As filed with the Securities and Exchange Commission on July 5, 2012

Registration No. 333-181331

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

AMENDMENT NO. 3

TO

FORM S-1

REGISTRATION STATEMENT

Under

The Securities Act of 1933

 

 

O NCO M ED P HARMACEUTICALS , I NC .

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   2834   38-3572512

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification Number)

800 Chesapeake Drive

Redwood City, CA 94063

(650) 995-8200

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

 

Paul J. Hastings

President & Chief Executive Officer

OncoMed Pharmaceuticals, Inc.

800 Chesapeake Drive

Redwood City, CA 94063

(650) 995-8200

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

 

Copies to:

Alan C. Mendelson, Esq.

Mark V. Roeder, Esq.

Latham & Watkins LLP

140 Scott Drive

Menlo Park, CA 94025

(650) 328-4600

 

Dr. Alicia J. Hager, Esq.

Vice President, Legal Affairs & Chief Patent Counsel

OncoMed Pharmaceuticals, Inc.

800 Chesapeake Drive

Redwood City, CA 94063

(650) 995-8200

 

Donald J. Murray, Esq.

Margaret S. Lam, Esq.

Covington & Burling LLP

620 Eighth Avenue

New York, NY 10018

(212) 841-1000

 

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box:     ¨

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   ¨    Accelerated filer   ¨
Non-accelerated filer   x   (Do not check if a smaller reporting company)    Smaller reporting company   ¨

 

 

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

 

 


Explanatory Note

This Amendment No. 3 is being filed for the purpose of refiling Exhibits 10.1(A), 10.1(B), 10.2 and 10.3(A) and amending the Exhibit Index that is incorporated by reference into Item 16 of Part II of the Registration Statement (File No. 333-181331). No changes or additions are being made hereby to the Prospectus constituting Part I of the Registration Statement (not included herein) or to Items 13, 14, 15 or 17 of Part II of the Registration Statement.


PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 13. Other Expenses of Issuance and Distribution

The following table sets forth the costs and expenses, other than the underwriting discounts and commissions, payable by the registrant in connection with the sale of common stock being registered. All amounts are estimates except for the Securities and Exchange Commission, or SEC, registration fee, the FINRA filing fee and The NASDAQ Global Market listing fee.

 

 

 

ITEM

   AMOUNT TO BE
PAID
 

SEC Registration Fee

   $ 13,179   

FINRA Filing Fee

     12,000   

The NASDAQ Global Market Listing Fee

       

Printing and Engraving Expenses

       

Legal Fees and Expenses

       

Premium Paid on Director and Officer Insurance Policy

       

Accounting Fees and Expenses

       

Blue Sky, Qualification Fees and Expenses

       

Transfer Agent Fees and Expenses

       

Miscellaneous Expenses

       
  

 

 

 

Total

   $   
  

 

 

 

 

 

* To be completed by amendment.

Item 14. Indemnification of Directors and Officers

As permitted by Section 102 of the Delaware General Corporation Law, we have adopted provisions in our amended and restated certificate of incorporation and bylaws that limit or eliminate the personal liability of our directors for a breach of their fiduciary duty of care as a director. The duty of care generally requires that, when acting on behalf of the corporation, directors exercise an informed business judgment based on all material information reasonably available to them. Consequently, a director will not be personally liable to us or our stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for:

 

  n  

any breach of the director’s duty of loyalty to us or our stockholders;

 

  n  

any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

 

  n  

any act related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or

 

  n  

any transaction from which the director derived an improper personal benefit.

These limitations of liability do not affect the availability of equitable remedies such as injunctive relief or rescission. Our amended and restated certificate of incorporation also authorizes us to indemnify our officers, directors and other agents to the fullest extent permitted under Delaware law.

As permitted by Section 145 of the Delaware General Corporation Law, our amended and restated bylaws provide that:

 

  n  

we may indemnify our directors, officers, employees and agents to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions;

 

  n  

we may advance expenses to our directors, officers and employees in connection with a legal proceeding to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions; and

 

  n  

the rights provided in our amended and restated bylaws are not exclusive.

 

II-1


Our amended and restated certificate of incorporation, attached as Exhibit 3.2 hereto, and our amended and restated bylaws, attached as Exhibit 3.4 hereto, provide for the indemnification provisions described above and elsewhere herein. We intend to enter into separate indemnification agreements with our directors and officers which may be broader than the specific indemnification provisions contained in the Delaware General Corporation Law. These indemnification agreements generally require us, among other things, to indemnify our officers and directors against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct. These indemnification agreements also generally require us to advance any expenses incurred by the directors or officers as a result of any proceeding against them as to which they could be indemnified. In addition, we have purchased a policy of directors’ and officers’ liability insurance that insures our directors and officers against the cost of defense, settlement or payment of a judgment in some circumstances. These indemnification provisions and the indemnification agreements may be sufficiently broad to permit indemnification of our officers and directors for liabilities, including reimbursement of expenses incurred, arising under the Securities Act of 1933, as amended, or the Securities Act.

The form of Underwriting Agreement, attached as Exhibit 1.1 hereto, provides for indemnification by the underwriters of us and our officers who sign this Registration Statement and directors for specified liabilities, including matters arising under the Securities Act.

 

Item 15. Recent Sales of Unregistered Securities

The following list sets forth information as to all securities we have sold since January 1, 2009, which were not registered under the Securities Act. The following share numbers and per share amounts have not been adjusted for the reverse stock split of our Class A common stock and Class B common stock to be effected before the completion of this offering.

1. We sold an aggregate of 578,494 shares of Class A common stock to employees, directors and consultants for cash consideration in the aggregate amount of $140,831 upon the exercise of stock options and stock awards.

2. We granted stock options and stock awards to employees, directors and consultants under our Stock Incentive Plan covering an aggregate of 5,074,458 shares of Class A common stock, at an average exercise price of $0.74 per share. Of these, options covering an aggregate of 51,667 shares were cancelled without being exercised.

3. In October 2009, we sold 3,529,410 shares of Series B-1 convertible preferred stock at a price of $1.70 per share for gross proceeds of $6.0 million to seven accredited investors.

We claimed exemption from registration under the Securities Act for the sales and issuances of securities in the transactions described in paragraphs (1) and (2) above under Section 4(2) of the Securities Act in that such sales and issuances did not involve a public offering or under Rule 701 promulgated under the Securities Act, in that they were offered and sold either pursuant to written compensatory plans or pursuant to a written contract relating to compensation, as provided by Rule 701.

We claimed exemption from registration under the Securities Act for the sales and issuances of securities in the transaction described in paragraph (3) above under Section 4(2) of the Securities Act and Regulation D promulgated thereunder, as transactions by an issuer not involving any public offering. The purchasers of the securities in these transactions represented that they were accredited investors and that they were acquiring the securities for investment only and not with a view toward the public sale or distribution thereof. Such purchasers received written disclosures that the securities had not been registered under the Securities Act of 1933, as amended, and that any resale must be made pursuant to a registration statement or an available exemption from registration. All purchasers either received adequate financial statement or non-financial statement information about the Registrant or had adequate access, through their relationship with the Registrant, to financial statement or non-financial statement information about the Registrant. The sale of these securities was made without general solicitation or advertising.

 

Item 16. Exhibits and Financial Statement Schedules

(a) Exhibits

See the Exhibit Index attached to this Registration Statement, which is incorporated by reference herein.

 

II-2


(b) Financial Statement Schedules

Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto.

Item 17. Undertakings

The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.

The undersigned registrant hereby undertakes that:

1. For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

2. For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

II-3


SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this amendment to this Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in Redwood City, California, on July 5, 2012.

 

ONCOMED PHARMACEUTICALS, INC.
By:   /s/ Paul J. Hastings
 

Paul J. Hastings

President and Chief Executive Officer

Pursuant to the requirements of the Securities Act, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.

 

SIGNATURE

  

        TITLE        

 

    DATE    

/s/ Paul J. Hastings

Paul J. Hastings

  

President, Chief Executive Officer and

Director (Principal Executive Officer)

  July 5, 2012

/s/ William D. Waddill

William D. Waddill

  

Senior Vice President and

Chief Financial Officer (Principal

Financial and Accounting Officer)

 

July 5, 2012

*

James N. Woody, M.D., Ph.D.

   Chairman of the Board of Directors  

July 5, 2012

*

James W. Broderick, M.D.

   Director  

July 5, 2012

*

Terry Gould

   Director  

July 5, 2012

*

Jack W. Lasersohn, J.D.

   Director  

July 5, 2012

*

Laurence Lasky, Ph.D.

   Director  

July 5, 2012

*

Deepa R. Pakianathan, Ph.D.

   Director  

July 5, 2012

*

Denise Pollard-Knight, Ph.D.

   Director  

July 5, 2012

*

Jonathan D. Root, M.D.

   Director  

July 5, 2012

 

*By:   /s/ William D. Waddill
 

William D. Waddill,

Attorney-in-Fact

 

II-4


EXHIBIT INDEX

 

 

 

EXHIBIT NUMBER

 

DESCRIPTION

  1.1*   Form of Underwriting Agreement
  3.1+   Amended and Restated Certificate of Incorporation
  3.2*   Form of Amended and Restated Certificate of Incorporation, to be in effect upon completion of this offering
  3.3+   Bylaws
  3.4+   Form of Amended and Restated Bylaws, to be in effect upon completion of the offering
  4.1*   Form of Common Stock Certificate
  4.2(A)+   Warrant to Purchase Stock, dated October 14, 2004, issued to Silicon Valley Bank
  4.2(B)+   Amendment to Warrant Agreement, dated December 5, 2005, by and between the registrant and Silicon Valley Bank
  4.3(A)+   Plain English Warrant, dated January 12, 2007, issued to TriplePoint Capital LLC
  4.3(B)+   Plain English Warrant, dated January 12, 2007, issued to TriplePoint Capital LLC
  4.3(C)+   Plain English Warrant, dated March 7, 2008, issued to TriplePoint Capital LLC
  4.3(D)+   Plain English Warrant, dated October 7, 2008, issued to TriplePoint Capital LLC
  4.4(A)+   Amended and Restated Investor Rights Agreement, dated October 7, 2008, by and among the registrant and certain stockholders
  4.4(B)+   Amendment and Consent, dated September 16, 2010, by and among the registrant and certain stockholders
  5.1*   Opinion of Latham & Watkins LLP
10.1(A)†   Research and Development Collaboration, Option and License Agreement, dated December 7, 2007, by and between the registrant and SmithKline Beecham Corporation
10.1(B)†   Amendment No. 1 to the Research and Development Collaboration, Option and License Agreement, dated July 28, 2011, by and between the registrant and GlaxoSmithKline LLC
10.2†   Collaboration and Option Agreement, dated June 15, 2010, by and between the registrant and Bayer Schering Pharma AG
10.3(A)†   Subscription and License Agreement, dated June 1, 2006, by and between the registrant and MorphoSys AG
10.3(B)†+   Commercial License Requests under the Subscription and License Agreement, dated April 28, 2008 and May 6, 2008, by and between the registrant and MorphoSys AG
10.4(A)†+   License Agreement, dated January 5, 2001, by and between the registrant (as successor in interest to Cancer Stem Cell Genomics, Inc.) and the Regents of the University of Michigan
10.4(B)†+   Amendment Number 1 to License Agreement, dated July 21, 2004, by and between the registrant (as successor in interest to Cancer Stem Cell Genomics, Inc.) and the Regents of the University of Michigan
10.4(C)†+   Amendment Number 2 to License Agreement, dated August 13, 2004, by and between the registrant and the Regents of the University of Michigan

 

 


 

 

EXHIBIT NUMBER

 

DESCRIPTION

10.4(D)+   Amendment No. 3 to License Agreement, dated March 31, 2005, by and between the registrant and the Regents of the University of Michigan
10.4(E)+   Amendment No. 4 to License Agreement, dated December 12, 2005, by and between the registrant and the Regents of the University of Michigan
10.4(F)†+   Amendment No. 5 to License Agreement, dated March 12, 2007, by and between the registrant and the Regents of the University of Michigan
10.4(G)+   Amendment No. 6 to License Agreement, dated October 6, 2008, by and between the registrant and the Regents of the University of Michigan
10.4(H)+   Letter, dated September 4, 2008, from the University of Michigan to the registrant regarding the License Agreement
10.4(I)†+   Memorandum of Understanding, dated May 8, 2009, by and between the registrant and the Regents of the University of Michigan
10.5(A)+   Lease, dated May 30, 2006, by and between the registrant and Slough Redwood City, LLC
10.5(B)+   First Amendment to Lease, dated November __, 2006, by and between the registrant and Slough Redwood City, LLC
10.5(C)+   Second Amendment to Office Lease, dated December 22, 2010, by and between the registrant and HCP LS Redwood City, LLC
10.6(A)#+   2004 Stock Incentive Plan, as amended
10.6(B)#+   Form of Stock Option Agreement under 2004 Stock Incentive Plan
10.7#*   2012 Equity Award Incentive Plan
10.8#*   Employee Stock Purchase Plan
10.9#+   Offer Letter, dated November 12, 2005, by and between the registrant and Paul Hastings
10.10#+   Offer Letter, dated May 27, 2004, by and between the registrant (as successor in interest to Cancer Stem Cell Genomics, Inc.) and John A. Lewicki
10.11#+   Offer Letter, dated October 15, 2007, by and between the registrant and William D. Waddill
10.12#+   Offer Letter, dated June 18, 2009, by and between the registrant and Sunil Patel
10.13#+   Offer Letter, dated July 14, 2005, by and between the registrant and Tim Hoey
10.14#+   Offer Letter, dated September 27, 2004, by and between the registrant and Austin Gurney
10.15(A)#+   Offer Letter, dated February 5, 2007, by and between the registrant and Steven E. Benner
10.15(B)#+   Separation Agreement and General Release, dated November 22, 2011, by and between the registrant and Steven E. Benner
10.16#+   Form of Indemnity Agreement for directors and officers
10.17#+   Form of Change in Control and Severance Agreement for officers

 

 


 

 

EXHIBIT NUMBER

  

DESCRIPTION

10.18#+    Offer Letter, dated July 28, 2011, by and between the registrant and Jakob Dupont
10.19#+    Offer Letter, dated April 24, 2008, by and between the registrant and Alicia J. Hager
23.1+    Consent of independent registered public accounting firm
23.2*    Consent of Latham & Watkins LLP (included in Exhibit 5.1)
24.1+    Power of Attorney

 

 

* To be filed by amendment.

 

+ Previously filed.

 

Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit has been filed separately with the SEC.

 

# Indicates management contract or compensatory plan.

Exhibit 10.1(A)

Execution Version

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

RESEARCH AND DEVELOPMENT COLLABORATION, OPTION,

AND LICENSE AGREEMENT

BY AND BETWEEN

ONCOMED PHARMACEUTICALS, INC.

AND

SMITHKLINE BEECHAM CORPORATION

DECEMBER 7, 2007


TABLE OF CONTENTS

 

             Page  
1.  

D EFINITIONS

     2   
2.  

C OLLABORATION O VERVIEW ; G OVERNANCE

     15   
  2.1  

Collaboration Overview

     15   
  2.2  

Joint Steering Committee

     15   
  2.3  

Joint Program Committee

     18   
  2.4  

Creation of Joint Subcommittees

     18   
  2.5  

OncoMed’s Membership in Committees

     20   
  2.6  

Alliance Managers

     20   
3.  

D EVELOPMENT ; P ROGRAMS

     20   
  3.1  

General

     20   
  3.2  

OncoMed Research and Development Activities

     21   
  3.3  

Selection of Programs

     23   
  3.4  

Selection of Candidate Selection Compounds

     23   
  3.5  

Notice of Proof of Principle to GSK

     24   
  3.6  

Proof of Concept

     24   
  3.7  

Manufacture and Supply Prior to Exercise of GSK Program Option

     26   
  3.8  

Adverse Event Reporting

     26   
4.  

GSK P ROGRAM O PTION ; GSK D EVELOPMENT AND C OMMERCIALIZATION

     26   
  4.1  

GSK Program Option

     26   
  4.2  

GSK Development and Commercialization

     31   
  4.3  

Manufacture and Supply

     35   
5.      

L ICENSES ; T ECHNOLOGY T RANSFER

     36   
  5.1  

License to GSK for GSK Development and Products

     36   
  5.2  

Sublicenses

     37   
  5.3  

[***]

     38   
  5.4  

Research License to OncoMed

     38   
  5.5  

Development and Commercialization License to OncoMed

     38   
  5.6  

Diagnostic Product

     39   
 

5.7

 

Use of Names; Logo; Patent Marking

     39   
 

5.8

 

No Implied Licenses; Retained Rights

     40   
 

5.9      

 

Technology Transfer by OncoMed After Exercise by GSK of a GSK Program Option

     40   

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

- i -


6.  

O NCO M ED O PTIONS TO C O -D EVELOP AND C O -C OMMERCIALIZE C OLLABORATION C OMPOUNDS AND P RODUCTS

     40   
  6.1  

OncoMed’s Option to Co-Develop Collaboration Compounds

     40   
  6.2  

Consequences of Exercise of OncoMed’s Option to Co-Develop Collaboration Compounds

     41   
  6.3  

OncoMed’s Option to Co-Commercialize Products

     42   
  6.4  

Consequences of Exercise of OncoMed’s Option to Co-Commercialize Products

     42   
  6.5  

Level of Co-Commercialization

     44   
  6.6  

Training; Materials; Compliance

     44   
  6.7  

Payments by GSK to OncoMed for Co-Commercialization

     45   
  6.8  

Transferability; [***]

     45   
7.  

E XCLUSIVITY

     45   
  7.1  

Collaboration Target Exclusivity

     45   
  7.2  

Collaboration Compound Exclusivity

     51   
8.  

F INANCIAL T ERMS

     54   
  8.1  

Upfront Payment and Equity Investments

     54   
  8.2  

Milestone Payments to OncoMed

     54   
  8.3  

Royalty Payments to OncoMed

     57   
  8.4  

Payments to GSK

     61   
  8.5  

Royalty Payment Reports

     63   
  8.6  

Manner of Payment

     64   
  8.7  

Records Retention

     64   
  8.8  

Audits

     64   
  8.9  

Currency Exchange

     64   
  8.10  

Taxes

     65   
  8.11  

Interest Due

     65   
9.  

D ILIGENCE

     65   
  9.1  

OncoMed Requirements

     65   
  9.2  

GSK Requirements

     66   
10.    

R EPRESENTATIONS , W ARRANTIES , AND C OVENANTS ; D ISCLAIMERS ; L IMITATION OF L IABILITY

     66   
  10.1  

Mutual Representations and Warranties

     66   
  10.2  

Additional Representations and Warranties of OncoMed

     67   
  10.3  

Mutual Covenants

     68   
  10.4  

Additional Covenants of GSK

     69   
  10.5      

DISCLAIMERS

     69   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

- ii -


  10.6  

LIMITATION OF LIABILITY

     69   
11.  

I NTELLECTUAL P ROPERTY

     70   
  11.1  

Ownership of Inventions

     70   
  11.2  

Filing, Prosecution, and Maintenance of Patents

     70   
  11.3  

Enforcement of OncoMed Licensed Patents Against Infringers

     72   
  11.4  

Patent Term Extension

     74   
  11.5  

Enforcement of GSK Patents

     74   
  11.6  

Regulatory Data Protection

     75   
  11.7  

Defense Against Claims of Infringement of Third Party Patents

     75   
  11.8  

Third Party Licenses

     75   
12.  

N ONDISCLOSURE OF C ONFIDENTIAL I NFORMATION

     76   
  12.1  

Nondisclosure

     76   
  12.2  

Exceptions

     76   
  12.3  

Authorized Disclosure

     77   
  12.4  

Terms of this Agreement

     77   
  12.5  

Securities Filings

     77   
  12.6  

Relationship to Confidentiality Agreement

     78   
  12.7  

Publications

     78   
  12.8  

Publicity

     79   
13.  

I NDEMNITY AND I NSURANCE

     80   
  13.1  

GSK Indemnity

     80   
  13.2  

OncoMed Indemnity

     80   
  13.3  

Indemnification Procedure

     81   
  13.4  

Insurance

     82   
14.  

T ERM AND T ERMINATION

     82   
  14.1  

Term; Expiration

     82   
  14.2  

Termination for Cause

     83   
  14.3  

GSK Unilateral Termination Rights

     83   
  14.4  

Termination for Insolvency

     84   
  14.5  

Termination for Patent Challenge

     84   
  14.6  

Consequences of Expiration or Termination

     84   
  14.7  

Obligations of GSK with Respect to OncoMed Development Compounds

     90   
  14.8  

Survival

     91   
15.    

D ISPUTE R ESOLUTION

     92   
  15.1  

Exclusive Dispute Resolution Mechanism

     92   
  15.2      

Resolution by Executive Officers

     92   

 

- iii -


  15.3  

Arbitration

     92   
  15.4  

Preliminary Injunctions

     93   
  15.5  

Patent Disputes

     93   
  15.6  

Confidentiality

     93   
16.    

M ISCELLANEOUS

     93   
  16.1  

Tolling of Rights and Obligations

     93   
  16.2  

Severability

     95   
  16.3  

Notices

     95   
  16.4  

Force Majeure

     96   
  16.5  

Assignment

     96   
  16.6  

Further Assurances

     97   
  16.7  

Waivers and Modifications

     97   
  16.8  

Choice of Law

     97   
  16.9  

Relationship of the Parties

     97   
  16.10  

Entire Agreement

     97   
  16.11  

Counterparts

     97   
  16.12  

Exports

     97   
  16.13    

Interpretation

     97   

 

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RESEARCH AND DEVELOPMENT COLLABORATION, OPTION, AND LICENSE AGREEMENT

T HIS R ESEARCH AND D EVELOPMENT C OLLABORATION , O PTION , AND L ICENSE A GREEMENT (together with any exhibits attached hereto, this “Agreement” ) is made and entered into as of December 7, 2007 (the “Effective Date” ), by and between OncoMed Pharmaceuticals, Inc. , a Delaware corporation located at 800 Chesapeake Drive, Redwood City, California 94063, United States of America ( “OncoMed” ), and SmithKline Beecham Corporation , a Pennsylvania corporation doing business as GlaxoSmithKline with a principal place of business at One Franklin Plaza, Philadelphia, Pennsylvania 19102, United States of America ( “GSK” ). OncoMed and GSK are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”

RECITALS

W HEREAS , OncoMed has expertise in cancer stem cell, antibody, and drug discovery technologies;

W HEREAS , GSK has expertise in research, development, and commercialization of pharmaceutical products;

W HEREAS , OncoMed has rights under certain patent rights and know-how rights relating to monoclonal antibody targeting of cancer stem cells;

W HEREAS , GSK desires to engage in a collaborative effort with OncoMed pursuant to which OncoMed shall carry out research and development for certain Programs (as defined below) to discover and develop compounds within such Programs through to PoC Trials (as defined below), and for which GSK shall have the exclusive option to develop and commercialize such compounds on an exclusive basis for any and all uses in the Field (as defined below) in the Territory (as defined below), all on the terms and conditions set forth herein;

W HEREAS , upon exercise by GSK of an option with respect to a Program, OncoMed desires to grant to GSK, and GSK desires to obtain, an exclusive license in the Field in the Territory under this Agreement to make, use, sell, offer for sale, and import certain products in the Field in the Territory on the terms and conditions set forth herein; and

W HEREAS , contemporaneously with the execution of this Agreement, the Parties have executed a separate Series B-2 Preferred Stock Purchase Agreement (as defined below) pursuant to which GSK shall purchase shares of preferred stock of OncoMed.

AGREEMENT

N OW , T HEREFORE , in consideration of the foregoing and the mutual agreements set forth below, the Parties agree as follows:

 

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1. D EFINITIONS . The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below or, if not listed below, the meaning designated in places throughout this Agreement.

1.1 “Active Target” means:

(a) during the Research Collaboration Term, any Collaboration Target, except as otherwise set forth in Sections 4.1.5, 4.2.7, 7.1.3(b)(iii), 7.1.3(e), and/or 7.2.6;

(b) during the Development Collaboration Term, any Collaboration Target for which there is a Candidate Selection Compound, except as otherwise set forth in Sections 4.1.5, 4.2.7, 7.1.3(c)(iv), 7.1.3(e), and/or 7.2.6; or

(c) after the expiration of the Development Collaboration Term and continuing until the expiration of the Term, any Collaboration Target, except as otherwise set forth in Sections 4.1.5, 4.2.7, 7.1.3(d)(iii), 7.1.3(e), and/or 7.2.6 for which:

(i) there is a Collaboration Compound subject to diligence obligations pursuant to Article 9; or

(ii) there is not a Collaboration Compound subject to diligence obligations pursuant to Article 9, but

(A) there is a Collaboration Compound that has met the Lead Generation Criteria during the Research Collaboration Term or the Development Collaboration Term, and

(B) such Collaboration Target is identified as an Active Target by mutual written agreement of the Parties prior to [***] after the expiration of the Development Collaboration Term.

1.2 “Affiliate” of a Party means any Person, whether de jure or de facto, that directly or indirectly is controlled by, controls or is under common control with a Party to this Agreement. For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means (a) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors or (b) in the case of a non-corporate entity, direct or indirect ownership of at least fifty percent (50%) of the equity interests with the power to direct the management and policies of such entity; provided that, if local Laws restrict foreign ownership, control shall be established by direct or indirect ownership of the maximum ownership percentage that may, under such local Laws, be owned by foreign interests.

1.3 “Alliance Manager(s)” has the meaning set forth in Section 2.6.

1.4 “BLA” means a Biologics License Application, or similar application that is submitted to the applicable Regulatory Authority for marketing approval of a Product in a given jurisdiction.

 

[***] Certain information in this document 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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1.5 “Business Day” means a day other than Saturday, Sunday or any day on which commercial banks located in New York, New York are authorized or obligated by Laws to close.

1.6 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31; provided, however, that (a) the first Calendar Quarter of any particular period shall extend from the commencement of such period to the end of the first complete Calendar Quarter thereafter; and (b) the last Calendar Quarter shall end upon the expiration or termination of this Agreement.

1.7 “Calendar Year” means (a) for the first Calendar Year of the Term, the period beginning on the Effective Date and ending on December 31, 2008, (b) for each Calendar Year of the Term thereafter, each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31, and (c) for the last Calendar Year of the Term, the period beginning on January 1 of the Calendar Year in which the Agreement expires or terminates and ending on the effective date of expiration or termination of this Agreement.

1.8 “Candidate Selection” means that a Collaboration Compound has met the Candidate Selection Criteria and is ready for advancement into clinical Development, as confirmed by the JSC pursuant to Section 3.4.2.

1.9 “Candidate Selection Compound” means a Collaboration Compound that has met the Candidate Selection Criteria, or that is designated as a Candidate Selection Compound by the JSC, in either case as determined by the JSC as described in Section 3.4.

1.10 “Candidate Selection Criteria” means criteria for advancement of a Collaboration Compound into Development set forth in Exhibit 1.10.

1.11 “CDR(s)” means the six (6) complementarity determining regions, as defined by the Kabat database, of the heavy and light chains of a monoclonal antibody.

1.12 “Chairperson” has the meaning set forth in Section 2.2.2.

1.13 “Clinical Trials” means Phase I Trials, Phase II Trials, Phase III Trials, Phase IV Trials, and/or variations of such trials (for example, Phase II/III).

1.14 “Co-Commercialization” or “Co-Commercialize” means the activities conducted by GSK and OncoMed, as set forth in Article 6, to Commercialize Collaboration Compound(s).

1.15 “Co-Commercialization Agreement” has the meaning set forth in Section 6.3.

1.16 “Co-Commercialization Territory” means [***].

1.17 “Collaboration” means the Development and Commercialization activities conducted by the Parties pursuant to this Agreement.

 

[***] Certain information in this document 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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1.18 “Collaboration Compound” means any monoclonal antibody [***], and [***] that is [***].

1.19 “Collaboration Target” means any ligand or receptor that (a) [***] and (b) is in the Pathway, and [***].

1.20 “Combination Product” means a Product that includes a Collaboration Compound and at least one (1) additional approved therapeutically active pharmaceutical ingredient other than a Collaboration Compound. To be a Combination Product, the Product and all its ingredients (including without limitation the drug substance) must be sold together as a single product and invoiced as one (1) product. Except for those drug delivery vehicles, adjuvants or excipients that are recognized by the FDA as active ingredients, drug delivery vehicles, adjuvants, and excipients are hereby deemed not to be “therapeutically active pharmaceutical ingredients,” and their presence shall not be deemed to create a Combination Product for purposes of this Section 1.20.

1.21 “Commencement” or “Commence” means, when used with respect to a Clinical Trial, the dosing of the first human patient with the first dose in such Clinical Trial.

1.22 “Commercialization” or “Commercialize” means activities directed to and in support of the sale of products in the Territory, including without limitation marketing planning and product strategy, commercial-scale manufacturing, obtaining pricing and reimbursement approvals, negotiating with managed care and group purchasing organizations, professional and consumer promotion, advertising, distributing, importing, exporting, offering for sale or selling a Product, and medical affairs activities, including without limitation opinion leader development, medical inquiries, information and education, pharmacovigilance and carrying out Phase IV Trials commenced after First Commercial Sale of a Product anywhere in the world.

1.23 “Commercially Reasonable Efforts” means efforts consistent with the efforts and resources normally used by a Party in the exercise of its reasonable business discretion relating to the Research, Development or Commercialization of a similar product owned by such Party or to which such Party has exclusive rights, with similar product characteristics, that is of similar market potential at a similar stage in its Development or product life, taking into account issues of patent coverage, safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, the profitability of the applicable products (including without limitation pricing and reimbursement status achieved), and other relevant factors, including without limitation technical, legal, scientific and/or medical factors and in the case of OncoMed shall initially be based on start-up biotechnology companies that have not Developed or Commercialized a product.

1.24 “Committee” means each of the JSC and/or any subcommittees created pursuant to Section 2.2.1(j) or 2.4.

1.25 “Completion” or “Complete” means, when used with respect to a Clinical Trial, the date on which the Party conducting such Clinical Trial [***].

 

[***] Certain information in this document 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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1.26 “Confidential Information” means all trade secrets, processes, formulae, data, Know-How, improvements, inventions, chemical or biological materials, chemical structures, techniques, marketing plans, strategies, customer lists, or other information that has been created, discovered, or developed by a Party, or has otherwise become known to a Party, or to which rights have been assigned to a Party, as well as any other information and materials that are deemed confidential or proprietary to or by a Party (including without limitation all information and materials of a Party’s customers and any other Third Party and their consultants), in each case that are disclosed by such Party to the other Party, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other by the disclosing Party in oral, written, graphic, or electronic form. For purposes of this Agreement, any Know-How that is subject to a license granted hereunder shall be treated as being Confidential Information of both the licensor and the licensee.

1.27 “Controlled” or “Controls” means, when used in reference to intellectual property or intellectual property rights, the legal authority or right of a Party (or any of its Affiliates) to grant a license or sublicense of intellectual property rights to the other Party, or to otherwise disclose proprietary or trade secret information to such other Party, without breaching the terms of any agreement with a Third Party, or misappropriating the proprietary or trade secret information or Know-How of a Third Party.

1.28 “dAb” means a single immunoglobulin domain that contains a variable domain (i.e., V H , V HH , or V L ) that specifically binds (a) [***] and (b) [***]. For clarity, such variable domain may be present in a format (e.g., homo- or hetero-multimer) with other variable domains, where such other variable domains are not [***].

1.29 “Development” means pre-clinical and clinical drug development activities reasonably relating to the discovery and development of pharmaceutical compounds and submission of information to a Regulatory Authority, including without limitation toxicology, pharmacology, and other discovery and pre-clinical efforts, test method development and stability testing, manufacturing process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical studies (including without limitation pre– and post–Regulatory Approval studies) and activities relating to obtaining Regulatory Approval, but excluding other Commercialization activities. When used as a verb, “Develop” means to engage in Development.

1.30 “Development Collaboration Term” means the period (a) beginning on the earlier of (i) the date of Commencement of the first Clinical Trial for a Collaboration Compound or (ii) the expiration of the Research Collaboration Term and (b) ending upon the first to occur of either [***] provided that the Development Collaboration Term shall not end prior to the expiration of the Research Collaboration Term.

1.31 “Development Plan” means, with respect to any Program, a detailed multi-year plan for conducting anticipated Development activities with respect to each Collaboration Compound, including without limitation the following anticipated activities or events: preclinical and clinical studies and activities, a description of the indication targeted, timelines for starting and completing key activities, phasing of Development, primary endpoints, study size, timelines for data preparation and submission of Regulatory Filings, toxicology and a

 

[***] Certain information in this document 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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plan for selecting appropriate species for toxicology studies, ADME and pharmacology studies, and manufacturing process development. The Development Plan will include, without limitation, drug design and Development activities that are in keeping with each of the Parties’ current drug design and Development practices and that are reasonably calculated to result in the Development of Candidate Selection Compounds that may be progressed through to Commercialization.

1.32 “Dispute” has the meaning set forth in Section 15.1.

1.33 “Dollar” or “$” means the lawful currency of the United States.

1.34 “EMEA” means the European Agency for the Evaluation of Medicinal Products, or any successor agency thereto.

1.35 “Europe” or “EU” means the countries comprising the European Union as it may be constituted from time to time, together with those additional countries included in the European Economic Area as it may be constituted from time to time, and any successors to, or new countries created from, any of the foregoing.

1.36 “Executive Officers” has the meaning set forth in Section 2.2.3(a).

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

1.38 “Field” means, subject to the last sentence of this Section 1.38, any use or purpose, including without limitation the treatment, palliation, diagnosis (as further described in the last sentence of this Section 1.38), or prevention of any human or animal disease, disorder or condition. “ Field ” shall include diagnostic use solely to the extent such diagnostic use is of any particular Collaboration Compound that is also used for treatment, palliation or prevention.

1.39 “First Commercial Sale” means, with respect to any Product, the first sale for which payment has been received for use or consumption by an end-user of such Product in any country in the Territory after Regulatory Approval of such Product has been granted, or such marketing and sale is otherwise permitted, by the Regulatory Authority of such country, excluding registration samples, compassionate use, and use in Phase IV Trials for which no payment has been received. So-called “treatment IND sales” and “named patient sales” shall not be construed as a First Commercial Sale.

1.40 “GAAP” means generally accepted accounting principles in the United States, consistently applied.

1.41 “Global Commercialization Plan” has the meaning set forth in Section 4.2.1(b).

1.42 “GLP Toxicology Study” means the study to be undertaken by OncoMed with respect to OMP21M18.

 

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1.43 “Good Clinical Practices” or “GCP” means the standards, practices and procedures set forth in the guidelines entitled in “Good Clinical Practice: Consolidated Guideline,” including without limitation related regulatory requirements imposed by the FDA and (as applicable) any equivalent or similar standards in jurisdictions outside the United States.

1.44 “Good Laboratory Practices” or “GLP” means the regulations set forth in 21 C.F.R. Part 58 and the requirements expressed or implied thereunder imposed by the FDA and (as applicable) any equivalent or similar standards in jurisdictions outside the United States.

1.45 “Good Manufacturing Practices” or “GMP” means the regulations set forth in 21 C.F.R. Parts 210–211, 820 and 21 C.F.R. Subchapter C (Drugs), Quality System Regulations and the requirements thereunder imposed by the FDA, and, as applicable, any similar or equivalent regulations and requirements in jurisdictions outside the United States.

1.46 “GSK Development Compound” means any Collaboration Compound within a Program for which GSK exercises a GSK Program Option and with respect to which GSK, after such exercise, is conducting Development and/or Commercialization.

1.47 “GSK Toxicology Package” means data and results from (a) a dose range finding study in a pharmacologically relevant species, if appropriate, and (b) a study evaluating tissue cross-reactivity in a relevant species.

1.48 “GSK Program Option” has the meaning set forth in Section 4.1.1.

1.49 “GSK Program Option Period” has the meaning set forth in Section 4.1.2.

1.50 “IFRS” means the International Financial Reporting Standards.

1.51 “IND” means any Investigational New Drug application, as defined in the applicable regulations promulgated by the FDA, filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto. References herein to IND shall include, but not be limited to, any comparable filing(s) outside the United States (such as a CTA in the European Union), to the extent applicable.

1.52 “Indemnification Claim” has the meaning set forth in Section 13.3.

1.53 “Indemnitee” has the meaning set forth in Section 13.3.

1.54 “Indemnitor” has the meaning set forth in Section 13.3.

1.55 “Interfering Event” means the then-current existence of a condition or event (a) [***].

1.56 “Joint Commercialization Subcommittee” or “JCS” has the meaning set forth in Section 2.4.2.

 

[***] Certain information in this document 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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1.57 “Joint Development Subcommittee” or “JDS” has the meaning set forth in Section 2.4.1.

1.58 “Joint Manufacturing Subcommittee” or “JMS” has the meaning set forth in Section 2.4.4.

1.59 “Joint Patent Subcommittee” or “JPS” has the meaning set forth in Section 2.4.3.

1.60 “Joint Invention” has the meaning set forth in Section 11.1.

1.61 “Joint Patent(s)” has the meaning set forth in Section 11.1.

1.62 “Joint Program Committee” or “JPC” has the meaning set forth in Section 2.3.

1.63 “Joint Steering Committee” or “JSC” has the meaning set forth in Section 2.2.1.

1.64 “KOL” means a key opinion leader.

1.65 “Know-How” means technical information and know-how, including without limitation biological, chemical, pharmacological, toxicological, clinical, assay and related know-how and/or trade secrets, and/or manufacturing data, preclinical and clinical data, the specifications of ingredients, manufacturing processes, formulation, specifications, sourcing information, quality control and testing procedures, and related know-how and/or trade secrets.

1.66 “Laws” means all applicable laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.

1.67 Lead Generation Criteria ” means the criteria set forth in Exhibit 1.67 for [***].

1.68 “Licensed Intellectual Property” means the OncoMed Licensed Patents, OncoMed Licensed Know-How, and all copyrights Controlled by OncoMed that relate to the Collaboration Compounds or Products.

1.69 “Losses and Claims” has the meaning set forth in Section 13.1.

1.70 “MAA” means marketing authorization application filed with the EMEA or other Regulatory Authority in Europe.

1.71 “Manufacturing and Supply Transition Plan” has the meaning set forth in Section 4.3.2.

1.72 “Michigan License” means the license agreement among OncoMed, the State of Michigan and the Regents of the University of Michigan for rights to certain technology

 

[***] Certain information in this document 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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owned or otherwise controlled by the State of Michigan and the Regents of the University of Michigan, dated January 5, 2001.

1.73 “MSL” means a medical science liaison, also referred to by GSK as a regional medical scientist.

1.74 “Multi-Targeting Antibody” means any antibody directed to multiple targets [***].

1.75 “NDA” means a New Drug Application filed with the FDA required for marketing approval for the applicable Product in the United States.

1.76 “Net Sales” means, with respect to a particular Calendar Quarter, the total amounts billed to Third Parties by a Party, its Affiliates or its Sublicensees for sale or other distribution (provided such distribution is accounted for as a sale in accordance with GAAP or IFRS, as applicable) of Products during such time period to Third Parties in the Territory, less the following deductions to the extent actually allowed or incurred with respect to such sales:

(a) discounts, including without limitation cash and quantity discounts, credits, allowances, charge-back payments, and rebates, actually granted to trade customers, managed health care organizations, federal, state, or local government and the agencies, purchasers, and reimbursers of managed health organizations or federal, state, or local government (as required by Laws or applicable Regulatory Authorities); provided that such Party, its Affiliates and its Sublicensees will account for any such discount in accordance with its internal accounting practices and GAAP or IFRS, as applicable;

(b) credits or allowances actually granted upon damaged goods, rejections, or returns of such Products, including without limitation in connection with recalls;

(c) freight, postage, shipping, transportation, and insurance charges actually allowed or paid for delivery of Products, to the extent billed;

(d) taxes (other than income taxes), duties, tariffs, or other governmental charges levied on the sale of such Products to the extent billed, including without limitation value-added taxes, net of all reimbursements and allowances;

(e) commissions allowed or paid to Third Party distributors, brokers or agents other than sales personnel, sales representatives, and sales agents employed by such Party;

(f) deductions from gross invoiced sales amounts as reported by a Party in its financial statements in accordance with IFRS or GAAP, as applicable. A Party will notify the other Party if it becomes aware of any changes to IFRS or GAAP, as applicable, that will affect the deductions from Net Sales; and

(g) the actual amount of any write-offs for bad debt relating to such sales during the period in which a Party has the obligation to pay a royalty; provided that such

 

[***] Certain information in this document 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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write-off will not exceed [***] of the aggregate gross amount billed in the applicable Calendar Quarter on sales of a Product in the relevant country.

In the event that non-monetary consideration is received for any Product, Net Sales will be calculated based on the average price charged for such Product during the preceding royalty period, or in the absence of such sales, the fair market value of the Product, as determined by the Parties in good faith.

Notwithstanding the foregoing, any (1) [***] or sales to [***], (2) transfers of [***], (3) transfers of [***] and (4) transfers [***] will be excluded from the computation of Net Sales.

Notwithstanding the foregoing, in the event a Product is sold in a country in the Territory as a Combination Product, Net Sales of the Combination Product will be calculated as follows:

(i) If Product and other active component(s) each are sold separately in such country, Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction A/(A+B), where A is [***] during the relevant payment period in the same formulation and dosage. All Gross Selling Prices of the therapeutically active ingredients in the Combination Product shall be calculated as the [***] (the “Market Basket” ). “ Gross Selling Price ” means the gross price at which a product is sold to a Third Party before discounts, deductions, credits, taxes and allowances.

(ii) If either A or B (but not both) cannot be determined because [***] have not occurred in the applicable Calendar Quarter in which the sale of Combination Product was made or if [***], then the Net Sales of the Combination Product in such country for determining the royalty payment and sales milestones payable with respect to such Combination Product for such country for such period shall be calculated by multiplying Net Sales of such Combination Product in such country by either of the following; as applicable; [***].

(iii) If [***], or if [***] then the royalty payment and sales milestones payable on such Combination Product in such country for such period will be [***] of the royalty payment or milestone payment that would be due on a Product that is not a Combination Product if it contains [***] other than Product. If such Combination Product contains [***], then the royalty payment or sales milestone payment payable on such Combination Product in such country shall be [***]. However, if the manufacture, use or sale of [***], the Parties will meet and negotiate an appropriate mechanism for determining the royalty payable on such Combination Product.

For purposes of the foregoing, in the Calendar Year during which a Combination Product is first sold in a country, a [***] to be determined in good faith mutually by the Parties. Any over or under payment due to a difference between [***] shall be paid or credited, as applicable, in the first royalty payment of the following Calendar Year. In the following Calendar Year the average gross selling price of both the Product and the other active component(s) included in the Combination Product in the previous year shall apply.

Net Sales shall be accounted for in accordance with GAAP or IFRS, as applicable.

 

[***] Certain information in this document 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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1.77 “OncoMed Clinical Trial Plan” means the Phase II Trial plan designed by OncoMed as guidance for the design and scope of clinical testing of Candidate Selection Compounds, as set forth in Exhibit 1.77.

1.78 “OncoMed Development Compound” means any Collaboration Compound and/or Product for which OncoMed has the exclusive right to conduct Development and/or Commercialization, including without limitation any and all Collaboration Compounds or Products:

(a) for which GSK does not exercise its GSK Program Option during the GSK Program Option Period as described in Sections 4.1.3(e)(iii) and/or 4.1.5;

(b) that is terminated by GSK as described in Section 4.2.7;

(c) that is terminated in accordance with Section 16.1.3(c);

(d) that are within a Program that is terminated by GSK, as described in Section 14.6.2(b)(i); or

(e) if the Agreement is terminated by GSK pursuant to Section 7.2.6 or 14.3.1, or by OncoMed pursuant to Section 14.2.1, 14.4, or 14.5.

1.79 “OncoMed Licensed Know-How” means all Know-How known to and Controlled by OncoMed or its Affiliates as of the Effective Date and during the Term that is [***] the manufacture, Development and/or Commercialization of Collaboration Compounds and/or Products. OncoMed Licensed Know-How includes, without limitation, OncoMed’s interest in any Know-How [***]. Any Know-How [***] shall be deemed OncoMed Licensed Know-How.

1.80 “OncoMed Licensed Patent(s)” means all Patents in the Territory Controlled by OncoMed or its Affiliates as of the Effective Date as set forth on Exhibit 1.80 and any other Patents Controlled by OncoMed or its Affiliates during the Term that claim or cover [***] and all improvements related thereto, and/or [***] in the Field in the Territory. OncoMed Licensed Patents include, without limitation, OncoMed’s interest in any Joint Patent.

1.81 “OncoMed Logo” has the meaning set forth on Exhibit 1.81.

1.82 “Patents” means patents and patent applications and (a) any foreign counterparts thereof, (b) all divisionals, continuations, continuations in-part thereof or any other patent application claiming priority directly or indirectly to (i) any such specified patents or patent applications or (ii) any patent or patent application from which such specified patents or patent applications claim priority, and (c) all patents issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, renewals, supplemental protection certificates, or extensions of any of the foregoing, and any foreign counterparts thereof.

 

[***] Certain information in this document 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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1.83 “Pathway” means the biological pathway in cancer cells, specifically including cancer stem cells, including any member of the family of receptors and ligands, as set forth in Exhibit 1.83.

1.84 “Payor” has the meaning set forth in Section 8.8.

1.85 “Payee” has the meaning set forth in Section 8.8.

1.86 “Pending Claim” means a claim within a patent application filed in the Territory that has not issued, been abandoned, or been allowed to lapse.

1.87 “Person” means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture, governmental authority, association or other entity.

1.88 “Phase I Trial” means a human clinical trial of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

1.89 “Phase II Trial” means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

1.90 “Phase III Trial” means a human clinical trial of a product, performed after evidence suggesting effectiveness of the compound has been obtained pursuant to one (1) or more Phase II Trial(s), conducted for inclusion in: (a) that portion of an FDA submission and Regulatory Approval process that provides for the continued clinical trials of a product on sufficient numbers of human patients to confirm with statistical significance the safety and efficacy of a product sufficient to support a Regulatory Approval for the proposed indication, as more fully described in 21 C.F.R. 312.21(c), or (b) equivalent Regulatory Filings with similar requirements in a country other than the United States.

1.91 “Phase IV Trial” means a human clinical trial for a product Commenced after receipt of Regulatory Approval in the country for which such clinical trial is being conducted and that is conducted within the parameters of the Regulatory Approval for such product. Phase IV Trials may include, without limitation, epidemiological studies, modeling and pharmacoeconomic studies, investigator sponsored clinical trials of such product and post-marketing surveillance studies.

1.92 “PoC” or “Proof of Concept” means, with respect to a Candidate Selection Compound, determination by the JSC that such Candidate Selection Compound has met the PoC Criteria [***] in accordance with Section 3.6.2(c)(i).

 

[***] Certain information in this document 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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1.93 “PoC Compound” means a Candidate Selection Compound that has met the PoC Criteria, as determined by the JSC pursuant to Section 3.6.3.

1.94 “PoC Criteria” means clinical and non-clinical criteria established pursuant to Section 3.6.1 to determine whether a Candidate Selection Compound under study demonstrates a [***].

1.95 “PoC Trial Design” means, after the indications have been selected pursuant to Section 3.6.2(c)(i) or Section 3.6.2(c)(ii), as applicable, the design of each Phase II Trial for each such indication using the OncoMed Clinical Trial Plan as a guideline with respect to the overall scope and scale of all of the PoC Trials for a particular Candidate Selection Compound to provide evidence of efficacy, safety, and tolerability to meet the PoC Criteria for such Candidate Selection Compound.

1.96 “PoC Trial(s)” means the Phase II Trial(s) for a Candidate Selection Compound carried out in accordance with the PoC Trial Design for such Candidate Selection Compound.

1.97 “PoC Trial Report” has the meaning set forth in Section 3.6.3.

1.98 “PoP” or “Proof of Principle” means that a Candidate Selection Compound has met the PoP Criteria as determined by the JSC pursuant to Section 3.5.

1.99 “PoP Criteria” means evidence of [***].

1.100 “Product” means any product that contains a Collaboration Compound as a therapeutically active ingredient.

1.101 “Program” means the activities by the Parties under this Agreement directed against a particular Collaboration Target, including without limitation the Research and Development of Collaboration Compounds directed to such Collaboration Target.

1.102 “Regulatory Approval” means, with respect to any product in any jurisdiction, all approvals from any Regulatory Authority necessary for the sale of such product in such jurisdiction in accordance with Laws, [***].

1.103 “Regulatory Authority” means any national or supranational governmental authority, including without limitation the FDA, EMEA or Koseisho (i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto), that has responsibility in countries in the Territory over the Development and/or Commercialization of a Collaboration Compound and/or a Product.

1.104 “Regulatory Filings” means any and all regulatory applications, filings, approvals and associated correspondence required to Develop, manufacture, market, sell and import Products in, or into, each country or jurisdiction in the Territory.

1.105 “Research” means the scientific investigation aimed at discovering compounds that target cancer stem cells and/or treat cancer.

 

[***] Certain information in this document 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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1.106 “Research Collaboration Term” means the period commencing on the Effective Date and ending upon the first to occur of either (a) identification by OncoMed, and confirmation by the JSC, that [***], or (b) five (5) years after the Effective Date.

1.107 “Series B-2 Preferred Stock Purchase Agreement” has the meaning set forth in Section 8.1.2(a).

1.108 “Sublicense” means a written agreement pursuant to which a Third Party became a Sublicensee.

1.109 “Sublicensee” means any Third Party granted a sublicense by GSK or OncoMed as permitted under this Agreement of any of the rights licensed to GSK or OncoMed by the other Party under this Agreement. For avoidance of doubt, a “Sublicensee” shall include, without limitation, (a) a Third Party to whom GSK or OncoMed has granted the right to promote or distribute a Product if such Third Party is principally responsible for marketing and promotion of such Product within a particular country or territory, (b) the party to a further sublicense as set forth in Section 5.2.6, and/or (c) a Third Party to whom OncoMed has granted the right to Research, Develop and/or Commercialize an OncoMed Development Compound as set forth in Section 5.5 or Collaboration Compounds as set forth in Sections 7.1.3(b)(iii), 7.1.3(c)(iv), 7.1.3(d)(iii), 7.1.3(e), 7.2.3(c), 7.2.4(b), or 7.2.6.

1.110 “Target 1 Program” means [***].

1.111 “Target 2 Program” means the [***].

1.112 “Target Product Profile” or “TPP” means a description of Product performance aspirations for launch, established by GSK and OncoMed pursuant to Section 3.4.4.

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

1.114 “Territory” means any and all countries in the world.

1.115 “Third Party” means any Person other than GSK, OncoMed, and their respective Affiliates.

1.116 “United States” or “U.S.” means the United States of America and all its territories and possessions

1.117 “U.S. Commercialization Plan” shall have the meaning set forth in Section 4.2.1(c).

1.118 “Valid Claim” means a claim within [***] that has not expired, lapsed, or been cancelled or abandoned, and that has not been dedicated to the public, disclaimed, or held unenforceable, invalid, or been cancelled by a court or administrative agency of competent jurisdiction in an order or decision from which no appeal has been or can be taken, including without limitation through opposition, re-examination, reissue or disclaimer.

 

[***] Certain information in this document 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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2. C OLLABORATION O VERVIEW ; G OVERNANCE

2.1 Collaboration Overview. Pursuant to this Agreement, OncoMed shall use Commercially Reasonable Efforts to: (a) Research and progress [***]; (b) Develop [***]; and (c) [***]. If GSK exercises a GSK Program Option for any Candidate Selection Compound in accordance with Section 4.1, GSK shall (i) use Commercially Reasonable Efforts to further Develop and Commercialize such Candidate Selection Compound in accordance with Articles 4 and 9 and (ii) pay milestones and royalties to OncoMed in accordance with Article 8; provided that, OncoMed, in its discretion, shall have the right to participate in the Development and Commercialization of Candidate Selection Compounds through the JSC, and, with respect to Candidate Selection Compounds, by exercise of its option, in accordance with and only to the extent set forth in Article 6, to undertake co-Development and/or Co-Commercialization activities with respect to any such Candidate Selection Compounds.

2.2 Joint Steering Committee.

2.2.1 General. As soon as practicable after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC” ) to oversee the Collaboration and to make certain decisions regarding the Research, Development, and Commercialization activities of the Parties during the Term as set forth in this Section 2.2. The JSC shall have review and oversight responsibilities for (1) all Research and Development activities performed by OncoMed with respect to each Collaboration Compound prior to the exercise of a GSK Program Option by GSK for such Collaboration Compound, (2) all Research and Development activities performed by the Parties with respect to a GSK Development Compound after the exercise of a GSK Program Option by GSK for such GSK Development Compound, including without limitation OncoMed’s co-Development rights, if any, and (3) the Parties’ Commercialization activities, including without limitation OncoMed’s Co-Commercialization rights, if any. The JSC shall also provide a forum for sharing advice, progress and results relating to such activities and shall attempt to facilitate the resolution of any disputes between the Parties, as described in Section 2.2.3. As provided in Section 4.2.1, as applicable, the JSC shall have [***], and each Party, through its representatives on the JSC, shall be permitted to provide advice and commentary with respect to such [***], and each Party shall consider such advice and commentary in good faith. More specifically, the JSC shall:

(a) modify Candidate Selection Criteria from time to time where appropriate for each Program in accordance with Section 2.2.3(b)(ii);

(b) establish, and modify as applicable, the Program specific PoC Criteria in accordance with Section 3.6.1;

(c) select [***] for which the PoC Trials will be directed for a Candidate Selection Compound as described in Section 3.6.2(c)(i); provided that any Disputes between the Parties concerning the selection of the [***] shall not be submitted to arbitration for resolution;

(d) review, provide comments relating to, and approve each Development Plan, and any modifications thereof, to ensure that, prior to achievement of PoC

 

[***] Certain information in this document 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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with respect to a Collaboration Compound, the Development Plan is reasonably designed to meet the objectives of Developing Collaboration Compounds that meet the Candidate Selection Criteria and PoC Criteria;

(e) review and provide advice regarding the overall progress of OncoMed’s efforts to Research and Develop Collaboration Compounds in accordance with the Candidate Selection Criteria and PoC Criteria and each Development Plan;

(f) for each Collaboration Compound, determine if the Candidate Selection Criteria have been met as further described in Section 3.4.2;

(g) for each Collaboration Compound, determine if the PoP Criteria have been met as further described in Section 3.5;

(h) for each Candidate Selection Compound, determine if the PoC Criteria have been met as further described in Section 3.6.3;

(i) review, provide comments and approve the PoC Trial Design in accordance with Section 3.6.2; provided that [***] as described in Section 3.6.2(c)(i), and that [***] as described in Section 3.6.2(c)(ii), and any Disputes concerning these issues will not be submitted to arbitration for resolution;

(j) appoint and oversee subcommittees as it deems appropriate for carrying out activities under this Agreement, including without limitation oversight of any specific aspects of the Development activities (for example, a subcommittee may be formed to discuss and plan each PoC Trial) or Commercialization activities or other matters;

(k) review and provide comments relating to each Development Plan, and any modifications thereof, to ensure that such Development Plan is reasonably designed to meet the objectives of Developing each GSK Development Compound using Commercially Reasonable Efforts;

(l) review the overall progress of the Parties under the Development Plans, the Global Commercialization Plans, and the U.S. Commercialization Plans;

(m) agree whether to initiate Research and Development activities for more than one Collaboration Compound within a Program, taking into account whether such additional Collaboration Compound(s) will need to meet a different Target Product Profile; and

(n) agree to terminate Development activities under this Agreement with respect to a Collaboration Compound prior to Completion of PoC Trials for such Collaboration Compound, which terminated Collaboration Compound shall be subject to Section 7.2.

2.2.2 Membership; Meetings. The JSC shall be composed of four (4) employees of GSK and four (4) employees of OncoMed or such number as the Parties may agree, and, during the Term, shall meet three (3) times per Calendar Year, or more often as the

 

[***] Certain information in this document 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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JSC shall determine, in person, by teleconference or by video-teleconference. Notwithstanding the foregoing, the presence of at least three (3) of the four (4) such members of each Party at any meeting of the JSC shall constitute a quorum for such meeting, and any and all decisions made at such a meeting shall be deemed a decision of the JSC. In-person meetings shall alternate between OncoMed and GSK locations within the United States whenever possible unless otherwise agreed by the Parties. The first such meeting shall be within sixty (60) days after the Effective Date. Any member of the JSC may designate a substitute to attend with prior written notice to the other Party. There will be an annually rotating chairperson (the “Chairperson” ) during the Research Collaboration Term with the first Chairperson to be designated by OncoMed. After the conclusion of the Research Collaboration Term, for the remainder of the Term, the JSC shall be chaired by a GSK representative. Ad hoc guests who are employees of neither GSK nor OncoMed but who are subject to written confidentiality obligations commensurate in scope to the provisions in Article 12 may be invited to the JSC meetings. Each Party may replace its JSC members with other of its employees, at any time, upon prior written notice to the other Party.

2.2.3 Decision-Making; Limitations on JSC.

(a) Except as otherwise expressly provided in this Agreement, decisions of the JSC shall be made by consensus, with each Party having collectively one (1) vote in all decisions. The JSC shall have only such powers as are specifically delegated to it in this Agreement and such powers shall be subject to the terms and conditions set forth in this Agreement. Without limiting the generality of the foregoing, the JSC shall have no power to amend this Agreement. In the event that the JSC is unable to reach a consensus decision on a matter that is within its decision-making authority within [***] after it has met and attempted to reach such decision, then either Party may, by written notice to the other, have such issue referred to the Chief Executive Officer of OncoMed, or such other person designated in writing by OncoMed from time to time, and the Senior Vice President for External Drug Discovery of GSK, or such other person designated in writing by GSK from time to time, (collectively, the “Executive Officers” ) for resolution. In such a circumstance, the Executive Officers shall meet promptly to discuss the matter submitted and to determine a resolution. If the Executive Officers are unable to resolve the Dispute in accordance with Section 15.2, unless the matter is one over which GSK or OncoMed has final decision-making authority, such Dispute will be resolved through arbitration under Section 15.3.

(b) Notwithstanding Section 2.2.3(a):

(i) [***] will have final decision-making authority with respect to any Disputes between the Parties concerning [***] except as otherwise set forth in Section 2.2.3(b)(v), and Disputes regarding such issues will not be submitted to arbitration under Section 15.3.

(ii) [***] have final decision-making authority with respect to (A) [***] or (B) [***]. Disputes, if any, in the JSC regarding the foregoing will be escalated to the Executive Officers for resolution pursuant to Section 15.2 and, if the Executive Officers cannot agree on such matter after such escalation in accordance with Section 15.2, the Parties will submit such matter to arbitration pursuant to Section 15.3.

 

[***] Certain information in this document 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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(iii) The indications for the PoC Trial Designs shall be selected in accordance with Section 3.6.2(c).

(iv) In accordance with Section 3.6.2(c)(i), [***] will have final decision-making authority regarding [***] (A) [***] (B) [***]. Disputes regarding such PoC Trial Designs will not be submitted to arbitration under Section 15.3.

(v) In accordance with Section 3.6.2(c)(ii), [***] will have final decision-making authority regarding [***] for (A) [***] and (B) [***]. Disputes regarding such PoC Trial Design will not be submitted to arbitration under Section 15.3.

2.2.4 Secretary; Minutes. The Chairperson shall designate a secretary of the JSC who will be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and circulating minutes within fifteen (15) days after each meeting of the JSC setting forth, among other things, a description, in reasonable detail, of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JSC. Such minutes shall be effective only after being approved by both Parties. Definitive minutes of all JSC meetings shall be finalized no later than thirty (30) days after the meeting to which the minutes pertain.

2.2.5 After Exercise of a GSK Program Option. If GSK has exercised a GSK Program Option with respect to a Candidate Selection Compound, such Candidate Selection Compound shall be deemed a GSK Development Compound, and the JSC shall continue as a forum for discussion between the Parties regarding the progression of such GSK Development Compound. The Parties may appoint additional members to the JSC that have specialized knowledge regarding the Development and Commercialization of a GSK Development Compound. The JSC shall continue to meet three (3) times per year, either by teleconference or face-to-face. The Parties will discuss [***]. Subject to Article 6, however, all decisions with respect to the Development and Commercialization of any such GSK Development Compound shall be made at the sole discretion of GSK.

2.3 Joint Program Committee. The Parties shall establish a joint program committee (the “Joint Program Committee” or “JPC” ) for each Program when a Candidate Selection Compound has been identified for such Program. The JPC will be composed of an equal number of representatives from OncoMed and GSK. The JPC will report to the JSC, and any disagreement between the Parties’ members on the JPC shall be submitted for resolution to the JSC. The JPC, in particular, will be responsible for planning the PoC Trials for Candidate Selection Compounds in each Program using the OncoMed Clinical Trial Plan as the guideline for the scale and scope of all of the PoC Trials. The JPC will meet in person, by teleconference or by video-teleconference at least three (3) times per Calendar Year.

2.4 Creation of Joint Subcommittees.

2.4.1 In the event that OncoMed elects to co-Develop a Collaboration Compound pursuant to Article 6, the JSC shall establish a joint Development subcommittee of the JSC (the “Joint Development Subcommittee” or “JDS” ). The JDS will be composed of an equal number of representatives from OncoMed and GSK. The JDS will report to the JSC, and

 

[***] Certain information in this document 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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any disagreement between the Parties’ members on the JDS will be submitted for resolution to the JSC. The JDS will be responsible for the coordination of OncoMed’s review and consultation of the Development efforts with respect to such Collaboration Compound. The JDS will meet in person, by teleconference or by video-teleconference at least three (3) times per Calendar Year to review and discuss material decisions and key activities that relate to such Development. OncoMed and GSK will both contribute to discussions at meetings of the JDS, [***].

2.4.2 In the event that OncoMed elects to Co-Commercialize a Collaboration Compound pursuant to Article 6, the JSC shall establish a joint Commercialization subcommittee of the JSC (the “Joint Commercialization Subcommittee” or “JCS” ). The JCS will be composed of an equal number of representatives from each of OncoMed and GSK. The JCS will report to the JSC, and any disagreement between the Parties’ members on the JCS will be submitted for resolution to the JSC. The JCS will be responsible for the communication, review and discussion of the U.S. Commercialization Plan and the Commercialization activities between the Parties with respect to any Product in the Co-Commercialization Territory after exercise by OncoMed of such option. The JCS will meet in person, by teleconference or by video-teleconference at least three (3) times per Calendar Year to review and discuss material decisions and key activities that relate to Commercialization, including but not limited to [***] support. OncoMed and GSK will both contribute to discussions at meetings of the JCS, but the GSK members of the JCS will have final decision-making authority on all strategic and operational marketing matters associated with the Co-Commercialized Product.

2.4.3 Promptly after the Effective Date, the JSC shall establish a joint patent subcommittee of the JSC (the “ Joint Patent Subcommittee ” or “ JPS ”). The JPS will be composed of an equal number of representatives from each of OncoMed and GSK. The JPS will report to the JSC. The JPS will meet in person, by teleconference or by video-teleconference at such times as agreed to by the Parties, and will be responsible for the coordination of the Parties’ intellectual property efforts in accordance with the provisions set forth in Article 11, including without limitation the review and filing of applications for Joint Patents and assessments of inventorship of inventions created during the Term. In the event of a Dispute within the JPS, such matter shall be escalated to the Senior Vice President of Corporate Intellectual Property for GSK, or such other person designated in writing by GSK for resolution, and the Senior Vice President of Corporate Development of OncoMed, or such other person designated in writing by OncoMed for resolution. If the Dispute cannot be resolved after such escalation, the Dispute shall be submitted to arbitration for resolution under Section 15.3.

2.4.4 At any time after the Effective Date but no later than the Commencement of the first Phase II Trial for a Candidate Selection Compound, the JSC shall establish a joint manufacturing subcommittee of the JSC (the “Joint Manufacturing Subcommittee” or “JMS” ). The JMS shall be comprised of an equal number of representatives from each of OncoMed and GSK. The JMS will report to the JSC, and any disagreement between the Parties’ members on the JMS will be submitted for resolution to the JSC. The JMS will meet in person, by teleconference or by video-teleconference at such times as agreed to by the Parties. The JMS will be responsible for the coordination of the Parties’ efforts in accordance with the provisions set forth in Section 4.3, including without limitation discussion of

 

[***] Certain information in this document 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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manufacturing and supply activities conducted by or on behalf of the Parties and oversight of the orderly transition of manufacture and supply responsibilities for a Candidate Selection Compound from OncoMed to GSK upon exercise by GSK of a GSK Program Option for such Candidate Selection Compound. In the event of a Dispute within the JMS, such Dispute shall be escalated to the Senior Vice President of External Drug Discovery for GSK, or such other person designated in writing by GSK for resolution, and the Senior Vice President of R&D of OncoMed, or such other person designated in writing by OncoMed for resolution. If the Dispute cannot be resolved after such escalation, the Dispute shall be submitted to arbitration for resolution under Section 15.3.

2.5 OncoMed’s Membership in Committees. OncoMed’s membership in any Committee shall be at its sole discretion, as a matter of right and not obligation, for the sole purpose of participation in governance, decision-making, and information exchange with respect to activities within the jurisdiction of such Committee. At any time prior to the disbanding of such Committee pursuant to this Section 2.5, OncoMed shall have the right to withdraw from membership in any or all of the Committees upon thirty (30) days’ prior written notice to GSK, which notice shall be effective as to the relevant Committee upon the expiration of such thirty (30) day period. Following the issuance of such notice for a given Committee, (a) OncoMed’s membership in such Committee shall be terminated and (b) OncoMed shall have the right to continue to receive the information it would otherwise be entitled to receive under the Agreement. If, at any time, following issuance of such a notice, OncoMed wishes to resume participation in the Committees, OncoMed shall notify GSK in writing and, thereafter, OncoMed’s representatives to the Committees shall be entitled to attend any subsequent meeting of the Committees and to participate in the activities of, and decision-making by, the Committees as provided in this Article 2 as if such notice had not been issued by OncoMed pursuant to this Section 2.5. If the JSC is disbanded, then any data and information shall be provided by such Party directly to the other Party.

2.6 Alliance Managers. Promptly after the Effective Date, each Party shall appoint an individual (other than an existing member of the JSC) to act as the alliance manager for such Party (each, an “Alliance Manager” ). Each Alliance Manager shall thereafter be permitted to attend meetings of the JSC as a nonvoting observer, subject to the confidentiality provisions of Article 12. The Alliance Managers shall be the primary point of contact for the Parties regarding the Collaboration activities contemplated by this Agreement and shall facilitate communication regarding all activities hereunder. The Alliance Managers shall lead the communications between the Parties and shall be responsible for following-up on decisions made by the JSC. The name and contact information for such Alliance Manager, as well as any replacement(s) chosen by OncoMed or GSK, in their sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 16.3.

3. D EVELOPMENT ; P ROGRAMS

3.1 General OncoMed shall undertake Research and Development activities with the objective of Developing Collaboration Compounds that meet the Candidate Selection Criteria, PoP Criteria, and PoC Criteria as described in Section 2.1. OncoMed shall have the right to engage Third Parties as subcontractors to conduct certain Development activities to be undertaken under this Agreement, as further provided in Section 3.2.8. Generally, except as

 

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otherwise expressly provided herein, OncoMed shall be responsible for, and shall solely bear the costs and expenses incurred in connection with the conduct of, all Research and Development activities with respect to a Program prior to exercise by GSK of a GSK Program Option with respect to such Program and, generally, except as otherwise expressly provided herein, GSK shall be responsible for, and shall solely bear the costs and expenses incurred in connection with the conduct of, all Development and Commercialization activities with respect to all GSK Development Compounds and all Products containing such GSK Development Compounds and continuing for so long as such GSK Development Compounds or such Products are being Developed or Commercialized, subject to OncoMed’s right to co-Develop and Co-Commercialize such GSK Development Compounds and such Products pursuant to Article 6.

3.2 OncoMed Research and Development Activities.

3.2.1 Commencement of OncoMed Development Activities. OncoMed shall commence Research and Development efforts for each Program as soon as reasonably practicable after the Effective Date. OncoMed shall provide written notice to GSK promptly after commencing Research and Development efforts for each Program. The Parties hereby confirm that OncoMed has initiated Research activities for the Target 2 Program and the Target 1 Program as of the Effective Date.

3.2.2 GSK Consultation. GSK will act in a consultative manner as reasonably requested by OncoMed and, on occasion, may elect to perform, or assist in the performance, of OncoMed’s Research and Development activities under this Agreement, all as and to the extent agreed upon by each of the Parties in its sole discretion.

3.2.3 Supplemental Development Work. GSK, upon agreement of OncoMed, such agreement not to be unreasonably withheld, delayed, or conditioned, shall have the right, at its sole cost and expense, to conduct additional formulation development and/or Collaboration Compound scale-up ( “Supplemental Development Work” ) that GSK and OncoMed deem useful for supplementing Development activities conducted by OncoMed and relating to one or more of the Collaboration Compounds. OncoMed shall reasonably cooperate with GSK in relation to such Supplemental Development Work, and, subject to availability, will transfer reasonable quantities of Collaboration Compounds, if necessary. It is understood and agreed by the Parties that any such Supplemental Development Work is to be conducted by GSK and not as part of any Program or PoC Trial and that GSK and OncoMed each shall use Commercially Reasonable Efforts to not delay the progress of any Development Plan to await the results of any such Supplemental Development Work or to transfer any responsibility to GSK for the conduct of any activities under the Development Plan prior to exercise by GSK of the GSK Program Option unless agreed to in writing by the Parties.

3.2.4 Development Reports. OncoMed will provide the JSC with written Development reports or presentations at JSC meetings. Each report or presentation shall include the Development activities accomplished by OncoMed since the previous JSC meeting, including a summary of significant results, information and data generated, significant challenges anticipated and updates regarding significant intellectual property issues relating to each Program. Upon request by GSK, OncoMed shall provide GSK additional information with respect to the experimental data underlying such summary. Upon request by the JSC, OncoMed

 

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shall provide the JSC with summaries of available clinical protocols, investigator brochures, non-clinical protocols and reports (including without limitation activities relating to CMC), regulatory submissions and correspondence from Regulatory Authorities with respect to Collaboration Compounds.

3.2.5 Records. OncoMed shall, and shall require its contractors and Sublicensees (to the extent OncoMed is permitted to sublicense its rights with respect to OncoMed Development Compounds) to, maintain complete and accurate records of all work conducted in furtherance of the Development of Collaboration Compounds and all results, data and developments made in conducting such activities. Such records shall be complete and accurate and shall fully and properly reflect all such work done and results achieved in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.

3.2.6 Development Responsibilities and Costs. OncoMed shall have responsibility for conducting all Development activities, including without limitation PoC Trials, for each Collaboration Compound prior to exercise by GSK of the GSK Program Option for such Collaboration Compound. OncoMed shall conduct all such Development activities up to and including the PoC Trials in compliance with all material Laws including without limitation all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials. The Parties agree to cooperate during the Research Collaboration Term in identifying and implementing opportunities to reduce the costs incurred by OncoMed in the conduct of Development of Collaboration Compounds. After exercise of a GSK Program Option, such responsibilities and costs shall be determined in accordance with Section 4.2.4.

3.2.7 Regulatory Responsibilities and Costs. Prior to GSK’s exercise of a GSK Program Option with respect to any Candidate Selection Compound, OncoMed shall prepare, file, maintain and own all Regulatory Filings and related submissions with respect to each such Candidate Selection Compound and shall bear the cost of such preparation, subject to transfer, where appropriate, to GSK of such Regulatory Filings for a Candidate Selection Compound upon exercise by GSK of the GSK Program Option for such Collaboration Compound as provided in Section 4.2.5. Upon request, OncoMed will provide the JSC with copies of all Regulatory Filings and related, material correspondence submitted to Regulatory Authorities or received from Regulatory Authorities with respect to such Candidate Selection Compound. The Parties agree to cooperate during the Research Collaboration Term in identifying and implementing opportunities to reduce the costs incurred by OncoMed with respect to such regulatory activities.

3.2.8 Subcontracting. OncoMed may perform any activities in support of its Development of Collaboration Compounds through subcontracting to a Third Party contractor or contract service organization; provided that: (a) none of the rights of GSK hereunder are materially adversely affected as a result of such subcontracting; (b) any such Third Party subcontractor to whom OncoMed discloses Confidential Information shall enter into an appropriate written agreement obligating such Third Party to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than the obligations in Article 12; (c) OncoMed will retain or obtain exclusive Control of any and all intellectual property (and patent rights covering such intellectual property) made by such Third Party in performing such services for OncoMed that are necessary for the Development

 

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and Commercialization of Products, and to the extent such exclusive Control of rights cannot be obtained with respect to any intellectual property from any such subcontractor, prior to entering into any such arrangement, OncoMed shall bring such matter to the JSC in a timely fashion in order to seek the approval of the JSC to enter into such an arrangement; (d) OncoMed shall at all times be responsible for the performance of such subcontractor; and (e) OncoMed shall not subcontract the conduct of Clinical Trials for any Candidate Selection Compound in any of the Programs, except through use of contract research organizations and selected independent contractors.

3.2.9 Data Integrity. OncoMed acknowledges the importance to GSK of ensuring that the Programs are undertaken in accordance with the following good data management practices, and OncoMed agrees to carry out the Programs and collect and record any data generated therefrom in a manner consistent with the requirements set forth below:

(a) data are being generated using sound scientific techniques and processes;

(b) data are being accurately recorded in accordance with good scientific practices by persons conducting Research hereunder;

(c) data are being analyzed appropriately without bias in accordance with good scientific practices; and

(d) data and results are being stored securely and can be easily retrieved.

3.3 Selection of Programs. The Parties acknowledge that the first two (2) Programs for the Collaboration are Target 2 Program and the Target 1 Program. Within twelve (12) months following the Effective Date, the JSC will select the third and fourth Programs from within the Pathway based on the scientific understanding at that time. Any Disputes regarding the selection of the third and fourth Programs will not be submitted to arbitration for resolution.

3.4 Selection of Candidate Selection Compounds.

3.4.1 General. OncoMed Development efforts will generally begin with achievement of Lead Generation Criteria with respect to a Collaboration Compound and continue with the testing of such Collaboration Compound using OncoMed’s proprietary assays, and using other analytical and evaluative tools and methods, to generate the data required to evaluate such Collaboration Compound against the Candidate Selection Criteria.

3.4.2 Notification of Candidate Selection Compounds; JSC Review. OncoMed will notify the JSC when OncoMed believes a proposed Candidate Selection Compound has met the Candidate Selection Criteria and will provide the JSC with all material data and information supporting OncoMed’s determination that the Collaboration Compound has met the Candidate Selection Criteria. The JSC shall have a period of [***] following receipt from OncoMed of such notice and all of the data and information that is available to OncoMed to notify OncoMed in writing whether it agrees with OncoMed’s designation of the Collaboration

 

[***] Certain information in this document 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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Compound as a Candidate Selection Compound. If the JSC does not agree with OncoMed’s designation of a Collaboration Compound as a Candidate Selection Compound, then the JSC shall advise OncoMed in writing of the basis for its position within such [***] period. In case of a Dispute that cannot be resolved by the JSC, such Dispute will be referred to the Executive Officers for resolution pursuant to Section 15.2. If the Executive Officers cannot agree on such Dispute after such escalation, the Parties will submit such Dispute to arbitration pursuant to Section 15.3. Notwithstanding anything to the contrary, the Parties agree that, as of the Effective Date, the compound designated OMP21M18 by OncoMed is a Candidate Selection Compound.

3.4.3 Collaboration Compound Not Meeting Candidate Selection Criteria; Rejection of Collaboration Compound. The JSC shall have the discretion to designate any Collaboration Compound as a Candidate Selection Compound that does not meet the Candidate Selection Criteria, and upon such designation, such Collaboration Compound shall be a Candidate Selection Compound for all purposes under this Agreement, including, but not limited to, milestone payments under Article 8. [***]

3.4.4 Establishment of Target Product Profile. For each Program, within [***] days following notification by OncoMed of a proposed Candidate Selection Compound, GSK will present a draft TPP to OncoMed, and the Parties shall discuss and review the proposed TPP at the JPC, and shall subsequently provide such TPP to the JSC for approval. If the JSC cannot agree on the TPP for any Program, then the matter will be referred to [***]. The TPP associated with any Program is subject to revision by agreement between the Parties at any time as the clinical, regulatory and market environments dictate. Any material changes to a TPP for a Program must also be approved by the JSC. If the JSC cannot agree on the changes to the TPP for any Program, then the matter will be referred to [***]. In the event more than one Collaboration Compound in a Program are being progressed, each Collaboration Compound in a Program may have a different TPP.

3.5 Notice of Proof of Principle to GSK. OncoMed shall promptly notify the JSC after OncoMed determines that a Collaboration Compound has achieved the PoP Criteria. The JSC shall have a period of [***] after receipt from OncoMed of such notice and all of the data and information that is available to OncoMed to agree on whether such Collaboration Compound has met such PoP Criteria. Notwithstanding anything to the contrary, Disputes, if any, in the JSC regarding whether PoP Criteria have been met will be escalated to the Executive Officers for resolution pursuant to Section 15.2 and, if the Executive Officers cannot resolve such Dispute after such escalation, the Parties will submit such Dispute to arbitration pursuant to Section 15.3.

3.6 Proof of Concept.

3.6.1 PoC Criteria. Beginning after [***], the Parties shall begin to develop PoC Criteria to be used to evaluate Candidate Selection Compounds directed to such Collaboration Target in the PoC Trials. The JSC shall establish the PoC Criteria for a Candidate Selection Compound directed to a particular Collaboration Target not later than the earlier of either (a) [***] prior to the expected [***] or (b) [***] have been made available to the JSC for review. Such PoC Criteria shall be documented with sufficient specificity and clarity to determine whether a particular Candidate Selection Compound meets such criteria. If the JSC

 

[***] Certain information in this document 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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cannot agree on PoC Criteria for any Collaboration Target, then the matter will be referred to the Executive Officers pursuant to Section 15.2; provided that, if the Executive Officers are unable to resolve such matter, then such matter will [***]. The Parties agree that the PoC Criteria for any particular Collaboration Target may not be materially amended after establishment by [***], except upon agreement of the Parties.

3.6.2 PoC Trials.

(a) OncoMed shall conduct [***] PoC Trials [***] with respect to [***] Candidate Selection Compounds [***] through to Completion of such PoC Trials. In addition, if OncoMed elects to Develop any antibody under Sections 4.1.5(c), 4.2.7(d), 7.1 and/or 7.2, OncoMed shall use Commercially Reasonable Efforts in accordance with Section 9.1 to conduct [***].

(b) The OncoMed Clinical Trial Plan will serve as a guide for the PoC Trial Design for each Candidate Selection Compound such that, for example, the total number of patients to be treated in the PoC Trials with respect to a Candidate Selection Compound will not exceed the total number of patients set forth in the OncoMed Clinical Trial Plan for such Candidate Selection Compound. The PoC Trial Design for Candidate Selection Compounds in any Program cannot be materially amended after Commencement of the PoC Trials, except upon agreement of the Parties.

(c) Decision-Making Authority Regarding PoC Trials.

(i) The JSC, after review of the plan for PoC Trials provided by the JPC pursuant to Section 2.3, will review the indications proposed by the Parties and establish the PoC Trial Design for [***]. If the JSC cannot reach agreement on [***] then such Dispute relating to [***] will be referred to the Executive Officers for resolution pursuant to Section 15.2. If such Executive Officers cannot resolve such Dispute after such escalation, such Dispute shall not be submitted to arbitration and the Parties will not progress such Candidate Selection Compound in any PoC Trial.

(ii) After the Parties have agreed upon selection of [***] in accordance with Section 3.6.2(c)(i), [***]. Notwithstanding the foregoing, [***] shall take into account [***].

(iii) In the event the scope and scale of the [***] PoC Trials described in Section 3.6.2(c)(i) are such that the overall scope and scale of the [***] PoC Trials described in Section 3.6.2(c)(i) and (ii) would be [***] than that described in the OncoMed Clinical Trial Plan, then OncoMed shall [***] described in Section 3.6.2(c)(ii).

3.6.3 Notice of Proof of Concept to the JSC. Once OncoMed determines that a Candidate Selection Compound has completed a PoC Trial, OncoMed, as soon as possible after data lock for such PoC Trial, shall provide a data package to the JSC containing the following information: all analyses, results and raw data from such PoC Trial, as well as all other preclinical data and/or clinical data generated and any related material correspondence or information received from or sent to any Regulatory Authority up to the Completion of such PoC

 

[***] Certain information in this document 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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Trial (the “PoC Trial Report” ). Such information shall be used by the JSC solely to confirm that such Candidate Selection Compound has met the PoC Criteria and [***]. The JSC shall have a period of [***] after receipt of such PoC Trial Report to review, comment and agree on whether such Candidate Selection Compound in such PoC Trial has met the PoC Criteria. Notwithstanding anything to the contrary, Disputes, if any, in the JSC regarding whether PoC Criteria have been met will be escalated to the Executive Officers for resolution pursuant to Section 15.2 and, if the Executive Officers cannot resolve such Dispute after such escalation, the Parties will submit such Dispute to arbitration pursuant to Section 15.3.

3.7 Manufacture and Supply Prior to Exercise of GSK Program Option. [***] shall manufacture, handle, store and ship all Collaboration Compounds in compliance with all Laws, with all Regulatory Filings, and with its applicable internal specifications and quality control procedures.

3.8 Adverse Event Reporting. Beginning on the Effective Date and continuing until such time, if any, that GSK exercises the GSK Program Option with respect to a Candidate Selection Compound, OncoMed shall be responsible for reporting all adverse drug reaction experiences related to such Candidate Selection Compound in connection with the activities of OncoMed under this Agreement to the appropriate Regulatory Authorities in the countries in the Territory in which such Candidate Selection Compound is being Developed, in accordance with the Laws of the relevant countries and Regulatory Authorities. OncoMed shall provide GSK notice of any such adverse drug reaction experience within forty-eight (48) hours and provide copies of all reports to GSK as soon as possible prior to any filing with a Regulatory Authority. Through the JSC, GSK shall have the right to review from time to time OncoMed’s pharmacovigilance policies and procedures. GSK and OncoMed agree to cooperate and use good faith efforts to ensure that OncoMed’s adverse event database is organized in a format that is compatible with GSK’s adverse event databases. After exercise of a GSK Program Option, such responsibilities shall be determined in accordance with Section 4.2.5.

4. GSK P ROGRAM O PTION ; GSK D EVELOPMENT AND C OMMERCIALIZATION

4.1 GSK Program Option.

4.1.1 GSK Program Option Grant. Subject to the terms and conditions of this Agreement, including without limitation the payment of amounts to OncoMed as and when they become due hereunder, OncoMed hereby grants to GSK, with respect to a Candidate Selection Compound in any Program, the exclusive right, exercisable at GSK’s sole discretion either [***], to elect, on a Candidate Selection Compound–by–Candidate Selection Compound basis, to obtain an exclusive worldwide license under Section 5.1 to Develop and Commercialize such Candidate Selection Compound for which such option is exercised under this Agreement as a Product under the terms and conditions set forth in this Agreement (each such right to elect, a “GSK Program Option” ).

4.1.2 GSK Program Option Period. The GSK Program Option exercise period for each Candidate Selection Compound (a) shall begin upon [***] for such Candidate Selection Compound, and (b) shall expire upon either (i) [***], or (ii) [***] (the “GSK Program Option Period” ). Notwithstanding the foregoing, the GSK Program Option

 

[***] Certain information in this document 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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Period for any Candidate Selection Compounds exercisable under Section 4.1.3(b)(ii), 4.1.3(f), 4.1.5(b), 4.2.7(c), 7.1.3(c)(i)(C) or 7.2 shall be determined as set forth in Sections 4.1.3(b)(ii), 4.1.3(f), 4.1.5(b), 4.2.7(c), 7.1.3(c)(i)(C) and 7.2, respectively. Each GSK Program Option, if not exercised by GSK during the GSK Program Option Period for the applicable Candidate Selection Compound, shall expire and be of no further force or effect after expiration of such GSK Program Option Period, except as otherwise set forth in Section 4.1.3(e).

4.1.3 GSK Program Option Exercise.

(a) Notification; Designation of GSK Development Compound. A GSK Program Option with respect to any particular Candidate Selection Compound shall only be exercisable during the applicable GSK Program Option Period and will terminate upon expiration of such GSK Program Option Period, except as otherwise set forth in Section 4.1.3(e). GSK shall exercise its GSK Program Option, if at all, by written notice to OncoMed, which notice shall make reference to this Agreement and the relevant Candidate Selection Compound and Program. Upon exercise of a GSK Program Option, subject to Section 16.1, the relevant Candidate Selection Compound shall be designated as a GSK Development Compound, unless and until GSK terminates its Development and/or Commercialization activities with respect to such GSK Development Compound pursuant to Section 4.2.7 or this Agreement is terminated, whether in its entirety or with respect to such GSK Development Compound and such Program (alone or with other Programs).

(b) Exercise at Candidate Selection.

(i) In accordance with Section 3.4.2, on a Program-by-Program basis, OncoMed will notify GSK when it believes it has successfully developed a Collaboration Compound that meets the Candidate Selection Criteria. If the JSC determines that such Collaboration Compound satisfies the Candidate Selection Criteria pursuant to Section 3.4.2, such Collaboration Compound shall be deemed a Candidate Selection Compound. [***] for which OncoMed has not Completed PoC Trials except pursuant to Section 4.1.3(b)(ii), 4.1.3(f), 4.1.5(b), 4.2.7(c), or 7.1.3(c).

(ii) OncoMed may, at its sole discretion and at any time after OncoMed has initiated PoC Trials for [***] offer any other Candidate Selection Compound to GSK to continue Development of such Candidate Selection Compound as a GSK Development Compound. No later than [***] after the date of notification by OncoMed of such offer, GSK shall have the option, at its sole discretion, to exercise the GSK Program Option for such Candidate Selection Compound. If GSK exercises the GSK Program Option for such Candidate Selection Compound, GSK shall pay all milestone payments set forth in Section 8.2 and royalty payments set forth in Section 8.3. If GSK does not exercise such GSK Program Option within such time period, OncoMed may in its sole discretion continue to use Commercially Reasonable Efforts to progress such Candidate Selection Compound through to Completion of the PoC Trials for such Candidate Selection Compound. For clarity, GSK’s election to exercise the GSK Program Option prior to Completion of a PoC Trial shall not affect OncoMed’s obligation to use Commercially Reasonable Efforts to progress [***].

 

[***] Certain information in this document 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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(c) Exercise at PoC.

(i) In accordance with Section 3.6.3, OncoMed will notify the JSC when it believes it has successfully developed a Candidate Selection Compound that meets the PoC Criteria. If the JSC determines that such Candidate Selection Compound satisfies the PoC Criteria pursuant to Section 3.6.3, the Candidate Selection Compound will be deemed a PoC Compound.

(ii) Upon OncoMed’s first Completed PoC Trial GSK will thereafter have the right to exercise the GSK Program Option as set forth in Section 4.1.1 within the GSK Program Option Period, and, after such exercise, (A) OncoMed will continue to use Commercially Reasonable Efforts to Complete any remaining PoC Trial for such Candidate Selection Compound such that [***] are Completed for such Candidate Selection Compound, (B) GSK shall use Commercially Reasonable Efforts to further Develop and Commercialize such PoC Compound as a GSK Development Compound, subject to OncoMed’s co-Development and Co-Commercialization rights under Article 6, and (C) GSK shall pay all milestone payments set forth in Section 8.2 and royalty payments set forth in Section 8.3 with respect to such PoC Compound. If GSK does not elect to exercise the GSK Program Option as set forth in Section 4.1.1 within the GSK Program Option Period, the GSK Program Option shall terminate with respect to such Candidate Selection Compound as provided in Section 4.1.5, except as otherwise set forth in Section 4.1.3(e).

(d) Exercise After Failure to Meet PoC. Notwithstanding anything to the contrary, if GSK has not exercised a GSK Program Option for a Candidate Selection Compound in a Program, and [***] and such Candidate Selection Compound did not meet the PoC Criteria for such Program, GSK, in its sole discretion, during the applicable GSK Program Option Period as set forth in Section 4.1.2(b)(ii), may elect to exercise its GSK Program Option for such Candidate Selection Compound. If GSK exercises such GSK Program Option, (i) GSK will pay to OncoMed milestone payments pursuant to Section 8.2.2 and all milestones pursuant to Section 8.2.1 subsequent to the “Commencement of Phase II Trial” milestone, if any, that correspond to an achieved milestone event and that have not been paid at the time of exercise of such GSK Program Option, and (ii) such Candidate Selection Compound thereafter will be a GSK Development Compound, subject to the terms and conditions of the Agreement.

(e) Conduct of and Exercise After Additional PoC Trial.

(i) If (A) OncoMed Completes the [***] but PoC is determined not to have been met with respect to such Candidate Selection Compound, (B) GSK does not exercise the GSK Program Option with respect to such Candidate Selection Compound within the GSK Program Option Period, and (C) there are no other Collaboration Compounds in the same Program that have met the Lead Generation Criteria, then OncoMed may, at its sole discretion, provide notice to GSK of its desire to conduct an additional PoC Trial under this Agreement with respect to such Candidate Selection Compound. If, after receipt of such notice, GSK agrees that OncoMed should conduct such additional PoC Trial under this Agreement, [***] in connection with such additional PoC Trial and, prior to Commencement of such additional PoC Trial, [***]. If the Parties dispute whether OncoMed should conduct such additional PoC Trial, such Dispute shall not be submitted to arbitration pursuant to Section 15.3,

 

[***] Certain information in this document 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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and such additional PoC Trial shall not be conducted hereunder. If OncoMed does not give notice to GSK of its desire to conduct an additional PoC Trial for such Candidate Selection Compound, [***].

(ii) Upon Completion of such additional PoC Trial, GSK shall have the right to exercise the GSK Program Option with respect to such Candidate Selection Compound within [***] after receipt by the JSC of a PoC Trial Report that has been updated to include the results of such additional PoC Trial, which period may be extended by [***] days upon GSK’s reasonable request. If GSK elects to exercise the GSK Program Option within such period, (A) such Candidate Selection Compound shall be deemed a GSK Development Compound and (B) GSK shall pay to OncoMed the milestone payment set forth in Section 8.2.1, which is due upon exercise by GSK of the GSK Program Option at PoC [***] in addition to all subsequent milestone payments under Section 8.2 and royalties under Section 8.3.

(iii) If GSK does not agree that OncoMed should conduct such additional PoC Trial under this Agreement after receipt of notice from OncoMed of OncoMed’s desire to conduct such additional PoC Trial, or if the Parties do agree that OncoMed should conduct such additional PoC Trial under this Agreement but GSK elects not to exercise the GSK Program Option with respect to such Candidate Selection Compound after Completion of such additional PoC Trial in accordance with Section 4.1.3(e)(ii), then such Candidate Selection Compound shall be deemed an OncoMed Development Compound and OncoMed will thereafter have all rights, itself or with a Third Party or through a Sublicensee, to Develop and Commercialize such OncoMed Development Compound at OncoMed’s sole expense, subject to the terms of this Agreement, including without limitation the grant of the license by GSK to OncoMed under Section 5.5 and the payment by OncoMed of royalties to GSK under the applicable provision of Section 8.4.

(f) In the event that GSK believes that an Interfering Event with respect to a Candidate Selection Compound has occurred, GSK shall notify OncoMed and the JSC. The JSC, pursuant to Section 2.2.3(a), shall determine whether an Interfering Event occurred and, if so, whether such Interfering Event is specific to such Candidate Selection Compound or will have a materially adverse effect on all Candidate Selection Compounds under Development pursuant to this Agreement and in existence at the time of such Interfering Event. No later than [***] after the date of such determination (by the JSC or under arbitration pursuant to Section 15.3, as applicable), GSK shall have the option, at its sole discretion, to exercise the GSK Program Option for [***]. After such exercise, GSK shall continue Development of such Candidate Selection Compound(s) as GSK Development Compound(s) and shall pay all milestone payments set forth in Section 8.2 and royalty payments set forth in Section 8.3. If no Interfering Event is determined to have occurred, or if such Interfering Event is determined to have occurred but GSK elects not to exercise the GSK Program Option with respect to such Candidate Selection Compound(s) within such [***] period, OncoMed shall continue to progress such Candidate Selection Compound(s) in accordance with Section 9.1, and GSK shall have the right, during the applicable GSK Program Option Period, to exercise the GSK Program Option at PoC for such Candidate Selection Compound(s). GSK’s rights and obligations with respect to any such Candidate Selection Compound(s) after such Interfering Event is so established, including without limitation any financial obligations to OncoMed, will be addressed under this

 

[***] Certain information in this document 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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Section 4.1.3(f) and Sections 8.2 and 8.3. Notwithstanding this Section 4.1.3(f), above, GSK shall only be permitted to exercise the GSK Program Option [***]. For clarity, if OncoMed [***]

4.1.4 GSK Rights and Obligations on Exercise of a GSK Program Option. Following exercise of a GSK Program Option for a Candidate Selection Compound, such Candidate Selection Compound shall be designated a GSK Development Compound, and GSK shall use Commercially Reasonable Efforts to Develop and Commercialize such GSK Development Compound. In its sole discretion, GSK may terminate Development of any GSK Development Compound as provided in Section 4.2.7. Upon GSK’s exercise of a GSK Program Option, OncoMed will provide GSK with all information, materials and data for such GSK Development Compound subject to such GSK Program Option, and OncoMed will cooperate with GSK to provide a smooth transfer of such information, materials and data as soon as reasonably practical after exercise of such GSK Program Option, including without limitation as set forth in Section 4.3.2.

4.1.5 Failure to Exercise GSK Program Option.

(a) If GSK does not exercise the GSK Program Option with respect to a Candidate Selection Compound in a Program that achieves PoC in an indication that was designated by the JSC pursuant to Section 3.6.2(c)(i), and, upon expiration of the applicable GSK Program Option Period, [***] then, subject to Section 4.1.5(b) and (c): (i) such Candidate Selection Compound shall be deemed terminated by GSK, shall be an OncoMed Development Compound, and shall no longer be subject to Section 7.2, (ii) the Collaboration Target in such Program shall no longer be deemed an Active Target or subject to the exclusivity provisions of Sections 7.1.1 and 7.1.3, and such Program shall be deemed terminated by GSK pursuant to Section 14.3.2, and (iii) any Candidate Selection Compound or Collaboration Compound in such Program shall no longer be subject to the exclusivity provisions of Section 7.2. OncoMed will thereafter have all rights, itself or with a Third Party or through a Sublicensee, to Develop and Commercialize such OncoMed Development Compound, Candidate Selection Compound, or Collaboration Compound [***] at OncoMed’s sole expense, subject to the terms of this Agreement, including without limitation the grant of the license by GSK to OncoMed under Section 5.5 and the payment by OncoMed of royalties to GSK under the applicable provision of Section 8.4. Thereafter, GSK will provide OncoMed with any material information, materials and data for such Program and will cooperate with OncoMed to provide a smooth transfer of such material information, materials and data as soon as reasonably practical after GSK’s notice of such non-election, and GSK shall have no right or license to practice the OncoMed Licensed Patents, to use OncoMed Licensed Know-How, or to use the OncoMed Confidential Information relating to such OncoMed Development Compound, Candidate Selection Compound, or Collaboration Compound, if any, as applicable, for any purpose.

(b) If, upon expiration of the GSK Program Option Period described in the first sentence of Section 4.1.5(a), [***] and OncoMed [***], OncoMed shall provide notice thereof to GSK. GSK shall have the right to exercise, no later than [***] days after delivery of such notice, the GSK Program Option for such other Candidate Selection Compound. If GSK exercises the GSK Program Option for such other Candidate Selection Compound, then (i) GSK will continue Development of such other Candidate Selection

 

[***] Certain information in this document 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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Compound as a GSK Development Compound, subject to the terms of this Agreement, including without limitation GSK’s obligations under Section 9.2 and to make payments to OncoMed pursuant to Sections 8.2 and 8.3, (ii) the Collaboration Target in such Program shall continue to be deemed an Active Target and shall continue to be subject to the exclusivity provisions of Sections 7.1.1 and 7.1.3, (iii) any other Candidate Selection Compound and/or Collaboration Compounds in such Program shall continue to be subject to the exclusivity provisions of Section 7.2, and (iv) the Candidate Selection Compound for which GSK did not exercise its GSK Program Option referenced in Section 4.1.5(a) shall not be further Developed by either Party.

(c) If, upon expiration of the GSK Program Option Period described in the first sentence of Section 4.1.5(a), [***], and OncoMed [***], OncoMed shall provide notice thereof to GSK. If OncoMed [***], then (i) OncoMed shall continue to use Commercially Reasonable Efforts pursuant to Section 9.1 to Develop such other Candidate Selection Compound, (ii) the Collaboration Target in such Program shall continue to be deemed an Active Target and shall continue to be subject to the exclusivity provisions of Sections 7.1.1 and 7.1.3, (iii) any other Candidate Selection Compound and/or Collaboration Compounds in such Program shall continue to be subject to the exclusivity provisions of Section 7.2, (iv) the Candidate Selection Compound for which GSK did not exercise its GSK Program Option referenced in Section 4.1.5(a) shall not be further Developed by either Party, (v) GSK will continue to make milestone payments pursuant to Section 8.2, and (vi) GSK will have the right, upon achievement of the PoC Criteria for such other Candidate Selection Compound, to exercise the GSK Program Option to continue Development of such PoC Compound as a GSK Development Compound, subject to the terms of this Agreement, including without limitation GSK’s obligations under Section 9.2 and to make payments to OncoMed pursuant to Sections 8.2 and 8.3. For clarity, if GSK does not exercise the GSK Program Option for such other Candidate Selection Compound pursuant to Section 4.1.5(b), and OncoMed [***], then OncoMed shall be free to Research, Develop, and Commercialize any Candidate Selection Compounds and Collaboration Compounds in such Program either on its own or with or through a Third Party outside of the Collaboration pursuant to Section 4.1.5(a).

4.2 GSK Development and Commercialization.

4.2.1 Development Plan; Global Commercialization Plan; U.S. Commercialization Plan.

(a) Development Plan. In accordance with its obligations under Section 9.2, within [***] following the exercise by GSK of a GSK Program Option, for each GSK Development Compound, GSK will prepare and provide to the JSC for review and consideration pursuant to Section 2.2.1(k), a draft Development Plan for such GSK Development Compound. GSK will consider in good faith any comments provided by OncoMed.

(b) Global Commercialization Plan. Not later than [***] after the exercise by GSK of a GSK Program Option, GSK will prepare and provide to the JSC for review and consideration a draft global commercialization plan (to include, but not be limited to, the United States) with respect to the relevant GSK Development Compound (the “Global Commercialization Plan” ). The Global Commercialization Plan will outline the strategic commercial objectives for the Product brand in each geographical region, product positioning

 

[***] Certain information in this document 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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aspirations, pricing and reimbursement strategy, anticipated launch timings, the expected competitive landscape for the Product and initial sales and volume forecasts with key assumptions and sensitivities. During the development of the Global Commercialization Plan and subsequent Commercialization activities, OncoMed may appoint a marketing manager at its own expense to work with the GSK commercial team to receive information from and to provide information to the GSK commercial team. GSK will consider in good faith any comments on the draft Global Commercialization Plan provided by OncoMed. After GSK has received OncoMed’s comments on the draft Global Commercialization Plan, GSK will prepare a revised version of the Global Commercialization Plan.

(c) U.S. Commercialization Plan. Not later than [***] prior to the reasonably anticipated date of the filing of the BLA for a Product from the Target 2 Program in the United States, where OncoMed has exercised its right to Co-Develop the GSK Development Compound corresponding to such Product pursuant to Section 6.1, GSK will provide to the JSC for review and comment a draft Commercialization plan for such Product for the Co-Commercialization Territory. Such draft plan will detail [***] its Commercialization in the Co-Commercialization Territory, to enable OncoMed to consider in good faith its decision to exercise the Co-Commercialization option, as set forth in Section 6.3. After GSK has received OncoMed’s comments on the draft U.S. Commercialization Plan, GSK will prepare a revised version of the U.S. Commercialization Plan for such Product (the “U.S. Commercialization Plan” ).

