SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): January 27, 2009
EXACT SCIENCES CORPORATION
(Exact Name of Registrant as Specified in its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
000-32179 |
|
02-0478229 |
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
|
|
100 Campus Drive, Marlborough, Massachusetts |
|
01752 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrants telephone number, including area code: (508) 683-1200
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
x Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement.
On January 27, 2009, EXACT Sciences Corporation (the Company) entered into a Collaboration, License and Purchase Agreement (the CLP Agreement) with Genzyme Corporation (Genzyme). Pursuant to the CLP Agreement, the Company (i) assigned to Genzyme all of its intellectual property applicable to the fields of prenatal and reproductive health (the Transferred Intellectual Property), (ii) granted Genzyme an irrevocable, perpetual, exclusive, worldwide, fully-paid, royalty-free license to use and sublicense all of the Companys remaining intellectual property (the Retained Intellectual Property) in the fields of prenatal and reproductive health (the Genzyme Core Field), and (iii) granted Genzyme an irrevocable, perpetual, non-exclusive, worldwide, fully-paid, royalty-free license to use and sublicense the Retained Intellectual Property in all fields other than the Genzyme Core Field and other than colorectal cancer detection and stool-based disease protection (the Company Field). Further, subject to the terms of the JHU Amendment (defined below), the Company assigned to Genzyme its rights under the license agreement between the Company and The Johns Hopkins University (JHU) dated March 25, 2003, as amended (the JHU Agreement) (collectively, with the licenses and assignment described herein, the Sale Transaction). The CLP Agreement also provides for the formation of a joint advisory committee to assist both parties in the achievement of product development and regulatory goals. The collaboration period under the CLP Agreement may be terminated upon certain events. Additional termination rights concerning the collaboration period arise after five years.
Under the CLP Agreement, the Company retained ownership of intellectual property rights other than the Transferred Intellectual Property. In addition, with respect to the Transferred Intellectual Property, Genzyme granted the Company an irrevocable, perpetual, exclusive, worldwide, fully-paid, royalty-free license to use and sublicense such intellectual property in the Company Field. The parties also granted to each other a perpetual (subject to termination for uncured material breaches), exclusive, worldwide, fully-paid, royalty-free license to use and sublicense any improvements Genzyme or the Company makes to the Transferred Intellectual Property that is applicable to the Company Field (in the case of the Company as licensee) or all fields other than the Company Field (the Genzyme Field) (in the case of Genzyme as licensee). Further, the parties granted to each other a perpetual (subject to termination for uncured material breaches), exclusive, worldwide, fully-paid, royalty-free license to use and sublicense intellectual property jointly developed pursuant to the collaboration between the parties (the Joint Technology). The license to the Joint Technology granted by the Company to Genzyme is exclusive in the Genzyme Field and the license to the Joint Technology granted by Genzyme to the Company is exclusive in the Company Field. The Company also granted to Genzyme an exclusive option to obtain an exclusive license, in the Genzyme Core Field, to certain technology that the Company may develop or acquire that has applicability in the Genzyme Core Field. The CLP Agreement contains representations, warranties and covenants with respect to the Sale Transaction and provides, under certain circumstances, for the Company and Genzyme to indemnify each other for breaches of their respective representations, warranties and covenants.
As part of the Sale Transaction, the Company entered into an Assignment, Sublicense, Consent and Eighth Amendment to License Agreement with Genzyme and JHU (the JHU Amendment) on January 27, 2009, whereby the Company assigned its rights under the JHU Agreement to Genzyme. Pursuant to the JHU Amendment, Genzyme sublicensed to the Company the intellectual property
2
subject to the JHU Agreement for colorectal cancer detection and stool-based disease detection, including the BEAMing technology for the detection of colorectal cancer. Under the JHU Amendment, the Company and Genzyme will share in the royalty and annual payment obligations to JHU. The JHU Amendment also modified the minimum annual license fee due to JHU under the JHU Agreement. The JHU Agreement terminates upon the later of 20 years from the effective date of the JHU Agreement and the expiration of the last to expire of the patents for the licensed technology, or upon certain uncured defaults of JHU or Genzyme. Pursuant to the JHU Amendment, the sublicense to the Company terminates upon certain uncured defaults of the Company. The JHU Amendment also provides that, in the event the JHU Agreement terminates upon an uncured default of Genzyme, if the Company is in good standing under the JHU Agreement at such time, the sublicense to the Company will become a direct license from JHU to the Company.
Also as part of the Sale Transaction, the Company entered into an Amended and Restated License Agreement (the Restated License) with Genzyme on January 27, 2009, which amends and restates the License Agreement between the parties dated March 25, 1999, effective as of January 27, 2009. Pursuant to the Restated License, Genzyme granted to the Company a non-exclusive license to use technology related to the use of certain genes, specifically APC and p53, and methodologies related thereto. In exchange for the license, which continues until the expiration of the last to expire licensed patent, the Company has agreed to pay Genzyme royalties based on net revenues received from performing tests that incorporate the licensed technology and sales of reagents and diagnostic test kits that incorporate the licensed technology, as well as certain minimum royalties, milestone payments and maintenance fees.
Pursuant to the Sale Transaction, Genzyme agreed to pay an aggregate of $18.5 million to the Company, of which $16.65 million was paid at closing and $1.85 million (the Holdback Amount) is subject to a holdback by Genzyme to satisfy certain potential indemnification obligations of the Company. Subject to the terms and conditions of the CLP Agreement, one-half of the Holdback Amount will be released to the Company in 12 months and one-half will be released in 18 months. Genzyme also agreed to pay a double-digit royalty to the Company on income received by Genzyme as a result of any licenses or sublicenses to third parties of the Transferred Intellectual Property or the Retained Intellectual Property in any field other than the Genzyme Core Field or the Company Field.
In addition, the Company entered into a Common Stock Subscription Agreement with Genzyme (the Purchase Agreement) on January 27, 2009, which provided for the private issuance and sale to Genzyme of 3,000,000 shares (the Shares) of the Companys common stock, $0.01 par value per share (Common Stock), at a per share price of $2.00, for an aggregate purchase price of $6.0 million. Pursuant to the Purchase Agreement, Genzyme has the right until December 31, 2010 to participate in certain future private offerings of equity securities by the Company up to the amount necessary to maintain Genzymes pro-rata percentage ownership of the Company, at a price per share equal to the greater of $2.00 or the closing price of the Common Stock on the Companys trading market on the day prior to the date that the Company notifies Genzyme of its right to purchase additional shares. This right is subject to certain customary exclusions, including issuances to employees pursuant to a stock plan, issuances in connection with a change of control transaction and issuances in connection with strategic partnerships. Under the Purchase Agreement, Genzyme also has the right to include the Shares on a registration statement filed by the Company or, under certain circumstances, cause the Company to file a registration statement covering the resale of the Shares by Genzyme with the Securities and Exchange Commission.
3
The Board of Directors of the Company engaged Merriman Curhan Ford & Co. (Merriman), an independent, third-party full-service investment bank, to consider and render to the Companys Board of Directors its opinion as to the fairness to the Company of the consideration to be paid by Genzyme to the Company in connection with the transactions described in this Item 1.01. Merriman delivered its written opinion to the Companys Board of Directors on January 25, 2009. The opinion stated Merrimans view that, as of such date, and based upon and subject to the assumptions made, matters considered and limitations on its review as set forth in the opinion, the consideration to be paid by Genzyme to the Company in the transaction was fair to the Company from a financial point of view.
The foregoing descriptions of the CLP Agreement, JHU Amendment, Restated License and Purchase Agreement are not complete and are qualified in their entirety by reference to the agreements which are filed as Exhibits 10.1 through 10.4 hereto, respectively, and which are incorporated herein by reference.
Item 2.01 Completion of Acquisition or Disposition of Assets.
On January 27, 2009, the Company consummated the Sale Transaction with Genzyme. Additional details regarding the Sale Transaction are provided in Item 1.01 above, and are incorporated herein by reference.
One of the Companys directors, Connie Mack, III, is also a director of Genzyme. Mr. Mack recused himself from the approval of the transactions between the Company and Genzyme.
Item 3.02 Unregistered Sales of Equity Securities.
On January 27, 2009, pursuant to the Purchase Agreement, the Company consummated the sale of 3,000,000 shares of its Common Stock, at a per share price of $2.00 for aggregate consideration of $6.0 million. The Company sold the Shares to Genzyme without registration under the Securities Act of 1933, as amended, or state securities laws, in reliance on the exemptions provided by Section 4(2) of the Act and/or Regulation D promulgated thereunder and in reliance on similar exemptions under applicable state laws. Additional information regarding the Shares and the Purchase Agreement is included under Item 1.01 of this Report on Form 8-K and is incorporated herein by reference.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On January 27, 2009, the Company announced that it has initiated a search for a new Chief Executive Officer. Jeffrey R. Luber, the Companys current President and Chief Executive Officer, will continue in his role as Chief Executive Officer until his successor is named.
On January 27, 2009, upon, and as a result of, the consummation of the transactions with Genzyme, the Companys Board of Directors awarded bonuses to certain of the Companys employees pursuant to the terms of their respective Employee Retention Agreements with the Company, each dated April 18, 2008 (the Transaction Bonuses). The Transaction Bonuses included cash bonuses of $315,000 to Mr. Luber, the Companys current President and Chief Executive Officer, and $230,000 to
4
Charles R. Carelli, Jr., the Companys Senior Vice President, Chief Financial Officer, Treasurer and Secretary. The Transaction Bonuses were awarded in lieu of the Companys annual bonus program.
Item 7.01 Regulation FD Disclosure.
On January 27, 2009, the Company issued a press release, a copy of which is being furnished as Exhibit 99.1 to this Report on Form 8-K.
The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
ADDITIONAL INFORMATION
On January 27, 2009, Sequenom, Inc. (Sequenom) commenced an unsolicited exchange offer to acquire all of the outstanding shares of common stock of the Company in a stock-for-stock transaction. This communication is not a recommendation on how any stockholder should act with respect to any such exchange offer. Sequenom has filed a Schedule TO and a registration statement on Form S-4 with the Securities and Exchange Commission to register the Sequenom shares to be issued in such exchange offer. Unless the exchange offer is terminated, the Company will file a solicitation/recommendation statement on Schedule 14D-9 with the Securities and Exchange Commission with respect to the exchange offer. The Companys stockholders are strongly advised to read those documents, as well as any amendments or supplements to those documents, because they will contain important information that should be read carefully and considered before any decision is made with respect to any such exchange offer. Investors and security holders may obtain a free copy of the registration statement and the solicitation/recommendation statement (when and if available) and other relevant documents at the Commissions Internet web site at www.sec.gov. The solicitation/recommendation statement (when and if available) may also be obtained free of charge from the Company by directing such request to: Investor Relations, EXACT Sciences Corporation, 100 Campus Drive, Marlborough, MA 01752.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
10.1** |
|
Collaboration, License and Purchase Agreement between Genzyme Corporation and the Company, dated January 27, 2009 |
|
|
|
10.2** |
|
Assignment, Sublicense, Consent and Eighth Amendment to License Agreement among the Company, Genzyme Corporation and The Johns Hopkins University, dated January 27, 2009 |
|
|
|
10.3** |
|
Amended and Restated License Agreement between Genzyme Corporation and the Company, dated January 27, 2009 |
5
10.4 |
|
Common Stock Subscription Agreement between the Company and Genzyme Corporation, dated January 27, 2009 |
|
|
|
99.1 |
|
Press Release issued by the Company on January 27, 2009, furnished herewith. |
** Confidential treatment has been requested for portions of this exhibit.
6
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
EXACT Sciences Corporation |
|
|
|
|
|
|
|
|
|
January 28, 2009 |
|
By: |
/s/ Charles R. Carelli, Jr. |
|
|
Charles R. Carelli, Jr. |
|
|
|
Senior Vice President, Chief Financial
|
7
EXHIBIT INDEX
Exhibit Number |
|
Description |
|
|
|
10.1** |
|
Collaboration, License and Purchase Agreement between Genzyme Corporation and the Company, dated January 27, 2009 |
|
|
|
10.2** |
|
Assignment, Sublicense, Consent and Eighth Amendment to License Agreement among the Company, Genzyme Corporation and The Johns Hopkins University, dated January 27, 2009 |
|
|
|
10.3** |
|
Amended and Restated License Agreement between Genzyme Corporation and the Company, dated January 27, 2009 |
|
|
|
10.4 |
|
Common Stock Subscription Agreement between the Company and Genzyme Corporation, dated January 27, 2009 |
|
|
|
99.1 |
|
Press Release issued by the Company on January 27, 2009, furnished herewith. |
** Confidential treatment has been requested for portions of this exhibit.
8
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 Companys 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 Companys 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 |
Secretarys 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 |
Secretarys Certificate |
27 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys 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 Companys 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 Companys 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 Companys 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 EXACTs 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 EXACTs 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.
[********]
2
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
3
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
4
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
5
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
6
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
7
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
8
Article 2 Sale and Purchase .
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.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
9
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
10
Article 3 Licenses and Other Rights .
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
11
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
12
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
13
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
14
Article 4 Collaboration .
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
15
Article 5 Closing .
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
16
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:
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
17
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
18
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
Article 7 Representations and Warranties of Genzyme .
In order to induce EXACT to enter into and perform this Agreement and to consummate the Transactions, Genzyme hereby represents and warrants to EXACT as follows:
Article 8 Covenants and Agreements .
Article 9 Conditions Precedent to the Obligations of Genzyme to Consummate the Sale .
The obligations of Genzyme to consummate the Transactions are subject to the fulfillment of the following conditions, any one or more of which may be waived by Genzyme:
Article 10 Condition Precedent to the Obligation of EXACT to Consummate the Sale .
The obligations of EXACT to consummate the Transactions are subject to the fulfillment of the following conditions, any one or more of which may be waived by EXACT:
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
27
Article 11 Payment .
(a) |
|
Wire Instructions for Genzyme Corporation: |
|
|
|
|
|
[********] |
29
(b) |
|
Wire Instructions for EXACT Sciences Corporation: |
|
|
|
|
|
|
|
[********] |
|
Article 12 Intellectual Property Matters .
37
Article 13 Confidentiality .
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
38
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
39
Article 14 Indemnification .
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
40
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
41
Claims for indemnification not specified with a time limitation in this Section 14.3 are not subject to the limitations set forth in this Section 14.3 and will be governed by the applicable statute of limitations. For avoidance of doubt, claims will be deemed to have been made within the survival period if a reasonably complete description of the claim based upon the facts available at the time is presented by the party seeking indemnification to the Indemnifying Party within the specified time period in this Agreement.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
42
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
43
Article 15 Potential Liabilities Holdback . At the Closing, the Potential Liabilities Holdback Amount will be retained by Genzyme to be released in accordance with the following:
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
44
Article 16 Miscellaneous .
Genzyme Genetics
1700 West Park Drive
Westborough, Massachusetts 01581
Attn: |
Sr. Vice President & General Manager |
Fax: |
(508) 870-7504 |
Phone: |
(508) 870-5232 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
45
with a copy to:
Genzyme Corporation
500 Kendall Street
Cambridge, Massachusetts 02142
Attn: |
General Counsel |
Fax: |
(617) 252-7553 |
Phone: |
(617) 252-7500 |
EXACT
Sciences Corporation
100 Campus Drive
Marlborough, Massachusetts 01752
Attn: |
Chief Executive Officer |
Fax: |
(508) 683-1201 |
Phone: |
(508) 683-1200 |
with a copy to:
Goodwin|Procter LLP
53 State Street
Boston, Massachusetts 02109
Attn: |
Edward A. King, Esq. & Kingsley L. Taft, Esq. |
Fax: |
(617) 523-1231 |
Phone: |
(617) 570-1000 |
Either party may, by notice given in accordance with this Section 16.1 to the other parties, designate another address or person for receipt of notices hereunder.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
46
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
47
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
48
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first stated above.
|
GENZYME CORPORATION |
|
|
|
|
|
|
|
|
By |
/s/ Earl M. Collier, Jr. |
|
Name: |
Earl M. Collier, Jr. |
|
Title: |
Executive Vice President |
|
|
|
|
|
|
|
EXACT SCIENCES CORPORATION |
|
|
|
|
|
|
|
|
By |
/s/ Jeffrey R. Luber |
|
Name: |
Jeffrey R. Luber |
|
Title: |
President and Chief Executive Officer |
[Signature Page to Collaboration, License and Purchase Agreement]
DISCLOSURE SCHEDULE
TO THE COLLABORATION, LICENSE AND PURCHASE AGREEMENT
These Schedules are being furnished by EXACT Sciences Corporation (EXACT), in connection with the execution and delivery of that certain Collaboration, License and Purchase Agreement (the Agreement), dated as of January 27, 2009, by and between EXACT and Genzyme Corporation (Genzyme). Except as otherwise provided herein or in the Agreement, all disclosures contained in these Schedules are made as of the date of the Agreement. Capitalized terms used but not otherwise defined herein will have the meanings ascribed to them in the Agreement.
Any matter disclosed in one section of these Schedules will be deemed disclosed in all other applicable sections of these Schedules to the extent that such section is reasonably cross-referenced or the relevance to such other section is readily apparent on the face of the disclosure that the matter is responsive to another representation. Disclosure of a matter in a section of these Schedules will not affect (directly or indirectly) the interpretation of the Agreement or the scope of the disclosure obligation of EXACT under the Agreement. These Schedules may include items or information which EXACT is not required to disclose under the Agreement. The fact that any fact, circumstance, matter or event is disclosed in a section of these Schedules does not necessarily mean that it is material to EXACT, whether considered individually or in combination with other facts, circumstances, matters, or events disclosed herein, and such inclusion will not be deemed an acknowledgement that such fact, item, circumstance, matter, transaction or event is required to be so disclosed pursuant to the Agreement. All agreements listed in these Schedules will be deemed to include all appendices, exhibits, schedules, modifications, amendments to, and all orders, purchase orders, implementation contracts, statements of work, program descriptions and other documents issued under, such agreements, and all associated documentation. No disclosure in these Schedules relating to any possible breach or violation of or default under any contract or law will be construed as an admission or indication that any such breach, violation or default exists or has actually occurred.
The information in these Schedules is disclosed confidentially, and the recipients agree by their receipt of these Schedules that such information will be held subject to the obligations of Article 13 of the Agreement. In disclosing the information set forth herein, EXACT expressly does not waive any attorney-client privilege associated with any such information or any protection afforded by the work product doctrine with respect to any of the matters disclosed herein.
