-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, H3XgKL6AELo2zekckaOrDCWdwruBrBr2jlYkZYiwCSes/Zie77JNMaI08uzGdvIq ZaJPCZLR8spWuzTe1TBbrg== 0001193125-05-073501.txt : 20050411 0001193125-05-073501.hdr.sgml : 20050411 20050411104539 ACCESSION NUMBER: 0001193125-05-073501 CONFORMED SUBMISSION TYPE: 10-Q/A PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20040630 FILED AS OF DATE: 20050411 DATE AS OF CHANGE: 20050411 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CURAGEN CORP CENTRAL INDEX KEY: 0001030653 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 061331400 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q/A SEC ACT: 1934 Act SEC FILE NUMBER: 000-23223 FILM NUMBER: 05743057 BUSINESS ADDRESS: STREET 1: 555 LONG WHARF DRIVE STREET 2: 11TH FL CITY: NEW HAVEN STATE: CT ZIP: 06511 BUSINESS PHONE: 2034013330 MAIL ADDRESS: STREET 1: 555 LONG WHARF DRIVE CITY: NEW HAVEN STATE: CT ZIP: 06511 10-Q/A 1 d10qa.htm AMENDMENT NO. 1 TO FORM 10-Q AMENDMENT NO. 1 TO FORM 10-Q

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q/A

(Amendment No. 1)

 


 

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

 

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2004

 

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

 

FOR THE TRANSITION PERIOD FROM              TO

 

Commission File Number 0-23223

 


 

CURAGEN CORPORATION

(Exact name of registrant as specified in its charter)

 


 

Delaware   06-1331400

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

555 Long Wharf Drive, 11th Floor, New Haven, Connecticut 06511

(Address of principal executive office) (Zip Code)

 

Registrant’s telephone number, including area code: (203) 401-3330

 


 

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

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act)    Yes  x    No  ¨

 

The number of shares outstanding of the Registrant’s common stock as of July 30, 2004 was 50,084,106.

 



EXPLANATORY NOTE

 

We are filing this Amendment No. 1 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2004 as an exhibit-only filing in response to comments we received from the Securities and Exchange Commission on a confidential treatment request we made for certain portions of Exhibits 10.1 and 10.2 in our original Form 10-Q. This Amendment No. 1 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2004 is being filed solely to amend Item 6.A. to re-file Exhibits 10.1 and 10.2. The re-filed exhibits disclose portions that had previously been redacted pursuant to our request for confidential treatment.

 

This Amendment No. 1 to our Form 10-Q for the quarter ended June 30, 2004 does not reflect events occurring after the filing of our original Form 10-Q or modify or update those disclosures affected by subsequent events. No other modifications or changes have been made to our Form 10-Q for the quarter ended June 30, 2004 as originally filed or the exhibits filed therewith.

 

We are refiling Exhibit 10.1, Second Restated Collaboration Agreement, dated April 12, 2004, between Abgenix, Inc. and the Registrant, and Exhibit 10.2 License and Collaboration Agreement, dated June 3, 2004, between TopoTarget A/S and the Registrant. Confidential treatment has been granted for certain portions of Exhibits 10.1 and 10.2, which have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

 

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Part II - Other Information

 

Item 6. Exhibits and Reports on Form 8-K

 

  A. Exhibits

 

*Exhibit 10.1    Second Restated Collaboration Agreement, dated April 12, 2004, between Abgenix, Inc. and the Registrant.
*Exhibit 10.2    License and Collaboration Agreement, dated June 3, 2004, between TopoTarget A/S and the Registrant.
Exhibit 31.1    Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Exhibit 31.2    Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
! Exhibit 32    Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code).

* Confidential treatment has been granted for the redacted portions of this agreement. A complete copy of this agreement, including the redacted portions, has been filed separately with the Securities and Exchange Commission.
! Previously filed.

 

3


SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

    CuraGen Corporation
Dated: April 11, 2005   By:  

/s/ David M. Wurzer


        David M. Wurzer
       

Executive Vice-President, Chief Financial Officer

and Treasurer (principal financial and accounting

officer of the registrant)

 

4


CURAGEN CORPORATION

 

EXHIBIT INDEX

 

No.

   
*Exhibit 10.1   Second Restated Collaboration Agreement, dated April 12, 2004, between Abgenix, Inc. and the Registrant.
*Exhibit 10.2   License and Collaboration Agreement, dated June 3, 2004, between TopoTarget A/S and the Registrant.
Exhibit 31.1   Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Exhibit 31.2   Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
! Exhibit 32   Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code).

* Confidential treatment has been granted for the redacted portions of this agreement. A complete copy of this agreement, including the redacted portions, has been filed separately with the Securities and Exchange Commission.
! Previously filed.

 

 

EX-10.1 2 dex101.htm 2ND RESTATED COLLABORATION AGREEMENT 2ND RESTATED COLLABORATION AGREEMENT

Exhibit 10.1

 

SECOND RESTATED COLLABORATION AGREEMENT

 

THIS SECOND RESTATED COLLABORATION AGREEMENT (this “Agreement”), dated as of April 12, 2004, the “Revision Date”, is made between ABGENIX, INC., a Delaware corporation (“ABX”), having a place of business at 7601 Dumbarton Circle, Fremont, California 94555, and CURAGEN CORPORATION, a Delaware corporation (“CuraGen”), having a place of business at 555 Long Wharf Drive, New Haven, Connecticut 06511, with respect to the following facts:

 

RECITALS

 

A. The parties entered into the Collaboration Agreement effective as of December 8, 1999 (the “Original Agreement”) and a Restated Collaboration Agreement effective as of November 27, 2000, as subsequently amended on January 23, 2001, January 16, 2002 and January 10, 2003 (the “Restated Agreement”).

 

B. The parties desire to amend the Restated Agreement in certain respects effective as of the date hereof, and for convenience to restate the Restated Agreement, 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 amend the Restated Agreement and agree as follows:

 

  1. DEFINITIONS

 

For purposes of this Agreement, the terms set forth in this Article 1 shall have the respective meanings set forth below:

 

1.1 “ABX In-License” shall mean a license, sublicense or other agreement under which ABX acquired rights to the ABX Patent Rights or ABX Know-How, specifically including (a) that certain license agreement between ABX and the Medical Research Council, dated December 14, 1998 (as amended or restated from time to time), (b) that certain license agreement between ABX and Babraham Bioscience Technologies Limited dated May 14, 2002 (as amended or restated from time to time) and (c) that certain license agreement between ABX and ImmunoGen, Inc. dated September 5, 2000 (as amended or restated from time to time) (the “ImmunoGen Agreement”) .

 

1.2 “ABX Know-How” shall mean, collectively, all inventions, discoveries, data, information, methods, techniques, technology and other results, whether or not patentable but which are not generally known, regarding ABX Technology and Information. All ABX Know-How shall be Confidential Information of ABX.

 

1.3 “ABX Licensed Antigens” shall mean all ABX Optioned Antigens for which ABX has exercised an option to obtain a commercial license pursuant to Article 7 below, and “ABX Licensed Antigen” shall mean any one of the ABX Licensed Antigens.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 


1.4 “ABX Optioned Antigens” shall mean all antigens which are selected from the Eligible Antigens by ABX pursuant to Article 5 below (or otherwise pursuant to the Extended Research Program), for which CuraGen has the right to grant ABX the commercial license under Article 7 below, and which are not Licensed Antigens, and “ABX Optioned Antigen” shall mean any one of the ABX Optioned Antigens.

 

1.5 “ABX Patent Claim” shall mean a Patent Claim within the Licensed ABX Intellectual Property Rights.

 

1.6 “ABX Patent Rights” shall mean, collectively, (a) all patents and patent applications listed on Exhibit A and any foreign counterparts claiming priority thereof; (b) all patent applications heretofore or hereafter filed in any country which claim (and only to the extent they claim) ABX Technology and Information or the use thereof; (c) all patents that have issued or in the future issue from any of the foregoing patent applications, including without limitation utility models, design patents and certificates of invention; and (d) all divisionals, continuations, continuations-in-part, reissues, renewals, supplemental protection certificates, extensions or additions to any such patents and patent applications.

 

1.7 “ABX Product” shall mean, with respect to any ABX Licensed Antigen, any product comprising (a) an Antibody or Antibody Equivalent which binds to such ABX Licensed Antigen; or (b) Genetic Material that encodes such an Antibody or Antibody Equivalent, wherein, in respect of each ABX Product, said Genetic Material does not encode multiple antibodies.

 

1.8 “ABX Technology and Information” shall mean, collectively, (a) [*******************************]; (b) [*******************************]; (c) [*******************************], and (d) [*******************************]. [*****************************************************************].

 

1.9 “Affiliate” shall mean, with respect to any person or entity, any other person or entity which controls, is controlled by or is under common control with such person or entity. A person or entity shall be regarded as in control of another entity if it owns or controls at least fifty percent (50%) of the equity securities of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority).

 

1.10 “Antibody” shall mean a composition comprising (a) a whole antibody, or any fragment thereof, derived from the XenoMouse Animals hereunder; or (b) a whole antibody, or any fragment thereof, which is derived from a whole antibody or any fragment thereof, which itself is derived from the XenoMouse Animals hereunder or which is derived from the Genetic Material encoding or derived from, or the amino acid sequences of or derived from, a whole antibody or any fragment thereof, which itself is derived from the XenoMouse Animals hereunder.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
2


1.11 “Antibody Cells” shall mean all cells that contain, express, or secrete antibodies or Genetic Materials that encode antibodies.

 

1.12 “Antibody Equivalent” shall mean (i) [***************************], or (ii) [***************************]. For purposes of clarification, the following are not [**************]: (a) [***************************************************] and (b) [***************************************************].

 

1.13 “Antigen Specific Materials and Information” shall mean with respect to an Antigen, collectively, (a) [***********************************************]; and (b) [**********************************************************************].

 

1.14 “Antigens” shall mean, collectively, the Research Antigens, Eligible Antigens, Optioned Antigens and Licensed Antigens, and “Antigen” shall mean any one of the Antigens.

 

1.15 “BLA” shall mean a Biologics License Application, Product License Application, New Drug Application, or similar application for marketing approval of a product for use in the Therapeutic Field submitted to the FDA, or its foreign equivalent.

 

1.16 “Commercial Field” shall mean, collectively, the Therapeutic Field and the Diagnostic Field.

 

1.17 “Confidential Information” shall mean, with respect to a party, all information of any kind whatsoever, and all tangible and intangible embodiments thereof of any kind whatsoever, which is disclosed by such party to the other party pursuant to this Agreement, and (if disclosed in writing or other tangible medium) is marked or identified in writing as confidential at the time of disclosure to the receiving party or (if otherwise disclosed or if not so marked or identified in writing) is identified as confidential at the time of disclosure to the receiving party and is summarized and identified as confidential in writing or by electronic means within thirty (30) days after such disclosure. Notwithstanding the foregoing, Confidential Information of a party shall not include information which, and only to the extent, the receiving party can establish by written documentation or electronic records (a) has been publicly known prior to disclosure of such information by the disclosing party to the receiving party; (b) has become publicly known without fault on the part of the receiving party, subsequent to disclosure of such information by the disclosing party to the receiving party; (c) has been received by the receiving party at any time from a source, other than the disclosing party, rightfully having possession of and the right to disclose such information free of confidentiality obligations; (d) has been otherwise known by the receiving party free of confidentiality obligations prior to disclosure of such information by the disclosing party to the receiving party; or (e) has been independently developed (as demonstrated by contemporaneous written or electronic evidence maintained in the ordinary course of business of the receiving party) by employees or agents of the receiving party without access to or use of such information disclosed by the disclosing party to the receiving party.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
3


1.18 “CuraGen Databases” shall mean, collectively, all data, information and materials (other than Research Program Technology and Information) related to human Genetic Materials and the expression products thereof which as of the Effective Date are contained in CuraGen’s SeqCalling Database or which at any time during the term of this Agreement are added thereto. For purposes hereof, the CuraGen SeqCalling Database shall include without limitation the following data, information, and materials possessed, acquired or developed by CuraGen as of the Effective Date or at any time during the term of this Agreement, the acquisition or development of which has not been sponsored or directed by a commercial Third Party to whom rights in such data, information, and materials have been granted in advance (without breaching the exclusivity obligations of this Agreement): (i) sequence data with respect to human Genetic Materials (including expressed sequences) and expression products thereof; (ii) the tissue or cellular distribution relating to such Genetic Materials, their expression and expression products; (iii) literature publications and patent status (i.e., information related to CuraGen filing dates, priority of claim(s) and any related patents and patent applications, and any information known by CuraGen regarding Third Party patents and patent applications) related to such Genetic Materials and expression products; (iv) the biological function of such Genetic Materials and expression products; (v) clones, expression products, proteins, cell lines and vectors related to such Genetic Materials and expression products, and (vi) all of the data, information, and materials described in the foregoing clauses (i) to (v) with respect to any homologs of such Genetic Materials and expression products. As of the Effective Date, the CuraGen SeqCalling Database includes at least [************************************].

 

1.19 “CuraGen Exclusive Antigen” shall mean an antigen (other than a Research Antigen) or Research Antigen that is designated by CuraGen as a CuraGen Exclusive Antigen in accordance with Section 4.6.

 

1.20 “CuraGen Know-How” shall mean, collectively, all inventions, discoveries, data, information, methods, techniques, technology and other results, whether or not patentable but which are not generally known, regarding CuraGen Technology and Information. All CuraGen Know-How shall be Confidential Information of CuraGen.

 

1.21 “CuraGen Licensed Antigens” shall mean all CuraGen Optioned Antigens for which CuraGen has exercised an option to obtain a commercial license pursuant to Article 7 below, and “CuraGen Licensed Antigen” shall mean any one of the CuraGen Licensed Antigens.

 

1.22 “CuraGen Optioned Antigens” shall mean all antigens which are selected from the Eligible Antigens by CuraGen pursuant to Article 5 below (or otherwise pursuant to the Extended Research Program), for which ABX has the right to grant CuraGen the commercial license under Article 7 below, and which are not Licensed Antigens, and “CuraGen Optioned Antigen” shall mean any one of the CuraGen Optioned Antigens.

 

1.23 “CuraGen Patent Claim” shall mean a Patent Claim within the Licensed CuraGen Intellectual Property Rights, other than Patent Claims that are (i) directed to a method of use of the Research Antigen or antibodies to such antigen that is initially identified solely

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
4


through the use of Antigen Specific Materials and Information or (ii) enabled solely by data relating to or supporting a specific indication that was initially identified solely through the use of the Antigen Specific Materials and Information.

 

1.24 “CuraGen Patent Rights” shall mean, collectively, (a) all patent applications heretofore or hereafter filed in any country which claim (and only to the extent they claim) CuraGen Technology and Information or the use thereof; (b) all patents that have issued or in the future issue from any of the foregoing patent applications, including without limitation utility models, design patents and certificates of invention; and (c) all divisionals, continuations, continuations-in-part, reissues, renewals, supplemental protection certificates, extensions or additions to any such patents and patent applications.

 

1.25 “CuraGen Product” shall mean, with respect to any CuraGen Licensed Antigen, any product comprising (a) an Antibody or Antibody Equivalent which binds to such CuraGen Licensed Antigen, or (b) Genetic Material that encodes such an Antibody or Antibody Equivalent wherein, in respect of each CuraGen Product, said Genetic Material does not encode multiple antibodies.

 

1.26 “CuraGen Technology and Information” shall mean, collectively, (a) [*******************************]; (b) [*********************************]; (c) [*******************************]; and (d) [******************************]. [*************************************************************************].

 

1.27 “Derived” or “derived” shall mean obtained, developed, created, synthesized, designed, derived or resulting from, based upon or otherwise generated (whether directly or indirectly, or in whole or in part).

 

1.28 “Diagnostic Field” shall mean the use of Products for the following human medical purposes: the detection, diagnosis and monitoring of [*************], predisposition, state or condition in humans or the selection of a particular patient(s) to receive a particular therapeutic treatment(s).

 

1.29 “Effective Date” shall mean December 8, 1999.

 

1.30 “Eligible Antigen” shall mean a Research Antigen which satisfies the criteria of Exhibit B as determined by the JMC pursuant to Section 3.2 below or the arbitrator pursuant to Section 3.5 below, and which is not an Optioned Antigen.

 

1.31 “Excluded ABX Technology” shall mean, collectively, [***********************************] (a) [*********************************]; (b) [********************************]; (c) [***************************]; (d) [***************************]; (e) [***************************]; and (f) [***************************].

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
5


1.32 “Excluded CuraGen Technology” shall mean, collectively, [**************************************] (a) [*******************************]; (b) [***********************************]; and (c) [***************************].

 

1.33 “FDA” shall mean the United States Food and Drug Administration or its successor agency.

 

1.34 “First Commercial Sale” shall mean, with respect to each Product in each country, the date of first commercial sale (other than for purposes of obtaining regulatory approval) of such Product by a party hereto, its Sublicensee or their respective Affiliates to an unaffiliated Third Party in such country.

 

1.35 “Gene Therapy” shall mean the treatment or prevention of a disease by means of Ex Vivo or In Vivo delivery (via viral or nonviral gene transfer systems) of compositions comprising either (a) Genetic Material that encodes an Antibody, wherein such Antibody serves a material function in the treatment or prevention of such disease; (b) Genetic Material that encodes a moiety other than an Antibody, wherein the moiety serves a material function in the treatment or prevention of such disease and wherein such composition incorporates an Antibody (or Genetic Material that encodes such Antibody), which Antibody is used as a targeting vehicle for the composition; or (c) Genetic Material that encodes an Antibody that serves a material function in the treatment or prevention of such disease, wherein such composition also incorporates an Antibody (or Genetic Material that encodes such Antibody) which Antibody is used as a targeting vehicle for the composition. “Ex Vivo” delivery shall mean the introduction, outside of the body of a human, of such compositions into a cell, tissue, organoid, or organ, followed by the administration of the cell, tissue, organoid, or organ which contains such introduced compositions into the body of the same (autologous) or different (allogeneic) human, without limitation as to the formulation, anatomic site, or route of administration or the use of encapsulation or other devices for such administration. “In Vivo” delivery shall mean the introduction of such compositions into an individual, without limitation as to the formulation, anatomic site, or route of administration or the use of encapsulation or other devices for such administration.

 

1.36 “Genetic Material” shall mean a nucleic acid, including DNA, RNA, and nucleic acid complementary and reverse complementary to such nucleotide sequences or nucleic acid, whether coding or noncoding and whether intact or a fragment.

 

1.37 “GenPharm Cross License Agreement” shall mean that certain Cross License Agreement entered into by and between ABX, JTI, XT, Cell Genesys, Inc., and GenPharm International, Inc., effective as of March 26, 1997, as the same may be amended from time to time.

 

1.38 “Human Antibody Equivalent” shall mean (i) [*********************], or (ii) [********************************************************************].

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
6


1.39 “IND” shall mean an Investigational New Drug application filed with the FDA, or any similar filing with any foreign regulatory authority, to commence human clinical testing of any Product in any country.

 

1.40 “JMC” shall mean the joint management committee comprising representatives of ABX and CuraGen described in Section 3.1 below.

 

1.41 “JTI” shall mean Japan Tobacco Inc., a Japanese corporation.

 

1.42 “Licensed Antigens” shall mean, collectively, the ABX Licensed Antigens and CuraGen Licensed Antigens, and “Licensed Antigen” shall mean any one of the Licensed Antigens.

 

1.43 “Licensed ABX Intellectual Property” shall mean ABX’s rights in the ABX Patent Rights, ABX Know-How, Research Program Patent Rights and Research Program Know-How; provided, however, that the Licensed ABX Intellectual Property (a) is all to the extent and only to the extent that ABX has the right to grant (sub) licenses thereunder (including without limitation to the extent permitted under the applicable ABX In-Licenses); (b) is expressly subject to the ABX In-Licenses; and (c) shall exclude the Excluded ABX Technology.

 

1.44 “Licensed CuraGen Intellectual Property” shall mean CuraGen’s rights in the CuraGen Patent Rights, CuraGen Know-How, Research Program Patent Rights and Research Program Know-How; provided, however, that the Licensed CuraGen Intellectual Property (a) is all to the extent and only to the extent that CuraGen has the right to grant (sub) licenses thereunder; and (b) shall exclude the Excluded CuraGen Technology.

 

1.45 “Licensed Intellectual Property” shall mean, collectively, the Licensed ABX Intellectual Property and the Licensed CuraGen Intellectual Property.

 

1.46 “Net Sales” shall mean, with respect to a Product, the gross sales price charged by a party, its Sublicensees and their respective Affiliates for sales of such Product to non-Affiliate customers, less (a) [***************************]; (b) [*****************]; and (c) [**********************************************************************]. [****************************************************************************].

 

1.47 “Optioned Antigens” shall mean, collectively, the ABX Optioned Antigens and CuraGen Optioned Antigens, and “Optioned Antigen” shall mean any one of the Optioned Antigens.

 

1.48 “Patent Claim” shall mean a claim of a pending patent application (pending for no longer than five (5) years) or issued and unexpired patent included within the Licensed Intellectual Property which has not been held unenforceable or invalid by 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, disclaimer or otherwise.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
7


1.49 “Person” shall mean an individual, corporation, partnership, limited liability company, 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.

 

1.50 “Phase I Clinical Trial” shall mean a human clinical trial in any country that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects, or that would otherwise satisfy requirements of 21 CFR 312.21(a), or its foreign equivalent.

 

1.51 “Phase II Clinical Trial” shall mean a human clinical trial in any country that is intended to initially evaluate the effectiveness of a Product for a particular indication or indications in patients with the disease or indication under study, or that would otherwise satisfy requirements of 21 CFR 312.21(b), or its foreign equivalent.

 

1.52 “Phase III Clinical Trial” shall mean a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a Product as a basis for a marketing approval application submitted to the FDA, or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

 

1.53 “PMA” shall mean a Pre-Market Approval Application, 510(k) notice or similar application for marketing approval of a product for use in the Diagnostic Field submitted to the FDA, or its foreign equivalent.

 

1.54 “Products” shall mean, collectively, the ABX Products and the CuraGen Products, and “Product” shall mean any one of the Products.

 

1.55 “Program Year” shall mean any period commencing on the Effective Date or any anniversary thereof, and continuing through the first anniversary thereof, during the term of the Research Program.

 

1.56 “Research Antigens” shall mean, collectively, the antigens which are selected by the JMC, ABX or CuraGen pursuant to Section 4.1 below for use in the Research Program, for which ABX and CuraGen have the right to grant the other party the commercial license under Article 7 below, and which are not Optioned Antigens or Licensed Antigens, and “Research Antigen” shall mean any one of the Research Antigens.

 

1.57 “Research Field” shall mean the use of materials derived from XenoMouse Animals that are immunized with Research Antigens solely for the creation, identification, analysis, research, characterization and preclinical development of potential Products for use in the Commercial Field.

 

1.58 “Research Program” shall mean the collaborative research program described in Section 4.4 below

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
8


1.59 “Research Program Know-How” shall mean, collectively, all inventions, discoveries, data, information, methods, techniques, technology and other results, whether or not patentable but which are not generally known, regarding Research Program Technology and Information or the use thereof.

 

1.60 “Research Program Technology and Information” shall mean, with respect to an Antigen, collectively, (a) [**************************************************]; and (b) [*********************************************************************].

 

1.61 “Research Program Patent Rights” shall mean, collectively, (a) all patent applications hereafter filed in any country which claim Research Program Technology and Information or the use thereof; (b) all patents that have issued or in the future issue from any of the foregoing patent applications, including without limitation utility models, design patents and certificates of invention; and (c) all divisionals, continuations, continuations-in-part, reissues, renewals, supplemental protection certificates, extensions or additions to any such patents and patent applications.

 

1.62 “Royalty Commencement Date” shall mean, with respect to each Product in each country, the date of the First Commercial Sale of such Product in such country.

 

1.63 “Sublicense” shall mean, with respect to a Product, an agreement or arrangement pursuant to which a (sub) license or distribution right regarding such Product has been granted to a Sublicensee.

 

1.64 “Sublicense Income” shall mean, with respect to a Product, the aggregate cash consideration, and the fair market value of the non-cash consideration, received by a party or its Affiliate in connection with the Sublicense of such Product, excluding consideration received (a) in reimbursement of such party’s or its Affiliate’s cost to perform research, development or similar services conducted for such Product after the grant of such Sublicense, (b) in reimbursement of patent or other out-of-pocket expenses on such Product, or (c) in consideration for the purchase of any securities of such party or its Affiliates at a price equal to no more than 120% of the then fair market value of such securities).

 

1.65 “Sublicensee” shall mean a Third Party that is granted (a) a (sub) license under the Licensed Intellectual Property to develop, make, use, offer for sale, sell or import a Product in the Commercial Field; or (b) a right to distribute a Product in the Commercial Field, provided that such Third Party is responsible for marketing and promotion of such Product within the applicable territory.

 

1.66 “Technology and Information” shall mean, collectively, the ABX Technology and Information, CuraGen Technology and Information and Research Program Technology and Information.

 

1.67 “Therapeutic Field” shall mean the use of Products for the following human medical purposes: the prevention or treatment of [***************************].

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
9


1.68 “Third Party” shall mean any Person other than ABX, CuraGen and their respective Affiliates.

 

1.69 “XenoMouse Animals” shall mean the transgenic mice capable of producing human antibodies when immunized by ABX with an antigen.

 

1.70 “XT” shall mean Xenotech, L.P., a California limited partnership.

 

1.71 “XT Master Research License and Option Agreement” shall mean that certain Master Research License and Option Agreement entered into by and among XT, JTI and Cell Genesys, Inc. effective as of June 28, 1996, and subsequently assigned to ABX by Cell Genesys, Inc., as the same may be amended from time to time.

 

1.72 “XT/ABX Product License Agreement” shall mean a license agreement between XT and ABX entered into pursuant to the XT Master Research and License Agreement granting to ABX a license (with the right to grant sublicenses) to commercialize Products in one or more territories.

 

1.73 “Conjugate” shall mean a specific composition, as mutually agreed upon by the parties in writing, which ABX owns or to which ABX otherwise has rights (including the right to grant sublicenses to CuraGen hereunder) to be conjugated to one or more Antibodies hereunder. “DM1”, as defined under the ImmunoGen Agreement, is the initial Conjugate.

 

1.74 “Imaging Peptide” shall mean a peptide that (a) is less than fifty (50) amino acids in length, and (b) is not derived from an Antibody Equivalent.

 

1.75 “Lambda Antibodies” shall mean Antibodies derived from the Lambda XenoMouse Animals hereunder comprising a human lambda light chain.

 

1.76 “Lambda Licensed Antigen” shall mean an Optioned Antigen that is designated as a Lambda Licensed Antigen at the time CuraGen exercises an option to take a commercial license to such Optioned Antigen under Article 7.

 

1.77 “Lambda Optioned Antigen” shall mean an Optioned Antigen for which Lambda XenoMouse Animals will or may be immunized under the Research Program and designated as such pursuant to Section 5.

 

1.78 “Lambda XenoMouse Animals” shall mean XenoMouse Animals that are transgenic for a portion of the human lambda light chain immunoglobulin locus and produce human lambda light chain-containing immunoglobulin molecules.

 

1.79 “Specifically Binds” refers to those antibodies that have a minimum affinity (KD value) of [******] (as measured by standard techniques such as the BIAcore) toward a specified antigen and do not bind to related isozymes, proteins or antigens with an affinity of better than [***].

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
10


  2. REPRESENTATIONS AND WARRANTIES

 

Each party hereby represents and warrants to the other party as follows:

 

2.1 Existence. Such party is duly organized, validly existing and in good standing under the laws of the state in which it is organized.

 

2.2 Authorization and Enforcement of Obligations. Such party: (a) has the requisite power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder; and (b) has taken all requisite action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation enforceable against such party in accordance with its terms except as enforcement may be limited by equitable remedies or defenses and applicable bankruptcy laws.

 

2.3 No Consents. 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 have been obtained.

 

2.4 No Conflict. The execution and delivery of this Agreement and the performance of such party’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 it.

 

2.5 ABX In-Licenses. ABX has made available to counsel to CuraGen correct copies of ABX In-Licenses, as in effect on the Effective Date.

 

2.6 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND REGARDING TECHNOLOGY AND INFORMATION, PRODUCTS OR LICENSED INTELLECTUAL PROPERTY EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OR VALIDITY. ALL TECHNOLOGY AND INFORMATION IS PROVIDED “AS IS.”

 

  3. JOINT MANAGEMENT COMMITTEE

 

3.1 Composition. The JMC shall comprise three (3) named representatives of CuraGen and three (3) named representatives of ABX. Each party shall notify the other party in writing of its initial representatives to the JMC within ten (10) days after the Effective Date, and may substitute one or more representatives from time to time effective upon written notice to the other party.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
11


3.2 Responsibilities. The JMC shall be responsible for (a) selecting antigens from the CuraGen Databases as Research Antigens; (b) monitoring and reporting the progress of the Research Program; (c) recommending to the parties any modifications to the Research Program with respect to any or all of the Research Antigens; (d) facilitating open and frequent exchange of information between the parties regarding the Research Program; (e) reviewing the data and information regarding Research Antigens and determining whether a Research Antigen satisfies the criteria set forth in Exhibit B; and (f) making selections of Eligible Antigens under Article 5 below. The JMC shall also be responsible for discussing potential Conjugates that are to be utilized in the Research Program; provided, however, that no Conjugate shall be utilized in the Research Program until the parties have mutually agreed in writing (i) that such Conjugate shall be used in the Research Program, and (ii) those specific one or more Antibodies with which such Conjugate will be utilized.

 

3.3 Meetings. The JMC shall meet in person (unless otherwise agreed on a meeting-by-meeting basis) not less than once each calendar quarter during the term of the Research Program, on such dates and at such times and places as agreed to by CuraGen and ABX, alternating between Fremont, California and New Haven, Connecticut, or such other locations as the parties mutually agree. For all other meetings, the JMC may meet by telephonic or video conference or in person, as the parties mutually agree. Each party shall have the right to have one (or such greater number as the parties mutually agree) employee or agent who is not a member of the JMC attend each meeting of the JMC as a non-voting observer. Each party shall be responsible for all its own personnel, travel and related expenses relating to JMC meetings. The first meeting of the JMC shall take place at the offices of ABX as soon as practicable after the Effective Date, but in no event later than thirty (30) days after the Effective Date.

 

3.3.1 Within thirty (30) days following each JMC meeting, the party hosting the meeting (or entitled to host the meeting, if held by telephonic or video conference or at a location other than Fremont, California or New Haven, Connecticut) shall prepare and provide to the other party mutually acceptable, reasonably detailed written minutes describing (a) all matters reviewed or considered by the JMC; (b) all discussions regarding potential and actual Antigens; and (c) all determinations and actions of the JMC and the reasons therefor. Such minutes shall be the Confidential Information of both ABX and CuraGen; provided, however, that to the extent that such minutes relate to the Optioned Antigens and Licensed Antigens of a party they shall be the Confidential Information solely of such party.

 

3.3.2 Not less than ten (10) days prior to each regularly scheduled quarterly meeting of the JMC, each party shall provide the other party with all data and information, not previously disclosed to the other party, regarding the activities of such party under the Research Program.

 

3.3.3 Not less than five (5) days prior to each regularly scheduled meeting of the JMC, each party shall provide the other party with a list of the antigens that such party desires to discuss at such JMC meeting for potential use in the Research Program.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
12


3.4 Actions. ABX and CuraGen each shall be entitled to cast one vote on matters before the JMC. Decisions of the JMC shall be made by unanimous approval.

 

3.5 Disagreements. All disagreements within the JMC shall be resolved in the following manner:

 

3.5.1 Promptly upon receipt of written notice (a “Dispute Notice”) from one party to the other of a disagreement to be resolved under this Paragraph 3.5, the JMC representatives of each party promptly shall present the disagreement to the chief executive officer of such party.

 

3.5.2 The chief executive officers of each party thereafter shall meet to discuss each party’s view and to explain the basis for their respective positions of such disagreement, and in good faith shall attempt to resolve such disagreement among themselves.

 

3.5.3 If, within thirty (30) days after receipt of a Dispute Notice as to whether a Research Antigen satisfies the criteria of Exhibit B, the chief executive officers of each party cannot resolve such disagreement, then upon written notice from one party to the other party, such disagreement shall be settled as follows. Within forty five (45) days after receipt of such Dispute Notice, the parties shall attempt to mutually agree upon a single independent Third Party arbitrator, who shall be a scientific professional in the antibody field, to resolve such disagreement. If the parties are unable to mutually agree upon one such person, then each party shall appoint one independent Third Party scientific professional in the antibody field prior to the expiration of such forty five (45) day period, and within sixty (60) days after receipt of such Dispute Notice, such person(s) shall select a single independent Third Party arbitrator, who shall be a scientific professional in the antibody field, to resolve such disagreement. Each party shall present all information presented to the JMC and all other information as such party reasonably desires regarding such disagreement. Within ninety (90) days after receipt of such Dispute Notice, such arbitrator shall determine whether such Research Antigen satisfies the criteria of Exhibit B and provide written notice to the parties regarding such determination.

 

  4. RESEARCH ANTIGEN IDENTIFICATION AND RESEARCH

 

4.1.1 Searches for Research Antigens. During the term of the Research Program, CuraGen shall have primary responsibility for the screening of the CuraGen Databases and shall conduct searches thereof to identify and recommend to the JMC potential antigens of interest hereunder. CuraGen shall recommend to the JMC [***] antigens of interest (whether or not the genes encoding such antigens are contained in the CuraGen Databases) that, based on the data and information in the CuraGen Databases and such other data and information as CuraGen may have acquired or developed, (i) CuraGen reasonably believes is not the subject of any Third Party intellectual property rights (or the parties mutually believe, as evidenced by written agreement, that a license to all applicable Third Party intellectual property rights can be

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
13


reasonably obtained), (ii) CuraGen reasonably believes could be subject (or the parties mutually believe, as evidenced by written agreement, that the antibodies to which could be subject) to a proprietary position of CuraGen, (iii) CuraGen reasonably believes would be available hereunder as a Research Antigen, and (iv) CuraGen reasonably believes is reasonably likely to have potential as a target for antibody-based therapeutics. In addition, CuraGen will use its best efforts to recommend to the JMC antigens that would have an IP Score (as defined below) of 1, 2, or 3 and not 4 or 5 in a sufficient number to allow selection of at least [*****] Priority Research Antigens per year from the CuraGen Databases. ABX shall have the right, but not the obligation, to recommend to the JMC antigens of interest from the CuraGen Databases or from other sources that ABX reasonably believes are not the subject of Third Party intellectual property rights and would be available hereunder as Research Antigens and are reasonably likely to have potential as targets for antibody-based therapeutics.

 

4.1.2 Research Antigen Selection.

 

During the term of the Research Program, based upon the data and information provided by the parties regarding potential antigens of interest, the JMC shall select at any JMC meeting, from those antigens proposed by the parties under Section 3.3.3 and 4.1, potential antigens of interest for use in the Research Program. With respect to each potential antigen which is selected, by the action of the JMC, for use under the Research Program, within thirty (30) days after the date of such JMC meeting, each party shall notify the other party in writing if such party does not have the right to grant the other party a commercial license under Article 7 below for such antigen. Unless a party timely notifies the other party in writing that it does not have the right to grant the other party a commercial license under Article 7 below for such antigen, such antigen thereafter shall be a Research Antigen.

 

4.1.3 Notwithstanding anything to the contrary in this Agreement, if a party gives written notice to the other party at any time stating that such party does not have the right to grant the other party a commercial license under Article 7 below for a Research Antigen, then effective thirty (30) days after the receipt by the other party of such notice, such antigen shall cease to be a Research Antigen and both parties shall destroy all Antigen Specific Materials and Information pertaining to such antigen. A party shall give such written notice to the other party promptly upon the occurrence of the event giving rise to such party’s not having the right to grant the other party a commercial license under Article 7, to the extent such party has the right to do so.

 

4.2 Research Program.

 

4.2.1 Research Responsibilities. During the term of the Research Program, each party shall use its commercially reasonable efforts to perform its obligations set forth in the Work Plan within the time schedules contemplated therein. The JMC may recommend changes to the allocation of responsibilities set forth in Exhibit C, from time to time; provided, however, that such changes shall only be effective if in a written amendment duly executed by both parties. Other than the activities specified in Exhibit C as being the

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
14


responsibility of one party or another, the JMC shall allocate the responsibility for each such activity between the parties, taking into account the skills of each party, in an effort to divide the resources and internal costs reasonably required to be dedicated by each party to the conduct of such activities [*******************]. In the event that any activities with respect to Research Antigens (other than CuraGen Exclusive Antigens), other than those specified in Exhibit C as being the responsibility of one party or another, require any payments to a Third Party for goods or services (e.g., specific animal models), such payments shall be [*******************], provided that all such goods and services and payments therefor are approved by the JMC prior to incurring any such expense. Notwithstanding anything to the contrary in this Agreement, all activities with respect to Research Antigens that are CuraGen Exclusive Antigens, other than the generation and biochemical characterization of Antibodies as described and allocated to ABX in Exhibit C, shall be the sole and exclusive responsibility of CuraGen, at its sole cost and expense. With respect to each Research Antigen, during the term of the Research Program, each party may conduct, in its sole discretion, such additional preclinical research in the Research Field as such party reasonably desires to evaluate its interest in such Research Antigen, provided that, the preceding right shall not apply to ABX in the case of Research Antigens that are CuraGen Exclusive Antigens, and provided further that prior to commencing such additional preclinical research with respect to Research Antigens that are not CuraGen Exclusive Antigens, such party shall give prior written notice to the other party of the nature and scope of such additional preclinical research regarding such Research Antigen and shall provide the other party with all results of such research, which research shall be deemed to have been part of the Research Program. Each party shall provide the personnel, materials, equipment and other resources required to conduct its obligations hereunder; provided, however, that CuraGen shall transfer to ABX all information and materials available to CuraGen that are useful in the conduct of all assays conducted by or on behalf of CuraGen in connection with the Research Program. ABX shall reimburse CuraGen for all reasonable out-of-pocket expenses incurred in effecting such transfer. CuraGen grants to ABX the nonexclusive, worldwide license (without the right to grant sublicenses) to practice and use all such assays both (a) for use in the Research Program, and (b) for research purposes (unrelated to the Research Program or CuraGen) related to the research and development of antigens and/or antibodies. Each party shall perform its obligations hereunder in accordance with high scientific and professional standards, and in compliance in all material respects with the requirements of applicable laws and regulations. Each party shall provide reasonable assistance required by the other party in connection with the performance of the Research Program. Each party shall have the right, at reasonable times during normal business hours and upon reasonable notice, to visit the facilities of the other party where the other party is conducting its obligations under the Research Program to observe such activities.

 

4.2.2 Research Antigen Work Plans.

 

(a) Each year, the JMC will prioritize up to [****] Research Antigens for immunization based on IP Score (as defined below) and biology (“Priority Research Antigens”). The Parties agree that for purposes of this Agreement, an “IP Score” for a Research Antigen shall be determined as follows: (i) if CuraGen has priority for the composition of matter for a full length Research Antigen (that is not a variant) such Research Antigen will be accorded a IP

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
15


Score of 1, (ii) if CuraGen has priority for the composition of matter of a Research Antigen that is a variant and has priority for data demonstrating a novel method of use for such variant or antibodies thereto such Research Antigen shall be accorded an IP Score of 2, (iii) if the composition of matter of a Research Antigen has been publicly disclosed in the literature (other than the patent literature, unless such disclosure does not include a disclosure of antibodies) before CuraGen’s priority date and CuraGen has priority for data demonstrating a novel method of use for such variant or antibodies thereto, such Research Antigen shall be accorded an IP Score of 3, (iv), if the composition of matter of a Research Antigen (or antibodies thereto) has been disclosed in patent literature together with a disclosure of antibodies before CuraGen’s priority date such Research Antigen shall be accorded an IP Score of 4, and (v) if the composition of matter of a Research Antigen (or antibodies thereto) has been claimed in an issued or granted patent in the patent literature together with a disclosure of antibodies before CuraGen’s priority date such Research Antigen shall be accorded an IP Score of 5. Unless agreed as provided herein, neither Party shall have any obligation to undertake any work or continue any work with respect to a Research Antigen accorded an IP Score of 4 or 5 and no Research Antigen accorded an IP Score of 4 or 5 shall be a Priority Research Antigen unless ABX agrees in writing. In the event that CuraGen reasonably believes that, notwithstanding a Research Antigen having an IP Score of 4 or 5, CuraGen has priority for a substantive method of use for the Research Antigen not previously disclosed in the literature, CuraGen shall have the right to propose such Research Antigen for reconsideration by ABX and if ABX agrees to such reconsideration, present information demonstrating such method of use and CuraGen’s priority information. Upon a determination by ABX that such a Research Antigen would be acceptable, such Research Antigen shall be accorded an IP Score of “4-MOU” or “5-MOU”, as the case may be, and may be designated a Priority Research Antigen. From the pool of Priority Research Antigens, ABX will attempt to raise Antibodies by immunization of Xenomouse Animals and the Parties will attempt to generate and characterize such Antibodies to such Priority Research Antigens. The Parties will use reasonable efforts to analyze or reanalyze, as the case may be, the IP Score of each proposed Priority Research Antigen within ten (10) business days of its becoming a proposed Priority Research Antigen. If the JMC determines to reimmunize a Xenomouse Animal with a Research Antigen, it will be counted as one of the Priority Research Antigens.

