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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 10-Q

 


(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2007

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from              to             

Commission file number 0-32405

 


SEATTLE GENETICS, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware   91-1874389
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)

21823 30 th Drive SE

Bothell, Washington 98021

(Address of principal executive offices, including zip code)

(Registrant’s telephone number, including area code): (425) 527-4000

 


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    YES   x     NO   ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

Large Accelerated Filer   ¨     Accelerated Filer   x     Non-accelerated filer   ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    YES   ¨     NO   x

As of May 4, 2007, there were 57,006,346 shares of the registrant’s common stock outstanding.

 



Table of Contents

Seattle Genetics, Inc.

For the quarter ended March 31, 2007

INDEX

 

          Page

PART I.

   FINANCIAL INFORMATION (Unaudited)   

Item 1.

   Financial Statements    3
   Condensed Balance Sheets    3
   Condensed Statements of Operations    4
   Condensed Statements of Cash Flows    5
   Notes to Condensed Financial Statements    6

Item 2.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations    9

Item 3.

   Quantitative and Qualitative Disclosures About Market Risk    13

Item 4.

   Controls and Procedures    14

PART II.

   OTHER INFORMATION   

Item 1A.

   Risk Factors    14

Item 6.

   Exhibits    14

SIGNATURES

   15

EXHIBIT INDEX

   16


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PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

Seattle Genetics, Inc.

Condensed Balance Sheets

(Unaudited)

(In thousands)

 

     March 31,
2007
    December 31,
2006
 

Assets

    

Current assets

    

Cash and cash equivalents

   $ 17,508     $ 9,137  

Short-term investments

     91,059       73,450  

Interest receivable

     799       539  

Accounts receivable

     3,733       898  

Prepaid expenses and other

     1,212       1,405  
                

Total current assets

     114,311       85,429  

Property and equipment, net

     8,087       7,794  

Other non-current assets

     492       486  

Long-term investments

     31,692       3,986  
                

Total assets

   $ 154,582     $ 97,695  
                

Liabilities and Stockholders’ Equity

    

Current liabilities

    

Accounts payable and accrued liabilities

   $ 4,792     $ 5,389  

Current portion of deferred revenue

     14,171       3,160  
                

Total current liabilities

     18,963       8,549  
                

Long-term liabilities

    

Deferred rent

     456       513  

Deferred revenue, less current portion

     53,583       399  
                

Total long-term liabilities

     54,039       912  
                

Commitments and contingencies

    

Stockholders’ equity

    

Preferred stock, $0.001 par value, 5,000,000 shares authorized:

    

Series A convertible preferred stock, 928,500 shares issued and outstanding at March 31, 2007 and 1,500,000 shares issued and outstanding at December 31, 2006

     1       2  

Common stock, $0.001 par value, 100,000,000 shares authorized; 56,942,107 shares issued and outstanding at March 31, 2007 and 51,029,542 shares issued and outstanding at December 31, 2006

     57       51  

Additional paid-in capital

     270,052       267,807  

Accumulated other comprehensive loss

     (113 )     (37 )

Accumulated deficit

     (188,417 )     (179,589 )
                

Total stockholders’ equity

     81,580       88,234  
                

Total liabilities and stockholders’ equity

   $ 154,582     $ 97,695  
                

The accompanying notes are an integral part of these financial statements.

 

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Seattle Genetics, Inc.

Condensed Statements of Operations

(Unaudited)

(In thousands, except per share amounts)

 

     Three months ended
March 31,
 
   2007     2006  

Revenues from collaboration and license agreements

   $ 4,336     $ 2,141  
                

Operating expenses

    

Research and development

     11,805       9,251  

General and administrative

     2,820       2,307  
                

Total operating expenses

     14,625       11,558  
                

Loss from operations

     (10,289 )     (9,417 )

Investment income, net

     1,461       714  
                

Net loss

   $ (8,828 )   $ (8,703 )
                

Net loss per share – basic and diluted

   $ (0.16 )   $ (0.21 )
                

Shares used in computation of net loss per share – basic and diluted

     54,539       42,418  
                

The accompanying notes are an integral part of these financial statements.

 

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Seattle Genetics, Inc.

Condensed Statements of Cash Flows

(Unaudited)

(In thousands)

 

     Three months ended
March 31,
 
     2007     2006  

Operating activities

    

Net loss

   $ (8,828 )   $ (8,703 )

Adjustments to reconcile net loss to net cash used in operating activities

    

Share-based compensation expense

     1,374       954  

Depreciation and amortization

     593       588  

Amortization on investments

     (382 )     216  

Deferred rent

     (4 )     6  

Changes in operating assets and liabilities

    

Interest receivable

     (260 )     (10 )

Accounts receivable

     (2,835 )     326  

Prepaid expenses and other

     193       (384 )

Accounts payable and accrued liabilities

     (650 )     —    

Deferred revenue

     64,195       (1,623 )
                

Net cash provided by (used in) operating activities

     53,396       (8,630 )
                

Investing activities

    

Purchases of securities available for sale

     (83,316 )     (6,823 )

Proceeds from maturities of securities available for sale

     38,301       15,891  

Purchases of property and equipment

     (886 )     (174 )
                

Net cash (used in) provided by investing activities

     (45,901 )     8,894  
                

Financing activities

    

Proceeds from exercise of stock options and employee stock purchase plan

     876       289  
                

Net cash provided by financing activities

     876       289  
                

Net increase in cash and cash equivalents

     8,371       553  

Cash and cash equivalents, at beginning of period

     9,137       11,156  
                

Cash and cash equivalents, at end of period

   $ 17,508     $ 11,709  
                

The accompanying notes are an integral part of these financial statements.

 

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Seattle Genetics, Inc.

Notes to Condensed Financial Statements

(Unaudited)

1. Basis of presentation

The accompanying unaudited condensed interim financial statements of Seattle Genetics, Inc. (“Seattle Genetics” or the “Company”) have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission, or SEC, and generally accepted accounting principles for unaudited condensed interim financial information. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. These financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. Management has determined that the Company operates in one segment; the development of pharmaceutical products on its own behalf, or in collaboration with others. Unless indicated otherwise, all amounts presented in financial tables are presented in thousands, except for per share amounts.

These unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2006 as filed with the Securities and Exchange Commission.

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The results of the Company’s operations for the three month period ended March 31, 2007 are not necessarily indicative of the results to be expected for a full year.

2. Recent Accounting Pronouncements

In February 2007, the Financial Accounting Standards Board issued SFAS No. 159 “Fair Value Option for Financial Assets and Financial Liabilities” (“SFAS 159”) which permits entities to measure many financial instruments and certain other items at fair value. Companies are required to adopt the new standard for fiscal years beginning after November 15, 2007. The Company is evaluating the impact of this standard and currently does not expect to have any financial instruments for which it intends to elect the fair value method of accounting.

3. Collaboration, license and contract manufacturing agreements

In January 2007, the Company entered into a collaboration agreement with Genentech for the development and commercialization of SGN-40, which became effective February 5, 2007. Under the terms of the agreement, the Company received an upfront payment of $60 million, and is entitled to receive potential milestone payments exceeding $800 million and royalties on annual net sales of SGN-40. The Company will receive a minimum of $20 million in milestone payments during the first two years of the agreement. Genentech will fund future research, development, manufacturing and commercialization costs for SGN-40. The Company has agreed to continue certain phase I and phase II clinical trials and development activities for SGN-40 over a six year development period, the costs of which will be reimbursed by Genentech. The Company also has an option to co-promote SGN-40 in the United States. Payments received from Genentech, consisting of the upfront payment, milestone payments and payments for services provided by the Company to Genentech under this agreement, are being recognized as revenue over the six year development period of the agreement using a time-based method. The Company initially licensed its anti-CD40 program to Genentech in June 1999. In March 2003, the Company entered into license agreements with Genentech providing for the return to the Company of the rights relating to the anti-CD40 program as well as a license under Genentech’s Cabilly patent covering the recombinant expression of antibodies. As a result of the January 2007 collaboration agreement, any milestone or royalty obligations of the Company pursuant to these previous license agreements were waived.

In January 2007, the Company entered into an agreement with Agensys to jointly research, develop and commercialize antibody-drug conjugates, or ADCs, for cancer. The collaboration encompasses combinations of the Company’s ADC technology with antibodies developed by Agensys to proprietary cancer targets. Under the terms of the multi-year agreement, Agensys and the Company will jointly screen and select ADC product candidates to an initial target that has already been selected, co-fund all development and commercialization costs and share equally in any profits. Agensys will also conduct further preclinical studies aimed at identifying ADC product candidates to up to three additional targets. The Company has the right to exercise a co-development option for one of these additional ADC product candidates upon filing of an investigational new drug (IND) application, and Agensys will have the right to develop and commercialize the other two ADC product candidates on its own, subject to paying the Company fees, milestones and royalties. Either party may opt out of co-development and profit-sharing in return for receiving milestones and royalties from the continuing party. Costs associated with activities performed under this collaboration, net of reimbursement paid to and received from Agensys, are reflected in research and development expense in the accompanying statement of operations and were not significant for the period ended March 31, 2007.

 

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In March 2007, Genentech paid the Company $4.5 million to exercise exclusive licenses to specific targets and extend the research term under the parties’ existing ADC collaboration agreement. Under the terms of the agreement, Genentech has rights to use the Company’s ADC technology with antibodies against targets selected by Genentech. Genentech is responsible for research, product development, manufacturing and commercialization activities under the collaboration. The Company is entitled to receive fees, progress-dependent milestone payments and royalties on net sales of any resulting ADC products. The $4.5 million payment has been deferred and will be recognized over the three year extended research term of the collaboration using a time-based approach.

4. Income Taxes

The Company adopted the provisions of Financial Standards Accounting Board Interpretation No. 48 Accounting for Uncertainty in Income Taxes (“FIN 48”) an interpretation of FASB Statement No. 109 (“SFAS 109”) on January 1, 2007. Because of the Company’s historical net operating losses, it has not been subject to income taxes since its inception and the Company had no material unrecognized tax benefits as of December 31, 2006. As a result, the adoption of FIN 48 had no impact on the Company’s financial statements.

The Company’s deferred tax assets primarily consist of net operating loss carryforwards, capitalized research and development expense and research and development tax credit carryforwards. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. Accordingly, the deferred tax assets have been fully offset by a valuation allowance. If not utilized, the federal net operating loss carryforwards will expire from 2018 to 2026 and research and development tax credit carryforwards will expire from 2019 to 2026. Utilization of these net operating loss and research and development credit carryforwards may be subject to certain limitations under Section 382 of the Internal Revenue Code of 1986, as amended, in the event of a change in the Company’s ownership, as defined therein. The Company has performed an ownership analysis as of December 2006 which identified certain changes under Section 382. Based upon this analysis, substantially all of the Company’s net operating loss carryforwards as of December 31, 2006 have, or will, become available to offset taxable income. However, it is possible that there will be a future change in ownership that will limit the utilization of our net operating loss or research and development credit carryforwards. No amounts are being presented as an uncertain tax position under FIN 48. Interest and penalties related to the settlement of uncertain tax positions, if any, will be reflected in income tax expense. Tax years 1998 to 2006 remain subject to future examination for federal income taxes.

5. Net loss per share

Basic and diluted net loss per share has been computed using the weighted-average number of shares of common stock outstanding during the period. The Company has excluded all convertible preferred stock, warrants and options to purchase common stock from the calculation of diluted net loss per share as such securities are antidilutive for all periods presented. The increase in the number of shares used in the computation of net loss per share for the period ended March 31, 2007 is primarily the result of the conversion of 571,500 shares of Series A Convertible Preferred Stock into 5,715,000 shares of common stock during the period.

The following table presents the weighted-average shares that have been excluded from the number of shares used to calculate basic and diluted net loss per share (in thousands):

 

     Three months ended,
March 31,
   2007    2006

Convertible preferred stock

   11,604    15,000

Warrants to purchase common stock

   2,050    2,050

Options to purchase common stock

   6,600    5,298
         

Total

   20,254    22,348
         

6. Comprehensive loss

Comprehensive loss includes certain changes in equity that are excluded from net loss. Specifically, unrealized gains or losses in available for sale investments are included in accumulated other comprehensive loss. Comprehensive loss and its components were as follows (in thousands):

 

     Three months ended
March 31,
 
   2007     2006  

Net loss

   $ (8,828 )   $ (8,703 )

Unrealized loss on securities available for sale, net of reclassification adjustment

     (76 )     (25 )
                

Comprehensive loss

   $ (8,904 )   $ (8,728 )
                

 

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7. Investments

Investments consist of available-for-sale securities as follows (in thousands):

 

    

Amortized

cost

  

Gross

Unrealized

Gains

  

Gross

Unrealized

Losses

   

Fair

Value

March 31, 2007

          

U.S. corporate obligations

   $ 60,485    $ 3    $ (107 )   $ 60,381

Auction rate securities

     37,500      —        —         37,500

U.S. government and agencies

     20,784      1      (10 )     20,775

Taxable municipal bonds

     4,588      —        (1 )     4,587
                            

Total

   $ 123,357    $ 4    $ (118 )   $ 123,243
                            

Contractual Maturities

          

Due in one year or less

   $ 91,617         $ 91,551

Due in one to three years

     31,740           31,692
                  

Total

   $ 123,357         $ 123,243
                  

Reported as:

          

Short-term investments

           $ 91,059

Long-term investments

             31,692

Restricted investments

             492
              

Total

           $ 123,243
              

December 31, 2006

          

U.S. corporate obligations

   $ 68,917    $ 8    $ (44 )   $ 68,881

U.S. government and agencies

     6,337      —        (3 )     6,334

Taxable municipal bonds

     2,706      1      —         2,707
                            

Total

   $ 77,960    $ 9    $ (47 )   $ 77,922
                            

Contractual Maturities

          

Due in one year or less

   $ 73,960         $ 73,936

Due in one to three years

     4,000           3,986
                  

Total

   $ 77,960         $ 77,922
                  

Reported as:

          

Short-term investments

           $ 73,450

Long-term investments

             3,986

Restricted investments

             486
              

Total

           $ 77,922
              

Auction rate securities have contractual maturities in excess of one year, but are typically subject to resets in interest rate over a time period of 28 days or less. Investments in auction rate securities are available to fund current operations and are therefore classified as short-term investments in the accompanying financial statements. The Company has determined that unrealized losses are temporary and insignificant as to the extent of the decline, in both dollars and percentage of cost. The Company has the ability and intent to hold investments in temporary unrealized loss positions until substantially all of the costs of the investment are recovered. As of March 31, 2007, investments in unrealized loss positions have been in a continuous loss position for less than 12 months.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Forward-Looking Statements

The following discussion of our financial condition and results of operations contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as may, might, will, should, expect, plan, anticipate, project, believe, estimate, predict, potential, intend or continue, the negative of terms like these or other comparable terminology, and other words or terms of similar meaning in connection with any discussion of future operating or financial performance. These statements are only predictions. All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. Any or all of our forward-looking statements in this document may turn out to be wrong. Actual events or results may differ materially. Our forward-looking statements can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. In evaluating these statements, you should specifically consider various factors, including the risks outlined under the caption “Risk Factors” set forth in Item 1A. of Part I of our Form 10-K for the fiscal year ended December 31, 2006, as well as those contained from time to time in our other filings with the SEC. We caution investors that our business and financial performance are subject to substantial risks and uncertainties.

Overview

We are a biotechnology company developing monoclonal antibody-based therapies for the treatment of cancer and autoimmune diseases. Our business strategy is focused on advancing our portfolio of product candidates in diseases with unmet medical need and significant market potential. We currently have four product candidates in ongoing clinical trials, SGN-40, SGN-33, SGN-30 and SGN-35. In addition, we have two other lead preclinical product candidates, SGN-70 and SGN-75. Our pipeline of product candidates is based upon two technologies: genetically engineered monoclonal antibodies and monoclonal antibody-drug conjugates (ADCs). These technologies enable us to develop monoclonal antibodies that can kill target cells on their own as well as to increase the potency of monoclonal antibodies by linking them to a cell-killing payload to form an ADC.

In addition to our internal pipeline of product candidates, we have ADC collaborations with leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics, MedImmune, PDL BioPharma and Agensys. We also have internal research and in-licensing programs for novel antigens and new monoclonal antibodies to provide future opportunities for pipeline growth.

We do not currently have any commercial products for sale. All of our product candidates are in relatively early stages of development, and significant further research and development, financial resources and personnel will be required to develop commercially viable products and obtain regulatory approvals. As of March 31, 2007, we had an accumulated deficit of approximately $188.4 million. Over the next several years, we expect to incur substantial expenses as we continue to invest in research, development and manufacturing and move towards commercialization of our product candidates. Our commitment of resources to research and the continued development and potential commercialization of our product candidates will require substantial additional funds and resources. Our operating expenses will likely increase as we invest in research or acquire additional technologies, as additional product candidates are selected for clinical development and as some of our earlier stage product candidates move into later stage clinical development. In addition, we will incur significant milestone payment obligations as our product candidates progress through clinical trials towards commercialization. Because a substantial portion of our revenues for the foreseeable future will depend on achieving development and clinical milestones under our existing collaboration and license agreements, particularly our SGN-40 collaboration with Genentech, as well as entering into new collaboration and license agreements, our results of operations may vary substantially from year to year and from quarter to quarter. We believe that period to period comparisons of our operating results may not be meaningful and you should not rely on them as indicative of our future performance.

Financial summary

To date, we have generated revenues principally from our collaboration and license agreements. These revenues include upfront technology access fees, milestone payments and reimbursement for support and materials supplied to our collaborators. For the three months ended March 31, 2007, revenues increased 103% to $4.3 million compared to $2.1 million for the same period in 2006. Operating expenses increased 27% to $14.6 million compared to $11.6 million for the same period in 2006. Our loss for the three month period ended March 31, 2007 was $8.8 million, or $0.16 per share, compared to $8.7 million, or $0.21 per share, for the same period in 2006. As of March 31, 2007, we had approximately $140.3 million in cash, cash equivalents, short-term and long-term investments and $81.6 million in total stockholders’ equity.

 

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Results of Operations

Three months ended March 31, 2007 and 2006

Revenues.

Total collaboration and license agreement revenues increased 103% to $4.3 million in the first quarter of 2007 from the comparable period in 2006. These increases were primarily due to amounts earned under our SGN-40 collaboration agreement with Genentech established in January 2007. Revenues are summarized by collaborator as follows:

 

Collaboration and license agreement revenues ($ in thousands)

   Three months ended
March 31,
 
   2007    2006    % change  

Genentech

   $ 2,732    $ 792    245 %

Progenics

     758      192    295 %

Bayer

     420      233    80 %

MedImmune

     264      204    29 %

CuraGen

     25      506    -95 %

Other Collaborations

     137      214    -36 %
                    

Total

   $ 4,336    $ 2,141    103 %
                    

Genentech revenues increased 245% to $2.7 million in the first quarter of 2007 from the comparable period in 2006. This increase is primarily the result of revenues earned under the new SGN-40 collaboration agreement with Genentech entered into in January 2007. Under the terms of the agreement, we received an upfront payment of $60 million and are entitled to receive progress-dependent milestone payments and royalties on net sales of any resulting products. We also perform research and development activities under the agreement that are reimbursed by Genentech. All payments received under this agreement, including future milestone payments, will be aggregated to deferred revenue and recognized as revenue over the six year development period using a time-based method. In March 2007, Genentech also paid us $4.5 million to exercise exclusive licenses to specific targets and extend the research term under our ADC collaboration agreement established in April 2002. These fees are being recognized as revenue over the three year extension period of the collaboration using a time-based approach. Revenues earned under our Progenics collaboration increased 295% to $758,000 in the first quarter of 2007 from the comparable period in 2006 primarily due to a preclinical milestone earned during the first quarter of 2007. Revenues earned under our CuraGen collaboration decreased 95% to $25,000 in the first quarter of 2007 from the comparable period in 2006 due to the completion of the amortization of the upfront technology access fee over the research program term which ended in June 2006.

We expect that our revenues in 2007 will increase over 2006 levels, driven primarily by the SGN-40 collaboration with Genentech. In addition, we may receive progress-dependent milestones, annual maintenance fees and support fees as our collaborators advance their ADC product candidates through the development process. We expect that future revenues will vary from quarter to quarter depending on the progress made by our collaborators with their product candidates, the level of support we provide our partners, the timing of milestones achieved and our ability to enter into additional collaboration agreements.

Research and development.

Research and development expenses increased 28% to $11.8 million in the first quarter of 2007 from the comparable period in 2006. Our research and development expenses are summarized as follows:

 

Research and development ($ in thousands)

   Three months ended
March 31,
 
   2007    2006    % change  

Research

   $ 3,465    $ 3,336    4 %

Development and contract manufacturing

     4,840      3,461    40 %

Clinical

     2,519      1,870    35 %

Share-based compensation expense

     981      584    68 %
                    

Total

   $ 11,805    $ 9,251    28 %
                    

Research expenses remained relatively stable, increasing 4% to $3.5 million in the first quarter of 2007 from the comparable period in 2006. Development and contract manufacturing costs increased 40% to $4.8 million in the first quarter of 2007 from the comparable period in 2006 primarily due to manufacturing activities with Laureate Pharma for production of SGN-70 and SGN-33 clinical supply resulting in an increase in related expenses of $982,000 in 2007. Clinical costs increased 35% to $2.5 million in the first quarter of 2007 from the comparable period in 2006 due to increased third party costs associated with our SGN-33, SGN-40 and SGN-35 clinical trials, which were partially offset by decreased third party costs for our SGN-30 program. Share-based compensation expense increased 68% to $981,000 during the first quarter of 2007 from the comparable period in 2006 reflecting the combination of an increase in the number of options outstanding associated with increased staffing levels and slightly higher weighted average grant-date fair values.

 

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The following table shows expenses incurred for preclinical study support, contract manufacturing for clinical supplies and clinical trial services provided by third parties as well as milestone payments for in-licensed technology for each of our product candidates. The table also presents unallocated costs which consist of personnel, facilities and other costs not directly allocable to development programs:

 

Product Candidates ($ in thousands)

  

Three months ended

March 31,

   Five years ended
March 31,
   2007    2006    2007

SGN-33

   $ 1,048    $ 103    $ 3,554

SGN-70

     1,044      288      4,251

SGN-40

     690      445      7,956

SGN-35

     384      762      9,011

SGN-30

     267      619      19,641

SGN-15

     0      77      7,989
                    

Total third party costs

     3,433      2,294      52,402

Unallocated costs and overhead

     7,391      6,373      103,140

Share-based compensation expense

     981      584      5,390
                    

Total research and development

   $ 11,805    $ 9,251    $ 160,932
                    

Our third party costs for SGN-33 and SGN-70 in the first quarter of 2007 primarily reflect activities conducted by Laureate Pharma to perform scale-up and GMP manufacturing to support clinical trials. We expect third party costs for SGN-70 and SGN-33 to increase during 2007 compared to 2006 as a result of higher pharmacology/toxicology, clinical and manufacturing costs. SGN-40 costs in the first quarter of 2007 primarily reflect third party clinical costs. We expect third party costs associated with clinical trials of SGN-40 to increase as we continue to enroll patients and expand our SGN-40 phase I and II clinical trials and initiate additional trials. Under our SGN-40 collaboration agreement, Genentech reimburses us for development activities that we perform under the agreement. The cost of such activities is reflected in research and development expense as incurred and reimbursement payments are amortized into revenue along with other payments received from Genentech. SGN-35 third party costs in the first quarter of 2007 are primarily attributable to patient enrollment in our phase I clinical trial. SGN-35 costs decreased from 2006 following the completion of contract manufacturing and preclinical studies to support the clinical trial that was initiated in November 2006. We expect third party costs for SGN-35 to increase as we continue to enroll patients and expand our clinical trials. We have substantially completed company-sponsored clinical trials of SGN-30. Our ongoing clinical trials of SGN-30 are being conducted in cooperation with the National Cancer Institute (NCI). The majority of the costs for these trials will be incurred by the NCI and not reflected in our future financial results. As a result, we expect third party costs for SGN-30 to decrease from the amounts incurred in 2006.

Our expenditures on current and future preclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. In order to advance our product candidates toward commercialization, the product candidates are tested in numerous preclinical safety, toxicology and efficacy studies. We then conduct clinical trials for those product candidates that may take several years or more to complete. The length of time varies substantially based upon the type, complexity, novelty and intended use of a product candidate. The cost of clinical trials may vary significantly over the life of a project as a result of a variety of factors, including:

 

   

The number of patients who participate in the trials;

 

   

The length of time required to enroll trial participants;

 

   

The number of sites included in the trials;

 

   

The costs of producing supplies of the product candidates needed for clinical trials and regulatory submissions;

 

   

The safety and efficacy profile of the product candidate;

 

   

The use of clinical research organizations to assist with the management of the trials; and

 

   

The costs and timing of, and the ability to secure, regulatory approvals.

 

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Furthermore, our strategy may include entering into collaborations with third parties to participate in the development and commercialization of some of our product candidates. In these situations, the preclinical development or clinical trial process for a product candidate and the estimated completion date may largely be under the control of that third party and not under our control. We cannot forecast with any degree of certainty which of our product candidates will be subject to future collaborations or how such arrangements would affect our development plans or capital requirements.

We anticipate that our research, development, contract manufacturing and clinical expenses will continue to grow in the foreseeable future as we expand our discovery and preclinical activities and advance new product candidates into clinical trials. These expenses will fluctuate based upon many factors including the degree of collaborative activities, timing of manufacturing campaigns, numbers of patients enrolled in our clinical trials and the outcome of each clinical trial event.

The risks and uncertainties associated with our research and development projects are discussed more fully in the section entitled “Risk Factors” that appears in our periodic reports filed with the SEC. As a result of the uncertainties discussed above, we are unable to determine with any degree of certainty the anticipated completion dates or completion costs of our research and development projects or when and to what extent we will receive cash inflows from the commercialization and sale of a product candidate.

General and administrative.

 

General and administrative ($ in thousands)

   Three months ended
March 31,
 
   2007    2006    % change  

General and administrative

   $ 2,427    $ 1,937    25 %

Share-based compensation expense

     393      370    6 %
                    

Total

   $ 2,820    $ 2,307    22 %
                    

General and administrative expenses increased 22% to $2.8 million in the first quarter of 2007 from the comparable period in 2006. General and administrative expenses, excluding share-based compensation expense, increased 25% in the first quarter of 2007 from the comparable period in 2006 primarily due to higher professional services and recruiting expenses. We anticipate that general and administrative expenses will continue to increase in 2007 as a result of increased costs related to adding personnel in support of our operations.

Investment income, net.

Investment income increased 105% to $1.5 million in the first quarter of 2007 from the comparable period in 2006. This increase is primarily the result of higher cash and investment balances due to the payment received from Genentech pursuant to the SGN-40 collaboration as well as an increase in the average yield of invested funds.

Liquidity and capital resources.

 

Liquidity and capital resources ($ in thousands)

   March 31,
2007
   December 31,
2006

Cash, cash equivalents and investments

   $ 140,259    $ 86,573

Working capital

   $ 95,348    $ 76,880

Stockholders’ equity

   $ 81,580    $ 88,234

 

     Three months ended
March 31,
 
   2007     2006  

Cash provided by (used in ):

    

Operating activities

   $ 53,396     $ (8,630 )

Investing activities

   $ (45,901 )   $ 8,894  

Financing activities

   $ 876     $ 289  

Capital expenditures (included in Investing activities)

   $ (886 )   $ (174 )

We have financed the majority of our operations through the issuance of equity securities, which is supplemented by funding received from our collaboration and license agreements. To a lesser degree, we have also financed our operations through interest earned on cash, cash equivalents and investments. These financing sources have historically allowed us to maintain adequate levels of cash and investments.

Our combined cash, cash equivalents and investment securities increased to $140.3 million at March 31, 2007, compared to

 

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$86.6 million at December 31, 2006. This increase was caused primarily by cash provided by operating activities, which included the upfront payment of $60 million received from Genentech pursuant to the SGN-40 collaboration and $4.5 million received from Genentech to extend its ADC collaboration established with us in April 2002. Our working capital was $95.3 million at March 31, 2007, compared to $76.9 million at December 31, 2006. We have structured our investment portfolio so that scheduled maturities of investment securities can be used to fund our working capital needs. Our cash, cash equivalents and investments are held in a variety of interest-bearing instruments and subject to investment guidelines allowing for U.S. government and agency securities, high-grade U.S. corporate bonds, taxable municipal bonds, adjustable mortgage-backed securities, auction-rate securities, commercial paper and money market accounts.

Capital expenditures during the first three months of 2007 were $886,000 compared to $174,000 in the comparable period of 2006, which consisted primarily of lab equipment and tenant improvements in support of our research and development activities. We expect that our capital expenditures for the year 2007 will increase compared to 2006 due primarily to tenant improvements.

At our currently planned spending rate, we believe our remaining financial resources in addition to the expected fees and milestone payments earned under the SGN-40 collaboration agreement with Genentech and other existing collaboration and license agreements will be sufficient to fund our operations into 2010. However, changes in our spending rate may occur that would consume available capital resources sooner, such as increased manufacturing and clinical trial expenses preceding commercialization of a product candidate. We may seek additional funding through some or all of the following methods: corporate collaborations, licensing arrangements, or public or private equity financings. We do not know whether additional capital will be available when needed, or that, if available, we will obtain financing on terms favorable to our stockholders or us. If we are unable to raise additional funds should we need them, we may be required to delay, reduce or eliminate some of our development programs, which may adversely affect our business and operations.

We expect to incur substantial costs as we continue to develop and commercialize our product candidates. We anticipate that our rate of overall spending will accelerate as a result of the increased costs and expenses associated with adding personnel, clinical trials, regulatory filings, manufacturing, and research and development activities. We expect that these costs will fluctuate from quarter to quarter based on the timing of manufacturing campaigns, accrual of patients to clinical trials and collaborative activities. Certain external factors may influence our cash spending including the cost of filing and enforcing patent claims and other intellectual property rights, competing technological and market developments and the progress of our collaborators.

Some of our manufacturing, license and collaboration agreements provide for periodic maintenance fees over specified time periods, as well as payments by us upon the achievement of development and regulatory milestones and the payment of royalties based on commercial product sales. We do not expect to pay any royalties on net sales of products under any of these agreements for at least the next several years. The amounts set forth below could be substantially higher if we make certain development achievements that require us to make milestone payments or if we receive regulatory approvals or achieve commercial sales and are required to pay royalties earlier than anticipated.

The following are our future minimum contractual commitments for the periods subsequent to March 31, 2007 (in thousands):

 

     Total    Remainder
of 2007
   2008    2009    2010    2011    Thereafter

Operating leases

   $ 9,390    $ 1,653    $ 2,231    $ 2,253    $ 2,291    $ 962    $ —  

Manufacturing, license and collaboration agreements

     5,338      4,373      335      205      210      215      —  
                                                

Total

   $ 14,728    $ 6,026    $ 2,566    $ 2,458    $ 2,501    $ 1,177    $ —  
                                                

The minimum payments under manufacturing, license and collaboration agreements in 2007 primarily represent contractual obligations related to manufacturing campaigns to perform scale-up and cGMP manufacturing for monoclonal antibody and ADC products for use in our clinical trials, including our contract manufacturing agreement with Laureate Pharma. The above table excludes royalties and payments of up to approximately $10.0 million in potential future milestone payments to third parties under manufacturing, license and collaboration agreements for our current development programs, which generally become due and payable only upon achievement of certain developmental, regulatory and/or commercial milestones. Because the achievement of these milestones is neither probable nor reasonably estimable with respect to timing, such contingent payments have not been included in the above table.

