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
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Page
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Article 1
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Definitions
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1
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Article 2
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Sale and Purchase
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9
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2.1
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Purchased Assets
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9
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2.2
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Consideration
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10
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2.3
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Assumed and Retained
Liabilities
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10
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Article 3
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Licenses and Other Rights
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11
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3.1
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License to Genzyme under Retained
Patent Rights
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11
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3.2
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License to Genzyme under EXACT
Licensed Improvements and Joint Collaboration Technology
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11
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3.3
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Option to License Additional EXACT
Technology
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12
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3.4
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License to EXACT under Transferred
Technology, Genzyme Licensed Improvements and Joint Collaboration
Technology
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13
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3.5
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Sublicensing
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13
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3.6
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Use of Technology
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14
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3.7
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Termination of License
Rights
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14
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3.8
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Rights in Bankruptcy
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14
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Article 4
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Collaboration
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15
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4.1
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Joint Advisory Committee
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15
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4.2
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Committee Meetings and
Activities
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15
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4.3
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Termination of the Collaboration
Period
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16
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Article 5
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Closing
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16
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5.1
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Closing
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16
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5.2
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Deliverables
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16
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5.3
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Post-Closing
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17
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Article 6
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Representations and Warranties of
EXACT
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17
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6.1
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Organization
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17
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6.2
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Power and Authorization
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17
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6.3
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Authorization of Governmental
Authorities
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18
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6.4
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Noncontravention
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18
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6.5
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Absence of Liabilities
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18
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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
treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.
i
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6.6
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Absence of Certain Developments
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18
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6.7
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Assets
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18
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6.8
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Intellectual Property
Rights
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19
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6.9
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Government Authorizations and
Registrations
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21
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6.10
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Legal Compliance
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21
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6.11
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Contracts
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21
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6.12
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Litigation; Governmental
Orders
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22
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6.13
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Insurance
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22
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6.14
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No Brokers
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22
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6.15
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Solvency
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22
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6.16
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Disclosure
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23
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Article 7
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Representations and Warranties of
Genzyme
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23
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7.1
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Organization
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23
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7.2
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Power and Authorization
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23
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7.3
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Authorization of Governmental
Authorities
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23
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7.4
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Noncontravention
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24
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7.5
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No Brokers
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24
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Article 8
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Covenants and Agreements
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24
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8.1
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Expenses
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24
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8.2
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Payment of Liabilities
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24
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8.3
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Restrictions on EXACT Dissolution
and Distributions
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24
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8.4
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Further Assurances
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24
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Article 9
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Conditions Precedent to the
Obligations of Genzyme to Consummate the Sale
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26
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9.1
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Representations and
Warranties
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26
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9.2
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Corporate Certificates
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27
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9.3
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Secretary’s
Certificate
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27
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9.4
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Concurrent Transactions
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27
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9.5
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Consents
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27
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9.6
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Opinion of Counsel to
EXACT
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27
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Article 10
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Condition Precedent to the
Obligation of EXACT to Consummate the Sale
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27
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10.1
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Representations and
Warranties
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27
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10.2
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Secretary’s
Certificate
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27
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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
treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.
ii
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10.3
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Concurrent Transactions
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28
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Article 11
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Payment
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28
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11.1
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Royalty for Licenses under
Transferred Technology and Retained Patent Rights Outside Genzyme
Core Field
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28
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11.2
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Payment for Optioned Technology
In-Licensed From a Third Party
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29
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11.3
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Payment Provisions
Generally
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29
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11.4
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Maintenance of Records;
Audit
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30
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Article 12
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Intellectual Property
Matters
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30
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12.1
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Ownership
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30
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12.2
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Filing, Prosecution and Maintenance
of Patent Rights
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31
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12.3
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Enforcement
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34
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12.4
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Claimed Infringement of Third Party
Intellectual Property Rights
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37
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12.5
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Prosecution and Enforcement of Other
Intellectual Property Rights
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38
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12.6
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Cross License Agreement
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38
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12.7
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Termination of Rights and
Obligations Under Article 12
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38
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Article 13
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Confidentiality
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38
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13.1
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Confidentiality
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38
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13.2
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Permitted Disclosure
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39
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13.3
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Required Disclosure
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39
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13.4
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Public Statements
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40
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13.5
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Mutual Non-Disclosure
Agreement
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40
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Article 14
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Indemnification
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40
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14.1
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Indemnification by EXACT
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40
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14.2
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Indemnification by
Genzyme
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41
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14.3
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Time for Claims
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42
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14.4
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Procedure for Third Party
Claims
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42
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14.5
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Consent to Jurisdiction Regarding
Third Party Claims
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44
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14.6
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Exclusive Remedy
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44
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Article 15
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Potential Liabilities
Holdback
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44
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15.1
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Use of Holdback Amount
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44
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15.2
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12 Month Release
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45
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15.3
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18 Month Release
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45
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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
treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.
iii
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15.4
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Outstanding Claims
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45
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Article 16
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Miscellaneous
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45
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16.1
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Notices
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45
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16.2
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Entire Agreement
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46
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16.3
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Binding Effect; No Assignment; No Third-Party
Beneficiaries
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46
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16.4
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Amendment
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47
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16.5
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Waiver
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47
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16.6
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Disclaimer
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47
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16.7
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Section Headings, Construction
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47
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16.8
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Counterparts
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47
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16.9
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Severability
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48
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16.10
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Withholding
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48
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16.11
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Governing Law
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48
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16.12
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Dispute Resolution
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48
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16.13
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Submission to Jurisdiction; Waiver
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48
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16.14
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Enforcement
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49
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16.15
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Rules of Construction
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49
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16.16
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Waiver of Jury Trial
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49
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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
treatment under Rule 24b-2 of the Exchange Act; [*] denotes
omissions.
iv
EXHIBITS
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Exhibit A
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Form of APC/p53 License
Amendment
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Exhibit B
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Form of JHU-EXACT License
Amendment
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Exhibit C
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Form of Bill of Sale
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Exhibit D
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Form of Assignment and Assumption
Agreement
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Exhibit E
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Form of Assignment of Patent
Rights
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SCHEDULES
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Schedule A
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Primary Patent Rights
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Schedule B
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Secondary Patent Rights
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Schedule 2.1(a)(ii)
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Assigned Contracts
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Schedule 2.1(b)(vii)
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Retained Patent Rights
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Schedule 3.1(b)
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Rights of Third Parties
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Schedule 3.2(b)
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EXACT Licensed Improvements
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Schedule 3.3(b)
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Optioned Technology
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Schedule 3.4(c)
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Genzyme Licensed Improvements
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Schedule 6.4
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Noncontravention (EXACT)
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Schedule 6.7
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Assets
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Schedule 6.8
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Intellectual Property
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Schedule 6.11
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Contracts
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Schedule 6.12
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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.
8
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.
9
(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.
10
(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.
11
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.
12
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.
13
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.
16
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.
18
(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.
19
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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