 

(b) For each Priority Research Antigen a Work Plan will be created, including design of the immunogen(s) and specification of all assays required for Eligible Antigen designation pursuant to Exhibit B. For each Research Antigen for which research activities have already begun as of the Revision Date, a Work Plan will be created that summarizes the work already completed and the work that remains for Eligible Antigen designation pursuant to Exhibit B. In each case, the Work Plan will detail the work to be done or remaining to be done and define the responsibility of each party in conducting the work under the Work Plan consistent with Section 4.2.2. It is understood and agreed by the Parties that Exhibit C shall serve as a guide for the creation of the Work Plans of each Research Antigen, however, the Work Plan once created and agreed to by the Parties shall take precedence over Exhibit C with respect to the particular Research Antigen to which the Work Plan applies.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
16


(c) Failure by ABX to immunize a Xenomouse Animal within thirty (30) days of delivery of an immunogen by CuraGen for a Priority Research Antigen meeting the Work Plan criteria for such Priority Research Antigen will result in that Priority Research Antigen being no longer designated as a Research Antigen. ABX will return all CuraGen Technology and Information to CuraGen related to such Research Antigen and CuraGen will no longer be subject to exclusivity provisions of Section 4.4 with respect to such Research Antigen.

 

4.2.3 Neither Party is obligated to perform any further research on a Research Antigen outside the scope of the agreed upon Work Plan once such Work Plan is completed unless a new Work Plan is agreed to by the JMC. If either Party unreasonably fails to perform an assigned task under a Work Plan after written request for more than 90 days from the date of the request, unless such delay is due to the failure of the other Party to perform, the other Party can perform it instead and be reimbursed by the originally assigned Party.

 

4.2.4 The parties shall [**********] all costs incurred by ABX for the provision of the Conjugates prior to the selection of an Eligible Antigen by one of the parties including without limitation (a) fees paid by ABX in consideration for the Conjugate in-licensed technology to the extent such fees are directly related to the use of the Conjugates hereunder and are payable prior to such selection, and (b) costs of scale-up manufacturing of Conjugates incurred by ABX prior to such selection.

 

4.2.5 Access. Without limiting the generality of Section 4.1, each party shall permit up to three (3) employees of the other party access to such party’s facilities, upon reasonable advance notice, at all times during normal business hours during the term of the Research Program Term to work with the employees of such party in the development and use of assays pursuant to the Research Program. Each party shall provide such employees of the other party in person access to one or more employees of such party skilled in the development and use of such assays to enable such employees of such other party to utilize such assays and develop similar assays for use in the Research Program and, in the case of ABX, as contemplated under Section 4.2.2; provided, however, except as otherwise provided in Section 4.2.2, that no license (or sublicense, as the case may be) to any intellectual property relating to such assays is granted hereby, whether expressly or by implication.

 

4.2.6 Term of the Research Program. Unless this Agreement is earlier terminated, the term of the Research Program shall commence on the Effective Date and shall continue through completion of all Work Plans for Research Antigens for which CuraGen has delivered to ABX for immunization on or prior to June 30, 2005 an immunogen meeting the Work Plan criteria for such Research Antigen (the “Last Immunization Date”). Without limiting the generality of the foregoing, CuraGen will have no obligation to deliver Research Antigens after June 30, 2005 and ABX will have no obligation to immunize Xenomouse Animals with Research Antigens delivered after June 30, 2005 or conduct any further work with respect to such unimmunized antigens.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
17


4.2.7 Extended Research. Subject to Sections 6.1.4, 6.1.5, 6.1.6, both parties may use Antibody Specific Materials and Information and Research Program Technology and Information relating to Research Antigens (i) for which Xenomouse Immunizations were conducted but that failed to become Eligible Antigens, as listed on Exhibit E and as updated by agreement of the JMC, or (ii) which became Unpicked Eligible Antigens under Section 5.2.12 (“Extended Research Antigens”). At any time during the term of the Extended Research License under Section 6.1.6 (the “Extended Research License Term”), either party can designate such a Research Antigen as an Optioned Antigen by notice to the other and payment of the Section 8.2.1 fee, provided that a commercial license is available from the other party. If a commercial license is not available, the Extended Research License shall terminate for such Antigen and each party shall destroy all Antigen Specific Materials and Information related to such antigen. Further, at any time during the Extended Research License Term, should an antigen subject to the Extended Research License cease to be available for commercial license, the party no longer having the right to grant the exclusive license shall notify the other party and the Extended Research License shall immediately terminate and each party shall destroy all Antigen Specific Materials and Information related to such antigen.

 

4.3 Research Records and Reports.

 

4.3.1 Research Records. Each party shall maintain records, in sufficient detail and in good scientific manner appropriate for patent purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of the activities under the Research Program. Each party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all such records of the other party to the extent reasonably required for the performance of its obligations under this Agreement. Each party shall maintain such records and the information of the other party contained therein in confidence in accordance with Article 11 below.

 

4.3.2 Research Reports and Information. Each party shall keep the other informed of the progress of its own activities under the Research Program. At a minimum, within thirty (30) days following the last day of each calendar quarter during the term of the Research Program, each party shall prepare, and provide to the other party, a reasonably detailed written summary report which shall describe the work performed by such party to date under the Research Program.

 

4.4 Exclusivity.

 

4.4.1 Except as otherwise expressly permitted under this Agreement, during the term of the Research Program, CuraGen shall not, and shall not grant any license (or sublicense, as the case may be), immunity or other right to any Person to, research, develop, make, have made, use, import, offer to sell or sell any Antibody Equivalent to [**************(***************)] for use in the prevention, treatment, detection, diagnosis or monitoring of, or the determination of a predisposition for, or the selection of a particular patient(s) to receive a particular therapeutic treatment(s) for, any disease, state or condition in

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
18


humans; provided, however, that the foregoing limitation shall not apply to antigens as to which ABX has notified CuraGen that it does not have the right to grant CuraGen a commercial license under Article 7 unless ABX has agreed to pay CuraGen the amounts provided hereunder upon the development and commercialization of an antibody product targeting such antigen as if it were an ABX Product hereunder in return for the licenses from CuraGen for such product as if it were an ABX Product hereunder. Notwithstanding the foregoing, CuraGen shall have the right to research, develop, make, have made, use, import, offer to sell or sell, on its own or with a Third Party, and to grant a license (or sublicense, as the case may be) to a Third Party to research, develop, make, have made, use, import, offer to sell or sell, an Antibody Equivalent to an antigen for use in the prevention, treatment, detection, diagnosis or monitoring of, or the determination of a predisposition for, or the selection of a particular patient(s) to receive a particular therapeutic treatment(s) for, any disease, state or condition in humans, (i) pursuant to the provisions of an agreement set forth in Exhibit D as such agreements are in effect on November 27, 2000 or (ii) if CuraGen does not, in good faith, have the beliefs set forth in clauses (i) and (ii) of the second sentence of Section 4.1 with respect to an antigen that is not a Research Antigen. Notwithstanding anything to the contrary in Section 4.1, if CuraGen does not, in good faith, have the beliefs set forth in clauses (i) and (ii) of the second sentence of Section 4.1 with respect to a Research Antigen for which both (i) no Antibodies exist and (ii) immunizations of XenoMouse Animals in attempt to generate Antibodies are not in progress, CuraGen may give written notice thereof to ABX and propose dropping such Research Antigen as a Research Antigen. If, within thirty (30) days after ABX receives such notice with respect to such Research Antigen, ABX does not give written notice to CuraGen of its consent to designate such Research Antigen as a Priority Research Antigen, then such Research Antigen shall no longer be a Research Antigen and notwithstanding anything to the contrary in this Section 4.4, (a) CuraGen shall have the right to research, develop, make, have made, use, import, offer to sell or sell, and to grant a license (or sublicense, as the case may be) to a Third Party to research, develop, make, have made, use, import, offer to sell or sell, an Antibody Equivalent to such former Research Antigen, and (b) ABX will be free to research, develop, make, have made, use, import, offer to sell or sell, an Antibody Equivalent to such former Research Antigen, provided that ABX shall have no right to use any Confidential Information or patent rights of CuraGen in such activities.

 

4.4.2 For a period commencing on November 27, 2000, and ending on the earlier of (i) the Last Immunization Date, and (ii) the effective date of a termination of the Research Program and the options, licenses and rights of ABX under this Agreement by CuraGen pursuant to Section 14.2.3 upon an uncured material breach of a material obligation by ABX, CuraGen shall not enter into any agreement (other than permitted license and sublicense agreements hereunder) with any other Person under which:

 

(a) CuraGen grants to any other Person rights related to Antibody Equivalents, if the research concepts to identify antigens used in connection with such agreement are not solely presented by such other Person.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
19


(b) CuraGen grants to any other Person rights related to Antibody Equivalents, if the composition of such Antibody Equivalent or the target thereof, or the utility of either, is discovered by CuraGen through CuraGen’s internal research programs.

 

(c) CuraGen grants to any other Person rights related to Antibody Equivalents, if such Antibody Equivalent is identified through access to or use of the CuraGen Databases or the Antibodies.

 

(d) CuraGen grants to any other Person actual or effective exclusivity with respect to Antibody Equivalents regarding any prophylactic or therapeutic field (e.g., cancer, autoimmune disease, inflammation, or cardiovascular disease). For purposes of this provisions, (i) actual exclusivity shall mean that CuraGen cannot conduct material research or development activities to identify new antigens related to such field for use under the Research Program; and (ii) effective exclusivity shall mean that CuraGen is obligated under such agreement to commit or reserve more than [******] of CuraGen’s capacity to conduct research or development to identify new antigens related to such field (whether calculated on the basis of CuraGen’s personnel, capital or other resources or the maximum number of antigens deliverable under such agreement).

 

(e) CuraGen retains any rights to Antibody Equivalents to any antigen unless (i) CuraGen retains the right to grant a commercial license under Article 7 below for such antigen (without any reservation of rights to any other Person), (ii) CuraGen discloses such antigen to the JMC as a potential antigen of interest for use in the Research Program at the first meeting of the JMC following discovery of such antigen, and (iii) such antigen is available for inclusion in the Research Program under this Agreement; provided, however, that conditions (i) and (iii) shall not apply if CuraGen designates such antigen as a CuraGen Exclusive Antigen at the first meeting of the JMC at which such antigen is presented to the JMC.

 

4.4.3 Except as otherwise expressly permitted under this Agreement, for a period ending on the earlier of (a) the Last Immunization Date, and (b) the effective date of a termination of the Research Program and the options, licenses and rights of ABX under this Agreement by CuraGen pursuant to Section 14.2.3 upon an uncured material breach of a material obligation by ABX, CuraGen shall not, and shall not grant any license (or sublicense, as the case may be), immunity or other right to any Person to, research, develop, make, have made, use, import, offer to sell or sell any Antibody Equivalent to an [**********************]. for use in the Commercial Field from and after the date on which a XenoMouse Animal was first immunized with such Antigen; provided, however, that the foregoing limitation shall not apply to antigens as to which ABX has notified CuraGen that it does not have the right to grant CuraGen a commercial license under Article 7 unless ABX has agreed to pay CuraGen the amounts provided hereunder upon the development and commercialization of an antibody product targeting such antigen as if it were an ABX Product hereunder in return for the licenses from CuraGen for such product as if it were an ABX Product hereunder. For the avoidance of doubt, nothing in this Agreement shall preclude CuraGen from granting any license (or sublicense, as the case may be), immunity or other right to any Person to research, develop,

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
20


make, have made, use, import, offer to sell or sell any Antibody Equivalent to an antigen contained in the CuraGen Databases [**********************] for any purpose other than for use in the prevention, treatment, detection, diagnosis or monitoring of, or the determination of a predisposition for, or the selection of a particular patient(s) to receive a particular therapeutic treatment(s) for, [**********************], unless and until a XenoMouse Animal has been immunized with such Antigen under this Agreement.

 

4.4.4 Except as otherwise expressly permitted under this Agreement, for a period ending on the earlier of (a) the Last Immunization Date, and (b) the effective date of a termination of the Research Program and the options, licenses and rights of CuraGen under this Agreement by ABX pursuant to Section 14.2.3 upon an uncured material breach of a material obligation by CuraGen, ABX shall not, and shall not grant any license (or sublicense, as the case may be), immunity or other right to any Person to, research, develop, make, have made, use, import, offer to sell or sell any Antibody Equivalent to an [***************************] for use in the Commercial Field from and after the date on which a XenoMouse Animal was first immunized with such Antigen. For the avoidance of doubt, nothing in this Agreement shall preclude ABX from granting any license (or sublicense, as the case may be), immunity or other right to any Person to research, develop, make, have made, use, import, offer to sell or sell any Antibody Equivalent to an [****************************] for any purpose, unless and until a XenoMouse Animal has been immunized with such Antigen under this Agreement.

 

4.4.5 Except as otherwise expressly permitted under this Agreement, during the term of this Agreement, ABX shall not, and shall not grant any license (or sublicense, as the case may be), immunity or other right to any Person to, research, develop, make, have made, use, import, offer to sell or sell any Antibody Equivalent to a CuraGen Optioned Antigen [***************************], for so long as such antigen remains a CuraGen Exclusive Antigen, CuraGen Optioned Antigen, or a CuraGen Licensed Antigen [***************************] for use in the Commercial Field.

 

4.4.6 Except as otherwise expressly permitted under this Agreement, during the term of this Agreement, CuraGen shall not, and shall not grant any license (or sublicense, as the case may be), immunity or other right to any Person to, research, develop, make, have made, use, import, offer to sell or sell any Antibody Equivalent to an ABX Optioned Antigen [***************************], for so long as such antigen remains an ABX Optioned Antigen, or an ABX Licensed Antigen [***************************] for use in the Commercial Field.

 

4.5 Research Program Licenses.

 

4.5.1 Subject to the terms and conditions of this Agreement, ABX hereby grants to CuraGen a nonexclusive license (or sublicense, as the case may be) under the Licensed ABX Intellectual Property, without right to grant Sublicenses, in the Research Field solely to conduct its obligations under the Research Program and to conduct additional preclinical research as permitted under Sections 4.2 and 4.6. Except as expressly set forth in this

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
21


Agreement or otherwise expressly agreed in writing by the parties, CuraGen shall not use the Licensed ABX Intellectual Property or any ABX Technology and Information or any Research Program Technology and Information for any use other than those uses expressly licensed under this Section 4.5.1.

 

4.5.2 Subject to the terms and conditions of this Agreement, CuraGen hereby grants to ABX a nonexclusive license (or sublicense, as the case may be) under the Licensed CuraGen Intellectual Property, without right to grant Sublicenses, in the Research Field solely to conduct its obligations under the Research Program and to conduct additional preclinical research as permitted under Section 4.2. Except as expressly set forth in this Agreement or otherwise expressly agreed in writing by the parties, ABX shall not use the Licensed CuraGen Intellectual Property or any CuraGen Technology and Information or any Research Program Technology and Information for any use other than those uses expressly licensed under this Section 4.5.2.

 

4.6 CuraGen Exclusive Antigens.

 

4.6.1 Designation of CuraGen Exclusive Antigens.

 

(a) As of the Revision Date, Exhibit E lists the antigens designated as CuraGen Exclusive Antigens. Subject to Section 4.6.3, CuraGen shall have no right to designate any additional CuraGen Exclusive Antigens pursuant to this Agreement.

 

(b) Each CuraGen Exclusive Antigen shall be a Research Antigen, but shall not be a part of the Pool (as defined in Section 5.2), (i) CuraGen shall have the exclusive right to select such Research Antigen as an Optioned Antigen or Licensed Antigen regardless of whether such Research Antigen is an Eligible Antigen; and (ii) ABX shall have no right to select such Research Antigen as an Optioned Antigen or Licensed Antigen.

 

4.6.2 Selection of CuraGen Exclusive Antigens as Optioned Antigens. CuraGen shall have the right to select any Research Antigen that is a CuraGen Exclusive Antigen as an Optioned Antigen regardless of whether such CuraGen Exclusive Antigen is an Eligible Antigen. CuraGen shall make any such selection by giving express written notice to ABX at any time during the first eight (8) years after the Effective Date. CuraGen’s right to make such selections under this Section 4.6.2 shall be outside, and in addition to, the selection process for Optioned Antigens under Section 5.2.

 

4.6.3 If ABX notifies CuraGen in writing that ABX does not have the right to grant CuraGen a commercial license under Article 7 below for an antigen that CuraGen has designated as a CuraGen Exclusive Antigen, then CuraGen shall be allowed to replace such antigen with another antigen by amending Exhibit E.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
22


4.7 Material Transfer.

 

4.7.1 Subject to the reimbursement of costs, each party will use commercially reasonable efforts to support the research activities of the other party under this Section 4.

 

4.7.2 ABX will supply CuraGen with Control Antibody Material at commercial prices and subject to the Control Antibody Material Transfer Agreement dated April 4, 2003, (the “Control Antibody MTA”).

 

4.7.3 With respect to Antibody Specific Materials and Information and Research Program Technology and Information regarding any Research Antigen, other than a CuraGen Exclusive Antigen or an Optioned Antigen or Licensed Antigen of a Party, transfer to a Third Party shall be done under the terms of an MTA under which both ABX and CuraGen are parties. The Parties agree they will execute any such MTA if it is in the form of Exhibit F (the “Three-way MTA”). Any change will require the approval of both Parties, not to be unreasonably withheld. The Parties will dedicate sufficient resources to review and comment on Three-way MTAs within ten business days and to execute such Three-way MTAs within one week of receipt of the execution version. A Party will be free to execute a Two-way MTA with respect to Antibody Specific Materials and Information and Research Program Technology and Information regarding any Research Antigen should the other Party fail to reasonably adhere to these timelines with respect to such Research Antigen.

 

4.7.4 With respect to Optioned Antigens and Licensed Antigens, this Second Restated Collaboration Agreement supercedes Transferred Cell Line Material Transfer Agreement dated April 4, 2003 (the “Transferred Cell Line MTA”).

 

4.7.5 Notwithstanding the provisions of Section 12.6 or any other provisions hereof, CuraGen may transfer to any Third Party (a) CuraGen Optioned Antigens, and Antibody Specific Materials and Information and Research Program Technology and Information regarding any CuraGen Optioned Antigen, (b) any Antibodies to any such CuraGen Optioned Antigens and (c) any Control Antibody Material, provided, that, in each such instance, (a) CuraGen shall use a materials transfer and services agreement substantially in the form attached hereto as Exhibit G (the “Two-way MTA”), (b) such Third Party shall have first executed the Two-way MTA, (c) CuraGen shall diligently enforce, and shall provide prompt written notice to ABX of any breach of, any such Two-way MTA by such Third Party and (d) CuraGen shall have made commercially reasonable efforts to include ABX as a third party beneficiary of any such Two-way MTA as described more fully in Section 15 of the form of Two-way MTA. CuraGen shall provide to ABX copies of any reports provided to CuraGen by a Third Party utilizing the materials covered by a Two-way MTA, shall timely notify ABX of the proposed publication or required disclosure of Confidential Information by any Third Party and shall disclose to ABX any inventions arising under a Two-way MTA. CuraGen agrees to indemnify ABX and hold it harmless from any and all claims, liabilities, and/or losses which arise as a result of any Third Party’s use of the materials transferred, and shall not permit a Third Party to undertake an assignment of its rights without the prior consent of ABX. In addition,

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
23


transfer to a third party of any Control Antibody Materials shall be made only pursuant and subject to the Control Antibody MTA.

 

4.7.6 Notwithstanding the provisions of Section 12.6 or any other provisions hereof, ABX may transfer to any Third Party (a) ABX Optioned Antigens and Antibody Specific Materials and Information and Research Program Technology and Information regarding any ABX Optioned Antigen, and (b) any Antibodies to any such ABX Optioned Antigens, provided, that, in each such instance, (a) ABX shall use a materials transfer and services agreement substantially in the form of the Two-way MTA, (b) such Third Party shall have first executed a Two-way MTA, (c) ABX shall diligently enforce, and shall provide prompt written notice to CuraGen of any breach of, any such Two-way MTA by such Third Party and (d) ABX shall have made commercially reasonable efforts to include CuraGen as a third party beneficiary of any such Two-way MTA as described more fully in Section 15 of the form of MTA. ABX shall provide to CuraGen copies of any reports provided to ABX by a Third Party utilizing the materials covered by a Two-way MTA, shall timely notify CuraGen of the proposed publication or required disclosure of Confidential Information by any Third Party and shall disclose to CuraGen any inventions arising under a Two-way MTA. ABX agrees to indemnify CuraGen and hold it harmless from any and all claims, liabilities, and/or losses which arise as a result of any Third Party’s use of the materials transferred, and shall not permit a Third Party to undertake an assignment of its rights without the prior consent of CuraGen.

 

4.7.7 A Party will be considered to have made commercially reasonable efforts to have the other party included as a third party beneficiary if such language is included in the initial draft Two-way MTA sent to a Third Party.

 

4.7.8 CuraGen may use and transfer to any Third Party (a) CuraGen Exclusive Antigens and CuraGen Licensed Antigens and Antibody Specific Materials and Information and Research Program Technology and Information regarding any CuraGen Exclusive Antigen or CuraGen Licensed Antigen, and (b) Antibodies (and Antibody Cells thereto) to CuraGen Exclusive Antigens and CuraGen Licensed Antigens, all without the approval of ABX, provided, that, in each such instance, (a) CuraGen shall use a materials transfer and services agreement substantially in the form of the Two-way MTA, (b) such Third Party shall have first executed the Two-way MTA, and (c) CuraGen shall diligently enforce, and shall provide prompt written notice to ABX of any breach of, any such Two-way MTA by such Third Party.

 

4.7.9 ABX may use and transfer to any Third Party (a) ABX Licensed Antigens and Antibody Specific Materials and Information and Research Program Technology and Information regarding any ABX Licensed Antigen, and (b) Antibodies (and Antibody Cells thereto) to ABX Licensed Antigens, all without the approval of CuraGen, provided, that, in each such instance, (a) ABX shall use a materials transfer and services agreement substantially in the form of the Two-way MTA, (b) such Third Party shall have first executed the Two-way MTA, (c) ABX shall diligently enforce, and shall provide prompt written notice to CuraGen of any breach of, any such Two-way MTA by such Third Party.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
24


  5. SELECTION OF OPTIONED ANTIGENS

 

5.1 Eligible Antigens. Not less than ten (10) days prior to each regularly scheduled meeting of the JMC, each party shall provide the other party with a dossier for each Research Antigen that it proposes to be considered as a potential Eligible Antigen. Such dossier shall contain all information reasonably available to such party demonstrating whether such Research Antigen satisfies the criteria set forth in Exhibit B. At such regularly scheduled meeting of the JMC, the JMC shall consider whether such Research Antigen satisfies the criteria set forth in Exhibit B. A Research Antigen shall be an Eligible Antigen at such time as it is determined to satisfy the criteria set forth in Exhibit B, as determined by the JMC under Section 3.2 above or the arbitrator under Section 3.5 above. Notwithstanding anything to the contrary in this Agreement, if a party gives written notice to the other party at any time stating that such party does not have the right to grant the other party a commercial license under Article 7 below for an Eligible Antigen, then effective thirty (30) days after the receipt by the other party of such notice, such antigen shall cease to be an Eligible Antigen and both parties shall destroy all Antigen Specific Materials and Information pertaining to such Eligible Antigen.

 

5.2 Selection of Optioned Antigens. During the first eight (8) years after the Effective Date, each party shall have the right, in its sole discretion, to select Optioned Antigens from the list of Eligible Antigens at the time in question (the “Pool”) as follows:

 

5.2.1 CuraGen shall have the right to select [****************] from the Pool by giving written notice to ABX of such selection.

 

5.2.2 After CuraGen has selected [****************], ABX shall have the right to select [***(*)*************] from the Pool by giving written notice to CuraGen of such selection.

 

5.2.3 After ABX has selected [***(*)*************] under Section 5.2.2 or 5.2.4, CuraGen shall have the right to select [***(*)*************] from the Pool by giving written notice to ABX of such selection.

 

5.2.4 After CuraGen has selected [***(*)*************] under Section 5.2.3 above, ABX shall have the right to select [***(*)*************] from the Pool by giving written notice to CuraGen of each such selection.

 

5.2.5 A party having then the right to pick an Optioned Antigen may exercise such right at any time and select an Eligible Antigen from the Pool.

 

5.2.6 If CuraGen shall not have exercised its right to select [******************] pursuant to Section 5.2.1 no later than [****(**)****] after the earlier of (i) determination by the JMC under Section 3.2 above and/or the arbitrator under Section 3.5 above that there are at least [*****] Eligible Antigens in the Pool or (ii) [****(**)****] after

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
25


determination by the JMC under Section 3.2 above or the arbitrator under Section 3.5 above of the first Eligible Antigen hereunder, then ABX shall have the right, exercisable within [****(**)****] after the end of such [****(**)****] period, to select [***(*)**************] from the Pool, as it existed at the commencement of such [****(**)****] period, by giving written notice to CuraGen of such selection. If ABX shall have exercised such right and made such selection, then such pick shall be deemed to have been ABX’s selection under Section 5.2.2 and the right of CuraGen to select a CuraGen Optioned Antigen pursuant to Section 5.2.1 shall be terminated and its right to select a CuraGen Optioned Antigen pursuant to Section 5.2.3 shall be increased from [***(*)*****(*)] until such time as CuraGen has selected [***(*)*********]. If ABX shall not have exercised such right and made such selection, then ABX may again exercise such right within [****(**)****] after each time CuraGen fails or refuses to exercise its right to select [*************] pursuant to Section 5.2.1 within [****(**)****] after determination by the JMC under Section 3.2 above or the arbitrator under Section 3.5 above of the addition of at least [**********(**)***********] to the Pool.

 

5.2.7 For each subsequent pick of an Optioned Antigen pursuant to Section 5.2.2, 5.2.3 or 5.2.4, if the party with the right to then pick (the “picking party”) shall not have exercised its right to select an Optioned Antigen no later than [*****(**)****] after the earlier of (i) determination by the JMC under Section 3.2 above and/or the arbitrator under Section 3.5 above that there are then at least [******] Eligible Antigens in the Pool at least [****] of which has not been the subject of a prior right of a party to select an Optioned Antigen therefrom or (ii) [***(*)*******] after determination by the JMC under Section 3.2 above or the arbitrator under Section 3.5 above of the first of the Eligible Antigens added to the Pool which has not been the subject of a prior right of a party to select an Optioned Antigen therefrom, then the non-picking party shall have the right, exercisable within [******(**)****] after the end of such [******(**)***] period, to select [***(*)*********] from the Pool, as it existed at the commencement of such [******(**)***] period, by giving written notice to the picking party of such selection. If the non-picking party shall have exercised such right and made such selection, then (i) in the event the picking party is ABX pursuant to Section 5.2.2 or 5.2.4, as the case may be, such selection by CuraGen shall be deemed to have been a CuraGen selection under Section 5.2.3, ABX shall retain the right to make the next pick and such pick shall be made pursuant to Section 5.2.2 or 5.2.4, as the case may be, ABX’s right to select [*************] pursuant to such Section shall be [************************************************ ************************************] until such time as ABX has selected [****************************], the right of CuraGen to make its next selection of [*************] pursuant to Section 5.2.3 (other than deemed selections pursuant to operation of this clause (i)) shall be reduced by [***(*)], and the right of CuraGen to select [*************] pursuant to Section 5.2.3 (other than pursuant to operation of this Section 5.2.7) shall not be exercisable until such time as ABX has selected [****************] calculated in accordance with this clause (i), and (ii) in the event the picking party is CuraGen pursuant to Section 5.2.3, such selection by ABX shall be deemed to have been ABX’s selection under Section 5.2.4, CuraGen’s right to select [*****************] pursuant to Section 5.2.3 shall be [************(*)] until such time as CuraGen has selected [********************* ****************] and the right of ABX to select [*************] pursuant to Section 5.2.4

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
26


(other than pursuant to operation of this Section 5.2.7) shall not be exercisable until such time. If the non-picking party shall not have exercised such right and made such selection, then the non-picking party may again exercise such right within [******(**)****] after each time the picking party fails or refuses to exercise its right to select an Optioned Antigen pursuant to Section 5.2.2, 5.2.3 or 5.2.4, as the case may be, within [******(**)****] after determination by the JMC under Section 3.2 above or the arbitrator under Section 3.5 above of the addition of at least [****(*)***********] to the Pool which has not been the subject of a prior right of a party to select an Optioned Antigen therefrom.

 

5.2.8 It is the intention of the parties that the process for selecting Optioned Antigens under this Section 5.2 shall operate in a manner that preserves CuraGen’s right to select [***(*)**************] for each [***(*)**************] selected by ABX, and preserves ABX’s right to select [***(*)**************] for each [***(*)**************] selected by CuraGen.

 

5.2.9 With respect to each Eligible Antigen which is selected by CuraGen as a CuraGen Optioned Antigen pursuant to this Section 5.2, ABX shall notify CuraGen in writing, within thirty (30) days of receipt of the notice of selection from CuraGen, if ABX does not have the right to grant CuraGen a commercial license under Article 7 below for such Eligible Antigen. Unless ABX timely notifies CuraGen in writing that ABX does not have the right to grant CuraGen a commercial license under Article 7 below for such antigen, ABX shall use its good faith efforts to nominate such Eligible Antigen under the XT/ABX Master Research and License Agreement and to obtain the right thereunder to obtain an XT/ABX Product License Agreement with respect to CuraGen Products to such Eligible Antigen. If ABX is successful in nominating such Eligible Antigen and in obtaining the right to obtain an XT/ABX Product License Agreement for CuraGen Products to such Eligible Antigen, the ABX shall give prompt written notice to CuraGen. Effective upon such notice, such Eligible Antigen shall be a CuraGen Optioned Antigen. If CuraGen desires that an Eligible Antigen selected by CuraGen as a CuraGen Optioned Antigen is also designated as a Lambda Optioned Antigen, then CuraGen shall so notify ABX in writing at the time CuraGen selects such Eligible Antigen, and subject to this Section 5.2.9, if such an Eligible Antigen becomes a CuraGen Optioned Antigen it shall also be a Lambda Optioned Antigen hereunder.

 

5.2.10 With respect to each Eligible Antigen which is selected by ABX as an ABX Optioned Antigen pursuant to this Section 5.2, CuraGen shall notify ABX in writing, within thirty (30) days of receipt of the notice of selection from ABX, if CuraGen does not have the right to grant ABX a commercial license under Article 7 below for such Eligible Antigen. Unless CuraGen timely notifies ABX in writing that CuraGen does not have the right to grant ABX a commercial license under Article 7 below for such antigen, such Eligible Antigen thereafter shall be an ABX Optioned Antigen upon the expiration of such thirty (30) day period.

 

5.2.11 At such time as an Eligible Antigen becomes an Optioned Antigen of one of the parties (the “Optioning Party”), the other party shall deliver to the Optioning Party all Antigen Specific Materials and Information in its possession pertaining to such Optioned

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
27


Antigen and all related Confidential Information of such other party, and such Antigen Specific Materials and Information and Confidential Information shall thereafter be the Confidential Information of the Optioning Party.

 

5.2.12 Within sixty (60) days after completion of the Research Program Term, the Parties will meet to select any remaining Eligible Antigens in the Pool, with the Party possessing the next pick selecting first, and then alternating, until all Eligible Antigens are selected or both parties have passed on any remaining Eligible Antigens (“Unpicked Eligible Antigens”). Within thirty (30) days after completion of the Research Program Term, each Party will advise the other as to whether it has the right to grant the other Party a commercial license under Article 7 for each such remaining Eligible Antigen.

 

  6. RESEARCH FIELD LICENSES FOR OPTIONED ANTIBODIES

 

6.1 Research Field Licenses.

 

6.1.1 Subject to the terms and conditions of this Agreement, ABX hereby grants to CuraGen a nonexclusive license (or sublicense, as the case may be) under the Licensed ABX Intellectual Property, without right to grant Sublicenses, (a) to research, develop, make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or an interest in) Antibody Cells that contain, express or secrete Antibodies to the CuraGen Optioned Antigens solely for use in the Research Field, (b) to research, develop, make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or an interest in) Antibodies that bind to the CuraGen Optioned Antigens and Genetic Material that encodes such Antibodies, solely for use in the Research Field for the research and development of potential CuraGen Products and (c) with respect to one or more Antibodies that bind to a CuraGen Optioned Antigen, if the parties have mutually agreed in writing to a Conjugate to be conjugated to such one or more Antibodies that bind to such CuraGen Optioned Antigen, to research, develop, make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or interest in) such Conjugates conjugated to such Antibodies that bind to such CuraGen Optioned Antigens, solely for use in the Research Field for the research and development of potential CuraGen Products. Except as expressly agreed in this Agreement or otherwise expressly agreed in writing by the parties, CuraGen shall not use the Licensed ABX Intellectual Property, the ABX Technology and Information or the Research Program Technology and Information for any use other than those uses expressly licensed under this Section 6.1.1.

 

6.1.2 Subject to the terms and conditions of this Agreement, CuraGen hereby grants to ABX a nonexclusive license (or sublicense, as the case may be) under the Licensed CuraGen Intellectual Property, without right to grant Sublicenses, (a) to research, develop, make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or an interest in) Antibody Cells that contain, express or secrete Antibodies to the ABX Optioned Antigens solely for use in the Research Field, and (b) to research, develop, make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or an interest in) Antibodies that bind to the ABX Optioned Antigens and Genetic Material that encodes such

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
28


Antibodies, solely for use in the Research Field for the research and development of potential ABX Products. Except as expressly agreed in this Agreement or otherwise expressly agreed in writing by the parties, ABX shall not use the Licensed CuraGen Intellectual Property, the CuraGen Technology and Information or the Research Program Technology and Information for any use other than those uses expressly licensed under this Section 6.1.2.

 

6.1.3 The licenses (or sublicenses, as the case may be) granted under this Section 6.1 shall terminate with respect to each Optioned Antigen on the second anniversary of the date on which such antigen became an Optioned Antigen; provided, however, if a party has timely exercised its option under Article 7 below to obtain a license (or sublicense, as the case may be) for Products to such Optioned Antigen, such license (or sublicense, as the case may be) shall remain in effect for Products to such Optioned Antigen for the term of the applicable license (or sublicense, as the case may be) under Article 7 below. If a party does not timely exercise its option under Article 7 below to obtain a license (or sublicense, as the case may be) for Products to an Optioned Antigen and the other party does not timely exercise its standby option under Section 7.1.2 or 7.2.2, as the case may be, for Products to such Optioned Antigen, such Antigen shall cease to be an Optioned Antigen but shall be restored as an Eligible Antigen.

 

Extended Research License

 

6.1.4 Subject to the terms and conditions of this Agreement, ABX hereby grants to CuraGen a nonexclusive license (or sublicense, as the case may be) under the Licensed ABX Intellectual Property and ABX’s interest in Antibody Specific Materials and Information and Research Program Technology and Information relating to Research Antigens, without right to grant Sublicenses, (a) to research, develop, make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or an interest in) Antibody Cells that contain, express or secrete Antibodies to the Extended Research Antigens solely for use in the Research Field, (b) to research, develop, make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or an interest in) Antibodies that bind to the Extended Research Antigen and Genetic Material that encodes such Antibodies, solely for use in the Research Field for the research and development of potential CuraGen Products and (c) with respect to one or more Antibodies that bind to an Extended Research Antigen, if the parties have mutually agreed in writing to a Conjugate to be conjugated to such one or more Antibodies that bind to such Extended Research Antigen, to research, develop, make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or interest in) such Conjugates conjugated to such Antibodies that bind to such Extended Research Antigens, solely for use in the Research Field for the research and development of potential CuraGen Products. Except as expressly agreed in this Agreement or otherwise expressly agreed in writing by the parties, CuraGen shall not use the Licensed ABX Intellectual Property, the ABX Technology and Information or the Research Program Technology and Information for any use other than those uses expressly licensed under this Section 6.1.4.

 

6.1.5 Subject to the terms and conditions of this Agreement, CuraGen hereby grants to ABX a nonexclusive license (or sublicense, as the case may be) under the

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
29


Licensed CuraGen Intellectual Property and CuraGen’s interest in Antibody Specific Materials and Information and Research Program Technology and Information relating to Research Antigens, without right to grant Sublicenses, (a) to research, develop, make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or an interest in) Antibody Cells that contain, express or secrete Antibodies to the Extended Research Antigens solely for use in the Research Field, and (b) to research, develop, make and use (but not to transfer, sell, lease, offer to sell or lease, or otherwise transfer title to or an interest in) Antibodies that bind to the Extended Research Antigens and Genetic Material that encodes such Antibodies, solely for use in the Research Field for the research and development of potential ABX Products. Except as expressly agreed in this Agreement or otherwise expressly agreed in writing by the parties, ABX shall not use the Licensed CuraGen Intellectual Property, the CuraGen Technology and Information or the Research Program Technology and Information for any use other than those uses expressly licensed under this Section 6.1.5.

 

6.1.6 The licenses (or sublicenses, as the case may be) granted under Sections 6.1.4 and 6.1.5 shall terminate with respect to each Extended Research Antigen on the [********] anniversary of the date on which such antigen became an Extended Research Antigen; provided, however, if a party has timely exercised its option under Article 7 below to obtain a license (or sublicense, as the case may be) for Products to such Extended Research Antigen, such license (or sublicense, as the case may be) shall remain in effect for Products to such Extended Research Antigen for the term of the applicable license (or sublicense, as the case may be) under Article 7 below. If neither Party timely exercise its option under Article 7 below to obtain a license (or sublicense, as the case may be) for Products to an Extended Research Antigen, such Extended Research Antigen shall cease to be an Antigen and all Antigen Specific Materials and Information shall be destroyed by both Parties.

 

6.2 Research and Preclinical Development.

 

6.2.1 As between ABX and CuraGen, ABX shall have the sole right and responsibility, at its sole expense, to conduct research and preclinical development of Antibodies that bind to the ABX Optioned Antigens and Genetic Material that encodes such Antibodies for use in the research and development of potential ABX Products in the Research Field.

 

6.2.2 As between ABX and CuraGen, CuraGen shall have the sole right and responsibility, at its sole expense, to conduct research and preclinical development of Antibodies that bind to the CuraGen Optioned Antigens and Genetic Material that encodes such Antibodies for use in the research and development of potential CuraGen Products in the Research Field.

 

6.2.3 Each party shall conduct such research and preclinical development in accordance with high scientific and professional standards, and in compliance in all material respects with the requirements of applicable laws and regulations.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
30


  7. COMMERCIAL FIELD LICENSES FOR LICENSED ANTIGENS

 

7.1 CuraGen Products.

 

7.1.1 Options for CuraGen Optioned Antigens. Subject to the terms and conditions of this Agreement, ABX hereby grants to CuraGen exclusive, non-transferable options to obtain a license (or sublicense, as the case may be) under Section 7.1.3 below for CuraGen Products to each CuraGen Optioned Antigen, with each such option being exercisable in accordance with the provisions of this Section 7.1.1 until the earliest of (a) the second anniversary of the date on which such antigen became a CuraGen Optioned Antigen; (b) such time as ABX no longer would be obligated to grant a license (or sublicense, as the case may be) under Section 7.1.3 below for such CuraGen Products, and (c) the twelfth anniversary of the Effective Date.