As part of the terms of our office and laboratory lease, we have collateralized certain obligations under the lease with approximately $492,000 of our investments and the majority of our property and equipment. These investment securities are restricted as to withdrawal and are managed by a third party. In the event that we fail to meet specific thresholds of market capitalization, stockholders’ equity or cash and investment balances, we are obligated to increase our restricted investment balance to approximately $3.4 million. At March 31, 2007, we were in compliance with these thresholds.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

In accordance with our investment policy, we do not have any derivative financial instruments in our investment portfolio. We invest in high quality interest-bearing instruments, including U.S. government and agency securities, high-grade U.S. corporate bonds,

 

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taxable municipal bonds, adjustable mortgage-backed securities, auction-rate securities, commercial paper and money market accounts. Such securities are subject to interest rate risk and will rise and fall in value if market interest rates change; however, we do not expect any material loss from such interest rate changes.

 

Item 4. Controls and Procedures

(a) Evaluation of disclosure controls and procedures. The Chief Executive Officer and the Chief Financial Officer have reviewed the Company’s disclosure controls and procedures prior to the filing of this quarterly report. Based on that review, they have concluded that, as of the end of the period covered by this quarterly report, these disclosure controls and procedures were, in design and operation, effective to assure that the required information has been properly recorded, processed, summarized and reported to those responsible in order that it may be included in this quarterly report.

(b) Changes in internal control over financial reporting. There have not been any changes in the Company’s internal control over financial reporting during the quarter ended March 31, 2007 which have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

Part II. Other Information

 

Item 1A. Risk Factors

Certain factors may have a material adverse effect on our business, financial condition and results of operations and you should carefully consider them. It is not possible to predict or identify all such factors, and additional risks and uncertainties not currently known to us or that we currently deem immaterial also may adversely affect our business, financial condition and results of operations. For discussion of some of our potential risks or uncertainties, refer to Part I, Item 1A., Risk Factors, included in our Form 10-K for the fiscal year ended December 31, 2006 as filed with the SEC.

 

Item 6. Exhibits

 

Number  

Description

  3.1(1)   Amended and Restated Certificate of Incorporation of Seattle Genetics, Inc.
  3.2(2)   Certificate of Designations of Series A Convertible Preferred Stock of Seattle Genetics, Inc.
  3.3(4)   Amended and Restated Bylaws of Seattle Genetics, Inc.
  4.1(1)   Specimen Stock Certificate.
  4.2(3)   Form of Common Stock Warrant.
  4.3(3)   Investor Rights Agreement dated July 8, 2003 among Seattle Genetics, Inc. and certain of its stockholders.
10.1†   Collaboration and License Agreement dated January 7, 2007 between Seattle Genetics, Inc. and Agensys, Inc.
10.2†   Collaboration Agreement dated February 5, 2007 between Seattle Genetics, Inc. and Genentech, Inc.
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(a).
31.2   Certification of Chief Financial Officer pursuant to Rule 13a-14(a).
32.1   Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350.
32.2   Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350.

(1) Previously filed as an exhibit to Registrant’s registration statement on Form S-1, File No. 333-50266, originally filed with the Commission on November 20, 2000, as subsequently amended, and incorporated herein by reference.
(2) Previously filed as an exhibit to the Registrant’s current report on Form 8-K filed with the Commission on June 5, 2003.
(3) Previously filed as an exhibit to the Registrant’s current report on Form 8-K filed with the Commission on May 15, 2003.
(4) Previously filed as an exhibit to the Registrant’s quarterly report on Form 10-Q for the quarter ended June 30, 2003 and incorporated herein by reference.
Confidential treatment requested as to certain portions of this Exhibit.

 

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

SEATTLE GENETICS, INC.

By:

 

/s/ Todd E. Simpson

  Todd E. Simpson
  Chief Financial Officer

Date: May 8, 2007

 

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EXHIBIT INDEX

 

Item 6. Exhibits

 

Number   

Description

  3.1(1)    Amended and Restated Certificate of Incorporation of Seattle Genetics, Inc.
  3.2(2)    Certificate of Designations of Series A Convertible Preferred Stock of Seattle Genetics, Inc.
  3.3(4)    Amended and Restated Bylaws of Seattle Genetics, Inc.
  4.1(1)    Specimen Stock Certificate.
  4.2(3)    Form of Common Stock Warrant.
  4.3(3)    Investor Rights Agreement dated July 8, 2003 among Seattle Genetics, Inc. and certain of its stockholders.
10.1†    Collaboration and License Agreement dated January 7, 2007 between Seattle Genetics, Inc. and Agensys, Inc.
10.2†    Collaboration Agreement dated February 5, 2007 between Seattle Genetics, Inc. and Genentech, Inc.
31.1    Certification of Chief Executive Officer pursuant to Rule 13a-14(a).
31.2    Certification of Chief Financial Officer pursuant to Rule 13a-14(a).
32.1    Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350.
32.2    Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350.

(1) Previously filed as an exhibit to Registrant’s registration statement on Form S-1, File No. 333-50266, originally filed with the Commission on November 20, 2000, as subsequently amended, and incorporated herein by reference.
(2) Previously filed as an exhibit to the Registrant’s current report on Form 8-K filed with the Commission on June 5, 2003.
(3) Previously filed as an exhibit to the Registrant’s current report on Form 8-K filed with the Commission on May 15, 2003.
(4) Previously filed as an exhibit to the Registrant’s quarterly report on Form 10-Q for the quarter ended June 30, 2003 and incorporated herein by reference.
Confidential treatment requested as to certain portions of this Exhibit.

 

16

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).


[***] 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.

 

-2-


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.

 

-3-


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:

 

Schedule A

   -    Outline Research Plan

Schedule B

   -    SGI Patents

Schedule C

   -    Designated Antigens and Exclusive Antigens (to be added by amendment)

Schedule D

   -    Designated Antigen Specific Research Plans (to be added by amendment)

Schedule E

   -    Agensys In-Licenses

Schedule F

   -    [***]

Schedule G

   -    Initial Collaboration Product Plan

Schedule H

   -    Initial JSC Representatives

Schedule I

      Terms for Co-Promotion Agreement

[***] ” 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 ”).


[***] 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.

 

-4-


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.

 

-5-


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.


[***] 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.

 

-6-


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 (the “ [***] ”). Following Initiation of the first clinical trial under the [***] , no further Clinical Trials would be Initiated under the [***] , unless specifically requested by the JSC. As Lead Regulatory Party for the Second Collaboration Product [***] “Sponsor” on each IND for the Second Collaboration Product.

Section 7.2 Ownership of Regulatory Approvals . Unless otherwise proposed by the JSC and agreed to by the Parties, the Lead Regulatory Party shall own all INDs, BLAs and other Regulatory Approvals for the Collaboration Product for which it is responsible. The Lead Regulatory Party shall promptly license, transfer, provide a letter of reference with respect to, or take other action necessary to make available such Regulatory Approvals (including INDs and BLAs) to the other Party as may be reasonably necessary to enable such other Party to fulfill its Development and Commercialization obligations hereunder. SGI shall, in all cases, prepare, own and be responsible for the section of the applicable DMF that describes the Drug Conjugation Technology. Agensys may reference such section, but shall have no right, and SGI shall have no obligation, to provide any such information to Agensys and may require the applicable Regulatory Authority to maintain such information as confidential.

Section 7.3 Regulatory Coordination .

7.3.1 Responsibilities of Lead Regulatory Party . The Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, all applicable Regulatory Authorities with respect to the relevant therapeutic areas of the relevant Collaboration Product. The Lead Regulatory Party shall also be responsible for interfacing, corresponding and meeting with the applicable Regulatory Authorities with respect to the relevant therapeutic areas of the relevant Collaboration Product. The Lead Regulatory Party will use its best efforts to include a representative of the other Party in all meetings and telephone discussions between representatives of the Lead Regulatory Party and such Regulatory Authority related to a Collaboration Product.


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7.3.2 Review of Correspondence . The Lead Regulatory Party shall provide the other Party with drafts of any material documents and other correspondence to be submitted to a Regulatory Authority pertaining to a Collaboration Product, sufficiently in advance of submission so that the other Party may review and comment on such documents or other correspondence and have a reasonable opportunity to influence the substance of such submissions. The Lead Regulatory Party shall promptly provide the other Party with copies of any documents or other correspondence received from or submitted to a Regulatory Authority pertaining to a Collaboration Product.

Section 7.4 Assistance . Each Party shall cooperate with the other Party to provide all reasonable assistance and take all actions reasonably requested by the other Party that are necessary to enable such Party to comply with any regulatory requirements under Applicable Law with respect to any Collaboration Product, including (a) obtaining and maintaining Regulatory Approvals, (b) submitting annual reports and (c) performing pharmacovigilance activities. Such assistance and actions shall include, among other things, notifying the other Party within [***] of any information it receives from a Regulatory Authority which (i) raises any material concerns regarding the safety or efficacy of a Collaboration Product, (ii) indicates or suggests a potential material liability for either Party to Third Parties arising in connection with a Collaboration Product or (iii) is reasonably likely to lead to a recall or market withdrawal of a Collaboration Product.

Section 7.5 Adverse Events .

7.5.1 Reporting to Government Authorities . Each Party shall, and shall cause its respective Affiliates to, furnish timely notice as required by applicable worldwide regulations (i.e. currently not later than [***] for deaths and immediately life-threatening Adverse Events and not later than [***] for Serious Adverse Events to all competent governmental agencies in the Territory of all side effects, drug interactions and other Adverse Events identified or suspected with respect to any Product administered, distributed, marketed and sold under authority of any IND or Regulatory Approval. Each Party shall provide the other Party with all necessary assistance in complying with all Adverse Event reporting requirements established by, or required under, any applicable IND and/or Regulatory Approval in the Territory. Accordingly, each Party shall provide the other with timely information, in accordance with the time frames set forth below, on any side effects, drug interactions and Serious Adverse Events relating to any Product to the extent that such Serious Adverse Events could affect the Regulatory Approval for the Product, or relate to the safety, efficacy or potency of the Product.

7.5.2 Reporting to Other Party . Each Party shall, and shall cause its respective Affiliates to, furnish the other Party written notice of all side effects, drug interactions and other Serious Adverse Events regarding a Product reported to such Party or its Affiliates within [***] after any such report. Each Party shall also use its best efforts to obtain, and to furnish to the


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other Party hereto, such information, including, but not limited to, patients, circumstances, consequences and sources of information, reasonably sufficient to permit that other Party to evaluate such side effects, drug interactions or other Serious Adverse Events of the Product. Each Party shall retain all documents, reports, studies and other materials relating to any and all such side effects, drug interactions, or other Serious Adverse Events, as the case may be. Upon reasonable written notice, each Party shall permit the other Party hereto to inspect, and to make copies of, all such documents, reports, studies and other materials, subject to all applicable laws and regulations regarding patient confidentiality and privacy.

Article 8

COMMERCIALIZATION OF COLLABORATION PRODUCTS

Section 8.1 Objectives for Commercialization of Collaboration Products . The Parties shall collaborate in Commercializing the Collaboration Products in accordance with the Commercialization Plan and Co-Promotion Agreement (if applicable) with the objective of achieving the commercial potential of the Collaboration Products and sharing equally in (i) all Development Costs and Commercialization Expenses and (ii) any Product Profit. The Parties agree and acknowledge that, to the extent a given Collaboration Product is Commercialized for use in different therapeutic areas, such Collaboration Product shall have a different commercial presentation for each such therapeutic area (e.g., different dosage strengths or other differentiating characteristics).

Section 8.2 Commercialization Principles . The Parties shall mutually agree, in no event later than [***] after the initiation of the first [***] with respect to a Collaboration Product, a mechanism or structure (including, if required, the formation of a jointly owned entity subject to the written approval of both Parties) that maximizes the positive Product Profit to be shared equally between the Parties. In the event the Parties intend to utilize sales representatives employed by one or both of the Parties to Co-promote Collaboration Products they shall enter into a Co-Promotion Agreement the terms of which shall include without limitation the terms set forth in Schedule I and the applicable provisions of this Article 8.

Section 8.3 Preparation of Commercialization Plan . Promptly, but in no event later than [***] after the initiation of the first [***] with respect to a Collaboration Product: (i) the JSC shall prepare and approve an initial Commercialization Plan for a duration to be decided by the JSC but for not less than the balance of the then current Calendar Year plus the following Calendar Year for review and final written approval by the Parties. Thereafter, the JSC shall prepare a Commercialization Plan for each Calendar Year during which Commercialization activities are anticipated to occur at least [***] prior to the commencement of such Calendar Year. Each Commercialization Plan shall contain the specific Commercialization objectives to be achieved during the applicable period, the specific activities to be performed by each of the Parties in connection with the Commercialization of the Collaboration Products (including promotion, distribution, detailing and marketing activities), as well as a detailed budget for performing such activities. Each Commercialization Plan shall be consistent with the terms and conditions of both this Agreement and the Co-Promotion Agreement (if applicable).


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8.3.1 Amendment of Commercialization Plan . The JSC shall update and amend, as appropriate, the then current Commercialization Plan from time to time.

Section 8.4 Commercialization Activities . Each Party shall use Commercially Reasonable Efforts to perform its obligations with respect to the Commercialization of the Collaboration Products in accordance with the applicable Commercialization Plan and Co-Promotion Agreement (if applicable) and all such activities shall be conducted in accordance with all Applicable Laws, including GMPs. As part of such efforts, each Party shall commit the personnel and other resources necessary to carry out its obligations under the Commercialization Plan and Co-Promotion Agreement (if applicable). Neither Party shall be required to undertake any activity relating to the Commercialization of a Collaboration Product that it believes, in good faith, may violate any Applicable Law.

Section 8.5 Reports . Each Party shall submit periodic reports to the JSC, as may be required by the Commercialization Plan and Co-Promotion Agreement (if applicable), but in all cases no less than [***] per [***] , detailing its activities with respect to the Commercialization of the Collaboration Product, including all Commercialization Expenses incurred by such Party for such [***] and all FTEs utilized in connection with such Commercialization activities. The JSC shall use such periodic reports to monitor the Parties’ respective contributions to the Commercialization of the Collaboration Products.

Section 8.6 Promotional Materials . The JSC shall be responsible for creating and developing advertising, promotional, educational and communication materials for marketing, advertising and promotion of the Collaboration Products in the Territory which are intended for distribution to Third Parties (including medical professionals) and to the Parties’ respective sales forces in accordance with the terms of the Commercialization Plan (the “Promotional Materials”). The Parties shall jointly own all copyrights in and to any Promotional Materials which are specifically directed to the Collaboration Products and each Party shall execute all documents and take all actions as are reasonably requested by the other Party to effectuate such joint ownership in such copyrights. Neither Party shall produce (other than as concepts for consideration by the JSC), distribute or otherwise use any Promotional Materials relating to the Collaboration Products which have not been approved in accordance with the procedures established by the JSC.

Section 8.7 Recalls and Medical Inquiries . The JSC shall establish procedures for handling any recalls or customer complaints with respect to Collaboration Products and responding to medical inquiries regarding the Collaboration Products for approval by the JSC. Without limiting the generality of the foregoing, prior to the First Commercial Sale of a Collaboration Product, the Parties shall enter into a pharmacovigilance agreement detailing each Party’s pharmacovigilance responsibilities in connection with the Collaboration Products. Expenses of any recall shall be included in Commercialization Expenses, except that each Party shall be solely


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responsible for costs of a recall to the extent based on (i) the negligence, recklessness or willful misconduct of that Party or its Affiliate, or (ii) the failure by that Party to manufacture or have manufactured by an Affiliate or Third Party the Collaboration Product in accordance with all applicable laws and cGMPs.

Section 8.8 Product Trademarks . The Parties’ shall propose and through the JSC select the trademark, trade dress, logos and slogans under which each Collaboration Product shall be exclusively marketed (each a “ Collaboration Product Trademark ”). The Parties shall register the Collaboration Product Trademark and shall take all such actions as are required to continue and maintain in full force and effect the trademarks and the registrations thereof. The Parties shall jointly own the trademarks which are specifically directed to the Collaboration Products and each Party shall execute all documents and take all actions as are reasonably requested by the other Party to effectuate such joint ownership in such copyrights. Collaboration Product Trademarks shall be used only pursuant to the terms of this Agreement to identify, and in connection with the marketing of, Collaboration Products and shall not be used by either Party to identify, or in connection with the marketing of, any other products.

Section 8.9 Commercialization Expenses . Commercialization Expenses shall be provided for in a budget to be included in the Commercialization Plan, and shall be borne equally on a Collaboration Product-by-Collaboration Product basis pursuant to Article 12. The JSC shall review on a [***] basis the Commercialization Expenses against the budget for such expenses in the applicable [***] . If in the course of such quarterly review the JSC determines that the actual amounts incurred for Commercialization Expenses 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 Commercialization Plan to permit such overrun or to reduce such activities such that no overrun is expected. To the extent that a Party incurs expenses in connection with the Commercialization of a Collaboration Product [***] of the [***] (as the same may be amended from time to time), [***] .

Section 8.10 Audit . For so long as any Commercialization 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 Commercialization Expenses incurred) in connection with the Commercialization activities hereunder. Not more than [***] per [***] , 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 and 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 Commercialization obligations and the provisions of Section 5.5.2 and Section 5.5.3 shall apply with respect to such inspection and costs related thereto, mutatis , mutandis .


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Section 8.11 Public Statements Regarding Collaboration Products . Each Party shall ensure that no claims or representations in respect of the Collaboration Products or the characteristics thereof are made by or on behalf of it (by members of its sales force or otherwise) which do not represent an accurate summary or explanation of the labeling of the Collaboration Product or a portion thereof, except to the extent permitted by Applicable Law.

Section 8.12 Labeling . To the extent not prohibited by Applicable Law and subject to approval by the applicable Regulatory Authorities, all product labels for Collaboration Products shall include, in equal prominence, the names of both SGI and Agensys; provided, however, that the name of a non-Continuing Party (as hereinafter defined) shall not be required to be displayed on product labels.

Section 8.13 Liability . In connection with conduct of the Commercialization 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 8.14 Use of Subcontractors . Each Party may perform its obligations regarding the Commercialization of Collaboration Products through one or more Approved Subcontractors; provided, that, such Party shall at all times be responsible for the performance by its Approved Subcontractor and such Party otherwise complies with the requirements for use of Approved Subcontractors as set forth in Section 5.8.

Article 9

DEVELOPMENT AND COMMERCIALIZATION OF UNILATERAL PRODUCTS

Section 9.1 Development and Commercialization of Unilateral Products .

Section 9.2 Diligence . Each Party shall use Commercially Reasonable Efforts to develop, manufacture and commercialize Unilateral Products. Agensys shall have sole responsibility for making all decisions regarding the development, manufacture and marketing of Agensys Products and Agensys Licensed Products and SGI shall have sole responsibility for making all decisions regarding the development, manufacture and marketing of SGI Products.

Section 9.3 Conduct . Each Party shall comply with all Applicable Laws (including GCPs, GLPs and GMPs, to the extent applicable) in the development and commercialization of such Unilateral Products, and shall cause its Affiliates and Sublicensees to do the same.

Section 9.4 Funding and Progress Reports . Except as expressly set forth herein, as between SGI and Agensys, Agensys shall be solely responsible for funding all costs of the development and commercialization of Agensys Products and Agensys Licensed Products and SGI shall be solely responsible for funding all costs of the development and commercialization of SGI Products. The Parties shall keep each other informed in a timely manner as to the progress of the development of Unilateral Products.

 

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Section 9.5 Manufacturing . Except as otherwise expressly set forth in this Agreement, Agensys shall be responsible for all manufacturing and supply of Agensys Products and Agensys Licensed Products and SGI shall be responsible for all manufacturing and supply of SGI Products. Notwithstanding the foregoing, during the term of the ADC Research Program, [***] (a) use Commercially Reasonable Efforts to [***] , (b) shall consult with [***] , and (c)  [***] . In the event [***] any materials pursuant to either (b) or (c) above, and such materials are to be cGMP materials, the Parties shall negotiate in good faith a supply agreement governing the terms of any such supply by [***] prices and other such terms as may be appropriate and customary in agreements for the supply of similar products at similar volumes.

Section 9.6 Regulatory . Agensys shall be solely responsible for, and shall solely own, all applications for Regulatory Approval with respect to Agensys Licensed Products and Agensys Products and SGI shall be solely responsible for, and shall solely own, all applications for Regulatory Approval with respect to SGI Products. If ownership of a regulatory filing for a former Collaboration Product cannot be assigned to the Continuing Party under Section 5.9.1 in any country, the non-Continuing party shall grant to the Continuing Party a permanent, exclusive and irrevocable right of access and reference to such regulatory filing for such former Collaboration Product in such country. Should Agensys desire to file an IND or an application for Regulatory Approval, or equivalents of the foregoing, for an Agensys Licensed Product or Agensys Product, SGI will use Commercially Reasonable Efforts to provide at Agensys’ request, technical information reasonably required by Agensys, including information relating to the [***] , as well as documents necessary to compile the Chemistry Manufacturing and Controls section of any application for Regulatory Approval, or to provide other [***] data for such filings, and any other relevant information as the Parties may mutually agree. Agensys shall [***] in providing any such information [***] personnel engaged in such activities, as set forth in Section 11.1. Alternatively, if SGI (a) has a DMF with the FDA or equivalent that contains information related to Drug Conjugation Materials that is useful to support an IND or application for Regulatory Approval, or (b) does not have a DMF with the FDA or equivalent that contains information related to Drug Conjugation Materials that is useful to support an IND or application for Regulatory Approval, then Agensys may request that [***] . In the case of 9.6(a) or (b), Agensys shall have a right of reference to such [***] .

Section 9.7 [***] .

Section 9.7.1 General. [***] . For the avoidance of doubt, [***] have a [***] for any Designated Antigen which becomes a Collaboration Antigen or a SGI Product Antigen, as the case may be, to the extent [***] (prior to the time such Antigen became a [***] ) an IND that includes a [***] . For the avoidance of doubt, [***] . Upon (a)  [***] , or (b) a [***] (prior to the time such Antigen [***] ) an IND that includes a [***] (as the case may be) and [***] have [***] from receipt of the [***] (as the case may be) to decide whether to [***] . If [***] to [***] , such [***]


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and its associated Antigen shall become a [***] , respectively, and all provisions that apply to [***] shall apply to such [***] and associated [***] , mutatis , mutandis , provided [***] , [***] shall [***] for [***] of its Development Costs specifically incurred by [***] with respect to such [***] to such [***] up until the [***] , and such [***] .

9.7.2 Reports . [***] shall submit periodic reports to [***] than [***] each [***] , detailing [***] activities with respect to the Development for an [***] to any [***] . Unless and until such [***] product becomes a [***] , all such information shall be considered [***] .

Article 10

LICENSES AND RELATED RIGHTS

Section 10.1 Licenses to Agensys .

10.1.1 Research License . Subject to the terms and conditions of this Agreement, SGI shall automatically be deemed to have granted to Agensys and its Affiliates an exclusive, worldwide, royalty-free license under the SGI Independent Technology solely to conduct the ADC Research Program in accordance with Article 3 of this Agreement (the “ Research License ”). The Research License shall include the right to evaluate and conduct research on ADC Product Candidates solely for the purpose of determining Agensys’ interest in obtaining an Exclusive License for such Designated Antigen, but shall not include (a) the right to grant sublicenses thereto to any Third Party, (b) the right to initiate any human clinical trial utilizing such ADC Product Candidate in any country or (c) the right to make, have made, use or sell an ADC Product Candidate or any SGI Independent Technology. In addition, Agensys shall not, (i) without SGI’s prior written permission, file any patent applications that claim ADC Product Candidates to Designated Antigens unless and until Agensys obtains an Exclusive License as set forth in Section 10.1.2, at which time Agensys may file such patent applications relating to such Exclusive Antigen subject to the terms and conditions of this Agreement, or (ii) without SGI’s prior written permission, make any publications directly relating to ADC Product Candidates unless and until Agensys obtains the Exclusive License set forth in Section 10.1.2, at which time Agensys may make such publications to such Exclusive Antigen subject to the terms and conditions of this Agreement, including, without limitation, Section 14.6. Notwithstanding the foregoing, Agensys shall be allowed to send ADC Product Candidates under a material transfer or similar agreement to a bona fide Third Party research collaborator for pre-clinical research, provided that such Third Party collaborator is bound by obligations of confidentiality and assignment of inventions to Agensys or SGI, as applicable, consistent with the terms of this Agreement. The Research License shall continue on a Designated Antigen-by-Designated Antigen basis for the Research License Period and shall expire with respect to each Designated Antigen on the earlier of (i)  [***] , or (ii)  [***] , or (iii)  [***] . For the avoidance of doubt, all Research Licenses granted hereunder shall terminate immediately upon the date Agensys obtains the last of three (3) Exclusive Licenses hereunder.


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10.1.2 Option for Exclusive License . Subject to the provisions of this Agreement, SGI hereby grants Agensys and its Affiliates an option to obtain an Exclusive License (each an “ Option ”) described below to up to three (3) Exclusive Antigens. Agensys may exercise the Option at any time during the applicable Research License Period (and subject to SGI’s Opt-In Right as set forth in Section 4.1.2) by notifying SGI in writing and paying SGI the Option Exercise Fee described in Section 11.2 if applicable. Subject to SGI’s Opt-In Right as set forth in Section 4.1.2, (a) such Designated Antigen shall be deemed an Exclusive Antigen, for purposes of this Agreement, and (b) SGI shall be deemed to have granted to Agensys and its Affiliates an exclusive (even as to SGI), royalty-bearing license under the SGI Independent Technology, with the right to sublicense as permitted in Section 10.1.3, to discover, develop, have developed, make, have made, import, use, offer for sale, sell and have sold Agensys Licensed Products within the Field in the Territory (an “ Exclusive License ”), without any further action of the Parties. The Exclusive License shall continue for the Royalty Term, unless earlier terminated pursuant to Article 17. Agensys must exercise the Option with respect to each Designated Antigen within [***] from the later of (i)  [***] , and (ii)  [***] . For the avoidance of doubt, if SGI no longer has an Opt-In Right, Agensys must exercise the Option within [***] .

10.1.3 Right to Sublicense Agensys Licensed Products . Agensys and its Affiliates shall have the right to grant sublicenses of each Exclusive License to any Third Party (each an “ Agensys Sublicensee ”) with respect to any Agensys Licensed Product, provided, such sublicense includes the assignment or license by Agensys to such Agensys Sublicensee of the right, under intellectual property that was not licensed from SGI hereunder, to make, have made, use, sell, offer to sell or import such Agensys Licensed Product. Agensys shall remain fully liable for payment of milestones, royalties and other amounts owing under this Agreement. Each sublicensee shall comply with the terms and conditions of this Agreement and the SGI In-Licenses applicable to Agensys (including all terms of this Agreement identified as applicable to Sublicensee). Agensys shall also require any such Agensys Sublicensee to agree in writing to keep such books and records as are necessary for Agensys to calculate royalties or milestones payable hereunder and will obtain for SGI rights to review the information concerning such books and records in accordance with the terms of this Agreement. Agensys shall notify SGI of each sublicense granted to Third Parties hereunder and shall provide SGI with the name and address of each Agensys Sublicensee and a description of the rights granted and the territory covered by each Agensys Sublicensee.

10.1.4 License to Agensys for Collaboration Products . Subject to the terms of this Agreement, SGI hereby grants Agensys a worldwide, co-exclusive license (with SGI), including the right to sublicense (as proposed by the JSC and approved by the written consent of the Parties and in accordance with Section 10.7), under the SGI Technology and SGI’s interest in the Joint Patents to (a) perform its obligations hereunder with respect to the Collaboration Antigens and associated Collaboration Products in accordance with the Development Plan as mutually agreed upon by the Parties through the JSC, and (b) to make, have made, use, research, develop, test, sell, offer to sell, have sold and import Collaboration Products within the Field in the Territory in accordance with the Commercialization Plan as mutually agreed upon by the Parties through the JSC.


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10.1.5 License to Agensys for Unilateral Products . Subject to the terms of this Agreement, SGI hereby grants Agensys a worldwide, exclusive license (even as to SGI) under the SGI Patents, SGI Technology and SGI’s interest in the Joint Patents solely to make, have made, use, research, develop, test, sell, offer to sell, have sold and import Agensys Products and Agensys Licensed Products within the Field in the Territory. Agensys may grant sublicenses of the licenses granted in this Section 10.1.5 solely for the purpose of research, development, manufacturing and Commercialization of Agensys Products.

Section 10.2 Licenses to SGI .

10.2.1 License to SGI for Designated Antigens . Subject to the provisions of this Agreement, Agensys hereby grants to SGI during the ADC Research Program Term a non-exclusive, royalty-free license under the Agensys Independent Patents, Agensys ADC Patents, Agensys Independent Know-How and Agensys ADC Know-How, solely to enable SGI to perform or have performed its responsibilities under the ADC Research Program with respect to Designated Antigens and associated ADC Product Candidates. SGI may sublicense the rights granted under this Section 10.2.1 only with the prior written consent of Agensys. Any such permitted sublicense shall be expressly made subject to the applicable terms and conditions of this Agreement.

10.2.2 License to SGI for Collaboration Products . Subject to the terms of this Agreement, Agensys hereby grants SGI a worldwide, co-exclusive license (with Agensys), including the right to sublicense (as proposed by the JSC and approved by the written consent of the Parties and in accordance with Section 10.7) under the Agensys Technology and Agensys’ interest in the Joint Patents to (a) perform its obligations hereunder with respect to the Collaboration Antigens and associated Collaboration Products in accordance with the Development Program as mutually agreed upon by the Parties through the JSC, and (b) to make, have made, use, develop, test, sell, offer to sell, have sold and import Collaboration Products within the Field in the Territory in accordance with the Commercialization Plan as mutually agreed upon by the Parties through the JSC.

10.2.3 License to SGI for SGI Products . Subject to the terms of this Agreement, Agensys hereby grants SGI a worldwide, exclusive license under the Agensys Technology and Agensys’ interest in the Joint Patents solely to make, have made, use, develop, test, sell, offer to sell, have sold and import SGI Products within the Field in the Territory. SGI may grant sublicenses of the licenses granted in this Section 10.2.3 solely for the purpose of research, development, manufacturing and Commercialization of SGI Products. In addition, subject to the terms of this Agreement, Agensys hereby grants SGI a fully-paid-up, royalty-free, worldwide, non-exclusive license under the Agensys Technology and Agensys’ interest in the Joint Patents (including antibodies and materials generated during the Collaboration Program for the applicable SGI Product) solely to make, have made, use, develop, test, sell, offer to sell, have sold and import diagnostic products within the Field in the Territory for the sole purpose of enabling SGI to commercialize such SGI Product. Such non-exclusive license shall terminate when the exclusive license to which it relates under this Section 10.2.3 expires or terminates.