(d) The Parties acknowledge that the Development Plan, Global Commercialization Plan, and U.S. Commercialization Plan for a particular GSK Development Compound may need to be revised and amended from time to time. GSK will provide the JSC a final version of each Development Plan, Global Commercialization Plan and, if applicable, U.S. Commercialization Plan, and any updates and revisions to each such Development Plan, Global Commercialization Plan and U.S. Commercialization Plan as and when they occur for the JSC’s review.

4.2.2 Development and Commercialization Reports. At each JSC meeting or as otherwise agreed between the Parties, during the Term, GSK will provide the JSC with presentations regarding the Development activities performed by GSK, including without limitation [***]. GSK shall provide the JSC with a summary of [***] with respect to each GSK Development Compound. In addition, at the first meeting of the JSC following the exercise of the first GSK Program Option, GSK will provide the JSC with an initial outline of its [***], and thereafter will provide an update at each JSC meeting of Commercialization activities undertaken by GSK for that Product that have occurred since the last JSC meeting. Once a formal Global Commercialization Plan has been developed for each Product, in accordance with Section 4.2.1, GSK will provide the JSC updates on activities with respect to such Global Commercialization Plan at each JSC meeting.

4.2.3 Records. GSK shall maintain, and require its contractors and Sublicensees (to the extent GSK is permitted to sublicense its rights with respect to GSK Development Compounds) to maintain, complete and accurate records of all work conducted in furtherance of the Development and Commercialization of GSK Development Compounds and Products and all results, data and developments made in conducting such activities. Such records

 

[***] Certain information in this document 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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shall be complete and accurate and shall fully and properly reflect all work done and results achieved in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.

4.2.4 Development and Commercialization Responsibilities and Costs. Subject to OncoMed’s co-Development and Co-Commercialization rights under Article 6, GSK, at its sole cost and expense, shall have responsibility, in accordance with Section 9.2, for conducting all Development and Commercialization activities with respect to any GSK Development Compound and Products containing such GSK Development Compound following exercise of a GSK Program Option for such GSK Development Compound. GSK shall conduct such activities in compliance with all applicable legal and regulatory requirements, including without limitation all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials after exercise of the GSK Program Option and the Commercialization of Products containing such Candidate Selection Compound. If GSK fails to use Commercially Reasonable Efforts to Commercialize a GSK Development Compound in accordance with Section 9.2, OncoMed shall have the right to terminate the Program containing such GSK Development Compound pursuant to Section 14.2.1.

4.2.5 Regulatory Responsibilities and Costs. Promptly after GSK’s exercise of a GSK Program Option, OncoMed shall assign to GSK any Regulatory Filings for the relevant GSK Development Compound. After the exercise of a GSK Program Option, GSK shall (a) prepare, file, maintain, and own all Regulatory Filings relating to such GSK Development Compound, (b) have responsibility for, and shall prepare, all Regulatory Filings and related submissions with respect to such GSK Development Compound, and (c) be responsible for maintaining a safety database with respect to such GSK Development Compound, and reporting all adverse drug reaction experience related to such GSK Development Compound in connection with the activities of GSK under this Agreement to the appropriate Regulatory Authorities in the countries in the Territory in which the GSK Development Compound is being developed, in accordance with the Laws of the relevant countries and Regulatory Authorities in accordance with GSK’s internal policies. Upon the request of OncoMed, GSK will provide OncoMed with copies of material Regulatory Filings and related material correspondence submitted to Regulatory Authorities or received from Regulatory Authorities with respect to any such GSK Development Compound.

4.2.6 Subcontracting. Subject to and without limiting Section 5.2, GSK may perform any activities in support of its Development and Commercialization of GSK Development Compounds through subcontracting to a Third Party contractor or contract service organization; provided that: (a) none of the rights of OncoMed hereunder are materially adversely affected as a result of such subcontracting; (b) any such Third Party subcontractor to whom GSK discloses Confidential Information shall enter into an appropriate written agreement obligating such Third Party to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than the obligations in Article 12; (c) GSK will retain or obtain exclusive Control of any and all intellectual property (and patent rights covering such intellectual property) made by such Third Party in performing such services for GSK that are necessary for the Development and Commercialization of GSK Development Compounds or Products containing such GSK Development Compounds, and to the extent such

 

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exclusive Control of rights cannot be obtained with respect to any intellectual property from any such subcontractor, prior to entering into any such arrangement, GSK shall bring such matter to the JSC in a timely fashion in order to seek the approval of the JSC to enter into such an arrangement; and (d) GSK shall at all times be responsible for the performance of such subcontractor.

4.2.7 Termination of GSK Development Compound.

(a) After exercise of the GSK Program Option with respect to a Candidate Selection Compound in a Program, GSK shall have the right, at any time, to terminate Development and Commercialization of such resulting GSK Development Compound in accordance with this Section 4.2.7 for any reason or for no reason at all, effective upon [***] written notice to OncoMed; provided that, if GSK terminates Development of the GSK Development Compound during a Clinical Trial, GSK will Complete such Clinical Trial and shall bear all costs and expenses actually incurred to Complete such Clinical Trial(s) regardless of the effective date of such termination; provided that GSK may [***]. Upon Completion of such Clinical Trial(s), when such GSK Development Compound becomes an OncoMed Development Compound, GSK will provide OncoMed with any material information, materials and data for such Program and will cooperate with OncoMed to provide a smooth transfer of such material information, materials and data as soon as reasonably practical.

(b) If there is [***] then, subject to Section 4.2.7(c) and (d): (i) such GSK Development Compound shall be deemed an OncoMed Development Compound and shall no longer be subject to Section 7.2, (ii) such Program shall be deemed terminated by GSK pursuant to Section 14.3.2, (iii) the Collaboration Target in such Program shall no longer be deemed an Active Target and shall no longer be subject to the exclusivity provisions of Sections 7.1.1 and 7.1.3, and (iv) any Candidate Selection Compound or Collaboration Compound in such Program shall no longer be subject to the exclusivity provisions of Section 7.2. OncoMed will thereafter have all rights, itself or with a Third Party or through a Sublicensee, to Develop and Commercialize such terminated GSK Development Compound, Candidate Selection Compound, or Collaboration Compound that has or has not met the Lead Generation Criteria directed to such Collaboration Target, at OncoMed’s sole expense, subject to the terms of this Agreement, including without limitation the grant of the license by GSK to OncoMed under Section 5.5 and the payment by OncoMed of royalties to GSK under the applicable provision of Section 8.4. Thereafter, GSK will provide OncoMed with any material information, materials and data for such Program and will cooperate with OncoMed to provide a smooth transfer of such material information, materials and data as soon as reasonably practical after GSK’s notice of such termination, and GSK shall have no right or license to practice the OncoMed Licensed Patents, to use OncoMed Licensed Know-How, or to use the OncoMed Confidential Information relating to such terminated GSK Development Compound, Candidate Selection Compound, or Collaboration Compound for any purpose.

(c) If, upon termination of a GSK Development Compound as described in the first sentence of Section 4.2.7(a), [***], OncoMed shall provide notice thereof to GSK. GSK shall have the right to exercise, no later than [***] after delivery of such notice, the GSK Program Option for such other Candidate Selection Compound. If GSK exercises the GSK Program Option for such other Candidate Selection Compound, then (i) GSK will continue

 

[***] Certain information in this document 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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Development of such other Candidate Selection Compound as a GSK Development Compound, subject to the terms of this Agreement, including without limitation GSK’s obligations under Section 9.2 and to make payments to OncoMed pursuant to Sections 8.2 and 8.3, (ii) such Program shall not be deemed terminated by GSK pursuant to Section 14.3.2, (iii) the Collaboration Target in such Program shall continue to be deemed an Active Target and shall continue to be subject to the exclusivity provisions of Sections 7.1.1 and 7.1.3, and (iv) any other Candidate Selection Compound or Collaboration Compound in such Program shall continue to be subject to the exclusivity provisions of Section 7.2, and (v) the Candidate Selection Compound terminated under Section 4.2.7(a) shall not be further Developed by either Party.

(d) If, upon termination of a GSK Development Compound as described in the first sentence of Section 4.2.7(a), [***], OncoMed shall provide notice thereof to GSK. If OncoMed elects to further Develop such other Candidate Selection Compound under this Agreement, then (i) OncoMed shall continue to use Commercially Reasonable Efforts pursuant to Section 9.1 to Develop such other Candidate Selection Compound, (ii) such Program shall not be deemed terminated by GSK pursuant to Section 14.3.2, (iii) the Collaboration Target in such Program shall continue to be deemed an Active Target and shall continue to be subject to the exclusivity provisions of Sections 7.1.1 and 7.1.3, and (iv) any other Candidate Selection Compound or Collaboration Compound in such Program shall continue to be subject to the exclusivity provisions of Section 7.2, (v) the terminated Candidate Selection Compound shall not be further Developed by either Party, (vi) GSK will continue to make milestone payments pursuant to Section 8.2, and (vii) GSK will have the right, upon achievement of the PoC Criteria for such other Candidate Selection Compound, to exercise the GSK Program Option to continue Development of such PoC Compound as a GSK Development Compound, subject to the terms of this Agreement, including without limitation GSK’s obligations under Section 9.2 and to make payments to OncoMed pursuant to Sections 8.2 and 8.3. For clarity, if GSK does not exercise the GSK Program Option for such other Candidate Selection Compound pursuant to Section 4.2.7(c), and OncoMed does not elect to further Develop such other Candidate Selection Compound pursuant to this Section 4.2.7(d), then OncoMed shall be free to Research, Develop, and Commercialize any Candidate Selection Compounds and Collaboration Compounds in such Program either on its own or with or through a Third Party outside of the Collaboration pursuant to Section 4.2.7(b).

4.3 Manufacture and Supply.

4.3.1 By OncoMed. OncoMed has entered into contract manufacturing agreements for the process, development, manufacture, fill and finish, testing and supply of Collaboration Compounds and, under such agreements, OncoMed will be responsible for manufacturing clinical supplies of Collaboration Compounds for all purposes, including without limitation Clinical Trials for Candidate Selection Compounds until GSK exercises a GSK Program Option for such Candidate Selection Compounds. If, prior to GSK’s exercise of a GSK Program Option, OncoMed enters into discussions with contract manufacturer(s) with respect to the negotiation of agreements for the process, analytical, or formulation development, and/or manufacture and supply of clinical supplies, of a Candidate Selection Compound to be used in Clinical Trials after Completion of the PoC Trials, OncoMed will notify GSK and collaborate with and include GSK in such discussions.

 

[***] Certain information in this document 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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4.3.2 Manufacturing and Supply Transition Plan. No later than [***], the JMS shall prepare a manufacturing and supply transition plan (the “Manufacturing and Supply Transition Plan” ). The Manufacturing and Supply Transition Plan shall set forth (a) activities and processes to maintain a timely and efficient advancement of such Candidate Selection Compound and ensure the orderly transition of manufacturing and supply responsibilities with respect to such Candidate Selection Compound from OncoMed to GSK upon GSK’s exercise of a GSK Program Option for such Candidate Selection Compound and (b) recommendations to ensure that, if the manufacturing process is transferred from OncoMed’s contract manufacturer, that the new manufacturing process produces clinical supplies of such Candidate Selection Compound that comply with all applicable regulatory requirements for the conduct of Clinical Trials. The Parties shall discuss all process, analytical, manufacturing, formulation and supply transition matters in meetings of the JMS. Notwithstanding the foregoing, OncoMed shall have sole responsibility and decision-making authority with respect to any and all manufacturing and supply matters for a Candidate Selection Compound prior to GSK’s exercise of a GSK Program Option for such Candidate Selection Compound, and GSK shall have sole responsibility and decision-making authority with respect to any and all manufacturing and supply matters for such Candidate Selection Compound after GSK’s exercise of such GSK Program Option.

4.3.3 By GSK. Upon GSK’s exercise of a GSK Program Option for a Candidate Selection Compound, GSK, at its sole discretion, will thereafter have the right and obligation to (a) manufacture all clinical and commercial supplies of such Candidate Selection Compound itself, (b) use the contract manufacturer utilized by OncoMed to produce clinical supplies of such Candidate Selection Compound used by OncoMed in Clinical Trials, or (c) subcontract such manufacture to a Third Party; provided that, to maintain a timely and efficient advancement of such Candidate Selection Compound into Phase III Trials, the transfer of the obligation to manufacture Candidate Selection Compounds from OncoMed to GSK will be made in accordance with the Manufacturing and Supply Transition Plan, and, prior to and after exercise of GSK’s Program Option, the Parties will discuss such matters in meetings of the JMS. Upon GSK’s exercise of a GSK Program Option for a Candidate Selection Compound, GSK will be responsible for paying, or for reimbursing OncoMed for, any amounts associated with the (i) cancellation of any one or more slots for the manufacture of such Candidate Selection Compound for which OncoMed has secured such slot(s) with OncoMed’s contract manufacturer, which have been cancelled due to GSK’s decision not to have such Candidate Selection Compound manufactured by such contract manufacturer, and/or (ii) manufacture and supply of clinical supplies of such Candidate Selection Compound to be used in Clinical Trials after GSK’s exercise of such GSK Program Option. GSK shall manufacture, handle, store, and ship the Products in compliance with all Laws, with all Regulatory Filings, and with its applicable internal specifications and quality control procedures. For clarity, if GSK elects not to exercise a GSK Program Option for a Candidate Selection Compound, and OncoMed continues to develop such Candidate Selection Compound, OncoMed will continue to be responsible for manufacturing clinical supplies of such Candidate Selection Compound.

5. L ICENSES ; T ECHNOLOGY T RANSFER

5.1 License to GSK for GSK Development and Products.

 

[***] Certain information in this document 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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5.1.1 Subject to the terms and conditions of this Agreement (including without limitation the reservation of rights in Section 5.8, OncoMed’s rights to co-Develop and/or Co-Commercialize under Article 6, and the payment by GSK of all amounts as and when they become due and payable under this Agreement, including without limitation Articles 7, 8, and 9 and Sections 4.3, 6.7, and 14.6.3), upon GSK’s exercise of a GSK Program Option for a Candidate Selection Compound in accordance with the terms of this Agreement, OncoMed shall grant, and hereby grants to GSK an exclusive (even as to OncoMed and its Affiliates), royalty-bearing, worldwide, nontransferable (except as provided in Section 16.5) license, with the right to grant sublicenses solely in accordance with Section 5.2, under the Licensed Intellectual Property, to make, have made, use, sell, offer to sell, import, and otherwise Develop and Commercialize such Candidate Selection Compound as a GSK Development Compound in accordance with the terms and conditions of this Agreement, during the Term, in the Territory in the Field. To the extent required under the Michigan License, the Parties will enter into a formal written agreement pursuant to which OncoMed will grant to GSK a sublicense under the Michigan License.

5.1.2 Trademarks for Products. To the extent that OncoMed owns any trademark(s) that pertain specifically to a Product for which GSK has exercised its GSK Program Option [***], OncoMed, on GSK’s request and reasonably in advance of GSK’s anticipated First Commercial Sale of such Product, shall grant to GSK a right and license to trademark(s) Controlled by OncoMed solely for use with respect to such Product, at no additional cost to GSK. During the Term, OncoMed will be responsible for the searching, registration, policing and maintenance of such trademark(s) in the Territory. All representations of such trademarks, other than the OncoMed name and the OncoMed Logo, that GSK intends to use, if not previously approved by OncoMed, will first be submitted to OncoMed for consent, which consent shall not be unreasonably withheld, delayed or conditioned, and OncoMed will have [***] to review each such representation of the OncoMed trademarks. If OncoMed does not provide written notice of its approval or disapproval (together with its reasons for such disapproval) within such [***] period, OncoMed will be deemed to have approved such representation. For clarity, use of a trademark of OncoMed in the same form, but within a different context, will not be deemed a new representation of such trademark. Alternatively, subject to Section 5.7, GSK may use its own trademark(s) for any Product(s).

5.2 Sublicenses. GSK shall have the right to grant sublicenses, in whole or in part on a GSK Development Compound (and Products containing such GSK Development Compound)–by–GSK Development Compound (and Products containing such GSK Development Compound) basis, to its Affiliates or any Third Party with respect to the rights licensed to GSK under Section 5.1; provided that:

5.2.1 such Sublicense shall refer to this Agreement and shall be subordinate to and consistent with the terms and conditions of this Agreement, and shall not limit the ability of GSK (individually or through the activities of its Sublicensee) to fully perform all of its obligations under this Agreement or OncoMed’s rights under this Agreement;

5.2.2 in such Sublicense, the Sublicensee shall agree in writing to be bound to GSK by terms and conditions substantially similar to, or less favorable to the Sublicensee than, the corresponding terms and conditions of this Agreement;

 

[***] Certain information in this document 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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5.2.3 promptly after execution of the Sublicense, GSK shall provide a summary of such Sublicense agreement to OncoMed. Such summary shall be treated as GSK Confidential Information hereunder;

5.2.4 GSK shall remain responsible for the performance of this Agreement and the performance of its Sublicensees under this Agreement, including without limitation the payment of all payments due, and making reports and keeping books and records, and shall cause such Sublicensee to enable GSK to comply with the terms and conditions of this Agreement;

5.2.5 each Sublicense shall terminate immediately upon the termination of this Agreement (in whole or only with respect to the rights that are subject to such Sublicense);

5.2.6 such Sublicensees shall have the right to grant further Sublicenses of same or lesser scope as its sublicense from GSK under the grants contained in Section 5.1 (the other party to such further sublicense also deemed a Sublicensee), provided that such further sublicenses shall be in accordance with and subject to all of the terms and conditions of this Section 5.2 (i.e., such Sublicensee shall be subject to this Section 5.2 in the same manner and to the same extent as GSK); and

5.2.7 GSK shall not grant a Sublicense under all rights received by GSK from OncoMed pursuant to Section 5.1 with respect to a GSK Development Compound (and all Products containing such GSK Development Compound) to a single Sublicensee without the prior written consent of OncoMed, which consent shall not be unreasonably withheld, delayed or conditioned.

5.3 [***]. In the event of any (a) bankruptcy or insolvency of OncoMed or (b) notification by the University of Michigan that it seeks to terminate the Michigan License as a result of material breach by OncoMed of the Michigan License: if GSK and/or its Affiliates [***] OncoMed hereby agrees to use reasonable efforts to assist GSK and/or its Affiliates to [***] to the extent necessary to Develop and Commercialize Products

5.4 Research License to OncoMed. During the Research Collaboration Term, GSK hereby grants, and shall grant, to OncoMed a royalty-free, non-exclusive, non-sublicensable license, under any intellectual property Controlled by GSK solely as and to the extent necessary to enable OncoMed to perform activities under this Agreement.

5.5 Development and Commercialization License to OncoMed.

5.5.1 Subject to the terms and conditions of this Agreement, if, at any time during the Term of the Agreement, OncoMed, itself or with a Third Party or through a Sublicensee, is Developing or Commercializing a Collaboration Compound as an OncoMed Development Compound pursuant to its rights under this Agreement, GSK shall grant, and hereby grants to OncoMed an exclusive (even as to GSK and its Affiliates), royalty-bearing, worldwide nontransferable (except as provided in Section 16.5) license, with the right to grant sublicenses, under any intellectual property Controlled by GSK to the extent such intellectual

 

[***] Certain information in this document 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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property covers the composition of matter of, a method of treatment using (provided such method is relevant to the indication for the Product that is covered by the relevant approved BLA), manufacture of, or formulation of the OncoMed Development Compound as necessary to Develop, manufacture, use, import, offer for sale, sell, and Commercialize such OncoMed Development Compound in the Territory in the Field. For clarity, such licenses are granted only to the extent pertaining specifically to the OncoMed Development Compound.

5.5.2 To the extent that GSK owns any trademark(s) that pertain specifically to an OncoMed Development Compound and that OncoMed believes would be necessary or useful for the Commercialization of a Product containing such OncoMed Development Compound, GSK, on OncoMed’s request and reasonably in advance of OncoMed’s anticipated First Commercial Sale of such Product, shall grant to OncoMed a right and license to trademark(s) Controlled by GSK solely for use with respect to such Product, at no additional cost to OncoMed. During the Term, GSK will be responsible for the searching, registration, policing and maintenance of such trademark(s) in the Territory. All representations of such trademarks, other than the GSK name, that OncoMed intends to use, if not previously approved by GSK, will first be submitted to GSK for consent, which consent shall not be unreasonably withheld, delayed or conditioned, and GSK will have [***] to review each such representation of the GSK trademarks. If GSK does not provide written notice of its approval or disapproval (together with its reasons for such disapproval) within such [***] period, GSK will be deemed to have approved such representation. For clarity, use of a trademark of GSK in the same form, but within a different context, will not be deemed a new representation of such trademark. Alternatively, OncoMed may use its own trademark(s) for any Product(s).

5.6 Diagnostic Product. In the event OncoMed seeks to Research, Develop and Commercialize a diagnostic that pertains to how a Collaboration Compound may be used in clinical practice, OncoMed will consult first with GSK on a Development and Commercialization plan for any such diagnostic product prior to approaching any Third Party with whom OncoMed could work to Develop such diagnostic, either by means of a collaboration or a license. If OncoMed and GSK do not enter into an agreement for the Development and Commercialization of any such diagnostic within [***] after the date of OncoMed’s initial request for such consultation with GSK, OncoMed will be free to initiate discussions with Third Parties and may enter into such an agreement, either with GSK or with a Third Party, on terms that, in OncoMed’s sole discretion, are acceptable to OncoMed. In the event OncoMed enters into an agreement for the Development and Commercialization of any such diagnostic with a Third Party, subject to any obligations of confidentiality with such Third Party, OncoMed will consult with GSK regarding whether the Development and Commercialization plan for such diagnostic is [***]. OncoMed will use good faith efforts to [***].

5.7 Use of Names; Logo; Patent Marking. The packaging for each Product Commercialized by GSK under this Agreement shall be marked (to the extent not prohibited by Laws): (a) with a notice that such Product is sold under a license from OncoMed (as applicable) and (b) with applicable patent and other intellectual property notices relating to the OncoMed Licensed Patents in such a manner as may be permitted or required by Laws. To the extent permitted under Laws, the packaging and labeling for Products will bear both the GSK name and logo and the OncoMed name and OncoMed Logo, and such names and logos will be presented

 

[***] Certain information in this document 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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with substantially equivalent prominence in any Product presentations, exhibit booths, conferences, or promotion materials or activities. OncoMed will be responsible for registering and policing the OncoMed Logo in the Territory in order to enable GSK to appropriately mark any packaging with the OncoMed Logo, to the extent permitted or required by Laws. Except as set forth in Section 5.1.2, no right or license, express or implied, is granted to GSK to use any trademark, trade name, trade dress, or service mark Controlled by OncoMed or any of its Affiliates. Likewise, no right or license, express or implied, is granted to OncoMed to use any trademark, trade name, trade dress or service mark Controlled by GSK or any of its Affiliates. GSK, at its sole cost and expense, shall be responsible for the selection, registration, policing, and maintenance of all GSK trademarks that GSK employs in connection with its activities conducted pursuant to this Agreement.

5.8 No Implied Licenses; Retained Rights. No license or other right is or shall be created or granted hereunder by implication, estoppel, or otherwise. All licenses and rights are or shall be granted only as expressly provided in this Agreement. All rights not expressly granted by OncoMed under this Agreement are reserved by OncoMed and may be used by OncoMed for any purpose.

5.9 Technology Transfer by OncoMed After Exercise by GSK of a GSK Program Option. As soon as reasonably practical after GSK exercises its GSK Program Option for a Candidate Selection Compound, OncoMed shall transfer to GSK all OncoMed Licensed Know-How, materials, and other information in OncoMed’s possession and Control that are necessary for the exercise by GSK of the rights granted under Section 5.1.

6. O NCO M ED O PTIONS TO C O -D EVELOP AND C O -C OMMERCIALIZE C OLLABORATION C OMPOUNDS AND P RODUCTS

6.1 OncoMed’s Option to Co-Develop Collaboration Compounds.

6.1.1 If GSK exercises the GSK Program Option for a Candidate Selection Compound [***], OncoMed shall have an option to co-Develop the resulting GSK Development Compounds in any and all indications pursuant to a Development Plan for such Products in such indications to support registration of such indications. GSK hereby grants, and shall grant, under any intellectual property Controlled by GSK, to OncoMed the exclusive right, exercisable at OncoMed’s sole discretion, to elect, on a GSK Development Compound–by–GSK Development Compound basis, to obtain a co-exclusive (with GSK) worldwide license and, upon OncoMed’s exercise of such right, a license to Develop any GSK Development Compound [***] under the terms and conditions set forth in this Agreement. Such right to co-Develop [***] shall cease upon [***]; provided that cessation of OncoMed’s co-Development right [***] shall not be deemed to be an election by OncoMed not to exercise its co-Development option for [***] for purposes of Section 8.3.3(b). Such co-Development option shall expire [***] pursuant to Section [***] (the “Co-Development Option Period” ). OncoMed will have an option to co-Develop Products [***].

6.1.2 OncoMed shall exercise such co-Development option, if at all, by written notice to GSK, which notice shall make reference to this Agreement and the relevant GSK Development Compound and shall include OncoMed’s decision to exercise such co-

 

[***] Certain information in this document 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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Development option with respect to the specific GSK Development Compound. Upon exercise of a co-Development option, the Parties together shall Develop the applicable GSK Development Compound as set forth in this Agreement until either Party terminates its activities with respect to such GSK Development Compound or this Agreement terminates or expires, whether in its entirety or with respect to such GSK Development Compound. If such co-Development option is not so exercised during the Co-Development Option Period, then such co-Development option shall expire with respect to such GSK Development Compound and be of no further force or effect at the end of the Co-Development Option Period.

6.1.3 OncoMed may assign or transfer the co-Development rights granted to OncoMed by GSK under this Section 6.1, upon an acquisition, merger or similar transaction of OncoMed resulting in a change of control of OncoMed; provided that, if such acquisition, merger or similar transaction is by [***] GSK, at its sole discretion, will have a right to terminate such co-Development rights, such termination to be effective immediately upon receipt by OncoMed of written notice thereof from GSK. GSK will not have a right to terminate OncoMed’s co-Development rights under this Section 6.1 upon an acquisition, merger or similar transaction of OncoMed, resulting in a change of control of OncoMed, by any Person other than a Person set forth in (a), (b), or (c), above. OncoMed, to the full extent that it is able to do so, will provide to GSK, [***], shall notify OncoMed whether GSK, as a consequence of an acquisition of OncoMed by such Third Party acquirer, will terminate the co-Development rights set forth in Section 6.1.1.

6.2 Consequences of Exercise of OncoMed’s Option to Co-Develop Collaboration Compounds. After OncoMed exercises an option to co-Develop a GSK Development Compound, OncoMed’s co-Development activities with respect to such GSK Development Compound will be limited to the following, and shall apply only until Regulatory Approval is obtained for such GSK Development Compound in each indication being co-Developed:

6.2.1 OncoMed will participate in Development via membership of the JDS;

6.2.2 On an indication-by-indication basis, GSK will provide OncoMed reasonable updated Development Plans, together with budgets for such Development Plans, during the Term, and OncoMed will have the right to review, and obtain the comments and suggestions of OncoMed consultants regarding, such Development Plans and related budgets;

6.2.3 OncoMed, at OncoMed’s sole discretion, will fund between [***] in such Development Plan and related budget. [***];

6.2.4 OncoMed and GSK will both contribute to discussions at the JDS but the GSK members of the JDS will have the final decision-making authority with respect to Development of such GSK Development Compound;

6.2.5 Where an ad-hoc JDS meeting cannot be arranged in a timely manner to discuss any material issue that arises suddenly, or where there is a pressing medical,

 

[***] Certain information in this document 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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safety or regulatory issue and time is of the essence with respect to such issue, GSK will have the right to act without review by the JDS;

6.2.6 OncoMed shall have the right to send at least one representative to any global KOL advisory panel arranged by GSK; and

6.2.7 Royalty rates shall be increased as set forth in Section 8.3.3.

6.3 OncoMed’s Option to Co-Commercialize Products. If GSK exercises a GSK Program Option for a GSK Development Compound [***] and OncoMed exercises its right to co-Develop such GSK Development Compound pursuant to Section 6.1, OncoMed shall have an option to Co-Commercialize any Product containing such GSK Development Compound in the Co-Commercialization Territory; provided, however, that [***]. GSK hereby grants to OncoMed the exclusive right, exercisable at OncoMed’s sole discretion, on a Product-by-Product basis, to obtain a co-exclusive (with GSK) worldwide license and, upon OncoMed’s exercise of such right, a license to Co-Commercialize any Product [***] under the terms and conditions set forth in this Agreement. Upon OncoMed’s request, GSK will grant a license to OncoMed to use the GSK trademark(s) selected for the Product(s) for the sole purpose of Co-Commercializing such Product(s). OncoMed shall exercise such Co-Commercialization option, if at all, by written notice to GSK, which notice shall make reference to this Agreement and the applicable Product and shall include OncoMed’s decision to exercise such Co-Commercialization option with respect to such Product. Within [***] after the exercise by OncoMed of such Co-Commercialization option, the Parties shall negotiate in good faith a definitive written Co-Commercialization agreement, which will specify the terms of the Co-Commercialization arrangement, which terms shall be consistent with all of the terms and conditions in this Article 6 and all other relevant provisions of this Agreement ( “Co-Commercialization Agreement” ). The Co-Commercialization Agreement will set forth [***]. The Co-Commercialization Agreement will afford OncoMed [***]. GSK and OncoMed agree to cooperate in good faith to agree upon additional terms and conditions for inclusion in the Co-Commercialization Agreement to ensure that such Product is optimally Commercialized in a manner that is consistent with the then-current standards and practices in the pharmaceutical industry in the United States, and GSK’s U.S. Commercialization Plan for such Product. All Co-Commercialization options under this Agreement, if not exercised by OncoMed, shall expire and be of no further force or effect [***] days after OncoMed has received from GSK a copy of the U.S. Commercialization Plan for such Product as described in Section 4.2.1(c).

6.4 Consequences of Exercise of OncoMed’s Option to Co-Commercialize Products. After OncoMed exercises an option to Co-Commercialize a Product, the following shall apply:

6.4.1 OncoMed’s Co-Commercialization right, once exercised, will be a right to provide in the Co-Commercialization Territory a team of MSLs to provide scientific support in order to ensure the acceptance and proper utilization of the Co-Commercialized Product by health care professionals, through communication of medically meaningful scientific information. Specific duties will include, without limitation, those duties set forth in Exhibit 6.4.1;

 

[***] Certain information in this document 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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6.4.2 The JCS will manage planning of the Co-Commercialization in the Co-Commercialization Territory;

6.4.3 OncoMed will participate in Commercialization of a Product via the interface between its MSL team and a named point of contact in the GSK medical liaison function and its membership on the JCS, and in addition OncoMed may, at its own expense, hire a marketing manager to liaise directly with the GSK commercial operations team;

6.4.4 GSK will have overall responsibility and decision making authority for all aspects of Product Commercialization, including but not limited to strategic marketing planning, pricing and contracting, professional and consumer promotion and supporting medical affairs activities;

6.4.5 GSK will book sales for all Products Commercialized from the Collaboration and OncoMed will have the right to disclose sales for all Products on a quarterly basis;

6.4.6 Each year, including without limitation the launch year (as described in Section 4.2.1(c)), GSK will produce and share with OncoMed a draft U.S. Commercialization Plan for the upcoming [***] period, describing in detail the strategy and tactics for Commercializing the Co-Commercialized Product(s) in the Co-Commercialization Territory and OncoMed’s contribution to such effort. OncoMed and GSK will discuss in good faith such U.S. Commercialization Plan at the JCS, and GSK will then revise such U.S. Commercialization Plan to a final version at its sole discretion;

6.4.7 Where an ad-hoc JCS meeting can not be arranged in a timely manner to discuss a material Commercialization issue that arises suddenly, GSK will have the right to act without review by the JCS;

6.4.8 A GSK U.S. Brand Team ( “GUBT” ) will manage day-to-day commercialization decisions and operations and will interface with OncoMed’s marketing manager, if any, and OncoMed’s MSLs will also communicate with the GUBT through the GSK medical liaison point of contact assigned to support Commercialization of the Co-Commercialized Product;

6.4.9 OncoMed’s MSLs will operate under GSK’s direction, using approved medical information responses to scientific inquiries, and will work towards GSK medical affairs objectives as communicated to OncoMed;

6.4.10 At least [***] days prior to the anticipated launch date of the Product for which OncoMed has exercised the Co-Commercialization option, OncoMed shall have employed a sufficient number of appropriate and qualified staff and shall have the infrastructure in place to fulfill its obligations under the Co-Commercialization Agreement; provided that GSK provides to OncoMed the anticipated launch date concurrently with filing the BLA for such Product;

 

[***] Certain information in this document 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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6.4.11 OncoMed will pay [***]. Each OncoMed MSL must hold a Pharm.D., M.D, D.O. or Ph.D. in a clinically related area, consistent with industry practice qualification;

6.4.12 OncoMed will not be permitted to use contractors or consultants to fulfill its Co-Commercialization responsibilities; and

6.4.13 GSK will own and maintain all INDs, Regulatory Approvals (including without limitation BLAs), trademarks, and brand names of the Product.

6.5 Level of Co-Commercialization. The specific number of MSLs that OncoMed will be required to provide to fulfill its Co-Commercialization obligations will be determined prior to the anticipated launch of a Product, as described in the U.S. Commercialization Plan and Co-Commercialization Agreement. Where GSK deems it appropriate to have a single dedicated MSL team supporting Commercialization of the relevant Product, it is the intention of the Parties that OncoMed will provide all necessary MSLs, and that the size of OncoMed’s MSL team shall be in accordance with an MSL team typically required for an equivalent GSK product.

6.6 Training; Materials; Compliance. GSK will supply all training materials and instructors for the training of the OncoMed MSLs. OncoMed will be required to pay travel and accommodation expenses for its MSLs to attend any specific training events. OncoMed shall be responsible for ensuring that its MSLs have comparable levels of knowledge, experience and skills as other oncology MSL representatives employed by GSK. OncoMed will ensure that its MSLs achieve similar pass rates in training exams. As necessary and to the extent permitted by GSK commercial policies and practices, and at GSK’s request and direction, OncoMed MSLs may participate as educators in training events for GSK sales representatives for the Co-Commercialized Product. In the conduct of OncoMed’s Co-Commercialization responsibilities, OncoMed’s MSLs will use only GSK-approved documents, information and materials and will comply with all relevant GSK standard operating procedures and commercial practices and policies in effect during the Co-Commercialization period as such are communicated to OncoMed. OncoMed’s Co-Commercialization activities will be conducted in accordance with all Laws (including without limitation those promulgated by the FDA and the Division of Drug Marketing and Communications), and OncoMed’s MSLs will be required to act in accordance with GSK’s Corporate Integrity Agreement and the PhRMA Code of Conduct. At all times, OncoMed will be solely responsible for ensuring its MSLs abide by GSK’s “Regional Medical Scientist Practice Policy,” and/or Laws. As part of the training materials to be supplied to OncoMed by GSK under this Section 6.6, GSK shall provided a copy of the then-current GSK Corporate Integrity Agreement, and the GSK Regional Medical Scientist Practice Policy, and the PhRMA Code of Conduct, and Laws promulgated by the FDA and the Division of Drug Marketing and Communications, each as applicable to the conduct of OncoMed’s Co-Commercialization activities under the terms of this Agreement, and, during the term of such Co-Commercialization activities, updates to such materials, as appropriate. If an OncoMed MSL [***], each as applicable to the conduct of OncoMed’s Co-Commercialization activities under the terms of this Agreement, where such violation is [***], GSK shall notify OncoMed immediately of such violation. If such violation is determined to have been the result of [***], each as applicable to the conduct of OncoMed’s Co-Commercialization activities under the terms

 

[***] Certain information in this document 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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of this Agreement, GSK will have the right to terminate the applicable Co-Commercialization Agreement; provided, however, that, if such violation was the result of activities of one or more of OncoMed’s MSLs acting independently and in violation of training guidelines maintained by OncoMed, OncoMed shall have the right to terminate such individual(s) and, if such termination is effective within [***] days after receipt of notice from GSK, GSK shall not have the right to terminate the applicable Co-Commercialization Agreement.

6.7 Payments by GSK to OncoMed for Co-Commercialization. In addition to any royalties that OncoMed will receive under Articles 8 and 9, OncoMed will also receive annually from GSK [***].

6.8 Transferability; [***]. Upon any [***] of OncoMed, by (a) [***] GSK will have the right to terminate the Co-Commercialization rights granted to OncoMed by GSK under Section 6.3, such termination to be effective [***]. GSK will not have a right to terminate OncoMed’s Co-Commercialization rights under Section 6.3, or any resulting Co-Commercialization Agreement between the Parties, upon an acquisition, merger or similar transaction of OncoMed, resulting in a change of control of OncoMed, by any Person other than a Person set forth in (a), (b), or (c), above. OncoMed, to the full extent that it is able to do so, will provide to GSK, information regarding any discussion between OncoMed and a potential Third Party acquirer that is relevant to OncoMed’s Co-Commercialization option, and GSK, within [***] after receipt of such information, shall notify OncoMed whether GSK, as a consequence of an acquisition of OncoMed by such Third Party acquirer, will terminate the Co-Commercialization rights set forth in Section 6.3.

7. E XCLUSIVITY

7.1 Collaboration Target Exclusivity.

7.1.1 OncoMed Exclusivity. Prior to expiration of the Development Collaboration Term, OncoMed will not [***], except as set forth in Section 4.1.5, 4.2.7, 7.1.3(b)(iii) or 7.1.3(c)(iv), as applicable. Upon expiration of the Development Collaboration Term, OncoMed shall be free to [***] (as defined in Section 1.1(c)), subject to Sections 7.2.2, 7.2.3, and 7.2.4.

7.1.2 GSK Exclusivity.

(a) During the Research Collaboration Term. During the Research Collaboration Term, GSK will not [***], except in accordance with Section 7.1.3(b).

(b) After the Research Collaboration Term and During the Development Collaboration Term. After the expiration of the Research Collaboration Term and continuing until the expiration of the Development Collaboration Term, GSK will not [***], except in accordance with Section 7.1.3(c).

(c) After the Development Collaboration Term and During the Term. After the expiration of the Development Collaboration Term and continuing until the expiration of the Term, GSK will not [***], except in accordance with Section 7.1.3(d).

 

[***] Certain information in this document 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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7.1.3 GSK Activities Outside of the Collaboration.

(a) Election; Notice.

(i) At any time during the Term, upon achievement of the Lead Generation Criteria by GSK for a monoclonal antibody, dAb or Multi-Targeting Antibody directed to an Active Target(s) (as defined in Section 1.1 and as further described in Sections 7.1.3(b), (c), and (d), below) that GSK has decided to Develop and Commercialize, GSK shall provide written notice of such decision to OncoMed, each such notice to include, without limitation:

(A) the identity of such Active Target(s); and

(B) where OncoMed has the right to Develop such antibody under Sections 7.1.3(b), (c), and (d), GSK shall provide the following:

(1) data and information supporting the achievement of the Lead Generation Criteria;

(2) the GSK Toxicology Package, as soon as it is available; and

(3) sufficient quantities of such antibody to conduct head-to-head xenograft studies, such quantities and studies to be determined by the JSC. OncoMed shall provide data resulting from such studies to the JSC.

(ii) Where OncoMed has the right to Develop such product under Sections 7.1.3(b), (c), and (d), beginning with receipt by OncoMed from GSK of notice under this Section 7.1.3(a), and continuing until the later of (A) [***] after receipt by OncoMed from GSK of sufficient quantities of antibody in accordance with Section 7.1.3(a)(i)(B)(3), or (B) [***] after receipt by OncoMed of the GSK Toxicology Package, OncoMed shall have the right to elect to progress such antibody to which such notice applies as a Collaboration Compound through Development and, if applicable, Commercialization in accordance with the terms and conditions of this Agreement.

(b) Through the Research Collaboration Term.

(i) After OncoMed’s receipt of such notice during the Research Collaboration Term from GSK in accordance with Section 7.1.3(a)(i), where such notice applies to [***]. If OncoMed elects to progress such [***] Development and, if applicable, [***], GSK shall transfer to OncoMed all data, information and materials relating to such [***], in each case to the extent available to GSK.

(ii) If OncoMed elects to conduct [***], as applicable, then (A) [***] and (B) GSK will pay to OncoMed (1) each milestone payment in the tables in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, for each [***], where such milestone payments will be adjusted, on a product-by-product basis, to an amount equal to [***] of the amounts set forth in the tables in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, and (2) the royalties

 

[***] Certain information in this document 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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payable under Section 8.3.1 for any such product, where such royalties will be adjusted to rates equal to [***] of the rates determined in accordance with Section 8.3.1. If OncoMed progresses any such antibody through to Completion of PoC Trials, then such antibody may be one of the Collaboration Compounds for which OncoMed has diligence obligations under Section 9.1.1(a) to progress [***].

(iii) If OncoMed elects not to conduct the Development of such [***], and GSK, or an Affiliate or sublicensee of GSK, elects to conduct such Development and Commercialization, then (A) GSK may Develop and Commercialize such [***], on its own or with or through a Third Party, with no obligation to make any payments of any kind to OncoMed with respect to such [***], and (B) OncoMed may Research, Develop, and Commercialize any antibody directed to such Active Target, other than any Collaboration Compounds that have [***], outside of the Collaboration, on its own or with or through a Third Party, without any obligation to make any payments of any kind to GSK with respect to such antibody. For clarity, as of the date of such non-election by OncoMed, such Collaboration Target shall cease to be an Active Target under this Agreement and shall no longer be subject to Section 7.1.1, and Collaboration Compounds that have not met Lead Generation Criteria shall no longer be subject to Section 7.2.

(c) Post–Research Collaboration Term and During the Development Collaboration Term.

(i) Where GSK provides notice under Section 7.1.3(a)(i), after the Research Collaboration Term and prior to the expiration of the Development Collaboration Term, with respect to a [***] directed to an Active Target(s) for which [***] or GSK provides notice under Section 7.1.3(a)(i) with respect to [***], then:

(A) After OncoMed’s receipt of such notice from GSK in accordance with Section 7.1.3(a)(i), OncoMed and GSK shall confer regarding the Development and Commercialization of such [***]. If OncoMed elects to progress such [***] through Development and, if applicable, Commercialization, the provisions of Section 7.1.3(c)(ii) shall apply, and GSK shall transfer to OncoMed all data, information and materials relating to such [***], including without limitation the cell lines producing such antibody, in each case to the extent available to GSK.

(B) If OncoMed has a Candidate Selection Compound directed to the same Active Target(s) against which GSK’s [***] is directed, OncoMed shall have the right with respect to such Candidate Selection Compound directed to such Active Target(s) to offer the Candidate Selection Compound to GSK to continue Development as a GSK Development Compound pursuant to this Section 7.1.3(c) and Section 4.1.3(b)(ii), if applicable.

(C) If GSK elects to further Develop such Candidate Selection Compound, GSK will be deemed to have exercised the GSK Program Option with respect to such Candidate Selection Compound and thereafter will Develop such Candidate Selection Compound as a GSK Development Compound, subject to the terms of this

 

[***] Certain information in this document 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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Agreement, including without limitation GSK’s obligations under Section 9.2 and its obligation to make payments to OncoMed pursuant to Sections 8.2 and 8.3.

(D) If GSK elects not to continue Development of such Candidate Selection Compound, OncoMed may in its sole discretion continue to use Commercially Reasonable Efforts to progress such Candidate Selection Compound through to Completion of the PoC Trials for such Candidate Selection Compound, and GSK shall pay all milestone payments set forth in Section 8.2 and royalty payments set forth in Section 8.3 with respect to such Candidate Selection Compound.

(ii) If OncoMed elects to conduct Development of any [***] under Section 7.1.3(c)(i)(A), then (A) the Collaboration Target subject to such notice shall continue to be deemed an Active Target and subject to Section 7.1.1 and (B) GSK will pay to OncoMed (1) each milestone payment in the table in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, for each product containing such [***], as applicable, where such milestone payments will be adjusted, on a product–by–product basis, to an amount equal to [***] of the amounts set forth in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, and (2) the royalties payable under Section 8.3.1 for any such product, where such royalties will be adjusted to rates equal to [***] of the rates determined in accordance with Section 8.3.1; provided that such percentage of adjustment shall be reduced by an amount equal to [***] on each anniversary of the end of the Research Collaboration Term that occurs prior to the date on which GSK has demonstrated that such [***]. For purposes of illustration, if the Research Collaboration Term terminates on [***], GSK demonstrates on [***] that such [***] and OncoMed elects to conduct Development and Commercialization of such [***], the payments with respect to any product containing such [***], will be adjusted, as described in this Section 7.1.3(c)(ii), above, to [***] of the amounts otherwise payable, but if such demonstration occurs [***], such payments will be adjusted to [***] of the amounts otherwise payable. If OncoMed progresses such antibody through to Completion of PoC Trials, then such antibody may be [***].

(iii) If OncoMed elects to conduct Development of any [***], then: (A) the Collaboration Target subject to such notice shall continue to be deemed an Active Target and subject to Section 7.1.1; and (B) GSK will pay to OncoMed (1) each milestone payment in the tables in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, for each product containing such [***], where such milestone payments will be adjusted, on a product-by-product basis, to an amount equal to [***] of the amounts set forth in the tables in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, and (2) the royalty rates in the table in Section 8.3.1 for any such product, where such royalties will be adjusted to rates equal to [***] of the rates determined in accordance with Section 8.3.1. If OncoMed progresses such antibody through to Completion of PoC Trials, then such antibody may be [***].

(iv) If OncoMed elects not to conduct such Development of such [***], and GSK, or an Affiliate or Sublicensee of GSK, elects to conduct such Development and Commercialization, then (A) GSK may Develop and Commercialize such [***], on its own or with or through a Third Party, with no obligation to make any payments of any kind to OncoMed with respect to such [***], and (B) OncoMed may Research, Develop, and Commercialize any antibody directed to such Active Target, other than any Collaboration Compounds [***], on its own or with or through a Third Party, without any obligation to make

 

[***] Certain information in this document 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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any payments of any kind to GSK with respect to such product. For clarity, as of the date of such non-election by OncoMed, such Collaboration Target shall cease to be an Active Target under this Agreement and shall no longer be subject to Section 7.1.1, and Collaboration Compounds [***] are no longer subject to Section 7.2.

(v) For clarity, where GSK provides notice under Section 7.1.3(a)(i), after the Research Collaboration Term and prior to the expiration of the Development Collaboration Term, with respect to a [***] directed to an Active Target for which there is no Candidate Selection Compound in a Clinical Trial, then (A) GSK may Develop and Commercialize such [***], on its own or with or through a Third Party, with no obligation to make any payments of any kind to OncoMed with respect to such [***], and (B) the Collaboration Target subject to such notice shall no longer be deemed an Active Target and will no longer be subject to Section 7.1.1; and (C) OncoMed may Research, Develop, and Commercialize any antibody directed to such Collaboration Target, other than any [***] (which shall be subject to the restrictions set forth in Section 7.2), outside of the Collaboration, on its own or with or through a Third Party, without any obligation to make any payments of any kind to GSK with respect to such antibody.

(d) Post–Development Collaboration Term Through the Term.

(i) Where GSK provides notice under Section 7.1.3(a)(i), after the Development Collaboration Term and through the Term, with respect to any [***] then, after OncoMed’s receipt of such notice from GSK in accordance with Section 7.1.3(a)(i), OncoMed and GSK shall confer regarding the Development and Commercialization of such [***]. If OncoMed elects to progress such [***] through Development and, if applicable, Commercialization, GSK shall transfer to OncoMed all data, information and materials relating to such [***], including without limitation the cell lines producing such [***], in each case to the extent available to GSK.

(ii) If OncoMed elects to conduct Development of any such [***], then (A) the Collaboration Target subject to such notice shall continue to be deemed an Active Target and subject to Section 7.1.1 and (B) GSK will pay to OncoMed (1) each milestone payment in the table in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, for each product containing such [***], where such milestone payments will be adjusted, on a product–by–product basis, to an amount equal to [***] of the amounts set forth in the tables in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, and (2) the royalties payable under Section 8.3.1 for any such product, where such royalties will be adjusted to rates equal to [***] of the rates determined in accordance with Section 8.3.1.

(iii) If OncoMed elects not to conduct Development of such [***], and GSK, or an Affiliate or Sublicensee of GSK, elects to conduct Development and Commercialization of any product containing such [***], as applicable, then (A) GSK may Develop and Commercialize such product outside of the Collaboration with no obligation to make any payments of any kind to OncoMed with respect to such product, and (B) OncoMed may Research, Develop, and Commercialize any antibody directed to such Active Target, other than [***] prior to such non-election (which shall be subject to the restrictions set forth in

 

[***] Certain information in this document 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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Section 7.2), outside of the Collaboration, on its own or with or through a Third Party, without any obligation to make any payments of any kind to GSK with respect to such product. For clarity, as of the date of such non-election by OncoMed, such Collaboration Target shall cease to be an Active Target under this Agreement and shall no longer be subject to Section 7.1.1, and [***] are no longer subject to Section 7.2.

(e) At any time during the Term, when GSK provides notice under Section 7.1.3(a) with respect to a [***] directed to an Active Target(s), then, as of the date that GSK has demonstrated that such [***], subject to Sections 7.1.3(b), (c) and (d), (i) such Collaboration Target shall cease to be an Active Target under this Agreement and (ii) OncoMed may thereafter Research, Develop, and Commercialize any antibody directed to such Collaboration Target, other than [***] prior to the date of such demonstration by GSK (which shall be subject to the restrictions set forth in Section 7.2), outside of the Collaboration, on its own or with or through a Third Party, without any obligation to make any payments of any kind to GSK with respect to such product.

(f) If OncoMed elects to conduct Development of any [***] pursuant to this Section 7.1.3, and thereafter fails to use Commercially Reasonable Efforts to Develop such [***] prior to Completion of PoC Trials with respect to such [***], GSK shall have the right to terminate Development of such [***] under this Agreement in accordance with the provisions of Section 14.6.3(b) and GSK shall thereafter have the right to progress Development and Commercialization of such antibody, subject to its obligations to make royalty payments to OncoMed pursuant to Section 14.6.3(b). If any such [***] becomes an OncoMed Development Compound, and OncoMed thereafter either elects to terminate its Development or Commercialization activities with respect to such OncoMed Development Compound, or fails to use Commercially Reasonable Efforts with respect to the Development or Commercialization of such OncoMed Development Compound, OncoMed’s rights with respect to such OncoMed Development Compound shall terminate, GSK shall have the right to progress Development and Commercialization of such antibody, and OncoMed shall automatically grant to GSK an exclusive license under Licensed Intellectual Property covering such [***]. In such event:

(i) GSK shall pay to OncoMed a [***] royalty on Net Sales by GSK, its Affiliates, and its Sublicensees of any Product incorporating such antibody that has met the Candidate Selection Criteria and is covered [***] that covers the [***]; or

(ii) GSK shall pay to OncoMed a [***] royalty on Net Sales by GSK, its Affiliates, and its Sublicensees of any Product incorporating such antibody that has met the Candidate Selection Criteria and is not covered [***] that covers the [***]; and

(iii) GSK’s obligation to pay the royalty in this Section 7.1.3(f) on Net Sales of Products incorporating any such Candidate Selection Compound will continue until, and end on the date upon which (1) a Third Party’s product or Third Parties’ products having the [***] enters the market in a given country (so long as such Third Party’s product or Third Parties’ products were [***]), and (2) such Third Party’s product or Third Parties’ products account for [***] or more of aggregate unit sales of such Product plus such Third Party’s product or Third Parties’ products in the given country during any Calendar Year,

 

[***] Certain information in this document 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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and all other payment obligations hereunder shall terminate except those that are accrued and unpaid as of the effective date of termination.

7.2 Collaboration Compound Exclusivity.

7.2.1 Prior to expiration of the Development Collaboration Term, OncoMed will not [***], except as provided in Sections 4.1.5, 4.2.7, and 7.1. Upon expiration of the Development Collaboration Term, subject to the limitations set forth in the second sentence of Section 7.1.1, OncoMed shall be free to Research, Develop or Commercialize, either on its own or with or through a Third Party, any Collaboration Compound that [***].

7.2.2 Subject to Sections 4.1.5, 4.2.7, and 7.1, upon expiration of the Development Collaboration Term, for so long as GSK is Developing and/or Commercializing a GSK Development Compound under this Agreement:

(a) OncoMed will not [***].

(b) If a Collaboration Compound has [***], OncoMed shall have the right, but not the obligation, to continue to progress such Collaboration Compound on its own to meet the Candidate Selection Criteria such Collaboration Compound upon meeting the Candidate Selection Criteria shall be subject to milestone payments from GSK pursuant to Section 8.2.

(c) With respect to any Collaboration Compound that [***] in accordance with OncoMed’s efforts as set forth Section 7.2.2(b):

(i) OncoMed shall have the right, but not the obligation, to continue to Develop such Candidate Selection Compound through to Completion of the PoC Trials. If OncoMed elects to Develop the Candidate Selection Compound through to Completion of the PoC Trials, OncoMed shall continue to use Commercially Reasonable Efforts pursuant to Section 9.1 to Develop such Candidate Selection Compound, and GSK will continue to make milestone payments pursuant to Section 8.2. GSK will have the right, upon achievement of the PoC Criteria for such Candidate Selection Compound, to exercise the GSK Program Option to continue Development of the PoC Compound as a GSK Development Compound, subject to the terms of this Agreement, including without limitation GSK’s obligations under Section 9.2 and to make payments to OncoMed pursuant to Sections 8.2 and 8.3.

(ii) If OncoMed elects not to continue to Develop such Candidate Selection Compound through to Completion of the PoC Trials, then OncoMed shall offer such Candidate Selection Compound to GSK for further Development as a GSK Development Compound. No later than [***] days after the date of notification by OncoMed of such offer, GSK shall have the option, at its sole discretion, to exercise the GSK Program Option for such Candidate Selection Compound. If GSK exercises the GSK Program Option for such Candidate Selection Compound, GSK will continue to use Commercially Reasonable Efforts pursuant to Section 9.2 to Develop and Commercialize such Candidate Selection Compound as a GSK Development Compound, subject to the terms of the Agreement, including without

 

[***] Certain information in this document 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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limitation GSK’s obligations under Section 9.2 and to make payments to OncoMed pursuant to Sections 8.2 and 8.3.

7.2.3 Subject to Section 7.1, if, after the expiration of the Development Collaboration Term, GSK at any time is not progressing the Development and/or Commercialization of any GSK Development Compound, but [***] remain for which Development has not been terminated either by a joint decision of the JSC or unilaterally by GSK, then, as determined for each such Candidate Selection Compound:

(a) OncoMed shall have the right, but not the obligation, to Develop each such remaining Candidate Selection Compound through to Completion of the PoC Trials, subject to the terms of this Agreement, including without limitation OncoMed’s obligations under Section 9.1, GSK’s right to exercise the GSK Program Option at PoC (and thereafter further Develop such Candidate Selection Compound as a GSK Development Compound), and GSK’s obligation to make payments to OncoMed pursuant to Sections 8.2 and 8.3.

(b) If OncoMed elects not to further Develop any such remaining Candidate Selection Compound through to Completion of the PoC Trials, OncoMed shall offer such Candidate Selection Compound to GSK for further Development as a GSK Development Compound. No later than [***] days after the date of notification by OncoMed of such offer, GSK shall have the option, at its sole discretion, to exercise the GSK Program Option for such Candidate Selection Compound. If GSK exercises the GSK Program Option with respect to such Candidate Selection Compound, GSK shall thereafter further Develop such Candidate Selection Compound as a GSK Development Compound, subject to the terms of this Agreement, including without limitation GSK’s obligations under Section 9.2 and GSK’s obligation to make payments to OncoMed pursuant to Sections 8.2 and 8.3.

(c) If both OncoMed and GSK elect not to further Develop all such remaining Candidate Selection Compounds, OncoMed shall be free to Research, Develop, and Commercialize any remaining Collaboration Compounds outside the Collaboration, either on its own or with or through any Third Party, in accordance with its rights under Section 14.6.2(a), and this Agreement shall be deemed terminated by GSK pursuant to Section 14.3.1.

7.2.4 If, at any time after expiration of the Development Collaboration Term, GSK is not progressing the Development and/or Commercialization of any GSK Development Compound and there are no Candidate Selection Compounds remaining for which Development has not been terminated either by a joint decision of the JSC or unilaterally by GSK, but there are [***] prior to the expiration of the Development Collaboration Term, then, as determined for each such Collaboration Compound:

(a) OncoMed shall have the right, but not the obligation, to progress any such [***] prior to the expiration of the Development Collaboration Term to Candidate Selection and further through to Completion of the PoC Trials subject to the terms of this Agreement, including without limitation OncoMed’s obligations under Section 9.1, GSK’s right to exercise the GSK Program Option at PoC (and thereafter further Develop such Candidate

 

[***] Certain information in this document 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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Selection Compound as a GSK Development Compound), GSK’s obligations under Section 9.2, and GSK’s obligation to make payments to OncoMed pursuant to Sections 8.2 and 8.3.

(b) If OncoMed does not elect to further Develop any [***] prior to the expiration of the Development Collaboration Term through to Completion of the PoC Trials, OncoMed shall, at GSK’s request, continue to Research and Develop such Collaboration Compounds through to Candidate Selection. Upon such request by GSK, GSK shall pay to OncoMed [***]. If GSK does not elect to have OncoMed progress any such Collaboration Compounds through to Candidate Selection, then OncoMed shall be free to Research, Develop, and Commercialize any remaining [***] prior to the expiration of the Development Collaboration Term either on its own or with or through a Third Party outside of the Collaboration, and this Agreement shall be deemed terminated by GSK pursuant to Section 14.3.1.

(c) If GSK elects to have OncoMed Develop any Collaboration Compound through to Candidate Selection as described in Section 7.2.4(b), once such Collaboration Compound has met the Candidate Selection Criteria, OncoMed shall have the right, but not the obligation, to continue to Develop such Candidate Selection Compound through to Completion of the PoC Trials. If OncoMed elects to continue to Develop such Candidate Selection Compound, OncoMed will do so, subject to the terms of this Agreement, including without limitation OncoMed’s obligations under Section 9.1, GSK’s right to exercise the GSK Program Option at PoC (and thereafter further Develop such Candidate Selection Compound as a GSK Development Compound), GSK’s obligations under Section 9.2 and GSK’s obligation to make payments to OncoMed pursuant to Sections 8.2 and 8.3.

(d) If OncoMed elects not to further Develop such a Candidate Selection Compound through to Completion of the PoC Trials, OncoMed shall offer such Candidate Selection Compound to GSK for further Development as a GSK Development Compound. No later than [***] days after the date of notification by OncoMed of such offer, GSK shall have the option, at its sole discretion, to exercise the GSK Program Option for such Candidate Selection Compound. If GSK exercises the GSK Program Option with respect to such Candidate Selection Compound, GSK shall thereafter further Develop such Candidate Selection Compound as a GSK Development Compound, subject to the terms of this Agreement, including without limitation GSK’s obligations under Section 9.2 and GSK’s obligation to make payments to OncoMed pursuant to Sections 8.2 and 8.3.

(e) If, after Collaboration Compound(s) have met the Candidate Selection Criteria under this Section 7.2.4, both OncoMed and GSK elect not to further Develop all such remaining Candidate Selection Compounds, OncoMed shall be free to Research, Develop, and Commercialize any remaining Collaboration Compounds outside the Collaboration, either on its own or with or through any Third Party, in accordance with its rights under Section 14.6.2(a), and this Agreement shall be deemed terminated by GSK pursuant to Section 14.3.1.

7.2.5 For the avoidance of doubt, while either Party is Developing a [***] under this Agreement, excluding OncoMed Development Compounds, OncoMed will not Research, Develop, or Commercialize any remaining [***] prior to the expiration of the

 

[***] Certain information in this document 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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Development Collaboration Term outside of the Collaboration, either on its own or with or through a Third Party, except as set forth in Sections 7.1.3, 7.2.3(c), 7.2.4(b), and 7.2.4(e).

7.2.6 In-Licensing. GSK may at any time in-license for Development and/or Commercialization (a) [***] that is an Active Target or (b) [***]; provided that, if such in-license (i) is for [***] rights, including without limitation a right to obtain a commercial license, (ii) is for [***], or (iii) is for [***], GSK shall terminate this Agreement prior to such in-licensing in accordance with its rights under Section 14.3 and, upon such termination, all Collaboration Compounds, including without limitation Collaboration Compounds previously designated as GSK Development Compounds or as Candidate Selection Compounds, will thereafter be deemed OncoMed Development Compounds, and OncoMed will thereafter have all rights, itself or with a Third Party or through a Sublicensee, to Develop and Commercialize such OncoMed Development Compound at OncoMed’s sole expense, subject to the terms of this Agreement, including without limitation the grant of the license by GSK to OncoMed under Section 5.5 and the payment by OncoMed of royalties to GSK under the applicable provision of Section 8.4. For clarity, for purposes of Sections 7.2.6(i) and (ii), the term “Development” shall not include [***].

8. F INANCIAL T ERMS

8.1 Upfront Payment and Equity Investments.

8.1.1 Upfront Payment. In consideration for the rights granted to GSK under this Agreement, GSK, upon the Effective Date, shall pay to OncoMed a one-time-only, nonrefundable, noncreditable payment of Seventeen Million Five Hundred Thousand Dollars ($17,500,000). Within [***] of a receipt of an invoice therefor, such invoice to be sent by OncoMed on or after the Effective Date, GSK shall make such payment by wire transfer of immediately available funds into an account designated in writing by OncoMed.

8.1.2 Equity Investments.

(a) Upon the Effective Date, GSK shall purchase Seventeen Million Five Hundred Thousand Dollars ($17,500,000) of Series B-2 Preferred Stock of OncoMed, pursuant to the terms and conditions of a stock purchase agreement substantially in the form attached hereto as Exhibit 8.1.2 (the “Series B-2 Preferred Stock Purchase Agreement” ) at Two Dollars and Thirteen Cents ($2.13) per share.

(b) GSK, at GSK’s discretion, will have the right to purchase additional OncoMed equity corresponding to up to twenty percent (20%) of the shares made available in an initial public offering of common stock of OncoMed, if any. Any such initial public offering shall be made solely at the discretion of OncoMed and at the time chosen by OncoMed.

8.2 Milestone Payments to OncoMed. In consideration for the rights granted to GSK under this Agreement, GSK shall make milestone payments to OncoMed upon achievement of each of the milestone events in the amounts set forth in this Section 8.2. Except as otherwise specifically indicated, each milestone payment set forth in this Section 8.2 will be

 

[***] Certain information in this document 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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payable by GSK to OncoMed after achievement of the specified milestone event and within the applicable time periods set forth in this Section 8.2. Such milestone payments shall not be refundable or returnable in any event, nor shall they be creditable against royalties or other payments. Each milestone payment shall be payable by wire transfer of immediately available funds into an account designated in writing by OncoMed.

8.2.1 Milestone Payments upon Initiation of a Program by OncoMed. GSK shall make the following milestone payments to OncoMed upon achievement of each of the milestone events in the amounts set forth below within [***] days after GSK’s of a receipt of an invoice therefor, such invoice to be sent by OncoMed on or after the date on which OncoMed notifies GSK of achievement of the applicable milestone event for each Collaboration Compound, each Candidate Selection Compound, each GSK Development Compound or each Product, as applicable:

 

Milestone Event   

Payment

(millions of Dollars)

 
     Target 2
Program
   Each other
Program
 

[***

        ]   

 

* For purposes of this Section 8.2.1, “Successful Completion of GLP Toxicology Study” [***].
** This payment for a Candidate Selection Compound is payable upon exercise by GSK of a GSK Program Option for such Candidate Selection Compound whenever such exercise occurs, subject to Section 16.1, but such payment may be reduced as set forth in Section 8.2.4. In addition, all other payments in the table in this Section 8.2.1, above, may be reduced as set forth in Section 8.2.4.

Notwithstanding anything to the contrary, each of the following milestone payments shall be payable only once:

 

Milestone Event   

Payment

(millions of Dollars)

 

[***]

     [***

8.2.2 Milestone Payments After Exercise of a GSK Program Option. If GSK exercises a GSK Program Option for a Candidate Selection Compound, GSK shall provide OncoMed with prompt written notice of the achievement of any milestone described in the table in this Section 8.2.2, below, by GSK, its Affiliates or its Sublicensees, and GSK will make the following milestone payments in the amounts set forth below to OncoMed with respect to such resulting GSK Development Compound within [***] days after receipt of an invoice therefor, such invoice to be sent by OncoMed on or after receipt of notification of the achievement of the specified milestone event by GSK, its Affiliate or its Sublicensee:

 

[***] Certain information in this document 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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Milestone Event   

Payment

(millions of Dollars)

 

[***]

     [***]   

Each milestone payment in the table in this Section 8.2.2, above, will be paid in full for each GSK Development Compound upon the first achievement of the corresponding event. Each milestone payment in the table in this Section 8.2.2, above, will be reduced to an amount equal to [***] of the amounts set forth in such table for each GSK Development Compound for the second achievement of the corresponding event for the same GSK Development Compound in a new indication.

For clarity, if GSK exercises the GSK Program Option for a Candidate Selection Compound after Candidate Selection but prior to Completion of a PoC Trial, the milestone payments above will be reduced as set forth in Section 8.2.4.

8.2.3 Net Sales Milestones. If GSK has exercised a GSK Program Option for a Candidate Selection Compound at PoC, the following Net Sales threshold milestone payments will be paid the first time in any Calendar Year that the total aggregate Net Sales of all Products (including without limitation all indications and formulations of such Products) containing the applicable GSK Development Compound in a Calendar Year by GSK, its Affiliates and its Sublicensees in the Territory reach the amounts set forth in the table in this Section 8.2.3, below.

 

Annual worldwide Calendar Year Net Sales (millions of Dollars)

for Products containing the GSK Development Compound in all Indications

  

Payment

(millions of Dollars)

 

[***]

     [***]   

Each of the sales milestone payments described in this Section 8.2.3 shall be available only one time per GSK Development Compound under this Agreement upon the first achievement of the applicable event. [***].

For clarity, if GSK exercises the GSK Program Option for a Candidate Selection Compound after Candidate Selection but prior to Completion of a PoC Trial, the milestone payments above will be reduced as set forth in Section 8.2.4.

8.2.4 Option Exercise Adjustment to Milestone Payments. Each milestone payment in the tables in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, for each Collaboration Compound, Candidate Selection Compound, GSK Development Compound, or Product, as applicable, will be reduced on a compound-by-compound basis, for example, pursuant to Section 4.1.3(b)(ii), 4.1.3(f), 4.1.5(b), 4.2.7(c), 7.1.3(c)(i)(C), or 7.2, to an amount equal to:

(a) [***] of the amount set forth in the tables in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, for any Candidate Selection Compound for which OncoMed

 

[***] Certain information in this document 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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has [***] at the time that GSK exercises the GSK Program Option with respect to such Candidate Selection Compound;

(b) [***] of the amounts set forth in the tables in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, for any Candidate Selection Compound for which OncoMed has [***] at the time that GSK exercises its GSK Program Option with respect to such Candidate Selection Compound; and

(c) [***] of the amounts set forth in the tables in Sections 8.2.1, 8.2.2, and/or 8.2.3, as applicable, for any Candidate Selection Compound for which OncoMed has [***] at the time that GSK exercises the GSK Program Option with respect to such Candidate Selection Compound; provided, however, that this Section 8.2.4(c) shall not apply if GSK exercises the GSK Program Option after [***];

provided that GSK undertakes Development (including without limitation bearing all costs thereof) of such Candidate Selection Compound after GSK exercises the GSK Program Option and continues such Development using Commercially Reasonable Efforts thereafter.

8.2.5 GSK Credit. So long as GSK has not unilaterally terminated any Programs pursuant to Section 14.3.2, if OncoMed does not identify [***] within [***] years after the Effective Date, GSK will be entitled to deduct [***] from future milestone payments due to OncoMed under this Agreement. In addition, if OncoMed does not progress [***] within [***] years after the Effective Date, GSK will be entitled to deduct a total of [***] from future milestone payments due to OncoMed under this Agreement. Upon the first approval of a BLA for a GSK Development Compound in the United States, GSK will reimburse OncoMed any amounts credited to GSK under this Section 8.2.5.

8.3 Royalty Payments to OncoMed.

8.3.1 Royalty Rates. As further consideration for the rights granted to GSK under this Agreement, subject to any adjustments pursuant to Sections 8.3.2, 8.3.3, and/or 8.3.4, GSK will pay OncoMed royalties on Net Sales by GSK, its Affiliates and its Sublicensees of each Product during a Calendar Year, on a country-by-country basis and on a Product-by-Product basis, in those countries of the Territory in which there is a [***] within the Licensed Intellectual Property that [***], for the applicable country in the amounts as follows:

 

Annual Net Sales in the Territory
(millions of Dollars)
  

Royalty

Rate

 

[***]

     [***]   

For purposes of calculation of the royalties due under this Section 8.3, the rates set forth in the table in this Section 8.3.1 shall be subject to Section 8.3.4. Section 8.3.4 also sets forth the term during which such royalties shall be payable. Royalties shall then be adjusted, as applicable, pursuant to Sections 7.1.3 and 8.3.2. The rate resulting from any such adjustment shall then be adjusted, as applicable, pursuant to Section 8.3.3.

 

[***] Certain information in this document 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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8.3.2 Option Exercise Adjustment to Royalty Rates. If GSK exercises its GSK Program Option for a Candidate Selection Compound prior to PoC for such Candidate Selection Compound, for example, pursuant to Section 4.1.3(b)(ii), 4.1.3(f), 4.1.5(b), 4.2.7(c), 7.1.3(c)(i)(C), or 7.2, the royalty rates in the table in Section 8.3.1 for such Candidate Selection Compound will be adjusted to rates equal to:

(a) [***] of the rates set forth in the table in Section 8.3.1 for any Candidate Selection Compound for which OncoMed has [***] at the time that GSK exercises the GSK Program Option with respect to such Candidate Selection Compound;

(b) [***] of the rates set forth in the table in Section 8.3.1 for any Candidate Selection Compound for which OncoMed has [***] at the time that GSK exercises its GSK Program Option with respect to such Candidate Selection Compound;

(c) [***] of the rates set forth in the table in Section 8.3.1 for any Candidate Selection Compound for which OncoMed has [***] at the time that GSK exercises the GSK Program Option with respect to such Candidate Selection Compound; provided, however, that this Section 8.3.2(c) shall not apply if GSK exercises the GSK Program Option after Completion of [***];

provided that GSK undertakes Development (including without limitation bearing all costs thereof) of such Candidate Selection Compound after GSK exercises the GSK Program Option and continues such Development using Commercially Reasonable Efforts thereafter.

8.3.3 Co-Development Adjustment to Royalty Rates.

(a) Notwithstanding the terms of Sections 8.3.1, 8.3.2, and 8.3.4, if OncoMed exercises its option under Section 6.1 with respect to Development for all indications, the royalty rates payable under Section 8.3.1 will increase in all tiers of worldwide annual Net Sales by percentage points equal to [***], subject to Section 8.3.3(b). For example, if OncoMed contributes [***].

(b) Notwithstanding the terms of Sections 8.3.1, 8.3.2, and 8.3.4, if OncoMed elects to exercise its option under Section 6.1 for at least [***], but OncoMed elects [***], the increase in the number of percentage points pursuant to Section 8.3.3(a) shall be reduced by [***]. Each such reduction of the royalty rate increase under Section 8.3.3(a), if any, shall be effective only as of [***]. For purposes of illustration, if [***]. For purposes of this Section 8.3.3(b), [***] means the use of a Collaboration Compound [***].

8.3.4 Intellectual Property Adjustment to Royalty Rates. All royalties payable in accordance with Section 8.3.1 shall be subject to the provisions of this Section 8.3.4, and shall only be payable as follows:

(a) [***].

(i) Valid Claim – [***]. Beginning on the date of First Commercial Sale and continuing for so long as a Valid Claim of an OncoMed Licensed

 

[***] Certain information in this document 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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Patent covers or claims [***], the GSK Development Compound included in such Product (as determined on a Product-by-Product and country-by-country basis), then [***] of the royalties due on such Product in accordance with Section 8.3.1 will be paid by GSK to OncoMed. Thereafter, continuing until the expiration of the obligation to pay royalties as described in Section 8.3.4(a)(vi), such royalty rate shall be reduced by [***].

(ii) Valid Claim – [***]. Beginning on the date of First Commercial Sale and continuing for so long as a Valid Claim of an OncoMed Licensed Patent covers or claims [***] GSK Development Compound included in a Product (as determined on a Product-by-Product and country-by-country basis), then [***] of the royalties due on such Product in accordance with Section 8.3.1 will be paid by GSK to OncoMed. Thereafter, prior to the expiration of the obligation to pay royalties as described in Section 8.3.4(a)(vi), such royalty rate shall be reduced by [***].

(iii) [***]. With respect to any Product sold in any country of the Territory in which there is [***] that covers or claims the [***], the GSK Development Compound included in such Product (as determined on a Product-by-Product and country-by-country basis), then:

(A) For the period beginning on the date of such First Commercial Sale and ending [***] years after the date of such First Commercial Sale, GSK will pay to OncoMed [***] of the royalties due on such Product in accordance with Section 8.3.1, and GSK will pay [***] of the royalties due on such Product in accordance with Section 8.3.1 [***].

(B) For the period beginning [***] years after the date of such First Commercial Sale and ending [***] years after the date of such First Commercial Sale, GSK will pay to OncoMed [***] of the royalties due on such Product in accordance with Section 8.3.1, and GSK will pay [***] of such royalties [***].

(C) If a [***] within [***] after the date of such First Commercial Sale, [***] and GSK will thereafter pay to OncoMed royalties on Net Sales of such a Product at the full rates in accordance with Section 8.3.4(a)(i).

(D) If a [***] within [***] after the date of such First Commercial Sale and there is [***], as set forth in Section 8.3.4(a)(v), [***], unless, at a later date, a [***], the GSK Development Compound included in such Product (as determined on a Product-by-Product and country-by-country basis), at which time GSK will pay royalties to OncoMed on Net Sales of such a Product at the full rates in accordance with Section 8.3.4(a)(i).

(iv) [***]. With respect to any Product sold in any country of the Territory in which there is [***] in such country that covers or claims [***] such Product (as determined on a Product-by-Product and country-by-country basis), then:

(A) For the period beginning on the date of such First Commercial Sale and ending [***] years after the date of such First Commercial Sale, GSK

 

[***] Certain information in this document 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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will pay to OncoMed [***] of the royalties due on such Product as in accordance with Section 8.3.1, and GSK will pay [***] of such royalties [***].

(B) For the period beginning [***] years after the date of such First Commercial Sale and ending [***] years after the date of such First Commercial Sale, GSK will pay to OncoMed [***] of the royalties due on such Product in accordance with Section 8.3.1, and GSK will pay [***] of such royalties [***].

(C) If a [***] within [***] years after the date of such First Commercial Sale, [***].

(D) If a [***] within [***] years after the date of such First Commercial Sale and [***] in the applicable country, as set forth in Section 8.3.4(a)(v), [***] unless, at a later date, a [***] such Product (as determined on a Product-by-Product and country-by-country basis), at which time GSK will pay royalties to OncoMed on Net Sales of such a Product at the rates determined in accordance with Section 8.3.4(a)(ii).

(v) [***]. If, on a country-by-country and Product-by-Product basis, there is [***], but there [***] such Product on the date of First Commercial Sale of such Product, GSK will pay OncoMed [***] equal to [***] of the royalties due on such Product in accordance with Section 8.3.1. OncoMed shall use Commercially Reasonable Efforts to [***]. For purposes of this Section 8.3.4(a)(v), any [***] after such disclosure. After OncoMed transfers such [***], in the event that GSK does [***], such royalty shall continue to be due to OncoMed.

(vi) The obligation to pay royalties under this Section 8.3 shall:

(A) commence, on a country-by-country and Product-by-Product basis, only if there is a:

[***]

in each of (1), (2), or (3), [***] that is covered by [***] of such Product in the applicable country; and

(B) expire, on a country-by-country and Product-by-Product basis, on the date upon which:

(1) a Third Party’s product or Third Parties’ products having [***] enters the market in a given country (so long as such Third Party’s product or Third Parties’ products were [***] from such Product); and

(2) such Third Party’s product or Third Parties’ products account for [***] or more of aggregate unit sales of such Product plus such Third Party’s product or Third Parties’ products in the given country during any Calendar Year.

 

[***] Certain information in this document 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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(vii) Notwithstanding anything to the contrary, only one royalty payment shall be due under this Section 8.3.4(a) with respect to the sale of any particular Product, regardless of whether multiple [***], cover or claim or relate to [***]. In the event that [***] such Product, the royalty payment due under this Section 8.3.4(a) will be the payment corresponding to the highest of the royalty payments determined under Section 8.3.4(a)(i), (ii), (iii), (iv), or (v), as applicable.

(b) [***]. In the event that [***], and the Parties [***] a Patent containing [***], the royalty rates determined in accordance with Section 8.3.1 for a Product will be reduced to an amount that will be [***] of the rates determined in accordance with Section 8.3.1.

(c) Incremental Royalties. The royalty rates determined in accordance with Section 8.3.1 are incremental rates, which apply only for the respective increment of annual Net Sales described in the annual Net Sales column. Thus, once a total annual Net Sales figure is achieved for a Calendar Year, the royalties owed on any lower tier portion of annual Net Sales are not adjusted up to the higher tier rate for such Calendar Year.

8.4 Payments to GSK.

8.4.1 After Termination by GSK.

(a) If GSK:

(i) terminates this Agreement in its entirety pursuant to Section 7.2.6 or 14.3.1, or

(ii) (A) terminates this Agreement on a Program-by-Program basis pursuant to Section 14.3.2; (B) elects not to exercise the GSK Program Option for a Candidate Selection Compound under Section 4.1; or (C) terminates the Development and Commercialization of a GSK Development Compound pursuant to Section 4.2.7; and

(b) OncoMed thereafter Develops and Commercializes any terminated [***] prior to such termination or GSK Development Compound as an OncoMed Development Compound;

(c) then OncoMed will pay to GSK a royalty of:

(i) [***] on Net Sales by OncoMed, its Affiliates, and its Sublicensees of any Product (or Combination Product, if applicable) containing such OncoMed Development Compound on a Product-by-Product basis and country-by-country basis; plus

(ii) [***] on such Net Sales if, prior to such termination, GSK Completed a Phase III Trial that served as a pivotal Clinical Trial in obtaining Regulatory Approval for such a Product; plus

 

[***] Certain information in this document 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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(iii) [***] on such Net Sales; provided that any Patent Controlled by GSK and licensed by GSK exclusively to OncoMed with respect to such Product pursuant to Section 5.5, including for example any Patent jointly owned by GSK and OncoMed, covers the [***].

(d) OncoMed’s obligation to pay to GSK such royalty payments under this Section 8.4.1 will begin, on a Product-by-Product basis on the date of First Commercial Sale of a Product (or Combination Product, if applicable) Commercialized by OncoMed, its Affiliates or Sublicensees in a country, and will end on the date upon which GSK has been paid an amount equal to [***] of those expenses actually incurred by GSK Developing or Commercializing all Collaboration Compounds under this Agreement, including without limitation the payment set forth in Section 8.1.1 (but not including any payment set forth in Section 8.1.2); provided that OncoMed’s obligation to pay to GSK a royalty payment of [***] on Net Sales as set forth in Section 8.4.1(c)(iii), if applicable, will continue until, and end on, the date upon which (A) a Third Party’s product or Third Parties’ products [***] enters the market in a given country (so long as such Third Party’s product or Third Parties’ products were [***]), and (B) such Third Party’s product or Third Parties’ products account for [***] or more of aggregate unit sales of such Product plus such Third Party’s product or Third Parties’ products in the given country during any Calendar Year.

8.4.2 After Termination by OncoMed.

(a) If OncoMed:

(i) terminates this Agreement (A) on a Program-by-Program basis pursuant to Section 14.2.1 for failure by GSK to use Commercially Reasonable Efforts, or (B) in its entirety pursuant to Section 14.2 for any other material breach of GSK, or (C) in its entirety pursuant to Section 14.4 or 14.5; and

(ii) thereafter Develops and Commercializes any Collaboration Compound from a terminated Program [***] prior to such termination or GSK Development Compound as an OncoMed Development Compound;

(b) then OncoMed will pay to GSK a royalty on Net Sales by OncoMed, its Affiliates, and its Sublicensees of Products (or Combination Products, if applicable) containing such OncoMed Development Compound, on a Product-by-Product basis and country-by-country basis, such royalty to be:

(i) [***] with respect to any Product containing such OncoMed Development Compound; and

(ii) [***] on such Net Sales of any Product containing such OncoMed Development Compound, provided that [***].

(c) OncoMed’s obligation to pay to GSK such royalty payments under this Section 8.4.2 will begin, on a Product-by-Product basis, on the date of First Commercial Sale of a Product (or Combination Product, if applicable) Commercialized by

 

[***] Certain information in this document 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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OncoMed, its Affiliates or Sublicensees in a country, and will continue until, and end on, the date upon which GSK has been paid an amount equal to [***]; provided that, if OncoMed terminates a Program as described in Section 8.4.2(a)(i)(A) or the entire Agreement as described in Section 8.4.2(a)(i)(B), OncoMed’s obligation to pay to GSK a royalty payment of [***] on Net Sales as set forth in Section 8.4.2(b)(ii), if applicable, will continue until, and end on expiration of the last Valid Claim in GSK intellectual property licensed to OncoMed [***] Product that is covered [***] the Product containing such OncoMed Development Compound. If OncoMed terminates this Agreement as described in Section 8.4.2(a)(i)(C), OncoMed’s obligation to pay to GSK a royalty payment of [***] on Net Sales as set forth in Section 8.4.2(b)(ii), if applicable, will continue until, and end on, the date upon which (A) a Third Party’s product or Third Parties’ products [***] enters the market in a given country (so long as such Third Party’s product or Third Parties’ products [***]), and (B) such Third Party’s product or Third Parties’ products account for [***] or more of aggregate unit sales of such Product plus such Third Party’s product or Third Parties’ products in the given country during any Calendar Year.

8.5 Royalty Payment Reports. After the First Commercial Sale of a Product and for so long as there is any obligation to pay royalties or milestone payments under this Agreement, GSK shall furnish to OncoMed a written report estimating the royalties owed in the just-ended Calendar Quarter, within [***] after the end of each Calendar Quarter. Royalty and Net Sales milestone payments for each Calendar Quarter (or portion thereof if this Agreement terminates during a Calendar Quarter) shall be due no later than [***] days after the end of each Calendar Quarter (or portion thereof if this Agreement terminates during a Calendar Quarter). With each quarterly payment, GSK shall deliver to OncoMed a full and accurate accounting to include at least the following information:

8.5.1 the Net Sales for the applicable Product by GSK, its Affiliates, and Sublicensees in the currency in which sales were made and in Dollars after the application of the exchange rate during the reporting period as reported in Section 8.5.3.

8.5.2 the royalties payable in Dollars that have accrued hereunder in respect of such Net Sales and the basis for calculating those royalties;

8.5.3 the exchange rates and other methodology used in converting into Dollars, from the currencies in which sales were made;

8.5.4 [***]; and

8.5.5 withholding taxes, if any, required by Laws to be deducted in respect of such royalties.

If OncoMed Commercializes a product on which royalties are due to GSK under the applicable provision in Section 8.4, OncoMed shall provide similar royalty payment reports to GSK, commencing with the First Commercial Sale of such product and continuing for the period during which royalty payments are due to GSK, containing the information set forth in this Section 8.5, above.

 

[***] Certain information in this document 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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8.6 Manner of Payment. All payments to be made by GSK or by OncoMed under this Agreement shall be made in Dollars by wire transfer of immediately available funds to such U.S. bank account as shall be designated by OncoMed or GSK, respectively. Late payments shall bear interest at the rate provided in Section 8.11.

8.7 Records Retention. Commencing with the First Commercial Sale of a Product by GSK or a product Commercialized by OncoMed, as applicable, GSK and OncoMed each shall keep, and shall cause each of its respective Affiliates, and Sublicensees, if any, to keep, full and accurate books of accounting in accordance with IFRS or GAAP, as applicable, containing all particulars that may be necessary for the purpose of calculating all royalties payable to the other Party under this Article 8 and Article 9, for a period of [***] after the Calendar Year in which such sales occurred, in sufficient detail to permit GSK or OncoMed, as applicable, to confirm the accuracy of royalties paid under this Agreement. Such books of accounting or, in the alternative, a Party’s financial consolidation system (including without limitation those of GSK’s and OncoMed’s respective Affiliates and Sublicensees, if any) shall be kept at their respective principal place of business.

8.8 Audits. During the Term and for a period of [***] thereafter, at the request and expense of a Party receiving royalties or Net Sales milestone payments, if any, under this Articles 8 and Article 9 (the “Payee” ), the Party making any payment (the “Payor” ) shall permit an independent, certified public accountant of nationally recognized standing appointed by the Payee, and reasonably acceptable to the Payor, at reasonable times and upon reasonable notice, but in no case more than once per Calendar Year thereafter, to examine such records as may be necessary for the sole purpose of verifying the calculation and reporting of Net Sales in the previous [***] and the correctness of any royalty payment made under this Agreement for the previous [***]. Results of any such examination shall be made available to both Payor and Payee. The independent, certified public accountant shall disclose to the Payee only the amount of royalties or Net Sales milestone payments, if any, that the independent auditor believes to be due and payable hereunder to the Payee, details concerning any discrepancy from the amount paid and the amount due, and shall disclose no other information revealed in such audit. Any and all records examined by such independent accountant shall be deemed the Payor’s Confidential Information which may not be disclosed by said independent, certified public accountant to any Third Party. If, as a result of any inspection of the books and records of the Payor, it is shown that a Payee’s payments under this Agreement were less than the amount which should have been paid, then the Payor shall pay all amounts required to be paid to eliminate any discrepancy revealed by such inspection within [***], including any interest on such amounts determined in accordance with Section 8.11; provided that such interest shall apply only to amounts payable during [***] prior to such inspection. The Payee shall pay for such audits, except that in the event that the royalty payments made by the Payor were less than [***] of the undisputed amounts that should have been paid during the period in question as per the audit, the Payor shall pay the reasonable costs of the audit.

8.9 Currency Exchange. All payments under this Agreement shall be payable, in full, in Dollars, regardless of the country(ies) in which sales are made. For the purposes of computing Net Sales of Products or products Commercialized by OncoMed that are sold in a currency other than Dollars, such currency shall be converted into Dollars as calculated

 

[***] Certain information in this document 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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at the actual average rates of exchange for the pertinent quarter or year to date, as the case may be, as used by GSK or OncoMed in producing its quarterly and annual accounts, as confirmed by their respective auditors.

8.10 Taxes. In the event that the Payor is required to withhold any tax to the tax or revenue authorities in any country regarding any payment to the Payee due to the Laws of such country, such amount shall be deducted from the payment to be made by the Payor, and the Payor shall promptly notify the Payee of such withholding and, within a reasonable amount of time after making such deduction, furnish the Payee with copies of any tax certificate if such information has been provided by the relevant taxing authority or other documentation evidencing such withholding. Each of Payor and Payee agrees to cooperate with the other in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect. However, any such deduction or withholding shall be an expense of and borne solely by the Payee.

8.11 Interest Due. Without limiting any other rights or remedies available to either Party, each Party shall pay the other interest on any payments that are not paid on or before the date such payments are due under this Agreement at a rate of [***] calculated on the total number of days payment is delinquent.

9. D ILIGENCE

9.1 OncoMed Requirements.

9.1.1 OncoMed will use Commercially Reasonable Efforts (a) during the Research Collaboration Term to [***]. If during the Term, OncoMed elects to conduct Development and Commercialization of a [***] provided by GSK pursuant to Section 7.1.3, then OncoMed will use Commercially Reasonable Efforts to progress such [***].

9.1.2 The Parties acknowledge and agree that OMP21M18 has been designated a Candidate Selection Compound and, beginning on the Effective Date, OncoMed will use Commercially Reasonable Efforts to progress OMP21M18 [***]. In addition, the Parties acknowledge and agree that the Target 1 Program is an active Program and, beginning on the Effective Date, OncoMed will use Commercially Reasonable Efforts to continue to progress Collaboration Compounds in the Target 1 Program to Candidate Selection. OncoMed will use Commercially Reasonable Efforts to [***], which selection shall be based on then-current scientific information.

9.1.3 OncoMed and GSK may agree through the JSC to progress more than [***] Collaboration Compound within a Program through Candidate Selection and through to Completion of the PoC Trials for each such Program in accordance with Section 2.2.1(m); provided that OncoMed will have no obligation to do so after [***] and further provided that the decision to progress [***] Collaboration Compound within a Program must be agreed by the Parties and any disputes arising therefrom shall not be submitted to arbitration for resolution.

 

[***] Certain information in this document 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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9.1.4 If OncoMed elects to progress a [***] pursuant to Section 7.1.3, OncoMed shall use Commercially Reasonable Efforts to Complete [***], in accordance with Section 3.6.2.

9.1.5 If OncoMed elects to progress a Candidate Selection Compound pursuant to Section 4.1.5(c), 4.2.7(d), 7.2.2, 7.2.3, or 7.2.4, OncoMed shall use Commercially Reasonable Efforts to Complete [***], in accordance with Section 3.6.2.

9.1.6 If activities regarding a Collaboration Compound in a Program are terminated by the JSC:

(a) During the Research Collaboration Term because such Collaboration Compound did not meet the Candidate Selection Criteria for such Program or because the JSC agrees that Research and Development efforts around such Collaboration Compound should be terminated, and (i) there are no other Collaboration Compounds [***] progressing in such Program at an earlier stage of Development, (ii) no other Collaboration Compounds have met the Candidate Selection Criteria for such Program and (iii) a Collaboration Compound has not met the Candidate Selection Criteria in [***] Programs, OncoMed will use Commercially Reasonable Efforts to [***]. If the Parties cannot agree on a new Program to progress, such matter will not be submitted to arbitration for resolution.

(b) Prior to Commencement of the PoC Trials, but after Candidate Selection, for such Program and (i) no other Candidate Selection Compounds in such Program are being progressed, either at an earlier or later stage of Development and (ii) PoC Trials have not been initiated for [***]. If the Parties cannot agree on a new Program to progress, such matter will not be submitted to arbitration for resolution.

9.1.7 If OncoMed fails to use Commercially Reasonable Efforts to progress any Collaboration Compound in accordance with Sections 9.1.1–9.1.6, GSK shall have the right to terminate the relevant Program in accordance with Section 14.2.1.

9.2 GSK Requirements. Upon GSK’s exercise of any GSK Program Option, GSK will use Commercially Reasonable Efforts during the Term to Develop and Commercialize GSK Development Compounds and any Products containing such GSK Development Compounds. If GSK fails to use Commercially Reasonable Efforts as set forth in the preceding sentence, OncoMed will have the right to terminate the relevant Program in accordance with Section 14.2.1.

10. R EPRESENTATIONS , W ARRANTIES , AND C OVENANTS ; D ISCLAIMERS ; L IMITATION OF L IABILITY

10.1 Mutual Representations and Warranties. Each Party represents and warrants to the other Party as of the Effective Date that:

10.1.1 such Party is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

 

[***] Certain information in this document 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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10.1.2 execution of this Agreement and the performance by such Party of its obligations hereunder have been duly authorized;

10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;

10.1.4 the performance of this Agreement by it does not create a breach or default under any other agreement to which it is a party;

10.1.5 the execution, delivery and performance of this Agreement by such 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 such Party;

10.1.6 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Series B-2 Preferred Stock Purchase Agreement or, upon exercise of a GSK Program Option, to obtain Hart-Scott-Rodino clearance; and

10.1.7 to its knowledge, such Party has not employed and has not used a contractor or consultant that has employed, any individual or entity debarred by the FDA (or subject to a similar sanction of other Regulatory Authorities in the Territory), or, to its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of other Regulatory Authorities in the Territory), in the conduct of its activities prior to the Effective Date.

10.2 Additional Representations and Warranties of OncoMed. OncoMed hereby represents and warrants to GSK, as of the Effective Date, that, to its knowledge:

10.2.1 OncoMed Controls, and has the right to grant all rights and licenses it grants to GSK hereunder with respect to, the OncoMed Licensed Patents and OncoMed Licensed Know-How;

10.2.2 there is no pending litigation that alleges that the OncoMed Licensed Patents are invalid or unenforceable, or that OncoMed has misappropriated any intellectual property rights of any Third Party;

10.2.3 there is no pending litigation that alleges that OncoMed’s activities with respect to Collaboration Compounds have infringed or misappropriated any intellectual property rights of any Third Party and in the event OncoMed becomes aware at any time during the Term that any aspect of this Section 10.2.3 is no longer accurate, it shall promptly inform GSK in writing of the same;

 

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10.2.4 OncoMed has not, as of the Effective Date, granted any right or license to any Third Party relating to any of the OncoMed Licensed Patents or OncoMed Licensed Know-How that would conflict or interfere with any of the rights or licenses granted to GSK hereunder and in the event OncoMed becomes aware at any time during the Term that any aspect of this Section 10.2.4 is no longer accurate, it shall promptly inform GSK in writing of the same; and

10.2.5 OncoMed has disclosed to GSK all material data and information, and all material correspondence to or from any Regulatory Authority, relating to any and all of OncoMed’s Collaboration Compounds in existence as of the Effective Date.

10.3 Mutual Covenants. Each Party hereby covenants to the other Party that:

10.3.1 all employees of such Party or its Affiliates working under this Agreement shall be under the obligation to assign all right, title and interest in and to their inventions and discoveries, whether or not patentable, if any, to such Party as the sole owner thereof;

10.3.2 such Party shall (a) perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Laws and regulations of the country and the state and local government wherein such activities are conducted; (b) with respect to the care, handling and use in Research and Development activities hereunder of any non-human animals by or on behalf of such Party, at all times comply (and shall ensure compliance by any of its subcontractors) with all Laws, with current best practices for comparable-sized pharmaceutical companies for the proper care, handling and use of animals in Research and Development activities, and with the “3R Principles” (reducing the number of animals used, replacing animals with non-animal methods whenever possible and refining the research techniques used), subject to the other Party’s reasonable right of inspection; and (c) promptly and in good faith undertake reasonable corrective steps and measures to remedy the situation to the extent that any significant deficiencies are identified as a result of such inspection;

10.3.3 Neither Party shall employ (or, to the best of its knowledge, shall not use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of other Regulatory Authorities in the Territory), or, to the best of its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of other Regulatory Authorities in the Territory), in the conduct of its activities under this Agreement;

10.3.4 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls which would conflict or interfere with any of the rights or licenses granted to the other Party hereunder; and

10.3.5 Each Party shall disclose to the other Party all material data and information, and all material correspondence to or from any Regulatory Authority, relating to any and all Collaboration Compounds Developed and/or Commercialized under this Agreement.

 

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10.4 Additional Covenants of GSK. GSK covenants that it shall perform it obligations and exercise it rights hereunder in compliance with all Laws. GSK further covenants that it shall not knowingly engage in any activities that use the OncoMed Licensed Patents and/or OncoMed Licensed Know-How in a manner that is outside the scope of the license rights granted to it hereunder or that infringe the intellectual property rights of any Third Party.

10.5 DISCLAIMERS.

10.5.1 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, ONCOMED MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE ONCOMED LICENSED PATENTS, ONCOMED LICENSED KNOW-HOW, ANY ONCOMED CONFIDENTIAL INFORMATION, OR ANY LICENSE GRANTED BY ONCOMED HEREUNDER, OR WITH RESPECT TO ANY COLLABORATION COMPOUNDS OR PRODUCTS. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE ONCOMED LICENSED PATENTS ARE VALID OR ENFORCEABLE OR THAT USE OF THE ONCOMED LICENSED PATENTS AND ONCOMED LICENSED KNOW-HOW CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.

10.5.2 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, GSK MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY GSK CONFIDENTIAL INFORMATION OR ANY LICENSE GRANTED BY GSK HEREUNDER, OR WITH RESPECT TO ANY GSK DEVELOPMENT COMPOUNDS OR PRODUCTS. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY THAT USE OF THE GSK CONFIDENTIAL INFORMATION CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.

10.6 LIMITATION OF LIABILITY. EXCEPT FOR A BREACH OF ARTICLE 12 OR FOR CLAIMS OF A THIRD PARTY THAT ARE SUBJECT TO INDEMNIFICATION UNDER ARTICLE 13, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF BUSINESS).

 

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11. I NTELLECTUAL P ROPERTY

11.1 Ownership of Inventions. Inventorship of inventions conceived or reduced to practice in the course of activities performed under or contemplated by this Agreement shall be determined by application of U.S. patent Laws pertaining to inventorship. If such inventions are jointly invented by one or more employees, consultants or contractors of each Party, such inventions shall be jointly owned (each such invention, a “Joint Invention” ), and if one or more claims included in an issued Patent or pending Patent application which is filed in a patent office in the Territory claim such Joint Invention, such issued Patent or such pending Patent application shall be jointly owned (each such patent application or patent, a “Joint Patent” ). If an invention is solely invented by an employee, consultant or contractor of a Party, such invention shall be solely owned by such Party, and any Patent application filed claiming such solely owned invention shall also be solely owned by such Party. Each Party shall enter into binding agreements obligating all employees, consultants and contractors performing activities under or contemplated by this Agreement, including without limitation activities related to the Collaboration Compounds or Products, to assign his or her interest in any invention conceived or reduced to practice in the course of such activities to the Party for which such employee, consultant or contractor is providing its services.

11.2 Filing, Prosecution, and Maintenance of Patents.

11.2.1 OncoMed Licensed Patents . OncoMed shall be responsible, at its own cost and expense, using patent counsel selected by OncoMed (for avoidance of doubt, all references in this Article 11 to “patent counsel” shall include inside patent counsel as well as outside patent counsel), for the preparation, filing, prosecution (including without limitation any interferences, reissue proceedings, cancellations, oppositions and reexaminations) and maintenance of OncoMed Licensed Patents. In the event a Collaboration Compound being Developed by OncoMed meets the Lead Generation Criteria OncoMed shall inform the JPS and provide a description of data and information with respect to such Collaboration Compound. OncoMed shall reasonably consult with GSK, through the JPS, and shall consider any GSK comments in good faith, with respect to the preparation, filing, prosecution and maintenance of the OncoMed Licensed Patents. OncoMed shall provide to GSK copies of any papers relating to the filing, prosecution or maintenance of the OncoMed Licensed Patents promptly upon their being filed or received. GSK may, from time to time, identify in writing to OncoMed certain countries in which GSK desires that OncoMed file, prosecute and maintain OncoMed Licensed Patents and OncoMed may, subject to Section 11.2.4, thereafter file, prosecute and maintain such OncoMed Licensed Patents in such country or countries or OncoMed may, subject to Section 11.2.4, transfer to GSK the authority to file, prosecute and maintain such OncoMed Licensed Patents; provided that any and all prosecution activities by GSK will be at GSK’s sole cost and expense and will require OncoMed’s review and prior written consent, which consent shall not be unreasonably withheld, delayed or conditioned. OncoMed shall not knowingly take any action during prosecution and maintenance of the OncoMed Licensed Patents that would materially adversely affect them (including any reduction in claim scope), without consultation with GSK. This shall not be construed as any assignment of any OncoMed Licensed Patent to GSK.

 

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11.2.2 Joint Patents. In the event an invention or discovery is made relating to a Collaboration Compound being Developed or Commercialized under this Agreement the Parties shall inform the JPS and provide a description of data and information with respect to such Collaboration Compound necessary for determining whether to file a patent application with respect to such discovery or invention relating to such Collaboration Compound. The JPS shall determine inventorship. If it is determined the invention is a Joint Invention relating to a Collaboration Compound that was invented (a) prior to GSK’s exercise of a GSK Program Option for such Collaboration Compound, then OncoMed shall be responsible, using patent counsel selected by OncoMed, for the preparation, filing, prosecution (including without limitation any interferences, reissue proceedings, cancellations, oppositions and reexaminations) and maintenance of such Joint Patent, or (b) after GSK’s exercise of a GSK Program Option for such Collaboration Compound, then GSK shall be responsible, using patent counsel selected by GSK, for the preparation, filing, prosecution (including without limitation any interferences, reissue proceedings, cancellations, oppositions and reexaminations) and maintenance of such Joint Patent (OncoMed or GSK, as applicable, the “Prosecuting Party” ). Any dispute with respect to such inventorship determination by the JPS shall be resolved in accordance with Section 2.4.3. The Prosecuting Party shall reasonably consult with the other Party, and shall consider any comments from the other Party in good faith, with respect to the preparation, filing, prosecution and maintenance of such Joint Patent. The Prosecuting Party shall provide to such other Party copies of any papers relating to the filing, prosecution or maintenance of such Joint Patent promptly upon their being filed or received. The other Party may, from time to time, identify in writing to the Prosecuting Party certain countries in which the non-Prosecuting Party desires that the Prosecuting Party file, prosecute and maintain Joint Patents and the Prosecuting Party shall, subject to Section 11.2.4, thereafter file, prosecute and maintain such Joint Patents in such country or countries. The Prosecuting Party shall not knowingly take any action during prosecution and maintenance of such Joint Patent that would materially adversely affect them (including any reduction in claim scope), without consultation with such other Party. The Parties shall share equally all reasonable costs and expenses related to the preparation, filing, prosecution and maintenance of any Joint Patents.

