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COLLABORATION, LICENSE and PURCHASE AGREEMENT

Collaboration Agreement

COLLABORATION, LICENSE and PURCHASE AGREEMENT | Document Parties: EXACT SCIENCES CORPORATION | GENZYME CORPORATION You are currently viewing:
This Collaboration Agreement involves

EXACT SCIENCES CORPORATION | GENZYME CORPORATION

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Title: COLLABORATION, LICENSE and PURCHASE AGREEMENT
Governing Law: Massachusetts     Date: 1/28/2009
Industry: Biotechnology and Drugs     Law Firm: Ropes Gray     Sector: Healthcare

COLLABORATION, LICENSE and PURCHASE AGREEMENT, Parties: exact sciences corporation , genzyme corporation
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Exhibit 10.1

 

COLLABORATION, LICENSE and PURCHASE AGREEMENT

 

BETWEEN

 

GENZYME CORPORATION

 

AND

 

EXACT SCIENCES CORPORATION

 


 

Dated as of January 27, 2009

 


 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 



 

TABLE OF CONTENTS

 

 

 

Page

 

 

 

Article 1

Definitions

1

 

 

 

Article 2

Sale and Purchase

9

 

 

 

2.1

Purchased Assets

9

 

 

 

2.2

Consideration

10

 

 

 

2.3

Assumed and Retained Liabilities

10

 

 

 

Article 3

Licenses and Other Rights

11

 

 

 

3.1

License to Genzyme under Retained Patent Rights

11

 

 

 

3.2

License to Genzyme under EXACT Licensed Improvements and Joint Collaboration Technology

11

 

 

 

3.3

Option to License Additional EXACT Technology

12

 

 

 

3.4

License to EXACT under Transferred Technology, Genzyme Licensed Improvements and Joint Collaboration Technology

13

 

 

 

3.5

Sublicensing

13

 

 

 

3.6

Use of Technology

14

 

 

 

3.7

Termination of License Rights

14

 

 

 

3.8

Rights in Bankruptcy

14

 

 

 

Article 4

Collaboration

15

 

 

 

4.1

Joint Advisory Committee

15

 

 

 

4.2

Committee Meetings and Activities

15

 

 

 

4.3

Termination of the Collaboration Period

16

 

 

 

Article 5

Closing

16

 

 

 

5.1

Closing

16

 

 

 

5.2

Deliverables

16

 

 

 

5.3

Post-Closing

17

 

 

 

Article 6

Representations and Warranties of EXACT

17

 

 

 

6.1

Organization

17

 

 

 

6.2

Power and Authorization

17

 

 

 

6.3

Authorization of Governmental Authorities

18

 

 

 

6.4

Noncontravention

18

 

 

 

6.5

Absence of Liabilities

18

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

i



 

6.6

Absence of Certain Developments

18

 

 

 

6.7

Assets

18

 

 

 

6.8

Intellectual Property Rights

19

 

 

 

6.9

Government Authorizations and Registrations

21

 

 

 

6.10

Legal Compliance

21

 

 

 

6.11

Contracts

21

 

 

 

6.12

Litigation; Governmental Orders

22

 

 

 

6.13

Insurance

22

 

 

 

6.14

No Brokers

22

 

 

 

6.15

Solvency

22

 

 

 

6.16

Disclosure

23

 

 

 

Article 7

Representations and Warranties of Genzyme

23

 

 

 

7.1

Organization

23

 

 

 

7.2

Power and Authorization

23

 

 

 

7.3

Authorization of Governmental Authorities

23

 

 

 

7.4

Noncontravention

24

 

 

 

7.5

No Brokers

24

 

 

 

Article 8

Covenants and Agreements

24

 

 

 

8.1

Expenses

24

 

 

 

8.2

Payment of Liabilities

24

 

 

 

8.3

Restrictions on EXACT Dissolution and Distributions

24

 

 

 

8.4

Further Assurances

24

 

 

 

Article 9

Conditions Precedent to the Obligations of Genzyme to Consummate the Sale

26

 

 

 

9.1

Representations and Warranties

26

 

 

 

9.2

Corporate Certificates

27

 

 

 

9.3

Secretary’s Certificate

27

 

 

 

9.4

Concurrent Transactions

27

 

 

 

9.5

Consents

27

 

 

 

9.6

Opinion of Counsel to EXACT

27

 

 

 

Article 10

Condition Precedent to the Obligation of EXACT to Consummate the Sale

27

 

 

 

10.1

Representations and Warranties

27

 

 

 

10.2

Secretary’s Certificate

27

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

ii



 

10.3

Concurrent Transactions

28

 

 

 

Article 11

Payment

28

 

 

 

11.1

Royalty for Licenses under Transferred Technology and Retained Patent Rights Outside Genzyme Core Field

28

 

 

 

11.2

Payment for Optioned Technology In-Licensed From a Third Party

29

 

 

 

11.3

Payment Provisions Generally

29

 

 

 

11.4

Maintenance of Records; Audit

30

 

 

 

Article 12

Intellectual Property Matters

30

 

 

 

12.1

Ownership

30

 

 

 

12.2

Filing, Prosecution and Maintenance of Patent Rights

31

 

 

 

12.3

Enforcement

34

 

 

 

12.4

Claimed Infringement of Third Party Intellectual Property Rights

37

 

 

 

12.5

Prosecution and Enforcement of Other Intellectual Property Rights

38

 

 

 

12.6

Cross License Agreement

38

 

 

 

12.7

Termination of Rights and Obligations Under Article 12

38

 

 

 

Article 13

Confidentiality

38

 

 

 

13.1

Confidentiality

38

 

 

 

13.2

Permitted Disclosure

39

 

 

 

13.3

Required Disclosure

39

 

 

 

13.4

Public Statements

40

 

 

 

13.5

Mutual Non-Disclosure Agreement

40

 

 

 

Article 14

Indemnification

40

 

 

 

14.1

Indemnification by EXACT

40

 

 

 

14.2

Indemnification by Genzyme

41

 

 

 

14.3

Time for Claims

42

 

 

 

14.4

Procedure for Third Party Claims

42

 

 

 

14.5

Consent to Jurisdiction Regarding Third Party Claims

44

 

 

 

14.6

Exclusive Remedy

44

 

 

 

Article 15

Potential Liabilities Holdback

44

 

 

 

15.1

Use of Holdback Amount

44

 

 

 

15.2

12 Month Release

45

 

 

 

15.3

18 Month Release

45

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

iii



 

15.4

Outstanding Claims

45

 

 

 

Article 16

Miscellaneous

45

 

 

 

16.1

Notices

45

 

 

 

16.2

Entire Agreement

46

 

 

 

16.3

Binding Effect; No Assignment; No Third-Party Beneficiaries

46

 

 

 

16.4

Amendment

47

 

 

 

16.5

Waiver

47

 

 

 

16.6

Disclaimer

47

 

 

 

16.7

Section Headings, Construction

47

 

 

 

16.8

Counterparts

47

 

 

 

16.9

Severability

48

 

 

 

16.10

Withholding

48

 

 

 

16.11

Governing Law

48

 

 

 

16.12

Dispute Resolution

48

 

 

 

16.13

Submission to Jurisdiction; Waiver

48

 

 

 

16.14

Enforcement

49

 