 

(a) If CuraGen desires to exercise its option for CuraGen Products to such CuraGen Optioned Antigen, CuraGen shall so notify ABX in writing. At the time CuraGen exercises its option to obtain a license (or sublicense, as the case may be) under Section 7.1.3 for any CuraGen Optioned Antigen that is a Lambda Optioned Antigen, if CuraGen wishes such license to include rights for CuraGen Products for use in the Therapeutic Field directed to a CuraGen Licensed Antigen and comprising a Lambda Antibody or Genetic Material that encodes such Lambda Antibody, then CuraGen shall designate such CuraGen Licensed Antigen as a Lambda Licensed Antigen.

 

(b) Effective upon such notice, such CuraGen Optioned Antigen shall be a CuraGen Licensed Antigen, and the exclusive license (or sublicense, as the case may be) grant under Section 7.1.3 below for CuraGen Products to such CuraGen Licensed Antigen shall then be effective.

 

7.1.2 Standby Options for ABX Optioned Antigens. If ABX fails to timely exercise its option under Section 7.2.1 below for any ABX Optioned Antigen, within ten (10) days after the written request by CuraGen, ABX shall provide CuraGen with copies of, or access to, all data and information of ABX regarding such ABX Optioned Antigen and Antibodies thereto. Except as otherwise expressly provided in this Agreement or the parties otherwise expressly agree in writing, CuraGen shall have the right to use such data and information for the sole purpose of evaluating its interest in exercising its option under this Section 7.1.2 for such ABX Optioned Antigen. Subject to the terms and conditions of this Agreement, ABX hereby grants to CuraGen exclusive, non-transferable options to obtain a license (or sublicense, as the case may be) under Section 7.1.3 below for CuraGen Products to each ABX Optioned Antigen for which ABX fails to timely exercise its option under Section 7.2.1 below, with each such option being exercisable in accordance with the provisions of this Section 7.1.2 commencing on the expiration of ABX’s option under Section 7.2.1 below until the earliest of (a) the date six (6) months thereafter, (b) such time as ABX no longer would be obligated to grant a license (or sublicense, as the case may be) under Section 7.1.3 below for such CuraGen Products, and (c) the twelfth anniversary of the Effective Date.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
31


(a) If CuraGen desires to exercise its option for CuraGen products to such ABX Optioned Antigen, CuraGen shall so notify ABX in writing. At the time CuraGen exercises its option to obtain a license (or sublicense, as the case may be) under Section 7.1.3 for any ABX Optioned Antigen that is a Lambda Optioned Antigen, if CuraGen wishes such license to include the rights for CuraGen Products for use in the Therapeutic Field directed to a CuraGen Licensed Antigen and comprising a Lambda Antibody or Genetic Material that encodes such Lambda Antibody, then CuraGen shall designate such CuraGen Licensed Antigen as a Lambda Licensed Antigen.

 

(b) Within thirty (30) days after receipt of such notice, ABX shall notify CuraGen in writing if ABX does not have the right to grant CuraGen the license (or sublicense, as the case may be) under Section 7.1.3 below for CuraGen products to such ABX Optioned Antigen. If ABX does not have such a right, ABX shall have no obligation to grant CuraGen the license (or sublicense, as the case may be) under Section 7.1.3 below for CuraGen Products to such ABX Optioned Antigen.

 

(c) Unless ABX timely notifies CuraGen in writing that it does not have such a right, effective upon the expiration of such thirty (30) day period, such antigen shall be a CuraGen Licensed Antigen, and the exclusive license (or sublicense, as the case may be) grant under Section 7.1.3 below for CuraGen Products to such CuraGen Licensed Antigen shall be effective upon the expiration of such thirty (30) day period.

 

7.1.3 Commercial Field License. Subject to the terms and conditions of this Agreement, ABX hereby grants to CuraGen an exclusive worldwide license (or sublicense, as the case may be) (with the right to grant Sublicenses) under Licensed ABX Intellectual Property to research, develop, make, have made, use, import, offer to sell and sell CuraGen Products in the Commercial Field. CuraGen shall provide ABX with a copy of each Sublicense promptly after executing the same; provided, however, that CuraGen shall have the right to redact any confidential financial terms or confidential research, development or commercialization plans from the copy provided to ABX. Any Sublicense shall be subject and subordinate to the terms and conditions of this Agreement, and CuraGen shall remain responsible for all payments due to ABX hereunder.

 

7.2 ABX Products.

 

7.2.1 Options for ABX Optioned Antigens. Subject to the terms and conditions of this Agreement, CuraGen hereby grants to ABX exclusive, non-transferable options to obtain a license (or sublicense, as the case may be) under Section 7.2.3 below for ABX Products to each ABX Optioned Antigen, with each such option being exercisable in accordance with the provisions of this Section until the earliest of (a) the second anniversary of the date on which such antigen became a ABX Optioned Antigen, (b) such time as CuraGen no longer would be obligated to grant a license (or sublicense, as the case may be) under Section 7.2.3 below for such ABX Products, and (c) the twelfth anniversary of the Effective Date.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
32


(a) If ABX desires to exercise its option for ABX Products to such ABX Optioned Antigen, ABX shall so notify CuraGen in writing.

 

(b) Effective upon such notice, such antigen shall be an ABX Licensed Antigen, and the exclusive license (or sublicense, as the case may be) grant under Section 7.2.3 below for ABX Products to such ABX Licensed Antigen shall be effective.

 

7.2.2 Standby Options for CuraGen Optioned Antigens. If CuraGen fails to timely exercise its option under Section 7.1.1 above for any CuraGen Optioned Antigen that is not a CuraGen Exclusive Antigen, within ten (10) days after the written request by ABX, CuraGen shall provide ABX with copies of, or access to, all data and information of CuraGen regarding such CuraGen Optioned Antigen and Antibodies thereto. Except as otherwise expressly provided in this Agreement or the parties otherwise expressly agree in writing, ABX shall have the right to use such data and information for the sole purpose of evaluating its interest in exercising its option under this Section 7.2.2 for such CuraGen Optioned Antigen. Subject to the terms and conditions of this Agreement, CuraGen hereby grants to ABX non-exclusive, non-transferable options to obtain a license (or sublicense, as the case may be) under Section 7.2.3 below for ABX Products to each CuraGen Optioned Antigen that is not a CuraGen Exclusive Antigen for which CuraGen fails to timely exercise its option under Section 7.1.1 above, with each such option being exercisable in accordance with the provisions of this Section 7.2.2 commencing on the expiration of CuraGen’s option under Section 7.1.1 above until the earliest of (a) the date six (6) months thereafter, (b) such time as CuraGen no longer would be obligated to grant a license (or sublicense, as the case may be) under Section 7.2.3 below for such ABX Products, and (c) the twelfth anniversary of the Effective Date.

 

(a) If ABX desires to exercise its option for ABX products to such CuraGen Optioned Antigen, ABX shall so notify CuraGen in writing.

 

(b) Within thirty (30) days after receipt of such notice, CuraGen shall notify ABX in writing if CuraGen does not have the right to grant ABX the license (or sublicense, as the case may be) under Section 7.2.3 below for ABX products to such CuraGen Optioned Antigen. If CuraGen does not have such a right, CuraGen shall have no obligation to grant ABX the license (or sublicense, as the case may be) under Section 7.2.3 below for ABX Products to such CuraGen Optioned Antigen.

 

(c) Unless CuraGen timely notifies ABX in writing that it does not have such a right, effective upon the expiration of such thirty (30) day period, such antigen shall be an ABX Licensed Antigen, and the exclusive license (or sublicense, as the case may be) grant under Section 7.2.3 below for ABX Products to such ABX Licensed Antigen shall be effective upon the expiration of such thirty (30) day period.

 

7.2.3 Commercial Field License. Subject to the terms and conditions of this Agreement, CuraGen hereby grants to ABX an exclusive worldwide license (or sublicense, as the case may be) (with the right to grant Sublicenses) under Licensed CuraGen Intellectual Property to research, develop, make, have made, use, import, offer to sell and sell ABX Products

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
33


in the Commercial Field. ABX shall provide CuraGen with a copy of each Sublicense promptly after executing the same; provided, however, that ABX shall have the right to redact any confidential financial terms or confidential research, development or commercialization plans from the copy provided to CuraGen. Any Sublicense shall be subject and subordinate to the terms and conditions of this Agreement, and ABX shall remain responsible for all payments due to CuraGen hereunder.

 

7.3 No Other Rights. No rights other than those expressly set forth in this Agreement are granted to either party hereunder, and no additional rights shall be granted to either party by implication, estoppel or otherwise.

 

7.4 Further Restrictions.

 

7.4.1 Notwithstanding anything to the contrary in this Agreement, neither a party, nor its Sublicensees hereunder nor their respective Affiliates shall submit an IND for, or otherwise commence human clinical testing of, any Product to any Antigen unless and until such party has obtained a commercial license under this Article 7 for Products to such Antigen.

 

7.4.2 For purposes of this Agreement, if (a) ABX has otherwise granted exclusive rights to antibodies to an antigen to a Third Party without breach of the exclusivity provisions of Section 4.4, or (b) ABX has an active research and development program ongoing for antibodies to an antigen (that was not provided by CuraGen hereunder) that is independent of its efforts hereunder and does not and did not involve access to, or otherwise make use of, the CuraGen Databases, then ABX shall not have the right to grant CuraGen a license (or sublicense, as the case may be) hereunder to use such antigen in the Research Field or a license (or sublicense, as the case may be) regarding the related CuraGen Products in the Commercial Field.

 

7.4.3 For purposes of this Agreement, if CuraGen has granted exclusive rights to antibodies to an antigen to a Third Party without breach of the exclusivity provisions of Section 4.4, then CuraGen shall not have the right to grant ABX a license (or sublicense, as the case may be) hereunder to use such antigen in the Research Field or a license (or sublicense, as the case may be) regarding the related ABX Products in the Commercial Field.

 

  8. PAYMENTS

 

8.1 Research Funding.

 

8.1.1 CuraGen has paid to ABX aggregate research funding of [***************************(**********)] to date. CuraGen shall pay to ABX additional research funding of [***********************************************************].

 

8.1.2 CuraGen shall pay ABX [******************(**********)] for [***********] immunizations of Xenomouse Animals with Research Antigens after the Revision Date, payable [*******************************************************].

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
34


8.2 Certain Fees.

 

8.2.1 Each party shall pay to the other party a non-refundable, non-creditable technology access fee of [*********************(**********)] for each Eligible Antigen it selects under Article 5 above that becomes an Optioned Antigen within ten (10) days after such Eligible Antigen becomes an Optioned Antigen. CuraGen additionally shall pay to ABX a non-refundable, non-creditable technology access fee of [*************(**********)] for each Eligible Antigen that becomes a Lambda Optioned Antigen hereunder, within ten (10) days after such Eligible Antigen becomes a Lambda Optioned Antigen.

 

8.2.2 Each party shall pay to the other party a non-refundable, non-creditable exercise fee of [*************(**********)] for each Optioned Antigen for which it exercised an option to obtain a commercial license under Article 7 above within ten (10) days after such Optioned Antigen becomes a Licensed Antigen. CuraGen additionally shall pay to ABX a non-refundable, non-creditable exercise fee of [*************(**********)] for each Lambda Optioned Antigen for which CuraGen exercised an option to obtain a commercial license under Article 7 above within ten (10) days after such Lambda Optioned Antigen becomes a Lambda Licensed Antigen.

 

8.2.3 With respect to each Licensed Antigen for which a party exercised an option to obtain a commercial license under Article 7 above, but for which it was not required to pay an option fee under Section 8.2.1 above because it was not selected as an Optioned Antigen by such party under Article 5 above, such party shall pay to the other party, in lieu of the amounts set forth in Sections 8.2.1 and 8.2.2, a non-refundable, non-creditable exercise fee of [*************(**********)] for such Licensed Antigen within ten (10) days after such antigen becomes a Licensed Antigen. CuraGen additionally shall pay to ABX a non-refundable, non-creditable exercise fee of [*************(**********)] for each CuraGen Licensed Antigen for which CuraGen exercised an option to obtain a commercial license and designated such CuraGen Licensed Antigen as a Lambda Licensed Antigen under Article 7 above, but for which it was not required to pay an option fee under Section 8.2.1 above because it was not selected as an Optioned Antigen by CuraGen under Article 5 above, and within ten (10) days after such antigen becomes a Lambda Licensed Antigen.

 

8.3 Milestone Payments.

 

8.3.1 In the Therapeutic Field.

 

(a) Subject to Section 8.3.1(d), and, in the case of Sublicenses, to Section 8.4.3(c) below, within thirty (30) days following the achievement of each of the following milestones with respect to each CuraGen Product for use in the Therapeutic Field (other than a CuraGen Product directed to a CuraGen Licensed Antigen and comprising a Lambda Antibody or Genetic Material that encodes such Lambda Antibody), on a CuraGen Product-by-CuraGen Product basis, CuraGen shall give written notice to ABX thereof and shall (i) pay to ABX the corresponding milestone payments described below and (ii) pay to ABX the milestone payments due any Third Party under an ABX In-License arising from use of a Conjugate as part of such

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
35


CuraGen Product (as permitted under this Agreement), as applicable. Subject, in the case of Sublicenses, to Section 8.4.3(a) below, within thirty (30) days following the achievement of each of the following milestones with respect to each ABX Product for use in the Therapeutic Field, on an ABX Product-by-ABX Product basis, ABX shall give written notice to CuraGen thereof and shall pay to CuraGen the corresponding milestone payments described below.

 

[*******]

     [***************************************************]

[*******]

     [***************************************************]

[*******]

     [***************************************************]

[*******]

     [***************************************************]

[*******]

     [***************************************************]

 

(b) Subject to Section 8.3.1(d), and, in the case of Sublicenses, to Section 8.4.3(c) below, within thirty (30) days following the achievement of each of the following milestones with respect to each CuraGen Product for use in the Therapeutic Field directed to a CuraGen Licensed Antigen and comprising a Lambda Antibody or Genetic Material that encodes such Lambda Antibody, on a CuraGen Product-by-CuraGen Product basis, CuraGen shall give written notice to ABX thereof and shall (i) pay to ABX the corresponding milestone payments described below, and (ii) pay to ABX the milestone payments due any Third Party under an ABX In-License arising from use of a Conjugate as part of such CuraGen Product (as permitted under this Agreement), as applicable.

 

[*******]

    

[***************************************************]

[*******]

    

[***************************************************]

[*******]

    

[***************************************************]

[*******]

    

[***************************************************]

[*******]

    

[***************************************************]

 

(c) If, at the time when any milestone payment listed in this Section 8.3.1, with respect to a Product for use in the Therapeutic Field, is due from a party, such party has not paid all other milestone payments (if any) previously listed in this Section 8.3.1 with respect to such Product, then at such time such party shall pay all such unpaid milestone payments (if any) previously listed in this Section 8.3.1 with respect to such Product. If, at the time of the First Commercial Sale by a party, its Affiliate or their respective Sublicensee of a Product for use in the Therapeutic Field, such party has not paid all milestone payments (if any) listed in this Section 8.3.1 with respect to such Product, then at such time such party shall pay all such unpaid milestone payments (if any) listed in this Section 8.3.1 with respect to such Product. If at any

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
36


time a party abandons the development of a Product after the payment to the other party of one or more milestone payments under this Section 8.3.1 and subsequently commences or continues the development of another Product directed to the same Licensed Antigen as the abandoned Product, then such party shall have no obligation to pay to the other party a milestone payment upon the occurrence of a milestone event for the subsequent Product for which such party previously has paid to the other party a milestone payment under this Section 8.3.1 for the abandoned Product.

 

(d) Notwithstanding Sections 8.3.1(a) and (b), CuraGen shall only be required to make the higher payments set forth in Section 8.3.1(b) with respect to a CuraGen Product comprising a Lambda Antibody or Genetic Material that encodes a Lambda Antibody if and to the extent that the additional amounts are owed or paid by ABX to the licensors under the licenses specified in Section 1.2 of Amendment No. 2. If such payments to such licensors are not owed or paid by ABX, CuraGen shall only be required to make the payments set forth in Section 8.1.3(a).

 

8.3.2 In the Diagnostic Field.

 

(a) Subject to Section 8.3.2(d), and, in the case of Sublicenses, to Section 8.4.3(d) below, within thirty (30) days following the achievement of each of the following milestones with respect to each CuraGen Product for use in the Diagnostic Field (other than a CuraGen Product directed to a CuraGen Licensed Antigen and comprising a Lambda Antibody or Genetic Material that encodes such Lambda Antibody), on a CuraGen Product-by-CuraGen Product basis, CuraGen shall give written notice to ABX thereof and shall (i) pay to ABX the corresponding milestone payments described below, and (ii) pay to ABX the milestone payments due any Third Party under an ABX In-License arising from use of a Conjugate as part of such CuraGen Product (as permitted under this Agreement), as applicable. Subject, in the case of Sublicenses, to Section 8.4.3(b) below, within thirty (30) days following the achievement of each of the following milestones with respect to each ABX Product for use in the Diagnostic Field, on an ABX Product-by-ABX Product basis, ABX shall give written notice to CuraGen thereof and shall pay to CuraGen the corresponding milestone payments described below.

 

[*******]

  

[***************************************************]

[*******]

  

[***************************************************]

[*******]

  

[***************************************************]

 

(b) Subject to Section 8.3.2(d), and, in the case of Sublicenses, to Section 8.4.3(d) below, within thirty (30) days following the achievement of each of the following milestones with respect to each CuraGen Product for use in the Diagnostic Field directed to a CuraGen Licensed Antigen and comprising a Lambda Antibody or Genetic Material that encodes such Lambda Antibody, on a CuraGen Product-by-CuraGen Product basis, CuraGen shall give written notice to ABX thereof and shall (i) pay to ABX the corresponding milestone payments described below, and (ii) pay to ABX the milestone payments due any Third Party under an

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
37


ABX In-License arising from use of a Conjugate as part of such CuraGen Product (as permitted under this Agreement), as applicable.

 

[*******]

  

[***************************************************]

[*******]

  

[***************************************************]

[*******]

  

[***************************************************]

 

(c) If, at the time when any milestone payment listed in this Section 8.3.2, with respect to a Product for use in the Diagnostic Field, is due from a party, such party has not paid all other milestone payments (if any) previously listed in this Section 8.3.2 with respect to such Product, then at such time such party shall pay all such unpaid milestone payments (if any) previously listed in this Section 8.3.2 with respect to such Product. If, at the time of the First Commercial Sale by a party, its Affiliate or permitted (sub)licensee of a Product for use in the Diagnostic Field, such party has not paid all milestone payments (if any) listed in this Section 8.3.2 with respect to such Product, then at such time such party shall pay all such unpaid milestone payments (if any) listed in this Section 8.3.2 with respect to such Product. If at any time a party abandons the development of a Product after the payment to the other party of one or more milestone payments under this Section 8.3.2 and subsequently commences or continues the development of another Product directed to the same Licensed Antigen as the abandoned Product, then such party shall have no obligation to pay to the other party a milestone payment upon the occurrence of a milestone event for the subsequent Product for which such party previously has paid to the other party a milestone payment under this Section 8.3.2 for the abandoned Product.

 

(d) Notwithstanding Sections 8.3.2(a) and (b), CuraGen shall only be required to make the higher payments set forth in Section 8.3.2(b) with respect to a CuraGen Product comprising a Lambda Antibody or Genetic Material that encodes a Lambda Antibody if and to the extent that the additional amounts are owed or paid by ABX to the licensors under the licenses specified in Section 1.2 of Amendment No. 2. If such payments to such licensors are not owed or paid by ABX, CuraGen shall only be required to make the payments set forth in Section 8.1.3(a).

 

8.4 Royalties.

 

8.4.1 Notice of Royalty Commencement Date. Within thirty (30) days following the Royalty Commencement Date for each CuraGen Product in each country, CuraGen shall give written notice to ABX thereof. Within thirty (30) days following the Royalty Commencement Date for each ABX Product in each country, ABX shall give written notice to CuraGen thereof.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
38


8.4.2 Royalties on Net Sales.

 

(a) Subject, in the case of Sublicenses, to Sections 8.4.3(a) and (b) below, where [***************************], ABX shall pay to CuraGen royalties equal to (a) [**********(**)] of the aggregate Net Sales by ABX and its Affiliates and their respective Sublicensees of each ABX Product for use in the Therapeutic Field, and (b) [**********(**)] of the aggregate Net Sales by ABX and its Affiliates and their respective Sublicensees of each ABX Product for use in the Diagnostic Field. ABX shall have the right to offset, against the royalties owing to CuraGen under the previous sentence for any ABX Product, [**********(***)] of the amount of royalties (if any) owing to any third party in connection with the license or acquisition of patent rights or know-how that is necessary or useful to practice the technology licensed by CuraGen to ABX hereunder to develop or commercialize such ABX Product; provided, however, ABX shall not be entitled, by operation of this sentence, to reduce the royalties owing to CuraGen under the previous sentence to less than (x) [******************(**)] of Net Sales of the aggregate Net Sales by ABX and its Affiliates and their respective Sublicensees of such ABX Product for use in the Therapeutic Field, and (y) [******************(**)] of the aggregate Net Sales by ABX and its Affiliates and their respective Sublicensees of such ABX Product for use in the Diagnostic Field.

 

(b) Subject, in the case of Sublicenses, to Sections 8.4.3(a) and (b) below, where [***************************], ABX shall pay to CuraGen royalties equal to [***************(**)] of the aggregate Net Sales by ABX and its Affiliates and their respective Sublicensees of each ABX Product for use in the Therapeutic Field or Diagnostic Field. ABX shall have the right to offset, against the royalties owing to CuraGen under the previous sentence for any ABX Product, [**********(**)] of the amount of royalties (if any) owing to any third party in connection with the license or acquisition of patent rights controlled by such third party claiming the relevant Licensed Antigen that (i) were filed and published prior to CuraGen’s priority date for any CuraGen Patent Claims to such Licensed Antigen and (ii) that are necessary or useful to practice the technology licensed by CuraGen to ABX hereunder to develop or commercialize such ABX Product; provided, however, ABX shall not be entitled, by operation of this sentence, to reduce the royalties owing to CuraGen under the previous sentence (a) with respect to Licensed Antigens that were used to immunize Xenomouse Animals after the Revision Date, in the event that ABX consents to using the Licensed Antigen for immunization after disclosure of such third party patent rights or (b) to less than [******(**)] of the aggregate Net Sales by ABX and its Affiliates and their respective Sublicensees of such ABX Product for use in the Therapeutic Field or Diagnostic Field.

 

(c) Subject, in the case of Sublicenses, to Sections 8.4.3(c) and (d) below, where [***************************], CuraGen shall pay to ABX royalties equal to (a) [***********(**)] of the aggregate Net Sales by CuraGen and its Affiliates and their respective Sublicensees of each CuraGen Product for use in the Therapeutic Field, (b) [***********(**)] of the aggregate Net Sales by CuraGen and its Affiliates and their respective Sublicensees of each CuraGen Product for use in the Diagnostic Field and (c) with respect to (1) each CuraGen Product directed to a CuraGen Licensed Antigen and comprising a

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
39


Lambda Antibody or Genetic Material that encodes such Lambda Antibody, and (2) each CuraGen Product comprising a Conjugate (as permitted under this Agreement), the amount of royalties which ABX owes to any Third Party pursuant to each ABX In-License, based on sales of such CuraGen Product, within the applicable royalty payment period set forth in such ABX In-License. CuraGen shall have the right to offset, against the royalties owing to ABX under (a) and (b) of the previous sentence for any CuraGen Product, [***********(**)] of the amount of royalties (if any) owing to any third party in connection with the license or acquisition of patent rights or know-how that is necessary or useful to practice the technology licensed by ABX to CuraGen hereunder to develop or commercialize such CuraGen Product; provided, however, CuraGen shall not be entitled, by operation of this sentence, to reduce the royalties owing to ABX under the previous sentence to less than (x) [*******************(**)] of Net Sales of the aggregate Net Sales by CuraGen and its Affiliates and their respective Sublicensees of such CuraGen Product for use in the Therapeutic Field, and (y) [*******************(**)] of the aggregate Net Sales by CuraGen and its Affiliates and their respective Sublicensees of such CuraGen Product for use in the Diagnostic Field.

 

(d) Subject, in the case of Sublicenses, to Sections 8.4.3(a) and (b) below, where [***************************], CuraGen shall pay to ABX royalties equal to (x) in the Therapeutic Field, the sum of (i) [***************(**)] of aggregate Net Sales by CuraGen and its Affiliates and their respective Sublicensees of such CuraGen Product in such calendar quarter, plus (ii) an amount (not to exceed [*********(**)],of Net Sales by CuraGen and its Affiliates and their respective Sublicensees of such CuraGen Product in such calendar quarter) equal to the royalties (if any) owing to Third Parties by ABX pursuant to those ABX In-Licenses existing as of the Effective Date with respect to Net Sales by CuraGen and its Affiliates and their respective Sublicensees of each CuraGen Product for use in the Therapeutic Field or (y) in the Diagnostic Field, the sum of (i) [*********(**)] of the aggregate Net Sales by CuraGen and its Affiliates and their respective Sublicensees plus (ii) an amount (not to exceed [*********(**)] of the aggregate Net Sales by CuraGen and its Affiliates and their respective Sublicensees where ABX owes royalties to Third Parties pursuant to those ABX In-Licenses existing as of the Effective Date of based on Net Sales by CuraGen and its Affiliates and their respective Sublicensees of such CuraGen Product in such calendar quarter for use in the Diagnostic Field.

 

8.4.3 Royalties on Sublicense Income.

 

(a) In the event that ABX grants a Sublicense with respect to any ABX Product for use in the Therapeutic Field, ABX shall notify CuraGen in writing, within fifteen (15) days of the grant of such Sublicense, whether ABX elects to pay to CuraGen (i) the milestone payments set forth in Section 8.3.1 upon the occurrence with respect to such ABX Product of the milestone events set forth therein and the royalties set forth in Section 8.4.2 based on Net Sales of such ABX Product or (ii) the following payments and royalties equal to the following percentage of Sublicense Income received by ABX and its Affiliates in connection with such Sublicense for each ABX Product for use in the Therapeutic Field:

 

[***]

   if such Sublicense is granted prior to the enrollment of the first patient in the first Phase I Clinical Trial for such ABX Product

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
40


[***]

   if such Sublicense is granted after the enrollment of the first patient in the first Phase I Clinical Trial for such ABX Product and prior to the enrollment of the first patient in the first Phase II Clinical Trial for such ABX Product

[***]

   if such Sublicense is granted after the enrollment of the first patient in the first Phase II Clinical Trial for such ABX Product

 

Notwithstanding the foregoing, the royalties owing by ABX under this Section 8.4.3(a) in any calendar quarter, with respect to Net Sales by such Sublicensee and its Affiliates of any ABX Product for use in the Therapeutic Field, shall not be less than [*********(**)] of Net Sales by such Sublicensee and its Affiliates of such ABX Product in such calendar quarter. Once made, the election of the basis of payment hereunder may not be changed, and ABX shall pay the amounts determined in accordance with its election.

 

(b) In the event that ABX grants a Sublicense with respect to any ABX Product for use in the Diagnostic Field, ABX shall notify CuraGen in writing, within fifteen (15) days of the grant of such Sublicense, whether ABX elects to pay to CuraGen (i) the milestone payments set forth in Section 8.3.2 upon the occurrence with respect to such ABX Product of the milestone events set forth therein and the royalties set forth in Section 8.4.2 based on Net Sales of such ABX Product or (ii) the following payments and royalties equal to the following percentage of Sublicense Income received by ABX and its Affiliates in connection with such Sublicense for each ABX Product for use in the Diagnostic Field:

 

[***]

   if such Sublicense is granted prior to the commencement of clinical trials of the prototype of such ABX Product

[***]

   if such Sublicense is granted after the commencement of clinical trials of the prototype of such ABX Product and prior to the submission of a PMA for such ABX Product

[***]

   if such Sublicense is granted after the submission of a PMA for such ABX Product

 

Notwithstanding the foregoing, the royalties owing by ABX under this Section 8.4.3(b) in any calendar quarter, with respect to Net Sales by such Sublicensee and its Affiliates of any ABX Product for use in the Diagnostic Field, shall not be less than [**********(**)] of Net Sales by such Sublicensee and its Affiliates of such ABX Product in such calendar quarter. Once made, the election of the basis of payment hereunder may not be changed, and ABX shall pay the amounts determined in accordance with its election.

 

(c) In the event that CuraGen grants a Sublicense with respect to any CuraGen Product for use in the Therapeutic Field, CuraGen shall notify ABX in writing, within

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
41


fifteen (15) days of the grant of such Sublicense, whether CuraGen elects to pay to ABX (i) the milestone payments set forth in Section 8.3.1 upon the occurrence with respect to such CuraGen Product of the milestone events set forth therein and the royalties set forth in Section 8.4.2 based on Net Sales of such CuraGen Product or (ii) the following payments and royalties equal to the following percentage of Sublicense Income received by CuraGen and its Affiliates in connection with the Sublicense for each CuraGen Product for use in the Therapeutic Field:

 

[***]

   if such Sublicense is granted prior to the enrollment of the first patient in the first Phase I Clinical Trial for such CuraGen Product

[***]

   if such Sublicense is granted after the enrollment of the first patient in the first Phase I Clinical Trial for such CuraGen Product and prior to the enrollment of the first patient in the first Phase II Clinical Trial for such CuraGen Product

[***]

   if such Sublicense is granted after the enrollment of the first patient in the first Phase II Clinical Trial for such CuraGen Product

 

Notwithstanding the foregoing, the royalties owing by CuraGen under this Section 8.4.3(c) in any calendar quarter, with respect to Net Sales by such Sublicensee and its Affiliates of any CuraGen Product for use in the Therapeutic Field, shall not be less than the aggregate of (i) [*********(**)] of Net Sales by such Sublicensee and its Affiliates of such CuraGen Product in such calendar quarter, plus (ii) an amount (not to exceed [*********(**)] of Net Sales by such Sublicensee and its Affiliates of such CuraGen Product in such calendar quarter) equal to the royalties (if any) owing to Third Parties by ABX pursuant to those ABX In-Licenses existing as of the Effective Date on sales of such CuraGen Product in such calendar quarter (other than the ABX In-Licenses described in clause (iii) below), plus (iii) with respect to (A) each CuraGen Product directed to a CuraGen Licensed Antigen and comprising a Lambda Antibody or Genetic Material that encodes such Lambda Antibody, and (B) each CuraGen Product comprising a Conjugate (as permitted under this Agreement), an amount equal to the royalties owing by ABX to any Third Party pursuant to the applicable ABX In-License, based on sales of such CuraGen Product, within the applicable royalty payment period set forth in such ABX In-License. Once made, the election of the basis of payment hereunder may not be changed, and CuraGen shall pay the amounts determined in accordance with its election.

 

(d) In the event that CuraGen grants a Sublicense with respect to any CuraGen Product for use in the Diagnostic Field, CuraGen shall notify ABX in writing, within fifteen (15) days of the grant of such Sublicense, whether CuraGen elects to pay to ABX (i) the milestone payments set forth in Section 8.3.2 upon the occurrence with respect to such CuraGen Product of the milestone events set forth therein and the royalties set forth in Section 8.4.2 based on Net Sales of such CuraGen Product or (ii) the following payments and royalties equal to the following percentage of Sublicense Income received by CuraGen and its Affiliates in connection with the Sublicense for such CuraGen Product for use in the Diagnostic Field:

 

[***]

   if such Sublicense is granted prior to the commencement of clinical trials of the prototype of such CuraGen Product

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
42


[***]

   if such Sublicense is granted after the commencement of clinical trials of the prototype of such CuraGen Product and prior to the submission of a PMA for such CuraGen Product
[***]    if such Sublicense is granted after the submission of a PMA for such CuraGen Product

 

Notwithstanding the foregoing, the royalties owing by CuraGen under this Section 8.4.3(d) in any calendar quarter, with respect to Net Sales by such Sublicensee and its Affiliates of any CuraGen Product for use in the Diagnostic Field, shall not be less than the aggregate of (i) [**********(**)] of Net Sales by such Sublicensee and its Affiliates of such CuraGen Product in such calendar quarter, plus (ii) an amount (not to exceed [**********(**)] of Net Sales by such Sublicensee and its Affiliates of such CuraGen Product in such calendar quarter) equal to the royalties (if any) owing to Third Parties by ABX pursuant to those ABX In-Licenses existing as of the Effective Date on sales of such CuraGen Product in such calendar quarter (other than the ABX In-Licenses described in clause (iii) below), plus (iii) with respect to (A) each CuraGen Product directed to a CuraGen Licensed Antigen and comprising a Lambda Antibody or Genetic Material that encodes such Lambda Antibody, and (B) each CuraGen Product comprising a Conjugate (as permitted under this Agreement), an amount equal to the royalties owing by ABX to any Third Party pursuant to the applicable ABX In-License, based on sales of such CuraGen Product, within the applicable royalty payment period set forth in such ABX In-License. Once made, the election of the basis of payment hereunder may not be changed, and CuraGen shall pay the amounts determined in accordance with its election.

 

(e) Length of Royalty Obligations. Each party’s obligations to pay royalties (including without limitation percentages of Sublicense Income) with respect to each Product in each country shall commence on the Royalty Commencement Date for such Product in such country, and shall continue for such Product in such country until (i) if, as of the First Commercial Sale of such Product in such country, there exists a Patent Claim of the applicable Licensed Intellectual Property in the country where such Product is made, used or sold that (A) covers the manufacture, use or sale of such Product, such date as no such Patent Claim exists in the country where such Product is made, used or sold, or (B) covers XenoMouse Animals or their use, such date as no such Patent Claim exists in the country where such Product is made, used or sold, or (ii) otherwise, ten (10) years after the First Commercial Sale of such Product in such country.

 

8.4.4 Discounting. If a party, its Sublicensees or their respective Affiliates sells a Product to a Third Party who also purchases other products or services from such party, its Sublicensees or their respective Affiliates, and such party, its Sublicensees or their respective Affiliates discounts the purchase price of such Product to a greater degree than it generally discounts the price of its other products or services to such customer, then in such case the Net Sales for the sale of such Product to such Third Party shall equal the arm’s length price that Third Parties would generally pay for the Product alone when not purchasing any other

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
43


product or service from such party, its Sublicensee or their respective Affiliates. For purposes of this provision “discounting” includes establishing the list price at a lower-than-normal level.

 

  9. ACCOUNTING AND RECORDS

 

9.1 Royalty Reports and Payments. Commencing with the first calendar quarter in which the Royalty Commencement Date for a Product occurs, CuraGen in the case of CuraGen Products, and ABX in the case of ABX Products (the “Payor”) shall make written reports to the other party (the “Payee”) within sixty (60) days after the end of each calendar quarter, stating in each such report (a) the number, description, and aggregate Net Sales of such Product sold during the calendar quarter, (b) the calculation of the royalties and other amounts payable under Article 8 above, and (c) otherwise satisfying the royalty reporting requirements under each ABX In-License applicable to such Product (in the case of CuraGen Products). Concurrently with the making of such reports, the Payor shall pay to the Payee all royalties payable under Article 8 above. With respect to (1) each CuraGen Product directed to a CuraGen Licensed Antigen and comprising a Lambda Antibody or Genetic Material that encodes such Lambda Antibody, and (2) each CuraGen Product comprising a Conjugate, prior to the date any Third Party royalty is due for such CuraGen Products pursuant to Section 8.4, ABX shall provide to CuraGen information from the applicable ABX In-License(s) sufficient for CuraGen to calculate the royalty then owing and to satisfy the royalty reporting obligations under such ABX In-License(s).

 

9.2 Records; Inspection. The Payor shall keep (and cause its Affiliates, Sublicensees and Sublicensees’ Affiliates to keep) complete, true and accurate books of account and records for the purpose of determining the royalties payable to the Payee under this Agreement. Such books and records shall be kept at the principal place of business of the Payor, its Sublicensee or their respective Affiliates, as the case may be, for at least three years following the end of the calendar quarter to which they pertain. Such records of the Payor and its Affiliates shall be open for inspection during such three-year period by independent accountants chosen by the Payee, and subject to the approval of the Payor, which approval shall not be unreasonably withheld or delayed, (which accountants, in the case of ABX, may also represent XT) for the purpose of verifying the royalty statements. The Payor shall require each of its Sublicensees to maintain similar books and records and to open such records for inspection during the same three-year period by a representative of the Payor reasonably satisfactory to the Payee on behalf of, and as required by, the Payee for the purpose of verifying the royalty statements. All such inspections may be made no more than once each calendar year at reasonable times mutually agreed by the Payor and the Payee. The independent accountants chosen by the Payee will be obliged to execute a reasonable confidentiality agreement prior to commencing any such inspection. Inspections conducted under this Section 9.2 shall be at the expense of the Payee, unless a variation or error producing an increase exceeding five percent (5%) of the amount stated for any period is established in the course of any such inspection, whereupon all costs relating to the audit of such period will be paid by the Payor.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
44


9.3 Payment Method. All payments by the Payor to the Payee hereunder shall be in United States Dollars in immediately available funds and shall be made by wire transfer from a United States bank located in the United States to such bank account as designated by the Payee to the Payor.

 

9.4 Currency Conversion. If any currency conversion shall be required in connection with the calculation of royalties hereunder, such conversion shall be made using the selling exchange rate for conversion of the foreign currency into United States Dollars, quoted for current transactions reported under the heading “Currency Trading – Exchange Rates” in The Wall Street Journal in the United States for the last business day of the calendar quarter to which such payment pertains. If The Wall Street Journal ceases to be published, then the rate of exchange to be used shall be that reported in such other business publication of national circulation in the United States as the parties reasonably agree.

 

9.5 Late Payments. Any payments due from the Payor that are not paid on the date such payments are due under this Agreement shall bear interest at the lesser of (i) the Prime Rate as reported under the heading “Money Rates” in The Wall Street Journal in the United States on the date such payment is due, plus an additional two percent (2%), or (ii) the maximum rate permitted by applicable law, in each case calculated on the number of days such payment is delinquent. This Section 9.5 shall in no way limit any other remedies available to any party. If The Wall Street Journal ceases to be published, then the prime rate to be used shall be that reported in such other business publication of national circulation in the United States as the parties reasonably agree.

 

9.6 Withholding Taxes. Each party shall be entitled to deduct from the royalties owing to the other party hereunder 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 such party, or any taxes required to be withheld by such party, to the extent such party pays to the appropriate governmental authority on behalf of the other party such taxes, levies or charges. The withholding party shall use reasonable efforts to minimize any such taxes, levies or charges required to be withheld on behalf of the other party by such party. The withholding party promptly shall deliver to the other party proof of payment of all such taxes, levies and other charges, together with copies of all communications from or with such governmental authority with respect thereto, and shall reasonably assist the other party in obtaining a refund thereof (to the extent permitted under applicable law) or to obtain a foreign tax credit therefor.

 

  10. DILIGENCE

 

10.1 Diligence Obligation of CuraGen.

 

10.1.1 CuraGen shall use commercially reasonable efforts to actively research, develop and obtain regulatory approvals as expeditiously as reasonably practicable to market in major markets throughout the world at least one CuraGen Product to each CuraGen Licensed Antigen, and following such approval to maximize Net Sales of such CuraGen Product.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
45


10.1.2 Without limiting Section 10.1.1, CuraGen, its Sublicensees or their respective Affiliates shall file an IND with the FDA for at least one CuraGen Product to each CuraGen Licensed Antigen within three (3) years after the effective date of the applicable XT/ABX Product License Agreement. After the filing of an IND for at least one CuraGen Product to a CuraGen Licensed Antigen, CuraGen, its Sublicensees or their respective Affiliates, shall have an active IND and actively and diligently conduct clinical trials in pursuit of regulatory approval for at least one such CuraGen Product in the United States until at least one such CuraGen Product may be sold commercially in the United States.

 

10.1.3 During the term of this Agreement and for a period of five (5) years thereafter, CuraGen shall keep complete and accurate records of its activities conducted under this Agreement regarding the commercialization of CuraGen Products and the results thereof. Within thirty (30) days after the end of each semi-annual period during the term of this Agreement, CuraGen shall prepare and provide ABX with a reasonably detailed written report of such activities and results, through such date.