The headings and descriptions of the representations and warranties used herein are for convenience of reference only and are not intended to and do not alter the meaning of any provision of the Agreement.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
1
Schedule A
Primary Patent Rights
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
2
Schedule B
Secondary Patent Rights
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
3
Schedule 2.1(a)(ii)
Assigned Contracts
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
4
Schedule 2.1(b)(vii)
Retained Patent Rights
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
5
Schedule 3.1(b)
Rights to Retained Patent Rights
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
6
Schedule 3.2(b)
EXACT Licensed Improvements
To be added.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
7
Schedule 3.3(b)
Optioned Technology
To be added.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
8
Schedule 3.4(c)
Genzyme Licensed Improvements
To be added.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
9
Schedule 6.4(c)
Noncontravention
Consent of JHU needed for transfer of the Transferred In-License Agreement, which is satisfied by the JHU-EXACT License Amendment.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
10
Schedule 6.7(a)
Assets
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
11
Schedule 6.7(b)
Assets
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
12
Schedule 6.8(a)
Transferred Technology
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
13
Schedule 6.8(b)
Rights to Transferred Technology
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
14
Schedule 6.8(d)
Indemnification Obligations
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
15
Schedule 6.8(e)
Maintenance of Intellectual Property
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
16
Schedule 6.8(f)
Royalties
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
17
Schedule 6.8(g)
Employees
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
18
Schedule 6.8(h)
Government Funding
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
19
Schedule 6.11(a)
Contracts
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
20
Schedule 6.12(a)
Litigation
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
21
Exhibit 10.2
ASSIGNMENT, SUBLICENSE, CONSENT AND
EIGHTH AMENDMENT TO LICENSE AGREEMENT
This ASSIGNMENT, SUBLICENSE, CONSENT AND EIGHTH AMENDMENT TO LICENSE AGREEMENT (this ASSIGNMENT, SUBLICENSE AND AMENDMENT) is made and entered into as of January 27, 2009, by and among EXACT Sciences Corporation, a Delaware corporation (EXACT), Genzyme Corporation, a Massachusetts corporation (GENZYME) and Johns Hopkins University, a Maryland corporation (JHU). Unless otherwise indicated, all capitalized terms used herein and not otherwise defined shall have the meanings given them in the AGREEMENT (as defined below).
WHEREAS, EXACT and GENZYME are parties to that certain Collaboration, License and Purchase Agreement, dated as of January 27, 2009 (the CLP AGREEMENT), pursuant to which, among other things, EXACT is to sell to GENZYME, and GENZYME is to purchase from EXACT, the Purchased Assets (as the term is defined in the CLP AGREEMENT);
WHEREAS, pursuant to the CLP AGREEMENT, EXACT has agreed to assign to GENZYME that certain Amended and Restated License Agreement having a final signature date of March 25, 2003, by and between EXACT Laboratories, Inc. (now known as EXACT) and JHU, as amended (the AGREEMENT), and GENZYME has agreed to assume EXACTs obligations under the AGREEMENT, as set forth herein; and
WHEREAS, the parties desire to amend certain provisions of the AGREEMENT.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
1. Assignment . EXACT hereby transfers and assigns to GENZYME all of EXACTs right, title and interest in, to and under, the AGREEMENT, to have and to hold the same unto GENZYME and its successors and assigns from and after the date hereof subject to the covenants, conditions and provisions therein provided. EXACT, GENZYME and JHU agree that Exhibit 1 attached hereto contains a complete list of all amendments to the AGREEMENT prior to the date hereof.
2. Assumption . GENZYME hereby accepts the transfer and assignment of the AGREEMENT, and GENZYME hereby agrees to pay, defend, discharge and perform all obligations under the AGREEMENT arising from and after the closing of the CLP AGREEMENT (the CLOSING).
3. Consent . Contingent upon the Closing, JHU hereby consents to (a) the transfer and assignment of the AGREEMENT by EXACT to GENZYME such that upon such transfer and assignment, all references to EXACT (whether as EXACT or COMPANY) in the AGREEMENT shall be references to GENZYME and (b) the sublicense by GENZYME to EXACT of certain rights under the AGREEMENT pursuant to Section 4 below (the SUBLICENSE). JHUs consent to the transfer and assignment of the AGREEMENT shall not be construed either as a consent by JHU to, or as permitting, any other or further assignment of
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
the AGREEMENT, whether in whole or in part, or as a waiver of the requirement of obtaining JHUs consent thereto . To the best of JHUs knowledge, EXACT is not in breach of the AGREEMENT as of the date first set forth above.
4. Sublicense .
(a) Subject to the terms and conditions of the AGREEMENT, and expressly subject to Article 2.3 therein, and subject to the terms and conditions of this Section 4, GENZYME hereby grants to EXACT the following sublicenses, under the license grants by JHU in the AGREEMENT, solely in the EXACT FIELD, as defined below:
(i) an exclusive license under the PATENT RIGHTS to make, have made, use, have used, sell, have sold, import, and have imported any method or product worldwide, solely in the FIELD, as the FIELD may be limited in the AGREEMENT with respect to particular PATENT RIGHTS;
(ii) an exclusive license under the BEAMING PATENT RIGHTS in the BEAMING EXCLUSIVE FIELD to make, have made, use, have used, sell, have sold, import, and have imported any method, service or product worldwide; and
(iii) a non-exclusive license under the BEAMING PATENT RIGHTS in the BEAMING NONEXCLUSIVE FIELD to make, have made, use, have used, sell, have sold, import, and have imported any method, service or product worldwide.
(b) EXACT (and its sublicensees) shall have the right to grant further sublicenses under the foregoing sublicenses to EXACT provided that any such sublicenses comply with the terms of the AGREEMENT and further provided that GENZYME will have, along with JHU, the review rights under the 2 nd through 5 th sentences of Section 2.2 of the AGREEMENT regarding any such sublicenses.
(c) 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 the purposes of this definition, (1) FDA KITS
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
2
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, and (2) FECAL BASED TESTS as defined in the AGREEMENT are within the EXACT FIELD.
(d) EXACT hereby acknowledges and agrees to be bound by and comply with, and to cause any sublicensees of EXACT to comply with, as if EXACT and those sublicensees were GENZYME under the AGREEMENT, the following sections of the AGREEMENT: 2.3 (Retained Rights), 5.2 (Records), 6.1 (Representations by JHU), 7.1 (Indemnification), 8 (Confidentiality), 9.4 (Obligations and Duties upon Termination), 10.1 (Use of Name), 10.4 (Product Liability), and 10.19 (Howard Hughes Medical Institute). In addition, as between GENZYME and EXACT, EXACT agrees to be responsible for and perform all obligations of GENZYME as licensee under the AGREEMENT to the extent relating to the EXACT FIELD. Notwithstanding the foregoing, GENZYME will remain solely responsible for all obligations under ARTICLE 4 of the AGREEMENT (PATENT PROSECUTION).
(e) During such time as the SUBLICENSE is in effect, EXACT will pay to GENZYME (i) [********] due to JHU with respect to activities in the EXACT FIELD (including [********] due with respect to FECAL BASED TESTS) and (ii) [********] due to JHU pursuant to the AGREEMENT (as may be further amended from time to time) (collectively, the EXACT JHU PAYMENT). GENZYME shall remit the EXACT JHU PAYMENT to JHU, together with other amounts payable by GENZYME under the AGREEMENT. GENZYME and not EXACT will be solely responsible for (1) [********], and (2) all amounts owed to JHU under the AGREEMENT for [********]. For the avoidance of doubt, except as explicitly specified herein, amounts due with respect to activities in the EXACT FIELD will be calculated in the same manner as they were prior to the execution of this ASSIGNMENT, SUBLICENSE AND AMENDMENT, as if EXACT were the direct licensee of JHU.
(f) EXACT will provide GENZYME with all assistance reasonably requested to allow GENZYME to meet its reporting obligations under the AGREEMENT, including furnishing within 15 days after the end of March 31st, June 30th, September 30th and December 31st each year (or on such other dates as reasonably requested by GENZYME) a written report with respect to the preceding 3 month period providing detail reasonably satisfactory to GENZYME to calculate the amounts due to JHU pursuant to the AGREEMENT.
(g) Within 60 days after the end of each calendar year, GENZYME and EXACT will agree in good faith in writing on the amount of the EXACT JHU PAYMENT due with respect to such year. EXACT will remit to GENZYME the total EXACT JHU PAYMENT due for such year in two equal payments made on or before June 30th and December 31st of the
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
3
following year. In the event that the amount actually paid by GENZYME to JHU with respect to activities in the EXACT FIELD in a calendar year is different than the parties had assumed in calculating the JHU EXACT PAYMENT, the parties will negotiate in good faith a reasonable adjustment to such JHU EXACT PAYMENT and such adjustment will promptly be corrected by a payment or refund, as appropriate.
(h) GENZYME may terminate the SUBLICENSE any time by giving written notice to EXACT in the event that EXACT fails to materially perform or otherwise materially breaches its obligations under the SUBLICENSE (including under Section 4(e) of this ASSIGNMENT, SUBLICENSE AND AMENDMENT) and such failure remains uncured for 45 days, measured from the date written notice of such failure is given to EXACT.
(i) EXACTs failure to perform under the SUBLICENSE shall not be a breach by GENZYME of the AGREEMENT, but rather, shall give JHU the right to terminate the SUBLICENSE on the terms and conditions set forth in the AGREEMENT.
(j) If the AGREEMENT is terminated and at such time EXACT is then in good standing under the AGREEMENT, JHU hereby grants to EXACT a direct license on substantially the same terms as EXACT has as a sublicensee of GENZYME, so that EXACT would be put in the same position as it was prior to such AGREEMENT termination, provided that JHU will not have any increased obligations as a result of such direct license to EXACT. If such a direct license goes into effect, EXACT and JHU agree to memorialize in writing such direct license promptly.
(k) GENZYME, EXACT and JHU each agrees to provide the other parties hereto with copies of any notices given under the AGREEMENT to the extent relating to the EXACT FIELD and the SUBLICENSE.
5. Amendments .
(a) EXACT, GENZYME and JHU hereby delete the definition of SECOND BEAMING EXCLUSIVE FIELD in the AGREEMENT and replace it in its entirety with the following:
SECOND BEAMING EXCLUSIVE FIELD, for the purposes of the BEAMING PATENT RIGHTS only, shall mean [********]:
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
4
(b) Notwithstanding anything to the contrary in the AGREEMENT, EXACT, and not GENZYME, will be solely responsible for the diligence obligations of GENZYME (as licensee under the AGREEMENT) in the EXACT FIELD, as contained in Section 5.3 of the AGREEMENT, to the extent relating to the EXACT FIELD. Notwithstanding the foregoing, Genzyme will remain solely responsible for all obligations under ARTICLE 4 of the AGREEMENT (PATENT PROSECUTION).
(c) EXACT, GENZYME and JHU hereby delete Sections 1.12.1(a) and 1.12.2(a) of the AGREEMENT and replace them in their entirety with the following:
[********]
The parties hereby agree that all references, express or implied, to the [********] minimum license fee set forth in the AGREEMENT shall, instead, be amended to reference [********] and any calculations set forth in the AGREEMENT, for purposes of example, shall be deemed illustrative only to the extent appropriate based on the change in minimum annual fee from [********] to [********] as set forth above. The minimum annual fee shall be reduced to [********]. Thereafter, the minimum annual fee shall be [********] ([********] if the SECOND BEAMING OPTION has been exercised).
(d) EXACT, GENZYME and JHU hereby delete Section 10.8 of the AGREEMENT and replace it in its entirety with the following:
Neither this Agreement nor any of the rights or obligations created herein, except for the right to receive any remuneration hereunder, may be assigned by either party, in whole or in part, without the prior written consent of the other party. Notwithstanding the preceding sentence, JHU and COMPANY shall be free to assign this Agreement in connection with any sale of substantially all of such partys assets to which this Agreement relates without the consent of the other party hereunder, and COMPANY and JHU shall be free to assign this Agreement or otherwise to transfer all of their respective rights and obligations under this Agreement to a successor by merger without the consent of the other party hereunder. This Agreement shall bind and inure to the benefit of the successors and permitted assigns of the parties hereto.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
5
(e) EXACT, GENZYME and JHU agree to amend the second sentence of Section 2 of the Fifth Amendment to the AGREEMENT, [********] from the date of this ASSIGNMENT, SUBLICENSE AND AMENDMENT. EXACT, GENZYME and JHU agree further to delete the last sentence of Section 2 of the Fifth Amendment to the AGREEMENT and replace it in its entirety with the following:
GENZYME may exercise the BEAMING OPTION granted hereunder by providing to JHU, prior to the end of the option period: (a) written Notice of its intent, and, (b) a written statement of its commercially reasonable plans and apabilities to develop a product or service in the SECOND BEAMING EXCLUSIVE FIELD for public use or benefit.
6. Upfront Payment . GENZYME will pay [********] to JHU within 15 business days of the execution of this ASSIGNMENT, SUBLICENSE AND AMENDMENT.
7. Option Exercise Payment . GENZYME will pay [********] to JHU within 30 business days of exercising the BEAMING OPTION.
8. Milestones .
(a) GENZYME shall pay to JHU the following one-time event milestone payments:
(i) [********]
(ii) [********]
(b) GENZYME shall pay to JHU the following one-time sales milestone payments:
(i) [********]
(ii) [********]
(iii) [********]
(c) Once GENZYME has made any particular milestone payment under Section 8(a) or 8(b), GENZYME will not be obligated to make any payment with respect to the re-occurrence of the same milestone.
9. Miscellaneous .
(a) This ASSIGNMENT, SUBLICENSE AND AMENDMENT shall be binding upon and shall inure to the benefit of the parties hereto, their respective successors, assigns, and legal representatives. Neither this ASSIGNMENT, SUBLICENSE AND AMENDMENT nor any interest or obligation hereunder is assignable (i) by EXACT without the prior written consent of GENZYME , provided, however, that EXACT shall be free to
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
6
assign this ASSIGNMENT, SUBLICENSE AND AMENDMENT in connection with any merger, reorganization, or transfer of all or substantially all assets of EXACT or other change in control of EXACT; (ii) by GENZYME, other than in connection with an assignment of the AGREEMENT permitted under Section 10.8 of the AGREEMENT (Successors and Assigns).
(b) This ASSIGNMENT, SUBLICENSE AND AMENDMENT may not be orally changed, modified or terminated, nor shall any oral waiver of any of its terms be effective. This ASSIGNMENT, SUBLICENSE AND AMENDMENT may be changed, modified or terminated only by an agreement in writing signed by EXACT, JHU and GENZYME.
(c) This ASSIGNMENT, SUBLICENSE AND AMENDMENT may be executed in separate and several counterparts, each of which shall be an original, but which together shall constitute one and the same instrument.
(d) This ASSIGNMENT, SUBLICENSE AND AMENDMENT will only supersede the AGREEMENT to the extent that this Amendment and the AGREEMENT conflict. In the event of a conflict between this ASSIGNMENT, SUBLICENSE AND AMENDMENT and the AGREEMENT, then this ASSIGNMENT, SUBLICENSE AND AMENDMENT will control. Except as otherwise provided in this ASSIGNMENT, SUBLICENSE AND AMENDMENT, all terms of the AGREEMENT shall remain in full force and effect.
(e) This ASSIGNMENT, SUBLICENSE AND AMENDMENT, and all disputes, actions or proceedings arising out of or relating to this ASSIGNMENT, SUBLICENSE AND AMENDMENT, shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to its conflict of laws provisions.
[Remainder of Page Intentionally Left Blank]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
7
IN WITNESS WHEREOF, each of the undersigned has executed this Assignment, Sublicense, Consent and Eighth Amendment to License Agreement as of the date first set forth above.
|
EXACT SCIENCES CORPORATION |
|
|
|
|
|
|
|
|
By: |
/s/ Jeffrey R. Luber |
|
|
Name: Jeffrey R. Luber |
|
|
Title: President and Chief Executive Officer |
|
|
|
|
|
|
|
JOHNS HOPKINS UNIVERSITY |
|
|
|
|
|
|
|
|
By: |
/s/ Wesley D. Blakeslee |
|
|
Name: Wesley D. Blakeslee |
|
|
Title: Executive Director |
|
|
|
|
|
|
|
GENZYME CORPORATION |
|
|
|
|
|
|
|
|
By: |
/s/ Earl M. Collier, Jr. |
|
|
Name: Earl M. Collier, Jr. |
|
|
Title: Executive Vice President |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
Exhibit 1
Amendments to AGREEMENT:
· Second Amendment, effective as of November 9, 2004
· Third Amendment, effective as of May 11, 2006
· Fourth Amendment, effective as of March 19, 2007
· Fifth Amendment, effective as of October 17, 2008
· Sixth Amendment, effective as of October 30, 2008
· Seventh Amendment, effective as of December 15, 2008
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
Exhibit 10.3
AMENDED AND RESTATED LICENSE AGREEMENT
by and between
GENZYME CORPORATION
and
EXACT SCIENCES CORPORATION
(formerly EXACT LABORATORIES, INC.)