 

 

16.15

Rules of Construction

49

 

 

 

16.16

Waiver of Jury Trial

49

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

iv



 

EXHIBITS

 

Exhibit A

 

Form of APC/p53 License Amendment

 

 

 

Exhibit B

 

Form of JHU-EXACT License Amendment

 

 

 

Exhibit C

 

Form of Bill of Sale

 

 

 

Exhibit D

 

Form of Assignment and Assumption Agreement

 

 

 

Exhibit E

 

Form of Assignment of Patent Rights

 

SCHEDULES

 

Schedule A

 

Primary Patent Rights

 

 

 

Schedule B

 

Secondary Patent Rights

 

 

 

Schedule 2.1(a)(ii)

 

Assigned Contracts

 

 

 

Schedule 2.1(b)(vii)

 

Retained Patent Rights

 

 

 

Schedule 3.1(b)

 

Rights of Third Parties

 

 

 

Schedule 3.2(b)

 

EXACT Licensed Improvements

 

 

 

Schedule 3.3(b)

 

Optioned Technology

 

 

 

Schedule 3.4(c)

 

Genzyme Licensed Improvements

 

 

 

Schedule 6.4

 

Noncontravention (EXACT)

 

 

 

Schedule 6.7

 

Assets

 

 

 

Schedule 6.8

 

Intellectual Property

 

 

 

Schedule 6.11

 

Contracts

 

 

 

Schedule 6.12

 

Litigation; Governmental Orders

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

v



 

AGREEMENT

 

THIS COLLABORATION, LICENSE and PURCHASE AGREEMENT (this “ Agreement ”), dated as of January 27, 2009 (the “ Effective Date ”), is by and between Genzyme Corporation, a Massachusetts corporation (“ Genzyme ”) and EXACT Sciences Corporation, a Delaware corporation (“ EXACT ”).

 

RECITALS

 

A.      EXACT is engaged in the development of proprietary DNA-based technologies, which have applicability in multiple fields.  Genzyme desires to purchase all of EXACT’s right, title and interest in and to certain assets, including certain intellectual property rights, and to license from EXACT certain other intellectual property rights for use outside of the EXACT Field (defined below).

 

B.       EXACT desires to obtain from Genzyme, and Genzyme desires to grant to EXACT, an exclusive license back under the intellectual property being transferred under this Agreement for use in the EXACT Field.

 

C.       Genzyme desires to obtain from EXACT, and EXACT desires to grant to Genzyme, an exclusive option to obtain from EXACT an exclusive license under certain additional EXACT technology in the Genzyme Core Field (defined below).

 

D.      Concurrently with the execution of this Agreement, Genzyme and EXACT are entering into a Common Stock Subscription Agreement, dated as of the Effective Date (the “ Common Stock Subscription Agreement ”), pursuant to which, among other things, Genzyme agrees to buy and EXACT agrees to sell up to 3,000,000 shares of EXACT’s common stock, par value $0.01 per share.

 

In consideration of the mutual representations, warranties and covenants contained in this Agreement, the parties hereto agree as follows:

 

Article 1      Definitions .  Capitalized terms used in this Agreement have the meanings set forth in this Agreement.  In addition, for purposes of this Agreement, the following terms, when used in this Agreement, have the meanings assigned to them in this Article 1.

 

Action ” means any claim, action, cause of action, chose in action or suit (whether in contract or tort or otherwise), litigation (whether at law or in equity, whether civil or criminal), controversy, assessment, arbitration, examination, audit, investigation, hearing, charge, complaint, demand, notice or proceeding to, from, by or before any Governmental Authority or arbitrator.

 

Additional EXACT Technology ” means all Intellectual Property Rights (other than Transferred Technology, EXACT Licensed Improvements or Joint Collaboration Technology) that are Controlled by EXACT or its Affiliates [********] with applicability in the Genzyme Core Field; provided , however , that

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 



 

“Additional EXACT Technology” excludes Intellectual Property Rights owned or Controlled as a result of or subsequent to a Change of Control of EXACT.

 

Affiliate ” means, with respect to any Person, any other Person that, directly or indirectly, through one or more intermediaries controls, is controlled by, or is under common control with, such Person.  For purposes of this definition, “control” means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through ownership of voting securities or general partnership or managing member interests, by contract or otherwise.  Without limiting the generality of the foregoing, a Person will be deemed to control any other Person in which it owns, directly or indirectly, a majority of the ownership interests.

 

Ancillary Agreements ” has the meaning set forth in Section 5.2(a).

 

APC/p53 License ” means the License Agreement, dated as of March 25, 1999, by and between EXACT and Genzyme.

 

APC/p53 License Amendment ” means the waiver by Genzyme and amendment and restatement of the APC/p53 License, effective as of the Closing Date, to be executed and delivered by EXACT and Genzyme at the Closing, substantially in the form attached hereto as Exhibit A .

 

Assigned Contracts ” has the meaning set forth in Section 2.1(a)(ii).

 

Assignment and Assumption Agreement ” has the meaning set forth in Section 5.2(a)(ii).

 

Assumed Liabilities ” has the meaning set forth in Section 2.3(a).

 

Bankruptcy Code ” has the meaning set forth in Section 3.8.

 

[********]

 

Change of Control ” means, with respect to a party, (a) a sale of all or substantially all of such party’s assets, voting stock, securities, or business; (b) a merger, reorganization, or consolidation involving such party in which the stockholders of such party immediately prior to such transaction cease to own collectively (either directly or through one or more intermediate entities) a majority of the voting equity securities of a successor entity; or (c) the acquisition by a Person or group of Persons acting in concert of 50% or more of the voting equity securities of such party.

 

Closing ” has the meaning set forth in Section 5.1.

 

Closing Date ” has the meaning set forth in Section 5.1.

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

2



 

Closing Payment ” means $18,500,000, payable, subject to the Holdback set forth in Article 15, at the Closing.

 

Code ” means the U.S. Internal Revenue Code of 1986, as amended.

 

Collaboration Period ” means the period of time beginning on the Closing Date and ending, if at all, on the effective date of termination of such period by a party pursuant to Section 4.3.

 

Committee ” has the meaning set forth in Section 4.1.

 

Common Stock Subscription Agreement ” has the meaning set forth in Recital D.

 

Confidential Information ” of a party means all Know-How or other information, including proprietary information and materials (whether or not patentable), regarding such party’s or its Affiliate’s technology, products, business information, or objectives, that is communicated in any way or form by the Disclosing Party to the Receiving Party, and whether or not designated as confidential by the Disclosing Party at the time any such Know-How or other information is disclosed by the Disclosing Party to the Receiving Party.

 

Consideration ” has the meaning set forth in Section 2.2.

 

Control or Controlled ” means, with respect to any item or right, the possession (whether by ownership or license, other than pursuant to this Agreement) by a party of the ability to grant to the other party access or a license as provided in this Agreement under such item or right without violating the terms of any agreement or other arrangements with any Third Party.

 

Cross License Agreement ” means the Cross License and Collaboration Agreement, dated as of April 1, 2003, by and between EXACT and Genzyme.

 

[********]

 

Disclosed Contract ” has the meaning set forth in Section 6.11(b).

 

Disclosing Party ” has the meaning set forth in Section 13.1.

