Party beyond those specifically contemplated by this Agreement without the prior written consent of the Party on which such burden is imposed.

4.3.6 Disputes; Final Decision Making Authority . Any disputes or disagreements arising in the Joint Steering Committee that are unable to be resolved within [***] after the matter is first referred to the Joint Steering Committee shall be referred to executive officers of each Party with subject matter expertise for the current dispute for resolution. If such executive officers are unable to resolve a matter within [***] after the matter is first referred to them, the matter shall be referred to the [***] of each Party for resolution. If the [***] are unable to resolve a matter within [***] after the matter is first referred to them, then the final decision on such matters shall be made through expedited “ Short Form Arbitration ” in accordance with Section 23.4.

Section 4.4 Collaboration Accounting Policies . Promptly, but in no event later than [***] , following the Effective Date the Parties shall develop the Collaboration Accounting Policies. Following adoption by the Parties, the Collaboration Accounting Policies can be changed or deviations approved only with the written consent of both Parties.

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Section 4.5 Certain Terms Relating to [***].

4.5.1 Requests for [***] . No later than [***] , Agensys shall [***] requesting a [***] pursuant to [***] with respect to [***] . No later than [***] , Agensys shall [***] of the requirement to [***] set forth in [***] . If necessary, [***] in order to insure that the provisions of [***] will not be [***] . SGI shall be provided with [***] . In addition, if it is likely that the requirements of [***] , or any [***] , as the case may be, then no later than [***] prior to [***] set forth in [***] with respect to any [***] shall request either additional [***] or, in the case where [***] have already been granted, [***] such that, if [***] , the provisions of [***] would not be [***] , as the case may be. Agensys shall provide SGI with [***] .

4.5.2 [***] Collaboration Antigens. In the event that (a) Agensys [***] , and [***] of receipt of such [***] , or (b)  [***] , and such [***] is not resolved within [***] , or (c) the commercial license with respect to any Collaboration Antigen, [***] , or (d) the [***] , or (e) with respect to the [***] of the time periods set forth in [***] , (each of (a) through (e), a “ Triggering Event ”) then with respect to each Collaboration Antigen or SGI Product Antigen that is the subject of such Triggering Event (a “ [***] ”), (x) SGI may in its sole discretion, pursuant to written notice to Agensys within [***] of the Triggering Event, [*** ] in accordance with the provisions of this Agreement [***], or (y) if the Triggering Event is (e) above, SGI may, [***] , pursuant to the terms of this Agreement, provided that, [***] ; provided further, that if SGI elects to exercise its rights under this Section 4.5.2(y) and any Triggering Event occurs pursuant to subsections (a) through (d), [***] , provided that, such designation may only occur within [***] of [***] , and provided further, that the Research License Period for such [***] of (a)  [***] , and (b)  [***] .

4.5.3 Credit for [***] . Agensys shall [***] that relate to a [***] , Agensys shall [***] under this Agreement with respect to any other Collaboration Product, provided that, if SGI does [***] after the Triggering Event, Agensys shall [***] .

4.5.4 [***]; Notification. In addition, in the event that any [***] as a result of a [***] , or the [***] or other [***] , (each an “ [***] ” ) with respect to any Collaboration Antigen, any SGI Product Antigen (provided the [***] occurred prior to the Collaboration Antigen becoming an SGI Product Antigen), and/or products targeting such Antigens, [***] , provided that, in the case of a payment that is accelerated, but would otherwise become due and [***] under this Agreement, SGI shall [***] , provided, SGI and Agensys are obligated to share such costs on the Payment Date. [***] . [***] . [***] . Agensys shall promptly, and in no event later than [***] , advise SGI through the JSC of any and all [***] , including without limitation, [***] .

Article 5

DEVELOPMENT PROGRAM FOR COLLABORATION PRODUCTS

Section 5.1 Preparation of Manufacturing , Preclinical and Clinical Development Plan. Promptly, but in no event later than [***] after designation of a Collaboration Product under Section 4.1, the JSC shall prepare and agree upon the initial Manufacturing,

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Preclinical and Clinical Development Plan for the then current Calendar Year. Thereafter, the Joint Steering Committee shall prepare a Manufacturing, Preclinical and Clinical Development Plan for each Calendar Year during which it is anticipated that Development activities will occur at least [***] prior to the commencement of such Calendar Year. In the event that the JSC does not approve such Manufacturing, Preclinical and Clinical Development Plan, then the Manufacturing, Preclinical and Clinical Development Plan in effect for the prior Calendar Year shall be automatically extended for up to [***] while the JSC works to agree upon an updated Manufacturing, Preclinical and Clinical Development Plan for such Calendar Year which is satisfactory to the Parties.