11.2.3 GSK Patents. GSK shall be responsible, at its own cost and expense, using patent counsel selected by GSK, for the preparation, filing, prosecution (including without limitation any interferences, reissue proceedings, cancellations, oppositions and reexaminations) and maintenance of Patents Controlled by GSK which cover an OncoMed Development Compound and which are licensed to OncoMed under Section 5.5. After a Collaboration Compound becomes an OncoMed Development Compound, GSK shall reasonably consult with OncoMed, through the JPS, and shall consider any OncoMed comments in good faith, with respect to the preparation, filing, prosecution and maintenance of any such Patents. GSK shall provide to OncoMed copies of any papers relating to the filing, prosecution or maintenance of such Patents promptly upon their being filed or received. GSK shall not knowingly take any action during prosecution and maintenance of such Patents that would materially adversely affect such Patents (including any reduction in claim scope), without consultation with OncoMed. In the event GSK decides not to file, prosecute or maintain certain Patents Controlled by GSK and covering any OncoMed Development Compound, OncoMed shall have the option to take up or progress any such filing, prosecution or maintenance of such Patents, at OncoMed’s own cost and expense, to the extent they claim or cover an OncoMed

 

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Development Compound. This shall not be construed as any assignment of any Patent Controlled by GSK to OncoMed.

11.2.4 Patent Abandonment. In no event will either Party permit [***] to be abandoned in any country in the Territory, or elect not to file a new Patent application claiming priority to a Patent application within [***] either [***], without the other Party first being given an opportunity to assume full responsibility for the continued prosecution and maintenance of such Patents, or the filing of such new Patent application. Each Party shall provide the other Party with notice of the allowance and expected issuance date of any Patent within such Patents, and any of the aforementioned filing deadlines, and such Party shall provide such other Party with prompt notice as to whether it desires to file such new Patent application. In the event that a Party responsible for the filing, prosecution and maintenance of Patents under Section 11.2.1, 11.2.2, or 11.2.3 (the “Filing Party” ) decides either (a) not to continue the prosecution or maintenance of a Patent application or Patent in any country or (b) not to file a new Patent application requested to be filed by the other Party (the “Non-Filing Party” ), the Filing Party shall provide the Non-Filing Party with notice of this decision at least [***] prior to any pending lapse or abandonment thereof. In such event, the Filing Party shall provide the Non-Filing Party with an opportunity to assume responsibility, at the Non-Filing Party’s own cost and expense of the filing and/or further prosecution and maintenance of such Patents or Patent applications and any Patent issuing thereon; provided that any and all prosecution activities by the Non-Filing Party will require the Filing Party’s review and prior written consent, which consent shall not be unreasonably withheld, delayed or conditioned. In the event that the Non-Filing Party assumes such responsibility for such filing, prosecution and maintenance costs, the Non-Filing Party shall have the right to transfer the responsibility for such filing, prosecution and maintenance of such Patent applications and Patents to patent counsel selected by the Non-Filing Party and reasonably acceptable to the Filing Party. Such Patent applications and Patents shall otherwise continue to be subject to all of the terms and conditions of the Agreement in the same manner and to the same extent as the other such Patents.

11.3 Enforcement of OncoMed Licensed Patents Against Infringers.

11.3.1 Enforcement.

(a) In the event that OncoMed or GSK become aware of a suspected infringement of any OncoMed Licensed Patent or any OncoMed Licensed Patent is challenged in any action or proceeding (other than any oppositions, cancellations, interferences, reissue proceedings or reexaminations, which are addressed above), such Party shall notify the other Party promptly.

(b) With respect to actions relating to any OncoMed Licensed Patent prior to the exercise by GSK of the GSK Program Option, OncoMed will have the first right, but not an obligation, to bring any action or proceeding anywhere in the Territory, at its own expense, in its own name and entirely under its own direction and control. GSK shall reasonably assist OncoMed, at OncoMed’s expense with respect to external costs, in any such action or proceeding if so requested, and GSK shall have the right to participate and be represented in any such suit by GSK’s own counsel at its own expense. No settlement of any such action or proceeding which restricts or adversely affects the scope of the license granted by

 

[***] Certain information in this document 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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OncoMed to GSK under the terms of this Agreement will be entered into by OncoMed without the prior written consent of GSK, which consent shall not be unreasonably withheld, delayed or conditioned. OncoMed will have an obligation to consult with GSK and will take any GSK comments into good faith consideration with respect to the infringement, claim construction, or defense of the validity or enforceability of any claim in an OncoMed Licensed Patent. OncoMed shall provide to GSK copies of any papers relating to the infringement and/or validity litigation of the involved OncoMed Licensed Patents promptly upon their being filed or received.

(c) With respect to actions relating to any OncoMed Licensed Patent that covers a GSK Development Compound or a Product containing such GSK Development Compound, as soon as possible after notification of such suspected infringement or challenge, the Parties will meet and confer, through the JPS, regarding litigation strategy, choice of and use of outside counsel. All decisions relating to such action or proceeding will be agreed by the Parties through the JPS, in accordance with Section 2.4.3. [***].

(d) With respect to any action relating to any OncoMed Licensed Patent that covers a GSK Development Compound or a Product containing such GSK Development Compound, if OncoMed elects not to be involved in any action or proceeding as described in Section 11.3.1(c), then GSK may bring such action or proceeding at its sole expense, in its own name and entirely under its own direction and control, subject to the following. OncoMed will reasonably assist GSK (at GSK’s expense with respect to external costs) in any such action or proceeding if so requested, and will lend its name to such actions or proceedings if requested by GSK or required by Laws. No settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of an OncoMed Licensed Patent shall be entered into by GSK without the prior written consent of OncoMed, which consent shall not be unreasonably withheld, delayed or conditioned. GSK shall not knowingly take any action during such litigation of the OncoMed Licensed Patents that would materially adversely affect any such OncoMed Licensed Patent, without the prior written consent of OncoMed, which consent shall not be unreasonably withheld, delayed or conditioned.

(e) To the extent applicable, for infringement actions similar to those contemplated under 35 U.S.C. Section 271(e)(2) where GSK has exercised a GSK Program Option under Section 4.1 and where GSK is the holder of the applicable BLA or MAA, GSK has the sole right to initiate legal action or proceedings to enforce, at its sole expense, all OncoMed Licensed Patents licensed to GSK pursuant to Section 5.1, against infringement or misappropriation by Third Parties or defend any declaratory judgment action relating thereto. Such activities shall be at the sole expense of GSK. No settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of an OncoMed Licensed Patent may be entered into by GSK without the prior written consent of OncoMed, which consent shall not be unreasonably withheld, delayed or conditioned. GSK will have the obligation to consult with OncoMed and will take any OncoMed comments into good faith consideration with respect to the infringement, claim construction, or defense of the validity or enforceability of any claim in an OncoMed Licensed Patent. GSK will provide to OncoMed copies of any papers relating to the infringement and/or validity litigation of the involved OncoMed Licensed Patents promptly upon the filing or receipt of such papers. GSK will not

 

[***] Certain information in this document 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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knowingly take any action during such litigation of the OncoMed Licensed Patents that would materially adversely affect them, without consultation with OncoMed.

11.3.2 Withdrawal. If either Party brings an action or proceeding under this Section 11.3 and subsequently ceases to pursue or withdraws from such action or proceeding, it shall promptly notify the other Party and the other Party may substitute itself for the withdrawing Party under the terms of this Section 11.3.

11.3.3 Damages. In the event that either Party exercises the rights conferred in this Section 11.3 and recovers any damages or other sums in such action, suit or proceeding or in settlement thereof, such damages or other sums recovered shall first be applied to all out-of-pocket costs and expenses incurred by the Parties in connection therewith, including without limitation attorneys’ fees. If such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be shared in proportion to the total of such costs and expenses incurred by each Party. If after such reimbursement any funds shall remain from such damages or other sums recovered, such funds shall be distributed between the Parties as if such funds were Net Sales subject to Section 8.3.

11.4 Patent Term Extension. OncoMed and GSK shall each cooperate with one another and shall use Commercially Reasonable Efforts in obtaining patent term extension or supplemental protection certificates or their equivalents in any country with respect to Patents covering the Products, as applicable. If elections with respect to obtaining such patent term extensions are to be made, GSK shall have the right to make the election to seek patent term extension or supplemental protection, provided that such election will be made so as to maximize the period of marketing exclusivity for the Product, if available. For such purpose, for all Regulatory Approvals GSK shall provide OncoMed with written notice of any expected Regulatory Approval at least [***] prior to the expected date of Regulatory Approval, as well as notice within [***] of receiving each Regulatory Approval confirming the date of such Regulatory Approval.

11.5 Enforcement of GSK Patents.

11.5.1 In the event that OncoMed or GSK become aware of a suspected infringement of any Patent Controlled by GSK and covering a Collaboration Compound or any such Patent is challenged in any action or proceeding (other than any oppositions, cancellations, interferences, reissue proceedings or reexaminations, which are addressed above), such Party shall notify the other Party promptly.

11.5.2 With respect to actions relating to any Patents Controlled by GSK and covering an OncoMed Development Compound or a Product containing an OncoMed Development Compound where such Patents are licensed to OncoMed under Section 5.5, GSK will have the first right, but not an obligation, to bring any action or proceeding anywhere in the Territory, at its own expense, in its own name and entirely under its own direction and control. OncoMed shall reasonably assist GSK, at GSK’s expense with respect to external costs, in any such action or proceeding if so requested, and OncoMed shall have the right to participate and be represented in any such suit by OncoMed’s own counsel at its own expense. No settlement of any such action or proceeding which restricts or adversely affects the scope of any licenses

 

[***] Certain information in this document 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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granted by GSK to OncoMed under the terms of this Agreement will be entered into by GSK without the prior written consent of OncoMed, which consent shall not be unreasonably withheld, delayed or conditioned. GSK will have an obligation to consult with OncoMed and will take any OncoMed comments into good faith consideration with respect to the infringement, claim construction, or defense of the validity or enforceability of any claim in any such Patent. GSK shall provide to OncoMed copies of any papers relating to the infringement and/or validity litigation of the involved Patents promptly upon their being filed or received.

11.6 Regulatory Data Protection. To the extent required by or permitted by Law, each Party will use commercially reasonable efforts to promptly, accurately and completely list, with the applicable Regulatory Authorities during the Term, all applicable Patents for any Collaboration Compound or Product that such Party intends to, or has begun to Commercialize, and that have become the subject of a marketing application submitted to the relevant Regulatory Authority. Prior to such listings, the Parties will meet to evaluate and identify all applicable Patents. Notwithstanding the preceding sentence, the Party responsible for marketing the applicable Collaboration Compound or Product will retain final decision-making authority as to the listing of all applicable Patents for such Collaboration Compound or Product, regardless of which Party owns such Patents.

11.7 Defense Against Claims of Infringement of Third Party Patents. If a Third Party asserts that a Patent or other right owned by it is or has been infringed by the manufacture, use, sale, offer for sale, or import of a Collaboration Compound or Product in the Territory, the Party first obtaining knowledge of such a claim shall immediately provide the other Party notice of such claim through the JPS along with the related facts in reasonable detail. In such event, unless the Parties otherwise agree, the Party being sued may, in its absolute discretion and at its own cost and expense, choose to respond to and/or defend, such suit. The other Party shall cooperate with the Party being sued, at such Party’s reasonable request and expense, and shall have the right to be represented separately by counsel of its own choice. The Party being sued shall also control settlement of such claim; provided, however, that no settlement shall be entered into without the prior consent of the other Party if such settlement would adversely affect the rights and benefits of, or impose or adversely affect any obligations on, such other Party.

11.8 Third Party Licenses.

11.8.1 If either Party reasonably determines that (a) any licenses existing as of the Effective Date to any Third Party intellectual property rights, or (b) on or after the Effective Date, certain Third Party intellectual property rights, are necessary for (i) the Development or Commercialization of a Product, where such Third Party intellectual property rights are necessary for use of any Collaboration Compound in connection with the relevant Collaboration Target for the indications designated pursuant to Section 3.6.2, or for any license that may be required for the use or exploitation of Licensed Intellectual Property as contemplated under this Agreement for the Research, manufacture, or use of Collaboration Compounds and Products, or (ii) to manufacture or commercialize any Product, then such Party will notify the JSC.

 

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11.8.2 If the JSC determines that it needs to obtain one or more licenses from one or more Third Parties for such Development and/or Commercialization, the JSC will determine which Party will negotiate the most favorable license. The chosen Party shall obtain a license to such Third Party intellectual property, with the right to sublicense, in order to permit both Parties to conduct their obligations under the Agreement. Subject to the foregoing, the terms and conditions involved in obtaining such rights shall be determined at such chosen Party’s sole discretion. If such chosen Party is unsuccessful in obtaining such rights, then the other Party shall have the right (but not the obligation) to negotiate and obtain rights from such Third Party at its sole discretion and expense.

11.8.3 OncoMed shall [***]. With respect to any Third Party license necessary for the Commercialization of a Product (other than any license described in the foregoing sentence), including without limitation under any Third Party license under Patents set forth in Exhibit 11.8.3(b), to the extent such Patents relate to Collaboration Compounds, Candidate Selection Compound, GSK Development Compounds, and/or Products, [***] for any such license(s) required from a Third Party, including, for example, any license for rights to the composition of matter of, a method of treatment using, the manufacture of, or formulation of, a Collaboration Compound or Product.

12. N ONDISCLOSURE OF C ONFIDENTIAL I NFORMATION

12.1 Nondisclosure. Each Party agrees that, during the Term and for a period of ten (10) years thereafter, a Party (the “Receiving Party” ) receiving Confidential Information of the other Party (the “Disclosing Party” ) (or that has received any such Confidential Information from the Disclosing Party prior to the Effective Date) shall (a) maintain in confidence such Confidential Information using reasonable efforts, but not less than the efforts such Receiving Party uses to maintain in confidence its own proprietary industrial information of similar kind and value, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted below, and (c) not use such Confidential Information for any purpose except those permitted by this Agreement (it being understood that this clause (c) shall not create or imply any rights or licenses not expressly granted under this Agreement).

12.2 Exceptions. The obligations in Section 12.1 shall not apply with respect to any portion of the Confidential Information that the Receiving Party can show by competent proof:

12.2.1 is publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party hereunder;

12.2.2 was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party;

12.2.3 is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use; or

[***] Certain information in this document 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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12.2.4 is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party.

12.3 Authorized Disclosure. The Receiving Party may disclose Confidential Information belonging to the Disclosing Party to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:

12.3.1 filing or prosecuting patents;

12.3.2 submitting Regulatory Filings and obtaining Regulatory Approvals;

12.3.3 prosecuting or defending litigation, including without limitation responding to a subpoena in a Third Party litigation;

12.3.4 subject to Section 12.5, complying with Laws (including without limitation the rules and regulations of the Securities and Exchange Commission or any national securities exchange) and with judicial process, if in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance; and

12.3.5 disclosure, solely on a “need to know basis”, to Affiliates, potential and future collaborators (including Sublicensees), potential or actual acquirers, merger partners, or assignees permitted under Section 16.5, potential or actual Research and Development collaborators, subcontractors, investment bankers, investors, lenders, or other potential financial partners, and their and each of the Parties’ respective directors, employees, contractors and agents, each of whom prior to disclosure must be bound by obligations of confidentiality and non-use no less restrictive than the obligations set forth in this Article 12; provided, however, that, in each of the above situations, the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information pursuant to this Section 12.3.5 to treat such Confidential Information as required under this Article 12.

If and whenever any Confidential Information is disclosed in accordance with this Section 12.3, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (otherwise than by breach of this Agreement). Where reasonably possible and subject to Section 12.5 and other than pursuant to Section 12.3.5, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make such disclosure pursuant to this Section 12.3 sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information.

12.4 Terms of this Agreement. The Parties acknowledge that this Agreement, the Series B-2 Preferred Stock Purchase Agreement and all of the respective terms of this Agreement and the Series B-2 Preferred Stock Purchase Agreement shall be treated as Confidential Information of both Parties.

12.5 Securities Filings. In the event either Party proposes to file with the Securities and Exchange Commission or the securities regulators of any state or other

 

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jurisdiction a registration statement or any other disclosure document which describes or refers to the terms and conditions of this Agreement or the Series B-2 Preferred Stock Purchase Agreement under the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any other applicable securities Law, the Party shall notify the other Party of such intention and shall provide such other Party with a copy of relevant portions of the proposed filing not less than [***] prior to such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), including without limitation any exhibits thereto relating to the terms and conditions of this Agreement, and shall use reasonable efforts to obtain confidential treatment of the terms and conditions of this Agreement and the Series B-2 Preferred Stock Purchase Agreement that such other Party requests be kept confidential, and shall only disclose Confidential Information that it is advised by counsel is legally required to be disclosed or required to be disclosed. No such notice shall be required under this Section 12.5 if the description of or reference to this Agreement contained in the proposed filing has been included in any previous filing made by the either Party hereunder or otherwise approved by the other Party.

12.6 Relationship to Confidentiality Agreement. This Agreement supersedes the Confidential Disclosure Agreement between the Parties executed February 27, 2007 and the Confidential Disclosure Agreement between the Parties executed May 25, 2007, as amended, provided that all “Confidential Information” disclosed or received by the Parties thereunder shall be deemed “Confidential Information” hereunder and shall be subject to the terms and conditions of this Agreement.

12.7 Publications.

12.7.1 Publication by GSK. After exercise of a GSK Program Option, GSK may publish or present data and/or results relating to a GSK Development Compound or Product in scientific journals and/or at scientific conferences, subject to the prior review and comment by OncoMed as follows. GSK shall provide OncoMed with the opportunity to review any such proposed abstract, manuscript or presentation by delivering a copy thereof to OncoMed no less than [***] before its intended submission for publication or presentation. OncoMed shall have [***] after its receipt of any such abstract, manuscript or presentation in which to notify GSK in writing of any specific objections to the disclosure of Confidential Information of OncoMed (including without limitation OncoMed Licensed Know-How). In the event OncoMed objects to the disclosure in writing within such [***] period, GSK agrees not to submit the publication or abstract or make the presentation containing the objected-to information until the Parties have agreed to the content of the proposed disclosure, and GSK shall delete from the proposed disclosure any OncoMed Confidential Information upon the reasonable request by OncoMed. Once any such abstract or manuscript is accepted for publication, GSK will provide OncoMed with a copy of the final version of the manuscript or abstract.

12.7.2 Publication by OncoMed. OncoMed may publish or present data and/or results relating to a Collaboration Compound, Product or the activities conducted under this Agreement in scientific journals and/or at scientific conferences, subject to the prior review and comment by GSK as follows. OncoMed shall provide GSK with the opportunity to review any such proposed abstract, manuscript or presentation by delivering a copy thereof to GSK no less than [***] before its intended submission for publication or presentation. GSK

 

[***] Certain information in this document 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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shall have [***] after its receipt of any such abstract, manuscript or presentation in which to notify OncoMed in writing of any specific objections to the disclosure of Confidential Information of GSK. In the event GSK objects to the disclosure in writing within such [***] period, OncoMed agrees not to submit the publication or abstract or make the presentation containing the objected-to information until the Parties have agreed to the content of the proposed disclosure, and OncoMed shall delete from the proposed disclosure any GSK Confidential Information upon the reasonable request of GSK. Once any such abstract or manuscript is accepted for publication, OncoMed will provide GSK with a copy of the final version of the manuscript or abstract. The Parties acknowledge that publications relating to Collaboration Compounds submitted for publication by OncoMed prior to the Effective Date shall not be subject to the above review procedure.

12.7.3 Publication of Clinical Trial Results. GSK will have the right to publish summaries of results of all Clinical Trials conducted by GSK with respect to a Product or Combination Product incorporating a GSK Development Compound on GSK’s Clinical Trial register; provided, however, that GSK will use reasonable effort to provide such summaries to OncoMed at least [***] prior to publishing such summaries for the purposes of preparing any necessary Patent filings. It is understood that the Parties will collaborate to ensure that the data is reviewed to ensure adequate patent protection is obtained in advance of publication of such data.

12.8 Publicity. Upon execution of this Agreement, the Parties shall issue the press release announcing the existence of this Agreement in the form and substance as set forth in Exhibit 12.8. Each Party agrees not to issue any other press release or other public statement disclosing other information relating to this Agreement or the transactions contemplated hereby without the prior written consent of the other Party, except that OncoMed may disclose such financial information, including without limitation the total upfront payment under Sections 8.1.1 and 8.1.2, as deemed necessary by OncoMed for presentation at professional conferences, symposia and other similar meetings (including without limitation one-on-one sessions) where the audience is primarily investors; provided that OncoMed does not disclose the breakdown of the upfront payment under Sections 8.1.1 and 8.1.2 nor the premium on the equity purchase, except that OncoMed shall be permitted to disclose such information in discrete meetings with potential investors. Notwithstanding the foregoing, any disclosure that is required by Laws (including without limitation the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended), or the rules of a securities exchange or the Securities and Exchange Commission or the securities regulations of any state or other jurisdiction, as reasonably advised by the disclosing Party’s counsel, may be made; provided, however, that any such required disclosure will not contain confidential business or technical information, including without limitation Confidential Information, and, if disclosure of such information is required by Laws or such rules or regulations, the Parties will use appropriate diligent efforts to minimize such disclosure and obtain confidential treatment for any such information that is disclosed to a governmental agency. Each Party agrees to provide to the other Party a copy of any public announcement regarding this Agreement or the subject matter thereof as soon as reasonably practicable under the circumstances prior to its scheduled release. Except under extraordinary circumstances, each Party shall provide the other with an advance copy of any such announcement at least [***] prior to its scheduled release. Each Party shall have the right

 

[***] Certain information in this document 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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to expeditiously review and recommend changes to any such announcement and, except as otherwise required by Laws or such rules or regulations, the Party whose announcement has been reviewed shall remove any Confidential Information of the reviewing Party that the reviewing Party reasonably deems to be inappropriate for disclosure. The contents of any announcement or similar publicity that has been reviewed and approved by the reviewing Party (including without limitation the press release set forth in Exhibit 12.8) can be re-released by either Party without a requirement for re-approval. Nothing in this Section 12.8 shall be construed to prohibit GSK, OncoMed or their respective Affiliates or Sublicensees from making a public announcement or disclosure to their respective actual or potential partners, investors, bankers, or acquirers or a public announcement or disclosure regarding the stage of Development of Collaboration Compounds, GSK Development Compounds and Products or disclosing Clinical Trial results with respect thereto, as may be required by Laws or such rules or regulations, as reasonably advised by GSK’s (or its Affiliates’ or Sublicensees’) or OncoMed’s (or its Affiliates’ or Sublicensees’) counsel.

13. I NDEMNITY AND I NSURANCE

13.1 GSK Indemnity. GSK shall indemnify, defend and hold harmless OncoMed and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives (the “OncoMed Indemnitees” ), from and against any and all claims, threatened claims, damages, losses, suits, proceedings, liabilities, costs (including without limitation reasonable legal expenses, costs of litigation and reasonable attorney’s fees) or judgments, whether for money or equitable relief, of any kind ( “Losses and Claims” ), to the extent arising out of or relating to, directly or indirectly: (a) the negligence, recklessness or wrongful intentional acts or omissions of GSK, its Affiliates, and/or its Sublicensees and its or their respective directors, officers, employees and agents, in connection with GSK’s performance of its obligations or exercise of its rights under this Agreement; (b) any breach by GSK of any representation, warranty, or covenant set forth in Article 10; and (c) the Research, Development, Commercialization (including without limitation promotion, advertising, offering for sale, sale or other disposition), transfer, importation or exportation, manufacture, labeling, handling or storage, or use of, or exposure to, any Collaboration Compounds or Product actually conducted by or for GSK or any of its Affiliates, Sublicensees, agents and contractors (and excluding any Development or Commercialization activities carried out by and/or on behalf of OncoMed hereunder), including without limitation for each of clauses (a), (b) and (c), above, claims and threatened claims based on (i) product liability, bodily injury, risk of bodily injury, death or property damage or (ii) the failure to comply with Law; except in any such case for Losses and Claims to the extent reasonably attributable to any OncoMed Indemnitee having committed an act or acts of gross negligence, recklessness or willful misconduct.

13.2 OncoMed Indemnity. OncoMed shall indemnify, defend and hold harmless GSK and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives (the “GSK Indemnitees” ), from and against any and all Losses and Claims, to the extent arising out of or relating to, directly or indirectly: (a) the negligence, recklessness or wrongful intentional acts or omissions of OncoMed, its Affiliates, and/or its Sublicensees and its or their respective directors,

 

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officers, employees and agents, in connection with OncoMed’s performance of its obligations or exercise of its rights under this Agreement; (b) any breach by OncoMed of any representation, warranty, or covenant set forth in Article 10; (c) the Research, Development, Commercialization (including without limitation promotion, advertising, offering for sale, sale or other disposition), transfer, importation or exportation, manufacture, labeling, handling or storage, or use of, or exposure to, any Collaboration Compound or OncoMed Development Compound actually conducted by or for OncoMed or any of its Affiliates, Sublicensees, agents and contractors (and excluding any Development or Commercialization activities carried out by and/or on behalf of GSK hereunder), including without limitation for each of clauses (a), (b) and (c), above, claims and threatened claims based on (i) product liability, bodily injury, risk of bodily injury, death or property damage and (ii) the failure to comply with Law; and (d) any Loss or Claim by a Third Party alleging that OncoMed’s general (that is, not specific to a Product) exploitation of OncoMed’s proprietary platform technology as would be or is actually used pursuant to any Program hereunder does or would infringe or misappropriate the intellectual property rights of any Third Party; except in any such case for Losses and Claims to the extent reasonably attributable to any GSK Indemnitee having committed an act or acts of gross negligence, recklessness or willful misconduct.

13.3 Indemnification Procedure. A claim to which indemnification applies under Section 13.1 or Section 13.2 shall be referred to herein as an “ Indemnification Claim ”. If any Person or Persons (collectively, the “Indemnitee” ) intends to claim indemnification under this Article 13, the Indemnitee shall notify the other Party (the “Indemnitor” ) in writing promptly upon becoming aware of any claim that may be an Indemnification Claim (it being understood and agreed, however, that the failure by an Indemnitee to give such notice shall not relieve the Indemnitor of its indemnification obligation under this Agreement except and only to the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice). The Indemnitor shall have the right to assume and control the defense of the Indemnification Claim at its own expense with counsel selected by the Indemnitor and reasonably acceptable to the Indemnitee; provided, however, that an Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitee, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party represented by such counsel in such proceedings. If the Indemnitor does not assume the defense of the Indemnification Claim as described in this Section 13.3, above, the Indemnitee may defend the Indemnification Claim but shall have no obligation to do so. The Indemnitee shall not settle or compromise the Indemnification Claim without the prior written consent of the Indemnitor, and the Indemnitor shall not settle or compromise the Indemnification Claim in any manner which would have an adverse effect on the Indemnitee’s interests (including without limitation any rights under this Agreement or the scope or enforceability of the OncoMed Licensed Patents Rights or OncoMed Licensed Know-How, or Confidential Information or Patent or other rights licensed to OncoMed by GSK hereunder), without the prior written consent of the Indemnitee, which consent, in each case, shall not be unreasonably withheld, delayed or conditioned. The Indemnitee shall reasonably cooperate with the Indemnitor at the Indemnitor’s expense and shall make available to the Indemnitor all pertinent information under the control of the Indemnitee, which information shall be subject to Article 12.

 

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13.4 Insurance.

13.4.1 By GSK. GSK hereby represents and warrants to OncoMed that it is self-insured against liability and other risks associated with its activities and obligations under this Agreement for the activities to be conducted by it under this Agreement.

13.4.2 By OncoMed . OncoMed shall, beginning with the initiation of the first Clinical Trial for a Collaboration Compound, maintain at all times thereafter during the Term, and until the later of (a) three (3) years after termination or expiration of the Agreement or (b) the date that all statutes of limitation covering claims or suits that may be brought for personal injury based on the sale or use of a Collaboration Compound by OncoMed have expired in all states in the United States, commercial general liability insurance from a recognized, creditworthy insurance company, on an “occurrence basis” which includes contractual liability coverage and product liability, on a “claims-made basis” with coverage limits of at least [***] per claim and annual aggregate, and is increased to at least [***] before OncoMed initiates the First Commercial Sale of any Product hereunder. The minimum level of insurance set forth herein shall not be construed to create a limit on OncoMed’s liability hereunder. Within [***] days following written request from GSK, OncoMed shall furnish to GSK a certificate of insurance evidencing such coverage as of the date. In the case of a modification or cancellation of such coverage, OncoMed shall promptly provide GSK with a new certificate of insurance evidencing that OncoMed’s coverage meets the requirements of this Section 13.4.2.

14. T ERM AND T ERMINATION

14.1 Term; Expiration. This Agreement shall become effective as of the Effective Date and shall continue in force and effect until expiration as described in this Section 14.1, unless earlier terminated pursuant to Section 14.2, 14.3, 14.4, or 14.5, and shall expire as follows:

14.1.1 on a Product-by-Product and country-by-country basis, on the date of expiration of all payment obligations of both GSK and OncoMed under this Agreement with respect to each Product in each country, as applicable; and

14.1.2 in its entirety upon the expiration of all payment obligations under this Agreement with respect to the last Product Commercialized in the last country in the Territory; or

14.1.3 at any time at which no Collaboration Compound is being Researched, Developed and/or Commercialized.

The period beginning on the Effective Date and ending on expiration or termination of this Agreement, or as the case may be, until the date of expiration or termination of a Program, shall be the “ Term ” of this Agreement in its entirety or with respect to a given Product or Program, as applicable.

 

[***] Certain information in this document 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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14.2 Termination for Cause.

14.2.1 Material Breach. Either Party (the “Non-breaching Party” ) may, without prejudice to any other remedies available to it at law or in equity, terminate this Agreement in its entirety (except as provided below), or terminate the Program that is affected by a material breach, as it shall determine in its sole discretion, in the event the other Party (the “Breaching Party” ) has materially breached this Agreement, and such breach has continued for sixty (60) days (the “Cure Period” ) after written notice thereof is provided to the Breaching Party by the Non-breaching Party, such notice describing the alleged material breach in sufficient detail to put the Breaching Party on notice. For clarity, in the event a Party materially breaches this Agreement by failing to use Commercially Reasonable Efforts with respect to a Program hereunder, the other Party’s sole remedy shall be to terminate such Program after the Cure Period.

14.2.2 Disagreement as to Material Breach; Cure Period. If the Parties reasonably and in good faith disagree as to whether there has been a material breach, the Party that disputes that there has been a material breach may contest the allegation in accordance with Section 15.3. Notwithstanding the preceding sentence, the Cure Period for any allegation made in good faith as to a material breach under this Agreement will run from the date that written notice was first provided to the Breaching Party by the Non-Breaching Party. Any such termination of the Agreement under this Section 14.2 shall become effective at the end of the Cure Period, unless the Breaching Party has cured any such breach or default prior to the expiration of such Cure Period, or, if such breach is not susceptible to cure within the Cure Period, then, the Non-Breaching Party’s right to termination shall be suspended only if and for so long as the Breaching Party has provided to the Non-Breaching Party a written plan that is reasonably calculated to effect a cure and such plan is acceptable to the Non-Breaching Party, or in the event of arbitration, such plan is acceptable to the arbitrator(s), and the Breaching Party commits to and does carry out such plan as provided to the Non-Breaching Party. The right of either Party to terminate this Agreement, or a Program, as provided in this Section 14.2, shall not be affected in any way by such Party’s waiver or failure to take action with respect to any previous default. During the pendency of such a Dispute, all of the terms and conditions of this Agreement shall remain in effect, and the Parties shall continue to perform all of their respective obligations under this Agreement. Any payments that are made by one Party to the other Party pursuant to this Agreement pending resolution of such Dispute shall be promptly refunded if the arbitrator determines pursuant to Section 15.3 that such payments are to be refunded by one Party to the other Party.

14.3 GSK Unilateral Termination Rights.

14.3.1 Termination of Agreement in Its Entirety. GSK may, in its sole discretion, exercisable at any time during the Term, terminate this Agreement in its entirety for any reason or no reason at all, upon one hundred and twenty (120) days written notice to OncoMed.

14.3.2 Termination on a Program-by-Program Basis. GSK may, in its sole discretion, exercisable at any time during the Term, terminate this Agreement on a Program-by-Program basis for any reason or no reason at all, effective upon ninety (90) days

 

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written notice to OncoMed. The Agreement shall continue in full force as to all other Programs, notwithstanding such termination; provided that, if no Collaboration Compound that has met Lead Generation Criteria for at least one (1) Program is being Researched, Developed and/or Commercialized as of the effective date of such termination, this Agreement shall be terminated in its entirety.

14.4 Termination for Insolvency. Either Party may terminate this Agreement, if, at any time, the other Party files in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Party or of substantially all of its assets, or if the other Party is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within one hundred and eighty (180) days after the filing thereof, or if the other Party shall propose or be a party to any dissolution or liquidation, or if the other Party shall make an assignment of substantially all of its assets for the benefit of creditors. All rights and licenses granted under or pursuant to any section of this Agreement are and shall otherwise be deemed to be for purposes of Section 365(n) of Title 11, United States Code (the “Bankruptcy Code” ) licenses of rights to “intellectual property” as defined in Section 101 (56) of the Bankruptcy Code. The Parties shall retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code. Upon the bankruptcy of any Party, the non-bankrupt Party shall further be entitled to a complete duplicate of, or complete access to, any such intellectual property, and such, if not already in its possession, shall be promptly delivered to the non-bankrupt Party, unless the bankrupt Party elects to continue, and continues, to perform all of its obligations under this Agreement.

14.5 Termination for Patent Challenge. OncoMed shall have the right to terminate this Agreement immediately upon written notice if GSK challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the OncoMed Licensed Patents. If a Sublicensee of GSK challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the OncoMed Licensed Patents under which such Sublicensee is sublicensed, then GSK shall, upon written notice from OncoMed, terminate such Sublicense. Each Party shall include provisions in all agreements under which a Third Party obtains a license under any Patent included in the OncoMed Licensed Patents providing that if the Sublicensee challenges the validity or enforceability of or otherwise opposes any such Patent under which the Sublicensee is sublicensed, the Party that granted such Sublicense may terminate such Sublicense.

14.6 Consequences of Expiration or Termination. All of the following effects of expiration or termination, as applicable, are in addition to the other rights and remedies that may be available to the Parties at law or in equity.

14.6.1 Consequences of Expiration of the Term. Upon expiration of the Term, as determined on a Product-by-Product and country-by-country basis, GSK shall have an exclusive, fully paid, royalty-free license, with the right to grant sublicenses, under all OncoMed Licensed Patents and OncoMed Licensed Know-How to make, use, sell, offer to sell and import the expired Product in the Field and in the Territory, for so long as GSK continues to do so, and GSK shall grant, and does hereby grant to OncoMed, effective upon expiration of the Term, as determined on a Product-by-Product and country-by-country basis, an exclusive, fully

 

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paid, royalty-free license, with the right to grant sublicenses, to make, use, sell, offer to sell and import the applicable OncoMed Development Compounds in the Field and in the Territory, for so long as OncoMed continues to do so.

14.6.2 Consequences of (1) Termination by GSK Without Cause or (2) Any Termination by OncoMed.

(a) Termination of Agreement. In the event of a unilateral termination of this Agreement in its entirety by GSK pursuant to Section 14.3.1 or a termination of this Agreement in its entirety by OncoMed pursuant to Section 14.2.1 (for material breach), Section 14.4 (insolvency), or Section 14.5 (for patent challenge):

(i) Any and all Collaboration Compounds (including without limitation rejected compounds as described in Section 3.4.3, GSK Development Compounds and Products) shall be deemed to be OncoMed Development Compound(s), and OncoMed will thereafter have all rights, itself or with a Third Party or through a Third Party Sublicensee, to Develop and Commercialize such OncoMed Development Compound(s) at OncoMed’s sole discretion;

(ii) GSK shall cease any and all Development and Commercialization activities with respect to any and all Collaboration Compounds (including without limitation rejected compounds as described in Section 3.4.3, GSK Development Compounds and Products), and GSK shall not be required to use Commercially Reasonable Efforts to progress any Collaboration Compounds under this Agreement as of the date of notice of such termination, except as set forth in Section 14.6.2(a)(vii);

(iii) Notwithstanding anything contained in this Agreement to the contrary, all rights (including without limitation all GSK Program Options) and licenses granted herein to GSK with respect to any and all Collaboration Compounds (including without limitation rejected compounds as described in Section 3.4.3, GSK Development Compounds and Products), shall terminate as of the effective date of such termination, except to the extent required for the conduct of activities, if any, under Section 14.6.2(a)(vii), and GSK shall have no right or license to practice the OncoMed Licensed Patents, to use OncoMed Licensed Know-How, to use any trademark(s) Controlled by OncoMed or the OncoMed Logo, or to use the OncoMed Confidential Information for any purpose;

(iv) GSK will grant, and hereby grants, the license set forth in Section 5.5;

(v) All payment obligations under this Agreement shall terminate, other than those that are accrued and unpaid as of the effective date of such termination and any payment obligations that survive such termination as expressly provided in Section 8.4;

(vi) The provisions in Article 7 shall terminate in their entirety;

 

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(vii) Notwithstanding anything to the contrary, in the event that such a termination occurs during and prior to the Completion of any Clinical Trial(s), GSK shall Complete such Clinical Trial(s) and [***] Clinical Trial(s) as if such a termination had not occurred; provided that GSK may prematurely suspend or terminate any such Clinical Trial(s) if (A) a priori protocol defined stopping rules are met for safety or efficacy or (B) unacceptable safety signals are observed by GSK or the Data and Safety Monitoring Board with respect to the Product or related Development compounds that present an unacceptable risk to patients participating in such Clinical Trial(s); and

(viii) GSK will provide OncoMed with any material information, materials and data for any and all Collaboration Compounds (including without limitation rejected compounds as described in Section 3.4.3, GSK Development Compounds and Products) and Programs and will cooperate with OncoMed to provide a smooth transfer of such material information, materials and data as soon as reasonably practical after GSK’s notice of such termination, and, upon Completion of any Clinical Trial(s) described in Section 14.6.2(a)(vii), GSK will provide OncoMed with any material information, materials and data for such compounds and Programs and will cooperate with OncoMed to provide a smooth transfer of such material information, materials and data as soon as reasonably practical.

(b) Termination of Program. In the event of a termination by: (1) GSK with respect to a Program pursuant to Section 14.3.2, or (2) OncoMed with respect to a Program pursuant to Section 14.2.1 (for material breach):

(i) Any and all Collaboration Compounds (including without limitation rejected compounds as described in Section 3.4.3, GSK Development Compounds and Products) pertaining to any such terminated Program shall be deemed OncoMed Development Compound(s), and OncoMed will thereafter have all rights, itself or with a Third Party or through a Third Party sublicensee, to Develop and Commercialize such OncoMed Development Compound(s) at OncoMed’s sole discretion;

(ii) GSK shall cease any and all Development and Commercialization activities with respect to any and all Collaboration Compounds (including without limitation rejected compounds as described in Section 3.4.3, GSK Development Compounds and Products) pertaining to any such terminated Program, and GSK shall not be required to use Commercially Reasonable Efforts to progress any Collaboration Compounds that are subject to such terminated Program as of the date of notice of such termination, except as set forth in this Section 14.6.2(b)(viii);

(iii) Notwithstanding anything contained herein to the contrary, all rights (including without limitation all GSK Program Options) and licenses granted herein to GSK with respect to any and all Collaboration Compounds (including without limitation rejected compounds as described in Section 3.4.3, GSK Development Compounds and Products) pertaining to any such terminated Program shall terminate as of the effective date of such termination, except to the extent required for the conduct of activities, if any, under Section 14.6.2(b)(viii), and GSK shall have no right or license to practice the OncoMed Licensed Patents, to use OncoMed Licensed Know-How, to use any trademark(s) Controlled by OncoMed

 

[***] Certain information in this document 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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or the OncoMed Logo, or to use the OncoMed Confidential Information for any purpose with respect to such terminated Program;

(iv) GSK will grant, and hereby grants, the license set forth in Section 5.5;

(v) All payment obligations under Article 8 shall terminate with respect to such terminated Program, GSK Development Compound or Product, other than those which are accrued and unpaid as of the effective date of termination and any payment obligations that survive such termination as expressly provided in Section 8.4;

(vi) The provisions of Article 7 with respect to the terminated Program shall terminate in their entirety; provided that the Collaboration Target in the terminated Program shall continue to be deemed an Active Target solely for purposes of Section 7.2.6 for a period of [***] after the effective date of termination of the terminated Program;

(vii) All rights and obligations under the terms of this Agreement (other than for such terminated Program) that are in effect as of the date of such termination shall remain in full force and effect, in accordance with their terms;

(viii) Notwithstanding anything to the contrary, in the event that such a termination occurs during and prior to the Completion of any Clinical Trial(s) being conducted by GSK, its Affiliates, or its Sublicensees, GSK shall Complete such Clinical Trial(s) and shall [***] as if such a termination had not occurred; provided that GSK may prematurely suspend or terminate any such Clinical Trial(s) if (A) a priori protocol defined stopping rules are met for safety or efficacy or (B) unacceptable safety signals are observed by GSK or the Data and Safety Monitoring Board with respect to the Product or related Development compounds that present an unacceptable risk to patients participating in such Clinical Trial(s); and

(ix) GSK will provide OncoMed with any material information, materials and data for any and all Collaboration Compounds (including without limitation rejected compounds as described in Section 3.4.3, GSK Development Compounds and Products) pertaining to any such terminated Program and will cooperate with OncoMed to provide a smooth transfer of such material information, materials and data as soon as reasonably practical after GSK’s notice of such termination, and, upon Completion of any Clinical Trial(s) described in Section 14.6.2(b)(viii), GSK will provide OncoMed with any material information, materials and data for such compounds and will cooperate with OncoMed to provide a smooth transfer of such material information, materials and data as soon as reasonably practical.

14.6.3 Consequences of Termination by GSK for Cause or Insolvency of OncoMed.

(a) Termination of Agreement. In the event of a termination of this Agreement in its entirety by GSK pursuant to Section 14.4 (insolvency) or Section 14.2.1 (for material breach):

 

[***] Certain information in this document 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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(i) GSK shall have the right to progress the Development and Commercialization of any Collaboration Compounds that have met the Lead Generation Criteria as of the effective date of such termination, and OncoMed will grant licenses to GSK in accordance with Section 5.1 as if GSK had exercised its GSK Program Option, and GSK shall use Commercially Reasonable Efforts to Develop and Commercialize a Product in the Territory under the licenses described in this Section 14.6.3(a)(i), or such licenses shall terminate;

(ii) All licenses granted to GSK prior to the effective date of such termination with respect to a Collaboration Target, a Collaboration Compound, and Products directed to such Collaboration Target shall continue in full force, in accordance with the terms and conditions of this Agreement;

(iii) GSK shall have no obligation to grant OncoMed the license set forth in Section 5.5;

(iv) OncoMed shall cease any and all Development and Commercialization activities with respect to any and all Collaboration Compounds (including without limitation rejected compounds as described in Section 3.4.3, GSK Development Compounds and Products) that have met the Lead Generation Criteria as of the effective date of such termination;

(v) In the case of termination pursuant to Section 14.2.1, GSK shall pay to OncoMed a [***] royalty on Net Sales by GSK, its Affiliates, and its Sublicensees of any Product incorporating a Collaboration Compound licensed to GSK under Section 14.6.3(a)(i) and (ii) that has met the Candidate Selection Criteria as of the effective date of termination of this Agreement. If this Agreement is terminated before a Collaboration Compound has been deemed a Candidate Selection Compound by the JSC, then the royalty to OncoMed will be reduced to a [***] royalty payable to OncoMed on Net Sales by GSK, its Affiliates, and its Sublicensees. GSK’s obligation to pay the royalty in this Section on Net Sales of Products incorporating any such Collaboration Compound will continue until, and end on expiration of the [***] that covers [***], and all other payment obligations hereunder shall terminate except those that are accrued and unpaid as of the effective date of such termination;

(vi) In the case of termination pursuant to Section 14.4:

(A) GSK shall pay to OncoMed a [***] royalty on Net Sales by GSK, its Affiliates, and its Sublicensees of any Product incorporating a Collaboration Compound licensed to GSK under Section 14.6.3(a)(i) and/or (ii) that has met the Candidate Selection Criteria as of the effective date of termination of this Agreement and on the date of First Commercial Sale is covered by a [***] that covers [***] or

(B) GSK shall pay to OncoMed a [***] royalty on Net Sales by GSK, its Affiliates, and its Sublicensees of any Product incorporating a Collaboration Compound licensed to GSK under Section 14.6.3(a)(i) and/or (ii) that has met the Candidate Selection Criteria as of the effective date of termination of this Agreement and on the date of First Commercial Sale is not covered by a [***] that covers [***]; or

 

[***] Certain information in this document 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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(C) GSK shall pay to OncoMed a [***] royalty on Net Sales by GSK, its Affiliates, and its Sublicensees of any Product incorporating a Collaboration Compound licensed to GSK under Section 14.6.3(a)(i) and/or (ii), if this Agreement is terminated before a Collaboration Compound has been deemed a Candidate Selection Compound by the JSC, whether or not such Collaboration Compound is [***] that covers [***]; provided that no royalty shall be payable to OncoMed on Net Sales of any Collaboration Compound that originated from GSK pursuant to Section 7.1.3 that has not met Candidate Selection Criteria; and

(D) GSK’s obligation to pay the royalty in this Section 14.6.3(a)(vi) on Net Sales of Products incorporating any such Collaboration Compound will continue until, and end on the date upon which (1) a Third Party’s product or Third Parties’ products [***] enters the market in a given country (so long as such Third Party’s product or Third Parties’ products were [***]), and (2) such Third Party’s product or Third Parties’ products account for [***] or more of aggregate unit sales of such Product plus such Third Party’s product or Third Parties’ products in the given country during any Calendar Year, and all other payment obligations hereunder shall terminate except those that are accrued and unpaid as of the effective date of termination.

(vii) The provisions of Article 7 applicable to GSK shall terminate in their entirety, but the provisions of Article 7 applicable to OncoMed shall continue in full force and effect; and

(viii) OncoMed shall promptly return to GSK all data and materials transferred by GSK to OncoMed.

(b) Termination of Program. In the event of a termination by: GSK with respect to a Program pursuant to Section 14.2.1 (for material breach):

(i) GSK shall have the right to progress the Development and Commercialization of any Collaboration Compounds that [***] in the terminated Program as of the effective date of termination of the terminated Program, and OncoMed will grant licenses to GSK in accordance with Section 5.1 as if GSK had exercised its GSK Program Option for the terminated Program, and GSK shall use Commercially Reasonable Efforts to Develop and Commercialize a Product from the terminated Program in the Territory under the licenses described in this Section 14.6.3(b)(i), or such licenses shall terminate;

(ii) All licenses granted to GSK prior to the effective date of such termination with respect to the terminated Program shall continue in full force, in accordance with the terms and conditions of this Agreement;

(iii) GSK shall have no obligation to grant OncoMed the license set forth in Section 5.5 with respect to the terminated Program;

(iv) OncoMed shall cease any and all Development and Commercialization activities with respect to any and all Collaboration Compounds in the terminated Program (including without limitation rejected compounds as described in Section

 

[***] Certain information in this document 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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3.4.3, GSK Development Compounds and Products) that [***] as of the effective date of such termination;

(v) GSK shall pay to OncoMed a [***] royalty on Net Sales by GSK, its Affiliates, and its Sublicensees of any Product incorporating a Collaboration Compound in the terminated Program licensed to GSK under Sections 14.6.3(b)(i) and 14.6.3(b)(ii) that has met the Candidate Selection Criteria as of the effective date of termination of the terminated Program. If the terminated Program is terminated before a Collaboration Compound in the terminated Program has been deemed a Candidate Selection Compound by the JSC, then the royalty to OncoMed will be [***] royalty payable to OncoMed on Net Sales by GSK, its Affiliates, and its Sublicensees. GSK’s obligation to pay the royalty in this Section on Net Sales of Products incorporating any such Collaboration Compound in such Program will continue until, and end on [***] that [***], and all other payment obligations hereunder shall terminate except those that are accrued and unpaid as of the effective date of such termination;

(vi) The provisions of Article 7 applicable to GSK with respect to the terminated Program and compounds within the terminated Program shall terminate in their entirety, but the provisions of Article 7 applicable to OncoMed shall continue in full force and effect;

(vii) All rights and obligations under the terms of this Agreement (other than for such terminated Program) that are in effect as of the date of such termination shall remain in full force and effect, in accordance with their terms; and

(viii) OncoMed shall promptly return to GSK all data and materials with respect to the terminated Program and compounds within the terminated Program transferred by GSK to OncoMed.

14.7 Obligations of GSK with Respect to OncoMed Development Compounds. When compounds and products become OncoMed Development Compounds under Section 4.1.3(e)(iii), 4.1.5, 4.2.7, 7.2.6, or 14.6.2, the following shall occur with respect to each such OncoMed Development Compound:

14.7.1 GSK shall promptly return to OncoMed, at no cost to OncoMed, all OncoMed Licensed Know-How, materials, and other data and information transferred by OncoMed to GSK with respect to each such OncoMed Development Compound, including without limitation all OncoMed Licensed Know-How, materials, and other information transferred to GSK with respect to each such OncoMed Development Compound pursuant to Section 5.9;

14.7.2 GSK shall transfer to OncoMed, at OncoMed’s request, any and all data and information pertaining to the applicable OncoMed Development Compounds in its possession and other related materials, including without limitation copies of all clinical study data and results, and all other information, and the like developed by or for the benefit of GSK relating to such OncoMed Development Compounds and other documents to the extent directly and solely relating to the OncoMed Development Compounds that are necessary in the continued Development and Commercialization of such OncoMed Development Compounds (including

 

[***] Certain information in this document 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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without limitation material documents and agreements relating to the sourcing, manufacture, promotion, distribution, sale or use of a product) throughout the Territory;

14.7.3 GSK shall assign to OncoMed any and all Regulatory Filings relating to such OncoMed Development Compounds, including without limitation any BLAs described in Section 6.4.13; and

14.7.4 Subject to the obligation to pay to GSK the applicable royalty set forth under the applicable provision in Section 8.4, OncoMed shall be free to Develop and Commercialize any and all such OncoMed Development Compounds, alone or with any Third Party or through any Third Party sublicensee. In the event OncoMed decides to further Develop and/or Commercialize such OncoMed Development Compounds, OncoMed shall be solely responsible for satisfying any and all obligations to Third Parties with respect to the Development, manufacture or Commercialization of such OncoMed Development Compounds including, but not limited to, any ongoing obligations of GSK under any Third Party manufacturing or licensing agreements to the extent such obligations are contained in agreements which GSK may assign to OncoMed, in accordance with the terms of such agreements, and as such agreements may be assumed by OncoMed at its request hereunder.

14.8 Survival. The following provisions shall survive termination or expiration of this Agreement in its entirety, as well as any other provision which by its terms or by the context thereof, is intended to survive such termination: Articles 1 (for interpretation purposes only), 8 (to the extent payments have accrued prior to the effective date of such termination or expiration and remain unpaid or to the extent payments accrue under Section 8.4 after such termination or expiration), 12 (for the period set forth in Section 12.1), 13, 15, and 16 and Sections 3.2.5, 3.2.9, 3.8, 4.2.3, 4.2.5, 5.8, 10.5, 10.6, 11.1, 11.2, 11.3 (if GSK obtains or retains a license to Licensed Intellectual Property after termination or expiration), 11.5 (if OncoMed obtains or retains a license to intellectual property Controlled by GSK after termination pursuant to Sections 14.6.3(a)(v), 14.6.3(b)(v), or 14.7.4 or expiration), 14.6, and 14.8. Termination or expiration of this Agreement shall not relieve the Parties of any liability or obligation which accrued hereunder prior to the effective date of such termination or expiration nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity, subject to Article 15, with respect to any breach of this Agreement nor prejudice either Party’s right to obtain performance of any obligation. All other rights, licenses and obligations shall terminate upon expiration of this Agreement.

 

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15. D ISPUTE R ESOLUTION

15.1 Exclusive Dispute Resolution Mechanism. In the event that the Parties cannot reach agreement on a matter under this Agreement, one Party does not have the final decision-making authority with respect to such matter, as provided in the Agreement, and such matter is subject to arbitration under this Agreement, the procedures set forth in this Article 15 shall be the exclusive mechanism for resolving any dispute, controversy, or claim (collectively, “Disputes” ) between the Parties that may arise from time to time pursuant to this Agreement relating to any Party’s rights and/or obligations hereunder that cannot be resolved through good faith negotiation between the Parties.

15.2 Resolution by Executive Officers. Except as otherwise provided in this Agreement, in the event of any Dispute between the Parties in connection with this Agreement, the construction hereof, or the rights, duties or liabilities of either Party under this Agreement, the Parties shall first attempt in good faith to resolve such Dispute by negotiation and consultation between themselves. In the event that such Dispute is not resolved on an informal basis within [***] after one Party provides notice to the other Party of such Dispute, either Party may, by written notice to the other Party, refer such Dispute to the other Party for attempted resolution by good faith negotiation within [***] days after such notice is received. Any Disputes relating to Programs shall be referred to the Executive Officers for attempted resolution. In the event that any Dispute is not resolved under the foregoing provisions, and one Party does not have decision-making authority with respect to such Dispute, each Party may, at its sole discretion, seek resolution of such Dispute in accordance with Section 15.3; provided that any Dispute relating to patent matters under the jurisdiction of the JPS shall be resolved in accordance with Section 2.4.3.

15.3 Arbitration.

15.3.1 Any and all unresolved Disputes for which one Party does not have final decision-making authority, and that are subject to arbitration under this Agreement, shall be exclusively and finally resolved by binding arbitration.

15.3.2 Any arbitration concerning a Dispute shall be conducted in New York, New York, United States of America, unless otherwise agreed to by the Parties in writing. Each and any arbitration shall be administered by the American Arbitration Association (the “AAA” ), and shall be conducted in accordance with the Commercial Arbitration Rules of the AAA (the “Rules” ), as such Rules may be amended from time to time.

15.3.3 Within [***] days after receipt of an arbitration notice from a Party, the Parties shall attempt in good faith to agree on a single neutral arbitrator with relevant industry experience to conduct the arbitration. If the Parties do not agree on a single neutral arbitrator within [***] after receipt of an arbitration notice, each Party shall select one (1) arbitrator and the two (2) Party-selected arbitrators shall select a third arbitrator with relevant industry experience to constitute a panel of three (3) arbitrators to conduct the arbitration in accordance with the Rules. In the event that only one of the Parties selects an arbitrator, then such arbitrator shall be entitled to act as the sole arbitrator to resolve the Dispute or any and all unresolved issues subject to the arbitration. Each and every arbitrator of the arbitration panel

 

[***] Certain information in this document 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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conducting the arbitration must and shall agree to render an opinion within [***] days after the final hearing before the panel.

15.3.4 The decision or award of the arbitrator(s) shall be final, binding, and incontestable and may be used as a basis for judgment thereon in any jurisdiction. To the full extent permissible under Law, the Parties hereby expressly agree to waive the right to appeal from the decision of the arbitrator(s), there shall be no appeal to any court or other authority (government or private) from the decision of the arbitrator(s), and the Parties shall not dispute nor question the validity of such decision or award before any regulatory or other authority in any jurisdiction where enforcement action is taken by the Party in whose favor the decision or award is rendered, except in the case of fraud. The arbitrator(s) shall, upon the request of any Party, issue a written opinion of the findings of fact and conclusions of law and shall deliver a copy to each of the Parties. Each Party shall bear its own costs and attorney’s fees, and the Parties shall equally bear the fees, costs, and expenses of the arbitrator(s) and the arbitration proceedings; provided, however, that the arbitrator(s) may exercise discretion to award costs, including attorney’s fees, to the prevailing Party. Without limiting any other remedies that may be available under Law, the arbitrator(s) shall have no authority to award provisional remedies of any nature whatsoever, or punitive, special, consequential, or any other similar form of damages.

15.4 Preliminary Injunctions. Notwithstanding anything in this Agreement to the contrary, a Party may seek a temporary restraining order or a preliminary injunction from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the decision of the arbitrator(s) on the ultimate merits of any Dispute.

15.5 Patent Disputes. Notwithstanding anything in this Agreement to the contrary, any and all issues regarding the scope, construction, validity, and enforceability of any patent in a country within the Territory shall be determined in a court or other Governmental Authority of competent jurisdiction under the applicable patent Laws of such country.

15.6 Confidentiality. All proceedings and decisions of the arbitrator(s) shall be deemed Confidential Information of each of the Parties, and shall be subject to Article 12.

16. M ISCELLANEOUS

16.1 Tolling of Rights and Obligations.

16.1.1 If, upon exercise of a GSK Program Option with respect to a Candidate Selection Compound under Article 4, GSK reasonably determines in good faith that the exercise by GSK of such GSK Program Option requires the making of filings with the Federal Trade Commission ( “FTC” ) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (15 U.S.C. §18a) ( “HSR Act” ), or under any similar premerger notification provision in the European Union or any other jurisdiction, then all rights and obligations that arise from the exercise of such GSK Program Option, including without limitation any payments under Section 8.2, other than payments that are due and payable prior to the date of such exercise, shall be tolled until the later of: (a) the applicable waiting period has expired or terminated without further regulatory inquiry; (b) GSK withdraws its request for regulatory review; or (c) final

 

[***] Certain information in this document 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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approval or clearance from the reviewing authority has been received, and each Party agrees to cooperate at the request of the Party which decides in its sole discretion to respond to any such request for information to expedite review of such transaction.

16.1.2 Second Request.

(a) If the antitrust enforcement authorities in the U.S. make a second request under the HSR Act following a filing made under the HSR Act pursuant to Section 16.1.1, or any antitrust enforcement authority in another jurisdiction commences an investigation into the exercise by GSK of a GSK Program Option (each, a “Second Request” ), and, if GSK in its sole discretion determines that it wishes to respond to such Second Request, then the Parties shall, in good faith, cooperate with each other and take reasonable actions to attempt to:

(i) [***]

(ii) [***]

(iii) [***] during the time when GSK is responding to such Second Request ( “Interim Period” ); provided that OncoMed shall not continue Development of any such Candidate Selection Compound until [***] the date of exercise by GSK of the GSK Program Option pursuant to Section 4.1.2; and

(iv) discuss the terms and conditions pursuant to which GSK may, at its sole discretion, provide financial assistance to OncoMed for the purpose of continuing the conduct of Clinical Trials for the applicable Candidate Selection Compound during the Interim Period.

(b) To the extent legally permissible, the Parties will endeavor to implement pre-agreed (i) Development protocols pursuant to which OncoMed will continue to Develop any Candidate Selection Compound under Section 16.1.2(a)(iii), and (ii) the estimated reasonable costs and expenses, including without limitation Clinical Trial and/or manufacturing costs and expenses, for such Development. If GSK obtains HSR clearance with respect to such Candidate Selection Compound, subject to Section 16.1.4, [***].

16.1.3 If HSR clearance is not obtained, or if, at any time during the Interim Period, GSK, after good faith consideration, elects to withdraw its request for regulatory review,

(a) The applicable Program shall be deemed terminated pursuant to Section 14.3.2;

(b) GSK shall have no obligation to make the “Exercise of a GSK Program Option” payment set forth in the table in Section 8.2.1 with respect to the applicable GSK Program Option or any other payment arising from the exercise of such GSK Program Option;

(c) OncoMed shall thereafter have the right to progress the Development and Commercialization of such Candidate Selection Compound as well as any Collaboration Compounds from the same Program as the terminated Candidate Selection

 

[***] Certain information in this document 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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Compound, in all cases, as OncoMed Development Compounds, subject to OncoMed’s obligation [***], including without limitation [***]); and

(d) If, after such Candidate Selection Compound and Collaboration Compounds become OncoMed Development Compounds in accordance with Section 16.1.3(c), OncoMed sublicenses its rights to such OncoMed Development Compounds to a Third Party, [***].

16.1.4 Upon receipt of final clearance from the FTC, GSK shall pay to OncoMed any amounts that have been tolled pursuant to Section 16.1.1; provided that, if any such final clearance is conditioned on [***], GSK, at its sole discretion, may elect either to (i) [***] or (ii) [***]. Notwithstanding the foregoing, nothing in this Section 16.1 shall require either Party to divest any assets or to take action to respond to any such Second Request or obtain clearance.

16.1.5 GSK hereby represents and warrants that as of the Effective Date, to the best of its knowledge without having conducted any inquiry and without any further duty of inquiry, it has no knowledge or basis for believing that any Second Request as described above is likely to occur with respect to any Collaboration Compounds or Programs.

16.2 Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable, such provision(s) shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision(s) with a valid and enforceable provision(s) such that the objectives contemplated by the Parties when entering this Agreement may be realized.

16.3 Notices. Any notice required or permitted to be given by this Agreement shall be in writing and shall be (a) delivered by hand overnight courier with tracking capabilities, (b) mailed postage prepaid by first class, registered or certified mail addressed as set forth below unless changed by notice so given, or (c) delivered by facsimile to the number set forth below unless changed by notice so given, followed by delivery via either of the methods set forth in Section 16.3(a) and (b):

If to GSK:

Attention: Senior Vice President,

Center of Excellence for External Drug Discovery

GlaxoSmithKline

2301 Renaissance Blvd.

Mail Code RN0210

King of Prussia, PA 19406

Telephone: 610-787-4093

Facsimile: 610-787-4105

 

[***] Certain information in this document 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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With a copy to:

Attention: Vice President and Associate General Counsel, R&D Legal Operations

GlaxoSmithKline

2301 Renaissance Blvd.

Mail Code RN0220

King of Prussia, PA 19406

Facsimile: 610-787-7084

If to OncoMed:

OncoMed Pharmaceuticals, Inc.

800 Chesapeake Drive

Redwood City, California 94063 U.S.A.

Attention: Chief Executive Officer

Telephone: 650-995-8200

Facsimile: 650-298-8600

Any such notice shall be deemed given on the date received if delivered in accordance with Section 16.3(a), five (5) days after mailing if mailed in accordance with Section 16.3(b), or the date of facsimile transmission if delivered in accordance with Section 16.3(c). A Party may add, delete, or change the person or address to which notices should be sent at any time upon written notice delivered to the Party’s notices in accordance with this Section 16.3.

16.4 Force Majeure. Neither Party shall be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to causes beyond its reasonable control, including without limitation acts of God, fires, earthquakes, acts of war, terrorism, or civil unrest ( “Force Majeure” ); provided, however, that the affected Party promptly notifies the other Party and further provided that the affected Party shall use Commercially Reasonable Efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance with the utmost dispatch whenever such causes are removed. When such circumstances arise, the Parties shall negotiate in good faith any modifications of the terms of this Agreement that may be necessary or appropriate in order to arrive at an equitable solution.

16.5 Assignment. Each Party may, without the consent of the other Party, assign or transfer all of its rights and obligations hereunder to an Affiliate of or to a successor in interest by reason of merger or consolidation or sale of all or substantially all of the assets of such Party relating to the subject matter of this Agreement; provided however, that (a) such assignment includes, without limitation, all rights and obligations under this Agreement and (b) where this Agreement is assigned or transferred to an Affiliate, the assigning Party remains responsible for the performance of this Agreement. Subject to the foregoing, this Agreement shall inure to the benefit of and be binding on the Parties’ successors and assigns. Any assignment or transfer in violation of the foregoing shall be null and void and wholly invalid, the assignee or transferee in any such assignment or transfer shall acquire no rights whatsoever, and

 

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the non-assigning non-transferring Party shall not recognize, nor shall it be required to recognize, such assignment or transfer. In the event that GSK assigns or otherwise transfers this Agreement to an Affiliate of GSK, GSK hereby agrees to be jointly and severally liable with any such Affiliates for the actions of such Affiliates and for any and all amounts that become due and payable hereunder to OncoMed.

16.6 Further Assurances. Each Party agrees to do and perform all such further acts and things and shall execute and deliver such other agreements, certificates, instruments and documents necessary or that the other Party may deem advisable in order to carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder. GSK and its Affiliates shall take all measures reasonably requested by OncoMed to give effect to the provisions of this Agreement. Any Affiliate that acquires rights hereunder will be deemed to be bound by the provisions of this Agreement.

16.7 Waivers and Modifications. The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification, release or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by both Parties.

16.8 Choice of Law. This Agreement shall be governed by, enforced, and shall be construed in accordance with the Laws of the State of Delaware without regard to any conflicts of law provision that would result in the application of the Laws of any State other than the State of Delaware.

16.9 Relationship of the Parties. Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute OncoMed and GSK as partners, agents or joint venturers. Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party. There are no express or implied third party beneficiaries hereunder.

16.10 Entire Agreement. This Agreement and the Series B-2 Preferred Stock Agreement constitute the entire agreement between the Parties as to the subject matter of this Agreement, and supersedes and merges all prior and contemporaneous negotiations, representations, agreements and understandings regarding the same.

16.11 Counterparts. This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.

16.12 Exports. Each Party agrees not to export or re-export, directly or indirectly, any information, technical data, the direct product of such data, samples or equipment received or generated under this Agreement in violation of any applicable export control Laws.

16.13 Interpretation.

 

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16.13.1 Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including without limitation the language whereby it has been expressed, represents the joint efforts of the Parties and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

16.13.2 The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The word “will” shall be construed to have the same meaning and effect as the word “shall”. The word “any” shall mean “any and all” unless otherwise clearly indicated by context.

16.13.3 Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (b) any reference to any Laws herein shall be construed as referring to such Laws as from time to time enacted, repealed or amended, (c) any reference herein to any Person shall be construed to include the Person’s successors and assigns, and (d) all references herein to Articles, Sections or Exhibits, unless otherwise specifically provided, shall be construed to refer to Articles, Sections and Exhibits of this Agreement.

16.13.4 Headings and captions are for convenience only and are not be used in the interpretation of this Agreement.

[ Signature Page Follows ]

 

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IN WITNESS WHEREOF, the Parties have caused this Research and Development Collaboration, Option, and License Agreement to be executed by their respective duly authorized officers as of the Effective Date.

 

O NCO M ED P HARMACEUTICALS , I NC .    

S MITH K LINE B EECHAM

DBA G LAXO S MITH K LINE

By:  

/s/ Paul J. Hastings

    By:  

/s/ Donald F. Parman

Name:  

Paul J. Hastings

    Name:  

Donald F. Parman

Title:  

CEO

    Title:  

Vice President and Secretary

[ Signature Page to Research and Development Collaboration, Option, and License Agreement ]


Exhibit 1.10

Candidate Selection Criteria

[***]

 

[***] Certain information in this document 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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Exhibit 1.67

Lead Generation Criteria

[***]

 

[***] Certain information in this document 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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Exhibit 1.77

OncoMed Clinical Trial Plan

[***]

 

[***] Certain information in this document 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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Exhibit 1.80

OncoMed Licensed Patents

[***]

 

[***] Certain information in this document 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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Exhibit 1.81

OncoMed Logo

 

LOGO

 

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Exhibit 1.83

Pathway

The Notch pathway, [***]

 

[***] Certain information in this document 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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Exhibit 1.110

Target 1 Program

[***]

 

[***] Certain information in this document 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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Exhibit 1.111

Target 2 Program

[***]

 

[***] Certain information in this document 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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Exhibit 6.4.1

OncoMed Co-Commercialization Duties

(1) [***]

(2) [***]

 

[***] Certain information in this document 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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Exhibit 8.1.2

Series B-2 Preferred Stock Purchase Agreement

 

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Exhibit 11.8.3(a)

Third Party Patents

[***]

 

[***] Certain information in this document 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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Exhibit 11.8.3(b)

Third Party Patents

[***]

 

[***] Certain information in this document 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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Exhibit 12.8

Press Release

GlaxoSmithKline and OncoMed Pharmaceuticals Form Strategic Alliance

To Develop Cancer Stem Cell Antibody Therapeutics

Issued – x, London UK, Philadelphia, PA and Redwood City, CA

GlaxoSmithKline (GSK) and OncoMed Pharmaceuticals (OncoMed) today announced a worldwide strategic alliance to discover, develop and market novel antibody therapeutics to target cancer stem cells which are believed to play a key role in the establishment, metastasis and recurrence of cancer. The alliance with GSK will be conducted through its Center of Excellence for External Drug Discovery (CEEDD).

The alliance leverages OncoMed’s expertise in the discovery and development of cancer stem cell antibody therapeutics and provides GSK with an option to license four product candidates directed at multiple cancer stem cell targets from OncoMed’s broad library of monoclonal antibodies. OncoMed will receive an undisclosed initial payment comprised of cash as well as an equity investment. In addition, OncoMed is eligible to earn milestone payments up to $1.4 billion from GSK based on the achievement of specified discovery, development, regulatory and commercial milestones. OncoMed will also receive double-digit royalties on all collaboration product sales. Furthermore, GSK will have an option to invest in a future initial public offering by OncoMed.

OncoMed has established a diverse pipeline of monoclonal antibodies to target multiple pathways important in the activity of cancer stem cells. The alliance with GSK includes OncoMed’s lead antibody product candidate, OMP-21M18, a monoclonal antibody, which is scheduled to enter the clinic in 2008.

In the alliance, OncoMed will utilize its proprietary in vivo xenograft cancer stem cell models to identify monoclonal antibodies in a specific, undisclosed cancer stem cell pathway. OncoMed will develop the most promising of these monoclonal antibodies, including OMP-21M18, through clinical proof of concept across multiple indications. Upon OncoMed’s achievement of clinical proof of concept in an agreed indication, GSK will have an exclusive option to license such monoclonal antibody. GSK would then assume responsibility for funding of further clinical development and commercialization on a worldwide basis. OncoMed retains the option to participate in development and commercialization of OMP-21M18 on pre-agreed terms.

“This alliance confirms GSK’s growing status as a world leader in the development of new oncology medicines for use in the treatment, prevention and supportive care of cancer patients and provides us access to an exciting new area of drug discovery. We believe that targeting cancer stem cells has the potential to change the paradigm of how oncology patients are treated and we are very excited to be working with OncoMed to develop novel and innovative medicines in this regard,” said Hugh Cowley, M.D., Senior Vice President and head of the CEEDD.

 

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“We are extremely pleased to be collaborating with GSK given their proven commitment to innovation and their expertise in the development and commercialization of novel oncology medicines,” said Paul J. Hastings, President and CEO of OncoMed. “This strategic alliance provides important validation of our scientific expertise in the field of cancer stem cell research and drug development. In addition, we gain access to significant non-dilutive financing to support the development of our novel cancer therapeutics, which we believe have the potential to significantly impact the outcome of cancer treatment.”

About Cancer Stem Cells

Cancer stem cells, a small subset of cells found in tumors, have the capacity to self-renew and differentiate, initiate and drive tumor growth, recurrence and metastasis. Also termed “tumor-initiating cells”, these cells were discovered by OncoMed’s scientific founders in breast cancer and have subsequently been identified in many other types of solid tumors including: colon, head and neck, lung, prostate, glioblastoma and pancreatic. Cancer stem cells appear to be preferentially resistant to both standard chemotherapy and radiotherapy. OncoMed’s strategy is to improve cancer treatment by specifically targeting the key biologic pathways critical for the activity and survival of cancer stem cells. OncoMed’s antibodies targeting cancer stem cell proteins have the potential to be developed against a range of solid tumor types such as breast, colon, prostate and lung cancers.

About OncoMed Pharmaceuticals

OncoMed Pharmaceuticals is discovering and developing novel therapeutics targeting cancer stem cells, the cells believed to be capable of driving tumor growth, recurrence and metastases. The company has established a library of antibodies to cancer stem cell proteins for the treatment of solid tumors such as breast, colon, prostate, and lung cancers. OncoMed is a leader in cancer stem cell research and the identification of novel cancer stem cell targets. Privately-held, the company’s investors include US Venture Partners, Latterell Venture Partners, Morgenthaler Ventures, The Vertical Group, Adams Street Partners, De Novo Ventures and Bay Partners. Additional information can be found at the company's website: www.oncomed.com.

About the CEEDD

GlaxoSmithKline is enhancing the way it discovers and develops drugs by creating a small, dedicated team that will feed the GSK pipeline solely through the efforts of its external alliances. The CEEDD (Center of Excellence for External Drug Discovery) was formed as further validation of GSK’s strategy to create small, independent and accountable R&D teams (known as Centers of Excellence for Drug Discovery or CEDDs). In essence, the CEEDD is virtualizing a portion of the GSK pipeline; namely from target to clinical proof of concept, by forming multiple risk-sharing/reward sharing alliances. Capitalizing on the speed and efficiency of its collaborators will allow GSK to deliver pharmaceutical products faster to patients. For more information, visit the CEEDD at www.ceedd.com.

About GSK

GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of life by enabling people to do more, feel

 

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better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com

 

GlaxoSmithKline Contacts:   

OncoMed Pharmaceutical Contacts:

Paul J. Hastings, Chief Executive Officer

William D. Waddill, Chief Financial Officer

1-650-938-9400

 

Media Inquiries:

Karen L. Bergman or Michelle Corral

BCC Partners

650-575-1509 or 415-794-8662

 

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Exhibit 10.1(B)

EXECUTION COPY

CONFIDENTIAL

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

AMENDMENT NO. 1

TO THE RESEARCH AND DEVELOPMENT COLLABORATION, OPTION, AND LICENSE AGREEMENT

This AMENDMENT NO. 1 TO THE RESEARCH AND DEVELOPMENT COLLABORATION, OPTION, AND LICENSE AGREEMENT (the “ Amendment No. 1 ”) is made this 28th day of July, 2011 (the “ Amendment No. 1 Effective Date ”) by and between OncoMed Pharmaceuticals, Inc. , a Delaware corporation located at 800 Chesapeake Drive, Redwood City, California 94063, United States of America (“ OncoMed ”) and GlaxoSmithKline LLC , a Delaware limited liability company with a principal place of business at One Franklin Plaza, Philadelphia, Pennsylvania 19102, United States of America (formerly known as SmithKline Beecham Corporation) (“ GSK ”). OncoMed and GSK are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties ”.

RECITALS

WHEREAS , on December 7, 2007 GSK and OncoMed entered into that certain Research and Development Collaboration, Option, and License Agreement (the “ Agreement ”); and

WHEREAS , the Parties now desire to amend the Agreement to, among other things:

enable the Program in which the Collaboration Target is Notch 1 (the “ Anti-Notch 1 Program ”) to progress as a clinical Program under the Agreement and to provide several alternative paths forward for the Development of the Collaboration Compound identified in the Anti-Notch 1 Program, which is designated “ OMP-52M51 ”;

to modify the obligations of the Parties with respect to the conduct of the Clinical Trials for the Program in which the Collaboration Target is Notch 2/3 (the “ Anti-Notch 2/3 Program ”), pursuant to which the Collaboration Compound identified in the Anti-Notch 2/3 Program and designated “ OMP-59R5 ” is being developed;

terminate all of GSK’s exclusive option rights to any and all Collaboration Compounds that OncoMed is Researching and Developing that are antibodies bi-specific to DLL4 and VEGF (the “ [***] Group ”), subject to a right of first negotiation retained by GSK to obtain rights to Products arising from the [***] Group;

terminate OncoMed’s obligation under the Agreement to develop and deliver to GSK any Candidate Selection Compound from any Program other than the Anti-Notch 1 Program and the Anti-Notch 2/3 Program; and

terminate the Program in which the Collaboration Target is DLL4 (the “ Anti-DLL4 Program ”), all on the terms and conditions as set forth in this Amendment No. 1.


NOW, THEREFORE, in consideration of the foregoing and the mutual agreements set forth below, the Parties hereby agree as follows:

AGREEMENT

 

1. Definitions . Capitalized terms used in this Amendment No. 1 that are not otherwise defined herein will have the meanings given to such terms in the Agreement. References in this Amendment No. 1 to Section numbers shall refer to such Sections in the Agreement. References in this Amendment No. 1 to Paragraph numbers shall refer to such Paragraphs in this Amendment No. 1.

 

2. Establishment of the Joint Clinical Sub-team for the Existing Programs; Decision-Making Authority with respect to the Existing Programs.

 

  2.1 Establishment of the joint Clinical Sub-team . Within a reasonable period of time after the Amendment No. 1 Effective Date, as contemplated by Section 2.4 of the Agreement (but subject to this Paragraph 2.1) the Parties will establish a Joint Clinical Sub-team to serve as a forum for discussing the progress and results relating to the clinical Development activities conducted by the Parties under the Anti-Notch 1 Program and/or the Anti-Notch 2/3 Program (each, an “ Existing Program ”). The Joint Clinical Sub-team shall also make, where appropriate, certain recommendations to the JSC related to clinical Development activities to be conducted pursuant to the Existing Programs. Specifically, the Joint Clinical Sub-team shall be responsible for:

 

  a. Collaboratively discussing the on-going clinical data, information and results arising from the conduct of the Existing Programs;

 

  b. Discussing any issues that may arise in relation to the clinical Development of any Existing Program and making recommendations to the JSC or escalating any disagreements within the Joint Clinical Sub-team to the JSC with respect thereto; and

 

  c. Any such additional matters as the JSC may, from time to time, delegate to the Joint Clinical Sub-team.

For clarity, the Joint Clinical Sub-team’s sole function shall be to serve as a forum for the discussion of information and data regarding the clinical Development of the Existing Programs and, where appropriate, to make recommendations related thereto to the ]SC. The Joint Clinical Sub-team is not intended to have or to assume any decision-making authority.

 

  2.2

Membership; Meetings . The Joint Clinical Sub-team shall be composed of employee representatives from each of OncoMed and GSK. The initial members of the Joint Clinical Sub-team will include the OncoMed and GSK employee representatives (the “ OncoMed Representatives ” and the “ GSK Representatives ”,

 

2


  respectively), as set forth on Exhibit 4 , attached hereto and incorporated herein by reference. Upon prior written notice to the other Party, which may be provided by electronic mail, OncoMed, with respect to the OncoMed Representatives, and GSK, with respect to the GSK Representatives, may add, remove, or substitute an OncoMed Representative or a GSK Representative, as applicable, on the Joint Clinical Sub-team. The Joint Clinical Sub-team shall meet as frequently as the Joint Clinical Sub-team determines to be necessary, such meetings to occur in person, by teleconference or by video-teleconference.

 

  2.3 Escalation of Disputes Within the Remit of the Joint Clinical Sub-team . The Joint Clinical Sub-team shall use reasonable efforts to mutually agree upon any clinical Development matters within its remit that are discussed and any recommendations to be made by the Joint Clinical Sub-team either to the Parties hereunder or to the JSC as set forth in Paragraph 2.1 of this Amendment No. 1 with respect thereto. In the event that the Joint Clinical Sub-team is unable to reach agreement on a matter within it remit, then the Joint Clinical Sub-team shall escalate such matter to the JSC for resolution. If, within [***] after such escalation, the JSC is unable to reach agreement on a matter escalated to the JSC in accordance with this Paragraph 2.3, then either Party may escalate the issue to the Head of the Ceedd of GSK and the CEO of OncoMed, or their respective designees with the appropriate authority to resolve such issue (the “ Senior Management ”). If, after [***] after such issue is escalated, the Senior Management members are unable to mutually agree upon a resolution, then [***]. For all other Disputes arising within the Joint Clinical Sub-team’s remit, such Dispute shall be resolved in accordance with the terms of the Agreement.

 

  2.4 GSK’s Final Decision-Making Authority with respect to the Anti-Notch 1 Program . Notwithstanding the foregoing, GSK shall have the final decision-making authority with respect to the following matters:

 

  a. All material issues with respect to the Anti-Notch 1 Preliminary Studies (as defined in Paragraph 3.2.1), provided that GSK shall exercise such right consistent with Exhibit 1 , attached hereto and incorporated herein by reference;

 

  b. The design and content of the Anti-Notch 1 Program Phase I Trials, provided that GSK shall exercise such right consistent with Exhibit 2 , attached hereto and incorporated herein by reference, including without limitation any later adjustments thereto;

 

  c. [***], and the design and content of the Anti-Notch 1 Program Phase II Trials conducted under Scenario #1, including without limitation any later adjustments thereto, provided that GSK shall exercise such right consistent with Exhibit 2 , attached hereto and incorporated herein by reference, including without limitation any later adjustments thereto;

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


  d. The design and content for the two (2) Anti-Notch 1 Program PoC Trials to be conducted by OncoMed under Scenario #2, provided that GSK shall exercise such right consistent with Exhibit 3 , attached hereto and incorporated herein by reference, including without limitation any later adjustments thereto;

 

  e. [***] OncoMed will progress the Anti-Notch 1 Program following completion of the Anti-Notch 1 Preliminary Studies, in accordance with Paragraph 4 of this Amendment No. 1; and

 

  f. [***] OncoMed will proceed under for the progression of the Anti-Notch 1 Program into a Phase II Trial;

provided , however , that it is understood by the Parties that for matters described in Paragraph 2.4 (b), (c), or (d) above, that GSK will only exercise its final decision-making authority after discussion of such matters by the Joint Clinical Sub-team and, if the Joint Clinical Sub-team is unable to reach agreement with respect to such matters, such matter may be escalated as set forth in Paragraph 2.3 above, after which, if such matter remains unresolved, [***]. For clarity, GSK’s final decision-making authority with respect to the matters set forth in Paragraphs 2.4 (a), (e) and (f) shall not be subject to any [***] the Joint Clinical Sub-team and shall not be [***] in Paragraph 2.3 herein or otherwise under any provision of the Agreement or this Amendment No. 1.

 

  2.5 Governance and final decision-making authority of the Parties with respect to the Anti-Notch 2/3 program . With regard to the Anti-Notch 2/3 Program, the rights of the Parties and of the JSC regarding governance of the Anti-Notch 2/3 Program, final decision-making authority, and dispute resolution procedures shall be as set forth in the Agreement.

 

  2.6 Reports . OncoMed will provide to the Joint Clinical Sub-team timely updates on the conduct of the Anti-Notch 1 Program in advance of each meeting of the Joint Clinical Sub-team, such updates to include without limitation, the data and results (including any negative results) of, and information on the progress of activities conducted in accordance with, the Anti-Notch 1 Program as of the date of such update.

 

3. Anti-Notch 1 Program – Overview and Preliminary Studies .

 

  3.1 Overview . The Anti-Notch 1 Program will be progressed through Anti-Notch 1 Preliminary Studies (as defined in Paragraph 3.2.1), Phase I Trial activities (including without limitation “Parts 1 and 2”, as described in Exhibit 2 , attached hereto and incorporated herein by reference), and Phase II Trial activities by OncoMed beyond Candidate Selection in accordance with the terms and conditions set forth in the Agreement, as such terms and conditions are modified

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


  by this Amendment No. 1, including without limitation Sections 3.4 through 3.6 of the Agreement, the revised payment and milestone obligations with respect to the Anti-Notch 1 Program, governance, and the GSK Program Option points for the Anti-Notch 1 Program, in each case as set forth in this Amendment No. 1.

 

  3.2 Anti-Notch 1 Program Preliminary Studies .

 

  3.2.1 Conduct of the Anti-Notch 1 Preliminary Studies . OncoMed shall conduct the preliminary studies, including without limitation [***] as set forth in Exhibit 1 , attached hereto and incorporated herein by reference (the “ Anti-Notch 1 Preliminary Studies ”). The Anti-Notch 1 Preliminary Studies shall be conducted by OncoMed [***]. On an ongoing basis, the Parties will discuss the plans for conducting the Anti-Notch 1 Preliminary Studies. If the Parties disagree upon a material aspect of the Anti-Notch 1 Preliminary Studies, then GSK shall have final decision making authority with respect to such material issues; provided, that GSK will exercise its final decision making authority within the guidelines set forth in Exhibit 1.

 

  3.3 Anti-Notch 1 Preliminary Studies Payments . The Anti-Notch 1 Preliminary Studies shall be [***] with GSK contributing a total two million dollars ($2,000,000) (assuming a total cost of [***] for the Anti-Notch 1 Preliminary Studies), as follows: GSK shall make a first payment to OncoMed of one million, five hundred thousand dollars ($1,500,000) within [***] after receipt an invoice by GSK from OncoMed, to be submitted to GSK on or after the Amendment No. 1 Effective Date. GSK shall make a second payment to OncoMed as set forth herein [***] the first payment, or if such Anti-Notch 1 Preliminary Studies are not completed at such time, then upon [***] the second payment will be made, such second payment to be equal to [***] incurred by OncoMed in connection with the conduct of the Anti-Notch 1 Preliminary Studies, up to an additional five hundred thousand dollars ($500,000). OncoMed shall submit an invoice to GSK for such second payment, and GSK shall pay the invoiced amount within [***] after receipt of such invoice.

 

4. GSK’s Election to Proceed Under Scenario #1, Scenario #2 or Scenario #3 for Progression of the Anti-Notch 1 Program . Following completion of the Anti-Notch 1 Preliminary Studies, OncoMed shall provide to GSK, and GSK shall review, the complete data, results and information generated by OncoMed during the conduct of the Anti-Notch 1 Preliminary Studies (the “ Anti-Notch 1 Preliminary Data Package ”). GSK will consult with OncoMed with respect to the Anti-Notch 1 Preliminary Data Package and, after meaningful consultation with OncoMed and based on GSK’s overall assessment of the sum total of the data generated, giving reasonable weight, [***] to the various components of the Anti-Notch 1 Preliminary Data Package, [***] after receipt of the Anti-Notch 1 Preliminary Data Package, [***] OncoMed to follow either Scenario #1, Scenario #2 or Scenario #3 for the progression of the Anti-Notch 1 Program, as set forth in Paragraphs 5, 7, and 8 below. If [***] then [***] with respect to the Anti-Notch 1 Program. [***] with respect to the selection of either Scenario #1, Scenario #2 or

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5


  Scenario #3 for the development of the Anti-Notch 1 Program [***] and such selection shall [***] hereunder or under the Agreement or this Amendment No. 1. Upon [***] OncoMed shall proceed to follow Scenario #1, Scenario #2, or Scenario #3, as determined in accordance with the above. Upon [***].

 

5. Selection of Scenario #1 for the Progression of the Anti-Notch 1 Program . If, in accordance with Paragraph 4 of this Amendment No. 1 [***] the Anti-Notch 1 Program under Scenario #1, the following provisions set forth in this Paragraph 5 shall apply and together shall constitute “ Scenario #1 ”:

 

  5.1 Conduct of Phase I Trial (Parts 1 and Part 2) under Scenario #1 . OncoMed shall, as soon as reasonably practical [***] Scenario #1, commence activities under Scenario #l as set forth in Exhibit 2 , attached hereto and incorporated herein by reference, using its Commercially Reasonable Efforts to conduct such Phase I Trials (Parts 1 and 2) as set forth therein through to Completion of such Phase I Trials in accordance with Paragraph 11. [***] of the Phase I Trials (Parts 1 and 2) conducted by OncoMed under this Scenario #1, [***] of this Amendment No. 1.

 

  5.2 Milestone Payments: Anti-Notch 1 Program Phase I Trial (Parts 1 and 2) Under Scenario #1 . In lieu of the payments for the (i) [***] milestones set forth in the first table of Section 8.2.1 of the Agreement that are applicable to the Anti-Notch 1 Program under the Agreement, GSK would pay to OncoMed the following [***] milestone payments, which shall each be payable only when achieved, as one-time only, non-refundable, non-returnable, and non-creditable milestone payments upon the first achievement of each specified milestone event in the Anti-Notch 1 Program Phase I Trial Parts 1 and 2 conducted in accordance with Scenario #1, and which shall replace such (i) [***] milestones for the Anti-Notch 1 Program in their entirety:

 

Scenario #1 Anti-Notch 1 Program

Milestone Event

  

One-Time Payment (millions of Dollars)

[***]

  

[***]

 

  5.3 Early Option Exercise by GSK Under Scenario #1; Payment of Early Option Exercise Fee .

 

  5.3.1 Early Option Exercise Completion of Phase I Trials Parts 1 and 2 . GSK shall have the right to exercise, in GSK’s sole discretion, in accordance with Section 4.1.3(a) of the Agreement and notwithstanding anything to the contrary in Section 4.1 of the Agreement, the GSK Program Option for the Anti-Notch 1 Program within [***] after the Completion of Part 2 of the Phase I Trials for the Anti-Notch 1 Program under Scenario #1 and receipt by GSK of [***] (the “ Early Option Exercise Period ”). GSK may exercise its GSK Program Option for the Anti-Notch 1 Program at any time during the Early Option Exercise Period by providing written notice

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

6


  of such GSK Program Option exercise to OncoMed. If, upon the expiration of the Early Option Exercise Period, GSK has not exercised its GSK Program Option for the Anti-Notch 1 Program and has not, in the alternative, provided written notice to OncoMed of GSK’s election for OncoMed to continue the Development of the Anti-Notch 1 Program under Scenario #2 as set forth in Paragraph 6 of this Amendment No. 1, then [***] OncoMed to continue to progress the Anti-Notch 1 Program [***] in accordance with Paragraph 5.4 of this Amendment No. 1 below. For the avoidance of doubt, prior to the earlier of (i) [***] or (ii) [***].

 

  5.3.2 Early Option Exercise Fee; [***] . If GSK exercises its GSK Program Option for the Anti-Notch 1 Program in accordance with Paragraph 5.3.1 of this Amendment No. 1, then GSK shall pay to OncoMed an early GSK Program Option exercise fee pursuant to Section 8.2.1 of the Agreement for the Anti-Notch 1 Program of [***] (the “ Early Option Exercise Fee ”), which reflects the [***] GSK Program Option exercise fee set forth in Section 8.2.1 of the Agreement. Any subsequent milestone and royalty payments owed by GSK to OncoMed with respect to the Anti-Notch 1 Program following such early GSK Program Option exercise by GSK shall be [***]. GSK will pay the Early Option Exercise Fee to OncoMed within [***] after GSK’s receipt of an invoice from OncoMed therefor, such invoice to be sent by OncoMed to GSK on or after the date on which GSK notifies OncoMed of GSK’s early exercise of such GSK Program Option. Notwithstanding Section 8.2.1 of the Agreement, in the event that GSK exercises its GSK Program Option for the Anti-Notch 1 Program at the Completion of Part 2 of the Phase I Trial in accordance with Paragraph 5.3.1 of this Amendment No. 1, [***].

 

  5.4 Election by GSK to Continue Under Scenario #1 Following Completion of the Phase I Trial Parts 1 and 2; Payment for Commencement of Phase II Trials Under Scenario #1.

 

  5.4.1 Election to Commence Phase II Trial under Scenario #1 . If, upon the expiration of the Early Option Exercise Period, GSK has not exercised its early GSK Program Option for the Anti-Notch 1 Program as set forth in Paragraph 5.3.1 and [***] as set forth in Paragraph 5.5 of this Amendment No. 1, then [***] OncoMed to continue to progress the Anti-Notch 1 Program in accordance with Scenario #1, and OncoMed shall, following expiration of the Early Option Exercise Period, use its Commercially Reasonable Efforts to continue Development of the Anti-Notch 1 Program under Scenario #1 through to Completion of the Phase II Trials [***] as set forth for Scenario #1 in the attached Exhibit 2 , in accordance with Paragraph 11. GSK shall have the final decision-making authority with respect to [***] design and content of any such Phase II Trials, including without limitation any later adjustments thereto, such final decision-

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

7


  making authority to be exercised by GSK consistent with Paragraph 2.4 of this Amendment No. 1, and GSK shall notify OncoMed of its decisions on these parameters in a reasonably timely manner. [***] will be consistent with the Clinical Plan for Scenario #1 Guidelines set forth in Exhibit 2 , attached hereto and incorporated herein by reference.

 

  5.4.2 Milestone Payment for Commencement of Phase II Trials for the Anti-Notch 1 Program under Scenario #1; Option Exercise Fee Following Completion of the final Phase II Trial for the Anti-Notch 1 Program under Scenario #1 .

 

  a. Milestone Payment upon [***] under Scenario #1 . If [***] Development of the Anti-Notch 1 Program under Scenario #1 through to the Completion of the Phase II Trials as set forth in Paragraph 5.4.1 of this Amendment No. 1, then [***] with respect to the Anti-Notch 1 Program as is set forth in the first table in Section 8.2.1 of the Agreement. OncoMed shall invoice GSK on or after [***] milestone and GSK shall pay such milestone payment to OncoMed within [***] of receipt of an invoice therefor from OncoMed.

 

  b. Option Exercise Fee . Notwithstanding anything to the contrary in Section 4.1 of the Agreement, GSK may elect to exercise its GSK Program Option for the Anti-Notch 1 Program within [***] with respect thereto by providing written notice in accordance Section 4.1.3(a) of the Agreement of such GSK Program Option exercise to OncoMed. If GSK elects to exercise its GSK Program Option in accordance with this Paragraph 5.4.2(b), GSK shall pay to OncoMed the one-time GSK Program Option exercise fee for the Anti-Notch 1 Program of [***]. OncoMed shall invoice GSK for such GSK Program Option exercise fee on or after receipt from GSK of GSK’s notice of exercise of such GSK Program Option and GSK shall pay such GSK Program Option exercise fee to OncoMed within [***] after receipt of an invoice therefor from OncoMed. If GSK does not exercise its GSK Program Option in accordance with this Paragraph 5.4, then Section 4.1.5 of the Agreement shall apply with respect to the Anti-Notch 1 Program.

 

  5.5 Election by GSK to Continue the Progression of the Anti-Notch 1 Program Under Scenario #2 Following Completion of the Phase I Trial Parts 1 and 2 . If, following the completion by OncoMed of the Anti-Notch 1 Preliminary Studies under Paragraph 3.2, GSK determines and notifies OncoMed in writing that OncoMed should progress the Anti-Notch 1 Program under Scenario #2, the following provisions set forth in Paragraph 7 shall apply. If, following the completion by OncoMed of the Anti-Notch 1 Program Phase I Trial Parts 1 and 2 for the Anti-Notch 1 Program under Paragraph 5.1, GSK determines and notifies

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

8


  OncoMed in writing that OncoMed should progress the Anti-Notch 1 Program under Scenario #2, the following provisions set forth in Paragraph 6 shall apply. The provisions set forth in Paragraph 6 or 7, as applicable, shall constitute “ Scenario #2 ”.

 

6. Election to Continue the Progression of the Anti-Notch 1 Program Under Scenario #2 Following Completion of the Phase I Trial Parts 1 and 2 under Scenario #1 . If GSK does not elect to exercise its GSK Program Option for the Anti-Notch 1 Program [***] as set forth in Paragraph 5.3, [***] OncoMed to proceed with the Anti-Notch 1 Program under Scenario #2, in lieu of Commencing Phase II Trials under Scenario #1, in which case the following provisions shall apply, and Scenario #1 will no longer apply with respect to the Anti- Notch 1 Program:

 

  6.1 Progression of the Anti-Notch 1 Program Under Scenario #2 . If [***] the Anti-Notch 1 Program in accordance with Scenario #2 following the Completion of the Phase I Trial Parts 1 and 2 for such Program (in lieu of Commencing Phase II Trials in accordance with Scenario #1), [***] set forth in Paragraph 5.3.1 of this Amendment No. 1 of [***]. OncoMed shall, as soon as reasonably practicable [***] proceed under Scenario #2, use Commercially Reasonable Efforts to continue with the clinical Development of the Anti-Notch 1 Program through to [***] in each case consistent with the guidelines set forth in Exhibit 3 , attached hereto and incorporated herein by reference, and in accordance with Paragraph 11. The JSC shall select, within [***] following the Completion of the Phase I Trials Parts 1 and 2 for the Anti-Notch 1 Program, the [***] consistent with the terms set forth in Section 3.6.2(c)(i) of the Agreement. GSK shall have the final decision-making authority as set forth in the Agreement over the design and content of such two (2) PoC Trials to be conducted by OncoMed, including without limitation any later adjustments made thereto, under Scenario #2; provided that such design and content is consistent with the guidelines of Exhibit 3 . Such final decision-making authority shall be exercised by GSK in a reasonably timely manner and shall not be subject to the decision-making escalation process set forth in Paragraph 2.3 in this Amendment No. 1, but shall be subject to Paragraph 2.4. Notwithstanding Section 3.6.2 of the Agreement, OncoMed shall [***].

 

  6.2 Payment of [***] Milestone; Option Exercise Fee . If [***] the Anti-Notch 1 Program under Scenario #2 in accordance with Paragraph 6.1 of this Amendment No. 1, then, in addition to any and all other payments due under the Agreement as such payments are amended by this Amendment No. 1, (a) upon the [***], GSK shall pay to OncoMed [***] as set forth in Paragraph 5.4.2(a) of this Amendment No. 1; and (b) if GSK elects to exercise its GSK Program Option for the Anti-Notch 1 Program following the [***] then GSK shall pay to OncoMed [***] GSK Program Option exercise fee set forth in Paragraph 5.4.2(b) of this Amendment No. 1. If GSK does not exercise its GSK Program Option in accordance with this

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

9


  Paragraph 6.2, then Section 4.1.5 of the Agreement shall apply with respect to the Anti-Notch 1 Program.

 

7. Selection of Scenario #2 for the Progression of the Anti-Notch 1 Program Directly Following Completion of the Anti-Notch 1 Preliminary Studies . If, in accordance with Paragraph 4 of this Amendment No. 1, [***] the Anti-Notch 1 Program under Scenario #2, the following provisions set forth in this Paragraph 7 shall apply:

 

  7.1 Conduct of PoC Trials Under Scenario #2. OncoMed shall, as soon as reasonably practical after [***] commence activities under Scenario #2 as set forth in Exhibit 2, attached hereto and incorporated herein by reference, and shall use Commercially Reasonable Efforts to continue with the clinical Development of the Anti-Notch 1 Program [***] consistent with the guidelines set forth on Exhibit 3 , attached hereto and incorporated herein by reference, in accordance with Paragraph 11. The JSC shall select [***] to be conducted under Scenario #2, consistent with the terms set forth in Section 3.6.2(c)(i) of the Agreement. GSK shall have the final decision-making authority as set forth in the Agreement over the design and content of such two (2) PoC Trials to be conducted by OncoMed, including without limitation any later adjustments made thereto, under Scenario #2; provided that such design and content is consistent with the guidelines of Exhibit 3 . Such final decision-making authority shall be exercised in a reasonably timely manner in accordance with Paragraph 2.4 of this Amendment No. 1. Notwithstanding Section 3.6.2 of the Agreement, OncoMed shall [***].

 

  7.2 Anti-Notch 1 Scenario #2 Milestone Payments. If, [***] the Anti-Notch 1 Program under Scenario #2 in lieu of Scenario #1, then GSK would pay to OncoMed the following [***] milestone payments, each shall be payable only when achieved, as one-time only, non-refundable, non-returnable, and non-creditable milestone payments upon the first achievement of each specified milestone event under Scenario #2, such milestones to be paid by GSK in lieu of, and to replace, the payments for [***] milestones set forth in the first table of Section 8.2.1 of the Agreement that are applicable to the Anti-Notch 1 Program under the Agreement:

 

Scenario #2 Anti-Notch 1 Program
Milestone Event

  

One-Time Payment (millions of Dollars)

[***]

  

[***]

 

  7.3 Option Exercise Fee. Notwithstanding anything to the contrary in Section 4.1 of the Agreement, GSK may exercise its GSK Program Option for the Anti-Notch 1 Program within [***] by providing written notice in accordance with Section 4.1.3(a) of the Agreement of such GSK Program Option exercise to OncoMed. If GSK exercises its GSK Program Option in accordance with this Paragraph 7.3, GSK shall pay to OncoMed the one-time GSK Program Option exercise fee of [***]. OncoMed shall invoice GSK for such GSK Program Option exercise fee

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

10


  on or after receipt from GSK of GSK’s notice of exercise of such GSK Program Option and GSK shall pay the GSK Program Option exercise fee to OncoMed within [***] after receipt of an invoice therefor from OncoMed. If GSK does not exercise its GSK Program Option for the Anti- Notch 1 Program in accordance with this Paragraph 7.3, then Section 4.1.5 of the Agreement shall apply with respect to such Program.