 

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Section 10.3 Rights to Sublicense Collaboration Products . Each Party and its Affiliates shall have the right to grant sublicenses of each license set forth under Sections 10.1.4 and 10.2.2 with respect to any Collaboration Product to Approved Subcontractors and Collaboration Sublicensees.

Section 10.4 Improvements and New Technologies for Exclusive Antigens .

10.4.1 Improvements . In the event that, during the ADC Research Program Term, either Party conceives, develops or reduces to practice an Improvement, such Party shall promptly notify the other Party of the discovery of such Improvement. SGI shall own all Improvements and, to the extent that any such Improvements shall have been conceived, developed or reduced to practice by Agensys, Agensys hereby assigns all of its right, title and interest therein to SGI. SGI’s interest in any such Improvements shall be included in the SGI Independent Technology and licensed to Agensys pursuant to the Research License and/or Exclusive License(s) provided in this Article 10.

10.4.2 [***] . Subject to the [***] , [***] and its Affiliates shall have the right to practice any [***] that arise during the ADC Research Program Term pursuant to the Research Licenses and/or Exclusive Licenses with respect to [***] granted under Article 10 as follows: [***] of any [***] that arise during the ADC Research Program Term only by providing to [***] a [***] of such [***] , including all [***] under which [***] would be able to access such [***] , such terms to be [***] to [***] than those [***] of [***] . If [***] at its [***] is interested in [***] such [***] with respect to [***] , the Parties shall discuss [***] for such [***] pursuant to this Agreement, which shall include [***] use of such [***] with respect to such [***] and; provided that the [***] shall be deemed to include [***] and [***] (as applicable) relating to or covering such [***] only after the Parties execute an amendment to this Agreement specifying such [***] . Except as set forth in the foregoing sentence and any [***] including any such [***] , [***] shall be [***] .

10.4.3 Amendment of [***] . [***] shall be amended from time to time to add the patents and patent applications [***] covering [***] in accordance with this Section 10.4.

Section 10.5 New Collaboration Technologies .

10.5.1 New Collaboration Technologies . If either Party reasonably believes that a license to, or other acquisition of, rights under Third Party intellectual property rights is reasonably necessary for the Development or Commercialization of a Collaboration Product, or an ADC targeting the Initial Collaboration Antigen, and should be included in the collaboration hereunder, then such Party may propose entering into a license (or other appropriate acquisition agreement) with such Third Party regarding such intellectual property rights to the JSC and include with such proposal the results of any due diligence such Party may have conducted. If the JSC agrees that such proposed agreement should be entered into (a “ Third Party License Agreement ”), then the Parties may jointly obtain such license (provided, however that the JSC may designate a Party (or both Parties) to take the lead in negotiating such Third Party License Agreement on such


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terms (economic or otherwise) as the Parties may mutually agree. In the event the JSC proposes one Party to take the lead in negotiating the Third Party License Agreement, and subject to such Party’s consent to such role, such Party shall provide the other Party with terms 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 License Agreement (or any amendment, waiver or other modification thereof) without the written approval of the other Party. From and after the execution of each Third Party License Agreement entered into in accordance with this Section 10.5.1, the payments owing to such Third Party arising from the activities of the Parties in the conduct of the Development or Commercialization of a Collaboration Product, or an ADC targeting a Collaboration Antigen, shall be shared by the Parties as described in Section 10.5.2. For purposes of clarity, the foregoing is not intended to obligate either Party to enter into, or prevent either Party from entering into, any agreement not approved by the JSC for use in connection with the Development or Commercialization of a Collaboration Product so long as the Party acquiring such rights assumes all financial and other obligations associated therewith and such proposed agreement does not otherwise adversely impact the rights granted to the other Party hereunder or the conduct of the Development Plan and/or Commercialization Plan.

10.5.2 Payments to Third Parties . Any amounts paid to a Third Party (whether in the form of a royalty, up-front payment, milestone or otherwise) from and after the Effective Date on account of any payments under a Third Party License Agreement, in each case as a result of the activities under the Development and/or Commercialization Program hereunder, shall be considered a [***] , as applicable (the “ Payments to Third Parties ”); provided, however that to the extent the agreements giving rise to such Payments to Third Parties cover multiple products, only an allocable portion of such payment shall be considered a “ [***] ” hereunder (based on the overall number of products covered by such agreement as compared to the number of [***] covered by such agreement) as reasonably determined by the JSC and agreed by the Parties.

Section 10.6 Compliance with the SGI In-Licenses .

10.6.1 SGI In-Licenses .

(a) General . Agensys, its Affiliates and Sublicensees shall comply with all obligations, covenants and conditions of the SGI In-Licenses applicable to Agensys and its Affiliates and Sublicensees, and any amendments thereto, following written disclosure thereof by SGI to Agensys. The Parties agree that [***] .

(b) SGI Obligation . SGI will not enter into any amendment to an SGI In-License that [***] .

10.6.2 Agensys In-Licenses .

(a) General . SGI, its Affiliates and Sublicensees shall comply with all obligations, covenants and conditions of the Agensys In-Licenses applicable to SGI and its Affiliates and Sublicensees, and any amendments thereto, following written disclosure thereof by Agensys to SGI. The Parties agree that [***] .


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(b) Agensys Obligation . Agensys will not enter into any amendment to an Agensys In-License(s) that [***] .

Section 10.7 Sublicensing General Provisions . A Party granting sublicenses under Section 10.1.5 or 10.2.3, as the case may be, shall remain fully liable for payment of milestones, royalties and other amounts owing under this Agreement. Each sublicense shall comply with the terms and conditions of this Agreement and the SGI In-Licenses applicable to Agensys or the Agensys In-Licenses applicable to SGI, as the case may be, (including all terms of this Agreement identified as applicable to Sublicensee). The Sublicensing Party shall also require any such Collaboration Sublicensee to agree in writing to keep such books and records as are necessary for such Party to calculate amounts payable hereunder and will obtain for the non Sublicensing Party rights to review the information concerning such books and records in accordance with the terms of this Agreement. The Sublicensing Party shall notify the non-Sublicensing Party of each sublicense granted to Third Parties hereunder and shall provide the non-Sublicensing Party with the name and address of each Sublicensee and a description of the rights granted and the territory covered by each Sublicensee and a copy of the sublicense agreement. The Sublicensing Party may redact from such sublicense agreements any terms that are not relevant to the terms of this Agreement, so long as the terms that are relevant to the terms of this Agreement, including the terms related to the royalties and milestones payable under this Agreement, remain comprehensible. The terms of each sublicense agreement shall be the Confidential Information of the Sublicensing Party. The Parties shall jointly determine the procedures for sublicensing to Collaboration Sublicensees pursuant to Section 10.3 through the JSC.

Article 11

FEES, ROYALTIES AND PAYMENTS FOR UNILATERAL PRODUCTS

Section 11.1 Research Fees for Designated Antigens . Agensys shall pay to SGI the following amounts in consideration of the ADC Research Program:

11.1.1 Agensys shall pay SGI all applicable FTE Fees for technical assistance and/or training as requested in writing by Agensys pursuant to this Agreement. Within [***] after the end of each [***] , SGI shall submit a report to Agensys supporting the calculation of the FTE Fees due for such [***] . Agensys shall pay all FTE Fees to SGI within [***] of receipt of each FTE Fees report.

11.1.2 Agensys shall pay SGI for all research grade Drug Conjugation Materials, ADC Product Candidates, Agensys Licensed Products or Agensys Products delivered by SGI to Agensys at the rate of [***] of [***] therefor (the “ Supply Fees ”). Within [***] after the end of each [***] , SGI shall submit a report to Agensys supporting the calculation of the Supply Fees due for such [***] . Agensys shall pay all Supply Fees to SGI within [***] of receipt of each Supply Fees report.


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Section 11.2 Option Exercise Fee . If Agensys obtains an Exclusive License to a Designated Antigen pursuant to Section 10.1.2 that becomes the second (2nd) or third (3rd) Exclusive License because SGI has either (a) elected not to exercise its Opt-In Right, and/or (b) has already utilized its Opt-In Right with respect to a previous Exclusive Antigen, then Agensys would pay SGI a fee of [***] with respect to the second (2nd) Exclusive License and [***] with respect to the third (3rd) Exclusive License. For purposes of clarification, there shall be no exercise payment associated with the first (1st) Exclusive Antigen.

Section 11.3 Exclusive License Maintenance Fees . With respect to each Unilateral Product, the Continuing Party, in the case of an SGI Product or Agensys Product, and Agensys in the case of an Agensys Licensed Product, shall be required to pay an annual maintenance fee to the non-Continuing Party, or to SGI in the case of an Agensys Licensed Product, in the sum of [***] for each associated Unilateral Product by wire transfer of immediately available funds (the “ Unilateral Product Maintenance Fee ”). Such Unilateral Product Maintenance Fee shall be due on the yearly anniversary of (i) the date the Option was exercised by Agensys or (ii) the date such ADC Product Candidate or Collaboration Product became a Unilateral Product, up through the date on which the Continuing Party, or Agensys in the case of an Agensys Licensed Product, receives Regulatory Approval for a Unilateral Product. Notwithstanding the foregoing, the Unilateral Product Maintenance Fee will not be payable if any payments have been made under [***] of this Agreement with respect to the same Unilateral Product during the [***] preceding the date on which a Unilateral Product Maintenance Fee is due.

Section 11.4 Payments on Agensys Products and SGI Products .

11.4.1 General . During the Royalty Term, the Continuing Party would pay the following royalties (“ Royalties ”) on Net Sales of each SGI Product or Agensys Product, as the case may be, dependent on the stage of development when the Opt-Out Notice occurred:

 

Stage

  

Percent

[***]

   [***]

[***]

   [***]

[***]

   [***]

Section 11.4.2 Payments for the [***] . If applicable and subject to Section 4.5, SGI shall also pay to Agensys [***] on SGI Products occurring after such SGI Product became a SGI Product (i.e., after the Opt-Out Date) pursuant to [***] . In the event of any conflict between the terms related to calculation of [***] payable [***] .


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Section 11.5 Royalties Payable on Agensys Products and Agensys Licensed Products .

11.5.1 General . Notwithstanding the provisions of Section 11.3, during the Royalty Term, Agensys shall pay a royalty to SGI of [***] of Net Sales of Agensys Licensed Products in each Calendar Year.

11.5.2 Royalties Payable for the Benefit of [***] . If applicable, Agensys shall also pay to SGI a royalty of [***] of Net Sales of Agensys Products and Agensys Licensed Products in each Calendar Year pursuant to the terms and conditions of the [***] . In the event of any conflict between the terms related to calculation of royalties payable under the [***] and the terms of this Agreement, the terms of the [***] .

Section 11.6 Payment Terms . Royalties shown to have accrued by each Royalty Report provided for under Sections 11.4 or 11.5 of this Agreement shall be due [***] after the date such Report is due pursuant to Section 11.9.2.

Section 11.7 Third Party Royalties; Adjustments to Royalties .

11.7.1 General . Each Party shall be solely responsible for paying all royalties owed to Third Parties by such Party on account of sales of Unilateral Products by such Party, its Affiliates or Sublicensees, including royalties owed due to use of the SGI Technology pursuant to the SGI In-Licenses or owed due to use of the Agensys Technology pursuant to the Agensys In-Licenses, [***] . Agensys shall be responsible for the payment of all other consideration (including any milestone payments) due and payable under the SGI In-Licenses triggered by Agensys’ development of Agensys Licensed Products or Agensys Products except as described in the foregoing sentence and/or except as set forth in [***] with regard to any [***] . SGI represents and warrants that all Third Party royalties and milestones owed pursuant to the existing SGI In-Licenses are described in Schedule B (“ SGI Existing Third Party Royalties ”). Agensys represents and warrants that all Third Party royalties and milestones owed pursuant to the existing Agensys In-Licenses are as set forth in [***] (“ Agensys Existing Third Party Royalties ”).

11.7.2 Adjustment to Royalties Owed on Agensys Products and Agensys Licensed Products . If the royalty payable to [***] under [***] above by [***] , is [***] to less than [***] of Net Sales (the amount of any such [***] ), then the royalty otherwise due and payable by Agensys to SGI under Sections 11.4 and 11.5 shall be [***] of the [***] ; provided, that any such [***] in the Royalty set forth in Sections 11.4 or 11.5 shall be [***] .

Section 11.8 Milestone Payments . For each Unilateral Product, the Continuing Party shall pay the non-Continuing Party, or in the case of Agensys Licensed Products, Agensys shall pay SGI the following amounts within [***] after each Unilateral Product achieves the stated milestone:

(a) [***] ;


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(b) [***] ;

(c) [***] ;

(d) [***] ;

(e) [***] ;

(f) [***] ;

(g) [***] ; and

(h) [***] .

If any of (a) through (d) above is achieved before a preceding milestone payment has become due, then such payment shall be deemed to become due upon achievement of the subsequent milestone. Milestone payments for Unilateral Products (other than Agensys Licensed Products) shall only be due for milestones that occur after the date a Product becomes a Unilateral Product hereunder.

Section 11.9 Royalty Reports, Exchange Rates .

11.9.1 Royalty Reports . During the Royalty Term, any Party paying royalties hereunder (the “ Paying Party ”) shall furnish to the non-Paying Party, with respect to each Calendar Quarter, a written report showing, on a consolidated basis in reasonably specific detail and on a country-by-country basis, (a) the Net Sales of Products sold by the Paying Party, its Affiliates and its Sublicensees in the Territory during the corresponding Calendar Quarter including a description of the credits and offsets deducted on a Product by Product and country by country basis to calculate Net Sales; (b) the royalties payable in U.S. dollars, if any, which shall have accrued hereunder based upon such Net Sales of Products; (c) the withholding taxes, if any, required by law to be deducted in respect of such royalties; (d) the dates of the First Commercial Sale of each Product in each country in the Territory, if it has occurred during the corresponding Calendar Quarter; and (e) the exchange rates (as determined pursuant to Section 11.9.3 herein) used in determining the royalty amount expressed in U.S. dollars (collectively, “ Royalty Reports ”).

11.9.2 Report Due Date . Royalty Reports shall be due on the [***] following the end of the [***] to which such Royalty Report relates. The Parties shall keep complete and accurate records in sufficient detail to properly reflect all gross sales and Net Sales and to enable the royalties payable hereunder to be determined.


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11.9.3 Exchange Rates . With respect to sales of Products invoiced in U.S. dollars, the gross sales, Net Sales, and royalties payable shall be expressed in U.S. dollars. With respect to sales of Products invoiced in a currency other than U.S. dollars, the gross sales, Net Sales and royalties payable shall be expressed in the currency of the invoice issued by the party making the sale together with the U.S. dollars equivalent of the royalty due, calculated at the average rate of exchange published as U.S. daily closing rates by Reuters during the applicable Calendar Quarter.

Article 12

FINANCIAL PROVISIONS FOR COLLABORATION PRODUCTS

Section 12.1 Development Costs . Unless otherwise provided in this Agreement, during the Term, SGI and Agensys shall [***] all Development Costs.

Section 12.2 Reporting and Payment of Development Costs .

12.2.1 Reports .

(a) Within [***] after the end of each Calendar Quarter during which any Development activities are performed hereunder, SGI shall report to Agensys SGI’s individual Development Cost items (with appropriate supporting information) actually incurred during such Calendar Quarter (the “ SGI Development Cost Report ”).

(b) Within [***] after the end of each Calendar Quarter during which any Development activities are performed hereunder, Agensys shall report to SGI Agensys’ individual Development Cost items (with appropriate supporting information) actually incurred during such Calendar Quarter (the “ Agensys Development Cost Report ”).

(c) The SGI Development Cost Reports and the Agensys Development Cost Reports will be in such form as the JSC may reasonably agree from time to time.

(d) Within [***] after the end of each Calendar Quarter, the JSC (or the Party appointed by the JSC) shall provide one consolidated Financial Statement for the Development Costs to each Party. Within [***] after receipt of the Financial Statement, the [***] .

Section 12.3 Collaboration Product Profit . During the Term, SGI and Agensys shall share equally (50:50) in all Product Profit created by each Collaboration Product.


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Section 12.4 Reporting and Payment of Commercialization Expenses and Product Profit .

12.4.1 Reports . Pursuant to Section 8.2 the Parties shall mutually agree, through the JSC, a mechanism or structure to under which they will share equally (50:50) in all Product Profit created by each Collaboration Product. In reaching this agreement the Parties shall also define and mutually agree, through the JSC, the appropriate arrangements for making reports and payments between the Parties.

Section 12.5 Product Profit Term . Unless this Agreement is earlier terminated pursuant to Article 17, the Parties shall share Product Profit hereunder with respect to each Collaboration Product until each such Collaboration Product is permanently withdrawn from, and is no longer being sold anywhere in, the Territory.

Section 12.6 Other Research Expenses, Development Costs and Commercialization Expenses . For purposes of clarity, the Parties hereto agree and acknowledge that all expenses which are not set forth in the Initial Collaboration Product Plan, or in an Manufacturing, Preclinical and Clinical Development Plan, or Commercialization Plan, (as each may be amended by the JSC from time to time), or otherwise approved by the JSC, shall be borne by the Party incurring such expenses.

Section 12.7 Internal Resources . The Parties agree and acknowledge that it is intended that the activities under each Manufacturing, Preclinical and Clinical Development Plan and Commercialization Plan, when taken as a whole for a given Calendar Year, be allocated and assigned to each Party such that the internal resources devoted to, and participation by the Parties in, the Development and Commercialization activities hereunder, taken as a whole, be substantially equal on an ongoing basis for such Calendar Year. The JSC may propose amendments to the Manufacturing, Preclinical and Clinical Development Plan and the Commercialization Plan as necessary to maintain substantial equality in resources devoted to, and participation by the Parties in, such activities for review and approval by the JSC.

Article 13

PAYMENT TERMS; BOOKS AND RECORDS; AUDIT

Section 13.1 Payment Terms .

13.1.1 Currency . All payments hereunder will be in United States dollars in immediately available funds and will be made by wire transfer from a United States bank located in the United States to such bank account as payee may designate in writing from time to time.

13.1.2 Exchange . All amounts accruing in a currency other than United States dollars will be converted to United States dollars using an exchange rate equal to the arithmetic average of the U.S. daily closing rates published by Reuters during the applicable Calendar Quarter for which payments are being made. The conversation calculations will be provided in any statement reporting converted amounts.

 

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13.1.3 Late Fee . Any payments or portions thereof due hereunder which are not paid on the date such payments are due under this Agreement will bear interest at a rate equal to the lesser of (i) the prime rate as published in The Wall Street Journal, Eastern Edition, under the heading “Money Rates,” on the first day of each calendar quarter in which such payments are overdue, plus [***] , or (ii) the maximum rate permitted by law, calculated on the number of days such payment is delinquent, compounded monthly using a three hundred sixty-five (365)-day year.

13.1.4 Legal Restrictions . If at any time legal restrictions prevent the prompt remittance of any monies owed with respect to the Products in any jurisdiction, the remitting Party will notify the receiving Party and make such payments by depositing the amount thereof in local currency in a bank account or other depository in such country in the name of the receiving Party or its designee, and the remitting Party will have no further obligations under this Agreement with respect thereto.

Section 13.2 Record Keeping . In accordance with GAAP consistently applied, each Party and its Affiliates will maintain, and will use Commercially Reasonable Efforts to cause its permitted sublicensees, contractors and agents to maintain, books of account and accurate records relating to the Collaboration Program and each Collaboration Product and Unilateral Product and all amounts payable or receivable under this Agreement, in sufficient detail to permit the other Party to confirm the correctness of such items. All books of account and records will be maintained for a period not less than relevant time permitted for audit of such accounts and records pursuant to Section 13.3 below and for any applicable tax period.

Section 13.3 Audits . Upon the written request of a Party (the “ Requesting Party ”) and not more than once in each Calendar Year, the other Party (the “ Responding Party ”) will permit an independent certified public accounting firm of nationally recognized standing, selected by the Requesting Party and reasonably acceptable to the Responding Party, at the Requesting Party’s expense, to have access during normal business hours to the records of the Responding Party as may be reasonably necessary to verify the accuracy of the reports provided under Articles 11 and 12, for any year ending not more than [***] prior to the date of such request. The provisions of Section 5.5.2 and Section 5.5.3 shall apply with respect to such inspection and the costs of such inspection, mutatis , mutandis .

Section 13.4 Tax Matters . Except as otherwise provided below, all amounts due from any paying Party to any receiving Party under this Agreement are gross amounts. The paying Party shall be entitled to deduct the amount of any withholding taxes payable or required to be withheld by it, its Affiliates, licensees, or sublicensees (as applicable) to the extent such paying Party, its Affiliates, licensees, or sublicensees (as applicable) actually pay such withheld amounts to the appropriate governmental authority on behalf of the receiving Party. The paying Party shall use Commercially Reasonable Efforts to minimize any such taxes, levies or charges required to be


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withheld on behalf of the receiving Party. The paying Party promptly shall deliver to the receiving Party proof of payment of all such taxes, levies and other charges, together with copies of all communications from or with such governmental authority with respect thereto, and shall cooperate with the receiving Party in seeking any related tax credits that may be available to the receiving Party with respect thereto.

Article 14

CONFIDENTIALITY

Section 14.1 Confidential Information . For purposes of this Agreement, “ Confidential Information ” means all information, data, documents (including, without limitation, unpublished patent applications), inventions, trade secrets, know-how or materials (collectively, “ Information ”) supplied by the other Party under this Agreement, whether disclosed orally, visually, in writing or in any tangible or electronic form or media, that is confidential or proprietary and is marked or otherwise identified as “Confidential” or which the receiving party should reasonably recognize as being confidential. Confidential Information may be owned by the disclosing Party or its Affiliates or held by the disclosing Party or its Affiliates under an obligation of confidentiality to a Third Party. Confidential Information of SGI shall include SGI Independent and Collaboration Know-How and SGI’s interest in any Improvements, Program Inventions, Collaboration Inventions and [***] . Confidential Information of Agensys shall include Agensys Independent and Collaboration Know-How, Agensys Materials and Agensys’ interest in Program Inventions and Collaboration Inventions. The terms of this Agreement shall be the Confidential Information of both Parties. Confidential Information of a Party may also include information relating to such Party’s or its Affiliates’ research programs, development, marketing, manufacturing, regulatory matters, business practices and finances. Information shall not be considered Confidential Information to the extent the receiving Party can demonstrate by competent evidence that such Information:

(a) has been published or otherwise entered the public domain other than by breach by the receiving Party or its Affiliates of this Article 14 or directly or indirectly under another agreement between the Parties that imposed obligations of confidentiality;

(b) has been disclosed to the receiving Party or its Affiliates by a Third Party, provided such Information was not obtained by such Third Party directly or indirectly from the disclosing Party or its Affiliates on a confidential basis;

(c) prior to disclosure by the disclosing Party under this Agreement or directly or indirectly under another agreement between the Parties that imposed obligations of confidentiality, was already in the possession of the receiving Party or its Affiliates; or

(d) was developed independently of and without reference to the disclosing Party’s or its Affiliates’ Confidential Information.


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Section 14.2 Non-Disclosure Obligations . Except as otherwise provided in this Article 14, during the Term and for a period of [***] thereafter, each Party shall maintain in confidence, and use only for purposes as expressly authorized and contemplated by this Agreement, all Confidential Information supplied by the other Party or its Affiliates under this Agreement. Each Party shall use at least reasonable care, and in no event less than the same standard of care as it uses to protect its own Confidential Information, to ensure that its and its Affiliates’ employees, agents, consultants and clinical investigators only make use of the other Party’s Confidential Information for purposes as expressly authorized and contemplated by this Agreement and do not make any unauthorized use or disclosures of such Confidential Information.

Section 14.3 Permitted Disclosures . Notwithstanding Section 14.1, Confidential Information may be disclosed by the receiving Party or its Affiliates solely to the extent such Confidential Information:

(a) is permitted to be disclosed by prior written consent of the other Party;

(b) is disclosed in the filing, prosecution or maintenance of patents solely in accordance with this Agreement, provided (i) such disclosure may be only to the extent reasonably necessary for such purpose and (ii) the receiving Party complies with the obligations set forth in Section 14.1 hereof;

(c) is disclosed to a Regulatory Authority solely in accordance with this Agreement to gain or maintain a Regulatory Approval provided such disclosure may be only to the extent reasonably necessary for such purpose;

(d) is deemed necessary by the receiving Party to be disclosed to such Party’s financial advisors, attorneys or independent accountants for the sole purpose of enabling such financial advisors, attorneys or independent accountants to provide professional advice to the receiving Party on the condition that such Third Parties are bound by confidentiality and non-use obligations customary for the type of professional and are advised that the information being disclosed is confidential;

(e) is deemed necessary by the receiving Party to be disclosed to accredited investors, lenders or potential acquirers or merger candidates in the context of due diligence investigations of such Party solely for the purpose of evaluating a potential business relationship, on the condition that such Third Parties are bound by confidentiality and non-use obligations (i) customary for the type of recipient in the case of all recipients who are not potential acquirers or merger candidates, and (ii) contained in this Agreement, in the case of potential acquirers or merger candidates, but in no event pursuant to (i) or (ii) for a term of less than [***] , and are advised that the information being disclosed is confidential;

(f) is deemed necessary by the receiving Party to be disclosed to such potential Sublicensees as permitted hereunder, provided that any such potential Sublicensee is bound by obligations of confidentiality and limitations on use of such Confidential Information contained herein; and


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(g) are disclosed to a potential or bona fide collaborator or manufacturing, development or sales contractor or partner, or Approved Subcontractor but only to the extent directly relevant to the collaboration, partnership or contract and provided that such collaborator, partner or contractor is bound by obligations of confidentiality and limitations on use of such Confidential Information contained herein.

Notwithstanding the disclosures permitted under subsections (a)-(g), such Confidential Information shall remain otherwise subject to the non-disclosure and non-use provisions of this Article 14.

Section 14.4 Compelled Disclosure . If a Party is required by law or judicial or administrative process to disclose Confidential Information of the other Party, the Party being compelled shall (if not prohibited from doing so) promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by law or judicial or administrative process shall remain otherwise subject to the non-disclosure and non-use provisions of this Article 14, and the Party disclosing Confidential Information pursuant to law or court order shall take all steps reasonably necessary, including without limitation seeking an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information. Each Party agrees that it shall cooperate fully and in a timely manner with the other with respect to all disclosures to the Securities and Exchange Commission and any other governmental or regulatory agencies, including requests for confidential treatment of Confidential Information of either Party included in any such disclosure.

Section 14.5 Press Releases . Neither SGI nor Agensys will, without the prior written consent of the other, issue any press release or make any other public announcement or furnish any statement to any person or entity (other than either Parties’ respective Affiliates) concerning the existence of this Agreement, its terms and the transactions contemplated hereby, except for (i) an initial press release mutually agreed upon by the Parties and (ii) disclosures made in compliance with Sections 14.3, 14.4 or 14.6.

Section 14.6 Publications Regarding Results of the ADC Research Program or the Collaboration Program . Neither Party may publish, present or announce results of the ADC Research Program or the Collaboration Program either orally or in writing (a “ Publication ”) without complying with the provisions of this Section 14.6. The other Party shall have [***] from receipt of a proposed Publication to provide comments and/or proposed changes to the publishing Party. The publishing Party shall take into account the comments and/or proposed changes made by the other Party on any Publication and shall agree to designate employees or others acting on behalf of the other Party as co-authors on any Publication describing results to which such persons have contributed in accordance with standards applicable to authorship of scientific publications. If the


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other Party reasonably determines that the Publication would entail the public disclosure of such Party’s Confidential Information and/or of a patentable invention upon which a patent application should be filed prior to any such disclosure, submission of the concerned Publication to Third Parties shall be delayed for such period as may be reasonably necessary for deleting any such Confidential Information of the other Party (if the other Party has requested deletion thereof from the proposed Publication), and/or the drafting and filing of a patent application covering such invention, provided such additional period shall not exceed [***] from the date the publishing Party first provided the proposed Publication to the other Party. Any disputes between the Parties regarding a publication shall be referred to the JSC, to the extent it is in existence at the time of such dispute.

Section 14.7 Existing Confidentiality Agreement . The Parties acknowledge having entered into a Non-Disclosure Agreement made as of [***] , and confirm that such Non-Disclosure Agreement shall remain in full force and effect and the confidentiality provisions in this Agreement shall be in addition to, and are not intended to supersede, such Non-Disclosure Agreement. Notwithstanding the foregoing, in the event of any conflict between the terms of the Non-Disclosure Agreement and the terms of this Agreement, the terms of this Agreement shall control with respect to the matters addressed by this Agreement.

Article 15

INVENTIONS AND PATENTS

Section 15.1 Ownership of Inventions and Technology; Use of Data .

15.1.1 Disclosure of Inventions . Each Party shall promptly disclose to the other Party the making, conception or reduction to practice of any Program Inventions, Collaboration Inventions or Improvements.

15.1.2 Ownership of Program Inventions . All right, title and interest in all Program Inventions that are discovered, made or conceived as part of the activities conducted pursuant solely to (x) the ADC Research Program, or (y) development or commercialization of Unilateral Products outside the Collaboration Program and in accordance with the rights and licenses set forth herein shall be owned as follows:

(a) Agensys shall own all Program Inventions that (i) are invented solely by one or more employees, agents or consultants of Agensys and do not primarily relate to the SGI Technology or SGI Products or (ii) are invented solely or jointly by employees, agents or consultants of Agensys and/or SGI and primarily relate to an [***] . To the extent that any such Program Inventions referred to in this Section 15.1.2 shall have been invented by SGI and are owned by SGI, SGI hereby assigns all of its right, title and interest therein to Agensys.

(b) SGI shall own all Program Inventions that (i) are invented solely by one or more employees, agents or consultants of SGI and do not primarily relate to an [***] , or (ii) are invented solely or jointly by employees, agents or consultants of Agensys and/or SGI and primarily relate to the [***] . To the extent that any Program Inventions referred to in this Section 15.1.2 shall have been invented by Agensys and are owned by Agensys, Agensys hereby assigns all of its right, title and interest therein to SGI.


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(c) Except as set forth in Sections 15.1.2(a) and 15.1.2(b), Agensys and SGI shall jointly own all other Program Inventions.

15.1.3 Ownership of Collaboration Inventions . All right, title and interest in all Collaboration Inventions that are discovered, made or conceived as part of the activities conducted pursuant to the Collaboration Program shall be owned as follows:

(a) [***] own all Collaboration Inventions that are invented solely or jointly by employees, agents or consultants of [***] and/or [***] primarily relate to a [***] . To the extent that any such Collaboration Inventions referred to in this Section 15.1.3(a) shall have been invented by [***] are owned by [***] hereby assigns all of its right, title and interest therein to [***] .

(b) [***] shall own all Collaboration Inventions that are invented solely or jointly by employees, agents or consultants of [***] and/or [***] primarily relate to the [***] , but [***] . To the extent that any Collaboration Inventions referred to in this Section 15.1.3(b) shall have been invented by [***] and are owned by [***] hereby assigns all of its right, title and interest therein [***] .

(c) Except as set forth in Sections 15.1.3(a) and 15.1.3(b), [***] and [***] shall [***] own all other Collaboration Inventions, including, without limitation, all [***] . In the event [***] .