 

10.2 Diligence Obligation of ABX.

 

10.2.1 ABX shall use commercially reasonable efforts to actively research, develop and obtain regulatory approvals as expeditiously as reasonably practicable to market in major markets throughout the world at least one ABX Product to each ABX Licensed Antigen, and following such approval to maximize Net Sales of such ABX Product.

 

10.2.2 Without limiting Section 10.2.1, ABX, its Sublicensees or their respective Affiliates shall file an IND with the FDA for at least one ABX Product to each ABX Licensed Antigen within three (3) years after the effective date of the applicable XT/ABX Product License Agreement. After the filing of an IND for at least one ABX Product to a ABX Licensed Antigen, ABX, its Sublicensees or their respective Affiliates, shall have an active IND and actively and diligently conduct clinical trials in pursuit of regulatory approval for at least one such ABX Product in the United States until at least one such ABX Product may be sold commercially in the United States.

 

10.2.3 During the term of this Agreement and for a period of five (5) years thereafter, ABX shall keep complete and accurate records of its activities conducted under this Agreement regarding the commercialization of ABX Products and the results thereof. Within thirty (30) days after the end of each semi-annual period during the term of this Agreement, ABX shall prepare and provide CuraGen with a reasonably detailed written report of such activities and results, through such date.

 

10.3 Standards of Performance. The development and commercialization of a Product hereunder by a party, its Sublicensees and their respective Affiliates shall be performed in accordance with high scientific and professional standards, and in compliance in all material respects with the requirements of applicable laws and regulations. ABX, its Sublicensees and their respective Affiliates shall be solely responsible for providing the personnel, materials, equipment, and other resources for the development and commercialization of ABX Products

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
46


hereunder. CuraGen, its Sublicensees and their respective Affiliates shall be solely responsible for providing the personnel, materials, equipment, and other resources for the development and commercialization of CuraGen Products hereunder.

 

10.4 Gene Therapy Applications. Each party’s intention as of the Effective Date is to commercialize a Product hereunder for an application other than Gene Therapy before commercializing a Product hereunder for a Gene Therapy application. It is understood, however, that either party may or may not also intend to develop and sell Products for use in Gene Therapy, and that such Gene Therapy application may ultimately be commercialized before a Product is commercialized hereunder for a non-Gene Therapy application.

 

  11. CONFIDENTIALITY

 

11.1 Confidential Information. During the term of this Agreement and for a period of five (5) years following the expiration or earlier termination hereof, each party shall maintain in confidence the Confidential Information of the other party, and shall not disclose, use or grant the use of the Confidential Information of the other party except on a need-to-know basis to such party’s directors, officers employees, consultants and collaborators, and to the Third Party licensors of the Licensed Intellectual Property, to the extent such disclosure is reasonably necessary or required in connection with such party’s activities as expressly authorized by this Agreement. To the extent that disclosure by a party to any Person is authorized by this Agreement, prior to disclosure, a party shall obtain written agreement of such Person to hold in confidence and not disclose, use or grant the use of the Confidential Information of the other party except as expressly permitted under this Agreement. Each party shall notify the other promptly upon discovery of any unauthorized use or disclosure of the other party’s Confidential Information. Upon the expiration or earlier termination of this Agreement, each party shall return to the other party all tangible items regarding the Confidential Information of the other party and all copies thereof, except for Confidential Information pertaining to any Licensed Antigen and related Products for which, and for so long as, such party retains a license (or sublicense, as the case may be) hereunder; provided, however, that each party shall have the right to retain one (1) copy for its legal files for the sole purpose of determining its obligations hereunder.

 

11.2 Terms of Agreement. Neither party shall disclose any terms or conditions of this Agreement to any Third Party without the prior consent of the other party; provided, however, that either party may disclose the terms or conditions of this Agreement, (a) on a need-to-know basis to its legal and financial advisors to the extent such disclosure is reasonably necessary in connection with such party’s activities as expressly permitted by this Agreement or for the conduct of its business; (b) to the Third Party licensors of the Licensed Intellectual Property; (c) to a Third Party in connection with (i) an equity investment or other form of financing in such party by a Third Party; (ii) a merger, consolidation or similar transaction entered into by such party; or (iii) the sale of all or substantially all of the assets of such party; and (d) as may, in the reasonable opinion of such party’s counsel, be required by applicable law, regulation or court order, including without limitation, a disclosure in connection with such

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
47


party’s filing of a registration statement or other filing with the United States Securities and Exchange Commission (in which event such party will first consult with the other party, to the extent reasonably practicable, with respect to such disclosure). Notwithstanding the foregoing, (i) the parties will jointly issue a press release in mutually agreed form promptly after execution hereof and (ii) prior to execution of this Agreement CuraGen and ABX shall agree upon the substance of information that can be used to describe the terms of this transaction, and CuraGen and ABX may disclose such information, as modified by mutual agreement from time to time, without the other party’s consent.

 

  12. TECHNOLOGY, INFORMATION AND INTELLECTUAL PROPERTY

 

12.1 Ownership.

 

12.1.1 ABX shall solely own all right, title and interest in the ABX Technology and Information and in all patent rights and other intellectual property rights therein. CuraGen shall not (and shall not attempt or purport to) file or prosecute any patent application in any country which claims or purports to claim the ABX Technology and Information, unless the parties otherwise expressly agree in writing. ABX shall solely own all right, title and interest in the Excluded ABX Technology and in all patent rights and other intellectual property rights therein. CuraGen shall not (and shall not attempt or purport to) file or prosecute any patent application in any country which claims or purports to claim the Excluded ABX Technology.

 

12.1.2 CuraGen shall solely own all right, title and interest in the CuraGen Technology and Information and in all patent rights and other intellectual property rights therein. ABX shall not (and shall not attempt or purport to) file or prosecute any patent application in any country which claims or purports to claim the CuraGen Technology and Information, unless the parties otherwise expressly agree in writing. CuraGen shall solely own all right, title and interest in the Excluded CuraGen Technology and in all patent rights and other intellectual property rights therein. ABX shall not (and shall not attempt or purport to) file or prosecute any patent application in any country which claims or purports to claim the Excluded CuraGen Technology.

 

12.1.3 ABX shall solely own all right, title and interest in Research Program Technology and Information conceived, reduced to practice or otherwise derived solely by Persons on behalf of ABX, together with all patent rights and other intellectual property rights therein and, subject to the provisions of this Agreement, shall have the right to freely exploit, transfer, license, or encumber its rights thereto. CuraGen shall solely own all right, title and interest in Research Program Technology and Information conceived, reduced to practice or otherwise derived solely by Persons on behalf of CuraGen, together with all patent rights and other intellectual property rights therein and, subject to the provisions of this Agreement, shall have the right to freely exploit, transfer, license, or encumber its rights thereto. The parties jointly shall own all right, title and interest in Research Program Technology and Information conceived, reduced to practice or otherwise derived jointly by Persons on behalf of ABX and by Persons on behalf of CuraGen, together with all patent rights and other intellectual property

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
48


rights therein. Each party shall have the right, subject to the provisions of this Agreement, to freely exploit, transfer, license or encumber its rights in any jointly-owned Research Program Technology and Information (and all patent rights and other intellectual property rights therein) without the consent of, or payment or accounting to, the other party.

 

12.1.4 The transfer of physical possession of any Technology and Information owned by, and the physical possession and use of any Technology and Information by, CuraGen or ABX, as the case may be, shall not be (nor be construed as) a sale, lease, offer to sell or lease, or other transfer of title of such Technology and Information to CuraGen or ABX, as the case may be.

 

12.1.5 During the term of this Agreement, neither party shall (and neither party shall attempt or purport to) assign, sell, have sold, lease, offer to sell or lease, otherwise transfer title to, or otherwise distribute or license, sublicense or otherwise commercialize or exploit, any Research Program Technology and Information, except as otherwise set forth herein or the parties otherwise expressly agree in writing.

 

12.2 Assignment and Disclosure. Each party shall cause all employees and others conducting work on its behalf under this Agreement to promptly disclose to the other party all Technology and Information in which the other party has an ownership interest, and to assign any and all right, title and interest in all Technology and Information and all patent rights and other intellectual property rights therein in accordance with this Agreement. Each party shall maintain records in sufficient detail and in good scientific manner appropriate for patent purposes to properly reflect all work done and results achieved in conducting its work hereunder, and shall respond to reasonable requests of the other party for information regarding Technology and Information in which the other party has an ownership interest.

 

12.3 Research Program Patent Rights.

 

12.3.1 Prosecution and Maintenance.

 

(a) Subject to the provisions of Section 12.3.1(e) and Section 12.3.1(g) below, ABX shall have the right (but not the obligation), at its sole expense, to prepare, file, prosecute and maintain the ABX Patent Rights. ABX will use reasonable efforts to file Antibody composition of matter claims (i) with respect to any ABX Patent Rights arising before the Revision Date, within 6 months of the Revision Date and (ii) with respect to any ABX Patent Rights arising after the Revision Date, within 6 months of characterization of Antibody supernatants resulting from immunizations with Research Antigens. If ABX unreasonably fails to file such claims in such time period, CuraGen may, by written notice to ABX, assume control of the preparation, filing, prosecution and maintenance of the ABX Patent Rights, to the extent and only to the extent, that such ABX Patent Rights claim such Antibodies as a composition of matter, and ABX shall reimburse CuraGen on demand for all expenses of the preparation, filing, prosecution and maintenance of such ABX Patent Rights.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
49


(b) CuraGen shall have the right (but not the obligation), at its sole expense, to prepare, file, prosecute and maintain the CuraGen Patent Rights. CuraGen shall have the right to use Antigen Specific Materials and Information and Research Program Technology and Information in preparing, prosecuting, maintaining and defending CuraGen Patent Rights; provided, however, that CuraGen shall not claim any ABX Technology.

 

(c) Subject to the provisions of Section 12.3(a) above and Section 12.3.1(e) and (f) below, (i) ABX shall have the right (but not the obligation), at its sole expense, to prepare, file, prosecute and maintain the Research Program Patent Rights owned solely by ABX; (ii) CuraGen shall have the right (but not the obligation), at its sole expense, to prepare, file, prosecute and maintain the Research Program Patent Rights owned solely by CuraGen; and (iii) CuraGen shall have the right (but not the obligation) to prepare, file, prosecute and maintain the Research Program Patent Rights owned jointly by the parties, and ABX shall reimburse CuraGen on demand for one-half the reasonable expenses thereof.

 

(d) Any method of use data arising from the conduct of in-vitro assays or use of in-vivo models in the Research Program will be filed by the responsible party simultaneously in the patent applications claiming Antibodies and Research Antigens, regardless of the category in which such patent applications fall. The parties will coordinate such filings and will use reasonable efforts to file such applications within three months of generating the data.

 

(e) Upon the effective date of a research license under Article 6 to a CuraGen Optioned Antigen, and for so long as such license or a commercial license under Article 7 for such Antigen remains in effect, (i) CuraGen shall have the right (but not the obligation) to assume control of the preparation, filing, prosecution and maintenance of the Research Program Patent Rights that specifically and solely claim such CuraGen Licensed or Optioned Antigen or the use thereof; (ii) CuraGen shall have the right (but not the obligation) to assume control of the preparation, filing, prosecution and maintenance of the ABX Patent Rights that specifically and solely claim the use of such CuraGen Antigen or Antibodies to such CuraGen Licensed or Optioned Antigen or the use thereof; (iii) CuraGen shall reimburse ABX on demand for all previously unreimbursed expenses of the preparation, filing, prosecution and maintenance of such ABX Patent Rights and Research Program Patent Rights; and (iv) CuraGen shall be solely responsible for the expenses of the preparation, filing, prosecution and maintenance of such ABX Patent Rights and Research Program Patent Rights thereafter. In the event there are any Research Program Patent Rights or ABX Patent Rights with such claims and other claims, ABX shall file such divisional or other applications, to the extent legally permitted, as may be necessary to separate such claims into a separate application, which CuraGen shall then have the right to control as aforesaid. If the claims cannot be so separated ABX will take no action with respect to any such claim that would materially narrow the scope thereof without CuraGen’s express written consent, which consent shall not be unreasonably withheld or delayed. If CuraGen assumes control of any patent application pursuant to this Section and determines to abandon such application, CuraGen shall give written notice of such intention to

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
50


ABX at least thirty (30) days before taking such action, and ABX shall have the right, by written notice to CuraGen, to assume the prosecution and maintenance thereof.

 

(f) Upon the effective date of a research license under Article 6 to an ABX Optioned Antigen, and for so long as such license or a commercial license under Article 7 for such Antigen remains in effect, (i) ABX shall have the right (but not the obligation) to assume control of the preparation, filing, prosecution and maintenance of the Research Program Patent Rights that specifically and solely claim such ABX Licensed or Optioned Antigen or the use thereof; (ii) ABX shall have the right (but not the obligation) to assume control of the preparation, filing, prosecution and maintenance of the CuraGen Patent Rights that specifically and solely claim antibodies to such ABX Licensed or Optioned Antigen or the use thereof; (iii) ABX shall reimburse CuraGen on demand for all previously unreimbursed expenses of the preparation, filing, prosecution and maintenance of such Research Program Patent Rights and CuraGen Patent Rights; and (iv) ABX shall be solely responsible for the expenses of the preparation, filing, prosecution and maintenance of such Research Program Patent Rights and CuraGen Patent Rights thereafter. In the event there are any Research Program Patent Rights or CuraGen Patent Rights with such claims and other claims, CuraGen shall file such divisional or other applications, to the extent legally permitted, as may be necessary to separate such claims into a separate application, which ABX shall then have the right to control as aforesaid. If the claims cannot be so separated CuraGen will take no action with respect to any such claim that would materially narrow the scope thereof without ABX’s express written consent, which consent shall not be unreasonably withheld or delayed. If ABX assumes control of any patent application pursuant to this Section and determines to abandon such application, ABX shall give written notice of such intention to CuraGen at least thirty (30) days before taking such action, and CuraGen shall have the right, by written notice to ABX, to assume the prosecution and maintenance thereof.

 

(g) CuraGen shall have the right (but not the obligation) to control the preparation, filing, prosecution and maintenance of any Research Program Patent Rights and ABX Patent Rights that specifically and solely claim any CuraGen Exclusive Antigen or the use thereof or Antibodies that Specifically Bind to such CuraGen Exclusive Antigen or the use thereof. In the event there are any Research Program Patent Rights or ABX Patent Rights with such claims and other claims, ABX shall file such divisional or other applications, to the extent legally permitted, as may be necessary to separate such claims into a separate application, which CuraGen shall then have the right to control as aforesaid. If the claims cannot be so separated ABX will take no action with respect to any such claim that would materially narrow the scope thereof without CuraGen’s express written consent, which consent shall not be unreasonably withheld or delayed.

 

(h) With respect to each patent application and patent within the Licensed Intellectual Property Rights or Research Program Patent Rights that specifically and solely claims an Optioned Antigen, a Licensed Antigen, an Antibody that Specifically Binds to an Optioned Antigen, an Antibody to a Licensed Antigen or the use thereof and with respect to each other patent and patent application within the Research Program Patent Rights owned jointly by

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
51


the parties, the controlling party shall (i) provide the non-controlling party with any patent application filed by the controlling party prior to filing in order to provide the non-controlling party with an opportunity to comment thereon, and consider in good faith reasonable comments by the non-controlling party thereon; (ii) provide the non-controlling party with any patent application filed by the controlling party promptly after such filing; and (iii) provide the non-controlling party promptly with copies of all substantive communications received from or filed in patent office(s) with respect to such filings and consider in good faith reasonable comments by the non-controlling party thereon; and (iv) use commercially reasonable efforts to obtain the broadest reasonable claims.

 

(i) The non-controlling party shall assist the controlling party, upon the controlling party’s request, and to the extent commercially reasonable, in preparing, filing or maintaining the patent applications and patents within the Research Program Patent Rights and Licensed Intellectual Property Rights.

 

12.3.2 Enforcement.

 

(a) Subject to the provisions of Section 12.3.2(e) below, ABX shall have the right (but not the obligation), at its sole expense, to control the enforcement of the ABX Patent Rights; provided, however, that CuraGen shall have the right (but not the obligation), at its sole expense, to control the enforcement of those ABX Patent Rights (if any) for which CuraGen assumes control of the preparation, filing, prosecution and maintenance under Section 12.3.1(e) and (g) above.

 

(b) Subject to the provisions of Section 12.3.2(e) below, CuraGen shall have the right (but not the obligation), at its sole expense, to control the enforcement of the CuraGen Patent Rights; provided, however, that ABX shall have the right (but not the obligation), at its sole expense, to control the enforcement of those CuraGen Patent Rights (if any) for which ABX assumes control of the preparation, filing, prosecution and maintenance under Section 12.3.1(f) above.

 

(c) Subject to the provisions of Section 12.3.2(e) below, the controlling party identified under Section 12.3.1 above shall have the first right (but not the obligation), at its sole expense, to enforce the Research Program Patent Rights.

 

(d) With respect to each patent within the Licensed Intellectual Property Rights or Research Program Patent Rights that specifically and solely claims a Licensed Antigen, an Antibody to a Licensed Antigen or the use thereof, the controlling party shall keep the non-controlling party informed and consider in good faith the reasonable comments of the non-controlling party, both prior to and during any such enforcement. The non-controlling party shall assist the controlling party, upon request and at the controlling party’s sole expense, and to the extent commercially reasonable, in taking any action to enforce such Licensed Intellectual

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
52


Property Rights or Research Program Patent Rights to the extent the non-controlling party has the right to do so.

 

(e) If the controlling party fails to abate an infringement of any patent within the Licensed Intellectual Property Rights or Research Program Patent Rights that specifically and solely claims a Licensed Antigen, an Antibody to a Licensed Antigen or the use thereof, or to file an action to abate such infringement, within ninety (90) days after a written request from the non-controlling party to do so, or if the controlling party discontinues the prosecution of any such action after filing patent, the non-controlling party at its expense may, in its discretion, undertake such action as it determines appropriate to enforce the Research Program Patent Rights. In such case, the controlling party shall assist the non-controlling party, upon request and at the non-controlling party’s sole expense, and to the extent commercially reasonable, in taking any action to enforce such patent within the Licensed Intellectual Property Rights or Research Program Patent Rights to the extent the controlling party has the right to do so.

 

(f) All monies recovered upon the final judgment or settlement of any such action regarding the Licensed Intellectual Property Rights or Research Program Patent Rights that specifically and solely claims a Licensed Antigen, an Antibody to a Licensed Antigen or the use thereof shall be used (i) first, to reimburse the costs and expenses (including reasonable attorneys’ fees and costs) of the controlling party and the non-controlling party, and (ii) the remainder, [***********************************************************].

 

12.4 Patent Marking. Each party shall mark, and shall cause its Sublicensees and their respective Affiliates to mark all Products, sold pursuant to this Agreement by such party, its Sublicensees and their respective Affiliates in accordance with the requirements of applicable laws and regulations in the country or countries of manufacture and sale thereof.

 

12.5 Limitation. Notwithstanding any other provision in this Article 12, (a) ABX shall not be obligated to prepare, file, prosecute, and maintain patents and patent applications, or to bring or pursue enforcement proceedings or defend declaratory judgment actions regarding the Licensed ABX Intellectual Property if, and to the extent that, ABX is not entitled to do so under one or more ABX In-Licenses, and (b) any rights conveyed under this Article 12 permitting CuraGen to prepare, file, prosecute and maintain certain patents and patent applications, or to bring and pursue enforcement proceedings, or defend declaratory judgment actions, regarding the Licensed ABX Intellectual Property, shall be subject to all applicable ABX In-Licenses, and are conveyed only to the extent permitted under such agreements.

 

12.6 Use and Transfer Restrictions. Each party shall use the Technology and Information owned by the other party solely for purposes of conducting its obligations or exercising its rights under this Agreement, at its facilities, under commercially and scientifically reasonable containment conditions, and not for any other commercial, business or other use or purpose, without the prior express written consent of the other party. Except as otherwise provided in this Agreement, (a) a party shall not transfer or provide access to the Technology and

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
53


Information owned by the other party to any Affiliate or Third Party; (b) a party shall not transfer or transport the Technology and Information owned by the other party from its facilities to any other location; (c) a party shall limit access to the Technology and Information owned by the other party to those of its employees working on its premises, to the extent such access is reasonably necessary to conduct its obligations or exercise its rights under this Agreement; and (d) a party shall not (and shall not attempt or purport to) assign, sell, have sold, lease, offer to sell or lease, otherwise transfer title to, or otherwise distribute or license, sublicense or otherwise commercialize or exploit, any Technology and Information owned by the other party or any interest therein.

 

12.7 Grant Backs.

 

12.7.1 It is the intent of the parties that this Agreement shall not restrict ABX’s freedom to practice and commercialize the Licensed ABX Intellectual Property, the XenoMouse Animals and the ABX Technology and Information, except as expressly set forth herein. CuraGen hereby grants to ABX a royalty-free, perpetual, irrevocable, exclusive, worldwide license (with the right to grant sublicenses) under CuraGen’s rights in the Research Program Patent Rights and Research Program Know-How to research, develop, make, have made, use, offer for sale, sell and import Human Antibody Equivalents and products comprising Human Antibody Equivalents (other than CuraGen Products) for all uses. CuraGen hereby grants to ABX a royalty-free, perpetual, irrevocable, nonexclusive worldwide license (with the right to grant sublicenses) under CuraGen’s rights in the Research Program Patent Rights and Research Program Know-How to research, develop, make and use Antibody Equivalents (other than Human Antibody Equivalents) solely in connection with the research, development, making, having made, using, offering for sale, selling and importing of Human Antibody Equivalents and products comprising Human Antibody Equivalents (other than CuraGen Products) for all uses. CuraGen hereby grants to ABX a royalty-free, perpetual, irrevocable, nonexclusive, worldwide license (with the right to grant sublicenses) under those certain one or more CuraGen Patent Rights, which have a common claim of priority and relate to the same antigen and in which the claims within such CuraGen Patent Rights are supported by information or data derived from the use of the ABX Technology and Information and/or Research Program Technology and Information, solely in connection with the research, development, making, having made, using, offering for sale, selling and importing of Human Antibody Equivalents and products comprising Human Antibody Equivalents (other than CuraGen Products) for all uses.

 

12.7.2 It is the intent of the parties that this Agreement shall not restrict CuraGen’s freedom to practice and commercialize the Licensed CuraGen Intellectual Property, the CuraGen Databases, and the CuraGen Technology and Information, except as expressly set forth herein. ABX hereby grants to CuraGen a royalty-free, perpetual, irrevocable, exclusive, worldwide license (with the right to grant sublicenses) under ABX’s rights in the Research Program Patent Rights and Research Program Know-How to research, develop, make, have made, use, offer for sale, sell and import Antibody Equivalents (other than Human Antibody Equivalents) and compositions other than Antibody Equivalents, and products (other than ABX Products) comprising Antibody Equivalents (other than Human Antibody Equivalents) and

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
54


compositions other than Antibody Equivalents, for all uses; provided, however, that ABX reserves, for itself and its sublicensees, the right under ABX’s rights in the Research Program Patent Rights and Research Program Know-How to exercise its license rights granted under Section 12.7.1 above. ABX hereby grants to CuraGen a royalty-free, perpetual, irrevocable, nonexclusive, worldwide license (with the right to grant sublicenses) under those certain one or more ABX Patent Rights, which have a common claim of priority and relate to the same antigen and in which the claims within such ABX Patent Rights are supported by information or data derived from the use of the CuraGen Technology and Information and/or Research Program Technology and Information, solely in connection with the research, development, making, having made, using, offering for sale, selling and importing of Antibody Equivalents (other than Human Antibody Equivalents) and compositions other than Antibody Equivalents, and products (other than ABX Products) comprising Antibody Equivalents (other than Human Antibody Equivalents) and compositions other than Antibody Equivalents, for all uses.

 

12.8 Imaging Peptides. Nothing in this Agreement shall preclude CuraGen from making, using, offering for sale, selling or importing Imaging Peptides for purposes of in vivo diagnostic imaging use.

 

  13. INDEMNIFICATION

 

13.1 ABX. ABX shall indemnify and hold harmless CuraGen, and its directors, officers, employees and agents, from and against all losses, liabilities, damages and expenses, including reasonable attorneys’ fees and costs (collectively, “Liabilities”), resulting from any claims, demands, actions or other proceedings by any Third Party arising from (a) the material breach of any representation, warranty or covenant by ABX under this Agreement, (b) any use, handling or storage by ABX, its Sublicensees (other than CuraGen) and their respective Affiliates of the CuraGen Technology and Information or the Research Program Technology and Information, (c) the manufacture, use, sale, handling or storage by ABX, its Sublicensees (other than CuraGen) and their respective Affiliates of ABX Products (without regard to culpable conduct), or (d) any use by ABX, its Sublicensees (other than CuraGen) and their respective Affiliates of the Confidential Information of CuraGen; provided, however, that ABX shall not be obligated to indemnify or hold harmless CuraGen for such Liabilities to the extent that such Liabilities arise from the gross negligence or willful misconduct of CuraGen.

 

13.2 CuraGen. CuraGen shall indemnify and hold harmless ABX, and its directors, officers, employees and agents, from and against all Liabilities resulting from any claims, demands, actions or other proceedings by any Third Party arising from (a) the material breach of any representation, warranty or covenant by CuraGen under this Agreement, (b) any use, handling or storage by CuraGen, its Sublicensees (other than ABX) and their respective Affiliates of the ABX Technology and Information or the Research Program Technology and Information, (c) the manufacture, use, sale, handling or storage by CuraGen, its Sublicensees (other than ABX) and their respective Affiliates of CuraGen Products (without regard to culpable conduct), or (d) any use by CuraGen, its Sublicensees (other than ABX) and their respective Affiliates of the Confidential Information of ABX; provided, however, that CuraGen shall not be

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
55


obligated to indemnify or hold harmless ABX for such Liabilities to the extent that such Liabilities arise from the gross negligence or willful misconduct of ABX.

 

13.3 Procedure. If a party (an “Indemnitee”) intends to claim indemnification under this Article 13, it shall promptly notify the indemnifying party (the “Indemnitor”) in writing of any claim, demand, action or other proceeding for which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have the right to participate in, and, to the extent the Indemnitor so desires, to assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitor, 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 proceeding. The indemnity agreement in this Article 13 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed unreasonably. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to its ability to defend such action, shall relieve such Indemnitor of any liability to the Indemnitee under this Article 13, but the omission so to deliver written notice to the Indemnitor shall not relieve it of any liability that it may have to any party claiming indemnification otherwise than under this Article 13. The party claiming indemnification under this Article 13, its employees and agents, shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by this indemnification.

 

13.4 Insurance. Each party shall maintain insurance, including product liability insurance, with respect to the research, development, manufacture and sale of Products hereunder by such party, its Sublicensees and their respective Affiliates in such amount as such party customarily maintains with respect to the research, development, manufacture and sale of its other products. Each party shall maintain such insurance for so long as such party, its Sublicensees and their respective Affiliates continues to research, develop, manufacture or sell any Products hereunder, and thereafter for so long as such party customarily maintains insurance covering the research, development, manufacture and sale of its other products.

 

  14. TERM AND TERMINATION

 

14.1 Term. The term of this Agreement shall commence on the Effective Date and, unless earlier terminated, shall continue in full force and effect until the expiration of the parties’ respective royalty obligations pursuant to this Agreement.

 

14.2 Termination.

 

14.2.1 If CuraGen breaches its obligations under Section 8.2, 8.3 or 8.4 above, or materially breaches its obligations under Section 10.1 above, with respect to any Antigen or to CuraGen Products to any CuraGen Licensed Antigen, and such breach shall have continued for ten (10) days, in the case of breaches under Section 8.2, 8.3, or 8.4, or for thirty

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
56


(30) days, in the case of material breaches under Section 10.1, after written notice of such breach was provided to CuraGen by ABX, ABX shall have the right at its option to terminate the licenses (or sublicenses, as the case may be) under this Agreement with respect to such Antigen or to CuraGen Products to such CuraGen Licensed Antigen (as applicable) effective at the end of such ten (10) day or thirty (30) day period, as the case may be, without otherwise affecting the other licenses (or sublicenses, as the case may be) granted under this Agreement or the other remaining provisions of this Agreement. In the event of such termination by ABX, the Antigen which was the subject of the termination shall be subject to ABX’s standby option under Section 7.2.2, CuraGen’s obligation to provide data and information under Section 7.2.2 shall apply to all data and information in existence at the time of the termination, the six-month period in which to exercise such option shall commence on the date of termination, and no payment shall be due under Section 8.2.3 upon the exercise by ABX of such option.

 

14.2.2 If ABX breaches its obligations under Section 8.2, 8.3 or 8.4 above, or materially breaches its obligations under Section 10.2 above, with respect to any Antigen or to ABX Products to any ABX Licensed Antigen, and such breach shall have continued for ten (10) days, in the case of breaches under Section 8.2, 8.3, or 8.4, or for thirty (30) days, in the case of material breaches under Section 10.2, after written notice of such breach was provided to ABX by CuraGen, CuraGen shall have the right at its option to terminate the licenses (or sublicenses, as the case may be) under this Agreement with respect to such Antigen or to ABX Products to such ABX Licensed Antigen (as applicable) effective at the end of such ten (10) day or thirty (30) day period, as the case may be, without otherwise affecting the other licenses (or sublicenses, as the case may be) granted under this Agreement or the other remaining provisions of this Agreement. In the event of such termination by CuraGen, the Antigen which was the subject of the termination shall be subject to CuraGen’s standby option under Section 7.1.2, ABX’s obligation to provide data and information under Section 7.1.2 shall apply to all data and information in existence at the time of the termination, the six-month period in which to exercise such option shall commence on the date of termination, and no payment shall be due under Section 8.2.3 upon the exercise by CuraGen of such option.

 

14.2.3 If a party shall have materially breached any of its material obligations hereunder (other than under Sections 8.2, 8.3, 8.4, 10.1 and 10.2 above), and such breach shall have continued for thirty (30) days after written notice of such breach was provided to the breaching party by the nonbreaching party, the nonbreaching party shall have the right (at its option), effective at the end of such thirty (30) day period, to terminate the Research Program and all options, licenses, and rights to obtain additional options and licenses granted to the breaching party under this Agreement; provided, however, that any commercial licenses previously granted to the breaching party under Article 7 above (and any related continuing research licenses to the breaching party under Section 6.1 above), all licenses granted to the breaching party under Section 12.7 above, and all options, licenses, and rights to obtain additional options and licenses granted to the nonbreaching party under this Agreement shall survive any such termination by the nonbreaching party under this Section 14.2.3.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
57


14.3 Effect of Expiration or Termination.

 

14.3.1 Expiration or termination of this Agreement shall be without prejudice to any rights which shall have accrued to the benefit of a party prior to such expiration or termination. Without limiting the foregoing, the license rights granted under Section 4.2.7, Section 4.2.2 and the provisions of Sections 4.4.4 and 8.1 and Articles 9, 11, 12, 13, 14 and 15 shall survive any expiration or termination of this Agreement.

 

14.3.2 Following the expiration under Section 8.4.3(e) of CuraGen’s obligation to pay royalties to ABX hereunder with respect to a CuraGen Product (provided that CuraGen’s option, license or other rights with respect to such CuraGen Product have not been previously terminated), CuraGen shall have a fully-paid up, non-exclusive license (or sublicense, as the case may be) (with the right to grant sublicenses) under the ABX Know-How and Research Program Know-How solely to make, have made, use, offer for sale, sell and import such CuraGen Product for use in the Commercial Field. Following the expiration under Section 8.4.3(e) of ABX’s obligation to pay royalties to CuraGen hereunder with respect to an ABX Product (provided that ABX’s option, license or other rights with respect to such ABX Product have not been previously terminated), ABX shall have a fully-paid up, non-exclusive license (or sublicense, as the case may be) (with the right to grant sublicenses) under the CuraGen Know-How and Research Program Know-How solely to make, have made, use, offer for sale, sell and import such ABX Product for use in the Commercial Field.

 

14.3.3 Upon termination of this Agreement, or upon termination of the licenses (or sublicenses, as the case may be) hereunder for any CuraGen Product, CuraGen, its Sublicensees and their respective Affiliates shall have the right to sell or otherwise dispose (consistent with all applicable laws and regulations and subject to Articles 8 and 9 above) of the stock of any CuraGen Product then on hand. Upon termination of this Agreement, or upon termination of the licenses (or sublicenses, as the case may be) hereunder for any ABX Product, ABX, its Sublicensees and their respective Affiliates shall have the right to sell or otherwise dispose (consistent with all applicable laws and regulations and subject to Articles 8 and 9 above) of the stock of any ABX Product then on hand.

 

14.3.4 Upon termination of this Agreement by ABX, or upon termination by ABX of the licenses (or sublicenses, as the case may be) hereunder for any CuraGen Product, any Sublicense granted by CuraGen hereunder shall survive, provided that upon request by ABX, such Sublicensee promptly agrees in writing that such Sublicensee shall be bound by the terms of such Sublicense for the benefit of ABX and ABX shall have all of the rights of CuraGen under such Sublicense, but ABX shall not be bound by any obligation of CuraGen thereunder except to the extent it is already bound to an equivalent obligation hereunder. Upon termination of this Agreement by CuraGen, or upon termination by CuraGen of the licenses (or sublicenses, as the case may be) hereunder for any ABX Product, any Sublicense granted by ABX hereunder shall survive, provided that upon request by CuraGen, such Sublicensee promptly agrees in writing that such Sublicensee shall be bound by the terms of such Sublicense for the benefit of CuraGen and CuraGen shall have all of the rights of ABX under such Sublicense, but CuraGen shall not be bound by any obligation of ABX thereunder except to the extent it is already bound to an equivalent obligation hereunder.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
58


14.3.5 Except as otherwise expressly agreed in writing by the parties, promptly upon the expiration of the Extended Research License Term, each party shall destroy all remaining Research Program Technology and Information and Antigen Specific Materials and Information; in each case except to the extent such party retains an option or license (or sublicense, as the case may be) thereto hereunder; that survives such expiration or termination.

 

14.3.6 Except as otherwise expressly agreed in writing by the parties, promptly upon the expiration or earlier termination of this Agreement, (a) CuraGen shall destroy or return to ABX (as ABX shall direct) all remaining ABX Technology and Information; (b) ABX shall destroy or return to CuraGen (as CuraGen shall direct) all remaining CuraGen Technology and Information; and (c) each party shall destroy all remaining Research Program Technology and Information and Antigen Specific Materials and Information; in each case except to the extent such party retains a license (or sublicense, as the case may be) thereto hereunder; that survives such expiration or termination.

 

14.3.7 Except as otherwise expressly agreed in writing by the parties, promptly upon the termination of the license (or sublicense, as the case may be)s granted to CuraGen hereunder regarding any Antigen, CuraGen shall destroy or return to ABX (as ABX shall direct) all remaining ABX Technology and Information regarding such Antigen, Antibodies to such Antigens and Products to such Antigen, and shall destroy all remaining Research Program Technology and Information and Antigen Specific Materials and Information regarding such Antigen, Antibodies to such Antigens and Products to such Antigen.

 

14.3.8 Except as otherwise expressly agreed in writing by the parties, promptly upon the termination of the license (or sublicense, as the case may be)s granted to ABX hereunder regarding any Antigen, ABX shall destroy or return to CuraGen (as CuraGen shall direct) all remaining CuraGen Technology and Information regarding such Antigen, Antibodies to such Antigens and Products to such Antigen, and shall destroy all remaining Research Program Technology and Information and Antigen Specific Materials and Information regarding such Antigen, Antibodies to such Antigens and Products to such Antigen.

 

  15. MISCELLANEOUS

 

15.1 Governing Laws. This Agreement shall be governed by, interpreted and construed in accordance with the laws of the State of Delaware, without regard to conflicts of law principles.

 

15.2 Waiver. No waiver by any party hereto of any breach or default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar breach or default.

 

15.3 Assignments. Neither this Agreement nor any right or obligation hereunder may be assigned or delegated, in whole or part, by either party without the prior express written consent of the other; provided, however, that either party may, without the written consent of the other, assign this Agreement and its rights and delegate its obligations

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
59


hereunder in connection with the transfer or sale of all or substantially all of its business, or in the event of its merger, consolidation, change in control or similar transaction. Any permitted assignee shall assume all obligations of its assignor under this Agreement. Any purported assignment in violation of this Section 15.3 shall be void.

 

15.4 Independent Contractors. The relationship of the parties hereto is that of independent contractors. The parties hereto shall not be deemed to be agents, partners or joint venturers of the others for any purpose as a result of this Agreement or the transactions contemplated thereby.

 

15.5 Further Actions. Each party agrees to execute, acknowledge and deliver such further instruments and to do all such other acts as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

15.6 Notices. All requests and notices required or permitted to be given to the parties hereto shall be given in writing, shall expressly reference the section(s) of this Agreement to which they pertain, and shall be delivered to the other party, effective on receipt, at the appropriate address as set forth below or to such other addresses as may be designated in writing by the parties from time to time during the term of this Agreement.

 

If to ABX:

 

Abgenix, Inc.

7601 Dumbarton Circle

Fremont, California 94555

Attn: President

 

with a copy to:

 

Gray Cary Ware & Freidenrich LLP

4365 Executive Drive, Suite 1600

San Diego, California 92121-2189

Attn: Mark R. Wicker

 

If to CuraGen:

 

CuraGen Corporation

555 Long Wharf Drive

New Haven, Connecticut 06511

Attn: President

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
60


with a copy to:

 

Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C.

One Financial Center

Boston, Massachusetts 02111

Attn: Jeffrey M. Wiesen

 

15.7 No Implied Licenses. Only licenses (or sublicenses, as the case may be) and rights granted expressly herein shall be of legal force and effect. No license (or sublicense, as the case may be) or other right shall be created hereunder by implication, estoppel or otherwise. By way of clarification and not limitation, no license (or sublicense, as the case may be) is granted hereunder to CuraGen to have in its possession any XenoMouse Animals or to conduct immunizations thereof.

 

15.8 Compliance with Laws. Each party shall use the Technology and Information of the other party and the Research Program Technology and Information in compliance in all material respects with all applicable laws, guidelines and regulations which are applicable to such Technology and Information or the use thereof, including without limitation any biosafety procedures and all safety precautions accompanying such Technology and Information. Except as otherwise expressly agreed in this Agreement or otherwise expressly agreed in writing by the parties, neither party shall administer the Technology and Information of the other party or the Research Program Technology and Information to humans under any circumstances.

 

15.9 Export Laws. Notwithstanding anything to the contrary contained herein, all obligations of ABX and CuraGen are subject to prior compliance with United States export regulations and such other United States laws and regulations as may be applicable, and to obtaining all necessary approvals required by the applicable agencies of the government of the United States. Each party shall be responsible for obtaining such approvals as required of it, and shall use efforts consistent with prudent business judgment to obtain such approvals. Each party shall cooperate reasonably with the other party and provide reasonable assistance to the other party as may be reasonably necessary to obtain any required approvals.

 

15.10 Force Majeure. Nonperformance of a party (other than for the payment of money) shall be excused to the extent that performance is rendered impossible by strike, fire, earthquake, flood, governmental acts or orders or restrictions, failure of suppliers, or any other reason where failure to perform, is beyond the reasonable control and not caused by the negligence, intentional conduct or misconduct of the nonperforming party.

 

15.11 No Consequential Damages. IN NO EVENT SHALL A PARTY HERETO BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING WITHOUT LIMITATION LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 15.11 IS INTENDED TO

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
61


LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY.

 

15.12 Third Party Rights. Notwithstanding anything to the contrary in this Agreement, the grant of rights by ABX under this Agreement shall be subject to and limited in all respects by the terms of the applicable ABX In-License(s) pursuant to which ABX acquired any Licensed ABX Intellectual Property, and all rights or sublicenses granted under this Agreement shall be limited to the extent that ABX may grant such rights and sublicenses under such ABX In-Licenses. Additionally, and without limiting the foregoing, the rights granted to CuraGen hereunder, including without limitation any grant of “exclusive” rights, shall be subject to the rights granted to or retained by GenPharm under the GenPharm Cross License Agreement.

 

15.13 Complete Agreement. This Agreement constitutes the entire agreement between the parties regarding the subject matter hereof, and all prior representations, understandings and agreements regarding the subject matter hereof (including without limitation, the Original Agreement and the letter dated July 5, 2000, from Christopher McLeod to Raymond Withy) either written or oral, expressed or implied, are superseded and of no effect.