 

8. Selection of Scenario #3 for the Progression of the Anti-Notch 1 Program . If, in accordance with Paragraph 4 of this Amendment No. 1, [***] the Anti-Notch 1 Program under Scenario #3 in lieu of Scenario #1 or Scenario #2, the following provisions set forth in this Paragraph 8 shall apply and shall constitute “ Scenario #3 ”:

 

  8.1 Reversion of the GSK Program Option for the Anti-Notch 1 Program to OncoMed; No Further Funding or Payment Obligations . Subject to GSK’s right of first negotiation (“ ROFN ”), over the Anti-Notch 1 Program and the payment of reverse royalties, as applicable, as set forth in Paragraph 8.2 below, (i) the Anti-Notch 1 Program shall be deemed terminated effective as of [***] to progress the Anti-Notch 1 Program under Scenario #3, (ii) Section 14.6.2(b) of the Agreement shall apply to the Anti-Notch 1 Program, and (iii) OncoMed may proceed with Development of the Anti-Notch 1 Program under Scenario #3. In such event, the GSK Program Option set forth in Section 4.1 of the Agreement for the Anti-Notch 1 Program shall terminate and shall be of no further force or effect with respect to the Anti-Notch 1 Program, and, subject to Paragraph 8.2 herein, Section 4.1.5 of the Agreement shall apply with respect to such Program. Upon [***] Scenario #3, GSK shall have no further obligation to provide any further funding of any kind to OncoMed under the Anti-Notch 1 Program and shall not be under any obligation to pay any milestones to OncoMed or to make any other payments to OncoMed with respect to the Anti-Notch 1 Program unless and until GSK exercises its ROFN to acquire the Anti-Notch 1 Program as set forth in Paragraph 8.2 and enters into a definitive agreement with OncoMed with respect thereto.

 

  8.2 GSK’s ROFN over the Anti-Notch 1 Program . If, following the termination of the Anti-Notch 1 Program under Paragraph 8.1, (i) OncoMed [***] and (ii) OncoMed elects to seek a partner in order to partner, license, lease, transfer, assign, sale, or otherwise dispose of OncoMed’s rights in or to the Anti-Notch 1 Program or any portion thereof, then at the time that OncoMed decides to enter into bona fide license, partnering or divestiture discussions with a potential partner, OncoMed shall so notify GSK in writing, and GSK shall have a one-time ROFN with respect to the Anti-Notch 1 Program to exclusively negotiate with OncoMed for an exclusive license to the Anti-Notch 1 Program on commercially reasonable terms negotiated in good faith and reflecting the then-current fair market value, as follows: (a) If OncoMed provides such written notice to GSK prior to [***], then, if GSK elects to exercise its ROFN, GSK and OncoMed shall exclusively negotiate such in-license as set forth above for a period of [***],

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

11


  unless extended by mutual written agreement of the Parties, from the date of receipt of such notice by GSK; and (b) if OncoMed provides such written notice to GSK upon or following [***] OncoMed shall also provide to GSK [***] for the Anti-Notch 1 Program and GSK shall have [***] after receipt of such notice and [***] from OncoMed to determine whether to exercise its ROFN. If in the case of subparagraph (b) GSK notifies OncoMed in writing within such [***] that GSK desires to exercise its ROFN and to enter into negotiations with OncoMed, then the [***] exclusive negotiation period shall commence and the Parties shall thereafter negotiate the terms under which GSK may obtain an exclusive license to the Anti-Notch 1 Program for a period of up to [***], unless mutually extended in writing by the Parties. If, in the case of subparagraph (b), GSK does not notify OncoMed within such [***] data review period that GSK is interested in exercising its ROFN with respect to the Anti-Notch 1 Program, then GSK’s ROFN shall expire at the end of such [***] period. If the Parties do not enter into a definitive partnering agreement with respect to the Anti-Notch 1 Program as set forth in (a) or (b) above within such [***] negotiation period (or longer mutually agreed period), or if GSK does not notify OncoMed within the [***] review period set forth in (b) above that GSK elects to exercise its ROFN for the Anti-Notch 1 Program, then GSK’s rights under this Paragraph 8.2 shall expire and OncoMed shall be free to seek out and to negotiate with any Third Party the terms under which such Third Party would obtain Rights with respect to the Anti-Notch 1 Program, subject to Paragraph 8.2.2. For the avoidance of doubt, in the event that OncoMed elects to seek a Third Party partner for the Anti-Notch 1 Program as set forth above [***] in the Anti-Notch 1 Program, or [***] GSK’s ROFN shall not apply and OncoMed shall be free to seek out and to negotiate with any Third Party with respect to Collaboration Compounds in the Anti-Notch 1 Program without first entering into negotiations with GSK as provided in this Paragraph 8.2, subject to Paragraph 8.2.2. Notwithstanding anything to the contrary in this Paragraph 8.2, GSK’s ROFN with respect to the Anti-Notch 1 Program shall apply only with respect to the first time that OncoMed has demonstrated in good faith by its activities and the dedication of appropriate resources that it is actively seeking to enter into a deal with a bona fide Third Party partner for the Anti-Notch 1 Program, and GSK’s ROFN with respect to the Anti-Notch 1 Program shall expire if OncoMed has not provided any such notification to GSK within [***].

 

  8.2.1 GSK and OncoMed Conclude an Agreement During the Exclusive ROFN Period . Any definitive agreement under which GSK in-licenses or acquires the Anti-Notch 1 Program shall include [***].

 

  8.2.2 OncoMed Development Compounds from the Anti-Notch 1 Program . Following the termination of the Agreement with respect to the Anti-Notch 1 Program under Paragraph 8.1, all Collaboration Compounds within the Anti-Notch 1 Program shall be deemed to be OncoMed Development Compounds, subject to Paragraph 8.2. If, as set forth in

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

12


  Paragraph 8.2, OncoMed and GSK do not enter into a definitive agreement with respect to the Anti- Notch 1 Program in accordance with Paragraph 8.2, then all OncoMed Development Compounds within the Anti-Notch 1 Program shall be subject to the applicable terms and conditions of the Agreement, including without limitation, OncoMed’s obligation to pay to GSK the reverse royalties with respect to such OncoMed Development Compounds as set forth in Section 8.4.1 of the Agreement.

 

9. Development of the Anti-Notch 2/3 Program . Effective as of the Amendment No. 1 Effective Date, Paragraph 2.5 of this Amendment No. 1 and the guidelines set forth in the attached Exhibit 3 shall govern the clinical Development of the Anti-Notch 2/3 Program in lieu of the guidelines set forth in Exhibit 1.77 of the Agreement, which are hereby replaced and superseded by Exhibit 3 of this Amendment No. 1.

 

10. Termination of the Anti-DLL4 Program .

 

  10.1 Termination of the Anti-DLL4 Program. Effective immediately as of the Amendment No. 1. Effective Date, the Agreement is hereby terminated with respect to the Anti-DLL4 Program pursuant to Section 14.3.2 of the Agreement, and Section 14.6.2(b) of the Agreement is applicable with respect to the Anti-DLL4 Program; provided that the Anti-DLL4 Program shall be subject to GSK’s ROFN under Paragraph 10.2 and the reverse royalty payment obligations under Section 8.4.1 of the Agreement with respect thereto, if applicable, in each case as set forth in Paragraph 10.2. OncoMed may hereafter, but is not obligated, to elect to independently progress the Anti-DLL4 Program, and all Collaboration Compounds within the Anti-DLL4 Program shall be deemed to be OncoMed Development Compounds. For the avoidance of doubt, as of the Amendment No. 1 Effective Date, GSK shall have no further payment obligations of any kind with respect to the Anti-DLL4 Program. For clarity, although Collaboration Compounds in the Anti-DLL4 Program [***].

 

  10.2 GSK’s ROFN over the Anti-DLL4 Program . If, following the Amendment No. 1. Effective Date, [***] and (ii) OncoMed elects to seek a partner in order to partner, license, lease, transfer, assign, sale, or otherwise dispose of OncoMed’s rights in or to the Anti-DLL4 Program or any portion thereof, then at the time that OncoMed decides to enter into bona fide license, partnering or divestiture discussions with a potential partner, OncoMed shall notify GSK in writing, and GSK shall have a one-time, exclusive ROFN with respect to the Anti-DLL4 Program to exclusively negotiate with OncoMed for a period of [***] after GSK’s receipt of such notice, which may be extended by mutual agreement of the Parties, to exclusively in-license the Anti-DLL4 Program on commercially reasonable terms negotiated in good faith and reflecting the then-current fair market value, as set forth in this Paragraph 10.2 below. Such ROFN shall expire on the earlier of (a) the end of such [***] negotiation period, unless extended by mutual written agreement of the Parties, or (b) the Completion of the Post-

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

13


  Termination PoC Trials for the Anti-DLL4 Program. If the Parties do not enter into a definitive partnering agreement with respect to the Anti-DLL4 Program as set forth above within such [***] period (or longer mutually agreed period), or OncoMed does not provide a notice pursuant to this Paragraph 10.2 of its decision to enter into discussions with a potential partner prior to expiration of the time period described in subparagraph (b), then GSK’s rights under this Paragraph 10.2 shall expire and OncoMed shall be free to seek out and to negotiate with any Third Party the terms under which such Third Party would obtain rights with respect to the Anti-DLL4 Program, subject to Paragraph 10.2.2. For the avoidance of doubt, in the event that OncoMed elects to seek a Third Party partner for the Anti-DLL4 Program as set forth above [***] GSK’s ROFN shall not apply and OncoMed shall be free to seek out and to negotiate with any Third Party with respect to Collaboration Compounds in the Anti-DLL4 Program without first entering into negotiations with GSK as provided in this Paragraph 10.2, subject to Paragraph 10.2.2. Notwithstanding anything to the contrary in this Paragraph 10.2, GSK’s ROFN with respect to the Anti-DLL4 Program shall apply only with respect to the first time that OncoMed has demonstrated in good faith by its activities and the dedication of appropriate resources that it is actively seeking to enter into a deal with a bona fide Third Party partner for the Anti-DLL4 Program, and GSK’s ROFN with respect to the Anti-DLL4 Program shall expire if OncoMed has not provided any such notification to GSK within [***].

 

  10.2.1 GSK and OncoMed Conclude an Agreement During the Exclusive ROFN Period . Any definitive agreement under which GSK in-licenses or acquires the Anti-DLL4 Program shall include [***].

 

  10.2.2 OncoMed Development Compounds from the Anti-DLL4 Program . Following the Amendment No. 1 Effective Date, all Collaboration Compounds within the Anti-DLL4 Program shall be deemed to be OncoMed Development Compounds, subject to Paragraph 10.2. If, as set forth in Paragraph 10.2, OncoMed and GSK do not enter into a definitive agreement with respect to the Anti-DLL4 Program in accordance with Paragraph 10.2, then all OncoMed Development Compounds within the Anti-DLL4 Program shall be subject to the applicable terms and conditions of the Agreement, including without limitation, OncoMed’s obligation to pay to GSK the reverse royalties with respect to such OncoMed Development Compounds as set forth in Section 8.4.1 of the Agreement.

 

11. OncoMed Diligence Obligations . OncoMed shall continue to comply with Section 9.1 of the Agreement as amended by this Amendment No. 1. Subject to the terms and conditions of the Agreement as amended by this Amendment No. 1, OncoMed shall be required to use Commercially Reasonable Efforts to [***]. OncoMed shall have no obligations under Sections 9.1.1, 9.1.2, or 9.1.6 of the Agreement except as provided in

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

14


  this Amendment No. 1. OncoMed’s obligation to use Commercially Reasonable Efforts [***].

 

12. Reversion of GSK’s Rights over [***] Collaboration Compounds to OncoMed . As of the Amendment No. 1 Effective Date, GSK’s rights over all Collaboration Compounds within the [***] Group shall revert back to OncoMed and, subject to GSK’s ROFN as set forth herein, OncoMed shall have the right, but not the obligation, to progress the Development of the [***] Group outside of the Collaboration, and the [***] Group shall not be subject to the Agreement. If OncoMed elects to seek a partner in order to partner, license, lease, transfer, assign, sale, or otherwise dispose of OncoMed’s rights in or to the [***] Group or any portion thereof, then at the time that OncoMed decides to enter into bona fide license, partnering or divestiture discussions with a potential partner, OncoMed shall notify GSK in writing, and GSK shall have a one-time, exclusive ROFN with respect to the [***] Group to exclusively negotiate with OncoMed for a period of [***] after GSK’s receipt of such notice, which may be extended by mutual agreement of the Parties, to exclusively in-license the [***] Group on commercially reasonable terms negotiated in good faith and reflecting the then-current fair market value, as set forth in this Paragraph 12 below. Such ROFN shall expire on the earlier of (a) the end of such [***] negotiation period, unless extended by mutual written agreement of the Parties, or (b) [***]. If the Parties do not enter into a definitive partnering agreement with respect to the [***] Group as set forth above within such [***] period (or longer mutually agreed period), or OncoMed does not provide a notice pursuant to this Paragraph 12 of its decision to enter into discussions with a potential partner prior to expiration of the time period described in subparagraph (b), then GSK’s rights under this Paragraph 12 shall expire and OncoMed shall be free to seek out and to negotiate with any Third Party the terms under which such Third Party would obtain rights with respect to the [***] Group. For the avoidance of doubt, in the event that OncoMed elects to seek Third Party partner for the [***] Group as set forth above prior to the generation by OncoMed of any such new material data with respect to Collaboration Compounds in the [***] Group, or after the Completion of the first two Phase II Trials for the [***] Group, GSK’s ROFN shall not apply and OncoMed shall be free to seek out and to negotiate with any Third Party with respect to Collaboration Compounds in the [***] Group without first entering into negotiations with GSK as provided in this Paragraph 12. Notwithstanding anything to the contrary in this Paragraph 12, GSK’s ROFN with respect to the [***] Group shall apply only with respect to the first time that OncoMed has demonstrated in good faith by its activities and the dedication of appropriate resources that it is actively seeking to enter into a deal with a bona fide Third Party partner for the [***] Group, and GSK’s ROFN with respect to the [***] Group shall expire if OncoMed has not provided any such notification to GSK within [***] for the [***] Group.

 

13. Termination of OncoMed’s Obligations to Deliver a [***] Program; [***] .

 

  13.1 Release of Obligations Relating to the Delivery of a [***] Program . As of the Amendment No. 1 Effective Date, OncoMed shall be released from OncoMed’s contractual obligation under Section 9.1.1 of the Agreement to progress a

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

15


  Collaboration Compound during the Research Collaboration Term in each of [***] Programs to confirmation by the JSC that each such Collaboration Compound has met the Candidate Selection Criteria, and instead such obligation shall apply with respect to only the two (2) Existing Programs. OncoMed shall be deemed to have had no further obligation to conduct any work towards the delivery of, and shall have no further obligations to deliver, a Candidate Selection Compound for a Program other than the two (2) Existing Programs to GSK. Unless a Program is reinitiated pursuant to Paragraph 13.3, GSK shall have no obligation to pay [***] as set forth in Section 8.2.1 of the Agreement.

 

  13.2 Exclusivity . Notwithstanding Article 7 of the Agreement, as of the Amendment No. 1 Effective Date, the [***] Group and all Collaboration Compounds within the Anti-DLL4 Program shall not be subject to the exclusivity obligations set forth in Article 7 of the Agreement, and OncoMed, its Affiliates, and sublicensees shall be free to develop, manufacture, sell or otherwise exploit any such compounds in the [***] Group or in the Anti-DLL4 Program, respectively, subject to GSK’s ROFN with respect thereto and the payment of any reverse royalties owed to GSK with respect to OncoMed Development Compounds pursuant to Paragraphs 12 and 10.2, as applicable. For the avoidance of doubt, except as set forth in this Paragraph 13.2 above, and except as set forth in Paragraph 8, nothing set forth herein shall be construed to modify, amend or otherwise release either Party from any obligations set forth in Article 7 of the Agreement, except with respect to the Anti-DLL4 Program and the [***] Group, for which Article 7 shall not apply with respect to either Party as of the Amendment No. 1 Effective Date.

 

  13.3 Re-Initiation of [***] Program . If, at any time following the Amendment No. 1 Effective Date, GSK desires to re-initiate a Program that has been removed from the Collaboration under this Amendment No. 1, or initiate a new Program with OncoMed with respect to any Candidate Selection Compounds in the Pathway, GSK will provide written notice to OncoMed of GSK’s desire to initiate or restart [***], which may be based upon previous efforts or newly arising work on the Pathway, and the Parties shall discuss in good faith the inclusion of such Program into the Collaboration; provided that OncoMed’s obligations to discuss such initiation or restart shall not apply to the Anti-DLL4 Program, the [***] Group or, if Paragraph 8 applies, the Anti-Notch 1 Program, if OncoMed has previously partnered, licensed, leased, transferred, assigned, sold, or otherwise exclusively disposed of OncoMed’s rights in or to such Program or the [***] Group, or any portion thereof, after complying with its obligations with respect to any ROFNs under this Amendment No. 1 with respect thereto. If both Parties mutually agree in writing to include a Program into the Collaboration at such time, then such mutually agreed upon Program shall be added to the Collaboration upon the terms and conditions of the Agreement and Collaboration Compounds in such Program shall be eligible for milestone and royalty payments as set forth therein, including without limitation payment of [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

16


14. Consideration of Co-Development and Co-Commercialization Rights for the Anti-Notch 1 Program and the Anti-Notch 2/3 Program. OncoMed’s rights under Article 6 of the Agreement for Collaboration Compounds within Programs other than the Anti-DLL4 Program shall remain unchanged. OncoMed may request at any time following the Amendment No. 1 Effective Date, and [***] any co-Development and/or co-Commercialization rights with respect to the Anti-Notch 1 Program and/or the Anti-Notch 2/3 Program, such co-Development and/or co-Commercialization rights, [***] to be the same rights as set forth in Article 6 of the Agreement with respect to the Anti-DLL4 Program. For the avoidance of doubt, unless and until [***] co-Development and/or co-Commercialization rights to OncoMed with respect to the Anti-Notch 1 Program and/or the Anti-Notch 2/3 Program, OncoMed shall [***].

 

15. Modification of Research Collaboration Term Obligations . As of the Amendment No. 1 Effective Date, OncoMed shall have no obligation to continue to identify, Research, Develop, and/or deliver any Collaboration Compounds through to achievement of Candidate Selection Criteria for any Research Program, unless and until the [***] Research Program is initiated or re-initiated by mutual agreement of the Parties pursuant to Paragraph 13.3.

 

16. Section 8.2.5 of the Agreement . Section 8.2.5 of the Agreement shall be deleted in its entirety, and replaced with the following:

“8.2.5 GSK Credit. If OncoMed does not [***] within [***] from the Effective Date of the Agreement, GSK will be entitled to deduct [***] from future milestone payments due to OncoMed under this Agreement; [***]. Upon the first approval of a BLA for a GSK Development Compound in the United States, GSK will reimburse OncoMed any amounts credited to GSK under this Section 8.2.5. The Parties agree that, solely for the purposes of this Section 8.2.5, the Anti-DLL4 Program shall be deemed to have Commenced a PoC Trial in satisfaction of the requirement of this Section 8.2.5.”

 

17. Press Release. Each Party agrees not to issue any press release or other public statement disclosing other information relating to this Amendment No. 1 or the transactions contemplated hereby without the prior written review and approval of the other Party as to the content of such release, such approval not to be unreasonably withheld.

 

18. Counterparts . This Amendment No. 1 may be executed in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Facsimile signatures and signatures transmitted via PDF shall be treated as original signatures.

 

19. Governing Law . Section 16.8 of the Agreement shall apply to this Amendment No. 1.

 

20. Parties in Interest . All of the terms and conditions of this Amendment No. 1 shall be binding upon, and shall inure to the benefit of and be enforceable by the Parties hereto and their respective successors, heirs, administrators and permitted assigns.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

17


21. Entire Agreement; Conflicting Terms. The Parties hereby confirm and agree that, as amended hereby, the Agreement, including the payment terms set forth therein as expressly amended by this Amendment No. 1, remains in full force and effect and is a binding obligation of the Parties, and their respective successors, heirs, administrators, and permitted assigns. To the extent that anything set forth in this Amendment No. 1, either expressly or by interpretation, conflicts with any of the terms or provisions set forth in the Agreement, the terms of this Amendment No. 1 shall supersede and control.

[Signatures Follow on Next Page]

 

18


IN WITNESS WHEREOF, the Parties have caused this Amendment No. 1 to be executed by their duly authorized representatives as of the Amendment No. 1 Effective Date.

 

O NCO M ED P HARMACEUTICALS , I NC .     G LAXO S MITH K LINE LLC
By:  

/s/ Paul J. Hastings

    By:  

/s/ Justin T. Huang

Name:  

Paul J. Hastings

    Name:  

Justin T. Huang

Title:  

CEO

    Title:  

Assistant Secretary


Exhibit 1

PRELIMINARY STUDIES—ANTI-NOTCH 1 PROGRAM

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit 2

CLINICAL PLAN FOR SCENARIO #1 GUIDELINES

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

21


Exhibit 3

GUIDELINES FOR SCENARIO #2 FOR ANTI-NOTCH 1 PROGRAM AND FOR THE ANTI-NOTCH 2/3 PROGRAM

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

22


Exhibit 4

INITIAL JOINT CLINICAL SUB-TEAM MEMBERS

OncoMed Representatives

[***]

GSK Representatives

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

23

Exhibit 10.2

Execution Copy

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

COLLABORATION AND OPTION AGREEMENT

BY AND BETWEEN

ONCOMED PHARMACEUTICALS, INC.

AND

BAYER SCHERING PHARMA AG

DATED

JUNE 15, 2010


TABLE OF CONTENTS

 

              Page  

1.

  

D EFINITIONS

     1   

2.

  

C OLLABORATION O VERVIEW ; R ESEARCH AND D EVELOPMENT OF C OLLABORATION C OMPOUNDS

     20   
   2.1  

Collaboration Overview

     20   
   2.2  

Efforts

     21   
   2.3  

Research and Development Activities Prior to Exercise of a BSP Option or Small Molecule Advancement

     21   
   2.4  

Selection of Candidate Selection Compounds

     23   
   2.5  

Development Plans for Candidate Selection Compounds

     24   
   2.6  

Manufacture and Supply

     25   
   2.7  

Adverse Event Reporting

     25   

3.

  

BSP O PTION ; S MALL M OLECULE A DVANCEMENT ; D EVELOPMENT AND C OMMERCIALIZATION OF BSP D EVELOPMENT C OMPOUNDS

     26   
   3.1  

BSP Option

     26   
   3.2  

Small Molecule Advancement

     28   
   3.3  

Additional Development

     28   
   3.4  

BSP Rights and Obligations for a Late BSP Development Compound

     29   
   3.5  

Technology Transfer

     30   
   3.6  

Development and Commercialization of BSP Development Compounds

     30   
   3.7  

Manufacture and Supply of Late BSP Development Compounds and Small Molecule Collaboration Compounds

     34   
   3.8  

OncoMed’s Right to Co-Develop BSP Development Compounds

     35   
   3.9  

Third Party Information

     36   
   3.10  

Diagnostic Kits

     37   

4.

  

G OVERNANCE

     37   
   4.1  

Joint Steering Committee

     37   
   4.2  

Joint Development Sub-Committee

     40   
   4.3  

Joint Project Team

     41   
   4.4  

Membership in Committees

     42   
   4.5  

Patent Representatives

     42   
   4.6  

Alliance Managers

     43   

5.

  

L ICENSES

     43   
   5.1  

Licenses to BSP for BSP Development Compounds and Products

     43   
   5.2  

Sublicensing

     44   
   5.3  

Licenses to OncoMed

     45   
   5.4  

Patent Marking

     46   

 

- i -


   5.5  

Existing Agreements

     47   
   5.6  

No Implied Licenses; Government Rights

     47   

6.

  

F INANCIAL T ERMS

     48   
   6.1  

Upfront Payment

     48   
   6.2  

Option Extension Fee for BSP Option for the Fzd-Fc Class

     48   
   6.3  

Milestone Payments

     48   
   6.4  

Royalty Payments

     49   
   6.5  

Royalty Payment Reports

     50   
   6.6  

Manner of Payment

     51   
   6.7  

Records Retention

     51   
   6.8  

Audits

     51   
   6.9  

Currency Exchange

     52   
   6.10  

Taxes

     52   
   6.11  

Interest Due

     52   

7.

  

R EPRESENTATIONS , W ARRANTIES , AND C OVENANTS ; D ISCLAIMERS ; L IMITATION OF L IABILITY

     53   
   7.1  

Mutual Representations and Warranties

     53   
   7.2  

Additional Representations, Warranties, and Covenants of OncoMed

     54   
   7.3  

Additional Representations and Warranties of BSP

     56   
   7.4  

Mutual Covenants

     56   
   7.5  

Additional Covenant of OncoMed and BSP

     56   
   7.6  

DISCLAIMERS

     57   
   7.7  

LIMITATION OF LIABILITY

     57   

8.

  

I NTELLECTUAL P ROPERTY

     58   
   8.1  

Ownership of Inventions and Know-How

     58   
   8.2  

Prosecution of OncoMed Patents

     60   
   8.3  

Prosecution of Relevant BSP Patents

     62   
   8.4  

Enforcement of OncoMed Patents and BSP Patents Against Infringers

     63   
   8.5  

Patent Term Extension

     65   
   8.6  

Notification of Patent Certification

     65   
   8.7  

Regulatory Data Protection

     65   
   8.8  

Defense Against Claims of Infringement of Third Party Patents

     66   
   8.9  

Third Party Licenses

     66   
   8.10  

Trademarks and Domain Names

     67   

9.

  

C ONFIDENTIALITY

     68   
   9.1  

Nondisclosure

     68   
   9.2  

Exceptions

     68   
   9.3  

Authorized Disclosure

     69   
   9.4  

Terms of this Agreement

     70   
   9.5  

Securities Filings

     70   

 

- ii -


   9.6  

Relationship to Confidentiality Agreement

     71   
   9.7  

Publications

     71   
   9.8  

Publicity

     73   

10.

  

I NDEMNITY AND I NSURANCE

     74   
   10.1  

BSP Indemnity

     74   
   10.2  

OncoMed Indemnity

     75   
   10.3  

Indemnification Procedure

     75   
   10.4  

Insurance

     75   

11.

  

T ERM AND T ERMINATION

     76   
   11.1  

Term; Expiration

     76   
   11.2  

Termination for Cause

     76   
   11.3  

BSP Unilateral Termination Rights

     77   
   11.4  

Termination for Insolvency

     77   
   11.5  

Termination for Patent Challenge

     78   
   11.6  

Consequences of Expiration or Termination

     78   
   11.7  

Survival

     82   

12.

  

D ISPUTE R ESOLUTION

     82   
   12.1  

Exclusive Dispute Resolution Mechanism

     82   
   12.2  

Dispute Resolution Procedure

     83   
   12.3  

Expert Dispute Resolution Procedure

     83   
   12.4  

Arbitration

     83   
   12.5  

Preliminary Injunctions

     84   
   12.6  

Patent Disputes

     84   
   12.7  

Confidentiality

     84   

13.

  

M ISCELLANEOUS

     85   
   13.1  

Severability

     85   
   13.2  

Notices

     85   
   13.3  

Force Majeure

     86   
   13.4  

Assignment

     86   
   13.5  

BSP Election

     87   
   13.6  

Further Assurances

     87   
   13.7  

Waivers and Modifications

     87   
   13.8  

Governing Law

     87   
   13.9  

Relationship of the Parties

     88   
   13.10  

Entire Agreement

     88   
   13.11  

Exports

     88   
   13.12  

Interpretation

     88   
   13.13  

Performance by Affiliates

     88   
   13.14  

Compliance with Law

     89   
   13.15  

Counterparts; Electronic Delivery

     89   

 

- iii -


COLLABORATION AND OPTION AGREEMENT

T HIS C OLLABORATION AND O PTION A GREEMENT (the “Agreement” ) is made and entered into as of June 15, 2010 (the “Effective Date” ), by and between OncoMed Pharmaceuticals, Inc. , a Delaware corporation located at 800 Chesapeake Drive, Redwood City, California 94063, United States of America ( “OncoMed” ), and Bayer Schering Pharma AG , a German corporation located at Müllerstrasse 178, 13353 Berlin, Germany ( “BSP” ). OncoMed and BSP are sometimes referred to herein individually as a “Party” and collectively as the “Parties .

RECITALS

W HEREAS , OncoMed has expertise in cancer-related cellular processes, including without limitation those of cancer stem cells, as well as the research and development of biologic and pharmaceutical therapeutic molecules for the treatment of diseases and conditions;

W HEREAS , BSP has expertise in research, development, and commercialization of pharmaceutical products, including development of small molecules and cancer therapeutics and diagnostics;

W HEREAS , OncoMed has rights under certain patent rights and know-how rights relating to the targeting of cancer stem cells and the identification and development of cancer therapeutics and biomarkers;

W HEREAS , BSP and OncoMed desire to conduct research and development activities to discover and develop biologic and small molecule compounds directed to targets within a certain cancer cell pathway; and

W HEREAS , BSP desires to have an option to obtain, or ability to elect, an exclusive license to develop and commercialize such compounds for the treatment of cancer, and upon exercise of such option or such election, OncoMed is willing to grant to BSP such rights on the terms and conditions set forth herein.

AGREEMENT

N OW , T HEREFORE , in consideration of the foregoing and the mutual agreements set forth below, the Parties agree as follows:

1. D EFINITIONS . The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below or, if not listed below, the meaning designated in places throughout this Agreement.

1.1 “18R5 Class” means (a) subject to Section 3.1.2(d), the 18R5 Collaboration Compound, and (b) all 18R5 Backup Compounds.

 

- 1 -


1.2 “18R5 Backup Compound” means any Antibody Collaboration Compound that [***], and is designated as a backup for 18R5 Collaboration Compound pursuant to Section 2.3.2. .

1.3 “18R5 Collaboration Compound” means the compound existing as of the Effective Date that [***].

1.4 “Acceptance” means, with respect to an IND for a Product, that thirty (30) days have passed since such IND has been submitted to the FDA or, if earlier, the date upon which the FDA notifies a Party, its Affiliate or Sublicensee that Clinical Trials may proceed pursuant to such IND.

1.5 “Affiliate” of a Party means any Person that directly or indirectly is controlled by, controls or is under common control with a Party. For the purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means (a) in the case of a corporate entity, direct or indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors or (b) in the case of a non-corporate entity, direct or indirect ownership of at least fifty percent (50%) of the equity interests with the power to direct the management and policies of such entity; provided that, if local Law restrict foreign ownership, control shall be established by direct or indirect ownership of the maximum ownership percentage that may, under such local Law, be owned by foreign interests.

1.6 “Alliance Manager” has the meaning set forth in Section 4.6.

1.7 “Antibody Collaboration Compound” means any monoclonal antibody [***] (a) [***] and (b) [***]. For clarity, Antibody Collaboration Compounds include without limitation the 18R5 Collaboration Compound.

1.8 “Assay Technology” means any (a) OncoMed Know-How that is (i) [***], and (iii) provided to BSP by OncoMed under this Agreement as agreed by the JSC and (b) [***], each of subsections (a) and (b) together with any Patents Controlled by either Party claiming inventions [***] the Know-How and assays described in subsections (a) and (b) that are [***] in the course of [***].

1.9 “Assay Technology Improvements” means the improvements and assays described in Section 1.8(b).

1.10 “Biologic Collaboration Compound” means an Antibody Collaboration Compound or a Fzd-Fc Collaboration Compound.

1.11 “Biologic Collaboration Compound Class” means any Class other than the Small Molecule Class.

1.12 “Biologic Development Plan” means a plan that, depending upon the stage of development, details the Research and/or Development activities to be conducted

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

- 2 -


pursuant to this Agreement with respect to Biologic Collaboration Compounds included in a given Class during the Term as they arise during the Term, and may include without limitation the following anticipated Development activities or events: [***]. The Biologic Development Plan will include, without limitation, drug design and Development activities [***], and will be subject to Section 3.3.

1.13 “Biologic Research and Early Development Term” means the period commencing on the Effective Date and ending upon the [***], (b) [***] or (c) five (5) years after the Effective Date.

1.14 “Biologic Technology” means any and all Know-How relating to (a) methods and compositions [***]. “Biologic Technology” shall not include any Biomarker Technology .

1.15 “Biomarker” means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

1.16 “Biomarker Compounds” means compounds useful for (a) the measurement of the activity and/or modulation [***] in a patient or Patient Sample, and/or (b) to measure Biomarkers in a patient or Patient Sample.

1.17 “Biomarker Technology” means (a) [***] Biomarker Compounds, (b) [***] Biomarkers, (c) [***], and (d) [***]. “Biomarker Technology” shall not include (i) [***], (ii) the [***], or (iii) [***].

1.18 “BLA” means a Biologics License Application, or similar application that is submitted to the FDA, or a foreign equivalent of the FDA, for marketing approval of a Product containing a Biologic Collaboration Compound in the United States or any other country in the Territory, respectively.

1.19 “BLA Approval” means the approval of a BLA by the FDA or other applicable Regulatory Authority for a Product containing a Biologic Collaboration Compound in the United States or any other country in the Territory, respectively.

1.20 “BSP Development Compound” means any Collaboration Compound within either (a) a Biologic Collaboration Compound Class for which BSP exercises a BSP Option or (b) the Small Molecule Class after the Small Molecule Advancement occurs, in each of subsection (a) and (b) excluding any OncoMed Development Compound.

1.21 “BSP Diagnostic Kit” means a Diagnostic Kit that is Developed, based on Biomarker Technology, by BSP [***].

1.22 “BSP Intellectual Property” means the BSP Know-How and the BSP Patent(s).

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

- 3 -


1.23 “BSP Know-How” means all Know-How Controlled by BSP or its Affiliates as of the Effective Date or at any time during the Term that is (a) primarily and directly related to and reasonably necessary for (i) [***], (b) [***]. “BSP Know-How” shall include any and all Know-How Controlled by BSP that is within the BSP Owned Inventions.

1.24 “BSP Option” has the meaning set forth in Section 3.1.1.

1.25 “BSP Option Period” means, as to a Biologic Collaboration Compound Class, the time period beginning on the Effective Date and expiring upon the date that is [***] after (a) [***] (or such longer time period as provided in Section 3.1.4 or as the JSC or an expert pursuant to Section 12.3, as applicable, may determine pursuant to Section 3.1.3) or (b) if the Parties [***]; provided that in no event shall the BSP Option Period be longer than [***] after the Effective Date; and further provided that the BSP Option Period for the Fzd-Fc Class shall expire [***] within the time period set forth therein.

1.26 “BSP Owned Inventions” has the meaning set forth in Section 8.1.2.

1.27 “BSP Patents” means any and all Patents that are Controlled by BSP or its Affiliates as of the Effective Date or at any time during the Term and claim or disclose (a) inventions reasonably necessary for [***] (b) compositions of matter comprising a Biologic Collaboration Compound or Product containing a Biologic Collaboration Compound, or methods of using, [***], provided that BSP Patents shall not include any [***] and/or (d) [***]. “BSP Patents” shall include any and all Patents Controlled by BSP that claim or disclose any [***].

1.28 “Business Day” means a day other than Saturday, Sunday or any day on which commercial banks located in New York, New York or in Leverkusen, Germany are authorized or obligated by Law to close.

1.29 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31; provided, however, that (a) the first Calendar Quarter of any particular period shall extend from the commencement of such period to the end of the first complete Calendar Quarter thereafter; and (b) the last Calendar Quarter shall end upon the expiration or termination of this Agreement.

1.30 “Calendar Year” means (a) for the first Calendar Year of the Term, the period beginning on the Effective Date and ending on December 31, 2010, (b) for each Calendar Year of the Term thereafter, each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31, and (c) for the last Calendar Year of the Term, the period beginning on January 1 of the Calendar Year in which the Agreement expires or terminates and ending on the effective date of expiration or termination of this Agreement.

1.31 “Candidate Selection” means that a Collaboration Compound has met the relevant Candidate Selection Criteria and is ready for advancement into pre-clinical and clinical Development, as verified by the JSC pursuant to Section 2.4.2.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

- 4 -


1.32 “Candidate Selection Compound” means a Collaboration Compound that has met the relevant Candidate Selection Criteria, or that is otherwise designated as a Candidate Selection Compound by the JSC, in either case as verified by the JSC as more fully described in Section 2.4.

1.33 “Candidate Selection Criteria” means criteria for advancement of a Collaboration Compound into pre-clinical Development, as set forth in Exhibit 1.33 and as updated from time to time pursuant to Section 2.4.1.

1.34 “CDR(s)” shall mean the six (6) complementarity determining regions, as defined by the Kabat database, of the heavy and light chains of a monoclonal antibody.

1.35 “Change of Control” means the occurrence of any of the following:

(a) A Party entering into a merger, consolidation, stock sale or sale or transfer of all or substantially all of its assets, or other similar transaction or several transactions with another entity, unless, following such transaction or transactions, (i) the individuals and entities who were the beneficial owners of the outstanding voting securities of such Party immediately prior to such transaction or transactions beneficially own, directly or indirectly, at least fifty percent (50%) of the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors or similar governing persons of the corporation or other entity resulting from such transaction or transactions ( “Successor” ) in substantially the same proportions as their ownership immediately prior to such transaction or transactions of such outstanding voting securities, and (ii) at least fifty percent (50%) of the members of the Board of Directors or similar governing body of the Successor were members of the Board of Directors of such Party at the time of the execution of the initial agreement, or the action of the Board of Directors of such Party, governing such transaction or transactions; or

(b) any transaction or series of transactions in which any person or entity or group of persons or entities acquires beneficial ownership of securities of a Party representing more than fifty percent (50%) of the combined voting power of the then outstanding securities of such Party;

provided, however, that, notwithstanding subsections (a) or (b) above, a sale of a Party’s securities in an underwritten public offering of such Party’s securities to multiple non-affiliated investors shall not constitute a Change of Control.

1.36 “Class” means one of (a) the 18R5 Class, (b) the Fzd-Fc Class, (c) the Small Molecule Class, or (d) the Other Antibody Class.

1.37 “Clinical Trials” means Phase I Trials, Phase II Trials, Phase III Trials, Phase IV Trials, and/or variations of such trials (for example, phase II/III studies and other Pivotal Trials).

1.38 “Co-Development Option Period” means the period beginning on [***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

- 5 -


1.39 “Co-Development Plan” means a plan that details the Development activities to be conducted by OncoMed pursuant to this Agreement with respect to Biologic Collaboration Compounds included in a given Class as they arise during the Term after OncoMed elects to co-Develop a given Biologic Collaboration Compound pursuant to Section 3.8, and may include without limitation the following anticipated Development activities or events: [***]. The Co-Development Plan will include, without limitation, [***], and will be subject to Section 3.8.

1.40 “Collaboration” means the Research and Development activities, including without limitation any co-Development activities, conducted by the Parties pursuant to this Agreement.

1.41 “Collaboration Compound” means any Biologic Collaboration Compound or any Small Molecule Collaboration Compound.

1.42 “Collaboration Target” means any target that (a) was [***] (b) is in the Pathway.

1.43 “Combination Product” means a Product that includes a Collaboration Compound and at least one (1) additional therapeutically active pharmaceutical ingredient other than a Collaboration Compound. To be a Combination Product, the Product and all of its ingredients (including without limitation the drug substance) must be [***]. Except for those drug delivery vehicles, adjuvants or excipients that are recognized by the FDA as active ingredients, drug delivery vehicles, adjuvants, and excipients are hereby deemed not to be “therapeutically active pharmaceutical ingredients,” and their presence shall not be deemed to create a Combination Product for purposes of this Section 1.43.

1.44 “Commencement” or “Commence” means, when used with respect to Clinical Trials, the dosing of the first human patient with the first dose in such Clinical Trials.

1.45 “Commercialization” or “Commercialize” means activities directed to commercial-scale manufacturing, obtaining pricing and reimbursement approvals, marketing, promoting, distributing, importing, exporting, offering for sale or selling a Product, and carrying out Phase IV Trials or other Clinical Trials conducted for the purpose of market expansion, each commenced after First Commercial Sale of a Product anywhere in the world.

1.46 “Commercialization Plan” means, with respect to any BSP Development Compound, a plan that details the Commercialization activities to be conducted by BSP with respect to such BSP Development Compound and any Product containing such BSP Development Compound, which plan will outline the strategic commercial objectives for the Product brand in each geographical region, product positioning aspirations, pricing and reimbursement strategy, anticipated launch timings, the expected competitive landscape for the Product, initial sales and volume forecasts with key assumptions and sensitivities and plans for formation of advisory boards for Commercial activities and performance of other market research activities.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

- 6 -


1.47 “Commercially Reasonable Efforts” means, as to a Party and a Product, efforts consistent with the efforts and resources normally used by a pharmaceutical or biotechnology company, as applicable, of comparable size and resources of such Party, in the exercise of its reasonable business discretion relating to the Research, Development or Commercialization of a similar product with similar product characteristics, that is of similar market potential at a similar stage in its Development or product life, taking into account issues of patent coverage, safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, and other technical, legal, scientific and/or medical factors, and, solely with respect to BSP’s Development and/or Commercialization (but not Research) of Collaboration Compounds under this Agreement, the profitability of such Collaboration Compounds (including without limitation pricing and reimbursement status achieved) as compared to other products within BSP’s portfolio.

1.48 “Commercially Unreasonable” means that the activity referred to would be unreasonable to pursue given the efforts and resources normally used by a pharmaceutical or biotechnology company, as applicable, of comparable size and resources of such Party, in the exercise of its reasonable business discretion relating to such activity with respect to a similar product with similar product characteristics, that is of similar market potential at a similar stage in its Development or product life, taking into account issues of patent coverage, safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, and other technical, legal, scientific and/or medical factors, and, solely with respect to BSP’s Development and/or Commercialization (but not Research) of Collaboration Compounds under this Agreement, the profitability of such Collaboration Compounds (including without limitation pricing and reimbursement status achieved) as compared to other products within BSP’s portfolio.

1.49 “Committee” means each of the JSC and/or any subcommittees created by the JSC pursuant to Section 4.1.1(n).

1.50 “Competitive Infringement” has the meaning set forth in Section 8.4.1.

1.51 “Competitive Product” means any product sold by a Third Party, which product has received Regulatory Approval (a) through the use of an Abbreviated New Drug Application referencing a Product containing a Collaboration Compound under the Hatch-Waxman Act, or foreign equivalent thereof, or (b) as a biosimilar to a Product containing a Collaboration Compound as defined by Section 7002(a)(2) of the Biologics Price Competition and Innovation Act of 2009, or foreign equivalent thereof.

1.52 “Completion” means, when used with respect to a Clinical Trial, the date on which the Party conducting such Clinical Trial completes the statistical analysis and delivers to the other Party the findings of such statistical analysis for such Clinical Trial.

1.53 “Confidential Information” means all trade secrets, processes, formulae, data, Know-How, improvements, inventions, chemical or biological materials, chemical structures, techniques, marketing plans, strategies, customer lists, or other information that has

 

- 7 -


been created, discovered, or developed by a Party, or has otherwise become known to a Party, or to which rights have been assigned to a Party, as well as any other information and materials that are deemed confidential or proprietary to or by a Party (including without limitation all information and materials of a Party’s customers and any other Third Party and their consultants) in each case that are disclosed by such Party to the other Party, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other by the disclosing Party in oral, written, graphic, or electronic form. Any such information that relates to Inventions or Know-How invented or otherwise discovered or generated in whole or in part by one Party that are owned pursuant to Article 8 by the other Party shall be deemed disclosed by the Party owning such Invention or Know-How.

1.54 “Controlled” or “Controls” means, when used in reference to Know-How, Confidential Information, or intellectual property rights, the legal authority or right of a Party (or any of its Affiliates) to grant a license or sublicense of such Know-How or intellectual property rights to the other Party, or to otherwise disclose such Know-How or Confidential Information to such other Party, without breaching the terms of any agreement with a Third Party, or misappropriating such Know-How or Confidential Information of a Third Party.

1.55 “Data” means any test data including, by way of example, data generated by pharmacological, medicinal chemistry, biological, chemical, biochemical, or toxicological tests conducted in any pre-clinical or clinical experiment or trial, including but not limited to any Clinical Trial, as well as analytical and quality control data, stability data, data arising from other studies and procedures and manufacturing process and development activities.

1.56 “Development” means all non-clinical, pre-clinical and clinical drug development activities reasonably relating to the development of therapeutic compounds, including without limitation biologic or small molecule compounds, and submission of information to a Regulatory Authority. Development shall include without limitation toxicology, pharmacology, and other non-clinical and pre-clinical efforts, test method development and stability testing, manufacturing process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical studies and activities relating to obtaining Regulatory Approval, but excluding all Research and Commercialization activities. When used as a verb, “Develop” means to engage in Development.

1.57 “Development Plan” means a Biologic Development Plan, Small Molecule Development Plan and/or Co-Development Plan, individually or collectively.

1.58 “Diagnostic Kit” means a product containing reagents and other items necessary to conduct a test to detect the presence of or to measure a given Biomarker in a given Patient Sample.

1.59 “Dispute Resolution Procedure” means the dispute resolution procedure described in Section 12.2.

1.60 “Dollar” or “$” means the lawful currency of the United States.

 

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1.61 “Domain Name” means any identification label that defines a realm of administrative autonomy, authority, or control on the Internet that is identical or similar to any Trade Mark.

1.62 “Early Development” means, on a compound-by-compound basis:

(a) with respect to any Biologic Collaboration Compound other than an OncoMed Development Compound, those Development activities relating to such Biologic Collaboration Compound that occur prior to the occurrence of both of the following subsections (i) and (ii) with respect to such Biologic Collaboration Compound:

(i) [***] and

(ii) the [***]; and

(b) with respect to any Small Molecule Collaboration Compound, those activities that occur prior to the occurrence of both of the following subsections (i) and (ii) with respect to such Small Molecule Collaboration Compound:

(i) [***]

(ii) [***].

1.63 “EMA” means the European Medicines Agency, or any successor agency thereto.

1.64 “Europe” or “EU” means the countries that are members of the European Union as of the Effective Date of this Agreement or that become members of the European Union thereafter.

1.65 “Exclusivity Extension” means any applicable exclusivity extensions for a pharmaceutical product, including without limitation pediatric, biologic product, or data exclusivity, in a country with respect to a product (such as those periods listed in the FDA’s Orange Book or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83, and equivalents in other countries in the Territory).

1.66 “Executive Officers” has the meaning set forth in Section 12.2.

1.67 “Existing Agreements” means (a) the Michigan License, (b) the Lonza Agreements, (c) the MorphoSys Agreement, and (d) any amendments thereof or successor agreements or agreements entered into pursuant to the terms of any such agreements.

1.68 “Expert Dispute Resolution Procedure” means the dispute resolution procedure described in Section 12.3.

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

 

[***] Certain information in this document 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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1.70 “Field” means the treatment or prevention of any human or animal disease, disorder or condition.

1.71 “First Commercial Sale” means, with respect to any Product, the first sale invoiced for use or consumption by an end-user of such Product in any country in the Territory after Regulatory Approval of such Product has been granted, or such marketing and sale is otherwise permitted, by the Regulatory Authority of such country, excluding registration samples, compassionate use, and use in Phase IV Trials for which no payment has been received.

1.72 “Fzd-Fc Class” means [***].

1.73 “Fzd-Fc Collaboration Compound” means any compound in the Fzd-Fc Class.

1.74 “Fzd-Fc Decision Date” means the date upon which BSP must decide whether to maintain the BSP Option for the Fzd-Fc Class, which shall be the [***] of subsections (a) and (b):

(a) the date upon which the BSP Option for the Fzd-Fc Class would expire under Section 1.25 without regard to the second proviso in Section 1.25; and

(b) [***] days after the date upon which both of the following subsections (i) and (ii) have occurred:

(i) [***]

(ii) [***].

1.75 “GAAP” means generally accepted accounting principles in the United States, consistently applied.

1.76 “Good Clinical Practices” or “GCP” means the standards, practices and procedures set forth in the guidelines entitled in “Good Clinical Practice: Consolidated Guideline,” including without limitation related regulatory requirements imposed by the FDA and (as applicable) any equivalent or similar standards in jurisdictions outside the United States, to the extent that such standards are applicable in the jurisdiction in which the relevant Clinical Trial is conducted or required to be followed in the jurisdiction in which Regulatory Approval of a product will be sought.

1.77 “Good Laboratory Practices” or “GLP” means the regulations set forth in 21 C.F.R. Part 58 and the requirements expressed or implied thereunder imposed by the FDA and (as applicable) any equivalent or similar standards in jurisdictions outside the United States.

1.78 “Good Manufacturing Practices” or “GMP” means the regulations set forth in 21 C.F.R. Parts 210–211, 820 and 21 C.F.R. Subchapter C (Drugs), Quality System Regulations and the requirements thereunder imposed by the FDA, and, as applicable, any similar or equivalent regulations and requirements in jurisdictions outside the United States.

 

[***] Certain information in this document 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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1.79 “IFRS” means the International Financial Reporting Standards.

1.80 “IND” means any Investigational New Drug application, as defined in the United States Federal Food, Drug and Cosmetics Act, as amended from time to time, and the regulations promulgated thereunder, filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the United States (such as a clinical trial authorization, or CTA, in the European Union) necessary to commence Clinical Trials.

1.81 “Indemnification Claim” has the meaning set forth in Section 10.3.

1.82 “Indemnitee” has the meaning set forth in Section 10.3.

1.83 “Indemnitor” has the meaning set forth in Section 10.3.

1.84 “Independent BSP Assay Inventions” means all Assay Technology Improvements invented or otherwise discovered or generated in whole or in part by BSP in the course of performing activities pursuant to this Agreement that are [***].

1.85 “Indication” means any disease or condition for which a Product can be used to treat or prevent, which use is the subject of a separate Regulatory Filing to support a Regulatory Approval for such use.

1.86 “Inventions” has the meaning set forth in Section 8.1.1.

1.87 “Joint Development Sub-Committee” or “JDS” has the meaning set forth in Section 4.2.1.

1.88 “Joint Project Team” or “JPT” has the meaning set forth in Section 4.3.1.

1.89 “Joint Steering Committee” or “JSC” has the meaning set forth in Section 4.1.1.

1.90 “JSC Chairperson” has the meaning set forth in Section 4.1.2.

1.91 “Know-How” means Materials, Data, Results, technical information and know-how, including without limitation biological, chemical, pharmacological, toxicological, clinical, assay and related Materials, manufacturing, preclinical and clinical data, specifications for ingredients, the manufacturing processes, formulation, other specifications, sourcing information, quality control and testing procedures, and related know-how and trade secrets.

1.92 “Late BSP Development Compound” means:

(a) [***]; or

 

[***] Certain information in this document 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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(b) [***];

in each of subsection (a) and (b), with respect to which BSP will conduct Development and Commercialization pursuant to this Agreement, subject to Section 3.6.7.

1.93 “Late Development” means, on a compound-by-compound basis:

(a) with respect to any Biologic Collaboration Compound other than an OncoMed Development Compound, those Development activities relating to such Biologic Collaboration Compound that occur after the occurrence of both of the following subsections (i) and (ii) with respect to such Biologic Collaboration Compound:

(i) [***]; and

(ii) [***]; and

(b) with respect to any Small Molecule Collaboration Compound, those activities that occur after the occurrence of both of the following subsections (i) and (ii) with respect to such Small Molecule Collaboration Compound:

(i) [***]

(ii) [***].

1.94 “Law” means all applicable laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.

1.95 “Lonza Agreements” means (a) the Research Evaluation Agreement, by and between OncoMed and Lonza Sales AG, effective as of October 9, 2006, as novated and amended ( “Lonza Research Agreement” ), (b) the Master Services Agreement, by and between OncoMed and Lonza Sales AG, effective as of October 9, 2006, as amended ( “Lonza MSA” ), and (c) any amendments thereof or successor agreements or agreements entered into pursuant to the terms of any such agreements (subject to Section 5.5.1), including without limitation any commercial license described in Section 3(a) of Exhibit 5.5.

1.96 “Losses and Claims” has the meaning set forth in Section 10.1.

1.97 “Major Country” means (a) [***].

1.98 “Materials” means any tangible biological, chemical or physical materials, including, for example, compounds, cell lines, gene constructs, and laboratory animals, and parts or components thereof, including without limitation tissues and fluids.

1.99 “Michigan License” means the license agreement among OncoMed, the State of Michigan and the Regents of the University of Michigan for rights to certain technology

 

[***] Certain information in this document 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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owned or otherwise controlled by the State of Michigan and the Regents of the University of Michigan, dated January 5, 2001, as amended.

1.100 “MorphoSys Agreement” means the Subscription and License Agreement, by and between OncoMed and MorphoSys AG, effective as of June 1, 2006.

1.101 “NDA” means a New Drug Application that is submitted to the FDA, or a foreign equivalent of the FDA, for marketing approval for a Product containing a Small Molecule Collaboration Compound in the United States or any other country in the Territory, respectively.

1.102 “NDA Approval” means the approval of an NDA by the FDA or other applicable Regulatory Authority for a Product containing a Small Molecule Collaboration Compound in the United States or any other country in the Territory, respectively.

1.103 “Net Sales” means, with respect to a particular time period, the total amounts invoiced to Third Parties by either Party, its Affiliates or Sublicensees for sale of Products made during such time period to Third Parties, less the following deductions:

(a) discounts, including without limitation cash and quantity discounts, credits, allowances, charge-back payments, revenue-based bonuses paid to distributors, and rebates, actually granted to trade customers, managed health care organizations, federal, state, or local government and the agencies, purchasers, and reimbursers of managed health organizations or federal, state, or local government (as required by Law or applicable Regulatory Authorities);

(b) credits or allowances actually given or allowed upon damaged goods, rejections, or returns of such Products, including without limitation in connection with recalls;

(c) freight, postage, distribution, shipping, transportation, packing, handling and insurance charges, in the amount of [***] of the total amounts invoiced;

(d) bad debts actually written off in connection with such Products, not to exceed [***] of the total amounts invoiced;

(e) taxes (other than income or withholding taxes), duties, tariffs, or other governmental charges levied on the sale of such Products to the extent billed, including without limitation value-added taxes, sales and excise taxes, net of all reimbursements and allowances; and

(f) costs of customer programs, such as cost effectiveness or patient assistance studies or programs designed to aid in patient compliance with medication schedules in connection with the sales of a Product, solely to the extent such programs are mutually agreed upon by the Parties.

 

[***] Certain information in this document 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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Notwithstanding the foregoing, amounts billed by the Party, its Affiliates, or their respective sublicensees for the sale of Products among the Party, its Affiliates or their respective Sublicensees for resale shall not be included in the computation of Net Sales hereunder. Net Sales shall be accounted for in accordance with GAAP or IFRS, as applicable. Net Sales shall exclude any samples of Product transferred or disposed of at no cost for promotional or educational purposes.

Notwithstanding the foregoing, in the event a Product is sold in a country in the Territory as a Combination Product, Net Sales of the Combination Product will be calculated as follows:

(i) If Product and other active component(s) each are sold separately in such country, Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction A/(A+B), where A is the average gross selling price in such country of the Product sold separately in the same formulation and dosage, and B is the sum of the average gross selling prices in such country of such other active component(s) sold separately in the same formulation and dosage, during the applicable Calendar Year.

(ii) If the Product is sold independently of the other active component(s) therein in such country, but the average gross selling price of such other active component(s) cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction A/C where A is the average gross selling price in such country of such Product sold independently and C is the average gross selling price in such country of the entire Combination Product.

(iii) If the other active component(s) are sold independently of the Product therein in such country, but the average gross selling price of such Product cannot be determined, Net Sales will be calculated by multiplying the total Net Sales (as described above) of the Combination Product by the fraction [1-B/C], where B is the average gross selling price in the Territory of such other active component(s) and C is the average gross selling price in the Territory of the entire Combination Product.

(iv) If the Product and other active component(s) are not sold separately, or if they are sold separately but the average gross selling price of neither such Product nor other active component(s) within can be determined, in such country, Net Sales of the Combination Product will be calculated by multiplying the total Net Sales of the Combination Product in such country by the fraction X/(X+Y), where X is the average cost of manufacturing actually incurred by BSP for such Product, and Y is the sum of the average manufacturing costs of such other active components.

For purposes of the foregoing, in the Calendar Year during which a Combination Product is first sold in a country, a forecasted average gross selling price shall be used for the Product and the other active component(s), to be determined in good faith mutually by the Parties. Any over or under payment due to a difference between forecasted and actual average gross selling prices in such country shall be paid or credited, as applicable, in the first royalty payment of the following Calendar Year. In the following Calendar Year the average gross selling price of both the

 

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Product and the other active component(s) included in the Combination Product in the previous Calendar Year shall apply.

1.104 “ODC Competitive Infringement” has the meaning set forth in Section 8.4.1.

1.105 “OncoMed Development Compound” means any Collaboration Compound and/or Product for which OncoMed has the exclusive (as between the Parties) right to conduct Development and/or Commercialization as described in Sections 3.1.2(d), 3.1.4(c), 3.4.1, 3.6.7, and 11.6.1.

1.106 “OncoMed Diagnostic Kit” means a Diagnostic Kit that is being Developed, based on Biomarker Technology, by OncoMed or a collaborator with which OncoMed is Developing such Diagnostic Kit, but that is not commercially available, and that is useful for the Development or Commercialization of BSP Development Compounds.

1.107 “OncoMed Intellectual Property” means the OncoMed Patents and the OncoMed Know-How.

1.108 “OncoMed Know-How” means all Know-How Controlled by OncoMed or its Affiliates as of the Effective Date or at any time during the Term that is (i) [***] or (ii) [***] . “OncoMed Know-How” shall include any and all Know-How Controlled by OncoMed that is within the OncoMed Owned Inventions.

1.109 “OncoMed Owned Inventions” has the meaning set forth in Section 8.1.3.

1.110 “OncoMed Patents” means any and all (a) Patents that are Controlled by OncoMed as of the Effective Date as set forth on Exhibit 1.110 and (b) other Patents that (i) are Controlled by OncoMed or its Affiliates during the Term and (ii) claim or disclose (A) compositions of matter comprising a Collaboration Compound or Product, or methods of using, [***], provided that [***]. “OncoMed Patents” shall include any and all Patents Controlled by OncoMed that claim or disclose any OncoMed Owned Inventions.

1.111 “Other Antibody Class” means all Antibody Collaboration Compounds that are not [***].

1.112 “Patent Representative” has the meaning set forth in Section 4.5.1.

1.113 “Patents” means patents and patent applications and (a) any foreign counterparts thereof, (b) all divisionals, continuations, continuations in-part thereof or any other patent application claiming priority directly or indirectly to (i) any such specified patents or patent applications or (ii) any patent or patent application from which such specified patents or patent applications claim direct or indirect priority, and (c) all patents issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues,

 

[***] Certain information in this document 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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re-examinations, renewals, supplemental protection certificates, or extensions of any of the foregoing, and any foreign counterparts thereof.

1.114 “Pathway” has the meaning set forth in Exhibit 1.113.

1.115 “Patient Sample” means tissue, fluid, or cells collected from a patient, or components of the foregoing.

1.116 “Person” means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture, governmental authority, association or other entity.

1.117 “Phase I Trial” means a Phase Ia Trial and/or a Phase Ib Trial.

1.118 “Phase Ia Trial” means a human clinical trial of a compound, the principal purpose of which is a preliminary determination of safety, pharmacokinetics, and pharmacodynamic parameters in healthy individuals or patients, as described in 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

1.119 “Phase Ib Trial” means a human clinical trial of a product, the principal purpose of which is a further determination of safety and pharmacokinetics of the compound in combination with concomitant treatment after an initial Phase Ia Trial, prior to Commencement of Phase II Trials or Phase III Trials, and which provides (itself or together with other available Data) sufficient evidence of safety to be included in filings for a Phase II Trial or a Phase III Trial with Regulatory Authorities, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

1.120 “Phase II Trial” means a human clinical trial of a compound in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) or equivalent Regulatory Filings with similar requirements in a country other than the United States and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population.

1.121 “Phase III Trial” means a human clinical trial of a compound performed after evidence suggesting effectiveness of the compound has been obtained pursuant to one (1) or more Phase II Trial(s), conducted for inclusion in: (a) that portion of an FDA submission and approval process which provides for the continued trials of a product on sufficient numbers of human patients to confirm with statistical significance the safety and efficacy of a product sufficient to support a Regulatory Approval for the proposed indication, as more fully described in 21 C.F.R. 312.21(c), or (b) equivalent Regulatory Filings with similar requirements in a country other than the United States.

1.122 “Phase IV Trial” means a human clinical trial for a Product Commenced after receipt of Regulatory Approval in the country for which such trial is being conducted and that is conducted within the parameters of the Regulatory Approval for the Product. Phase IV

 

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Trials may include, without limitation, epidemiological studies, modeling and pharmacoeconomic studies, investigator sponsored clinical trials of Product and post-marketing surveillance studies.

1.123 “Pivotal Trial” means any Clinical Trial of a Product, including without limitation a Phase III Trial, that is designed to support the filing of a BLA or NDA for such Product.

1.124 “Product” means any product that contains a Collaboration Compound as a therapeutically active ingredient.

1.125 “Reasoned Decision” is a decision that is not arbitrary and capricious and shall be explained to the Party entitled to receive such decision.

1.126 “Regulatory Approvals” means, with respect to any product in any jurisdiction, all approvals from any Regulatory Authority necessary for the sale of the product in such jurisdiction in accordance with Law, including without limitation a BLA Approval or an NDA Approval.

1.127 “Regulatory Authority” means any national or supranational governmental authority, including without limitation the FDA, EMA or Koseisho (i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto), that has responsibility in countries in the Territory over the Development and/or Commercialization of a Collaboration Compound and/or a Product.

1.128 “Regulatory Filings” means any and all regulatory applications, filings, approvals and associated correspondence required to Develop, manufacture, market, sell and import Products in, or into, each country or jurisdiction in the Territory.

1.129 “Relevant BSP Patents” has the meaning set forth in Section 8.3.1.

1.130 “Research” means the scientific investigation conducted to discover compounds that are useful to treat or prevent diseases or conditions, including without limitation cancer, by modulation of the Pathway.

1.131 “Results” means any analysis, conclusions or hypotheses drawn from any Data regarding the safety, efficacy, performance or other characteristic of any chemical, compound, reagent or biological material, regardless of whether such analysis, conclusions or hypotheses are published or submitted to any Regulatory Authority.

1.132 “Royalty Term” means, on a country-by-country and Product-by-Product basis, subject to Section 6.4.2:

(a) for Products containing BSP Development Compounds that are Small Molecule Collaboration Compounds, the period commencing upon First Commercial Sale of such Product in the country of sale and ending on the date that is the last to occur of:

 

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(i) expiration of the last Valid Claim of [***] covering [***] Compound in such country;

(ii) expiration of the last Valid Claim of [***] covering [***] in each case that is not described in subsection (i) and that covers [***] such Product in such country;

(iii) expiration of the last Valid Claim of [***] that is not described in subsection (i) or subsection (ii), that covers [***] and that issues from a patent application, or claims priority to [***], that was [***] such Product;

(iv) expiration of all applicable Exclusivity Extensions in such country with respect to such Product; or

(v) ten (10) years after First Commercial Sale of such Product in such country.

(b) for Products containing BSP Development Compounds that are Biologic Collaboration Compounds, the period commencing upon the First Commercial Sale of such Product in the country of sale and ending on the date that is the last to occur of:

(i) expiration of the last Valid Claim covering [***] such Product in such country that is within either (A) [***] (B) [***]

(ii) expiration of all applicable Exclusivity Extensions in such country with respect to such Product; or

(iii) ten (10) years after First Commercial Sale of such Product in such country.

1.133 “Small Molecule Advancement” means the decision by BSP to advance Small Molecule Collaboration Compounds into the Collaboration for further Development and potential Commercialization and to obtain the license set forth in Section 5.1.1, which shall be deemed to occur upon [***].

1.134 “Small Molecule Class” means any and all Small Molecule Collaboration Compounds.

1.135 “Small Molecule Collaboration Compound” means any molecule that [***]. “Small Molecule Collaboration Compounds” shall not include (a) [***].

1.136 “Small Molecule Development Plan” means a plan that, depending upon the stage of Development, details the Research and/or Development activities to be conducted pursuant to this Agreement with respect to Small Molecule Collaboration Compounds during the

 

[***] Certain information in this document 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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Term, and may include without limitation the following anticipated Development activities or events: [***]. The Small Molecule Development Plan will include, without limitation, [***].

1.137 “Small Molecule Research Term” means the period commencing from the Effective Date and ending upon the [***] to occur or either (a) [***].

1.138 “Sublicense” means a written agreement pursuant to which a Third Party or an Affiliate became a Sublicensee.

1.139 “Sublicensee” means any Third Party granted a sublicense by BSP of any of the rights licensed to BSP by OncoMed under Section 5.1 or under any Patents and Know-How Controlled by BSP claiming or disclosing Small Molecule Collaboration Compounds. For avoidance of doubt, a “Sublicensee” shall include, without limitation, (a) a Third Party to whom BSP has granted the right to promote or distribute a Product if such Third Party is principally responsible for marketing and promotion of such Product within a particular country or territory, (b) the party to a further sublicense as set forth in Section 5.2.5, and/or (c) a Third Party granted a sublicense by OncoMed of any of the rights granted to it by BSP hereunder.

1.140 “Substitute Compound” has the meaning set forth in Section 2.4.4.

1.141 “Term” has the meaning set forth in Section 11.1.

1.142 “Territory” means any and all countries in the world.

1.143 “Third Party” means any Person other than BSP, OncoMed, and their respective Affiliates.

1.144 “Trade Mark” means any trademark, name, logotype or trade dress owned or otherwise Controlled by BSP or any Affiliate of BSP, and used by BSP in connection with the marketing of any Product under this Agreement in the Territory.

1.145 “United States” or “U.S.” means the United States of America and all its territories and possessions.

1.146 “Valid Claim” means:

(a) an issued claim of an issued patent that has not (i) expired or been canceled, (ii) been declared invalid by a decision of a court or other appropriate body of competent jurisdiction, from which no appeal is or can be taken, (iii) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (iv) been abandoned or disclaimed; and

(b) a claim included in a pending patent application that is being prosecuted in good faith and that has not been (i) canceled, (ii) withdrawn from consideration, (iii) finally determined to be unallowable by the applicable governmental authority (from which no appeal is or can be taken), or (iv) abandoned or disclaimed; provided, however, that, if a claim of a patent application has been pending for more than [***], such claim will not constitute

 

[***] Certain information in this document 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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a Valid Claim for the purposes of this Agreement unless and until a Patent issues with such claim, provided, further, that, for purposes of the foregoing proviso, any [***] shall be considered [***].

2. C OLLABORATION O VERVIEW ; R ESEARCH AND D EVELOPMENT OF C OLLABORATION C OMPOUNDS

2.1 Collaboration Overview.

2.1.1 OncoMed shall undertake Research and Early Development activities for all Biologic Collaboration Compound Classes with the objective of Developing Biologic Collaboration Compounds that meet the Candidate Selection Criteria to enable BSP to determine its interest in exercising the BSP Option for the respective Biologic Collaboration Compound Classes pursuant to Section 3.1.1. In addition, BSP, with the assistance of OncoMed, shall undertake Research and Early Development activities with the objective of Developing Small Molecule Collaboration Compounds that meet the Candidate Selection Criteria to enable BSP to determine whether to advance Small Molecule Collaboration Compounds into the Collaboration.

2.1.2 If BSP exercises a BSP Option for any Biologic Collaboration Compound Class in accordance with Section 3.1 or if the Small Molecule Advancement occurs in accordance with Section 3.2, the Biologic Collaboration Compounds in such Biologic Collaboration Compound Class that are Late BSP Development Compounds or the Small Molecule Collaboration Compounds, respectively, shall be further Developed and Commercialized by BSP, its Affiliates or Sublicensees, as described in, and subject to the terms and conditions of, this Agreement. Except as otherwise provided in this Agreement, any Product containing any Biologic Collaboration Compound in a Class for which the BSP Option is exercised, or any Small Molecule Collaboration Compound, if the Small Molecule Advancement occurs, shall be marketed and sold by BSP, its Affiliates and Sublicensees, and BSP shall pay milestones and royalties to OncoMed in accordance with Article 6 with respect thereto; provided that OncoMed may exercise its option to undertake co-Development activities with respect to any such Candidate Selection Compounds that are Biologic Collaboration Compounds as and to the extent set forth in Section 3.8.

2.1.3 Generally, except as otherwise expressly provided in this Agreement or in a Biologic Development Plan, (a) OncoMed shall be responsible for, and shall bear the costs and expenses incurred in connection with the conduct of, all Research and Early Development activities with respect to Biologic Collaboration Compounds, including without limitation BSP Development Compounds that are Biologic Collaboration Compounds but are not Late BSP Development Compounds, under this Agreement during the Biologic Research and Early Development Term, subject to Section 3.3, and (b) BSP shall be responsible for, and shall bear the costs and expenses incurred in connection with the conduct of, all Late Development activities under this Agreement with respect to Biologic Collaboration Compounds that are Late BSP Development Compounds. Generally, except as otherwise expressly provided in this Agreement or in a Small Molecule Development Plan, BSP (with the assistance of OncoMed as set forth in the Small Molecule Development Plan) shall be primarily responsible for, and shall

 

[***] Certain information in this document 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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bear the costs and expenses incurred in connection with the conduct of, all Research and Development activities with respect to Small Molecule Collaboration Compounds. OncoMed, at its expense, will perform certain assays, in vitro and/or in vivo screening, or other Development activities, and provide the quantities of Materials required for the [***] described in the initial Small Molecule Development Plan, and additional reasonable quantities of other Materials required by BSP in connection with the Development of Small Molecule Collaboration Compounds conducted under a Development Plan, as described in Section 2.3.3.

2.2 Efforts.

2.2.1 Pursuant to this Agreement, OncoMed shall use Commercially Reasonable Efforts to, during the Biologic Research and Early Development Term: (a) Research and progress at least three (3) Biologic Collaboration Compounds [***] and (b) advance at least two (2) Candidate Selection Compounds that are Biologic Collaboration Compounds through to [***]. For clarity, the Parties acknowledge that the [***] has [***] Candidate Selection Compound, [***].

2.2.2 Pursuant to this Agreement, BSP shall use Commercially Reasonable Efforts to, during the Small Molecule Research Term: (a) [***] and (b) [***].

2.2.3 Each Party shall use Commercially Reasonable Efforts to perform the activities assigned to such Party in each Development Plan.

2.3 Research and Development Activities Prior to Exercise of a BSP Option or Small Molecule Advancement.

2.3.1 Commencement of Research and Development Activities. Each Party shall commence Research and Development efforts to identify Candidate Selection Compounds other than the 18R5 Collaboration Compound as soon as reasonably practicable after the Effective Date as described in Sections 2.1 and 2.2. The Parties hereby confirm that OncoMed has initiated Research and Development activities with respect to the 18R5 Collaboration Compound and an Fzd-Fc Collaboration Compound as of the Effective Date.

2.3.2 Inclusion of Collaboration Compounds in a Class. During the Biologic Research and Early Development Term, as OncoMed identifies Biologic Collaboration Compounds, OncoMed shall inform the JSC of the identity of such compound and the Biologic Collaboration Compound Class to which such compound belongs. After the JSC verifies that such a Collaboration Compound is a member of the applicable Biologic Collaboration Compound Class, the relevant Collaboration Compound shall be designated as a member of the 18R5 Class, a member of the Fzd-Fc Class, or a member of the Other Antibody Class. During the Small Molecule Research Term, as BSP identifies Small Molecule Collaboration Compounds, BSP shall inform the JSC of the identity of such compound. After the JSC verifies that such a Small Molecule Collaboration Compound is a member of the Small Molecule Class, such compound shall be so designated. If the JSC cannot agree whether a particular compound should be designated as a member of the 18R5 Class, a member of the Fzd-Fc Class, a member of the Other Antibody Class, or a member of the Small Molecule Class, the dispute shall be first

 

[***] Certain information in this document 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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escalated as described in Section 12.1 and, if necessary, then decided under the Expert Dispute Resolution Procedures set forth in Section 12.3.

2.3.3 Transfer of Assay Technology. From time to time during the Small Molecule Research Term, OncoMed shall transfer to BSP OncoMed Know-How necessary to enable BSP to practice the Assay Technology identified by the JSC as necessary for BSP to perform in vitro assays, or other activities that the JSC agrees are necessary for BSP to perform, in Developing Small Molecule Collaboration Compounds pursuant to the Small Molecule Development Plan. OncoMed shall transfer the quantities of Materials for the [***] to be performed pursuant to the initial Small Molecule Development Plan as described in Section 2.1.3 and other Materials as set forth in the Small Molecule Development Plan. The Small Molecule Development Plan shall specify any additional OncoMed Know-How and Materials to be transferred; [***]. During the Small Molecule Research Term, each Party will keep the other Party informed of any and all Assay Technology Improvements and otherwise provide additional materials, protocols, and other information necessary to enable the other Party to practice such Assay Technology Improvements. After the expiration of the Small Molecule Research Term, BSP shall not be permitted to use any OncoMed Know-How for the practice of the Assay Technology, and BSP shall return any tangible OncoMed Know-How transferred by OncoMed to BSP under this Section 2.3.3 promptly after such expiration, unless there is an active ongoing program to identify back-up Small Molecule Collaboration Compounds. [***].

2.3.4 Consultation. Each Party will provide reasonable consultation to the other Party, as requested by the other Party, in connection with such other Party’s Research and Development activities under this Agreement, [***] other than as set forth in Section 3.6.7.

2.3.5 Development Presentations. Subject to Section 3.6.2, each Party will provide the JSC with presentations at JSC meetings at the request of the other Party’s JSC members. Each presentation shall include [***]. Such presentations may also include summaries of the costs incurred by such Party in the performance of such Research and Development activities prior to the date of such report. Upon request by the JSC, each Party shall provide the JSC with information included in Exhibit 4.1.1.

2.3.6 Records. Each Party shall, and shall require its contractors and Sublicensees to, maintain complete and accurate hard and/or electronic copies of records of all work conducted in furtherance of the Research and Development of Collaboration Compounds and all results, data, and developments made in conducting such activities. Such records shall be complete and accurate and shall fully and properly reflect all such work done and results achieved in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.

2.3.7 Research and Development Standards. Each Party shall conduct all such Research and Development activities in compliance with Law, including without limitation all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials.

 

[***] Certain information in this document 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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2.3.8 Regulatory Responsibilities and Costs. OncoMed shall prepare, file, maintain, and own all Regulatory Filings and related submissions with respect to each Biologic Collaboration Compound that is not a Late BSP Development Compound, and shall bear the cost of such preparation. BSP shall prepare, file, maintain and own all Regulatory Filings and related submissions with respect to each Late BSP Development Compound and each Small Molecule Collaboration Compound and shall bear the cost of such preparation. Any Regulatory Filing prepared, filed, maintained or owned by OncoMed with respect to any Clinical Trial for a Late BSP Development Compound prior to exercise of the BSP Option with respect to such compound, and any related submissions, shall be transferred to BSP and OncoMed shall conduct co-Development activities, if any, under such Regulatory Filings. If OncoMed makes any such filings or submissions, it shall provide copies of such proposed filings or submissions to BSP in advance and incorporate BSP’s reasonable comments on such filings or submissions.

2.3.9 Subcontracting. Each Party may perform any activities in support of its Research and Early Development of Collaboration Compounds under this Agreement through subcontracting to a Third Party contractor or contract service organization; provided that: (a) none of the rights of the other Party hereunder are materially adversely affected as a result of such subcontracting; (b) any such Third Party subcontractor to whom such Party discloses Confidential Information shall enter into an appropriate written agreement obligating such Third Party to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than the obligations in Article 9; (c) such Party will obligate such Third Party to agree [***], and Know How generated by such Third Party, in performing such services for such Party that are necessary for the Development or Commercialization of Collaboration Compounds, Candidate Selection Compounds, or Products, as applicable; and (d) such Party shall at all times be responsible for the performance of such subcontractor. Each Party shall provide the other Party [***] any subcontracts proposed to be entered into after the Effective Date for [***]. BSP shall [***] the JSC shall discuss and agree upon [***].

2.4 Selection of Candidate Selection Compounds.

2.4.1 General. The Parties have agreed upon the initial Candidate Selection Criteria for each Class, attached as Exhibit 1.33 as of the Effective Date. The JSC may modify the Candidate Selection Criteria for each Class from time to time during the Term pursuant to Section 4.1.1(a) [***]; provided that, if OncoMed has used Commercially Reasonable Efforts to perform its obligations under a Small Molecule Development Plan in accordance with the originally agreed upon Candidate Selection Criteria, OncoMed shall not be in breach of its obligations under Section 2.2.3 to the extent such obligations relate to the changes made to such Candidate Selection Criteria, but OncoMed shall nonetheless use good faith efforts to perform activities in connection with such changed Candidate Selection Criteria. Each Party will test the Collaboration Compounds for which it is responsible for performing Research and Early Development pursuant to Section 2.2 using the Assay Technology as set forth in the Biologic Development Plan or the Small Molecule Development Plan, and using other appropriate analytical and evaluative tools and methods, to generate the data required to evaluate such a Collaboration Compound against the Candidate Selection Criteria.

 

[***] Certain information in this document 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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2.4.2 Notification of Candidate Selection Compounds. Each Party will notify the JSC upon its identification of a Candidate Selection Compound and will provide the JSC with data and information supporting such Party’s determination that the Collaboration Compound has met the Candidate Selection Criteria. The JSC shall verify such Party’s designation of the Collaboration Compound as a Candidate Selection Compound as soon as reasonably practicable, but in no event later than [***] following the receipt of such notice and data and information from the notifying Party. If the JSC cannot agree whether a Biologic Collaboration Compound has met the Candidate Selection Criteria, [***] such dispute shall be first escalated as described in Section 12.2 and, if necessary, then decided under the Expert Dispute Resolution Procedures set forth in Section 12.3. Notwithstanding anything to the contrary, the Parties agree that [***]. If the JSC cannot agree whether [***], such dispute shall be first escalated as described in Section 12.2, but if such executives cannot resolve such dispute, [***].

2.4.3 Selection of Collaboration Compounds Not Meeting Candidate Selection Criteria. The JSC shall have the discretion to accept any Collaboration Compound as a Candidate Selection Compound that does not meet the Candidate Selection Criteria for the relevant Class, and upon such acceptance, such Collaboration Compound shall be a Candidate Selection Compound for all purposes under this Agreement. If the JSC does not agree that such Collaboration Compound should be selected as a Candidate Selection Compound, such matter shall not be escalated for resolution, and such Collaboration Compound shall not be deemed a Candidate Selection Compound under this Agreement.

2.4.4 Substitute Compounds. Within [***] after selection by the JSC of a Candidate Selection Compound pursuant to Section 2.4.2 or 2.4.3, the JSC shall determine whether such Candidate Selection Compound shall be deemed a compound that may be substituted as a backup compound at a later time for any previously selected Candidate Selection Compound that binds to and/or directly modulates the same Collaboration Target if, based on properties of the previously selected Candidate Selection Compound, the previously selected Candidate Selection Compound Development is terminated and the newly identified Candidate Selection Compound may possess improved properties more suitable for Development (any such Candidate Selection Compound, a “Substitute Compound” solely with respect to such previously selected Candidate Selection Compound); provided that, for each Candidate Selection Compound that is not deemed a Substitute Compound itself, there may be no more than [***] that [***] a Substitute Compound therefor at any given time. If the JSC cannot agree whether a particular compound should be designated as a Substitute Compound, neither Party will have final decision-making authority, and such dispute shall be first escalated as described in Section 12.2 and, if necessary, then decided under the Expert Dispute Resolution Procedures set forth in Section 12.3. For clarity, this Section 2.4.4 is intended to address only the characterization of a Collaboration Compound as a Substitute Compound for purposes of payments to be made pursuant to Section 6.3.4, and nothing in this Section 2.4.4 shall impact BSP’s or OncoMed’s own decisions on whether or not to Develop and/or Commercialize any Substitute Compound.

2.5 Development Plans for Candidate Selection Compounds. The Parties have agreed on a Biologic Development Plan proposed by OncoMed for the Research activities

 

[***] Certain information in this document 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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to be initiated with regard to the identification of new Biologic Collaborations Compounds and Early Development activities for each Biologic Collaboration Compound to be Developed as of the Effective Date, and a Small Molecule Development Plan proposed by BSP for Research activities to be initiated with regard to the identification of Small Molecule Collaboration Compounds as of the Effective Date. Such Development Plans are appended to this Agreement as Exhibit 2.5. The JSC may approve modifications of such Development Plans from time to time, provided, however, that no Small Molecule Development Plan may [***] taking into account [***]. Thereafter, during the Biologic Research and Early Development Term, the JSC shall approve a Biologic Development Plan proposed by OncoMed for each new Biologic Collaboration Compound that OncoMed elects to Develop after the Effective Date, and during the Small Molecule Research Term the JSC shall approve a Small Molecule Development Plan proposed by BSP for each new Small Molecule Collaboration Compound that BSP elects to Develop after the Effective Date. Such Development Plans shall be similarly updated and approved annually or more frequently as approved by the JSC.

2.6 Manufacture and Supply. OncoMed shall be solely responsible at its expense for making or having made all of its requirements of any Biologic Collaboration Compound that is not a Late BSP Development Compound, including without limitation the conduct of process development, manufacturing, fill and finish, testing and supply of clinical supplies of such Biologic Collaboration Compounds for Development purposes, itself or through Third Party contract manufacturers; provided that, with respect to any material subcontracts entered into after the Effective Date, [***]. As described in Section 3.7, BSP shall be solely responsible at its expense for making or having made all of its requirements of any Late BSP Development Compound and any Small Molecule Collaboration Compound. Each Party and its Third Party contractors shall manufacture, handle, store and ship all Collaboration Compounds and Products containing such compounds in compliance with all Law, with all applicable Regulatory Filings, and with its applicable internal specifications and quality control procedures.

2.7 Adverse Event Reporting. The Parties agree to exchange all relevant information that relates to the safety of Collaboration Compounds (e.g., serious adverse drug reactions). Prior to the earlier of ninety (90) days after the Effective Date, enrollment of the first patient in a Clinical Trial relating to a Collaboration Compound that is conducted by or on behalf of BSP, or the filing of the first IND for a Product by BSP, the Parties will enter into a pharmacovigilance agreement to govern the investigation of and action to be taken with regard to Collaboration Compound-related serious adverse experiences. Such agreement shall contain reasonable terms and conditions as are typically included in agreements of similar nature, including without limitation provisions enabling each of the Parties to comply with its legal obligations with respect to Collaboration Compound-related serious adverse experiences worldwide. Such pharmacovigilance agreement will promptly be amended as changes in legal obligations require or as otherwise agreed by the Parties.

 

[***] Certain information in this document 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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3. BSP O PTION ; S MALL M OLECULE A DVANCEMENT ; D EVELOPMENT AND C OMMERCIALIZATION OF BSP D EVELOPMENT C OMPOUNDS

3.1 BSP Option.

3.1.1 BSP Option Exercise. Subject to the terms and conditions of this Agreement, OncoMed hereby grants to BSP the exclusive right to elect, at its sole discretion, to obtain an exclusive, worldwide license under Section 5.1.1 to Develop and Commercialize Biologic Collaboration Compounds within a given Biologic Collaboration Compound Class as Products under the terms and conditions set forth in this Agreement (each such right to elect, a “BSP Option” ). The BSP Option for each Biologic Collaboration Compound Class shall expire at the end of the BSP Option Period relevant to such Class. BSP shall exercise the BSP Option by written notice to OncoMed within the applicable BSP Option Period. Upon exercise of a BSP Option, all Biologic Collaboration Compounds in the Class for which the BSP Option has been exercised shall be designated as BSP Development Compounds, except as otherwise provided in Section 3.1.2, unless and until Section 3.6.7 applies. For clarity, if OncoMed undergoes a Change of Control, BSP shall nonetheless be entitled to exercise the BSP Option as provided in this Section 3.1.

3.1.2 Consequences of Exercise of BSP Option with Respect to Certain Payment Obligations or Other Classes. In general, BSP may exercise the BSP Option on a Class-by-Class basis prior to expiration of the relevant BSP Option Period. However, the [***], as set forth in this Section 3.1.2 below.

(a) BSP may exercise the BSP Option for the [***] Class in its entirety [***]. In such case, BSP shall [***], and BSP shall pay the [***] payment set forth in the column in Exhibit 6.3.2 [***] but BSP shall not be required to pay the [***] However, in such case, [***].

(b) BSP may exercise the BSP Option for the [***] Class [***], in which case it shall pay the [***] payment set forth in the [***]

(c) BSP may exercise the BSP Option for the [***] Class in its entirety [***]. In such case, BSP shall pay the [***] payment due to OncoMed set forth in the [***] upon exercise of the BSP Option for the [***] Class [***].

(d) BSP may exercise the BSP Option for the [***] Class in either of the situations described in subsections (a) or (c), but choose to [***]. In such case, subsections (a) or (c) shall apply, as applicable, but (i) [***], (ii) BSP shall become obligated to pay to OncoMed [***], upon such exercise of the BSP Option, and (iii) for clarity, if such exercise is in the situation described in subsection (c), BSP shall pay [***].

(e) BSP may exercise the BSP Option with respect to the [***] Class, in which case it shall pay to OncoMed [***].

 

[***] Certain information in this document 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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3.1.3 Additional Studies. At least [***] prior to the end of the BSP Option Period for a Biologic Collaboration Compound Class, BSP shall notify the JSC as to its determination as to whether the data resulting from the Phase Ib Trial for the first Collaboration Compound in such Class is reasonably sufficient for BSP to determine whether to exercise the BSP Option for such Class, or whether additional preclinical studies or Phase I Trials should be performed to provide data reasonably sufficient for BSP to determine whether to exercise its BSP Option for such Class. If the JSC determines that additional preclinical studies or Phase I Trials should be performed, OncoMed (reasonably considering any guidance and comments from BSP with respect to such additional preclinical studies or Phase I Trials), or at OncoMed’s discretion BSP, shall conduct such additional preclinical studies or Phase I Trials, at BSP’s expense, pursuant to an updated Biologic Development Plan for such activities, which shall include a timeline for completion of such activities. If the JSC determines to conduct such additional preclinical studies or Phase I Trials, the BSP Option Period for such Class will be extended until the date that is [***] after such additional preclinical activities have been completed or such additional Phase I Trials have been Completed, whichever is later. If the JSC cannot agree whether additional preclinical studies or Phase I Trials should be conducted, [***]. Notwithstanding anything to the contrary, BSP can request such additional studies to be conducted under this Section 3.1.3 [***].

3.1.4 HSR.

(a) If the exercise of any BSP Option requires clearance under the Hart-Scott Rodino Act of 1976, as amended (the “HSR Act” ), as determined by BSP, the Parties shall cooperate with each other in the preparation, execution and filing of all documents that are required (as reasonably determined by BSP) to be filed pursuant to the HSR Act and will use reasonable good faith efforts with all deliberate speed to comply with any information requests from the Federal Trade Commission ( “FTC” ) or Department of Justice in connection with such filing, including without limitation a Request for Additional Information under 15 U.S.C. § 18a and 16 C.F.R. § 803.20 (a “Second Request” ), if applicable.

(b) Without limiting the foregoing, the Parties shall promptly make such filings after BSP’s notice to OncoMed of BSP’s intention to exercise such BSP Option, pending HSR Act clearance. For purposes of clarification, in the event that clearance under the HSR Act is required with respect to any BSP Option, as described above, exercise of such BSP Option shall not be effective, and no payment under Section 6.3.2 shall be due as a consequence of exercise of such BSP Option, until after the expiration or termination of all applicable waiting periods under the HSR Act; provided that, as long as BSP has provided notice of its intention to exercise such BSP Option prior to the expiration of the applicable BSP Option Period, then the BSP Option Period will be deemed to extend until the expiration or termination of such waiting periods (subject to Section 3.1.4(c)). Filing fees under the HSR Act shall be paid by BSP.

(c) If a Second Request issues in connection with any filings required under the HSR Act as described in this Section 3.1.4 and notwithstanding the good faith efforts of the Parties under Section 3.1.4(a), clearance of the relevant exclusive license has not been obtained from the FTC within [***] after the Parties’ initial premerger notification under

 

[***] Certain information in this document 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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the HSR Act in connection with the exercise of a BSP Option, then all Biologic Collaboration Compounds within the relevant Class shall become OncoMed Development Compounds; provided, however, that if OncoMed has not certified its compliance with all FTC requests made of OncoMed in any Second Request within [***] after the Parties’ initial premerger notification under the HSR Act, such [***] time period shall be extended by a number of days equal the number of days between the date that is [***] after such notification and the date upon which OncoMed certifies such compliance.

(d) If BSP exercises the BSP Option but then fails to obtain clearance from the FTC with respect thereto prior to expiration of the foregoing [***] time period (subject to extension as provided in Section 3.1.4(c)), and OncoMed subsequently itself or through a licensee Develops and Commercializes OncoMed Development Compounds within such Class, then [***], provided that (i) such failure to clear HSR review was not attributed in material part by the FTC to BSP’s interest in any compound or product that was licensed or acquired by BSP after the Effective Date from a Third Party that modulates a target in the Pathway and (ii) BSP did not divest its interest in such other compound or product, or take other actions, required by the FTC to obtain such clearance. Such reimbursement shall be paid in the form of an annual royalty of [***] of Net Sales of OncoMed Development Compound, provided that such payments due to BSP pursuant to this Section 3.1.4(d) shall not [***]. Any disputes relating to [***] under this Section 3.1.4(d) shall be settled using the Expert Dispute Resolution Procedure of Sections 12.2 and 12.3 to the extent such dispute relates to calculation of the relevant amounts, or, for any other such dispute, shall be settled using the Dispute Resolution Procedure of Sections 12.2 and 12.4.

3.2 Small Molecule Advancement. Subject to the terms and conditions of this Agreement, OncoMed hereby grants to BSP the exclusive right, at any time during the time period set forth in Section 6.3.3, to elect to advance Small Molecule Collaboration Compounds into the Collaboration for further Development and potential Commercialization and to obtain the license under Section 5.1.1 with respect thereto. To exercise such right, BSP shall notify OncoMed in writing. Upon OncoMed’s receipt of such notice and payment in accordance with Section 6.3.3, all Small Molecule Collaboration Compounds shall be designated as BSP Development Compounds. If BSP does not exercise such right as provided herein, [***]. For clarity, if OncoMed undergoes a Change of Control, BSP shall nonetheless be entitled to advance Small Molecules into the Collaboration as provided in this Section 3.2.

3.3 Additional Development. If, due to unexpected [***] factors, OncoMed determines that it is advisable to perform Early Development work not anticipated in the then-current Biologic Development Plan that is necessary for OncoMed to progress [***] Collaboration Compounds to [***] (“Additional Development”), the costs of which, together with the costs of previous Development activities OncoMed performed under this Agreement to meet its obligations under Section 2.2.1 prior to its first knowledge of such unexpected factors, are anticipated to exceed the amounts received from BSP under this Agreement prior to such date by [***] or more (the foregoing, and “Unexpected Cost Increase”), the Parties shall meet to discuss the circumstances giving rise to the Unexpected Cost Increase and to evaluate possible

 

[***] Certain information in this document 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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ways of avoiding such Unexpected Cost Increases, or updating the Development Plan and of [***]. If any such Unexpected Cost Increase is anticipated or occurs, [***].

3.4 BSP Rights and Obligations for a Late BSP Development Compound.

3.4.1 Following exercise of a BSP Option for a Biologic Collaboration Compound Class or the occurrence of Small Molecule Advancement, as applicable, all Collaboration Compounds within such Class for which Phase Ib Trials have been Completed shall be designated Late BSP Development Compounds (subject to Section 3.1.2), and BSP shall use Commercially Reasonable Efforts to Develop and Commercialize Late BSP Development Compounds that are Biologic Collaboration Compounds and Small Molecule Collaboration Compounds, respectively, in accordance with Section 3.4.1(a) through (e). [***], BSP may terminate Development of any Late BSP Development Compound as provided in Section 11.3.2.

(a) After exercise of a BSP Option with respect to at least one (1) Biologic Collaboration Compound Class, BSP shall use Commercially Reasonable Efforts to Develop [***], except as otherwise provided in Section 3.4.1(c). After occurrence of Small Molecule Advancement, BSP shall use Commercially Reasonable Efforts to Develop [***].

(b) If the Small Molecule Advancement does not occur within the time period set forth in Section 6.3.3, and BSP has exercised its BSP Option with respect to [***], BSP shall use Commercially Reasonable Efforts to Develop [***]; provided, however, that BSP shall not be obligated to perform Development work on the [***] Biologic Collaboration Compound until [***] for the [***] have been Completed (for clarity, if, in the course of exercising its rights under Section 3.1 with respect to [***] Class, BSP obtains rights to [***], for purposes of this Section 3.4, BSP shall be deemed to have exercised its rights as to [***], whether or not it [***].

(c) BSP shall have fulfilled its obligations to use Commercially Reasonable Efforts to Develop Late BSP Development Compounds under this Section 3.4.1 if (i) BSP [***] or (ii) [***], or, [***], then BSP shall not be deemed to have fulfilled its obligations under this Section 3.4.1. BSP shall provide to the JSC information explaining the basis of its determination to [***], the dispute as to whether such [***] under this Section 3.4.1 shall be first escalated as described in Section 4.1.3 and, if necessary, then decided under the Dispute Resolution Procedures set forth in Sections 12.2 and 12.4. For clarity, if [***], but [***].

(d) BSP shall have fulfilled its obligations to use Commercially Reasonable Efforts to Commercialize Late BSP Development Compounds under this Section 3.4.1 if it [***], provided, however, that it shall be at [***] to determine [***].

(e) BSP acknowledges OncoMed’s requirements under Section 4.8(a) of the MorphoSys Agreement, and BSP agrees that, if it exercises the BSP Option for the 18R5 Class (and does not elect to omit from such Class the 18R5 Collaboration Compound pursuant to Section 3.1.2), BSP shall use Commercially Reasonable Efforts to Develop and Commercialize the [***].

 

[***] Certain information in this document 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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(f) If BSP breaches its obligations under this Section 3.4.1, the provisions of Section 3.6.7 shall apply. OncoMed’s right to terminate, exercisable upon [***] written notice to BSP, the relevant Biologic Collaboration Compound Class(es) shall be [***].

3.4.2 Following exercise of a BSP Option for a Biologic Collaboration Compound Class, to enable OncoMed to continue to meet its obligations under Section 2.2.1, OncoMed shall have the right to continue performing Research and Early Development activities under this Agreement with respect to BSP Development Compounds in such Biologic Collaboration Compound Class, other than Late BSP Development Compounds. For clarity, if BSP exercises its BSP Option for a Biologic Collaboration Compound Class before OncoMed has [***] in such Biologic Collaboration Compound Class, OncoMed will be deemed to have fulfilled its obligations under Section 2.2.1 to [***].

3.5 Technology Transfer. As soon as reasonably practical after BSP exercises its BSP Option for a Biologic Collaboration Compound Class or occurrence of the Small Molecule Advancement, OncoMed will provide BSP with all OncoMed Know-How directly relevant to all Late BSP Development Compounds in the Class for which the BSP Option is exercised or all Small Molecule Collaboration Compounds as appropriate, to the extent such OncoMed Know-How is necessary for the exercise by BSP of the rights granted under Section 5.1. [***]. OncoMed shall provide to BSP training at BSP’s site in Berlin, Germany, or another location as mutually agreed to by the Parties, for [***] BSP employees over a period not to exceed [***], including without limitation all Materials and information necessary to enable BSP to manufacture BSP Development Compounds in accordance with Section 3.7 and to conduct Clinical Trials of BSP Development Compounds, within [***] after receiving an invoice therefor from OncoMed. If requested by BSP, OncoMed shall provide reasonable assistance to BSP in practicing any such transferred Materials, [***] as the Parties may mutually agree in advance.

3.6 Development and Commercialization of BSP Development Compounds.

3.6.1 Development Plan. Within [***] following the exercise of a BSP Option for a Biologic Collaboration Compound Class or the occurrence of the Small Molecule Advancement, BSP will prepare and provide to OncoMed an updated Development Plan for all BSP Development Compounds in such Class for which BSP intends to conduct Late Development. BSP shall provide to OncoMed through the JSC all updates to such Development Plans. [***]; provided, however, that no such updated Development Plan may require OncoMed to provide, without OncoMed’s prior written consent, resources to or support for activities included therein beyond what is reasonable, taking into account OncoMed’s specific resources, expertise, and Know-How.

3.6.2 Development and Commercialization Information. During the Term, BSP will provide, on a [***] basis, OncoMed with the [***] regarding the Late Development and Commercialization activities performed by BSP relevant to Late BSP Development Compounds listed in Exhibits 3.6.2, 4.1.1, and 4.2.1. Following First Commercial Sale of a Product, upon OncoMed’s request, BSP will provide to OncoMed [***] regarding

 

[***] Certain information in this document 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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Development and Commercialization activities for such Product not otherwise provided to OncoMed as necessary to enable OncoMed to comply with Law. If BSP, at any time during the Term, reasonably believes that the disclosure to OncoMed of information regarding Development and/or Commercialization activities for a Product as required under this Agreement ( “Required Disclosure” ) is prohibited under applicable antitrust or competition Law, BSP shall so notify OncoMed and the Parties shall discuss reasonable ways in which such required disclosure may be modified or limited to render disclosure thereof to comply with applicable antitrust or competition Law. If after such discussion OncoMed disputes whether the Required Disclosure is prohibited under applicable antitrust or competition Law, the Parties shall submit such question to a mutually acceptable, independent Third Party who is an attorney with at least 15 years experience advising companies on compliance with applicable antitrust or competition Law applicable to the Required Disclosure. The Parties will use reasonable efforts to select such independent Third Party within [***] after OncoMed notifies BSP that OncoMed disputes such matter. Such Third Party shall render his or her decision within [***] after selection of such Third Party and provision of all necessary information for such Third Party properly to evaluate the question. If such Third Party decides that such Required Disclosure would be a disclosure prohibited by applicable antitrust or competition Law applicable to BSP, then regardless of any term of this Agreement, BSP shall have no obligation to make the Required Disclosure. If such Third Party determines that such Required Disclosure would not be prohibited by applicable antitrust or competition Law applicable to BSP, then BSP shall make the Required Disclosure.

3.6.3 Records. BSP shall maintain, and require its contractors and Sublicensees to maintain, complete and accurate records of all work conducted in furtherance of the Development and Commercialization of BSP Development Compounds and Products and all results, data and developments made in conducting such activities. Such records shall be complete and accurate and shall fully and properly reflect all work done and results achieved in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. [***].

3.6.4 Development and Commercialization Responsibilities and Costs. Subject to OncoMed’s co-Development rights under Section 3.8, BSP, at its sole cost and expense, shall have responsibility for conducting all Late Development and Commercialization activities with respect to BSP Development Compounds and Products containing such BSP Development Compounds. BSP shall conduct such activities in compliance with all Law, including without limitation all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials after exercise of the BSP Option or the occurrence of the Small Molecule Advancement for, and the Commercialization of Products containing, such BSP Development Compounds.

3.6.5 Regulatory Responsibilities and Costs. Promptly after BSP’s exercise of a BSP Option for a Biologic Collaboration Compound Class, OncoMed shall assign to BSP any Regulatory Filings then held in OncoMed’s name for Late BSP Development Compounds in such Biologic Collaboration Compound Class, and OncoMed will provide to BSP copies of all Regulatory Filings, and other papers related to such Regulatory Filings that are

 

[***] Certain information in this document 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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relevant to such Late BSP Development Compound. After such assignment occurs, BSP shall prepare, file, maintain, and own all Regulatory Filings and related submissions relating to such Late BSP Development Compound at BSP’s expense. During the Term, BSP shall prepare, file, maintain, and own all Regulatory Filings and related submissions relating to the BSP Development Compounds within the Small Molecule Class at BSP’s expense. Upon the request of OncoMed, BSP will provide OncoMed with the information described in Exhibit 4.2.1.