15.1.4 Inventorship . Inventorship, for the purposes of this Agreement, shall be determined in accordance with U.S. laws of inventorship.

15.1.5 Ownership of Technology .

(a) Agensys shall own all right, title and interest in and to all Agensys Independent Know-How, Agensys Independent Patents, Agensys Materials, [***] , Agensys ADC Know-How, Agensys ADC Patents and Agensys Licensed Products.

(b) SGI shall own all right, title and interest in and to all SGI Technology, Drug Conjugation Materials and Drug Conjugation Technology.

(c) Agensys and SGI will jointly own all right, title and interest in and to all Joint Patents and Joint Know-How and, subject to the terms and conditions of this Agreement, during the term of this Agreement, neither Party nor its Affiliates will have the right to exploit any Joint Patents or Joint Know How without accounting to, or consent from, the other Party.


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Section 15.2 Employee Assignment and Disclosure . To the extent permissible under Applicable Law, each Party will cause each employee and contractor conducting work on such Party’s behalf under this Agreement to be subject to a contract that (a) compels prompt disclosure to the Party of all inventions and other intellectual property conceived, created or reduced to practice by such employee or contractor during any performance under the ADC Research Program or the Collaboration Program and (b) automatically assigns to the Party all right, title and interest in and to all such inventions and other intellectual property and all related Patents. Each Party will require each employee and contractor conducting work on such Party’s behalf under this Agreement to maintain records in sufficient detail and in a good scientific manner appropriate for patent purposes to properly reflect all work done. Each Party shall maintain separate books and records for performance of the ADC Research Program and performance of the Collaboration Program for patent purposes and to insure compliance by each Party with the intellectual property and other terms of this Agreement.

Section 15.3 Transfer of Agensys Technology . Agensys will use Commercially Reasonable Efforts to make available to SGI all Agensys Independent Technology and Agensys Collaboration Technology that is necessary for SGI to perform its obligations under this Agreement or is required to be provided pursuant to any Development Plan or Commercialization Plan. Without the prior written consent of Agensys, neither SGI nor its Affiliates may use any Agensys Independent Technology or Agensys Collaboration Technology that is Agensys Confidential Information for any purpose not expressly authorized by the terms of this Agreement. For the avoidance of doubt, any Agensys Technology to be transferred under the ADC Research Program is set forth in Section 3.8 and nothing in this Section 15.3 shall require Agensys to transfer any Technology for the ADC Research Program, except as expressly set forth in Section 3.8.

Section 15.4 Transfer of SGI Technology . SGI will use Commercially Reasonable Efforts to make available to Agensys all SGI Independent Technology and SGI Collaboration Technology that is necessary for Agensys to perform its obligations under this Agreement or is required to be provided pursuant to any Development Plan or Commercialization Plan. Without the prior written consent of SGI, neither Agensys nor its Affiliates may use any SGI Independent Technology or SGI Collaboration Technology that is SGI Confidential Information for any purpose not expressly authorized by the terms of this Agreement. For the avoidance of doubt, any SGI Technology to be transferred under the ADC Research Program is set forth in Section 3.9 and nothing in this Section 15.4 shall require SGI to transfer any Technology for the ADC Research Program, except as expressly set forth in Section 3.9.

Section 15.5 No Title Transfer . The transfer to a Party of any physical item that embodies any Independent Technology or Collaboration Technology owned by the transferring Party will not be, and will not be construed to be: (a) a sale, lease, offer to sell or lease or other transfer of title or ownership to the receiving Party of such Independent Technology or Collaboration Technology; or (b) a license to the receiving Party (except as expressly provided in this Agreement) under such Independent Technology or Collaboration Technology.

 

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Section 15.6 Patent Prosecution Maintenance and Enforcement of Independent Patents .

15.6.1 Prosecution . Each Party will have the exclusive right, but not the obligation, at its sole expense, to prepare, file, prosecute, maintain and abandon all of its Independent Patents. Expenses associated with preparation, filing, prosecution and maintenance of Independent Patents will not be IP and Trademark Costs. Each Party shall, at its sole expense, prepare, file, prosecute and maintain such Independent Patents in good faith consistent with its customary patent policy and its reasonable business judgment, and shall consider in good faith the interests of the other Party in so doing. If, during the term of this Agreement, either Party intends to allow any patent in that Party’s Independent Patents that may effect the development or commercialization of a Product hereunder to expire or intends to otherwise abandon any such patent, such Party shall notify the other Party of such intention at least [***] prior to the date upon which such patent shall expire or be abandoned, and the non-Controlling Party shall thereupon have the right, but not the obligation, to assume responsibility for the preparation, filing, prosecution or maintenance thereof, at its sole costs and expense.

15.6.2 . Enforcement . Each Party (the “ Controlling Party ”) will have the first right (but not the obligation) to take the appropriate steps to enforce or defend any Patent within its Independent Patents against an infringement by a Third Party. The Controlling Party may take steps including the initiation, prosecution and control any suit, proceeding or other legal action by counsel of its own choice. The Controlling Party will bear the costs of such enforcement or defense. Notwithstanding the foregoing, the non-Controlling Party will have the right, at its own expense, to be represented in any such action by counsel of its own choice. If the Controlling Party fails to take the appropriate steps to enforce or defend any Patent within its Independent Patents against an infringement by a Third Party with respect to any product that competes with an existing Collaboration Product or Unilateral Product, as the case may be, (an “ Infringing Product ”) within [***] after a request by the non-Controlling Party to do so, then the non-Controlling Party will have the right (but not the obligation), at its own expense, to bring any such suit, action or proceeding by counsel of its own choice and the Controlling Party will have the right, at its own expense, to be represented in any such action by counsel of its own choice.

15.6.2 Recoveries Relating to SGI Independent Patents . All monies recovered upon the final judgment or settlement of any such suit to enforce any SGI Independent Patents with respect to the manufacture, use or sale by Third Parties of an Infringing Product shall be allocated first to any Third Party from which SGI obtained a license with respect to such SGI Independent Patents, to the extent required under the relevant SGI In-License and to the extent SGI Independent Patents were the subject of the enforcement; second to the Party controlling the enforcement action to the extent necessary to compensate it for its expenses in its enforcement and to the other Party to the extent necessary to compensate it for its expenses in cooperating with the enforcement; and finally prorated in accordance with the damages for which such judgment or settlement is reasonably intended to compensate.


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15.6.2 Recoveries Relating to Agensys Independent Patents . All monies recovered upon the final judgment or settlement of any such suit to enforce any Agensys Independent Patents with respect to the manufacture, use or sale by Third Parties of an Infringing Product shall be allocated first to any Third Party from which Agensys obtained a license with respect to such Agensys Independent Patents, to the extent required under the relevant Agensys In-License and to the extent Agensys Independent Patents were the subject of the enforcement; second to the Party controlling the enforcement action to the extent necessary to compensate it for its expenses in its enforcement and to the other Party to the extent necessary to compensate it for its expenses in cooperating with the enforcement; and finally prorated in accordance with the damages for which such judgment or settlement is reasonably intended to compensate.

Section 15.7 Patent Prosecution and Maintenance of Collaboration Patents .

15.7.1 Independent Collaboration Patents . Each Party will have the exclusive right, but not the obligation, at its sole expense (subject to reimbursement under Section 12.2), to prepare, file, prosecute and maintain all of its Collaboration Patents. All reasonable costs and fees incurred by a Party in connection with preparation, filing, prosecution and maintenance of Collaboration Patents in a Major Market Country will be included as an element of IP and Trademark Costs. To the extent any Collaboration Patent is or becomes necessary for or important to performance by either Party of any aspect of the Collaboration Program or necessary for or important to manufacture or Commercialization of a Collaboration Product or SGI Product or Agensys Product, as the case may be, the Party owning such Collaboration Patent will exercise Commercially Reasonable Efforts consistent with good faith business practices to maintain Control of such Collaboration Patents.

(a) To the extent a Party elects not to file for a Collaboration Patent in a Major Market Country or elects to abandon any Collaboration Patent already filed in any country, that Party will notify the other Party in writing not less than [***] prior to the date such election is irrevocable without additional cost, and will offer the other Party the opportunity to assume, [***] , the right to file for, prosecute and maintain such Collaboration Patent in such country. If the other Party accepts the offer by written notice to the first Party, the first Party will assign such Collaboration Patent to the other Party and will reasonably assist the other Party in assuming the filing, prosecution and maintenance of such Collaboration Patent in such country. Such Collaboration Patent thereafter will be the other Party’s Independent Patent.

(b) With respect to each United States Patent that is a Collaboration Patent, not less than [***] before filing any application for corresponding patent protection in foreign countries, the Party owning the Collaboration Patent will give to the JSC a copy of the priority application and written notice of the foreign countries selected for filing. The JSC, in writing within [***] after such notice, may reject any selected country outside the Major Market Countries and may request filing of applications in additional foreign countries. The Party will file in such additional countries and may file in the rejected countries. All reasonable costs associated with filing, prosecution and maintenance of Patents in Major Market Countries and in any such additional countries requested by the JSC will be included as an element of IP and Trademark Costs (as applicable).


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(c) Pursuant to schedules determined by the JSC, each Party will provide to the other Party a written report of the status of each pending and issued Collaboration Patent.

15.7.2 Joint Collaboration Patents .

(a) The JSC will select mutually-acceptable outside counsel (to be agreed upon by the JSC within [***] of the Effective Date) to conduct the preparation, filing, prosecution and maintenance of each Joint Collaboration Patent under the joint control of both Parties. The outside counsel will prepare, file, prosecute and maintain all Joint Collaboration Patents in each of the Major Market Countries and such other countries as the JSC approves, and the reasonable expenses thereof will be IP and Trademark Costs (as applicable).

(b) If a Party elects not to share the cost of a Joint Collaboration Patent in any country (other than a Major Market Country or such other countries as the JSC approves) or elects to discontinue sharing expenses for any Joint Collaboration Patent already filed in any country, such Party will notify the other Party in writing of such election and will offer the other Party the opportunity to assume, at the other Party’s sole expense, the right to file for, prosecute and maintain such Joint Collaboration Patent in such country. If the other Party accepts the offer by written notice to the one Party within [***] after the notice, the one Party will assign its interest in such Joint Collaboration Patent to the other Party and will reasonably assist the other Party in assuming the filing, prosecution and maintenance of such Joint Collaboration Patent in such country. Such Joint Collaboration Patent thereafter will be the other Party’s Independent Patent.

(c) With respect to filing, prosecution and maintenance of each Joint Collaboration Patent, the outside counsel will provide to each Party: (i) a copy of the patent application sufficiently prior to filing to permit each Party reasonable opportunity to review and make reasonable comments thereon; (ii) a copy of the patent application promptly after such filing; (iii) copies of all substantive communications received from patent office(s) with respect to such filings; and (iv) copies of all substantive communications to be sent to the patent office(s) with respect to such filings sufficiently before a due date to permit each Party to review and make reasonable comments thereon.

(d) Each Party, when requested by the outside counsel, will use commercially reasonable efforts to assist the counsel in preparing, filing or maintaining the patent applications and patents within the Joint Collaboration Patents. The reasonable expenses associated with providing such assistance will be IP and Trademark Costs.


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Section 15.8 Independent Collaboration Patents Enforcement . Each Party will promptly notify the other Party in writing if it learns of any actual, alleged or threatened infringement of any Collaboration Patent by a Third Party. The Party Controlling the affected Collaboration Patent will have the first right, but not the obligation, at its own expense, to bring suit (or take other appropriate legal action) against any actual, alleged or threatened infringement of the Collaboration Patent by a Third Party, including the defense and settlement. If the Controlling Party does not initiate an infringement action or otherwise take affirmative measures to abate any such actual, alleged or threatened Third Party infringement of the Collaboration Patent within [***] of the later of: (a) receiving notification from the other Party under this Section 15.8 of such infringement; (b) sending notice to the other Party under this Section 15.8 of such infringement; or (c) receiving a written request from the other Party to take action with respect to such infringement, then the other Party will have the right, but not the obligation, [***] , to bring suit (or take other appropriate legal action) against any such actual, alleged or threatened infringement of the Collaboration Patent by a Third Party, including the defense and settlement thereof. In the event either Party brings an infringement action in accordance with this Section 15.8, such Party will notify the other Party in writing at least [***] prior to filing such action and the other Party will provide reasonable assistance and authority to file and bring the action, including, if required to bring such action, being joined as a party plaintiff; provided, however, that neither Party will be required to transfer any right, title or interest in or to any of its Collaboration Patents to the other Party or a Third Party to confer standing on a Party hereunder. In addition, if either Party brings an infringement action hereunder, the other Party will have the right to be represented separately in such action by counsel of its own choice, [***] . Any recovery realized as a result of such suit, claim or action or related settlement will first be applied [***] . Reasonable expenses not offset will be IP and Trademark Costs; provided, however, that the Party not bringing the infringement action may, by written notice to the other Party within [***] from receipt of the notice of intent to file such action, [***] , in which event [***] and the Party electing [***] .

Section 15.9 Joint Collaboration Patents Enforcement . A Party wishing to enforce a Joint Collaboration Patent against infringement will notify the JSC in writing and identify the accused infringer(s). If both Parties approve of the action through the JSC, any monetary recovery will be considered Product Profit and all reasonable expenses incurred in the enforcement action will be IP and Trademark Costs. If the enforcement action for infringement is not approved by both Parties through the JSC, the Party wishing to enforce a Joint Collaboration Patent may still bring the action, but such Party will be solely responsible for all expenses incurred in the enforcement action and will be solely entitled to retain any monetary recovery. In either case, the other Party will cooperate in any such action by (i) agreeing to be named as party to the action solely to the extent necessary to maintain the action, and (ii) not granting any license under the Joint Collaboration Patent to the identified accused infringer(s) until after such action is finally resolved. Neither Party will settle the action without the other Party’s prior written consent, which consent will not be unreasonably withheld or delayed, if the terms of settlement would deprive the other Party of its rights in the asserted Joint Collaboration Patents.


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Section 15.10 Patent Prosecution, Maintenance and Enforcement of Joint Program Improvement Patents.

15.10.1 Patent Prosecution and Maintenance . Patents claiming Program Inventions owned jointly by both Parties in accordance with Section 15.1.2(c) (“ Joint Program Invention Patents ”) shall be controlled, prepared, filed, prosecuted and maintained by an outside legal firm mutually agreed to between the Parties, under the direction and control (a) of SGI, if primarily related to [***] , (b) of Agensys, if primarily related to an [***] or (c) of both Parties, if such Joint Patents are not covered under (a) or (b) above. The Party responsible for filing and controlling patent prosecution and maintenance for Program Inventions, as the case may be, shall provide to the other Party copies of any response, document or communication with patent authorities that could materially affect the scope of any Patent covering Program Inventions or detrimentally effect the rights of the Parties in such inventions in any way, at least [***] prior to the planned submission or communication. Such other Party shall have the opportunity to comment on the response or document within such [***] period, which comments shall be reasonably considered by the Party primarily responsible for the prosecution. If either Party decides not to continue prosecuting Patent or not to maintain a Patent claiming an invention assigned to such Party pursuant to Section 15.1.2 in whole or in part, then such Party shall promptly so notify the other Party (which notice shall be at least [***] before any relevant deadline for such Patent). Thereafter, the other Party shall have the right to prosecute or maintain such Patent, at such Party’s sole expense.

15.10.2 Enforcement of Joint Program Improvement Patents . In the event either Party becomes aware of an infringement by a Third Party of a Joint Program Improvement Patent, it shall promptly notify the other Party and the Parties shall determine a mutually agreeable course of action, prior to any action being taken by either Party.

15.10.3 Recoveries . All monies recovered upon the final judgment or settlement of any such suit to enforce any Joint Patents shall be allocated (i) first to the costs and expenses of the Party taking such action, (ii) second to the costs and expenses (if any) of the other Party, and (iii) any remaining amounts shall be shall be shared equally between the Parties.

Section 15.11 Defense of Third Party Infringement Actions. If Agensys, SGI or any of their respective Affiliates, or Sublicensees, is sued by a Third Party for infringement of a Third Party’s patent because of the use of the SGI Technology or the Agensys Technology in connection with activities conducted pursuant to this Agreement, the Party that has been sued shall promptly notify the other Party within [***] of its receipt of notice of such suit. The notice shall set forth the facts of such infringement available to the relevant Party. The Parties shall then meet to discuss each Party’s commercial interests in the defense of the suit, a plan for the defense of the suit, how the costs of the suit should be allocated, and which Party should have primary control of the suit, provided that if such infringement relates previously to (i) SGI Technology, then SGI shall have the first right to control such suit and (ii) Agensys Technology, then Agensys shall have the first right to control such suit. In no event may the Party controlling the suit settle or otherwise consent to an adverse judgment in such suit that diminishes the rights or interests of the non-controlling Party without the express written consent of the non-controlling Party. If the alleged infringement relates to a Collaboration Product, all reasonable costs associated with the defense of the action will be IP and Trademark Costs, and any payment due to such Third Party as damages or in settlement


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allocated to sales of Collaboration Products during the term of this Agreement will be IP and Trademark Costs if approved in advance in writing by both Parties. Any settlement that requires payment to the Third Party for the prospective right to Commercialize the Collaboration Product will require prior written approval of both Parties. Each Party will individually bear the risks and costs of infringing Third Party Patents for its activities which are outside the scope of this Agreement.

Section 15.12 Cooperation . The Parties shall at all times fully cooperate in order to reasonably implement the foregoing provisions, such cooperation may include the execution of necessary legal documents, coordinating filing and/or prosecution of applications to avoid potential issues during prosecution including novelty, enablement, estoppel and double patenting, execution of amendments and documents for reliance on the CREATE Act (if needed), and the provision of the assistance of its relevant personnel. Without limiting the forgoing, it is understood that even if a Party is permitted to reference the other Party’s Technology in a Patent pursuant to this Article 15, it shall not file any such Patent without first confirming with the non-filing Party in writing that any such filing could not reasonably be expected to adversely affect such Party’s patent strategy. If the non-filing Party determines that any such filing could adversely affect its filing strategy, the filing Party shall not file any such Patent and the Parties shall cooperate in accordance with this Section 15.12 to determine a strategy forward that would protect each Party’s interests, including, without limitation, delaying the filing or co-owning such Patent, as the case may be. Except as otherwise provided in this Agreement, Agensys shall not disclose and/or claim in any patent application, patent or publication any Confidential Information within any SGI Technology, Drug Conjugation Technology or Drug Conjugation Materials without SGI’s prior written consent. Except as otherwise provided in this Agreement, SGI shall not disclose and/or claim in any patent application, patent or publication any Confidential Information within any Agensys Technology without Agensys’ prior written consent.

Section 15.13 Prior Patents . Notwithstanding anything to the contrary in this Agreement, with respect to any SGI Patents that are subject to the SGI In-Licenses or Agensys Independent Patents, Agensys Collaboration Patents and Agensys ADC Patents that are subject to the Agensys In-Licenses, the rights and obligations of the Parties under this Article 15 shall be subject to such Party’s licensors’ rights to participate in and control prosecution, maintenance and enforcement of such Party’s Patents, and to receive a share of damages recovered in such action, in accordance with the terms and conditions of the applicable Party’s In-License.

Article 16

REPRESENTATIONS AND WARRANTIES; ADDITIONAL COVENANTS

Section 16.1 Representations and Warranties .

16.1.1 This Agreement has been duly executed and delivered by each Party and constitutes the valid and binding obligation of each Party, enforceable against such Party in accordance with its terms, except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium or other laws relating to or affecting creditors’ rights generally and by general equitable principals. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of each Party, its officers and directors.

 

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16.1.2 The execution, delivery and performance of the Agreement by each Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

16.1.3 SGI represents and warrants that: (a) the [***] ; (b) it has the right to grant the licenses granted herein and that as of the Effective Date [***] ; (c) as of the Effective Date, [***] ; (d)  [***] ; (e)  [***] ; and (f) as of the Effective Date, (i)  [***] , (ii)  [***] .

16.1.4 Agensys represents and warrants that: (a)  [***] ; (b) as of the Effective Date, [***] ; (c)  [***] ; (d)  [***] ; and (f) as of the Effective Date, (i)  [***] , (ii)  [***] , and (iii)  [***]. Agensys represents and warrants, as of the Effective Date, [***] .

Section 16.2 Represented by Counsel . Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted such terms and provisions.

Section 16.3 Debarment . Each Party represents and warrants to the other Party that neither it, nor any of its Affiliates, has been debarred or is subject to debarment. Each Party covenants to the other Party that neither such Party nor any of its Affiliates will use in any capacity, in connection with the services to be performed under this Agreement, any Party who has been debarred pursuant to Section 306 of the Federal Food, Drug, and Cosmetic Act, as amended, or who is the subject of a conviction described in such section. Each Party will inform the other Party in writing immediately if it or any Third Party who is performing services under this Agreement is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to such Party’s knowledge, is threatened, relating to the debarment or conviction of such Party or any Third Party performing services hereunder.

Section 16.4 Maintenance of In-Licenses .

16.4.1 SGI In-Licenses. SGI covenants that (a) it will use Commercially Reasonable Efforts to maintain all SGI In-Licenses for the duration of this Agreement, (b) it shall not [***] and (c) it shall provide Agensys with prompt written notice if it receives or issues any notice of breach or alleged breach under the SGI In-Licenses. Without the prior written approval of Agensys, SGI will not consent to any modifications to the SGI In-Licenses or take any other action or fail to take any action that would have the effect of imposing any greater financial or other obligations on, or impairing the exercise of or reduce the rights granted hereunder to, Agensys, its Affiliates or Sublicensees.


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16.4.2 Agensys In-Licenses. Agensys covenants that (a) it will use Commercial Reasonable Efforts to maintain all Agensys In-Licenses for the duration of this Agreement and (b) it shall provide SGI with prompt written notice if it receives or issues any notice of breach or alleged breach under the Agensys In-Licenses. Without the prior written approval of SGI, Agensys will not consent to any modifications to the Agensys In-Licenses or take any other action or fail to take any action that would have the effect of imposing any greater financial or other obligations on, or impairing the exercise of or reduce the rights granted hereunder to, SGI, its Affiliates or Sublicensees.

Section 16.5 Disclaimer of Warranties . EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 16 AND SECTION 11.7.1, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO ANY PRODUCTS, COLLABORATION TECHNOLOGY, COLLABORATION PATENTS, OR ANY OF ITS INDEPENDENT TECHNOLOGY OR INDEPENDENT PATENTS, OR THAT THE MANUFACTURE, USE, SALE, OFFER FOR SALE, IMPORT, COPYING OR DISTRIBUTION OF ANY PRODUCT OR METHOD SUBJECT TO THIS AGREEMENT WILL NOT INFRINGE OR MISAPPROPRIATE THE INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY. EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 16, ALL TECHNOLOGY PROVIDED BY ONE PARTY TO THE OTHER PARTY PURSUANT TO THIS AGREEMENT IS PROVIDED “AS IS.”

Article 17

TERM AND TERMINATION

Section 17.1 Term . Unless earlier terminated pursuant to this Article 17, the term of this Agreement (the “ Term ”) shall commence on the Effective Date and shall remain in full force and effect until the later of: (a) the expiration of all payment obligations under this Agreement, or the (b) day upon which the Parties cease all Development and Commercialization of Collaboration Products.

Section 17.2 Termination for Convenience by Agensys . Agensys shall have the right to terminate any Research License(s), any Exclusive License(s) or any license granted under Section 10.1.5 to Agensys Products and/or Agensys Licensed Products under this Agreement by providing not less than [***] prior written notice to SGI of such termination. Any such termination by Agensys under this Section 17.2 shall not affect the other Research Licenses, Exclusive Licenses, Agensys Product, Agensys Licensed Product, or Collaboration Product licenses or any sublicense agreement then in effect with respect to the non-terminated licenses. The foregoing notwithstanding, [***] . [***] shall terminate and any [***] . In addition, [***] , immediately upon notice from SGI that SGI intends to [***] .


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Section 17.3 Termination for Convenience by SGI . SGI shall have the right to terminate any license granted under Section 10.2.3 to SGI Products by providing not less than [***] prior written notice to Agensys of such termination. Any such termination under this Section 17.3 shall not affect the other SGI Product or Collaboration Product licenses or any sublicense agreement then in effect with respect to the non-terminated licenses.

Section 17.4 Termination by Mutual Agreement . The Parties may agree to terminate the Agreement at any time on mutually agreed upon terms.

Section 17.5 Termination for Cause . Either Party may terminate this Agreement for material breach by the other Party (the “ Breaching Party ”) of any material provision of the Agreement, if the Breaching Party has not cured such breach within [***] after written notice thereof. Following receipt of a notice of breach, the Breaching Party may (i) cure such asserted material breach within [***] after actual receipt of such written notice (or such longer period as may be agreed by the Parties) or (ii) if the Breaching Party disagrees that it is in material breach, initiate dispute resolution pursuant to Section 23.3, whereupon the cure period shall be tolled until the dispute is resolved.

Section 17.6 Termination Upon Bankruptcy . Either Party may terminate this Agreement if, at any time, (a) the other Party shall file in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy under Chapter 7 of the U.S. Bankruptcy Code, (b) such other Party shall be served with an involuntary petition in bankruptcy under Chapter 7 of the U.S. Bankruptcy Code against it, and such petition shall not be dismissed within sixty (60) days after the filing thereof, (c) such other Party shall propose or be a party to any dissolution or liquidation, other than a dissolution or liquidation for the purpose of completing a reorganization, consolidation or merger with another entity, or (d) such other Party shall make an assignment for the benefit of its creditors. All rights and licenses granted under this Agreement are, and shall be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(56) of the United States Bankruptcy Code. The Parties agree that in the event of the commencement of a bankruptcy proceeding by or against one Party hereunder under the United States Bankruptcy Code, the other Party shall be entitled to complete access to any such intellectual property, and all embodiments of such intellectual property, pertaining to the rights granted in the licenses hereunder of the Party by or against whom a bankruptcy proceeding has been commenced, subject, however, to payment of the fees, milestone payments and royalties set forth in this Agreement through the effective date of any termination hereunder.


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Section 17.7 Termination of In-Licenses . All rights and obligations under an Agensys In-License sublicensed under this Agreement shall terminate upon [***] prior written notice by Agensys to SGI if SGI performs any action that would constitute a material breach of any material provision of such Agensys In-License Agreement and fails to cure such breach within such [***] period; provided, however, such cure period may be extended by mutual written consent of the Parties. All rights and obligations under an SGI In-License sublicensed under this Agreement shall terminate upon [***] prior written notice by SGI to Agensys if Agensys performs any action that would constitute a material breach of any material provision of such SGI In-License Agreement and fails to cure such breach within such [***] period; provided, however, such cure period may be extended by mutual written consent of the Parties. All rights and obligations under the [***] shall automatically terminate if Agensys fails to maintain the insurance required under Article 22 of this Agreement.

Section 17.8 Effect of Termination of Entire Agreement or Rights to a Particular Product .

17.8.1 Termination of Entire Agreement . Upon termination of this Agreement in its entirety for any reason and except as otherwise set forth in Section 17.9, all rights and licenses granted to a Party hereunder shall immediately terminate and be of no further force and effect and each Party, its Affiliates and Sublicensees will immediately cease all research, development, commercialization and selling of Collaboration Products and Unilateral Products, and all SGI Technology shall revert to SGI and all Agensys Technology shall revert to Agensys, and each Party shall immediately, at its sole cost and expense, return all material tangible manifestations of such intellectual property to the other Party, including, all data, Information and materials.

17.8.2 Termination of Rights with respect to a Unilateral Product . Upon termination of this Agreement with respect to a particular Unilateral Product pursuant to Section 17.2 or 17.3, all rights and licenses granted to a Party hereunder shall immediately terminate and be of no further force and effect with respect to such Unilateral Product and each Party, its Affiliates and Sublicensees will immediately cease all research, development, commercialization and selling of such Unilateral Product, and all SGI Technology shall revert to SGI and all Agensys Technology shall revert to Agensys, as applicable, with respect to such Unilateral Product and each Party shall immediately, at its sole cost and expense, return all material tangible manifestations of such intellectual property to the other Party with respect to such Unilateral Product, including, all data, Information and materials.

Section 17.9 Termination by Agensys .

17.9.1 General . In the event that this Agreement is terminated by Agensys pursuant to [***] or by either Party pursuant to [***] , Agensys shall (i) continue to have all Exclusive Licenses then in effect, subject to its continued payment of the applicable fees, milestone payments and royalties with respect thereto as set forth in Article 11, (ii) any Sublicense agreement in effect as of the date of such termination that is not the subject of the material breach shall not terminate but instead, at the election of Agensys in its sole discretion, shall become a direct license between Agensys and the Sublicensee and shall otherwise continue in full force and effect in accordance with its terms, subject to each such Sublicensee signing a written acknowledgement with


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Agensys agreeing to be bound by all of the terms and conditions of this Agreement applicable to such Sublicensee and (iii) Agensys may elect to continue to Develop and Commercialize any Collaboration Product hereunder, subject to its continued payment of the applicable fees, milestone payments and royalties with respect thereto as set forth in Article 11, in which case the license granted under Section 10.1.5 shall survive termination of the Agreement and any such Collaboration Product shall be an Agensys Product hereunder.

17.9.2 Grant Back . Upon any termination by [***] and in the case of any Designated Antigens for which the Option Period has expired, [***] . For the avoidance of doubt: (a) the purpose of this Section 17.9.2 is to allow [***] .

Section 17.10 Termination by SGI . In the event that this Agreement is terminated by SGI pursuant to [***] or [***]  all licenses granted by SGI to Agensys hereunder, including all Exclusive Licenses, will immediately terminate and (b) any Sublicense agreement in effect as of the date of such termination that is not the subject of the material breach shall not terminate but instead, shall become a direct license between SGI and the Sublicensee and shall otherwise continue in full force and effect in accordance with its terms, subject to each such Sublicensee signing a written acknowledgement with SGI agreeing to be bound by all of the terms and conditions of this Agreement applicable to such Sublicensee and (c) SGI may elect to continue to Develop and Commercialize any Collaboration Product hereunder, subject to its continued payment of the applicable fees, milestone payments and royalties with respect thereto as set forth in Article 11, in which case the license granted under Section 10.2.3 shall survive termination of the Agreement and any such Collaboration Product shall be an SGI Product hereunder.

Section 17.11 Rights and Obligations Not Extinguished . Except where explicitly provided within this Agreement, termination of this Agreement for any reason, or expiration of this Agreement, will not affect any: (a) obligations, including payment of any royalties or other sums which have accrued as of the date of termination or expiration, and (b) rights and obligations which, explicitly survive pursuant to this Article 17, or from the context thereof, are intended to survive termination or expiration of this Agreement, including provisions of Articles 1 (to the extent necessary in interpreting the other provisions which survive hereunder), 13, 14, 15 and 18 through 23 and Sections 5.5, 6.3.2 (to the extent applicable to effectuate the purposes thereof), 7.5, 8.7, 8.10, 8.13, 16.5, 17.8, 17.9, 17.10 and 17.11, and any payment obligations pursuant to Section 4.5 and Articles 11 and 12 incurred prior to termination or incurred as the result of a Party exercising licenses retained by such Party after termination of this Agreement.