January 27, 2009
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
i
TABLE OF CONTENTS
|
Page |
|
|
ARTICLE 1. DEFINITIONS |
1 |
|
|
ARTICLE 2. LICENSE GRANT AND WAIVER |
6 |
|
|
ARTICLE 3. DILIGENCE |
7 |
|
|
ARTICLE 4. PAYMENTS |
7 |
|
|
ARTICLE 5. REPORTS AND RECORDS |
12 |
|
|
ARTICLE 6. PATENT PROSECUTION; INFRINGEMENT |
13 |
|
|
ARTICLE 7. TERM AND TERMINATION |
15 |
|
|
ARTICLE 8. INDEMNIFICATION AND INSURANCE |
18 |
|
|
ARTICLE 9. REPRESENTATIONS, WARRANTIES AND DISCLAIMERS |
21 |
|
|
ARTICLE 10. NOTICES |
22 |
|
|
ARTICLE 11. ARBITRATION |
23 |
|
|
ARTICLE 12. RESTRICTIONS ON USE OF NAMES |
25 |
|
|
ARTICLE 13. CONFIDENTIALITY |
25 |
|
|
ARTICLE 14. PATENT MARKING |
26 |
|
|
ARTICLE 15. INDEPENDENT CONTRACTOR |
26 |
|
|
ARTICLE 16. SEVERABILITY |
27 |
|
|
ARTICLE 17. NON-ASSIGNABILITY |
27 |
|
|
ARTICLE 18. NON-SOLICITATION |
27 |
|
|
ARTICLE 19. ENTIRE AGREEMENT |
27 |
|
|
ARTICLE 20. MODIFICATIONS IN WRITING |
28 |
|
|
ARTICLE 21. GOVERNING LAW |
28 |
|
|
ARTICLE 22. CAPTIONS |
28 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
ii
ARTICLE 23. CONSTRUCTION |
28 |
|
|
ARTICLE 24. COUNTERPARTS |
28 |
|
|
ARTICLE 25. BINDING EFFECT |
28 |
|
|
ARTICLE 26. FORCE MAJEURE |
28 |
|
|
ARTICLE 27. JHU LICENSE AGREEMENT |
29 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
iii
AMENDED AND RESTATED LICENSE AGREEMENT
THIS AMENDED AND RESTATED LICENSE AGREEMENT effective as of the Closing Date (defined below) (the Effective Date ) is by and between Genzyme Corporation, a Massachusetts corporation having its principal offices at 500 Kendall Street, Cambridge, MA 02142 ( Genzyme ), through Genzymes Genetics Division (formerly through its Molecular Oncology Division), and EXACT Sciences Corporation (formerly EXACT Laboratories, Inc.), a Delaware corporation having its principal offices at 100 Campus Drive, Marlborough, MA 01752 ( EXACT ).
WITNESSETH:
WHEREAS, the parties have entered into a License Agreement effective as of March 25, 1999 (the License Agreement ) under which Genzyme granted to EXACT a license to certain patent rights;
WHEREAS, the parties expect to enter into a Collaboration, License and Purchase Agreement (the CLP Agreement ) contemporaneously with entering into this Agreement, and the parties acknowledge that the execution of the CLP Agreement is a precondition for the parties to be bound to this Agreement;
WHEREAS, Genzyme desires to waive any and all breaches of the License Agreement by EXACT that may have occurred (including any and all amounts due Genzyme thereunder), and release EXACT from any liability arising therefrom;
WHEREAS, the parties desire to amend and restate the License Agreement, effective as of the Effective Date;
NOW THEREFORE, in consideration of the mutual covenants herein contained and intending to be legally bound hereby, the parties hereto agree to amend and restate the License Agreement to read in its entirety as follows:
ARTICLE 1. DEFINITIONS
1.1. Affiliate shall mean any corporation or other entity which controls, is controlled by, or is under common control with EXACT. A corporation or other entity shall be regarded as in control of another corporation or entity if it owns or directly or indirectly controls more than fifty percent (50%) of the voting stock or other ownership interest of the other corporation or entity, or if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity or the power to elect or appoint more than fifty percent (50%) of the members of the governing body of the corporation or other entity.
1.2. Agreement shall mean this Amended and Restated License Agreement, together with all Appendices, Schedules and other attachments hereto.
1.3. Change of Control of EXACT has meaning given to it in the CLP Agreement.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
1
1.4. Closing Date has the meaning given to it in the CLP Agreement.
1.5. Diagnostic Service(s) shall mean the performance of laboratory-based assays covered in whole or in part by a Valid Claim of the Patent Rights.
1.6. FDA Approval means either 510(k) clearance or approval of a Pre-Marketing Authorization application ( PMA ) (or the equivalent of such submissions required at such time) for a Kit from the FDA or any equivalent foreign regulatory agency or body. FDA Approved has the correlative meaning.
1.7. Field shall mean (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 Approved 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.
1.8. First Commercial Sale shall mean, after the Effective Date, (a) the first performance for consideration of a Diagnostic Service in the Field or (b) the first sale for consideration of a Licensed Reagent or Kit for use in the Field, as applicable. Any performance of a Diagnostic Service or transfer of Licensed Reagents or Kits by EXACT solely for purposes of performing Research shall not be deemed to constitute a First Commercial Sale.
1.9. Gene Patent Rights shall mean the United States and foreign patents and patent applications relating to the APC gene and/or the p53 gene and licensed (with the right to grant sublicenses) to Genzyme pursuant to the JHU License Agreement together with patents arising therefrom and any extensions, registrations, confirmations, reissues, divisions, continuations or continuations-in-part, re-examinations or renewals thereof, including without limitation the patents and patent applications listed in Appendix A hereto (which may be updated from time to time to include such additional patents and patent application that may arise therefrom); provided , however, that Gene Patent Rights expressly excludes any claims of such patents and patent applications that fall outside of the Field, including, without limitation, claims to antibodies, to the treatment, prevention or remedying of a gene deficiency, to purified proteins, or to DNA sequences other than those sequences that correspond to the p53 gene and the APC gene; provided further that DNA sequences which are (i) immediately adjacent to the p53 or APC genes and (ii) necessary to the use of the p53 or APC genes, respectively, in the Field shall be considered within the Gene Patent Rights.
1.10. Instrument shall mean any instrument, apparatus, appliance, automated system or computer software that is covered in whole or in part by a Valid Claim of the Patent Rights and is useful or necessary for performing laboratory-based assays.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
2
1.11. JHU License Agreement shall mean the License Agreement dated as of February 5, 1992 by and between Genzyme (as successor to PharmaGenics, Inc.), The Johns Hopkins University ( JHU ) and Hoffman-La Roche Inc. ( Roche ), as amended from time to time.
1.12. Kit shall mean a collection of one or more Reagents, including at least one Licensed Reagent, packaged in the form of a kit (including an FDA Approved kit).
1.13. Licensed Reagent shall mean any Reagent covered in whole or in part by a Valid Claim of the Patent Rights.
1.14. Methodology Patent Rights shall mean the United States and foreign patents and patent applications relating to methods of detecting mammalian nucleic acids isolated from stool specimens and reagents therefor and licensed (with the right to grant sublicenses) to Genzyme pursuant to the JHU License Agreement together with patents resulting therefrom and any extensions, registrations, confirmations, reissues, divisions, continuations or continuations-in-part, re-examinations or renewals thereof, including without limitation the patents and patent application listed in Appendix B hereto (which may be updated from time to time to include such additional patents and patent applications that may arise therefrom).
1.15. (a) Net Sales shall mean the adjusted gross sales of Licensed Reagents and Kits by EXACT less [********] of adjusted gross sales in lieu of items such as custom duties, inbound transportation, insurance costs, agents commission, bad debts, etc. The adjusted gross sales shall mean the actual gross sales price of a Licensed Reagent or Kit billed by EXACT (not including miscellaneous items on the invoice such as taxes, etc.) less chargebacks, cash discounts, credits or allowances (not including miscellaneous items credited such as taxes, etc.) including those incurred or granted on account of price adjustments, rejections, returns, rebates or recalls of Licensed Reagents or Kits previously sold. Net Sales does not include no charge samples to the extent customary in the trade.
(b) In the event that EXACT decides to sell a Kit which combines Licensed Reagents with ingredients or components which are not Licensed Reagents (such other ingredients or components being Other Items ), then (i) EXACT shall notify Genzyme in writing of its intent to offer such combination, (ii) Genzyme and EXACT shall, within thirty (30) days after Genzymes receipt of such notification, initiate good-faith negotiations on the value of the Licensed Reagents which shall be used as the basis to calculate Net Sales pursuant to this clause (b) and (iii) if the parties can not reach agreement within thirty (30) days after the commencement of such negotiations, such dispute shall be referred to arbitration pursuant to Article 11 hereof. However, in no event shall the royalty rates on Net Sales be reduced by more than [********]. The term Other Items does not include solvents, diluents, carriers, excipients, enzymes used in amplification for diagnostic use, or the like used in formulating a product.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
3
(c) In the event that a Licensed Reagent or Kit is sold for non-monetary consideration in addition to or in lieu of money, the value of such consideration to the extent that it can be reasonably determined by EXACT shall be added to Net Sales in accordance with Sections 1.15 (a) and (b) hereof.
(d) No deductions shall be made for commissions paid to individuals whether they be with independent sales agencies or regularly employed by EXACT and on its payroll, or for cost of collections.
(e) Net Sales expressly excludes transfers or dispositions of Licensed Reagents or Kits at cost or less than cost for the sole purpose of conducting Research.
1.16. (a) Net Service Revenues shall mean actual billings by EXACT for the performance of Diagnostic Services less the following deductions to the extent that they are applicable and are not already deducted in the actual billings: (i) discounts allowed and taken, in amounts customary in the trade; (ii) sales and/or use taxes and/or duties imposed upon and with specific reference to particular sales.
(b) If a Diagnostic Service(s) is offered in combination with another diagnostic or other service(s) (such as patient counseling) provided by EXACT (such other services being referred to as Other Services and such Diagnostic Service(s) and Other Services collectively being referred to as Combination Services ), Net Service Revenues for purposes of determining royalties on the Diagnostic Service(s) shall be calculated as provided below:
(i) If the Diagnostic Service(s) and the Other Services are sold or provided separately, Net Service Revenues shall be calculated by multiplying the Net Service Revenues of the Combination Service (as determined in accordance with Section 1.16(a) above but applied to the Combination Service), by the fraction A/(A+B), where A is the invoice price of the Diagnostic Service(s) and B is the invoice price of the Other Services in the Combination Service if sold or provided separately.
(ii) If the Diagnostic Service(s) are sold or provided separately but the Other Services are not, Net Service Revenues shall be calculated by multiplying the Net Service Revenues of the Combination Service (as determined in accordance with Section 1.16(a) above but applied to the Combination Service), by the fraction A/C, where A is the invoice price of the Diagnostic Service(s) and C is the invoice price of the Combination Service.
(iii) If the Diagnostic Service(s) and the Other Services in the combination are not sold or provided separately, Net Service Revenues for purpose of determining royalties on the Diagnostic Service(s) shall be calculated by multiplying Net Service Revenues of the Combination Service (as determined in accordance with Section 1.16(a) above but applied to the
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
4
Combination Service) by the fraction E/(E+D), where E is the value of the Diagnostic Service(s) and D is the reasonably estimated value (using accepted diagnostic industry standards) of the Other Services based at least in part on the value of the other active component or components used in the Combination Service; provided, that (A) EXACT shall notify Genzyme in writing of its intent to offer such Combination Services, (B) Genzyme and EXACT shall, within thirty (30) days after Genzymes receipt of such notification, initiate good-faith negotiations on the value of the Diagnostic Service(s) and Other Services which shall be used as the basis to calculate Net Service Revenues pursuant to this clause (iii) and (C) if the parties can not reach agreement within thirty (30) days after the commencement of such negotiations, such dispute shall be referred to arbitration pursuant to Article 11 hereof.
(c) In the event that a Diagnostic Service is provided for non-monetary consideration in addition to or in lieu of money, the value of such non-monetary consideration to the extent that it can be reasonably determined by EXACT shall be added to Net Service Revenues in accordance with Sections 1.16(a) and (b) hereof.
(d) Net Service Revenues expressly excludes the use or performance of Diagnostic Services at cost or less than cost for the sole purpose of conducting Research.
1.17. Original Effective Date shall mean March 25, 1999.
1.18. Patent Rights shall mean collectively the Gene Patent Rights and the Methodology Patent Rights.
1.19. Reagents shall mean reagents useful in or necessary to the performance of laboratory-based assays, whether used individually or sold or used as one or more component(s) of a kit.
1.20. Research shall mean pre-clinical, clinical and regulatory activities conducted by or on behalf of EXACT to develop, evaluate, and obtain regulatory approvals of, products or services utilizing the Patent Rights licensed to EXACT hereunder.
1.21. Triggering Event means [********].
1.22. Valid Claim shall mean an issued claim of an unexpired patent, or a claim of a pending patent application, which shall not have been withdrawn, canceled or disclaimed, or held invalid or unenforceable by a court of competent jurisdiction in an unappealed or unappealable decision. Notwithstanding the foregoing to the contrary, a claim of a pending patent application, divisional application, or continuation-in-part application, or the foreign equivalents thereof, shall cease to be a Valid Claim if no patent has issued on such claim on or prior to the fifth (5th) anniversary of the date of filing such patent application (or, in the case of a continuation application or foreign equivalent thereof, the date of filing of the earliest parent application), provided that such claim shall once again
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
5
become a Valid Claim on the issue date of a patent that subsequently issues and includes such claim.
ARTICLE 2. LICENSE GRANT AND WAIVER
2.1. Genzyme hereby grants to EXACT, subject to all the terms and conditions of this Agreement, a worldwide, nonexclusive right and license (without the right to grant sublicenses) under the Patent Rights to: (a) use, offer to sell, sell and practice Diagnostic Services in the Field; (b) make, have made, use, offer to sell, sell and import Licensed Reagents in the Field; and (c) make, have made, use, offer to sell, sell and import Kits in the Field. Notwithstanding the foregoing, Genzyme hereby grants to EXACT the worldwide, non-exclusive right to convey to the end-user (purchaser) of FDA Approved Kits manufactured by EXACT the right to perform Diagnostic Services solely in conjunction with the use of FDA Approved Kits manufactured by or on behalf of EXACT (without the right to grant sublicenses).
2.2. The license granted hereunder shall not extend to Instruments. In the event that Genzyme becomes aware of any Instruments, Genzyme shall deliver written notice thereof to EXACT. In the event that after the Original Effective Date EXACT decides in good faith to develop Instruments for use in the Field and delivers written notice of such decision to Genzyme, Genzyme and EXACT shall, within thirty (30) days after Genzymes receipt of such notification from EXACT, enter into good faith negotiations for a worldwide, non-exclusive license (without the right to grant sublicenses) to be granted by Genzyme to EXACT under the Patent Rights to make, use, offer to sell, sell and import Instruments in the Field. Any such license shall include commercially reasonable terms and conditions. In the event that Genzyme and EXACT are unable to reach agreement on the terms of any such license within ninety (90) days after the date Genzyme and EXACT commence negotiations for such license, then the dispute shall be immediately referred to one (1) executive officer of each party, chosen at the sole discretion of that party, who shall negotiate in good faith with each other to resolve the dispute during the period ending thirty (30) days after the date of such referral. If the designated officers of the parties are unable to resolve the dispute within such thirty (30) day period, the dispute shall be referred to arbitration pursuant to Article 11 hereof.
2.3. Each party (the Granting Party ) hereby grants to the other party (the Recipient ) a one-time waiver of any and all rights the Granting Party may have based on any breaches of the License Agreement by the Recipient that occurred prior to the Effective Date of this Agreement, including any and all amounts due to the Granting Party under the License Agreement, and further including any and all obligations of the Recipient that may be interpreted to have accrued under this Agreement prior to the Effective Date, in each case whether or not known to the Granting Party. In the case of a breach by the Recipient that first occurred prior to the Effective Date, but such breach continues after the Effective Date, the waiver and release granted in the prior sentence will only apply to the extent that the breach occurred prior to the Effective Date, provided that such waiver and release shall apply in connection with the disclosure by EXACT of the terms of the License Agreement with the Securities and Exchange Commission prior to the Effective Date as a result of the expiration of the confidential treatment request filed with the Securities and Exchange Commission for the License Agreement. The Granting Party will not assert any, and hereby releases the Recipient and its Affiliates, and their officers, directors, employees, agents, trustees, successors and assigns, from any and all, claims,
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
6
rights, demands, actions, causes of action, suits, damages, losses, liabilities, obligations, matters and issues arising from any such breaches. This Section 2.3 shall apply to the Granting Party, the Granting Partys Affiliates and their successors and assigns.
ARTICLE 3. DILIGENCE
3.1. EXACT agrees to use commercially reasonable efforts to make (i) Diagnostic Services,(ii) Licensed Reagents and (iii) Kits available for the benefit of the general public consistent with regulatory compliance and public safety.
3.2. EXACTs material failure to perform in accordance with any subsection of Section 3.1 above shall be grounds for Genzyme to terminate the license under Section 2.1 above with respect to Diagnostic Services, Licensed Reagents or Kits, as applicable, pursuant to Section 7.8 hereof by delivering written notice of its intention to terminate to EXACT. If EXACT disputes Genzymes determination, (i) EXACT shall deliver written notice of such dispute within ten (10) business days after its receipt of notice from Genzyme of its intent to terminate, (ii) the matter shall be referred to arbitration pursuant to Article 11hereof and (iii) EXACTs license under Section 2.1 above to the Diagnostic Services, Licensed Reagents or Kits, as applicable, and EXACTs obligations with respect thereto shall continue in full force and effect until the resolution of such arbitration.
3.3. Within thirty (30) days after the Original Effective Date and subsequently no later than May 1 and November 1 of each year, commencing on November 1, 1999, EXACT shall provide a written report to Genzyme on its research, development and commercialization efforts with respect to (i) Diagnostic Services, (ii)Licensed Reagents and (iii) Kits (each individually), which report shall cite specific goals and objectives in researching, developing and commercializing the licensed technology and methodology and progress in meeting these goals and objectives. If Genzyme does not receive any such report(s) in a timely manner, it shall notify EXACT of such delinquency in writing. EXACT shall have thirty (30) days from its receipt of such notice to provide Genzyme with any and all overdue report(s). Failure by EXACT to provide such overdue report(s) within said thirty (30) day period may constitute grounds for termination of this Agreement by Genzyme as provided for in Section 7.5 hereof; provided , however , that the number of days elapsed since EXACT first received notice from Genzyme of the delinquent reports shall be counted for purposes of determining the sixty (60) day period described in Section 7.5 hereof.
ARTICLE 4. PAYMENTS
4.1. In partial consideration for the license granted hereunder, and upon the Original Effective Date, EXACT agrees to pay Genzyme [********], which amount shall not be creditable against any other amounts payable by EXACT to Genzyme hereunder. Such [********] payment has been made and no further upfront payment is due upon the Effective Date.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
7
4.2. EXACT shall pay to Genzyme during the term of this Agreement a royalty calculated as follows:
(a) before a total of [********] tests on individual patient samples in the aggregate have been sold by EXACT, whether sold by EXACT as Diagnostic Services or sold by or on behalf of EXACT as part of Licensed Reagents or Kits manufactured by or on behalf of EXACT,
(i) if the average gross sale price of such Diagnostic Services, Licensed Reagents or Kits is equal to or greater than [********], then the royalty shall be (i) the greater of [********] of Net Service Revenue worldwide or [********] per Diagnostic Service sold by EXACT, plus (ii) the greater of [********] of Net Sales worldwide or [********] per test included in the Licensed Reagent or Kit sold by or on behalf of EXACT; and
(ii) if the average gross sale price of such Diagnostic Services, Licensed Reagents or Kits is less than [********], then the royalty shall be (i) [********] per Diagnostic Service sold by EXACT, plus (ii) [********] per test included in the Licensed Reagent or Kit sold by or on behalf of EXACT.