5.1.1 Review and Amendment of Manufacturing, Preclinical and Clinical Development Plan . The JSC shall review the then current Manufacturing, Preclinical and Clinical Development Plan from time to time, but at least every [***] , and shall prepare and approve updates and amendments as appropriate.

5.1.2 Content of Manufacturing, Preclinical and Clinical Development Plan . Each Manufacturing, Preclinical and Clinical Development Plan shall contain the specific Development objectives to be achieved during the applicable Calendar Year, the specific activities to be performed by each of the Parties in connection with the Development of the Collaboration Products, the timelines for performing such activities and a detailed budget for performing such activities. Each Manufacturing, Preclinical and Clinical Development Plan shall be consistent with the other terms and conditions of this Agreement. For purposes of clarity, the allocation of regulatory activities relating to the Development of Collaboration Products shall be governed by Article 7 unless otherwise agreed upon in writing by the JSC.

Section 5.2 Development Activities . Each Party shall use Commercially Reasonable Efforts to perform its obligations with respect to the Development of Collaboration Products in accordance with the Manufacturing, Preclinical and Clinical Development Plan and all such activities shall be conducted in accordance with all Applicable Laws, including as applicable, GCPs, GLPs and GMPs. As part of such efforts, each Party shall commit the personnel and facilities necessary to carry out its obligations under the Manufacturing, Preclinical and Clinical Development Plan. Neither SGI nor Agensys shall be required to undertake any activity relating to the Development of a Collaboration Product that it believes, in good faith, may violate any Applicable Law. The Parties acknowledge and agree that neither Party guarantees the success of the Development tasks undertaken hereunder.

Section 5.3 Reports . Each Party shall submit periodic written reports to the JSC as may be required by the Manufacturing, Preclinical and Clinical Development Plan, but in all cases no less than [***] per [***] , detailing its activities with respect to the Development of the Collaboration Product, including all Development Costs incurred by such Party during such [***] and all FTEs utilized in such [***] in connection with such Development activities. The JSC shall use such periodic reports to monitor the Parties’ respective contributions to the Development of the Collaboration Product.

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Section 5.4 Development Costs . Unless otherwise provided in this Agreement, the Parties will [***] all Development Costs (which have been set forth in the applicable approved Manufacturing, Preclinical and Clinical Development Plan or in the Initial Collaboration Product Plan, as applicable) with respect to the Development activities hereunder in accordance with the provisions of Article 12. The JSC shall review on a quarterly basis the Development Costs against the budget for such expenses in the applicable Calendar Year. If in the course of such quarterly review the JSC determines that the actual amounts incurred for Development Costs are likely to be higher than budgeted, the JSC shall review the reasons for such potential overrun and determine whether such overrun is appropriate. The JSC may, if appropriate, amend the Manufacturing, Preclinical and Clinical Development Plan to permit such overrun or to reduce such activities such that no overrun is expected. [***] .

Section 5.5 Audit .

5.5.1 Development Cost Records . For so long as any Development activities are conducted hereunder and for a period of [***] thereafter, each Party shall keep and maintain, and shall require its Affiliates to keep and maintain, accurate and complete records of activities performed by each such Party (including Development Costs incurred and FTEs utilized) in connection with its Development activities hereunder. Not more than [***] , each Party shall have the right to engage an independent certified public accounting firm of nationally recognized standing and reasonably acceptable to the other Party, which shall have the right to examine in confidence the relevant books, records or other relevant reports, of such other Party and its respective Affiliates as may be reasonably necessary to determine and/or verify the accuracy of the reports submitted to the JSC in connection with the performance of a Party’s Development obligations hereunder.

5.5.2 Procedure . Such examination shall be conducted, and each Party shall make its records available, during normal business hours, after at least [***] prior written notice shall have been provided by the other Party, as applicable, and shall take place at the facility(ies) where such records are maintained. Each such examination shall be limited to pertinent books, records and reports for any year ending not more than [***] prior to the date of request; provided, that, no Party shall be permitted to audit the same period of time more than [***] . Before permitting such independent accounting firm to have access to such books and records, the non-requesting Party may require such independent accounting firm and its personnel involved in such audit to sign a confidentiality agreement (in form and substance reasonably acceptable to such Party) as to any confidential information which is to be provided to such accounting firm or to which such accounting firm will have access while conducting the audit under this paragraph. The accounting firm shall provide both SGI and Agensys with a written report stating whether the reports submitted by SGI or Agensys, as applicable, are correct or incorrect and the specific details concerning any discrepancies. Such accounting firm may not reveal to the other Party any information learned in the course of such audit other than the amount of any such discrepancies. Each Party agrees that all such information shall be Confidential Information of the other Party and further agrees to hold in strict confidence all information disclosed to it in accordance with Article 14.