3.6.6 Subcontracting. Subject to and without limiting Section 5.2, BSP may perform any activities in support of its Development and Commercialization of Late BSP Development Compounds through subcontracting to a Third Party contractor or contract service organization, provided that: (a) none of the rights of OncoMed hereunder are materially adversely affected as a result of such subcontracting; (b) any such Third Party subcontractor to whom BSP discloses Confidential Information shall enter into an appropriate written agreement obligating such Third Party to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than the obligations in Article 9; (c) BSP shall obligate such Third Party to agree [***] in performing such services for BSP that are necessary for the Development or Commercialization of Late BSP Development Compounds or Products containing such Late BSP Development Compounds; and (d) BSP shall at all times be responsible for performance of such subcontractor.

3.6.7 OncoMed Development Compounds.

(a) Conversion into OncoMed Development Compounds.

(i) If BSP fails to exercise the BSP Option for a Biologic Collaboration Compound Class within the relevant BSP Option Period pursuant to Section 3.1.1, then all Biologic Collaboration Compounds in such Class shall automatically be deemed OncoMed Development Compounds and shall no longer be Collaboration Compounds.

(ii) If (A) BSP terminates a Biologic Collaboration Compound, Biologic Collaboration Compound Class or this Agreement at will pursuant to Section 11.3 or (B) OncoMed terminates a Biologic Collaboration Compound Class or this Agreement pursuant to Section 11.2.1, 11.4, or 11.5 or for breach of Section 3.4.1, then such Biologic Collaboration Compound (if termination operates only as to such compound), or all Biologic Collaboration Compounds in the relevant Class, if BSP’s rights to such Class are so terminated, or all Biologic Collaboration Compounds in the case of a termination of this Agreement, shall automatically be deemed OncoMed Development Compounds and shall no longer be Collaboration Compounds, subject to Section 3.6.7(a)(iii), as applicable.

(iii) Notwithstanding OncoMed’s right to terminate BSP’s licenses with respect to Biologic Collaboration Compound Classes for breach of Section 3.4.1, OncoMed shall not have the right to terminate BSP’s licenses in connection with any such breach of Section 3.4.1 with respect to [***] ( “Retained Compound” ), (B) [***]. The licenses granted to BSP under Section 5.1 shall survive with respect to such Retained Compounds. By way of example, and without limitation, if BSP breaches its obligations under Section 3.4.1 with

 

[***] Certain information in this document 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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respect to [***], then all Collaboration Compounds [***] shall automatically be deemed OncoMed Development Compounds.

(b) Consequences.

(i) Upon a Biologic Collaboration Compound becoming an OncoMed Development Compound, OncoMed shall have the right, but not the obligation, to Research, Develop, and Commercialize any and all OncoMed Development Compounds, alone or with any Third Party or through any Third Party Sublicensee;

(ii) The licenses set forth in Sections 5.3.2 and 5.3.3 shall survive any event resulting in transition of a Biologic Collaboration Compound to an OncoMed Development Compound;

(iii) With respect to any Late BSP Development Compound that becomes an OncoMed Development Compound by virtue of a termination of a Biologic Collaboration Compound, a Biologic Collaboration Compound Class or this Agreement by BSP under Section 11.3 or OncoMed under Section 3.4.1 or 11.2, 11.4, or 11.5, OncoMed may elect by written notice to BSP within the [***] period following such termination (the “Evaluation Period” ) to Develop and Commercialize such OncoMed Development Compound. If a Late BSP Development Compound becomes an OncoMed Development Compound by virtue of a termination by BSP under Section 11.3 or OncoMed under Section 11.4, OncoMed shall reimburse BSP an amount equal to [***] (the sum of (x) and (y), the “Full Amount” ). Such reimbursement shall be in the form of the following payments: (A) a first payment of an amount equal to [***] of the Full Amount, which amount is due within [***], (B) a second payment in an amount equal to [***] of the Full Amount, which is due upon [***] such OncoMed Development Compound by OncoMed or any OncoMed Affiliate or Sublicensee, and (C) additional payments equal in the aggregate to [***] of the Full Amount, which shall be paid [***], until such time as the Full Amount has been fully paid. If a Late BSP Development Compound becomes an OncoMed Development Compound by virtue of a termination of a Biologic Collaboration Compound, a Biologic Collaboration Compound Class or this Agreement by OncoMed under Section 3.4.1 or Section 11.2 or 11.5, OncoMed shall reimburse BSP as provided in this Section 3.6.7(b)(iii) above except that the Full Amount shall be calculated by replacing “[***] in subsection (x), above, with [***] and replacing “[***] in subsection (y), above, with “[***]. Any disputes relating to the amounts to be reimbursed under this Section 3.6.7(b)(iii) shall be settled using the Expert Dispute Resolution Procedure of Sections 12.2 and 12.3 to the extent such dispute relates to calculation of the relevant amounts, or, for any other such dispute, shall be settled using the Dispute Resolution Procedure of Sections 12.2 and 12.4.

(iv) With respect to any Collaboration Compound that becomes an OncoMed Development Compound:

(A) BSP shall return to OncoMed within a reasonable time, at no cost to OncoMed, all OncoMed Know-How transferred by OncoMed to BSP with respect to each such OncoMed Development Compound;

 

[***] Certain information in this document 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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(B) Except to the extent not permitted [***] BSP shall provide to OncoMed, within a reasonable time, at OncoMed’s request, subject to [***] in connection with such transfer [***] any and all [***] pertaining to the applicable OncoMed Development Compounds [***] with respect to or incorporated in [***] including without limitation copies of [***] throughout the Territory. Except to the extent not permitted pursuant to any agreements between BSP and a Third Party, if such [***] BSP shall [***]. If any such [***] or if [***] then BSP shall [***];

(C) At OncoMed’s request, BSP shall [***] and that [***] prior to reversion of such OncoMed Development Compounds to OncoMed, or [***] the extent permitted under the terms of [***]. OncoMed shall pay to BSP, within [***], to the extent [***];

(D) BSP shall transfer within a reasonable time to OncoMed, at OncoMed’s request and [***] pertaining to the applicable OncoMed Development Compounds in its possession or Control; and

(E) with respect to any BSP Development Compound that becomes an OncoMed Development Compound as a result of termination of this Agreement or a Class by BSP pursuant to Section 11.3 or by OncoMed pursuant to Section 3.4.1 or Article 11 at a time during which BSP is conducting a Clinical Trial for such BSP Development Compound, BSP will, [***] with respect to such Clinical Trial, provided that BSP shall [***] by [***] such Clinical Trial, or [***] such Clinical Trial, [***].

(v) Promptly after termination of a Class by OncoMed under Section 3.4.1 or Article 11 or by BSP under Section 11.3, BSP shall [***] a [***] in Sections 3.6.7(b)(iv)(A), (B), (C), and (D), such [***] within [***] after the Parties have [***]; and

(vi) After any Biologic Collaboration Compound becomes an OncoMed Development Compound, BSP shall [***] which may include (A) BSP [***], as requested by OncoMed within [***] after such termination, such OncoMed Development Compound for up to [***] following such termination, provided that OncoMed [***] as soon as reasonably practicable after such termination, [***], and/or (B) [***]. Additionally, BSP shall transfer to OncoMed [***].

(vii) To the extent that BSP owns any [***] that pertain specifically to an OncoMed Development Compound that was previously a BSP Development Compound and that [***], OncoMed shall have the right to [***]. OncoMed shall exercise such right by written notice to BSP within [***] after such BSP Development Compound becomes an OncoMed Development Compound. The Parties shall [***] for up to [***] after BSP receives any such written notice from OncoMed.

3.7 Manufacture and Supply of Late BSP Development Compounds and Small Molecule Collaboration Compounds After the Small Molecule Advancement. BSP shall be responsible for the process, development, manufacture, fill and finish, testing and supply

 

[***] Certain information in this document 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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of Late BSP Development Compounds and Small Molecule Collaboration Compounds, at BSP’s expense. OncoMed shall transfer all OncoMed Know-How necessary for the fulfillment of BSP’s responsibility stated in the previous sentence. BSP will have the right and responsibility for process development, manufacturing, fill and finish, testing and supply of all clinical and commercial supplies of Late BSP Development Compounds, itself or through Third Party contract manufacturers; provided that, to maintain a timely and efficient advancement of any Late BSP Development Compounds into additional Clinical Trials, the transfer of OncoMed’s obligation to manufacture BSP Development Compounds under Section 2.6 to BSP will be made in consultation with OncoMed’s process development personnel (or equivalent). BSP’s decision to manufacture or subcontract such manufacture to a Third Party shall be at BSP’s sole discretion. Upon [***] for a Late BSP Development Compound, BSP will be responsible for paying, or for reimbursing OncoMed for, any amounts associated with the: [***]. The JSC shall develop a transition plan for transferring responsibility for the foregoing activities from OncoMed to BSP no later than [***] prior to BSP’s Commencement of Phase II Trials for such Late BSP Development Compound. Each Party shall perform its responsibilities under any such transition plan. To the extent permissible [***], OncoMed shall [***] in order to allow BSP to perform the activities set out in this Section 3.7.

3.8 OncoMed’s Right to Co-Develop BSP Development Compounds.

3.8.1 If BSP exercises the BSP Option for a Biologic Collaboration Compound Class, OncoMed shall have right, subject to this Section 3.8, on a Late BSP Development Compound-by-Late BSP Development Compound basis, to co-Develop any Late BSP Development Compounds in such Class by conducting certain Clinical Trials of such Late BSP Development Compounds.

3.8.2 If OncoMed elects to conduct such co-Development activities subject to Section 3.8.1, OncoMed shall provide written notice to BSP within the Co-Development Option Period. Any such notice shall specify the relevant Late BSP Development Compound as to which OncoMed is electing to co-Develop and shall include a high-level conceptual development plan governing the proposed co-Development activities to be conducted by OncoMed with respect to such Late BSP Development Compound to the JSC. If the JSC is unable to agree as to whether OncoMed shall have the right to co-Develop a particular Late BSP Development Compound, then [***]. If OncoMed obtains the right to co-Develop a Late BSP Development Compound, BSP shall grant to OncoMed a co-exclusive (with BSP or any sublicensees of BSP) worldwide license to Develop such Late BSP Development Compound, under the terms and conditions set forth in this Section 3.8.

3.8.3 If [***] a Late BSP Development Compound [***], the following shall apply:

(a) OncoMed shall have the right to perform specific Clinical Trials of the relevant Late BSP Development Compound, which activities shall be adjunct to the primary Development activities to be conducted and led by BSP pursuant to the relevant Development Plan for such Late BSP Development Compound, until all activities with respect to

 

[***] Certain information in this document 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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such Late BSP Development Compound terminate or this Agreement terminates or expires, whether in its entirety or with respect to such Late BSP Development Compound.

(b) OncoMed shall provide a draft detailed Co-Development Plan to the JSC, which draft shall be based on the then-current Biologic Development Plan and those activities to be conducted by OncoMed with respect to the relevant Late BSP Development Compound, as well as a budget for such activities. The JSC shall approve the Co-Development Plan within [***] after OncoMed provides such draft Co-Development Plan to the JSC. BSP’s JSC members shall have the right to reject [***].

(c) No reimbursement from BSP shall be due to OncoMed for OncoMed’s costs of conducting such co-Development activities. [***], BSP shall have a [***] period following the Completion of such Clinical Trial in which to evaluate [***]. If BSP notifies OncoMed within such evaluation period that [***] the Late BSP Development Compound subject to such Clinical Trial, [***] of [***] in connection with any such Clinical Trial [***] as follows: (i) a first payment in an amount equal to [***] of the [***], (ii) a [***] to [***] the [***], and (iii) additional [***] of the [***], to be [***] such Late BSP Development Compound until such time as [***].

(d) OncoMed will receive information relating to the Development of Late BSP Development Compounds for which OncoMed has exercised a right to co-Develop via its membership in the JSC or otherwise as set forth in Section 3.6.2.

(e) OncoMed and BSP will both contribute to discussions at the JSC, [***] with respect to Late Development of such Late BSP Development Compound, except that, subject to Section 3.8.3(a) and (b), after commencement of Co-Development, [***]. After the Commencement of a Clinical Trial by OncoMed under this Section 3.8, BSP may [***]. If OncoMed exercises the co-Development option, then BSP shall supply to OncoMed reasonable quantities of Products containing the relevant Late BSP Development Compound and placebo for use in Clinical Trials to be run by OncoMed, at [***] manufacturing or having manufactured such Products and placebo, which costs shall be borne by OncoMed.

3.8.4 If OncoMed undergoes a Change of Control in which OncoMed is merged with, is acquired by or transfers its assets to any entity [***] or if OncoMed or its successor in interest continuing to participate in Co-Development after such Change of Control would not be permitted under applicable antitrust Law, BSP may upon written notice within [***] (or any such longer time period necessary to wind down any Clinical Trial to protect subject safety) terminate all co-Development rights under this Section 3.8.

3.9 Third Party Information. Notwithstanding anything to the contrary in this Agreement, BSP acknowledges that it may be required to enter into appropriate confidentiality agreements with or with respect to specific Third Party contract manufacturers or other independent contractors engaged by OncoMed before OncoMed can share with BSP information relating to its agreement with such Third Party(ies) or such Third Party(ies)’ confidential information as required under this Agreement. In such case, OncoMed shall notify BSP promptly of such requirement, and the Parties shall cooperate to take such actions as are

 

[***] Certain information in this document 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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necessary to enable OncoMed to comply with such confidentiality requirements of OncoMed’s agreements with any such Third Party(ies).

3.10 Diagnostic Kits. If either Party desires to obtain a license under intellectual property rights Controlled by the other Party to Develop and Commercialize a Diagnostic Kit containing Biomarker Technology outside of the scope of the licenses granted under Article 5, such Party shall notify the other Party in writing setting forth a specific proposal for the type of Diagnostic Kit it desires to Develop and Commercialize. In such case, the Parties will negotiate in good faith, for a period not to exceed [***], commercially reasonable terms and conditions pursuant to which such other Party would grant to such Party a license or the right to Develop, manufacture and Commercialize such Diagnostic Kit for such purposes.

4. G OVERNANCE

4.1 Joint Steering Committee.

4.1.1 Formation and Role of the JSC. As soon as practicable after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC” ) to oversee the Collaboration and to make certain decisions regarding the Research and Early Development activities of the Parties during the Term as set forth in this Section 4.1. The JSC shall have review and oversight responsibilities for all Research and Early Development activities performed by OncoMed and BSP with respect to each Collaboration Compound, and OncoMed’s co-Development activities, if any. The JSC shall also receive information, from time to time, from BSP regarding, but have no power to review, oversee, or make any decisions relating to Late Development and Commercialization activities pertaining to Late BSP Development Compounds as provided in Section 3.6.2. Each Party shall provide to the JSC information described in the categories set forth on Exhibit 4.1.1. The JSC shall attempt to facilitate the resolution of any disputes between the Parties, as described in Section 4.1.3. More specifically, the JSC shall:

(a) modify Candidate Selection Criteria from time to time where appropriate for each Class in accordance with Section 2.4.1;

(b) [***];

(c) oversee, coordinate, and expedite the Early Development of Collaboration Compounds in the Territory;

(d) facilitate the flow of information from BSP to OncoMed with respect to Late Development and Commercialization activities being conducted for Late BSP Development Compounds in the Territory;

(e) review and provide advice regarding the overall progress of the Parties’ efforts to discover, identify, optimize, and Develop Collaboration Compounds in accordance with the Candidate Selection Criteria and each Development Plan insofar as it relates to [***] if any, including without limitation progress against timelines set forth therein;

 

[***] Certain information in this document 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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(f) review, provide comments relating to, and approve each Development Plan, and any modifications thereof, insofar as it relates to Early Development or co-Development activities, if any, to ensure that the Development Plan is reasonably designed to meet the objectives of Developing Collaboration Compounds that meet the Candidate Selection Criteria;

(g) direct and supervise the Parties’ activities under, and compliance with, each Development Plan insofar as it relates to Early Development or co-Development activities, if any, and adopt any amendments thereto;

(h) review the overall progress under the Development Plans insofar as each relates to Early Development or co-Development activities, if any;

(i) receive summary information [***];

(j) verify whether the Candidate Selection Criteria for each Collaboration Compound have been met as further described in Section 2.4.2;

(k) determine whether a Candidate Selection Compound shall be deemed a Substitute Compound with respect to another Candidate Selection Compound, as described in Section 2.4.4;

(l) determine whether any licenses from Third Parties may be required for the Early Development of Collaboration Compounds as set forth in Section 8.9;

(m) provide a forum for the Parties to discuss and attempt to resolve disputes; and

(n) appoint and oversee sub-Committees as it deems appropriate for carrying out activities under this Agreement, including without limitation with respect to any specific aspects of the Development activities or Commercialization activities or other matters within the jurisdiction of the JSC (with any such sub-Committee operating by rules substantially the same as those set forth in this Section 4.1, except that disputes shall be [***].

4.1.2 JSC Membership and Meetings. The JSC shall be composed of four (4) employees each from BSP and OncoMed (or such other number as the Parties may agree in writing), and shall meet [***], or more often if the JSC so agrees, in person, by teleconference or video-teleconference. In-person meetings shall alternate between OncoMed and BSP locations whenever possible unless otherwise agreed by the Parties. The first such meeting shall be within [***] after the Effective Date. Any member of the JSC may designate a substitute to attend with prior written notice to the other Party. There will be an annually rotating chairperson (the “JSC Chairperson” ) with the first JSC Chairperson to be designated by OncoMed. Ad hoc guests, including without limitation OncoMed’s Chief Executive Officer and BSP’s Global Head, Therapeutic Area, Oncology or the functional equivalent of such officer, who are bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than the obligations in Article 9 may be invited to the JSC meetings. Each

 

[***] Certain information in this document 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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Party may replace its JSC members with other of its employees, at any time, upon written notice to the other Party.

4.1.3 JSC Decision-Making; Limitations on JSC. Except as otherwise expressly provided herein, decisions of the JSC shall be made by consensus, with each Party having collectively one (1) vote in all decisions. The JSC shall have only such powers as are specifically delegated to it in this Agreement, and such powers shall be subject to the terms and conditions set forth herein. Without limiting the generality of the foregoing, the JSC shall have no power to amend this Agreement. In the event that the JSC is unable to reach a consensus decision on a matter that is within its decision-making authority in a meeting held within [***] after such matter is submitted to it or identified for resolution, then the JSC will hold a second meeting within [***] after such first meeting. If the JSC is unable to resolve the matter in the second meeting, then such dispute shall be submitted to the Executives pursuant to Section 12.2. If the Executives cannot resolve such matter within the time period provided in Section 12.2, then, except to the extent otherwise set forth in this Agreement, including without limitation where such dispute is specified for the Dispute Resolution Procedure in Section 12.4 pursuant to Section [***], (a). [***] will have final decision-making authority with respect to any disputes between the Parties that do not relate to a Party’s rights under this Agreement and/or the compliance of a Party with the terms and conditions of this Agreement ( “Legal Compliance Disputes” ) [***], and (b) [***] will have final decision-making authority with respect to any disputes between the Parties that are not Legal Compliance Disputes [***]. Notwithstanding anything to the contrary in the foregoing, any and all Legal Compliance Disputes shall be subject to the Dispute Resolution Procedure under Sections 12.1, 12.2 and 12.4 and shall not be subject to Expert Dispute Resolution Procedure under Section 12.3 or final decision making rights by one Party under this Section 4.1.3.

4.1.4 JSC Secretary and Minutes. The JSC Chairperson shall designate a secretary of the JSC who will be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and circulating minutes for review and approval within [***] after the meeting. Each Party will send any objections against the accuracy or completeness of such minutes by providing written notice to the other members of the JSC within [***] after receipt of the minutes. In the event of any such objection that is not resolved by mutual agreement of the Parties, such minutes will be amended to reflect such unresolved dispute. The minutes shall set forth, among other things, a description, in reasonable detail, of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JSC. Such minutes shall be effective only after being approved by both Parties. Definitive minutes of all JSC meetings shall be finalized no later than [***] after the meeting to which the minutes pertain.

4.1.5 JSC Role with Respect to Late BSP Development Compounds. As described in Section 4.1.3, the JSC shall not have any decision making authority with respect to Late BSP Development Compounds, [***] and, after the Small Molecule Advancement for a Small Molecule Collaboration Compound, will continue to lack any decision making authority regarding such Small Molecule Collaboration Compound. However, the JSC will continue to receive information regarding the progression of such Late BSP Development Compounds, as set

 

[***] Certain information in this document 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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forth in Section 4.1.1(d). In such case, the Parties may appoint additional members to the JSC that have specialized knowledge regarding the Development and Commercialization of such Late BSP Development Compounds, and the JSC shall continue to conduct meetings as provided in Section 4.1.2. [***]. For purposes of clarity, however, after a Collaboration Compound becomes a Late BSP Development Compound, [***]. After all Research and Early Development activities under this Agreement end, the JSC shall not be required to meet more than [***] per year; provided that information shall be exchanged more frequently directly between the Parties in accordance with Section 3.6.2.

4.2 Joint Development Sub-Committee.

4.2.1 Formation and Role of the JDS. Promptly after the Effective Date, the JSC will establish a joint development sub-committee (the “JDS” ) as a sub-Committee of the JSC, for managing Early Development activities, consisting of an appropriate number of representatives of each Party established by the JSC with expertise relevant to Development. In particular, the JDS will have the following tasks: (a) developing and proposing any updates or amendments to a Development Plan within the responsibilities of the JSC; (b) coordinating the activities undertaken pursuant to a Development Plan within the responsibilities assigned to the JSC, including assigning specific development tasks to the appropriate Party; (c) ensuring timely performance of the activities under the applicable Development Plan; (d) making proposals [***] pursuant to the applicable Development Plan; and (e) preparing presentations to the JSC. Each Party shall provide to the JDS information described in the categories set forth on Exhibit 4.2.1. For clarity, the JDS shall receive the information set forth in Exhibit 4.2.1 also with respect to Late BSP Development Compounds to the extent that such information is relevant to the activities of the JDS.

4.2.2 Meetings of the JDS. The JDS will meet not less than twice per Calendar Year. Meetings may be held in person or by means of telecommunication (telephone, video, or web conferences). The JDS may meet more frequently by agreement of the Parties or at the reasonable request of a Party with not less than twenty (20) Business Days notice to the other. Each Party will alternately be responsible for organizing the meetings of the JDS and for distributing the agenda of the meetings. Such responsible Party will include on the agenda any item within the scope of the responsibility of the JDS that is requested to be included by a Party, and will distribute the agenda to the Parties no less than one week before any meeting of the JDS. Each Party may, with the prior approval of the other Party (which will not be unreasonably withheld), invite non-voting employees, consultants or advisors (which consultants and advisors will be under an obligation of confidentiality no less stringent than the terms set forth in Article 9) to attend any meeting of the JDS. Each Party will bear its own costs associated with holding and attending JDS meetings.

4.2.3 Minutes of the JDS. The Party that is responsible for the organization of the respective JDS meeting will prepare the minutes, and send it to all members of the JDS for review and approval within [***] after the meeting. Each Party will send any objections against the accuracy or completeness of such minutes by providing written notice to the other members of the JDS within [***] of receipt of the minutes. In the event of any such

 

[***] Certain information in this document 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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objection that is not resolved by mutual agreement of the Parties, such minutes will be amended to reflect such unresolved dispute.

4.2.4 Decisions of the JDS. The JDS will take action by consensus, with each Party having a single vote, irrespective of the number of representatives actually in attendance at a meeting, or by a written resolution signed by the designated representatives of each Party. If the JDS is unable to reach consensus on a particular matter, such matter will be submitted to the JSC for resolution. The JDS will not have any power to amend this Agreement and will have only such powers as are specifically delegated to it under this Agreement.

4.3 Joint Project Team.

4.3.1 Formation and Role of the JPT. Promptly after the Effective Date, the JSC will establish a joint project team (the “JPT” ) as a Sub-Committee of the JSC, for managing the day-to-day work in Early Development, consisting of an appropriate number of representatives of each Party established by the JSC. In particular, the JPT will have the following tasks: (a) discussing key real-time data or results as they arise; (b) solving problems and providing assistance with respect to the performance of key assays and technology issues; (c) ensuring efficient technology transfer; (d) assessing [***] (e) suggesting timeline updates and changes; and (f) reviewing [***], when available internally at BSP or OncoMed.

4.3.2 Project Team Leader. Each Party will designate one of its JPT members as the project team leader (the “Project Team Leader” ) who will be the primary contact person for the other Party for matters relating to the Development of Collaboration Compounds by such Party. In order to ensure regular information of the JSC on the progress with respect to the Collaboration Compounds, the Project Team Leaders will be permanent guests of the JSC.

4.3.3 Meetings of the JPT. The JPT will meet not less than once per Calendar Quarter. Meetings may be held in person or by means of telecommunication (telephone, video, or web conferences). The JPT may meet more frequently by agreement of the Parties or at the reasonable request of a Party with not less than [***] notice to the other. The Project Team Leaders will alternately be responsible for organizing the meetings of the JPT and for distributing the agenda of the meetings. The Project Team Leaders will include on the agenda any item within the scope of the responsibility of the JPT that is requested to be included by a Party, and will distribute the agenda to the Parties no less than one week before any meeting of the JPT. Each Party may, with the prior approval of the other Party (which will not be unreasonably withheld), invite non-voting employees, consultants or advisors (which consultants and advisors will be under an obligation of confidentiality no less stringent than the terms set forth in Article 9) to attend any meeting of the JPT. Each Party will bear its own costs associated with holding and attending JPT meetings.

4.3.4 Minutes of the JPT. The Project Team Leader (or his or her designee) responsible for the organization of the respective JPT meeting will prepare the minutes, and send it to all members of the JPT for review and approval within [***] after the meeting. Each Party will send any objections against the accuracy or completeness of such

 

[***] Certain information in this document 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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minutes by providing written notice to the other members of the JPT within [***] of receipt of the minutes. In the event of any such objection that is not resolved by mutual agreement of the Parties, such minutes will be amended to reflect such unresolved dispute.

4.3.5 Decisions of the JPT. The JPT will take action by consensus, with each Party having a single vote, irrespective of the number of representatives actually in attendance at a meeting, or by a written resolution signed by the designated representatives of each Party. If the JPT is unable to reach consensus on a particular matter, such matter will be submitted to the JSC for resolution. The JPT will not have any power to amend this Agreement and will have only such powers as are specifically delegated to it under this Agreement.

4.4 Membership in Committees. After the expiration or termination of the Biologic Research and Early Development Term, (a) OncoMed’s membership in any Committee shall be at its sole discretion, as a matter of right and not obligation, for the sole purpose of participation in governance, decision-making, and information exchange with respect to activities within the jurisdiction of such Committee, and (b) OncoMed shall have the right to withdraw from membership in any or all of the Committees upon thirty (30) days’ prior written notice to BSP, which notice shall be effective as to the relevant Committee upon the expiration of such thirty (30) day period. Following the issuance of such notice for a given Committee, (i) OncoMed’s membership in such Committee shall be terminated and (ii) OncoMed shall have the right to continue to receive the information it would otherwise be entitled to receive under this Agreement. If, at any time, following issuance of such a notice, OncoMed wishes to resume participation in any Committee, OncoMed shall notify BSP in writing and, thereafter, OncoMed’s representatives to such Committee shall be entitled to attend any subsequent meeting of such Committee and to participate in the activities of, and decision-making by, such Committee as provided in this Article 4 as if such notice had not been issued by OncoMed pursuant to this Section 4.4. If the JSC is disbanded, then any data and information originally to be disclosed through the JSC shall be provided by such Party directly to the other Party.

4.5 Patent Representatives.

4.5.1 Appointment of Patent Representatives. Promptly after the Effective Date, each Party shall appoint one (1) or more patent attorneys or patent agents responsible for patent prosecution matters as set forth in this Agreement ( “Patent Representatives” ).

4.5.2 Communications Between Patent Representatives. The Patent Representatives shall, from time to time as appropriate, but not less than two (2) times per year, communicate and consult in person or by means of telecommunication (telephone, video, or web conferences) about the patent prosecution matters set forth in this Agreement, including without limitation the information described on Exhibit 4.5.2. The Patent Representatives shall provide to one another any and all patent filings each Party is required to provide to the other Party pursuant to Article 8 reasonably in advance of submission of such filings to the applicable patent office, and the Patent Representatives shall meet to discuss any such filing upon the request of either Party.

 

[***] Certain information in this document 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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4.5.3 Decisions of the Patent Representatives. The Patent Representatives will take action by consensus, with each Party having a single vote, except in cases in which one Party or the other has sole decision making authority. If the Patent Representatives are unable to reach consensus on a particular matter that is not within the sole decision making authority of either Party, the Party that owns the patent or patent application in question shall have the final decision making authority; provided that nothing in this Section 4.5.3 shall be deemed to waive or modify any rights of the Parties set forth in Article 8.

4.6 Alliance Managers. Promptly after the Effective Date, each Party shall appoint an individual (other than an existing member of the JSC) to act as the alliance manager for such Party (each, an “Alliance Manager”). Each Alliance Manager shall thereafter be permitted to attend meetings of the JSC as a nonvoting observer, subject to obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than the obligations in Article 9. The Alliance Managers shall be the primary point of contact for the Parties regarding the Collaboration activities contemplated by this Agreement and shall facilitate communication regarding all activities hereunder. The Alliance Managers shall lead the communications between the Parties and shall be responsible for following-up on decisions made by the JSC. The name and contact information for such Alliance Manager, as well as any replacement(s) chosen by OncoMed or BSP, in their sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 13.2.

5. L ICENSES

5.1 Licenses to BSP for BSP Development Compounds and Products.

5.1.1 License upon Exercise of BSP Option or the Small Molecule Advancement. Subject to the terms and conditions of this Agreement, upon BSP’s exercise of a BSP Option for a Biologic Collaboration Compound Class or the occurrence of the Small Molecule Advancement in accordance with the terms of this Agreement, OncoMed shall grant to BSP an exclusive (even as to OncoMed, except to the extent necessary for OncoMed to perform its obligations under this Agreement, including without limitation pursuant to Section 3.4.2), nontransferable (except as provided in Section 13.4) license in the Territory, with the right to grant sublicenses solely in accordance with Section 5.2, under the OncoMed Intellectual Property, to make, have made, use, have used, sell, have sold, offer to sell, have offered to sell, import, have imported, and otherwise Develop and have Developed (subject to OncoMed’s right to co-Develop BSP Development Compounds pursuant to Section 3.8 and to conduct Development under this Agreement on BSP Development Compounds that are not Late BSP Development Compounds) and Commercialize and have Commercialized all BSP Development Compounds and Products containing BSP Development Compounds in such Class, during the Term, in the Field; provided that the foregoing shall [***].

5.1.2 Research License. Subject to the terms and conditions of this Agreement, OncoMed hereby grants to BSP and its Affiliates a nonexclusive, royalty-free, non-sublicenseable and non-transferable (except as provided in Section 13.4) license in the Territory under all Know-How and Patent(s) Controlled by OncoMed claiming or disclosing compositions or methods useful for the practice of the Assay Technology, solely as necessary for BSP to

 

[***] Certain information in this document 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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practice the Assay Technology transferred to BSP pursuant to Section 2.3.3 to conduct BSP’s obligations under this Agreement with respect to Small Molecule Collaboration Compounds.

(a) Biomarker Technology License. Subject to the terms and conditions of this Agreement, OncoMed grants to BSP a non-exclusive, royalty-free [***], sublicenseable license in the Territory, under the OncoMed Intellectual Property, to Research, Develop, manufacture, use and import Inventions that are Biomarker Technology in connection with the Development and Commercialization of BSP Development Compounds. For the avoidance of doubt, the foregoing license shall not include the right to [***].

(b) If an OncoMed Diagnostic Kit is Developed by OncoMed or a collaborator with which OncoMed is Developing such Diagnostic Kit, BSP shall have the right to use such OncoMed Diagnostic Kit in connection with the Development and Commercialization of BSP Development Compounds solely prior to the time at which such OncoMed Diagnostic Kit becomes commercially available. Prior to commercial launch of such OncoMed Diagnostic Kit, upon request by BSP, OncoMed shall either, in its discretion, (i) provide to BSP in a one-time transfer of technology to BSP of all OncoMed Know-how necessary to enable BSP to make and use such OncoMed Diagnostic Kit in connection with the Development of BSP Development Compounds until such OncoMed Diagnostic Kit is commercially available, subject to BSP’s reimbursement of OncoMed’s actual out of pocket costs of such transfer, or (ii) supply to BSP, for a price equal to OncoMed’s actual out-of-pocket cost of supplying such OncoMed Diagnostic Kit, units of such OncoMed Diagnostic Kit reasonably necessary to enable BSP to Develop BSP Development Compounds until such OncoMed Diagnostic Kit is commercially available.

5.2 Sublicensing. BSP shall have the right to grant sublicenses to Affiliates and to Third Parties with respect to the rights licensed to BSP under Section 5.1; provided that any Sublicenses to Third Parties shall be subject to Sections 5.2.1 through 5.2.6:

5.2.1 such Sublicense shall refer to this Agreement and shall be subordinate to and consistent with the terms and conditions of this Agreement, and shall not limit the ability of BSP (individually or through the activities of its Sublicensee) to fully perform all of its obligations under this Agreement or OncoMed’s rights under this Agreement;

5.2.2 [***];

5.2.3 BSP shall remain responsible for the performance of this Agreement and the performance of its Sublicensees hereunder, and shall cause such Sublicensee to enable BSP to comply with all applicable terms and conditions of this Agreement;

5.2.4 each Sublicense shall terminate immediately upon the termination of this Agreement (in whole or only with respect to the rights that are subject to such Sublicense); however, OncoMed shall have the obligation to license each Sublicensee, at Sublicensee’s option, on substantially similar terms to those granted in such Sublicensee’s respective Sublicense, provided that such Sublicense has not been terminated for such Sublicensee’s breach or insolvency, such Sublicensee is otherwise performing activities in a

 

[***] Certain information in this document 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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manner consistent with this Agreement, and the terms and conditions of such Sublicense agreement are consistent with the terms and conditions of this Agreement; and

5.2.5 such Sublicensees shall have the right to grant further Sublicenses of same or lesser scope as its sublicense from BSP under the grants contained in Section 5.1 (the other party to such further sublicense also being a “Sublicensee” ), provided that such further Sublicenses shall be in accordance with and subject to all of the terms and conditions of this Section 5.2 (i.e., such Sublicensee shall be subject to this Section 5.2 in the same manner and to the same extent as BSP).

5.2.6 For purposes of clarity, where BSP retains a Third Party contractor to perform any activity permitted under this Agreement as provided in Section 2.3.9, where such activity is to be performed at the direction and control and for the sole benefit of BSP under any of BSP’s have made, have used, have sold, have offered for sale or have imported rights granted herein, such retention of the Third Party contractor is not a Sublicense within the meaning of this Section 5.2 but is considered an activity of BSP under the license granted in Section 5.1.

5.3 Licenses to OncoMed.

5.3.1 Research License. Subject to the terms and conditions of this Agreement, BSP hereby grants to OncoMed a non-exclusive, royalty-free, non-transferable (except as provided in Section 13.4) license in the Territory, under the BSP Intellectual Property, solely as and to the extent necessary to enable OncoMed to perform or have performed Research and Development activities under this Agreement with respect to Collaboration Compounds as defined in an applicable Biologic Development Plan or Co-Development Plan. For clarity, such license shall not extend to Research and Development activities for any OncoMed Development Compound.

5.3.2 OncoMed Development Compound License. Subject to the terms and conditions of this Agreement, including the conditions and limitations in Section 3.6.7, BSP grants to OncoMed a non-exclusive, royalty-free, non-transferable (except as provided in Section 13.4) license in the Territory, with the right to grant Sublicenses, under any [***], to Research, Develop, manufacture, use, import, offer for sale, sell, and Commercialize such OncoMed Development Compound in the Territory in the Field. Notwithstanding the foregoing, the license granted in this Section 5.3.2 shall exclude [***].

5.3.3 [***] Subject to the terms and conditions of this Agreement, BSP grants to OncoMed a non-exclusive, royalty-free, sublicenseable license in the Territory, under [***] (a) to Research, Develop, manufacture, use, import, offer for sale, sell, and Commercialize OncoMed Development Compounds in the Field, (b) to Research, Develop, manufacture, use, import, offer for sale, sell, and Commercialize biologic compounds and (c) to practice [***] otherwise in connection with the practice of the Assay Technology described in Section 1.8(a).

5.3.4 Third Party Contractors. For purposes of clarity, where OncoMed retains a Third Party contractor to perform any activity permitted under this

 

[***] Certain information in this document 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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Agreement as provided in Section 2.3.9, where such activity is to be performed at the direction and control and for the sole benefit of OncoMed under any of OncoMed’s have made, have used, or have imported rights granted herein, such retention of the Third Party contractor is not a sublicense within the meaning of this Section 5.3 but is considered an activity of OncoMed under the licenses granted in this Section 5.3.

5.3.5 Biomarker Technology. Subject to the terms and conditions of this Agreement, BSP grants to OncoMed a non-exclusive, royalty-free, sublicenseable license in the Territory, under Biomarker Inventions (as defined in Section 8.1.4) owned solely or jointly by BSP, to Research, Develop, manufacture, use, Commercialize, and import Inventions that are Biomarker Technology in connection with the Development and Commercialization of OncoMed Development Compounds. [***].

5.3.6 Diagnostic Kits.

(a) Subject to the terms and conditions of this Agreement, BSP grants to OncoMed a non-exclusive, royalty-free, sublicenseable license in the Territory, under any intellectual property rights Controlled by BSP that cover compositions of matter, or methods of using or making, that are necessary to Develop, use and Commercialize a BSP Diagnostic Kit, to Research, Develop, manufacture, use, Commercialize, and import such BSP Diagnostic Kit in connection with the Development and Commercialization of OncoMed Development Compounds in accordance with Section 5.3.6(b).

(b) If a BSP Diagnostic Kit is Developed by BSP or a collaborator with which BSP is Developing such Diagnostic Kit, OncoMed shall have the right to use such BSP Diagnostic Kit in connection with the Development and Commercialization of OncoMed Development Compounds solely prior to the time at which such BSP Diagnostic Kit becomes commercially available. Prior to commercial launch of such BSP Diagnostic Kit, upon request by OncoMed, BSP shall either, in its discretion, (i) provide to OncoMed in a one-time transfer of technology to OncoMed all BSP Know-how necessary to enable OncoMed to make and use such BSP Diagnostic Kit in connection with the Development of OncoMed Development Compounds until such BSP Diagnostic Kit is commercially available, [***], or (ii) supply to OncoMed, [***], units of such BSP Diagnostic Kit reasonably necessary to enable OncoMed to Develop OncoMed Development Compounds until such BSP Diagnostic Kit is commercially available.

5.4 Patent Marking. The packaging for each Product Commercialized by BSP under this Agreement shall be marked (to the extent not prohibited by Law): (a) with a notice that such Product is sold under a license from OncoMed and (b) with applicable patent notices relating to the OncoMed Patents in such a manner as may be permitted or required by Law; provided that OncoMed timely requests BSP to include the applicable Patent notices in consultation with BSP.

 

[***] Certain information in this document 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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5.5 Existing Agreements.

5.5.1 All licenses granted under this Article 5, to the extent they constitute sublicenses under intellectual property rights owned by a Third Party and licensed or sublicensed to OncoMed under an Existing Agreement and licensed to BSP under this Article 5 are subject to the relevant terms and conditions of the Existing Agreements. Any exclusive licenses that are granted under this Article 5 that constitute sublicenses under the Existing Agreements are exclusive only to the extent of the exclusive nature of the license granted to OncoMed under the Existing Agreements. To OncoMed’s knowledge as of the Effective Date, all terms and conditions contained in the Existing Agreements and reasonably believed by OncoMed to be relevant to the rights granted to BSP in this Agreement are summarized or referenced in Exhibit 5.5 and Sections 3.4.1(e), 5.5.2, 5.6.2, 6.4.3, 7.2.11, 8.2.3, 8.4.2(c), 10.1, and 10.4.1. OncoMed shall not modify any Existing Agreement in a manner that may affect BSP’s rights under this Agreement without the express written consent of BSP. BSP acknowledges that it has received copies of the Existing Agreements prior to the Effective Date.

5.5.2 Without limiting Section 5.5.1:

(a) BSP acknowledges the reservation of rights by the University of Michigan in the Patents and other intellectual property rights licensed by the University of Michigan to OncoMed under the Michigan License (the “Michigan Patents” ), on behalf of the University of Michigan and the Howard Hughes Medical Institute, for noncommercial research and education purposes under Section 3.2 of the Michigan License.

(b) BSP covenants not to sue, and not to assist other parties in suing, the University of Michigan for claims relating to the Technology (as such term is defined in the Michigan License), the Michigan Patents, and any Sublicenses granted under the Michigan Patents pursuant to this Agreement.

(c) BSP agrees and acknowledges that OncoMed shall have the right to assign its rights under this Agreement, as a Sublicense under the Michigan Patents, to the University of Michigan; provided however that such assignment shall not be effective without the University of Michigan’s prior acceptance of such assignment in writing.

5.6 No Implied Licenses; Government Rights.

5.6.1 No Implied Licenses. No license or other right is or shall be created or granted hereunder by implication, estoppel, or otherwise. All licenses and rights are or shall be granted only as expressly provided in this Agreement. All rights not expressly granted by OncoMed or BSP under this Agreement are reserved by OncoMed or BSP respectively.

5.6.2 Government Rights. This Agreement is expressly subject to the reservation on behalf of the U.S. government under Section 3.3 of the Michigan License as to the Michigan Patents (as defined in Section 5.5.2(a)). OncoMed will use Commercially Reasonable Efforts, upon a request by BSP, to request the University of Michigan to obtain a waiver of the

 

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United States manufacturing requirement contained in the Michigan License and shall otherwise cooperate to obtain such waiver, and, if such waiver is not obtained, to assist BSP in identifying a manufacturer in the United States so as to comply with Law and the Michigan License. If BSP does not request OncoMed to request the University of Michigan to obtain such a waiver, or such requested waiver is not obtained, BSP shall substantially manufacture Products claimed by the Michigan Patents in the United States to the extent required under Law and Section 7.3 of the Michigan License.

6. F INANCIAL T ERMS

6.1 Upfront Payment. In consideration for the rights granted to BSP under this Agreement, BSP, upon the Effective Date, shall pay to OncoMed a one-time-only, nonrefundable, noncreditable payment of forty million Dollars ($40,000,000). BSP shall make such payment within [***] after receipt of an invoice for such payment from OncoMed after the Effective Date.

6.2 Option Extension Fee for BSP Option for the [***] Class. In consideration for the rights granted to BSP under Section 3.1 with respect to the BSP Option for the [***] Class, BSP shall pay, within [***] after receipt of an invoice therefor, [***] to OncoMed. Such option extension fee shall not be refundable or returnable in any event, nor shall it be creditable against royalties or other payments. If BSP does not make such payment within such time period, the BSP Option with respect to the [***] Class shall expire at the end of such payment period. [***].

6.3 Milestone Payments. In consideration for the rights granted to BSP under this Agreement, BSP shall make milestone payments to OncoMed described in Sections 6.3.1 through 6.3.5. Such milestone payments shall not be refundable or returnable in any event, nor shall they be creditable against royalties or other payments.

6.3.1 Milestone Payments for Collaboration Compounds. BSP shall make the milestone payments set forth in the table in Exhibit 6.3.1 to OncoMed following the achievement of each of the corresponding milestone events set forth in the table in Exhibit 6.3.1 within [***] after receipt of an invoice for such payment, which invoice shall issue no earlier than the date of achievement of the applicable milestone event. Such payments shall be due to OncoMed for each Collaboration Compound within the description in the relevant column under “Payment” in the table in Exhibit 6.3.1.

6.3.2 Option Exercise Payments. BSP shall make the applicable BSP Option exercise payment set forth in the table in Exhibit 6.3.2 to OncoMed within [***] after receipt of an invoice for such payment, which invoice shall issue no earlier than the date on which BSP exercises a BSP Option for the relevant Class, as further described in Section 3.1.2.

6.3.3 Small Molecule Class Advancement Payment. BSP shall make a milestone payment of [***] to OncoMed within [***] days after receipt of an invoice for such payment, which invoice shall issue no earlier than the date BSP has decided to [***], which decision shall be made, if at all, prior to the earlier of (a) [***].

 

[***] Certain information in this document 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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6.3.4 Milestone Payments for BSP Development Compounds. If BSP exercises a BSP Option for a Biological Collaboration Compound Class or the Small Molecule Advancement occurs, the milestone payments set forth in the table in Exhibit 6.3.4 relevant to each BSP Development Compound in such Class shall become due on achievement of the relevant milestone event set forth in the table in Exhibit 6.3.4 for such BSP Development Compound; [***]. BSP shall provide OncoMed with prompt written notice of the achievement of any milestone described in the table in Exhibit 6.3.4 by BSP, its Affiliates or its Sublicensees for any BSP Development Compound within such Class. BSP will make such payments to OncoMed within [***] after receipt of an invoice for such payment, which invoice shall issue no earlier than the date of achievement of the specified milestone event for the relevant BSP Development Compound by BSP, its Affiliate or its Sublicensee. Such milestone payments are payable for each BSP Development Compound within the description for the relevant column in the table in Exhibit 6.3.4 for which such milestone is achieved.

6.3.5 Net Sales Milestones. BSP shall pay to OncoMed the applicable one-time-only Net Sales threshold milestone payments set forth in the table in Exhibit 6.3.5, [***], within [***] after receipt of an invoice for such payment, which invoice shall issue no earlier than the first time that the total aggregate Net Sales [***] in a Calendar Year by BSP, its Affiliates and its Sublicensees in the Territory reach or exceed the relevant amounts set forth in the table in Exhibit 6.3.5.

6.4 Royalty Payments.

6.4.1 Royalties. As further consideration for the rights granted to BSP under this Agreement, subject to Section 6.4.2, BSP will pay OncoMed incremental royalties on Net Sales by BSP, its Affiliates and its Sublicensees of all Products containing the type of BSP Development Compound described in each of the columns set forth in the table in Exhibit 6.4.1 during a Calendar Year, on a country-by-country basis and on a category of Product–by–category of Product basis, for the applicable country, in the amounts set forth in the table in Exhibit 6.4.1. If a Product contains more than one Collaboration Compound, then one (1) royalty payment shall apply to Net Sales of such Product, which payment shall be calculated using [***].

6.4.2 Royalty Rate Reductions.

(a) Notwithstanding Section 6.4.1, royalties payable with respect to each Product in a given country during the Royalty Term shall be reduced by [***], during the time period in which any of the following subsections (i) through (iv) apply during the Royalty Term for such Product in such country:

(i) [***]

(ii) [***]

(iii) [***]

 

[***] Certain information in this document 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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(iv) [***]

(b) Notwithstanding Section 6.4.1, solely with respect to a Product containing a Biologic Collaboration Compound and not a Small Molecule Collaboration Compound, in any country in which such Product is sold, royalties payable shall be reduced for so long as all of the following subsections (i) through (iii) apply in such country:

(i) [***]

(ii) [***]

(iii) [***]

(c) Notwithstanding Sections 6.4.1 and 6.4.2(a), BSP shall have no royalty obligation under Section 6.4.1 for a Product containing a Small Molecule Collaboration Compound in any country in which such Product is sold for so long as all of (i) through (iii) apply in such country: (i) the tenth (10th) anniversary of First Commercial Sale of such Product has occurred, (ii) the Exclusivity Extension for such Product has expired, and (iii) the only Valid Claim(s) covering such Product in such country either (A) [***].

(d) Notwithstanding Sections 6.4.1 and 6.4.2(a), BSP shall have no royalty obligation under Section 6.4.1 for a Product containing a Biologic Collaboration Compound in any country in which such Product is sold for so long as all of (i) through (iii) apply in such country: (i) the tenth (10th) anniversary of First Commercial Sale of such Product has occurred, (ii) the Exclusivity Extension for such Product has expired, and (iii) the only Valid Claim(s) covering such Product in such country are [***], that do not cover [***], but do cover [***] such Product.

6.4.3 Notwithstanding Sections 6.4.1 and 6.4.2, if, after expiration of BSP’s obligation to pay OncoMed royalties under this Agreement, OncoMed continues to be obligated to make payments under the Existing Agreements as a result of sales of Product by BSP, its Affiliates, or its Sublicensees, BSP shall pay to OncoMed amounts at such times and in such amounts that will allow OncoMed, after deduction of any applicable duties, fees or withholdings required by Law, to pass such payments through to the University of Michigan, MorphoSys, or Lonza so as to satisfy in full OncoMed’s payment obligations under the Existing Agreements with respect to such sales of Product. The royalties due under the Existing Agreements are summarized in Exhibit 5.5.

6.5 Royalty Payment Reports . After the First Commercial Sale of a Product and for the Royalty Term for such Product, BSP shall furnish to OncoMed a written report, no later than [***] after the end of each Calendar Quarter (or portion thereof if this Agreement terminates during a Calendar Quarter), showing the amount of royalty due for such Product for such Calendar Quarter (or portion thereof). Royalty payments for each Calendar Quarter shall be due [***]. With each quarterly payment, BSP shall deliver to OncoMed a full and accurate accounting to include at least the following information: (a) [***], (b) the Net Sales for the applicable Product by BSP, its Affiliates, and Sublicensees in the currency in which sales were

 

[***] Certain information in this document 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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made and in Dollars after the application of the exchange rate during the reporting period as reported in subsection (d), below, (c) the royalties payable in Dollars which shall have accrued hereunder in respect of such Net Sales and the basis for calculating those royalties, (d) the exchange rates and other methodology used in converting into Dollars, from the currencies in which sales were made; (e) [***]; and (f) withholding taxes, if any, required by Law to be deducted in respect of such royalties.

6.6 Manner of Payment. All payments to be made by BSP hereunder shall be made in Dollars by wire transfer of immediately available funds to such U.S. bank account as shall be designated by OncoMed. Unless otherwise indicated in this Agreement, all payments, other than royalty payments (which are addressed in Section 6.5), shall be made no later than [***] from receipt of an invoice. Late payments shall bear interest at the rate provided in Section 6.11.

6.7 Records Retention . Commencing with the First Commercial Sale of a Product by BSP, BSP shall keep, and shall cause each of its respective Affiliates, and Sublicensees, if any, to keep, full and accurate books of accounting in accordance with IFRS or GAAP, as applicable, containing all particulars that may be necessary for the purpose of calculating all royalties payable to OncoMed under this Article 6, for a period of [***] after the Calendar Year in which such sales occurred, in sufficient detail to permit OncoMed to confirm the accuracy of royalties paid hereunder.

6.8 Audits . During the Term and for a period of [***] thereafter, at the request and expense of OncoMed under this Article 6, BSP shall permit an independent, certified public accountant of nationally recognized standing appointed by OncoMed, and reasonably acceptable to BSP, at reasonable times and upon reasonable notice, but in no case more than once per Calendar Year thereafter, to examine such records as may be necessary for the sole purpose of verifying the calculation and reporting of Net Sales and the correctness of any royalty payment made under this Agreement for any period within the preceding [***]. Payments over each period of time may be audited only once during the lifetime of this Agreement. Results of any such examination shall be made available to both BSP and OncoMed. The independent, certified public accountant shall disclose to OncoMed only the royalty amounts which the independent auditor believes to be due and payable hereunder to OncoMed, details concerning any discrepancy from the amount paid and the amount due, and shall disclose no other information revealed in such audit. Any and all records examined by such independent accountant shall be deemed BSP’s Confidential Information which may not be disclosed by said independent, certified public accountant to any Third Party. If, as a result of any inspection of the books and records of BSP, it is shown that OncoMed’s payments under this Agreement were less than the amount which should have been paid, then BSP shall make all payments required to be made to eliminate any discrepancy revealed by said inspection within [***]. If, as a result of any inspection of the books and records of BSP, it is shown that payments to OncoMed under this Agreement were more than the amount which should have been paid, then the amount of the overpayment shall be refunded to BSP within [***] or be credited against future royalty payments, at BSP’s option. OncoMed shall pay for such audits, except that in the event that BSP

 

[***] Certain information in this document 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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underpaid royalty payments by more than [***] during the period in question as per the audit, BSP shall pay the reasonable costs of the audit.

6.9 Currency Exchange. All payments under this Agreement shall be payable, in full, in Dollars, regardless of the country(ies) in which sales are made. For the purposes of computing Net Sales of Products or products Commercialized by OncoMed that are sold in a currency other than Dollars, such currency shall be converted into Dollars as calculated at the actual average rates of exchange for the purchase of Dollars for the pertinent quarter or year to date, as the case may be, as obtained from Reuters, or such other source as may be used by BSP or OncoMed in producing its quarterly and annual accounts as such Party so notifies the other Party in writing from time to time.

6.10 Taxes. In the event that BSP determines that it is required to withhold any tax to the tax or revenue authorities in any country regarding any payment to OncoMed due to the Law of such country, BSP shall be entitled to deduct and withhold from the amount payable the tax for which BSP is liable under the applicable Law unless and until an exemption or reduction is granted by the applicable tax or revenue authority. Each of BSP and OncoMed agrees to cooperate in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect. If neither Party is permitted to claim an exemption from such deductions or withholdings, BSP may deduct the amount of tax required to be paid (which may include a reduced amount if a reduction is granted by the applicable tax or revenue authority) from the payment to be made by BSP to OncoMed after notice to OncoMed of such withholding. Within a reasonable amount of time after making such deduction, BSP shall furnish OncoMed with copies of any tax filing or other documentation evidencing such withholding. Any tax withheld shall be treated as having been paid by BSP to OncoMed all purposes of this Agreement. If it is determined by the applicable tax or revenue authority that BSP failed to make a withholding tax payment, OncoMed will promptly pay to BSP the amount due to enable BSP to make the missed payment. If it is determined that BSP overpaid withholding tax and OncoMed’s assistance is required to apply for a refund to the applicable tax or revenue authority, OncoMed shall promptly furnish such information or assistance as may be required.

6.11 Interest Due . Without limiting any other rights or remedies available to a Party, either Party shall pay to the other interest on any payments required by this Agreement that are not paid on or before the date such payments are due under this Agreement at a rate per annum equal to the one month USD-LIBOR as quoted on REUTERS screen <USDLIBOR01> plus a premium of [***] or the highest rate allowed by law, whichever is lower. The interest calculation will be based on the act / 360 computation method, which means that the numerator is calculated based on the actual days elapsed while the denominator remains 360 (flat). The interest rate will be fixed on the due date and adjusted for any subsequent thirty (30) day period to the rate then in effect on the first Business Day of such period. Interest will be compounded monthly in arrears. Such interest will be due and payable on the tender of the underlying principal payment.

 

[***] Certain information in this document 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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7. R EPRESENTATIONS , W ARRANTIES , AND C OVENANTS ; D ISCLAIMERS ; L IMITATION OF L IABILITY

7.1 Mutual Representations and Warranties . Each Party represents and warrants to the other Party as of the Effective Date that:

7.1.1 such Party is duly organized, validly existing and in good standing under the Law of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

7.1.2 execution of this Agreement and the performance by such Party of its obligations hereunder have been duly authorized;

7.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;

7.1.4 the performance of this Agreement by it does not create a breach or default under any other agreement to which it is a party;

7.1.5 the execution, delivery and performance of this Agreement by such 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 such Party;

7.1.6 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Law currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required to obtain Hart-Scott-Rodino clearance or other clearances as required by other government authorities;

7.1.7 all of its employees, officers, contractors, and consultants either (a) have executed agreements requiring assignment to such Party of all right, title and interest in and to their inventions and discoveries they have invented or otherwise discovered or generated during the course of and as a result of their association with such Party, whether or not patentable, if any, to such Party as the sole owner thereof or (b) if any of such Party’s employees, officers, contractors, and consultants shall not have executed such an agreement, (i) are subject to legal requirements to assign all right, title and interest in and to all inventions they have invented or otherwise discovered or generated during the course of and as a result of their association with such Party to such Party, or (ii) assignment by such employee, officer, contractor, and consultant of such inventions to such Party occurs by operation of Law;

 

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7.1.8 all of its employees, officers, contractors, and consultants either (a) have executed agreements obligating each such employee, officer, contractor, and consultant to maintain as confidential the Confidential Information of such Party, or (b) if any of such Party’s employees, officers, contractors, and consultants shall not have executed such an agreement, such employees, officers, contractors, and consultants are subject by operation of Law to maintain as confidential the Confidential Information of such Party; and

7.1.9 neither such Party, nor any of its employees, officers, subcontractors, or consultants who have rendered or will render services relating to the Collaboration Compounds or Products: (a) has ever been debarred or is subject or debarment or convicted of a crime for which an entity or person could be debarred by the FDA under 21 U.S.C. Section 335a (or subject to a similar sanction of EMA) or (b) has ever been under indictment for a crime for which a person or entity could be so debarred.

7.2 Additional Representations, Warranties, and Covenants of OncoMed . OncoMed hereby represents and warrants to BSP, as of the Effective Date, that, to its knowledge:

7.2.1 OncoMed owns or otherwise Controls the OncoMed Patents set forth on Exhibit 1.110;

7.2.2 no security interests exist in the OncoMed Patents set forth on Exhibit 1.110 in favor of any creditor, and OncoMed will not allow any security interest in any OncoMed Patents claiming inventions relating to a Collaboration Compound in favor of any creditor to be created without the written consent of BSP;

7.2.3 all agreements between OncoMed and any Third Party under which OncoMed receives a license under any intellectual property rights OncoMed reasonably believes are relevant to activities to be performed by BSP pursuant to this Agreement are listed in Exhibit 5.5.

7.2.4 there is no pending litigation that alleges either that any OncoMed Patent that claims Biologic Collaboration Compounds is, or for any patent application included in the OncoMed Patents claiming Biologic Collaboration Compounds, if issued, would be, invalid or unenforceable, or that OncoMed has misappropriated any intellectual property rights of any Third Party;

7.2.5 no oral or written communications have been received by OncoMed from any Third Parties that allege either that any issued OncoMed Patent claiming Biologic Collaboration Compounds existing as of the Effective Date is, or, for patent applications included in the OncoMed Patents claiming Biologic Collaboration Compounds existing as of the Effective Date, if issued substantially in the same form as they currently exist, would be, invalid or unenforceable, [***];

7.2.6 each of the issued patents, and any currently pending patent application or patent application from which any such patent has issued, in each case within the

 

[***] Certain information in this document 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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OncoMed Patents that claims Biologic Collaboration Compounds existing as of the Effective Date and that is owned by OncoMed, (a) has been prosecuted in compliance with all applicable rules, policies, and procedures of the U.S. Patent and Trademark Office in all material respects, (b) is subsisting unless noted on such Exhibit 1.110 as abandoned or expired, and (c) has not been prosecuted in a manner involving any material defects in prosecution or filings that could provide any reasonable basis for rendering a patent issuing therefrom to be invalid or unenforceable; recognizing that it would not be a material defect to file claims in an application in the ordinary course of prosecution that may have a different scope than those claims contained in the patent issuing from such application;

7.2.7 there is no pending litigation, [***] that alleges that OncoMed’s activities conducted prior to the Effective Date with respect to Biologic Collaboration Compounds have infringed or misappropriated any intellectual property rights of any Third Party;

7.2.8 there are no valid and enforceable, potentially relevant, issued patents owned by a Third Party that would be infringed by the Development, use, or sale of the 18R5 Collaboration Compound or Collaboration Compounds in the Fzd-Fc Class, each [***];

7.2.9 except as set forth in Sections 5.5 and 5.6, OncoMed has not, as of the Effective Date, granted any right or license to any Third Party under the OncoMed Intellectual Property that would conflict or interfere with any of the rights or licenses granted to BSP hereunder and OncoMed will not in the future grant any right or license to any Third Party under the OncoMed Intellectual Property that would conflict or interfere with any of the rights or licenses granted to BSP hereunder without the express written consent of BSP;

7.2.10 OncoMed has [***] this Agreement, including without limitation 18R5 Collaboration Compound or the Fzd-Fc Collaboration Compound existing as of the Effective Date;

7.2.11 OncoMed has used such commercially reasonable efforts as a prudent business person would undertake to meet its obligations under Section 4.8(a) of the MorphoSys Agreement;

7.2.12 OncoMed has made available to BSP information in OncoMed’s possession and Control that provides reasonable insight into the current financial condition of OncoMed as of the Effective Date and OncoMed’s management’s projections (subject to change) relating to anticipated activities of OncoMed through 2013; and

7.2.13 OncoMed covenants to provide BSP with written notice if at any time during the Term OncoMed’s reported cash balance (including without limitation cash and cash equivalents) falls below [***] based on the OncoMed’s then-existing cash balance and burn rate, assuming no additional financing or fund raising is conducted by OncoMed during such time period and that OncoMed receives no additional income from Third Parties during such time period.

 

[***] Certain information in this document 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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Reference to “knowledge” in the first sentence of Section 7.2 for purposes of Sections 7.2.1 through 7.2.9 means actual knowledge of [***].

7.3 Additional Representations and Warranties of BSP . BSP hereby represents and warrants to OncoMed, as of the Effective Date, that, [***].

7.4 Mutual Covenants. Each Party hereby covenants to the other Party that:

7.4.1 all employees, officers, contractors, and consultants of such Party or its Affiliates working under this Agreement shall execute agreements requiring assignment to such Party of all right, title and interest in and to their inventions and discoveries invented or otherwise discovered or generated during the course of and as a result of their association with such Party, whether or not patentable, if any, to such Party as the sole owner thereof, or, if any of such Party’s employees, officers, contractors, and consultants shall not have executed such an agreement, assignment by such employee, officer, contractor, and consultant of such inventions to such Party shall occur by operation of Law or other legal requirements;

7.4.2 such Party shall perform its activities pursuant to this Agreement in compliance with GLP, GCP, and GMP, in each case as applicable under the Law and regulations of the country and the state and local government wherein such activities are conducted, and with respect to the care, handling and use in research and Development activities hereunder of any non-human animals by or on behalf of such Party, shall at all times comply (and shall ensure compliance by any of its subcontractors) with all Law, and also with the standards in the pharmaceutical industry for the Development and Commercialization of pharmaceutical products;

7.4.3 neither Party shall employ (or, to the best of its knowledge, shall not use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMA), or, to the best of its knowledge, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA), in the conduct of its activities under this Agreement;

7.4.4 such Party shall perform its obligations and exercise its rights hereunder in compliance with all Law;

7.4.5 such Party shall not engage in any activities that use the other Party’s intellectual property rights licensed to such Party hereunder in a manner that is outside the scope of the license rights granted to it hereunder; and

7.4.6 such Party shall not knowingly infringe the intellectual property rights of any Third Party in connection with its activities pursuant to this Agreement.

7.5 Additional Covenant of OncoMed and BSP . OncoMed hereby covenants to BSP that, after the Effective Date, OncoMed shall (a) prosecute patent applications in the OncoMed Patents in compliance with all applicable rules, policies, and procedures of the U.S. Patent and Trademark Office in all material respects, and (b) not prosecute patent

 

[***] Certain information in this document 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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applications in the OncoMed Patents in a manner involving any material defects that could provide that is reasonably likely to result in any material defects in prosecution or filings that could provide any reasonable basis for rendering a patent issuing therefrom to be invalid or unenforceable, recognizing that it would not be a material defect to file claims in an application in the ordinary course of prosecution that may have a different scope than those claims contained in the patent issuing from such application. BSP hereby covenants to OncoMed that, after the Effective Date, BSP shall (i) prosecute patent applications in the Relevant BSP Patents in compliance with all applicable rules, policies, and procedures of the U.S. Patent and Trademark Office in all material respects, and (ii) not prosecute patent applications in the Relevant BSP Patents in a manner involving any material defects that could provide that is reasonably likely to result in any material defects in prosecution or filings that could provide any reasonable basis for rendering a patent issuing therefrom to be invalid or unenforceable, recognizing that it would not be a material defect to file claims in an application in the ordinary course of prosecution that may have a different scope than those claims contained in the patent issuing from such application.

7.6 DISCLAIMERS.

7.6.1 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT: (a) ONCOMED MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE ONCOMED INTELLECTUAL PROPERTY OR ANY LICENSE GRANTED BY ONCOMED HEREUNDER, OR WITH RESPECT TO ANY COLLABORATION COMPOUNDS OR PRODUCTS; AND (b) NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE ONCOMED PATENTS ARE VALID OR ENFORCEABLE OR THAT USE OF THE ONCOMED CONFIDENTIAL INFORMATION OR ONCOMED INTELLECTUAL PROPERTY CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.

7.6.2 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT: (a) BSP MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY BSP CONFIDENTIAL INFORMATION OR ANY LICENSE GRANTED BY BSP UNDER ITS INTELLECTUAL PROPERTY RIGHTS HEREUNDER, OR WITH RESPECT TO ANY BSP DEVELOPMENT COMPOUNDS OR PRODUCTS; AND (b) NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR WARRANTY THAT USE OF THE BSP CONFIDENTIAL INFORMATION OR BSP INTELLECTUAL PROPERTY CONTEMPLATED HEREUNDER DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.

7.7 LIMITATION OF LIABILITY . EXCEPT FOR CLAIMS OF A THIRD PARTY THAT ARE SUBJECT TO INDEMNIFICATION UNDER ARTICLE 10,

 

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NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF BUSINESS). [***].

8. I NTELLECTUAL P ROPERTY

8.1 Ownership of Inventions and Know-How.

8.1.1 Inventions. Inventorship of inventions invented or otherwise discovered or generated in the course of activities performed under or contemplated by this Agreement ( “Inventions” ) shall be determined by application of U.S. patent Law pertaining to inventorship.

8.1.2 BSP Owned Inventions. BSP shall solely own all Inventions, and all intellectual property rights therein, including without limitation Know-How discovered or generated in the course of activities performed under or contemplated by this Agreement during the Term, regardless of the inventorship thereof: (a) that relate to [***] ( “BSP Owned Inventions” ). BSP Owned Inventions shall also include all [***], and [***]. If any BSP Owned Invention is invented or otherwise discovered or generated solely by one or more Affiliates, employees, consultants, Sublicensees, agents, or independent contractors of OncoMed or invented or otherwise discovered or generated jointly by one or more Affiliates, employees, consultants, Sublicensees, agents, or independent contractors of each Party, OncoMed shall, and hereby does, assign all of its right, title, and interest in and to such BSP Owned Invention to BSP.

8.1.3 OncoMed Owned Inventions. OncoMed shall solely own all Inventions, and all intellectual property rights therein, including without limitation Know-How discovered or generated during the Term in the course of activities performed under or contemplated by this Agreement, [***], other than BSP Owned Inventions or [***], and any and all intellectual property rights therein ( “OncoMed Owned Inventions” ). “OncoMed Owned Inventions” shall include [***]. If any OncoMed Owned Invention is invented or otherwise discovered or generated solely by one or more Affiliates, employees, consultants, Sublicensees, agents, or independent contractors of BSP or invented or otherwise discovered or generated jointly by one or more Affiliates, employees, consultants, Sublicensees, agents, or independent contractors of each Party, BSP shall, and hereby does, assign all of its right, title, and interest in and to such OncoMed Owned Invention, and any and all intellectual property rights therein, to OncoMed.

8.1.4 Biomarker Inventions. Any Invention that is Biomarker Technology (determined after giving effect to Sections 8.1.2 and 8.1.3), and any and all intellectual property rights therein, including without limitation Know-How discovered or generated during the Term in the course of activities performed under or contemplated by this

 

[***] Certain information in this document 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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Agreement, ( “Biomarker Inventions” ) that is [***] shall be owned [***]. Any Biomarker Invention that is [***] shall be owned [***].

8.1.5 Ownership Disputes. In the event that the Parties dispute whether any Invention is a BSP Owned Invention or an OncoMed Owned Invention, or which Party(ies) own any Invention relating to Biomarker Technology, each of the Parties shall notify the other Party’s Patent Representative. If the dispute remains unresolved after discussion by the Patent Representatives, the Expert Dispute Resolution Procedures of Sections 12.2 and 12.3 shall apply, as appropriate. Additionally, the Patent Representatives shall discuss ways in which patent application filing and prosecution efforts can be undertaken so as to give effect to the provisions of this Agreement, such as, for example, claiming BSP Owned Inventions, OncoMed Owned Inventions, and Inventions relating to Biomarker Technology in separate patent applications.

8.1.6 Biomarker Invention License and Right of First Negotiation.

(a) Subject to the terms and conditions of this Agreement, BSP grants to OncoMed a non-exclusive, royalty-free, sublicenseable license in the Territory, under any intellectual property rights Controlled by BSP that claim Biomarker Inventions, to Research, Develop, manufacture, use and import such Biomarker Technology in connection with [***]. For the avoidance of doubt, the foregoing license shall not include the right to Develop or Commercialize a Collaboration Compound or a Biomarker Compound [***] (a “Modified Collaboration Compound” ) [***].

(b) If either Party desires to obtain rights under Biomarker Inventions of broader scope than the licenses granted to such Party in Article 5 or 8 (as applicable), with the exception of licenses for [***], the Parties agree to negotiate in good faith the terms and conditions of an agreement pursuant to which such Party may be granted such rights.

(c) In the event either Party desires to initiate [***], such Party will notify the other Party. If OncoMed is the notifying Party, the Parties shall negotiate, during the [***] period following such notification, over terms for an exclusive license pursuant to which BSP would develop and commercialize such Modified Collaboration Compound for such use. If in such case OncoMed and BSP do not enter into such a license agreement within such [***] period, OncoMed will be free to initiate discussions with Third Parties and may enter into an agreement with a Third Party under which such activities may be conducted, provided that such agreement does not contain terms and conditions more favorable to such Third Party than the terms last proposed by BSP in any discussions between the Parties during the consultation period, and further provided that such agreement is consistent with and is not reasonably likely to affect adversely the Parties’ rights and obligations under this Agreement.

8.1.7 Cooperation. Each Party shall promptly disclose to the other Party in writing, and shall cause its Affiliates, licensees and Sublicensees to so disclose, the conception of any Invention which, in accordance with this Section 8.1, is owned solely by the other Party. Each Party shall cause its Affiliates, employees, consultants, Sublicensees, agents, or independent contractors to so assign to such Party, such person’s or entity’s right, title and

 

[***] Certain information in this document 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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interest in and to any such Inventions, and intellectual property rights therein, as is necessary to enable such Party to fully effect the ownership of such Inventions, and intellectual property rights therein, as provided for in Section 8.1.2 through 8.1.4. Each Party shall also include provisions in its relevant agreements with Third Parties performing activities on its behalf pursuant to this Agreement, that effect the intent of this Article 8. Each Party agrees to provide reasonable cooperation to the other Party to execute and deliver all documents reasonably required to evidence or record any assignment pursuant to this Agreement. Each Party shall, and shall cause its Affiliates, employees, consultants, Sublicensees, agents, or independent contractors to, cooperate with the other Party and take all reasonable additional actions and execute such agreements, instruments and documents as may be reasonably required to perfect such other Party’s right, title and interest in and to Inventions, and intellectual property rights therein, as set forth in this Section 8.1.

8.1.8 Prompt Filing. Each Party agrees to file reasonably promptly any patent applications for which it is responsible for filing, prosecuting and maintaining under this Article 8, [***]. If BSP fails to file promptly any patent applications for which it is responsible for filing, prosecuting and maintaining under this Article 8, and such failure would result in [***].

8.2 Prosecution of OncoMed Patents.

8.2.1 Filing, Prosecution, and Maintenance of OncoMed Initial Prosecution Patents. OncoMed shall be responsible, using patent counsel selected by OncoMed and reasonably acceptable to BSP (for clarity, all references in this Article 8 to “patent counsel” shall include inside patent counsel as well as outside patent counsel), for the preparation, prosecution (including without limitation any interferences, oppositions, reissue proceedings and reexaminations) and maintenance of OncoMed Patents, [***] ( “OncoMed Initial Prosecution Patents” ). OncoMed shall reasonably inform and consult with BSP, and shall take BSP’s comments into good faith consideration, with respect to the preparation, prosecution and maintenance of such OncoMed Initial Prosecution Patents; provided, however, that OncoMed shall endeavor to pursue patents claiming a Late BSP Development Compound in at least every country listed in Exhibit 8.2.1, unless otherwise agreed by the Parties. OncoMed shall provide to BSP copies of any papers relating to the filing, prosecution or maintenance of such OncoMed Initial Prosecution Patents reasonably in advance of their being filed or promptly upon their being received, including without limitation draft filings reasonably in advance of their being filed so that BSP can comment and provide input with respect to such draft filings. OncoMed agrees to discuss in good faith any changes reasonably requested by BSP to such papers, including without limitation draft filings, promptly upon their being received. OncoMed agrees to implement any such recommended changes with the goal of optimizing overall patent protection for Late BSP Development Compounds, unless those changes would, in OncoMed’s reasonable belief, be detrimental to the issuance and validity of other OncoMed Initial Prosecution Patents or Patents then being prosecuted by OncoMed. In any event, OncoMed will not finally abandon any claims or will not limit any claims specific to Late BSP Development Compounds without BSP’s prior written consent. BSP hereby agrees that the law firms Sterne,

 

[***] Certain information in this document 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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Kessler, Goldstein & Fox and Casimir Jones are acceptable to BSP for purposes of this Section 8.2.1.

8.2.2 Abandonment of OncoMed Initial Prosecution Patents. In no event will OncoMed permit the OncoMed Initial Prosecution Patents to be abandoned in any country in the Territory, or elect not to file a new Patent application claiming priority to a Patent application within such OncoMed Initial Prosecution Patents either before such Patent application’s issuance or within the time period required for the filing of an international (i.e., Patent Cooperation Treaty), regional (including without limitation the European Patent Office) or national Patent application, without BSP first being given an opportunity reasonably in advance to assume full responsibility for the continued prosecution and maintenance of such OncoMed Initial Prosecution Patents, or the filing of such new Patent application included in the OncoMed Initial Prosecution Patents. OncoMed shall provide BSP with notice of the allowance and expected issuance date of any Patent within such OncoMed Initial Prosecution Patents, and any of the aforementioned filing deadlines, and OncoMed shall provide BSP with prompt notice as to whether it desires to file such new Patent application. In the event that OncoMed decides either (a) not to continue the prosecution or maintenance of a Patent application or Patent within such OncoMed Initial Prosecution Patents in any country or (b) not to file such new Patent application requested to be filed by BSP, OncoMed shall provide BSP with notice of this decision at least [***] prior to any pending lapse or abandonment thereof. In such event, OncoMed shall provide BSP with an opportunity to assume responsibility for all costs reasonably associated with the filing and/or further prosecution and maintenance of such Patent application and any Patent issuing thereon (such filing to occur prior to the issuance of the Patent to which the application claims priority or expiration of the applicable filing deadline, as set forth above). In the event that BSP assumes such responsibility for such filing, prosecution and maintenance costs, BSP shall have the right to transfer the responsibility for such filing, prosecution and maintenance of such Patent applications and Patents to patent counsel selected by it and reasonably acceptable to OncoMed. If BSP decides to assume the filing or prosecution of any such Patent owned by OncoMed, [***]. Such Patent applications and Patents [***] subject to all of the terms and conditions of this Agreement in the same manner and to the same extent as the other OncoMed Initial Prosecution Patents.

8.2.3 Notwithstanding Section 8.2.1 and 8.2.2, BSP acknowledges that the University of Michigan has the first right to prosecute and maintain the Michigan Patents. If the University of Michigan decides to refrain from or to cease prosecuting or maintaining the Michigan Patents, then under the Michigan License, OncoMed has the right to continue such prosecution or maintenance. If OncoMed continues such activities, then OncoMed shall proceed as provided in this Section 8.2 with respect to the Michigan Patents, provided that BSP agrees and acknowledges that OncoMed is obligated to provide to the University of Michigan any and all draft filings and applications for the Michigan Patents, as well as responses to patent authorities in connection therewith, before filing such items, for review and comment by the University of Michigan. Additionally, BSP acknowledges that, notwithstanding anything to the contrary in this Agreement, (a) MorphoSys has the first right, pursuant to Section 9.1 and 9.2 of the MorphoSys Agreement, to prosecute, maintain or enforce certain OncoMed Patents covering Research Inventions (as such term is defined in the MorphoSys Agreement) if OncoMed elects

 

[***] Certain information in this document 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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not to do so and (b) OncoMed has no rights to prosecute or maintain the Patents licensed to OncoMed pursuant to the MorphoSys Agreement.

8.3 Prosecution of Relevant BSP Patents.

8.3.1 Filing, Prosecution, and Maintenance of Relevant BSP Patents. For purposes of this Section 8.3, “Relevant BSP Patents” shall mean those BSP Patents that claim or disclose [***]. BSP shall be responsible, using patent counsel selected by BSP and reasonably acceptable to OncoMed, for the preparation, prosecution (including without limitation any interferences, oppositions, reissue proceedings and reexaminations) and maintenance of Relevant BSP Patents. BSP shall reasonably inform and consult with OncoMed, and shall take OncoMed’s comments into good faith consideration, with respect to the preparation, prosecution and maintenance of such Relevant BSP Patents; provided, however, that BSP shall endeavor to pursue patents claiming Biologic Collaboration Compounds in at least every country listed in Exhibit 8.2.1, unless otherwise agreed by the Parties. BSP shall provide to OncoMed copies of any papers relating to the filing, prosecution or maintenance of such Relevant BSP Patents reasonably in advance of their being filed or promptly upon their being received, including without limitation draft filings reasonably in advance of their being filed so that OncoMed can comment and provide input with respect to such draft filings. BSP agrees to discuss in good faith any changes reasonably requested by OncoMed to such papers, including without limitation draft filings, promptly upon their being received. BSP agrees to implement any such recommended changes with the goal of optimizing overall patent protection for Biologic Collaboration Compounds and/or any BSP Owned Inventions, unless those changes would, in BSP’s reasonable belief, be detrimental to the issuance and validity of other BSP Patents or Patents then being prosecuted by BSP. In any event, BSP will not finally abandon any claims or will not limit any claims specific to Biologic Collaboration Compounds and/or any BSP Owned Inventions without OncoMed’s prior written consent.

8.3.2 Abandonment of Relevant BSP Patents. In no event will BSP permit the BSP Relevant Patents to be abandoned in any country in the Territory, or elect not to file a new Patent application claiming priority to a Patent application within such Relevant BSP Patents either before such Patent application’s issuance or within the time period required for the filing of an international (i.e., Patent Cooperation Treaty), regional (including without limitation the European Patent Office) or national Patent application, without OncoMed first being given an opportunity reasonably in advance to assume full responsibility for the continued prosecution and maintenance of such Relevant BSP Patents, or the filing of such new Patent application included in the Relevant BSP Patents. BSP shall provide OncoMed with notice of the allowance and expected issuance date of any Patent within such Relevant BSP Patents, and any of the aforementioned filing deadlines, and BSP shall provide OncoMed with prompt notice as to whether it desires to file such new Patent application. In the event that BSP decides either (a) not to continue the prosecution or maintenance of a Patent application or Patent within such Relevant BSP Patents in any country or (b) not to file such new Patent application requested to be filed by OncoMed, BSP shall provide OncoMed with notice of this decision at least [***] prior to any pending lapse or abandonment thereof. In such event, BSP shall provide OncoMed with an opportunity to assume responsibility for all costs reasonably associated with the filing

 

[***] Certain information in this document 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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and/or further prosecution and maintenance of such Patent application and any Patent issuing thereon (such filing to occur prior to the issuance of the Patent to which the application claims priority or expiration of the applicable filing deadline, as set forth above). In the event that OncoMed assumes such responsibility for such filing, prosecution and maintenance costs, OncoMed shall have the right to transfer the responsibility for such filing, prosecution and maintenance of such Patent applications and Patents to patent counsel selected by it and reasonably acceptable to BSP. If OncoMed decides to assume the filing or prosecution of any such Patent, [***]. Such Patent applications and Patents shall otherwise continue to be subject to all of the terms and conditions of this Agreement in the same manner and to the same extent as the other Relevant BSP Patents.

8.4 Enforcement of OncoMed Patents and BSP Patents Against Infringers.

8.4.1 Notice. In the event that OncoMed or BSP become aware of any actual or suspected infringement of any OncoMed Patent or BSP Patent by a product or a method involving a product similar to or the same as a Late BSP Development Compound (a “Competitive Infringement” ) or a product or a method involving a product similar to or the same as an OncoMed Development Compound (an “ODC Competitive Infringement” ), or any such OncoMed Patent or Relevant BSP Patent is challenged in any action or proceeding (other than any oppositions, cancellations, interferences, reissue proceedings or reexaminations, which are addressed above), such Party shall notify the other Party promptly, and following such notification, the Parties shall confer.

8.4.2 Enforcement of OncoMed Patents.

(a) OncoMed will have the first right, but not an obligation, to bring any action or proceeding involving Competitive Infringement, at its own expense, to enforce or defend, as applicable, any OncoMed Patent in its own name and entirely under its own direction and control, subject to the following. BSP shall reasonably assist OncoMed (at OncoMed’s expense) in any such action or proceeding if so requested, and shall lend its name to such actions or proceedings if required by Law. BSP shall have the right to participate and be represented in any such suit by its own counsel at its own expense if permitted by Law. No settlement of any such action or proceeding which restricts or adversely affects the scope of the licenses granted by OncoMed to BSP under the terms of this Agreement, or which may adversely affect the Commercialization of a Product, will be entered into by OncoMed without the prior written consent of BSP, which consent shall not be unreasonably withheld, delayed or conditioned. OncoMed will have an obligation to consult with BSP and will take any BSP comments into good faith consideration with respect to the infringement, claim construction, or defense of the validity or enforceability of any claim in any such OncoMed Patent, as applicable. OncoMed shall provide to BSP copies of any papers relating to the infringement and/or validity litigation of any such involved OncoMed Patents promptly upon their being filed or received.

(b) If OncoMed elects not to settle, or bring any action or proceeding as described in this Section 8.4.2 within the earlier of (a) [***] after first notifying BSP or being notified by BSP with respect thereto, or (b) to the extent applicable, the applicable

 

[***] Certain information in this document 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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period for listing patents under Section 7002(a) of the Biologics Price Competition and Innovation Act of 2009, then, upon and after the exercise by BSP of a BSP Option during the Term, BSP may bring such action or proceeding at its own expense, in its own name and entirely under its own direction and control, subject to the following. OncoMed will reasonably assist BSP (at BSP’s expense) in any such action or proceeding if so requested, and will lend its name to such actions or proceedings if requested by BSP or required by Law. OncoMed shall have the right to participate and be represented in any such suit by its own counsel at its own expense with respect to a Competitive Infringement relating to a BSP Development Compound. No settlement of any such action or proceeding which restricts the scope, or adversely affects the enforceability, of any such OncoMed Patent shall be entered into by BSP without the prior written consent of OncoMed, which consent shall not be unreasonably withheld, delayed or conditioned. BSP shall not knowingly take any action during such litigation of any such OncoMed Patent that would materially adversely affect them, without consultation with OncoMed.

(c) Notwithstanding Sections 8.4.2(a) and (b), BSP acknowledges that Article 11 of the Michigan License governs enforcement of the Michigan Patents. Accordingly, BSP agrees that the provisions of Sections 11.1 through 11.3 of the Michigan License shall be given effect before the provisions of this Section 8.4.2 apply as to actions involving the Michigan Patents. Furthermore, BSP acknowledges that OncoMed does not have the right to enforce the Patents licensed to OncoMed pursuant to the MorphoSys Agreement.

8.4.3 Enforcement of BSP Patents. BSP will have the sole right, but not an obligation, to bring any action or proceeding involving Competitive Infringement, at its own expense, to enforce or defend, as applicable, any BSP Patent in its own name and entirely under its own direction and control, subject to the following. OncoMed shall reasonably assist BSP (at BSP’s expense) in any such action or proceeding if so requested, and shall lend its name to such actions or proceedings if required by Law. BSP shall have the final decision making authority with regard to any action involving the enforcement of a BSP Patent. BSP shall provide to OncoMed copies of any papers relating to the infringement and/or validity litigation of any such involved Relevant BSP Patents promptly upon their being filed or received.

8.4.4 ODC Competitive Infringement. OncoMed will have the sole right, but not an obligation, to bring any action or proceeding involving ODC Competitive Infringement, at its own expense, to enforce or defend, as applicable, any OncoMed Patent in its own name and entirely under its own direction and control. BSP shall have the right to participate in such action if a challenge is made to the validity or enforceability of any OncoMed Patent that claims a Product that includes a Late BSP Development Compound. In any such action in which BSP participates, the Parties will reasonably cooperate to conduct such action in view of each Party’s respective interest in such action.

8.4.5 Damages. In the event that either Party exercises the rights conferred in this Section 8.4 and recovers any damages or other sums in such action, suit or proceeding or in settlement thereof, such damages or other sums recovered shall first be subject to Section 8.4.2(c) if such damages relate to the Michigan Patents, and then shall be applied to all

 

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out-of-pocket costs and expenses incurred by the Parties directly in connection with such litigation, including without limitation attorneys’ fees. If such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be [***]. If after such reimbursement any funds remain from such damages or other sums recovered, [***] (i) [***], and (ii) [***].

8.4.6 Upstream Limitations. Each Party’s rights to enforce an OncoMed Patent pursuant to this Section 8.4, or to defend against a challenge in any action or proceeding described in Section 8.4.1, shall be subject to the applicable provisions of any agreements between the OncoMed and its licensor. In the event of any conflict between this Section 8.4 and such other agreements, the provisions of the other agreements shall control.

8.5 Patent Term Extension. OncoMed and BSP shall each cooperate with one another and shall use Commercially Reasonable Efforts in obtaining patent term extension (including without limitation any pediatric exclusivity extensions as may be available) or supplementary protection certificates or their equivalents in any country with respect to Patents claiming the Products, as applicable. If elections with respect to obtaining such patent term extensions are to be made, BSP shall have the right to elect to seek patent term extension or supplementary protection, provided that such election will be made so as to maximize the period of marketing exclusivity for the Product. For such purpose, for all Regulatory Approvals, BSP shall provide OncoMed with written notice of any expected Regulatory Approval at least thirty (30) days prior to the expected date of Regulatory Approval, as well as notice within three (3) Business Days of receiving each Regulatory Approval confirming the date of such Regulatory Approval.

8.6 Notification of Patent Certification. Each Party shall notify and provide the other Party with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of an OncoMed Patent or Relevant BSP Patent pursuant to a Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application, an application under Section 505(b)(2), a notification or claim analysis relating to patents under the Biologics Price Competition and Innovation Act of 2009, or other similar patent certification by a Third Party, and any foreign equivalent thereof. Such notification and copies shall be provided to the other Party within ten (10) days after receipt of such certification. In addition, upon request by OncoMed, BSP shall provide reasonable assistance and cooperation (including without limitation making available to OncoMed documents possessed by BSP that are reasonably required by OncoMed and making available personnel for interviews and testimony) in any actions reasonably undertaken by OncoMed in accordance with Section 8.4 to contest any such patent certification or notification.

8.7 Regulatory Data Protection. To the extent required by or permitted by Law, BSP will, [***] decide whether to list with the applicable Regulatory Authorities during the Term any applicable Patents for any Collaboration Compound or Product that BSP intends to, or has begun to Commercialize, and that have become the subject of a marketing application submitted to FDA. Such listings may include without limitation all so called “Orange Book” listings required under the Hatch-Waxman Act and all so called “Patent Register” listings as required in Canada, or listing of Patents as provided in the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act of 2009. Prior to such decision on

 

[***] Certain information in this document 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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listings, the Parties will meet to evaluate and identify all applicable Patents to be listed and BSP shall listen to any information or opinions provided by OncoMed as to the listing or non-listing of any applicable Patents.

8.8 Defense Against Claims of Infringement of Third Party Patents. If a Third Party asserts that a Patent or other right owned by it is or has been infringed by the manufacture, use, sale, offer for sale, or import of a Late BSP Development Compound or Product in the Territory, the Party first obtaining knowledge of such a claim shall immediately provide the other Party notice of such claim along with the related facts in reasonable detail. In such event, unless the Parties otherwise agree, BSP shall have the right, but not the obligation, at its expense, to control such defense with respect to such Late BSP Development Compound or Product. OncoMed shall cooperate with BSP, at BSP’s reasonable request and expense, and shall have the right to be represented separately by counsel of its own choice. BSP shall also control settlement of such claim; provided, however, that no settlement shall be entered into without the prior consent of OncoMed if such settlement would adversely affect the rights and benefits of, or impose or adversely affect any obligations on, OncoMed.

8.9 Third Party Licenses.

8.9.1 If either Party reasonably determines that any Third Party intellectual property rights may be necessary for the Early Development of a Collaboration Compound, where such Third Party intellectual property rights are necessary for use of any Collaboration Compound, or otherwise that may be required for the use or exploitation of OncoMed Intellectual Property as contemplated under this Agreement for the discovery, research, manufacture, or use of Collaboration Compounds and Products, then such Party will notify the JSC.

8.9.2 After receiving the notification provided in Section 8.9.1, the JSC, in consultation with the Patent Representatives, will discuss whether the Parties should obtain one or more licenses from one or more Third Parties for such activities or take other appropriate measures in view of such Third Party rights, such as whether the Parties should obtain an opinion relating to such Third Party intellectual property rights, or take alternative approaches to avoid using such Third Party intellectual property rights. If the JSC determines that the Parties should obtain one or more licenses from one or more Third Parties for such activities, the JSC will determine which Party [***]. The chosen Party shall use Commercially Reasonable Efforts obtain a license to such Third Party intellectual property, with the right to sublicense to the extent necessary for the other Party to conduct its obligations under this Agreement. The non-chosen Party may elect to participate or be consulted in any negotiations for such license and, if the non-chosen Party will bear any obligation in the resulting license or share costs under Section 8.9.4 with respect to such license, the non-chosen Party must approve the terms of the license. If such chosen Party elects not to obtain rights to such Third Party intellectual property, or is unsuccessful in obtaining such rights within [***], then the other Party shall have the right (but not the obligation) to negotiate and obtain rights from such Third Party at its sole discretion and expense (subject to Section 8.9.4).

 

[***] Certain information in this document 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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8.9.3 If either Party reasonably determines that any Third Party intellectual property rights may be necessary for the Late Development, manufacture, or Commercialization of a Product and are not otherwise described in Section 8.9.1, then BSP shall have the right, but not the obligation, to obtain a license to such Third Party intellectual property, with the right to sublicense, in order to permit BSP to conduct its obligations under the Agreement. The terms and conditions involved in obtaining such rights shall be determined at BSP’s sole discretion and expense (subject to Section 8.9.4).

8.9.4 BSP shall have the right to offset against royalties payable to OncoMed pursuant to Section 6.4 an amount equal to [***] of the [***] owed by BSP to a Third Party pursuant to any license under such Third Party’s intellectual property rights that is necessary for and directly attributable to the exploitation of, and cover [***] (a “Necessary License” ) (other than payments potentially due pursuant to any of the Existing Agreements, which shall be borne solely by OncoMed); provided that the royalties payable to OncoMed under Section 6.4 may not be reduced by more than [***] of those otherwise due to OncoMed pursuant to Section 6.4 in any Calendar Quarter as a result of such offset. Any unused offset earned in a Calendar Quarter may be carried forward from such Calendar Quarter to the subsequent Calendar Quarters and may be used in such subsequent Calendar Quarters, subject to the [***] limitation set forth in the immediately preceding sentence. BSP shall pay OncoMed an amount equal to [***] of the royalties and other license fees and costs owed and payable by OncoMed to a Third Party (other than pursuant to the Existing Agreements) pursuant to any Necessary License to which OncoMed is a party within [***] days after receiving an invoice therefor; excluding, for clarity, any amounts paid to such Third Party to the extent directly attributable to the exploitation solely of an OncoMed Development Compound. The Parties shall discuss and determine whether any such Third Party License, other than an Existing Agreement, is a Necessary License.

8.10 Trademarks and Domain Names.

8.10.1 BSP shall be responsible for the selection, registration and maintenance of all Trade Marks which it employs in connection with the commercialization of any Product under this Agreement. BSP shall own and control such Trade Mark and pay all relevant costs thereto.

8.10.2 OncoMed recognizes the exclusive ownership by BSP of all BSP Trade Marks. OncoMed shall not, either while this Agreement is in effect, or at any time thereafter, register, use or challenge or assist others to challenge the BSP Trademarks, nor shall OncoMed attempt to obtain any right in or to any name, logotype, trademark or trade dress confusingly similar for the marketing, sale or distribution of any goods or products, notwithstanding whether such goods or products have a different use or are dissimilar to the Products.

8.10.3 Only BSP will be authorized to initiate at its own discretion legal proceedings against any infringement or threatened infringement of any Trade Mark.

 

[***] Certain information in this document 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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8.10.4 BSP shall be responsible for the registration, hosting, maintenance and defense of any Domain Name. BSP may at its sole and absolute discretion register in its own name or in name of others, host on its own servers or on Third Party servers, maintain and defend such Domain Names and use them for websites.

9. C ONFIDENTIALITY

9.1 Nondisclosure. Each Party agrees that, during the Term and for a period of [***] thereafter, a Party (the “Receiving Party” ) receiving Confidential Information of the other Party (the “Disclosing Party” ) (or that has received any such Confidential Information from the other Party prior to the Effective Date) or who has discovered or generated Confidential Information relating to technology or Inventions that are owned pursuant to Article 8 by the other Party (in which case such other Party shall be deemed to be the Disclosing Party for purposes of this Article 9), shall (a) maintain in confidence such Confidential Information using not less than the efforts such Receiving Party uses to maintain in confidence its own proprietary industrial information of similar kind and value, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted below, and (c) not use such Confidential Information for any purpose except those permitted by this Agreement (it being understood that this clause (c) shall not create or imply any rights or licenses not expressly granted under this Agreement). Notwithstanding anything to the contrary in the foregoing, the obligations of confidentiality and non-use with respect to any trade secret within such Confidential Information shall survive such [***] period for so long as such Confidential Information remains protected as a trade secret.

9.2 Exceptions. The obligations in Section 9.1 shall not apply with respect to any portion of the Confidential Information that the Receiving Party can show by competent proof:

9.2.1 is publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party hereunder;

9.2.2 was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party;

9.2.3 is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use;

9.2.4 is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party; or

9.2.5 was independently discovered or generated outside of the activities conducted under this Agreement by the Receiving Party or its Affiliates, as evidenced by their written records, without the use of Confidential Information of the Disclosing Party.

 

[***] Certain information in this document 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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9.3 Authorized Disclosure. The Receiving Party may disclose Confidential Information belonging to the Disclosing Party to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:

9.3.1 filing or prosecuting patents;

9.3.2 Regulatory Filings and obtaining Regulatory Approvals;

9.3.3 prosecuting or defending litigation, including without limitation responding to a subpoena in a Third Party litigation;

9.3.4 subject to Section 9.5, complying with Law (including without limitation the rules and regulations of the Securities and Exchange Commission or any national securities exchange) and with judicial process, if in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance; and

9.3.5 disclosure, (i) solely on a “need to know basis” for the purposes of the performance of this Agreement or exercise of any rights under this Agreement, to [***] or (ii) solely on a “need to know basis”, to [***], and, in each case, their and each of the Parties’ respective directors, employees, and agents, each of whom prior to disclosure must be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than the obligations in this Article 9; provided, however, that, in each of the above situations, the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information pursuant to this Section 9.3.5 to treat such Confidential Information as required under this Article 9, and provided further that this Section 9.3.5 shall not [***] other than disclosures of the terms of this Agreement to the extent permitted in Section 9.4, shall be subject to the following additional requirement. For purposes of this Section 9.3.5, a [***] means any [***] or with whom [***].

(a) If OncoMed is negotiating with a [***] the terms under which such [***] and OncoMed may [***] and OncoMed [***] in the course of such [***] that OncoMed [***] then [***], with a [***]. Such [***]. In no event shall OncoMed be required to disclose to BSP [***]; provided, however, that [***].

(b) During the [***] period after [***], the Parties shall [***] implement in connection with [***] the confidentiality obligations [***] in connection with OncoMed’s [***] as well as [***] with the goal of having [***] after the [***] and OncoMed reasonably believes that [***].

(c) Solely with respect to proposed disclosures to [***] the following shall apply: During the Parties’ discussion period under Section 9.3.5(b), BSP may inform OncoMed if BSP [***] of the Confidential Information [***] would be a [***]. In such case, BSP shall [***] and the Parties shall discuss [***]. If after such discussion OncoMed [***].

 

[***] Certain information in this document 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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(d) If other than in circumstances described in Section 9.3.5(c), BSP desires that OncoMed [***] BSP shall so notify OncoMed [***] reasonable actions OncoMed [***] disclosure of such information it believes appropriate to be conducted in compliance with [***]. OncoMed shall use reasonable efforts to [***].

(e) For clarity, provided that OncoMed [***] as provided in this Section 9.3.5, subject to Sections 9.3.5(c), OncoMed shall [***] to the extent OncoMed [***].

If and whenever any Confidential Information is disclosed in accordance with this Section 9.3, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement).

9.4 Terms of this Agreement. The Parties acknowledge that this Agreement and all of the respective terms of this Agreement shall be treated as Confidential Information of both Parties; provided that, for clarity, each Party may disclose such Confidential Information (other than Exhibit 2.5, which may be disclosed only in accordance with Section 9.3.5), to the extent (and only to the extent) such disclosure is reasonably necessary, (a) solely on a “need to know basis” for the purposes of the performance of this Agreement or exercise of any rights under this Agreement, to Affiliates, subcontractors, advisors, potential or actual permitted sublicensees and research and development collaborators, or (b) solely on a “need to know basis”, to advisors, potential or actual acquirors (including without limitation acquirors of assets), merger partners, investment bankers, investors, lenders, or other financial partners, and, in each case, their and each of the Parties’ respective directors, employees, and agents, each of whom prior to disclosure must be bound by written obligations of confidentiality and restrictions on use of such Confidential Information that are no less restrictive than the obligations in this Article 9; provided, however, that, in each of the above situations, the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information pursuant to this Section 9.4 to treat such Confidential Information as required under this Article 9.

9.5 Securities Filings. In the event either Party proposes to file with the Securities and Exchange Commission or the securities regulators of any state or other jurisdiction a registration statement or any other disclosure document which describes or refers to the terms and conditions of this Agreement under the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any other applicable securities Law, such Party shall notify the other Party of such intention and shall provide such other Party with a copy of relevant portions of drafts of the proposed filing as soon as reasonably practicable, but in no event less than [***] prior to such filing, and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof, including without limitation any exhibits thereto relating to the terms and conditions of this Agreement. The Party making such filing shall use reasonable efforts to obtain confidential treatment of the terms and conditions of this Agreement that such other Party requests be kept confidential, and shall only disclose Confidential Information that it is advised by counsel is legally required to be disclosed or required to be disclosed. No such notice shall be required under this Section 9.5 if the

 

[***] Certain information in this document 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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description of or reference to this Agreement contained in the proposed filing has been included in any previous filing made by the either Party hereunder or otherwise approved by the other Party.

9.6 Relationship to Confidentiality Agreement. This Agreement supersedes the Secrecy Agreement between OncoMed Pharmaceuticals, Inc. and Bayer Schering Pharma AG executed on [***], provided that all “Confidential Information” disclosed or received by the Parties thereunder shall be deemed “Confidential Information” hereunder and shall be subject to the terms and conditions of this Agreement.

9.7 Publications.

9.7.1 Publication by BSP.

(a) Subject to the limitations herein, prior to Small Molecule Advancement for a Small Molecule Collaboration Compound, BSP may publish or present Data and/or Results relating to such Small Molecule Collaboration Compound, Product or the activities conducted under this Agreement in scientific journals and/or at scientific conferences, [***]. BSP shall provide OncoMed with the opportunity to review any such proposed abstract, manuscript or presentation by delivering a copy thereof to OncoMed no less than [***] before its intended submission for publication or presentation. OncoMed shall have [***] after its receipt of any such abstract, manuscript or presentation in which to notify BSP in writing [***]. In the event OncoMed objects to the disclosure in writing within such [***] period, [***]. Additionally, if OncoMed objects to such disclosure on the basis that a patent application covering information contained in such disclosure should be filed prior to such disclosure, [***] after OncoMed’s receipt of any such abstract, manuscript or presentation, or until such application has been filed, if earlier. Once any such abstract or manuscript is accepted for publication, BSP will provide OncoMed with a copy of the final version of the manuscript or abstract.