(b) after [********] tests on individual patient samples in the aggregate have been sold by EXACT, whether sold by EXACT as Diagnostic Services or sold by or on behalf of EXACT as part of Licensed Reagents or Kits manufactured by or on behalf of EXACT,
(i) if the average gross sale price of such Diagnostic Services, Licensed Reagents or Kits is equal to or greater than [********], then the royalty shall be (i) the greater of [********] of Net Service Revenue worldwide or [********] per Diagnostic Service sold by EXACT, plus (ii) the greater of [********] of Net Sales worldwide or [********] per test included in the Licensed Reagent or Kit sold by or on behalf of EXACT; and
(ii) if the average gross sale price of such Diagnostic Services, Licensed Reagents or Kits is less than [********], then the royalty shall be (i) [********] per Diagnostic Service sold by EXACT, plus (ii) [********] per test included in the Licensed Reagent or Kit sold by or on behalf of EXACT.
(c) for revenue, other than Net Sales and Net Services Revenue, generated by EXACT by exploiting the rights granted by Genzyme under this Agreement, [********] of such revenue.
For clarity, (i) the foregoing royalties and the milestones set forth in Section 4.5 that are applicable to Diagnostic Services shall only apply to Diagnostic Services performed by EXACT and not by end-users (purchasers) and (ii) for purposes of this Section 4.2, the
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
8
average gross sales price of Licensed Reagents and Kits shall be calculated over the applicable calendar quarter for which royalties are payable.
4.3. (a) With respect to the licenses granted for Diagnostic Services, EXACT shall pay Genzyme a minimum royalty of, (i) before a Triggering Event has occurred, [********] per year, (ii) if a Triggering Event has occurred at any time prior to the [********] anniversary of the Effective Date of this Agreement, [********] per year, (iii) if a Triggering Event has occurred at any time on or after the [********] anniversary of the Effective Date and prior to the [********] anniversary of the Effective Date, [********] per year, and (iv) if a Triggering Event has occurred at any time on or after the [********] anniversary of the Effective Date, [********] per year. In each case, the minimum royalty will be payable on January 1 of each year with respect to the licenses granted for Diagnostic Services; provided , however , that the minimum royalty for a given year shall be creditable against any royalties subsequently due during said year under Section 4.2. For clarity, if a Triggering Event occurs in such a year, the applicable minimum royalty described in clauses (ii) through (iv) in this Section 4.3(a) shall not apply until January 1 of the year following the occurrence of such Triggering Event, unless such Triggering Event occurs on January 1 of a year.
(b) With respect to the licenses granted for Licensed Reagents and Kits, EXACT shall pay Genzyme a minimum royalty of, (i) before a Triggering Event has occurred, [********] per year, (ii) if a Triggering Event has occurred at any time prior to the [********] anniversary of the Effective Date of this Agreement, [********] per year, (iii) if a Triggering Event has occurred at any time on or after the [********] anniversary of the Effective Date and prior to the [********] anniversary of the Effective Date, [********] per year, and (iv) if a Triggering Event has occurred at any time on or after the [********] anniversary of the Effective Date, [********] per year. In each case, the minimum royalty will be payable on January 1 of each year with respect to the licenses granted for Licensed Reagents and Kits; provided , however , that the minimum royalty for a given year shall be creditable against any royalties subsequently due during said year under Section 4.2. For clarity, if a Triggering Event occurs in such a year, the applicable minimum royalty described in clauses (ii) through (iv) in this Section 4.3(b) shall not apply until January 1 of the year following the occurrence of such Triggering Event, unless such Triggering Event occurs on January 1 of a year.
(c) Waiver or deferral of any minimum royalty payment by Genzyme shall not be construed as waiver or deferral of any such subsequent payment.
4.4. (a) In the event that the First Commercial Sale of a Diagnostic Service by EXACT has not occurred within [********] after the Effective Date, EXACT shall pay Genzyme an annual maintenance fee of [********] payable on each anniversary of the Effective Date commencing with the [********] anniversary of the Effective Date; provided , however , that if EXACT has submitted a bona fide application to the U.S. Food and Drug Administration or the equivalent authority at that time ( FDA ) to obtain final marketing approval for a Diagnostic Service within said [********] period and EXACTs failure to make such First Commercial Sale is due to delays in obtaining such approval that are
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
9
caused by the FDA and are not related to a substantial deficit in said application, then Genzyme may elect, in its sole discretion, acting reasonably, to extend said [********] period and shall notify EXACT in writing of any such determination and election and of the amount of time by which such period has been extended; provided further that if the parties disagree as to whether said application contained a substantial deficit and the time for resolution of such deficit, the dispute shall be referred to arbitration pursuant to Article 11 hereof and, until final resolution of the dispute, EXACT shall deposit any amounts otherwise due and payable to Genzyme under this Section4.4(a) into an escrow account established by EXACT exclusively for such purpose in a recognized commercial banking institution reasonably selected by EXACT and promptly identified by written notice from EXACT to Genzyme. If the arbitrator resolves the dispute in favor of Genzyme, then the amounts held in escrow plus all interest accrued thereon shall be promptly paid to Genzyme in same day funds. Amount payable under this Section 4.4(a) shall not be creditable against any royalties or other payments due during said year under this Article 4. Waiver or deferral of any maintenance fee by Genzyme shall not be construed as waiver or deferral of any such subsequent payment.
(b) In the event that the First Commercial Sale of a Kit by EXACT has not occurred within [********] after the Effective Date and the license granted pursuant to Section 2.1 (c) hereof has not been terminated by Genzyme pursuant to Section 7.7 hereof, EXACT shall pay Genzyme an annual maintenance fee of [********] payable on each anniversary of the Effective Date commencing with the [********] anniversary of the Effective Date; provided , however , that if EXACT has submitted a bona fide application to the FDA to obtain final marketing approval for a Kit prior to [********] and EXACTs failure to make such First Commercial Sale is due to delays in obtaining such approval that are caused by the FDA and are not related to a substantial deficit in said application, then Genzyme may elect, in its sole discretion, acting reasonably, to extend said [********] period and shall notify EXACT in writing of any such determination and election and of the amount of time by which such period has been extended; provided further that if the parties disagree as to whether said application contained a substantial deficit and the time for resolution of such deficit, the dispute shall be referred to arbitration pursuant to Article 11 hereof and, until final resolution of the dispute, EXACT shall deposit any amounts otherwise due and payable to Genzyme under this Section 4.4(b) into an escrow account established by EXACT exclusively for such purpose in a recognized commercial banking institution reasonably selected by EXACT and promptly identified by written notice from EXACT to Genzyme. If the arbitrator resolves the dispute in favor of Genzyme, then the amounts held in escrow plus all interest accrued thereon shall be promptly paid to Genzyme in same day funds. Amount payable under this Section 4.4(b) shall not be creditable against any royalties or other payments due during said year under this Article 4. Waiver or deferral of any maintenance fee by Genzyme shall not be construed as waiver or deferral of any such subsequent payment.
4.5. (a) EXACT shall pay Genzyme a one-time milestone payment in the amount of [********] within [********] after first receiving FDA Approval. Such amount shall not be creditable against any royalties or other payments due under this Article 4.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
10
(b) EXACT shall pay Genzyme a one-time milestone payment in the amount of [********] within [********] after EXACT has sold [********] tests on individual patient samples in the aggregate, whether sold as Diagnostic Services or as part of Licensed Reagents or Kits.
(c) EXACT shall pay Genzyme a one-time milestone payment in the amount of [********] within [********] after EXACT has sold [********] tests on individual patient samples in the aggregate, whether sold as Diagnostic Services or as part of Licensed Reagents or Kits.
(d) For clarification, once EXACT has made any particular milestone payment under this Section 4.5, EXACT will not be obligated to make any payment under this Section 4.5 with respect to the reoccurrence of the same milestone.
4.6. Payment of royalties specified in Section 4.2 shall be made by EXACT to Genzyme within forty-five (45) days after March 31, June 30, September 30 and December 31 each year during the term of this Agreement covering Net Sales and Net Service Revenues during the preceding calendar quarter. The last such payment shall be made within forty-five (45) days after the expiration or earlier termination of this Agreement.
4.7. No multiple royalties shall be payable on any Diagnostic Service, Licensed Reagent or Kit because such Diagnostic Service, Licensed Reagent or Kit or its practice, manufacture, use, importation or sale is or shall be covered by more than one of the Patent Rights.
4.8. All payments to be made under this Article 4 shall be paid in United States dollars, in Boston, Massachusetts or at such other place and in such other way as Genzyme may reasonably designate in writing, without deduction of exchange, collection or other charges. Conversion of foreign currency into United States dollars shall be calculated using the applicable exchange rate as published in The Wall Street Journal on the date that the payment is first due and payable. If by law, regulation or fiscal policy of a particular country, conversion into United States dollars or transfers of funds of a convertible currency to the Untied States is restricted or forbidden, EXACT shall give Genzyme prompt written notice of such restriction or prohibition, which notice shall satisfy the forty-five (45) day payment deadline set forth in Section 4.6. EXACT shall pay any amounts due to Genzyme through whatever lawful methods Genzyme reasonably designates in writing; provided , however , that if Genzyme fails to designate such payment method within thirty (30) days after Genzyme is notified of the restriction, EXACT may deposit such payment in local currency to the credit of Genzyme in a recognized commercial banking institution reasonably selected by EXACT and promptly identified by written notice from EXACT to Genzyme, and such deposit shall fulfill all obligations of EXACT to Genzyme with respect to such payment.
4.9. In the event that any payment due hereunder is not made when due, the payment shall accrue interest beginning on the first day following the due date as herein specified, calculated at the annual rate of the sum of [********], the interest being compounded on
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
11
the last day of each calendar quarter; provided, that in no event shall said annual rate exceed the maximum legal interest rate in Massachusetts. The payment of such interest shall not foreclose Genzyme from exercising any other rights it may have as a consequence of the lateness of any payment.
4.10. Royalty payments and other payments due to Genzyme under this Agreement shall not be reduced by reason of any withholding or similar taxes applicable to such payments to Genzyme.
4.11. [********]
ARTICLE 5. REPORTS AND RECORDS
5.1. EXACT shall maintain true, accurate and complete books of account, records and files containing an accurate record of all data reasonably necessary for the full computation and verification of sales and the determination of the amounts payable under Article 4 hereof for a period of at least four (4) years following the period of each report required by Section 5.2 below. Said books and records shall be kept at EXACTs principal place of business and shall be in accordance with generally accepted accounting principles, consistently applied. Said books and records, to the extent not previously audited, shall be available for inspection by an independent certified public accountant selected by Genzyme (or its licensor of the Patent Rights) and reasonably acceptable to EXACT, upon ten (10) business days advance written notice and during regular business hours, for three (3) years following the end of the calendar year to which they pertain in order to enable Genzyme (or its licensor of the Patent Rights) to ascertain the correctness of any report and/or payment made under this Agreement. Such inspections may be conducted no more than once in any twelve (12) month period and, except as provided below, shall be conducted at the expense of Genzyme (or its licensor, as the case may be). If such examination reveals that royalties have been misstated, any adjustment shall be promptly refunded or paid, as appropriate. Genzyme (or its licensor, as the case may be) shall pay the fees and expenses of the accountant engaged to perform the audit, unless such audit reveals an underpayment of five percent (5%) or more for the period examined, in which case EXACT shall pay all reasonable costs and expenses incurred by Genzyme (or its
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
12
licensor, as the case may be) in the course of making such determination, including without limitation the fees and expenses of the accountant.
5.2. Within forty-five (45) days after March 31, June 30, September 30 and December 31, of each year in which this Agreement is in effect, EXACT shall deliver to Genzyme full, true and accurate reports of its activities relating to this Agreement during the preceding three month period. These reports shall include at least the following:
(a) the total actual billings for Diagnostic Services on a country-by-country basis during the applicable period;
(b) the total gross sales of Licensed Reagents and Kits, each individually, on a country-by-country basis during the applicable period;
(c) the calculation of Net Service Revenues and Net Sales on a country-by-country basis for the applicable period, including a detailed listing of the applicable deductions permitted under Sections 1.15 and 1.16 hereof on an item-by-item basis and a detailed explanation of the calculation of Net Service Revenues and Net Sales of any Combination Services or combination products; and
(d) the calculation of total royalties due in U.S. dollars, together with the exchange rates used for conversion, to the extent applicable.
5.3. With each such report, EXACT shall pay to Genzyme the royalties due and payable as provided for in Section 4.2. To the extent that royalties for the applicable period are creditable against minimum royalties paid pursuant to Section 4.3 hereof, EXACT shall so report. If no royalties are due, EXACT shall so report.
ARTICLE 6. PATENT PROSECUTION; INFRINGEMENT
6.1. The prosecution, filing and maintenance of all patents and the expense thereof shall be the responsibility of Genzyme (and/or its licensor of the Patent Rights).
6.2. (a) EXACT agrees to provide Genzyme with prompt written notice after becoming aware of any infringement of any of the Patent Rights.
(b) Genzyme (or its licensor, as the case may be) shall have the right, under its control and at its expense, to prosecute any third party infringement of the Patent Rights or to defend the Patent Rights in any declaratory judgment action brought by a third party which alleges the invalidity, unenforceability or non-infringement of any Patent Right. EXACT agrees to cooperate fully in any action under this Section 6.2, provided that Genzyme (or its licensor, as the case may be) reimburses EXACT for its reasonable costs and expenses incurred in connection with providing such assistance.
(c) In the event that
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
13
(i) EXACT notifies Genzyme that a third party is conducting activities in the Field that infringe the Patent Rights in any country,
(ii) said third party continues to infringe for [********] after receipt by Genzyme of such notice and does not obtain a license from Genzyme under the applicable Patent Rights within such period, and
(iii) EXACT can demonstrate to Genzymes reasonable satisfaction through written documentation that (A) EXACT has Net Sales or Net Service Revenues in one or more countries in which there is any Valid Claim within the Patent Rights, and (B) the infringing activities of said third party have resulted in annualized income to said third party equal to or greater than (x) [********] worldwide in countries in which there is any Valid Claim within the Patent Rights (determined based on Net Sales or Net Service Revenues of the [********]) or (y) [********] of EXACTs annualized Net Sales or Net Service Revenues (as applicable) worldwide in countries in which there is any Valid Claim within the Patent Rights (determined based on Net Sales or Net Service Revenues of the [********]), whichever is greater,
then, after making such a demonstration, EXACT may withhold up to [********] of the royalty payments that would otherwise be payable to Genzyme on Net Services Revenues from Diagnostic Services covered in whole or in part by the infringed Patent Rights or on Net Sales of Licensed Reagents or Kits covered in whole or in part by the infringed Patent Rights, as applicable, in such countries until such time as the infringement is abated; provided , however , that in the event that Genzyme (or its licensor, as the case may be) either (A) fails to use good faith efforts to undertake the prosecution of such third party infringement or otherwise Resolve such infringement within two hundred and forty (240) days after receipt by Genzyme of the notice delivered by EXACT pursuant to clause (c)(i) above or (B) delivers written notice to EXACT that Genzyme (or its licensor, as the case may be) does not intend to undertake the prosecution of such third party infringement, then EXACT may withhold [********] of the aforementioned royalty payments; provided further that, if EXACT withholds such royalty payments and Genzyme (or its licensor, as the case may be) either successfully Resolves such infringement or undertakes the prosecution of such third party infringement and obtains a favorable judgment, settlement, consent judgment or other final disposition of the suit, EXACT shall resume full payment of the aforementioned royalties due under this Agreement on Net Service Revenues and Net Sales in such countries upon receipt of either written notice of the successful abatement of such infringement by prosecution or Resolution signed by an officer of Genzyme or a copy of an official, written evidence of such favorable judgment, settlement, consent judgment or other final disposition; provided further that in the event that Genzyme (or its licensor, as the case may be) undertakes the prosecution of such infringement and obtains a favorable settlement, an order to dismiss shall constitute adequate official written evidence for purposes of this sentence. For purposes of this clause (c), Resolve(s) or Resolution means the cessation of such third party infringement other than as a result of prosecution, including
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
14
without limitation the grant of a nonexclusive license under the Patent Rights or the discontinuance by such third party of the infringing activities.
(d) If Genzyme notifies EXACT in writing within ten (10) days of receiving written documentation pursuant to Section 6.2(c)(iii) above that Genzyme is not reasonably satisfied that EXACT has demonstrated conditions sufficient to justify the withholding of royalty payments under Section 6.2(c) above, then, until final resolution of the dispute, EXACT shall deposit all withheld royalty payments otherwise due and payable to Genzyme into an escrow account established by EXACT exclusively for such purpose in a recognized commercial banking institution reasonably selected by EXACT and promptly identified by written notice from EXACT to Genzyme. If the parties are unable to resolve the dispute within thirty (30) days after EXACTs receipt of Genzymes notice, then the dispute shall immediately be referred to one (1) executive officer of each party, chosen in the sole discretion of that party, who shall negotiate with each other in good faith to resolve the dispute during the period ending thirty (30) days after the date of such referral. If the designated officers of the parties are unable to resolve the dispute within such thirty (30) day period, the dispute shall be referred to arbitration pursuant to Article 11 hereof. If such officers or the arbitrator, as applicable, resolves the dispute in favor of Genzyme, then the amounts held in escrow plus all interest accrued thereon shall be promptly paid to Genzyme in same day funds and EXACT shall resume full payment of royalties under this Agreement.
(e) In the event that EXACT withholds royalty payments pursuant to Section 6.2(c), EXACT shall include the amount of such withheld royalties and the basis for the calculation thereof on a country-by-country basis in the reports deliverable by EXACT to Genzyme pursuant to Section 5.2 hereof as distinct line items.
(f) EXACT hereby acknowledges and agrees that Roche has rights under the Patent Rights under an agreement with JHU and, therefore, activities by Roche in accordance with such agreement with JHU will not be subject to this Section 6.2.