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5.5.3 Cost of Audit . The Party initiating such Audit shall bear the full cost of such audit unless such audit discloses that the actual expenses incurred in the conduct of a Party’s obligations under a Development Plan, as applicable, are lower than that reported by such Party by [***] , in which case the other Party shall [***] .

Section 5.6 Development Program Records . All work conducted by either Party in connection with the Development Program under this Article 5 and, with respect to the Initial Collaboration Product, Article 4 as well, shall be completely and accurately recorded in sufficient detail and in good scientific manner and in any event completely separated from any work done under the ADC Research Program. On reasonable notice, and at reasonable intervals, each Party shall have the right to inspect and copy all such records of the other Party reflecting Development done hereunder to the extent reasonably required to carry out its obligations and to exercise its rights hereunder. All such records shall be considered Collaboration Inventions.

Section 5.7 Liability . In connection with conduct of the Development activities hereunder, each Party shall be responsible for, and hereby assumes, any and all risks of personal injury or property damage attributable to the negligent acts or omissions of that Party or its Affiliates, and their respective directors, officers, employees and agents.

Section 5.8 Use of Approved Subcontractors . Either Party may perform some or all of its obligations under the Development Program through one or more Approved Subcontractors; provided, that (a) none of the rights of the other Party hereunder are diminished or are otherwise adversely affected as a result of such subcontracting and (b) the Approved Subcontractor undertakes in writing all obligations of confidentiality and non-use regarding both Party’s Confidential Information which are substantially the same as those undertaken by the Parties hereunder. In the event that a Party performs one or more of its obligations under the Development Program through any such Approved Subcontractor, then such Party shall at all times be responsible for the performance by such Approved Subcontractor of such Party’s obligations hereunder.

Section 5.9 Termination of Co-Funding; Out-License of Collaboration Products .

5.9.1 Voluntary Termination by Either Party . Either Party shall have the right to terminate its co-funding obligation (the “ Non-Continuing Party ”) for the Collaboration Program for the Initial Collaboration Products and/or the Collaboration Program for the Second Collaboration Products, effective [***] (the “ Opt-Out Date ”) after providing irrevocable, written notice to the other Party (the “ Continuing Party ”) of such election to terminate (the “ Opt-Out Notice ”). For the avoidance of doubt, if a Party exercises its right to terminate its co-funding obligation with respect to a Collaboration Program, such termination shall cover [***] . Within [***] after receipt of such notice, the Continuing Party shall notify the Non-Continuing Party in writing whether or not it elects to assume sole responsibility for, and all costs and obligations of, the continued Development and Commercialization of such Collaboration Product. If the Continuing Party so elects, upon the effective date of such termination: (a) such Collaboration Product shall

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thereafter be deemed an “ Agensys Product ” if Agensys is the Continuing Party or an “ SGI Product ” if SGI is the Continuing Party; (b) the Non-Continuing Party shall [***] , and (c) promptly after the Non-Continuing Party’s election, the Parties shall work together to transfer and assign all regulatory documents, contracts, materials and Information that related solely to such Unilateral Product to the Continuing Party or its designees to the extent necessary for the Continuing Party to assume such sole responsibility. The Non-Continuing Party shall [***] for the Development of such Unilateral Product and shall [***] with respect to such Product through the effective date of such termination, except that the Non-Continuing Party shall remain responsible for its share of non-cancellable Development Costs that have already been approved by the JSC beyond the effective date of termination. If the Continuing Party utilizes the goods or services purchased with such non-cancellable Development Costs, the Continuing Party shall [***] .

5.9.2 Third Party Collaboration Agreements . In the event the JSC determines to engage a Third Party to collaborate with the Parties with respect to the Development or Commercialization of a Collaboration Product, or in the event that both Parties wish to opt-out of Development of a Collaboration Product, the JSC shall determine the strategy, timing and other matters relating to finding such Third Party and entering into the appropriate Third Party Collaboration Agreement. At such time as the JSC determines to recruit a Third Party, the JSC shall determine whether to designate a Party to take the lead in negotiating and entering into the applicable Third Party Collaboration Agreement or to allocate such responsibilities between the Parties. If one Party is designated to take the lead in negotiating the Third Party Collaboration Agreement, such Party shall provide the other Party with term sheets and agreement drafts during the negotiations (including any proposed execution version) for review and comment and the designated Party shall not enter into any such Third Party Collaboration Agreement (or any amendment, waiver or other modification thereof) without the written approval of the other Party. [***] . If neither Party wishes to continue the Development and Commercialization of a Collaboration Product, and the JSC decides not to license such Collaboration Product to a Third Party or if no good faith negotiation has commenced with a Third Party within a [***] after both Parties have exercised their right to opt-out, then (a)  [***] and (b)  [***] .