 

15.14 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and both together shall be deemed to be one and the same agreement.

 

15.15 Headings. The captions to the several Articles and Sections hereof are not a part of this Agreement, but are included merely for convenience of reference only and shall not affect its meaning or interpretation.

 

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.

 

ABGENIX, INC.

By:    
       

(Signature)

         
       

(Printed Name)

         
       

(Title)

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
62


CURAGEN CORPORATION

By:    
       

(Signature)

       

Christopher K. McLeod

       

(Printed Name)

       

Executive Vice President

       

(Title)

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
63


 

EXHIBIT A

 

ABX PATENT RIGHTS

 

I. Pursuant to the MRLOA

 

  A. Any of the patent applications listed in the following Table:

 

[*******]

  [*******]

  [*******]

  [*******]

  [*******]

[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]
[**********]   [************]   [*************]   [***************]   [********************]

 

     B.    [****************************************************************]:
     [**********************************************************************].
     D.    [****************************************************************]:
     [**********************************************************************].
     E.    [****************************************************************]:
     [**********************************************************************].
II.    [*********************************]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
64


A.    [**********************************************************************].
B.    [**********************************************************************].
C.    [******************************************************************]:
[**********************************************************************].

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
65


 

EXHIBIT B

 

ELIGIBLE ANTIGEN CRITERIA

 

A Research Antigen shall become an Eligible Antigen if it meets the following criteria:

 

1. [*****************************************************************]

 

2. [*****************************************************************]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
66


 

EXHIBIT C

 

RESEARCH PLAN

 

CuraGen/ABX Research Plan

 

[ATTACHED]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
67


 

EXHIBIT D

 

THIRD PARTY AGREEMENTS

 

Collaboration Agreements between CuraGen and

 

[***********************************]
[***********************************]
[***********************************]
[***********************************]
[***********************************]
[***********************************]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
68


 

EXHIBIT E

 

RESEARCH ANTIGEN DESIGNATION

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
69


 

EXHIBIT F

 

FORM OF THREE-WAY MTA

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
70


 

EXHIBIT G

 

FORM OF TWO-WAY MTA

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
71
EX-10.2 3 dex102.htm LICENSE & COLLABORATION AGREEMENT LICENSE & COLLABORATION AGREEMENT

Exhibit 10.2

 

LICENSE AND COLLABORATION AGREEMENT

 

BETWEEN

 

TOPOTARGET A/S

 

AND

 

CURAGEN CORPORATION

 

DATED AS OF June 3, 2004

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
 


LICENSE AND COLLABORATION AGREEMENT

 

THIS LICENSE AND COLLABORATION AGREEMENT (this “Agreement”), dated as of June 3, 2004, is between TopoTarget A/S, a company duly organized and existing under the laws of Denmark and having offices at Symbion Science Park, Fruebjergvej 3, 2100 Copenhagen, Denmark (“TOPOTARGET”), and CURAGEN Corporation, a company duly organized and existing under the laws of the State of Delaware and having offices at 555 Long Wharf Drive, New Haven, CT 06511, USA (“CURAGEN”).

 

PRELIMINARY STATEMENTS

 

A. TOPOTARGET is a biotechnology company with a development program, a library of compounds, and other intellectual property rights relating to HDAC Inhibitors.

 

B. CURAGEN is a biopharmaceutical company with an interest in commercializing HDAC Inhibitors in the Territory.

 

C. TOPOTARGET and CURAGEN wish to collaborate in connection with the research, development and commercialization of TOPOTARGET HDAC Inhibitors, upon the terms and conditions set forth in this Agreement.

 

D. TOPOTARGET and CURAGEN are willing to grant to each other certain rights owned or controlled by them relating to HDAC Inhibitors in connection with their collaboration, upon the terms and conditions set forth in this Agreement.

 

NOW, THEREFORE, in consideration of the foregoing preliminary statements and the mutual covenants and agreements of the Parties contained in this Agreement, the Parties hereby agree as follows:

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
 


1. DEFINITIONS.

 

As used in this Agreement, the following terms shall have those meanings set forth in this Section 1 unless the context dictates otherwise.

 

1.1 “Affiliate” with respect to either Party, shall mean any Person controlling, controlled by, or under common control with, such Party. For purposes of this Section 1.1, “control” shall mean (i) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract or otherwise, or (ii) the beneficial ownership (as such term is defined in the 1934 Act) of at least 50% of the voting securities or other ownership interest of a Person.

 

1.2 “Back-Up Product” shall mean, subject to Section 7.2(e), an HDAC Inhibitor other than the First Product or any Future Product that (i) could be claimed under U.S. patent law by the broadest independent composition of matter claim that could be supported by the disclosure of any single Patent within the TOPOTARGET Licensed Technology that covers such First Product or Future Product and (ii) demonstrates at least equivalent efficacy in the same animal model of any disease that was the determining model for selecting the First Product or Future Product for development in such disease, adjusted for therapeutic index (defined by the exposure of the First or Future Product at NOAEL (“no observed adverse effect level”) divided by exposure of the First or Future Product at the ED50 in the same animal species).

 

1.3 “Collaboration Product” shall mean the First Product, the Future Products and Back-Up Products, unless and until CURAGEN’s license to any such Collaboration Product under this Agreement has terminated in accordance with the terms hereof.

 

1.4 “Combination Product” means any Covered Product containing (whether in the same formulation or packaged together) both a pharmaceutically active agent which is itself a Covered Product and one or more other pharmaceutically active agents which are not Covered Products.

 

1.5 “Confidential Information” shall have the meaning set forth in Section 12.1.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
2


1.6 “Controlled” shall mean the legal authority or right of a Party hereto or an Affiliate of a Party to grant a license or sublicense of intellectual property rights to the other Party hereto to effectuate the purposes of this Agreement, or to otherwise disclose proprietary, trade secret information, or other Confidential Information to such other Party, without breaching the terms of any agreement with a Third Party.

 

1.7 “Covered Product” shall mean any Collaboration Product the manufacture, sale or use of which in the Field in the country of sale is covered by a Valid Claim of any Patent included in the TOPOTARGET Licensed Technology, the TOPOTARGET Collaboration Technology or the Joint Collaboration Technology.

 

1.8 “CURAGEN Clinical Data” shall have the meaning set forth in Section 8.5.

 

1.9 “CURAGEN Collaboration Technology” shall mean all Inventions and Know-How first conceived and reduced to practice solely by employees of CURAGEN or of any Third Party working on behalf of or for the benefit of CURAGEN and/or in whose Inventions and Know-How CURAGEN shall have secured rights, in each case in the course of or in connection with the Research Program, as well as any and all Patents covering same.

 

1.10 “CURAGEN Licensed Technology” shall mean all Patents owned or controlled by, or licensed to, CURAGEN, and all Know-How and Inventions developed, owned or controlled by, or licensed to, CURAGEN, as of the Effective Date, or acquired by or licensed to CURAGEN after the Effective Date to the extent that such Patents, Know-How and/or Inventions are not included within any CURAGEN Collaboration Technology or Joint Collaboration Technology, and which, in the reasonable opinion of the Parties, is necessary for the development, manufacture, use or sale of the relevant Collaboration Product, or which was actually used in the Research Program or by CURAGEN in the development, manufacture, use or sale of such Collaboration Product, all to the extent that CURAGEN has the right to license or otherwise make available such Patents, Know-How and Inventions to TOPOTARGET hereunder.

 

1.11 “CURAGEN Trademarks” shall have the meaning set forth in Section 8.8.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
3


1.12 “Development Program” shall mean the development efforts to be conducted by the Parties as provided in Section 8.

 

1.13 “Effective Date” shall mean the date first set forth above.

 

1.14 “EU” shall mean the European Union.

 

1.15 “FDA” shall mean the United States Food and Drug Administration, or any successor thereto.

 

1.16 “Field” shall mean the prevention, diagnosis, control or treatment of any human disease or condition by use of a Collaboration Product, either as a single agent or in combination with any other therapy.

 

1.17 “First Commercial Sale” shall mean, with respect to any Covered Product, the first sale for use or consumption by the general public of such Covered Product in a country in the Territory after all required marketing and pricing approvals have been granted, or otherwise permitted, by the governing health authority of such country. “First Commercial Sale” shall not include the sale of any Covered Product for use in clinical trials or for compassionate use prior to the approval of an NDA.

 

1.18 “First Product” shall mean any formulation of the chemical compound known as PXD101, as further described in Exhibit A.

 

1.19 “Future Product(s)” shall mean, subject to Sections 7.2(c), (d) and (f), any formulation of an HDAC Inhibitor other than the First Product which is deemed a Future Product as provided in Section 5.2.

 

1.20 “HDAC Inhibitor” shall mean [***********************************].

 

1.21 “IND” shall mean an Investigational New Drug Application to be filed with the FDA, or the equivalent thereof in other countries or regulatory jurisdictions.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
4


1.22 “Invention” shall mean any new or useful method, process, manufacture, compound or composition of matter, whether or not patentable or copyrightable, or any improvement thereof.

 

1.23 “Joint Collaboration Technology” shall mean all Inventions and Know-How first conceived jointly and/or reduced to practice jointly by one or more employees of CURAGEN (or of any Third Party working on behalf of or for the benefit of CURAGEN and/or in whose Inventions and Know-How CURAGEN otherwise has rights) and one or more employees of TOPOTARGET (or of any Third Party working on behalf of or for the benefit of TOPOTARGET and/or in whose Inventions and Know-How TOPOTARGET otherwise has rights), or first conceived by such employees of one Party and reduced to practice by such employees of the other Party, in all cases during the performance of the Parties’ respective obligations under the Agreement, as well as any and all Patents covering same. It is understood, however, that no compounds in TOPOTARGET’s library of HDAC Inhibitors at the outset of the Research Program shall be brought within the “Joint Collaboration Technology” by virtue of CURAGEN and TOPOTARGET employees or Third Parties working on their behalf jointly reducing to practice or demonstrating utility of such compound in any medical or clinical application or indication.

 

1.24 “Joint Steering Committee” shall mean the entity organized and acting pursuant to Section 4.

 

1.25 “Know-How” shall mean unpatented technical and other information which is not in the public domain including information comprising or relating to discoveries, inventions, data, designs, formulae, methods, models, assays, research plans, procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development), processes (including manufacturing processes, specifications and techniques), laboratory records, chemical, pharmacological, toxicological, clinical, analytical and quality control data, trial data, case report forms, data analyses, reports or summaries, and information contained in submissions to and information from ethical committees and regulatory authorities (provided that inclusion of the latter information as “Know-How” shall not be understood to

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
5


limit or restrict a Party’s ability to submit appropriate information to an ethical committee and/or regulatory authority). Know-How includes rights protecting Know-How. No combination of information shall be deemed to be within the public domain because individual features of the information are in the public domain. No information shall be deemed to be within the public domain because it is embraced by more general information in the public domain.

 

1.26 “NDA” shall mean a New Drug Application to be filed with the FDA, or the equivalent thereof in other countries or regulatory jurisdictions.

 

1.27 “Net Sales” shall mean, with respect to any Covered Product, the gross amount invoiced to Third Parties by CURAGEN, its Affiliates or its Sublicensees, as the case may be, for such Covered Product, commencing with the First Commercial Sale of such Covered Product, less deductions for: (i) trade, quantity and/or cash discounts actually granted to the extent consistently applied by CURAGEN to its products; (ii) credits, refunds and allowances (including, without limitation, cash, credit and free goods allowances) actually allowed or given for chargebacks but only to the extent it is a sales related deduction which is accounted for within CURAGEN on a product-by-product basis, (iii) retroactive price reductions, billing errors and rebates (including, without limitation, government-mandated and managed healthcare negotiated rebates), credits and refunds for Covered Product that is rejected, spoiled, damaged, outdated or returned, to the extent each was actually allowed or given and as consistently applied by CURAGEN to its products; (iv) freight, postage, shipping, insurance and other transportation costs actually incurred in transporting Covered Product to a Third Party; and (v) taxes, tariffs, customs duties, surcharges and other governmental charges incurred in connection with the sale, exportation or importation of Covered Product. For reductions identified in items (i) – (iv) that are not accounted for on a product by product basis by CURAGEN, such deductions may not exceed [*********(***)] of the total gross sales price without the prior approval of TOPOTARGET, such approval to not be unreasonably withheld. The books and records of CURAGEN, its Affiliates or its Sublicensees, as the case may be, shall be maintained in accordance with the generally accepted accounting principles, consistently applied, and with sufficient particulars as necessary to determine such deductions and amounts.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
6


In the event that CURAGEN, its Affiliates, or Sublicensees intend to sell a Combination Product, the Parties shall meet approximately one (1) year prior to the anticipated Launch of such Combination Product to negotiate in good faith and agree to an appropriate adjustment to Net Sales to reflect the relative significance and value of the Covered Product and the other pharmaceutically active agent(s) contained in the Combination Product on a country-by-country basis. If there is a stand alone Covered Product on the market in a given country which corresponds to the HDAC Inhibitor within the Combination Product, the adjustment to Net Sales for such country shall equal the Net Sales of the Combination Product multiplied by a fraction, the numerator of which is the current price of the Covered Product and the denominator of which is the reasonable fair market value, in the aggregate, of all pharmaceutically active agents contained in the Combination Product in each case in the same country as the country in which the Combination Product is to be sold. If no such Covered Product is on the market in a given country, and if, after good faith negotiations (not to exceed ninety (90) days), the Parties cannot agree to an appropriate adjustment, Net Sales for such country shall equal Net Sales of the Combination Product multiplied by a fraction, the numerator of which is the reasonable fair market value of the Product and the denominator of which is the reasonable fair market value, in the aggregate, of all pharmaceutically active agents contained in the Combination Product. If the Parties cannot agree on the “fair market value” of either the Product or any of the pharmaceutically active agents, the Parties shall retain a panel of three valuation experts to make such a determination, the costs for which shall be shared equally by the Parties. Each Party shall select one expert, who shall not be an employee of either and who shall have at least at least a university degree in economics and five (5) years experience in conducting such valuations. The two experts shall promptly select a mutually agreeable third expert with like qualifications. The experts shall render a written opinion binding on the Parties for the relevant countries within thirty (30) days, which shall be binding, with no right of appeal, on both Parties and any Affiliates and Sublicensees.

 

Notwithstanding the foregoing, in connection with (X) any sale or other disposition of Covered Product that is not a bona fide, arms length transaction for money, or (Y) any other use of Covered Product that does not result in or give rise to sales revenue that is customary in the

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
7


country in which such use takes place (except as provided in the next paragraph), Net Sales shall be calculated at the relevant open market price in the country in which such sale, disposition or use takes place, or, if such price is not reasonably ascertainable, at a reasonable price, assessed on an arms length basis, for the goods and/or services received in consideration of the sale, disposition or use of Covered Product.

 

CURAGEN’s or any of its Affiliate’s transfer of Covered Product to another Affiliate or a Sublicensee shall not result in any Net Sales, unless such Covered Product is consumed by such Affiliate or Sublicensee in the course of its commercial activities. In such case, Net Sales shall occur upon such other Affiliate’s or Sublicensee’s sale of such Covered Product to a Third Party. Further, the disposition of Covered Product for, or the use of Covered Product in, pre-clinical or clinical (Phase I – III) trials or other market-focused (Phase IV or V) trials or free samples shall not result in any Net Sales, unless CURAGEN, its Affiliate or Sublicensee is permitted to receive payment for Covered Product used in clinical trials which includes a reasonable profit.

 

1.28 “NIH” shall mean the U.S. National Institutes of Health.

 

1.29 “1934 Act” shall mean the Securities Exchange Act of 1934, as amended, and all regulations promulgated pursuant thereto from time to time.

 

1.30 “Party” shall mean TOPOTARGET or CURAGEN and, when used in the plural, shall mean TOPOTARGET and CURAGEN.

 

1.31 “Patents” shall mean all letters patent and patent applications, as well as any and all substitutions, extensions, supplementary protection certificates, renewals, continuations, continuations-in-part, divisions, patents-of-addition and/or reissues thereof.

 

1.32 “Person” shall mean any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government or any agency or political subdivision thereof.

 

1.33 “Phase II” shall mean within oncology, one or more trials with enough patients (usually 20 patients or more) in at least one treatment arm designed to determine a reasonable

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
8


estimate of response rate (usually a confidence interval narrow enough to be acceptable as evidence of activity versus active or historical control data). For other indications, one or more randomized controlled trials of sufficient size to determine with 80% power an a priori agreed upon clinical effect.

 

1.34 “Phase III” shall mean one or more pivotal trials designed and powered for registration with FDA. Agreement from the FDA on study design must be obtained before Phase III initiation in a pre-Phase III meeting or through FDA’s Special Protocol Assessment Procedures.

 

1.35 “Phase II Initiation” shall mean the day when the first patient in the first Phase II clinical trial of the relevant Collaboration Product, which trial has been approved by the Joint Steering Committee, gets dosed. If the trial is a Phase I/II trial, the Initiation of Phase II refers to the day when the first patient in the treatment arm designed to determine a reasonable estimate of response rate gets dosed.

 

1.36 “Phase III Initiation” shall mean the day when the first patient in the first Phase III clinical trial of the relevant Collaboration Product, which trial has been approved by the Joint Steering Committee, gets dosed.

 

1.37 “Research Plan” shall have the meaning set forth in Section 5.1.

 

1.38 “Research Program” shall mean the research program that is conducted by TOPOTARGET and CURAGEN pursuant to Section 5.

 

1.39 “Research Term” shall have the meaning set forth in Section 5.8.

 

1.40 “Royalty Term” shall mean, with respect to each Covered Product sold in a country, the period of time commencing on the First Commercial Sale in such country and ending on the date of expiration of the last Valid Claim of any Patent included in the TOPOTARGET Licensed Technology, or the TOPOTARGET Collaboration Technology, or the Joint Collaboration Technology in such country which is directed to the composition of matter or use in the Field of such Covered Product or a pharmaceutical preparation containing such

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
9


Covered Product, or which is directed to a manufacturing process actually used for the manufacture of such Covered Product; provided, however, that in any country where only Valid Claims of such manufacturing process patents remain, the Royalty Term shall end on the last day of the first calendar quarter in which units of generic versions of the Covered Product sold in such country equal or exceed [******(****)] of all units of Covered Product sold in such country.

 

1.41 “Sublicensee” shall mean a Third Party to which CURAGEN has granted sublicense rights under the TOPOTARGET Licensed Technology, TOPOTARGET Collaboration Technology, and/or Joint Collaboration Technology.

 

1.42 “Substances” shall have the meaning assigned thereto in Section 5.6.

 

1.43 “Supply Agreement” shall have the meaning assigned thereto in Section 11.2.

 

1.44 “Territory” shall mean all of the countries in the entire world other than those countries in the TOPOTARGET Territory.

 

1.45 “Third Party” shall mean any Person who or which is neither a Party nor an Affiliate of a Party.

 

1.46 “TOPOTARGET Clinical Studies” shall have the meaning assigned thereto in Section 8.4.

 

1.47 “TOPOTARGET Collaboration Technology” shall mean all Inventions and Know-How first conceived and reduced to practice solely by employees of TOPOTARGET, or of any Third Party working on behalf of or for the benefit of TOPOTARGET and/or in whose Inventions and Know-How TOPOTARGET shall have secured rights, in each case in the course of or in connection with the Research Program, as well as any and all Patents covering same. It is understood, however, that no compounds in TOPOTARGET’s library of HDAC Inhibitors at the outset of the Research Program shall be brought within the “TOPOTARGET Collaboration Technology” (as opposed to being within “TOPOTARGET Licensed Technology”) by virtue of TOPOTARGET reducing to practice or demonstrating utility of such compound in any medical

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
10


or clinical application or indication during the course of or in connection with the Research Program.

 

1.48 “TOPOTARGET Licensed Technology” shall mean all Patents owned or controlled by, or licensed to, TOPOTARGET, and all Know-How and Inventions developed, owned or controlled by, or licensed to, TOPOTARGET, as of the Effective Date, or which are developed, acquired by or licensed to TOPOTARGET after the Effective Date to the extent such Patents, Know-How and/or Inventions are not included within any TOPOTARGET Collaboration Technology or Joint Collaboration Technology, and which, in the reasonable opinion of the Parties, is necessary for or may be useful in the development, manufacture, use or sale of Collaboration Products in the Field in the Territory, all to the extent that TOPOTARGET has the right to license or otherwise make available such Patents, Know-How and Inventions to CURAGEN hereunder. A list of all such Patents in existence on the Effective Date is included in Exhibit A attached.

 

1.49 “TOPOTARGET Territory” shall mean the following countries: Norway, Iceland, Switzerland, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, United Kingdom, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia, Russian Federation, Ukraine, Albania, Andorra, Belarus, Bosnia-Hercegovina, Bulgaria, Croatia, Liechtenstein, Moldova, Monaco, Romania, Serbia-Montenegro, Yugoslavia (Macedonia), Turkey, and Israel.

 

1.50 “Valid Claim” shall mean a claim of any issued letters patent that, in each case, has not been held invalid or unenforceable by final decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and that is not admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
11


2. REPRESENTATIONS AND WARRANTIES.

 

2.1 Representations and Warranties of Both Parties. Each Party represents and warrants to the other Party that, as of the Effective Date:

 

(a) Such Party is duly organized and validly existing 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;

 

(b) Such Party has taken all corporate action necessary to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement;

 

(c) This Agreement is a legal and valid obligation of such Party, binding upon such Party and enforceable against such Party in accordance with the terms of this Agreement, except as such enforceability may be affected by laws affecting creditors’ rights generally. The execution, delivery and performance of this Agreement by such Party do not and shall not conflict with any agreement, instrument or understanding, oral or written, to which such Party is a party or by which such Party may be bound, except as expressly set forth in Section 2.2(g), and do not and shall not, to the best of such Party’s knowledge, violate any law or regulation of any court, governmental body or administrative or other agency having authority over such Party. All consents, approvals and authorizations from all governmental authorities or other Third Parties required to be obtained by such Party in connection with the execution, delivery and performance of this Agreement have been obtained;

 

(d) Such Party has sufficient facilities, experienced personnel and other capabilities to enable it to perform its obligations under this Agreement; and

 

(e) No Person has or will have, as a result of the transactions contemplated by this Agreement, any right, interest or valid claim against or upon such Party for any commission, fee or other compensation as a finder or broker because of any act by such Party or of any agent of such Party.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
12


2.2 Additional Representations and Warranties of TOPOTARGET. TOPOTARGET represents and warrants to CURAGEN that, as of the Effective Date:

 

(a) TOPOTARGET and/or its Affiliates are the owner of, or have exclusive rights to, all of the Patents included in the TOPOTARGET Licensed Technology in existence on the Effective Date, and have the exclusive right to grant the licenses granted under this Agreement;

 

(b) All such Patents consist of either patent applications that have been filed and are pending and actively being prosecuted as of the Effective Date, or issued letters patent that are in full force and effect and have been maintained through the Effective Date;

 

(c) TOPOTARGET is not aware of any asserted or unasserted claim or demand which it believes can be enforced by a Third Party against any such Patents;

 

(d) To the best of TOPOTARGET’s knowledge and belief, the practice of all inventions claimed in such Patents and the performance of the Research Program as currently contemplated by the Parties does not and shall not infringe upon or conflict with any patent, copyright or other proprietary right of any Third Party;

 

(e) TOPOTARGET and/or its Affiliates are the owner(s) of, or have exclusive rights to all of the Know-How and Inventions included in the TOPOTARGET Licensed Technology in existence on the Effective Date, and have the right to grant the licenses granted under this Agreement;

 

(f) To the best of TOPOTARGET’s knowledge and belief, such Know-How and Inventions were not obtained by TOPOTARGET in violation of any contractual or fiduciary obligation to which TOPOTARGET, or any of its employees or staff members are or were bound, or by the misappropriation of the trade secrets of any Third Party;

 

(g) TOPOTARGET has not entered into any agreement with any Third Party, except for The NATIONAL INSTITUTES OF HEALTH/NATIONAL CANCER INSTITUTE, LEO PHARMA A/S and the WORLD HEALTH ORGANIZATION, as set out in Section 3 below, which is in conflict with the rights granted to CURAGEN under to this Agreement, and the execution and performance of this Agreement by TOPOTARGET do not and shall not violate any agreement or undertaking to which TOPOTARGET is a party; and

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
13


(h) To the best of TOPOTARGET’s knowledge and belief, all of the data and information that TOPOTARGET has provided to CURAGEN prior to the Effective Date relating to such Patents, Know-How and Inventions, are reasonably accurate, and to the best of TOPOTARGET’s knowledge and belief, TOPOTARGET has not omitted therefrom any material data or information in TOPOTARGET’s possession or control reasonably in advance of the Effective Date concerning same that a reasonable Person in CURAGEN’s position would want to have examined prior to executing this Agreement.

 

2.3 Disclaimer. THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY SET FORTH HEREIN. TOPOTARGET AND CURAGEN DISCLAIM ALL OTHER REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO EACH OF THEIR RESEARCH, DEVELOPMENT AND COMMERCIALIZATION EFFORTS HEREUNDER, INCLUDING, WITHOUT LIMITATION, WHETHER THE PRODUCTS CAN BE SUCCESSFULLY DEVELOPED OR MARKETED, THE ACCURACY, PERFORMANCE, UTILITY, RELIABILITY, TECHNOLOGICAL OR COMMERCIAL VALUE, COMPREHENSIVENESS, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE WHATSOEVER OF THE PRODUCTS.

 

3. THIRD PARTY AGREEMENTS, EXCLUSIVITY.

 

3.1 Representations and Warranties of TOPOTARGET with respect to Collaborative Research and Development Agreement (“CRADA”). TOPOTARGET represents and warrants to CURAGEN that, as of the Effective Date.

 

(a) TOPOTARGET has entered into a Letter of Intent for Proposed Collaborative Research and Development Agreement with the NIH dated as of March 24, 2004 (the “CRADA LOI”), a copy of which has been furnished to CURAGEN;

 

(b) TOPOTARGET and NIH are diligently pursuing execution of a formal Collaborative Research and Development Agreement (“CRADA”), but have not yet entered such

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
14


an agreement. TOPOTARGET shall include CURAGEN as a party to the CRADA, or else TOPOTARGET shall not include any aspect of clinical research in the CRADA and shall use its best efforts to cause any aspects of the proposed CRADA which are relevant to clinical research to be embodied in a separate CRADA between CURAGEN and NIH; and

 

(c) TOPOTARGET shall include in the CRADA provision(s) permitting CURAGEN to receive all information described under Section 3.2, and permitting CURAGEN employees to participate on the CRADA Steering Committee as described under Section 3.2 and CURAGEN shall do the same for TOPOTARGET if CURAGEN enters into any CRADA as provided above.

 

3.2 TOPOTARGET Obligations. TOPOTARGET agrees that during the term of the CRADA:

 

(a) TOPOTARGET will designate two CURAGEN employees, as selected by CURAGEN from time to time, as representatives on the CRADA Steering Committee (as defined in the CRADA), provided that all matters relating to the CRADA shall be discussed by the Joint Steering Committee or its designated subcommittees, as applicable, pursuant to Article 4 below, and provided further that all official communications and/or decisions on behalf of CURAGEN and/or TOPOTARGET with respect to any CRADA shall be communicated to the CRADA Steering Committee and/or NIH by the TOPOTARGET representatives of the CRADA Steering Committee with respect to any pre-clinical products and by the CURAGEN representatives of the CRADA Steering Committee with respect to any products in clinical trials.

 

(b) TOPOTARGET will use commercially reasonable efforts to fulfill all of its material obligations under the CRADA, to the extent such obligations have not been expressly delegated to CURAGEN hereunder;

 

(c) TOPOTARGET shall not enter into any subsequent agreement with the NIH that modifies or amends the CRADA in any way that could potentially adversely affect CURAGEN’s rights under this Agreement without CURAGEN’s prior written consent, which shall not be unreasonably withheld, and shall provide CURAGEN with a copy of all

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
15


modifications to or amendments of the CRADA, regardless of whether CURAGEN’s consent was required with respect thereto;

 

(d) TOPOTARGET shall not terminate the CRADA in whole or in part, directly or indirectly, without CURAGEN’s prior written consent, which shall not be unreasonably withheld; provided, however, that the Joint Steering Committee shall have the right, upon written notice to TOPOTARGET, to require TOPOTARGET to terminate the CRADA, in whole or in part, in accordance with its terms at any time, if in the reasonable judgment of the Joint Steering Committee the continuation of the CRADA will adversely impact the clinical development of Collaboration Products in the Territory;

 

(e) TOPOTARGET shall request the NIH to allow TOPOTARGET and CURAGEN to be involved in the planning of any Data Safety Monitoring Board (DSMB) and to be involved in any Serious Adverse Events (SAE) communication cascades;

 

(f) TOPOTARGET shall promptly notify CURAGEN and furnish CURAGEN with copies of all reports and other communications TOPOTARGET receives from NIH pursuant to the CRADA that relate to the subject matter of this Agreement, including those related to DSMB or SAE;

 

(g) TOPOTARGET shall allow CURAGEN to review and approve prior to submission to NIH all reports and other communications that TOPOTARGET intends to furnish to NIH which relate to the subject matter of this Agreement;

 

(h) TOPOTARGET shall furnish CURAGEN with copies of all notices received by TOPOTARGET relating to any alleged breach or default of any material obligation by TOPOTARGET under the CRADA within three business days after TOPOTARGET’s receipt thereof and, if TOPOTARGET cannot or chooses not to cure or otherwise resolve any such alleged breach or default, TOPOTARGET shall allow CURAGEN, in CURAGEN’s sole discretion, to cure or otherwise resolve any such alleged breach or default; and

 

(i) Except for the initiation of litigation of any type against NIH or the National Cancer Institute, TOPOTARGET shall use all commercially reasonable efforts, at

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
16


TOPOTARGET’s sole expense, to exercise and enjoy the direct benefit of all of TOPOTARGET’s affirmative rights under the CRADA, to the extent they relate to Collaboration Products in the Field and in the Territory, including without limitation obtaining exclusive license rights in the Field and Territory to all Subject Inventions as defined therein.

 

(j) In the event that CURAGEN enters into any CRADA as provided in Section 3.1(b), CURAGEN shall adhere to each of (b) through (i) above, with the designations of the Parties reversed.

 

3.3 Rights of, and Obligations to LEO PHARMA A/S and the World Health Organization.

 

(a) Leo.

 

(i) The Parties acknowledge that TOPOTARGET has entered into a Material Transfer and Screening Agreement with LEO PHARMA A/S (“Leo”) dated as of October 27, 2003 (the “Leo Agreement”), and that pursuant to such Leo Agreement, Leo may obtain worldwide rights to certain HDAC Inhibitors for use solely in the field of dermatological diseases, as defined in the Leo Agreement (the “Leo Field”). The Parties further acknowledge that TOPOTARGET is prohibited from entering into any agreement regarding the screening or development in the Leo Field of the 10 HDAC Inhibitors provided to Leo for evaluation pursuant to the Leo Agreement during the term of the Leo Agreement, as defined therein. The Parties hereby agree that notwithstanding anything herein to the contrary, the rights granted to CURAGEN by TOPOTARGET hereunder, including without limitation any grant of “exclusive” rights, shall be subject to TOPOTARGET’s obligations to Leo, and the rights granted to Leo, under the Leo Agreement; provided, however, that CURAGEN shall have the right to approve in advance the terms and conditions of any license to be granted to Leo regarding the use of HDAC Inhibitors in the Leo Field (such approval to not be unreasonably withheld), and that TOPOTARGET shall pay to CURAGEN [******(*****)] of any consideration received by TOPOTARGET under any such license, net of

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
17


TOPOTARGET’s fully-burdened labor costs for any collaborative research or development activities required to be performed by TOPOTARGET pursuant to any such license and its out-of-pocket expenses related to the granting of such license, which payments shall be made within thirty (30) days of receipt of any such consideration.

 

(ii) TOPOTARGET hereby represents and warrants to CURAGEN than it has disclosed to CURAGEN the identity of the 10 HDAC Inhibitors that it has provided to Leo pursuant to the Leo Agreement and that it will inform CURAGEN of the status of any and all license negotiations which are conducted with Leo pursuant to the Leo Agreement.

 

(b) The World Health Organization.

 

(i) The Parties acknowledge that TOPOTARGET has transferred HDAC Inhibitors to the World Health Organization (“WHO”) pursuant to a letter dated as of March 28, 2003 (the “WHO Agreement”), and that pursuant to such WHO Agreement, WHO may desire to obtain rights to certain HDAC Inhibitors for use in the field of malarial diseases (the “WHO Field”). The Parties hereby agree that notwithstanding anything herein to the contrary, the rights granted to CURAGEN by TOPOTARGET hereunder, including without limitation any grant of “exclusive” rights, shall be subject to any of TOPOTARGET’s obligations to WHO, and any rights granted to WHO, under the WHO Agreement; provided, however, that CURAGEN shall have the right to approve in advance the terms and conditions of any license to be granted to WHO regarding the use of HDAC Inhibitors in the WHO Field (such approval to not be unreasonably withheld), and that TOPOTARGET shall pay to CURAGEN [******(*****)] of any consideration received by TOPOTARGET under any such license, received by TOPOTARGET under any such license, net of TOPOTARGET’s fully-burdened labor costs for any collaborative research or development activities required to be performed by TOPOTARGET pursuant to any such license and its out-of-pocket

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
18


expenses related to the granting of such license, which payments shall be made within thirty (30) days of receipt of any such consideration.

 

3.4 Exclusivity. (a) During the Research Term - For the duration of the Research Term, CURAGEN shall be TOPOTARGET’s exclusive collaborator for HDAC Inhibitors in the Territory, and CURAGEN therefore agrees that, during the Research Term, CURAGEN and its Affiliates shall not, for the benefit of CURAGEN or any Third Party, acquire rights from any Third Party, perform any research or clinical development for, collaborate with or grant licenses to any Third Party, in all cases with respect to any HDAC Inhibitors other than Collaboration Products, except as provided in Section 3.4(d) below.

 

(b) Without limiting the generality of Section 3.4(a), during the Research Term, (i) TOPOTARGET agrees that it shall not, itself or through another party, perform research for, collaborate with or grant licenses to any Third Party with respect to any HDAC Inhibitor for use in the Field within the Territory, and will not, itself or through another party, undertake such activities with respect to any HDAC Inhibitor for use in the Field within the Territory for the benefit of any Third Party, except in connection with the Third Party Agreements described in Section 3.1 hereof or as otherwise expressly permitted herein in Section 3.3, and (ii) TOPOTARGET shall be permitted, itself and/or with one or more other parties, to perform research for, collaborate with and/or grant licenses to any Third Party with respect to any HDAC Inhibitor for development, sale and/or use solely within the TOPOTARGET Territory, subject only to the provisions of Section 3.5 hereof and to the provisions of Section 8.4 hereof.

 

(c) Following the Research Term. TOPOTARGET agrees that, following the Research Term, it shall not, itself or through another party, for the benefit of TOPOTARGET or any Third Party, perform research for, collaborate with or grant licenses to any Third Party with respect to any Collaboration Product for use in the Territory, or perform clinical development anywhere in the world with respect to, or market or sell any HDAC Inhibitor in a therapeutic indication (e.g., lung cancer) within the Territory, for which, at the time of the commencement of any such research, collaboration, license grant, clinical development, marketing or selling, any

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
19


Collaboration Product is being marketed or developed, or is planned for development based on demonstrated efficacy in a relevant animal model of a disease (“CURAGEN Indications”) for use in the Territory in the Field and such Collaboration Product continues to be diligently developed in that indication by CURAGEN. CURAGEN shall regularly advise TOPOTARGET of such development and planning for development, and TOPOTARGET shall notify CURAGEN of any intent to exercise its rights hereunder within the Territory and provide CURAGEN with [******(*****)] business days in which to update any such information as to which indications are currently in development or planned for development based on demonstrated efficacy in a relevant animal model of a disease. In the event that any such prohibited clinical development of a TOPOTARGET HDAC Inhibitor is conducted by an independent Third Party which leads to the use of any such HDAC Inhibitor in a CURAGEN Indication in competition with actual sales of a Collaboration Product that has been developed specifically for that indication, the Parties shall agree in good faith on appropriate compensation to CURAGEN [***************************************************************]; PROVIDED THAT such compensation shall not exceed the lesser of (i) [****************** *********************************] or (ii) [***********************************]. In the event that the parties cannot agree on appropriate compensation after ninety (90) days of good faith negotiations, the parties shall refer the matter to an independent expert agreed upon by the parties, who will set such compensation at an amount not to exceed the lesser of (i) and (ii) above. The decision of the expert shall be binding on the parties, and any compensation provided to CURAGEN pursuant to this Section 3.4(c) shall be CURAGEN’s exclusive remedy and TOPOTARGET’s sole obligation and liability with respect to any independent Third Party clinical development as described herein.

 

(d) The Parties hereby agree that, during the Research Term, CURAGEN shall not be permitted to license an HDAC Inhibitor or acquire a Third Party with an HDAC Inhibitor program and CURAGEN shall prohibit its Affiliates from licensing HDAC Inhibitors from Third Parties or acquiring a Third Party with an HDAC Inhibitor program as provided above. Notwithstanding the foregoing, in the event that CURAGEN is acquired by a Third Party which has an HDAC Inhibitor program, such transaction shall not be precluded by this Section 3.4

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
20


and, subject to compliance with Sections 7.2(f), 8.2(a) and Article 12, CURAGEN shall be free to develop and commercialize any HDAC Inhibitors arising from such Third Party’s program alone or in conjunction with such Third Party following any such transaction.

 

(e) TOPOTARGET’s activities with respect to HDAC Inhibitors which are not Collaboration Products shall not be limited except as expressly provided in this section. Nothing in this Section 3.4 shall in any way be deemed to affect the scope of any licenses or rights expressly granted to CURAGEN pursuant to Section 7 below, or the Parties’ obligations pursuant to Section 8 or Section 12 below.

 

3.5 Licensing by TOPOTARGET within the TOPOTARGET Territory; CURAGEN’s Right of First Negotiation.

 

(a) In the event that TOPOTARGET wishes to grant any Third Party licenses or rights in any country within the TOPOTARGET Territory with respect to the development, marketing or distribution of a Collaboration Product (regardless of whether TOPOTARGET or such Third Party initiated discussions of such sublicensing), it may do so during the Research Term only after such Collaboration Product has completed Phase II clinical studies and after the Research Term it may do so at any development stage. In any event, before making or accepting any such Third Party offer, as the case may be, TOPOTARGET shall first propose to grant such rights to CURAGEN. Such proposal shall be in writing, be made in good faith, and set forth terms no less favorable to CURAGEN than those to be offered to, or offered by, such Third Party. Within [********] days after receipt of any such proposal, CURAGEN shall notify TOPOTARGET as to whether CURAGEN wishes to enter into negotiations for such rights. If CURAGEN provides timely notice that it wishes to do so, then the Parties shall conduct exclusive negotiations and use good faith efforts to conclude an agreement within [********] days thereafter. If the Parties are unable to agree upon the terms of such agreement despite the use of good faith efforts for a period of at least [********] days, CURAGEN shall put its proposal in writing (the “Last Offer”). Thereafter, TOPOTARGET shall be free to grant a license or other rights to Third Parties to the rights described in such Last Offer, but only during a [*****(***)] month period following receipt of such Last Offer and only on terms more

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
21


favorable to TOPOTARGET as the Last Offer made by CURAGEN. If, on the other hand, (i) CURAGEN gives TOPOTARGET notice that CURAGEN does not wish to enter into any such license, or (ii) CURAGEN does not respond to TOPOTARGET’s initial proposal within [********] days after receipt thereof, then TOPOTARGET shall be free to grant a license or other rights as outlined in the initial proposal to Third Parties on any terms, but only during a [*****(***)] month period following such initial proposal.

 

(b) For [*****(***)] months after the Effective Date, TOPOTARGET shall exclusively negotiate in good faith with CURAGEN for a license to its E2F program. At CURAGEN’s option, such license can include screening assays and/or compounds.

