AMENDED AND RESTATED LICENSE AGREEMENT

License Agreement

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EXACT LABORATORIES, INC | EXACT SCIENCES CORPORATION | GENZYME CORPORATION

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Title: AMENDED AND RESTATED LICENSE AGREEMENT
Governing Law: Massachusetts Date: 1/28/2009
Industry: Biotechnology and Drugs Sector: Healthcare

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 Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

TABLE OF CONTENTS

	Page

ARTICLE 1. DEFINITIONS	1

ARTICLE 2. 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

ARTICLE 23. CONSTRUCTION	28

ARTICLE 24. COUNTERPARTS	28

ARTICLE 25. BINDING EFFECT	28

ARTICLE 26. FORCE MAJEURE	28

ARTICLE 27. JHU LICENSE AGREEMENT	29

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 Genzyme’s 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.

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.

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, agent’s 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 Genzyme’s 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.

(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

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 Genzyme’s 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

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 Genzyme’s 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,

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 Party’s 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. EXACT’s 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 Genzyme’s 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) EXACT’s license under Section 2.1 above to the Diagnostic Services, Licensed Reagents or Kits, as applicable, and EXACT’s 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.

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,

(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

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 EXACT’s 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 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 EXACT’s 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.

(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

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