 

Dispute ” has the meaning set forth in Section 16.12(a).

 

EXACT Field ” means (a) stool-based detection of any disease or condition (including pre-cancers, staging and monitoring of the foregoing, and therapeutic response) for research and development, Clinical Laboratory Improvement Amendments (CLIA) testing services (and their foreign equivalents), and FDA Kits; and (b) a screening assay (regardless of other uses to which such assay is put) for colorectal cancer in any type of patient samples, excluding tests solely for staging and/or monitoring of colorectal cancer which do not obsolete or adversely impact such screening assay.  For

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

3



 

the avoidance of doubt, without limitation, the EXACT Field includes (i) the rights pertaining to stool-based colorectal cancer screening tests for which EXACT has granted a nonexclusive license to [********], (ii) the rights pertaining to colorectal cancer screening tests and test kits for which EXACT has granted a nonexclusive license to [********], and (iii) all applications for which EXACT has granted to [********] a license as of the Effective Date pursuant to the [********].

 

EXACT Indemnitee ” has the meaning set forth in Section 14.2(a).

 

EXACT Licensed Improvements ” means all improvements or enhancements to, or derivatives of, the Transferred Technology discovered, conceived, created, made or invented (as applicable) by or on behalf of EXACT [********] that the parties agree have applicability in the Genzyme Field after consultation as provided in Section 3.2(b); provided , however , that “EXACT Licensed Improvements” excludes (a) Joint Collaboration Technology, (b) Intellectual Property Rights acquired or in-licensed from a Third Party after the Closing Date and (c) Intellectual Property Rights owned or Controlled as a result of or subsequent to Change of Control of EXACT.  For clarity, a Patent Right that is first filed after a Change of Control but claims priority (direct or indirect, in whole or in part) to a Patent Right that was subject to the license granted by EXACT to Genzyme under Section 3.2(a) prior to a Change of Control will be an “EXACT Licensed Improvement” hereunder.

 

FDA Kits ” means a collection of one or more reagents, packaged in the form of a kit that has received approval from the U.S. Food and Drug Administration (FDA) or any equivalent foreign regulatory agency or body.

 

Genzyme Core Field ” means reproductive and prenatal health [********]

 

Genzyme Field ” means all applications other than the EXACT Field.

 

Genzyme Indemnitee ” has the meaning set forth in Section 14.1(a).

 

Genzyme Licensed Improvements ” means all improvements or enhancements to, or derivatives of, the Transferred Technology discovered, conceived, created, made or invented (as applicable) by or on behalf of Genzyme [********] that the parties agree have applicability in the EXACT Field after consultation as provided in Section 3.4(c); provided , however , that “Genzyme Licensed Improvements” excludes (a) Joint Collaboration Technology, (b) Intellectual Property Rights acquired or in-licensed from a Third Party after the Closing Date and (c) Intellectual Property Rights owned or Controlled as a result of or subsequent to Change of Control of Genzyme.  For clarity, a Patent Right that is first filed after a Change of Control but claims priority (direct or indirect, in whole or in part) to a Patent Right that

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

4



 

was subject to the license granted by Genzyme to EXACT pursuant to Section 3.4(b) prior to a Change of Control will be a “Genzyme Licensed Improvement” hereunder.

 

Genzyme Third Party Payment ” has the meaning set forth in Section 11.2(a).

 

Governmental Authority ” means any government or any agency, bureau, board, commission, court, department, political subdivision, tribunal or other instrumentality of any government (including any regulatory or administrative agency), whether federal, state or local, domestic or foreign.

 

Holdback Indemnity Cap ” has the meaning set forth in Section 14.1(b).

 

Indemnifying Party ” means, with respect to any claim for indemnification pursuant to Article 14, the party against whom such claim is asserted under Section 14.1 or 14.2, as the case may be.

 

Indemnitee ” means, with respect to any claim for indemnification pursuant to Article 14, the Genzyme Indemnitee or the EXACT Indemnitee asserting such claim under Section 14.1 or 14.2, as the case may be.

 

Indemnity Basket ” has the meaning set forth in Section 14.1(b).

 

Infringement Claim ” has the meaning set forth in Section 12.4(a).

 

Intellectual Property Rights ” means all intangible proprietary rights of any kind or nature throughout the world, including the following (and all statutory and/or common law rights in, arising out of, or associated therewith): (i) all Patent Rights; (ii) all works of authorship, copyrights, mask works, copyright and mask work registrations and applications, copyrightable subject matter whether or not registration for any such copyright exists or is pending, and all other copyright interests accruing by reason of international copyright conventions pertaining thereto (“ Copyrights ”); (iii) all Know-How; and (iv) all databases and data collections.

 

JHU ” means The Johns Hopkins University, a Maryland corporation.

 

JHU-EXACT License Amendment ” means the Assignment, Sublicense, Consent and Eighth Amendment to License Agreement among EXACT, JHU and Genzyme, dated as of the Closing Date, to be executed and delivered by EXACT, JHU and Genzyme prior to the Closing, substantially in the form attached hereto as Exhibit B .

 

Joint Collaboration Technology ” means all Know-How, Patent Rights and Copyrights that are discovered, conceived, created, made or invented (as applicable) [********] jointly by (a) employees or agents of EXACT and (b) employees or agents of Genzyme or any of its Affiliates.

 

Joint Patent Rights ” means all Patent Rights included within the Joint Collaboration Technology.

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

5



 

Know-How ” means all inventions, discoveries, data, information, processes, methods, correspondence, techniques, trade secrets, materials, technology, concepts, ideas, algorithms, standards, methods, compositions, formulae, procedures, results and other know-how, whether or not patentable or copyrightable.

 

[********]

 

[********] means all Technology licensed by EXACT to [********] pursuant to the [********].  The parties understand and agree that the Patent Rights that are included in both the Transferred Technology and the [********] as of the Effective Date are only those Patent Rights set forth on Schedule 6.8(a)(i) .

 

Losses ” has the meaning set forth in Section 14.1(a).

 

Material Adverse Effect ” means any material adverse effect on the Purchased Assets, on the parties’ ability to consummate the transactions contemplated by this Agreement or on the parties’ ability to perform their obligations under this Agreement.

 

Maximum Indemnity Cap ” has the meaning set forth in Section 14.1(b).

 

Need-to-Know ” has the meaning set forth in Section 13.2.

 

Option ” has the meaning set forth in Section 3.3(a).

 

Option Exercise Notice ” has the meaning set forth in Section 3.3(b).

 

Optioned Technology ” means Additional EXACT Technology for which Genzyme has exercised the Option pursuant to Section 3.3.

 

Patent Rights ” means all (i) issued patents; (ii) pending patent applications and rights to file applications, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, re-examinations, national phase PCT applications, PCT international applications and all foreign counterparts; (iii) patents-of-addition, reissues, renewals, revivals, reexamination certificates and extensions and restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates and the equivalent thereof; (iv) inventor’s certificates; and (v) forms of government-issued rights substantially similar to any of the foregoing, in each case throughout the world.

 

Person ” means any individual or legal entity.

 

Potential Liabilities Holdback Amount ” means an amount equal to the Holdback Indemnity Cap, payable by Genzyme to EXACT as set forth in Article 15.

 

Primary Goals ” has the meaning set forth in Section 4.1.