 

4. JOINT STEERING COMMITTEE

 

4.1 Members. The Parties shall establish a Joint Steering Committee (the “Joint Steering Committee”), which shall comprise three representatives designated by each Party (or such other number as the Parties may agree). The initial members of the Joint Steering Committee are set forth on Exhibit B. Members of the Joint Steering Committee may be represented at any meeting by a designee who is appointed by such member for such meeting and who has authority to act on behalf of such member. The chairperson shall be selected by CURAGEN and the initial chairperson is designated on Exhibit B. Each Party shall be free to replace its representative members with new appointees who have authority to act on behalf of such Party, on notice to the other Party.

 

4.2 Responsibilities. The Joint Steering Committee shall be responsible for overseeing and directing the Research Program and the Development Program. Its duties, therein, shall include, without limitation:

 

(i) evaluating and determining scientific criteria to be implemented under the Research Program;

 

(ii) after providing thirty (30) days notice, proposing, approving and, from time to time, updating and modifying the Research Plans and Development Program plans;

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
22


(iii) providing guidance for the implementation of the Research Plans and Development Program plans;

 

(iv) determining the deliverables each Party is responsible for under the Research Plans and Development Program;

 

(v) reviewing expenditures made by TOPOTARGET to verify that such expenditures conformed with the budget established in the annual Research Plan

 

(vi) allocating responsibilities and resources between the Parties with respect to the Research Program and Development Program;

 

(vii) determining whether to commence or terminate various projects under the Research Program;

 

(viii) setting patent filing policies and making patent filing determinations, as contemplated by Sections 6.4(a) – (d);

 

(ix) evaluating data from the Research Program and designating Future Products for further development;

 

(x) reviewing the results of any clinical trials conducted by CURAGEN or by TOPOTARGET pursuant to the Development Program and assigning to the Parties’ activities under the Development Program based on such results, as appropriate;

 

(xi) reviewing and evaluating progress, milestone achievement and diligence under the Research Program and the Development Program, provided that the Joint Steering Committee shall not have authority to make any determination that either Party is in breach of its obligations under this Agreement or any Research Plan or other plan created by the Joint Steering Committee;

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
23


(xii) providing for the exchange of information between the Parties relating to the Research Program and the Development Program;

 

(xiii) addressing issues and resolving differences that may arise between the Parties with respect to the Research Program and the Development Program;

 

(xiv) approving all CRADA research plans and amendments thereto and all other official decisions to be communicated to NIH with respect to any CRADA; and

 

(xv) approving any Party’s entrance into agreements and other arrangements with third party service providers for services necessary to effectuate the purposes of the Research Plan.

 

4.3 Research Team and Development Team. The Joint Steering Committee shall, at request of either Party, be authorized to constitute separate committees to oversee the Research Program and/or the Development Program, which committees will operate under written guidelines set forth by the Joint Steering Committee and which are consistent with the terms of this Agreement. Such committees shall have the same allocation of members from each party as the allocation for the Joint Steering Committee.

 

4.4 Meetings. The Joint Steering Committee shall meet at least once every calendar quarter, and more frequently as the Parties deem appropriate, on such dates and at such times as the Parties shall agree, on 10 days’ written notice to the other Party unless such notice is waived by the Parties. The Joint Steering Committee may convene or be polled or consulted from time to time by means of telecommunications, video conferences or correspondence, as deemed necessary or appropriate by the Parties. To the extent that meetings are held in person, they shall alternate between the offices of the Parties unless the Parties otherwise agree. The chairperson shall be responsible for sending notices of meetings to all members.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
24


4.5 Decisions.

 

(a) A quorum for a meeting of the Joint Steering Committee shall require the presence of at least one TOPOTARGET member (or designee) and at least one CURAGEN member (or designee) in person or by telephone. All decisions made or actions taken by the Joint Steering Committee shall be made unanimously by its members, with the TOPOTARGET members cumulatively having one vote and the CURAGEN members cumulatively having one vote.

 

(b) In the event that unanimity cannot be reached by the Joint Steering Committee with respect to a matter that is a subject of its decision-making authority, (i) any matter concerning the development and commercialization of any First Product or Future Product after the acceptance for filing of an IND by the FDA, or the appropriate scope of any regulatory toxicity studies of any Future Product, shall be decided by the designated officer of CURAGEN in good faith, taking into account the reasonable commercial interests of TOPOTARGET and the express provisions of this Agreement, and (ii) any matter concerning the development of any First Product or Future Product prior to the acceptance for filing of an IND by the FDA, or the allocation of any funds provided by CURAGEN pursuant to Section 5.3(a), shall be decided by the designated officer of TOPOTARGET in good faith, taking into account the reasonable commercial interests of CURAGEN and the express provisions of this Agreement.

 

4.6 Minutes. Within 15 days after each Joint Steering Committee meeting, the Chairman, of the Joint Steering Committee or another member of the Steering Committee designated by the Chairman, shall have prepared and distributed minutes of the meeting, which shall provide a description in reasonable detail of the discussions had at the meeting and a list of any actions, decisions or determinations approved by the Joint Steering Committee. Draft minutes shall circulated to all members of the Joint Steering Committee sufficiently in advance of the next meeting to allow adequate review and comment prior to the meeting. Minutes shall be approved or disapproved, and revised as necessary, at the next meeting. Final minutes shall be distributed to the members of the Joint Steering Committee.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
25


4.7 Term. The Joint Steering Committee shall exist until the termination or expiration of the Research Program and the Development Program.

 

4.8 Expenses. Each Party shall be responsible for all travel and related costs for its representatives to attend meetings of, and otherwise participate on, the Joint Steering Committee.

 

5. COLLABORATIVE RESEARCH PROGRAM.

 

5.1 Scope of Research Program. The Parties agree to undertake a Research Program for the pre-clinical development of the First Product, including use as a combination therapy, and for pre-clinical development of Future Products. The Joint Steering Committee shall prepare, or have prepared, and provide to each Party a detailed description, mutually acceptable to the Parties in form and substance, of the activities to be undertaken during each 12-month period during the Research Program, which shall include a reasonably detailed description of the goals and scope of such research, a corresponding detailed budget for each Party, the allocation of responsibilities to the respective Parties and a work plan, milestones and project target dates for such period (including the personnel, equipment and facilities that TOPOTARGET or CURAGEN is required to provide) (each such 12-month plan, as may be updated or modified from time to time, a “Research Plan”). The objective of the Research Plan will be to allow and support US IND submissions and submissions to governmental authorities of other countries as determined by the Joint Steering Committee concerning the First Product and Future Products. The initial Research Plan is attached as Exhibit C. Each subsequent Research Plan shall be embodied in a letter agreement to be executed by the Parties and shall be finalized at least thirty (30) days prior to the end of the prior twelve-month period. The Joint Steering Committee shall regularly review, update and, as necessary, modify each Research Plan from time to time. The Joint Steering Committee shall promptly provide each Party with any such updates or modifications.

 

5.2 Selection of Future Products. As of the Effective Date, TOPOTARGET shall have disclosed to CURAGEN all HDAC Inhibitors that have met the conditions set forth in Exhibit D and, during the Research Term, TOPOTARGET shall promptly disclose to CURAGEN all future HDAC Inhibitors Controlled by TOPOTARGET that meet such

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
26


conditions, whether identified during the course of performance of the Research Program or otherwise. All such HDAC Inhibitors that meet the conditions set forth in Exhibit D and that are shown to have efficacy in an animal model other than the [********] model prior to or during the course of the Research Program shall be deemed Future Products for purposes of this Agreement. Each disclosure hereunder regarding an HDAC Inhibitor shall include the composition of the HDAC Inhibitor and all data with respect thereto in the possession or Control of TOPOTARGET.

 

5.3 Support of Research Program.

 

(a) Subject to Section 5.3(e), on or before the first day of each calendar quarter during the Research Term, CURAGEN shall advance one fourth of the annual Research Program budget for TOPOTARGET as specified in the relevant Research Plan via wire transfer into an account designated by TOPOTARGET. Payments for any partial calendar quarter during the Research Term shall be prorated. Such payments shall cover all pre-clinical development costs incurred by TOPOTARGET in conducting the Research Plan for selected HDAC Inhibitors Controlled by TOPOTARGET and meeting the criteria in Exhibit D, including animal models of efficacy and ADME, PK, toxicology and mutagenicity studies, and including any such work related to use in combination therapy, and also including all pre-clinical studies (other than regulatory toxicity studies) for Future Products, and including all relevant product supply costs, in each case as authorized in advance by the Joint Steering Committee under each Research Plan. If any such costs include labor costs for TOPOTARGET employees, they shall be budgeted at an annual FTE rate of [*********************(********)] which amount includes an allocation of direct overhead expenses, which rate shall be revised annually at TOPOTARGET’s request subject to approval of the Joint Steering Committee. At the end of each calendar quarter, TOPOTARGET shall provide the STEERING COMMITTEE with a list itemizing expenditures and charges over the preceding quarter.

 

(b) At the end of each calendar year, TOPOTARGET shall provide a full accounting to CURAGEN of actual expenditures for work actually done by TOPOTARGET under the Research Plan during the preceding calendar year. If the expenses and charges of

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
27


TOPOTARGET exceed the budgeted amount for any quarter, as such budget may be amended in accordance with the terms hereof, CURAGEN shall have no obligation to reimburse TOPOTARGET for any such overrun. At the time of the final annual report, any such excess funds shall be carried forward to the next calendar year for use by TOPOTARGET in discharging its duties under the next annual Research Plan. However, in no case shall any quarterly payment by CURAGEN be reduced or withheld by CURAGEN because of any excess funds remaining in the designated account of TOPOTARGET.

 

(c) Costs for regulatory toxicology studies required to support the initial US IND for the First Product shall be paid from and charged against the Research Program budget as specified in Section 5.3(e). Any costs for any regulatory toxicology studies for any Future Product and for new formulations or different administration schedules of the First Product shall not be paid from or be charged against the quarterly advances made by CURAGEN pursuant to Section 5.3(a), and shall be CURAGEN’s responsibility unless CURAGEN has provided written notice within thirty (30) days of receipt of written notice of a Joint Steering Committee recommendation regarding such studies that it does not wish to fund such studies, in which event Section 7.2(d) shall apply.

 

(d) In no event shall costs incurred by CURAGEN in carrying out any work directed by the Joint Steering Committee under Section 5.3(f) be paid for from the funds described in Section 5.3(a) above. Such funds shall also not be used to fund any SAR chemistry or manufacturing process development work performed by TOPOTARGET or any in-vitro research as described in Section II of Exhibit C hereto performed by either Party, which work shall be funded by the Party who is to perform such work.

 

(e) Pursuant to Section 5.3(a), CURAGEN shall be obligated to pay a maximum of US$6,000,000 towards costs of the Research Program over the first three (3) years of the Research Program and aggregate payments shall not at any time exceed more than $500,000 per quarterly period for all quarterly periods which have elapsed since the Effective Date without CURAGEN’s prior written consent. The Joint Steering Committee may recommend an increase or an acceleration in such budget to the extent necessary to complete any

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
28


relevant work allocated to TOPOTARGET under this Agreement or under the Research Plan; provided, however, that CURAGEN shall not be required to fund any such excess amount or agree to any acceleration of payments without its prior written consent. In the event that TOPOTARGET’s budgeted expenses as approved by the Joint Steering Committee reach US$6,000,000 prior to the end of the Research Term, the Research Program shall terminate unless otherwise agreed by the Parties. Neither party shall be liable to the other party for any costs, damages, expenses or other liabilities as a result of such termination, and neither party shall have any obligation to continue work under the Research Plan following the date of such termination.

 

(f) If requested by the Joint Steering Committee, CURAGEN shall utilize its systems biology technologies to support the Research Program, subject to CURAGEN’s prior approvals, not to be unreasonably withheld, with advance notice to TOPOTARGET. The Joint Steering Committee may decide that CURAGEN should participate in certain activities other than as described above relating to identification and in-vitro evaluation of Future Products. If so agreed, then such activities shall be documented in writing and reported to TOPOTARGET and the Joint Steering Committee.

 

5.4 Conduct of Research Program. During the term of the Research Program, each Party shall:

 

(a) undertake an interactive, cooperative Research Program with the other Party as set forth in the Research Plans, and such other activities that the Joint Steering Committee decides, from time to time, are necessary for the scientific or commercial success of the Research Program, consistent with Article 4, this Agreement, and the intent of the Parties as evidenced by this Agreement;

 

(b) use all reasonable efforts and proceed diligently to perform the work set out for such Party to perform under the Research Plan, including, without limitation, by using personnel with sufficient skills and experience, together with sufficient equipment and facilities;

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
29


(c) conduct the Research Program in good scientific manner, in compliance with all requirements of all applicable laws, rules and regulations and all other requirements of any applicable good laboratory practices and using resources consistent with those that such party would dedicate to its own research efforts, to attempt to achieve the objectives of the Research Program in a reasonably efficient and expeditious manner;

 

(d) provide the other Party with notice of all significant developments and of all milestones achieved in the performance of the Research Program as they occur, in accordance with any guidelines established by the Joint Steering Committee;

 

(e) promptly provide an invention disclosure report to the other Party with respect to any Invention included in the TOPOTARGET Licensed Technology, TOPOTARGET Collaboration Technology, CURAGEN Collaboration Technology or Joint Collaboration Technology;

 

(f) allow representatives of the other Party, upon reasonable notice and during normal business hours, and subject to reasonable restrictions necessary to protect the confidentiality of such Party’s other programs, to visit the facilities of such Party where the Research Program is being conducted, and consult informally, during such visits and by telephone, with such Party’s personnel performing work on the Research Program; and

 

(g) with respect to each Party, ensure that all of its employees and agents involved in the Research Program on such Party’s behalf agree, in writing, to assign to such Party, directly or indirectly, such Person’s entire interest in and to any and all Inventions arising from such involvement.

 

5.5 Records.

 

(a) TOPOTARGET and CURAGEN each shall maintain records in a manner suitable for carrying out the purposes of the Research Program, and in sufficient detail and in good scientific manner (which shall be complete and accurate in all material respects) and in a form required under all applicable laws and regulations. Each Party shall use reasonable efforts to maintain its records, and to require its subcontractors to do so, in an electronic form suitable

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
30


for electronic filing with any regulatory authority. In addition, TOPOTARGET shall retain records of personnel commitments and other expenditures made in support of the Research Program in sufficient detail to satisfy its reporting requirements to the Steering Committee. CURAGEN shall maintain its records in a similar form.

 

(b) TOPOTARGET and CURAGEN shall share all information contained in such records, and each shall have the right, during normal business hours, upon reasonable notice and subject to such reasonable procedures as the other Party may require, to inspect and copy all such records of the other Party relating specifically to the Research Program to the extent reasonably required for the performance of the inspecting Party’s obligations, or exercise of such Party’s rights, under this Agreement. TOPOTARGET and CURAGEN each shall maintain such records and the information of the other Party contained therein in confidence in accordance with Section 12 and shall not use such records or information except to the extent otherwise permitted by this Agreement.

 

5.6 Material Transfer. In order to facilitate the Research Program, either Party may provide to the other Party certain biological materials or chemical compounds (collectively, the “Substances”) owned by or licensed to the supplying Party (other than under this Agreement) for use by the other Party in furtherance of the Research Program. Except as otherwise provided under this Agreement, all Substances delivered to the other Party shall remain the sole property of the supplying Party, shall be used only in furtherance of the Research Program or the receiving Party’s rights under this Agreement, shall remain under the sole control of the other Party. Substances shall not be used by or delivered to any Third Party except under a written Material Transfer Agreement containing terms and conditions substantially similar to those contained in the form attached as Exhibit E. Any rights to inventions acquired by either Party pursuant to any such Material Transfer Agreement shall be deemed Joint Collaboration Technology. The Substances supplied under this Section 5.6 shall not be used in research or testing involving human subjects, and must be used otherwise with prudence and appropriate caution in any experimental work, since not all of their characteristics may be known. THE SUBSTANCES ARE PROVIDED HEREUNDER “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
31


LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE SUBSTANCES WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.

 

5.7 Liability. Each Party shall be responsible for, and hereby assumes, any and all risks of personal injury or property damage attributable to the grossly negligent or willful acts or omissions, during the term of the Research Program, of such Party, its Affiliates, Sublicensees and their respective directors, officers, employees and agents.

 

5.8 Term of Research Program. The term of the Research Program (“Research Term”) shall commence on the Effective Date, and shall continue until the third anniversary of the Effective Date, unless earlier terminated as provided herein; provided, however, that CURAGEN may elect, at its sole discretion, to extend the Research Term for one or more additional 12-month periods by committing to fund any such continued Research Program at a level of at least US$2,000,000 per year, such amount, to the extent greater than $2,000,000, to be negotiated in good faith, giving due consideration to prior research costs and expenses under the Research Program and mutually agreed to by the Parties on or before the expiration of the prior period. Notice of any such election shall be made, if at all, at least 90 days prior to the relevant anniversary of the Effective Date. In the event that the election is made but the parties cannot agree upon appropriate consideration by the expiration of the prior period, then the Research Program shall terminate as of such date.

 

5.9 Termination of Research Program; Effect.

 

(a) At any time during the term of the Research Program, either Party shall have the right to terminate the Research Program upon 30 days’ written notice to the other Party, in the event that:

 

(i) the other Party is acquired (whether through merger, consolidation, acquisition (directly or indirectly) of stock representing 50% or more of the outstanding voting stock or other of its equity securities, sale of all or

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
32


substantially all of its assets, or otherwise) by a Third Party which is reasonably perceived by the non-acquired Party as a competitor with respect to HDAC Inhibitors or not capable of meeting the requirements of the Research Program or the purposes of this Agreement; or

 

(ii) Either Party has become entitled to terminate this Agreement under clause (b) or (c) of Section 15.3.

 

(iii) Notwithstanding any other provisions of this Agreement, CURAGEN shall have the right to terminate the Research Program at any time after the first anniversary of the Effective Date upon three (3) months’ notice to TOPOTARGET (x) in its entirety or solely with respect to additional Future Products, and with no penalty, in the event that CURAGEN reasonably concludes, in good faith and based on the results of the Research Program and other appropriate scientific and commercial information available to CURAGEN, which conclusion and the grounds therefor shall be presented to the Joint Steering Committee in writing, that it is not likely that any additional Future Products will be identified for which an IND can properly be filed in the United States or that any Future Product which is likely to be identified for which an IND can properly be filed in the United States is not likely to be sufficiently commercially successful to warrant the cost of filing an IND and conducting the necessary clinical trial to obtain approval of an NDA in the United States; or (y) for any reason upon payment of a penalty equal to 50% of any remaining unexpended portion of the US $6,000,000 in research funding to be provided pursuant to Section 5.3. In the event the Research Program is terminated under Section 5.9(a)(iii)(x) only with respect to additional Future Products, the Parties will negotiate, in good faith, a revised budget for the continued development of then existing Collaboration Products. If the parties cannot agree upon appropriate budget within thirty (30) days, then this matter will be referred to the Chief Executive Officers of the Parties for resolution through good faith negotiations. If the budget is not agreed by such individuals within thirty (30) days, then the

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
33


Parties shall utilize a mutually agreed upon expert, who shall decide on the appropriate reductions from the current budget, if any, and whose decision will be binding on the parties.

 

Either Party shall promptly notify the other Party of the occurrence of any of the events specified in Sections 5.9(a)(i) or (ii).

 

(b) At any time during the term of the Research Program, either Party (the “terminating Party”) shall have the right to terminate the Research Program upon notice to the other Party (the “defaulting Party”) in the event the defaulting Party materially defaults with respect to any of its material obligations in connection with the Research Program and fails to cure such default within 60 days after the receipt of a notice from the terminating Party specifying the nature of, and requiring the remedy of, such default.

 

(c) In the event of termination of the Research Program by CURAGEN pursuant to Section 5.9(a) or (b), or by TOPOTARGET pursuant to Section 5.9(a)(i), CURAGEN may elect to have the Agreement and the license rights granted hereunder continue in effect as follows: CURAGEN shall thereafter be permitted to continue development and commercialization within the Territory with respect to the First Product and all Future Products identified pursuant to Section 5.2 prior to such termination, provided that such activities are not contrary to the terms of this Agreement and that the provisions of this Agreement are observed at all times, including, but not limited to, Section 7.2(f), Article 8 and others requiring diligence in development and commercialization, payment of fees and milestones under this Article and Article 9, and termination under Article 15. TOPOTARGET shall (i) promptly transfer to CURAGEN copies, whether in written or electronic form, of all data, reports, and records, in TOPOTARGET’s possession or control, relating to TOPOTARGET Licensed Technology and/or TOPOTARGET Collaboration Technology but only to the extent required to enable CURAGEN to continue to conduct the Research Program with respect to the Future Products identified under Section 5.2, and all to the extent not previously disclosed to CURAGEN; (ii) return to CURAGEN all relevant records and materials, whether in written or electronic form, in TOPOTARGET’s possession or control containing Confidential Information of CURAGEN and

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
34


(iii) furnish to CURAGEN all unused Substances provided to TOPOTARGET by CURAGEN in connection with the Research Program. Thereafter, CURAGEN shall have no further obligation to fund the Research Program and, except as provided in Article 11, TOPOTARGET shall not thereafter be obligated to provide CURAGEN with any Collaboration Product(s) in inventory or be obligated to continue to supply any such product for purposes of the Research Program.

 

(d) In the event of termination of the Research Program by TOPOTARGET pursuant to Section 5.9 (a)(ii) or (b), or a termination by CURAGEN pursuant to Section 5.9(a)(i) or (iii), TOPOTARGET may elect to have the Agreement and the license rights granted hereunder continue in effect as follows: TOPOTARGET shall thereafter be permitted to continue development and commercialization within the TOPOTARGET Territory with respect to the First Product and all Future Products, provided that such activities are not contrary to the terms of this Agreement. CURAGEN shall (i) promptly provide TOPOTARGET with copies, whether in written or electronic form, of all data, reports, and records, in CURAGEN’s possession or control, relating to any CURAGEN Licensed Technology, CURAGEN Collaboration Technology, or CURAGEN’s interest in Joint Collaboration Technology but only to the extent required to enable TOPOTARGET to continue to conduct of the Research Program, all to the extent not previously disclosed to TOPOTARGET; (ii) return to TOPOTARGET all relevant records and materials, whether in written or electronic form, in CURAGEN’s possession or control containing Confidential Information of TOPOTARGET; and (iii) furnish to TOPOTARGET all unused Substances provided to CURAGEN by TOPOTARGET in connection with the Research Program, and TOPOTARGET may elect to have the licenses granted to it pursuant to this Agreement and the rights granted to it pursuant to this Agreement continue in effect, subject to the provisions of this Agreement relating to such activities.

 

(e) Either Party’s termination of the Research Program pursuant to this Section 5.9 shall be without prejudice to, and shall not affect, any of the Parties’ respective rights and obligations under this Agreement that do not specifically relate to the Research Program. Without limiting the generality of the foregoing, in the event of a termination by either CURAGEN or TOPOTARGET of the Research Program pursuant to Section 5.9(a) or (b), either terminating Party’s right to exploit the licenses granted to it hereunder, in accordance with the

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
35


terms of this Agreement, shall not be terminated but shall continue in effect as further provided in Section 5.9(c) and 5.9(d) as relevant.

 

6. OWNERSHIP; PATENT PROTECTION.

 

6.1 Ownership of CURAGEN Collaboration Technology. Except as otherwise provided in this Agreement, the entire right, title and interest in and to all CURAGEN Collaboration Technology shall be owned solely by CURAGEN.

 

6.2 Ownership of TOPOTARGET Licensed Technology, TOPOTARGET Collaboration Technology. Except as otherwise provided in this Agreement, the entire right, title and interest in and to all TOPOTARGET Licensed Technology and TOPOTARGET Collaboration Technology shall be owned solely by TOPOTARGET.

 

6.3 Ownership of Joint Collaboration Technology. Except as otherwise provided in this Agreement, the right, title and interest in and to all Joint Collaboration Technology shall be owned jointly and in undivided shares by TOPOTARGET and CURAGEN.

 

6.4 Patent Filing, Prosecution and Maintenance.

 

(a) Reasonably promptly after the Effective Date the Joint Steering Committee, in consultation with the Parties’ respective patent counsel, shall agree upon a patent filing policy with respect to Collaboration Products. In addition, from time to time, the Joint Steering Committee shall determine, in accordance with such policy, whether and in what jurisdictions patent applications should be filed with respect to any Know-How or Inventions included in the TOPOTARGET Licensed Technology, TOPOTARGET Collaboration Technology, CURAGEN Collaboration Technology, and Joint Collaboration Technology.

 

(b) Following a determination by the Joint Steering Committee that a patent application should be filed with respect to any Know-How or Inventions included in the TOPOTARGET Licensed Technology or TOPOTARGET Collaboration Technology, TOPOTARGET, through outside patent counsel (including, without limitation, foreign patent counsel and agents) reasonably acceptable to CURAGEN and TOPOTARGET, shall promptly

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
36


file a patent application with respect thereto in the jurisdiction(s) selected by the Joint Steering Committee, and thereafter TOPOTARGET shall prosecute such application and maintain any letters patent issuing therefrom. TOPOTARGET shall take all such actions in consultation with CURAGEN and its patent counsel and shall keep CURAGEN apprised as to the status of all pending patent applications. The costs of filing, prosecuting and maintaining any Patents under this Section 6.4(b) in the Territory shall be borne solely by TOPOTARGET. To the extent that TOPOTARGET disagrees with any such filing, prosecution or maintenance of a Patent under this Section 6.4(b) and such actions are required by the Joint Steering Committee, the associated costs and fees shall be borne solely by CURAGEN and such Patents shall be assigned to CURAGEN and shall no longer be deemed TOPOTARGET Licensed Technology or TOPOTARGET Collaboration Technology, as relevant, provided that, solely with respect to Patents on TOPOTARGET Collaboration Technology, such Patents shall be included within the CURAGEN Collaboration Technology for the purpose of the license granted to TOPOTARGET pursuant to Section 7.4.

 

(c) Following a determination by the Joint Steering Committee that a patent application should be filed with respect to any Know-How or Inventions included in any CURAGEN Collaboration Technology, CURAGEN shall promptly file a patent application with respect thereto in the jurisdiction(s) selected by the Joint Steering Committee, and thereafter CURAGEN shall prosecute such application and maintain any letters patent issuing therefrom. CURAGEN shall take all such actions in consultation with TOPOTARGET and its patent counsel and shall keep TOPOTARGET apprised as to the status of all pending patent applications. The costs of filing, prosecuting and maintaining any Patents under this Section 6.4(c) shall be borne solely by CURAGEN.

 

(d) Following a determination by the Joint Steering Committee that a patent application should be filed with respect to a any Know-How or Invention included in the Joint Collaboration Technology, CURAGEN shall promptly file a patent application with respect thereto, in the Parties’ joint names, in the jurisdiction(s) selected by the Joint Steering Committee, and thereafter CURAGEN shall prosecute such application and maintain any letters patent issuing therefrom. CURAGEN shall take all such actions in consultation with

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
37


TOPOTARGET and shall keep TOPOTARGET apprised as to the status of all pending patent applications. The costs of filing, prosecuting and maintaining any Patents under this Section 6.4(d) shall be shared equally by the Parties.

 

6.5 Termination of Support. Either Party shall have the right to terminate all of its obligations, if any, under Section 6.4 with respect to the filing, prosecution or maintenance of any Patent, from time to time, upon notice to the other Party; provided, however, that no such notice shall be effective with respect to any such Patent if it is given fewer than 60 days prior to a deadline for taking any action that must be taken in order to preserve the owner’s rights in such Patent. Upon the delivery of any such effective notice, unless otherwise provided above, such Patent shall be removed from operation of this Agreement, assigned to the non-notifying Party upon request and all of the notifying Party’s rights, licenses and obligations under this Agreement, if any, with respect to such Patent shall terminate, except those patent expense obligations that shall have accrued prior to the Effective Date of such notice.

 

7. GRANT OF LICENSES; RESERVATION OF RIGHTS.

 

7.1 Mutual Research Licenses.

 

(a) TOPOTARGET hereby grants CURAGEN, during the term of the Research Program, a co-exclusive (solely with TOPOTARGET), paid-up right and license in the Field throughout the Territory under the TOPOTARGET Licensed Technology, TOPOTARGET Collaboration Technology, and TOPOTARGET’s interest in the Joint Collaboration Technology to conduct the Research Program and to make and use Collaboration Products in connection with the Research Program, each in accordance with the terms of this Agreement. Notwithstanding the foregoing, the parties recognize that the CRADA described in Section 3.1, and any other agreements entered into pursuant to Section 3.3, whether executed either before or after the Effective Date, shall not be considered in violation of CURAGEN’s co-exclusivity pursuant to this provision 7.1(a).

 

(b) CURAGEN hereby grants TOPOTARGET, during the term of the Research Program, a co-exclusive (solely with CURAGEN), paid-upright and license in the Field

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
38


throughout the TOPOTARGET Territory under the CURAGEN Licensed Technology, the CURAGEN Collaboration Technology and CURAGEN’s interest in the Joint Collaboration Technology to conduct the Research Program and to make and use Collaboration Products in connection with the Research Program, each in accordance with the terms of this Agreement.

 

7.2 CURAGEN Commercialization License.

 

(a) Subject to Section 7.2(c), 7.2(d) and 7.2(e), TOPOTARGET hereby grants to CURAGEN an exclusive (even as to TOPOTARGET), royalty-bearing right and license in the Field throughout the Territory, with the right to grant sublicenses in accordance with the terms of this Agreement, under the TOPOTARGET Licensed Technology, the TOPOTARGET Collaboration Technology and TOPOTARGET’s interest in the Joint Collaboration Technology to develop, have developed, make, have made, use, sell, offer for sale, and have sold, and to import, have imported, export and have exported within the Territory, Collaboration Products and, subject to Section 7.2(b), any HDAC Inhibitor that is not a Collaboration Product.

 

(b) From and after the date of expiration or termination of the Research Term, any HDAC Inhibitor which is not a Collaboration Product at such time, shall no longer be subject to the license granted to CURAGEN under Section 7.2(a).

 

(c) Notwithstanding Section 7.2(a), for any distinct Future Product for which an IND is filed in any country, whether during or after the Research Term, if CURAGEN fails to make any payment specified in Section 9.4 for such Future Product within the time period provided therein, such Future Product and its Back-Up Products shall no longer be deemed Collaboration Products and shall be removed from operation of this Agreement.

 

(d) In addition, for any distinct Future Product for which CURAGEN declines to fund regulatory toxicity studies recommended by the Joint Steering Committee within thirty (30) days of any written notice thereof provided to CURAGEN, such Future Product and its Back-Up Products shall no longer be deemed Collaboration Products and shall be removed from operation of this Agreement.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
39


(e) Unless CURAGEN has designated a specific Back-Up Product as a potential replacement for a Collaboration Product within [*****(****)] years after the first filing of an IND in the Territory for such Collaboration Product, CURAGEN’s license under Section 7.2(a) to Back-Up Products for such Collaboration Product, shall terminate as of such date and such Back-Up Products shall thereafter no longer be deemed Collaboration Products. If CURAGEN has designated a Back-Up Product prior to such date, such Back-Up Product shall continue to be licensed hereunder, but rights to all non-designated Back-Up Products shall terminate at such time.

 

(f) In order to maintain the license rights of Section 7.2(a), CURAGEN must diligently develop and commercialize Collaboration Products. CURAGEN will have satisfied the foregoing obligation by adhering to the clinical plan for Collaboration Products as determined by the Joint Steering Committee and, meeting targets for (i) initiating clinical trials: IND within [***(****)******] following completion of regulatory toxicity studies of each Collaboration Product recommended by the Joint Steering Committee, Phase II within [***(****)******] of Phase I completion, Phase III within [***(****)******] of Phase II completion, and filing at least one (1) NDA within [***(****)******] of Phase III completion (including all necessary data analysis) and (ii) prosecuting clinical trials: spending a minimum of [******************] for clinical development (all clinical expenses including patient fees, central lab fees and CRO fees, but excluding CURAGEN internal infrastructure costs) of a Collaboration Product that is in Phase I, [******************] for clinical development of a Collaboration Product that is in Phase II and [******************] for clinical development of a Collaboration Product that is in Phase III. The failure to achieve any specific target will not mean that CURAGEN has failed to meet the foregoing obligation; provided that CURAGEN can demonstrate that it has used commercially reasonable efforts to do so. Demonstration of commercial due diligence may include, but is not limited to developing a marketing plan to market the Covered Products in the Territory reflecting activities and resources customary in the industry for similar products, submitting the marketing plan to TOPOTARGET at least six (6) months prior to launch of the first Covered Product for comment and providing annual updates thereafter, establishing (directly or indirectly) a suitable sales force and committing sufficient

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
40


marketing resources and budget to meet the objectives of the marketing plan, and meeting minimum sales targets beginning in the third calendar year after market launch in the United States.

 

7.3 Sublicensing by CURAGEN.

 

(a) CURAGEN shall have the right to grant sublicenses to any of its Affiliates and/or to Third Parties of the licenses or rights granted to CURAGEN hereunder for purposes of permitting such Affiliate(s) or Third Party to perform CURAGEN’s rights and obligations hereunder, provided that: (i) CURAGEN shall provide TOPOTARGET written notice within 30 days of identifying said Affiliate or Third Party; (ii) the rights to be granted to any Third Party shall not include rights to any Future Product with respect to which the take up fee specified in Section 9.4 has not been paid; (iii) CURAGEN shall guarantee and be responsible for ensuring the diligent discharge of CURAGEN’s obligations under, and compliance with all applicable terms of, this Agreement, whether by CURAGEN or any Sublicensee; (iv) each Affiliate or Sublicensee agrees in writing to keep books and records and permit TOPOTARGET to review such books and records pursuant to the relevant provisions of, and to observe and to be bound by all other applicable terms of, this Agreement (including, without limitation, those set forth in Sections 8.2, 8.7, 12, 13, 15 and 17); and (v) the rights of TOPOTARGET under this Agreement are preserved in connection with any such sublicensing. CURAGEN shall promptly provide TOPOTARGET with notice of any sublicense granted pursuant to this Section 7.3. Notwithstanding the foregoing, for any sublicense with respect to a Collaboration Product which has not yet entered Phase II clinical studies, TOPOTARGET shall have the right within 20 days of any notice provided pursuant to (i) above, to prevent CURAGEN from granting such sublicense if TOPOTARGET notifies CURAGEN that it believes that such proposed Sublicensee lacks sufficient capability to conduct clinical development of such Collaboration Product, and such belief is reasonable.

 

(b) CURAGEN hereby unconditionally guarantees the performance of any of its Affiliates and its Sublicensees hereunder.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
41


(c) Activities of any Sublicensee shall be subject to milestone, royalty or other payments as if the activity was conducted by CURAGEN, and CURAGEN shall make payments to TOPOTARGET on behalf of its Sublicensee, unless CURAGEN and TOPOTARGET mutually agree to allow the Sublicensee to make payments directly to TOPOTARGET.

 

7.4 TOPOTARGET Commercialization License. CURAGEN hereby grants to TOPOTARGET an exclusive (even as to CURAGEN), royalty-bearing right and license in the Field throughout the TOPOTARGET Territory, with the right to grant sublicenses in accordance with the terms of this Agreement, under the CURAGEN Licensed Technology, the CURAGEN Collaboration Technology and CURAGEN’s interest in the Joint Collaboration Technology to develop, have developed, make, have made, use, sell, offer for sale, and have sold, and to import, have imported, export and have exported within the TOPOTARGET Territory, Collaboration Products.

 

7.5 Trademark License. CURAGEN hereby grants to TOPOTARGET a fully paid, exclusive right and license, with the right to sublicense subject to CURAGEN’s prior written approval, which approval shall not be unreasonably withheld, to use the CURAGEN Trademarks in the TOPOTARGET Territory solely in connection with the sale or distribution of Collaboration Products substantially identical to those for which such CURAGEN Trademarks are used by CURAGEN in the Territory and for which TOPOTARGET has become obligated to pay royalties to CURAGEN pursuant to Section 9.9. TOPOTARGET agrees that prior to any such use, it will submit to CURAGEN for reasonable review samples of the labels and other materials which depict such CURAGEN Trademarks and which TOPOTARGET intends to use. TOPOTARGET further agrees to cooperate with CURAGEN in connection with CURAGEN’s reasonable efforts to exercise quality control with respect to TOPOTARGET’s use of any CURAGEN Trademark. To the extent TOPOTARGET desires CURAGEN to enforce against a Third Party the rights to any CURAGEN Trademark in the TOPOTARGET Territory, TOPOTARGET shall be responsible for all costs and expenses associated therewith. TOPOTARGET agrees that all use of any CURAGEN Trademark by TOPOTARGET shall inure to the benefit of CURAGEN and that TOPOTARGET will not undertake any effort or cause a Third Party to undertake any efforts to challenge the rights of CURAGEN to any CURAGEN

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
42


Trademark. TOPOTARGET hereby unconditionally guarantees the performance of any of its Affiliates or sublicensees with respect to any rights granted hereunder.

 

8. DEVELOPMENT AND COMMERCIALIZATION.

 

8.1 Development Program. The Parties agree to conduct a Development Program as further provided in this Section 8 to coordinate the global clinical development of the Collaboration Products. The Joint Steering Committee will approve specific Development Program plans for Collaboration Products in accordance with the principles outlined in Exhibit F. All risk-benefit decisions related to the development of Collaboration Products, including which pre-clinical toxicology studies and safety testing are to be performed, will be made by the Joint Steering Committee.

 

8.2 Development And Commercialization Efforts by CURAGEN.

 

(a) CURAGEN shall use commercially reasonable efforts, consistent at least with those described in Section 7.2(f), (including, but not limited to, conducting clinical trials (other than the TOPOTARGET Clinical Studies), filing for regulatory approvals, diligently pursuing such approvals and, upon the grant of regulatory approval, marketing Collaboration Products) to develop, commercialize and market at least one Collaboration Product in the Field in the Territory. In connection therewith, CURAGEN shall dedicate resources to the development, commercialization and marketing of Collaboration Products in the Territory that are consistent with the resources that CURAGEN, at all relevant times, would dedicate to products containing compounds with similar commercial potential generated from CURAGEN’s own research efforts that CURAGEN decided to develop commercially and market. Except as otherwise provided in this Agreement, CURAGEN shall be solely responsible for conducting all such development, commercialization and marketing activities in the Territory, and for all costs and expenses thereof.

 

(b) CURAGEN shall provide TOPOTARGET and the Joint Steering Committee on a timely basis (that is, promptly after generation) with all data, results, reports and other information generated in connection with CURAGEN’s development, either alone or in

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
43


permitted collaboration with any Third Party(ies), of any Collaboration Products in the Territory. CURAGEN shall promptly inform the Joint Steering Committee regarding all significant developments and issues in connection with any such development of Collaboration Products in the Territory that may arise from time to time.

 

8.3 Exchange of Regulatory Information; Ownership of Regulatory Filings. The Parties acknowledge and agree that as of the Effective Date TOPOTARGET is conducting a Phase I clinical trial of the First Product in the TOPOTARGET Territory. Promptly after the Effective Date, TOPOTARGET shall provide to CURAGEN copies of all data, information and regulatory filings made or exchanged with any regulatory authority with respect to any Collaboration Product. All INDs, NDAs and other regulatory filings in the TOPOTARGET Territory with respect to any Collaboration Products shall be in the name of, and be owned solely by, TOPOTARGET. Subject to applicable laws and regulations, unless this Agreement is terminated in its entirety by TOPOTARGET pursuant to Section 15.3 as a result of a payment breach, TOPOTARGET shall provide CURAGEN with the right to cross-reference any relevant existing regulatory filings and dossiers in connection with CURAGEN’s exercise of the rights granted hereunder. All INDs, NDAs and other regulatory filings in the Territory with respect to any Collaboration Products shall be in the name of, and be owned solely by, CURAGEN. CURAGEN shall provide to TOPOTARGET copies of all data, information and regulatory filings made or exchanged with any regulatory authority in such countries with respect to any Collaboration Product, promptly after generation of such data, information or regulatory filing. Subject to applicable laws and regulations, unless this Agreement is terminated by CURAGEN in its entirety pursuant to Section 15.3 as a result of a payment breach, CURAGEN shall provide TOPOTARGET with the right to cross-reference any such relevant existing regulatory filings and dossiers in connection with TOPOTARGET regulatory activities in the TOPOTARGET Territory.