Article 6

MANUFACTURE AND SUPPLY OF COLLABORATION PRODUCTS

Section 6.1 Clinical Trial Supply . The Parties agree to develop a [***] to each Collaboration Product as soon as practicable after the selection of the Antibody to be incorporated in the Collaboration Product. As part of the Manufacturing, Preclinical and Clinical Development Plan for each Collaboration Product, the JSC shall direct the transition from any use of a [***] to manufacture the Collaboration Product to the use of a [***] to manufacture the Collaboration Product. The Parties hereby agree that the Lead Regulatory Party, or a Third Party designated by such Lead Regulatory Party and approved by the JSC, shall be responsible for all process science and manufacturing issues related to developing a [***] and any manufacture of a Collaboration Product using a [***] required for Clinical Trials. The costs of manufacturing Collaboration Product using either a [***] or [***] for Clinical Trials shall be deemed Development Costs. All materials for Clinical Trials shall be produced in accordance with all relevant manufacturing standards and all applicable laws and cGMPs.

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Section 6.2 Commercial Supply . As part of each Commercialization Plan for each Collaboration Product, the JSC shall propose which Party, or Third Party(ies), shall be responsible for manufacturing the Collaboration Product and the components thereof for commercial sale in the Territory.

Section 6.3 Supply Agreements .

6.3.1 SGI or Agensys as Supplier . In the case where either SGI or Agensys agrees to be responsible for manufacturing a Collaboration Product (or any component thereof) under the Collaboration Program for research, development, clinical studies and/or commercial sale, the Parties shall enter into a clinical supply agreement or commercial supply agreement, as applicable, on customary and reasonable terms and conditions. Each such supply agreement shall provide, among other things, for a transfer price for such Collaboration Product (or any component thereof) at such Party’s [***] , forecasting and ordering requirements and inventory maintenance requirements, and shall be reasonably acceptable to the JSC.

6.3.2 Supply Cooperation . To the extent a Party manufactured a Collaboration Product (or any component thereof) prior to an Opt-Out Date, such Party shall continue such manufacturing for a period of [***] following delivery of the Opt-Out Notice and shall cooperate with the Continuing Party in providing reasonable quantities of such component(s), SGI Product or Agensys Product (as the case may be) to effectuate the smooth transition of such manufacture to the Continuing Party or to a Third Party selected by the Continuing Party. At the request of the Continuing Party the Non-Continuing Party shall continue to manufacture reasonable quantities of such component(s), SGI Product or Agensys Product (as the case may be) [***] . The provisions of this Section 6.3.2 are contingent on the Continuing Party paying the Non-Continuing Party for such manufacture at the rate of [***] of Non-Continuing Party’s [***] .

6.3.3 Third Party as Supplier . In the case where the JSC elects to designate a Third Party to be responsible for manufacturing a Collaboration Product (or any component thereof) for clinical studies and/or commercial sale, the Parties shall enter into a clinical supply agreement or commercial supply agreement, as applicable, with such Third Party on customary and reasonable terms and conditions. Each such supply agreement shall provide, among other things, for forecasting and ordering requirements and inventory maintenance requirements, and shall be reasonably acceptable to the JSC. The JSC shall determine the strategy, timing and other matters relating to finding such Third Party and entering into the appropriate clinical supply agreement or commercial supply agreement, as applicable. At such time as the JSC determines to recruit a Third Party, the JSC shall determine whether to designate a Party to take the lead in negotiating and entering into the applicable clinical supply agreement or commercial supply agreement, as applicable, or to allocate such responsibilities between the Parties. If one Party is designated to take the lead in negotiating such agreement, such Party shall provide the other Party

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with term sheets and agreement drafts during the negotiations (including any proposed execution version) for review and comment and the designated Party shall not enter into any such clinical supply agreement or commercial supply agreement, as applicable, (or any amendment, waiver or other modification thereof) without the written approval of the other Party.

Article 7

REGULATORY MATTERS FOR COLLABORATION PRODUCTS

Section 7.1 General . The JSC shall be responsible for overseeing, monitoring and coordinating regulatory actions, communications and filings with, and submissions to, all applicable Regulatory Authorities with respect to a given Collaboration Product and shall delegate operational activities to the Party that is named “Sponsor” of the regulatory filing as per 21 CFR 312.3 (Part B) and/or 21 CFR 312.50 with respect to such Collaboration Product (the “ Lead Regulatory Party ”). The Parties agree to develop a [***] to each Collaboration Product as soon a practicable after the selection of the Antibody to be incorporated in the Collaboration Product. As Lead Regulatory Party for the Initial Collaboration Product, [***] “Sponsor” on the IND for the Initial Collaboration Product comprising the [***] (the “ [***] ”). Subject to JSC approval, [***] “Sponsor” on the IND for the Initial Collaboration Product comprising the [***] to the Initial Collaboration Antigen (