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

6



 

Primary Intellectual Property Rights ” means the Primary Patent Rights and other Transferred Technology chiefly related to the Primary Patent Rights, but not any Secondary Patent Rights.

 

Primary Patent Rights ” means (a) those Patent Rights within the Transferred Technology listed on Schedule A , and (b) all Patent Rights first filed after the Effective Date that claim priority (direct or indirect, in whole or in part) to any Patent Right identified in clause (a) above.

 

Purchased Assets ” has the meaning set forth in Section 2.1(a).

 

Receiving Party ” has the meaning set forth in Section 13.1.

 

Representatives ” has the meaning set forth in Section 13.2.

 

Requesting Party ” has the meaning set forth in Section 12.2(d).

 

Retained Assets ” has the meaning set forth in Section 2.1(b).

 

Retained Liabilities ” has the meaning set forth in Section 2.3(b).

 

Retained Patent Rights ” means any Patent Right owned by EXACT as of the Closing Date that is included in the Retained Assets.  The parties understand and agree that if EXACT jointly owns any such Patent Right, such Patent Right is included only with respect to EXACT’s joint ownership interest therein.  For clarity, (i) the Retained Patent Rights include all Patent Rights first filed after the Effective Date that claim priority (direct or indirect, in whole or in part) to any Patent Right included within the Retained Assets as of the Effective Date and (ii) the Retained Patent Rights include those Patent Rights listed on Schedule 2.1(b)(vii) .

 

Royalty ” has the meaning set forth in Section 11.1(a).

 

Sale ” has the meaning set forth in Section 2.1(a).

 

Secondary Patent Rights ” means (a) those Patent Rights within the Transferred Technology listed on Schedule B , and (b) all Patent Rights first filed after the Effective Date that claim priority (direct or indirect, in whole or in part) to any Patent Right identified in clause (a) above.

 

Supporting Materials ” means (i) all research and development reports and records, pre-clinical studies, clinical protocols, clinical studies, pre-clinical and clinical data, results and analyses used in or resulting from any pre-clinical study or clinical trial relating to use of the Transferred Technology in the Genzyme Field; (ii) all files, correspondence, records and other documentation relating to the Transferred Technology, including all invention disclosures and assignments of inventions related to the Transferred Technology; (iii) all records and other documents relating to the use of the Transferred Technology in the Genzyme 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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

7



 

Technology ” means the Transferred Technology, the Genzyme Licensed Improvements, the EXACT Licensed Improvements, the Joint Collaboration Technology, the Optioned Technology and the Retained Patent Rights.

 

Third Party ” means any Person other than Genzyme, EXACT, or their respective Affiliates.

 

Third Party Claim ” has the meaning set forth in Section 14.4(a).

 

Transactions ” means: (i) the Sale, (ii) the licenses and other rights granted pursuant to Article 3 and the related research and development collaboration in Article 4, (iii) the APC/p53 License Amendment and (iv) the JHU-EXACT License Amendment.

 

Transferred In-License Agreement ” means the Amended and Restated License Agreement, having a final signature date of March 25, 2003, as further amended pursuant to a Second Amendment dated as of November 9, 2004, a Third Amendment dated as of May 11, 2006, a Fourth Amendment dated as of March 19, 2007, a Fifth Amendment dated as of October 17, 2008, a Sixth Amendment dated as of October 30, 2008 and a Seventh Amendment dated as of December 15, 2008, by and between JHU and EXACT.  The term “Transferred In-License Agreement” also includes, when effective, the JHU-EXACT License Amendment.

 

Transferred In-Licensed Technology ” means the Intellectual Property Rights licensed to EXACT by JHU under the Transferred In-License Agreement.  The Patent Rights included in the Transferred In-Licensed Technology as of the Effective Date are set forth on Schedule 6.8(a)(iii) .

 

Transferred Technology ” means (a) all Intellectual Property Rights with applicability in the Genzyme Core Field owned by EXACT as of the Closing Date and (b) the Transferred In-Licensed Technology.  The parties understand and agree that the Patent Rights included in the Transferred Technology are only those set forth on Schedule 6.8(a)(i)  and Schedule 6.8(a)(ii)  (including those included by way of clause (ii) below), and any Retained Patent Rights of EXACT that are later determined to have applicability in the Genzyme Core Field after the Closing Date will not become Transferred Technology hereunder but instead will remain “Retained Patent Rights” hereunder.  For clarity, (i) Transferred Technology may have applicability in fields other than the Genzyme Core Field, but each item of Transferred Technology has some applicability in the Genzyme Core Field; (ii) the Transferred Technology includes all Patent Rights first filed after the Effective Date that claim priority (direct or indirect, in whole or in part) to any Patent Right included within the Transferred Technology as of the Effective Date and (iii) no Patent Rights set forth on Schedule 2.1(b)(vii)  or identified in Section 2.1(b)(vii) are included within the definition of Transferred Technology.

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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Article 2    Sale and Purchase .

 

2.1                 Purchased Assets .

 

(a)       At the Closing, subject to the conditions of this Agreement, EXACT will sell, convey, assign, transfer and deliver to Genzyme, and Genzyme will purchase from EXACT, all of EXACT’s rights, title and interests in and to the following assets (collectively, the “ Purchased Assets ”):

 

(i)        the Transferred Technology, including all Actions and rights to sue at law or in equity for any past or future infringement or other impairment of any of the Transferred Technology and the right to receive all proceeds and damages therefrom;

 

(ii)       all of EXACT’s rights under the Transferred In-License Agreement and all contracts and licenses listed on Schedule 2.1(a)(ii)  (the “ Assigned Contracts ”);

 

(iii)      all Supporting Materials;

 

(iv)      all of EXACT’s rights under any confidentiality agreement relating to any of the Purchased Assets; and

 

(v)       all claims of EXACT against Third Parties relating to any Purchased Assets, whether choate or inchoate, known or unknown, contingent or otherwise.

 

Notwithstanding any other provision of this Agreement, the transfer of the Purchased Assets pursuant to this Agreement (the “ Sale ”) will not include the assumption of any liabilities except those Genzyme expressly assumes pursuant to Section 2.3.

 

(b)       All assets of EXACT other than the Purchased Assets (collectively, the “ Retained Assets ”) are not part of the Sale, and are not being transferred to Genzyme pursuant to this Agreement.  For the avoidance of doubt, the Retained Assets include, but are not limited to:

 

(i)        all of EXACT’s cash, cash equivalents and short-term investments;

 

(ii)       all minute books, stock records and corporate seals of EXACT;

 

(iii)      all real property assets, including leasehold rights, of EXACT;

 

(iv)      all of EXACT’s plant and equipment;

 

(v)       all of EXACT’s rights under contracts other than the Assigned Contracts;

 

(vi)      all of EXACT’s personnel records; 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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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(vii)     all Intellectual Property Rights owned or in-licensed by EXACT that are not included in the Transferred Technology, including the Patent Rights listed on Schedule 2.1(b)(vii)  (plus all Patent Rights first filed after the Effective Date that claim priority (direct or indirect, in whole or in part) to any such Patent Rights).

 

2.2                 Consideration .  The consideration for the Purchased Assets (the “ Consideration ”) will be (i) the Closing Payment, (ii) the assumption of the Assumed Liabilities, (iii) the waiver pursuant to the APC/p53 License Amendment and (iv) the obligation to pay the Royalty during the Royalty Period.