 

8.4 TOPOTARGET’s Development of Collaboration Products

 

(a) TOPOTARGET shall conduct, at CURAGEN’s expense, those clinical studies for the First Product and the Future Products in the TOPOTARGET Territory as listed on

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
44


Exhibit G attached hereto and as otherwise approved by the Joint Steering Committee (“TOPOTARGET Clinical Studies”). Notwithstanding the foregoing, CURAGEN shall not be required to pay for the expenses of any TOPOTARGET personnel involved in planning, coordinating or monitoring any such TOPOTARGET Clinical Studies.

 

(b) TOPOTARGET shall retain the option to conduct, or have conducted, at its own expense, any clinical trial it deems appropriate to support registrations for commercialization of Collaboration Products in the TOPOTARGET Territory; provided, however, that all protocols for such trials shall be reviewed with the Joint Steering Committee prior to initiation of any such trial.

 

(c) TOPOTARGET shall provide CURAGEN and the Joint Steering Committee on a timely basis (that is, promptly after generation) with all data, results, reports and other information generated in connection with TOPOTARGET’s development, either alone or in permitted collaboration with any Third Party(ies), of any Collaboration Products outside the Territory, including without limitation all data and information relating to any TOPOTARGET Clinical Studies. TOPOTARGET shall promptly inform the Joint Steering Committee regarding all significant developments and issues in connection with any such clinical studies of Collaboration Products that may arise from time to time.

 

(d) Notwithstanding the foregoing, the Joint Steering Committee shall have the right to require TOPOTARGET to terminate, for reasonable cause, any clinical trial of a Collaboration Product. The Parties acknowledge and agree that for purposes of this Section 8.4(d), reasonable cause shall include, without limitation, the Joint Steering Committee’s reasonable determination that [*************************************************].

 

8.5 Use of CURAGEN Clinical Data. Notwithstanding Section 12.1, and subject to compliance with Section 9.9, TOPOTARGET shall be permitted to use, and to allow its Affiliates and licensees to use, clinical data and information generated or obtained by CURAGEN or resulting from clinical trials paid for by CURAGEN hereunder (“CURAGEN Clinical Data”) with respect to TOPOTARGET’s efforts to obtain regulatory approval for Collaboration Products outside the Territory so long as TOPOTARGET informs CURAGEN of

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
45


any such intended use, limits the extent of any concomitant disclosure to the maximum extent possible, and provides copies to CURAGEN of any documents which embody any such CURAGEN clinical data and/or information which are to provided to any Third Party. TOPOTARGET hereby unconditionally guarantees the performance of any of its Affiliates and licensees with respect to the rights granted hereunder.

 

8.6 Reporting.

 

(a) The Joint Steering Committee shall establish data collection and data sharing standards, which will include without limitation, standards regarding the collection and provision to each Party of all safety data. The Parties shall use best efforts to adhere to such data collection standards.

 

(b) In the event of a change of control of TOPOTARGET (whether through merger, consolidation, acquisition (directly or indirectly) of stock representing 50% or more of the outstanding voting stock or other of its equity securities, sale of all or substantially all of its assets, or otherwise) which results in control of TOPOTARGET by any Third Party that, in the good faith determination of CURAGEN, is a competitor of CURAGEN and is developing an HDAC inhibitor, CURAGEN shall not be required to include in any report furnished by CURAGEN pursuant to this Agreement, or provide to any representative of TOPOTARGET (or any successor thereto), any information that CURAGEN, acting in good faith, determines to be competitively sensitive or enabling information. Nothing in this provision should be understood to restrict CURAGEN’s right to cross-reference regulatory filings and dossiers pursuant to Section 8.3 or to limit any obligation pursuant to Section 8.7 hereof.

 

(c) In the event of a change of control of CURAGEN (whether through merger, consolidation, acquisition (directly or indirectly) of stock representing 50% or more of the outstanding voting stock or other of its equity securities, sale of all or substantially all of its assets, or otherwise) which results in control of CURAGEN by any Third Party that, in the good faith determination of TOPOTARGET, is a competitor of TOPOTARGET and is developing an HDAC inhibitor, TOPOTARGET shall not be required to include in any report furnished by TOPOTARGET pursuant to this Agreement, or provide to any representative of CURAGEN (or

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
46


any successor thereto), any information that TOPOTARGET, acting in good faith, determines to be competitively sensitive or enabling information. Nothing in this provision should be understood to restrict TOPOTARGET’s right to cross-reference regulatory filings and dossiers pursuant to Section 8.3 or to limit any obligation pursuant to Section 8.7 hereof.

 

8.7 Adverse Events.

 

(a) The Parties shall develop standard operating procedures for the investigation and reporting of adverse events concerning Collaboration Products. The Parties shall immediately implement such agreed procedures and shall provide each other in a time frame consistent with regulatory obligations with any information which has become available to them and which is relevant to the safe use of the Collaboration Products or which is required by local law in all countries where the Collaboration Products are marketed or are in clinical trials.

 

(b) Both as an integral part of the procedures referred to in (a) above and as a separate obligation under this Agreement, each Party shall notify the other Party of each report of a “serious adverse event” (as defined below). The notification shall be made in the appropriate format prescribed in the said procedures by the fastest available means. The responsibility for submitting any such report to health registration authorities in particular countries shall be stipulated in the said procedures. Upon the request of one Party, the other Party shall promptly investigate a serious adverse event and shall promptly submit follow-up reports upon the receipt of new information. The said procedures are subject to such changes as may be adjudged necessary or as shall be required by applicable law. For the purposes of this provision, “serious adverse event” shall mean any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (i.e. placing the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
47


patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above.

 

(c) Each Party shall promptly notify the other of, and provide copies of, any proposed, pending, threatened or completed governmental action concerning adverse events which might affect any Collaboration Product.

 

(d) Each Party shall cooperate with the other Party to comply with any new applicable regulatory requirements on adverse drug event reporting which may from time to time be imposed in the countries where a Collaboration Product is developed, tested or marketed.

 

8.8 Trademarks. CURAGEN shall designate the generic name of any Collaboration Product and register such name with USAN (United States Adopted Name/International Nonproprietary Name). CURAGEN shall market the Collaboration Products throughout the Territory under trademarks (collectively, the “CURAGEN Trademarks”) selected by CURAGEN, which shall not use, incorporate or be confusingly similar to any trademark, trade name, or service mark of TOPOTARGET in existence as of the later of the Effective Date or the registration date of any such CURAGEN Trademark. CURAGEN shall own all right, title and interest in and to such CURAGEN Trademarks and shall bear all costs and expenses of registering, and maintaining the registration of, same, within or outside the Territory. TOPOTARGET may not use any marks similar to the CURAGEN Trademarks without the prior written consent of CURAGEN except as expressly set forth in Section 7.5 hereof. TOPOTARGET has retained the right to market the Collaboration Products outside the Territory and may select trademarks for such purposes in TOPOTARGET’s discretion, subject to the restrictions set forth above (collectively, the “TOPOTARGET Trademarks”). TOPOTARGET shall own all right, title and interest in and to such TOPOTARGET Trademarks and shall bear all costs and expenses of registering, and maintaining the registration of, same. CURAGEN may not use any marks similar to the TOPOTARGET Trademarks without the prior written consent of TOPOTARGET.

 

8.9 Publications. Each Party shall be free to publish and/or make presentations concerning the results of its development efforts under this Section 8, subject to its compliance

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
48


with this Section 8.9 and with any other guidelines established by the Joint Steering Committee. Each Party shall deliver to the other Party and the Joint Steering Committee copies of all articles and papers to be published, and reasonably detailed abstracts of presentations to be made, concerning such subject matter at least 30 days prior to the anticipated submission or presentation date thereof. The non-publishing Party shall have 30 days after receipt of said copies to object to such proposed publication or presentation because Confidential Information of such non-publishing Party is contained in the proposed publication or presentation, because such proposed publication or presentation would disclose Know-How or the proprietary and confidential details of an Invention for which such non-publishing Party has a license under this Agreement and that the Joint Steering Committee has determined, either generally or in particular, should be the subject of Patent protection. In the event the non-publishing Party makes such objection due to inclusion of the non-publishing Party’s Confidential Information, the Parties shall negotiate an acceptable version of such proposed publication or presentation. In the event that the non-publishing Party makes such objection due to the need for patent protection, then such publication or presentation shall be delayed for a reasonable period of time (not to exceed 90 days) during which the Party having responsibility therefore (under Section 6.4) shall file a patent application in the appropriate jurisdiction(s) with respect to such Know-How or Invention.

 

9. MONETARY OBLIGATIONS.

 

9.1 License Fee. In partial consideration of the rights and licenses granted to CURAGEN under this Agreement, within 30 days after the execution of this Agreement CURAGEN shall pay TOPOTARGET a non-refundable, non-creditable one-time license fee in the amount of US$5,000,000.

 

9.2 Loan Commitment. In partial consideration of the rights and licenses granted to CURAGEN hereunder, CURAGEN hereby agrees to advance certain sums to TOPOTARGET as further provided in the Convertible Debenture and Convertible Loan Agreement executed by the Parties and of even date herewith, copies of which are attached hereto in Exhibit H (the “Loan Agreements”).

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
49


In the event CURAGEN exercises its rights hereunder to terminate this Agreement pursuant to Section 15.3, CURAGEN shall have the right to accelerate the Loan and make immediate written demand for payment of all amounts due thereunder, and notwithstanding any provision of the Loan Agreements, all amounts due under the Loan shall become due and payable in cash thirty (30) days after delivery of such written demand for payment.

 

9.3 Additional Upfront Payment. In addition to the consideration specified above, in partial consideration of the rights and licenses granted to CURAGEN under this Agreement, CURAGEN shall pay to TOPOTARGET a non-refundable, non-creditable payment of US$5,000,000 on Phase II Initiation in the United States for the First Product, provided that such event occurs by [*************]. Otherwise, the amount payable pursuant to this Section 9.3 shall be reduced by [***********************************************************].

 

9.4 Take Up Fee.

 

(a) The Parties acknowledge and agree that during the Research Program, the Parties may identify Future Products. In order to retain its rights to any such Future Products, CURAGEN shall pay to TOPOTARGET a non-refundable, non-creditable fee (the “Take Up Fee”) for each distinct Future Product within the earlier of (i) thirty (30) days after the first acceptance of the filing of an IND for such Future Product anywhere in the world or (ii) twenty-four months following the expiration or termination of the Research Term. The Take Up Fee shall be US$500,000 for each of the first two Future Products and US$1,000,000 for each Future Product thereafter.

 

(b) In addition, for each Future Product for which the Take Up Fee has not been paid within twelve (12) months following the expiration or termination of the Research Term, in order to retain its rights to such Future Product, CURAGEN shall pay to TOPOTARGET a non-refundable fee of [***************] (a “Maintenance Fee”) on or before such twelve-month anniversary, which amount shall be fully creditable against any Take Up Fee subsequently paid for the same Future Product. Failure to pay any such amount when due shall cause such Future Product and its Back-Up Products to be removed from operation of this Agreement as provided in Section 7.2(c).

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
50


9.5 Development Milestone Payments by CURAGEN.

 

(a) In partial consideration of the rights and licenses granted to CURAGEN under this Agreement, CURAGEN shall pay TOPOTARGET the following non-refundable, non-creditable milestone payments upon the first occurrence of each event set forth below with respect to the First Product, whether such occurrence is achieved by CURAGEN or its Affiliates or its Sublicensees (or TOPOTARGET with respect to Phase II Initiation), so long as such event occurs prior to the expiration of the Royalty Term for the First Product:

 

(i) US$3,000,000 upon Phase II initiation for such First Product; provided, however, that such amount shall be reduced by [***************];

 

(ii) [***************] upon Phase III Initiation for the First Product;

 

(iii) [***************] upon acceptance of filing of the NDA for the First Product by the FDA;

 

(iv) [***************] upon acceptance of filing of the first NDA for the First Product by relevant authorities in Japan;

 

(v) [***************] upon First Commercial Sale of the First Product in the United States; and

 

(vi) [***************] upon First Commercial Sale of the First Product in Japan.

 

Each of the foregoing payments shall be made within 30 days after achievement of such milestone. For the avoidance of doubt, after CURAGEN has made any of the foregoing payments with respect to the First Product, CURAGEN shall have no further obligation to make the same milestone payment with respect to the First Product, or with respect to any other product which is an alternative formulation of the First Product, regardless of the number of clinical trials, NDAs or regulatory approvals for such First Product.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
51


(b) In partial consideration of the rights and licenses granted to CURAGEN under this Agreement, CURAGEN shall pay TOPOTARGET the following non-refundable, non-creditable milestone payments upon the first occurrence of each event set forth below with respect to each Future Product, whether such occurrence is achieved by CURAGEN or its Affiliates or its Sublicensees so long as such event occurs prior to the expiration of the relevant Royalty Term:

 

(i) US$3,000,000 upon Phase II Initiation for such Future Product; provided, however, that such amount shall be reduced by [****************************************************************];

 

(ii) [************] upon Phase III Initiation for the Future Product;

 

(iii) [************] upon acceptance of filing of the first NDA for the Future Product by the FDA;

 

(iv) [************] upon acceptance of filing of the first NDA for the Future Product by relevant authorities in Japan;

 

(v) [************] upon First Commercial Sale of the Future Product in the United States; and

 

(vi) [************] upon First Commercial Sale of the Future Product in Japan.

 

Each of the foregoing payments shall be made within 30 days after achievement of such milestone. For the avoidance of doubt, after CURAGEN has made any of the foregoing payments with respect to any Future Product, CURAGEN shall have no further obligation to make the same milestone payment with respect to such Future Product, or with respect to any other Future Product that is an alternative formulation of such Collaboration Product for which milestones have been paid pursuant to Section 9.5(a) or (b) hereof, regardless of the number of clinical trials, NDAs or regulatory approvals for any such Future Product.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
52


(c) If CURAGEN notifies TOPOTARGET that it is developing both a lead Collaboration Product and a Back-Up Product in the Territory, CURAGEN shall be obligated to pay only one set of milestones as set forth in (a) or (b) above until the acceptance for filing of an NDA on the second of such two Collaboration Products in the United States or Japan, at which time CURAGEN shall pay: (i) the specified milestone for such event; and (ii) to the extent such payments were not previously made or applicable, all preceding milestones which have been met for such second Collaboration Product, plus interest on such amounts at an annual percentage rate equal to [*********(***)] per year or the highest rate allowed under applicable law, whichever is lower, compounded annually from the date the milestone would have been met until the payment is made; and (iii) the remaining milestones for such second Collaboration Product when the specified events are achieved.

 

(d) If the development or commercialization of a Collaboration Product is abandoned during the term of this Agreement for any specific, medical or commercial reason after one or more of the milestone payments specified in (a) or (b) above are made, and a Back-Up Product is developed to replace the abandoned Collaboration Product, then no milestone payment shall be required with respect to the Back-Up Product to the extent that such milestone payment has already been made with respect to the abandoned Collaboration Product.

 

9.6 Royalties.

 

(a) In partial consideration of the rights and licenses granted to CURAGEN under this Agreement, CURAGEN shall pay TOPOTARGET a royalty on Net Sales of each Covered Product, commencing on the First Commercial Sale of each such Covered Product by or on behalf of CURAGEN, its Affiliates or its Sublicensees in each country in the Territory and continuing during the Royalty Term for such Covered Product for such country, in an amount calculated by multiplying the applicable percentage (i.e., the royalty payable thereon) from the following chart by the aggregate Net Sales of each such Covered Product throughout the Territory during each calendar year (or portion thereof) during the term of this Agreement:

 

Increment of Annual Net Sales (“ANS”) of Subject
Covered Product In the Territory Achieved During Calendar Year


   Royalty Payable
Thereon


[************]

   [*****]

[************]

   [*****]

[************]

   [*****]

[************]

   [*****]

[************]

   [*****]

[************]

   [*****]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
53


(b) CURAGEN’s obligation to pay royalties with respect to each Covered Product in each country in the Territory shall expire upon the expiration of the Royalty Term with respect to such Covered Product in such country.

 

(c) The obligation to pay royalties to TOPOTARGET under this Section 9.6 is imposed only once with respect to the same unit of Covered Product, regardless of the number of Patents pertaining thereto.

 

9.7 Third Party Royalties.

 

(a) CURAGEN, at its sole expense, shall pay all license fees, milestones and earned royalties owing to any Third Party with respect to patents regarding the composition or method of manufacture of the HDAC Inhibitor component of any Collaboration Product (“Third Party HDAC Patents”) that CURAGEN determines, in its reasonable business judgment, are necessary in order to develop, make, have made, use, sell, offer for sale, have sold or export any such Collaboration Product in the Territory (collectively, “Third Party HDAC Royalties”).

 

(b) CURAGEN shall be entitled to a credit against royalties due to TOPOTARGET under this Agreement for any Covered Product in an amount equal to [******]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
54


of the aggregate Third Party HDAC Royalties paid by CURAGEN in any country in the Territory with respect to the relevant Covered Product; provided, however, that the application of such credit shall not reduce the royalties payable by CURAGEN under this Agreement for such Covered Product with respect to any given calendar quarter by more than [******]. Notwithstanding the foregoing, if CURAGEN, in lieu of or in addition to any Third Party HDAC Royalties, is required to pay an award of damages or a settlement amount in the form of a reasonable royalty based on sales during any period of previous infringement of any Third Party HDAC Patents (as opposed to the on-going payment of a running royalty), then such payment shall be allocated to the several calendar quarters during such period of infringement, and the limits set forth in the previous sentence shall apply to each portion of such payment allocated to a specific quarter and not to such payment as a whole, and an appropriate credit shall be permitted so long as no quarterly payment is reduced by more than [******].

 

(c) Each Party, at its sole expense, shall pay all license fees, milestones and earned royalties owing to any Third Party as a result of the licensing of Patents other than Third Party HDAC Patents (“Other Third Party Patents”), that the Joint Steering Committee determines, in its reasonable business judgment, are necessary in order to develop, make, have made, use, sell, offer for sale, have sold or export any Collaboration Product in its respective territory (collectively, “Other Third Party Royalties”). All such amounts that are due with respect to a particular country shall be borne by the Party in whose territory such country falls hereunder. All other amounts shall be allocated based on the ratio of affected sales in each Party’s territory, as mutually agreed by the Parties.

 

(d) Each Party shall be entitled to a credit against royalties due to the other Party under this Agreement on any Covered Product from CURAGEN pursuant to Section 9.6, or on any Collaboration Product from TOPOTARGET pursuant to Section 9.9. in each case in an amount equal to [******] of the aggregate Other Third Party Royalties paid by such Party in any country in its territory; provided, however, that the application of such credit shall not reduce the royalties payable by such Party under this Agreement for such Covered Product or Collaboration Product, as relevant, with respect to any given calendar quarter, after any adjustment permitted to CURAGEN pursuant to (b) above where CURAGEN has paid both Third Party HDAC Royalties

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
55


and Other Third Party Royalties, by more than [******]. Notwithstanding the foregoing, if such Party, in lieu or in addition to any Other Third Party Royalties, is required to pay an award of damages or a settlement amount in the form of a reasonable royalty based on sales during any period of previous infringement of Other Third Party Patents (as opposed to the on-going payment of a running royalty), then such payment shall be allocated to the several calendar quarters during such period of infringement, and the limits set forth in the previous sentence shall apply to each portion of such payment allocated to a specific quarter and not to such payment as a whole, and an appropriate credit shall be permitted so long as no quarterly payment is reduced by more than [******].

 

9.8 Royalty Increases. Notwithstanding any provision herein to the contrary, TOPOTARGET shall have the right, at its sole option, to share in the expenses of developing any Collaboration Product in the Territory and increase the royalties due to TOPOTARGET on sales of the resulting Covered Product(s) in the Territory as follows:

 

(a) TOPOTARGET must notify CURAGEN of its desire to exercise its option to increase royalties pursuant to this Section 9.8 by delivering written notice thereof to CURAGEN prior to Phase III Initiation of the relevant Collaboration Product;

 

(b) TOPOTARGET shall pay CURAGEN [*******(****)] of the development costs incurred by CURAGEN, its Affiliates and Sublicensees with respect to such Collaboration Product, including any Research Program funding provided by CURAGEN under Section 5.3 and excluding any milestones paid under Section 9, prior to the date of such notice, within thirty (30) days of receipt of an invoice from CURAGEN for such costs;

 

(c) TOPOTARGET shall, from and after the date of such notice, be responsible for [*******(****)] of all future development costs for such Collaboration Product and shall make payments therefore within ten (10) days of receipt of monthly invoices for such expenses from CURAGEN; and

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
56


(d) Subject to TOPOTARGET making all payments specified above in full, the royalties on the relevant Covered Product(s) shall thereafter be as follows instead of as stated in Section 9.6:

 

Increment of Annual Net Sales (“ANS”) of Subject
Covered Product In the Territory Achieved During Calendar Year


   Royalty Payable
Thereon


[********************]

   [*****]

[********************]

   [*****]

[********************]

   [*****]

[********************]

   [*****]

[********************]

   [*****]

[********************]

   [*****]

 

9.9 Royalties to CURAGEN. In the event that TOPOTARGET exercises its rights as provided in Section 8.5 to use CURAGEN Clinical Data, and makes any material use of any CURAGEN Clinical Data in connection with any registration or marketing of any Collaboration Product in the TOPOTARGET Territory, whether by itself or in collaboration with any Third Party, TOPOTARGET shall notify CURAGEN of such use and shall become obligated to make royalty payments to CURAGEN as partial consideration for access to such clinical data and the investment made by CURAGEN therein. Unless otherwise provided in Section 15.6(c), royalty payments shall be owed to CURAGEN at the rates specified in Section 9.6 on the Net Sales in the TOPOTARGET Territory of each Collaboration Product with respect to which such CURAGEN Clinical Data was used or whose use or sale in the relevant country is covered by one or more Valid Claims of CURAGEN Licensed Technology or the CURAGEN Collaboration Technology. The Parties hereby agree that, unless a shorter period is otherwise provided in Section 15.2, such payments shall continue in each country for the duration of any Royalty Term

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
57


for a corresponding Covered Product in such country, notwithstanding the fact that such royalties are being provided as consideration for access to rights which are not necessarily patent rights. All such payments shall be subject to the Net Sales definition as if each such Collaboration Product was a Covered Product therein, and shall be subject to the Third Party Royalty provisions of Section 9.7(c) and (d) and the reporting and payment provisions as provided in Section 10, with the rights and obligations of the Parties under such definition and such Sections reversed. Notwithstanding the foregoing, royalty payments due to CURAGEN under this Section 9.9 during any royalty period shall be applied as a credit against any milestones and royalties owed by CURAGEN to TOPOTARGET on any or all Collaboration Products during the relevant royalty period; provided, however, that if any credit cannot be fully utilized in any royalty period, it shall be carried forward into future periods until exhausted, and such future credits shall accrue interest at the rate of [********(****)] compounded annually. Other than as provided in Article 15, TOPOTARGET shall not be obligated to submit actual payment of any royalty calculated to be due hereunder to CURAGEN.

 

10. PAYMENTS AND REPORTS.

 

10.1 Payment. Except as otherwise provided in this Agreement, all royalty and other payments due hereunder shall be paid quarterly within 45 days after the end of each calendar quarter. Each such payment shall be accompanied by a statement, Covered Product-by-Covered Product and country-by-country, of the amount of Net Sales during such quarter and the amount of royalties due on such Net Sales.

 

10.2 Mode of Payment. CURAGEN shall make all payments required under this Agreement as directed by TOPOTARGET from time to time, in U.S. Dollars (except as provided in Section 10.6). All royalties due hereunder shall first be determined in the currency of the country in which the Covered Products in question were sold and then converted into equivalent U.S. funds. The exchange rate for such conversion shall be that rate quoted in The Wall Street Journal on the last business day of the applicable reporting period.

 

10.3 Records Retention. CURAGEN, its Affiliates and its Sublicensees shall keep complete and accurate records pertaining to the sale of Covered Products in the Territory and

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
58


covering all transactions from which Net Sales are derived for a period of three calendar years after the year in which such sales occurred, and in sufficient detail to permit TOPOTARGET to confirm the accuracy of royalty payments due hereunder.

 

10.4 Audit Request. At the request and expense (except as provided below) of TOPOTARGET, CURAGEN, its Affiliates and its Sublicensees shall permit an independent, certified public accountant appointed by TOPOTARGET and reasonably acceptable to CURAGEN, at reasonable times and upon reasonable notice, to examine those records and all other material documents relating to or relevant to Net Sales in the possession or control of CURAGEN, its Affiliates or its Sublicensees, for a period of three calendar years after the year in which such royalties have accrued. The results of any such examination shall be made available to both Parties. If, as a result of any inspection of the books and records of CURAGEN, its Affiliates or its Sublicensees, it is shown that CURAGEN’s royalty payments under this Agreement were less than the amount which should have been paid, then CURAGEN shall make all payments required to eliminate any discrepancy revealed by said inspection within 45 days after TOPOTARGET’s demand therefor. Furthermore, if the aggregate royalty payments CURAGEN made were less than [********] of the amount which should have been paid made during the period in question, CURAGEN shall also reimburse TOPOTARGET for the reasonable out-of-pocket cost of such inspection.

 

10.5 Taxes. In the event that CURAGEN is required to withhold any tax to the tax or revenue authorities in any country in the Territory in connection with any payment to TOPOTARGET due to the laws of such country, such amount shall be deducted from the royalty or other payment to be made by CURAGEN, and CURAGEN shall notify TOPOTARGET and promptly furnish TOPOTARGET with copies of any tax certificate or other documentation evidencing such withholding. Each Party agrees to cooperate with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect.

 

10.6 Blocked Currency. If by law, regulations or fiscal policy of a particular country in the Territory, remittance of royalties in United States Dollars is restricted or forbidden, written

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
59


notice thereof shall promptly be given to TOPOTARGET, and payment of the royalty shall be made by the deposit thereof in local currency to the credit of TOPOTARGET in a recognized banking institution reasonably designated by TOPOTARGET by written notice to CURAGEN. When in any country in the Territory the law or regulations prohibit both the transmittal and the deposit of royalties on sales in such country, royalty payments shall be suspended for as long as such prohibition is in effect and as soon as such prohibition ceases to be in effect, all royalties that CURAGEN would have been under an obligation to transmit or deposit but for the prohibition shall forthwith be deposited or transmitted, to the extent allowable.

 

11. MANUFACTURING.

 

11.1 Manufacturing Responsibility.

 

(a) Until the completion of any transfer of responsibility to CURAGEN as provided in (b) below, TOPOTARGET shall use reasonable commercial efforts, to the extent it is reasonably capable of doing so, to supply CURAGEN, itself or through TOPOTARGET’s use of Third Party manufacturers, with CURAGEN’s requirements for Collaboration Products for use under this Agreement. The cost to CURAGEN of Collaboration Products supplied for use in the Development Program for studies conducted at CURAGEN’s expense, including without limitation studies conducted under the CRADA so long as CURAGEN has rights to use all resulting data in the Territory, shall be [********] of the invoiced price TOPOTARGET pays therefor or [********] of TOPOTARGET’s fully burdened cost of goods sold (which cost shall not include process development costs). Any supply for commercial purposes shall be at a price to be agreed for each Collaboration Product, assuring a reasonable profit to TOPOTARGET. TOPOTARGET shall manufacture Collaboration Products, or shall cause TOPOTARGET’s Third Party manufacturers to manufacture same, in accordance with current Good Manufacturing Practices under 21 C.F.R. 210 and 211 and all applicable laws, rules and regulations. TOPOTARGET shall provide CURAGEN with copies of, or permission to reference, as appropriate, any Drug Master File or similar filing (“DMF”) made by TOPOTARGET with respect to any Collaboration Product, and shall not withdraw or modify any such DMF without prior written notice to CURAGEN. TOPOTARGET shall promptly notify CURAGEN of any

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
60


event which could materially affect TOPOTARGET’s ability to supply Collaboration Product to CURAGEN hereunder, and shall provide to CURAGEN copies of any correspondence with any regulatory authority that relates to its manufacturing activities with respect to Collaboration Products.

 

(b) Upon request of CURAGEN delivered at any time after the conclusion of the Research Term, TOPOTARGET shall give reasonable consideration to and agrees to discuss with CURAGEN in good faith the possibility of transferring responsibility for manufacturing Collaboration Products for use by CURAGEN from TOPOTARGET to CURAGEN. Any such proposal must take into consideration TOPOTARGET’s own needs for a reliable and economical supply of Collaboration Products.

 

11.2 Negotiation, Execution of Supply Agreement. Promptly upon request by CURAGEN, the Parties shall negotiate, diligently and in good faith, and execute a supply agreement (the “Supply Agreement”) pursuant to which TOPOTARGET shall sell to CURAGEN, and CURAGEN shall purchase from TOPOTARGET, CURAGEN’s commercial requirements of Collaboration Products as provided in Section 11.1(a) above.

 

11.3 Cost of Manufacturing and Related Activities. Except as expressly provided to the contrary in this Section 11, each Party shall be solely responsible for all of the costs and expenses it has incurred before, or incurs after, the Effective Date, in connection with the manufacture of any Collaboration Product.

 

11.4 Manufacturing Liaisons. Each Party shall have the right to appoint one employee or consultant to act as a liaison between TOPOTARGET’s and CURAGEN’s relevant manufacturing teams. Each Party shall inform the other Party’s liaison regarding the status of such Party’s manufacturing-related efforts (including scale-up, process development and actual manufacturing) under this Agreement and/or the Supply Agreement, and the two liaisons shall coordinate such efforts with the Parties’ performance of their other respective obligations under this Agreement and/or the Supply Agreement.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
61


12. CONFIDENTIALITY.

 

12.1 Confidentiality; Exceptions. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that, during the term of this Agreement and for five years thereafter each Party, its Affiliates and its Sublicensees, if any (collectively, a “receiving Party”), shall use their best efforts to keep completely confidential, shall not publish or otherwise disclose and shall not use for any purpose other than the performance of this Agreement both the financial terms of this Agreement and any information furnished to it by the other Party, its Affiliates or its Sublicensees, if any (collectively, a “disclosing Party”), or developed under or in connection with the Research Program or any product development efforts pursuant to this Agreement (and shall ensure that its and its Affiliates’ and its Sublicensees’ respective directors, officers, employees or agents do likewise), except to the extent that it can be established by the receiving Party by competent proof that such information: (i) is, or hereafter becomes, generally available to the public other than by reason of any default by the receiving Party with respect to its confidentiality obligations hereunder; or, (ii) with respect to information disclosed by one Party to the other Party (a) was already known to the receiving Party at the time of disclosure by the disclosing Party; (b) was lawfully disclosed to the receiving Party by a Third Party who was not in default of any confidentiality obligation to the disclosing Party; or (c) is independently developed by or for the receiving Party without reference to or reliance upon the information furnished by the disclosing Party (all such information to which none of the foregoing exceptions applies, “Confidential Information”).

 

12.2 Exclusions to Confidentiality. The restrictions contained in Section 12.1 shall not apply to any Confidential Information in the hands of a receiving Party to the extent that it (i) is submitted by the receiving Party to governmental authorities to facilitate the issuance of marketing approvals for a Collaboration Product in accordance with the terms of this Agreement, provided that reasonable measures shall be taken to assure confidential treatment of such information, if practicable; (ii) is provided by a Party to any Third Party under appropriate terms and conditions, including confidentiality provisions equivalent to those in this Agreement, for consulting, manufacturing development, manufacturing, external testing, marketing trials and sublicensing or potential sublicensing in accordance with the terms hereof; or (iii) is otherwise required to be disclosed in compliance with applicable laws or regulations (including, without

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
62


limitation, to comply with any governmental or stock exchange disclosure requirements) or an order by a court or other regulatory body having competent jurisdiction; provided, however, that if a receiving Party is required to make any such disclosure of the disclosing Party’s Confidential Information such receiving Party shall, except where impracticable for necessary disclosures (for example to physicians conducting studies or to health authorities), give reasonable advance notice to the other Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications or otherwise, will use its best efforts to secure confidential treatment of such Confidential Information required to be disclosed.

 

12.3 Injunctive Relief. The Parties acknowledge that monetary damages alone would not adequately compensate the disclosing Party in the event of a breach by the receiving Party of this Section 12, and that, in addition to all other remedies available to the disclosing Party under this Agreement, at law or in equity, it shall be entitled to injunctive relief for the enforcement of its rights under this Section 12, without the posting of a bond or other security, and to an accounting of profits made during the period of any breach of the receiving Party’s obligations under this Section 12.

 

13. INTELLECTUAL PROPERTY.

 

13.1 Patent Enforcement.

 

(a) Each Party shall notify the other promptly after such Party becomes aware of any alleged infringement in the Field of any Patent licensed to either Party under this Agreement in any country. CURAGEN shall have the first right, but not the duty, to institute patent infringement actions against Third Parties with respect to any such alleged infringement in the Field and in the Territory. CURAGEN shall take all such actions under this Section 13.1(a) (other than with respect to a Patent included solely in the CURAGEN Collaboration Technology) in reasonable consultation with TOPOTARGET and shall keep TOPOTARGET apprised as to the status of any such infringement action CURAGEN institutes. TOPOTARGET shall execute all reasonable, necessary and proper documents and take such actions, at CURAGEN’s request and expense, as shall be appropriate to allow CURAGEN to institute and prosecute infringement actions under this Section 13.1(a).

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
63


(b) The costs and expenses of bringing and maintaining any infringement action under Section 13.1(a) shall be borne solely by CURAGEN.

 

(c) Any award or compensation (including the fair market value of non-monetary compensation) paid by Third Parties as a result of any infringement action brought by CURAGEN under Section 13.1(a) (whether by way of settlement or otherwise) shall be allocated first to reimbursement of CURAGEN for all expenses incurred by it in connection with such action. Any remaining award or compensation shall be allocated to the Parties in the following proportions: [*************************************************].

 

(d) In the event CURAGEN elects not to, or fails to, exercise its rights under Section 13.1(a) with respect to any alleged infringement of a Patent licensed to CURAGEN under this Agreement (i.e., excluding any Patent included solely in the CURAGEN Collaboration Technology) within 120 days after receiving notice thereof, TOPOTARGET shall have the right, but not the duty, to institute patent infringement actions against Third Parties with respect to any such alleged infringement. TOPOTARGET shall take all such actions under this Section 13.1(d) in reasonable consultation with CURAGEN and shall keep CURAGEN apprised as to the status of any such infringement action TOPOTARGET institutes. CURAGEN shall execute all reasonable, necessary and proper documents and take such actions, at TOPOTARGET’s request and expense, as shall be appropriate to allow TOPOTARGET to institute and prosecute infringement actions under this Section 13.1(d). The costs and expenses of bringing and maintaining any infringement action under this Section 13.1(d) shall be borne solely by TOPOTARGET, and TOPOTARGET shall be entitled to retain any award or compensation (including the fair market value of non-monetary compensation) paid by Third Parties as a result of any such action.

 

13.2 Infringement Actions by Third Parties.

 

(a) Each Party shall notify the other Party promptly in writing of any claim of, or action for, infringement of any Patents owned or licensed by Third Parties which is threatened, made or brought against either Party by reason of either Party’s performance of its

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
64


obligations under this Agreement or manufacture, use or sale of any Collaboration Products in the Territory in the Field.

 

(b) In the event that such an action for infringement is commenced solely against a Party or both Parties jointly and/or any of their respective Affiliates or Sublicensees, as the case may be, with respect to any Collaboration Product developed and commercialized by CURAGEN, its Affiliates and/or Sublicensees, CURAGEN shall defend such action at its own expense, and TOPOTARGET hereby agrees to assist and cooperate with CURAGEN to the extent necessary in the defense of such suit, in accordance with Section 13.2(c). CURAGEN shall have the right to settle any such action or consent to an adverse judgment thereto, and TOPOTARGET’s consent shall not be required unless such settlement or consent: (i) imposes any material obligation on TOPOTARGET (including under Section 13.2(d)), or (ii) materially impairs TOPOTARGET’s rights in or to any TOPOTARGET Licensed Technology, TOPOTARGET Collaboration Technology, CURAGEN Collaboration Technology and/or Joint Collaboration Technology, in which event TOPOTARGET’s consent shall not be unreasonably withheld or delayed.

 

(c) The costs of defending any infringement action with respect to a Collaboration Product developed and commercialized by CURAGEN, its Affiliates and/or Sublicensees shall be borne solely by CURAGEN.

 

(d) Subject to Section 9.6(b), during the pendency of any such action, CURAGEN shall continue to pay all royalties due hereunder and CURAGEN shall be fully liable for the payment of any award for damages, or any amount due pursuant to any settlement entered into by CURAGEN, to the extent that any such action pertains to a Collaboration Product developed and commercialized by CURAGEN and/or its Affiliates or Sublicensees.

 

(e) Except to the extent that the provisions of Section 13.1 shall apply to any portion thereof, CURAGEN shall retain any award or compensation (including the fair market value of non-monetary compensation) received by CURAGEN as a result of any such action (i.e., as a result of a counterclaim).

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
65


(f) In the event that such an action for infringement is commenced solely against a Party or both Parties jointly and/or any of their respective Affiliates or sublicensees, as the case may be, with respect to any Collaboration Product developed and commercialized by TOPOTARGET, its Affiliates and/or sublicensees, TOPOTARGET shall defend such action at its own expense, and CURAGEN hereby agrees to assist and cooperate with TOPOTARGET to the extent necessary in the defense of such suit, in accordance with Section 13.2(g). TOPOTARGET shall have the right to settle any such action or consent to an adverse judgment thereto, and CURAGEN’s consent shall not be required unless such settlement or consent: (i) imposes any material obligation on CURAGEN (including under Section 13.2(h)), or (ii) materially impairs CURAGEN’s rights in or to any TOPOTARGET Licensed Technology, TOPOTARGET Collaboration Technology, CURAGEN Collaboration Technology and/or Joint Collaboration Technology, in which event CURAGEN’s consent shall not be unreasonably withheld or delayed.

 

(g) The costs of defending any infringement action with respect to a Collaboration Product developed and commercialized by TOPOTARGET, its Affiliates and/or sublicensees shall be borne solely by TOPOTARGET.

 

(h) During the pendency of any such action, TOPOTARGET shall continue to pay any royalties due hereunder. TOPOTARGET shall be fully liable for the payment of any award for damages, or any amount due pursuant to any settlement entered into by TOPOTARGET, to the extent that any such action pertains to a Collaboration Product developed and commercialized by TOPOTARGET and/or its Affiliates or sublicensees.

 

(i) Except to the extent that the provisions of Section 13.1 shall apply to any portion thereof, TOPOTARGET shall retain any award or compensation (including the fair market value of non-monetary compensation) received by TOPOTARGET as a result of any such action (i.e., as a result of a counterclaim).

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
66


14. INDEMNIFICATION.

 

14.1 By CURAGEN. CURAGEN shall indemnify and hold TOPOTARGET and its Affiliates and their respective directors, officers, employees and agents, harmless from and against any and all liabilities, damages, losses, costs and expenses (including the reasonable fees of attorneys and other professionals and other reasonable litigation expenses) arising out of or resulting from:

 

(i) any and all product liability claims resulting from the development and/or commercialization of any Collaboration Product by CURAGEN, its Affiliates or its Sublicensees; and

 

(ii) any warranty claims, Collaboration Product recalls or any tort claims of personal injury (including death) or property damage relating to or arising out of the manufacture, use, distribution or sale of any Collaboration Product by CURAGEN, its Affiliates or its Sublicensees due to any negligence, recklessness or intentional misconduct by, or strict liability of, CURAGEN, its Affiliates or its Sublicensees, and their respective directors, officers, employees and agents.

 

14.2 By TOPOTARGET. TOPOTARGET shall indemnify and hold CURAGEN, its Affiliates and their respective directors, officers, employees and agents, harmless from and against any and all liabilities, damages, losses, costs and expenses (including the reasonable fees of attorneys and other professionals and other reasonable litigation expenses) arising out of or resulting from:

 

(i) any and all product liability claims resulting from the development and/or commercialization of any Collaboration Product by TOPOTARGET, its Affiliates or its licensees (other than CURAGEN); and

 

(ii) any warranty claims, Collaboration Product recalls or any tort claims of personal injury (including death) or property damage relating to or arising out of the manufacture, use, distribution or sale of any Collaboration Product by TOPOTARGET, its Affiliates or its licensees (other than CURAGEN)

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
67


due to any negligence, recklessness or intentional misconduct by, or strict liability of, TOPOTARGET, its Affiliates or its licensees (other than CURAGEN), and their respective directors, officers, employees and agents.