ARTICLE 7. TERM AND TERMINATION
7.1. Unless earlier terminated as hereinafter provided, this Agreement shall remain in full force and effect until the expiration of the last to expire Patent Rights. Royalties on Net Service Revenues from Diagnostic Services and on Net Sales of Licensed Reagents and Kits covered by the Gene Patent Rights shall cease upon the expiration of the last to expire Gene Patent Right. Royalties on Net Service Revenues of Diagnostic Services and on Net Sales of Licensed Reagents and Kits covered by the Methodology Patent Rights shall cease upon the expiration of the last to expire Methodology Patent Right.
7.2. If (a) Genzyme, acting reasonably, determines that EXACT has ceased to carry on its business with respect to the performance of Diagnostic Services in the Field and/or the provision of Licensed Reagents and/or Kits in the Field in any country in North America or Europe for a period of more than [********] with no plan to resume such business within the following [********], then (b) Genzyme shall have the right to terminate this
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
15
Agreement and all rights, privileges and license hereunder granted with respect to such Diagnostic Services and/or Licensed Reagents and/or Kits, as applicable, upon [********] prior written notice to EXACT; provided , however , that if EXACT is temporarily unable to carry on such business due to a corporate reorganization or restructuring of EXACT, then the [********] time period set forth in clause (a) of this Section 7.2 shall be reasonably extended to accommodate such corporate circumstance by a period to be mutually agreed upon by the parties, which extension period shall not exceed [********]. Such termination shall become effective immediately upon the conclusion of such notice period unless EXACT shall have resumed such business in good faith prior to the expiration of such notice period.
7.3. Should EXACT fail to pay Genzyme any amounts as are due and payable hereunder, Genzyme shall have the right to terminate this Agreement upon forty-five (45) days prior written notice, unless EXACT shall pay Genzyme within said forty-five (45) day period such delinquent amounts and all interest due and payable thereon. If EXACT shall not have paid all such delinquent amounts and interest due and payable thereon within said period, Genzyme, at its sole option, may immediately terminate this Agreement and all rights, privileges and license hereunder granted.
7.4. EXACT shall have the right to terminate this Agreement and all rights, privileges and license hereunder granted at any time upon one hundred eighty (180) days prior written notice to Genzyme.
7.5. Upon any material breach or default of this Agreement by EXACT, other than those delineated in Sections 7.2 and 7.3, which shall always take precedence in that order over any material breach or default referred to in this Section 7.5, Genzyme shall have the right to terminate this Agreement and the rights, privileges and license hereunder granted upon sixty (60) days prior written notice to EXACT. Such termination shall become effective immediately at the conclusion of such notice period unless EXACT shall have cured any such breach or default prior to the expiration of said sixty (60) day period.
7.6. (a) If no royalties have been paid by EXACT with respect to any Diagnostic Service within [********] after the First Commercial Sale by EXACT of a Diagnostic Service, the rights, privileges and license granted under this Agreement to EXACT under Section2.1 (a) hereof shall automatically terminate.
(b) If no royalties have been paid by EXACT with respect to any Licensed Reagent within [********] after the First Commercial Sale of a Licensed Reagent, the rights, privileges and license granted under this Agreement to EXACT under Section 2.1 (b) hereof shall automatically terminate.
7.7. (a) If EXACT fails to make a 510(k) or PMA submission for a Kit to the FDA (or the equivalent of such submissions as may be required by the FDA at such time) on or before [********], Genzyme may, in its sole discretion, elect to terminate the rights, privileges and license granted under Section 2.1 (c) hereof in any or each country in which
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
16
Genzyme has Patent Rights unless such license grant is sooner terminated according to the terms of this Agreement.
(b) If EXACT fails to achieve annual Net Sales of Licensed Reagents and Kits for use in the Field of [********] or more within [********] after the First Commercial Sale of a Kit, Genzyme may, in its sole discretion, elect to terminate the rights, privileges and license granted under Section 2.1 (c) hereof in any and each country in which Genzyme has Patent Rights unless such license grant is sooner terminated according to the terms of this Agreement.
7.8. If EXACT materially fails to perform in accordance with clauses (i), (ii) or (iii) of Section 3.1 hereof, Genzyme may elect to terminate the rights, privileges and license granted under Section 2.1 with respect to the subject matter of the clause or clauses of Section 3.1 under which EXACT has materially failed to perform, as set forth in Section 3.2, hereof upon thirty (30) days prior written notice to EXACT. Notwithstanding the foregoing, any termination of the license granted under any one clause of Section 2.1 pursuant to this Section 7.8 will be effective only with respect to the subject matter of the clause of Section 3.1 under which EXACT has materially failed to perform, and the remaining clauses of Section 3.1 and the remaining rights granted under 2.1 shall be unaffected by such termination.
7.9. Upon any termination of this Agreement in its entirety or any of the rights, privileges and licenses granted under Section 2.1 hereof, EXACT shall be entitled to finish any work-in-progress and to sell any completed inventory of Licensed Reagents or Kits, as applicable, which remain on hand as of the date of the termination provided that EXACT pays Genzyme the royalties applicable to said subsequent sales in accordance with the terms and conditions set forth in this Agreement.
7.10. (a) In the event that Genzyme terminates this Agreement and the rights, privileges and licenses hereunder granted pursuant to Section 7.2 above, then Genzyme shall refund to EXACT the pro rata share of the amount equal to the sum of (i) any payment made by EXACT pursuant to Section 4.3 hereof on January 1 of the calendar year in which the effective date of such termination falls plus (ii) any payment made by EXACT pursuant to Section 4.4 hereof on the anniversary of the Original Effective Date immediately preceding the effective date of such termination plus (iii) one-half of any payment made by EXACT pursuant to Section 4.5 hereof if the license granted under Section 2.1 (c) is being terminated and if such payment was made by EXACT within the six (6) month period immediately preceding the effective date of such termination less (iv) the aggregate amount of any payments made by Genzyme to JHU in that Year under the JHU License Agreement based on the payments described in clauses (i), (ii) and (iii) above.
(b) In the event that Genzyme terminates the license granted under Section 2.1 (a) hereof with respect to Diagnostic Services pursuant to Section 7.6 or 7.8 hereof, then Genzyme shall refund to EXACT the pro rata share of the amount equal to the sum of (i) any payment made by EXACT pursuant to Section 4.3(a) hereof on January 1 of the calendar year in which the effective date of such termination falls plus (ii) any payment
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
17
made by EXACT pursuant to Section 4.4(a) hereof on the anniversary of the Original Effective Date immediately preceding the effective date of such termination less (iii) the amount of any payment made by Genzyme to JHU in that Year based on the payments described in clauses (i) and (ii) above.
(c) In the event that Genzyme terminates the rights, privileges and license granted under Section 2.1 (b) or (c) hereof with respect to Licensed Reagents and Kits pursuant to Sections 7.7 or 7.8 hereof, then Genzyme shall refund to EXACT the pro rata share of the amount equal to the sum of (i) any payment by EXACT to Genzyme pursuant to Section 4.3(b) hereof on January 1 in which the calendar year of the effective date of such termination falls plus (ii) any payment made by EXACT pursuant to Section 4.4(b) hereof on the anniversary of the Original Effective Date immediately preceding the effective date of such termination plus (iii) one-half of any payment made by EXACT pursuant Section 4.5 hereof to if the license granted under Section 2.1 (c) is being terminated and if such payment was made to Genzyme within six (6) months immediately preceding the effective date of such termination less (iv) the aggregate amount of any payments made by Genzyme to JHU in that Year based on the payments described in clauses (i), (ii) and (iii) above.
(d) The pro rata share of any amounts to be refunded by Genzyme pursuant to this Section 7.10 shall be determined based on either (i) the portion of the twelve (12) month period after said anniversary of the Original Effective Date or (ii) the portion of said calendar year, as applicable, during which this Agreement shall not be in effect. In no event shall any amounts be refundable by Genzyme to the extent they have been credited by Genzyme against royalties payable by EXACT in accordance with Sections 4.3 and/or 4.4 hereof. Interest paid to Genzyme pursuant to Section 4.9 hereof or on any amounts held in escrow during the pendency of a dispute shall not be included in the calculation of any amounts refundable by Genzyme.
(e) Any and all amounts refundable by Genzyme to EXACT pursuant to this Section 7.10 shall be paid to EXACT within thirty (30) days after the applicable effective date of the termination.
7.11. Upon the expiration or the earlier termination of this Agreement for any reason, nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such expiration or the termination. The provisions of Articles 5, 8, 10, 11, 13, 18 and 21, Section 4.6, 7.9, 7.10 and this Section 7.11 shall survive the expiration or earlier termination of this Agreement.
ARTICLE 8. INDEMNIFICATION AND INSURANCE
8.1. (a) Subject to the provisions of Section 8.3 hereof, EXACT shall indemnify, defend and hold harmless Genzyme, JHU, The John Hopkins Health System ( JHHS ) and their respective present and former officers, directors, trustees, employees, consultants, agents, students, faculty, treating and consulting physicians, inventors of the Patent Rights, subsidiaries, successors, heirs and assigns (collectively, the Genzyme Indemnitees )
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
18
against any liability, damage, loss or expense (including reasonable attorneys fees and expenses of litigation) incurred by or imposed upon the Genzyme Indemnitees, or any one of them, in connection with any claims, suits, actions, demands or judgments arising out of (i) the design, sale, use, manufacture or promotion by EXACT and its officers, directors, employees, representatives and agents, of any process, service or product relating to, or developed, manufactured, used or commercialized pursuant to, this Agreement and (ii) the practice and use of the Patent Rights by EXACT and its officers, directors, employees, representatives and agents.
(b) EXACTs indemnification under this Section 8.1 shall not apply to any liability, damage, loss or expense to the extent that it is directly attributable to the negligence, reckless misconduct or intentional misconduct of the Genzyme Indemnitees.
(c) EXACT agrees, at its own expense, to provide attorneys to defend against any actions brought or filed against any Genzyme Indemnitee with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought, such attorneys to be reasonably acceptable to Genzyme and not to be subject to any conflict of interest in representing any of the Genzyme Indemnitees nor to have been deemed within the preceding ten (10) years by any Genzyme Indemnitee to have provided unsatisfactory legal representation of such Genzyme Indemnitee.
8.2. (a) Subject to the provisions of Section 8.3 hereof Genzyme shall indemnify, defend and hold harmless EXACT and its present and former officers, directors, employees, agents, consultants, successors, heirs and assigns (collectively, the EXACT Indemnitees ) against any liability, damage, loss or expense (including reasonable attorneys fees and expenses of litigation) incurred by or imposed upon the EXACT Indemnitees, or anyone of them, in connection with any claims, suits, actions, demands or judgments arising out of (i) the design, sale, use, manufacture or promotion by Genzyme and its officers, directors, employees, representatives and agents, of any process, service or product utilizing the Patent Rights in the Field and (ii) the practice and use of the Patent Rights in the Field by Genzyme and its officers, directors, employees, representatives and agents.
(b) Genzymes indemnification under this Section 8.2 shall not apply to any liability, damage, loss or expense to the extent it is directly attributable to the negligence, reckless misconduct or intentional misconduct of the EXACT Indemnitees.
(c) Genzyme agrees, at its own expenses to provide attorneys to defend against any actions brought or filed against any EXACT Indemnitee with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought, such attorneys to be reasonably acceptable to EXACT and not to be subject to any conflict of interest in representing any of the EXACT Indemnitees not to have been deemed within the preceding ten (10) years by any EXACT Indemnitee to have provided unsatisfactory legal representation of such EXACT Indemnitee.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
19
8.3. In the event any such action is commenced or claim made or threatened against an indemnified party covered by Section 8.1 or 8.2 hereof, the indemnified party shall promptly notify the indemnifying party in writing of such event. The failure of indemnified party to deliver notice to the indemnifying party within a reasonable time after the commencement of any such action, if materially prejudicial to the ability of the indemnifying party to defend such action, shall relieve the indemnifying party of any liability to the indemnified party under this Article 8 solely with respect to such action, but the failure to deliver notice to the indemnifying party will not relieve it of any liability with respect to such action that it may have to the indemnified party otherwise than under this Article 8. The indemnifying party shall assume, with the reasonable cooperation of the indemnified party, the investigation and defense of, and may settle that part of, any such claim or action commenced or made against the indemnified party which relates to the indemnifying partys indemnification and the indemnifying party may take such other steps as may be necessary to protect itself. The indemnifying party shall not be liable to indemnified party on account of any settlement of any such claim or litigation affected without the indemnifying partys express written consent, which consent shall not be unreasonably withheld or delayed. The right of the indemnifying party to assume the defense of any action shall be limited to that part of the action commenced against an indemnified party which relates to the indemnifying partys obligation of indemnification and holding harmless.
8.4. (a) Beginning at such time as any Diagnostic Service, Licensed Reagent or Kit relating to, or developed pursuant to, this Agreement is being made available (other than for the purpose of obtaining regulatory approvals) by EXACT, EXACT shall, at its sole cost and expense, procure and maintain commercial general liability insurance, applicable worldwide, in amounts not less than [********] per incident and [********] annual aggregate and naming Indemnitees as additional insureds. Such commercial general liability insurance shall provide (i) product liability coverage and (ii) contractual liability coverage for EXACTs indemnification under Section 8.1 of this Agreement. If EXACT elects to self-insure all or part of the limits described above (including deductibles or retentions that are in excess of [********] annual aggregate) such self-insurance program must be acceptable to Genzyme. The minimum amounts of insurance coverage required under this Section 8.4(a) shall not be construed to create a limit of EXACTs liability with respect to its indemnification obligation under Section 8.1 of this Agreement.
(b) Genzyme shall, at its sole cost and expense, procure and maintain commercial general liability insurance, applicable worldwide, in amounts not less than [********] per incident and [********] annual aggregate and naming the EXACT Indemnitees as additional insureds. Such commercial general liability insurance shall provide (i) product liability coverage and (ii) contractual liability coverage for Genzymes indemnification under Section 8.2 of this Agreement. If Genzyme elects to self-insure all or part of the limits described above (including deductibles or retentions that are in excess of [********] annual aggregate) such self-insurance program must be acceptable to EXACT. The minimum amounts of insurance coverage required under this Section 8.4(a)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
20
shall not be construed to create a limit of Genzymes liability with respect to its indemnification obligation under Section 8.2 of this Agreement.
(c) Each party shall provide the other with written evidence of such insurance upon request of the other party. Each party shall provide the other with written notice at least thirty (30) days prior to the cancellation, non-renewal or material change in such insurance. If such party does not obtain replacement insurance providing comparable coverage within such thirty (30) day period, the other party shall have the right to terminate this Agreement and the rights, privileges and license granted hereunder effective at the end of such thirty (30) day period without any notice or additional waiting periods.
(d) Each party shall maintain such comprehensive general liability insurance beyond the expiration or termination of this Agreement during (a) the period that any process, service or product relating to, or developed pursuant to, this Agreement is being made available (other than for the purpose of obtaining regulatory approvals) by EXACT and (b) a reasonable period after the period referred to in clause (a) above which in no event shall be less than fifteen (15) years.
ARTICLE 9. REPRESENTATIONS, WARRANTIES AND DISCLAIMERS
9.1. (a) Genzyme hereby represents and warrants to EXACT that it has the right and power to enter into this Agreement, to extend the rights and licenses granted herein and to perform its obligations hereunder, and that this Agreement is a valid and binding agreement, enforceable in accordance with its terms.
(b) Genzyme further represents and warrants to EXACT that Genzyme is not in material breach of the JHU License Agreement as of the Original Effective Date, and that Genzyme will use commercially reasonable and diligent efforts to comply with all of its material obligations and duties with regard to the Patent Rights under the JHU License Agreement, including without limitation any provisions of the JHU Agreement as may be reasonably necessary to maintain in effect this Agreement or preserve EXACTs rights under this Agreement, including without limitation the preservation of EXACTs rights hereunder in the event that Genzyme shall breach or default on its obligations under the JHU License Agreement.
(c) EXACT hereby represents and warrants to Genzyme that it has the right and power to enter into this Agreement and to perform its obligations hereunder, and that this Agreement is a valid and binding agreement, enforceable in accordance with its terms. EXACT agrees that it shall comply with all applicable local, state, Federal and international laws and regulations relating to the development, design, manufacture, sale, use in commerce and promotion of Diagnostic Services, Licensed Reagents and Kits.
9.2. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN SECTION 9.1, GENZYME MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR OF
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
21
FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT, TRADEMARK, SOFTWARE, NONPUBLIC OR OTHER INFORMATION, OR TANGIBLE RESEARCH PROPERTY, LICENSED OR OTHERWISE PROVIDED TO EXACT HEREUNDER AND HEREBY DISCLAIMS THE SAME.
9.3. GENZYME DOES NOT WARRANT THE VALIDITY OF THE PATENT RIGHTS LICENSED HEREUNDER AND MAKES NO REPRESENTATION WHATSOEVER WITH REGARD TO THE SCOPE OF THE LICENSED PATENT RIGHTS OR THAT SUCH PATENT RIGHTS MAY BE EXPLOITED BY EXACT WITHOUT INFRINGING OTHER PATENTS.
9.4. NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, EACH OF THE PARTIES HERETO DISCLAIMS ALL OBLIGATIONS ON THE PART OF SUCH PARTY FOR DAMAGES, INCLUDING BUT NOT LIMITED TO DIRECT, INDIRECT, SPECIAL AND CONSEQUENTIAL DAMAGES, ATTORNEYS AND EXPERTS FEES AND EXPENSES, AND COURT COSTS (EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE PROBABILITY OF SUCH DAMAGES, FEES, EXPENSES AND COSTS) ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, SALE OR PROVISION OF THE LICENSED REAGENTS, DIAGNOSTIC SERVICES UTILIZING THE LICENSED PROCESSES AND KITS BY THE OTHER PARTY. EXACT ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR ANY LOSS OR DAMAGES CAUSED BY A LICENSED REAGENT, DIAGNOSTIC SERVICE OR KIT MANUFACTURED, USED, SOLD OR PROVIDED BY EXACT. GENZYME ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR ANY LOSS OR DAMAGES CAUSED BY A LICENSED REAGENT, DIAGNOSTIC SERVICE OR KIT MANUFACTURED, USED, SOLD OR PROVIDED BY GENZYME.