Section 17.12 Expiration of Royalty Term . Upon the expiration of the Royalty Term:

17.12.1 SGI shall grant, and shall by this provision be deemed to have granted, to Agensys a royalty-free, perpetual, worldwide, nonexclusive license to use the SGI Technology to make, use, sell, offer for sale and import Agensys Licensed Products and Agensys Products with no further obligation to SGI; and


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17.2.2 Agensys shall grant, and shall by this provision be deemed to have granted, to SGI a royalty-free, perpetual, worldwide, nonexclusive license to use the Agensys Technology to make, use, sell, offer for sale and import SGI Products, with no further obligation to Agensys.

Article 18

INDEMNITY

Section 18.1 Direct Indemnity for Unilateral Products .

18.1.1 Each Party shall defend, indemnify and hold harmless the other Party, its Affiliates and their respective directors, officers, employees and agents (collectively, the “ Indemnitees ”) from and against all liabilities, losses, damages, and expenses, including reasonable attorneys’ fees and costs, (collectively, the “ Liabilities ”) resulting from all Third Party claims, suits, actions, or demands (collectively, the “ Claims ”) that are incurred, relate to or arise out of (a) the material breach of any material provision of this Agreement by the indemnifying Party (or the inaccuracy of any representation or warranty made by such Party in this Agreement), or (b) the gross negligence, recklessness or willful misconduct of the indemnifying Party in connection with the performance of its obligations hereunder.

18.1.2 Agensys shall defend, indemnify and hold harmless SGI Indemnitees from and against all Liabilities resulting from all Claims that are incurred, relate to or arise out of (a) the development, manufacture or commercialization of Agensys Licensed Products or Agensys Products by SGI for Agensys or by Agensys, its Affiliates or Sublicensees, including any failure to test for or provide adequate warnings of adverse side effects, or any manufacturing defect in any Agensys Licensed Product or Agensys Product; (b) any claims of infringement of Third Party rights arising out of the use of Agensys Technology to research, develop, manufacture or commercialize an SGI Product; and (c) any [***] , except in each case to the extent such Liabilities resulted from the gross negligence, recklessness or willful misconduct by SGI or the inaccuracy of any representation or warranty made by SGI in this Agreement or from any other action for which SGI must indemnify Agensys under Section 18.1.3.

18.1.3 SGI shall defend, indemnify and hold harmless Agensys Indemnitees from and against all Liabilities resulting from all Claims that are incurred, relate to or arise out of (a) the development, manufacture or commercialization of SGI Products by Agensys for SGI or by SGI, its Affiliates or Sublicensees, including any failure to test for or provide adequate warnings of adverse side effects, or any manufacturing defect in any SGI Product; and (b) any claims of infringement of Third Party rights arising out of the use of SGI Technology to research, develop, manufacture or commercialize an Agensys Licensed Product or Agensys Product, except to the extent such Liabilities resulted from the gross negligence, recklessness or willful misconduct by Agensys or the inaccuracy of any representation or warranty made by Agensys in this Agreement or any other action for which Agensys must indemnify SGI under Section 18.1.2.


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Section 18.2 Collaboration Products .

18.2.1 Each Party hereby agrees to indemnify, defend, and hold harmless the other Party’ Indemnitees from and against any and all Liabilities, incurred as a result of any Claims relating to the manufacture, use, handling, storage, Commercialization or other disposition of any Collaboration Product by the indemnifying Party, its Affiliates, employees, agents or Sublicensees, but only to the extent such Claims result from: (i) the negligence, recklessness or willful misconduct of the indemnifying Party, its Affiliates, employees, agents or sublicensees; or (ii) any breach by the indemnifying Party of any of its representations, warranties, covenants or obligations pursuant to this Agreement; except, in each case, to the comparative extent of any such Claim resulting from the negligence or willful misconduct of the Indemnitees.

18.2.2 Except for those Claims subject to Section 18.2.1, the Parties shall [***] in connection with: (i) any Claim brought against either Party by a Third Party resulting directly or indirectly from the manufacture, use, handling, storage, Commercialization or other disposition of any given Collaboration Product (in same manner as the Parties share Product Profit); and (ii) the defense or settlement of claims of infringement of Third Party patent rights in accordance with the procedures set forth in Section 15.11.

18.2.3 If either Party receives notice of a Claim with respect to any Collaboration Product, such Party shall inform the other Party in writing as soon as reasonably practicable. The Parties shall confer through the JSC how to respond to the Claim and how to handle the Claim in an efficient manner. In the absence of such an agreement, each Party shall have the right to take such action as it deems appropriate, subject to Section 18.3.

Section 18.3 Procedure . If a Party (the “ Indemnified Party ”) intends to claim indemnification under this Article 18 it will promptly notify the other Party (the “ Indemnitor ”) in writing of any Claim for which the Indemnified Party intends to claim such indemnification, and the Indemnitor may participate in, and, to the extent the Indemnitor so desires, assume the defense of such Claim with counsel selected by the Indemnitor and reasonably satisfactory to the Indemnified Party; provided, however, that an Indemnified Party will have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitor, if representation of such Indemnified Party by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between the Indemnified Party and any other Party represented by such counsel in such proceeding. The obligations of this Article 18 will not apply to amounts paid in settlement of any Claim if such settlement is effected without the consent of the Indemnitor, which consent will not be unreasonably withheld or delayed. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, will relieve the Indemnitor of any obligation to the Indemnitee under this Article 18 to the extent of such prejudice. The Indemnified Party will reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any Claim covered by this Article 18.


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Article 19

FORCE MAJEURE

No Party (or any of its Affiliates) shall be held liable or responsible to the other Party (or any of its Affiliates), or be deemed to have defaulted under or breached the Agreement, for failure or delay by such Party in fulfilling or performing any term of the Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party (or any of its Affiliates), including fire, floods, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, acts of God, earthquakes, or omissions or delays in acting by any governmental authority (collectively, “ Events of Force Majeure ”); provided, however, that the affected Party shall exert all reasonable efforts to eliminate, cure or overcome any such Event of Force Majeure and to resume performance of its covenants promptly. Notwithstanding the foregoing, to the extent that an Event of Force Majeure continues for a period in excess of [***] , the affected Party shall promptly notify in writing the other Party of such Event of Force Majeure and within [***] of the other Party’s receipt of such notice, the Parties shall negotiate in good faith either (a) a resolution of the Event of Force Majeure, if possible, (b) an extension by mutual agreement of the time period to resolve, eliminate, cure or overcome such Event of Force Majeure, (c) an amendment of this Agreement to the extent reasonably possible, or (d) an early termination of this Agreement.

Article 20

ASSIGNMENT

This Agreement may not be assigned or otherwise transferred, nor, except as expressly provided hereunder, may any right or obligations hereunder be assigned or transferred to any Third Party by either Party without the written consent of the other Party, such consent not to be unreasonably withheld; provided, however, that either Party may, without such consent but with notification, assign this Agreement and its rights and obligations hereunder to any of its Affiliates or in connection with the transfer or sale of all or substantially all of its business, or in the event of its merger or consolidation of such Party (such merger or consolidation shall be hereinafter referred to as a “ Change in Control ”). Any permitted assignee shall assume all rights and obligations of its assignor under this Agreement; provided, however, that an acquirer of SGI in connection with a Change of Control shall not be obligated, but shall have the right, to disclose or offer to Agensys pursuant to Section 10.4 any Improvements or New Technologies Controlled by such acquirer prior to the Change of Control, or any Improvements or New Technologies Controlled by such acquirer after a Change of Control. Any attempted assignment of this Agreement not in accordance with this Article 20 shall be void and of no effect.


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Article 21

SEVERABILITY

Each Party hereby agrees that it does not intend to violate any public policy, statutory or common laws, rules, regulations, treaty or decision of any government agency or executive body thereof of any country or community or association of countries. Should one or more provisions of this Agreement be or become invalid, the Parties hereto shall substitute, by mutual consent, valid provisions for such invalid provisions, in their economic effect, are sufficiently similar to the invalid provisions that it can be reasonably assumed that the Parties would have entered into this Agreement based on such valid provisions. In case such alternative provisions cannot be agreed upon, the invalidity of one or several provisions of this Agreement shall not affect the validity of this Agreement as a whole, unless the invalid provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid provisions.

Article 22

INSURANCE

During the Term and thereafter for the period of time required below, each Party shall maintain an [***] . Commencing not later than [***] prior to the first use in humans of any Collaboration Product, Agensys Licensed Product or Agensys Product utilizing [***] and thereafter for the period of time required below, Agensys shall obtain and maintain on an [***] . Commencing not later than [***] prior to the first use in humans of any Collaboration Product or SGI Product, and thereafter for the period of time required below, SGI shall obtain and maintain on an [***] . All of such insurance coverage shall be maintained with an insurance company or companies having an [***] or better and an aggregate deductible not to [***] . Upon the Effective Date and not later than [***] prior to the [***] of the first Collaboration Product, Agensys Licensed Product, Agensys Product or SGI Product, as the case may be, each Party shall provide to other Party a certificate(s) evidencing all required coverage hereunder. Each Party shall maintain such insurance coverage without interruption during the Term and for a period of at [***] thereafter. Each Party’s insurance shall name the other Party and (if any Collaboration Product, Agensys Licensed Product or Agensys Product utilizes [***] ) [***] as additional insureds on the products liability insurance required hereunder and shall state that the other Party shall be provided at least [***] prior written notice of any cancellation or material change in the insurance policy. The cost of insurance required by this Article 22 with respect to Collaboration Products shall be treated as an “other cost” for the purposes of calculating Product Profit.

Article 23

MISCELLANEOUS

Section 23.1 Notices . Any consent, notice or report required or permitted to be given or made under this Agreement by one of the Parties hereto to the other shall be in writing, delivered personally or by facsimile (and promptly confirmed by personal delivery, first class air mail or courier), first class air mail or courier, postage prepaid (where applicable), addressed to such other Party at its address indicated below, or to such other address as the addressee shall have last furnished in writing to the address or in accordance with this Section 23.1 and (except as otherwise provided in this Agreement) shall be effective upon receipt by the addressee.


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If to SGI:

Seattle Genetics, Inc.

21823 30th Drive S.E.

Bothell, WA 98021

Attention: General Counsel

Telephone: (425) 527-4000

Facsimile: (425) 527-4109

If to Agensys:

Agensys, Inc.

1545 17th Street

Santa Monica, California 90404

Attention: CEO, President

Telephone: (310) 820-8029

Facsimile: (310) 820-8489

Section 23.2 Applicable Law . The Agreement shall be governed by and construed in accordance with the laws of the State of California, without regard to the conflict of law principles thereof that may dictate application of the laws of any other state.

Section 23.3 Dispute Resolution . The Parties agree that if any dispute or disagreement arises between Agensys on the one hand and SGI on the other in respect of this Agreement (other than disputes or disagreements arising in the JSC, which shall be resolved in accordance with Section 4.3.6), they shall follow the following procedure in an attempt to resolve the dispute or disagreement.

23.3.1 The Party claiming that such a dispute exists shall give notice in writing (“ Notice of Dispute ”) to the other Party of the nature of the dispute;

23.3.2 Within [***] of receipt of a Notice of Dispute, a nominee or nominees of Agensys and a nominee or nominees of SGI shall meet in person and exchange written summaries reflecting, in reasonable detail, the nature and extent of the dispute, and at this meeting they shall use their reasonable endeavors to resolve the dispute.

23.3.3 If, within a further period of [***] , the dispute has not been resolved, the [***] shall meet at a mutually agreed upon time and location for the purpose of resolving such dispute.

23.3.4 Except as set forth in Section 23.4 below, if, within a further period of [***] , the dispute has not been resolved or if, for any reason, the required meeting has not been held, then the same shall be submitted by the Parties for resolution by binding arbitration before an arbitral body in San Francisco, California in accordance with the then-current commercial arbitration rules


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of the American Arbitration Association (“ AAA ”) except as otherwise provided herein. The Parties shall choose, by mutual agreement, [***] within [***] of receipt of notice of the intent to arbitrate. If no arbitrator is appointed within the times herein provided or any extension of time that is mutually agreed upon, the AAA shall make such appointment within [***] of such failure. The judgment rendered by the arbitrator shall include costs of arbitration, reasonable attorneys’ fees and reasonable costs for expert and other witnesses. Nothing in this Agreement shall be deemed as preventing either Party from seeking injunctive relief (or any other equitable or provisional remedy). If the issues in dispute involve scientific, technical or commercial matters, any arbitrator chosen hereunder shall have educational training and/or industry experience sufficient to demonstrate a reasonable level of relevant scientific, medical and industry knowledge.

23.3.5 In the event of a dispute regarding any payments owing under this Agreement, all undisputed amounts shall be paid promptly when due and the balance, if any, promptly after resolution of the dispute.

23.3.6 Notwithstanding the foregoing, any disputes relating to inventorship, ownership or the validity, enforceability or scope of any patent, copyright or trademark rights shall be submitted for resolution by a court of competent jurisdiction.

Section 23.4 Short Form Arbitration . Matters relating to JSC deadlocks and expressly identified in this Agreement for resolution using short form arbitration pursuant to this Section 23.4 as well as other matters as the Parties agree in writing shall be subject to resolution under this Section 23.4, shall be finally determined by binding arbitration in accordance with this Section 23.4 by a single arbitrator. In such arbitration, the arbitrator shall be an independent expert relating to the subject matter of such dispute who is mutually acceptable to the Parties. If the Parties are unable to agree on an arbitrator, the arbitrator shall be an independent expert as described in the preceding sentence selected by the AAA. Each Party to the arbitration shall prepare a written proposal setting forth its position with respect to the substance of the dispute. Without delaying the arbitration procedures, for a period not to exceed [***] commencing no later than [***] after the arbitrator has been selected, the Parties shall exchange and discuss the respective written proposal in good faith in an effort to resolve the matter. The arbitrator shall select one of the requested positions as her/his decision, and shall not have authority to render any substantive decision other than to so select the position of one of the Parties. If one Party does not submit to the arbitrator a written proposal setting forth its position within the time period established by the arbitrator therefor, the arbitrator shall select the other Party’s position. The costs of such arbitration shall be shared equally by the Parties, and each Party shall bear its own expenses in connection with the arbitration. The parties shall use good faith efforts to complete arbitration under this Section 23.4 within [***] following a request by any Party for such arbitration. Likewise, the arbitrator shall limit discovery as reasonably practicable to complete the arbitration in the foregoing timeframes. Nothing in this Agreement shall limit the right of either Party to seek to obtain in any court of competent jurisdiction any equitable or interim relief or provisional remedy, including injunctive relief. Seeking or obtaining such equitable or interim relief or provisional remedy in a court shall not be deemed a waiver of this Agreement to arbitrate. For clarity, any such equitable remedies shall be cumulative and not exclusive and are in addition to any other remedies that either Party may have under this Agreement or Applicable Law.


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Section 23.5 Entire Agreement . This Agreement, together with the Non-Disclosure Agreement, contains the entire understanding of the Parties with respect to the specific subject matter hereof. All express or implied agreements and understandings, either oral or written, heretofore made are expressly superseded by this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by both Parties hereto.

Section 23.6 Independent Contractors . SGI and Agensys each acknowledge that they shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture, agency or any type of fiduciary relationship. Neither SGI nor Agensys shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior consent of the other Party to do so.

Section 23.7 Affiliates . Each Party shall cause its respective Affiliates to comply fully with the provisions of this Agreement to the extent such provisions specifically relate to, or are intended to specifically relate to, such Affiliates, as though such Affiliates were expressly named as joint obligors hereunder.

Section 23.8 Waiver . The waiver by either Party hereto of any right hereunder or the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise.

Section 23.9 Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

[Signature page follows]

 

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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.

 

SEATTLE GENETICS, INC.
By:   /s/ Clay B. Siegall
Name:   Clay B. Siegall
Title:   President & CEO
AGENSYS, INC.
By:   /s/ Donald B. Rice
Name:   Donald B. Rice
Title:   Chairman, President & CEO

SIGNATURE PAGE


SCHEDULE A

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SCHEDULE B

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SCHEDULE C

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SCHEDULE D

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SCHEDULE E

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SCHEDULE F

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SCHEDULE G

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SCHEDULE H

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SCHEDULE I

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Exhibit 10.2

COLLABORATION AGREEMENT

This Collaboration Agreement is entered into as of the Effective Date by and between Seattle Genetics, Inc., a Delaware corporation having offices at 21823 30th Drive S.E., Bothell, WA 98021 ( “SGEN” ), and Genentech, Inc., a Delaware corporation having offices at 1 DNA Way, South San Francisco, CA 94080-4990 ( “GNE” ).

RECITALS

W HEREAS , GNE is engaged in the research, development and commercialization of human pharmaceuticals;

W HEREAS , SGEN possesses intellectual property relating to a proprietary humanized anti-CD40 monoclonal antibody known as SGN-40, as well as other anti-CD40 antibodies; and

W HEREAS , GNE and SGEN desire to enter into a collaboration under which GNE and SGEN would endeavor to jointly develop SGN-40, and if successful GNE would commercialize SGN-40 and SGEN would receive an option to co-promote SGN-40 in the U.S., all under the terms and conditions set forth below.

N OW THEREFORE , the Parties agree as follows:

ARTICLE 1

DEFINITIONS

1.1 “Abbott Agreement” has the meaning set forth in Section 2.1(b).

1.2 “ADC Collaboration Agreement” means that certain ADC Collaboration Agreement dated April 19, 2002 by and between SGEN and GNE.

1.3 “Affiliate” means any corporation or other business entity controlled by, controlling, or under common control with another entity, with “control” meaning direct or indirect beneficial ownership of [***] of the voting stock of, or [***] interest in the income of, such corporation or other business entity. For purposes of this Agreement, with respect to GNE, the term “Affiliate” shall not include [***] and its successors, or any entity that controls, is controlled by or is under common control with [***] , in each case that is not controlled by GNE.


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.

 

1


1.4 “Allocable Overhead” means [***] costs incurred by a Party that are attributable to that Party’s [***] . Allocable Overhead shall not include any costs attributable to [***] .

1.5 “Autoimmune Disease Indication” means a non-cancer disease or condition caused by an immune response against normal tissues, including multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, scleroderma and inflammatory indications.

1.6 “CD40” means the CD40 cell surface receptor, which is a member of the TNF superfamily and to which CD40 ligand (CD40L or also known as CD154) binds.

1.7 “Combination Product” has the meaning set forth in Section 1.54.

1.8 “Commercialization” means the marketing, promotion, sale and/or distribution of Licensed Product in the Territory. “ Commercialize ” has a correlative meaning.

1.9 “Competitive Product” means any antibody-based product containing an [***] that (i) specifically [***] and (ii) is not either a [***] or a [***] .

1.10 “Confidential Information” means all Information (whether in written, oral, electronic, visual, tangible, or other form) and materials, including biological and other tangible materials, that are disclosed by one Party to the other Party prior to the Effective Date or during the Term, provided that all information disclosed in tangible form is designated as confidential by the use of an appropriate stamp or legend and information disclosed in any other form is identified as confidential at the time of disclosure.

1.11 “Controlled” means, with respect to any intellectual property right or Information, that the Party owns or has a license to such intellectual property right or Information and has all the rights necessary (a) to grant to the other Party a license or sublicense to such intellectual property right as provided for herein or (b) to transfer such Information to the other Party as provided for herein (as applicable) without violating the terms of any agreement or other arrangements with any Third Party existing at the time such Party would be first required hereunder to grant the other Party such license or sublicense or to perform such transfer.


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1.12 Co-Promote ” means the detailing or promotion of a Co-Promote Product to physicians or other authorized prescribers in the U.S. under a single trademark.

1.13 Co-Promote Product ” has the meaning set forth in Section 6.6(a).

1.14 “Co-Promotion Notice” has the meaning set forth in Section 6.6(b).

1.15 “Co-Promotion Option” has the meaning set forth in Section 6.6(a).

1.16 “Co-Promotion Plan” has the meaning set forth in Section 6.6(c).

1.17 “Development” means all activities that relate to (a) obtaining, maintaining or expanding Regulatory Approval of a Licensed Product, (b) studies conducted to expand the scientific or medical understanding of a Licensed Product, whether for publication in a peer-reviewed journal or not, but not necessarily for the intent of obtaining, maintaining or expanding Regulatory Approval of Licensed Product ( e.g. , investigator-sponsored trials) or (c) developing the ability to manufacture clinical and commercial quantities of Licensed Product. This includes: (i) research, preclinical testing, toxicology, and clinical studies of Licensed Product; (ii) preparation, submission, review, and development of data or information for the purpose of submission to a governmental authority to obtain, maintain and/or expand Regulatory Approval of Licensed Product, and outside counsel regulatory legal services related thereto; (iii) manufacturing process development and scale-up, bulk production and fill/finish work associated with the supply of Licensed Product for preclinical and clinical studies, and related quality assurance technical support activities; and (iv) post-Regulatory Approval product support for a Licensed Product (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of the safety and efficacy of a Licensed Product. “Develop” has a correlative meaning.

1.18 “Development Costs” has the meaning set forth in Section 4.7.

1.19 “Development Plan” has the meaning set forth in Section 4.2(a).

1.20 “Diligent Efforts” means, with respect to particular obligations or tasks of a Party, the carrying out of such obligations or tasks in a diligent manner consistent with (a) as to [***] , [***] and (b) as to [***] , [***] , in each case of (a) and (b) as applicable to the


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development or commercialization of a product having similar technical and regulatory hurdles and similar market potential, profit potential and strategic value, that is at a similar stage in its development or product life cycle, and is based on conditions then prevailing and with due regard to the nature of efforts and cost required and the current corporate goals and priorities of such Party, but in any event, not less than the level of effort that such Party uses to conduct its own comparable business.

1.21 “Dollars” or “$” means the legal tender of the U.S.

1.22 “Drug Approval Application” means, with respect to a particular country, an application for regulatory approval required before commercial sale or use of a Licensed Product in such country. For clarity, in the U.S., a “Biologics License Application” and a “New Drug Application” (as such terms are used by the FDA) shall each be deemed to be a Drug Approval Application.

1.23 “Effective Date” means the date upon which all provisions of this Agreement become effective pursuant to Section 16.1.

1.24 “European Union” or “EU” means the European Union or any successor organization, including any of its member countries.

1.25 “Execution Date” means January 7, 2007, the date upon which this Agreement has been executed and delivered by both Parties.

1.26 “Executive Officer” means, in the case of SGEN, the Chief Executive Officer of SGEN or designee, and in the case of GNE, any of the following: the Vice President of Sales and Marketing, BioOncology or the Vice President, Clinical Hematology/Oncology of GNE, or their successor functionaries. In no case will any Executive Officer be a currently serving member of the JDC or JCC.

1.27 “FBMC” means, with respect to a given Licensed Product (or Termination Product), [***] of a Party’s fully-burdened manufacturing cost (as defined by such Party’s accounting policies consistently applied), which shall comprise the sum of: (a)  [***] and (b)  [***] . With respect to Licensed Products (or Termination Products) manufactured by a Third


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Party under contract with such Party and supplied either to such Party or directly to the other Party, Section 1.27(a) shall include the net sum of (i)  [***] ; (ii)  [***] ; and (iii) to the extent not otherwise captured in the deductions for Net Sales set forth in Section 1.54, [***] , and (iv)  [***] .

1.28 “FDA” means the U.S. Food and Drug Administration or any successor agency thereto.

1.29 “Field” means all uses.

1.30 “First Commercial Sale” means, with respect to a country in the Territory, the first sale to a Third Party of a Licensed Product in such country by GNE or its Affiliates or Sublicensees after the approval of the Drug Approval Application in such country, or where no Drug Approval Application is required to be approved, after compliance with such import requirements as are required to import such Licensed Product into such country for commercial sale.

1.31 “FTE” means the equivalent of a full-time employee of SGEN (including normal vacations, sick leave, and other similar matters). A Development FTE charged to GNE shall represent the percentage of time a full-time employee of SGEN spends working on Development activities assigned to SGEN under a Development Plan relative to total time over a given time period as recorded in the SGEN project time reporting system. For the avoidance of doubt, the time shall be recorded in a manner such that no employee of SGEN can report him/herself as more than [***] FTE in any given [***] . An FTE is measured on the basis of a total of [***] .

1.32 “GAAP” means United States generally accepted accounting principles.

1.33 “GNE Excluded Patents” means all rights in and to any of the following, each of which is defined on Exhibit D : [***].

1.34 “GNE Inventions” means all Inventions that are made during the Term by one or more employees of GNE or persons contractually required to assign or license such Inventions to GNE, excluding Joint Inventions.

1.35 “GNE Know-How” means all Information that is (a) Controlled by GNE or its Affiliates as of the Effective Date or any time during the Term, and (b) necessary or useful for SGEN to research, Develop, manufacture, use, sell, offer for sale, import, or export Licensed Products.


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1.36 “GNE Patents” means any and all Patents that (a) are Controlled by GNE or its Affiliates as of the Effective Date or any time during the Term, and (b) claim a Licensed Product, its use or manufacture, but excluding in any event the GNE Excluded Patents.

1.37 “GNE Technology” means the GNE Know-How and GNE Patents, including GNE’s interest in any Joint Patents.

1.38 “GNE Termination Technology” means the GNE Know-How and GNE Patents, including GNE’s interest in any Joint Patents, but in each case [***] .

1.39 “Hematologic Oncology Indication” means a cancerous disease of the blood or bone marrow, including non-Hodgkin’s lymphoma, multiple myeloma, chronic lymphocytic leukemia, acute lymphocytic leukemia, Hodgkin’s disease and Waldenstrom’s macroglobulinemia. For clarification and purposes of calculating milestone payments owed pursuant to Section 8.3, the following diseases shall each be considered a different Hematologic Oncology Indication: (a) aggressive lymphoma subtypes such as diffuse large B-cell lymphoma; (b) indolent lymphoma subtypes such as follicular lymphoma; (c) multiple myeloma; (d) chronic lymphocytic leukemia; (e) acute lymphocytic leukemia; and (f) Hodgkin’s disease.

1.40 “HSR Act” shall mean the Hart-Scott-Rodino Antitrust Improvements Act of 1974, as amended, 15 U.S.C. §18A.

1.41 “HSR Conditions” shall mean the following conditions, collectively: (a) the waiting period under the HSR Act shall have expired or earlier been terminated; (b) no injunction (whether temporary, preliminary or permanent) prohibiting consummation of the transaction contemplated by this Agreement or any material portion hereof shall be in effect; (c) no judicial or administrative proceeding opposing consummation of all or any part of this Agreement shall be pending; and (d) no requirements or conditions shall have been imposed by the United States Department of Justice or Federal Trade Commission (as applicable) in connection with the filings by the Parties under the HSR Act, other than requirements or conditions that are satisfactory to the Party on whom such requirements or conditions are imposed.


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1.42 “HSR Filing” shall mean filings by GNE and SGEN with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the subject matter of this Agreement, together with all required documentary attachments thereto.

1.43 “IND” means an investigational new drug application in the U.S. or any equivalent Regulatory Filing in another country.

1.44 “Initial Development Plan” has the meaning set forth in Section 4.2(b).

1.45 “Information” means all compositions of matter, techniques, data and other know-how and technical information, including inventions, improvements and developments, practices, methods, concepts, trade secrets, documents, computer data, computer code, apparatus, clinical and regulatory strategies, test data, analytical and quality control data, formulation, manufacturing, patent data or descriptions, development information, drawings, specifications, designs, plans, proposals and technical data and manuals and all other proprietary information.

1.46 “Inventions” means any Information (whether or not patentable) that is made, discovered, or created, or that otherwise arises from activities conducted by the Parties pursuant to this Agreement during the Term.

1.47 “Joint Inventions” means any Inventions that are made by at least one SGEN employee or person contractually required to assign or license such Inventions to SGEN and at least one GNE employee or person contractually required to assign or license such Inventions to GNE.

1.48 “Joint Patent(s)” has the meaning set forth in Section 10.1(b).

1.49 “JDC” has the meaning set forth in Section 3.1.

 

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1.50 “Licensed Molecule” means: (a) the humanized anti-CD40 monoclonal antibody referred to by SGEN as SGN-40 and having the amino acid sequence of hu sgn 26 described in US 60/684,853 filed May 26, 2005, [***] any [***], [***] or [***] thereof; (b) the murine monoclonal antibody S2C6, [***], [***] or [***] thereof; or (c) [***]. Licensed Molecules shall also include antibody-drug conjugates containing any antibody set forth in clauses (a), (b) or (c) above; provided, however, if the antibody-drug conjugate is subject to the ADC Collaboration Agreement, [***].

1.51 “Licensed Product” means any pharmaceutical product that uses, incorporates or contains a Licensed Molecule, including all formulations, line extensions, and modes of administration thereof.

1.52 MabTech Agreement ” means that certain License Agreement entered into between SGEN and MabTech AB with an effective date of June 14, 1998, as amended by the First Amendment to the License Agreement effective January 31, 2000.

1.53 “Marks” has the meaning set forth in Section 10.5.

1.54 “Net Sales” means, with respect to a particular time period, the gross amounts invoiced for sales of Licensed Products (or as the case may be, Competitive Products or Termination Products) (in final form for end use) by GNE and its Affiliates and Sublicensees, [***] :

 

  (i) [***] ;

 

  (ii) [***] ;

 

  (iii) [***] ;

 

  (iv) [***] ;

 

  (v) [***] ;

 

  (vi) [***] ;

 

  (vii) [***] ; and

 

  (viii) [***] .

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All of the foregoing elements of Net Sales calculations shall be determined on an [***] in accordance with GAAP or applicable international accounting standards.

Sales between or among GNE and its Affiliates and Sublicensees, shall be excluded from the computation of Net Sales, but Net Sales shall include the first sales to Third Parties by any such Affiliates or Sublicensees.

Notwithstanding anything else in this in this Section 1.54, the supply or other disposition of Licensed Products (i) as samples, (ii) for use in non-clinical or clinical studies, (iii) for use in any tests or studies reasonably necessary to comply with any applicable law, regulation or request by a regulatory or governmental authority or as is otherwise reasonable and customary in the industry, in each case shall not be included within the computation of Net Sales.

In the event a Licensed Product is sold in combination with one or more other active ingredients which are not the subject of this Agreement (as used in this definition of Net Sales, a “Combination Product” ), then the gross amount invoiced for that Licensed Product shall be calculated [***] . In the event that the other active ingredient is not sold separately, then the gross amount invoiced for that Licensed Product shall be calculated by [***] . In the event that no such separate sales are made, Net Sales for royalty determination shall be determined by the Parties in good faith.

1.55 Other SGEN Research ” means those research activities involving in vitro or non-clinical in vivo work (a) that are being conducted by SGEN as of the Effective Date or that are conducted by SGEN during the Term and (b) [***].

1.56 “Party” means SGEN or GNE individually, and “ Parties ” means SGEN and GNE collectively.

1.57 “Patents” means (a) United States patents, re-examinations, reissues, renewals, registrations, extensions and term restorations, and all foreign patents and counterparts of any of the foregoing (including any supplemental protection certificates), and (b) applications for United States patents, including provisional applications, continuations, continuations-in-part, divisional and substitute applications, inventors’ certificates, and extensions, any and all patents granted on the basis of such applications, and applications for foreign patents and counterparts of any of the foregoing.