 

14.3 Notice. In the event that any Person entitled thereto (an “indemnitee”) is seeking indemnification under Section 14.1 or 14.2, such indemnitee shall inform the indemnifying Party of a claim as soon as reasonably practicable after the indemnitee receives notice of the claim, shall permit the indemnifying Party to assume direction and control of the defense of the claim (including the sole right to settle it at the sole discretion of the indemnifying Party, provided that such settlement does not impose any material obligation on the indemnitee or the other Party) and shall cooperate as requested (at the expense of the indemnifying Party) in the defense of the claim (including, without limitation, granting the indemnifying Party limited access to pertinent records and making persons under such indemnitee’s control available for interview and testimony).

 

14.4 Complete Indemnification. As the Parties intend complete indemnification, all costs and expenses incurred by any indemnitee to enforce this Section 14 shall be reimbursed by the indemnifying Party.

 

15. TERM; TERMINATION.

 

15.1 Term. This Agreement shall commence as of the Effective Date and, unless sooner terminated as provided hereunder, shall expire upon the expiration of all Royalty Terms in all countries in the Territory with respect to all Collaboration Products.

 

15.2 Effect of Expiration. Following the expiration of the applicable Royalty Term with respect to a Collaboration Product in a country in the Territory, CURAGEN shall have the royalty-free, perpetual right to continue to make, have made, use, sell, offer for sale, have sold and export such Collaboration Product in such country and following the expiration of the last applicable Royalty Term with respect to a Collaboration Product in the Territory, TOPOTARGET shall have the royalty-free, perpetual right to continue to make, have made, use, sell, offer for sale, have sold and export such Collaboration Product throughout the

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
68


TOPOTARGET Territory. Following the expiration of the term of this Agreement in its entirety pursuant to Section 15.1, CURAGEN shall have the royalty-free, perpetual right to continue to make, have made, use, sell, offer for sale, have sold and export all Collaboration Products in all countries in the Territory, and TOPOTARGET shall have the royalty-free, perpetual right to continue to make, have made, use, sell, offer for sale, have sold and export all Collaboration Products in all countries in the TOPOTARGET Territory.

 

15.3 Termination For Cause. Each Party shall have the right to terminate this Agreement, upon notice to the other Party, in the event that:

 

(a) Such other Party materially defaults with respect to any of its material obligations under this Agreement and does not cure such default within [*****] days after the receipt of a notice in writing from the non-breaching Party specifying the nature of, and requiring the remedy of, such default (or, if such default cannot be cured within such [*****]-day period, if the breaching Party does not commence cure within such [*****] day period and thereafter diligently continue actions to cure and actually cure same within a period of [*************] days following such notice); provided, however, that such right to terminate shall be stayed with respect to alleged payment breaches in the event that during such [*****]-day period, the Party alleged to have been in default with respect to any payment due hereunder shall have paid all undisputed amounts and shall have initiated dispute resolution in accordance with Section 17.15 with respect to any disputed payment default, which dispute resolution the Parties shall use their best efforts to have conducted and completed within [*****] months of initiation, and which stay shall last until [*********] days following resolution of any such dispute and determination of what, if any, payments are in default.; provided, further, that if such payment dispute is not resolved within [*********] months as provided above, in order for the stay to continue, [*****] of any amount then is dispute must be prepaid to the non-breaching Party on or before such [*****] month date, which prepayment shall be credited against any amount found to be due or repaid within [*****] days following resolution of such dispute to the extent all or any portion of it is determined not to be due upon. resolution of such dispute.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
69


Notwithstanding the foregoing, if any such non-payment default is limited to the breaching Party’s obligations with respect to a particular Collaboration Product and/or a particular country, then any termination of this Agreement under this clause (a) due to such default shall be limited to the breaching Party’s rights under this Agreement with respect to such Collaboration Product and/or country unless termination in all countries is otherwise expressly provided below.

 

Any termination pursuant to this clause (a) shall be without prejudice to any of the non-breaching Party’s other rights under this Agreement, and in addition to any other remedies available to it by law or in equity;

 

(b) The other Party shall have: (i) voluntarily commenced any proceeding or filed any petition seeking relief under the bankruptcy, insolvency or other similar laws of any jurisdiction, (ii) applied for, or consented to, the appointment of a receiver, trustee, custodian, sequestrator, conciliator, administrator or similar official for it or for all or substantially all of its property, (iii) filed an answer admitting the material allegations of a petition filed against or in respect of it in any such proceeding, (iv) made a general assignment for the benefit of creditors of all or substantially all of its assets, (v) admitted in writing its inability to pay all or substantially all of its debts as they become due, or (vi) taken corporate action for the purpose of effecting any of the foregoing;

 

(c) An involuntary proceeding shall have been commenced, or any involuntary petition shall have been filed, in a court of competent jurisdiction seeking: (i) relief in respect of the other Party, or of its property, under the bankruptcy, insolvency or similar laws of any jurisdiction, (ii) the appointment of a receiver, trustee, custodian, sequestrator, conciliator, administrator or similar official for such other Party or for all or substantially all of its property, or (iii) the winding-up or liquidation of such other Party; and, in each case, such proceeding or petition shall have continued undismissed for 60 days, or an order or decree approving or ordering any of the foregoing shall have continued unstayed, unappealed and in effect for 30 days;

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
70


(d) In the event that TOPOTARGET becomes administered in bankruptcy, or goes into insolvent liquidation:

 

(i) This Agreement will remain in effect and binding upon the Parties if the trustee in bankruptcy decides to be subrogated to the rights and obligations of TOPOTARGET according to this Agreement.

 

(ii) Notwithstanding the foregoing, in the event that TOPOTARGET becomes administered in bankruptcy or goes into insolvent liquidation, TOPOTARGET shall, without any further notice and with immediate effect, transfer and assign to CURAGEN (A) all or, at CURAGEN’s option, part of TOPOTARGET’s right, title and interest in the Territory in and to any of the TOPOTARGET Licensed Technology, the TOPOTARGET Collaboration Technology and the Joint Collaboration Technology, and all data, reports, records, material and other intellectual property owned or controlled by TOPOTARGET, in each case solely to the extent that they have been licensed to CURAGEN under this Agreement, and in each case solely to the extent related to the Collaboration Products then included in the licenses granted to CURAGEN under this Agreement, (B) the full and complete right to file patent applications in the name of the CURAGEN, its designee, or in TOPOTARGET’s name at CURAGEN, or its designee’s election, on the aforesaid inventions, discoveries and applications in the Territory; (C) the entire right, title and interest in and to any Letters Patent which may issue thereon in the United States or in any country in the Territory, and any renewals, revivals, reissues, reexaminations and extensions thereof, and any patents of confirmation, registration and importation of the same; and (D) the entire right, title and interest in all Convention and Treaty Rights of all kinds thereon, including without limitation all rights of priority in any country of the world, in and to the above inventions, discoveries and applications. Such assignment or transfer shall require CURAGEN´s payment to TOPOTARGET or the estate thereof of an amount equivalent to [*********************************************************], which value shall be determined by an independent expert chosen by the Danish Institute of State Authorized Public Accountants (in Danish: Foreningen af Statsautoriserede Revisorer) following the methodology outlined on Exhibit I immediately following the effective date of any such transfer or assignment as provided below, and which amount shall be paid to TOPOGARGET or

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
71


the estate thereof in equal monthly installments over [*******(****)] years following the date of determination of such fair market value by such independent expert. Such transfer or assignment shall be effective as from the date on which the trustee in bankruptcy decides not to be subrogated to the rights and obligations of TOPOTARGET according to this Agreement in accordance with the Danish Act on Bankruptcy, chapter 7, or when the trustee in bankruptcy or the liquidator decides to transfer or assign the TOPOTARGET Licensed Technology, the TOPOTARGET Collaboration Technology and/or TOPOTARGET’s interest in the Joint Collaboration Technology to a Third Party. If, however, the trustee in bankruptcy decides to be subrogated to the rights and obligations of TOPOTARGET according to this Agreement, such assignment and transfer shall not occur.

 

(iii) In case the assignment or transfer as mentioned in the previous section cannot be carried out, regardless of the reason, and the trustee in bankruptcy has decided not to be subrogated to the rights and obligations of TOPOTARGET according to this Agreement, CURAGEN shall in any event have a right of first refusal to purchase the right, title and interest in the Territory in and to any of the TOPOTARGET Licensed Technology, the TOPOTARGET Collaboration Technology and the Joint Collaboration Technology, and all data, reports, records, materials and other intellectual property owned or controlled by TOPOTARGET that have been licensed to CURAGEN under this Agreement, upon receipt from the trustee in bankruptcy of an offer to purchase such right, title and interest from an independent third party, at the same price and conditions as such third party has offered. Further, in case neither the assignment nor the right of first refusal can be carried through, CURAGEN shall in such case have a preemption right to purchase the right, title and interest in the Territory in and to any of the TOPOTARGET Licensed Technology, the TOPOTARGET Collaboration Technology and the Joint Collaboration Technology, and all data, reports, records, materials and other intellectual property owned or controlled by TOPOTARGET that have been licensed to CURAGEN under this Agreement at a fixed fair market value determined by an independent expert chosen by the Danish Institute of State Authorized Public Accountants (in Danish: Foreningen af Statsautoriserede Revisorer) if the trustee in bankruptcy or the liquidator decides to transfer or assign the TOPOTARGET Licensed Technology, the TOPOTARGET

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
72


Collaboration Technology and/or TOPOTARGET’s interest in the Joint Collaboration Technology or at the latest at the time of winding up of the bankruptcy estate. CURAGEN shall from the date on which the trustee in bankruptcy decides not to subrogate and until either the right of first refusal or the pre-emption right is exercised be entitled to make any and all necessary payments and take any necessary actions in order to maintain relevant patents. Further, CURAGEN shall from the date on which the trustee in bankruptcy decides not to subrogate and until either the right of first refusal or the pre-emption right is exercised be entitled to continue the use of the TOPOTARGET Licensed Technology, the TOPOTARGET Collaboration Technology and the Joint Collaboration Technology subject to continued payment by CURAGEN according to the terms of this Agreement during such period. Any and all costs, including license payments made after the effective date of the valuation, incurred by CURAGEN according to these rights of CURAGEN, shall be set off against the final purchase amount according to clause (iii) (right of first refusal or pre-emption right).

 

(iv) In the event of any assignment or transfer to CURAGEN pursuant to clause (ii) CURAGEN shall have no further obligation to pay any milestones or royalties under this Agreement.

 

15.4 Termination Without Cause by CURAGEN. Notwithstanding any other provision of this Agreement, after the expiration or termination of the Research Term, CURAGEN shall have the right to terminate this Agreement, in its entirety or with respect to any particular Collaboration Product and/or country in the Territory, at any time upon three (3) months’ notice in writing to TOPOTARGET. Termination under this Paragraph shall automatically terminate any and all relevant CURAGEN license rights and relevant sublicenses granted hereunder by CURAGEN.

 

15.5 Effect of Termination.

 

(a) Upon any voluntary termination of any rights or licenses by CURAGEN pursuant to Section 15.4, any and all relevant licenses granted to CURAGEN hereunder, and all

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
73


relevant sublicenses, shall terminate and TOPOTARGET shall thereafter have rights as provided in Section 15.6(a) hereof with respect to such terminated rights, and shall retain its rights as provided in Section 15.6(b).

 

(b) Upon any termination under this Agreement by TOPOTARGET pursuant to Section 15.3 other than as a result of any payment breach or any breach of Section 7.2(f), CURAGEN shall retain its rights to exploit the licenses granted pursuant to Section 7.2 for the First Product and for all Future Products for which CURAGEN has paid any Take Up Fee as provided in Section 9.4, and, subject to Section 7.2(e), for all corresponding Back-Up Products, in all cases subject to continued compliance with the relevant terms of this Agreement. TOPOTARGET shall retain its rights as provided in Section 15.6(b).

 

(c) Upon any termination of this Agreement by TOPOTARGET pursuant to Section 15.3 as a result of a payment breach, CURAGEN shall no longer have rights to any Collaboration Products in any countries in the Territory and any and all licenses granted to CURAGEN hereunder, and all sublicenses, shall terminate. TOPOTARGET shall thereafter have rights as provided in Section 15.6(a) with respect to all Collaboration Products in all countries, and shall retain its rights as provided in Section 15.6(b).

 

(d) Upon any termination under this Agreement by TOPOTARGET pursuant to Section 15.3 as a result of a breach of Section 7.2(f) and not also as a result of a payment breach, CURAGEN shall no longer have rights in the Territory with respect to the relevant Collaboration Products for which breach of Section 7.2(f) was grounds for termination and any and all relevant licenses granted to CURAGEN, and all relevant sublicenses, shall terminate for the relevant Collaboration Product. However, CURAGEN shall retain its rights to exploit the licenses granted pursuant to Section 7.2 for all other Collaboration Products. TOPOTARGET shall thereafter have rights as provided in Section 15.6(a) for those Collaboration Products which were the subject of the breach of Section 7.2(f), and shall retain its rights as provided in Section 15.6(b).

 

(e) Upon termination under this Agreement by CURAGEN pursuant to 15.3, CURAGEN shall retain its rights to exploit the licenses granted pursuant to Section 7.2 for the

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
74


First Product and for all Future Products identified prior to such termination and, subject to Section 7.2(e), for all corresponding Back-Up Products, subject to continued compliance with the relevant terms of this Agreement, including without limitation payment obligations, other than those requiring collaboration with TOPOTARGET. In addition, the rights granted to CURAGEN pursuant to Section 3.5 shall survive such termination and CURAGEN shall receive additional rights as provided in Section 15.6(c). Notwithstanding the foregoing, in the event that any such termination by CURAGEN is the result of a payment breach by TOPOTARGET, the Territory as defined herein shall become worldwide and CURAGEN’s continuing rights pursuant to Section 7.2 shall be exclusive in such expanded Territory and TOPOTARGET’s rights pursuant to Sections 7.4, 7.5 and 8.5 shall terminate with respect to all Collaboration Products.

 

15.6 Access to Rights Following Termination.

 

(a) For all Collaboration Products for which CURAGEN’s rights do not continue following termination as provided in Sections 15.5(a), (b), (c), or (d) above, subject to (x) and (y) below, CURAGEN shall have no further rights pursuant to Section 7.2 for the relevant Collaboration Products following such termination and CURAGEN shall:

 

(i) transfer and assign to TOPOTARGET all of CURAGEN’s right, title and interest in and to any CURAGEN Collaboration Technology and all data, reports, records, materials and other intellectual property owned or controlled by CURAGEN that relates exclusively to such Collaboration Products;

 

(ii) grant TOPOTARGET a non-exclusive license, solely for the purpose of TOPOTARGET’s developing, making, having made, using, marketing and selling such Collaboration Products, under any CURAGEN Licensed Technology and CURAGEN Collaboration Technology that does not exclusively relate to such Collaboration Products;

 

(iii) transfer and assign to TOPOTARGET ownership of all INDs, NDAs and other regulatory filings made or filed with respect to any such Collaboration Product (or, if such transfer and assignment is not permitted under

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
75


the laws of any applicable jurisdiction, CURAGEN shall take such other permitted actions with respect to such filings as may be reasonably requested by TOPOTARGET);

 

all upon commercially reasonable, arms length financial terms, which shall in no event exceed royalties in amounts as specified in Section 9.9, that the Parties shall negotiate in good faith and agree upon as soon as practicable after such termination of this Agreement. In the event the Parties, despite the mutual use of good faith efforts, are unable to agree upon such terms and conditions within six (6) months of the relevant termination date, the Parties shall appoint an independent valuation expert who shall determine such terms and conditions, which determination shall be binding upon the Parties. If the Parties are unable to agree upon the appointment of such an expert, then each Party shall nominate an expert (the cost of whom shall be borne by such Party), and both experts appointed by the Parties shall jointly appoint the expert who shall make such determination. Any expert appointed pursuant to this Section 15.6(a) shall have at least 15 years’ experience in the business of pharmaceutical development and commercialization. Except as provided above, the costs and expenses of any expert acting under this Section 15.6(a) shall be borne equally by the Parties. Notwithstanding any other provision hereof, in the event that the royalty set pursuant to this Section 15.6(a) is less than that specified in Section 9.9, such reduced royalty shall apply both inside and outside the TOPOTARGET Territory for the relevant Collaboration Product(s).

 

Notwithstanding the foregoing: (x) in the event of any termination of this Agreement in which CURAGEN loses rights for any Collaboration Product with respect to fewer than all of the countries in the Territory, any rights, licenses and other benefits to be transferred, granted and otherwise assigned to TOPOTARGET as provided above for such Collaboration Product shall be expressly limited to those pertaining to the countries in the Territory to which such termination applies; and (y) at any time prior to any transfer, granting and assignment of rights, licenses and benefits to TOPOTARGET pursuant to this Section 15.6(a), TOPOTARGET may elect, upon notice to CURAGEN, to waive the application of this Section 15.6(a) with respect to such rights, licenses and benefits. Following any such waiver neither Party shall have any obligation or liability to the other with respect to such rights, licenses and benefits.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
76


(b) In the event of any termination of this Agreement by TOPOTARGET pursuant to Section 15.3 or by CURAGEN pursuant to Section 15.4, TOPOTARGET’s license rights pursuant to Sections 7.4 and 7.5 hereof, and its rights pursuant to Section 8.5 hereof, shall continue subject to continued compliance with the relevant terms of this Agreement; and provided that all royalties due to CURAGEN pursuant to Section 9.9 and/or Section 15.6(a) shall thereafter be payable to CURAGEN in accordance with Article 10 unless offsettable against milestones and royalties due with respect to any surviving rights of CURAGEN.

 

(c) In the event of termination of this Agreement by CURAGEN pursuant to Section 15.3, in addition to any relevant rights provided in Section 15.3(d), TOPOTARGET shall (i) promptly transfer to CURAGEN copies, whether in written or electronic form, of all data, reports, records and materials (including any TOPOTARGET Licensed Technology and/or TOPOTARGET Collaboration Technology necessary to allow CURAGEN to continue to conduct the Research Program and the Development Program all to the extent not previously disclosed to CURAGEN) in TOPOTARGET’s possession or control which relate to the Research Program and/or the Development Program; (ii) return to CURAGEN all relevant records and materials, whether in written or electronic form, in TOPOTARGET’s possession or control containing Confidential Information of CURAGEN, and (iii) furnish to CURAGEN all unused Substances provided to TOPOTARGET by CURAGEN in connection with the Research Program.

 

15.7 Right to Sell Stock on Hand. CURAGEN shall have the right for one year after any termination or expiration of this Agreement, to dispose of all Collaboration Product then in its inventory and to complete manufacture of and dispose of any work-in-progress then being manufactured, as though this Agreement had not terminated. CURAGEN shall pay royalties thereon, in accordance with the provisions of this Agreement, as though this Agreement had not terminated.

 

15.8 Accrued Rights, Surviving Obligations.

 

(a) Termination, relinquishment or expiration of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
77


Party prior to such termination, relinquishment or expiration. Such termination, relinquishment or expiration shall not relieve either Party from obligations which are expressly indicated to survive termination or expiration of this Agreement.

 

(b) Termination, relinquishment or expiration of this Agreement shall not terminate each Party’s obligation to pay all royalties, milestone payments and other monetary obligations that may have accrued hereunder prior to such termination. All of the Parties’ rights and obligations under Sections 4.7, 5.3(e), 5.5, 5.6, 5.7, 6.1, 6.2, 6.3, 6.4(d), 8.3, 8.5 (except in the event of termination by CURAGEN for a payment breach by TOPOTARGET), 8.7, 8.8, 8.9, 9.9, 10, 12, 13 (solely with respect to actions pending at such time), 14, 15.2, 15.5, 15.6, 15.7, 15.8, 17.1 (if in effect at such time), 17.2 (if in effect at such time), 17.4, 17.6, 17.12, 17.15, 17.16 and 17.17 shall survive termination, relinquishment or expiration hereof.

 

16. FORCE MAJEURE.

 

16.1 Events of Force Majeure. Neither Party shall be held liable or responsible to the other Party nor be deemed to be in default under or in breach of any provision of this Agreement for failure or delay in fulfilling or performing any obligation under this Agreement when such failure or delay is due to force majeure, and without the fault or negligence of the Party so failing or delaying. For purposes of this Agreement, force majeure shall be defined as causes beyond the control of the Party, including, without limitation, acts of God; acts, regulations, or laws of any government; war; civil commotion; destruction of production facilities or materials by fire, flood, earthquake, explosion or storm; labor disturbances; epidemic; and failure of public utilities or common carriers. In such event TOPOTARGET or CURAGEN, as the case may be, shall immediately notify the other Party of such inability and of the period for which such inability is expected to continue. The Party giving such notice shall thereupon be excused from such of its obligations under this Agreement as it is thereby disabled from performing for so long as it is so disabled and for 30 days thereafter. To the extent possible, each Party shall use reasonable efforts to minimize the duration of any force majeure.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
78


17. MISCELLANEOUS.

 

17.1 Non-Solicitation. During the term of the Research Program and for a period of one year thereafter, neither Party shall solicit, induce, encourage or attempt to induce or encourage any employee of the other Party to terminate his or her employment with such other Party or to breach any other obligation to such other Party.

 

17.2 Relationship of Parties. Nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employment or joint venture relationship between the Parties. Neither Party shall be entitled to, or shall, incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein.

 

17.3 Guaranty. TOPOTARGET A/S hereby unconditionally guaranties the performance of all obligations of any TOPOTARGET Affiliate under this Agreement and the Supply Agreement, when executed. In the event of a breach by any TOPOTARGET Affiliate in the observance of the terms of this Agreement, CURAGEN shall be entitled to proceed against either such TOPOTARGET Affiliate or directly against TOPOTARGET A/S, as CURAGEN may determine in its sole discretion, to enforce this Agreement. CURAGEN CORPORATION hereby unconditionally guaranties the performance of all obligations of any CURAGEN Affiliate under this Agreement and the Supply Agreement, when executed. In the event of a breach by any CURAGEN Affiliate in the observance of the terms of this Agreement, TOPOTARGET shall be entitled to proceed against either such CURAGEN Affiliate or directly against CURAGEN CORPORATION, as TOPOTARGET may determine in its sole discretion, to enforce this Agreement.

 

17.4 Assignment.

 

(a) Each Party shall be entitled to assign this Agreement to any of its Affiliates upon 60 days’ prior written notice to the other Party; provided, however, that in the event of any such assignment, the assigning Party shall remain jointly and severally liable with respect to all of its obligations hereunder, and in the event of any default relating to any such obligations, the other Party shall be entitled to proceed against either such Affiliate or directly against the assigning Party, as such other Party may determine in its sole discretion, to enforce this Agreement.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
79


(b) Except as provided in Section 17.4(a), neither Party shall be entitled to assign its rights hereunder without the express written consent of the other Party, except that each Party may assign this Agreement to any assignee of all or substantially all of such Party’s business (or that portion thereof to which this Agreement relates) or in the event of such Party’s merger, consolidation or similar transaction.

 

(c) No assignment contemplated by this Section 17.4 shall be valid or effective unless and until the assignee/transferee shall agree in writing to be bound by the provisions of this Agreement.

 

17.5 Disclaimer of Warranties. EXCEPT AS EXPRESSLY PROVIDED IN ARTICLE 2 AND SECTION 3.1, THE PARTIES EXPRESSLY DISCLAIM ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT OF THIRD PARTY RIGHTS, OR ARISING FROM A COURSE OF DEALING OR USAGE OF TRADE PRACTICE.

 

17.6 Further Actions. Each Party shall execute, acknowledge and deliver such further instruments, and take all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

17.7 Notice. Any notice or request required or permitted to be given under or in connection with this Agreement shall be deemed to have been sufficiently given if in writing and personally delivered or sent by certified mail (return receipt requested), facsimile transmission (receipt verified), or overnight express courier service (signature required), prepaid, to the Party for which such notice is intended, at the address set forth for such Party below:

 

  (i) In the case of CURAGEN, to:
    555 Long Wharf Drive
    New Haven, CT 06511
    Attention: President
    Facsimile No.: 203-401-3333

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
80


  (ii) In the case of TOPOTARGET, to:
    Attention:
    Facsimile No.:

 

or to such other address for such Party as it shall have specified by like notice to the other Party, provided that notices of a change of address shall be effective only upon actual receipt thereof. If delivered personally or by facsimile transmission, the date of delivery shall be deemed to be the date on which such notice or request was given. If sent by overnight express courier service, the date of delivery shall be deemed to be the next business day after such notice or request was deposited with such service. If sent by certified mail, the date of delivery shall be deemed to be the fifth business day after such notice or request was deposited with the postal service in the country of mailing.

 

17.8 Use of Name. Except as otherwise provided herein, neither Party shall have any right, express or implied, to use in any manner the name or other designation of the other Party or any other trade name or trademark of the other Party (including, without limitation, any Trademark) for any purpose in connection with the performance of this Agreement.

 

17.9 Public Announcements.

 

(a) Except as required by law (including, without limitation, the applicable disclosure requirements of any relevant regulatory authority or stock exchange) and as permitted by Section 12.2, neither Party shall make any public announcement concerning this Agreement, any Covered Product or any other subject matter hereof without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed. It shall not be unreasonable for a Party to withhold consent with respect to any public announcement containing any of such Party’s Confidential Information. In the event of any required or proposed public announcement, (i) the Parties shall consult with each other in good faith as to the timing thereof, and (ii) the Party making such announcement shall provide the other Party with a copy of the proposed text prior to such announcement sufficiently in advance of the scheduled release of such announcement to afford such other Party a reasonable opportunity to review and comment upon the proposed text.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
81


(b) Following a Party’s consent to or approval of the public announcement of any information pursuant to this Section 17.9, both Parties shall be entitled to make subsequent public announcements of such information without renewed compliance with this Section 17.9, unless the scope and/or duration of such consent or approval is expressly limited.

 

(c) Notwithstanding the foregoing, on the Effective Date the Parties shall issue one or more press releases in the form attached hereto as Exhibit J, the timing of which shall be mutually agreed.

 

17.10 Waiver. A waiver by either Party of any of the terms and conditions of this Agreement in any instance shall not be deemed or construed to be a waiver of such term or condition for the future, or of any subsequent breach hereof. All rights, remedies, undertakings, obligations and agreements contained in this Agreement shall be cumulative, and none of them shall be in limitation of any other remedy, right, undertaking, obligation or agreement of either Party.

 

17.11 Compliance with Law. Nothing in this Agreement shall be deemed to permit a Party to export, re-export or otherwise transfer any Collaboration Product sold under this Agreement without compliance with applicable laws.

 

17.12 Severability. When possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement.

 

17.13 Amendment. No amendment, modification or supplement of any provisions of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
82


17.14 Governing Law; English Original; Jurisdiction.

 

(a) This Agreement shall be governed by and interpreted in accordance with the laws of the State of New York without regard to its choice of law principles; provided, however, that any arbitration proceeding conducted pursuant to Section 17.15 shall be governed by the Convention on the Recognition and Enforcement of Foreign Arbitral Awards of June 10, 1958. The English original of this Agreement shall prevail over any translation hereof.

 

(b) Without prejudice to the rights and obligations of the Parties under Section 17.15, each Party hereby consents to the in personam jurisdiction of any state or federal court sitting in the State of New York with respect to any matter arising in connection with this Agreement and further consents to the service of any process, notice of motion or other application to any such court or a judge thereof outside the State of New York by registered or certified mail or personal service, provided that reasonable time is allowed for appearance. Each Party hereby waives, to the greatest extent it may do so, any defense it may have on the grounds of inconvenient forum with respect to any action or proceeding maintained in any state or federal court in New York.

 

17.15 Arbitration.

 

(a) Any dispute arising out of or relating to any provisions of this Agreement (a “Dispute”) shall first be referred to the professional mediator for resolution through good faith mediation (“Mediation”) involving the Chief Executive Officers of each respective Party. If the Dispute is not resolved by such individuals within thirty (30) days of written request of either Party for Mediation, then the Dispute shall be resolved as provided in (b) below.

 

(b) Any Dispute which is not resolved by Mediation as provided in (a) above shall be finally settled by arbitration to be held in New York, New York, under the auspices and then current commercial arbitration rules of the American Arbitration Association (the “AAA”). Such arbitration shall be conducted by three arbitrators. Within 30 days after the commencement of any arbitration, each Party shall appoint one arbitrator, and these two arbitrators shall jointly appoint the third arbitrator, who shall have significant experience in pharmaceutical drug development and commercialization; provided, however, that if the two arbitrators appointed by the Parties are unable to agree upon the third arbitrator within 30 days after their appointment,

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
83


then the third arbitrator shall be appointed by the AAA. The Parties shall instruct such arbitrators to render a determination of any such dispute within four months after their appointment. All arbitration proceedings shall be conducted in English. Judgment upon any award rendered may be entered in any court having jurisdiction, or application may be made to such court for a judicial acceptance of the award and an order of enforcement, as the case may be.

 

(c) Neither Section 17.15(a) or (b) shall prohibit a Party from seeking injunctive relief from a court of competent jurisdiction in the event of a breach or prospective breach of Section 3.4 or Articles 6, 7 or 12 of this Agreement by the other Party which would cause irreparable harm to the first Party.

 

17.16 No Consequential Damages. IN NO EVENT SHALL EITHER PARTY OR ANY OF ITS RESPECTIVE AFFILIATES OR SUBLICENSEES BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES OR SUBLICENSEES FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS OR REVENUE, OR CLAIMS OF CUSTOMERS OF ANY OF THEM OR OTHER THIRD PARTIES FOR SUCH OR OTHER DAMAGES.

 

17.17 Entire Agreement. This Agreement (together with the Exhibits hereto and the Research Plans, as approved and modified from time to time by the Joint Steering Committee) sets forth the entire agreement and understanding between the Parties as to the subject matter hereof and merges all prior discussions and negotiations between them, and neither of the Parties shall be bound by any conditions, definitions, warranties, understandings or representations with respect to such subject matter other than as expressly provided herein or as duly set forth on or subsequent to the Effective Date in writing and signed by a proper and duly authorized officer or representative of the Party to be bound thereby. Without limiting the generality of the foregoing, the terms and conditions of this Agreement shall supersede the terms and conditions of any

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
84


confidentiality, non-disclosure or similar such agreement that the Parties may have executed prior to the Effective Date.

 

17.18 Parties in Interest. All the terms and provisions of this Agreement shall be binding upon, inure to the benefit of and be enforceable by the Parties hereto and their respective permitted successors and assigns.

 

17.19 Section 365(n). All licenses granted under this Agreement are deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined in Section 101 of such Code. The Parties agree that either Party may fully exercise all of its rights and elections under the U.S. Bankruptcy Code, regardless of whether the other Party files for bankruptcy in the United States or another jurisdiction. The Parties further agree that, in the event the non-insolvent Party elects to retain its rights as a licensee under such Code, such Party shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology. Such embodiments of the technology shall be delivered to such Party not later than;

 

(a) the commencement of bankruptcy proceedings against the insolvent Party, upon written request, unless such insolvent Party elects to perform its obligations under the Agreement, or

 

(b) if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of the insolvent Party, upon written request.

 

17.20 Descriptive Headings. The descriptive headings of this Agreement are for convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement.

 

17.21 Counterparts. This Agreement may be executed simultaneously in two counterparts, any one of which need not contain the signature of more than one Party, but both such counterparts taken together shall constitute one and the same agreement.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
85


17.22 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.

 

17.23 Hart-Scott-Rodino Filing. The Parties shall cooperate fully and use all commercially reasonable efforts to comply with the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations issued thereunder (the “HSR Act”), to determine if a Notification Report is required thereunder, and to file any required Notification Report form with the Federal Trade Commission and the Department of Justice in accordance with such rules and regulations, with respect to the transactions contemplated in this Agreement.

 

* * *

 

IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by its duly authorized officer as of the day and year first above written.

 

TOPOTARGET A/S
By:    

Name:

   

Title:

   
CURAGEN CORPORATION
By:    

Name:

   

Title:

   

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
86


 

EXHIBIT A

 

EXISTING TOPOTARGET LICENSED TECHNOLOGY

 

[***********]

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[***********]:

 

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[*************************************]

 

[************]   [*********]   [************]   [**********]   [************]
[********]   [********]   [********]   [********]   [********]
[********]   [********]   [********]   [********]   [********]
[********]   [********]   [********]   [********]   [********]

 

*[*************************************]

 

[********************************************************************************************************

*********************************************************************************************************

*************************************************]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
1


[**********]:

 

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[*********************************]

 

[********]   [********]   [********]    
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[************************************************************]

[*********************************]

 

[********]   [********]   [********]    
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[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    

 

[************************************************************]

[*********************************]

 

[********]   [********]   [********]    
[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    
[************]   [************]   [************]    

 

[************************************************************]

[*********************************]

 

[********]   [********]   [********]    
[************]   [************]   [************]    
[************]   [************]   [************]    

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
2


[************************************************************]

[*********************************]

 

[********]   [********]   [********]    
[************]   [************]   [************]    
[************]   [************]   [************]    

 

[************************************************************]

[*********************************]

 

[********]   [********]   [********]    
[************]   [************]   [************]    
[************]   [************]   [************]    

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
3


 

EXHIBIT B

 

JOINT STEERING COMMITTEE

 

Initial TOPOTARGET Representatives:

 

[***********************]

 

[*****************]

 

[*****************]

 

Initial CURAGEN Representatives:

 

[***********************]

 

[*****************]

 

[*****************]

 

Chairperson:

 

[***********************]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
4


 

EXHIBIT C

 

INITIAL RESEARCH PLAN

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
5


 

EXHIBIT D

 

HDAC INHIBITOR CRITERIA

 

[*******************************************************]

 

[*******************************************************]

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
6


 

EXHIBIT E

 

FORM OF MATERIAL TRANSFER AGREEMENT

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
7


 

EXHIBIT F

 

DEVELOPMENT PROGRAM PRINCIPLES

 

TopoTarget and CuraGen have entered into a collaboration agreement to jointly develop HDAC inhibitors in cancer, as well as potentially other indications. The collaboration will be governed by a global joint steering committee (JSC). This exhibit lays out the principles by which the JSC will manage the clinical development of Collaboration Products.

 

Collaboration Goal

 

The goal of the collaboration is submission and registration in major markets of a medically important, competitive Collaboration Product in industry competitive timelines. The initial focus will be in oncology.

 

The JSC will manage all aspects of development in a manner consistent with this goal. This includes work performed by CuraGen, TopoTarget, or other collaborators (e.g. NCI), as well as all CMC work.

 

JSC Governance of Development Program

 

To meet its mandate, it is assumed that the JMC will meet in person once per quarter, and by remote means at all other monthly intervals.

 

The JSC reviews, approves, measures and manages the global development plan on an ongoing basis. A joint team of TopoTarget and CuraGen employees with appropriate development expertise will develop and implement the plan with appropriate measures by which to measure progress against plan as well as develop contingencies to manage variance to plan. As milestones are reached, this team will analyze data and communicate the implications of the data to the JSC. After initial generation and agreement to a clinical development plan for each Collaboration Product, plans should be reviewed for modification at least once a year, or more frequently if needed, based on emerging clinical data or other environmental changes. In events where it is needed, CuraGen will have the ability to break deadlocks within the JSC.

 

Principles for JSC Management of the Development Program

 

TopoTarget and CuraGen will jointly develop a global development plan for each Collaboration Product and determine who will be responsible for execution of various parts of the plan. In general, TopoTarget will be responsible for executing development activities in Europe and CuraGen will be responsible for executing development activities elsewhere.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
8


Principles of ICH should be followed including the principle of common technical documentation (CTD). This enables the same material body of information, analyses, and conclusions, as ultimately embodied in the product label, to serve the purposes of registration globally, including specifically the EU and NA.

 

Both parties will agree on and have the option to participate in venues where external input is sought for development plans (external clinical and/or regulatory consultation). Where feasible, efforts should be made to represent both parties in material external events.

 

TopoTarget will manage all EU regulatory strategic and operational maters and CuraGen will manage all other regulatory strategic and operational matters – both in a manner consistent with the global development plan.

 

To foster the goal of efficient clinical development, protocols, data management, and statistical analysis, medical report writing will be harmonized in a way that provides for efficient and consistent product information. This information includes consistency with all ICH dictated terms (AEs, SAEs), inclusion/exclusion criteria, data collection (standard CRF pages wherever possible, a common data base, common edit checks for the data base), common definitions for response rate, partial response, complete response and other efficacy parameters, common uses of oncology toxicity definitions based on accepted norms, common analytical methods and programming, internally consistent conclusions across studies, common study monitoring methodology and study auditing.

 

Clear mechanisms and responsibilities will be established to meet global requirements for expedited safety reporting, as well as for determining what consequences, if any, reported adverse events have on the risk-benefit of any ongoing clinical trials.

 

Clear mechanisms and responsibilities will be established to provide a common investigators’ brochure, and updates to it, as well as for IND annual reporting obligations. Whenever possible, these responsibilities will be synchronized as much as possible so that these documents are generated from the same database and data cut-off time, thus supporting consistent analysis and conclusions.

 

TopoTarget and CuraGen will work jointly with NCI to facilitate NCI’s productive participation in the development program. With this in mind, TopoTarget and CuraGen will work to make sure that as to a much extent as is reasonable, NCI fits the development governance paradigm described above.

 

Initial Clinical Development Program for PXD101

 

Within [********], TopoTarget and CuraGen will agree on a draft global development plan for PXD101. Within [********] thereafter, TopoTarget and CuraGen will meet with external

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
9


clinical advisors to review the draft plan, modify it based on their input, and agree to a final development plan.

 

The final plan will specify the party responsible for executing the planned clinical trials, incorporating the specifics:

 

TopoTarget will complete an ongoing Phase 1 study of PDX101 in solid tumors (TT20) and initiate and complete a Phase 1 study, followed by a Phase 2 study in [***************(************)].

 

CuraGen will prepare an IND for US filing, with the objective of commencing Phase 2 trials in [********].

 

In addition, TopoTarget has signed a LOI for a CRADA with the NCI. Discussions have begun with the NCI in terms of their potential role in exploring alternative dosing schedules and combination therapy. CuraGen will become involved in the CRADA as a third party. As part of the global development plan as governed by the JSC, TopoTarget and CuraGen will determine the optimal utilization of this CRADA from the TopoTarget/CuraGen perspective and jointly represent this to the NCI.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
10


 

EXHIBIT G

 

TOPOTARGET CLINICAL STUDIES

 

[************************************************************************].

 

[************************************************************************].

 

[************************************************************************].

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
11


 

EXHIBIT H

 

CONVERTIBLE DEBENTURE

 

AND

 

CONVERTIBLE LOAN AGREEMENT

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
12


 

EXHIBIT I

 

FAIR MARKET VALUE METHODOLOGY

 

[**************************]    [******************]     
[**************************]    [******************]     
[**************************]   

[******************]

    

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
13


 

EXHIBIT J

 

FORM OF PRESS RELEASE

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential Investment under Rule 24b-2 under the Securities Exchange Act of 1934.
14
EX-31.1 4 dex311.htm SECTION 302 CEO CERTIFICATION SECTION 302 CEO CERTIFICATION

EXHIBIT 31.1

 

CERTIFICATIONS UNDER SECTION 302

 

I, Jonathan M. Rothberg, certify that:

 

1. I have reviewed this Amendment No. 1 to Quarterly Report on Form 10-Q/A of CuraGen Corporation;

 

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

 

Date: April 11, 2005

 

/s/ Jonathan M. Rothberg, Ph.D.


Jonathan M. Rothberg, Ph.D.
Chief Executive Officer, President and
Chairman of the Board
EX-31.2 5 dex312.htm SECTION 302 CFO CERTIFICATION SECTION 302 CFO CERTIFICATION

EXHIBIT 31.2

 

CERTIFICATIONS UNDER SECTION 302

 

I, David M. Wurzer, certify that:

 

1. I have reviewed this Amendment No. 1 to Quarterly Report on Form 10-Q/A of CuraGen Corporation;

 

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

 

Date: April 11, 2005

 

/s/ David M. Wurzer


David M. Wurzer
Executive Vice-President, Chief Financial Officer
and Treasurer (principal financial and accounting officer of the registrant)
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