 

2.3                 Assumed and Retained Liabilities .

 

(a)       Assumed Liabilities .  On the Closing Date, Genzyme will assume and agree to discharge all liabilities arising after the Closing under the Assigned Contracts (other than any liability arising out of or relating to a breach that occurred prior to or upon the Closing) (the “ Assumed Liabilities ”).

 

(b)       Retained Liabilities .  All other liabilities of EXACT (the “ Retained Liabilities ”) will remain the sole responsibility of and will be retained, paid, performed and discharged solely by EXACT.  Retained Liabilities will include:

 

(i)        any liability under any Assigned Contract that arises after the Closing but that arises out of or relates to a breach that occurred prior to or upon the Closing;

 

(ii)       any liability for taxes, including (A) any taxes arising as a result of EXACT’s operation of its business or EXACT’s ownership of the Purchased Assets or otherwise arising from or with respect to the Purchased Assets, in each case for any taxable period or portion thereof ending on or prior to the Closing Date, (B) any taxes that will arise as a result of the sale of the Purchased Assets pursuant to this Agreement, and (C) any deferred taxes of any nature;

 

(iii)      any liability under any contract, agreement or understanding not included in the Assigned Contracts, including any amounts owed to any law firm, attorney, consultant or financial advisor;

 

(iv)      any liability relating to the operation of EXACT’s business (other than liabilities arising after the Closing under any of the Assigned Contracts that do not arise out of or relate to a breach that occurred prior to or upon the Closing) or EXACT’s leasing, ownership or operation of real property;

 

(v)       any liability to any current or former employee, director or agent of EXACT or any of its Affiliates, including under any employee benefit plan or relating to payroll, vacation, sick leave, workers’ compensation, unemployment benefits, pension benefits, employee stock option or profit-sharing plans, health care plans or benefits or any other employee plans or benefits of any kind for EXACT’s employees or former employees or both;

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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(vi)      any liability of EXACT arising out of or resulting from EXACT’s compliance or non-compliance with any legal requirement or order of any governmental entity; and

 

(vii)     any liability of EXACT with respect to this Agreement or any other document executed in connection with the Transactions.

 

Article 3    Licenses and Other Rights .

 

3.1                 License to Genzyme under Retained Patent Rights .

 

(a)       Effective at the time of, and contingent upon the occurrence of, the Closing, EXACT hereby grants to Genzyme an (i) irrevocable, perpetual, exclusive (even as to EXACT), worldwide, fully-paid, royalty-free license, with the right to sublicense through multiple tiers (subject to Section 3.5) under the Retained Patent Rights to make, have made, use, sell, offer for sale, import and export products, to offer for sale and perform services and to otherwise practice and exploit the Retained Patent Rights, in each case solely in the Genzyme Core Field, and (ii) irrevocable, perpetual, nonexclusive, worldwide, fully-paid, royalty-free license, with the right to sublicense through multiple tiers (subject to Section 3.5) under the Retained Patent Rights to make, have made, use, sell, offer for sale, import and export products, to offer for sale and perform services and to otherwise practice and exploit the Retained Patent Rights, in each case solely in the Genzyme Field other than the Genzyme Core Field; provided that any sublicense of the license set forth in this clause (ii) will only be made [********].

 

(b)       Genzyme understands and agrees that Genzyme’s license and other rights hereunder to the Retained Patent Rights (including under Article 12) are subject to the rights of Third Parties under the agreements listed on Schedule 3.1(b) .

 

3.2                 License to Genzyme under EXACT Licensed Improvements and Joint Collaboration Technology .

 

(a)       Subject to the terms and conditions of this Agreement, effective at the time of, and contingent upon the occurrence of, the Closing, EXACT hereby grants to Genzyme a perpetual (subject to Section 3.7(b)), exclusive (even as to EXACT), worldwide, fully-paid, royalty-free license, with the right to sublicense through multiple tiers (subject to Section 3.5), under the EXACT Licensed Improvements and the Joint Collaboration Technology to make, have made, use, sell, offer for sale, import and export products, to offer for sale and perform services and to otherwise practice and exploit the EXACT Licensed Improvements and Joint Collaboration Technology, in each case solely in the Genzyme Field.

 

(b)       EXACT will disclose to Genzyme any potential EXACT Licensed Improvement in writing in reasonable detail promptly after such improvement has been discovered,

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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conceived, created, made or invented that EXACT reasonably believes would have potential application in the Genzyme Field.  If the parties agree that such improvement has applicability in the Genzyme Field and therefore constitutes an EXACT Licensed Improvement, the parties will add a general description of such improvement to Schedule 3.2(b)  and such improvement will be become an EXACT Licensed Improvement for the purposes of this Agreement.

 

3.3                 Option to License Additional EXACT Technology .

 

(a)       Effective at the time of, and contingent upon the occurrence of, the Closing, EXACT hereby grants Genzyme an exclusive option (the “ Option ”) to obtain an exclusive license to Additional EXACT Technology in the Genzyme Core Field, subject to the terms and conditions of this Section 3.3.

 

(b)       EXACT will disclose to Genzyme any Additional EXACT Technology in writing in reasonable detail promptly after such technology has been discovered, conceived, created, made, invented or acquired.  If the Additional EXACT Technology is in-licensed by EXACT from a Third Party, then, if applicable, such disclosure will include any license fee or royalty payment that EXACT would be required to pay such Third Party as a result of EXACT’s granting to Genzyme a sublicense under such Additional EXACT Technology in the Genzyme Core Field and a copy of the license agreement between EXACT and such Third Party.  If Genzyme wishes to exercise the Option with respect to such disclosed Additional EXACT Technology, Genzyme will provide EXACT with written notice (the “ Option Exercise Notice ”) within [********] of receipt of EXACT’s disclosure.  Upon delivery of the Option Exercise Notice, Genzyme will add a general description of such Additional EXACT Technology to Schedule 3.3(b) , and such technology will be become Optioned Technology ([********] to Genzyme, other than pursuant to Section 11.2) for the purposes of this Agreement.  If Genzyme does not deliver an Option Exercise Notice within such [********] period, then Genzyme’s Option will automatically expire with respect to the disclosed item of Additional EXACT Technology and EXACT may sell, assign, license or otherwise transfer such item of Additional EXACT Technology in the Genzyme Core Field to any Third Party without any further obligation or liability to Genzyme.  If Genzyme takes a sublicense to Optioned Technology in-licensed by EXACT, then Genzyme’s sublicense to that Optioned Technology will be subject to Genzyme’s timely payment of the Genzyme Third Party Payment as provided in Section 11.2 and Genzyme’s compliance with the terms of the in-license agreement applicable to Genzyme as a sublicensee thereunder.

 

(c)       Subject to the terms and conditions of this Agreement, effective at the time of, and contingent upon the occurrence of, the Closing, EXACT hereby grants to Genzyme a perpetual (subject to Section 3.7(b)), exclusive (even as to EXACT), worldwide, fully-paid, royalty-free (except as provided in Section 11.2(a)) license or sublicense (as the case may be), with the right to sublicense through multiple tiers (subject to Section 3.5), under the Optioned Technology to make, have made, use, sell, offer for sale, import and export products, to offer for sale and perform services and 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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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otherwise practice and exploit the Optioned Technology, in each case solely in the Genzyme Core Field.