(b) Subject to the limitations herein, on a Late BSP Development Compound-by-Late BSP Development Compound basis:

(i) BSP may publish or present Data and/or Results relating to a Late BSP Development Compound that is a Small Molecule Collaboration Compound or a Product containing such Late BSP Development Compound in scientific journals and/or at scientific conferences. BSP shall provide OncoMed with a copy of a draft of any such proposed abstract, manuscript or presentation reasonably in advance of its intended submission for publication or presentation, subject to, upon BSP’s request, OncoMed providing reasonable assurances, which may include requiring OncoMed employees receiving drafts containing material Data and/or Results generated in the course of Developing such Late BSP Development Compound to sign an obligation of confidentiality with respect thereto, to protect the confidentiality of any BSP Confidential Information in such proposed abstract, manuscript or presentation. Once any such abstract or manuscript is accepted for publication, BSP will provide OncoMed with a copy of the final version of the manuscript or abstract.

 

[***] Certain information in this document 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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(ii) BSP may publish or present Data and/or Results relating to Late BSP Development Compound that is a Biologic Collaboration Compound or a Product containing such a Late BSP Development Compound or the activities conducted under this Agreement with respect to the foregoing in scientific journals and/or at scientific conferences, [***]. BSP shall provide OncoMed with the opportunity to review any such proposed abstract, manuscript or presentation by delivering a copy thereof to OncoMed no less than [***] before its intended submission for publication or presentation, subject to, upon BSP’s request, OncoMed providing reasonable assurances, which may include requiring OncoMed employees receiving drafts containing material Data and/or Results generated in the course of Developing such Late BSP Development Compound to sign an obligation of confidentiality with respect thereto, to protect the confidentiality of any BSP Confidential Information in such proposed abstract, manuscript or presentation. OncoMed shall have [***] after its receipt of any such abstract, manuscript or presentation in which to notify BSP in writing [***] other than [***]. In the event OncoMed objects to the disclosure in writing within such [***] period, [***]. Additionally, if OncoMed objects to such disclosure on the basis that [***] after OncoMed’s receipt of any such abstract, manuscript or presentation, or until such application has been filed, if earlier. Once any such abstract or manuscript is accepted for publication, BSP will provide OncoMed with a copy of the final version of the manuscript or abstract.

9.7.2 Publication by OncoMed. Subject to the limitations herein, OncoMed may publish or present Data and/or Results relating to a Collaboration Compound, Product or the activities conducted under this Agreement in scientific journals and/or at scientific conferences, subject to the prior review and comment [***] by BSP as follows. OncoMed shall provide BSP with the opportunity to review any such proposed abstract, manuscript or presentation by delivering a copy thereof to BSP no less than [***] before its intended submission for publication or presentation. BSP shall have [***] after its receipt of any such abstract, manuscript or presentation in which to notify OncoMed in writing of any specific objections to the disclosure of Confidential Information of BSP. In the event BSP objects to the disclosure in writing within such [***] period, [***]. Additionally, if BSP objects to such disclosure on the basis that [***] after BSP’s receipt of any such abstract, manuscript or presentation, or until such application has been filed, if earlier. Once any such abstract or manuscript is accepted for publication, OncoMed will provide BSP with a copy of the final version of the manuscript or abstract. The Parties acknowledge that publications relating to Collaboration Compounds submitted for publication by OncoMed prior to the Effective Date shall not be subject to the above review procedure. [***].

9.7.3 Clinical Trial Results Registers. BSP will have the right to publish summaries of Results of all Clinical Trials conducted by either Party with respect to a Product incorporating a BSP Development Compound after the Effective Date on BSP’s Clinical Trial register. The Parties shall reasonably cooperate in order to ensure the publication of any such summaries of Clinical Trials Data and Results as required under Law on the Clinical Trial registry of each respective Party.

9.7.4 Publication by Third Party Contractors. A Third Party contractor retained by a Party as provided in Section 2.3.9 may publish or present Data and/or

 

[***] Certain information in this document 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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Results relating to a Collaboration Compound or Product in scientific journals and/or at scientific conferences; provided that the Party engaging such subcontractor shall require the Third Party contractor to be bound to the same terms and conditions set forth in Section 9.7.1 in the case of a Third Party contractor retained by BSP or Section 9.7.2 in the case of a Third Party contractor retained by OncoMed.

9.8 Publicity.

9.8.1 Upon execution of this Agreement, the Parties shall issue the respective press releases announcing the existence of this Agreement in the form and substance as set forth in Exhibit 9.8. Each Party agrees not to issue any other press release or other public statement disclosing other information relating to this Agreement or the transactions contemplated hereby that contains information, the content and wording of which has not previously been publicly disclosed in accordance with this Section 9.8 without the prior written consent of the other Party, not to be unreasonably withheld, delayed, or conditioned.

9.8.2 Each Party may disclose certain information, such as the timeline for Development, the market and competition for Product, the upfront payment and potential milestones, as deemed reasonably necessary by such Party for presentation at professional conferences, symposia and other similar meetings (including one-on-one sessions) attended by actual or potential investors, provided that [***].

9.8.3 Each Party agrees to provide to the other Party a copy of any intended public announcement or other intended disclosure under Sections 9.8.1 or 9.8.2 regarding this Agreement or the Parties’ relationship at least [***] prior to its scheduled release unless extraordinary circumstances exist that prevent the provision of such copy at such time, in which case the copy shall be provided as soon as reasonably practicable under the circumstances. If the recipient does not object to such public disclosure within such [***] period or if the recipient notifies the other Party that it approves such public disclosure, the Party proposing such disclosure may proceed to make such disclosure. Otherwise, the Parties shall discuss promptly reasonably ways of modifying such public disclosure to address the recipient’s concerns with respect thereto.

9.8.4 Any public announcement or disclosure by OncoMed regarding the stage of development of [***], shall be subject to BSP’s prior written approval. Notwithstanding the foregoing, nothing in this Section 9.8 shall be construed to prohibit OncoMed or its respective Affiliates or Sublicensees from making a public announcement or disclosure to their respective actual or potential partners, investors, bankers, or acquirors or a public announcement or disclosure regarding such information, if such information has previously been approved for public disclosure in substantially the same form or is otherwise required by Law.

9.8.5 Notwithstanding anything to the contrary in this Section 9.8, any publications in scientific journals or presentations at scientific conferences relating to Data and/or Results of Development of Collaboration Compounds shall be governed by the terms of Section 9.7.

 

[***] Certain information in this document 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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9.8.6 Notwithstanding the foregoing, any disclosure that is required by Law (including without limitation the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended), or the rules of a securities exchange or the Securities and Exchange Commission or the securities regulations of any state or other jurisdiction, as reasonably advised by the disclosing Party’s counsel, may be made; provided, however, that, if any such required disclosure contains Confidential Information of the other Party or technical or business information not previously in the public domain relating to Collaboration Compounds or Products, and if such disclosure is not otherwise permitted under Section 9.5, then the disclosing Party shall disclose such information only to the extent it is advised by legal counsel such information is required by Law or the rules of a securities exchange to so disclose, and provided further that the disclosing Party shall provide to the other Party a copy of the proposed disclosure reasonably in advance of making such disclosure, the Parties shall reasonably cooperate to discuss ways of minimizing such disclosure and the disclosing Party shall use reasonable efforts to obtain confidential treatment for any such information. Each Party shall use reasonable efforts to respond to any proposed disclosure by the other Party under this Section 9.8.6 within [***] after its receipt thereof.

9.8.7 Notwithstanding the foregoing, subject to Section 9.7, BSP may issue a public announcement or disclosure relating to Collaboration Compounds or Products, or Data or Results relating thereto, without OncoMed’s consent, provided that BSP provides to OncoMed a copy of such proposed public disclosure reasonably in advance of making such disclosure, [***].

9.8.8 Except as previously approved by a Party for use of such Party’s name in substantially the same form and context, or is otherwise required by Law, the other Party will not make public use of such Party’s name except as required by applicable Law or regulation, or otherwise agreed in writing by such Party. If the Party whose name will be disclosed is BSP, BSP shall be referred to as “Bayer Schering Pharma AG, Germany”. BSP hereby notifies OncoMed that the rights to the Schering name in North America are owned by a Third Party not under the control of BSP.

10. I NDEMNITY AND I NSURANCE

10.1 BSP Indemnity. BSP shall indemnify, defend and hold harmless OncoMed and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives and the University of Michigan (the “OncoMed Indemnitees” ), from and against any and all claims, damages, losses, suits, proceedings, liabilities, costs (including without limitation reasonable legal expenses, costs of litigation and reasonable attorney’s fees) or judgments, whether for money or equitable relief, of any kind ( “Losses and Claims” ), to the extent arising out of or relating to, directly or indirectly: (a) the negligence, recklessness or wrongful intentional acts or omissions of BSP, its Affiliates, and/or its Sublicensees and its or their respective directors, officers, employees and agents, in connection with BSP’s performance of its obligations or exercise of its rights under this Agreement; (b) any breach by BSP of any representation, warranty, or covenant set forth in Article 7; (c) [***] including without limitation for each of clauses (a), (b) and (c), above, claims

 

[***] Certain information in this document 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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and threatened claims based on (i) [***] or (ii) [***] except in any such case for Losses and Claims to the extent [***].

10.2 OncoMed Indemnity. OncoMed shall indemnify, defend and hold harmless BSP and its Affiliates, and their respective officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives (the “BSP Indemnitees” ), from and against any and all Losses and Claims, to the extent arising out of or relating to, directly or indirectly: (a) the negligence, recklessness or wrongful intentional acts or omissions of OncoMed, its Affiliates, and/or its Sublicensees and its or their respective directors, officers, employees and agents, in connection with OncoMed’s performance of its obligations or exercise of its rights under this Agreement; (b) any breach by OncoMed of any representation, warranty, or covenant set forth in Article 7; (c) [***] including without limitation for each of clauses (a), (b) and (c), above, claims and threatened claims based on (i) [***] and (ii) [***]; except in any such case for Losses and Claims to the extent [***].

10.3 Indemnification Procedure. A claim to which indemnification applies under Section 10.1 or Section 10.2 shall be referred to herein as an “Indemnification Claim” . If any Person or Persons (collectively, the “Indemnitee” ) intends to claim indemnification under this Article 10, the Indemnitee shall notify the other Party (the “Indemnitor” ) in writing promptly upon becoming aware of any claim that may be an Indemnification Claim (it being understood and agreed, however, that the failure by an Indemnitee to give such notice shall not relieve the Indemnitor of its indemnification obligation under this Agreement except and only to the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice). The Indemnitor shall have the right to assume and control the defense of the Indemnification Claim at its own expense with counsel selected by the Indemnitor and reasonably acceptable to the Indemnitee; provided, however, that an Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitee, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party represented by such counsel in such proceedings. If the Indemnitor does not assume the defense of the Indemnification Claim as described in this Section 10.3, above, the Indemnitee may defend the Indemnification Claim but shall have no obligation to do so. The Indemnitee shall not settle or compromise the Indemnification Claim without the prior written consent of the Indemnitor, and the Indemnitor shall not settle or compromise the Indemnification Claim in any manner which would have an adverse effect on the Indemnitee’s interests (including without limitation any rights under this Agreement or the scope or enforceability of the OncoMed Intellectual Property, or Confidential Information or Patent or other rights licensed to OncoMed by BSP hereunder), without the prior written consent of the Indemnitee, which consent, in each case, shall not be unreasonably withheld or delayed. The Indemnitee shall reasonably cooperate with the Indemnitor at the Indemnitor’s expense and shall make available to the Indemnitor all pertinent information under the control of the Indemnitee, which information shall be subject to Article 9.

10.4 Insurance.

10.4.1 By BSP. BSP hereby represents and warrants to OncoMed that it is self-insured against liability and other risks associated with its activities and obligations under

 

[***] Certain information in this document 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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this Agreement for the activities to be conducted by it under this Agreement, and that such self-insurance is sufficient to meet the obligations set forth in Section 8.3 of the Michigan License.

10.4.2 By OncoMed. OncoMed shall, beginning with the initiation of the first Clinical Trial for a Collaboration Compound, maintain at all times thereafter during the Term, and for [***] after termination or expiration of this Agreement, commercial general liability insurance from a recognized, creditworthy insurance company, on an “occurrence basis” which includes contractual liability coverage and product liability, on a “claims-made basis” with coverage limits of at least [***] per claim and annual aggregate, and is increased to at least [***] before the earlier of the date that OncoMed initiates the First Commercial Sale of any Product containing an OncoMed Development Compound or BSP initiates the First Commercial Sale of any Product containing a BSP Development Compound. Within [***] following written request from BSP, OncoMed shall furnish to BSP a certificate of insurance evidencing such coverage as of the date. In the case of a modification or cancellation of such coverage, OncoMed shall promptly provide BSP with a new certificate of insurance evidencing that OncoMed’s coverage meets the requirements of this Section 10.4.2.

11. T ERM AND T ERMINATION

11.1 Term; Expiration. This Agreement shall become effective as of the Effective Date and shall continue in full force and effect until expiration as described in this Section 11.1, unless earlier terminated pursuant to Section 11.2, 11.3, 11.4, or 11.5 (the “Term”), and shall expire in its entirety upon the expiration of all payment obligations under this Agreement (including without limitation payments due under any Existing Agreement in accordance with Section 6.4.3) with respect to the last Product Commercialized in the last country in the Territory. If BSP does not exercise any of its BSP Options within the respective BSP Option Periods therefor or does not make the payment set forth in Section 6.3.3 for the Small Molecule Class within the time period set forth in Section 6.3.3, this Agreement will expire within thirty (30) days after the later of the termination of the last to expire BSP Option Period or the expiration of the time period set forth in Section 6.3.3. Upon expiration of all royalty and payment obligations (including without limitation under any Existing Agreement in accordance with Section 6.4.3) in each country in the Territory, the licenses granted to BSP in Section 5.1 shall become perpetual, irrevocable, sublicenseable, royalty-free, paid-up, non-exclusive licenses in such country except to the extent not permitted under any agreement between OncoMed and any Third Party licensor of OncoMed.

11.2 Termination for Cause.

11.2.1 Material Breach. Either Party (the “Non-Breaching Party” ) may, without prejudice to any other remedies available to it at law or in equity, terminate this Agreement in its entirety, or terminate this Agreement as to all Collaboration Compounds in a Class that is affected by a material breach, as it shall determine in its sole discretion, in the event the other Party (the “Breaching Party” ) has materially breached this Agreement, and such breach has continued for ninety (90) days (the “Cure Period” ) after written notice thereof is provided to the Breaching Party by the Non-Breaching Party, such notice describing the

 

[***] Certain information in this document 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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alleged material breach in sufficient detail to reasonably apprise the Breaching Party as to the nature of the breach.

11.2.2 Disagreement as to Material Breach; Cure Period. If the Parties reasonably and in good faith disagree as to whether there has been a material breach, the Party that disputes that there has been a material breach may contest the allegation in accordance with the Dispute Resolution Procedure in Sections 12.2 and 12.4. Notwithstanding the preceding sentence, the Cure Period for any allegation made in good faith as to a material breach under this Agreement [***]. Any such termination of the Agreement under this Section 11.2 shall [***] unless the Breaching Party has cured any such breach or default prior to the expiration of such Cure Period, or, if such breach is not susceptible to cure within the Cure Period, then, the Non-Breaching Party’s right of termination shall be suspended [***]. The right of either Party to terminate this Agreement in its entirety, or as to all Collaboration Compounds in a Class to which such material breach relates, as provided in this Section 11.2, shall not be affected in any way by such Party’s waiver or failure to take action with respect to any previous default.

11.3 BSP Unilateral Termination Rights.

11.3.1 Termination of Agreement in Its Entirety. BSP may, in its sole discretion, exercisable at any time during the Term, terminate this Agreement in its entirety for any reason or no reason at all, upon one hundred and eighty (180) days written notice to OncoMed.

11.3.2 Termination on a Class-by-Class or Compound-by-Compound Basis. BSP may, in its sole discretion, exercisable at any time during the Term, terminate this Agreement on a Class-by-Class or a Late BSP Development Compound-by-Late BSP Development Compound basis for any reason or no reason at all, effective upon ninety (90) days written notice to OncoMed.

11.4 Termination for Insolvency. Either Party may terminate this Agreement, if, at any time, the other Party files in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Party or of substantially all of its assets, or if the other Party is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within one hundred and eighty (180) days after the filing thereof, or if the other Party shall propose or be a party to any dissolution or liquidation, or if the other Party shall make an assignment of substantially all of its assets for the benefit of creditors. To the extent permitted under Law, all rights and licenses granted under or pursuant to any section of this Agreement, including any option to receive a license, are and shall otherwise be deemed to be for purposes of Section 365(n) of Title 11, United States Code (the “Bankruptcy Code” ) licenses of rights to “intellectual property” as defined in Section 101 (35A) of the Bankruptcy Code. The Parties acknowledge that each BSP Option provided herein is, to the extent permitted under Law, an exclusivity provision within the meaning of Section 365(n) of the Bankruptcy Code. The Parties shall retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code. Upon the bankruptcy of any Party, the non-bankrupt Party shall further be entitled to a complete duplicate

 

[***] Certain information in this document 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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of, or complete access to, any such intellectual property, and such, if not already in its possession, shall be promptly delivered to the non-bankrupt Party, unless the bankrupt Party elects to continue, and continues, to perform all of its obligations under this Agreement.

11.5 Termination for Patent Challenge. OncoMed shall have the right to terminate this Agreement immediately upon written notice if BSP challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the OncoMed Patents. If a Sublicensee of BSP challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the OncoMed Patents under which such Sublicensee is sublicensed, then BSP shall, upon written notice from OncoMed, terminate such sublicense. BSP shall include provisions in all agreements under which a Third Party obtains a license under any Patent included in the OncoMed Patents providing that if the Sublicensee challenges the validity or enforceability of or otherwise opposes any such Patent under which the Sublicensee is sublicensed, BSP may terminate its sublicense agreement with such Sublicensee.

11.6 Consequences of Expiration or Termination. All of the following effects of expiration or termination, as applicable, are in addition to the other rights and remedies that may be available to the Parties at law or in equity.

11.6.1 Consequences of Termination by BSP Without Cause or by OncoMed.

(a) Termination of this Agreement in its Entirety. In the event of (x) unilateral termination of this Agreement in its entirety by BSP pursuant to Section 11.3.1 or (y) termination of this Agreement in its entirety by OncoMed pursuant to Section 11.2.1 (for cause), Section 11.4 (insolvency of BSP), or Section 11.5 (for challenge by BSP), notwithstanding anything contained in this Agreement to the contrary, upon the effective date of such termination:

(i) all rights (including without limitation all BSP Options) and licenses granted herein to BSP shall terminate, BSP shall cease any and all Research, Development, and Commercialization activities with respect to all terminated Classes and all terminated Collaboration Compounds, and all such terminated Biologic Collaboration Compounds and Products including such terminated Biologic Collaboration Compounds shall be deemed to be OncoMed Development Compounds, and Section 3.6.7(b) shall apply;

(ii) BSP shall cease any and all Research activities with respect to Small Molecule Collaboration Compounds that are not, as of such date, BSP Development Compounds [***]; provided that BSP may Develop and/or Commercialize any such Small Molecule Collaboration Compound [***], and solely for [***];

(iii) OncoMed shall have an exclusive right to negotiate with BSP the terms and conditions pursuant to which OncoMed would obtain an exclusive license, under all intellectual property rights owned or otherwise Controlled by BSP that are necessary or useful to Research, Develop, make and Commercialize Small Molecule Collaboration Compounds, to Research, Develop, make, use, sell, offer for sale and import after

 

[***] Certain information in this document 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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such termination throughout the Territory Small Molecule Collaboration Compounds [***]. OncoMed shall provide to BSP written notice if OncoMed desires to negotiate such terms within [***] after the effective date of any such termination. BSP shall not offer to Third Parties, or enter into an agreement with any Third Party, with respect to such a license until such [***] period expires, and OncoMed fails to so provide such notice. If OncoMed provides such a notice, the Parties will negotiate such terms and conditions for up to [***] after BSP receives such notice, and BSP shall not offer to Third Parties, or enter into an agreement with any Third Party, with respect to such a license until such [***] period expires, if the Parties have not entered into an agreement governing such terms and conditions during such time period;

(iv) Sections [***] shall survive; and

(v) except as otherwise set forth in Section 3.6.7(b), all payment obligations hereunder shall terminate, other than those that are accrued and unpaid as of the effective date of such termination.

(b) Termination of Class or Late BSP Development Compound. In the event of (x) unilateral termination of a Class or Late BSP Development Compound by BSP pursuant to Section 11.3.2 or (y) termination of a Class by OncoMed pursuant to Section 3.4.1 or 11.2.1 (for cause), other than in connection with termination of this Agreement, notwithstanding anything contained in this Agreement to the contrary, upon the effective date of such termination with respect to such Class:

(i) if such Class is a Biologic Collaboration Compound Class:

(A) and such termination is effective prior to exercise of a BSP Option for such Class, all rights (including without limitation the BSP Option for such terminated Class) and licenses granted herein to BSP with respect to such terminated Class and all Biologic Collaboration Compounds within such Class shall terminate, BSP shall cease any and all Research and Development activities with respect thereto, and all such Biologic Collaboration Compounds shall be deemed to be OncoMed Development Compounds, and Section 3.6.7(b) shall apply to such Class or Biologic Collaboration Compound; and

(B) if such Class is a Biologic Collaboration Compound Class, or such terminated Late BSP Development Compound is in a Biologic Collaboration Compound Class, and such termination is effective after exercise of a BSP Option for such Class, except as otherwise set forth in Sections 3.6.7(a)(iii), all rights and licenses granted herein to BSP with respect to such terminated Biologic Collaboration Compound Class and all Biologic Collaboration Compounds within such Class, or such terminated Late BSP Development Compound, as applicable, shall terminate, BSP shall cease any and all Research, Development, and Commercialization activities with respect thereto, and all such terminated Biologic Collaboration Compounds shall be deemed to be OncoMed Development Compounds, and Section 3.6.7 shall apply to such Class or Biologic Collaboration Compound;

(ii) if

 

[***] Certain information in this document 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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(A) such terminated Class is the Small Molecule Class, no Small Molecule Collaboration Compound shall be an deemed OncoMed Development Compound, but BSP shall cease any and all Research, Development, and Commercialization activities with respect to Small Molecule Collaboration Compounds that [***]; provided that BSP may [***], and

(B) if such termination is of a Small Molecule Collaboration Compound, such Small Molecule Collaboration Compound shall not be deemed an OncoMed Development Compound, BSP shall cease any and all Research, Development, and Commercialization activities with respect to such Small Molecule Collaboration Compound; [***];

(iii) if such terminated Class is the Small Molecule Class, or if such termination is of a Small Molecule Collaboration Compound, upon the effective date of such termination: (A) all such terminated Small Molecule Collaboration Compounds shall no longer be subject to any obligation of BSP to use Commercially Reasonable Efforts, (B) no milestone or royalty payments shall be due under Sections 6.3 or 6.4 for such terminated Small Molecule Collaboration Compounds, [***] and (E) OncoMed shall have an exclusive right to negotiate with BSP the terms and conditions pursuant to which OncoMed would obtain an exclusive license, under all intellectual property rights owned or otherwise Controlled by BSP that are necessary or useful to Research, Develop, make and Commercialize such terminated Small Molecule Collaboration Compounds, to Research, Develop, make, use, sell, offer for sale and import after such termination throughout the Territory such terminated Small Molecule Collaboration Compounds [***]. OncoMed shall provide to BSP written notice if OncoMed desires to negotiate such terms within [***] after the effective date of any such termination. BSP shall not offer to Third Parties, or enter into an agreement with any Third Party, with respect to such a license until such [***] period expires, and OncoMed fails to so provide such notice. If OncoMed provides such a notice, the Parties will negotiate such terms and conditions for up to [***] after BSP receives such notice, and BSP shall not offer to Third Parties, or enter into an agreement with any Third Party, with respect to such a license until such [***] period expires, if the Parties have not entered into an agreement governing such terms and conditions during such time period;

(iv) If such terminated Class is a Biologic Collaboration Compound Class, or if such terminated Late BSP Development Compound is a Biologic Collaboration Compound, Sections [***] shall survive with respect to all Collaboration Compounds in such terminated Biologic Collaboration Compound Class, or such terminated Late BSP Development Compound, respectively; and

(v) except as otherwise set forth in Section 3.6.7(b), all payment obligations hereunder with respect to such Class, or such terminated Late BSP Development Compound, shall terminate, other than those that are accrued and unpaid as of the effective date of such termination.

 

[***] Certain information in this document 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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11.6.2 Consequences of Termination by BSP for Cause or Insolvency of OncoMed.

(a) Termination of this Agreement in its Entirety. In the event of termination of the Agreement in its entirety by BSP pursuant to Section 11.2.1 (for cause) or Section 11.4 (insolvency of OncoMed):

(i) all licenses granted to BSP with respect to a Class for which BSP previously exercised its BSP Option in accordance with Section 3.1 shall continue in full force, in accordance with the terms and conditions of this Agreement (other than for licenses for any Class that was previously terminated by OncoMed under Section 3.4.1, 11.2, 11.4, or 11.5 or by BSP under Section 11.3);

(ii) all BSP Class Options that are pending as of the effective date of such termination by BSP shall continue under their terms in Section 3.1.1, and BSP shall have the right immediately on such termination to exercise any BSP Class Options that are so pending by written notice to OncoMed. If BSP exercises any such BSP Class Option, all licenses granted to BSP with respect to the Class for which BSP exercises its BSP Class Option under Section 3.1.1 shall continue in full force, subject to Section 11.6.2(a)(i);

(iii) OncoMed shall promptly return to BSP all data and materials transferred by BSP to OncoMed under this Agreement;

(iv) Sections [***] shall survive; and

(v) all payment obligations hereunder shall terminate, except with respect to Products in a Class for which BSP retains licenses with respect to BSP [***], and (B) any payments that are accrued and unpaid as of the effective date of such termination.

(b) Termination of Class. In the event of termination of a Class by BSP pursuant to 11.2.1 (for cause):

(i) if such terminated Class is a Biologic Collaboration Compound Class:

(A) for which BSP previously exercised its BSP Option in accordance with Section 3.1, all licenses granted to BSP with respect to such Biologic Collaboration Compound Class shall continue in full force in accordance with the terms and conditions of this Agreement (other than for licenses that were previously terminated by OncoMed under Section 3.4.1, 11.2, 11.4, or 11.5 or by BSP under Section 11.3);

(B) if the BSP Class Option for such Class is pending as of the effective date of such termination by BSP, such BSP Class Option shall continue under its terms in Section 3.1.1, and BSP shall have the right immediately on such termination to exercise such BSP Class Option by written notice to OncoMed. If BSP exercises

 

[***] Certain information in this document 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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such BSP Class Option, all licenses granted to BSP with respect to such Class shall continue in full force, subject to Section 11.6.2(b)(i)(A); and

(C) OncoMed shall promptly return to BSP all data and materials transferred by BSP to OncoMed with respect to such terminated Class under this Agreement;

(ii) all payment obligations hereunder with respect to the terminated Class shall terminate, other than [***] and (B) any payments that are accrued and unpaid as of the effective date of such termination;

(iii) BSP’s payment obligations hereunder shall survive with respect to the Classes that were not terminated;

(iv) Sections [***] shall survive;

(v) Sections [***] shall survive solely as to activities for Classes that are not terminated; and

(vi) [***].

11.7 Survival . The following provisions shall survive termination or expiration of this Agreement in its entirety in addition to those which are expressly stated to survive elsewhere in this Article 11, as well as any other provision which by its terms or by the context thereof, is intended to survive such termination: Articles 1, 9 (for the period set forth in Section 9.1), 12, and 13 and Sections 5.6, 6.5 through 6.11 (solely with respect to payments payable after the effective date of such termination or expiration), 7.6, 7.7, 8.1, 8.2, 8.3, 8.4 (solely with respect to actions or proceedings that are pending as of the effective date of termination or expiration or to allow a Party retaining a license after such date to exercise its rights thereunder), 8.5 (solely to allow a Party retaining a license after such date to exercise its rights thereunder), 8.8 (solely to the extent BSP retains a license for the relevant Late BSP Development Compound), 8.9.4 (to the extent applicable to any surviving payment obligations under Article 6), 8.10.2, 10.1, 10.2, 10.3, 10.4 (for the period set forth therein), 11.6 (as applicable), and 11.7. Termination or expiration of this Agreement shall not relieve the Parties of any liability or obligation which accrued hereunder prior to the effective date of such termination or expiration nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity, subject to Article 12, with respect to any breach of this Agreement nor prejudice either Party’s right to obtain performance of any obligation. All other rights, licenses and obligations shall terminate upon expiration of this Agreement.

12. D ISPUTE R ESOLUTION

12.1 Exclusive Dispute Resolution Mechanism. The Parties agree that the procedures set forth in this Article 12 shall be the exclusive mechanism for resolving any dispute, controversy, or claim between the Parties that arises out of or in connection with this Agreement, including without limitation any issues regarding its existence, validity, or

 

[***] Certain information in this document 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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termination (collectively, “Disputes” ) that is not be resolved through the JSC (to the extent within the jurisdiction of the JSC under Section 4.1) or other good faith negotiation between the Parties.

12.2 Dispute Resolution Procedure. In the event of a Dispute, the Parties shall first attempt in good faith to resolve such Dispute by negotiation and consultation between themselves. Either Party may, by written notice to the other Party, refer the Dispute to the other Party for attempted resolution by formal good faith negotiation within thirty (30) days after such notice is received. If the Dispute remains unresolved after the good faith negotiation period provided in the previous sentence, either Party by written notice to the other Party may have such issue referred for resolution to the Chief Executive Officer of OncoMed, or such other person designated by OncoMed from time to time, and the General Manager of Oncology of BSP, or such other person designated by BSP from time to time (collectively, the “Executive Officers” ). The Executive Officers shall meet promptly to discuss the matter submitted and to determine a resolution. If the Executive Officers are unable to resolve the Dispute within [***] days after it is referred to them, the matter will be resolved through expert dispute resolution or arbitration under Section 12.3 or Section 12.4 as specified in this Agreement.

12.3 Expert Dispute Resolution Procedure. In the event that the Parties have any Dispute that is expressly stated to be resolved by expert resolution under this Section 12.3, the Parties shall attempt to resolve their Dispute in accordance with the procedures set forth in Section 12.2 except that the matter shall be referred to the ICC International Centre for Expertise. The expert shall render his or her decision no later than [***] after being appointed. The Parties shall implement and abide by the determination of the expert absent manifest error with any failure to do so being deemed a material breach of this Agreement subject to arbitration pursuant to Section 12.4.

12.4 Arbitration.

12.4.1 Within [***] after receipt of an arbitration notice from a Party, the Parties shall attempt in good faith to agree on a single neutral arbitrator with relevant industry experience to conduct the arbitration. If the Parties do not agree on a single neutral arbitrator within [***] after receipt of an arbitration notice, each Party shall select one (1) arbitrator and the two (2) Party-selected arbitrators shall select a third arbitrator with relevant industry experience to constitute a panel of three (3) arbitrators to conduct the arbitration in accordance with the ICC Rules. The arbitrators shall be appointed in accordance with the ICC Rules.

12.4.2 The place of arbitration shall be New York, New York, U.S., and the language to be used in any such proceeding (and for all testimony, evidence and written documentation) shall be English.

12.4.3 Any arbitration under this Section 12.4 shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by the arbitrators ( “ICC Rules” ) as such Rules may be amended from time to time. In such arbitration the governing law to be applied is as described in Section 13.8. The International Bar Association Rules on the Taking of Evidence in International Commercial Arbitration shall govern the taking

 

[***] Certain information in this document 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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of evidence in any such proceeding, it being the intent of the Parties to enable a reasonable amount of discovery in any such proceeding.

12.4.4 The Parties acknowledge that they desire for any arbitration to be conducted in an efficient, speedy and economical manner. The Parties shall use good faith efforts to complete arbitration under this Section 12.4 within [***] following the initiation of such arbitration. In order to effectuate this desire, the arbitrators shall establish procedures reasonably directed to facilitating such goals and completing such arbitration within such [***] period, including the streamlining of any discovery necessary to resolve the dispute.

12.4.5 The decision or award of the arbitrator(s) shall be final, binding, and incontestable and may be used as a basis for judgment thereon in any jurisdiction. To the full extent permissible under Law, the Parties hereby expressly agree to waive the right to appeal from the decision of the arbitrator(s), there shall be no appeal to any court or other authority (government or private) from the decision of the arbitrator(s), and the Parties shall not dispute nor question the validity of such decision or award before any regulatory or other authority in any jurisdiction where enforcement action is taken by the Party in whose favor the decision or award is rendered, except in the case of fraud. Without limiting any other remedies that may be available under Law, the arbitrator(s) shall have no authority to award punitive, special, consequential, or any other similar form of damages.

12.4.6 Each Party shall bear its own costs and attorney’s fees, and the Parties shall equally bear the fees, costs, and expenses of the arbitrator(s) and the arbitration proceedings; provided, however, that the arbitrator(s) may exercise discretion to award costs, including attorney’s fees, to the prevailing Party.

12.5 Preliminary Injunctions. Notwithstanding anything in this Agreement, including without limitation Section 12.2, to the contrary, a Party may, at any time, seek a temporary restraining order or a preliminary injunction from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the decision of the arbitrator(s) on the ultimate merits of any dispute.

12.6 Patent Disputes. Notwithstanding anything in this Agreement to the contrary, any and all issues regarding the validity and enforceability of any patent in a country within the Territory ( “Patent Matters” ) shall be determined in a court or other tribunal, as the case may be, of competent jurisdiction under the applicable patent laws of such country. If such Dispute involves both Patent Matters and other matters, the arbitrators will have the right to stay the arbitration until determination of Patent Matters material to the resolution of the Dispute as to other matters is resolved.

12.7 Confidentiality. Any and all activities conducted under Sections 12.1 through 12.4, including without limitation any and all proceedings and decisions of arbitrator(s) under Section 12.4, shall be deemed Confidential Information of each of the Parties, and shall be subject to Article 9.

 

[***] Certain information in this document 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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13. M ISCELLANEOUS

13.1 Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

13.2 Notices. Any notice required or permitted to be given by this Agreement shall be in writing and shall be (a) delivered by hand overnight courier with tracking capabilities, (b) mailed postage prepaid by first class, registered or certified mail addressed as set forth below unless changed by notice so given, or (c) delivered by facsimile to the number set forth below unless changed by notice so given, followed by delivery via the either of the methods set forth in Section 13.2(a) and (b):

If to BSP:

Bayer Schering Pharma AG

Attention: Head, Oncology Research

Müllerstrasse 178

13353 Berlin, Germany

Facsimile:    +49 202 364 585

With a copy to:

Bayer Schering Pharma AG

Attention: Head of Law & Patents

Müllerstrasse 178

13353 Berlin, Germany

Facsimile:    +49 30 468 14086

If to OncoMed:

OncoMed Pharmaceuticals, Inc.

800 Chesapeake Drive

Redwood City, California 94063 U.S.A.

Attention: Chief Executive Officer

Facsimile:    650-298-8600

Any such notice shall be deemed given on the date received if delivered in accordance with Section 13.2(a), five (5) days after mailing if mailed in accordance with Section 13.2(b), or the date of transmission if delivered in accordance with Section 13.2(c). A Party may add, delete, or change the person or address to which notices should be sent at any time upon written notice delivered to the Party’s notices in accordance with this Section 13.2.

 

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13.3 Force Majeure. Neither Party shall be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to causes beyond its reasonable control, including without limitation acts of God, fires, earthquakes, acts of war, terrorism, or civil unrest ( “Force Majeure” ); provided, however, that the affected Party promptly notifies the other Party and further provided that the affected Party shall use its Commercially Reasonable Efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance with the utmost dispatch whenever such causes are removed. When such circumstances arise, the Parties shall negotiate in good faith any modifications of the terms of this Agreement that may be necessary or appropriate in order to arrive at an equitable solution.

13.4 Assignment.

13.4.1 Each Party may, without the consent of the other Party, assign or transfer all of its rights and obligations hereunder to an Affiliate of or to a successor in interest by reason of merger or consolidation or sale of all or substantially all of the assets of such Party relating to the subject matter of this Agreement; provided however, that (a) such assignment includes, without limitation, all rights and obligations under this Agreement, (b) such successor in interest or Affiliate shall have agreed as of such assignment or transfer to be bound by the terms of this Agreement in a writing provided to the non-assigning Party, and (c) where this Agreement is assigned or transferred to an Affiliate, the assigning Party remains responsible for the performance of this Agreement.

13.4.2 Subject to Section 13.4.1, this Agreement shall inure to the benefit of and be binding on the Parties’ successors and assigns. Any assignment or transfer in violation of the foregoing shall be null and void and wholly invalid, the assignee or transferee in any such assignment or transfer shall acquire no rights whatsoever, and the non-assigning non-transferring Party shall not recognize, nor shall it be required to recognize, such assignment or transfer. In the event that BSP assigns or otherwise transfers this Agreement to an Affiliate of BSP, BSP hereby agrees to be jointly and severally liable with any such Affiliates for the actions of such Affiliates and for any and all amounts that become due and payable hereunder to OncoMed.

13.4.3 Notwithstanding anything to the contrary in this Agreement, in the event of any such assignment, the intellectual property rights of the acquiring party (if other than one of the Parties to this Agreement) shall not be included in the technology licensed to the other Party hereunder to the extent held by such acquirer prior to such transaction, or to the extent such technology is developed outside the scope of activities conducted with respect to Collaboration Compounds, Collaboration Targets or Products. The OncoMed Intellectual Property and the BSP Intellectual Property shall exclude any intellectual property owned or Controlled by a permitted assignee or successor and not developed in connection with Collaboration Compounds, Collaboration Targets or Products.

13.4.4 Notwithstanding anything to the contrary in this Agreement, OncoMed shall have the right to assign solely its rights to receive payments pursuant to Article 6, in whole or in part, to a Third Party purchasing only such interest in such revenues in connection with the monetization of OncoMed’s revenue stream under Article 6, but not the

 

- 86 -


performance of any obligation required under this Agreement without BSP’s written consent in connection with such assignment; provided that, OncoMed may not assign such interest to any entity that has in active clinical development, under application for Regulatory Approval or in commercialization any compound [***] without the consent of BSP, which may be withheld in BSP’s discretion. For clarity, this Section 13.4.4 shall not limit OncoMed’s right to assign its rights and obligations under this Agreement as provided in Sections 13.4.1 and 13.4.2.

13.4.5 If BSP assigns this Agreement to an Affiliate, and such assignment has an adverse tax consequence to OncoMed, then BSP shall make additional payments to OncoMed under this Agreement to provide OncoMed the payments that would have been due to OncoMed had such assignment not occurred.

13.5 BSP Election. BSP represents and warrants that as of the Effective Date it is not conducting Research, Development or Commercialization of any product that is primarily active against a target in the Pathway (each, a “Section 13.5 Product” ). If after the Effective Date either (a) BSP acquires, develops or otherwise comes into Control of any rights to any Section 13.5 Product other than by reason of activities under this Agreement, or (b) BSP undergoes a Change of Control in which BSP, BSP’s successor or BSP’s Affiliate after such Change of Control occurs Controls rights to, or is otherwise Researching, Developing or Commercializing, any Section 13.5 Product outside the scope of this Agreement, BSP shall promptly notify OncoMed of such fact in writing. BSP (or its successor) shall, within [***] after providing such notice, either (i) [***] BSP’s, its successor’s or its Affiliate’s rights with respect to such Section 13.5 Product within [***], (ii) [***] or [***].

13.6 Further Assurances. Each Party agrees to do and perform all such further acts and things and shall execute and deliver such other agreements, certificates, instruments and documents necessary or that the other Party may deem advisable in order to carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder. Each Party and its Affiliates shall take all measures reasonably requested by the other Party to give effect to the provisions of this Agreement. Any Affiliate that acquires rights hereunder will be deemed to be bound by the provisions of this Agreement.

13.7 Waivers and Modifications. The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification, release or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by both of the Parties.

13.8 Governing Law. This Agreement shall be governed by, enforced, and shall be construed in accordance with the Law of the State of New York, U.S. without regard to any conflicts of law provision that would result in the application of the Law of any State other than the State of New York, U.S.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

- 87 -


13.9 Relationship of the Parties. Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute OncoMed and BSP as partners, agents or joint venturers. Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party. There are no express or implied third party beneficiaries hereunder.

13.10 Entire Agreement. This Agreement and the attached exhibits constitutes the entire agreement between the Parties as to the subject matter of this Agreement, and supersedes and merges all prior and contemporaneous negotiations, representations, agreements and understandings regarding the same.

13.11 Exports. Each Party agrees not to export or re-export, directly or indirectly, any information, technical data, the direct product of such data, samples or equipment received or generated under this Agreement in violation of any applicable export control Law.

13.12 Interpretation.

13.12.1 Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties hereto and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

13.12.2 Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (b) any reference to any Law herein shall be construed as referring to such Law as from time to time enacted, repealed or amended, (c) any reference herein to any Person shall be construed to include the Person’s successors and assigns, and (d) all references herein to Articles, Sections or Exhibits, unless otherwise specifically provided, shall be construed to refer to Articles, Sections and Exhibits of this Agreement.

13.12.3 Headings and captions are for convenience only and are not be used in the interpretation of this Agreement.

13.13 Performance by Affiliates. Each Party recognizes that the other Party may perform some or all of its obligations under this Agreement through Affiliates to the extent permitted under this Agreement, provided, however, that such other Party shall remain responsible for the performance by its Affiliates as if such obligations were performed by such other Party.

 

- 88 -


13.14 Compliance with Law. For the avoidance of doubt, the Parties agree that nothing in this Agreement shall require either Party to commit any act that is in breach of applicable Law.

13.15 Counterparts; Electronic Delivery. This Agreement may be executed in counter-parts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument. Signatures to this Agreement transmitted by facsimile, by email in “portable document format” (“.pdf”), or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement shall have the same effect as physical delivery of the paper document bearing original signature.

[ Signature Page Follows ]

 

- 89 -


IN WITNESS WHEREOF, the Parties have caused this Collaboration and Option Agreement to be executed by their respective duly authorized officers as of the Effective Date.

 

ONCOMED PHARMACEUTICALS, INC      BAYER SCHERING PHARMA AG
By:  

/s/ Paul J. Hastings

     By:  

/s/ Andreas Fibig

Name:  

Paul J. Hastings

     Name:  

Andreas Fibig

Title:  

President and CEO

     Title:  

Chairman of the Board of Management

       By:  

/s/ Andreas Busch

       Name:  

Andreas Busch

       Title:  

Member of the Board of Management

[ Signature Page to Collaboration and Option Agreement ]


Exhibit 1.8

Assay Technology

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


Exhibit 1.33

Candidate Selection Criteria

For Biologic Collaboration Compounds:

 

   

[***]

For Small Molecule Collaboration Compounds:

 

   

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


Exhibit 1.110

OncoMed Patents

[***]

Registered Owner: [***]

 

Country

  

Application No.

  

Filing Date

  

Status

[***]    [***]    [***]    [***]

[***]

Registered Owner: [***]

 

Country

  

Application No.

  

Filing Date

  

Status

[***]         

[***]

Registered Owner: [***]

 

Country

  

Application No.

  

Filing Date

  

Status

[***]    [***]    [***]    [***]

[***]

[***]

Registered Owner: [***]

 

Country

  

Application No.

  

Filing Date

  

Status

[***]    [***]    [***]    [***]

[***]

Registered Owner: [***]

 

Country

  

Application No.

  

Filing Date

  

Status

[***]    [***]    [***]    [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


Exhibit 1.113

Pathway

[***] the Wnt pathway:

 

1. [***]
2. [***]
3. [***]
4. [***]
5. [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit 2.5

Development Plan(s)


Initial Biologic Development Plan(s)

18R5 Research Plan

 

1.      [***]

        
      [***]   
   [***]       [***]

•      [***]

        

-        [***]

         [***]

-        [***]

         [***]

•    [***]

        

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

•    [***]

        

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

•    [***]

        

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

-        [***]

         [***]

•    [***]

        

-        [***]

         [***]

-        [***]

         [***]

 

2.      [***]

3.      [***]

4.      [***]

        

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


Anti-Fzd 7 [***]

[***]

Fzd-Fc [***]

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


Initial Small Molecule Development Plan

Identification of Wnt pathway inhibitors – Small Molecule Approaches

 

1. Overview and Goal

 

2. Project Workflow

[***]

 

3. Timelines

1. Overview and Goal

[***]

2. Project Workflow

[***]

 

3. Timelines

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


Appendix 1. Table with Lead Target Profile for p.o. administration

 

      [***]
[ ***]    [***]    [***]
   [***]    [***]
   [***]    [***]
   [***]    [***]
   [***]    [***]
   [***]    [***]
   [***]    [***]
   [***]    [***]
[***]    [***]    [***]
[***]    [***]   
   [***]   
   [***]   
   [***]   
   [***]    [***]
   [***]   
[***]    [***]    [***]
   [***]    [***]
   [***]   
   [***]   
   [***]   
   [***]   
[***]    [***]   
   [***]    [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


Appendix 2. Table with Candidate Target Profile

 

      [***]
[***]    [***]    [***]
[***]    [***]   
   [***]   
   [***]   
   [***]   
   [***]    [***]
   [***]   
   [***]   
[***]    [***]   
   [***]   
   [***]   
   [***]   
   [***]   
   [***]   
   [***]   
   [***]   
[***]    [***]   
   [***]    [***]
   [***]   
   [***]   
   [***]   
   [***]   
   [***]   
   [***]   
   [***]   
[***]    [***]   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


   [***]    [***]
   [***]   
   [***]   
   [***]   

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


Exhibit 3.6.2

Development and Commercialization Information Shared by BSP

 

a. [***]
b. [***]
c. [***]
d. [***]
e. [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


Exhibit 4.1.1

Information Sharing at JSC

 

1. [***]

 

2. [***]

 

3. [***]

 

4. [***]

 

5. [***]

 

6. [***]

 

7. [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


Exhibit 4.2.1

Information Sharing at JDS

 

1. [***]
2. [***]
3. [***]
4. [***]
5. [***]
6. [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


Exhibit 4.5.2

Information Sharing between Patent Representatives

 

1. [***]
2. [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


Exhibit 5.5

Existing Agreements

This Agreement is expressly subject to the applicable terms and conditions of the Existing Agreements, including without limitation as described in Section 5.5 and 5.6.2 of this Agreement and in this Exhibit 5.5, below.

 

  1. MorphoSys Agreement.

(a) OncoMed’s requirements under Section 4.8(a) of the MorphoSys Agreement, and BSP agrees that, if it exercises the BSP Option for the 18R5 Class (and does not elect to omit from such Class the 18R5 Collaboration Compound pursuant to Section 3.1.2), BSP shall use Commercially Reasonable Efforts to Develop and Commercialize the 18R5 Collaboration Compound as provided in Section 4.8(a) of the MorphoSys Agreement.

(b) OncoMed shall have the right to grant to MorphoSys rights under the Inventions arising under this Agreement to the extent required to effect the Grantback License and the Improvement License (as such terms are defined in the MorphoSys Agreement) under Sections 4.10 and 4.11, respectively, of the MorphoSys Agreement.

(c) MorphoSys has the first right, pursuant to Section 9.1 and 9.2 of the MorphoSys Agreement, to prosecute, maintain or enforce certain OncoMed Patents covering Research Inventions (as such term is defined in the MorphoSys Agreement) if OncoMed elects not to do so.

(d) OncoMed has no rights to prosecute or maintain the Patents licensed to OncoMed pursuant to the MorphoSys Agreement.

(e) OncoMed is required to provide to MorphoSys periodic reports relating to the total Net Sales for each Licensed Product (as such terms are defined in the MorphoSys Agreement) in accordance with Section 6.5(a) of the MorphoSys Agreement. BSP is required, in accordance with Section 6.6 of the MorphoSys Agreement, to keep complete and accurate records of sales, and make such records available for inspection by an independent certified public accountant on behalf of MorphoSys, for a duration of [***] after MorphoSys’s receipt of the applicable payment report. [***].

(f) OncoMed is required to promptly notify MorphoSys in writing of this Agreement in accordance with Section 4.6 of the MorphoSys Agreement.

 

  2. Michigan License.

(a) The reservation of rights by the University of Michigan, on behalf of the University of Michigan and the Howard Hughes Medical Institute, for noncommercial research and education purposes under Section 3.2 of the Michigan License.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


(b) OncoMed shall notify the University of Michigan in writing of this Agreement and any material amendment to this Agreement in accordance with Section 8.2 of the Michigan License.

(c) The University of Michigan’s rights, pursuant to Section 8.3 of the Michigan License, in the Michigan Patents. As provided in Section 8.3 of the Michigan License, BSP acknowledges that the provisions of Sections 7.6, 7.7, 10.1, 10.3, and 10.4.1 of this Agreement inure to the benefit of the University of Michigan.

(d) In accordance with Section 8.3 of the Michigan License, BSP covenants not to sue, and not to assist other parties in suing, the University of Michigan for claims relating to the Technology (as such term is defined in the Michigan License), the Michigan Patents, and any sublicenses granted under the Michigan Patents pursuant to the terms of this Agreement.

(e) OncoMed shall have the right to assign this Agreement, as a sublicense under the Michigan Patents, to the University of Michigan in accordance with Section 8.4 of the Michigan License; provided however that such assignment shall not be effective without the University of Michigan’s prior acceptance of such assignment in writing.

(f) This Agreement incorporates with full force and effect the document attached as Exhibit A to the Michigan License.

(g) OncoMed and the University of Michigan shall cooperate to obtain and defend the Michigan Patents as set forth in Section 10.1 of the Michigan License.

(h) The University of Michigan has the first right to prosecute and maintain the Michigan Patents. If the University of Michigan decides to refrain from or to cease prosecuting or maintaining the Michigan Patents, then under the Michigan License, OncoMed has the right to continue such prosecution or maintenance. If OncoMed continues such activities, then OncoMed shall proceed as provided in Section 8.2 of this Agreement with respect to the Michigan Patents, provided that BSP agrees and acknowledges that OncoMed is obligated to provide to the University of Michigan any and all draft filings and applications for the Michigan Patents, as well as responses to patent authorities in connection therewith, before filing such items, for review and comment by the University of Michigan.

(i) The University of Michigan has back-up rights to enforce the Michigan Patents against alleged Third Party infringement as set forth in Section 11.3 of the Michigan License.

(j) OncoMed is required to provide to the University of Michigan periodic reports relating to the gross sales and Net Sales of Products and Processes (as such terms are defined in the Michigan License) in accordance with Section 5.1 of the Michigan License. BSP is required, in accordance with Section 5.3 of the Michigan License, to keep true and accurate records and books of account, and open such books and records for inspection by the University of Michigan, for a duration of four (4) years from the date of origination of such books or records.

 

2


(k) Neither the University of Michigan nor the Howard Hughes Medical Institute shall be responsible or liable for any direct, indirect, special, incidental or consequential damages or loss with respect to products and processes covered by the Michigan Patents, as set forth in Section 12.3 of the Michigan License. OncoMed, its Affiliates and BSP (i) shall not, as set forth in Section 12.5 of the Michigan License, take any actions that are inconsistent with the limitation of University of Michigan’s liability in the foregoing sentence, and (ii) shall, as set forth in Section 13.1 of the Michigan License, indemnify and hold harmless the University of Michigan and the Howard Hughes Medical Institute for any claims or liability resulting from the manufacture, use, practice, sale or other disposition of products and processes covered by the Michigan Patents, by OncoMed, its Affiliates and BSP.

(l) OncoMed, its Affiliates and BSP shall comply with all applicable Law relating to the license granted under the Michigan License and to the testing, production, importation, transportation, export, packaging, labeling, sale or use of products and processes covered by the Michigan Patents, and shall obtain written assurances regarding export of technical data as the Office of Export Administration Regulations may require, as set forth in Section 17.2 of the Michigan License.

(m) OncoMed, its Affiliates and BSP shall refrain from using the name of the University of Michigan or the Howard Hughes Medical Institute in publicity or advertising without the prior written approval of the University of Michigan or the Howard Hughes Medical Institute, as set forth in Section 19 of the Michigan License.

(n) OncoMed, its Affiliates and BSP shall mark products covered by the Michigan Patents with legally sufficient patent notices to the extent feasible, as set forth in Section 20 of the Michigan License.

 

  3. Lonza Agreements.

(a) OncoMed will need to obtain from Lonza a commercial license to the GS System and the Protein-Free System (as such terms are defined in the Lonza Research Agreement) for any use outside of Research Evaluation (as such term is defined in the Lonza Research Agreement), in accordance with Section 16.4 of the Lonza Research Agreement.

(b) With respect to the 18R5 Collaboration Compound and upon OncoMed’s request, Lonza will transfer the Process and Lonza-Know-How (as such terms are defined in the Lonza MSA) to OncoMed or its designee under a technology transfer agreement in accordance with Section 6.5 of the Lonza MSA.

 

  4. Other Agreement Provisions.

(a) BSP’s royalty obligations set forth in Section 6.4.3 of this Agreement derive from the Michigan Agreement and/or the MorphoSys Agreement.

(b) The University of Michigan and OncoMed have certain rights to prosecute, maintain and enforce certain Patents pursuant to the Michigan Agreement and/or

 

3


MorphoSys Agreement, which rights are set forth in Sections 8.2.3 and 8.4.2(c) of this Agreement.

(c) BSP has certain obligations to indemnify the University of Michigan as required under Section 8.3 of the Michigan Agreement, and such obligations are set forth in Section 10.1 of this Agreement.

(d) The insurance-related representations and warranties it makes to OncoMed under Section 10.4.1 of this Agreement are required under Section 8.3 of the Michigan Agreement.

(e) In addition to the provisions of the Existing Agreements described in this Exhibit 5.5 above, other provisions of the Existing Agreements may become relevant, depending on the Parties’ research and development plans and activities, and this Agreement shall be subject to such other provisions.

(f) OncoMed’s confidentiality obligations under the Existing Agreements.

(g) Under Section 6.3 of the MorphoSys Agreement, OncoMed must pay a royalty on Net Sales (as defined in the MorphoSys Agreement) of Licensed Products (as defined in the MorphoSys Agreement), on a country-by-country basis as from the date of the First Commercial Sale (as defined in the MorphoSys Agreement) in each such country, and until the later of (i) [***] after such First Commercial Sale of such Licensed Product in such country; and (ii) the expiration of the last Valid Claim (as defined in the MorphoSys Agreement) that covers the manufacture, sale, import or use of such Licensed Product as follows: (i) [***] on worldwide Net Sales in a Calendar Year of up to [***] Euros and (ii) [***] on worldwide Net Sales in a Calendar Year over [***] Euros; provided, however, in no case shall the obligation to pay a royalty exceed [***] from the first sale of such Licensed Product in the Territory.

(h) Under Sections 4.2 and 4.3 of the Michigan License, OncoMed shall pay Michigan royalties equal to [***] of Net Sales of Products (as defined in the Michigan License) for the term of the Michigan License, which continues until the last to expire Licensed Patent (as defined in the Michigan License). The term of the Michigan License expires upon expiration of the last to expire of Licensed Patents. At any time after the University of Michigan has received [***] in royalties from OncoMed, its Affiliates, and Sublicensees, OncoMed may elect to convert its license to a fully paid up license provided OncoMed transfers to the University of Michigan a specified number of shares of nonvoting stock of OncoMed.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


Exhibit 6.3.1

Milestone Payments for Collaboration Compounds

 

Milestone Event    Payment
   [***]
[***] 1    [***] 2

 

1  

For purposes of this Exhibit 6.3.1, “Commencement of Preclinical Development” means the Candidate Selection Criteria for Small Molecules set forth in Exhibit 1.33 have been satisfied.

2  

[***].

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit 6.3.2

Option Exercise Payments

[***]

 

[***] 3   [***] 4    [***] 5    [***] 6
  [***]      

 

3  

Payment subject to Section 3.1.2.

4  

Payment subject to Section 3.1.2(d).

5  

[***] .

6  

Payment subject to Section 3.1.2.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit 6.3.4

Milestone Payments for BSP Development Compounds

 

Milestone Event      Payment 7
     [***]
[***]

 

7  

[***] .

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit 6.3.5

Net Sales Milestones

 

[***] Net Sales [***]    Payment 8
   [***]
[***]

 

8  

[***] .

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit 6.4.1

Royalties

 

  [***]        [***] Royalty Rate
      [***]   
[***]          Royalty Rate
    [***]     

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit 8.2.1

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit 9.8

Press Releases

OncoMed Pharmaceuticals and Bayer Schering Pharma Announce Strategic Alliance to Develop Anti-Cancer Stem Cell Therapeutics

Companies Collaborate to Discover and Develop Multiple Antibody, Protein and Small Molecule Agents Targeting the Wnt Pathway

[Redwood City/Berlin] – June 16, 2010 – OncoMed Pharmaceuticals, Inc. and Bayer Schering Pharma AG, Germany,today announced a global strategic alliance to discover, develop and commercialize novel anti-cancer stem cell therapeutics targeting the Wnt signaling pathway. Cancer stem cells are a subset of tumor cells believed to play a significant role in the establishment, metastasis and recurrence of cancer.

The strategic alliance leverages OncoMed’s leadership in cancer stem cell drug discovery and development. Under the terms of the agreement, Bayer and OncoMed will develop antibodies, protein therapeutics, and small molecules as potential novel anti-cancer stem cell therapeutics targeting the Wnt signaling pathway. In addition to an upfront cash payment of $40 million, OncoMed is eligible to receive cash payments for product candidates that Bayer Schering Pharma options and possible additional payments upon achievement of certain development and commercialization milestones described below. The collaboration could potentially include up to 5 compounds. The agreement includes potential significant near-term milestone payments from Bayer.

OncoMed will utilize its proprietary human cancer stem cell models to discover and advance antibody and protein therapeutics through Phase 1 clinical studies. Bayer Schering Pharma receives an option to exclusively license antibody and protein therapeutic product candidates at any point up to the completion of Phase 1 testing. Following option exercise, Bayer will lead development and commercialization of licensed product candidates. For each biotherapeutic drug candidate successfully developed through phase III clinical trials and regulatory approval, OncoMed’s payments could total up to $387.5 million per program, including potential net sales milestones upon successful commercialization of biotherapeutic products. In addition, OncoMed will be eligible to receive double-digit royalties on net product sales. The agreement contains provisions under which OncoMed may co-develop antibody and protein therapeutics with Bayer. The collaboration includes OncoMed’s lead Wnt pathway antibody, OMP-18R5, which is currently planned to enter clinical testing in 2011.

In addition, Bayer will lead the discovery and advancement of small molecule therapeutic candidates that modulate Wnt pathway signaling. OncoMed will assist Bayer in the evaluation and advancement of small molecule candidates, and is eligible to receive milestone payments of up to $112 million per candidate upon successful development and regulatory approval, including potential net sales milestones upon successful commercialization of small molecule products. In addition, OncoMed will be eligible to receive single-digit royalties on net product sales.


“At Bayer, we recognize the high unmet medical need for cancer treatments. This collaboration with OncoMed demonstrates our commitment to the development of new and innovative treatment options,” said Prof. Andreas Busch, Head of Global Drug Discovery and Member of the Board of Management at Bayer Schering Pharma. “The development of anti-cancer stem cell therapeutics together with OncoMed is a highly innovative approach with the potential to perfectly complement our oncology portfolio. Anti-cancer stem cell research could turn out as one of the missing pieces in today’s cancer therapy .”

“Our alliance with Bayer represents a major opportunity to discover and develop an entirely new class of anti-cancer stem cell therapeutics with one of the leading pharmaceutical companies in the world. Bayer shares our vision for the potential of anti-cancer stem cell therapeutics, and we look forward to working closely with them,” said Paul J. Hastings, President and CEO of OncoMed. “OncoMed has established a rich pipeline of product candidates targeting a number of critical cancer stem cell pathways. Through this collaboration, we will gain significant additional funding to support the discovery and development of therapeutics targeting the Wnt pathway, as we continue, with our already strong cash position, and our other sources of collaborative revenue to fully finance and advance all of our programs for years to come.

About Cancer Stem Cells and the Wnt Signaling Pathway

Cancer stem cells, a small, resilient subset of cells found in tumors, have the capacity to self-renew and differentiate, leading to tumor initiation and driving tumor growth, recurrence and metastasis. Also referred to as “tumor-initiating cells”, these cells were first discovered by OncoMed’s scientific founders in breast cancer and have subsequently been identified in many other types of solid tumor cancers, including cancer of head and neck, lung, prostate, pancreas, and glioblastoma. Cancer stem cells appear to be preferentially resistant to both standard chemotherapy and radiotherapy. OncoMed’s strategy is to improve cancer treatment by specifically targeting the key biologic pathways which are thought to be critical to the activity and survival of cancer stem cells. OncoMed’s antibody therapeutics target cancer stem cell proteins and have the potential to be developed against a range of solid tumor types.

The Wnt signaling pathway is one of several identified by OncoMed as an important therapeutic target in halting cancer stem cell activity. In preclinical studies of monoclonal antibody drug candidates that target Wnt signaling, OncoMed scientists have observed broad-spectrum anti-tumor and anti-cancer stem cell activity in a number of solid tumor types.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover, manufacture and market products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com .


About Bayer Schering Pharma

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de .

About OncoMed Pharmaceuticals

OncoMed Pharmaceuticals is a clinical-stage company that discovers and develops novel therapeutics targeting cancer stem cells, the cells believed to be capable of driving tumor growth, recurrence and metastases. A leader in cancer stem cell research, the company has established a library of antibodies to cancer stem cell proteins for the treatment of solid tumors such as pancreatic, breast, colorectal and lung cancers. OncoMed’s lead candidate, OMP-21M18 is currently in Phase I clinical trials. In addition to OMP-21M18, OncoMed’s pipeline includes several novel preclinical product candidates targeting multiple validated cancer stem cell pathways. Privately-held, OncoMed’s investors include: US Venture Partners, Latterell Venture Partners, The Vertical Group, Morgenthaler Ventures, Nomura Phase4 Ventures, Delphi Ventures, Adams Street Partners, De Novo Ventures, Bay Partners and GlaxoSmithKline. Additional information can be found at the company’s website: www.oncomed.com .

Contacts:

 

OncoMed Pharmaceuticals

Paul Hastings

President and Chief Executive Officer

William D. Waddill

Senior Vice President, Chief Financial Officer

(650) 995-8200

phastings@oncomed.com

william.waddill@oncomed.com

  

BCC Partners

Karen L. Bergman or

Michelle Corral

(650) 575-1509 or (415) 794-8662

kbergman@bccpartners.com or

mcorral@bccpartners.com

# # #


LOGO

 

     Bayer Schering Pharma AG
     13342 Berlin
     Germany
     Tel. +49 30 468-1111
     www.bayerscheringpharma.de

News Release

Bayer Schering Pharma and OncoMed Pharmaceuticals Enter Strategic Alliance to Develop Anti-Cancer Stem Cell Therapeutics

 

 

Collaboration Focuses on the Discovery and Development of Multiple Antibody, Protein and Small Molecule Agents Targeting the Wnt Pathway

 

 

Berlin/Redwood City – June 16, 2010 – Bayer Schering Pharma AG, Germany, and OncoMed Pharmaceuticals, Inc., today announced a global strategic alliance to discover, develop and commercialize novel anti-cancer stem cell therapeutics targeting the Wnt signaling pathway. Cancer stem cells are a subset of tumor cells believed to play a significant role in the establishment, metastasis and recurrence of cancer and agents targeting the Wnt pathway have the potential to be developed as pan-tumor drugs.

The strategic alliance provides Bayer Schering Pharma with the option to exclusively license antibody and protein therapeutic product candidates at any point up to the completion of Phase I testing. In addition, Bayer and OncoMed will share technology and know-how to discover and develop small molecule inhibitors of the pathway.

“At Bayer, we recognize the high unmet medical need for cancer treatments. This collaboration with OncoMed demonstrates our commitment to the development of new and innovative treatment options,” said Prof. Andreas Busch, Head of Global Drug Discovery and Member of the Board of Management at Bayer Schering Pharma. “The development of anti-cancer stem cell therapeutics together with OncoMed is a highly innovative approach with the potential to perfectly complement our oncology portfolio. Anti-cancer stem cell research could turn out as one of the missing pieces in today’s cancer therapy.”


“Our alliance with Bayer represents a major opportunity to discover and develop an entirely new class of anti-cancer stem cell therapeutics with one of the leading pharmaceutical companies in the world. Bayer shares our vision for the potential of anti-cancer stem cell therapeutics, and we look forward to working closely with them,” said Paul J. Hastings, President and CEO of OncoMed. “OncoMed has established a rich pipeline of product candidates targeting a number of critical cancer stem cell pathways. Through this collaboration, we will gain significant additional funding to support the discovery and development of therapeutics targeting the Wnt pathway, as we continue, with our already strong cash position, and our other sources of collaborative revenue to fully finance and advance all of our programs for years to come.”

Under the terms of the agreement, Bayer and OncoMed will develop antibodies, protein therapeutics, and small molecules as potential novel anti-cancer stem cell therapeutics targeting the Wnt signaling pathway. In addition to an upfront payment of 40 million USD, OncoMed is eligible to receive cash payments for product candidates that Bayer Schering Pharma options and possible additional payments upon achievement of certain development and commercialization milestones. The collaboration could potentially include up to 5 compounds. The agreement includes potential significant near-term milestone payments from Bayer. For each biotherapeutic or small molecule drug candidate successfully developed through Phase III clinical trials and regulatory approval, OncoMed’s payments could total up to 387.5 million USD (biotherapeutic drug) and 112 million USD (small molecule drug) per program, already including potential net sales milestones.

OncoMed will utilize its proprietary human cancer stem cell models to discover and advance three potential first-in-class antibody and protein therapeutics into clinical testing and through Phase I studies. Bayer Schering Pharma receives an option to exclusively license antibody and protein therapeutic product candidates at any point up to the completion of Phase I testing. Following option exercise, Bayer will lead development and commercialization of licensed product candidates and will have rights to commercialize approved products in all markets. OncoMed will be eligible to receive double-digit royalties on net product sales. The agreement contains provisions under which OncoMed may co-develop biologic therapeutics with Bayer. The collaboration includes for example OncoMed’s lead Wnt pathway antibody, [OMP-18R5], which is intended to enter clinical testing in 2011.


In addition to the biologics approach, Bayer will use its in-house expertise and lead the discovery and development of small molecule compounds as therapeutic candidates modulating Wnt signaling. OncoMed will assist Bayer in the evaluation and advancement of such candidates by providing their proprietary assay technology and in vitro / in vivo profiling of the compounds. OncoMed will be eligible to receive single-digit royalties on net product sales.

About Cancer Stem Cells and the Wnt Signaling Pathway

Cancer stem cells, a small, resilient subset of cells found in tumors, have the capacity to self-renew and differentiate, leading to tumor initiation and driving tumor growth, recurrence and metastasis. Also referred to as “tumor-initiating cells”, these cells were first discovered by OncoMed’s scientific founders in breast cancer and have subsequently been identified in many other types of solid tumors, including cancer of head and neck, lung, prostate, pancreas, and glioblastoma. Cancer stem cells appear to be preferentially resistant to both standard chemotherapy and radiotherapy. OncoMed’s strategy is to improve cancer treatment by specifically targeting the key biologic pathways which are thought to be critical to the activity and survival of cancer stem cells. OncoMed’s antibody therapeutics target cancer stem cell proteins and have the potential to be developed against a range of solid tumor types.

The Wnt signaling pathway is one of several identified by OncoMed as an important therapeutic target in halting cancer stem cell activity. In preclinical studies of monoclonal antibody drug candidates that target Wnt signaling, OncoMed scientists have observed broad-spectrum anti-tumor and anti-cancer stem cell activity in a number of solid tumor types.

About OncoMed Pharmaceuticals

OncoMed Pharmaceuticals is a clinical-stage company that discovers and develops novel therapeutics targeting cancer stem cells, the cells believed to be capable of driving tumor growth, recurrence and metastases. A leader in cancer stem cell research, the company has established a library of antibodies to cancer stem cell proteins for the treatment of solid tumors such as pancreatic, breast, colorectal and lung cancers. OncoMed’s lead candidate, OMP-21M18 is currently in Phase I clinical trials. In addition to OMP-21M18, OncoMed’s pipeline includes several novel preclinical


product candidates targeting multiple validated cancer stem cell pathways. Privately-held, OncoMed’s investors include: US Venture Partners, Latterell Venture Partners, The Vertical Group, Morgenthaler Ventures, Nomura Phase4 Ventures, Delphi Ventures, Adams Street Partners, De Novo Ventures, Bay Partners and GlaxoSmithKline. Additional information can be found at the company’s website: www.oncomed.com.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover, manufacture and market products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com .

About Bayer Schering Pharma

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de .

Contact :

Kerstin Crusius, Tel. +49 30 468-14726

E-Mail: kerstin.crusius@bayerhealthcare.com

KC                    (2010-0290E)

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Exhibit 10.3(A)

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

SUBSCRIPTION AND LICENSE AGREEMENT

This Subscription and License Agreement (“ Agreement ”), is made effective as of June 1, 2006 (“ Effective Date ”), by and between

OncoMed Pharmaceuticals, Inc. , a Delaware corporation having its principal place of business at 265 N. Whisman Road, Mountain View, California 94043 (“ ONCOMED ”)

and

MorphoSys AG , a German stock corporation with its principal place of business at Lena-Christ-Str. 48, 82152 Martinsried/Planegg, Germany (“ MORPHOSYS ”).

MORPHOSYS and ONCOMED are each hereafter referred to individually as a “Party” and together as the “Parties”.

WHEREAS, ONCOMED desires to have access to certain MORPHOSYS technology, defined hereinafter, in order to facilitate the research, discovery, development and commercialization of HuCAL Antibodies, defined hereinafter, in the Field defined hereinafter; and

WHEREAS, ONCOMED desires to have the option to request MORPHOSYS to supply to ONCOMED optimized HuCAL Antibodies generated by MORPHOSYS using certain MORPHOSYS technology, for the use by ONCOMED in the evaluation and potential development of such HuCAL Antibodies, on the terms set forth herein; and

WHEREAS, ONCOMED desires to receive, and MORPHOSYS desires to grant, licenses to the MORPHOSYS Technology and resulting discoveries and products on the terms set forth herein.

NOW, THEREFORE, for valuable consideration, the receipt and adequacy of which is hereby acknowledged, the Parties hereby covenant and agree to be bound as follows:

 

1. DEFINITIONS

Whenever used in the Agreement with an initial capital letter, the terms defined in this Article 1 shall have the meanings specified below. The plural form of each definition shall have the correlative meaning.

 

1.1 Affiliate ” shall mean any corporation, firm, limited liability company, partnership or other entity that directly or indirectly controls or is controlled by or is under common control with a Party to this Agreement. “Control” or “controlled” means ownership, directly or through one (1) or more Affiliates, of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or more than fifty percent (50%) of the equity interests in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body of a corporation or other entity.


CONFIDENTIAL

 

1.2 Agreement Term ” shall have the meaning set forth in Section 10.1(b).

 

1.3

Agreement Year ” shall mean the one (1)-year period commencing on the Effective Date or any anniversary of the Effective Date. For example, the first (1 st ) Agreement Year shall be the period between the Effective Date and the commencement of the second (2 nd ) Agreement Year.

 

1.4 AME Patent Rights ” shall have the meaning set forth in Section 1.2 of the AME Sublicense Agreement.

 

1.5 AME Sublicense Agreement ” shall mean that certain sublicense agreement entered into by and between MORPHOSYS and Applied Molecular Evolution, a redacted copy of which is attached hereto as Appendix 4.5(c).

 

1.6 Antibody Affinity Optimization ” shall mean the modification of any complementarity determining region (CDR) of any HuCAL Antibody, which modification is carried out [***]

 

1.7 BLA ” shall mean any of the following: a Biologics License Application filed with the United States Food and Drug Administration, a New Drug Application filed with the United States Food and Drug Administration or any non-US equivalent of the foregoing.

 

1.8 CAT Covenant ” shall have the meaning set forth in Section 4.5(b).

 

1.9 CAT Framework Agreement ” shall have the meaning set forth in Section 4.5(b).

 

1.10 Clinical Monitoring ” shall mean the in vitro use of a HuCAL Antibody in a clinical setting for the purpose of patient screening or monitoring as part of the clinical development of any Licensed Product.

 

1.11 Collaboration ” shall have the meaning set forth in Section 3.1.

 

1.12 Collaboration Plan ” shall mean the written description of the research and development activities to be performed by the Parties under the direction of the JSC pursuant to each Collaboration project.

 

1.13 Commercial License ” shall mean a Commercial Therapeutic License.

 

1.14 Commercial Target ” shall mean a Target that is identified on an executed copy of Appendix 4.3(a), as executed in accordance with the protocol of Section 4.3 and is the subject of a Commercial License.

 

1.15 Commercial Therapeutic Development ” shall mean, with respect to a HuCAL Antibody: (i)  [***] and (ii) all subsequent activities that relate to the therapeutic development of such HuCAL Antibody.

 

1.16 Commercial Therapeutic License ” shall have the meaning set forth in Section 4.4.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


CONFIDENTIAL

 

1.17 Confidential Information ” shall have the meaning set forth in Section 7.1.

 

1.18 Dispute ” shall have the meaning set forth in Section 12.13.

 

1.19 Effective Date ” shall have the meaning set forth in the introductory paragraph of this Agreement.

 

1.20 Extended Research License ” shall have the meaning set forth in Section 4.13.

 

1.21 Extended Subscription Term ” shall have the meaning set forth in Section 10.1(a).

 

1.22 Field ” shall mean all therapeutic uses of one or more antibodies in humans.

 

1.23

First Commercial Sale ” shall mean the first (1 st ) sale of a Licensed Product in arm’s length sales to a Third Party.

 

1.24 FTE ” shall mean the equivalent of one (1) researcher of MORPHOSYS involved in the Collaboration or MORPHOSYS Customer Support on a full-time basis of at least thirty- two (32) hours per week of effort.

 

1.25 Grantback Patent Rights ” shall mean [***] that claims: (i) [***] [***] (iii)  a [***] (i) and/or (ii), and/or (iv)  a [***] (i) and/or (ii); provided , however , Grantback Patent Rights shall not include any [***] : (w)  [***] (x) a [***] (y) a [***] (w) and/or (x), and/or (z) a [***] (w) and/or (x); for which [***] Notwithstanding anything contained in this Section 1.25, [***] to [***] , as set forth in (i), (ii), (iii) or (iv) above, that includes as [***] shall be included in the Grantback Patent Rights, provided [***] .

 

1.26 HuCAL Antibody ” shall mean, whether in nucleic acid or protein form, individually and collectively: (i) an antibody or antibody fragment (including but not limited to antibody fragments such as Fv, Fab, F(ab’)2, single chain antibody, antibody conjugate bound to a toxin or bound to a label, or any other moiety) that, in each case, is based on [***] and/or includes [***] that in all cases [***] and (ii) any antibody or antibody fragment that, in each case, has been derived (either physically, intellectually or by reverse engineering, in one (1) or more steps) from an antibody or antibody fragment referred to in Section 1.26(i) hereof (including any antibody resulting from Antibody Affinity Optimization of a HuCAL Antibody).

 

1.27 Impartial Person ” shall be [***] As of the Effective Date, the Impartial Person, [***] , is listed on Appendix 1.27. Should a change in the Impartial Person be necessary, MORPHOSYS shall provide ONCOMED [***] advance written notice that a change is necessary, the reasons for the change and the proposed person to be the Impartial Person. Upon ONCOMED’s written notice to MORPHOSYS that [***] , that person will be identified in a written Appendix 1.27 initialed by both Parties and appended to this Agreement.

 

1.28 Improvement ” shall have the meaning set forth in Section 4.11.

 

1.29 Improvement License ” shall have the meaning set forth in Section 4.11.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


CONFIDENTIAL

 

1.30 IND ” shall mean an Investigational New Drug application filed with the United States Food and Drug Administration, or the equivalent regulatory filings in countries other than the United States required for commencement of human clinical trials of a pharmaceutical product.

 

1.31 Initial Subscription Term ” shall have the meaning set forth in Section 10.1(a).

 

1.32 Installation Site ” shall have the meaning set forth in Section 2.2.

 

1.33 JHU License Agreement ” shall mean that certain license agreement entered into by and between MORPHOSYS and The Johns Hopkins University, a redacted copy of which is appended hereto as Appendix 1.33.

 

1.34 Joint Steering Committee ” or “ JSC ” shall mean the committee comprising the members elected in accordance with Section 2.7 to carry out the duties set forth in Section 2.7.

 

1.35 License Request ” shall have the meaning set forth in Section 4.3(a).

 

1.36 License Response ” shall have the meaning set forth in Section 4.3(b).

 

1.37 Licensed Product ” shall mean Licensed Therapeutic Product.

 

1.38 Licensed Therapeutic Product ” shall mean [***] .

 

1.39 MORPHOSYS Antibody Affinity Optimization Technology ” shall mean that portion of the MORPHOSYS Technology used by MORPHOSYS (solely at MORPHOSYS) to perform Antibody Affinity Optimization, as set forth in Section III of Appendix 1.47.

 

1.40 MORPHOSYS Customer Support ” shall mean time spent by MORPHOSYS in the following areas: (i) providing technical support services to ONCOMED with regard to the MORPHOSYS Subscription Technology from MORPHOSYS’ facilities, by e-mail or telephone; (ii) supplying ONCOMED with MORPHOSYS HuCAL GOLD Library phage aliquots within thirty (30) days’ written notice by ONCOMED, and (iii) supplying ONCOMED with HuCAL user manual updates, as they become available.

 

1.41 MORPHOSYS HuCAL GOLD Library ” shall mean that portion of the MORPHOSYS Technology, including the human combinatorial antibody library (“HuCAL”) as further described in Section I of Appendix 1.47.

 

1.42 MORPHOSYS HuCAL GOLD Library Ancillary Technology ” shall mean that portion of the MORPHOSYS Technology that is an ancillary component of the MORPHOSYS HuCAL GOLD Library, as described in Section II of Appendix 1.47.

 

1.43 MORPHOSYS Indemnitees ” shall have the meaning set forth in Section 12.1(a).

 

1.44

MORPHOSYS Know-How ” shall mean, individually and collectively, all know-how as of the Effective Date, including but not limited to inventions, discoveries,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


CONFIDENTIAL

 

  compositions, technology, data, techniques, specifications, designs and other information (whether or not patentable) of any type whatsoever that satisfy each of the following criteria: (a) are not generally known; (b) relate to the MORPHOSYS Technology; and (c) in which MORPHOSYS has an ownership or other licensable interest with the right to grant licenses thereunder, without violating the terms of any agreement or other arrangement with any Third Party.

 

1.45 MORPHOSYS Patent Rights ” shall mean, individually and collectively, all patents and pending patent applications in any country (i) that are listed in Appendix 1.45 and (ii) all substitutions, continuations, continuations-in-part, divisions, and renewals, all letters patent granted thereon, and all reissues, reexaminations and extensions thereof.

 

1.46 MORPHOSYS Subscription Technology ” shall mean MORPHOSYS HuCAL GOLD Library and MORPHOSYS HuCAL GOLD Library Ancillary Technology.

 

1.47 MORPHOSYS Technology ” shall mean MORPHOSYS Subscription Technology and MORPHOSYS Antibody Affinity Optimization Technology.

 

1.48 MORPHOSYS Third Party Licensee ” shall mean any Third Party to whom MORPHOSYS has granted a license to use a proprietary antibody library of MORPHOSYS and/or any antibody or antibody fragment identified or developed therefrom.

 

1.49 Net Sales ” shall mean the amounts received on sales of Licensed Products by ONCOMED and any of its Sublicensees, less (i)  [***] , and (ii)  [***] .

 

1.50 Research Data ” shall mean all data generated by or on behalf of MORPHOSYS and/or ONCOMED, which data are reasonably related to the performance of the Collaboration, the Subscription or other activities otherwise permitted under this Agreement, including but not limited to technical data, information, processes and methods comprising any laboratory, analytical, synthesis, production or data processing methods, provided that Research Data shall not include (i) an Improvement or (ii) any improvement made by MORPHOSYS to the MORPHOSYS Technology that otherwise would meet the definition of an Improvement, but for the fact that it was made by MORPHOSYS instead of ONCOMED.

 

1.51 Research Invention ” shall mean any discovery, invention, know-how or trade secret made (including conceived) by or on behalf of MORPHOSYS and/or ONCOMED in the course of [***] , provided that a Research Invention shall not include (i) an Improvement or (ii) any improvement made by MORPHOSYS to the MORPHOSYS Technology that otherwise would meet the definition of an Improvement, but for the fact that it was made by MORPHOSYS instead of ONCOMED.

 

1.52 Research License ” shall have the meaning set forth in Section 4.1.

 

1.53

Research Materials ” shall mean any proprietary materials, including but not limited to [***] , provided that Research Materials shall not include (i) an Improvement or (ii) any

 

[***] Certain information in this document 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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  improvement made by MORPHOSYS to the MORPHOSYS Technology that otherwise would meet the definition of an Improvement, but for the fact that it was made by MORPHOSYS instead of ONCOMED.

 

1.54 Research Patent Rights ” shall mean the rights and interests in and to issued patents and pending patent applications in any country—including, but not limited to, all provisional applications, substitutions, continuations, continuations-in-part, divisions, and renewals, all letters patent granted thereon, and all reissues, reexaminations, extensions and supplementary patent certificates thereof—that [***]

 

1.55 Staffing Level ” shall mean the number of FTEs devoted to the preparation of the Collaboration Plan and performance of a single Collaboration project.

 

1.56 Sublicensee ” shall mean any Third Party (including any Affiliate) licensed or sublicensed by ONCOMED under any Commercial License granted to ONCOMED hereunder, to the extent permitted by the terms of this Agreement.

 

1.57 Subscription ” shall have the meaning set forth in Section 2.1.

 

1.58 Subscription Term ” shall mean the Initial Subscription Term and, as applicable, the Extended Subscription Term.

 

1.59 Success Criteria ” shall mean criteria that are [***] for [***] . Such criteria may or may not include [***] .

 

1.60 Target ” shall mean [***] .

 

1.61 Territory ” shall mean the world.

 

1.62 Third Party ” shall mean any person or entity that is neither MORPHOSYS nor ONCOMED.

 

1.63 Transaction ” shall have the meaning set forth in Section 12.10.

 

1.64 Valid Claim ” shall mean a claim in [***] or covered by [***] which claim has [***] , and which claim in each case [***] .

 

1.65 XOMA Covenant ” shall have the meaning set forth in Section 4.5(a).

 

1.66 XOMA License Agreement ” shall have the meaning set forth in Section 4.5(a).

 

2. LIBRARY ACCESS AND SUPPORT

 

2.1 Subscription in General . During the Subscription Term, personnel of ONCOMED shall have the right to use the MORPHOSYS Subscription Technology transferred to ONCOMED under Section 2.2, in accordance with the requirements and restrictions set forth herein and any licenses granted hereunder (“ Subscription ”).

 

[***] Certain information in this document 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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2.2 Installation . At a date and time mutually acceptable to the Parties, and not more than [***] days after the Effective Date, MORPHOSYS agrees to provide ONCOMED with on-site access to the MORPHOSYS Subscription Technology at ONCOMED’s headquarters 265 N. Whisman Rd., Mountain View, CA 94043 (the “ Installation Site ”). ONCOMED may [***] , provided ONCOMED gives MORPHOSYS a [***] written notice thereof and further provided that the [***] in the notice to MORPHOSYS. ONCOMED agrees to use the MORPHOSYS Subscription Technology solely at the [***] Installation Site and solely as permitted by this Agreement.

 

2.3 Training and Support .

 

  (a) MORPHOSYS will conduct, for [***] scientists of ONCOMED, [***] training program at MORPHOSYS’ facilities in Martinsried, Germany, at a date mutually agreed upon by the Parties, as soon as is reasonably possible after the Effective Date. ONCOMED will [***] .

 

  (b) Installation of the MORPHOSYS Subscription Technology includes, at the Installation Site, a [***] of the MORPHOSYS HuCAL GOLD Library which is [***] . ONCOMED will also have access to [***] of MORPHOSYS Customer Support per year, unused amounts of which are not creditable towards future years. Additional MORPHOSYS Customer Support may be purchased by ONCOMED on a [***] package basis, at a rate set out in Section 5.3. ONCOMED agrees [***] .

 

2.4 Loss, Theft, Unauthorized Disclosure or Use . ONCOMED shall use all reasonable efforts (including not less than those efforts that ONCOMED uses to protect its own confidential information of like character, but in no case less than those efforts a prudent business person would take) to protect the MORPHOSYS Technology from unauthorized disclosure and use. ONCOMED shall promptly notify MORPHOSYS of any loss, theft or unauthorized disclosure or use of any portion of the MORPHOSYS Technology that comes to ONCOMED’s attention.

 

2.5 Records . ONCOMED shall maintain records of access to and use of the MORPHOSYS Technology sufficient to enable ONCOMED and MORPHOSYS to determine, and monitor compliance with, ONCOMED’s obligations to MORPHOSYS under this Agreement. For reasonable cause or concern, at the request and the expense of MORPHOSYS, and upon at least ten (10) days’ prior written notice, ONCOMED shall permit an agent appointed by MORPHOSYS to examine these records solely to the extent necessary to verify the fulfillment of ONCOMED’s obligations under this Agreement, provided that such agent has entered into a confidentiality agreement with ONCOMED substantially similar to the confidentiality provisions of this Agreement.

 

2.6 Ownership . ONCOMED hereby acknowledges that the MORPHOSYS Technology at all times during the term of this Agreement and thereafter, shall remain the sole and exclusive property of MORPHOSYS.

 

[***] Certain information in this document 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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2.7 JSC . Within fifteen (15) business days after the Effective Date, each Party will appoint two (2) contact persons who will be responsible for performing any duties set forth in Section 3.3. Each Party shall designate and inform the other Party in writing of the one (1) contact person out of the two (2) appointed according to this Section 2.7 who will be responsible for (i) coordinating the installation of the technologies referenced in Section 2.2 and (ii) serving as principal liaison for Collaboration projects implemented under Article 3 (which may or may not be the same person).

 

3. OPTIONAL COLLABORATION

 

3.1 Objective . The objective of the optional collaboration under this Article 3 will be for MORPHOSYS, upon request of ONCOMED during the Subscription Term, to apply during the Subscription Term its proprietary MORPHOSYS Antibody Affinity Optimization Technology on behalf of ONCOMED at MORPHOSYS’ facilities to perform Antibody Affinity Optimization on one (1) or more HuCAL Antibodies discovered by ONCOMED under the Subscription, which HuCAL Antibodies are covered by a Commercial Therapeutic License (“ Collaboration ”). For the sake of clarity, before ONCOMED can request MORPHOSYS to conduct Antibody Affinity Optimization on any HuCAL Antibody, ONCOMED must have received a Commercial Therapeutic License covering such Target.

 

3.2 FTE Support .

 

  (a) Commencement and Notice . Subject to Sections 3.1 and 3.2(b), at any time during the Subscription Term, and upon a [***] notice, ONCOMED shall be entitled to request FTE support from MORPHOSYS to commence and to carry out the objective of the Collaboration set out in Section 3.1.

 

  (b) FTE Support . The minimum Staffing Level to be provided by MORPHOSYS shall be [***] , for MORPHOSYS to prepare a Collaboration Plan and to perform the activities under such Collaboration Plan. ONCOMED agrees to fund the minimum Staffing Level determined under this Section 3.2(b). ONCOMED and MORPHOSYS both acknowledge that the actual Staffing Level to be devoted by MORPHOSYS, and funded by ONCOMED, for any project under the Collaboration may be, as estimated in good faith by MORPHOSYS, higher than the aforementioned minimum number. In such case, the actual Staffing Level for each Collaboration project shall be mutually agreed upon by the Parties. Notwithstanding the foregoing, if MORPHOSYS determines in good faith that the minimum Staffing Level required to carry out a project under the Collaboration would be less than the number referred to in this Section 3.2(b), MORPHOSYS will notify ONCOMED accordingly, in which case the minimum Staffing Level will be reduced accordingly, and ONCOMED shall only pay for those FTEs that are devoted to such Collaboration project.

 

  (c)

Extension of FTE Support . After requesting FTE support under Section 3.2(a), ONCOMED shall, during the respective Collaboration Plan performance, and upon a [***] notice, be entitled to extend the Staffing Level in [***] increments,

 

[***] Certain information in this document 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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  provided that ONCOMED agrees to pay for any additional FTE(s) at a rate according to Section 5.4 during each increment, and further provided that such Collaboration project shall be completed before the end of the Subscription Term, according to timelines set forth in the relevant Collaboration Plan.

 

3.3 Communication and Coordination of Duties . The JSC members appointed under Section 2.7 will be responsible for communicating the decisions and coordinating the duties of his or her respective Party under the Collaboration. As from the commencement of the Collaboration under Section 3.2(a), the JSC shall meet at least quarterly, with such meetings to be held alternatingly at MORPHOSYS facilities in Martinsried (Munich, Germany) and at ONCOMED’s facilities in Northern California, or by video conference, or by telephone conference, unless the Parties agree otherwise. In particular, the JSC will be responsible for:

 

  (a) Planning, approving and monitoring each Collaboration Plan, and making necessary updates thereof.

 

  (b) Monitoring workflow, including experimental sample transfer, sample throughput, sample analysis and data quality control, data analysis and summarization, and overall research progress;

 

  (c) Monitoring budgets and timelines;

 

  (d) Assigning tasks and responsibilities taking into account each Party’s respective specific capabilities and expertise in order to avoid duplication and enhance efficiency and synergies; and

 

  (e) Reviewing the Success Criteria and making the final determination of whether or not each of the Success Criteria has been met.

 

3.4 Collaboration Plan & Success Criteria . MORPHOSYS, with the support of ONCOMED, shall prepare each Collaboration Plan within [***] after any Target is entered into the Collaboration and the Parties, through the JSC, will review and agree upon each Collaboration Plan for each Collaboration project. The JSC will agree on each Collaboration Plan within [***] after any Target is entered into the Collaboration, which Collaboration Plan shall be updated in writing and agreed to by the Parties from time to time. Each Collaboration Plan shall cover the activities to be performed by MORPHOSYS with regard to such Target and shall specify the Success Criteria, objectives, timelines and Staffing Level committed thereto, as well as the Target to be studied in as much detail as is reasonably possible. Nothing in this Agreement shall be interpreted as obligating ONCOMED to enter into a Collaboration or obligating MORPHOSYS to perform any additional work under the Collaboration beyond that which is set forth in any approved Collaboration Plan.

 

3.5

Efforts . Under each Collaboration Plan with respect to each Collaboration project, (i) ONCOMED will expend reasonable efforts to provide MORPHOSYS with [***] and (ii)

 

[***] Certain information in this document 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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  MORPHOSYS agrees to expend reasonable efforts to utilize the Antibody Affinity Optimization Technology to conduct such Collaboration project.

 

3.6 Minutes . It is the intent of the Parties that the JSC will keep accurate minutes of its deliberations that record all proposed decisions and all actions recommended or taken. It is, therefore, the intent of the Parties that drafts of minutes will be delivered to the JSC within twenty (20) days after any meeting, by email or any other written form, with the Party hosting the meeting being responsible for the preparation and circulation of the draft minutes. Draft minutes will be edited by the JSC members and will be issued in final form within twenty (20) days thereafter, upon approval and agreement of the JSC members, as evidenced by their written approval of the minutes.

 

3.7 Decisions . Each decision required to be made under the Collaboration, including decisions related to the tasks referred to under Section 2.7, shall be made by the JSC and shall be made by consensus. If the JSC is unable to resolve any matter as set forth in Section 2.7 (including an agreement on whether each of the Success Criteria has been met), such matter shall be referred to the senior management of ONCOMED and MORPHOSYS to attempt to reach a resolution. If such resolution is unattainable within [***] , then Section 12.13 shall govern.

 

3.8 Reports . At the completion of each Collaboration project, MORPHOSYS shall submit to ONCOMED a final report of the results of the related Collaboration Plan performance.

 

3.9 Expenses . [***] under the Collaboration, except as explicitly provided for herein or otherwise agreed in writing.

 

4. GRANT OF RIGHTS AND TARGET SELECTION

 

4.1 Research License to ONCOMED . During the Subscription Term, MORPHOSYS hereby grants to ONCOMED a personal, worldwide, non-exclusive, royalty-free research license (without the right to grant sublicenses) in the Field, under MORPHOSYS Know-How and MORPHOSYS Patent Rights, (i) to use the MORPHOSYS Subscription Technology, subject to Section 2.2 and on its own behalf, to generate Research Materials, Research Data and Research Inventions for research purposes only; and (ii) to use and develop Research Data, Research Inventions and Research Materials generated under the Subscription for research purposes only until such time as a Commercial License is required, according to Section 4.2 (“ Research License ”).

 

4.2 Timing for obtaining Commercial Licenses and Allowances .

 

  (a) ONCOMED shall obtain a Commercial Therapeutic License under Section 4.4 to further develop and commercialize [***] HuCAL Antibodies directed against any Target no later than [***] .

 

  (b)

For Targets not entered into the Collaboration, ONCOMED shall obtain a Commercial Therapeutic License under Section 4.4 to further develop and

 

[***] Certain information in this document 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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  commercialize [***] HuCAL Antibodies directed against any Target no later than [***] .

 

  (c) ONCOMED shall have the right to have granted by MORPHOSYS a maximum of [***] Commercial Therapeutic Licenses between the Effective Date and the end of the Initial Subscription Term and [***] Commercial Therapeutic Licenses between the end of the Initial Subscription Term and the end of the Extended Subscription Term.

 

4.3 Commercial License Election .

This Section 4.3 shall govern the request by ONCOMED of any Commercial License.

 

  (a) During the Subscription Term, if ONCOMED wishes or is required to receive a Commercial License that, in either case, covers the utilization of a HuCAL Antibody directed against a Target, then ONCOMED shall submit to MORPHOSYS a license request on a signed copy of Appendix 4.3(a), specifying the proposed Target in as much detail as is reasonably possible, as well as the type of Commercial License requested (“ License Request ”).

 

  (b) MORPHOSYS shall provide a written notice to ONCOMED within sixty (60) days after any License Request, specifying whether or not the requested license is available (“ License Response ”); provided: (i) that MORPHOSYS is not prohibited from granting the requested license covering such Target by a written agreement with a Third Party in effect at the time of receipt of the License Request and (ii) that MORPHOSYS was not, at the time of receipt of the License Request, conducting a bona fide internal product discovery or development program relating to such Target in the Field (as decided by resolution from the [***] as evidenced by written records). MORPHOSYS shall counter-sign the signed copy of Appendix 4.3(a) and such Target shall, retroactively upon the day of the License Request, become a Commercial Target, which shall be automatically licensed to ONCOMED as specified in Section 4.4, and ONCOMED shall pay the requisite fee under Section 6.1(a). Upon request by ONCOMED to MORPHOSYS, the Impartial Person shall provide ONCOMED a signed letter certifying that any Target that had been the subject of a negative License Response had satisfied criterion 4.3(b)(i) or 4.3(b)(ii), provided that the Impartial Person shall not specify which of the two bases gave rise to the negative License Response. Each positive License Response will include a Clinical Monitoring License (as defined in Section 4.4). For clarification purposes, an exemplary analysis by MORPHOSYS of a License Request is set forth in Appendix 4.3(b).

 

4.4

Commercial License Grants . For each Commercial Target which ONCOMED has requested to be the subject of a Commercial Therapeutic License and which has been the subject of a positive License Response in accordance with Section 4.3(b): MORPHOSYS hereby grants to ONCOMED, under MORPHOSYS Patent Rights and MORPHOSYS Know-How: a worldwide, exclusive, royalty-bearing license (with the

 

[***] Certain information in this document 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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  right to grant sublicenses), to develop, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, distribute, have distributed, import, have imported, export and have exported Licensed Therapeutic Products within the Field in the Territory (“ Commercial Therapeutic License ”). Together with any Commercial Therapeutic License granted hereunder, to the extent [***] MORPHOSYS grants to ONCOMED [***] a nonexclusive, non-royalty bearing license to make, have made, use and have used HuCAL Antibodies directed against such Commercial Target for clinical Monitoring for the clinical development of [***] Licensed Therapeutic Products directed against such Commercial Target (“ Clinical Monitoring License ”), [***] For purposes of clarification, ONCOMED shall not have the right to commercialize or sell, have sold, offer for sale, or have offered for sale a HuCAL Antibody for Clinical Monitoring or any other diagnostic purposes under the Clinical Monitoring License. Unless terminated as permitted under this Agreement, such Commercial Therapeutic License shall last until such time as no royalty on the Net Sales of Licensed Therapeutic Products covered by the Commercial Therapeutic License is due to MORPHOSYS, as provided under Section 6.3. Thereafter, the Commercial Therapeutic License shall convert to a fully paid-up non-exclusive license to develop, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, distribute, have distributed, import, have imported, export and have exported Licensed Therapeutic Products within the Field in the Territory.

 

4.5 Third Party Covenants-Not-To-Sue and Sublicense .

 

  (a) XOMA Covenant . Subject to the limitations contained therein, MORPHOSYS hereby grants to ONCOMED the benefits of the covenant-not-to-sue (“ XOMA Covenant ”) under a license agreement between MORPHOSYS and XOMA IRELAND LIMITED (“ XOMA License Agreement ”), with regard to the “Patent Rights” listed in Schedule 1.17 of the XOMA License Agreement, in order to permit ONCOMED to practice any licenses granted to it herein by MORPHOSYS. The benefits of the XOMA Covenant shall be personal to ONCOMED and nonsublicensable or further conveyable, and shall not include the right to commercialize any products under XOMA’s patent rights. ONCOMED hereby acknowledges that it has read the redacted copy of the XOMA License Agreement that is appended hereto as Appendix 4.5(a), and agrees to abide by the provisions contained therein. In particular, [***] ONCOMED acknowledges that its benefits under the XOMA Covenant are limited by the exclusions set forth in Section 2.3 of the XOMA License Agreement. MORPHOSYS does not warrant that the XOMA Covenant is enforceable.

 

  (b)

CAT Covenant . Subject to the limitations contained therein, MORPHOSYS hereby grants to ONCOMED the benefits of the covenant-not-to-sue (“ CAT Covenant ”) under a framework agreement between MORPHOSYS and Cambridge Antibody Technology (“ CAT Framework Agreement ”), with regard to the “CAT Patent Rights” described in Appendix 3.02 of the CAT Framework Agreement, in order to permit ONCOMED to practice any licenses granted to it herein by MORPHOSYS. ONCOMED hereby acknowledges that it has read the

 

[***] Certain information in this document 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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  redacted copy of the CAT Framework Agreement that is appended hereto as Appendix 4.5(b). MORPHOSYS makes no representations that the benefits of the CAT Covenant shall extend to ONCOMED if it: (i)  [***] or (iv) enters into a “Challenge of a CAT Patent Right” (as such term is defined in Section 3.07(c) of the CAT Framework Agreement). MORPHOSYS does not warrant that the CAT Covenant is enforceable.

 

  (c) AME Sublicense . MORPHOSYS hereby grants to ONCOMED a sublicense to the AME Patent Rights, to the extent necessary to practice any license granted by MORPHOSYS to ONCOMED herein; provided , however , that the sublicense to the AME Patent Rights granted under this Section 4.5(c) shall be subject to the limitations of the AME Sublicense Agreement and the “Kauffman Agreement” (as such term is defined in Section 1.10 of the AME Sublicense Agreement), redacted copies of which AME Sublicense Agreement and Kauffman Agreement are attached hereto. ONCOMED acknowledges that MORPHOSYS has the obligation to notify AME in writing that ONCOMED has received a sublicense to the AME Patent Rights.