ARTICLE 10. NOTICES
10.1. Any consent, notice or report required or permitted to be given or made under this Agreement shall be in writing, delivered (i) by certified or registered mail (postage prepaid, return receipt requested), (ii) by facsimile (and promptly confirmed by personal delivery, courier or next business day service of a nationally recognized courier service of good repute), (iii) by a next business day service of a nationally recognized courier service of good repute (with evidence of delivery) or (iv) by courier (postage prepaid and signature required), and in any case addressed to the other party at its address set forth in this Article 10, and shall be effective upon receipt by the addressee.
10.2. Reports, notices and other communications from EXACT to Genzyme as provided hereunder shall be sent to:
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
22
or to such other individual or address as shall hereafter be furnished by written notice to EXACT in accordance with this Article 10.
10.3. Reports, notices and other communications from Genzyme to EXACT as provided hereunder shall be sent to:
or to such other individual or address as shall hereafter be furnished by written notice to Genzyme in accordance with this Article 10.
ARTICLE 11. ARBITRATION
11.1. Any controversy or claim arising out of, or relating to any provisions of this Agreement or the breach thereof which cannot otherwise be resolved by good faith negotiations between the parties, or by any form of Alternate Dispute Resolution other than arbitration
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
23
which may be mutually acceptable to the parties, shall be resolved by final and binding arbitration in Boston, Massachusetts under the rules of the American Arbitration Association, or the Patent Arbitration Rules if applicable, then obtaining.
The arbitration shall be subject to the following terms:
(a) The number of arbitrators shall be one (1).
(b) The arbitrator shall be an independent, impartial third party having no direct or indirect personal or financial relationship to any of the parties to the dispute, who has agreed to accept the appointment as arbitrator on the terms set out in this Section 11.1.
(c) The arbitrator shall be an active or retired attorney, law professor, or judicial officer with at least five (5) years experience in the biotechnology or pharmaceuticals industries and a familiarity with the laws governing proprietary rights in intellectual property.
(d) The arbitrator shall be selected as follows:
(i) Each party shall submit a description of the matter to be arbitrated to the American Arbitration Association at its Regional Office in Boston, Massachusetts. Said Association shall submit to the parties a list of the arbitrators available to arbitrate any dispute between them. Thereafter, each party shall select, in numerical order, those persons on said list acceptable as arbitrators and return the same to the Association. The first arbitrator acceptable to both parties shall be deemed the selected arbitrator with respect to the dispute then at issue under this Agreement. In the event of a failure to select a mutually agreeable arbitrator, the Association shall be requested to submit as many subsequent lists of arbitrators as shall be necessary to effect a mutual selection.
(ii) If the method of selection set out in paragraph (d)(i) above fails for any reason, then either party may petition any state or federal court in Massachusetts having jurisdiction for appointment of the arbitrator in accordance with applicable law, provided that the arbitrator must satisfy the requirements of paragraphs (b) and (c) above.
(e) The arbitrator shall announce the decision and/or award in writing accompanied by written findings explaining the facts determined in support of the decision and/or award, and any relevant conclusions of law.
(f) Unless otherwise provided in this Section 11.1 or extended by agreement of the parties, each party shall submit an initial request for designation of an arbitrator within thirty (30) days after receipt of the first list of available arbitrators pursuant to Section 11.1 (d) of this Agreement, the dispute shall be submitted to the arbitrator within ninety
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
24
(90) days after the arbitrator is selected, and a decision shall be rendered within thirty (30) days after the dispute is submitted.
(g) The fees of the arbitrator and any other costs and fees associated with the arbitration shall be paid in accordance with the decision of the arbitrator.
(h) The arbitrator shall have no power to add to, subtract from, or modify any of the terms or conditions of this Agreement. Any award rendered in such arbitration may be enforced by either party in either the courts of the Commonwealth of Massachusetts, or in the United States District Court for the District of Massachusetts, to whose jurisdiction for such purposes Genzyme and EXACT each hereby irrevocably consents and submits.
11.2. Notwithstanding the foregoing, nothing in this Article shall be construed to waive any rights or timely performance of any obligations existing under this Agreement.
ARTICLE 12. RESTRICTIONS ON USE OF NAMES
12.1. EXACT shall not use the name of Genzyme or its divisions, JHU, JHHS or their respective directors, officers, trustees, affiliates, employees, faculty, students and the inventor(s) of the Patent Rights or any adaptations or contractions thereof in any advertising, promotional or sales literature without the prior written consent of Genzyme or JHU in each case, as applicable; provided , however , that EXACT (a) may refer to publications by employees of Genzyme in the scientific literature and (b) may state that a license from Genzyme has been granted as herein provided. With respect to reports to public agencies that are required by law, EXACT shall provide Genzyme with a reasonable opportunity to review the use of its name in each such report reasonably in advance of its submission.
12.2. EXACT shall not disclose this Agreement or any of the terms or conditions of this Agreement to any third party without the prior written consent of Genzyme except and to the extent required to comply with applicable laws or regulations; provided , that EXACT delivers prior written notice to Genzyme of any disclosure required by applicable laws or regulations and takes all reasonable and lawful actions to obtain confidential treatment for such disclosure and, if possible, to minimize the extent of such disclosure.
ARTICLE 13. CONFIDENTIALITY
13.1. During the term of this Agreement, each party (the Disclosing Party ) may communicate to the other party (the Receiving Party ) information which it considers to be confidential ( Confidential Information ). All Confidential Information shall be specifically designated as confidential. Such Confidential Information may include, without limitation, trade secrets, know-how, inventions, technical data or specifications, testing methods, business or financial information, research and development activities, product and marketing plans, and customer and supplier information. Confidential Information that is disclosed in writing shall be marked with a legend indicating its confidential status. Confidential Information that is disclosed orally or visually shall be
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
25
documented in a written notice prepared by the Disclosing Party and delivered to the Receiving Party within thirty (30) days of the date of disclosure; such notice shall summarize the Confidential Information disclosed to the Receiving Party and reference the time and place of disclosure.
13.2. The Receiving Party agrees that it shall: (a) maintain all Confidential Information in strict confidence, except that the Receiving Party may disclose or permit the disclosure of any Confidential Information to its directors, officers, employees, consultants and advisors who are obligated to maintain the confidential nature of such Confidential Information and who need to know such Confidential Information for the purposes set forth in this Agreement; (b) use all Confidential Information solely for the purposes set forth in this Agreement; and (c) allow its directors, officers, employees, consultants and advisors to reproduce the Confidential Information only to the extent necessary to effect the purposes set forth in this Agreement, with all such reproductions being considered Confidential Information.
13.3. The obligations of the Receiving Party under Section 13.2 above shall not apply to the extent that the Receiving Party can demonstrate that certain Confidential Information: (a) was in the public domain prior to the time of its disclosure under this Agreement; (b) entered the public domain after the time of its disclosure under this Agreement through means other than an unauthorized disclosure resulting from an act or omission by the Receiving Party; (c) was independently developed or discovered by the Receiving Party without use of the Confidential Information; (d) is or was disclosed to the Receiving Party at any time, whether prior to or after the time of its disclosure under this Agreement, by a third party having no fiduciary relationship with the Disclosing Party and having no obligation of confidentiality with respect to such Confidential Information; or (e) is required to be disclosed to comply with applicable laws or regulations, or with a court or administrative order, provided, that the Disclosing Party receives prior written notice of such disclosure and that the Receiving Party takes all reasonable and lawful actions to obtain confidential treatment for such disclosure and, if possible, to minimize the extent of such disclosure.
13.4. The obligations set forth in this Article 13 shall remain in effect for a period of five (5) years after the expiration or the earlier termination of this Agreement.
ARTICLE 14. PATENT MARKING
14. EXACT agrees to mark any Kits, Licensed Reagents or promotional materials, technical literature and the like that describe Kits, Licensed Reagents or Diagnostic Services with all applicable patent numbers, and to indicate Patent Pending status in accordance with each applicable countrys patent laws.
ARTICLE 15. INDEPENDENT CONTRACTOR
15. For the purpose of this Agreement and all services to be provided hereunder, both parties shall be, and shall be deemed to be, independent contractors and not agents or employees
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
26
of the other. Neither party shall have authority to make any statements, representations or commitments of any kind, or to take any action, that will be binding on the other party.
ARTICLE 16. SEVERABILITY
16. If any one or more of the provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions of this Agreement shall not in any way be affected or impaired thereby unless the invalid provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the parties would not have entered into this Agreement without the invalid provisions.
ARTICLE 17. NON-ASSIGNABILITY
17. Neither this Agreement nor any part hereof shall be assignable by either party without the express prior written consent of the other, which shall not be unreasonably withheld. Any attempted assignment without such consent shall be void. Notwithstanding the foregoing, such consent shall not be required for the assignment of this Agreement (i) by EXACT in connection with the sale or transfer of all or substantially all of the business or assets of EXACT however structured, or (ii) by Genzyme in conjunction with the transfer of all or substantially all of the business or assets of Genzyme or all or substantially all of the business or assets allocated to its Molecular Oncology Division however structured; provided , in any such case, that the assignor promptly notifies the other party hereto of such assignment and the assignee assumes all of the assignors obligations hereunder in writing, with a copy of such written assumption (which may be redacted to the extent reasonably necessary to protect confidential information) to be promptly delivered to the other party hereto.
ARTICLE 18. NON-SOLICITATION
18. During the term of this Agreement and during the period ending [********] after the expiration or earlier termination of this Agreement, neither party shall, without the prior written consent of the other, solicit the employment of, or employ, any person in any capacity who, at any time during the term of this Agreement, shall have been an employee of the other party.
ARTICLE 19. ENTIRE AGREEMENT
19. This Agreement constitutes the entire agreement between the parties with respect to the subject matter and supersedes any prior agreements and understandings between the parties relating to the subject matter hereof. No oral agreement, conversation or representation between any officers, agents or employees of the parties hereto either before or after the Effective Date of this Agreement shall affect or modify any of the terms or obligations herein contained.
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
27
ARTICLE 20. MODIFICATIONS IN WRITING
20. No change, modification, extension, termination or waiver of this Agreement, or any of the provisions herein contained, shall be valid unless made in writing and signed by a duly authorized representative of each party.
ARTICLE 21. GOVERNING LAW
21. The validity and interpretation of this Agreement and the legal relations of the parties to it shall be governed by the laws of the Commonwealth of Massachusetts without regard to the conflict of laws provisions thereunder.
ARTICLE 22. CAPTIONS
22. The captions are provided for convenience and are not to be used in construing this Agreement.
ARTICLE 23. CONSTRUCTION
23. Each of the parties agree that this Agreement is the result of mutual negotiation and therefore the language herein shall not be presumptively construed against either of them. The term including as used herein shall mean including, without limiting the generality of any description preceding such term.
ARTICLE 24. COUNTERPARTS
24. This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original, and all of which together shall be deemed to be one and the same instrument.
ARTICLE 25. BINDING EFFECT
25. This Agreement shall be binding upon and inure to the benefit of the parties and their respective permitted successors and permitted assigns.
ARTICLE 26. FORCE MAJEURE
26. Neither party shall be deemed to be in breach of this Agreement due to, or liable to the other party for damages or loss occasioned by failure of performance by the defaulting party if the failure is occasioned by war, fire, explosion, flood, acts of God, strike or lockout, embargo, or any similar cause beyond the control of the defaulting party; provided that the party claiming this exception has exerted all commercially reasonable and diligent efforts to avoid or remedy such event and that such event does not extend for more than nine (9) months; provided further that such party provides the other party with prompt written notice of any delay or failure to perform that occurs by reason of force majeure and continues performance hereunder with reasonable dispatch whenever such causes are removed. The parties shall mutually seek a resolution of the delay or failure to
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
28
perform in good faith if a force majeure event extends for more than nine (9) months, which resolution may be termination of this Agreement.
ARTICLE 27. JHU LICENSE AGREEMENT
27. In the event that Genzymes license to the Patent Rights under the JHU License Agreement is terminated, this Agreement shall remain in effect pursuant to the terms of the JHU License Agreement provided that at such time EXACT is not in material breach of the provisions of this Agreement and agrees to be bound to JHU as a licensor under the terms and conditions of this Agreement.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
29
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their respective duly authorized representatives as of the Effective Date.
GENZYME CORPORATION |
EXACT SCIENCES CORPORATION |
|||
|
|
|||
By: |
/s/ Earl M. Collier, Jr. |
|
By: |
/s/ Jeffrey R. Luber |
|
|
|
|
|
Name |
Earl M. Collier, Jr. |
|
Name |
Jeffrey R. Luber |
|
|
|
|
|
Title: |
Executive Vice President |
|
Title: |
President and Chief Executive Officer |
|
|
|
|
|
Date: |
January 27, 2009 |
|
Date: |
January 27, 2009 |
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
Appendix A
Gene Patent Rights
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
Appendix B
Methodology Patent Rights
[********]
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Companys application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
Exhibit 10.4
EXECUTION VERSION
COMMON STOCK SUBSCRIPTION AGREEMENT
THIS COMMON STOCK SUBSCRIPTION AGREEMENT (the Agreement ) is made as of January 27, 2009 by and between EXACT Sciences Corporation, a Delaware corporation (the Company ) , and Genzyme Corporation, a Massachusetts corporation (the Investor ).
WITNESSETH:
WHEREAS, the Company and the Investor are contemporaneously entering into a Collaboration, License and Purchase Agreement (the CLP Agreement ), dated as of the date hereof;
WHEREAS, the Company desires to issue and sell to the Investor and the Investor desires to purchase from the Company 3,000,000 shares (the Purchased Shares ) of Common Stock, par value $0.01 per share, of the Company (the Common Stock ) at a price per share of $2.00 (the Purchase Price ) for a total purchase price of $6,000,000 (the Total Purchase Price ), pursuant to the terms of this Agreement; and
WHEREAS, the parties hereto desire to enter into this Agreement for the purpose of setting forth certain representations, warranties and covenants made by each to the other as an inducement to the execution and delivery of this Agreement and the conditions precedent to the consummation of the transactions set forth in this Agreement.
NOW, THEREFORE, in consideration of the premises and of the mutual provisions, agreements and covenants contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
1.1 Authorization and Sale of the Purchased Shares . Subject to the terms and conditions set forth in this Agreement, the Company has authorized the issuance and sale of up to 3,000,000 shares of Common Stock.
1.2 Agreement to Sell and Purchase the Purchased Shares . Subject to the terms and conditions of this Agreement, the Investor agrees to purchase at the Closing (as such term is defined in Section 1.3), the Purchased Shares for the Total Purchase Price.
1.3 Delivery of the Purchased Shares at Closing .
as may be mutually agreed upon by the Company and the Investor. At the Closing, the Company shall either:
2
Except as disclosed by the Company in the Exchange Act Documents (as defined below), the Company hereby represents, warrants and covenants to the Investor, as follows:
2.1 Organization . The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. The Company has all requisite corporate power and authority to own, operate and occupy its properties and to conduct its business as presently conducted and as described in the documents filed or furnished by the Company under the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (the Exchange Act ), including, without limitation, its most recent report on Form 10-K (all of the foregoing filed at least two business days prior to the date hereof, including all exhibits included therein and financial statements and schedules thereto and documents (other than exhibits) incorporated by reference therein, being hereinafter referred to as the Exchange Act Documents ) , and is registered or qualified to do business and is in good standing in each jurisdiction in which the nature of the business conducted by it or the location of the properties owned or leased by it requires such qualification , except where the failure to be so authorized, qualified or in good standing would not have a Material Adverse Effect (as defined below). No proceeding to which the Company is a party has been instituted in any such jurisdiction, revoking, limiting or curtailing, or seeking to revoke, limit or curtail, such power and authority or qualification. The Companys sole subsidiary, as defined in Rule 405 under the Securities Act of 1933, as amended (the Securities Act ), is EXACT Sciences Securities Corporation, a Massachusetts securities corporation. The Companys Sixth Amended and Restated Certificate of Incorporation, as in effect on the date hereof, and Amended and Restated
3
By-laws, as in effect on the date hereof, are each filed as exhibits in the Exchange Act Documents.
2.2 Due Authorization and Valid Issuance . The Company has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement, and this Agreement has been duly authorized, validly executed and delivered by the Company and constitutes the legal, valid and binding agreement of the Company enforceable against the Company in accordance with its terms, except (i) as rights to indemnity and contribution may be limited by state or federal securities laws, (ii) as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors and contracting parties rights generally, or (iii) as enforceability may be subject to general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law). The issuance, sale and delivery of the Purchased Shares in accordance with this Agreement has been duly authorized by all necessary corporate action on the part of the Company. The Purchased Shares when so issued, sold and delivered against payment therefor in accordance with the provisions of this Agreement will be duly and validly issued, fully paid and non-assessable and will not be subject to preemptive rights or other similar rights of stockholders of the Company.
2.3 Non-Contravention . The execution and delivery of this Agreement , the issuance and sale of the Purchased Shares under this Agreement , the fulfillment of the terms of this Agreement and the consummation of the transactions contemplated hereby do not and will not (A) conflict with or constitute a violation of, or default (with the passage of time or otherwise) (including any covenant, restriction or provision with respect to financial ratios or tests or any aspect of the financial condition or results of operations of the Company) under, (i) any bond, debenture, note or other evidence of indebtedness, lease, contract, indenture, mortgage, deed of trust, loan agreement, joint venture or other agreement or instrument to which the Company is a
4
party or by which it or its properties are bound, (ii) the certificate of incorporation , by-laws or other organizational documents of the Company, or (iii) any law, regulation, ordinance or order of any court or governmental agency, arbitration panel or authority or the rules of the Trading Market applicable to the Company or its properties, except in the case of clauses (i) and (iii) for any such conflicts, violations or defaults which would not have a Material Adverse Effect or (B) result in the creation or imposition of any lien, encumbrance, claim, security interest or restriction whatsoever upon any of the properties or assets of the Company or an acceleration of indebtedness pursuant to any obligation, agreement or condition contained in any bond, debenture, note or any other evidence of indebtedness or any indenture, mortgage, deed of trust or any other agreement or instrument to which the Company is a party or by which it is bound or to which any of the property or assets of the Company is subject, except to the extent that such acceleration would not have a Material Adverse Effect. No consent, approval, authorization or other order of, or registration, qualification or filing with, any regulatory body, administrative agency, or other governmental body or any other Person is required for the execution and delivery of this Agreement by the Company, the valid issuance and sale of the Purchased Shares to be sold pursuant to this Agreement and the performance by the Company of its other obligations hereunder, other than such as have been made or obtained, and except for any post-closing securities filings or notifications required to be made under federal or state securities laws.