 

3.4                 License to EXACT under Transferred Technology, Genzyme Licensed Improvements and Joint Collaboration Technology .

 

(a)       Effective at the time of, and contingent upon the occurrence of, the Closing, Genzyme hereby grants to EXACT an irrevocable, perpetual, exclusive (even as to Genzyme), worldwide, fully-paid, royalty-free license, with the right to sublicense through multiple tiers (subject to Section 3.5), under the Transferred Technology other than the Transferred In-Licensed Technology to make, have made, use, sell, offer for sale, import and export products, to offer for sale and perform services and otherwise to practice and exploit the Transferred Technology other than the Transferred In-Licensed Technology, in each case solely in the EXACT Field.

 

(b)       Subject to the terms and conditions of this Agreement, effective at the time of, and contingent upon the occurrence of, the Closing, Genzyme hereby grants to EXACT a perpetual (subject to Section 3.7(a)), exclusive (even as to Genzyme), worldwide, fully-paid, royalty-free license, with the right to sublicense through multiple tiers (subject to Section 3.5), under the Genzyme Licensed Improvements and the Joint Collaboration Technology to make, have made, use, sell, offer for sale, import and export products, to offer for sale and perform services and to otherwise practice and exploit the Genzyme Licensed Improvements and Joint Collaboration Technology, in each case solely in the EXACT Field.

 

(c)       Genzyme will disclose to EXACT any potential Genzyme Licensed Improvement in writing in reasonable detail promptly after such improvement has been discovered, conceived, created, made or invented that Genzyme reasonably believes would have potential application in the EXACT Field.  If the parties agree that such improvement has applicability in the EXACT Field and therefore constitutes a Genzyme Licensed Improvement, the parties will add a general description of such improvement to Schedule 3.4(c)  and such improvement will be become a Genzyme Licensed improvement for the purposes of this Agreement.

 

(d)       For the avoidance of doubt, the licenses granted to EXACT pursuant to Section 3.4 do not include a sublicense to any rights under the Transferred In-License Agreement.  Such rights are covered by, and subject to, the JHU-EXACT License Amendment.

 

3.5                 Sublicensing .  Each party may grant sublicenses (including multiple tier sublicenses) under the licenses granted pursuant to Sections 3.1(a), 3.2(a), 3.3(c), 3.4(a) or 3.4(b) [********] (subject to the provisions of any agreement pursuant to which EXACT licenses an item of Optioned Technology from a Third Party); provided that the party granting such sublicense will be fully responsible for the performance of its sublicenses.

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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3.6                 Use of Technology .  Neither party will practice or grant any rights under Technology owned or Controlled by the other party except as expressly licensed under this Agreement.

 

3.7                 Termination of License Rights .

 

(a)       Termination by Genzyme .  Genzyme may terminate the license granted to EXACT pursuant to Section 3.4(b) at any time by giving written notice to EXACT in the event that EXACT commits a material breach of its obligations under this Agreement and such breach remains uncured for 90 days, measured from the date written notice of such breach is given to EXACT.  If there is a bona fide good faith dispute between the parties as to whether a material breach has occurred, whether such breach has been cured or the amount to be indemnified, the 90 day cure period will be tolled pending resolution of such dispute.  Notwithstanding the foregoing, if all monetary damages of Genzyme arising from any such uncured, material breach by EXACT are satisfied by the indemnity provisions of Article 14 and Genzyme does not have any material non-monetary damages related thereto, then Genzyme will not have the right to terminate the license under Section 3.4(b) on the basis of such breach.

 

(b)       Termination by EXACT .  EXACT may terminate the licenses and Option granted to Genzyme pursuant to Section 3.2(a) or Section 3.3 at any time by giving written notice to Genzyme in the event that Genzyme commits a material breach of its obligations under this Agreement and such breach remains uncured for 90 days, measured from the date written notice of such breach is given to Genzyme.  If there is a bona fide good faith dispute between the parties as to whether a material breach has occurred, whether such breach has been cured or the amount to be indemnified, the 90 day cure period will be tolled pending resolution of such dispute.  Notwithstanding the foregoing, if all monetary damages of EXACT arising from any such uncured, material breach by Genzyme are satisfied by the indemnity provisions of Article 14 and EXACT does not have any material non-monetary damages related thereto, then EXACT will not have the right to terminate any such licenses or Option on the basis of such breach.

 

(c)       Survival of Sublicenses .  If either party terminates a license granted under this Agreement pursuant to Section 3.7, and, on the effective date of such termination, (i) a sublicense under such terminated license as permitted by Section 3.5 is in effect and (ii) the applicable sublicensee is in good standing under the sublicense agreement between such sublicensee and the non-terminating party; then the terminating party will grant to such sublicensee a direct license on substantially the same terms as such sublicensee had as a sublicensee of the non-terminating party, so that the sublicensee will be put in the same position as it was prior to the termination of such license grant, provided , however , that the terminating party will not have any increased obligations as a result of such direct license to such sublicensee.

 

3.8                 Rights in Bankruptcy .  All rights and licenses now or hereafter granted under or pursuant to Sections 3.1, 3.2, 3.3 and 3.4 of this Agreement are rights to “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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

14



 

property” (as defined in Section 101(35A) of Title 11 of the United States Code (the “ Bankruptcy Code ”)).  Each party hereby grants to other party and all Affiliates of such other party a right of access and to obtain possession of, and to benefit from copies of, (a) research data and results and (b) tangible Technology, all of which ((a) and (b)) constitute “embodiments” of intellectual property pursuant to Section 365(n) of the Bankruptcy Code, and (c) all other embodiments of such intellectual property, in each case, solely in connection with the other party’s rights under this Agreement, whether any of the foregoing are in the granting party’s possession or control or in the possession and control of Third Parties.  Each party agrees not to interfere with the other party’s and the other party’s Affiliates’ exercise of rights and licenses to intellectual property licensed hereunder and embodiments thereof in accordance with this Agreement and agrees to use reasonable efforts to assist such other party and its Affiliates to obtain such intellectual property and embodiments thereof in the possession or control of Third Parties as reasonably necessary or desirable for such other party and Affiliates to exercise such rights and licenses in accordance with this Agreement.  The parties acknowledge and agree that all payments payable under this Agreement, other than (i) the Royalty payable by Genzyme in connection with the sublicensing of Retained Patent Rights or (ii) any Genzyme Third Party Payment payable by Genzyme, do not constitute “royalties” within the meaning of Bankruptcy Code Section 365(n) or relate to licenses of intellectual property hereunder.

 

Article 4    Collaboration .

 

4.1                 Joint Advisory Committee .  Promptly after the Closing Date, Genzyme and EXACT will establish a joint advisory committee (the “ Committee ”) to assist both parties in the achievement of product development and regulatory goals within their relevant fields (collectively, the “ Primary Goals ”).  The Primary Goals include (i) [********], (ii) [********] and (iii) [********].  Through the Committee, the parties will share expertise, guidance, plans, clinical plans, protocols and/or strategies.  By way of example only, [********].  The Committee will exist until the termination of the Collaboration Period unless the parties otherwise agree in writing.