 

4.6 Sublicenses . ONCOMED shall have the right to grant licenses or sublicenses to all or any portion of its rights under any Commercial License to any Sublicensee subject to the terms contained herein; provided , however , that ONCOMED shall remain obligated to ensure (i) payment of all relevant fees set forth in Article 6 and (ii) compliance with all other requirements under this Agreement, including, but not limited to, the diligence requirements of Section 4.8. ONCOMED shall promptly notify MORPHOSYS in writing upon the grant of a sublicense to all or any portion of its rights under a Commercial License to any Third Party (including any Affiliate).

 

4.7 Limitations on Use .

 

  (a) Notwithstanding any provision of this Agreement to the contrary, ONCOMED hereby covenants and agrees that it: (i) shall not commercialize or utilize in a clinical setting any HuCAL Antibody [***] until securing the appropriate Commercial License or otherwise utilize or commercialize any HuCAL Antibody outside of the Field; (ii)  [***] (iii) shall not transfer any portion of the MORPHOSYS Subscription Technology from the Installation Site, without the prior written approval of MORPHOSYS; [***] , as permitted under this Agreement, solely for the benefit of ONCOMED, upon (in either scenario (A) or (B)) submitting to MORPHOSYS prior written notification of such transfer; and (v) shall not reproduce, adapt, or prepare derivative works based upon the MORPHOSYS Technology, except as expressly permitted herein.

 

  (b) After MORPHOSYS has granted ONCOMED a Commercial Therapeutic License covering a particular HuCAL Antibody, ONCOMED [***] (i) the Antibody Affinity Optimization [***] mutually agreed-upon [***] ; (ii) the Parties reasonably determine that [***] to commence such Antibody Affinity Optimization [***] MORPHOSYS otherwise [***]

 

[***] Certain information in this document 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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  (c) Prior to MORPHOSYS granting ONCOMED a Commercial Therapeutic License covering a particular HuCAL Antibody, ONCOMED shall be permitted to [***] , provided that neither [***] , and further provided that neither [***] .

 

  (d) In the event that ONCOMED does not abide by each of the provisions of Section 4.7, MORPHOSYS shall have the right, but not the obligation, to terminate the Agreement in accordance with Section 10.2(a) and/or seek any remedy permitted under this Agreement.

 

4.8 Diligence .

 

  (a) Subject to Section 10.3, ONCOMED shall use commercially reasonable efforts to diligently develop, test, obtain regulatory approval of, market and sell [***] with respect to each Commercial Therapeutic License, as a prudent business person would undertake. At a minimum, ONCOMED shall use commercially reasonable efforts and diligence, for each Commercial Therapeutic License, to: [***] . MORPHOSYS agrees that in the event ONCOMED or its Sublicensee is not able to meet the foregoing milestones, then MORPHOSYS and ONCOMED will convene a discussion to review and approve changes to the time schedules for the diligence milestones based on [***] and taking into account that [***] directed to the [***] . Should the Parties fail to agree to changes to the time schedules for the diligence milestones then Section 12.13 shall govern. For each Commercial Therapeutic License for which the fee under Section 6.1(c) has been paid, ONCOMED shall provide to MORPHOSYS, annually, a reasonably detailed development report covering the preceding twelve (12) months and a summary of estimated development for the forthcoming twelve (12) months, which report shall first be due within [***] after such payment under Section 6.1(c).

 

  (b) MORPHOSYS shall use commercially reasonable efforts (i) to provide the MORPHOSYS Customer Support in accordance with Section 2.3(b), and (ii) should ONCOMED elect MORPHOSYS to carry out the objective of applying its MORPHOSYS Antibody Affinity Optimization Technology to a HuCAL Antibody selected by ONCOMED, to apply the MORPHOSYS Antibody Affinity Optimization Technology to optimize the HuCAL Antibody selected by ONCOMED, as specified in the Collaboration Plan.

 

4.9

Right of First Refusal . If MORPHOSYS receives a bona fide Third Party written request for a license to commercialize one or more therapeutic antibodies directed against a target covered by a Commercial Therapeutic License that has not yet been the subject of the full payment by ONCOMED under Section 6.1(c) (“ Third Party Request ”), then MORPHOSYS shall submit to ONCOMED a letter certifying that such Third Party Request exists and a description of the related Commercial Target, provided that MORPHOSYS also shall provide ONCOMED— [***] after submission to ONCOMED of such certification letter of MORPHOSYS—with a signed letter from the Impartial Person confirming that such Third Party Request exists. If ONCOMED does not respond within [***] to such written certification from MORPHOSYS by agreeing to pay, within [***] of receipt by ONCOMED of such written certification, [***] , then such

 

[***] Certain information in this document 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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  Commercial Target shall no longer be covered by a Commercial Therapeutic License and such Commercial Therapeutic License shall, retroactively with effect of the date of receipt of the Third Party Request, immediately and automatically revert to MORPHOSYS. If ONCOMED does, however, respond within [***] to such written certification by agreeing to pay, within [***] of receipt by ONCOMED of such written certification, [***] , then ONCOMED shall maintain the Commercial Therapeutic License, which shall no longer be subject to any Third Party Request, provided [***] .

 

4.10 Grantback . In consideration of the technology and rights licensed to ONCOMED herein, ONCOMED grants to MORPHOSYS a fully paid-up, non-exclusive, irrevocable, perpetual, worldwide, royalty-free license (with the right to sublicense), under Grantback Patent Rights, for the sole purpose of allowing MORPHOSYS and/or MORPHOSYS Third Party Licensees to utilize, develop and commercialize antibodies developed through the use of MORPHOSYS’ technology (including MORPHOSYS Technology), [***] (“ Grantback License ”).

 

4.11 Improvement License . To the extent legally possible, and in consideration of the technology and rights licensed to ONCOMED herein, ONCOMED grants to MORPHOSYS a fully paid-up, exclusive, worldwide, perpetual, irrevocable, royalty-free license, under ONCOMED’s interests, if any, in any improvements made by ONCOMED to the MORPHOSYS Technology that [***] (each an “ Improvement ”), to the extent necessary to allow [***] ; provided , however , that ONCOMED shall retain a [***] (“ Improvement License ”). MORPHOSYS shall be permitted to [***] . ONCOMED shall promptly notify MORPHOSYS of the existence of any Improvement, whether ONCOMED deems such Improvements patentable or not, and shall forthwith transfer any Improvement to MORPHOSYS. ONCOMED shall use reasonable efforts to ensure that ONCOMED has properly claimed the Improvements vis-à-vis its employee(s) who has/have made Improvement(s) in order to be able to grant the rights set forth in this Section 4.11.

 

4.12 Other Agreements . MORPHOSYS and ONCOMED hereby acknowledge that, subject to Article 7, MORPHOSYS shall have the right, alone or in conjunction with a Third Party, to utilize MORPHOSYS’ technology (including MORPHOSYS Technology), and grant licenses thereunder to utilize the same, with respect to research, development and commercialization of antibodies as a therapeutic, which antibodies are directed against any Target other than a Commercial Target that is the subject of an existing exclusive Commercial Therapeutic License. Furthermore, subject to Article 7, MORPHOSYS shall always have the right to grant to Third Parties licenses to MORPHOSYS technology (including MORPHOSYS Technology) for research purposes and commercial licenses to MORPHOSYS technology (including MORPHOSYS Technology) other than commercial therapeutic licenses.

 

4.13

Extended Research License . Upon ONCOMED’s written request no later than the expiration of the Subscription Term, MORPHOSYS shall grant ONCOMED, on [***] (“ Extended Research License ”), provided ONCOMED makes the annual payment required under Section 5.5 and provided ONCOMED provides MORPHOSYS the [***] within [***] of ONCOMED’s request for an Extended Research License. ONCOMED

 

[***] Certain information in this document 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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  agrees that it shall not conduct Commercial Therapeutic Development with any HuCAL Antibody covered by the Extended Research License, unless ONCOMED has obtained an applicable Commercial Therapeutic License under Section 4.4 with respect to such HuCAL Antibody.

 

5. SUBSCRIPTION FEES AND RESEARCH SUPPORT

 

5.1 Technology Access Fee . ONCOMED agrees to pay to MORPHOSYS a [***] technology access fee of EURO [***] , due on [***] and payable within [***] thereof.

 

5.2 Annual Subscription and Research License Fees . For each Agreement Year of the Subscription Term, ONCOMED agrees to pay to MORPHOSYS an annual Research License fee in consideration of being granted the Research License (each, a “ Research License Fee ”). This Research License Fee shall amount to:

 

  (a)

[***]

 

  (b)

[***]

 

  (c)

[***]

Each Research License Fee shall be payable within [***] of its respective due date.

 

5.3 Additional MORPHOSYS Customer Support Fee . In the event ONCOMED requests additional MORPHOSYS Customer Support as set out in Section 2.3(b), ONCOMED shall pay EURO [***] per [***] package.

 

5.4 FTE Support Fee . In consideration of MORPHOSYS’ performance of any work requested by ONCOMED according to Section 3.2, ONCOMED shall pay to MORPHOSYS [***] payments of EURO [***] per year per FTE in the Staffing Level as specified in each Collaboration Plan for the relevant payment period. Payments shall be made [***] , beginning at the period when [***] . Upon each anniversary of the Effective Date, MORPHOSYS shall be entitled to demand that the FTE cost be adjusted taking into account changes in the aggregate appreciation of the Consumer Price Index for Germany (“CPI”) as published by the German Federal Statistical Office from the Effective Date of this Agreement. For the sake of clarity, [***] .

 

5.5

Extended Research License Fee . ONCOMED shall pay to MORPHOSYS a non-refundable license fee of EURO Twenty Thousand (€20,000), due on the first (1 st ) day of each year and payable within thirty (30) days thereof, for which ONCOMED extends the Research License pursuant to Section 4.13.

 

[***] Certain information in this document 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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6. COMMERCIAL LICENSE FEES, MILESTONES, ROYALTIES, THIRD PARTY OBLIGATIONS

 

6.1 Commercial Therapeutic License Fees . For each Commercial Therapeutic License granted to ONCOMED by MORPHOSYS, ONCOMED shall pay a [***] fee of EURO [***] , due and payable in the following [***] :

 

  (a) Upon each grant of a Commercial Therapeutic License pursuant to Section 4.3(b), ONCOMED shall pay to MORPHOSYS, within [***]

 

  (b) For each Commercial Therapeutic License granted to ONCOMED hereunder, at the earlier of [***] ONCOMED shall pay to MORPHOSYS, [***]

 

  (c) For each Commercial Therapeutic License granted to ONCOMED hereunder, ONCOMED shall pay to MORPHOSYS the balance of [***] less any payments made under Sections 6.1(a) and 6.1(b), at the earlier of [***] ONCOMED shall also pay such amount to MORPHOSYS, to the extent ONCOMED wishes to maintain any Commercial Therapeutic License, including in response to a Third Party Request under Section 4.9.

If ONCOMED does not timely pay each fee under this Section 6.1, then the Commercial License shall immediately and automatically revert to MORPHOSYS.

 

6.2 Milestone Payments under Commercial Therapeutic Licenses . For each Licensed Therapeutic Product, within [***] following the occurrence of the relevant events specified below, ONCOMED shall make the following milestone payments to MORPHOSYS:

 

  (a) [***]

 

6.3 Royalties on Licensed Products . ONCOMED shall pay to MORPHOSYS a royalty on Net Sales for each Licensed Product, on a country-by-country basis as from the date of the First Commercial Sale in each such country, and until the later of (i)  [***] from the First Commercial Sale of such Licensed Product in such country; and (ii) the expiration in such country of the last Valid Claim that covers the manufacture, sale, import or use of such Licensed Product, as follows:

 

Worldwide Net Sales in Calendar Year

   Royalty Rate

For amounts up to EURO [***]

   [***]

For amounts over EURO [***]

   [***]

provided , however , in no case shall the obligation to pay a royalty exceed [***] from the first (1 st ) sale of a Licensed Therapeutic Product in the Territory.

 

6.4 Third Party Payments .

 

[***] Certain information in this document 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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  (a) MORPHOSYS will be responsible for any license fees and milestone and royalty payments owed to XOMA Ireland Limited (“XOMA”), Cambridge Antibody Technology LTD (“CAT”), Applied Molecular Evolution (“AME”) and The Johns Hopkins University (“JHU”), to the extent that such payments become due under the XOMA License Agreement, the CAT Framework Agreement, the AME Sublicense Agreement or the JHU License Agreement, respectively. For clarity, except as permitted under the the XOMA License Agreement, the CAT Framework Agreement, the AME Sublicense Agreement or the JHU License Agreement, MORPHOSYS does not grant any license under any intellectual property owned by Third Parties, permitting ONCOMED to conduct or have conducted Antibody Affinity Optimization.

 

  (b) In the event that ONCOMED or a Sublicensee is required to obtain other Third Party licenses (including licenses from Third Parties mentioned in Section 6.4(a)), either directly from such Third Party or a licensee of such Third Party, then ONCOMED shall have the responsibility to obtain such licenses and ONCOMED shall pay all relevant payments under such licenses. ONCOMED shall not be entitled to credit any payment paid by ONCOMED to a Third Party against any payment due to MORPHOSYS hereunder.

 

6.5 Payment Terms .

 

  (a) Royalty payments in accordance with Section 6.3 shall be made to MORPHOSYS in EURO [***] within [***] following the end of each [***] for which royalties are due. Each royalty payment shall be accompanied by a report summarizing the total Net Sales for each Licensed Product during the relevant [***] period and the calculation of royalties, if any, due thereon pursuant to this Article 6.

 

  (b)

All royalties shall be payable in full to the bank designated by MORPHOSYS in EURO, regardless of the countries in which sales are made. For the purpose of computing Net Sales for Licensed Products sold in a currency other than EURO, such currency shall be converted into EURO using the average of the exchange rate for the purchase of EURO reported in the Wall Street Journal on each of the following four (4) days: the first (1 st ) business day of the calendar quarter to which such royalty payments relate and the last business day of each of the three (3) months of the calendar quarter to which such royalty payments relate.

 

  (c) All fees paid under Articles 5 and 6 shall be non-refundable and non-creditable against any other fees, unless explicitly stated herein.

 

  (d) No financial obligation accruing before any termination of this Agreement shall be affected by such termination.

 

6.6

Records Retention; Audits . ONCOMED and its Sublicensees shall keep for [***] from the date of each payment of royalties complete and accurate records of sales by ONCOMED and Sublicensees of each Licensed Product in sufficient detail to allow the accruing royalties to be determined accurately. MORPHOSYS shall have the right for a

 

[***] Certain information in this document 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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  period of [***] after receiving any report or statement with respect to royalties due and payable to appoint an independent certified public accountant to inspect the relevant records of ONCOMED and Sublicensees to verify such report or statement. ONCOMED and Sublicensees shall each make its records available for inspection by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from MORPHOSYS, solely to verify the accuracy of the reports and payments. Such inspection right shall not be exercised more than once in any calendar year nor more than once with respect to sales of any Licensed Product in any given payment period. MORPHOSYS agrees to hold in strict confidence all information concerning royalty payments and reports, and all information learned in the course of any audit or inspection, except to the extent necessary for MORPHOSYS to reveal such information in order to enforce its rights under this Agreement or if disclosure is required by law, regulation or judicial order. The results of each inspection, if any, shall be binding on both Parties. MORPHOSYS shall pay for such inspections, except that in the event there is any upward adjustment in aggregate royalties payable for any year shown by such inspection of more than [***] of the amount paid, ONCOMED shall pay for such inspection, including reasonable attorney fees related thereto.

 

7. TREATMENT OF CONFIDENTIAL INFORMATION

 

7.1 Confidential Information . During the Agreement Term, each Party may disclose to the other Party proprietary information, materials and technical, business and strategic information considered as and marked “confidential”, relating to and including but not limited to MORPHOSYS Technology, Research Data, Research Inventions, Research Materials and Licensed Products (collectively, “ Confidential Information ”). For a period of [***] years after the receipt of any such Confidential Information, except as expressly permitted hereunder, the receiving Party shall keep confidential all such Confidential Information of the other Party and will not disclose such Confidential Information of the other Party to Third Parties by publication or otherwise, except that either Party may disclose the other Party’s Confidential Information, as needed, to its legal or financial advisors, under appropriate confidentiality and non-use restrictions. ONCOMED shall be able to disclose Confidential Information to its Affiliates and Sublicensees on a need to know basis for the performance of this Agreement, provided that such Affiliates and Sublicensees are bound by substantially equivalent confidentiality obligations as ONCOMED hereunder. Each Party further agrees not to use Confidential Information of the other Party for any purpose other than conducting research hereunder or exercising any rights granted to it or reserved by it hereunder. For the sake of clarity, MORPHOSYS agrees not to use Research Data, Research Inventions or Research Materials for any purpose other than conducting any activities permitted under Article 3 or Section 10.4(a) or 10.4(b). Upon termination or expiration of this Agreement, upon request, each Party shall return to the other Party all copies of any of the requesting Party’s Confidential Information which is not the subject of a license granted hereunder. Notwithstanding the foregoing, it is understood and agreed that the receiving Party’s obligations of confidentiality and nonuse herein shall not apply to any information which, as can be demonstrated by competent proof:

 

[***] Certain information in this document 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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  (a) is, at the time of disclosure by the disclosing Party hereunder, or thereafter becomes, a part of the public domain or publicly known or available through no fault or negligence of the receiving Party or any of its Sublicensees; or

 

  (b) was otherwise in the receiving Party’s or any of its Affiliates’ lawful possession prior to disclosure by the disclosing Party, other than under an obligation of confidentiality; or

 

  (c) was independently discovered or developed by the receiving Party or any of its Affiliates, without use of the other Party’s Confidential Information; or

 

  (d) is lawfully disclosed to the receiving Party or any of its Affiliates on a non-confidential basis by a Third Party who is not in violation of an obligation of confidentiality to the disclosing Party relative to such information.

Information disclosed that is not in written or electronic form shall be subject to the terms of this Section 7.1 for a period of [***] and shall be subject to this Section 7.1 for a continuing period only if confirmed in writing to the other Party within [***] of initial disclosure specifying with particularity that such information is Confidential Information under this Section 7.1. Each Party may disclose the other’s Confidential Information to the extent such disclosure is reasonably necessary in (i) filing, prosecuting or defending litigation or (ii) complying with applicable laws; provided , however , that if a Party is required to make any disclosure of the other Party’s Confidential Information, it will give reasonable advance notice to the other Party of such disclosure requirement and will use reasonable efforts to assist such other Party in efforts to secure confidential treatment of such Confidential Information required to be disclosed and to limit the scope of such disclosure as much as possible.

 

7.2 Publicity . The Parties mutually agreed on a press release announcing the execution of this Agreement, which is attached hereto as Appendix 7.2. The Parties shall also be permitted hereunder to disclose the general nature of this Agreement to the extent reasonably necessary to obtain financing from Third Parties or potential collaborators, and to make such other disclosures as mutually agreed by the Parties. Once any written statement is approved for disclosure by both Parties, either Party may make subsequent public disclosures of the contents of such statement without the further approval of the other Party.

 

7.3 Publications . Each Party may wish to publish the results of research under this Agreement. In order to safeguard intellectual property rights, the Party wishing to publish or otherwise publicly disclose the results of such research shall first submit a draft of each proposed manuscript to the other Party for review, comment and consideration of appropriate patent action at least [***] prior to any submission for publication or other public disclosure. Within [***] of receipt of the pre-publication materials, such other Party shall advise the Party seeking publication as to whether a patent application will be prepared and filed or whether trade secret protection should be pursued and, if so, such other Party shall determine the appropriate timing and content of any such publications.

 

[***] Certain information in this document 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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7.4 ONCOMED acknowledges that the MORPHOSYS Technology represents highly valuable and Confidential Information of MORPHOSYS; that any unauthorized use or transfer of any part of the MORPHOSYS Technology may diminish its value and may irrevocably harm MORPHOSYS; and that if ONCOMED breaches any of the obligations on use of the MORPHOSYS Technology provided in this Agreement, MORPHOSYS can immediately seek equitable relief, including but not limited to injunctive relief, to protect MORPHOSYS’ interests, in addition to any other remedies MORPHOSYS may have at law.

 

7.5 In the event of any dispute resolution process carried out in accordance with Section (b) or Section (c) of Appendix 12.13, each Party agrees to provide to the other Party any non-confidential and confidential documentation requested by the other Party (subject to any privilege, e.g. attorney-client privilege, recognized under applicable law), which documentation is reasonably necessary to determine whether any material breach under this Agreement has occurred.

 

8. INTELLECTUAL PROPERTY RIGHTS

 

8.1 Ownership and Inventorship . All MORPHOSYS Patent Rights shall be owned by MORPHOSYS and, except as expressly provided hereunder, all Research Inventions, Research Patent Rights, Research Data, Research Materials and Improvements shall be owned by ONCOMED. For the sake of clarity, all data and materials (including HuCAL antibodies) generated by or on behalf of MORPHOSYS or a MORPHOSYS Third Party Licensee, independent of any ONCOMED’s Confidential Information, Research Data or Research Materials, shall not be regarded as Research Data or Research Materials. For any inventions made under this Agreement, inventorship shall be determined in accordance with applicable inventorship laws. Despite inventorship and ownership, each Party shall receive licenses to the other Party’s intellectual property as set forth in Articles 4 and 10.

 

8.2 If a Party enters into an opposition to and/or appeal from any decision of any patent authority of any country relating to the other Party’s patent rights under this Agreement or otherwise contests in any court in any country a patent, patent application or claim thereof that is part of the other Party’s patent rights under this Agreement (each a “ Challenge of a Patent Right ”), or knowingly assist any third party in the Challenge of a Patent Right, then the other Party shall be entitled to terminate this Agreement under Section 10.2(a); provided , however , that this right to terminate shall not apply if a Party engages in the Challenge of a Patent Right, as required by any applicable law, regulation or court order.

 

9. PROVISIONS CONCERNING THE FILING, PROSECUTION, PROCUREMENT, AND ENFORCEMENT OF PATENT RIGHTS

 

9.1 Patent Filing, Prosecution, Cooperation .

 

  (a)

ONCOMED shall have the first right (but not the obligation) to prepare, file, prosecute, obtain and maintain patent applications and patents directed to

 

 

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  Research Inventions, at its sole expense; provided , however , if ONCOMED decides to relinquish any patent right covered by a patent or patent application referred to in this Section 9.1(a), then ONCOMED shall provide MORPHOSYS with adequate written notice to that effect, at which time MORPHOSYS shall have the first right (but not the obligation) to assume responsibility to file, prosecute, obtain and maintain such patent applications and patents at its sole expense, [***] The rights of ONCOMED under this Section 9.1(a) can be extended to any Sublicensee, provided that the respective Sublicensee agrees to be bound by the provisions of this Agreement.

 

  (b) MORPHOSYS shall have the sole right (but not the obligation) to prepare, file, prosecute, obtain and maintain patent applications and patents covered under MORPHOSYS Patent Rights and Improvements, at its sole expense.

 

  (c) The Party filing, prosecuting, obtaining and/or maintaining the patent applications and patents referred to in Section 9.1(a) shall keep the other Party reasonably informed, and such other Party shall have the right to comment, about the progress of obtaining such patent rights.

 

  (d) Each Party agrees to cooperate fully in the preparation, filing, and prosecution of any patent applications to be filed or prosecuted pursuant to Sections 9.1(a) and 9.1(b). Such cooperation includes, but is not limited to:

 

  (i) executing all papers and instruments, or requiring its employees or agents, to execute such papers and instruments, so as to effectuate the ownership of such patent applications and any patents thereon and to enable the filing and prosecution of applications in any country as contemplated herein; and

 

  (ii) promptly informing the other Party of any matters coming to such Party’s attention that may affect the preparation, filing, or prosecution of any such patent applications.

 

  (e) The Parties shall consult with each other and mutually agree before permitting any patent application or patent within Research Patent Rights hereunder to lapse or become revoked or withdrawn for whatever reason as well as before authorizing any amendment to any patent application or patent within such Research Patent Rights that would irrevocably limit the lawful scope of such Research Patent Rights.

 

  (f) ONCOMED shall promptly notify MORPHOSYS of any patents or patent applications that exist under the Research Patent Rights, provided that such patents or patent applications have become publicly available or have been published.

 

9.2 Infringement

 

[***] Certain information in this document 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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  (a) Notice of Infringement . If, during the Agreement Term or the term of any license hereunder, either Party learns of any infringement or threatened infringement by a Third Party of any MORPHOSYS Patent Rights licensed hereunder, such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such infringement, to the extent possible.

 

  (b) Infringement of Research Patent Rights . ONCOMED shall have the first right (but not the obligation) and at its own expense to bring suit (or take other appropriate legal action) against a Third Party for any actual or suspected infringement of any Research Patent Right. If ONCOMED does not take such action within [***] after written notice from MORPHOSYS of such infringement, MORPHOSYS shall have the right (but not the obligation), at its own expense, to bring suit against such infringement. Any amount recovered, whether by judgment or settlement, shall first be applied to reimburse the costs and expenses (including attorneys’ fees) of the Party bringing suit, then to the costs and expenses (including attorneys’ fees), if any, of the other Party. Any amounts remaining shall be allocated [***] to the Party bringing suit and [***] to the other Party, or shall be allocated [***] if the suit is brought jointly.

 

  (c) Infringement of MORPHOSYS Patent Rights and Improvement patent rights . MORPHOSYS shall have the sole right (but not the obligation) and at its own expense, to bring suit (or take other appropriate legal action) against a Third Party for any actual or suspected infringement of any MORPHOSYS Patent Rights and any patent rights covering Improvements.

 

9.3 Cooperation . Each Party shall execute all papers and perform such other acts (other than monetary) as may be reasonably required to maintain any infringement suit brought in accordance with Section 9.2 (including giving legal consent for bringing such suit, and agreeing to be named as a plaintiff or otherwise joined in such suit), and at its option and expense, may be represented in such suit by counsel of its choice. In addition, the Parties shall cooperate with each other in obtaining patent term restoration or supplemental protection certificates or their equivalents in any country where applicable to Licensed Products. In the event that elections with respect to obtaining such patent term restoration, supplemental protection certificates or their equivalents are to be made, the Parties shall agree upon such elections.

 

9.4 No Obligation . No Party shall have any obligation to the other Party under this Agreement to pay any fees or costs: (i) for either Party’s bringing a lawsuit or other action to enforce any patents or (ii) for either Party’s obtaining for its own benefit independent business or legal advice concerning any patent rights.

 

10. TERM AND TERMINATION

 

10.1 Term .

 

  (a)

Subscription . The Subscription shall begin on the Effective Date and end two (2) years thereafter, unless terminated earlier as provided herein (“ Initial

 

[***] Certain information in this document 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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  Subscription Term ”). ONCOMED may extend the Initial Subscription Term for a subsequent two (2)-year term upon a written notice six (6) months prior to the end of the Initial Subscription Term (“ Extended Subscription Term ”). If, at the end of the Initial Subscription Term, ONCOMED has not (i) obtained a Commercial Therapeutic License or (ii) extended the Subscription Term to include the Extended Subscription Term, then ONCOMED shall pay to MORPHOSYS; a termination fee of EURO [***] , within [***] from termination of the Initial Subscription Term.

 

  (b) Agreement . Unless earlier terminated as provided herein, the term of this Agreement shall extend from the Effective Date until the earlier of (i) the expiration or termination of the Subscription Term, if no Commercial License is in place; (ii) the time at which the last Commercial License terminates without the possibility of ONCOMED to request further Commercial Licenses from MORPHOSYS; and (iii) the date all obligations to pay all royalties have ceased under Section 6.3 (“ Agreement Term ”).

 

  (c) Collaboration . The optional Collaboration shall begin in accordance with Section 3.2(a) and shall end at the latest commensurately with the Subscription.

 

10.2 Termination for Material Breach or Insolvency .

 

  (a) This Agreement and the rights and options granted herein may be terminated by either Party upon any material breach by the other Party of any material obligation or condition, effective thirty (30) days after giving written notice to the breaching Party of such termination in the case of a payment breach and sixty (60) days after giving written notice to the breaching Party of such termination in the case of any other breach, which notice shall describe such breach in reasonable detail. Notwithstanding the foregoing, if such default or breach is cured or shown to be non-existent within the aforesaid thirty (30) or sixty (60) day period, the notice shall be deemed automatically withdrawn and of no effect. However, prior to giving any notice for breach, the Parties shall first attempt to resolve any disputes as to the existence of any breach as set forth in Section 12.13.

 

  (b) If either Party becomes insolvent, a (non-abusive) application to initiate insolvency proceedings against a Party has been filed, any such application has been rejected due to lack of assets, any executions against a Party have been fruitless or any execution measures have been initiated against a Party which have not been cancelled within one (1) month (e.g. cancellation of seizure), then the other Party may terminate this Agreement by providing a thirty (30)-day notice to such Party.

 

10.3

Failure to Use Diligence . If ONCOMED or a Sublicensee is not diligently pursuing, in accordance with Section 4.8, the development and commercialization of [***] Licensed Therapeutic Product with respect to each Commercial Therapeutic License granted to ONCOMED, then MORPHOSYS shall have the right to terminate such Commercial Therapeutic License under the terms and conditions of this Agreement. MORPHOSYS

 

[***] Certain information in this document 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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  shall only have the right to terminate the applicable Commercial Therapeutic License with respect to which MORPHOSYS asserts that [***] in accordance with Section 4.8. Furthermore, MORPHOSYS shall not have the right to terminate the applicable Commercial Therapeutic License unless: (i) ONCOMED is given a [***] prior written notice by MORPHOSYS of MORPHOSYS’ intent to terminate, stating the reasons and justification for such termination, and recommending steps which ONCOMED should take in such development, and (ii) ONCOMED has not [***] development and commercialization, in accordance with Section 4.8, of [***]

 

10.4 Effect of Termination .

 

  (a) Upon termination of this Agreement by MORPHOSYS pursuant to Section 10.2(a), (i) the Research License and any Commercial License that is the subject of the material breach shall immediately and automatically revert to MORPHOSYS; (ii) ONCOMED, its Sublicensees and any Third Party working on behalf of any of the foregoing (as applicable) shall cease all uses of, and destroy, all copies of: MORPHOSYS Technology and Improvements, and ONCOMED, its Sublicensees and any Third Party working on behalf of any of the foregoing (as applicable) shall cease all uses of, and destroy, all copies of: Research Data, Research Inventions, and Research Materials, except to the extent covered by and in compliance with the terms of, a Commercial License maintained in accordance with Section 10.4(a)(iii); (iii) any Commercial License in existence at the time of such termination and not the subject of the material breach shall be maintained on the terms and conditions set forth in this Agreement, including ONCOMED’s diligence obligations as provided under Section 4.8 and ONCOMED’s obligations to make payments as provided in Article 6; and (iv) ONCOMED shall be deemed to have granted to MORPHOSYS a perpetual, irrevocable, co-exclusive, worldwide, royalty-free license (including the right to grant sublicenses), under Grantback Patent Rights, as defined in Section 1.25, not covering Licensed Products that are the subject of an exclusive Commercial License maintained in accordance with Section 10.4(a)(iii), to make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, distribute, have distributed, import, have imported, export and have exported any and all antibody products (including those containing HuCAL Antibodies) not covered by an exclusive Commercial License maintained in accordance with Section 10.4(a)(iii) for use in the Territory and in all fields.

 

  (b) Upon termination of this Agreement by MORPHOSYS pursuant to Section 10.2(b), (i) all licenses granted to ONCOMED shall immediately and automatically revert to MORPHOSYS; (ii) ONCOMED, its Sublicensees and any Third Party working on behalf of any of the foregoing (as applicable) shall cease all uses of, and destroy, all copies of: MORPHOSYS Technology, Research Data, Research Inventions, Research Materials and Improvements; and (iii) all Grantback Patent Rights, as defined in Section 1.25, shall become MORPHOSYS Patent Rights.

 

[***] Certain information in this document 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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  (c) Upon termination of this Agreement by ONCOMED pursuant to Section 10.2(a) or 10.2(b), [***] (ii) MORPHOSYS shall cease all uses of and destroy all copies of ONCOMED’s Confidential Information; (iii) the Research License shall immediately and automatically terminate, except that [***] and ONCOMED shall provide MORPHOSYS the [***] after such termination; (iv) ONCOMED, its Sublicensees, and any Third Party working on behalf of any of the foregoing (as applicable) shall cease all uses and shall destroy all copies of: [***] reasonably necessary to practice a license under Section 10.4(c)(i) or under Section 10.4(c)(iii); and (v) when no longer and/or to the extent not covered by a license granted to ONCOMED under this Agreement, ONCOMED, its Sublicensees, and any Third Party working on behalf of any of the foregoing (as applicable) shall [***] and all [***] under Section 10.4(c)(iv).

 

  (d) Upon expiration of the Subscription Term, (i) ONCOMED shall cease all uses of the MORPHOSYS HuCAL GOLD Library, and, at MORPHOSYS’ request, destroy or return all copies of the same to MORPHOSYS; (ii) the Research License shall immediately and automatically revert to MORPHOSYS; (iii) ONCOMED, its Sublicensees and any Third Party working on behalf of any of the foregoing (as applicable) shall cease all uses of, and at MORPHOSYS’ request destroy all copies of Research Materials and all HuCAL Antibodies’ nucleic acid and protein sequence data and all portions of MORPHOSYS HuCAL GOLD Library Ancillary Technology, except that ONCOMED, its Sublicensees and any Third Party working on behalf of any of the foregoing (as applicable) shall be permitted to utilize those portions of Research Materials, HuCAL Antibody nucleic acid and protein sequence data and MORPHOSYS HuCAL GOLD Library Ancillary Technology covered by, or reasonably needed to practice, a maintained Commercial Therapeutic License or the Extended Research License.

 

10.5 Documentation . At the request of MORPHOSYS, ONCOMED shall execute and deliver such bills of sale, assignments and licenses and other documents as may be necessary to fully vest in MORPHOSYS all right, title and interest to which it is entitled as aforesaid pursuant to this Article 10.

 

11. REPRESENTATIONS AND WARRANTIES

 

11.1 MORPHOSYS Representations . MORPHOSYS represents and warrants that: (a) the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate MORPHOSYS corporate action; and (b) MORPHOSYS is under no obligation which is inconsistent with this Agreement. MORPHOSYS represents and warrants that, to its reasonable knowledge and belief, [***] that will be provided to ONCOMED.

 

11.2

ONCOMED Representations . ONCOMED represents and warrants that: (a) the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate ONCOMED corporate

 

[***] Certain information in this document 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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  action; and (b) ONCOMED is under no obligation which is inconsistent with this Agreement.

 

11.3 No Warranties .

 

  (a) NOTHING IN THIS AGREEMENT IS OR SHALL BE CONSTRUED AS:

 

  (i) A WARRANTY OR REPRESENTATION BY EITHER PARTY AS TO THE VALIDITY/ENFORCEABILITY OR SCOPE OF ANY PATENT APPLICATION OR PATENT LICENSED HEREUNDER; or

 

  (ii) A WARRANTY OR REPRESENTATION THAT ANYTHING MADE, USED, SOLD OR OTHERWISE DISPOSED OF UNDER ANY LICENSE GRANTED PURSUANT TO THIS AGREEMENT IS OR WILL BE FREE FROM INFRINGEMENT OF PATENTS, COPYRIGHTS, TRADEMARKS AND OTHER RIGHTS OF THIRD PARTIES;

 

  (b) EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, NOR ANY OTHER EXPRESS OR IMPLIED WARRANTIES.

 

12. MISCELLANEOUS

 

12.1 Indemnification .

 

  (a) ONCOMED shall indemnify, defend and hold harmless MORPHOSYS, its Affiliates and their respective directors, officers, employees, and agents and their respective successors, heirs and assigns (the “ MORPHOSYS Indemnitees ”), against any liability, damage, loss or expense (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon the MORPHOSYS Indemnitees, or any of them, in connection with any claims of Third Parties, including without limitation personal injury and product liability matters (except in cases where such claims, suits, actions, demands or judgments result from gross negligence or willful misconduct on the part of MORPHOSYS) arising out of or relating to any actions of ONCOMED or any licensee, Sublicensee, distributor or agent of ONCOMED under this Agreement or in the development, testing, production, manufacture, promotion, import, sale or use by any person of any Licensed Product manufactured or sold by ONCOMED, a licensee, Sublicensee, distributor or agent of ONCOMED.

 

  (b) The MORPHOSYS Indemnitees shall promptly notify ONCOMED of any action or claim for which it is to be indemnified hereunder.

 

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12.2 Liability . Notwithstanding anything else in this Agreement or otherwise, neither Party shall be liable with respect to any subject matter of this Agreement under any contract, negligence, strict liability or other legal or equitable theory for (i) any indirect, incidental consequential or punitive damages or lost profits or (ii) cost of procurement of substitute goods, technology or services.

 

12.3 Notices . Any notices, requests, deliveries, approvals or consents required or permitted to be given under this Agreement to ONCOMED or MORPHOSYS shall be in writing and shall be personally delivered or sent by telecopy (with written confirmation to follow via mail), overnight courier providing evidence of receipt or certified mail, return receipt requested, postage prepaid, in each case to the respective address specified below (or to such other address as may be specified in writing to the other Party hereto):

 

MORPHOSYS:    MORPHOSYS AG
   Lena-Christ-Str. 48
   82152 Martinsried/ Planegg
   Germany
   [***]
ONCOMED:    ONCOMED PHARMACEUTICALS, INC.
   265 N. Whisman Road
   Mountain View, California 94043
   United State of America
   Attn: Paul J. Hastings, Chief Executive Officer
   Telecopy: +1-650-938-4570

Such notices shall be deemed to have been sufficiently given when received by the recipient.

 

12.4 Governing Law and Venue . Subject to Section 12.13, this Agreement shall be construed, interpreted and applied in accordance with the laws of the State of New York, United States of America (excluding its body of law controlling conflicts of law). Subject to the provisions of Appendix 12.13, the Parties hereby consent to the exclusive jurisdiction of the U.S. Federal District Court for the Southern District of New York, United States of America, for any issue with respect to the validity scope or enforceability of patents licensed under this Agreement.

 

12.5 Limitations . Except as set forth elsewhere in this Agreement, neither Party grants to the other Party any right or license to any of its intellectual property, including its Trademarks or trade names, the use of which shall be previously agreed upon in writing by their owner.

 

12.6 Entire Agreement . This is the entire Agreement between the Parties with respect to the subject matter hereof and supersedes all prior agreements between the Parties with respect to the subject matter hereof. No modification shall be effective unless in writing with specific reference to this Agreement and signed by the Parties.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

28


CONFIDENTIAL

 

12.7 Surviving Provisions . Notwithstanding any provision herein to the contrary, the rights and obligations set forth in Sections 2.4-2.6 and 4.4-4.13 and Articles 1 and 5-12 hereof shall survive the expiration or termination of the Agreement Term for any reason.

 

12.8 Waiver . The terms or conditions of this Agreement may be waived only by a written instrument executed by the Party waiving compliance. The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later time to enforce the same. No waiver by either Party of any condition or term shall be deemed as a continuing waiver of such condition or term or of another condition or term.

 

12.9 Headings . Section and subsection headings are inserted for convenience of reference only and do not form part of this Agreement.

 

12.10 Assignment . This Agreement may not be assigned by either Party, except as specified in this Section 12.10. Either Party shall have the right to assign this Agreement to its Affiliates or to a Third Party in connection with any transaction (“ Transaction ”), including but not limited to: (1) acquisition (of or by), consolidation with, or merger into, any other corporation or other entity or person; (2) any corporate reorganization; or (3) the sale of its business to which this Agreement is related, provided that in any such Transaction, the assignee expressly obligates itself in a written instrument delivered to the non-assigning Party to this Agreement, on or before the date of closing of such Transaction, to fully perform all of the obligations of the assigning Party under this Agreement. This right of assignment shall likewise be available to the assignee in the same manner as it is to the assigning Party, and subsequent assignees in like manner, provided that in each instance of assignment, the assignee provides the writing specified above to the non-assigning Party to this Agreement prior to the date of closing of such Transaction.

 

12.11 Force Majeure . Neither Party shall be liable for failure of or delay in performing obligations set forth in this Agreement, and neither shall be deemed in breach of its obligations, if such failure or delay is due to natural disasters or any causes beyond the reasonable control of such Party. In event of such force majeure, the Party affected thereby shall use reasonable efforts to cure or overcome the same and resume performance of its obligations hereunder.

 

12.12 Construction . The Parties hereto acknowledge and agree that: (i) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (ii) the rule of construction to the effect that any ambiguities are resolved against the drafting Party shall not be employed in the interpretation of this Agreement; and (iii) the terms and provisions of this Agreement shall be construed fairly as to all Parties hereto and not in favor of or against any Party, regardless of which Party was generally responsible for the preparation of this Agreement.

 

12.13

Disputes . The Parties recognize that disputes as to certain matters may from time to time arise which relate to either Party’s rights and/or obligations hereunder. It is the intent and objective of the Parties to establish procedures to facilitate the resolution of such disputes

 

29


CONFIDENTIAL

 

  in an expedient manner by mutual cooperation and without resort to litigation. Accordingly, any controversy or claim arising out of or relating to this Agreement, including any such controversy or claim involving Affiliates of any Party (each, a “ Dispute ”), shall be resolved as set forth in Appendix 12.13.

 

12.14 Severability . If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable law from time to time in effect during the Agreement Term, it is the intention of the Parties that the remainder of this Agreement shall not be affected thereby provided that a Party’s rights under this Agreement are not materially affected. The Parties hereto covenant and agree to renegotiate any such term, covenant or application thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant or condition of this Agreement or the application thereof that is invalid, illegal or unenforceable, said renegotiated term, covenant or condition being deemed to be effective as of the Effective Date, it being the intent of the Parties that the basic purposes of this Agreement are to be effectuated as nearly as possible.

 

12.15 Status . Nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee, or joint venture relationship between the Parties.

 

12.16 Further Assurances . Each Party agrees to execute, acknowledge and deliver such further instructions, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

12.17 Mutual Duty of Good Faith . The Parties undertake to be loyal to one another. Each Party shall inform the other immediately of all events that arise during the Agreement Term and that may affect its conduct. Both Parties are prohibited, individually, from hiring or otherwise employing employees of the other Party who are or were involved in the performance of any activities under this Agreement, prior to expiration of a blocking period of [***] following termination of the Subscription Term. Moreover, both Parties undertake not to actively entice away the respective other Party’s employees involved in performance of this Agreement.

 

12.18 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.

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representative in two (2) originals.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

30


CONFIDENTIAL

 

M ORPHOSYS AG     O NCO M ED P HARMACEUTICALS , I NC .
By:  

[***]

    By:  

/s/ Paul J. Hastings

Title:  

[***]

    Title:  

CEO

Date:  

1.6.06

    Date:  

6.6.06

By:  

[***]

    By:  

 

Title:  

[***]

    Title:  

 

Date:  

1 June 2006

    Date:  

 

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

31


CONFIDENTIAL

 

APPENDIX 1.27

Impartial Person

[ *** ]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONFIDENTIAL

Appendix 1.33

REDACTED COPY OF THE JHU LICENSE AGREEMENT

(20 pages attached hereto)


9/14/93

LICENSE AGREEMENT

This Agreement, effective this 29 th day of September 1993, is between The Johns Hopkins University, a corporation of the State of Maryland, having a principal place of business at 720 Rutland Avenue, Baltimore, MD 21205 (hereinafter referred to as “JHU”) and MorphoSys Gesellschaft fur Proteinoptimierung mbH, a corporation organized and existing under the laws of Germany and having a principal place of business at Frankfurter Ring 193a, D-80807 Munich, GERMANY (hereinafter the “Company”).

WITNESSETH:

WHEREAS, as a center for research and education, JHU is interested in licensing PATENT RIGHTS (hereinafter defined) in a manner that will benefit the public by facilitating the distribution of useful products and the utilization of new methods, but is without capacity to commercially develop, manufacture, and distribute any such products or methods; and

WHEREAS, a valuable invention entitled “Mutagenesis with Trinucleotides” (JHU Ref. DM-9472), U.S. Patent Application Serial No. 07/868,489 filed on April 15, 1992, was developed during the course of research at JHU; and

WHEREAS, JHU has acquired through assignment all right, title and interest, with the exception of certain retained rights by the United States government, in said valuable invention; and

WHEREAS, Company desires to commercially develop, manufacture, use and distribute such products and processes throughout the world;

NOW, THEREFORE, in consideration of the foregoing premises and the following mutual covenants, and other good and valuable consideration, the receipt of which is hereby acknowledged, and intending to be legally bound hereby, the parties agree as follows:

ARTICLE 1 - DEFINITIONS

1.1 “PATENT RIGHTS” shall mean [***] and the invention disclosed and claimed therein, all continuations, continuations-in-part, divisions, and reissues thereof, and any corresponding foreign patent applications that may be filed in the future at the Company’s request and expense and any patents, patents of addition, or other equivalent foreign patent rights issuing, granted or registered thereon.

1.2 “LICENSED PRODUCTS” shall mean all products, the manufacture, use or sale of which is covered by any claim of one or more PATENT RIGHTS, including trinucleotide products and/or kits to be used by others in accordance with methods covered by any claim of one or more PATENT RIGHTS, and also including PROTEINS or OTHER PRODUCTS as defined in Paragraph 1.4.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


1.3 “LICENSED SERVICE(S)” shall mean all services which utilize a method or material covered by any claim of one or more PATENT RIGHTS.

1.4 “PROTEINS or OTHER PRODUCTS “shall mean proteins or other products generated by Company, AFFILIATED COMPANIES or its sublicensees that would not have been made but for the use of a material or method covered by any claim of one or more PATENT RIGHTS.

1.5 “NET SALES” shall mean gross sales revenues and fees received by Company, AFFILIATED COMPANY, and Company’s sublicensees from the sale of LICENSED PRODUCTS less trade discounts allowed, refunds, returns and recalls, and sales taxes. In the event that Company, AFFILIATED COMPANY or its sublicensee sells a LICENSED PRODUCT in combination with other active ingredients or components which are not LICENSED PRODUCTS (“Other Items”), the NET SALES for purposes of royalty payments on the combination shall be calculated as follows:

 

  (a) If all LICENSED PRODUCTS and Other Items contained in the combination are available separately, the NET SALES for purposes of royalty payments will be calculated by multiplying the NET SALES of the combination by the fraction A/A+B, where A is the separately available price of all LICENSED PRODUCTS in the combination, and B is the separately available price for all Other Items in the combination.

 

  (b) If the combination includes Other Items which are not sold separately (but all LICENSED PRODUCTS contained in the combination are available separately), the NET SALES for purposes of royalty payments will be calculated by multiplying the NET SALES of the combination by A/C, where A is as defined above and C is the invoiced price of the combination.

 

  (c) If the LICENSED PRODUCTS contained in the combination are not sold separately, the NET SALES for such combination shall be NET SALES of such combination as defined in the first sentence of this Paragraph 1.5. However, the royalty rate, paid on such combination NET SALES, as described in Paragraph 4.4, shall be reduced by [***] In no event shall the royalty rates be reduced by greater than [***]

The term “Other Items” does not include solvents, diluents, carriers, excipient or the like used in formulating a product.

1.6 “NET SERVICE REVENUE” shall mean the total revenue and fees received by Company and its AFFILIATED COMPANIES and sublicensees for providing services that utilize a LICENSED SERVICE(S) as part of the overall service provided.

1.7 “AFFILIATED COMPANY or AFFILIATED COMPANIES” shall mean any corporation, company, partnership, joint venture or other entity which controls, is controlled by or is under common control with the Company. For purposes of this Paragraph 1.7, control shall mean the direct or indirect ownership of more than fifty percent (50%), the maximum percentage

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


as allowed by applicable law of (a) the stock shares entitled to vote for the election of directors; or (b) ownership interest.

1.8 “EXCLUSIVE LICENSE” shall mean a license whereby Company’s rights are sole and entire and operate to exclude all others, subject to rights retained by the United States government in accordance with P.L. 96-517, as amended by P.L. 98-620, and subject to the retained right of JHU to make, have made, provide and use for its and The Johns Hopkins Health Systems’ non-profit purposes LICENSED PRODUCTS and LICENSED SERVICE(S).

ARTICLE 2 - GRANTS

2.1 Subject to the terms and conditions of this Agreement, JHU hereby grants to the Company an EXCLUSIVE LICENSE to make, have made, use, and sell the LICENSED PRODUCT and to provide the LICENSED SERVICE(S) in the United States and worldwide under the PATENT RIGHTS and to sublicense others under the PATENT RIGHTS.

2.2 Company shall provide a copy of each such sublicense agreement to JHU promptly after it is executed.

ARTICLE 3 - PATENT INFRINGEMENT

3.1 Each party will notify the other promptly in writing when any infringement by another is uncovered or suspected.

3.2 Company shall have the first right to enforce any patent within PATENT RIGHTS against any infringement or alleged infringement thereof, and shall at all times keep JHU informed as to the status thereof. Company may, in its sole judgment and at its own expense, institute suit against any such infringer or alleged infringer and control, settle, and defend such suit in a manner consistent with the terms and provisions hereof and recover, for its account, any damages, awards or settlements resulting therefrom, subject to Paragraph 3.4. This right to sue for infringement shall not be used in an arbitrary or capricious manner. JHU shall reasonably cooperate in any such litigation at Company’s expense; in particular JHU shall make all those formal and truthful statements in favor of the Company that may be required by the laws of that country where the lawsuit for infringement shall be brought (e.g., JHU would confirm it is the applicant of PATENT RIGHTS and the licensor.).

3.3 If Company elects not to enforce any patent within the PATENT RIGHTS, then it shall so notify JHU in writing within six (6) months of receiving notice that an infringement exists, and JHU may, in its sole judgment and at its own expense, do so and control, settle, and defend such suit in a manner consistent with the terms and provisions hereof, and recover, for its own account, any damages, awards or settlements resulting therefrom.

3.4 Any recovery by Company under Paragraph 3.2 shall be deemed to reflect loss of commercial sales, and Company shall pay JHU a royalty in accordance with this Agreement on said recovery minus all costs and expenses reasonably incurred by Company in connection with any such proceedings. If the cost and expenses exceed the recovery, then no royalty shall be paid on the recovery.


ARTICLE 4 - PAYMENTS

4.1 [Redacted]

4.2 [Redacted]

4.3 [Redacted]

4.4 [Redacted]

4.5 [Redacted]

4.6 [Redacted]

4.7 [Redacted]

4.8 [Redacted]

4.9 [Redacted]

4.10 [Redacted]

4.11 All payments under this Agreement shall be made in U.S. Dollars.

ARTICLE 5 - PATENT RIGHTS

5.1 JHU, at the Company’s expense, shall file, prosecute and maintain all patents and patent applications specified under PATENT RIGHTS upon authorization of the Company and the Company shall be licensed thereunder. Title to all such patents and patent applications shall reside in JHU. JHU shall have full and complete control over all patent matters in connection therewith under the PATENT RIGHTS. The Company will provide payment authorization at least one month before an action is due. Failure to do so can be considered by JHU as a Company decision not to authorize an action. In any country where the Company elects not to have a patent application filed or to pay expenses associated with filing, prosecuting, or maintaining a patent application or patent, JHU may file, prosecute, and/or maintain a patent application or patent at its own expense and the Company thereafter shall not be licensed under such patent or patent application.

5.2 Company agrees that all packaging containing individual LICENSED PRODUCTS are sold by Company, AFFILIATED COMPANY and sublicensees of Company will be marked with the number of the applicable patent(s) licensed hereunder in accordance with each country’s patent laws.

5.3 If necessary, JHU will communicate to Company information which it considers to be confidential. The Company agrees to accept the disclosure of said information which is marked as confidential at the time it is sent to Company and to employ all reasonable efforts to maintain the information secret and confidential, such efforts to be no less than the degree of care employed by the Company to preserve and safeguard the Company’s own confidential


information. The information shall not be disclosed or revealed to anyone except employees of the Company who have a need to know the information and who have entered into a secrecy agreement with the Company under which such employees are required to maintain confidential the proprietary information of the Company and such employees shall be advised by the Company of the confidential nature of the information and that the information shall be treated accordingly. The Company’s obligations under this Paragraph 5.3 shall not extend to any part of the information:

 

  (a) that can be demonstrated to have been in the public domain or publicly known and readily available to the trade or the public prior to the date of the disclosure; or

 

  (b) that can be demonstrated, from written records to have been in the Company’s possession or readily available to the Company from another source not under obligation of secrecy to JHU prior to the disclosure; or

 

  (c) that becomes part of the public domain or publicly known by publication or otherwise, not due to any unauthorized act by the Company.

The obligations of this Paragraph 5.3 shall also apply to AFFILIATED COMPANIES and/or sublicensees provided such information by Company. The Company’s obligations under this Paragraph 5.3 shall extend for a period of five (5) years after the termination of this Agreement.

ARTICLE 6 - TERM MILESTONES AND TERMINATION

6.1 This Agreement shall expire on the date of expiration of the last to expire patent included within PATENT RIGHTS or on that date where rejection of a patent application becomes final and all administrative and judicial appeals are exhausted or lapse.

6.2 The Company shall use all reasonable efforts to effect the development, regulatory approval and commercialization of the LICENSED PRODUCT and LICENSED SERVICE. To this end, Company shall meet the following milestones by the times so noted:

 

Milestones

   Date

[***]

   November, 1993

[***]

   February, 1994

6.3 Company shall use all best efforts to effect the lawful commercial sales of LICENSED PRODUCTS and LICENSED SERVICE(S) in each country in which PATENT RIGHTS are obtained as soon as is commercially practicable.

6.4 The Company may terminate this Agreement either in full or for certain countries at any time upon ninety (90) days written notice to JHU.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


6.5 Upon termination, the Company, AFFILIATED COMPANY or sublicensee shall return all information marked confidential first transferred to the Company by JHU. The Company, AFFILIATED COMPANY or sublicensee shall maintain confidential and not use any such information for a period of five (5) years after termination of this Agreement; however, the exceptions set out in Paragraph 5.3 apply accordingly.

6.6 Upon breach or default of any of the terms and conditions of this Agreement, the defaulting party shall be given notice of such default in writing and a period of thirty (30) days after receipt of such notice to correct the breach or default. If the breach or default is not corrected within said thirty (30) day period, the party not in default shall have the right to terminate this Agreement.

6.7 Termination shall not affect JHU’s right to recover unpaid royalties that become due prior to termination or reimbursement for Company approved patent expenses pursuant to Paragraph 4.1.

ARTICLE 7 - MISCELLANEOUS

7.1 All notices pertaining to this Agreement shall be in writing and sent certified mail, return receipt requested, to the parties at the following addresses or such other address as such party shall have furnished in writing to the other party in accordance with this Paragraph 7.1:

 

FOR JHU:    Dr. Francis J. Meyer
   Assistant Dean for Technology Licensing
   The Johns Hopkins University
   School of Medicine
   720 Rutland Avenue
   Baltimore, MD 21205
FOR COMPANY:    Simon E. Moroney
   MorphoSys Gesellschaft fur Proteinoptimierung mbH
   Frankfurter Ring 193a
   D-80807 Munich
   Germany

7.2 All written progress reports, royalty and other payments, and any other related correspondence shall be in writing and sent to:

 

  

Francis J. Meyer, Ph.D.

Assistant Dean for Technology Licensing

The Johns Hopkins University

School of Medicine

720 Rutland Avenue

Baltimore, MD 21205

or such other addressee which JHU may designate in writing from time to time. All checks should be made payable to The Johns Hopkins University.


7.3 This Agreement may be assigned by the Company to an AFFILIATE COMPANY or as part of its entire business relating to LICENSED PRODUCTS, provided JHU approves the assignment in writing, which approval shall not be unreasonably withheld. In the event of such transfer, the transferee shall assume and be bound by the provisions of this Agreement. (As a point of clarity, any sublicense is governed by the terms of Paragraph 2.1.)

7.4 In the event that any one or more of the provisions of this Agreement should for any reason be held by any court or authority having jurisdiction over this Agreement, or over any of the parties hereto to be invalid, illegal or unenforceable, such provision or provisions shall be reformed to approximate as nearly as possible the intent of the parties, and if unreformable, shall be divisible and deleted in such jurisdictions; elsewhere, this Agreement shall not be affected.

7.5 The construction, performance, and execution of this Agreement shall be governed by the laws of the State of Maryland.

7.6 The Company shall not use the name of THE JOHNS HOPKINS UNIVERSITY or any contraction thereof or the names of Drs. David Shortle and John Sondek in any advertising, promotional, or sales literature without prior written consent from JHU.

7.7 JHU warrants that it has good and marketable title to the invention claimed under PATENT RIGHTS with the exception of certain retained rights of the United States government. JHU does not warrant the validity of any patents or that practice under such patents shall be free of infringement. EXCEPT AS EXPRESSLY SET FORTH IN THIS PARAGRAPH 7.7, COMPANY, AFFILIATED COMPANY AND SUBLICENSEES AGREE THAT THE PATENT RIGHTS AND INFORMATION ARE PROVIDED “AS IS”, AND THAT JHU MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF LICENSED PRODUCTS AND LICENSED SERVICE(S) INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY. JHU DISCLAIMS ALL WARRANTIES WITH REGARD TO PRODUCTS AND SERVICE(S) LICENSED UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE. NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, JHU ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF JHU FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF JHU HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, OR SALE OF THE PRODUCTS AND SERVICE(S) LICENSED UNDER THIS AGREEMENT. COMPANY, AFFILIATED COMPANY AND sublicensees ASSUME ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT AND SERVICES MANUFACTURED, USED, OR SOLD BY COMPANY, ITS SUBLICENSEES AND AFFILIATES WHICH IS A LICENSED PRODUCT OR LICENSED SERVICE AS DEFINED IN THIS AGREEMENT.

7.8 JHU and the inventor of LICENSED PRODUCTS and LICENSED SERVICE(S) will not, under the provisions of this Agreement or otherwise, have control over the manner in which Company or AFFILIATED COMPANIES or its sublicensees or those operating for its


account or third parties who purchase LICENSED PRODUCTS and LICENSED SERVICE(S) from any of the foregoing entities, practice the inventions of LICENSED PRODUCTS and LICENSED SERVICE(S). The Company shall defend and hold JHU and said inventor harmless as against any judgments, fees, expenses, or other costs arising from or incidental to any product liability or other lawsuit, claim, demand or other action brought as a consequence of the practice of said inventions by any of the foregoing entities, whether or not JHU or said inventor, either jointly or severally, is named as a party defendant in any such lawsuit. Practice of the inventions covered by LICENSED PRODUCTS and LICENSED SERVICE(S), by an AFFILIATED COMPANY or an agent or a sublicensee or a third party on behalf of or for the account of the Company or by a third party who purchases LICENSED PRODUCTS and LICENSED SERVICE(S) from the Company, shall be considered the Company’s practice of said inventions for purposes of this Paragraph 7.8. The obligation of the Company to defend and indemnify as set out in this Paragraph 7.8 shall survive the termination of this Agreement.

7.9 The Company warrants that it now maintains and will continue to maintain, in each country which Company, AFFILIATED COMPANY or sublicensee sells LICENSED PRODUCTS and LICENSED SERVICE(S), product liability insurance coverage or self-insurance appropriate to the risks involved in marketing LICENSED PRODUCTS and LICENSED SERVICE(S) and will annually present evidence to JHU that such coverage is being maintained. The Company will furnish JHU with a Certificate of Insurance of each product liability insurance or self-insurance policy obtained and agrees to increase or change the kind of product liability insurance pertaining to the LICENSED PRODUCTS and LICENSED SERVICE(S) at the request of JHU. JHU shall be listed as a named insured in Company’s said insurance policy.

7.10 This Agreement constitutes the entire understanding between the parties with respect to the obligations of the parties with respect to the subject matter hereof, and supersedes and replaces all prior agreements, understandings, writings, and discussions between the parties relating to said subject matter.

7.11 This Agreement may be amended and any of its terms or conditions may be waived only by a written instrument executed by the authorized officials of the parties or, in the case of a waiver, by the party waiving compliance. The failure of either party at any time or times to require performance of any provision hereof shall in no manner affect its right at a later time to enforce the same. No waiver by either party of any condition or term in any one or more instances shall be construed as a further or continuing waiver of such condition or term or of any other condition or term.

7.12 This Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors and permitted assigns.

7.13 In the event Company becomes insolvent and/or enters into a bankruptcy or any comparable proceedings, notice will be immediately provided to JHU in writing and the license agreement is automatically terminated.

7.14 Upon termination of this Agreement for any reason, Paragraphs 6.5, 6.7, 7.6, 7.8, and 7.9 shall survive termination of this Agreement. (However, the requirement of Paragraph


7.9 shall cease when Company, AFFILIATED COMPANIES and its sublicensees cease practicing PATENT RIGHTS and selling LICENSED PRODUCTS and providing LICENSED SERVICE(S).)

IN WITNESS WHEREOF the respective parties hereto have executed this Agreement by their duly authorized officers on the date appearing below their signatures.

 

THE JOHNS HOPKINS UNIVERSITY     MorphoSys Gesellschaft fur Proteinoptimierung mbH
By:  

/s/ David A. Blake

    By:  

/s/ S. E. Moroney

  David A. Blake, Ph.D.       Simon Moroney
  Executive Vice Dean       Managing Director
Date:  

Sept. 29, 1993

    Date:  

16 .9 93

I have read and agree to abide with the terms of this Agreement.
By:  

/s/ David R. Shortle

    Date:  

September 28, 1993

  Dr. David Shortle      


AMENDMENT TO LICENSE AGREEMENT

This Amendment, having an effective date of December  27 , 1993 is made between The Johns Hopkins University, having a place of business at 720 Rutland Avenue, Baltimore, MD 21205 (hereinafter referred to as “JHU”) and MorphoSys Gesellschaft fur Proteinoptimierung mbH, a corporation organized and existing under the laws of Germany and having a principal place of business at Frankfurter Ring 193a, D-80807 Munich, GERMANY (hereinafter the “Company”).

WHEREAS, JHU and Company entered into a license agreement having an Effective Date of September 29, 1993 (hereinafter “License Agreement”).

WHEREAS, Company has requested certain modifications to the License Agreement so as to complete a 2.8 million DM funding round involving Atlas Ventures.

NOW THEREFORE, the parties hereto agree as follows:

 

  1 Page 2 line 2, after “expense” add — including pending PCT application serial number [***]

 

  2. Page 7 line 23, after “any” delete “agreement, understanding or arrangement with respect to consideration (such as, among other things,” and substitute therefore — commercial agreement specifying —.

 

  3. Page 8 line 8 after “RIGHTS” add — JHU agrees to provide copies of all correspondence to or from the patent offices and draft applications, responses and other patent related documents to Company for review. JHU and its patent counsel will reasonably consider suggestions made by Company —.

 

  4. Page 8 line 16 after “patent laws.” add the following new sentence — JHU will, at the written request of Company, supply Company with the Information at its disposal needed by Company to comply with this Paragraph 5.2 —.

 

  5. Page 8 line 18, after “which is” add — in writing and —.

 

  6. Page 9 line 11, delete “termination of this Agreement” and substitute therefore, — receipt date of such information —.

 

  7. Page 9, delete Paragraph 6.1 in its entirety and substitute therefore:

“6.1 This Agreement shall terminate as to a particular patent application included in PATENT RIGHTS on that date where rejection of that patent application becomes final and all administrative and judicial appeals are exhausted or lapse.”

 

  8. Page 10, delete Paragraph 6.3 in its entirety and substitute therefore:

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


“6.3 Company shall use all best efforts to effect the lawful commercial sales of LICENSED PRODUCTS or LICENSED SERVICE(S) in each country in which PATENT RIGHTS are obtained as soon as is commercially practicable and so as to obtain the maximum possible commercial benefit.”

 

  9. [Redacted]

 

  10. All other terms and conditions of the License Agreement, unless specifically amended herein, remain in full force and effect.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement by their duly authorized officers on the date, appearing below their signature.

 

THE JOHNS HOPKINS UNIVERSITY     MORPHOSYS GESELLSCHAFT FUR PROTEINOPTIMIERUNG MBH
By:  

/s/ [ILLEGIBLE]

    By:  

/s/ S. E. Moroney

  David A. Blake, Ph.D.       Simon Moroney
  Executive Vice Dean       Title: Managing Director
Date:  

1/24/94

    Date:  

27 .12 .93


2nd AMENDMENT TO LICENSE AGREEMENT

This Amendment having an effective date as of June 23, 1997, is made by and between MorphoSys, GmbH, a corporation having a principal place of business at Frankfurter Ring 193a, D-80807 Munich, Germany (hereinafter “MorphoSys”) and The Johns Hopkins University, having an address of 2024 East Monument Street, Suite 2-100, Baltimore, MD 21205 (hereinafter “JHU”).

WHEREAS, JHU and MorphoSys entered into a license agreement dated September 29, 1993 and thereafter amended said license agreement on December 27, 1993 (hereinafter “License Agreement”);

WHEREAS, MorphoSys has identified an ambiguity in the License Agreement; and

WHEREAS, MorphoSys and JHU both arc interested in clarifying such ambiguity;

NOW THEREFORE, the parties hereto agree as follows:

 

1. Paragraph 1.5: The first two lines of the definition for “Net Sales” shall be amended to read as follows: “NET SALES” shall mean gross sales revenues and fees received by Company and AFFILIATED COMPANY from the sale…”

 

2. Paragraph 4.4: Line 2 should read, “… by Company, and AFFILIATED COMPANY and…” Line 3 should read, “… provided by Company and AFFILIATED COMPANY the royalty…”

 

3. All other terms and conditions of the Agreement shall remain in full force and effect.

IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed the day and year first written above.

 

JOHNS HOPKINS UNIVERSITY     MORPHOSYS, GMBH
By:  

/s/ [ILLEGIBLE]

    By:  

/s/ S. E. Moroney

  John D. Stobo, M.D.       Simon Moroney
  Vice Dean for Research and Technology       Chief Executive Officer
Date:  

7/15/97

    Date:  

9 - 7 - 97


CONFIDENTIAL

 

APPENDIX 1.45

MORPHOSYS PATENT RIGHTS

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONFIDENTIAL

 

Appendix 1.47

MORPHOSYS Technology

This section represents the technology that MORPHOSYS will transfer to ONCOMED under the Subscription (MORPHOSYS HuCAL GOLD Library and MORPHOSYS HuCAL GOLD Library Ancillary Technology) and that MORPHOSYS will apply at MORPHOSYS to carry out the objectives of the Collaboration [***] .

[***]

 

 

[***]

 

 

[***]

[***]

[***]

[***]

 

 

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONFIDENTIAL

 

APPENDIX 4.3(a)

COMMERCIAL LICENSE REQUEST FORM

(To be completed for each Commercial Target)

Target requested pursuant to Section 4.3 of the Subscription and License Agreement (define: by common name(s), accession number, and amino acid sequence, if possible):

Type of Commercial License Requested: Commercial Therapeutic License

 

ONCOMED PHARMACEUTICALS, INC.      
By:  

 

     
Name:        
Title:        
this      day of             ,               
MORPHOSYS AG     MORPHOSYS AG
By:  

 

    By:  

 

Name:       Name:  
Title:       Title:  
this      day of             ,              this      day of             ,         

[to be filled out by MORPHOSYS:] [***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONFIDENTIAL

 

APPENDIX 4.3(b)

Exemplary analysis of a License Request

The following non-limiting hypothetical example is intended to illustrate how MORPHOSYS would analyze a License Request for a Target defined under Section 1.60(ii) [***] , where another partner of MORPHOSYS (a “MORPHOSYS Partner”) holds a license to commercialize therapeutic HuCAL-derived antibodies directed against [***] :

To the extent (at the time of the below-mentioned License Request) the MORPHOSYS Partner holds such a license from MORPHOSYS as referenced in the preceding paragraph, with respect to [***] , if ONCOMED submits a License Request for “ [***] ” (“ONCOMED Target”), then such existing license to such MORPHOSYS Partner would not prohibit the granting to ONCOMED of a Commercial Therapeutic License relating to such ONCOMED Target, to the extent that such [***] .

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONFIDENTIAL

APPENDIX 4.5(a)

REDACTED COPY OF THE XOMA LICENSE AGREEMENT

(24 pages attached hereto)


Schedule 4.2

CONFIDENTIAL

Redacted Version

LICENSE AGREEMENT

This License Agreement (this “ Agreement ”), effective as of February 1, 2002 (the “ Effective Date ”), is entered into by and between XOMA Ireland Limited, a company with limited liability organized under the laws of the Republic of Ireland having offices at Shannon Airport House, Shannon, County Clare, Ireland (with its Affiliates, “ XOMA ”), and MorphoSys AG, a German company having offices at Lena-Christ-Str. 48, 82152 Martinsried/Planegg, Germany (with its Affiliates, “ MORPHOSYS ”).

BACKGROUND

A. XOMA is the owner or exclusive licensee of certain patent rights relating to bacterial cell expression, and MORPHOSYS wishes to acquire non-exclusive licenses under such patent rights; and

B. XOMA is willing to grant MORPHOSYS non-exclusive licenses, on the terms and conditions set forth below, in order to permit MORPHOSYS to engage in certain research, development and commercial activities.

NOW, THEREFORE, in consideration of the promises and the mutual covenants hereinafter recited, the parties agree as follows:

ARTICLE 1

DEFINITIONS

In this Agreement, the following terms shall have the meanings set forth in this Article.

1.1. “ Affiliate ” means any corporation or other entity which is directly or indirectly controlling, controlled by or under common control with a party hereto. For purposes of this Agreement, “ control ” (including, with correlative meanings, the terms “ controlled ” and “ controlling ”) means the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of the subject corporation or other entity, whether through the ownership of voting securities, by agreement or otherwise.

1.2. “ Antibody Phage Display ” means the authorized use of Licensed Antibody Phage Display Materials to conduct Research and Development.

1.3. “ Change in Control ” means, with respect to a particular entity, any transaction or series of transactions as a result of which any person or group (as defined under the U.S.


Securities Exchange Act of 1934, as amended) becomes, directly or indirectly, the beneficial owner of more than fifty percent (50%) of the total voting power of such entity’s equity securities or otherwise gains control of such entity.

1.4. “ Confidential Information ” means any proprietary or confidential information or material disclosed by a party to the other party pursuant to this Agreement, which is (i) disclosed in tangible form hereunder and is designated thereon as “Confidential” at the time it is delivered to the receiving party, or (ii) disclosed orally hereunder and identified as confidential or proprietary when disclosed and such disclosure of confidential information is confirmed in writing within thirty (30) days by the disclosing party.

1.5. “ Dispose ” means to transfer, assign, lease, or in any other fashion dispose of control, ownership or possession, but shall not mean to license or sell. “ Disposition ” shall have the correlative meaning.

1.6. “ Immunoglobulin ” means any molecule, including without limitation, full immunoglobulin molecules ( e.g ., IgG, IgM, IgE, IgA and IgD molecules) and ScFv, Fv and Fab molecules, that has an amino acid sequence by virtue of which it specifically interacts with an antigen and wherein that amino acid sequence consists essentially of a functionally operating region of an antibody variable region including, without limitation, any naturally occurring or recombinant form of such a molecule.

1.7. “ Licensed Antibody Phage Display Materials ” means (i) any collection or library of polynucleotide sequences, created by and under the exclusive control of MORPHOSYS, which encodes at least one Immunoglobulin and which is contained in filamentous bacteriophage and/or bacteriophage or phagemid cloning vectors capable of propagation in bacteria; (ii) any collection or library of bacteriophage, created by or under the exclusive control of MORPHOSYS, wherein an Immunoglobulin is (a) expressed as a fusion protein comprising an Immunoglobulin or at least a functionally operating region of an antibody variable region and an outer surface polypeptide, or a fragment thereof, of a bacteriophage or (b) expressed separately and linked to an outer surface polypeptide, or a fragment thereof, of a bacteriophage; or (iii) any material required to generate any collection or library according to (i) and/or (ii), each of which under (i), (ii) and/or (iii) infringe, but for the license granted herein, the XOMA Patent Rights. For the avoidance of doubt, and without expanding the definition thereof, specifically excluded from the definition of Licensed Antibody Phage Display Materials are (x) any article of manufacture or composition of matter suitable for display, expression or secretion of an Immunoglobulin in or from any organism or system other than bacteria and (y) any materials or composition of matter otherwise meeting the definition of Licensed Antibody Phage Display Materials but created by or under the control of any entity, other than MORPHOSYS, engaged in the licensing, manufacture, sale, offer for sale, import or export of phage display services, products or materials; provided , that, notwithstanding the foregoing, any materials or composition of matter otherwise meeting the definition of Licensed Antibody Phage Display Materials but created by or under the exclusive control of a MORPHOSYS Collaborator shall constitute Licensed Antibody Phage Display Materials, but only to the extent derived by such

 

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MORPHOSYS Collaborator exclusively from Licensed Antibody Phage Display Materials created by or under the exclusive control of MORPHOSYS and properly transferred by MORPHOSYS to such MORPHOSYS Collaborator in accordance with the applicable provisions of this Agreement and such MORPHOSYS Collaborator acknowledges that the transfer restrictions and other provisions hereof apply thereto.

1.8. “ Licensed Immunoglobulin ” means any Immunoglobulin discovered, isolated or characterized by MORPHOSYS or a MORPHOSYS Collaborator (as defined below) through the use of Licensed Antibody Phage Display Materials.

1.9. “ Licensed Immunoglobulin Information ” means any data, know-how or other information relating, concerning or pertaining to a Product, including, without limitation, data, know-how or other information characterizing or constituting such Licensed Immunoglobulin’s polynucleotide or amino acid sequence, purported function or utility, antigen binding affinity, or physical or biochemical property.

1.10. “ MORPHOSYS Collaborator ” means any person or entity (including a corporation or an academic institution) who is an authorized end-user of Licensed Antibody Phage Display Materials, the intended recipient of Products or Licensed Immunoglobulin Information transferred from MORPHOSYS and/or a person or entity on whose behalf MORPHOSYS knowingly engages in Antibody Phage Display; provided , however , that such person or entity shall not be deemed to be a MORPHOSYS Collaborator unless and until the requirements of Section 2.4 are complied with. No person or entity shall be deemed to be a MORPHOSYS Collaborator if such person or entity is engaged in the out-licensing, commercial manufacture, sale, offer for sale, import for sale or export for sale of immunoglobulin or antibody phage display services, immunoglobulin or antibody phage display libraries, immunoglobulin or antibody phage display products or immunoglobulin or antibody phage display materials, unless, pursuant to a written agreement (other than this Agreement), executed after the Effective Date, XOMA has granted to such person or entity a valid license or covenant not to sue under the XOMA Patent Rights which explicitly extends to the activities identified in this second to last sentence of Section 1.10. XOMA shall provide MORPHOSYS prompt written notice of those written agreements or covenants not to sue which satisfy the requirements of the prior sentence. No person or entity may claim the status of MORPHOSYS Collaborator with respect to any acts or activities which are unrelated to the use of Licensed Antibody Phage Display Materials provided by MORPHOSYS.

1.11. “ Net Sales ” means, in the case of the sale, either directly or through a Third Party, of any Product by or on behalf of MORPHOSYS or any joint venture or similar entity or arrangement in which MORPHOSYS is a participant (a “MORPHOSYS Selling Entity”), the aggregate gross sales proceeds derived by MORPHOSYS therefrom less (a) any sales or other taxes, assessments, charges or fees imposed by any government authority which are paid, directly or indirectly, by MORPHOSYS and (b) a discount from the gross sales proceeds to cover costs associated with MORPHOSYS’s sale of Product, as applicable, in respect of transport, insurance premiums, returns, discounts, other miscellaneous costs and expenses and

 

3


rebates actually allowed and taken, all determined in accordance with U.S. generally accepted accounting principles. For the sake of clarity, it is understood that Net Sales does not include sales of Products developed by or solely on behalf of MORPHOSYS or a MORPHOSYS Collaborator unless sold by a MORPHOSYS Selling Entity. As used herein, “joint venture” means a legal entity in the nature of a partnership engaged in a joint undertaking for profit.

1.12. “ Product ” means any composition of matter or article of manufacture, including without limitation any diagnostic, prophylactic or therapeutic product, which (a) contains a Licensed Immunoglobulin; or (b) was discovered or created by or arose directly out of use of Licensed Antibody Phage Display Materials or the conduct of Antibody Phage Display by MORPHOSYS or a MORPHOSYS Collaborator.

1.13. “ Research and Development ” means the identification, selection, isolation, purification, characterization, study and/or testing and/or use of a Product for any purpose, including, without limitation, the discovery and development of human therapeutics or diagnostics. Included within the definition of “Research and Development” shall be all in vitro screening or assays customarily performed in pre-clinical and clinical research and uses associated with obtaining FDA or equivalent agency regulatory approval. “Research and Development” shall not include commercial or industrial manufacture or any activities solely directed to the creation of such capacities.

1.14. “ Research Quantities ” means those quantities of a Licensed Immunoglobulin reasonably required for Research and Development purposes.

1.15. “ Third Party ” means any person or entity other than MORPHOSYS or XOMA.

1.16. “ Valid Claim ” means (i) a claim of an issued and unexpired patent included within the XOMA Patent Rights which has not been held invalid in a final decision of a court of competent jurisdiction from which no appeal may be taken, and which has not been disclaimed or admitted to be invalid or unenforceable through reissue or otherwise, or (ii) a claim of a pending patent application within the XOMA Patent Rights.

1.17. “ XOMA Patent Right(s) ” means the patent applications and patents listed on Schedule 1.17 hereto and, solely to the extent any Valid Claim would cover or be included in the license grants provided for herein, all divisions, continuations, continuations-in-part, applications claiming priority thereto, and substitutions thereof; all foreign patent applications corresponding to the preceding applications; all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues and re-examinations; and any other patent rights owned by XOMA which XOMA has the right to license or sublicense and which would be infringed by the activities of MORPHOSYS contemplated hereunder but for this Agreement. XOMA Patent Rights shall also include (i) any improvements of the foregoing that are owned or controlled by XOMA and (ii) any patents or patent applications owned or controlled by XOMA containing a claim that is dominating over the foregoing patent rights (i.e., is necessarily infringed by the practicing of a claim in one of the foregoing applications).

 

4


ARTICLE 2

XOMA LICENSE TO MORPHOSYS

2.1. Grants . Subject to the other terms and conditions of this Agreement, XOMA hereby grants to MORPHOSYS a worldwide, non-exclusive, non-transferable license (unless transferred under Section 8.2), without any right to sublicense, under the XOMA Patent Rights to:

(a) solely on its own behalf and on behalf of a MORPHOSYS Collaborator, make or have made Licensed Antibody Phage Display Materials;

(b) solely on its own behalf and on behalf of a MORPHOSYS Collaborator and solely for Research and Development purposes, conduct Antibody Phage Display and use or have used Licensed Antibody Phage Display Materials and generate, use and have used Licensed Immunoglobulin Information;

(c) solely on its own behalf and on behalf of a MORPHOSYS Collaborator, make or have made, use or have used, Research Quantities of a Licensed Immunoglobulin;

(d) solely on its own behalf and on behalf of a MORPHOSYS Collaborator, transfer Antibody Phage Display Materials, Research Quantities of a Product or Licensed Immunoglobulin Information to a MORPHOSYS Collaborator;

(e) solely on its own behalf and on behalf of a MORPHOSYS Collaborator, subject to the provisions of Section 2.3(b), make, have made, use, have used, sell, offer to sell, have offered for sale, import, have imported, export and have exported Products; and

(f) solely on its own behalf, make or have made in commercial and/or industrial capacity, use, offer for sale, sell, import and export Products for use (i) in the treatment, prophylaxis, diagnosis or monitoring of a human disease state or condition or (ii) as research reagents. For the sake of clarity, the license granted in this Section 2.1(f) is personal to MORPHOSYS and is not to be used on behalf of any MORPHOSYS Collaborator or any other Third Party.

2.2. Covenant Not To Sue . (a) XOMA covenants that it shall not assert, nor shall it permit any third party that obtains a right to enforce the XOMA Patent Rights to assert, a claim of infringement under the XOMA Patent Rights against MORPHOSYS, any MORPHOSYS Collaborator or any other entity subject to Section 2.4(c) solely to the extent reasonably necessary to permit the authorized use of Licensed Antibody Phage Display Materials, Products or Licensed Immunoglobulin Information for activities or in a manner otherwise permitted under the provisions of this Agreement. The covenant not to sue provided by this Section 2.2:

 

5


(i) shall not extend to infringement of the XOMA Patent Rights arising out of making or the means or methods used to make any amount of a Licensed Immunoglobulin or Product other than Research Quantities (except as authorized by Section 2.1(f));

(ii) may be terminated by XOMA in accordance with Article 7 as to any entity or person who has failed to materially discharge or comply with any applicable term of a written agreement between MORPHOSYS and a MORPHOSYS Collaborator provided for in Section 2.4; provided , that any such termination shall be retroactive to the date of the first notice of such failure given by MORPHOSYS to such entity or person (giving effect to any subsequent cure of such failure);

(iii) is personal to MORPHOSYS or, as applicable, the MORPHOSYS Collaborator or other entity subject to Section 2.4(c), and, except as provided for by Section 8.2, cannot be assigned or transferred; and

(iv) does not constitute a release or waiver of past, present or future infringement of the XOMA Patent Rights by MORPHOSYS or any Third Party, including, without limitation, any MORPHOSYS Collaborator acting outside of the scope of the written agreement with MORPHOSYS provided for in Section 2.4.

(b) In addition to, but without limiting, the covenant not to sue provided by Section 2.2(a), XOMA hereby grants to Schering AG a non-exclusive and non-transferable license under the XOMA Patent Rights identical to, and limited by the scope of, the covenant not to sue contained in Sections 2.2(a) (the “Direct License”). Solely to the extent its activities are otherwise authorized as those of a MORPHOSYS Collaborator under the applicable terms of this Agreement, the Direct License permits Schering AG to enjoy the benefits of the covenant not to sue granted under Section 2.2(a) as if it were a direct licensee under the XOMA Patent Rights, provided, however, that the Direct License does not constitute an independent or free standing grant of a license and is expressly subject to and contingent upon the applicability of and compliance with the other provisions of this Agreement. The Direct License shall not be effective unless and until Schering AG delivers to XOMA a document, directly enforceable by XOMA, pursuant to which Schering AG (a) represents and warrants that it does and shall continue to meet the definition of MORPHOSYS Collaborator; and (b) agrees that it shall abide by the relevant limitations and obligations otherwise imposed upon MORPHOSYS Collaborators under this Agreement. The Direct License shall survive only as long as this Agreement remains in force and as to Schering AG has not been terminated.

2.3. No Implied Rights . Only the rights and licenses granted pursuant to the express terms of this Agreement shall be of any legal force or effect. No license or other rights shall be deemed to have been granted to MORPHOSYS or a MORPHOSYS Collaborator other than as expressly provided for in this Agreement. MORPHOSYS renounces and hereby quitclaims any implied rights to licenses under the XOMA Patent Rights that may arise by operation of this

 

6


Agreement or under applicable law. For the avoidance of doubt, the grants of rights made pursuant to Sections 2.1 and 2.2 do not include, and expressly exclude, the following:

(a) any right or license to engage in any activities on behalf of or in collaboration with any Third Party, other than a MORPHOSYS Collaborator;

(b) any right or license to make or have made any amount (other than Research Quantities or except as authorized under Section 2.1(f)) of a Licensed Immunoglobulin or Product by practicing the XOMA Patent Rights; provided , however , that MORPHOSYS or, as applicable, a MORPHOSYS Collaborator shall be permitted to make or have made any Product by any means of its selection other than those which otherwise infringe a Valid Claim of the XOMA Patent Rights; and/or

(c) any right to release any Third Party, including a MORPHOSYS Collaborator, from any claim of infringement under the XOMA Patent Rights.

Without limiting the foregoing, the parties acknowledge that nothing herein shall be deemed to impose on MORPHOSYS any obligation to provide consideration for, or grant MORPHOSYS any access or other rights to, any know-how of XOMA.

2.4. Transfer Restrictions . (a) MORPHOSYS shall not (i) undertake any Antibody Phage Display Activities on behalf of a Third Party or (ii) Dispose of Licensed Antibody Phage Display Materials, a Licensed Immunoglobulin, Licensed Immunoglobulin Information or the product of the practice of any method within the scope of the XOMA Patents (“ Transferred Materials ”) to any Third Party until (in the case of either clause (i) or clause (ii)) such time as it has provided to such Third Party the redacted copy of this Agreement referred to in Section 4.2 and the form of notice set out at Schedule 2.4 .

(b) If MORPHOSYS enters into a written arrangement with any Third Party arising out of or relating to activities as to which it or such Third Party does or intends to claim the benefits of any of the licenses or other grants provided for by this Agreement, such written arrangement shall contain provisions (i) pursuant to which the recipient of any Transferred Materials agrees to abide by each of the limitations, restrictions and other obligations provided for by this Agreement, including, without limitation, the restrictions on use of Transferred Materials for purposes other than Research and Development; (ii) implementing a covenant not to use Transferred Materials for any purpose other than for Research and Development purposes otherwise authorized by this Agreement; (iii) providing that the “first sale” doctrine does not apply to any Disposition; and (iv) permitting a MORPHOSYS Collaborator to further Dispose of Transferred Materials only to a Third Party who otherwise meets the definition of a MORPHOSYS Collaborator and who executes a written agreement in which it undertakes all of the obligations applied to the transferring party. XOMA shall be, and the agreements subject to this Section 2.4 shall provide that XOMA shall be, an intended third party beneficiary with respect to the foregoing provisions.

 

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(c) The restrictions set forth in Sections 2.4(a)(ii) and 2.4(b)(iv) shall not apply to any Disposition of Products, Licensed Immunoglobulins or Licensed Immunoglobulin Information by MORPHOSYS or a MORPHOSYS Collaborator to a Third Party, a MORPHOSYS Selling Entity or any joint venture or similar entity or arrangement in which such MORPHOSYS Collaborator is a participant (each a “Directed Third Party”), where such Directed Third Party (i) performs services or conducts activities which are otherwise authorized under this Agreement and which are solely for the benefit of MORPHOSYS or such MORPHOSYS Collaborator and/or (ii) does not require and does not claim the benefit of the licenses or covenant not to sue granted by XOMA under this Agreement, provided, however, that MORPHOSYS and any such MORPHOSYS Collaborator shall be responsible for ensuring compliance by any such Directed Third Party with all applicable terms of this Agreement. For the sake of clarity, nothing in this Section 2.4(c) shall constitute the grant of any rights or licenses under the XOMA Patent Rights to any Directed Third Party.

2.5. Reports, Records and Audits . (a) Thirty (30) days after the end of each calendar quarter, commencing with the first calendar quarter commencing after the Effective Date, MORPHOSYS shall deliver to XOMA a written report which shall specify the name, address and contact person for each and every MORPHOSYS Collaborator and any person or entity receiving Licensed Antibody Phage Display Materials or a Licensed Immunoglobulin.

(b) Thirty (30) days after the end of each calendar year, commencing with the first calendar year to commence after the Effective Date, MORPHOSYS shall deliver to XOMA a written report which shall summarize with reasonable particularity the current status of activities or compositions of matter as to which MORPHOSYS claims the right of license hereunder.

(c) MORPHOSYS shall maintain records fully and properly reflecting those activities covered by this Agreement (including, without limitation, work done with the Licensed Antibody Phage Display Materials) and/or to be reported to XOMA pursuant to Section 2.5(a) and (b) (the “ Records ”), in sufficient detail and in good scientific manner appropriate for patent, regulatory and manufacturing purposes for at least three (3) years. Upon the written request of XOMA and not more than once in each calendar year, MORPHOSYS shall permit an independent consultant appointed by XOMA, at XOMA’s expense, to have access during normal business hours to such of the records of MORPHOSYS as may be reasonably necessary to verify compliance with the terms of this Agreement, as well as the accuracy of the reports hereunder. MORPHOSYS shall certify any statements by MORPHOSYS personnel as to their accuracy and correctness. The consultant shall not be permitted to see or receive any specific information concerning targets or antibodies of either MORPHOSYS or any of its collaborators and shall disclose to XOMA only the results and conclusions of its review and the specific details concerning any discrepancies. No other information shall be shared by the consultant without the prior consent of MORPHOSYS unless disclosure is required by law, regulation or judicial order.

2.6. Ownership; Enforcement . At all times XOMA will retain ownership of the XOMA Patent Rights and may use and commercialize such XOMA Patent Rights itself or with any Third Party. XOMA retains the right, at its sole discretion, to enforce, maintain and

 

8


otherwise protect the XOMA Patent Rights. MORPHOSYS will reasonably cooperate with XOMA, at XOMA’s expense, with respect to any actions XOMA may choose to take related to the enforcement, maintenance or protection of the XOMA Patent Rights.

2.7. Oppositions and/or Appeals to Oppositions . MORPHOSYS hereby agrees not to enter into any opposition to and/or appeal from any decision by the patent authorities of any country on the XOMA Patent Rights and shall not assist or otherwise cooperate with another party in any such opposition or appeal.

2.8. Release From Past Infringement . XOMA releases MORPHOSYS from any claims, demands, and rights of action arising out of and/or based upon any act or omission committed by MORPHOSYS prior to the Effective Date, including, without limitation, claims of infringement under the XOMA Patent Rights (the “ Release ”) and XOMA releases each Third Party identified on Schedule 2.8 as a party on or prior to the Effective Date to an agreement set forth thereon from any claims, demands, and rights of action arising out of and based upon any infringement of the XOMA Patent Rights (the “ Third Party Release ”); provided , however , that the Release and Third Party Release provided for in this Section 2.8 shall extend only to claims, demands or rights of action existing as of the Effective Date and which arose solely out of those activities conducted pursuant to and in accordance with the agreements set forth on Schedule 2.8 as in effect on the Effective Date. Nothing in this Section 2.8 shall be deemed to be a release of any claim, demand or right of action XOMA may now or in the future have against Affitech AS, BioInvent Therapeutic AB, Biosite Incorporated, Cambridge Antibody Technology Limited, Crucell N.V., Dyax Corporation or any entity or person engaged in the out-licensing, commercial manufacture, sale, offer for sale, import for sale or export for sale of immunoglobulin or antibody phage display services, immunoglobulin or antibody phage display libraries, immunoglobulin or antibody phage display products or immunoglobulin or antibody phage display materials or any of their collaborators. For the sake of clarity, if any Third Party identified on Schedule 2.8 as a party on the Effective Date to an agreement set forth thereon has also collaborated with any other entity or person engaged in the out-licensing, commercial manufacture, sale, offer for sale, import for sale or export for sale of immunoglobulin or antibody phage display services, immunoglobulin or antibody phage display libraries, immunoglobulin or antibody phage display products or immunoglobulin or antibody phage display materials, including but not limited to those entities referred to in the immediately preceding sentence, then the release herein shall extend solely to the activities of such Third Party that are carried out pursuant to and in accordance with the agreement set forth on Schedule 2.8 to which it is a party as in effect on the Effective Date. The Release and the Third Party Release shall become irrevocable only upon receipt by XOMA of payment in full by MORPHOSYS of the amounts set forth in Section 3.1 and 3.3 and shall be revoked in their entirety and null and void ab initio , immediately and without further action of the parties, in the event such payment in full by MORPHOSYS is not received by XOMA on or prior to October 1, 2002, regardless of any payment received thereafter.

ARTICLE 3

 

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PAYMENTS

3.1. License Fee . In consideration for XOMA’s execution of this Agreement, MORPHOSYS shall pay XOMA a one time, non-refundable license fee of Four Million United States Dollars (US$4,000,000), which shall be considered as a fee for license from the Effective Date forward. This license fee shall be paid in one payment to XOMA and in no event later than October 1, 2002, provided that MORPHOSYS agrees to use commercially reasonable efforts to make such payment as soon as reasonably practicable.

3.2. Shares . (a) In full substitution for the payment obligations of MORPHOSYS pursuant to Section 3.1, MorphoSys may, until September 30, 2002, elect in its sole discretion to issue and transfer newly created MorphoSys shares (“New Shares”) to XOMA by using its authorized capital against contribution of the license granted in Section 2.1 of this Agreement (capital increase against contribution in kind). In this case, the Management Board (Vorstand) of MORPHOSYS will, with the approval of the Supervisory Board (Aufsichtsrat) of MORPHOSYS, resolve to issue the New Shares while excluding pre-emptive rights (the date of such resolution by the Management Board of MORPHOSYS, “Resolution Date”). The number of New Shares shall be calculated as follows:

 

US$4,800,000 converted into Euro according to the Exchange Rate

Relevant Share Price

; where,

Exchange Rate is the US$/Euro exchange rate published by Bloomberg one day prior to the Resolution Date;

Relevant Share Price is the price of MORPHOSYS shares traded on the Neuer Markt stock exchange as fixed in the Xetra afternoon auction (Xetra Nachmittagsauktion) one day prior to the Resolution Date; and

fractions of shares shall not be taken into account.

MORPHOSYS shall promptly notify XOMA of its election to issue New Shares. To the extent possible, MORPHOSYS will notify XOMA in advance of such decision. Subsequent to the resolution of the Management Board of MORPHOSYS to issue the New Shares, XOMA shall subscribe to the New Shares by executing a subscription certificate (Zeichnungsschein) in form and substance as attached hereto in Schedule 3.2.1. Pursuant to Sections 203,189 German Stock Corporation Act (AktG), the New Shares will come into existence upon registration with the Commercial Register. MORPHOSYS shall obtain such registration with the Commercial Register of Munich and shall obtain admission for trading of the New Shares at the Neuer Markt stock exchange as soon as reasonably practicable. XOMA shall use commercially reasonable

 

10


efforts to take all necessary steps and render all declarations necessary and appropriate to implement the transactions as described in this subparagraph.

(b) MORPHOSYS may, until September 30, 2002, elect to pay the license fee in part in cash (this cash component, the “Cash Component”) and in part in New Shares. In this case, Section 3.1 shall apply with respect to the payment of the Cash Component and this Section 3.2 shall apply with respect to the payment in New Shares; provided that the number of New Shares shall be calculated as follows:

 

(US$4,800,000 converted into Euro according to the

Exchange Rate - Cash Component)

Relevant Share Price

; where,

Exchange Rate is the US$/Euro exchange rate published by Bloomberg one day prior to the Resolution Date;

Relevant Share Price is the price of MORPHOSYS shares traded on the Neuer Markt stock exchange as fixed in the Xetra afternoon auction (Xetra Nachmittagsauktion) one day prior to the Resolution Date; and

fractions of shares shall not be taken into account.

(c) Attached hereto as Schedule 3.2.2 is a legal opinion of counsel of MorphoSys delivered to XOMA as of the date of this Agreement. If MorphoSys elects to pay the license fee in full or in part in New Shares pursuant to this Section 3.2, MORPHOSYS shall, upon registration of the New Shares with the Commercial Register, provide XOMA with an additional legal opinion of counsel of MORPHOSYS in form and substance as attached hereto in Schedule 3.2.3.

3.3. Release Payment . In consideration for the release provided by Section 2.8, MORPHOSYS shall pay XOMA a one time, non-refundable payment of One Million United States Dollars (US$1,000,000), which shall be applied retroactively as a fee for license from the first infringing use by MORPHOSYS through the Effective Date. This payment shall be paid within thirty (30) days of the receipt of a fully executed copy of the Agreement.

3.4. Milestones . Upon achievement of the following milestones with respect to each Product, MORPHOSYS shall pay XOMA the applicable milestone payments below:

 

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Event

   Payment  

Filing of an investigational new drug application or equivalent

   US$ 100,000   

First receipt of authorization or clearance to market

   US$ 250,000   

For the sake of clarity, it is understood that the foregoing milestone payments shall only be due with respect to any Product developed by or on behalf of MORPHOSYS or any joint venture or similar entity or arrangement in which MORPHOSYS is a participant.

3.5. Royalties . During the term of this Agreement, MORPHOSYS shall pay to XOMA a royalty in cash equal to [*] percent ([*] %) of the Net Sales of any Product(s) in each calendar quarter, commencing with the first calendar quarter ending after the Effective Date. Royalties due under this Article 3 shall be payable on a country-by-country and Product-by-Product basis from the first commercial sale of such Product until the expiration of the last-to-expire XOMA Patent Right in such country with respect to which a Valid Claim covers the manufacture, use, sale, offer for sale, import or export of such Product.

3.6. Commercially Reasonable Efforts . MORPHOSYS shall use commercially reasonable efforts to collect or receive any payments or other consideration due to it relating to any activities that would give rise to an obligation under Section 3.5.

3.7. Payments; Currency . All payments due hereunder shall be paid by wire transfer in United States dollars in immediately available funds to an account designated by XOMA. Payments required pursuant to Section 3.4 hereof shall be due and payable to XOMA when the corresponding milestone is achieved and shall be paid within thirty (30) days thereof. Payments required pursuant to Section 3.5 hereof shall be due and payable to XOMA when the corresponding Net Sales are recorded by MORPHOSYS (or any joint venture or similar entity in which MORPHOSYS is a participant) and shall be paid within thirty (30) days of the end of each calendar quarter. If any currency conversion shall be required in connection with the payment of any royalties hereunder, such conversion shall be made by using the exchange rate for the purchase of U.S. dollars quoted in the U.S. version of the Wall Street Journal on the last business day of the calendar quarter to which such payments relate.

3.8. Payment Reports . MORPHOSYS shall make a written report to XOMA within thirty (30) days of the achievement of each of the milestones set forth in Section 3.4 with respect to each Product, stating in each such report the Product to which such milestone relates and the specific milestone achieved, including the relevant agency or other regulatory body. After the first commercial sale of a Product on which royalties are required to be paid hereunder, MORPHOSYS shall make quarterly written reports to XOMA within sixty (60) days after the end of each calendar quarter, stating in each such report, by country, the number, description, and aggregate Net Sales of each Product sold during the calendar quarter. XOMA shall treat all

 

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such reports as Confidential Information of MORPHOSYS. Concurrently with the making of such reports, MORPHOSYS shall pay XOMA the amounts specified in Sections 3.4 and 3.5 hereof.

3.9. Payment Records and Inspection . MORPHOSYS shall keep complete, true and accurate books of account and records for the purpose of determining the amounts payable under this Agreement. Such books and records shall be kept at the principal place of business of MORPHOSYS for at least three (3) years following the end of the calendar quarter to which they pertain. Upon the written request of XOMA and not more than once in each calendar year, MORPHOSYS shall permit an independent certified public accounting firm of internationally recognized standing selected by XOMA and reasonably acceptable to MORPHOSYS, at XOMA’s expense, to have access during normal business hours to such of the records of MORPHOSYS as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any year ending not more than thirty-six (36) months prior to the date of such request. The accounting firm shall disclose to XOMA only the results and conclusions of its review and the specific details concerning any discrepancies. No other information shall be shared by the accounting firm without the prior consent of MORPHOSYS unless disclosure is required by law, regulation or judicial order. Inspections conducted under this Section 3.9 shall be at the expense of XOMA, unless an underpayment exceeding two percent (2%) of the amount stated for the full period covered by the inspection is identified, in which case all out-of-pocket costs relating to the inspection will be paid immediately by MORPHOSYS. Any underpayments or unpaid amounts discovered by such inspections or otherwise will be paid immediately by MORPHOSYS, with interest from the date(s) such amount(s) were due at a rate of one and one-half percent (1.5%) per month from the due date until paid in full.

3.10. No Admissions . The parties acknowledge and affirm that, as to any Third Party, the allocation of amounts set forth in Article 3 of this Agreement does not constitute an admission by either party either as to the damages actually suffered by XOMA with respect to any past infringement of the XOMA Patent Rights or respecting the calculation of a reasonable royalty by any court or trier of fact.

ARTICLE 4

CONFIDENTIALITY

4.1. Confidential Information . Except as expressly provided herein, the parties agree that, for the term of this Agreement and for ten (10) years thereafter, the receiving party shall keep completely confidential and shall not publish or otherwise disclose and shall not use for any purpose except for the purposes contemplated by this Agreement any Confidential Information furnished to it by the disclosing party hereto, except to the extent that it can be established by the receiving party by written proof that such Confidential Information:

(a) was already known to the receiving party, other than under an obligation of confidentiality, at the time of disclosure;

 

13


(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving party;

(c) became generally available to the public or otherwise part of the public domain after its disclosure other than through any act or omission of the receiving party in breach of this Agreement; or

(d) was subsequently lawfully disclosed to the receiving party by a person other than a party hereto.