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1.58 PDL Agreement ” means that certain Patent License Agreement between SGEN and Protein Design Labs, Inc., dated as of January 9, 2004.

1.59 “Phase I Trial” means that portion of the clinical development program that provides for the well-controlled clinical trials of a Licensed Product in a human patient population to determine the safe dose range in the proposed therapeutic indication, as more fully defined in 21 C.F.R. § 312.21(a), or its successor regulation, or the equivalent in any foreign country. For clarity, the term “Phase I Trial” shall include the Phase Ib trials referenced in Section 4.2(b).

1.60 “Phase II Trial” means that portion of the clinical development program that provides for the well-controlled clinical trials of a Licensed Product in a human patient population to determine the safe and effective dose range in the proposed therapeutic indication, as more fully defined in 21 C.F.R. § 312.21(b), or its successor regulation, or the equivalent in any foreign country.

1.61 “Phase III Trial” means that portion of the clinical development program that provides for continued clinical trials of a Licensed Product in an extended human patient population designed to obtain data determining efficacy and safety of such Licensed Product to support Regulatory Approvals in the proposed therapeutic indication, as more fully defined in 21 C.F.R. § 312.21(c), or its successor regulation, or the equivalent in any foreign country.

1.62 “Pivotal Trial” means a controlled study in humans that is prospectively designed, using predetermined endpoints, to demonstrate, both clinically and statistically, efficacy and safety sufficient to obtain Regulatory Approval. A Pivotal Trial would also include any study in humans that although not prospectively designed as such, results in obtaining Regulatory Approval.

1.63 “Prior Agreements” means the License Agreement between the Parties, dated March 6, 2003, and the Non-Exclusive Cabilly Patent License Agreement between the Parties, dated March 6, 2003 (the “ Cabilly Agreement ”), and, to the extent referenced in the foregoing agreements, that certain Amended and Restated Development and License Agreement between the Parties dated March 2, 2001.

 

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1.64 “Regulatory Approval” means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction. For countries where governmental approval is required for pricing or reimbursement for the Licensed Product, “ Regulatory Approval ” shall not be deemed to occur until such pricing or reimbursement approval is obtained.

1.65 “Regulatory Filings” means all applications, filings, dossiers and the like submitted to a regulatory authority in the Territory for the purpose of obtaining Regulatory Approval from that regulatory authority in the Territory. Regulatory Filings shall include, but not be limited to, all Drug Approval Applications.

1.66 “SGEN Development Period” means the six (6) year period commencing on the Effective Date.

1.67 “SGEN FTE Rate” means [***] per FTE per year, subject to annual adjustment on [***] of the Effective Date based on the percentage increase or decrease in the [***] , All Items during the applicable period. Rate includes [***] .

1.68 “SGEN Inventions” means all Inventions that are made by one or more employees of SGEN or persons contractually required to assign or license such Inventions to SGEN, excluding Joint Inventions.

1.69 “SGEN Know-How” means all Information that is (a) Controlled by SGEN as of the Effective Date or any time during the Term, and (b) necessary or useful for GNE to research, Develop, manufacture, use, sell, offer for sale, import, or export Licensed Products.

1.70 “SGEN Patents” means any and all Patents that (a) are Controlled by SGEN as of the Effective Date or at any time during the Term and (b) cover an antibody (including any variant, derivative, or fragment thereof) targeting CD40 or its manufacture, use or sale. For purposes of this Agreement and notwithstanding anything to the contrary, the Patents listed on Exhibit A shall be deemed, without limitation, to be SGEN Patents. Exhibit A may be updated from time to time. [***] .


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1.71 “SGEN Product” means a Licensed Product that uses, incorporates or contains a Licensed Molecule meeting the criteria set forth in Sections 1.50(a) or (b).

1.72 “SGEN Technology” means SGEN Know-How and SGEN Patents, including SGEN’s interest in any Joint Patents.

1.73 “Solid Tumor Indication” means any cancer other than a Hematologic Oncology Indication, including lung, colon, breast, renal cell, ovarian, bladder, head and neck, squamous cell or hepatocellular cancer.

1.74 “Sublicensee” means any Third Party which enters into an agreement with a Party or its Affiliate involving the grant to such Third Party of any rights under the licenses granted to such Party under this Agreement.

1.75 “Term” has the meaning set forth in Section 14.1.

1.76 “[***]” has the meaning set forth in Section 14.5(a)(ii).

1.77 “Territory” means the entire world.

1.78 “Third Party” means any person or entity other than a Party or its Affiliates.

1.79 “U.S.” means the United States of America, its territories and possessions, including the Commonwealth of Puerto Rico.

1.80 “U.S. Commercialization Plan” has the meaning set forth in Section 6.2(a).

1.81 “Valid Claim” means a claim of an issued and unexpired Patent (as defined in Section 1.57(a)) which has not been disclaimed, revoked, held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or is unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.


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1.82 “Valid Claim Product” means a Licensed Product that at the time of sale, the use or sale of which would, but for the license granted to GNE under Section 2.1, infringe a Valid Claim of a Patent (as defined in Section 1.57(a)) within the SGEN Patents in the country of sale, subject to Section 8.3(i).

ARTICLE 2

LICENSES

2.1 License to GNE.

(a) Subject to the terms and conditions of this Agreement, SGEN hereby grants to GNE, under the SGEN Technology, an exclusive (even as to SGEN) royalty-bearing license (or, as relevant, sublicense) to develop, make, have made, use, import, export, sell, offer for sale, and market Licensed Products in the Field in the Territory. Such license shall be sublicensable only with the prior written consent of SGEN, which shall not be unreasonably withheld. Notwithstanding the foregoing, [***] ; provided, however, that [***] . For the purpose of the preceding sentence, [***] shall be treated as an Affiliate of [***] . Each sublicense granted by GNE under this Section 2.1 shall be subordinate to this Agreement, and GNE shall be responsible for the performance of its Sublicensees. Any act or omission by a Sublicensee that would be a material breach of this Agreement had it been performed (or not performed) by GNE shall be treated as a material breach of this Agreement by GNE, provided, however, that SGEN shall not have the right to terminate this Agreement pursuant to Section 14.2 based upon such material breach if (i) GNE terminates the sublicense agreement with such Sublicensee; (ii) to the extent such material breach is capable of being cured, GNE cures any such material breach by such Sublicensee or commences a plan to cure such material breach within [***] days of its first awareness of such material breach; and (iii) to the extent such material breach is incapable of being cured, GNE shall, upon SGEN’s request, [***] .

(b) Prior to the Execution Date, SGEN has entered into a Development and Supply Agreement with Abbott Laboratories, Inc. ( “Abbott Laboratories” ) dated February 18, 2005 (the “Abbott Agreement”) granting certain rights to manufacture (but not to use, sell or offer to sell) SGN-40.


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2.2 License to SGEN. Subject to the terms and conditions of this Agreement, GNE hereby grants to SGEN, under the GNE Technology and the SGEN Technology, a non-exclusive, royalty-free license to make and use (but not to sell, offer for sale or import) solely to the extent necessary to conduct (a) those Development responsibilities expressly assigned to SGEN under the Development Plan as approved by the JDC and (b) solely during the SGEN Development Period, such Other SGEN Research as SGEN determines in its sole discretion. Such license shall be sublicensable solely to subcontractors approved by the JDC, such approval not to be unreasonably withheld.

2.3 No Non-Permitted Use. GNE hereby covenants that it shall not, nor shall it cause or permit any Affiliate or Sublicensee to, use or practice, directly or indirectly, any SGEN Technology for any purposes other than those expressly permitted by this Agreement.

2.4 No Other Licenses. Neither Party grants to the other Party any rights or licenses in or to any intellectual property, whether by implication, estoppel, or otherwise, other than the license rights that are expressly granted under this Agreement.

2.5 Sublicense Agreements. GNE shall, in each agreement under which it grants a sublicense under the license set forth in Section 2.1 (each, a “Sublicense Agreement” ), require the Sublicensee to transfer (i) to GNE or SGEN if this Agreement terminates, and such Sublicense Agreement does not survive in accordance with Section 14.5(a)(iii), either in whole or in part related to the country or region of such Sublicense Agreement and (ii) to GNE where only such Sublicense Agreement terminates: (a) all Regulatory Filings and Regulatory Approvals held or possessed by such Sublicensee and (b) results of preclinical studies and Clinical Trials generated by or on behalf of such Sublicensee. With respect to all Patents and Marks owned or controlled by such Sublicensee, and to the extent such Patents claim a SGEN Product or its use, manufacture or sale, each Sublicense Agreement will provide that such Patents and Marks are freely sublicensable to SGEN or GNE by means of a non-exclusive or exclusive license upon termination of this Agreement and such Sublicense Agreement [***]. Each Sublicense Agreement shall also include diligence obligations no less stringent than those set forth in Sections 4.3 and 6.3, but only to the extent applicable to the scope of rights granted to and obligations incurred by such Sublicensee under the terms of the Sublicense Agreement.


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2.6 Third Party Agreements. GNE (or its Affiliate or Sublicensee) shall be responsible, [***] and [***], for obtaining any agreements with Third Parties for any Third Party rights which, in the reasonable opinion of [***], would be infringed by the Development, manufacturing, and Commercialization activities with respect to Licensed Products in the Territory. GNE (or its Affiliate or Sublicensee) shall [***] to ensure that: (i) each Third Party clinical trial, contract manufacturing, or service agreement entered into by GNE or its Affiliates or Sublicensees with respect to the Licensed Products contains provision(s) permitting such Third Party contract to be [***]; and (ii) any Patents that are licensed by GNE (or its Affiliates or Sublicensees) from a Third Party after the Effective Date and that would constitute GNE Termination Technology if Controlled by GNE [***].

ARTICLE 3

GOVERNANCE

3.1 Joint Development Committee . Within [***] after the Effective Date, SGEN and GNE shall form a joint development committee (“ JDC ”) consisting of [***] representatives from SGEN and [***] representatives from GNE (or such other number as the Parties may agree, provided that each of the Parties shall have the same number of JDC members). Representatives must be appropriate for the tasks then being undertaken and the stage of development of the Licensed Product for which activities under the Development Plan will be performed, in terms of their seniority, availability, function in their respective organizations, training and experience. Each Party shall designate [***] of its representatives as its primary JDC contact. Each Party may replace its JDC representatives [***] upon prior written notice to the other Party. JDC membership may evolve over time as the project progresses so that each Party’s combined membership represents the key functions (such as Development, manufacturing or regulatory) that are the current focus of work on Licensed Products. The JDC shall continue to exist until the first to occur of (a) the Parties mutually agreeing to disband the JDC or (b) SGEN providing to GNE written notice of its intention to disband and no longer participate in the JDC following the end of the SGEN Development Period. Once SGEN has provided written notice as referred to in clause (b) above, the JDC shall have no further obligations under Sections 4.2 or 4.4.


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3.2 Meetings of the JDC. The JDC shall meet at least [***] times every calendar year, provided that the JDC may decide to schedule meetings on a [***] schedule of [***] times every [***] if indicated by the then-current stage of development and level of Development activity being conducted by the Parties. Such meetings shall be held on such dates and at such times and places as agreed to by GNE and SGEN; provided, however, that at least [***] shall be held in person, alternating between SGEN’s facilities in Seattle, Washington, and GNE’s facilities in South San Francisco, California. Responsibility for keeping minutes will alternate between the Parties, beginning with GNE. JDC meeting minutes will be sent to each member of the JDC for review as soon as practicable after a meeting. A Party may, with the prior written consent of the other Party (such consent not to be unreasonably withheld or delayed), invite a reasonable number of employees, consultants or scientific advisors to attend a meeting of the JDC, provided, however, that such invitees shall participate only as observers and advisors and shall not have a decision-making role. Those invitees must be bound by appropriate confidentiality obligations. Each Party shall be responsible for its own expenses for participating in the JDC. Meetings of the JDC shall be effective only if at least [***] of each Party is present or participating.

3.3 Responsibilities of the JDC. The JDC shall have the responsibility and authority to:

(a) Oversee the Regulatory Approval of Licensed Products in the Field in the U.S., the Development of Licensed Products throughout the Territory in support of such Regulatory Approval in the U.S., and manufacturing of Licensed Products in support of such activities;

(b) Review and approve the overall strategy for Development in the Field in the Territory;

(c) Review and approve any proposed amendments or updates to the Development Plan;

(d) Monitor the Development of Licensed Products in the Field in the Territory against the Development Plan;


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(e) Discuss the requirements for Regulatory Approval in applicable countries in the Territory and oversee regulatory matters with respect to Licensed Products in the Territory;

(f) Establish subcommittees pursuant to Section 3.11, oversee the activities of all subcommittees so established, and address disputes or disagreements arising in all such subcommittees;

(g) Designate and approve all Development activities assigned to SGEN (and agreed to be undertaken by SGEN pursuant to Section 4.1) under a Development Plan (subject to the approval mechanism set forth in Section 3.4); and

(h) Perform such other functions as the Parties may agree in writing.

3.4 Areas Outside the JDC’s Authority . The JDC shall have no authority other than that expressly set forth in Section 3.3 and, specifically, shall have no authority (a)  [***] , (b)  [***] (b) [***] provided that (i) such [***] may be evidenced by JDC meeting minutes recording [***] of a Development Plan if such meeting minutes have been approved [***] and (ii)  [***] (c)  [***] , (d)  [***] , or (e)  [***] . For clarity, the JDC is intended to oversee Development of Licensed Products for [***] and SGEN acknowledges and agrees that the JDC shall not have authority over Development of Licensed Products for Regulatory Approval and sale outside the U.S.. Nothing in this Agreement shall be interpreted as [***] to provide [***] to enter into discussions with, or otherwise directly influence the development of [***] ; provided, however that [***] , shall report on a regular basis as to the status of Development efforts by its Sublicensees outside the U.S. and the JDC shall be responsible for [***] .

3.5 JDC Decisions.

(a) [***]; Good Faith; Action Without Meeting. The JDC shall decide all matters by [***] , with each Party having [***] . The members of the JDC shall act in good faith to cooperate with one another and to reach agreement with respect to issues to be decided by the JDC. Action that may be taken at a meeting of the JDC also may be taken without a meeting if a [***] .


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(b) Failure to Reach Consensus. In the event that the members of the JDC [***] with respect to any matter over which the JDC has authority and responsibility, the JDC shall submit the respective positions of the Parties with respect to such matter for discussion in good faith by the Parties’ respective Executive Officers. If such individuals are not able to mutually agree upon the resolution to such matter [***] after the JDC’s submission to them, then, the Executive Officer of GNE [***] . In no event shall the Executive Officer of GNE decide any matter [***] , or in any other manner [***].

3.6 Joint Commercialization Committee . No later than [***] days following SGEN’s exercise of its Co-Promotion Option, and only if such Co-Promotion Option has been exercised by SGEN, SGEN and GNE shall form a joint commercialization committee ( “JCC” ) consisting of [***] representatives from SGEN and [***] representatives from GNE (or such other number as the Parties may agree, provided that each of the Parties shall have the same number of JCC members). Each Party may replace its JCC representatives at [***] upon prior written notice to the other Party. The JCC shall continue to exist until the first to occur of (i) the Parties [***] ; (ii)  [***] ; (iii)  [***] ; or (iv)  [***] .

3.7 Meetings of the JCC. The JCC shall meet on such dates and at such times and places as agreed to by GNE and SGEN, but in any event shall hold at least [***] on such dates at such times as it elects. The JCC shall record all decisions made, and otherwise take minutes as appropriate. Responsibility for keeping minutes will alternate between the Parties, beginning with GNE. JCC meeting minutes will be sent to each member of the JCC for review as soon as practicable after a meeting. A Party may, with the prior written consent of the other Party, invite a reasonable number of non-voting employees or consultants to attend a meeting of the JCC. Those invitees must be bound by appropriate confidentiality obligations. Each Party shall be responsible for its own expenses for participating in the JCC. Meetings of the JCC shall be effective only if at least [***] of each Party [***] present or participating.

3.8 Responsibilities of the JCC. The JCC shall have the responsibility and authority to:

(a) Review the U.S. Commercialization Plan and any proposed amendments or updates thereto;


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(b) Monitor the Commercialization of Licensed Products in the U.S. against the U.S. Commercialization Plan;

(c) Serve as a forum for discussing Commercialization issues relating to the Co-Promote Products;

(d) Oversee and coordinate the Parties’ field sales promotional activities in the U.S. with respect to Co-Promote Products;

(e) Establish subcommittees pursuant to Section 3.11, oversee the activities of all subcommittees so established, and address disputes or disagreements arising in all such subcommittees;

(f) Review and update the Co-Promotion Plan agreed upon by the Parties pursuant to Section 6.6 (c); and

(g) Perform such other functions as the Parties may agree in writing.

3.9 Areas Outside the JCC’s Authority . The JCC shall have no authority other than that expressly set forth in Section 3.8 and, specifically, shall have no authority (a)  [***] , (b)  [***] , (c) to determine whether or not a Party [***] , (d)  [***] .

3.10 JCC Decisions.

(a) [***]; Good Faith; Action Without Meeting. The JCC shall decide all matters by [***] , with each Party having [***] . The members of the JCC shall act in good faith to cooperate with one another and to reach agreement with respect to issues to be decided by the JCC. Action that may be taken at a meeting of the JCC also may be taken without a meeting if a [***] setting forth the action so taken is [***] , provided that such [***] .

(b) Failure to Reach Consensus. In the event that the members of the JCC cannot come to consensus within [***] with respect to any matter over which the JCC has authority and responsibility, then, [***] . [***] .


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3.11 Subcommittees. The JDC and JCC each shall have the right to establish subcommittees and to delegate certain of its powers and responsibilities thereto. Except as mutually agreed by the Parties, such subcommittees shall decide all matters by [***] , with each Party having [***] , and any disputes that cannot be resolved by a subcommittee in a reasonable time period shall be submitted to the JDC or JCC (whichever established such subcommittee) for resolution in accordance with Section 3.5 or 3.10(b) (as appropriate).

ARTICLE 4

DEVELOPMENT

4.1 Overview.

(a) GNE and SGEN shall perform all Development activities in accordance with the Development Plan. As between the Parties, GNE, or its Affiliates or Sublicensee(s) shall bear all costs associated with Development of Licensed Products in the Field in the Territory, as set forth in more detail in Section 4.7.

(b) SGEN shall only be obligated to perform Development activities during the SGEN Development Period, as and to the extent provided in this Section 4.1(b). SGEN hereby agrees and consents to conduct those Development activities assigned to SGEN as set forth in the Initial Development Plan, subject to GNE’s obligation to reimburse SGEN for its Development Costs pursuant to Section 4.7. SGEN’s obligation to perform any Development activities other than those set forth in the Initial Development Plan shall require SGEN’s written consent, in its sole discretion, provided that any Development activities assigned to SGEN and [***] .

(c) Following the end of the SGEN Development Period, SGEN shall have the right to voluntarily perform new Development activities if reasonably requested by GNE and agreed to in writing by SGEN. Both Parties have agreed that such right of SGEN to voluntarily perform such new Development activities as requested by GNE pursuant to this Section 4.1(c) does not constitute a future performance obligation of SGEN and, in particular, does not constitute an [***] . In addition, to the extent that after the SGEN Development Period, GNE requests and SGEN agrees to undertake further new Development pursuant to this Section 4.1(c) and [***] . Notwithstanding the foregoing, the Parties expect any creation and transfer of [***] under this provision and after the end of the SGEN Development Period to be [***] . In addition, it is understood that [***] .


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4.2 Development Plan .

(a) Scope. The Development of each Licensed Product in the Territory under this Agreement shall be governed by a development plan (each, a “Development Plan” ). Each Development Plan shall be developed in good faith with the overall objective of optimizing the commercial potential of such Licensed Product. Each Development Plan shall describe (i) the proposed overall program of Development for the applicable Licensed Product, including preclinical studies, toxicology, manufacturing, clinical studies, regulatory plans and other elements of obtaining Regulatory Approval(s) in each applicable country, (ii) timelines for key regulatory authority meetings, Drug Approval Applications and Regulatory Approvals, and (iii) the anticipated tasks and responsibilities of each Party (subject to Section 4.1(b)). Each Development Plan shall include a summary of estimated Development expenses of the program expected to be incurred during the Development process through obtaining Regulatory Approval for each proposed indication and route of delivery, [***]. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail. In the event that the JDC fails to formally approve the Development Plan or update or amendment thereto, the course of action actually taken by the Parties shall constitute the Development Plan for the purpose of this Agreement, unless and to the extent the Parties disagree on such course of conduct and provided further that this sentence shall in no way be construed as obligating SGEN to undertake any Development activities which are not otherwise agreed to by SGEN in accordance with Section 4.1(b).

(b) Initial Development Plan. The Parties have agreed on an outline of the initial Development Plan, a copy of which is attached hereto as Exhibit B (the “Initial Development Plan” ). Promptly but no later than [***] after the Effective Date, the Parties shall prepare and submit to the JDC for approval the full version of the Development Plan, which shall be consistent with Exhibit B , and in particular, the Development Plan shall allocate to SGEN responsibility for conducting (i)  [***] , (ii)  [***] and (iii)  [***] . It is anticipated that (w)  [***] ; (x)  [***] ; (y)  [***] ; and (z)  [***] . The Parties acknowledge that, as of the Execution Date, SGEN is performing certain pre-clinical work related to applications of SGN-40 in the Hematologic Oncology Indications, and the Development Plan shall include an explicit authorization permitting SGEN to continue to conduct such pre-clinical work. In addition, the Parties also acknowledge that as of the Execution Date,


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SGEN has entered into those certain material transfer agreements set forth in Exhibit E , and that the research studies contemplated to be performed thereunder may continue to be performed after the Execution Date in accordance with the terms and conditions of such material transfer agreements.

(c) Updates to the Development Plans . Following approval by the JDC of the full Development Plan, and commencing in [***] and [***] thereafter, GNE shall update and prepare the Development Plan for each Licensed Product for the following [***] to take into account completion of Development activities, or commencement or cessation of Development activities not contemplated by the then-current Development Plan and nonetheless approved by the JDC, and submit each such proposed amended Development Plan to the JDC for review no later than [***] and for approval no later than [***] of such [***] ; provided, that the Development activities in the Development Plan delegated to and agreed [***] , unless [***] .

(d) Diligence. SGEN will use Diligent Efforts to carry out the activities set forth in a Development Plan for which SGEN is responsible and agrees to undertake pursuant to Section 4.1(b).

4.3 Diligent Development. GNE shall use Diligent Efforts to Develop [***] and in at least [***] Activities by GNE’s Sublicensees and Affiliates will be considered as GNE’s activities under this Agreement for purposes of determining whether GNE has complied with its obligations under this Section 4.3, provided, however that the failure of a Sublicensee to be diligent is not a breach by GNE hereunder as long as GNE is taking steps to actively enforce the diligence obligation under the sublicense agreement, which shall be consistent with the level of diligence to be applied by GNE under this Section 4.3. Notwithstanding anything to the contrary, any failure by GNE to meet its diligence obligations under this Section 4.3 shall not be considered [***] to the extent that such failure was caused by any act, delay, omission or failure [***] of any of its obligations under the Development Plan or [***] .


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4.4 Development Reports. Each Party will keep the JDC fully informed regarding the progress and results of such Party’s Development activities and those of its Affiliates, Sublicensees, and Third Party contractors. At least [***] prior to each scheduled JDC meeting, each Party shall provide the JDC with a written report that summarizes, in reasonable detail, all Development activities performed by such Party and its Affiliates, Sublicensees, and Third Party contractors during such quarter, and compares such performance with the goals and timelines set forth in the Development Plan. Each Party shall also make itself available to further discuss with the JDC its Development of the Licensed Product as reasonably requested. The obligation to provide development reports under this Section 4.4 shall cease upon the date that the JDC ceases to exist; provided, however, that GNE shall thereafter provide directly to SGEN, on an annual basis, a written report that summarizes all Development activities performed or anticipated to be performed by GNE and its Affiliates, Sublicensees, and Third Party contractors, as well as such periodic updates as may be provided by GNE’s alliance management function.

4.5 Standards of Conduct. Each Party shall perform, and shall ensure that its Affiliates, Sublicensees, and Third Party contractors perform, the Development activities for which it is responsible under the Development Plan in a good scientific manner and in compliance with applicable laws, rules and regulations.

4.6 Development Limitations. SGEN may not conduct or have conducted on its behalf, or enable any Third Party to conduct, [***] . GNE may conduct or have conducted on its behalf, or enable any Third Party to conduct, any clinical activities in support of Regulatory Approval of a Licensed Product in the U.S. as approved under a Development Plan or by the JDC.

4.7 Development Costs. GNE shall be responsible for, and shall reimburse SGEN on a [***] basis for, all costs and expenses actually incurred by or on behalf of SGEN in connection with SGEN’s performance of its Development responsibilities specified in the Development Plan and agreed to by SGEN pursuant to Section 4.1(b). In particular, GNE shall reimburse SGEN for such costs and expenses as follows: (a)  [***] ; and (b)  [***] . For clarity, Development activities are exclusive of any Other SGEN Research activities and [***] , at which time GNE shall reimburse SGEN for all costs and expenses actually incurred by or on behalf of SGEN since the Execution Date in connection with SGEN’s performance of such [***] . In determining


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Development Costs chargeable under this Agreement, SGEN will use its project accounting systems, as consistently applied across all its projects. Within [***] after the beginning of [***] , SGEN shall provide to GNE a report detailing all Development Costs incurred during such prior [***] , including the number of FTEs dedicated to Development activities during that calendar quarter accompanied by the associated cost of such FTEs at the SGEN FTE Rate. Such report shall be accompanied by a [***] . Such report will provide information on out-of-pocket expenses incurred during the [***] at a sufficient level of detail to enable GNE to evaluate the reasonableness of such expenses. Such report will be accompanied by an itemized invoice for the Development Costs incurred during the [***] . GNE shall pay SGEN for such Development Costs incurred within [***] of receipt of a true and correct invoice. As between the Parties, GNE shall be responsible for all costs and expenses incurred by or on behalf of GNE, its Affiliates, or its Sublicensees in connection with Development of Licensed Products. All Development Costs shall be recorded in accordance with GAAP.

4.8 Development Coordination

The Parties, through their designated project liaisons hereunder (each, a “Project Liaison”) will coordinate regular interactions between their respective project teams for the Development of Licensed Products pursuant to the Development Plan. Each Project Liaison shall be primarily responsible for facilitating the flow of information and otherwise promoting communications and collaboration within and among the JDC and JCC, between the Parties and internally within the Parties. Each Project Liaison will be responsible for: (a) facilitating coordination among the various functional representatives of his or her appointing Party; (b) providing single-point communication for seeking consensus both internally within the respective Party’s organization and together regarding key strategy and Development Plan issues, as appropriate; and (c) raising disputes with, and facilitating the resolution of disputes by, the JDC or JCC, as appropriate, in a timely manner.


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ARTICLE 5

REGULATORY

5.1 Regulatory Filing s.

(a) GNE and/or its Sublicensees shall be responsible for preparing and filing all Regulatory Filings and seeking all Regulatory Approvals, including preparing all reports necessary as part of a Drug Approval Application. All Regulatory Filings for Licensed Products shall be filed in the name of GNE and/or its Sublicensees, and GNE and/or its Sublicensees shall have primary responsibility for all communications and other dealings with the regulatory agencies relating to the Licensed Products. As soon as practicable after the Effective Date (or such other date as mutually agreed by the Parties), SGEN shall transfer to GNE ownership of SGEN’s Regulatory Filings as of the Effective Date (including without limitation any INDs Controlled by SGEN as of the Effective Date), provided that SGEN shall not be required to transfer ownership of any INDs covering any clinical trials being performed by SGEN under the Initial Development Plan or the Development Plan until such clinical trials are completed, provided that in the case that SGEN stops work on any such clinical trial prior to completion SGEN shall transfer ownership of the IND to GNE upon GNE’s request. In any event, ownership of all such Regulatory Filings shall be transferred to GNE prior to the end of the SGEN Development Period. SGEN shall, and hereby does, grant GNE a right of reference with respect to such INDs, to the extent necessary for GNE to perform any of its Development Responsibilities under the Development Plan.

(b) The JDC shall develop and implement procedures for drafting and review of all U.S. Regulatory Filings, including Drug Approval Applications, for Licensed Products, which shall provide sufficient time for SGEN to [***] . [***] .

(c) Each Party will provide the other Party with reasonable advance notice of any scheduled meeting with any U.S. regulatory agency relating to Development, U.S. Regulatory Filings and/or a Regulatory Application in the U.S., and the notified Party shall have the right to participate in any such meeting, to the extent permitted by law. Each Party also shall promptly furnish the other Party with summaries of all material correspondence or material meetings with any U.S. regulatory agency relating to Development, U.S. Regulatory Filings and/or a Regulatory Approval in the U.S., and each Party shall, at the other Party’s request, promptly furnish the requesting Party with copies of such correspondence or copies of minutes of such meetings.


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(d) Following approval of a Drug Approval Application for a Licensed Product, GNE and/or its Sublicensees shall retain primary responsibility for dealings with the applicable regulatory agency with respect to such Licensed Product, including filing all supplements and other documents with such agency with respect to such Drug Approval Application.

5.2 Product Withdrawals and Recalls. In the event that any regulatory agency (a) threatens or initiates any action to remove a particular Licensed Product from the market in any country or (b) requires GNE, its Affiliates, or its Sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of any Licensed Product, GNE shall notify SGEN of such event as soon as practicable after GNE becomes aware of the action, threat, or requirement (as applicable). [***] , for conducting any recalls or taking such other necessary remedial action.

ARTICLE 6

COMMERCIALIZATION

6.1 General. Subject to the remainder of this Article 6, GNE and its Sublicensees shall have sole responsibility and decision-making authority for Commercialization activities. Commercialization activities within the U.S. shall be carried out in accordance with the U.S. Commercialization Plan. As between the Parties, GNE shall be responsible for all costs and expenses associated with the Commercialization activities.

6.2 U.S. Commercialization Plan.

(a) No later than [***] following the delivery by SGEN of its Co-Promotion Exercise Notice in accordance with Section 6.6, GNE shall deliver to the JCC for its review and comment a draft written U.S. Commercialization Plan setting forth strategic and tactical commercialization activities to be performed with respect to each Licensed Product by GNE or on its behalf or by SGEN (including market summaries and launch plan overview), as well as projected timelines for such activities within the U.S. (the “U.S. Commercialization Plan” ). GNE shall use Diligent Efforts to prepare the U.S. Commercialization Plan hereunder. GNE shall consider in good faith reasonable comments received from the JCC regarding the draft U.S. Commercialization Plan.


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(b) GNE shall thereafter update the U.S. Commercialization Plan on an annual basis as follows: GNE shall provide the JCC with a draft update to the U.S. Commercialization Plan no later than [***] of each [***] . GNE may, at its election, update the U.S. Commercialization Plan between [***] updates by notifying the JCC of such revised U.S. Commercialization Plan, provided that such [***] , including under the Co-Promotion Plan unless and only to the extent [***] .

(c) The U.S. Commercialization Plan shall include, without limitation: (i) a description of GNE’s anticipated major marketing activities (both pre- and post-launch); (ii)  [***] ; (iii) any requirements for additional planned marketing studies; and (iv)  [***] .