2.4 Capitalization . The authorized capital stock of the Company consists of 100,000,000 shares of Common Stock and 5,000,000 shares of preferred stock, par value $0.01 per share. As of November 3, 2008, 27,247,381 shares were issued and outstanding, consisting of 27,247,381 shares of Common Stock and no shares of preferred stock . The Company has not issued any capital stock since th e date above other than pursuant to (i) employee benefit plans disclosed in the Exchange Act Documents, or (ii) outstanding warrants, options or other securities disclosed in the Exchange Act Documents. The outstanding shares of capital stock of the Company have been duly authorized and validly issued, are fully paid and nonassessable, have been issued in compliance with all federal and state securities laws, and were not issued in violation of any preemptive rights or similar rights to subscribe for or purchase securities. Except as set forth in or contemplated by the Exchange Act Documents, there are no outstanding rights (including, without limitation, preemptive rights), warrants or options to acquire, or instruments convertible into or exchangeable for, any unissued shares of capital stock or other equity interest in the Company or any contract, commitment, agreement, understanding or arrangement of any kind to which the Company is a party or of which the Company has knowledge and relating to the issuance or sale of any capital stock of the Company, any such convertible or exchangeable securities or any such rights, warrants or options. Without limiting the foregoing and except as provided herein or as disclosed in the Exchange Act Documents , no preemptive right, co-sale right, right of first refusal, registration right, or other similar right exists with respect to the Purchased Shares or the issuance and sale thereof. No further approval or authorization of any stockholder, the Board of Directors of the Company or others is required for the issuance and sale of the Purchased Shares. Except as disclosed in the Exchange Act Documents, there are no stockholders agreements, voting agreements or other similar agreements with respect to the Common Stock to which the Company is a party or, to the knowledge of the Company, between or among any of the Companys stockholders.
5
2.5 Legal Proceedings . There is no material legal or governmental proceeding pending to which the Company is a party or of which the business or property of the Company is subject other than the warning letter from, and subsequent correspondence with, the U.S. Food and Drug Administration with respect to the PreGen-Plus testing service.
2.6 No Violations . The Company is not (i) in violation of its certificate of incorporation, by-laws, or other organizational document; (ii) in violation of any law, administrative regulation, ordinance or order of any court or governmental agency, arbitration panel or authority applicable to the Company, which violation, individually or in the aggregate, would have a Material Adverse Effect; or (iii) in default in the performance of any bond, debenture, note or any other evidence of indebtedness or any indenture, mortgage, deed of trust or any other agreement or instrument to which the Company is a party or by which the Company is bound or to which any property or assets of the Company is subject, which default, individually or in the aggregate, would have a Material Adverse Effect.
2.7 Governmental Permits , Etc . With the exception of the matters which are dealt with separately in Sections 2.1 (Organization), 2.8 (Intellectual Property), 2.11 (Exchange Act Compliance), and 2.12 (Reporting Status), the Company has all necessary franchises, licenses, certificates and other authorizations from any foreign, federal, state or local government or governmental agency, department, or body that are currently necessary for the operation of the business of the Company as currently conducted and as described in the Exchange Act Documents except where the failure to currently possess would not have a Material Adverse Effect. The Company has not received any notice of any actual proceeding relating to revocation or modification of any such franchise, license, certificate or other authorization except where such revocation or modification would not have a Material Adverse Effect.
2.8 Intellectual Property .
6
2.9 Financial Statements; Solvency .
2.10 No Material Adverse Change . Except as disclosed in the Exchange Act Documents or contemplated by this Agreement or the CLP Agreement, since September 30, 2008 there has not been (i) any material adverse change in the financial condition or results of operations of the Company, (ii) any event affecting the Company which has had or would have a Material Adverse Effect, (iii) any obligation, direct or contingent, that is material to the Company, incurred by the Company, except obligations incurred in the ordinary course of
7
business or (iv) any dividend or distribution of any kind declared, paid or made on the capital stock of the Company.
2.11 Compliance . The Companys Common Stock is registered pursuant to Section 12(b) of the Exchange Act and is listed on the Trading Market. Except as disclosed in the Exchange Act Documents, (i) the Company has taken no action designed to, or likely to have the effect of, terminating such registration and listing of the Common Stock, and (ii) the Company has not received any notification that the SEC, the Trading Market or the Financial Industry Regulatory Authority ( FINRA ) is contemplating terminating such registration or listing.
2.12 Reporting Status . Since January 1, 2008, the Company has filed or furnished with the SEC in a timely manner all of the documents that the Company was required to file or furnish under the Exchange Act. As of the date of filing thereof, each Exchange Act Document complied in all material respects with the requirements of the Exchange Act and the rules and regulations of the SEC applicable to such Exchange Act Document. None of the Exchange Act Documents, as of the date filed, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading.
2.13 No Manipulation of Stock . The Company has not taken, in violation of applicable law, any action designed to or that might reasonably be expected to cause or result in stabilization or manipulation of the price of the Common Stock to facilitate the sale or resale of the Purchased Shares.
2.14 Company Not an Investment Company . The Company has been advised of the rules and requirements under the Investment Company Act of 1940, as amended (the Investment Company Act ). The Company is not, and immediately after receipt of payment for the Purchased Shares will not be, an investment company within the meaning of the Investment Company Act.
2.15 Embargoed Person . The Company has no foreign operations and (i) none of the funds or other assets of the Company constitute or shall constitute property of, or shall be beneficially owned, directly or indirectly, by any person with whom U.S. persons are restricted from engaging in financial or other transactions under United States law, including, but not limited to, the International Emergency Economic Powers Act, 50 U.S.C. § 1701 et seq., The Trading with the Enemy Act, 50 U.S.C. App. 1 et seq., and any executive orders or regulations promulgated under any such United States laws (each, an Embargoed Person ), with the result that the investments evidenced by the Purchased Shares are or would be in violation of law; (ii) no Embargoed Person has any interest of any nature whatsoever in the Company with the result that the investments evidenced by the Purchased Shares are or would be in violation of law; and (iii) none of the funds of the Company are derived from any unlawful activity with the result that the investments evidenced by the Purchased Shares are or would be in violation of law; provided , that with respect to the covenants contained in this Section 2.15, the Company may assume that the Investor is not an Embargoed Person. The Company certifies that, to the Companys knowledge, the Company has not been designated, and is not owned or controlled, by an Embargoed Person.
8
2.16 Accountants . To the Companys knowledge, Ernst & Young LLP, which has expressed its opinion with respect to the financial statements included in the Companys Annual Report on Form 10-K for the year ended December 31, 2007, are independent accountants as required by the Securities Act and the rules and regulations promulgated thereunder.
2.17 Contracts . The contracts filed as exhibits to the Exchange Act Documents filed with the SEC since January 1, 2008 are valid and enforceable against the Company in accordance with their respective terms, and are in full force and effect on the date hereof, except as to contracts whose term has expired. The Company is not in breach of or default under any such contract, except as would not have a Material Adverse Effect. The Company has filed with the SEC all contracts and agreements required to be filed by the Exchange Act prior to the Closing and the Company has not received a notice of termination and is not otherwise aware of any threats to terminate any contract or agreement required to be filed by the Exchange Act.
2.18 Taxes . The Company has filed all material federal, state and foreign income and franchise tax returns due to be filed as of the date hereof, taking into account all extensions, and has paid or accrued all taxes shown as due thereon, and the Company has no knowledge of a tax deficiency which has been or might be asserted or threatened against it which would have a Material Adverse Effect.
2.19 Transfer Taxes . On the Closing Date, all stock transfer or other taxes (other than income taxes) which are required to be paid in connection with the sale and transfer of the Purchased Shares to be sold to the Investor hereunder will be, or will have been, fully paid or provided for by the Company and all laws imposing such taxes will be or will have been fully complied with.
2.20 Private Offering . Assuming the correctness of the representations and warranties of the Investor set forth in Article IV hereof, the offer and sale of the Purchased Shares hereunder shall be exempt from registration under the Securities Act. The Company has not in the past nor will it hereafter take any action to sell, offer for sale or solicit offers to buy any securities of the Company which would bring the offer, issuance or sale of the Purchased Shares as contemplated by this Agreement within the provisions of Section 5 of the Securities Act, unless such offer, issuance or sale was or shall be within the exemptions of Section 4 of the Securities Act. Neither the Company nor any Person acting on behalf of the Company has offered or sold any of the Purchased Shares by any form of general solicitation or general advertising (as those terms are used in Regulation D under the Securities Act).
2.21 Controls and Procedures . The Company is in material compliance with all provisions of the Sarbanes-Oxley Act of 2002 which are applicable to it as of the Closing Date. Except as provided in the Exchange Act Documents, the Company maintains a system of internal control over financial reporting (as such term is defined in the Exchange Act) sufficient to provide reasonable assurance that (i) transactions are executed in accordance with managements general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability, (iii) access to assets is permitted only in accordance with managements general or specific authorization, and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any
9
differences. The Companys certifying officers are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act) for the Company and they have (a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under their supervision, to ensure that material information relating to the Company, including its subsidiaries, is made known to the certifying officers by others within those entities, particularly during the periods in which the Exchange Act Documents have been prepared; (b) to the extent required by the Exchange Act, evaluated the effectiveness of the Companys disclosure controls and procedures and presented in the Exchange Act Documents their conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the periods covered by the Exchange Act Documents based on such evaluation; and (c) since the last evaluation date referred to in (b) above, there have been no material changes in the Companys internal control over financial reporting (as such term is defined in the Exchange Act) or, to the Companys knowledge, in other factors that could significantly affect the Companys internal control over financial reporting.
2.22 Brokers and Finders . No Person will have, as a result of the transactions contemplated by this Agreement, any valid right, interest or claim against or upon the Investor for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Company.
2.23 Disclosure . The representations and warranties of the Company contained in this Article II as of the date hereof and as of the Closing Date, do not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading. The Company understands and confirms that the Investor will rely on the foregoing representations in purchasing the Purchased Shares.
The Company hereby covenants as follows:
3.1 Participation Right .
10
11
3.2 Registration of the Shares; Compliance with the Securities Act .
12
(x) subject to receipt of necessary information from the Investor after prompt request from the Company to provide such information, prepare and file with the SEC, within thirty (30) days after receiving appropriate notice from the Investor as provided for in (i) above, a Demand Registration Statement to enable the resale of the Purchased Shares by the Investor; provided , that if the terms of the underwriting agreement executed in connection with any registration pursuant to Section 3.2(a) or 3.2(b) prohibit the Company from filing any Demand Registration Statement, the Company shall have the right to delay such filing for the required period, which period shall not exceed ninety (90) days;
(y) use its reasonable best efforts to cause the Demand Registration Statement to become effective as promptly as practicable after the initial filing thereof with the SEC and, in any event, within seventy five (75) days of the request provided by the Investor to the Company pursuant to Section 3.2(a)(i) or, in the event of a review of the Demand Registration Statement by the SEC, within one hundred fifty (150) days of the request provided by the Investor to the Company pursuant to Section 3.2(a)(i) (the date such Demand Registration Statement is initially declared effective by the SEC, the Effective Date ), such efforts to include, without limiting the generality of the foregoing, preparing and filing with the SEC in such period any financial statements that are required to be filed prior to the effectiveness of such Demand Registration Statement; and
(z) use its reasonable best efforts to prepare and file with the SEC such amendments and supplements to such Demand Registration Statement, as appropriate, and the prospectus used in connection therewith as may be necessary to keep such Demand Registration Statement current, effective and free from any material misstatement or omission to state a material fact for a period not exceeding, with respect to the Purchased Shares, the earliest of (x) the date on which the Investor may sell all Purchased Shares then held by the Investor without restriction by the volume limitations of Rule 144(e) of the Securities Act, (y) the second anniversary of the effective date of such Demand Registration Statement or (z) the date on which there cease to be any Purchased Shares outstanding.
13
14
15
16
17
(x) the term Selling Stockholder shall include the Investor and any affiliate of the Investor;
(y) the term Registration Statement shall include the p rospectus in the form filed as part of the Registration Statement at the time of effectiveness (or, in the case of an underwritten offering, at the time immediately prior to the pricing of the offering), and each exhibit, supplement (including any free writing prospectus as defined under Rule 405 of the Securities Act) or amendment included in or relating to such Registration Statement; and
(z) the term untrue statement shall include any untrue statement or alleged untrue statement of a material fact, or any omission or alleged omission to state in the Registration Statement a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading.
18
19
20
3.3 Issuance and Quotation . The Company shall comply with all requirements of FINRA and the SEC with respect to the issuance of the Purchased Shares and shall comply with the requirements of the Trading Market with respect to the listing of the Purchased Shares on the Trading Market.
3.4 No Manipulation of Stock . The Company will not take, in violation of applicable law, any action designed to or that might reasonably be expected to cause or result in stabilization or manipulation of the price of the Common Stock to facilitate the sale or resale of the Purchased Shares.
21
3.5 Investment Company . The Company shall conduct its business in a manner so that it will not become subject to the Investment Company Act.
3.6 No Integration . The Company shall not, and shall use its reasonable best efforts to ensure that no affiliate of the Company shall, sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that will be integrated with the offer or sale of the Purchased Shares in a manner that would require the registration under the Securities Act of the sale of the Purchased Shares to the Investor, or that will be integrated with the offer or sale of the Purchased Shares for purposes of the rules and regulations of any Trading Market such that it would require stockholder approval prior to the closing of such other transaction unless stockholder approval is obtained before the closing of such transaction.
3.7 Rule 144 . The Company covenants that it will timely file the reports required to be filed by it under the Securities Act and the rules and regulations adopted by the SEC thereunder and the Exchange Act (or, if the Company is not required to file such reports, it will, upon the request of the Investor if such request is made after the first anniversary of the Closing Date, make publicly available such information as necessary to permit sales pursuant to Rule 144 under the Securities Act), and it will take such further action as the Investor may reasonably request, all to the extent required from time to time to enable the Investor to sell Purchased Shares without registration under the Securities Act within the limitation of the exemptions provided by (a) Rule 144 under the Securities Act, as such Rule may be amended from time to time, or (b) any similar rule or regulation hereafter adopted by the SEC. For the avoidance of doubt, the Investor may request that the Company remove, and the Company agrees to authorize and instruct (including by causing any required legal opinion to be provided) the removal of any legend from the Purchased Shares promptly (x) following any sale of the Purchased Shares pursuant to an effective Registration Statement or Rule 144, (y) if the Purchased Shares are eligible for sale under Rule 144 without reference to volume or manner of sale limitations, or (z) after the Registration Statement becomes effective. Upon request, the Company will provide to the Investor written certification of its compliance with the provisions of this Section 3.7.
3.8 Form D and Blue Sky . The Company agrees to timely file a Form D with respect to the Purchased Shares as required under Regulation D. The Company, on or before the Closing Date, shall take such action as the Company shall reasonably determine is necessary in order to obtain an exemption for or to qualify the Purchased Shares for sale to the Investor at the Closing pursuant to this Agreement under applicable securities or blue sky laws of the states of the United States (or to obtain an exemption from such qualification). The Company shall make all filings and reports relating to the offer and sale of the Purchased Shares required under applicable securities or blue sky laws of the states of the United States following the Closing Date.
3.9 Further Assurances . The Company hereby agrees to take all further actions, execute all further documents and perform all further things necessary to give effect to the provisions of this Agreement.
3.10 Representations . The Company and the Investor acknowledge and agree that no party to this Agreement has made or makes any representations or warranties with respect to the
22
The Investor represents and warrants to the Company that:
4.1 Due Authorization . The Investor has all requisite power and authority to execute, deliver and perform its obligations under this Agreement. The execution of this Agreement and the consummation of the transactions contemplated hereby have been duly authorized by all necessary action on the part of the Investor and this Agreement has been validly executed and delivered and constitutes the valid and binding obligation of the Investor enforceable against the Investor in accordance with its terms, except as rights to indemnity and contribution may be limited by state or federal securities laws; except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors and contracting parties rights, generally; and, except as enforceability may be subject to general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law).
4.2 Purchase Entirely for Own Account . The Purchased Shares will be acquired for investment only for the Investors own account, not as a nominee or agent, and not with a present view to the resale or distribution of any part thereof in violation of the Securities Act, and the Investor has no present intention of selling, granting any participation in, or otherwise distributing the same. The Investor does not have any contract, undertaking, agreement, or arrangement with any Person to sell, transfer, or grant participation to any Person with respect to any of the Purchased Shares. Nothing contained herein shall be deemed a representation or warranty by the Investor to hold the Purchased Shares for any period of time.
4.3 Disclosure of Information . The Investor acknowledges that it has received all the information that it has requested relating to the Company and the purchase of the Purchased Shares. The Investor further represents that it has had an opportunity to ask questions and receive answers from the Company regarding the terms and conditions of the offering of the Purchased Shares. The Investor recognizes that an investment in the Purchased Shares involves a high degree of risk, including the risk of total loss of the Investors investment. The Investor has knowledge and experience in the financial and business matters such that it is capable of evaluating the risks of the investment in the Purchased Shares. The foregoing, however, does not limit or modify the representations and warranties of the Company in this Agreement or the right of the Investor to rely thereon. The Investor has, with respect to all matters relating to this Agreement and the offer and sale of the Purchased Shares, not relied upon counsel to the Company except for the legal opinion to be delivered to the Investor pursuant to Section 1.3(c)(vi).
4.4 Accredited Investor . The Investor is an accredited investor within the meaning of Rule 501 of Regulation D promulgated under the Securities Act, as presently in effect and the
23
Investor is also knowledgeable, sophisticated and experienced in making, and is qualified to make decisions with respect to the transactions contemplated hereby.
4.5 Restricted Securities . The Investor understands that the Purchased Shares that it is purchasing are characterized as restricted securities under the federal securities laws inasmuch as they are being acquired from the Company in a transaction not involving a public offering, and that under such laws and applicable regulations the Purchased Shares may be resold without registration under the Securities Act, only in certain limited circumstances. In this connection, the Investor represents that it is familiar with Rule 144, as presently in effect, and understands the resale limitations imposed thereby and by the Securities Act.