 

4.2                 Committee Meetings and Activities .  Each party will designate a Committee contact person, who will facilitate and make available 2 or more representatives of such party for participation in Committee meetings or other activities from time to time, which representatives will be scientific, technical development and/or FDA regulatory advisors or employees of such party with expertise suitable to the particular Committee activity.  During the Collaboration Period, the Committee will meet at least bi-monthly, in person or via teleconference.  Each party will be solely responsible for compensation of such party’s employees, advisors and Committee representatives who participate in Committee meetings or activities, and each party will be solely responsible for expenses incurred by its employees, advisors and Committee representatives in attending or otherwise participating in Committee meetings and activities.  The Committee will not have any authority to bind either party to any action or to amend or modify 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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

15



 

4.3                 Termination of the Collaboration Period .

 

(a)       Either party may terminate the Collaboration Period immediately upon [********] by providing written notice to the other party within [********] following [********].

 

(b)       Any time after the 5th anniversary of the Closing Date, either party may terminate the Collaboration Period [********] upon [********] advance written notice to the other party.

 

Article 5    Closing .

 

5.1                 Closing .  The consummation of the Transactions (the “ Closing ”) will take place at the offices of Genzyme’s counsel at Ropes & Gray LLP, One International Place, Boston, Massachusetts, commencing at 10:00 a.m. (Boston time) on the business day on which the last of the conditions required to be satisfied or waived pursuant to Article 9 and Article 10 of this Agreement is either satisfied or waived (other than conditions which by their nature are to be satisfied or waived at the Closing and are expected to be satisfied at the Closing) (the “ Closing Date ”), or at such other place or time as the parties may mutually agree.

 

5.2                 Deliverables .  In addition to any other documents to be delivered under other provisions of this Agreement, at the Closing:

 

(a)       EXACT will deliver to Genzyme the following documents (collectively referred to in this Agreement as the “ Ancillary Agreements ”):

 

(i)        a bill of sale for all of the Purchased Assets that are tangible personal property, executed by EXACT, substantially in the form attached hereto as Exhibit C ;

 

(ii)       an assignment of all of the Purchased Assets that are intangible personal property, which assignment will also contain Genzyme’s undertaking and assumption of the Assumed Liabilities (the “ Assignment and Assumption Agreement ”) executed by EXACT, substantially in the form attached hereto as Exhibit D ;

 

(iii)      an assignment of all Patent Rights included in the Transferred Technology, executed by EXACT, substantially in the form attached hereto as Exhibit E ;

 

(iv)      the APC/p53 License Amendment executed by EXACT;

 

(v)       the JHU-EXACT License Amendment executed by EXACT and JHU;

 

(vi)      the Common Stock Subscription Agreement executed by EXACT; and

 

(vii)     such other deeds, bills of sale, assignments, certificates of title, agreements, documents and other instruments of transfer and conveyance as may reasonably

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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be requested by Genzyme as set forth in Section 8.4, each in form and substance satisfactory to Genzyme and its legal counsel and executed by EXACT.

 

(b)       Genzyme will deliver to EXACT, together with the Closing Payment, less the Potential Liabilities Holdback Amount, by wire transfer of immediately available funds, the following Ancillary Agreements:

 

(i)        the Assignment and Assumption Agreement executed by Genzyme;

 

(ii)       the APC/p53 License Amendment executed by Genzyme;

 

(iii)      the JHU-EXACT License Amendment executed by Genzyme; and

 

(iv)      the Common Stock Subscription Agreement executed by Genzyme.

 

5.3                 Post-Closing .  Within 15 days of the Closing Date, EXACT will notify all of its agents that hold files or other tangible material included in the Purchased Assets, including any law firms holding files with respect to Transferred Technology, that effective as of the Closing, Genzyme will own such Purchased Assets, and EXACT will be responsible for any fees or expenses associated with such notification or related actions in connection with reflecting the transfer of ownership.

 

Article 6    Representations and Warranties of EXACT .

 

In order to induce Genzyme to enter into and perform this Agreement and to consummate the Transactions, EXACT hereby represents and warrants to Genzyme as follows:

 

6.1                 Organization .  EXACT is (a) duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization and (b) except where the failure to be so qualified or in good standing would not be reasonably likely to have a Material Adverse Effect, duly qualified to do business and in good standing in each jurisdiction in which it owns or leases real property or is otherwise required to be so qualified or in good standing.

 

6.2                 Power and Authorization .

 

(a)       The execution, delivery and performance by EXACT of this Agreement and each Ancillary Agreement and the consummation of each Transaction are within the power and authority of EXACT and have been duly authorized by all necessary action on the part of EXACT.  This Agreement and each Ancillary Agreement (i) has been (or, in the case of Ancillary Agreements to be entered into at or prior to the Closing, will be) duly executed and delivered by EXACT and (ii) is (or, in the case of Ancillary Agreements to be entered into at or prior to the Closing, will be) a legal, valid and binding obligation of EXACT, enforceable against EXACT in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ and contracting parties’ rights generally and subject to general

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

17



 

principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law).

 

(b)       EXACT has the full power and authority necessary to own and use its assets and carry on its business.

 

6.3                 Authorization of Governmental Authorities .  No action by (including any authorization, consent or approval), or in respect of, or filing or declaration with, any Governmental Authority is required for, or in connection with, the valid and lawful (i) authorization, execution, delivery and performance by EXACT of this Agreement and each Ancillary Agreement or (ii) consummation of each Transaction.

 

6.4                 Noncontravention .  Neither the execution, delivery and performance by EXACT of this Agreement or any Ancillary Agreement nor the consummation of any Transaction will:

 

(a)       violate any legal requirement applicable to EXACT;

 

(b)       result in a breach or violation of, or default under, any obligation under any contract, agreement or understanding;

 

(c)       except as disclosed on Schedule 6.4(c) , require any action by (including any authorization, consent or approval) or in respect of (including notice to), any party under any contract, agreement or understanding, including any consents required to assign rights under the Assigned Contracts, to assign the Transferred Technology or to grant the licenses set forth in Article 3;

 

(d)       result in the creation or imposition of an encumbrance upon, or the forfeiture of, any Purchased Assets; or

 

(e)       result in a breach or violation of, or default under, EXACT’s certificate of incorporation, by-laws or other organizational documents.

 

6.5                 Absence of Liabilities .  There are no liabilities of EXACT or, to EXACT’s knowledge, any Third Party that may be imposed on Genzyme due to consummation of the Transactions except for the Assumed Liabilities.

 

6.6                 Absence of Certain Developments .  Since December 31, 2007, no event or circumstance has occurred which has had, or is reasonably likely to have, a Material Adverse Effect.

 

6.7                 Assets .

 

(a)       Except as disclosed on Schedule 6.7(a) , EXACT has sole and exclusive, good and marketable title to, or, a sole and exclusive, enforceable right to use, all of the Purchased Assets.  There are no liens or encumbrances on any of the Purchased Assets.  EXACT does not own any real 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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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(b)       Except as disclosed on Schedule 6.7(b) , the Purchased Assets comprise all of the intangible assets, related Supporting Materials and rights of every type and description (including all Intellectual Property Rights) with applicability in the Genzyme Core Field that are (i) owned by EXACT, (ii) licensed to EXACT with rights extending in the Genzyme Core Field, or (iii) used by EXACT.