(d) It is understood that the initial U.S. Commercialization Plan delivered pursuant to Section 6.2(a) will likely include only a summary of the anticipated Commercialization efforts in the U.S. for the Licensed Product.

6.3 Diligent Commercialization.

(a) GNE, its Affiliates and Sublicensees shall use Diligent Efforts to Commercialize Licensed Products in each country in the Territory for each indication for which it receives Regulatory Approval. Without limiting the generality of the foregoing, GNE (or its Affiliate or Sublicensee) shall [***] with respect to such country.

(b) It is possible that one or more Licensed Products could be [***]. GNE agrees that it shall not [***].

6.4 Commercialization Reports. GNE shall keep the JCC informed regarding the overall progress and results of its Commercialization and those of its Affiliates, Sublicensees, and Third Party contractors. Within [***] after the end of each [***] , GNE shall provide the JCC with a written report that summarizes, in reasonable detail, U.S. Commercialization activities performed during such [***] . GNE shall also promptly provide the JCC with any additional Information regarding the Commercialization of Licensed Products in the U.S., as reasonably requested thereby.


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6.5 Sales Force Training. GNE shall be solely responsible for the creation of, and shall use commercially reasonable efforts to create, marketing and promotional materials for use in the Commercialization of Licensed Products. GNE shall develop and conduct training programs specifically relating to Licensed Products for its sales representatives. In the event SGEN exercises its Co-Promotion Option under Section 6.6, SGEN agrees to utilize such training programs on an ongoing basis consistent with GNE’s business practices with respect to sales of Licensed Products to assure a consistent, focused promotional strategy. In addition, in such event SGEN shall require its sales force to attend and participate in the sales force training programs conducted by GNE for the Co-Promote Product(s), subject to reasonable scheduling of such training events. GNE agrees to provide SGEN with the same marketing and promotional materials that are provided to GNE’s sales force for use by SGEN’s sales force in conducting its activities under the Co-Promotion Plan.

6.6 Option to Co-Promote .

(a) With respect to each [***] (each a “Co-Promote Product” ), GNE hereby grants to SGEN an option (a “Co-Promotion Option” ) to Co-Promote such Co-Promote Product in the U.S. in accordance with Section 6.6(d) and the Co-Promotion Plan (as agreed to in accordance with Section 6.6(c)). Such Co-Promotion Option shall be exercised as provided in Section 6.6(b).

(b) GNE shall provide SGEN with prompt written notice of [***] (the “Co-Promotion Notice” ). The Co-Promotion Notice will be accompanied by a detailed summary of the information presented to [***] and used in making the determination to [***] If SGEN desires to exercise its Co-Promotion Option as to such Co-Promote Product, SGEN shall provide GNE with written notice of such exercise (the “Co-Promote Exercise Notice” ) no later than [***] after receipt of written notice from GNE and the accompanying information under this Section 6.6(b). In the event [***] subsequently determines not to [***] hereunder upon the subsequent determination of the [***] to so [***] .

(c) Promptly following the date of SGEN’s Co-Promote Exercise Notice, the Parties shall negotiate in good faith a written plan consistent with the provisions of 6.6(d) containing the operational details related to the Parties’ Co-Promotion activities ( [***] ), as well as such additional terms consistent with the provisions in Section 6.6(d) as are reasonably


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necessary for SGEN to exercise its rights under Section 6.6(d) (the “Co-Promotion Plan” ). The Parties shall use good faith efforts to develop, negotiate and agree to such Co-Promotion Plan within [***] of SGEN’s exercise of the Co-Promotion Option. If the Parties have not agreed upon a Co-Promotion Plan despite good faith efforts within such [***] period, then the operational details of the Parties co-promotion activities shall be determined by the JCC, as an interim measure, and GNE and SGEN shall continue to negotiate in good faith for an additional period of [***] concerning the additional terms consistent with the provisions in Section 6.6(d) as are reasonably necessary for SGEN to exercise its rights under Section 6.6(d). The Parties shall update the Co-Promotion Plan on an [***] basis, or more frequently as needed, through the JCC.

(d) Under the Co-Promotion Option:

(i) SGEN will have the right to field, at its election, up to [***] of the [***] with an [***] for Co-Promote Products in the U.S.

(ii) Unless otherwise agreed to by GNE or set forth in the U.S. Commercialization Plan or the Co-Promotion Plan, SGEN’s sales representatives shall dedicate to Co-Promote Products, [***], in aggregate, measured across all SGEN sales representatives involved in such Co-Promotion, and as determined by SGEN’s [***], such policy and procedures to be reasonable and customary in the pharmaceutical sales industry. Notwithstanding the foregoing, SGEN’s sales representatives shall [***].

(iii) GNE will compensate SGEN for co-promoting such Co-Promote Product through payments based on [***] . The calculation of [***] will be described in the Co-Promotion Plan, but generally means the [***] , and will be consistent with any applicable standard practices of GNE with respect to its own [***] , to the extent GNE has established such standard practices and employs [***] of the activities of its sales force then in existence.

(iv) GNE will allow SGEN’s sales representatives to attend and participate in the training programs described in Section 6.5.

(v) The JCC shall be responsible for the coordination of GNE’s and SGEN’s activities in the sales force deployment and activities with respect to the sales of Co-Promote Products in the U.S.


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(vi) Notwithstanding SGEN’s exercise of a Co-Promotion Option, GNE shall remain responsible for, and have [***] .

ARTICLE 7

MANUFACTURE AND SUPPLY

7.1 Manufacturing Responsibility . Except as set forth in Section 7.3, GNE shall be responsible for the manufacturing of Licensed Products in bulk and finished form for use by GNE, its Affiliates, and its Sublicensees in Field in the Territory and for use by SGEN pursuant to the Development Plan.

7.2 Transfer of Manufacturing Technology.

(a) As soon as reasonably possible after the Effective Date SGEN shall transfer to GNE or a Third Party manufacturer designated by GNE all Information Controlled by SGEN as of the Effective Date reasonably necessary to enable GNE or such Third Party manufacturer (as appropriate) to replicate the process employed by SGEN’s Third Party contract manufacturer to manufacture Licensed Product in the Field as of the Effective Date. The costs and expenses incurred by SGEN in carrying out such transfer shall be reimbursed by GNE in accordance with Section 4.7, with such transfer being deemed to be a Development activity for the purpose of such section and such costs and expenses being deemed to be Development Costs.

(b) GNE and/or its Third Party manufacturer shall use any Information transferred pursuant to Section 7.2(a) in accordance with the license granted in Section 2.1.

(c) GNE acknowledges and agrees that prior to any transfer of any manufacturing technology or Information to a Third Party manufacturer designated by GNE, GNE will execute a confidentiality agreement between such Third Party manufacturer and GNE that contains terms substantially equivalent to those of Article 12 of this Agreement.


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7.3 Clinical Supply.

(a) Subject to the requirements set forth in this Section 7.3, SGEN will supply GNE with its clinical requirements of SGN-40 in the Territory until such time as the technology transfer described in Section 7.2 is complete and GNE is able to supply Licensed Products on its own or through a GNE contractor or Sublicensee; provided that [***] , unless mutually agreed upon by both Parties in writing. Upon GNE’s reasonable request, [***] . GNE shall [***] .

(b) Upon GNE’s reasonable request, SGEN shall use good faith efforts to assist GNE with obtaining [***] with respect to [***] for use in the conduct of clinical trials, either directly by GNE from [***] , or by SGEN ordering such [***] material from [***] , it being understood that SGEN shall be under no obligation to extend any [***] , or to [***] without its express written consent. In any event, GNE shall [***] SGEN for any [***] . In addition, [***] for the purpose of [***] . Notwithstanding anything to the contrary set forth herein, SGEN’s obligations under this Article 7 shall terminate in their entirety at the end of the SGEN Development Period. In the event that GNE decides to terminate, or have SGEN terminate, the [***] then GNE shall be [***] .

ARTICLE 8

PAYMENTS

8.1 Upfront Payment . GNE shall pay to SGEN a non-refundable, non-creditable payment of Sixty Million Dollars ($60,000,000) within fourteen (14) days after the Effective Date.

8.2 Maintenance Fee. On the [***] of the Effective Date and on each anniversary of the Effective Date thereafter, GNE shall pay SGEN an annual maintenance fee of [***] (each a “Maintenance Fee” ); provided, however, that no such payment shall be due if GNE has spent at least [***] on the Development of Licensed Products (other than Competitive Products) during the [***] period immediately preceding such anniversary date, as demonstrated by GNE’s reasonable written records, which shall be subject to audit as provided in Section 9.2. Any milestone payments made by GNE pursuant to Section 8.3 during the [***] period immediately preceding an anniversary date shall be [***] (if any) due on such anniversary date. GNE’s obligations under this Section 8.2 shall terminate in their entirety upon the date on which GNE or a Sublicensee first receives Regulatory Approval for a Licensed Product (other than a Competitive Product except a Competitive Product for which GNE has agreed to pay royalties in accordance with Section 8.7).


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8.3 Development Milestones .

(a) [***] . GNE shall make each of the following milestone payments to SGEN upon [***] of the corresponding milestone event with respect to the [***] to attain such milestone event in the [***].

 

Event

  

Payment

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

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(b) [***] . GNE shall make each of the following milestone payments to SGEN upon [***] of the corresponding milestone event with respect the [***] to attain such milestone event in a [***] .

 

Event

  

Payment

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

(c) [***] . GNE shall make each of the following milestone payments to SGEN upon [***] of the corresponding milestone event with respect to the [***] to attain such milestone event in a [***] .

 

Event

  

Payment

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

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(d) [***] . GNE shall make each of the following milestone payments to SGEN upon [***] of the corresponding milestone event with respect to the [***] to attain such milestone event in a [***] .

 

Event

  

Payment

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

(e) [***] . GNE shall make each of the following milestone payments to SGEN upon [***] of the corresponding milestone event with respect to the [***] to attain such milestone event in an [***] :

 

Event

  

Payment

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

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(f) One-Time MabTech Milestone . GNE shall pay a one-time milestone payment to SGEN in the amount of [***] within thirty (30) days following the commencement of the [***] with a Licensed Product (as that term is defined in the MabTech agreement), provided that such obligation to pay an equivalent milestone payment is actually incurred by SGEN under the MabTech Agreement.

(g) One-Time Milestone Payment . If GNE’s aggregate payments to SGEN under this Section 8.3 are [***] as of the [***] , then [***] . Such payment shall be due [***] thereafter, but shall be creditable against any [***] made by GNE to SGEN pursuant to this [***] prior to the date that is [***] of the Execution Date.

(h) Clarifications . For clarity, each of the milestone payments set forth in Sections 8.3(a) through (e) shall be made [***] . Furthermore, it is understood that all payments with respect to events involving a “ [***] ,” “ [***] ,” or “ [***] [***] shall be applicable to the [***] , [***] , or [***] ( [***] ) in which a particular milestone event occurs, even if earlier or later milestone events involve a different set of [***] , [***] , or [***] . For example, if a [***] In addition, in the event that a [***] .

(i) [***] . Solely for the purposes of this Section 8.3 and with respect to the achievement of the applicable [***] , the definition of a [***] shall be read to also include a [***] that is the subject of a [***] pending as of the time of [***] . Further, with respect to the achievement of any other milestone, the definition of [***] shall mean a [***] that at the date of [***] . For all other milestone events, [***] shall have the meaning provided in [***] .

(j) Notice; Payment . Each Party shall notify the other Party within [***] after the occurrence of an achievement of each milestone event giving rise to a payment obligation under Sections 8.3(a) through (e), and GNE shall pay SGEN the indicated amount no later than [***] after receipt of a written invoice from SGEN.


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8.4 Commercialization Milestones . For each [***] , GNE shall make the milestone payments indicated below to SGEN when [***] of such [***] in the indicated region [***] . For clarity, each of the milestone payments set forth in this Section 8.4 shall be made [***]

 

Calendar Year Net Sales

  

Payment

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

GNE shall notify SGEN within [***] after the occurrence of an achievement of each milestone event giving rise to a payment obligation under this Section 8.4, and GNE shall pay SGEN the indicated amount no later than [***] after receipt of a written invoice from SGEN.

8.5 Royalties .

(a) GNE shall pay to SGEN royalties on Net Sales of [***] in the U.S. at a royalty rate determined by total Net Sales in the U.S. in a calendar year as follows:

 

Calendar Year U.S. Net Sales

  

Royalty Rate

[***]

   [***]

[***]

   [***]

[***]

   [***]

(b) GNE shall pay to SGEN royalties on Net Sales of [***] by GNE and its Sublicensees outside the U.S. at a royalty rate determined by total Net Sales outside the U.S. in a calendar year as follows:

 

Calendar Year Ex-U.S. Net Sales

  

Royalty Rate

[***]

   [***]

[***]

   [***]

[***]

   [***]

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8.6 Additional Royalty .

(a) After expiration of the royalty obligations in Section 8.5 (a) and (b) with respect to a particular [***] and a particular country ( i.e. , [***]), GNE shall pay the following royalties until the first to occur of (a) [***], or (b) [***]:

(i) a [***] royalty equal to [***] of Net Sales of such [***] ; and

(ii) A [***] royalty equal to [***] of Net Sales of such [***] .

Notwithstanding anything to the contrary, where [***] is not available on a country-by-country basis for a country but [***] (x) is available on a regional basis for the geographic region containing such country, such available regional sales data across all countries in the applicable geographical region ( e.g. , Europe, North America, Africa, Asia) shall be used in the determination [***] or (y)  [***] , the [***] for the applicable major market countries will be used to determine the [***] . Where no [***] is available for a particular geographical region, the Parties will determine the [***] .

(b) On a country by country basis, GNE shall pay a quarterly royalty equal to [***] of Net Sales of any [***] in a given country as of the date of [***] . If such [***] subsequently becomes a [***] , the royalties payable pursuant to Section 8.5(a) or (b) shall apply; provided however, under no circumstances will GNE pay royalties to SGEN pursuant to this Section 8.6(b) and Section 8.5(a) or (b) concurrently.

8.7 [***] .

(a) [***] .

(b) In the case that GNE, its Affiliate or a Sublicensee [***] .

(c) Notwithstanding anything to the contrary in this Section 8.7, GNE shall not be required to make any payments under Section 8.7 (a) or (b) for [***] , but only in the event that [***] (but in no event [***] ) enters into a Sublicense with a [***] .


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37


(d) If a [***] , in the reasonable opinion of [***] and [***] , then GNE shall be [***] Third Party based upon the [***] provided that [***] to be [***] (a)  [***] , or (b)  [***] .

8.8 Royalty Adjustments .

(a) Third-Party Royalties . If a Patent or Patents of a Third Party should exist in any country during the Term which, [***] , then GNE shall be [***] , against the [***] in the applicable country, [***] in such country; provided that such [***] shall in no event cause the [***] (a)  [***] , with respect to [***] sold in such country prior to [***] , or (b)  [***] , with respect to [***] sold in such country on or after [***] .

Pass-Through Royalties . GNE shall be responsible for the following royalty payment obligations (the “Pass-Through Royalties” ):

(i) GNE shall pay [***] on [***] (as that term is defined in the [***] ) of [***] for a period of [***] from [***] , or as long as such [***] is incurred to SGEN under the [***] . GNE shall provide SGEN or directly to [***] , the information required to fulfill its reporting obligations related to such royalty payment.

(ii) GNE shall pay to [***] (as that term is defined in the [***]) of [***] (as that term is defined in the [***]) as long as such [***] is incurred to SGEN under the [***]. GNE shall pay [***] in accordance with the terms of the [***]. GNE shall provide, [***], all notification and reports required under the [***].

Such Pass-through Royalties shall be [***] , pursuant to the terms of [***] as if GNE were paying the Pass-Through Royalties [***] .

(c) Notwithstanding anything to the contrary in this Section 8.8, to the extent that [***] with respect to [***] on or after [***] in a particular country (after applying the [***] , [***] , against the [***] of such [***] in the applicable country, equal to [***] resulting in such excess; provided, that in no instance of the application of this [***] , will [***] .


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8.9 [***] . Notwithstanding the terms of the Prior Agreements, [***] and the [***] of the [***] or [***] that are set forth in the Prior Agreements, provided that such waiver shall not apply with respect to [***] with respect to [***] following termination pursuant to [***] .

ARTICLE 9

PAYMENT; REPORTS; AUDITS

9.1 GNE Quarterly Royalty Payments and Reports .

(a) Commencing with the First Commercial Sale of a Licensed Product and ending with the expiration of all of GNE’s royalty obligations under Sections 8.5, 8.6 and 8.7, GNE agrees to make written reports to SGEN within [***] after the end of each calendar quarter covering all sales of Licensed Products in the Territory by GNE and its Affiliates and Sublicensees for which invoices were sent during such calendar quarter, each such written report stating for the period in question the following information: (i) total Net Sales of all Licensed Products sold in the Territory during such calendar quarter, (ii) Net Sales on a country-by-country basis, (iii) the exchange rate used to convert Net Sales from the currency in which they are earned to U.S. dollars and (iv) the total royalty payments due.

(b) The information contained in each report under Section 9.1(a) shall be considered Confidential Information of GNE. Concurrent with the delivery of each quarterly report, GNE shall make the payment due SGEN under Sections 8.5, 8.6 or 8.7 for the calendar quarter covered by such report.

9.2 Accounting. Each Party shall keep full, true and accurate books of account containing the particulars of Net Sales, the calculation of royalties and Development Costs and other development expenditures which are included in the calculation of GNE’s expenditures under Section 8.2. Each Party shall keep such books of account and the supporting data and other records at its principal place of business. Such books and records must be maintained available for examination in accordance with this Section for [***] after the end of the calendar year to which they pertain, and otherwise as reasonably required to comply with GAAP. Each Party may appoint an internationally-recognized independent accounting firm reasonably acceptable to the audited Party to inspect the relevant books of account of the audited Party to verify any reports or statements provided, or amounts paid or invoiced (as appropriate), by that


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39


audited Party. The independent accounting firm (and any individuals, if applicable) appointed to perform the examination under this Agreement must execute a confidential disclosure agreement with the audited Party, or otherwise be subject to terms governing non-use and non-disclosure of information that the audited Party has agreed in writing are acceptable. Each Party may exercise its right to have the other Party’s relevant records examined only during the [***] during which the audited Party is required to maintain records, no more than once in any [***] , and only once with respect to records covering any specific period of time. The audited Party is required to make its records available for inspection only during regular business hours, only at such place or places where such records are customarily kept, and only upon receipt of at least [***] written advance notice from the other Party. The independent accountant will be instructed to provide an audit report containing its conclusions regarding the audit, and specifying whether the amounts paid were correct, and, if incorrect, the amount of any underpayment or overpayment. The independent accountant further will be instructed to provide that audit report first to the audited Party, and will be further instructed to redact any proprietary information of the audited Party not relevant to the calculation of royalties or Research Support Payments prior to providing that audit report to the other Party. That audit report shall be deemed to be Confidential Information of the audited Party, and used only for purposes germane to this Section. After review of the auditor’s report: (i) if there is an uncontested underpayment by the audited Party for the period in question, then the audited Party shall pay to the other Party the full amount of that uncontested underpayment plus interest as calculated pursuant to Section 9.5, and (ii) if there is an uncontested overpayment by the audited Party for the period in question, then the other Party shall provide to the audited Party a credit against future payments (such credit equal to the full amount of that overpayment), or, if the audited Party is not obligated to make any future payments, then the other Party shall pay to the audited Party the full amount of that overpayment. Contested amounts are subject to dispute resolution under Article 15. If the total amount of any underpayment (as agreed to by the audited Party or as determined under Article 15) exceeds [***] of the amount previously paid by the audited Party for the period subject to audit (as long as that period is at least [***] ), then the audited Party shall pay the reasonable costs for the audit.

9.3 Methods of Payments. All payments due to SGEN under this Agreement shall be paid in Dollars by wire transfer to a bank in the U.S. designated in writing by SGEN.


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9.4 Taxes. If a law or regulation of any country of the Territory requires withholding of taxes of any type, levies or other charges with respect to any amounts payable hereunder to SGEN, GNE shall promptly pay such tax, levy or charge for and on behalf of SGEN to the proper governmental authority, and shall promptly furnish SGEN with receipt of such payment. GNE shall have the right to deduct any such tax, levy or charge actually paid from payment due SGEN or be promptly reimbursed by SGEN if no further payments are due SGEN. GNE agrees to assist SGEN in claiming exemption from such deductions or withholdings under double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted.

9.5 Late Payments. Any amounts not paid within [***] after the date due under this Agreement are subject to interest from the date due through and including the date upon which payment is received. Interest is calculated, over the period between the date due and the date paid, at a rate equal to [***] over the “bank prime loan” rate, as such rate is published in the U.S. Federal Reserve Bulletin H.15 or successor thereto on the last business day of the applicable calendar quarter prior to the date on which such payment is due.

9.6 Rights Regarding Consolidation of SGEN Financial Data . If, at any time during the Term, compliance with any term or condition of this Agreement would, in GNE’s reasonable opinion and with the concurrence of GNE’s independent auditors, require GNE to consolidate SGEN within GNE’s financial statements in order to comply with GAAP, then upon GNE’s request, subject to GNE’s obligations under Article 12 regarding SGEN Confidential Information, SGEN shall provide to GNE SGEN’s unaudited quarterly consolidated financial statements, prepared in accordance with GAAP ( i.e., balance sheet, income statement and statement of cash flows) within [***] . In the event of any such consolidation, GNE shall notify SGEN in writing and shall provide to SGEN such information as SGEN may require to comply with its accounting and reporting obligations under GAAP and Applicable Law arising from any such consolidation.


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ARTICLE 10

INTELLECTUAL PROPERTY RIGHTS

10.1 New Inventions .

(a) Ownership of the SGEN Inventions and all intellectual property rights therein shall remain vested at all times in SGEN, and ownership of the GNE Inventions and all intellectual property rights therein shall remain vested at all times in GNE. Inventorship under this Section 10.1 shall be determined under U.S. patent laws.

(b) SGEN and GNE shall each own an undivided equal interest in all [***] , and any patents or patent applications claiming such [***] (collectively, “Joint Patents” ). SGEN and GNE shall each have the right to practice and to grant licenses under the Joint Patents to the extent provided in this Agreement or otherwise agreed in writing. GNE shall have the first right to prepare, file, prosecute and maintain, through mutually acceptable outside counsel, with input from SGEN, each Joint Patent. GNE shall be responsible for [***] of all costs and expenses incurred in connection with prosecution and maintenance of Joint Patents; provided they [***] . GNE shall keep SGEN informed of the status of each such Joint Patent, and shall [***] concerning the preparation, filing, prosecution and maintenance thereof. If, during the Term, GNE intends not to file or continue prosecuting or maintaining any Joint Patent, GNE shall notify SGEN of such intention at least [***] prior to any applicable deadline, and SGEN shall thereupon have the right, but not the obligation, to assume responsibility for the preparation, filing, prosecution and/or maintenance of such Joint Patent, for which [***] .

10.2 Patent Filings .

(a) Responsibilities. SGEN shall have the first right to prepare, file, prosecute and maintain, through mutually acceptable outside counsel, with input from GNE, each Patent within the SGEN Patents (other than Joint Patents), and GNE shall reimburse SGEN for [***] incurred by SGEN in connection with such prosecution and maintenance. Notwithstanding the foregoing, SGEN [***] incurred by SGEN in connection with the prosecution of maintenance of any SGEN Patents (other than Joint Patents), to the extent such SGEN Patents [***] . SGEN shall keep GNE informed of the status of each such SGEN Patent, and shall give reasonable consideration to any suggestions or recommendations of GNE concerning the preparation, filing, prosecution and maintenance thereof. If, during the Term, SGEN intends not to file or continue prosecuting or maintaining a SGEN Patent (other than a Joint Patent), SGEN shall notify GNE of such intention at least [***] prior to any applicable deadline, and GNE shall thereupon have the right, but not the obligation, to assume responsibility for the preparation, filing, prosecution and/or maintenance of such SGEN Patent in the name of SGEN, for which [***] .


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42


(b) Cooperation . The Parties agree to cooperate in the preparation, filing, prosecution and maintenance of all Patents under this Section 10.2, including obtaining and executing necessary powers of attorney and assignments by the named inventors, providing relevant technical reports to the filing Party concerning the invention disclosed in each such Patent, obtaining execution of such other documents which shall be needed in the filing, prosecution and maintenance of each such Patent, and, as requested, updating each other regarding the status of each such Patent, and shall cooperate with the other Party so far as reasonably necessary with respect to furnishing all information and data in its possession reasonably necessary to obtain or maintain such Patents.

10.3 Enforcement and Defense of Patents .

(a) Notice . If either Party becomes aware that a Third Party is infringing or allegedly infringing any SGEN Patent (an “Infringement” ) or that any Third Party claims that any such SGEN Patent is invalid or unenforceable (a “Patent Challenge” ), it will promptly notify the other Party thereof including available evidence of infringement or the claim of invalidity or unenforceability. The Parties will cooperate and use reasonable efforts to stop such Infringement or Patent Challenge without litigation, prior to either Party initiating any suit or becoming substantially involved in any suit or other legal action.

(b) Enforcement and Defense .

(i) With respect to any Infringement that involves activity other than a [***] or with respect to any Patent Challenge not covered in Section 10.3(b)(iv), [***] will have the sole right (but not the obligation) to take the appropriate steps to enforce any Patent within the [***] against such Infringement or to defend such Patent Challenge (as applicable), at its sole cost and discretion. [***] may, in any such instance, take steps including the initiation, prosecution and control any suit, proceeding or other legal action by counsel of its own choice.


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43


(ii) To the extent any Infringement involves the [***] , [***] will have the first right (but not the obligation), at its [***] , to take the appropriate steps to enforce any Patent within the [***] against [***] , including without limitation the initiation of a suit, proceeding or other legal action by counsel of its own choice. [***] will have the right, at its [***] , to be represented in any such suit, proceeding, or action by counsel of its own choice.

(iii) If [***] fails to take the appropriate steps to enforce any applicable [***] within [***] after the date one Party has provided notice to the other Party of a Field Infringement, then [***] will have the right (but not the obligation), at its sole expense, to take the appropriate steps to enforce such Patent(s), including without limitation the initiation of a suit, proceeding or other legal action by counsel of its own choice. [***] will have the right, at its [***] , to be represented in any such suit, proceeding, or action by counsel of its own choice.

(iv) The Party controlling any suit, action or proceeding against a [***] pursuant to Section 10.3(b)(ii) or 10.3(b)(iii) shall also have the right to control the response to any Patent Challenge asserted by the alleged infringer(s) as a counterclaim or affirmative defense in such suit, proceeding, or action.

(c) Cooperation .

(i) If one Party brings any suit, action or proceeding under this Section 10.3, the other Party agrees to be joined as party plaintiff if necessary to prosecute the suit, action or proceeding and to give the first Party reasonable authority to file and prosecute the suit, action or proceeding; provided, however, that neither Party will be required to transfer any right, title or interest in or to any property to the other Party or any other party to confer standing on a Party hereunder.

(ii) The Party not pursuing the suit, action or proceeding brought hereunder will provide reasonable assistance to the other Party, including by providing access to relevant documents and other evidence and making its employees available, subject to the other Party’s reimbursement of any out-of-pocket expenses incurred by the Party providing such assistance.

(iii) Neither Party will settle nor otherwise compromise any such suit, action or proceeding in a way that adversely affects the other Party’s intellectual property rights or its rights or interests with respect to Licensed Products without such Party’s prior written consent, such consent not to be unreasonably withheld.


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44


(d) Recovery. Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any settlements, damages or other monetary awards (the “Recovery” ) recovered pursuant to a suit, proceeding, or action brought pursuant to this Section 10.3 will be [***] (to the extent not otherwise reimbursed), [***] .

10.4 Defense of Infringement Actions .

(a) During the Term, each Party shall bring to the attention of the other Party all information the Party reasonably believes is relevant to potential infringement of Third Party intellectual property rights in connection with the Development, manufacture, or Commercialization of Licensed Product in the Territory. The Parties shall discuss such information and decide how to address the potential infringement.

(b) If GNE and/or SGEN are named as defendant(s) in a patent infringement suit filed by a Third Party concerning the development, manufacture, production, use, importation, offer for sale, or sale during the Term of Licensed Products in the Field, then [***] shall defend such suit [***] and shall indemnify and hold [***] harmless against any such patent or other infringement suits, and any claims, losses, damages, liabilities, expenses, including reasonable attorneys’ fees and cost, that may be incurred by [***] therein or in settlement thereof. Any and all settlements that restrict the scope or enforceability of the [***], before execution by [***]. [***].

(c) This Section 10.4 shall not be interpreted as placing on either Party a duty of inquiry regarding Third Party intellectual property rights.

10.5 Trademarks. GNE and its Sublicensees shall be responsible for the selection, registration, maintenance, and defense of all trademarks for use in connection with the sale or marketing of Licensed Products in the Field in the Territory (the “Marks” ), as well as all expenses associated therewith. All uses of the Marks shall be reviewed by the JCC and shall comply with all applicable laws and regulations (including those laws and regulations particularly applying to the proper use and designation of trademarks in the applicable countries).


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GNE shall not, without SGEN’s prior written consent, use any trademarks or house marks of SGEN (including the SGEN corporate name), or marks confusingly similar thereto, in connection with GNE’s Commercialization of Licensed Products under this Agreement. GNE shall own all Marks.

ARTICLE 11

REPRESENTATIONS, WARRANTIES, AND COVENANTS

11.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party:

(a) Such Party is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation or formation;

(b) The execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action;

(c) Such Party has the corporate power and authority to execute and deliver this Agreement and to perform its obligations hereunder, and such performance does not conflict with or constitute a breach of any agreement of such Party with a Third Party; and

(d) Such Party has the right to grant the rights and licenses described in this Agreement.

11.2 SGEN Representations and Warranties. SGEN hereby represents and warrants to GNE as follows:

(a) As of the Execution Date, SGEN owns or has rights to all [***] .

(b) As of the Execution Date, except as it may have previously disclosed to GNE in writing, it has not received any written communications [***] .

(c) As of the Execution Date, except as it may have previously disclosed to GNE in writing, there are no [***] and with respect to which SGEN has received notice and, [***] , there are [***] .


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46


(d) SGEN has not entered into any agreement with any Third Party, including those material transfer agreements listed on Exhibit E, (i) granting rights to any Third Party that [***] and (ii)  [***] . This clause (d) does not apply to the following: (1)  [***] ; (2)  [***] or (3)  [***] .

11.3 Disclaimer. EXCEPT AS PROVIDED IN SECTIONS 11.1 AND 11.2, THE TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY ARE PROVIDED “AS IS” AND EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO.

11.4 Limitation of Liability. NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT, EACH PARTY’S PERFORMANCE OR LACK OF PERFORMANCE HEREUNDER, OR ANY LICENSE GRANTED HEREUNDER, EXCEPT FOR DAMAGES ARISING FROM A BREACH OF SECTION 12.1. THE FOREGOING SHALL NOT LIMIT EITHER PARTY’S INDEMNIFICATION OBLIGATIONS HEREUNDER.