4.6 Legends . It is understood that the certificates evidencing the Purchased Shares shall bear a legend, reading substantially as follows:
THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE ACT), OR THE SECURITIES LAWS OF ANY STATE AND ARE SUBJECT TO RESTRICTIONS ON TRANSFERABILITY AS SET FORTH IN THIS CERTIFICATE. THE SECURITIES REPRESENTED HEREBY MAY NOT BE SOLD, TRANSFERRED, ASSIGNED, PLEDGED, HYPOTHECATED, OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT WITH RESPECT THERETO UNDER THE ACT UNLESS SUCH SALE, TRANSFER, ASSIGNMENT, PLEDGE, HYPOTHECATION OR OTHER DISPOSITION IS OTHERWISE EXEMPT FROM REGISTRATION AND ANY APPLICABLE STATE SECURITIES LAWS OR PURSUANT TO AN OPINION OF COUNSEL, REASONABLY ACCEPTABLE TO COUNSEL FOR EXACT SCIENCES CORPORATION, TO THE EFFECT THAT THE PROPOSED SALE, TRANSFER ASSIGNMENT, PLEDGE, HYPOTHECATION OR OTHER DISPOSITION MAY BE EFFECTUATED WITHOUT REGISTRATION UNDER THE ACT AND APPLICABLE STATE SECURITIES LAWS.
4.7 Brokers and Finders . No Person will have, as a result of the transactions contemplated by this Agreement, any valid right, interest or claim against or upon the Company for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Investor.
4.8 Disclosures to the Company . The Investor understands that the Company is relying on the statements contained herein to establish an exemption from registration under federal and state securities laws.
24
5.1 Survival of Representations , Warranties and Agreements . Notwithstanding any investigation made by any party to this Agreement, all covenants, agreements, representations and warranties made by the Company herein shall survive the execution of this Agreement, the delivery to the Investor of the Purchased Shares being purchased and the payment therefor; provided , that the representations and warranties of the parties hereunder shall only survive for a period of one (1) year following the Closing Date.
5.2 Notices . All notices, requests, consents and other communications hereunder shall be in writing, shall be mailed (a) if within the United States by first-class registered or certified airmail, or nationally recognized overnight express courier, postage prepaid, or by facsimile, or (b) if delivered from outside the United States, by International Federal Express or facsimile, and shall be deemed given and received (i) if delivered by first-class registered or certified mail, three business days after so mailed, (ii) if delivered by nationally recognized overnight carrier, one business day after so mailed, (iii) if delivered by International Federal Express, two business days after so mailed, (iv) if delivered by facsimile, upon electronic confirmation of receipt and shall be delivered as addressed as follows:
(A) if to the Company, to:
EXACT Sciences Corporation
100 Campus Drive
Marlborough, MA 01752
Attention: Chief Executive Officer
Fax: (508) 683-1201
with a copy to:
Goodwin Procter LLP
53 State Street
Boston, MA 02109
Attention: Edward A. King, Esq.
Fax: (617) 523-1231
(B) if to the Investor, at its address below, or at such other address or addresses as may have been furnished to the Company in writing:
Genzyme Genetics
1700 West Park Drive
Westborough, Massachusetts 01581
Attention: Sr. Vice President & General Manager
Fax: (508) 870-7504
with a copy to:
25
Genzyme Corporation
500 Kendall Street
Cambridge, Massachusetts 02142
Attention: General Counsel
Fax: (617) 252-7553
5.3 Changes . This Agreement may not be modified, waived or amended except pursuant to an instrument in writing signed by the Company and the Investor; provided that the Investor may waive in writing any provision that is intended for its benefit.
5.4 Headings . The headings of the various sections of this Agreement have been inserted for convenience of reference only and shall not be deemed to be part of this Agreement.
5.5 Severability . In case any provision contained in this Agreement should be invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby.
5.6 Governing Law; Consent to Jurisdiction; Waiver of Jury Trial; Currency . This Agreement shall be governed by, and construed in accordance with, the internal laws of the Commonwealth of Massachusetts, without regard to the choice of law principles thereof. Each of the parties hereto irrevocably submits to the exclusive jurisdiction of the courts of the Commonwealth of Massachusetts and the United States District Court for the District of Massachusetts for the purpose of any suit, action, proceeding or judgment relating to or arising out of this Agreement and the transactions contemplated hereby. Each of the parties hereto irrevocably consents to the jurisdiction of any such court in any such suit, action or proceeding and to the laying of venue in such court. Each party hereto irrevocably waives any objection to the laying of venue of any such suit, action or proceeding brought in such courts and irrevocably waives any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum. EACH OF THE PARTIES HERETO WAIVES ANY RIGHT TO REQUEST A TRIAL BY JURY IN ANY LITIGATION WITH RESPECT TO THIS AGREEMENT AND REPRESENTS THAT COUNSEL HAS BEEN CONSULTED SPECIFICALLY AS TO THIS WAIVER.
5.7 Equitable Relief. The Company recognizes that, if it fails to perform or discharge any of its obligations under this Agreement, any remedy at law may prove to be inadequate relief to the Investor. The Company therefore agrees that the Investor is entitled to seek temporary and permanent injunctive relief in any such case. The Investor also recognizes that, if it fails to perform or discharge any of its obligations under this Agreement, any remedy at law may prove to be inadequate relief to the Company. The Investor therefore agrees that the Company is entitled to seek temporary and permanent injunctive relief in any such case.
5.8 Counterparts . This Agreement may be executed in two counterparts, each of which shall constitute an original, but all of which, when taken together, shall constitute but one instrument, and shall become effective when one or more counterparts have been signed by each party hereto and delivered to the other parties.
26
5.9 Prior Agreements . This Agreement constitutes the entire agreement between the parties and supersedes any prior understandings or agreements (including without limitation oral agreements) concerning the purchase and sale of the Purchased Shares.
5.10 Costs , Expenses and Taxes . The Company and the Investor shall each pay the fees and expenses of their respective advisers, counsel, accountants and other experts, if any, and all other expenses incurred by such party in connection with the negotiation, preparation, execution, delivery and performance of this Agreement; provided , that all fees and expenses incident to the Companys performance of or compliance with its obligations under Section 3.2(a), (b) and (c) of this Agreement (excluding any underwriting discounts and selling commissions and all legal fees and expenses of legal counsel for the Investor) shall be borne by the Company. The Company shall pay all stamp taxes and other taxes and duties levied in connection with the sale and issuance of the Purchased Shares to the Investor.
5.11 Transfer of Rights . All covenants and agreements contained in this Agreement by or on behalf of any of the parties hereto shall bind and inure to the benefit of the respective successors and assigns of the parties hereto (including without limitation transferees of any Purchased Shares), whether so expressed or not; provided , however , that rights conferred to the Investor may be transferred to a transferee of Purchased Shares only if the Company has been given written notice thereof, such transfer complies with the requirements of applicable law and FINRA and the SEC and such transferee is a purchaser of Purchased Shares from the Investor representing at least fifty percent (50%) of the Purchased Shares.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK.]
27
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first above written.
EXACT SCIENCES CORPORATION
By: |
/s/ Jeffrey R. Luber |
|
||
|
Name: Jeffrey R. Luber |
|||
|
Title: President and Chief Executive Officer |
|||
|
||||
|
||||
GENZYME CORPORATION |
||||
|
||||
|
||||
By: |
/s/ Earl M. Collier, Jr. |
|
||
|
Name: Earl M. Collier, Jr. |
|||
|
Title: Executive Vice President |
|||
|
|
|||
Nominee name for stock certificate (if any): |
|
|
||
[Common Stock Subscription Agreement]
Exhibit 99.1
|
|
Press Release |
|
Contacts:
John Woolford
Westwicke Partners, LLC
443-213-0506
john.woolford@westwickepartners.com
EXACT
SCIENCES ANNOUNCES STRATEGIC TRANSACTION
WITH GENZYME INCLUDING INTELLECTUAL PROPERTY ASSET
PURCHASE AND EQUITY INVESTMENT
Assets Include Intellectual Property Related to Reproductive and Prenatal Health;
EXACT to Receive Total Cash Infusion of $24.5 Million
Marlborough, MA (January 27, 2009) EXACT Sciences Corporation (NASDAQ: EXAS) announced today that the company has formed a strategic relationship with Genzyme Corp. (NASDAQ: GENZ) pursuant to which Genzyme has acquired certain intellectual property assets related to the fields of prenatal and reproductive health as well as three million shares of EXACT common stock. Under the transaction, EXACT retained exclusive worldwide rights to its colorectal cancer screening and stool-based DNA testing intellectual property, and will receive a share of Genzymes sublicensing income derived from the purchased intellectual property outside the fields of prenatal and reproductive health.
Jeffrey R. Luber, EXACTs President and Chief Executive Officer, said, This strategic relationship with Genzyme is an important milestone in EXACTs continued evolution and will serve as a solid platform for us to grow our oncology diagnostics business. Genzyme is one of the worlds leading biotechnology companies and this transaction offers an ideal relationship for EXACT. In addition to the substantial infusion of capital into EXACT, we believe that our ability to access Genzymes extensive development and regulatory expertise will facilitate our efforts toward the introduction of our next-generation platform for colorectal cancer screening.
This transaction will bring Genzyme intellectual property in support of our development of non-invasive prenatal testing and other advanced diagnostic testing services, said Jon L. Hart, Senior Vice President and General Manager, Genzyme Genetics. We have a responsibility to bring forward more advanced testing options for physicians and families and we are strongly committed to driving continued innovation in this field. We
are pleased to be shareholders in EXACT and believe that our relationship may facilitate their important mission to bring novel stool-based cancer diagnostics to the public.
Terms of the Transaction
The transaction provides for EXACT to receive $24.5 million in cash in total. At closing, EXACT received $16.65 million, with an additional $1.85 million to be received over the next 18 months, contingent upon the non-occurrence of certain events, in exchange for the sale and license of certain of EXACTs intellectual property assets, including those relating to reproductive and prenatal health. In addition, Genzyme purchased 3.0 million shares of EXACT common stock at $2.00 per share for an aggregate purchase price of $6.0 million. The per share purchase price represents a 127% premium to the 30-day average closing price of EXACT shares as of Market close on Monday, January 26th.
EXACT will retain rights to the technology for stool-based detection of any disease and stool or blood-based screening assays for colorectal cancer in patient samples. Further, EXACT will receive exclusive rights in these fields to improvements to the purchased intellectual property that may be developed by Genzyme. EXACT will also receive rights in these fields to improvements resulting from any joint developments between EXACT and Genzyme.
In addition, EXACT and Genzyme have amended their March 1999 license to provide EXACT with the additional rights necessary to distribute FDA approved kits for stool-based detection of disease and colorectal cancer screening based on the detection of APC and P53 mutations. The license amendment as well as the ongoing assumption by Genzyme of certain patent costs will reduce EXACTs cash outlays going forward.
The companies have also agreed to form a joint advisory committee to assist both parties in the achievement of product development goals related to the purchased IP and to assist EXACT with its regulatory goals. Genzyme and EXACTs joint advisory committee will consist of internal experts and outside advisors who are recognized leaders in the technological, clinical, and regulatory aspects of diagnostic testing who will advise both organizations on their product development objectives. Finally, Genzyme has agreed to pay EXACT a double digit percentage of any sublicensing income that it receives outside the field of reproductive and prenatal health which utilize the intellectual property.
EXACTs Strategic Plan
Going forward, EXACT plans to focus on the development of a Version 3 colorectal cancer screening test based on an improved DNA detection technology developed by Johns Hopkins University. Previously, EXACT announced the published results from a proof of concept study using the BEAMing technology, an advanced form of digital PCR, in which stool and blood plasma were assessed in a head-to-head comparison for the detection of colorectal cancer (CRC). Study results demonstrated 92 percent sensitivity for detecting CRC in stool samples. These data were published in the August 2008 issue of Gastroenterology in a paper entitled Analysis of Mutations in DNA Isolated from Plasma and Stool of Colorectal Cancer Patients. The newly expanded APC/P53 gene license with Genzyme to the key genetic markers used in the August BEAMing publication will facilitate the Companys efforts to offer FDA-approved kits based on such a Version 3 technology.
EXACT intends to resume sample collection for a clinical trial aimed at securing FDA clearance or approval for a new Version 3 technology for non-invasive colorectal cancer screening. The Company currently plans to design the trial based on its extensive discussions held with the FDA in mid 2008 and will seek input from Genzyme through the joint advisory committee. EXACT intends to re-start the sample accrual process during the current fiscal quarter. This should allow EXACT to submit an application for FDA approval in 2011, assuming its platform development and sample collection goals have been met prior to this date. Achieving development goals more quickly may allow EXACT to pursue CLIA launch of a Version 3 test by early 2011, an opportunity the company plans to evaluate as part of its strategic plan. The Company also intends to continue its evaluation of related technologies, resources, and relationships that can accelerate its overall progress and allow it to access adjacent opportunities such as aero-digestive cancer screening.
EXACT remains encouraged by the recent momentum in state-based mandates for coverage of sDNA testing following its inclusion in the March 2008 American Cancer Society guidelines recommendation. The Company intends to continue its work with health insurers and other third party payors around the country to expand coverage.
Based on current expectations, EXACT believes that its cash resources should last into 2011, which would allow the Company to be opportunistic in seeking the further financing that will be needed to develop and launch a Version 3 test. The Company is continuing to develop a detailed implementation plan for its Version 3 technology.
Management Update
In conjunction with the completion of this transaction, Jeffrey R. Luber, EXACTs President and Chief Executive Officer, has announced his intention to work with the Board to find a new CEO with product and commercial development expertise directly aligned with EXACTs next phase of growth. To that end, the Board has set up a search committee to initiate the search process for a new Chief Executive Officer. Mr. Luber intends to remain President and CEO until the appointment of his replacement.
Patrick J. Zenner, Chairman of the Board of Directors of EXACT, said, We applaud Jeff for his many successes at EXACT, including leading us through inclusion in the American Cancer Society screening guidelines and this very successful strategic relationship with Genzyme. Jeff has played a pivotal role, on so many levels, in putting in place a platform for EXACTs future success, for which all of us on the Board are sincerely appreciative.
It remains a privilege to be part of a public health story as important as EXACT Sciences, commented Mr. Luber. It is equally gratifying to work with such a dedicated and passionate team of board members and managers, all with the same goal in minddecreasing mortality from colorectal cancer through the power of DNA. I look forward to working with the Board through this important period of transition.
Merriman Curhan Ford & Co. delivered an opinion to the board of Exact Sciences as to the fairness of the transaction.
Conference Call and Webcast
EXACT management will be hosting a conference call beginning at 8:30 am Eastern Time tomorrow, Wednesday, January 28, 2009, to discuss the Genzyme transaction. The dial-in number within the United States is 800-638-4817. The dial-in number for international callers is 617-614-3943. The participant passcode is 29573556.
A replay of the conference call will be available for one month, beginning at approximately 11:30 am Eastern Time Wednesday, January 28, 2009 until February 28, 2009. The dial-in number from within the United States is 888-286-8010. The dial-in number for international callers is 617-801-6888. The participant passcode is 80815079
The conference call will also be webcast and can be accessed from the companys website at www.exactsciences.com. The webcast will be available for one month.
About EXACT Sciences Corporation
EXACT Sciences Corporation uses applied genomics to develop patient-friendly screening technologies for use in the detection of cancer. EXACT maintains an exclusive license agreement in the United States and Canada with Laboratory Corporation of America® Holdings (LabCorp®) for certain intellectual property relating to stool-based DNA screening. Stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer (a group comprised of representatives from the American College of Gastroenterology, American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy), and the American College of Radiology. EXACT Sciences is based in Marlborough, Mass.
About Genzyme
One of the worlds leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The companys products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzymes commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
Risk Factors and Forward-Looking Statements
Certain statements made in this press release that are not based on historical information are express or implied forward-looking statements relating to, among other things, EXACT Sciences expectations concerning managements forecast of financial performance, including available
cash and cash savings, the development of EXACTs Version 3 technology and filing of an application for clearance or approval with the FDA, the hiring of a new Chief Executive Officer, the success of EXACTs strategic relationship with Genzyme, and similar matters. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond EXACT Sciences control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, EXACT Sciences ability to secure FDA approval or clearance for any of its products; changes in FDA guidance or policy; the success of EXACTs strategic relationship with Genzyme; the risks of litigation; the ability to attract prospective collaborators or other parties to enter into a collaboration, acquisition or other strategic transaction with EXACT; the ability to raise additional capital on acceptable terms; the clinical performance and market acceptance of its technologies; the reproducibility of its research results in subsequent studies and in clinical practice; sufficient investment in the sales and marketing of EXACT Sciences technologies; the success of its strategic relationship with LabCorp; EXACT Sciences ability to license certain technologies or obtain raw materials for its technologies; the ability to convince Medicare and other third-party payors to provide adequate reimbursement for EXACT Sciences technologies; the ability to convince medical practitioners to order tests using EXACT Sciences technologies; the ability to increase the performance its technologies; the ability of EXACT Sciences or LabCorp to lower the cost of stool-based DNA screening technologies through automating and simplifying key operational processes; the number of people who decide to be screened for colorectal cancer using EXACT Sciences technologies; competition; the ability to protect EXACT Sciences intellectual property and the cost of enforcing or defending EXACT Sciences in litigation relating to intellectual property rights; and the possibility that other companies will develop and market novel or improved methods for detecting colorectal cancer. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. EXACT Sciences undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by EXACT Sciences, see the disclosure contained in EXACT Sciences public filings with the Securities and Exchange Commission including, without limitation, its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC.
ADDITIONAL INFORMATION
On January 27, 2009, Sequenom, Inc. commenced an unsolicited exchange offer to acquire all of the outstanding shares of common stock of EXACT in a stock-for-stock transaction. This communication is not a recommendation on how any stockholder should act with respect to any such exchange offer. Sequenom has filed a Schedule TO and a registration statement on Form S-4 with the Securities and Exchange Commission to register the Sequenom shares to be issued in such exchange offer. Unless the exchange offer is terminated, EXACT will file a solicitation/recommendation statement on Schedule 14D-9 with the Securities and Exchange Commission with respect to the exchange offer. EXACT stockholders are strongly advised to read those documents, as well as any amendments or supplements to those documents, because they will contain important information that should be read carefully and considered before any decision is made with respect to any such exchange offer. Investors and security holders may obtain a free copy of the registration statement and the solicitation/recommendation statement (when and if available) and other relevant documents at the Commissions Internet web site at www.sec.gov. The solicitation/recommendation statement (when and if available) may also be obtained free of charge from EXACT by directing such request to: Investor Relations, EXACT Sciences, 100 Marlborough, MA 01752.