4.2. Permitted Use and Disclosures . Each party hereto may use or disclose information disclosed to it by the other party to the extent such use or disclosure is reasonably necessary in complying with applicable law or government regulations or conducting clinical trials; provided , however , that if a party is required to make any such disclosure of another party’s Confidential Information, other than pursuant to a confidentiality agreement, it will give reasonable advance notice to the latter party of such disclosure and, will use its reasonable efforts to secure confidential treatment of such information prior to its disclosure (whether through protective orders or otherwise). Attached hereto as Schedule 4.2 is a redacted copy of this Agreement which MORPHOSYS shall be free, without obtaining any consent from XOMA, to provide to Third Parties who indicate an interest in becoming a MORPHOSYS Collaborator. In addition, MORPHOSYS shall be free, without obtaining any consent from XOMA, to provide to Third Parties who indicate an interest in becoming a MORPHOSYS Collaborator an oral summary of the provisions of Section 2.4(c) hereof and to provide the text thereof to Third Parties who actually become MORPHOSYS Collaborators.

4.3. Confidential Terms . Except as expressly provided herein, MORPHOSYS agrees not to disclose any terms of this Agreement to any Third Party without the consent of XOMA; provided , that disclosures may be made as required by securities or other applicable laws, or to a party’s accountants, attorneys and other professional advisors.

4.4 Agreement Announcement . The parties hereby agree to the release of a press release in the form attached hereto as Schedule 4.4 upon full execution of this Agreement and that the consummation of this Agreement, as well as such terms as are expressly described in such press release, shall be deemed to be in the public domain.

ARTICLE 5

REPRESENTATIONS AND WARRANTIES, ETC.

5.1. Representations and Warranties . (a) XOMA represents and warrants to MORPHOSYS that: (i) it is the sole and exclusive owner or exclusive licensee of all right, title and interest in the XOMA Patent Rights; (ii) XOMA has the legal right, authority and power to enter into this Agreement; (iii) this Agreement shall constitute a valid and binding obligation of XOMA enforceable in accordance with its terms; and (iv) the performance of obligations under

 

14


this Agreement by XOMA shall not result in a breach of any agreements, contracts or other arrangements to which it is a party.

(b) MORPHOSYS represents and warrants to XOMA that: (i) MORPHOSYS has the legal right, authority and power to enter into this Agreement; (ii) this Agreement shall constitute a valid and binding obligation of MORPHOSYS enforceable in accordance with its terms; and (iii) the performance of obligations under this Agreement by MORPHOSYS will not result in a breach of any agreements, contracts or other arrangements to which it is a party.

5.2. Disclaimer . Nothing in this Agreement is or shall be construed as:

(a) A warranty or representation by XOMA as to the validity or scope of any claim or patent within the XOMA Patent Rights;

(b) A warranty or representation that anything made, used, sold, or otherwise disposed of under any license granted in this Agreement is or will be free from infringement of any patent rights or other intellectual property right of any Third Party;

(c) An obligation to bring or prosecute actions or suits against Third Parties for infringement of any of the XOMA Patent Rights; or

(d) Granting by implication, estoppel, or otherwise any licenses or rights under patents or other rights of XOMA, MORPHOSYS or Third Parties, regardless of whether such patents or other rights are dominant or subordinate to any patent within the XOMA Patent Rights.

5.3. No Other Warranties . EXCEPT AS OTHERWISE SET FORTH IN SECTION 5.1 ABOVE, XOMA MAKES NO WARRANTIES WITH RESPECT TO ANY OF THE PATENT RIGHTS LICENSED HEREUNDER, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND XOMA SPECIFICALLY DISCLAIMS ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF SUCH PATENT RIGHTS OR NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.

5.4. Certain Agreements . MORPHOSYS represents and warrants that it has in its possession, and agrees that throughout the term of this Agreement and for a period of three (3) years thereafter it will maintain in an accessible location, true, complete and legible copies of each of the agreements set forth on Schedule 2.8 as in effect on the Effective Date, including all schedules, exhibits and other similar documents necessary for the correct interpretation of the provisions thereof.

ARTICLE 6

 

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INDEMNIFICATION

6.1. Indemnification . (a) MORPHOSYS agrees to indemnify, defend and hold XOMA and its directors, officers, employees and agents (the “ Indemnified Parties ” and each, an “ Indemnified Party ”) harmless from and against any and all liabilities, losses and expenses (including, without limitation, attorneys and professional fees and other costs of litigation), resulting from any claims, demands or causes of action by any party other than MORPHOSYS (each, a “ Liability ”) arising out of (i) the possession, manufacture, use, sale or other disposition of Product, Antibody Phage Display Materials, Licensed Immunoglobulin or the provisions of any service or goods relating thereto by MORPHOSYS or any customer, vendor or other representative of MORPHOSYS, whether based on breach of warranty, negligence, product liability or otherwise, (ii) the exercise of any right granted to MORPHOSYS pursuant to this Agreement or (iii) any claim by Biosite Incorporated, as set forth below in Section 6.1(b), except to the extent, in each case, that such Liability is caused by the gross negligence or willful misconduct of XOMA.

(b) Notwithstanding any other provision of this Agreement, any indemnification of XOMA by MORPHOSYS for any claim by Biosite shall only arise in the event that MORPHOSYS brings a claim against Biosite for damages arising out of Biosite’s license with MORPHOSYS, effective January 1, 2000, and as a result Biosite then brings a claim against XOMA for damages. MORPHOSYS’s liability under this Section 6.1(b) shall be limited to reasonable attorneys’ fees (in the event that MORPHOSYS does not assume the defense under Section 6.2(c)) and the actual amounts paid to Biosite attributable to MORPHOSYS’s claim against Biosite. MORPHOSYS’S INDEMNIFICATION UNDER THIS SECTION 6.1(B) SHALL NOT INCLUDE ANY INCIDENTAL AND CONSEQUENTIAL DAMAGES SUFFERED BY XOMA. MORPHOSYS EXPRESSLY DISCLAIMS ALL OTHER INDEMNIFICATION, EXPRESS OR IMPLIED, ON EITHER LEGAL OR EQUITABLE GROUNDS AS TO THE SUBJECT MATTER OF THIS SECTION 6.1(B).

6.2. Procedure . To receive the benefit of indemnification under Section 6.1, an Indemnified Party must (a) promptly notify MORPHOSYS in writing of a claim or suit; provided , that failure to give such notice shall not relieve MORPHOSYS of its indemnification obligations except where, and solely to the extent that, such failure actually and materially prejudices the rights of MORPHOSYS); (b) provide reasonable cooperation (at MORPHOSYS’s expense); and (c) tender to MORPHOSYS (and its insurer) full authority to defend or settle the claim or suit; provided that no settlement requiring any admission by the Indemnified Party or that imposes any obligation on the Indemnified Party shall be made without the Indemnified Party’s consent; and, provided , further that nothing herein shall be deemed to give MORPHOSYS any right to control any proceeding involving the XOMA Patent Rights or any claim XOMA may bring against any Third Party. MORPHOSYS shall not have any obligation of indemnification in connection with any settlement made without MORPHOSYS’s written consent. The Indemnified Party has the right to participate at its own expense in the claim or suit

 

16


and in selecting counsel therefor. The Indemnified Party shall cooperate with MORPHOSYS (and its insurer), as reasonably requested.

ARTICLE 7

TERM AND TERMINATION

7.1. Term . Subject to Sections 7.5 and 7.6 hereof, the term of this Agreement will commence on the Effective Date and remain in full force and effect until the expiration of the last patent within the XOMA Patent Rights, unless earlier terminated pursuant to Sections 7.2 or 7.3.

7.2. Termination Event . This Agreement may be terminated by either Party upon any material breach by the other Party of any material obligation or condition of the Agreement, effective fifteen (15) days after giving notice to the breaching party of such termination in the case of a payment breach and sixty (60) days after giving written notice to the breaching Party of such termination in the case of any other breach, which notice shall describe such breach in reasonable detail. The foregoing notwithstanding, if such breach is cured or shown to be non-existent within the aforesaid fifteen (15) or sixty (60) day period, the notice shall be deemed automatically withdrawn and of no effect and the notifying Party shall provide written notice to the breaching Party of the withdrawal.

7.3. Termination for Insolvency . If voluntary or involuntary proceedings by or against MORPHOSYS are instituted in bankruptcy under any insolvency law, or a receiver or custodian is appointed for MORPHOSYS, or proceedings are instituted by or against MORPHOSYS for corporate reorganization or the dissolution of MORPHOSYS, which proceedings, if involuntary, shall not have been dismissed within sixty (60) days after the date of filing, or if MORPHOSYS makes an assignment for the benefit of creditors, or substantially all of the assets of MORPHOSYS are seized or attached and not released within sixty (60) days thereafter, XOMA may immediately terminate this Agreement effective upon notice of such termination.

7.4. Effect of Termination . (a) Termination of this Agreement shall not release any party hereto from any liability which, at the time of such termination, has already accrued to the other party or which is attributable to a period prior to such termination nor preclude either party from pursuing any rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. It is understood and agreed that monetary damages may not be a sufficient remedy for any breach of this Agreement and that the non-breaching party may be entitled to injunctive relief as a remedy for any such breach. Such remedy shall not be deemed to be the exclusive remedy for any such breach of this Agreement, but shall be in addition to all other remedies available at law or in equity.

(b) Upon any termination of this Agreement, MORPHOSYS and XOMA shall promptly return to the other party all Confidential Information received from the other party

 

17


(except that each party may retain one copy for its files solely for the purpose of determining its rights and obligations hereunder).

(c) All licenses granted under Article 2 hereof shall terminate and be of no further effect upon the termination of this Agreement; provided , however , that any MORPHOSYS Collaborator that is the beneficiary of certain rights under this Agreement shall maintain such rights, notwithstanding the termination of this Agreement, provided that such MORPHOSYS Collaborator complies with the applicable provisions of this Agreement.

7.5. Survival . Sections 2.5, 2.6, 2.7, 3.4, 3.5, 3.7, 3.8, 3.9, 3.10, 7.4 and 7.5, and Articles 4, 5, 6 and 8 of this Agreement shall survive any termination hereof.

7.6. Contested Validity . If MORPHOSYS or a MORPHOSYS Collaborator knowingly contests, directs another to contest or assists another in contesting the validity or enforceability of any of the XOMA Patent Rights licensed hereunder, XOMA shall have the right to terminate all of the rights and licenses hereby granted to MORPHOSYS and any MORPHOSYS Collaborator under the XOMA Patent Rights; provided , however , that in the event a MORPHOSYS Collaborator knowingly contests, directs another to contest or assists another in contesting the validity or enforceability of any of the XOMA Patent Rights licensed hereunder other than at the direction, and without the knowing assistance or other involvement (other than as required by law or court order), of MORPHOSYS, then the foregoing termination right of XOMA shall apply only to the rights hereby granted to such MORPHOSYS Collaborator.

ARTICLE 8

MISCELLANEOUS PROVISIONS

8.1. Governing Laws . This Agreement and any dispute, including without limitation any arbitration, arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the laws of the state of California, without reference to conflicts of laws principles.

8.2. Assignment . Neither party may transfer or assign this Agreement, directly or indirectly, or any of its rights hereunder, other than to one or more Affiliates and other than to a successor of XOMA Ltd. under a Change in Control of XOMA Ltd. or to a successor of MorphoSys AG under a Change in Control of MorphoSys AG to which Section 8.3 does not apply, without the prior written consent of the other party. Any such attempted transfer or assignment in violation of this Section 8.2 shall be void; provided , that in the event of a permitted Change in Control, the original party’s (or its successor’s) obligations hereunder shall continue. This Agreement shall be binding upon and inure to the benefit of the parties and their permitted successors and assigns.

 

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8.3. Certain Changes in Control . Notwithstanding any other provision of this Agreement to the contrary, this Agreement shall automatically terminate, without further action by the parties, in the event of (a) a transaction or series of related transactions in which Affitech AS, BioInvent Therapeutic AB, Biosite Incorporated, Cambridge Antibody Technology Limited, Crucell N.V., Dyax Corporation or any entity or person whose principal business is, or who has a substantial business in, the out-licensing, commercial manufacture, sale, offer for sale, import for sale or export for sale of immunoglobulin or antibody phage display services, immunoglobulin or antibody phage display libraries, immunoglobulin or antibody phage display products or immunoglobulin or antibody phage display materials is a party and which results in a Change in Control of MORPHOSYS, or (b) a transaction or series of related transactions in which MORPHOSYS is a party and which results in a Change in Control of a person or entity described in clause (a) above.

8.4. Waiver . No waiver of any rights shall be effective unless consented to in writing by the party to be charged and the waiver of any breach or default shall not constitute a waiver of any other right hereunder or any subsequent breach or default.

8.5. Severability . In the event that any provisions of this Agreement are determined to be invalid or unenforceable by a court of competent jurisdiction, the remainder of the Agreement shall remain in full force and effect without said provision.

8.6. Notices . All notices, requests and other communications hereunder shall be in writing and shall be delivered or sent in each case to the respective address specified below, or such other address as may be specified in writing to the other party hereto, and shall be effective on receipt:

 

MORPHOSYS:    MorphoSys AG
   Lena-Christ-Str. 48
   82152 Martinsried/Planegg
   Germany
   Attn:  General Counsel
with a copy (which shall not constitute notice) to:
   MorphoSys USA, Inc.
   5605 Carnegie Blvd., Suite 275
   Charlotte, NC 28209
   U.S.A.
   Attn:  President

 

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XOMA:    XOMA Ireland Limited
   Shannon Airport House
   Shannon, County Clare
   Ireland
   Attn:  Company Secretary
with a copy (which shall not constitute notice) to:
   XOMA (US) LLC
   2910 Seventh Street
   Berkeley, CA 94710
   U.S.A.
   Attn:  Company Secretary

8.7. Independent Contractors . Both parties are independent contractors under this Agreement. Nothing contained in this Agreement is intended nor is to be construed so as to constitute XOMA or MORPHOSYS as partners or joint venturers with respect to this Agreement. Except as expressly provided herein, neither party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other party or to bind the other party to any other contract, agreement, or undertaking with any third party.

8.8. Compliance with Laws . In exercising their rights under this license, the parties shall comply in all material respects with the requirements of any and all applicable laws, regulations, rules and orders of any governmental body having jurisdiction over the exercise of rights under this Agreement. MORPHOSYS shall be responsible, at its expense, for making any required registrations or filings with respect to this Agreement and obtaining any necessary governmental approvals with respect hereto.

8.9. Bankruptcy . All rights and licenses granted under or pursuant to this Agreement by one party to the other are, for all purposes of Section 365(n) of Title XI of the United States Code (“Title XI”), licenses of rights to “intellectual property” as defined in Title XI. During the term of this Agreement each party shall create and maintain current copies to the extent practicable of all such intellectual property. If a bankruptcy proceeding is commenced by or against one party under Title XI, the other party shall be entitled to a copy of any and all such intellectual property and all embodiments of such intellectual property, and the same, if not in the possession of such other party, shall be promptly delivered to it (a) upon such party’s written request following the commencement of such bankruptcy proceeding, unless the party subject to such bankruptcy proceeding, or its trustee or receiver, elects within thirty (30) days to continue to perform all of its obligations under this Agreement, or (b) if not delivered as provided under clause (a) above, upon such other party’s request following the rejection of this Agreement by or on behalf of the party subject to such bankruptcy proceeding. If a party has taken possession of all applicable embodiments of the intellectual property of the other party pursuant to this Section 8.9 and the trustee in bankruptcy of the other party does not reject this Agreement, the party in

 

20


possession of such intellectual property shall return such embodiments upon request. If a party seeks or involuntarily is placed under Title XI and the trustee rejects this Agreement as contemplated under 11 U.S.C. 365(n)(1), the other party hereby elects, pursuant to Section 365(n) of Title XI, to retain all rights granted to it under this Agreement to the extent permitted by law.

8.10. Use of Name . Neither party shall use the name or trademarks of the other party, except to the extent that a party is permitted to use the Confidential Information of the other party pursuant to Article 4, without the prior written consent of such other party.

8.11. Further Actions . Each party agrees to execute, acknowledge and deliver such further instruments, and do such other acts, as may be necessary and appropriate in order to carry out the purposes and intent of this Agreement.

8.12. Entire Agreement; Amendment . This Agreement constitutes the entire and exclusive Agreement between the parties with respect to the subject matter hereof and supersedes and cancels all previous discussions, agreements, commitments and writings in respect thereof. No amendment or addition to this Agreement shall be effective unless reduced to writing and executed by the authorized representatives of the parties.

8.13. Arbitration . (a) Solely with respect to any dispute between the parties to this Agreement (other than any dispute which arises out of or relates to infringement, validity and/or enforceability of the XOMA Patent Rights) upon ten (10) days written notice, any party involved in the dispute may initiate arbitration by giving notice to that effect to the other party or parties involved in the dispute and by filing the notice with the American Arbitration Association or its successor organization (“ AAA ”) in accordance with its Commercial Arbitration Rules. Such dispute shall then be settled by arbitration in New York, New York, in accordance with the Commercial Arbitration Rules of the AAA or other rules agreed to by the parties involved in the dispute, by a panel of three neutral arbitrators, who shall be selected by the parties involved in the dispute using the procedures for arbitrator selection of the AAA.

(b) The parties acknowledge that this Agreement evidences a transaction involving interstate commerce. Insofar as it applies, the United States Arbitration Act shall govern the interpretation of, enforcement of, and proceedings pursuant to the arbitration clause in this Agreement. Except insofar as the United States Arbitration Act applies to such matters, the agreement to arbitrate set forth in this Section 8.13 shall be construed, and the legal relations among the parties shall be determined in accordance with, the substantive laws of the State of New York.

(c) The panel shall render its decision and award, including a statement of reasons upon which such award is based, within thirty (30) days after the arbitration hearing. The decision of the panel shall be determined by majority vote among the arbitrators, shall be in writing and shall be binding upon the parties involved in the dispute, final and non-appealable.

 

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Judgment upon the award rendered by the panel may be entered in any court having jurisdiction thereof in accordance with Section 8.14(a).

(d) Except as provided under the United States Arbitration Act, no action at law or in equity based upon any dispute that is subject to arbitration under this Section 8.13 shall be instituted.

(e) All expenses of any arbitration pursuant to this Section 8.13, including fees and expenses of the parties’ attorneys, fees and expenses of the arbitrators, and fees and expenses of any witness or the cost of any proof produced at the request of the arbitrators, shall be paid by the non-prevailing party.

8.14. Venue; Jurisdiction . (a) Any action or proceeding brought by either party seeking to enforce any provision of, or based on any right arising out of, this Agreement must be brought against any of the parties in the courts of the State of New York. Each party (i) hereby irrevocably submits to the jurisdiction of the state courts of the State of New York and to the jurisdiction of any United States District Court in the State of New York, for the purpose of any suit, action, or other proceeding arising out of or based upon this Agreement or the subject matter hereof brought by any party or its successors or assigns, (ii) hereby waives, and agrees not to assert, by way of motion, as a defense, or otherwise, in any such suit, action, or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action, or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court, and (iii) hereby waives and agrees not to seek any review by any court of any other jurisdiction that may be called upon to grant an enforcement of the judgment of any such New York state or federal court.

(b) Process in any action or proceeding seeking to enforce any provision of, or based on any right arising out of, this Agreement may be served on any party anywhere in the world. Each party consents to service of process by registered mail at the address to which notices are to be given and further consent that any service of process, writ, judgment or other notice of legal process shall be deemed and held in every respect to be effectively served upon it in connection with proceedings in the State of New York, if delivered to CT Corporation System, whose current address is 111 Eighth Avenue, 13th Floor, New York, New York 10011, which each party irrevocably designates and appoints as its authorized agent for the service of process in the courts in the State of New York. Nothing herein shall affect the right of a party to serve process in any other manner permitted by applicable law. Each party further agrees that final judgment against it in any such action or proceeding arising out of or relating to this Agreement shall be conclusive and may be enforced in any other jurisdiction within or outside the United States of America by suit on the judgment, a certified or exemplified copy of which shall be conclusive evidence of the fact and of the amount of its liability.

 

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(c) Each party agrees that it shall not, and that it shall instruct those in its control not to, take any action to frustrate or prevent the enforcement of any writ, decree, final judgment, award (arbitral or otherwise) or order entered against it with respect to this Agreement or the XOMA Patent Rights and shall agree to be bound thereby as if issued or executed by a competent judicial tribunal having personal jurisdiction situated in its country of residence or domicile.

8.15. Force Majeure . Neither party shall be liable for failure of or delay in performing obligations set forth in this Agreement, and neither shall be deemed in breach of its obligations, if such failure or delay is due to natural disasters or any causes beyond the reasonable control of such party. In event of such force majeure, the party affected thereby shall use reasonable efforts to cure or overcome the same and resume performance of its obligations hereunder.

8.16. 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.

 

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IN WITNESS WHEREOF, XOMA and MORPHOSYS have executed this Agreement in duplicate originals by duly authorized officers.

 

MORPHOSYS AG     XOMA IRELAND LIMITED
By:  

 

    By:  

 

  Name:       Alan Kane, Director
  Title:       duly authorized for and on behalf of XOMA Ireland Limited in the presence of:
By:  

 

     

 

  Name:      
  Title:      

 

24


Schedule 1.17

Patent Rights

 

Title :   Modular Assembly of Antibody Genes, Antibodies Prepared Thereby and Use

 

Inventors :   Robinson, Liu, Horwitz, Wall, Better

 

1) Based on PCT/US86/02269, which is a continuation-in-part of U.S. Serial No. 06/793,980 filed November 1, 1985 (abandoned).

 

COUNTRY

  

SERIAL NO.

  

PATENT NO.

*United States

   06/793,980   

Australia

   65981/86    Issued 606,320

Canada

   521,909    Abandoned

Denmark

   3385/87    Pending

Taiwan

   75105650    Issued 51922

*United States

   06/086,266   

 

2) Based on PCT/US88/02514, which corresponds to U.S. Serial No. 07/077,528, which is a continuation-in-part of 06/086,266 (abandoned), which is a continuation-in-part of U.S. Serial No. 06/793,980 (abandoned).

 

COUNTRY

  

SERIAL NO.

  

PATENT NO.

Australia

   23244/88    Issued 632,462

Austria

   EP 88907510.7    Granted EP/0371998

Belgium

   EP 88907510.7    Granted EP/0371998

Canada

   572,398    Pending

Denmark

   192/90    Pending

Europe

   EP 88907510.7    Granted EP/0371998

Europe

   EP 95119798.7    Granted EP/0731167

France

   EP 88907510.7    Granted EP/0371998

Germany

   EP 88907510.7    Granted EP/0371998

Italy

   EP 88907510.7    Granted EP/0371998

Japan

   506481/88    Granted 2991720

Luxembourg

   EP 88907510.7    Granted EP/0371998

Netherlands

   EP 88907510.7    Granted EP/0371998

Sweden

   EP 88907510.7    Granted EP/0371998

Switzerland/Liechtenstein

   EP 88907510.7    Granted EP/0371998

United Kingdom

   EP 88907510.7    Granted EP/0371998

COUNTRY

  

SERIAL NO.

  

PATENT NO.

Europe

   EP 93100041.8    Granted EP/0550400

Austria

   EP 93100041.8    Granted EP/0550400

Belgium

   EP 93100041.8    Granted EP/0550400

 

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France

   EP 93100041.8    Granted EP/0550400

Germany

   EP 93100041.8    Granted EP/0550400

Italy

   EP 93100041.8    Granted EP/0550400

Luxembourg

   EP 93100041.8    Granted EP/0550400

Netherlands

   EP 93100041.8    Granted EP/0550400

Sweden

   EP 93100041.8    Granted EP/0550400

Switzerland/Liechtenstein

   EP 93100041.8    Granted EP/0550400

United Kingdom

   EP 93100041.8    Granted EP/0550400

*United States

   07/077,528   

 

3) Based on U.S. Serial No. 07/501,092 filed March 29, 1990, which is a continuation-in-part of U.S. Serial No. 07/077,528 (Modular Assembly of Antibody Genes, Antibodies Prepared Thereby and Use; Robinson, Liu, Horwitz, Wall, Better) and of U.S. Serial No. 07/142,039 (Novel Plasmid Vector with Pectate Lyase Signal Sequence; Lei, Wilcox).

 

COUNTRY

  

SERIAL NO.

  

PATENT NO.

*United States

   07/501,092   

*United States

   07/987,555   

*United States

   07/870,404   

*United States

   08/020,671   

United States

   08/235,225    5,618,920

United States

   08/299,085    5,595,898

United States

   08/357,234    5,576,195

United States

   08/472,696    5,846,818

United States

   08/472,691    6,204,023

United States

   08/467,140    5,698,435

United States

   08/450,731    5,693,493

United States

   08/466,203    5,698,417

 

* Cases abandoned in favor of a continuing application.

 

2


Schedule 2.4

Form of Notice

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Schedule 2.8

MorphoSys Partnerships

[***]

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONFIDENTIAL

APPENDIX 4.5(b)

REDACTED COPY OF THE CAT LICENSE AGREEMENT

(4 pages attached hereto)


CONFIDENTIAL

CAT Covenant not to sue for MorphoSys Partners:

Relevant Excerpts from CAT — MorphoSys “Framework Agreement”

ARTICLE III

Settlement Agreement / Covenant not to sue

 

3.01 <redacted>

 

3.02 CAT covenants that it shall not assert, nor shall it permit any third party that obtains a right to enforce any CAT Patent Rights as defined in Appendix 3.02 hereto to assert, a claim of infringement under the CAT Patent Rights solely in respect of MORPHOSYS GOLD Activities as defined in Appendix 3.02 hereto against MORPHOSYS, or any company affiliated with MORPHOSYS within the meaning of Sections 15 ff. German Stock Corporation Law (any such company, a “ MORPHOSYS Affiliate ”), or any MORPHOSYS Partner as defined in Appendix 3.02 hereto as further provided in Article 3 and Appendix B-1 of the Settlement Agreement (the “ Covenant ”). The Covenant shall be irrevocable unless CAT terminates the Covenant in accordance with the following provisions:

 

3.03 CAT may terminate the Covenant by written notice if and only if

 

  (a) MORPHOSYS is in Material Breach (as defined hereinafter) of this Agreement; and

 

  (b) CAT has given written notice of the Material Breach to MORPHOSYS, with a specific description of the Material Breach. Such notice shall provide sufficient detail to MORPHOSYS to understand the full basis of the Material Breach and the cure demanded by CAT; and

 

  (c) MORPHOSYS has not cured the Material Breach within forty five (45) days after receipt of the notice according to Subsection (b) above (the “Cure Period”).

 

3.04 Subject to mandatory German law, CAT may terminate the Covenant by written notice if a petition for insolvency against MORPHOSYS has been filed by MORPHOSYS or a third party and within three months from the filing of such petition, the petition has (i) neither been withdrawn, nor (ii) been dismissed by the court other than on the ground of the lack of assets (Abweisung mangels Masse). This shall not apply if Morphosys has elected the Buy-Out-Option (as defined hereinafter) and made the Buy-Out Payment (as defined hereinafter) prior to termination. Within three months after the termination, MORPHOSYS shall have the option to reinstate the Covenant in return for the payment of the Buy-Out-Payment.

 

3.05

In the event that CAT terminates the Covenant pursuant to this Article III, MORPHOSYS shall notify CAT within ten (10) days of all MORPHOSYS Partners and within thirty (30) days thereafter, CAT shall commence negotiations with such MORPHOSYS


CONFIDENTIAL

 

  Partners to grant them a continuation of the Covenant on commercially reasonable terms. CAT shall pursue such negotiations in good faith.

 

3.06 The Covenant shall extend to a third party to whom MORPHOSYS has transferred all or substantially all of the HUCAL GOLD Assets as defined in Appendix 3.02 hereto including, without limitation, transfers by way of assignment and exclusive license if

 

  (a) the third party acquiring the HUCAL GOLD Assets (the “Acquiror”) executes an agreement between MORPHOSYS, CAT and the Acquiror according to which (i) the Acquiror will be bound by all provisions of this Agreement from the day of transfer of the HUCAL GOLD Assets (the “Asset Transfer Date”), except for Articles I, II and IV hereof and (ii) MORPHOSYS shall remain to be bound by all provisions of this Agreement except for the forbearance covenant referred to in Article VI hereof from the Asset Transfer Date. MORPHOSYS shall also be jointly and severally liable for the payment of the covenant fees pursuant to Article V hereof by the Acquiror; and

 

  (b) MORPHOSYS does not continue the MORPHOSYS GOLD Activities except under a license from the Acquiror.

 

3.07 For the purpose of this Agreement, a material breach Material Breach”) shall have occurred if and only if MORPHOSYS

 

  (a) fails to make a payment of more than Euro [***] under Article IV hereof when due; or

 

  (b) subject to the provisions of Section 3.08 below, fails to make a payment of more than Euro [***] under Article V hereof when due; or

 

  (c) enters into an opposition to and/or appeal from any decision of any patent authority of any country relating to a CAT Patent Right or otherwise contests in any court in any country a patent, patent application or claim thereof that is part of the CAT Patent Rights (each a “Challenge of a CAT Patent Right”), or if MORPHOSYS knowingly assists any third party in the Challenge of a CAT Patent Right provided, however, that this shall not apply if MORPHOSYS, complying with an obligation imposed on it under due process of law engages in Challenges of a CAT Patent Right.

 

3.08 A Material Breach according to Subsection 3.07 (b) above shall be deemed not to have occurred if and to the extent that MORPHOSYS claims in writing within the Cure Period that the revenue payments demanded by CAT are not due under Article V hereof because the revenues demanded by CAT have not been based on MORPHOSYS GOLD Activities stating the reasons for such claim unless an Expert Panel (as defined hereinafter) has decided that the revenue payments demanded by CAT (in whole or in part) were based on MORPHOSYS GOLD Activities.

 

3.09 In the event that a MORPHOSYS Partner should engage in the Challenge of a CAT Patent Right or knowingly assist any third party in the Challenge of a CAT Patent Right,

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONFIDENTIAL

 

  CAT may terminate the Covenant with regard to such MORPHOSYS Partner provided, however, that this shall not apply if such MORPHOSYS Partner is complying with an obligation imposed on it under due process of law.

 

3.10 Any termination of the Covenant according to this Article III shall not extend to MORPHOSYS GOLD Activities in relation to any MORPHOSYS GOLD Antibody, as defined in Appendix 3.02, where such MORPHOSYS GOLD Antibody was identified prior to the termination.

 

3.11 CAT grants to MORPHOSYS an additional irrevocable covenant not to sue with respect to the [***] as further provided in Article 3, Appendix B-3 of the Settlement Agreement. Section 3.06 hereof shall also apply with respect to the [***]

Excerpt from “Appendix 3.02” to Framework Agreement

Alternative Selection ” shall mean any selection technology for the selection of Antibodies from libraries of Antibodies, including but not limited to MORPHOSYS CysDisplay, but specifically excluding (i) display on filamentous bacteriophage wherein the Antibody is genetically fused to a bacteriophage surface component and (ii) ribosome/polysome display.

Antibody ” shall mean a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications, or derivatives thereof, but excluding single variable domains (heavy or light) of such antibodies.

CAT Patent Rights ” shall mean arising out of or related to the “Patent Rights” identified, described, designated and included in the June 25, 1999 Settlement agreement between CAT, the Medical Research Council (“ MRC ”), The Scripps Research Institute (“ TSRI ”) and Stratagene (“ STRATAGENE ”), as well as all patents and patent applications (including but not limited to any reissues, reexaminations, extensions or substitutions) throughout the world (i) claiming priority to, or benefit under the Paris Convention and/or any applicable rules, laws or statutes of any country (including without limitation 35 USC §119 or §120) of, any of the following PCT applications: [***] , or (ii) claiming priority to, or benefit under the Paris Convention and/or any applicable rules, laws or statutes of any country (including without limitation 35 USC §119 or §120) of, any of the priority applications to which the foregoing PCT applications claim priority.

HUCAL GOLD Assets ” shall mean HuCAL GOLD Libraries as well as such MORPHOSYS patent rights and other intellectual property rights of MORPHOSYS that are required to practice MORPHOSYS GOLD Activities.

MORPHOSYS CysDisplay ” shall mean the display of a protein or polypeptide [***]

MORPHOSYS GOLD Activities ” shall mean

(i) all prior, present or future activities by either MORPHOSYS or a MORPHOSYS Partner relating to the making, using, selling, licensing, offering for sale or license, testing, importing, exporting or otherwise transferring to any third party any prior, existing or future

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONFIDENTIAL

 

HuCAL library using Alternative Selection, the library being based on HuCAL consensus sequences and being the result of CDR diversification of at least two CDR regions in the heavy amino acid chain (the “ HuCAL GOLD Library ”), and shall furthermore mean the making, using, selling, offering for sale or license, testing importing, exporting or otherwise transferring to any third party of any MORPHOSYS GOLD Antibody obtained from such libraries, and of any optimized or modified derivative thereof, provided that any optimization is performed by using Alternative Selection and does not involve the creation of a library of diverse CDR3 regions in an otherwise invariant VH gene.

(ii) all prior, present or future activities by either MORPHOSYS or a MORPHOSYS Partner relating to the making, using, selling, licensing, offering for sale or license, testing, importing, exporting or otherwise transferring to any third party of any HuCAL Antibody, including any optimized or modified derivative thereof, provided that such Antibody was obtained from MORPHOSYS HuCAL Fab-1 or HuCAL Fab-2 prior to September 18, 2001, and provided that any optimization after the Commencement Date (as defined in the License Agreement) is performed by using Alternative Selection and does not involve the creation of a library of diverse CDR3 regions in an otherwise invariant VH gene.

MORPHOSYS GOLD Antibody ” shall mean an antibody, in any form (including a fragment), obtained by MORPHOSYS GOLD Activities.

MORPHOSYS Partner ” shall mean any person or entity (including a corporation or an academic not for profit institution or a foreign equivalent) who is licensed by MORPHOSYS to engage in MORPHOSYS GOLD Activities and is using or MORPHOSYS is using on its behalf a HuCAL GOLD Library made by MORPHOSYS in connection with such activities.


CONFIDENTIAL

APPENDIX 4.5(c)

REDACTED COPY OF THE AME SUBLICENSE AGREEMENT

(37 pages attached hereto)


EXECUTION COPY (Redacted Version)    CONFIDENTIAL

SUBLICENSE AGREEMENT

THIS SUBLICENSE AGREEMENT (this “Agreement”) dated as of September 23, 2005 (the “Effective Date”), is entered into between Applied Molecular Evolution, Inc., having a place of business at 3520 Dunhill Street, San Diego, California 92121, U.S.A., along with its Affiliates and assigns, including but not limited to Eli Lilly and Company (“Lilly”) (collectively herein “AME”) and MorphoSys AG, a German corporation, along with its Affiliates and assigns, having a place of business at Lena-Christ-Str. 48, 82152 Martinsried/Planegg, Germany (collectively herein “MorphoSys”). AME and MorphoSys may be referred to herein individually as a “Party” or jointly as “Parties.”

WHEREAS AME is the exclusive licensee of the AME Patent Rights (as defined below) pursuant to the Kauffman Agreement (as defined below).

WHEREAS AME desires to grant to MorphoSys a non-exclusive sublicense with a limited right to further sublicense, pursuant to settlement of a patent infringement lawsuit filed by AME[Redacted].

NOW, THEREFORE, in consideration of the promises and the mutual covenants hereinafter recited, AME and MorphoSys hereby agree as follows:

 

1. DEFINITIONS

For purposes of this Agreement, the following terms shall have the respective meanings set forth below. The plural form of each definition shall have the correlative meaning:

1.1 “ Affiliate ” shall mean, with respect to a Party, any entity directly or indirectly controlling or controlled by or in common control with such Party, where “control” is defined as the ownership of at least fifty percent (50%) of the equity or beneficial interests of such entity, or the right to vote for or appoint a majority of the board of directors or other governing body of such entity.

1.2 “ AME Patent Rights ” shall mean (i) United States Patent Nos. [***] ; (ii) any patent applications claiming priority to any of the patent applications that issued as the preceding patents under (i), including any divisions, continuations, continuations-in-part and substitutions of the preceding; (iii) any patents that issue on any of the preceding patent applications, including any reissued patents, re-examined patents, divisions, renewals, continuations, continuations-in-part, substitutions, extensions, and (iv) any foreign counterparts of any of the preceding.

1.3 “ Antibody ” shall mean a whole antibody (including without limitation a murine, chimeric, humanized, human sequence, recombinant, transgenic, grafted and single chain antibody and the like), or any fragment thereof.

1.4 “ Derived ” shall mean obtained, developed, created, synthesized, designed or resulting from, based upon or otherwise generated (whether directly or indirectly, or in whole or in part, in one or more steps).

[***] Certain information in this document 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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1.5 “ Collaboration Agreement ” shall mean a bona-fide, arms length agreement between MorphoSys and a Third Party, pursuant to which MorphoSys and/or such Third Party (alone or together) engage in the research, identification, characterization, development and/or optimization of proteins, peptides or polypeptides.

1.6 “ Collaboration Partner ” shall mean a Third Party that is a party to an executed Collaboration Agreement.

1.7 “ HuCAL Antibody ” shall mean, individually and collectively, (a) an Antibody that is selected from a HuCAL Library (including [Redacted]), and (b) an Antibody Derived from the nucleotide sequence encoding, or amino acid sequence of, an Antibody described in clause 1.7(a) above.

1.8 “ HuCAL Library ” shall mean any of the human combinatorial antibody libraries as further described in Appendix B, as well as any library of synthetic Antibodies comprising modular regions developed by MorphoSys.

1.9 [Redacted]

1.10 “ Kauffman Agreement ” shall mean that certain license agreement between AME and Stuart Kauffman dated November 3, 1994, as amended on June 22, 2001, and January 8, 2004, redacted copies of which are attached as Appendix C hereto.

1.11 “ Third Party ” shall mean any entity other than MorphoSys or AME.

1.12 [Redacted]

1.13 [Redacted]

 

2. LICENSE GRANTS

2.1 License Grant to MorphoSys

2.1.1 AME hereby grants to MorphoSys a non-exclusive, non-transferable, worldwide, non-royalty-bearing sublicense (with a limited right to grant further sublicenses as provided herein) under the AME Patent Rights to make (including have made on behalf of MorphoSys), use, sell, offer to sell, develop (including have developed on behalf of MorphoSys), and import HuCAL Libraries (including [Redacted]) and [Redacted]

2.1.2 AME hereby grants to MorphoSys a non-exclusive, non-transferable, worldwide, non-royalty-bearing sublicense (with the limited right to grant further sublicenses as provided herein) under the AME Patent Rights to make (including have made on behalf of MorphoSys), use, sell, offer to sell, and import HuCAL Antibodies and [Redacted].

 

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2.2 No Implied Licenses . No rights or licenses with respect to the intellectual property rights owned or controlled by AME shall be deemed granted hereunder, other than those rights expressly granted in this Agreement.

2.3 Sublicenses . MorphoSys may further sublicense the AME Patent Rights to Collaboration Partners only to the extent necessary to make (including have made), use, sell, offer to sell, and import HuCAL Libraries, [Redacted], HuCAL Antibodies, and [Redacted] and for no other purpose[Redacted]. On a quarterly basis after the Effective Date, MorphoSys shall give AME written notice of each sublicense executed under this Agreement during the previous quarter. Each permitted sublicensee shall be subject to the applicable terms and conditions of this Agreement. Two examples of an acceptable form of a sublicense are provided as Appendices D-1 and D-2. The Parties agree that other forms of a sublicense also may be acceptable.

2.4 Kauffman Agreement Obligations .

2.4.1 Subject to Sections 2.4.2 and 6.2, MorphoSys hereby acknowledges that the licenses granted to it in Section 2.1 and 2.3 are subordinate to the Kauffman Agreement. MorphoSys shall be responsible for the compliance of its sublicensees with the terms of this Agreement and the terms of the Kauffman Agreement to the extent applicable.

2.4.2 AME agrees not to terminate, amend, or modify the Kauffman Agreement in any way, whether directly or indirectly, which would restrict or narrow the scope of MorphoSys’ rights under this Agreement, or which would impose additional obligations upon MorphoSys or its sublicensees permitted under this Agreement. AME has not committed, and agrees that it will not commit, any act or omission that would cause Stuart Kauffman, or any successor or assigns of his rights in the Kauffman Agreement, to terminate, amend, or modify the Kauffman Agreement in any way, whether directly or indirectly, which would restrict or narrow the scope of MorphoSys’ or its sublicensees’ rights under this Agreement, or which would impose additional obligations upon MorphoSys or its sublicensees under this Agreement.

 

3. PATENT MATTERS

3.1 Patent Prosecution and Enforcement . Nothing in this Agreement shall be construed as limiting the rights granted to AME pursuant to the Kauffman Agreement. AME shall continue to have the right but not the obligation to prosecute, maintain, and enforce all AME Patent Rights in any jurisdiction.

3.2 Patent Challenges . MorphoSys agrees to withdraw from, and cease any direct or indirect participation in, any existing oppositions, revocations, or litigation relating to the AME Patent Rights within fifteen (15) days from the Effective Date. Except as required by any applicable law, regulation or court order, MorphoSys agrees to refrain from any direct or indirect participation in future oppositions, revocations, or litigation relating to the AME Patent Rights.

 

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EXECUTION COPY (Redacted Version)    CONFIDENTIAL

 

4. CONSIDERATION

[Redacted]

 

5. CONFIDENTIALITY.

Neither Party shall disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other Party; provided that AME may disclose the terms of this Agreement under an appropriate confidentiality agreement to Stuart Kauffman, and MorphoSys may disclose the terms of this Agreement, including providing a copy of the redacted Kauffman Agreement attached hereto as Appendix C, under an appropriate confidentiality agreement to any sublicensee and prospective sublicensee with all payment terms redacted, and either party may disclose the terms of this agreement to its attorneys and financial auditors and advisors on a need-to-know basis under an appropriate confidentiality agreement. Further, each Party may disclose this Agreement and/or its terms only to the extent required by applicable security laws or other applicable law or regulation.

 

6. REPRESENTATIONS AND WARRANTIES

6.1 Both Parties . Each Party represents and warrants to the other that such Party (a) is a corporation duly organized, validly existing and in good standing under the laws of the state in which it is incorporated; (b) has the corporate power and authority and the legal right to own and operate its property and assets, to lease the property and assets it operates under lease, and to carry on its business as it is now being conducted; (c) is in compliance with all requirements of applicable law, except to the extent that any noncompliance would not have a material adverse effect on the properties, business, financial or other condition of it and would not materially adversely affect its ability to perform its obligations under this Agreement; and (d) has obtained all necessary consents, approvals and authorizations of all governmental authorities and other persons required to be obtained by such Party in connection with this Agreement.

6.2 AME . AME hereby represents and warrants to MorphoSys as of the Effective Date that (i) it has the full right and authority to enter into this Agreement and grant the rights and licenses granted herein; and (ii) it will not grant during the term of the Agreement, any right, license or interest in or to the AME Patent Rights that are in conflict with the licenses granted to MorphoSys. AME further represents and warrants to MorphoSys that, as of the Effective Date, the Kauffman Agreement is in full force and effect and that MorphoSys and its sublicensees permitted under the Agreement are entitled to enjoy the rights and benefits of sublicensees under the Kauffman Agreement only with respect to the licenses granted by AME to MorphoSys hereunder.

6.3 Disclaimer of Warranty .

Nothing in this Agreement shall be construed as:

(a) a warranty or representation by a Party as to the validity or scope of any patent rights owned or controlled by such Party; or

 

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EXECUTION COPY (Redacted Version)    CONFIDENTIAL

 

(b) a warranty or representation that anything made, used, sold or otherwise disposed of under any license granted in this Agreement is or will be free from infringement of patent or other intellectual property rights of Third Parties; or

(c) conferring the right to use in advertising, publicity or otherwise any trademark, trade name, or names, or any contraction, abbreviation, simulation or adaptation thereof, of either Party; or

(d) an obligation to bring or prosecute actions or suits against Third Parties for infringement of the AME Patent Rights.

Neither Party makes any representations other than those expressly set forth in this Article 6. EACH PARTY EXPRESSLY DISCLAIMS ALL OTHER REPRESENTATIONS, WARRANTIES AND CONDITIONS, EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, REGARDING THE PATENT RIGHTS OWNED OR CONTROLLED BY SUCH PARTY, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.

 

7. INDEMNIFICATION

MorphoSys shall indemnify and hold AME, its directors, officers, employees and agents harmless from and against all losses, liabilities, damages and expenses (including attorneys’ fees and costs), including those for death, personal injury, illness or property damage, incurred as a result of any claim, demand, action or other proceeding by a Third Party (other than an Affiliate) to the extent resulting from (a) any use by MorphoSys, its (sub)licensees or their respective Affiliates of any method, process or composition covered by, or derived by use of the technology covered by AME Patent Rights to the extent licensed to MorphoSys hereunder, or (b) any use, sale or other disposition of HuCAL Libraries, HuCAL Antibodies, and [Redacted] by MorphoSys, its (sub)licensees or their respective Affiliates or transferees.

 

8. TERM AND TERMINATION

8.1 Term and Termination . The term of this Agreement shall commence on the Effective Date, and unless earlier terminated as provided in Section 8.2, shall continue in full force and effect until the last to expire of the AME Patent Rights.

8.2 Termination for Cause . Either Party may terminate this Agreement upon or after the breach of any material provision of this Agreement by the other Party if such Party has not cured such breach within sixty (60) days after notice thereof by the non-breaching Party. In the event that either Party disputes in good faith the existence of a breach, then the other Party may not terminate until the dispute resolution process of Section 9.10 has been completed. If the conclusion of the dispute resolution process is that either Party has breached the agreement, then the other Party may terminate if such breach has not been cured within thirty (30) days of the conclusion. For the avoidance of doubt, AME may terminate this Agreement should MorphoSys either directly or through a third party, challenge or dispute the validity of any AME Patent Rights in a patent office proceeding or a court of law. Notwithstanding the foregoing, MorphoSys shall be permitted to take any action in order to comply with any applicable law,

 

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regulation or court order in any proceeding that is not initiated directly or indirectly by MorphoSys, whether or not such proceeding relates to any challenge or dispute concerning the validity of any AME Patent Rights in a patent office proceeding or a court of law.

8.3 Effect of Expiration or Termination .

8.3.1 Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination.

8.3.2 Termination of this Agreement by AME for breach by MorphoSys shall result in the immediate termination of all licenses granted to MorphoSys and only the provisions of Articles 5, 7, and 9 shall survive such termination; provided , however , that, subject to Section 8.3.3, any sublicensee of MorphoSys permitted under this Agreement who is the beneficiary of certain rights under this Agreement shall maintain such rights, notwithstanding the termination of this Agreement, provided that such sublicensee complies with the applicable provisions of this Agreement and has not otherwise materially breached any obligation due under this Agreement.

8.3.3 Should AME terminate this Agreement due to MorphoSys’s challenge or dispute of the validity of any AME Patent Rights in a patent office proceeding or a court of law, either directly or through a third party, then any sublicense granted by MorphoSys under Section 2.3 will also terminate.

 

9. MISCELLANEOUS

9.1 Governing Law and Venue . This Agreement shall be governed by and construed in accordance with the laws of New York, without reference to principles of conflicts of law.

9.2 Assignment . This Agreement shall not be assignable by any Party to any Third Party without the written consent of the other Party; except any Party may assign this Agreement, without such consent, to an entity that acquires all or substantially all of the business or assets of such Party to which this Agreement pertains, whether by merger, reorganization, acquisition, sale or otherwise. The terms and conditions of this Agreement shall be binding on and inure to the benefit of the permitted successors and assigns of the Parties.

9.3 Notices . All notices required or permitted under this Agreement shall be in writing, shall be sent to the respective addresses set forth below or to such other address as may be designated by a Party by giving written notice to the other Party pursuant to this Section 11.6, and shall be effective on receipt.

 

If to AME:      Applied Molecular Evolution, Inc.
     3520 Dunhill Street
     San Diego, California 92121
     Attn: General Patent Counsel/MJS

 

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EXECUTION COPY (Redacted Version)    CONFIDENTIAL

 

If to MorphoSys:      MorphoSys AG
     Lena-Christ-Str. 48,
     D-82152 Martinsried/Planegg
     Germany
     Attn: CEO

9.4 Entire Agreement . This Agreement (including the referenced Exhibits) constitutes the entire and exclusive agreement between the Parties regarding the subject matter hereof, and supersedes and cancels all previous and contemporaneous representations, agreements, commitments and writings regarding the subject matter hereof.

9.5 No Waiver . The failure of either Party to enforce any term or condition of this Agreement will not constitute a waiver of such Party’s rights to enforce subsequent breaches of any term or condition under this Agreement.

9.6 Modifications . No amendment or modification to this Agreement, nor any waiver of any rights hereunder, will be effective unless assented to in writing by the Party to be charged, and the waiver of any breach or default will not constitute a waiver of any other right hereunder or any subsequent breach of default.

9.7 Severability . If any provision of this Agreement is held to be invalid by a court of competent jurisdiction, then the remaining provisions will nevertheless remain in full force and effect. The Parties agree to renegotiate in good faith any term held invalid and to be bound by the mutually agreed substitute provision.

9.8 Headings . The headings and captions used in this Agreement are for convenience of reference only, and shall not in any way affect the interpretation of the provisions of this Agreement.

9.9 Counterparts . This Agreement may be executed in counterparts, each of which shall be an original and all of which together shall constitute one and the same instrument.

9.10 Disputes . The Parties recognize that disputes as to certain matters may from time to time arise which relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of such disputes in an expedient manner by mutual cooperation and without resort to litigation. Accordingly, any controversy or claim arising out of or relating to this Agreement, including any such controversy or claim involving the parent company, subsidiaries, or Affiliates under common control of any Party (each, a “Dispute”), shall be resolved as set forth in Appendix E.

 

7


EXECUTION COPY (Redacted Version)    CONFIDENTIAL

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized officers as of the day and year first above written.

 

APPLIED MOLECULAR EVOLUTION, INC.
By:  

 

Name:   Thomas F. Bumol
Title:   Chairman of the Board
  Applied Molecular Evolution
MORPHOSYS AG
By:  

 

Name:  

 

Title:  

 

By:  

 

Name:  

 

Title:  

 

 

8


CONFIDENTIAL

APPENDIX A

[Redacted]


CONFIDENTIAL

APPENDIX B

DESCRIPTION OF HUCAL LIBRARY

[Redacted]


CONFIDENTIAL

APPENDIX C

KAUFFMAN AGREEMENT

[begins on the following page]


LICENSE AGREEMENT

THIS LICENSE AGREEMENT dated as of November 3, 1994 (the “Agreement”), is entered into between STUART A. KAUFFMAN, M.D., an individual (“Kauffman”), having a place of business located at 15 Montecito, Santa Fe, New Mexico 87501, and IXSYS, INC., a Delaware corporation (“Ixsys”), having a place of business located at 3550 Dunhill Street, San Diego, California 92121.

W I T N E S S E T H :

WHEREAS, Kauffman owns or has rights in certain technology relating to the random generation of genes.

WHEREAS, Ixsys, desires to obtain, and Kauffman desires to grant to Ixsys, an exclusive worldwide license under Kauffman’s rights in certain patent rights and know-how relating to such technology, on the terms and subject to the conditions of the Agreement.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

For purposes of the Agreement, the terms defined in this Article 1 shall have the respective meanings set forth below:

1.1 “ Affiliate ” shall mean, with respect to any Person, any other Person which directly or indirectly controls, is controlled by, or is under common control with, such Person. A Person shall be regarded as in control of another Person if it owns, or directly or indirectly controls, at least fifty percent (50%) of the voting stock or other ownership interest of the other Person, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other Person by any means whatsoever.

1.2 “ B&K Know-How ” shall mean all information and data, which is not generally known, including, but not limited to, formulae, procedures, protocols, techniques and results of experimentation and testing, which are necessary for Ixsys to make, use, develop, sell or seek regulatory approval to market a composition, or to practice a method or process, claimed in the B&K Patent Rights in which Kauffman has an ownership or licensable interest.

1.3 “ B&K Patent Rights ” shall mean (a) United States Patent Application Serial No. 08/133,952, filed November 20, 1986, and all foreign counterpart patents and patent applications thereto, and (b) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or additions to such patents and patent applications (excluding the Random Chemistry Patent Rights if filed as a continuation-in-part to the B&K Patent Rights).


1.4 “ First Commercial Sale ” shall mean, with respect to any Product, the first sale for use or consumption by the general public of such Product.

1.5 “ Huse Patent Rights ” shall mean United States Patent No. 5,264,5634, and all foreign counterpart patents and patent applications thereto, together with all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or additions to such patents and patent applications.

1.6 “ Net Sales ” shall mean, with respect to any product (including any Product), the invoiced sales price of such product or Product billed to independent customers who are not Affiliates, less, to the extent included in the invoiced sales price, (a) credits, allowances, discounts and rebates to, and chargebacks from the account of, such independent customers for spoiled, damaged, out-dated, rejected or returned product or Product; (b) actual freight and insurance costs incurred in transporting such product or Product in final form to such customers; (c) cash, quantity and trade discounts; (d) sales, use, value-added and other taxes or governmental charges incurred in connection with the exportation or importation of such product or Product in final form; and (e) the cost to Ixsys of the devices for dispensing or administering such product or Product as well as diluents or similar materials which accompany such product or Product as it is sold.

1.7 “ Person ” shall mean an individual, corporation, partnership, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.

1.8 “ Products ” shall mean all products which contain or are derived from any compositions, which at the time such compositions are conceived, (a) incorporate, use or are based upon any process, method or composition claimed in a Valid B&K Patent Claim, or (b) if made, used or sold absent the license granted under the Agreement would infringe a Valid B&K Patent Claim.

1.9 “ Random Chemistry Patent Rights ” shall mean (a) United States Patent Application Serial No. 08/049,268, filed April 19, 1993, and all foreign counterpart patents and patent applications thereto, and (b) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or additions to such patents and patent applications.

1.10 “ Royalty Term ” shall mean, with respect to each Product, the period of time beginning on the date when a valid patent issues in the United States which claims a Valid B&K Patent Claim and ending on the date when all United States patents which claim any Valid B&K Patent Claim have expired or have been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.

1.11 “ Territory ” shall mean the entire world.

1.12 “ Third Party ” shall mean any Person other than Kauffman, Ixsys and their respective Affiliates.

 

2


1.13 “ Valid B&K Patent Claim ” shall mean a claim of an issued and unexpired patent in the United States included within the B&K Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.

ARTICLE 2

REPRESENTATIONS AND WARRANTIES

2.1 Kauffman Representations . Kauffman hereby represents and warrants to Ixsys as follows:

2.1.1 Existence and Power . He is an individual, resident in the State of New Mexico, and competent to conduct his affairs and to enter into and perform his obligations under the Agreement.

2.1.2 Capacity and Enforcement of Obligations . Kauffman has the capacity and the legal right to enter into the Agreement and to perform his obligations hereunder. The Agreement has been duly executed and delivered by Kauffman, and constitutes a legal, valid, binding obligation, enforceable against Kauffman in accordance with its terms.

2.1.3 No Consents . All necessary consents, approvals and authorizations of all governmental authorities and other Persons required to be obtained by Kauffman in connection with the Agreement have been obtained.

2.1.4 No Conflict . The execution and delivery of the Agreement and the performance of Kauffman’s obligations hereunder (a) do not conflict with or violate any requirement of applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any contractual obligation of him.

2.1.5 Licensed Technology . Kauffman is the sole owner of the B&K Patent Rights; the B&K Know-How and the Random Chemistry Patent Rights and has not granted to any Third Party any license or other interest in the B&K Patent Rights or the B&K Know-How that would limit his ability to exclusively license such rights to Ixsys hereunder.

2.2 Ixsys Representations . Ixsys hereby represents and warrants to Kauffman as follows:

2.2.1 Corporate Existence and Power . Ixsys (a) is a corporation duly organized, validly existing and in good standing under the laws of the state in which it is incorporated; (b) has the corporate power and authority and the legal right to own and operate its property and assets, to lease the property and assets it operates under lease, and to carry on its business as it is now being conducted and (c) is in compliance with all requirements of applicable law, except to the extent that any noncompliance would not have a material adverse effect on the properties, business, financial or other condition of it and would not materially adversely affect its ability to perform its obligations under the Agreement.

 

3


2.2.2 Authorization and Enforcement of Obligations . Ixsys (a) has the corporate power and authority and the legal right to enter into the Agreement and to perform its obligations hereunder and (b) has taken all necessary corporate action on its part to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder. The Agreement has been duly executed and delivered on behalf of Ixsys, and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms.

2.2.3 No Consents . All necessary consents, approvals and authorizations of all governmental authorities and other Persons required to be obtained by Ixsys in connection with the Agreement have been obtained.

2.2.4 No Conflict . The execution and delivery of the Agreement and the performance of Ixsys’ obligations hereunder (a) do not conflict with or violate any requirement of applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any contractual obligation of it.

ARTICLE 3

LICENSE GRANTS

3.1 License Grants to Ixsys .

3.1.1 Exclusive Grant to B&K Technology . Kauffman hereby grants to Ixsys an exclusive license (including the right to grant sublicenses) in the Territory under the B&K Patent Rights and the B&K Know-How to use the processes and methods, and to make, use and sell the compositions, claimed in the B&K Patent Rights or which constitute B&K Know-How.

3.1.2 Non-Exclusive Grant to B&K Technology . Kauffman hereby grants to Ixsys a non-exclusive, fully paid-up, royalty-free license (including the right to grant sublicenses) in the Territory (a) to use the processes and methods, and to make, use and sell the compositions, disclosed (but not claimed) in the B&K Patent Rights, and (b) to use all information and data, which is not generally known, including, but not limited to, formulae, procedures, protocols, techniques and results of experimentation and testing which are necessary for Ixsys to make, use, develop, sell or seek regulatory approval to market a composition, or to practice a method or process, claimed or disclosed in the B&K Patent Rights.

3.1.3 Random Chemistry Patent Rights . Kauffman hereby grants to Ixsys a non-exclusive, fully paid-up, royalty- free license (including the right to grant sublicenses) in the Territory under the Random Chemistry Patent Rights to the extent necessary or useful to use the processes and methods, and to make, use and sell the compositions, claimed or disclosed in the B&K Patent Rights or which constitute B&K Know-How.

3.1.4. Sublicenses . Ixsys shall give written notice to Kauffman of each sublicense under the Agreement promptly after granting the same. Each such sublicense shall be subject to the terms and conditions of the Agreement.

3.2 Sublicense Grantback to Kauffman .

 

4


3.2.1 B&K Technology . Ixsys hereby grants to Kauffman a limited non-exclusive, fully paid-up, royalty-free sublicense (including the right to grant further sublicenses) in the Territory under the B&K Patent Rights in the Territory to the extent necessary or useful to use the processes and methods, and to make, use and sell the compositions, claimed or disclosed in the Random Chemistry Patent Rights and B&K Know-How. Kauffman’s use of the B&K Patent Rights under such sublicense shall be limited to (a) the right to produce catalysts and if necessary, to use such catalysts for a reaction or sequence of reactions in the subsequent production of the discovered chemical molecules, (b) produce substrates in the process claimed by the Random Chemistry Patent Rights in which substrates are significantly modified in such process prior to being identified as candidate compositions or (c) other intermediate compounds or agents for use in the processes and methods claimed in the Random Chemistry Patent Rights but not for use as Products. Kauffman shall not use the B&K Patent Rights or the B&K Know-How under such sublicense to (x) use any composition derived through the limited sublicense as an end product or (y) derive a composition as an end product by any means other than directly through the processes and methods claimed in the Random Chemistry Patent Rights.

3.2.2 Sublicenses . Kauffman shall give written notice to Ixsys of each sublicense under the Agreement promptly after granting the same. Each such sublicense shall be subject to the terms and conditions of the Agreement.

3.3 Availability of the B&K Patent Rights and the B&K Know-How . Promptly upon execution of the Agreement, Kauffman shall provide Ixsys with all information available to Kauffman regarding the B&K Patent Rights, the B&K Know-How and, to the extent of the rights granted to Ixsys under the Agreement, the Random Chemistry Patent Rights.

ARTICLE 4

IXSYS LICENSE AND MAINTENANCE FEES AND ROYALTIES

4.1 License Fee . In consideration for the grant of the license under the B&K Patent Rights and the B&K Know-How, Ixsys shall pay to Kauffman a license fee in the aggregate amount of [***], payable in installments as follows:

 

Amount

  

Payment Date

[***]

   November 3, 1994

[***]

   November 3, 1995

[***]

   November 3, 1996

4.2 Annual Maintenance Fee . In consideration for the grant of the license under the B&K Patent Rights and the B&K Know-How, beginning November 3, 1997 and on each anniversary until the expiration or the earlier termination of the Agreement, Ixsys shall pay to Kauffman an annual maintenance fee. Such annual maintenance fee shall equal *** per year prior to, and *** per year after, either the issuance of one or more valid patents in the United States which claim,

 

5


or the irrevocable rejection of, all material claims originally claimed in United States Patent Application Serial No. 08/133,952, filed November 20, 1986, and claimed within the B&K Patent Rights as of the date hereof; provided, however, that all material claims originally claimed in United States Patent Application Serial No. 08/133,952, filed November 20, 1986, shall be included, and shall not be materially narrowed or materially modified, in the issued claims of such valid issued patent in the United States within the B&K Patent Rights. Notwithstanding the foregoing, if any material claim stated in United States Patent Application Serial No. 08/133,952, filed November 20, 1986, is not included, or has been materially narrowed or materially modified, in the issued claims of such valid issued patent in the United States within the B&K Patent Rights, Ixsys and Kauffman shall negotiate in good faith a reduced annual maintenance fee. Ixsys shall have the right to credit the aggregate amount of all such annual maintenance fees against any royalties payable to Kauffman pursuant to Section 4.4 below.

4.3 Sublicense Fees .

4.3.1 Random Chemistry Patent Rights . In consideration for the grant of the license under the Random Chemistry Patent Rights, Ixsys shall pay to Kauffman for each sublicense granted by Ixsys to a Third Party under the Random Chemistry Patent Rights (a) a sublicense fee equal to [***] payable upon the grant of such sublicense and (b) a sublicense maintenance fee equal to [***] (or until the earlier expiration or termination of each such sublicense).

4.3.2 B&K Patent Rights Aggregate Sublicense and Maintenance Fees . Ixsys shall pay to Kauffman an amount equal to [***] of the aggregate sublicense and maintenance fees received by Ixsys, in excess of [***] in any calendar year, in consideration for the grant of all such sublicenses to Third Parties under the B&K Patent Rights in any given calendar year. Such payments shall be made by Ixsys to Kauffman on a quarterly basis and shall commence after Ixsys has received in excess of [***] in such calendar year.

4.4 Royalties . In consideration for the grant of the license under the B&K Patent Rights and the B&K Know-How, during the Royalty Term, Ixsys shall pay, on a quarterly basis as set forth in Section 7.1 below, the following royalties to Kauffman:

4.4.1 On Sales by Ixsys and its Affiliates . With respect to sales in the Territory of Products by Ixsys, its Affiliates or its collaborators, Ixsys shall pay to Kauffman royalties equal to (a) [***] of Net Sales of any Product which contains one or more compositions conceived through a process or method claimed in the B&K Patent Rights and which is not modified or altered by Ixsys or others; (b) [***] of Net Sales of any Product which contains one or more compositions which are derivatives of any composition conceived through a process or method claimed in the B&K Patent Rights and in which at least one or more amino acid molecule has been modified or altered by Ixsys or others; or (c) [***] of Net Sales of any Product which contains one or more compositions which are not conceived through a process or method claimed in the B&K Patent Rights or a derivative thereof, but which are substantially based upon the structure of any composition conceived through a process or method claimed in the B&K Patent Rights.

4.4.2 On Sales by Third Party Sublicensees .

 

6


(a) With respect to sales in the Territory of Products by Third Party sublicensees, Ixsys shall pay to Kauffman royalties equal to [***] percent [***] of the aggregate royalties received by Ixsys directly in consideration for the sublicense by Ixsys of the B&K Patent Rights. If the B&K Patent Rights are sublicensed to a Third Party in conjunction with any additional patent or other intellectual property rights of Ixsys, then Ixsys shall, in its reasonable business judgment, apportion the royalties received from the Third Party under this Section 4.4.2(a) which are attributable to the B&K Patent Rights sublicense.

(b) Notwithstanding the foregoing, if Ixsys grants a sublicense under the B&K Patent Rights to any Third Party, in which such Third Party grants a cross-license under any patent or other intellectual property rights of such Third Party to Ixsys but which is not obligated to pay any royalties to Ixsys calculated on the basis of sales of products by or on behalf of such Third Party, then Ixsys shall pay to Kauffman royalties equal to (i) [***] of Net Sales by Ixsys, its Affiliates and sublicensees (other than such Third Party) of each product which incorporates, uses or is based on the B&K Patent Rights and which also incorporates, uses or is based on such cross-licensed patent or other intellectual property rights of such Third Party, or (ii) [***] of Net Sales by Ixsys, its Affiliates and sublicensees (other than such Third Party) of each product (other than a Product) which incorporates, uses or is based on such cross-licensed patent or other intellectual property rights of such Third Party.

4.4.3 Reduction of Royalties. Notwithstanding the foregoing, the royalties owing from Ixsys to Kauffman under this Section 4.4 shall be subject to the following reductions:

(a) If a product or a Product incorporates, uses or is based on the Huse Patent Rights, or would infringe the valid claim of the Huse Patent Rights if made, used or sold, then the royalty rates set forth in Sections 4.4.1 and 4.4.2(b) above shall be reduced to [***] of the respective percentages set forth therein.

(b) if any material claim stated in United States Patent Application Serial No. 08/133,952, filed November 20, 1986, is not included, or has been materially narrowed or materially modified, in the issued claims of such valid issued patent in the United States within the B&K Patent Rights, Ixsys and Kauffman shall negotiate in good faith a reduced royalty rate under Sections 4.4.1 and 4.4.2(b) above.

ARTICLE 5

KAUFFMAN SUBLICENSE AND MAINTENANCE FEES

In consideration for the grantback of the sublicense under the B&K Patent Rights, Kauffman shall pay to Ixsys for each sublicense granted by Kauffman to a Third Party under the B&K Patent Rights(a) a sublicense fee equal to [***] payable upon the grant of such sublicense, and (b) a sublicense maintenance fee equal to [***] payable on each anniversary of the grant of each such sublicense during the Royalty Term (or until the earlier expiration or termination of each such sublicense).

ARTICLE 6

 

7


ROYALTY REPORTS AND ACCOUNTING

6.1 Royalty Reports . During the term of the Agreement following the First Commercial Sale of a Product, Ixsys shall furnish to Kauffman a quarterly written report showing in reasonably specific detail (a) the gross sales of each Product sold by Ixsys, its Affiliates and its sublicensees in the Territory during the reporting period and the calculation of Net Sales from such gross sales; (b) the royalties received by Ixsys from Third Parties in consideration for the sublicense of the B&K Patent Rights; (c) the royalties payable, if any, which shall have accrued hereunder based upon the foregoing; and (d) withholding taxes, if any, required by law to be deducted in respect of such sales. Reports shall be due on the 90th day following the close of each quarter. Ixsys shall keep complete and accurate records in sufficient detail to properly reflect all gross sales, Net Sales and sublicense royalties and to enable the royalties payable hereunder to be determined.

6.2 Audits .

6.2.1 Independent Accounting . Upon the written request of Kauffman and not more than once in each calendar year, Ixsys shall permit an independent certified public accounting firm of nationally recognized standing selected by Kauffman and reasonably acceptable to Ixsys, at Kauffman’s expense, to have access during normal business hours to such of the records of Ixsys as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any year ending not more than twenty-four (24) months prior to the date of such request. The accounting firm shall disclose to Kauffman only whether the records are correct or not and the specific details concerning any discrepancies. No other information shall be shared.

6.2.2 Additional Payment . If such accounting firm concludes that additional royalties were owed during such period, Ixsys shall pay the additional royalties within thirty (30) days of the date Kauffman delivers to Ixsys such accounting firm’s written report so concluding. The fees charged by such accounting firm shall be paid by Kauffman; provided , however , if the audit correctly discloses that the royalties payable by Ixsys for the audited period are more than [***] of the royalties actually paid for such period, then Ixsys shall pay the reasonable fees and expenses charged by such accounting firm.

6.3 Confidential Financial Information . Kauffman shall treat all financial information subject to review under this Article 6 or under any sublicense agreement as confidential, and shall cause his accounting firm to retain all such financial information in confidence under Article 9 below.

ARTICLE 7

PAYMENTS

7.1 Payment Terms . Royalties shown to have accrued by each royalty report provided for under Article 6 above shall be due on the date such royalty report is due. Payment of royalties in whole or in part may be made in advance of such due date.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

8


7.2 Exchange Control . If at any time legal restrictions prevent the prompt remittance of part or all royalties with respect to any country in the Territory where the Product is sold, Ixsys shall have the right, in its sole discretion, to make such payments by depositing the amount thereof in local currency to Kauffman’s account in a bank or other depository institution in such country. If the royalty rate specified in the Agreement should exceed the permissible rate established in any country, the royalty rate for sales in such country shall be adjusted to the highest legally permissible or government-approved rate.

7.3 Withholding Taxes . Ixsys shall be entitled to deduct the amount of any withholding taxes, value-added taxes or other taxes, levies or charges with respect to such amounts, other than United States taxes, payable by Ixsys, its Affiliates or sublicensees, or any taxes required to be withheld by Ixsys, its Affiliates or sublicensees, to the extent Ixsys, its Affiliates or sublicensees pay to the appropriate governmental authority on behalf of Kauffman such taxes, levies or charges. Ixsys shall use reasonable efforts to minimize any such taxes, levies or charges required to be withheld on behalf of Kauffman by Ixsys, its Affiliates or sublicensees. Ixsys shall deliver promptly to Kauffman 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.

ARTICLE 8

DEVELOPMENT OBLIGATIONS

Ixsys shall use its commercially reasonable efforts to develop, as Ixsys determines is necessary or desirable, such Products as Ixsys determines are commercially feasible in the Territory.

ARTICLE 9

CONFIDENTIALITY

9.1 Confidential Information . During the term of the Agreement, and for a period of four (4) years following the expiration or earlier termination hereof, Kauffman shall maintain in confidence all information of Ixsys (including samples) disclosed by Ixsys to Kauffman pursuant to the Agreement, if such information of Ixsys (including samples) is (i) disclosed in writing and marked “Confidential” or (ii) disclosed orally and Ixsys has stated prior to or at the time of such disclosure that the information is confidential and Ixsys subsequently reduces such oral disclosure to a writing marked “Confidential” and delivers such marked writing to Kauffman within thirty (30) days if such oral disclosure (collectively, (i) and (ii) above shall be referred to as the “Confidential Information”), and shall not use, disclose or grant the use of the Confidential Information except on a need-to-know basis to those directors, officers, Affiliates, employees, permitted licensees, permitted assignees and agents, consultants, clinical investigators or contractors, to the extent such disclosure is reasonably necessary in connection with Kauffman’s activities as expressly authorized by the Agreement. To the extent that disclosure is authorized by the Agreement, prior to disclosure, Kauffman shall obtain agreement of any such Person to hold in confidence and not make use of the Confidential Information for any purpose other than those permitted by the Agreement. Kauffman shall

 

9


notify Ixsys promptly upon discovery of any unauthorized use or disclosure of the Confidential Information.

9.2 Permitted Disclosures . The confidentiality obligations contained in Section 9.1 above shall not apply to the extent that (a) Kauffman is (i) required to disclose information by law, order or regulation of a governmental agency or a court of competent jurisdiction, or (ii) Kauffman is required to disclose information to any governmental agency for purposes of obtaining approval to test or market a product, provided in either case that Kauffman shall provide written notice thereof to Ixsys and sufficient opportunity to object to any such disclosure or to request confidential treatment thereof; or (b) Kauffman can demonstrate that (i) the disclosed information was or had become public knowledge at the time of such disclosure by Kauffman other than as a result of actions of Kauffman, its Affiliates, employees, permitted licensees, permitted assignees and agents, consultants, clinical investigators or contractors in violation hereof; (ii) the disclosed information was rightfully known by Kauffman or its Affiliates (as shown by Kauffman’s written records) or permitted licensees prior to the date of disclosure to Kauffman by Ixsys; (iii) the disclosed information was received by Kauffman or its Affiliates or permitted licensees on an unrestricted basis from a source unrelated to Ixsys and not under a duty of confidentiality to Ixsys; or (iv) the disclosed information was independently developed by Kauffman, without the use of Confidential Information as evidenced by Kauffman’s written records.

9.3 Terms of the Agreement . Except as otherwise provided in Section 9.2 above, Kauffman shall not disclose any terms or conditions of the Agreement to any Third Party without the prior consent of Ixsys. Notwithstanding the foregoing, Kauffman may disclose the information set forth on Exhibit A attached hereto, to those certain Third Parties with whom Kauffman has, or proposes to enter into, a business relationship.

ARTICLE 10

PATENTS

10.1 Past Expenses . In consideration for the grant of the license under the B&K Patent Rights, and subject to proof of such past expenditures by Kauffman, Ixsys shall reimburse Kauffman for his past expenses incurred in the prosecution and maintenance of the B&K Patent Rights according to the following schedule:

 

Amount

  

Payment Date

[***]

   November 3, 1994

[***]

   November 3, 1995

[***]

   November 3, 1996

10.2 Patent Prosecution and Maintenance .

10.2.1 B&K Patent Rights . Ixsys shall be responsible for and shall control, at its sole cost, the preparation, filing, prosecution and maintenance of all patents and patent

 

10


applications related to the B&K Patent Rights (including any interference actions related to the B&K Patent Rights) in a commercially reasonable manner. If Ixsys elects to abandon any material claim in any patent application within the B&K Patent Rights without filing a continuation or continuation-in-part application containing such material claim, Kauffman shall have the right to assume control, at his sole cost, of the preparation, filing, prosecution and maintenance of such material claim in any patent application and all patent claims which issue therefrom, and such material claim in such patent application and patent claims shall be excluded from the B&K Patent Rights. Kauffman shall cooperate with Ixsys, execute all lawful papers and instruments and make all rightful oaths and declarations as may be necessary in the preparation, prosecution and maintenance of all patents and other filings referred to in this Section 10.2.1.

10.2.2 Random Chemistry Patent Rights . Kauffman shall be responsible for and shall control, at his sole cost, the preparation, filing, prosecution and maintenance of all patents and patent applications related to the Random Chemistry Patent Rights (including any interference actions relating thereto). Kauffman shall have the right, but not the obligation, to include the claims set forth in United States Patent Application Serial No. 08/049, 268, filed April 19, 1993, as a continuation-in-part to United States Patent Application Serial No. 08/133,952, filed November 20, 1986; provided , however , that such filing shall not (a) alter or impact negatively the claims set forth in United States Patent Application Serial No. 08/133,952, filed November 20, 1986 and licensed to Ixsys hereunder and (b) grant to Kauffman any additional rights to the B&K Patent Rights except as provided for in the Agreement. Ixsys shall cooperate with Kauffman, execute all lawful papers and instruments and make all rightful oaths and declarations as may be necessary in the preparation, prosecution and maintenance of all patents and other filings referred to in this Section 10.2.2.

10.3 Notification of Infringement . Each party shall notify the other party of any infringement in the Territory known to such party of any Patent Rights of the other party and shall provide the other party with the available evidence, if any, of such infringement.

10.4 Enforcement of Patent Rights . Ixsys, at its sole expense, shall have the right, at any time and at its sole discretion, to determine the appropriate course of action to enforce the B&K Patent Rights or otherwise abate the infringement thereof, to take (or refrain from taking) appropriate action to enforce the B&K Patent Rights, to control any litigation or other enforcement action and to enter into, or permit, the settlement of any such litigation or other enforcement action with respect to the B&K Patent Rights. Notwithstanding the foregoing, Ixsys shall have no obligation to abate any infringement of the B&K Patent Rights or to file any action to enforce the B&K Patent Rights against an infringing party in the Territory. Neither Kauffman, an Affiliate of Kauffman nor any Third Party shall take any action which (a) claims that the Agreement is invalid and/or (b) seeks or claims damages from Ixsys because Ixsys failed to abate any infringement of the B&K Patent Rights or to file any action to enforce the B&K Patent Rights against any infringing party in the Territory. Kauffman shall fully cooperate with Ixsys in the planning and execution of any enforcement action regarding the B&K Patent Rights. Ixsys shall be entitled to receive all monies recovered upon the final judgment or settlement of any such suit to enforce the B&K Patent Rights; provided , however , that if Ixsys receives monies in excess of Ixsys’ aggregate costs associated with any such suit to enforce the B&K Patent Rights (including, but not limited to, attorneys’ fees and costs), Ixsys shall pay to Kauffman any

 

11


royalties owed to Kauffman pursuant to Section 4.4. Ixsys shall reimburse Kauffman for reasonable out-of-pocket expenses incurred by Kauffman in connection therewith; provided , however , that such expenses shall have been approved in advanced, in writing, by Ixsys, which approval shall not be withheld unreasonably.

10.5 Reimbursement to Ixsys . If Ixsys, its Affiliates or sublicensees incur any un-reimbursed costs, including reasonable attorneys’ fees and costs (the “Reimbursement Amount”), in connection with the defense of any claim, demand or action by any Third Party alleging the infringement of a Third Party’s patent rights by the exercise of the license rights granted to Ixsys hereunder or the invalidity of any B&K Patent Rights (including, but not limited to, any allowed claims or issued patents in the Territory, including, but not limited to, any allowed claims or issued patents in the Territory, including, but not limited to, in Europe or any country thereof, Ixsys shall have the right to credit (a) an amount equal to twenty-five percent (25%) of the Reimbursement Amount against any amounts owed by Ixsys to Kauffman under Section 4.4.2 (a) above, and (b) the Reimbursement Amount against any royalties owed to Kauffman under Section 4.4.1 above; provided , however , that (i) Ixsys shall not reduce the amount of the royalties paid to Kauffman under Section 4.4.1 above (after giving effect to any royalty reductions contemplated in Section 4.4.3 above) for such period, and (ii) the aggregate amount of the credits under clauses (a) and (b) above shall not exceed the Reimbursement Amount.

ARTICLE 11

TERMINATION

11.1 Expiration . Subject to the provisions of Sections 11.2 and 11.3 below, the Agreement shall expire on the date when all issued patents which constitute B&K Patent Rights have expired or have been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise. Upon the expiration of the Agreement, (a) Ixsys shall have a paid-up, non-exclusive license under the B&K Know-How to use the processes and methods, and to make, use and sell the compositions, claimed in the B&K Patent Rights or which constitute B&K Know-How; and (b) the paid-up, non-exclusive licenses granted under Sections 3.1.2, 3.1.3 and 3.2.1 shall survive.

11.2 Termination by Ixsys . Ixsys may terminate the Agreement, in its sole discretion, upon thirty (30) days prior written notice to Kauffman.

11.3 Termination for Cause . Except as otherwise provided in Article 13, either party may terminate the Agreement upon or after the breach of any material provision of the Agreement by the other party if the other party has not cured such breach within ninety (90) days after notice thereof by the non-breaching party; provided , however , if any default is not capable of being cured within such ninety (90) day period and the other party is diligently undertaking to cure such default as soon as commercially feasible thereafter under the circumstances, the non-breaching party shall have no right to terminate the Agreement.

 

12


11.4 Effect of Expiration or Termination . Upon the expiration or earlier termination of the Agreement, all rights relating to the grant of the B&K Patent Rights license to Ixsys and all obligations of Ixsys and Kauffman, including without limitation, Ixsys’ obligations to pay maintenance or royalty fees pursuant to Sections 4.2 and 4.4, shall terminate. The expiration or earlier termination of the Agreement shall not relieve the parties of any obligation accruing prior to such expiration or earlier termination, including the payment of pro-rata amounts, if any, owed to Kauffman, and the provisions of Articles 9 and 12 shall survive the expiration or earlier termination of the Agreement.

ARTICLE 12

INDEMNIFICATION

12.1 Indemnification . Ixsys shall defend, indemnify and hold Kauffman harmless from all claims, demands, liabilities, damages and expenses, including attorneys’ fees and costs arising out of any breach of the Agreement by Ixsys, or the gross negligence or willful misconduct of Ixsys, its Affiliates or permitted sublicensees in the performance of its obligations contemplated by the Agreement.

12.2 Procedure . Kauffman promptly shall notify Ixsys of any liability or action in respect of which Kauffman intends to claim such indemnification, and Ixsys shall have the right to participate in, and, to the extent Ixsys so desires, jointly with any other indemnitor similarly noticed, to assume the defense thereof with counsel selected by Ixsys; provided , however , that Kauffman shall have the right to retain his own counsel, at his sole expense, if representation of Kauffman by the counsel retained by Ixsys would be inappropriate due to actual or potential differing interests between Kauffman and any other party represented by such counsel in such proceedings. The indemnity agreement in this Article 12 shall not apply to amounts paid in settlement of any loss, claim, damage, liability or action if such settlement is effected without the consent of Ixsys, which consent shall not be withheld unreasonably. The failure to deliver notice to Ixsys within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve Ixsys of any liability to Kauffman under this Article 12, but the omission so to deliver notice to Ixsys will not relieve it of any liability that it may have to Kauffman otherwise than under this Article 12. Kauffman under this Article 12, his employees and agents, shall cooperate fully with Ixsys and its legal representatives in the investigation and defense of any action, claim or liability covered by this indemnification.

ARTICLE 13

FORCE MAJEURE

Neither party shall be held liable or responsible to the other party nor be deemed to have defaulted under or breached the Agreement for failure or delay in fulfilling or performing any term of the Agreement to the extent, and for so long as, such failure or delay is caused by or results from causes beyond the reasonable control of the affected party including but not limited to fire, floods, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or the other party.

 

13


ARTICLE 14

MISCELLANEOUS

14.1 Notices . Any consent, notice or report required or permitted to be given or made under the Agreement by one of the parties hereto to the other party shall be in writing, delivered personally or by facsimile (and promptly confirmed by personal delivery, U.S. first class mail or courier), U.S. first class mail or courier, postage prepaid (where applicable), addressed to such other party at such party’s address indicated below, or to such other address as the addressee shall have last furnished in writing to the addressor and (except as otherwise provided in the Agreement) shall be effective upon receipt by the addressee.

 

If to Kauffman:    Stuart A. Kauffman, M.D.
   15 Montecito
   Santa Fe, NM 87501
with a copy to:    Holtzman, Wise & Shepard
   3030 Hansen Way
   Palo Alto, CA 94304
   Attention: Thomas L. Barton
If to Ixsys:    Ixsys, Inc.
   3550 Dunhill Street
   San Diego, CA 92121
   Attention: Michael J. Hanifin
with a copy to:    Pillsbury Madison & Sutro
   235 Montgomery Street, 15th Floor
   San Francisco, CA 94104
   Attention: Thomas E. Sparks, Jr.

14.2 Governing Law . The Agreement shall be governed by and construed in accordance with the laws of the State of California, without regard to the conflicts of law principles thereof.

14.3 Arbitration . Any dispute, controversy or claim originally initiated by either party relating to, arising out of or resulting from the Agreement, or the performance by either party of such party’s obligations hereunder, whether before or after termination of the Agreement, shall be finally resolved by binding arbitration. Whenever a party shall decide to institute arbitration proceedings, such party shall give written notice to that effect to the other party. The party giving such notice shall refrain from instituting the arbitration proceedings for a period of sixty (60) days following such notice. Any arbitration hereunder shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association. Each such arbitration shall be conducted by a panel of three (3) arbitrators appointed in accordance with such rules. Any such arbitration shall be held in San Diego, California. The arbitrators shall have the authority to grant specific performance, and to allocate between the parties the costs of arbitration in such equitable

 

14


manner as they determine. Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. In no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based upon such claim, dispute or other matter in question would be barred by the applicable statute of limitations.

14.4 Assignment . Ixsys shall not assign its rights or obligations under the Agreement without the prior written consent of Kauffman; provided , however , that Ixsys may, without such consent, assign the Agreement and its rights and obligations hereunder in connection with the transfer or sale of all or substantially all of its business, or in the event of its merger or consolidation or change in control or similar transaction. Any permitted assignee shall assume all obligations of its assignor under the Agreement.

14.5 Waivers and Amendments . No change, modification, extension, termination or waiver of the Agreement, or any of the provisions herein contained, shall be valid unless made in writing and signed by duly authorized representatives of the parties hereto.

14.6 Entire Agreement . The Agreement embodies the entire understanding between the parties and supersedes any prior understanding and agreements between and among them respecting the subject matter hereof. There are no representations, agreements, arrangements or understandings, oral or written, between the parties hereto relating to the subject matter of the Agreement which are not fully expressed herein.

14.7 Severability . Any of the provisions of the Agreement which are determined to be invalid or unenforceable in any jurisdiction shall be ineffective to the extent of such invalidity or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining provisions hereof and without affecting the validity or enforceability of any of the terms of the Agreement in any other jurisdiction.

14.8 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.

14.9 Counterparts . The 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.

 

15


IN WITNESS WHEREOF, the parties have executed the Agreement as of the date first set forth above.

 

/s/ Stuart A. Kauffman

STUART A. KAUFFMAN M.D.
IXSYS, INC.
By  

/s/ Janine M. Taylor

Title  

Director, Finance & Administration

 

16


LOGO

AMENDMENT TO LICENSE AGREEMENT

Stuart A. Kauffman, M.D., an individual, having a place of business located at 15 Montecito, Santa Fe, New Mexico 87501 and Ixsys, Incorporated, a Delaware corporation, now known as Applied Molecular Evolution, Inc., having a place of business located at 3520 Dunhill Street, San Diego, California 92121 (hereafter collectively referred to as the “Parties”) agree as follows:

ARTICLE I

BACKGROUND

1.1 On November 3, 1994, the Parties entered into the written License Agreement relating to the random generation of genes (hereafter “Agreement”).

1.2 The Parties have since discovered minor, inadvertent typographical and otherwise harmless errors in the text of the Agreement.

1.3 The Parties wish to correct these errors as provided for under Section 14.5 (“ Waivers and Amendments ”) of the Agreement.

ARTICLE II

AMENDMENTS TO THE AGREEMENT

2.1 The Parties hereby amend the portion of Section 1.5 (“ Huse Patent Rights ”) of the Agreement that reads “United States Patent No. 5,264,5634” to read instead “United States Patent No. 5,264,563.”

2.2 The Parties hereby amend the portions of Sections 1.3 (“ B & K Patent Rights ”), 4.2 (“ Annual Maintenance Fee ”), and Subsections 4.4.3 (b) (“ Reduction of Royalties ”), and 10.2.2 (“ Random Chemistry Patent Rights ”) of the Agreement that read “United States Patent Application Serial No. 08/133,952, filed November 20, 1986” to read instead “United States Patent Application Serial No. 942,630, filed November 20, 1986,” in all instances where the former incorrect phrase appears in the above-indicated Sections and Sub-Sections of the Agreement.


ARTICLE III

MISCELLANEOUS

3.01 The Parties agree that the amendments set forth above in Article II correctly reflect their intentions as of the effective date (November 3, 1994) of the Agreement.

3.02 The Sections and Subsection of the Agreement amended as set in Article II above are effective retroactively to the effective date (November 3, 1994) of the Agreement

3.03 The Parties agree that all other Provisions and Terms of the Agreement remain in force and that this Amendment is to be considered part of the Agreement.

IN WITNESS WHEREOF, the Parties have caused this Amendment to License Agreement to be executed by their duly authorized representatives as of the 22 day of June, 2001.

 

/s/ Stuart A. Kauffman

STUART A. KAUFFMAN M.D.
APPLIED MOLECULAR REVOLUTION, INC.
By  

/s/ William D. Huse

  William D. Huse
Title  

Chief Executive Officer


LOGO

SECOND AMENDMENT TO LICENSE AGREEMENT

This SECOND AMENDMENT TO LICENSE AGREEMENT (“Second Amendment”) is entered into by and between Applied Molecular Evolution, Inc., f/k/a Ixsys, Inc., a Delaware Corporation (“AME”), having a place of business at 3520 Dunhill Street, San Diego, California 92121 and Stuart A. Kauffman, M.D. (“Kauffman”), an individual, residing at [Address].

WITNESSETH

WHEREAS, the parties have previously entered into a License Agreement dated November 3, 1994 (the “Agreement”) and have previously entered into an AMENDMENT TO LICENSE AGREEMENT dated June 22, 2001 (the “Amendment”).

WHEREAS, the parties desire to amend the Agreement and the Amendment in certain respects on the terms and conditions set forth below.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the parties hereby amend the Agreement and the Amendment and otherwise agree as follows:

1.1. Wherever the words “IXSYS” or “Ixsys” appear in the Agreement and the Amendment, they will be replaced by “APPLIED MOLECULAR EVOLUTION” or “Applied Molecular Evolution” respectively.

1.2. The following paragraph is added to the Agreement as Section 11.5:

“11.5 Sublicenses . Upon termination of this Agreement for any reason, any sublicense authorized under Section 3.1 shall survive providing (i) the sublicense specifically provides for such survival, (ii) the sublicensee is not in breach of the terms of this Agreement or the sublicense, (iii) the sublicensee is capable of meeting the obligations of Applied Molecular Evolution, and (iv) within thirty (30) days of receiving notification of termination of the Agreement, the sublicensee gives notice to Kauffman that it wishes the sublicense to remain in effect. If the foregoing conditions are met, the subliccnse shall remain in effect under its own terms and Kauffman shall act as the licensor under such sublicense, provided, however, that Kauffman shall not be required to discharge any affirmative obligation to the sublicensce undertaken by Applied Molecular Evolution. As used in this section 11.5, the term “sublicense” shall mean the present, future, or contingent grant of any license or right under the B&K Patent Rights, the B&K Know-How, and the Random Chemistry Patent Rights.”

1.3 This Second Amendment shall be effective for all purposes as of January 8, 2004. Except as expressly provided by this Second Amendment, the Agreement and the Amendment shall remain in full force and effect in accordance with their terms.


1.4. This Second Amendment shall be governed by, interpreted and construed in accordance with the laws of the State of California, without regard to conflicts of laws principles.

1.5 All terms used, but not defined, herein shall have the respective meanings as set forth in the Agreement and the Amendment.

IN WITNESS WHEREOF, the undersigned have duly executed and delivered this Second Amendment.

 

APPLIED MOLECULAR EVOLUTION, Inc.       STUART KAUFFMAN
Signature  

/s/ Wiliam L. Respess

    Signature  

/s/ Stuart A. Kauffman

Name:   William L. Respess     Name:   Stuart A. Kauffman, M.D.
Title:   Vice President and General Counsel      


CONFIDENTIAL

APPENDIX D-1

SAMPLE SUBLICENSE AGREEMENT

[Redacted]


CONFIDENTIAL

APPENDIX D-2

SAMPLE SUBLICENSE LANGUAGE

Provided that MorphoSys enters into a license agreement with a party who qualifies as a Collaboration Partner, MorphoSys may grant such Collaboration Partner a sublicense to any portion of rights set forth in Section 2.3 of the Agreement, by including, for example, the following language in such license agreement:

MorphoSys grants to [Collaboration Partner] a sublicense to the AME Patent Rights [as such term is defined in the Agreement] to the extent necessary to practice any license granted by MORPHOSYS to [Collaboration Partner] herein; provided, however, that the sublicense to the AME Patent Rights granted under [this paragraph] shall be subject to the limitations of the [Agreement] and [the Kauffman Agreement], redacted copies of which are attached hereto. [Collaboration Partner] acknowledges that MorphoSys has the obligation to notify AME in writing that [Collaboration Partner] has received a sublicense to the AME Patent Rights.


CONFIDENTIAL

APPENDIX E

DISPUTE RESOLUTION

[Redacted]


CONFIDENTIAL

APPENDIX 7.2

PRESS RELEASE

Martinsried/Munich, Germany, and Mountain View, CA., U.S.A., xx, 2006

MorphoSys and OncoMed Pharmaceuticals Sign Agreement for

Use of HuCAL GOLD in Cancer Research

MorphoSys AG (Frankfurt Stock Exchange: MOR; Prime Standard Segment, TecDAX) and U.S. based biopharmaceutical company OncoMed Pharmaceuticals, Inc. announced today the signing of a license agreement on the use of MorphoSys’s HuCAL ® technology in the research and development of human therapeutic antibodies for the treatment of various cancers, including breast, lung, colon and prostate by targeting cancer stem cells. Under the terms of the agreement, MorphoSys grants OncoMed access to its proprietary antibody library HuCAL GOLD ® for use by Oncomed in its drug discovery programs. The two-year contract includes an option for OncoMed to develop HuCAL ® -derived therapeutic antibodies. The agreement includes an up-front payment and annual user fees. Further financial details were not disclosed.

Founded in August 2004, OncoMed Pharmaceuticals is discovering and developing monoclonal antibodies and proteins capable of destroying “cancer stem cells”, a recently discovered type of cell believed to seed the growth of cancers and underlie cancer’s ability to spread and take root in tissues. OncoMed is at the forefront of applying research from the University of Michigan to isolate, purify, and analyze cancer stem cells. The company has established a large library of antibodies as well as proteins capable of binding to the cell surface proteins expressed on cancer stem cells capable of inhibiting cancer stem cell growth. In September 2005 OncoMed announced the completion of a first round of funding for $14 million from venture capital firms including Latterell Venture Partners, US Venture Partners, Morgenthaler Ventures and The Vertical Group.

HuCAL GOLD ® is the latest and most powerful antibody library developed by MorphoSys. The technology utilizes an innovative concept for the in vitro generation of highly specific and fully human antibodies with unique optimization capabilities. It is ideally suited for a broad range of purposes reaching from target validation to drug development. OncoMed has the right to exercise an option for commercial development of therapeutic antibodies, in which case MorphoSys would receive exclusive license fees, milestone payments, as well as royalties.


CONFIDENTIAL

 

“We expect our agreement with MorphoSys to play an important role in expanding OncoMed’s ability for developing novel therapeutics to treat cancer by targeting cancer stem cells,” said Paul J. Hastings, President and Chief Executive Officer of OncoMed Pharmaceuticals, Inc.

“An important part of our strategy is to put our technology to work in creating the next generation of cancer drugs in selected partnerships,” commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys. “OncoMed’s approach to fight cancer by aiming at cancer stem cells is innovative and very interesting both scientifically and commercially. We are delighted, to enable OncoMed with our HuCAL GOLD ® technology as the basis to explore their therapeutic efforts in this space.”

About MorphoSys:

MorphoSys develops and applies innovative technologies for the production of synthetic antibodies which accelerate drug discovery and target characterization. Founded in 1992, the Company’s proprietary Human Combinatorial Antibody Library (HuCAL ® ) technology is used by researchers worldwide for human antibody generation. The Company currently has licensing agreements and/or research collaborations with Bayer (USA), Boehringer Ingelheim (Germany), Bristol-Myers Squibb (USA), Centocor Inc. (USA), Daiichi Sankyo & Co., Ltd. (Japan), GPC Biotech AG (Germany), Hoffmann-La Roche AG (Switzerland), ImmunoGen Inc. (USA), Merck & Co., Inc. (USA), Novartis AG (Switzerland), Novoplant GmbH (Germany), Pfizer Inc. (USA), ProChon Biotech Ltd. (Israel), Schering AG (Germany), Schering-Plough (USA), Shionogi & Co., Ltd. (Japan), Xoma Ltd. (USA) and others. Additionally, MorphoSys is active in the antibody research market through its Antibodies by Design business unit. Antibodies by Design was founded in 2003 for the purpose of exploiting the MorphoSys non-therapeutic antibody markets. MorphoSys’ activities in the research antibody segment were significantly strengthened through the acquisition of the U.K. and U.S.-based Biogenesis Group in January 2005 and the Serotec Group in 2006. For further information please visit the corporate website at: http://www.morphosys.com/.

Statements included in this press release which are not historical in nature are intended to be, and are hereby identified as, “forward-looking statements” for purposes of the safe harbour provided by Section 21E of the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words including “anticipates”, “believes”, “intends”, “estimates”, “expects” and similar expressions. The company cautions readers that forward-looking statements, including without limitation those relating to the company’s future operations and business prospects, are subject to certain risks and uncertainties that could cause actual results to differ materially from those indicated in the forward-looking statements. Factors that may affect future operations and business prospects include, but are not limited to, clinical and scientific results and developments concerning corporate collaborations and the company’s proprietary rights and other factors described in the prospectus relating to the company’s recent public offering.


CONFIDENTIAL

 

For more information, please contact:

 

MorphoSys AG    OncoMed Pharmaceuticals, Inc.
Dave Lemus    Paul J. Hastings
Chief Financial Officer    CEO
Phone: +49 (0) 89 / 899 27-439    Phone: +1 650 937 8206
Fax: +49 (0) 89 / 899 27-5439    Fax: +1 650 938 4570
investors@morphosys.com    Paul.hastings@oncomed.com
   Karen Bergman or Michelle Corral
Dr. Claudia Gutjahr-Löser    BCC Partners (US)
Director Corporate Communications    Phone:    +1 650 575 1509 or
Phone: +49 (0) 89 / 899 27-122       +1 415.794.8662
Fax: +49 (0) 89 / 899 27-5122    kbergman@bccprtners.com
gutjahr-loeser@morphosys.com    mcorral@bccpartners.com
Mario Brkulj   
Manager Public Relations      
Phone : +49 (0) 89 / 899 27-454      

Fax: +49 (0) 89 / 899 27-5454

brkulj@morphosys.com

     


CONFIDENTIAL

 

APPENDIX 12.13

DISPUTE RESOLUTION PROCEDURE

 

(a) Any Dispute shall be brought to the attention of a senior management representative of each Party, who shall attempt to resolve the Dispute in good faith. If, however, the senior management representatives of the Parties are unable to resolve a Dispute within thirty (30) days of being requested by a Party to do so, the CEOs or presidents (or their respective designee, provided the designee has authority to resolve the Dispute) of the Parties shall attempt in good faith to promptly resolve such Dispute within thirty (30) days.

 

(b) If the CEOs or presidents or permitted designees are unable to resolve such Dispute within such period, either Party may request the Dispute to be submitted to binding arbitration in accordance with the [***] ; provided, however, any dispute regarding the validity, scope or enforceability of patents licensed under this Agreement shall be submitted to a court of competent jurisdiction as described in Section 12.4 of the Agreement. Subject to Section (c) below, the arbitration shall be conducted in the English language in [***] by three arbitrators, one named by each Party and the third appointed in accordance with the [***] . The arbitrators, by accepting appointment, undertake to exert their best efforts to conduct the process so as to issue an award within [***] of the appointment of the last arbitrator. The arbitrators shall decide the Dispute in accordance with the law governing this Agreement. The award of the arbitrators may be entered in any court of competent jurisdiction.

 

(c) If, after exchange of the request for arbitration and the response, it appears that no Party has demanded damages greater than EURO [***] , and that no Party has demanded non-monetary relief, then there shall be only one (1) arbitrator. Such arbitrator shall be chosen by agreement of the Parties or, if the Parties are unable to reach agreement on the arbitrator within [***] of the response, the arbitrator will be appointed in accordance with the [***] .

 

(d) The costs of the arbitration as well as all reasonable out-of-pocket costs (including, without limitation, reasonable attorneys’ fees and reasonable travel expenses) shall be borne by [***] , or as determined otherwise by the arbitrators, and paid to [***] , or as determined by the arbitrators, within one (1) month from the final decision by the arbitration tribunal.

 

(e) Except as may be required by law, neither Party, nor any Affiliate thereof, nor an arbitrator may disclose the existence, content or result of any arbitration held with respect to this Agreement without the prior written consent of both Parties. The Parties mutually agree that all information, documents, testimony, exhibits and other written, recorded, graphic or other information produced, exchanged or used in any way in any arbitration proceeding under this Section are designated as confidential and shall not be disclosed to anyone other than the Parties, their attorneys and advisors, and the arbitrators.

 

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONFIDENTIAL

 

  Furthermore, any and all documents, materials or other information designated as confidential that are produced to or received by the other Party or any Affiliate as part of the arbitration proceeding shall be returned to the party that produced or provided such materials within ten (10) days of the conclusion of the arbitration, or such materials shall be certified in writing to have been destroyed within ten (10) days of the conclusion of the arbitration; provided, however, that the Parties and their counsel may retain copies of briefs and other papers filed with the arbitrators that contain or constitute such confidential material, so long as such briefs and other papers are maintained according to the confidentiality provisions of this Agreement.

 

(f) The Parties hereby agree that any award of any arbitral tribunal referred to herein may be entered by any court of competent jurisdiction.

[FINAL PAGE OF AGREEMENT]