ARTICLE 12

CONFIDENTIALITY

12.1 Confidentiality .

(a) Generally. During and after the Term, each Party (i) shall maintain in confidence all Confidential Information of the other Party; (ii) shall not use such Confidential Information for any purpose except as permitted by this Agreement; and (iii) shall not disclose such Confidential Information to anyone other than those of its Affiliates, Sublicensees, prospective Sublicensees, employees, consultants, agents or subcontractors who are bound by


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written obligations of nondisclosure and non-use no less stringent than those set forth in this Article 12 and to whom such disclosure is necessary in connection with such Party’s activities as contemplated in this Agreement. Each Party shall ensure that such Party’s Affiliates, Sublicensees, prospective Sublicensees, employees, consultants, agents and subcontractors comply with these obligations. Each Party shall notify the other promptly on discovery of any unauthorized use or disclosure of the other’s trade secrets or proprietary information.

12.2 Exceptions . The obligations of confidentiality, non-disclosure, and non-use set forth in Section 12.1 shall not apply to the extent the receiving Party (the “Recipient” ) can demonstrate that the disclosed information (a) was in the public domain at the time of disclosure to the Recipient by the other Party, or thereafter entered the public domain, in each case other than as a result of actions of the Recipient, its Affiliates, employees, licensees, agents or subcontractors, in breach of this Agreement; (b) was rightfully known by the Recipient or its Affiliates (as shown by its written records) prior to the date of disclosure to the Recipient by the other Party; (c) was received by the Recipient or its Affiliates on an unrestricted basis from a Third Party rightfully in possession of such information and not under a duty of confidentiality to the other Party; or (d) was independently developed by the Recipient or its Affiliates without use of such Confidential Information. Notwithstanding any other provision of this Agreement, Recipient’s disclosure of Confidential Information shall not be prohibited if such disclosure: (i) is in response to a valid order of a court or other governmental body, provided that Recipient provides the other Party with prior written notice of such disclosure in order to permit the other Party to seek a protective order or other confidential treatment of such Confidential Information; or (ii) is otherwise required by applicable law or regulation.

12.3 Scientific Publications. The publication strategy of the Parties shall be directed by the JDC and shall be subject to the following procedures:

(a) Prior to public disclosure or submission for publication or presentation of a proposed publication describing the results of any scientific or clinical activity relating to a Licensed Product, the Party disclosing or submitting such proposed publication ( “Submitting Party” ) shall provide the JDC and the other party ( “Responding Party” ) by expedited delivery (including electronic mail) a copy of the proposed publication to be submitted. The JDC and the

 

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Responding Party shall be permitted a reasonable time period (but no less than [***] from the date of confirmed receipt) to review the proposed publication or presentation. During such time, (i) the JDC shall determine whether the proposed publication or presentation is consistent with its publication strategy or whether the proposed publication contains information that is reasonably likely to have a material adverse impact on the Development or Commercialization of Licensed Product and (ii) the Responding Party will determine whether the proposed publication contains subject matter for which patent protection should be sought (prior to publication of such proposed publication) for the purpose of protecting an invention, or whether the proposed publication contains the Confidential Information of the Responding Party. Following the expiration of applicable time period for review and upon written approval from the JDC, the Submitting Party shall be free to submit such proposed publication or presentation for publication and publish or otherwise disclose to the public such scientific or clinical results, subject to the procedures set forth in Section 12.3(b).

(b) If the Responding Party believes that the subject matter of the proposed publication contains Confidential Information or a patentable invention of either Party, then prior to the expiration of the applicable time period for review, the Responding Party shall notify the Submitting Party in writing of its determination that such proposed publication contains such information or subject matter for which patent protection should be sought. On receipt of such written notice from the Responding Party, the Submitting Party shall delay public disclosure of such information or submission of the proposed publication for an additional period of [***] (or such shorter period mutually agreed by the Parties) to permit preparation and filing of a patent application on the disclosed subject matter. The Submitting Party shall thereafter be free to publish or disclose such information, except that the Submitting Party may not disclose any Confidential Information of the Responding Party in violation of Sections 12.1 and 12.2 hereof.

(c) [***] . [***] .

12.4 Publicity . The Parties agree that the public announcement of the execution of this Agreement shall be substantially in the form of the joint press release attached as Exhibit C , which shall be issued at a time to be mutually agreed by the Parties. Neither Party shall issue any additional press release or other publicity materials, or make any public presentation with respect


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to the terms or conditions of, this Agreement or the programs or efforts being conducted by the other Party hereunder, in each case without the prior written consent of the other Party. This restriction shall not apply to: (a) disclosures to a Party’s attorneys, advisors or current or potential investors on a need to know basis under circumstances that reasonably ensure the confidentiality thereof, and (b) any future disclosures required by law or regulation, including as may be required in connection with any filings made with, or by the requirements of the securities exchange on which such Party’s securities are traded, provided that the disclosing Party (i) use all reasonable efforts to inform the other Party at least [***] prior to making any such disclosures and cooperate with the other Party in seeking a protective order or other appropriate remedy (including redaction) and (ii) whenever possible, request confidential treatment of such information. Further, [***] : (w)  [***] ; (x)  [***] ; (y)  [***] ; and (z)  [***] . In addition and notwithstanding anything to the contrary herein, (a) if the relevant text of a proposed press release [***] in all material respects, then [***] in such proposed press release provided that the Party issuing such press release [***] and (b) if the [***] of a [***] such as a [***] has already previously been [***] by the other Party (whether in the form of an [***] ) and the text remains [***] , then such text may be included in such [***] .

ARTICLE 13

INDEMNIFICATION

13.1 Indemnification by SGEN . Unless otherwise provided herein, SGEN agrees to indemnify, hold harmless and defend GNE, its Affiliates, and their directors, officers, employees and agents (the “GNE Indemnitees” ) from and against any and all Third Party suits, claims, actions, demands, liabilities, expenses and/or losses (including without limitation attorneys’ fees, court costs, witness fees, damages, judgments, fines and amounts paid in settlement) ( “Losses” ) to the extent that such Losses arise out of (a)  [***] , (b)  [***] , (c)  [***] , or (d)  [***] . Notwithstanding the foregoing, SGEN’s obligation to indemnify, hold harmless, and defend the GNE Indemnitees shall not apply to the extent any Losses arise out of those actions set forth in Sections 13.2 (a) through (f).


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13.2 Indemnification by GNE . Unless otherwise provided herein, GNE shall indemnify, hold harmless and defend SGEN, its Affiliates, and their directors, officers, employees and agents (the “SGEN Indemnitees” ) from and against any and all Losses, to the extent that such Losses arise out of (a)  [***] (b)  [***] ; (c)  [***] ; (d)  [***] ; (e)  [***] ; or (f)  [***] . Notwithstanding the foregoing, GNE’s obligation to indemnify, hold harmless, and defend the SGEN Indemnitees shall not apply to the extent any Losses arise out of those actions set forth in Sections 13.1 (a) through (d).

13.3 Procedure . In the event of a claim by a Third Party against a Party entitled to indemnification under this Agreement (“ Indemnified Party ”), the Indemnified Party shall promptly notify the other Party (“ Indemnifying Party ”) in writing of the claim and the Indemnifying Party shall undertake and solely manage and control, at its sole expense, the defense of the claim and its settlement. The Indemnified Party shall cooperate with the Indemnifying Party, including, as requested by the Indemnifying Party entering into a joint defense agreement. The Indemnified Party may, at its option and expense, be represented in any such action or proceeding by counsel of its choice. The Indemnifying Party shall not be liable for any litigation costs or expenses incurred by the Indemnified Party without the Indemnifying Party’s written consent. The Indemnifying Party shall not settle any such claim unless such settlement fully and unconditionally releases the Indemnified Party from all liability relating thereto, unless the Indemnified Party otherwise agrees in writing.

13.4 Insurance .

(a) Commencing as of the Effective Date, each Party shall obtain and maintain at its own expense on [***].

(b) Each Party shall obtain and maintain on [***] , provided that upon the [***] , the [***] required by this section shall [***] .

(c) Additional Requirements . Except to the extent that GNE self-insures, the following provisions apply:

(i) All insurance coverages shall be primary insurance with respect to each Party’s own participation under this Agreement, and shall be maintained with an insurance company or companies having an [***] .


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(ii) Each Party shall name the other Party as an additional insured by endorsement under its Commercial General Liability and Products Liability insurance policies.

(iii) The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then in such a case, such Party shall maintain the insurance coverage for at least [***] following such Party’s completing performance of its obligations under this Agreement.

(iv) Each Party shall provide to the other Party its respective certificates of insurance evidencing the insurance coverages. Each Party shall provide to the other Party at least [***] prior written notice of any cancellation, nonrenewal or material change in any of the insurance coverages. Each Party shall, upon receipt of written request from the other Party, provide renewal certificates to the other Party for as long as such Party is required to maintain insurance coverages hereunder.

ARTICLE 14

TERM AND TERMINATION

14.1 Term. The term of this Agreement shall begin on the Effective Date and, unless earlier terminated in accordance with the terms of this Article 14, will expire on the date on which neither Party has nor will have any additional payment obligations to the other Party under this Agreement (the “Term” ).

14.2 Termination for Breach. Subject to the terms and conditions of this Section 14.2, a Party (the “non-breaching Party” ) shall have the right, in addition to any other rights and remedies, to terminate this Agreement in the event the other Party (the “breaching Party” ) is in breach of any of its material obligations under this Agreement. The non-breaching Party shall first provide written notice to the breaching Party, which notice shall identify with particularity the alleged breach. The breaching Party shall have a period of [***] ( [***] in the case of non-payment) after such written notice is provided to cure such breach. If such breach is not cured within such period, this Agreement shall terminate immediately at end of such period on written notice from the non-breaching Party so long as the notifying Party included its intent to terminate in such notice, unless the breaching Party requests arbitration pursuant to Section 15.2, in which case, this Agreement shall remain in effect until the outcome of the arbitration and its termination subject to such outcome.


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14.3 Termination by GNE. GNE shall have the right to terminate this Agreement [***] prior written notice to SGEN.

14.4 Termination for Bankruptcy. GNE shall have the right to terminate this Agreement upon written notice to SGEN, in the event that SGEN seeks protection of any bankruptcy or insolvency law, a proceeding in bankruptcy or insolvency is filed by or against SGEN and is not dismissed within [***] , or there is an adjudication by a court of competent jurisdiction that SGEN is bankrupt or insolvent. SGEN shall have the right to terminate this Agreement upon written notice to GNE, in the event that GNE seeks protection of any bankruptcy or insolvency law, a proceeding in bankruptcy or insolvency is filed by or against GNE and is not dismissed within [***] , or there is an adjudication by a court of competent jurisdiction that GNE is bankrupt or insolvent.

14.5 Effects of Termination .

(a) Upon termination of this Agreement by SGEN for GNE’s [***] or due to GNE’s [***] or by GNE under [***] :

(i) Each Party shall promptly return to the other Party all relevant records and materials in its possession or control containing or comprising the other Party’s Confidential Information and to which the Party does not retain rights hereunder.

(ii) All licenses granted by each Party to the other shall terminate (except as set forth in Section 14.5(a)(vi)), and [***] .

(iii) Any sublicense granted to a Sublicensee of GNE outside the U.S. shall survive termination of this Agreement, provided that such Sublicensee (x) is not, on the effective date of such termination, in breach of any provisions of its Sublicense Agreement that materially affects SGEN; (y) agrees, in a subsequent writing, to perform and deliver directly to SGEN all obligations and payments that would be due to SGEN under this Agreement with respect to matters within the scope of such Sublicense Agreement; and (z) agrees, in a


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subsequent writing, that, regardless of GNE’s rights and obligations to such Sublicensee under such Sublicense Agreement, SGEN’s rights and obligations to such Sublicensee shall not be materially different than SGEN’s rights and obligations to GNE under this Agreement. Upon termination of this Agreement pursuant to this [***] and execution of the written agreements contemplated in this clause (iii), [***] .

(iv) GNE and its Affiliates shall discontinue making any representation regarding its status as a licensee of or distributor for SGEN, for all Licensed Products. GNE and its Affiliates shall cease conducting any activities with respect to the marketing, promotion, sale or distribution of Licensed Products.

(v) Subject to this Section 14.5(a), SGEN shall have the right to develop and commercialize the [***] itself or with one or more Third Parties, and shall have the right, [***] .

(vi) GNE hereby grants to SGEN, [***] to make, have made, import, use, offer for sale and sell [***] . In consideration for such license, [***] based on the developmental stage of the most advanced [***] at the time of termination, as follows:

 

Stage of Development

  

Royalty Rate

[***]

   [***]

[***]

   [***]

[***]

  

[***]

[***]

Such royalty shall be payable, on a country-by-country and [***] basis until the later of [***] by SGEN or the expiration of the [***] in such country that covers such [***] or the manufacture, use, or sale of such [***] . Notwithstanding anything to the contrary, the royalty payments set forth above shall be [***] as set forth in this [***] . For clarity, the royalty payments set forth in this Section 14.5(a)(vi) do not include the [***] . The license granted in this Section 14.5(a)(vi) shall be exclusive of any rights under [***] , unless SGEN agrees in writing to [***] .


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(vii) GNE shall assign, or cause to be assigned, to SGEN, and will provide full copies of, all Regulatory Approvals and INDs, BLAs, NDAs and other similar regulatory applications owned by GNE, its Affiliates, and its Sublicensees that relate to [***] . GNE shall also take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights thereunder to SGEN.

(viii) GNE will provide to SGEN copies of all material reports and data, including clinical and non-clinical data and reports, obtained or generated by or on behalf of GNE or its Affiliates (or Sublicensees whose rights have terminated) pursuant to this Agreement that relate to [***] , within [***] of such termination, and SGEN shall have the right [***] ;

(ix) If GNE used one or more Marks with regard to any [***] in a country, GNE shall grant to SGEN an [***] solely in connection with the development and commercialization of such [***] , subject to any trademark rights granted in an ex-U.S. sublicense agreement surviving termination in accordance with [***] . For clarity, [***] .

(x) At SGEN’s request, GNE shall promptly provide to SGEN copies of all clinical trial, contract manufacturing, or service agreements entered into by GNE or its Affiliates with respect to the [***] . At SGEN’s request, [***] , to the extent [***] . In the event that such an assignment or sublicense is not permitted under a particular clinical trial, contract manufacturing, or service agreement, then GNE shall reasonably cooperate (at SGEN’s request) to assist SGEN in obtaining the benefits of such agreement.

(xi) At SGEN’s request, GNE shall supply, or cause to be supplied, SGEN’s requirements of [***] for a period of [***] following the effective date of termination, [***] . If the termination of the Agreement occurs after the first [***] , then SGEN may elect, on written notice at least [***] in advance to GNE to [***] . [***] .

(xii) [***] .


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(xiii) Promptly after the effective date of such termination, GNE shall provide reasonable technical assistance for the period from the effective date of such termination until [***] after such date as necessary to provide technology transfer necessary for SGEN to commence or continue to commercially manufacture [***] .

(xiv) GNE hereby grants to SGEN, effective only upon the [***] .

(b) Upon termination of this Agreement by [***] under [***] for a [***] (as defined below):

(i) SGEN shall promptly return to GNE all relevant records and materials in its possession or control containing or comprising GNE’s Confidential Information and to which [***] .

(ii) All licenses granted by [***] .

(iii) All licenses granted by [***] .

(iv) GNE’s obligations under [***] ; provided, however that the [***] shall be [***] and the [***] shall be [***] .

(v) [***] .

(vi) [***] .

(vii) In addition to the provisions set forth in Sections 14.5(b)(iii-iv) and Section 14.6, the following provisions shall survive termination of the Agreement under this Section 14.5(b): [***] .

(viii) As used herein, a “ [***] ” shall mean (i)  [***], (ii) [***] ; (iii)  [***] ; (v)  [***] ; (vi)  [***] ; and (vii)  [***] (i) through (vii)  [***] .

(ix) Notwithstanding any termination by GNE under this Section 14.5(b), in the event GNE brings an action against SGEN for a breach of this Agreement which is a [***] , and GNE is [***], GNE shall be required either to (i)  [***] ; or (ii)  [***] .


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(c) Upon termination of this Agreement by GNE under Section 14.2 for a material breach by SGEN of this Agreement [***] :

(i) SGEN shall promptly return to GNE all relevant records and materials in its possession or control containing or comprising GNE’s Confidential Information and to which SGEN does not retain rights hereunder.

(ii) All licenses granted by [***] .

(iii) All licenses granted by [***] .

(iv) [***] ;

(v) [***] .

(vi) [***] .

(vii) In addition to the provisions set forth in Sections 14.5(c)(iii-iv) and in Section 14.6, the following provisions shall survive termination of the Agreement under this Section 14.5(b): [***] .

14.6 Survival; Accrued Rights . The rights and obligations of the Parties under the following provisions of this Agreement shall survive any expiration or termination of this Agreement: [***] . In any event, expiration or termination of this Agreement shall not relieve the Parties of any liability which accrued hereunder prior to the effective date of such expiration or termination nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor prejudice either Party’s right to obtain performance of any obligation.

ARTICLE 15

DISPUTE RESOLUTIONS; GOVERNING LAW

15.1 Disputes . Unless otherwise set forth in this Agreement, in the event of any significant controversy, claim, or dispute arising out of or relating to this Agreement, or its interpretation, performance, nonperformance or any breach of any respective obligations hereunder (hereinafter collectively referred to as a “ Dispute ”) arising under this Agreement between the Parties, the Parties shall [***] .


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15.2 Arbitration . If the Parties are unable resolve a given Dispute pursuant to Section 15.1 within [***] , either Party may have the given Dispute settled by binding arbitration in the manner described below:

(a) Arbitration Request . If a Party intends to begin arbitration to resolve a Dispute arising under this Agreement, such Party shall provide written notice (the “Arbitration Request” ) to the other Party of such intention and the issues for resolution. From the date of the Arbitration Request and until such time as the Dispute has become finally settled, the running of the time periods as to which Party must cure a breach of this Agreement becomes suspended as to any breach that is the subject matter of the Dispute.

(b) Additional Issues . Within [***] after the receipt of the Arbitration Request, the other Party may, by written notice, add additional issues for resolution.

(c) Subject Matter Exclusions . This Section 15.2 shall not apply to any Dispute relating to (i)  [***] ; (ii)  [***] ; or (iii)  [***] .

(d) Arbitration Procedure . Discovery shall be under the U.S. Federal Rules of Civil Procedure then in effect in the [***] . The Arbitration shall be held in [***] under the rules of the American Arbitration Association ( “AAA” ). The arbitration shall be conducted [***] who are knowledgeable in the subject matter at issue in the Dispute. [***] . Each Party shall make its selection of arbitrator within [***] after the date of the Arbitration Request. Unless agreed otherwise by the Parties, the Parties shall have [***] from the appointment of the last to be appointed of the [***] to present and/or submit their positions to the arbitrators, and the Parties shall have a hearing before the arbitrators within [***] of such submission. The arbitrators shall hear evidence by each Party and resolve each of the issues identified by the Parties. The arbitrators shall be instructed and required to render a [***] . The written [***] shall be delivered to the Parties as expeditiously as possible, but in no event more than [***] after conclusion of the hearing, unless otherwise agreed to by the Parties. The arbitrators may proceed to an [***] . Each Party agrees to use reasonable efforts to make all of its current employees available, if reasonably needed, and agrees that the arbitrators may deem any party as


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“necessary.” The arbitrators shall be authorized to [***] . The Parties may apply to any court of competent jurisdiction for a temporary restraining order, preliminary injunction or other interim or conservatory relief, as necessary, without breaching these arbitration provisions and without abridging the powers of the arbitrators. At the request of either Party, the arbitrators shall enter an appropriate protective order to maintain the confidentiality of information produced or exchanged in the course of the arbitration proceedings. The arbitrators shall have the power to decide all questions of arbitrability. The arbitrators also shall be authorized to grant any temporary, preliminary or permanent equitable remedy or relief the arbitrators deem just and equitable and within the scope of this Agreement, including, without limitation, an injunction or order for specific performance. The award of the arbitrators shall be the [***] . Judgment on the award rendered by the arbitrators may be enforced in any court having competent jurisdiction thereof, subject only to revocation on grounds of fraud or clear bias on the part of the arbitrators. Notwithstanding anything contained in this Section 15.2 to the contrary, each Party shall have the right to institute judicial proceedings against the other Party or anyone acting by, through or under such other Party, in order to enforce the instituting Party’s rights hereunder through specific performance, injunction or similar equitable relief.

(e) Costs; Satisfaction. Each Party shall bear its own attorneys’ fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrators; provided, however , that the arbitrators shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges and travel expenses), and/or the fees and costs of the arbitrators. Absent the filing of an application to correct or vacate the arbitration award as permitted by applicable law, each Party shall fully perform and satisfy the arbitration award within [***] of the service of the award.

15.3 Waiver . By agreeing to this binding arbitration provision, the Parties understand that they are waiving certain rights and protections which may otherwise be available if a Dispute between the Parties were determined by litigation in court, including the right to seek or obtain certain types of damages precluded by this provision, the right to a jury trial, certain rights of appeal, and a right to invoke formal rules of procedure and evidence.


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15.4 Choice of Law . The validity, performance, construction, and effect of this Agreement shall be governed by the laws of the State of California, without regard to conflicts of law principles that would provide for application of the law of another jurisdiction.

ARTICLE 16

MISCELLANEOUS

16.1 HSR Act.

(a) HSR Filing. Each of GNE and SGEN shall, within fifteen (15) days after Execution Date, file with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice, any HSR Filing required of it under the HSR Act with respect to the subject matter of this Agreement, which forms shall specifically request early termination of the initial HSR Act waiting period. The Parties will cooperate with one another to the extent necessary in the preparation of any such HSR Filing . The Parties hereto commit to instruct their respective counsel to cooperate with each other and use good faith, diligent efforts to facilitate and expedite the identification and resolution of any such issues and, consequently, the expiration of the applicable HSR Act waiting period, such good faith diligent efforts to include counsel’s undertaking: (i) to keep each other appropriately informed of communications received from and submitted to personnel of the reviewing antitrust authority; and (ii) to confer with each other regarding appropriate contacts with and response to personnel of the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice. Each Party will be responsible for its own costs, expenses, and filing fees associated with any HSR Filing. In respect of any HSR Filing, each of GNE and SGEN will use its good faith, diligent efforts to eliminate any concern on the part of any court or governmental authority regarding the legality of the proposed transaction, including cooperating in good faith with any government investigation and the prompt production of documents and information demanded by a second request for documents and of witnesses if requested, and to cause the Effective Date of this Agreement to occur as soon as practical, as provided in Section 16.1(b). Nothing in this Section shall require either Party to consent to the divestiture or other disposition of any of its or its Affiliates’ assets or to consent to any other structural or conduct remedy, and each Party and its Affiliates shall have no obligation to contest, administratively or in court, any ruling, order or other action of the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice or any Third Party respecting the transactions contemplated by this Agreement.

 

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(b) Effective Date. Except for the specific provisions expressly identified in Section 16.1(c), this Agreement shall not be effective until such time as the HSR Conditions are met. Immediately at the time when all the HSR Conditions are met, this Agreement shall be effective automatically in its entirety.

(c) Portions of Agreement Effective as of Execution Date. Notwithstanding Section 16.1(b) and anything in this Agreement to the contrary, the following provisions of this Agreement shall be in full force and effect as of the Execution Date: Article 1 (Definitions), Article 12 (Confidentiality), Article 14 (Term and Termination), and Article 16 (Miscellaneous).

16.2 Assignment. Either Party may assign this Agreement (a) to any Affiliate of such Party without the prior written consent of the other Party, provided that such Party provides the other Party with written notice of such assignment and remains fully liable for the performance of such Party’s obligations hereunder by such Affiliate, or (b) without the prior written consent of the other Party, to its successor in interest by way of merger, acquisition, or sale of [***] or more of its voting shares or assets (“Change in Control” ), provided that such Party provides the other Party with written notice of such assignment. Any other assignment of this Agreement by a Party requires the prior written consent of the other Party. Any assignment in violation of this Section 16.2 shall be null and void. This Agreement shall be binding on and shall inure to the benefit of the permitted successors and assigns of the Parties hereto. Notwithstanding the foregoing, in the event that a Party assigns this Agreement in connection with a Change in Control to its successor all of its assets to which this Agreement relates, the intellectual property rights of such successor in interest, and of any of its Affiliates as of just prior to such Change in Control, as existing immediately prior to the closing of such Change in Control, shall be automatically excluded from the rights licensed to the other Party under this Agreement. In addition, [***] after the later of (a) closing of such Change in Control and (b) GNE’s receipt of written notice of such Change in Control.


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16.3 Force Majeure. If either Party shall be delayed, interrupted in or prevented from the performance of any obligation hereunder by reason of force majeure including an act of God, fire, flood, earthquake, war (declared or undeclared), public disaster, act of terrorism, strike or labor differences, cell culture contamination, lack of access to essential materials or ingredients required for manufacturing, governmental enactment, rule or regulation, or any other cause beyond such Party’s control, such Party shall not be liable to the other therefor; and the time for performance of such obligation shall be extended for a period equal to the duration of the force majeure which occasioned the delay, interruption or prevention. The Party invoking such force majeure rights of this Section 16.3 must notify the other Party by courier or overnight dispatch ( e.g. , Federal Express) within a period of [***] of both the first and last day of the force majeure unless the force majeure renders such notification impossible in which case notification will be made as soon as possible. If the delay resulting from the force majeure exceeds [***] , both Parties shall consult together to find an appropriate solution.

16.4 Entire Agreement. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter herein and, effective on the Effective Date, supersedes all previous agreements between the Parties with respect to the subject matter herein, , whether written or oral, including without limitation the existing mutual confidentiality agreement between SGEN and GNE dated February 6, 2006 covering the subject matter of this Agreement, but excluding the Prior Agreements which remain in full force and effect subject to the terms of this Agreement. This Agreement shall not be changed or modified orally, but only by an instrument in writing signed by both Parties.

16.5 Severability . If any provision of this Agreement is declared invalid by a court of last resort or by any court or other governmental body from the decision of which an appeal is not taken within the time provided by law, then and in such event, this Agreement will be deemed to have been terminated only as to the portion thereof that relates to the provision invalidated by that decision and only in the relevant jurisdiction, but this Agreement, in all other respects and all other jurisdictions, will remain in force; provided, however, that if the provision so invalidated is essential to the Agreement as a whole, then the Parties shall negotiate in good faith to amend the terms hereof as nearly as practical to carry out the original intent of the Parties, and, failing such amendment, either Party may submit the matter for resolution pursuant to Article 15.


[***] 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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16.6 Notices . Any notice or report required or permitted to be given under this Agreement shall be in writing and shall be mailed by certified or registered mail, or telexed or telecopied and confirmed by mailing, as follows and shall be effective five (5) days after such mailing:

 

If to SGEN:    Seattle Genetics, Inc.
   21823 30th Drive S.E.
   Bothell, WA 98021
   Attention: Chief Executive Officer
With copy to:    Seattle Genetics, Inc.
   21823 30th Drive S.E.
   Bothell, WA 98021
   Attention: General Counsel
If to GNE:    Genentech Inc.
   1 DNA Way
   South San Francisco, CA 94080
   Attention: Corporate Secretary
   Telephone: (650) 225-1000
   Facsimile: (650) 467-9146
With a copy to:    Genentech Inc.
   1 DNA Way
   South San Francisco, CA 94080
   Attention: Vice President, Alliance Management
   Telephone: (650) 225-1000
   Facsimile: (650) 467-3294

 

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16.7 Further Assurances . The Parties agree to reasonably cooperate with each other in connection with any actions required to be taken as part of their respective obligations under this Agreement, and shall (a) furnish to each other such further information; (b) execute and deliver to each other such other documents; and (c) do such other acts and things (including working collaboratively to correct any clerical, typographical, or other similar errors in this Agreement), all as the other Party may reasonably request for the purpose of carrying out the intent of this Agreement.

16.8 Agency. Neither Party is, nor will be deemed to be an employee, agent, fiduciary or representative of the other Party for any purpose. Each Party is an independent contractor, not an employee or partner of the other Party. Neither Party shall have the authority to speak for, represent or obligate the other Party in any way without prior written authority from the other Party.

16.9 No Waiver . Any omission or delay by either Party at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof, by the other Party, shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement. Any waiver by a Party of a particular breach or default by the other Party shall not operate or be construed as a waiver of any subsequent breach or default by the other Party.

16.10 No Strict Construction . This Agreement has been prepared jointly by the Parties and shall not be strictly construed against either Party.

16.11 Headings . The captions used herein are inserted for convenience of reference only and shall not be construed to create obligations, benefits, or limitations.

16.12 Counterparts . This Agreement may be executed in counterparts, all of which taken together shall be regarded as one and the same instrument.

16.13 Interpretation of Certain Terms. In this Agreement, the singular shall include the plural and vice versa, the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular

 

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provision hereto, and the word “including” shall be deemed to be followed by the phrase “without limitation.” References to any Section or Article include Sections that are part of the related Section ( e.g ., a Section numbered “Section 3.4.1” would be part of “Section 3.4”, and references to “Section 5.9.1” would also refer to material contained in the Section described as “Section 5.9.1(a)”). The Article and Section headings contained in this Agreement are inserted for convenience only and shall not affect in any way the meaning or interpretation of this Agreement.

[***]


[***] 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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IN WITNESS WHEREOF, the Parties have executed this Collaboration Agreement through their duly authorized representatives to be effective as of the Effective Date.

 

SEATTLE GENETICS, INC.     GENENTECH, INC.
By:   /s/ Clay B. Siegall     By:   /s/ Arthur D. Levinson
Name:   Clay B. Siegall     Name:   Arthur D. Levinson
Title:   President & CEO     Title:   Chairman & CEO


E XHIBIT A

[***]


[***] 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.

 

A-1


E XHIBIT B

[***]


[***] 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.

 

B-1


E XHIBIT C

[***]


[***] 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.

 

C-1


E XHIBIT D

[***]


[***] 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.

 

D-1


E XHIBIT E

[***]


[***] 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.

 

E-1

Exhibit 31.1

CERTIFICATIONS

I, Clay B. Siegall, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Seattle Genetics, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 8, 2007

 

/s/ Clay B. Siegall

Clay B. Siegall

Chief Executive Officer

 

17

Exhibit 31.2

CERTIFICATIONS

I, Todd E. Simpson, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of Seattle Genetics, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting.

Date: May 8, 2007

 

/s/ Todd E. Simpson

Todd E. Simpson

Chief Financial Officer

 

18

Exhibit 32.1

SEATTLE GENETICS, INC.

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Seattle Genetics, Inc. (the “Company”) on Form 10-Q for the quarter ended March 31, 2007, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Clay B. Siegall, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

  (1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ Clay B. Siegall

 

Clay B. Siegall

 

Chief Executive Officer

 

May 8, 2007

 

 

19

Exhibit 32.2

SEATTLE GENETICS, INC.

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Seattle Genetics, Inc. (the “Company”) on Form 10-Q for the quarter ended March 31, 2007, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Todd E. Simpson, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

  (1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

/s/ Todd E. Simpson

 

Todd E. Simpson

 

Chief Financial Officer

 

May 8, 2007

 

 

20