 

6.8                 Intellectual Property Rights .

 

(a)       Schedule 6.8(a)(i)  identifies all Patent Rights included in the Transferred Technology that are licensed by EXACT to [********] under the [********], and EXACT has provided to Genzyme true, correct and complete copies of all amendments to the [********] as of the Effective Date.  Schedule 6.8(a)(ii)  identifies all Patent Rights included in the Transferred Technology that are not licensed by EXACT to [********] pursuant to the [********].  For each Patent Right, Schedule 6.8(a)(i)  and Schedule 6.8(a)(ii)  identifies the country, title, patent number (if issued), application number, filing date, issue date, inventors and any continuity relationship with respect to any other Patent Right (such as continuation, continuation-in-part, divisional), and identification of those Patent Rights included in the Transferred In-Licensed Technology.  Schedule 6.8(a)(iii)  identifies the Transferred In-License Agreement, including the identification and description of the applicable Transferred Technology that is the subject of such Transferred In-License Agreement, and any other contracts, agreements or understandings that EXACT has entered into with Third Parties that grant such Third Party rights with respect to, or that otherwise affect EXACT’s rights in, the Transferred Technology.  True, accurate and complete copies of all such registrations, applications, contracts, agreements or understandings (a written summary if oral), in each case, as amended, or otherwise modified and in effect, have been made available to Genzyme as well as true, accurate and complete copies of all other written documentation evidencing ownership and prosecution (if applicable) of such item.

 

(b)       Except as disclosed on Schedule 6.8(b)(i) , EXACT is the sole owner of all rights, title and interests in and to the Transferred Technology. Except as disclosed on Schedule 6.8(b)(ii) , none of the Transferred Technology is subject to any license to any Third Party.

 

(c)       Neither EXACT nor any of its Affiliates has granted to any Third Party any rights with respect to the Transferred Technology in the Genzyme Field.  Each of the Transferred In-License Agreement and the other contracts with Third Parties required to be disclosed on Schedule 6.8(a)  represents the complete agreement and understanding between EXACT or its Affiliates and the other respective party or parties thereto relating to the Transferred Technology that is the subject of such contract.

 

(d)       Neither EXACT nor any of its Affiliates has received any written (or to EXACT’s knowledge, oral) charge, complaint, claim, demand or notice alleging any interference, infringement, misappropriation or conflict with any Intellectual Property Rights of Third Parties (including any written (or to EXACT’s knowledge, oral) claim that

 

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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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EXACT or any of its Affiliates must license or refrain from using any Intellectual Property Right).  Except as disclosed on Schedule 6.8(d) , neither EXACT nor its Affiliates are obligated to indemnify any Person against a charge of infringement of Intellectual Property Rights with respect to use of the Transferred Technology.

 

(e)       Except as disclosed on Schedule 6.8(e)(i) , all registered or issued Transferred Technology (as identified on Schedule 6.8(a) ) is subsisting and enforceable (or, in the case of applications, is pending).  Except as disclosed on Schedule 6.8(e)(ii) , EXACT has taken all steps necessary to maintain such registrations and diligently pursue the registration of such applications, including the payment when due of all maintenance fees, application and prosecution fees and annuities, the filing of all necessary renewals, statements and certifications and the timely response to all office actions, requests and other correspondence from Governmental Authorities in connection therewith.  To EXACT’s knowledge, EXACT and all individuals to whom the duty of candor and good faith applies with respect to the Transferred Technology have complied with such duty, including the duty to disclose to the United States Patent and Trademark Office all information believed to be material to the patentability of the Patent Rights included in the Transferred Technology.  Except as disclosed on Schedule 6.8(e)(ii) , EXACT is not aware of any colorable grounds for invalidating any issued Patent Right within the Transferred Technology.

 

(f)        Except as disclosed on Schedule 6.8(f) , there are no royalties or other payments payable by EXACT or its Affiliates for the use of any Transferred Technology, including pursuant to the Transferred In-License Agreement.  For each royalty disclosed on Schedule 6.8(f) , such schedule sets forth the date on which such royalty will cease to be payable.

 

(g)       Except as disclosed on Schedule 6.8(g) , all current and former employees, agents and consultants of EXACT or its Affiliates who have contributed to the development of the Transferred Technology in any way or who have had access to EXACT’s confidential and proprietary information with respect to the Transferred Technology prior to the Closing have entered into binding written agreements with EXACT whereby (i) EXACT is entitled to all ownership rights in any Transferred Technology prior to the Closing that the employee, agent or consultant may have invented, discovered, originated, made or conceived while working for EXACT or its Affiliates, and all such ownership rights are duly assigned to EXACT, and (ii) the employee, agent or consultant agrees to hold and maintain in confidence all confidential and proprietary information of EXACT.

 

(h)       Except as disclosed on Schedule 6.8(h) , to EXACT’s knowledge, neither government funding nor government, academic or non-profit research facilities were used in the development of any Transferred Technology.  To the extent that any of the Transferred Technology arose from work funded in whole or in part by U.S. federal funding, to EXACT’s knowledge, all requirements necessary to (i) vest the entire right, title and interest in EXACT or in the licensor of such Transferred Technology and (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 treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

20



 

assign (and, as applicable, license) such Transferred Technology to Genzyme pursuant to the terms of this Agreement, have been satisfied.

 

6.9                 Government Authorizations and Registrations .  EXACT has been duly granted all governmental authorizations and duly filed all governmental registrations under all legal requirements for the possession of the Purchased Assets and the use of those Purchased Assets as used by EXACT.  Such authorizations and registrations are valid, in good standing and in full force and effect, and there are no proceedings pending or, to the knowledge of EXACT, threatened that seek the revocation, cancellation, suspension or adverse modification to such authorizations or registrations.  EXACT is not in default or non-compliance under any such authorization or registration.

 

6.10               Legal Compliance .  EXACT is not in breach or violation of, or default under:

 

(a)       its articles of incorporation, by-laws and other organizational documents nor, to EXACT’s knowledge, is there a basis which could constitute such a breach, violation or default; or

 

(b)       any legal requirement that, if breached or violated, would be reasonably likely to have a Material Adverse Effect.

 

6.11               Contracts .

 

(a)       Except as disclosed on Schedule 6.11(a) , EXACT is not bound by or a party to any contract, agreement or understanding relating to or affecting the Purchased Assets.

 

(b)       To EXACT’s knowledge, each Assigned Contract and each other contract, agreement or understanding required to be disclosed on Schedule 6.8(a)(iii)  or Schedule 6.11(a)  (each, a “ Disclosed Contract ”) is enforceable against each party to such contract, and is in full force and effect, and, subject to obtaining any necessary consents disclosed on Schedule 6.4(c) , will continue to be so enforceable and in full force and effect on identical terms following the consummation of the Transactions.  Complete and correct copies of the Disclosed Contracts (including all amendments, supplements and waivers thereto) have been delivered to Genzyme.

 

(c)       EXACT has performed all of its obligations under each Disclosed Contract and neither EXACT nor, to EXACT’s knowledge, any other party to any Disclosed Contract, is (with or without the lapse of time or the giving of notice, or both) in breach or violation of, or default under, or has repudiated any provision of, any Disclosed Contract


 
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