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SUBLICENSE AGREEMENT

License Agreement

SUBLICENSE AGREEMENT | Document Parties: Beckman Coulter, Inc | EXACT Sciences Corporation You are currently viewing:
This License Agreement involves

Beckman Coulter, Inc | EXACT Sciences Corporation

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Title: SUBLICENSE AGREEMENT
Governing Law: Delaware     Date: 3/31/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

SUBLICENSE AGREEMENT, Parties: beckman coulter  inc , exact sciences corporation
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Exhibit 10.13

 

SUBLICENSE AGREEMENT

 

This Sublicense Agreement (the “Agreement”) is entered into as of July 28th, 2003 (the “Effective Date”) by and between Beckman Coulter, a Delaware corporation, having a principal place of business at 4300 North Harbor Boulevard, Fullerton, California 92835 (“BECKMAN”), and EXACT Sciences Corporation, a Delaware corporation having a principal place of business at 100 Campus Drive, Marlborough, Massachusetts 01754 (“EXACT”).

 

In consideration of the mutual promises and conditions contained in this Agreement, BECKMAN and EXACT agree as follows:

 

ARTICLE 1 - DEFINITIONS

 

1.1                                  “Affiliate” shall mean any company, corporation or other business entity that is controlled by, controlling, or under common control with the subject company, corporation or other business. For this purpose “control” means direct or indirect beneficial ownership of at least fifty percent (50%) interest in the voting stock (or the equivalent) of the company, corporation or other business or having the right to direct, appoint or remove a majority of members of its board of directors (or their equivalents) or having the power to control the general management of the company, corporation or other business, by law or contract.

 

1.2                                  “EXACT Net Revenues” shall mean:

 

(i)                                      gross royalties received by EXACT from its Sublicensee relating to the Third Party’s sale or provision of Licensed Services, and

 

(ii)                                   gross revenues received by EXACT relating to EXACT’s direct provision of Licensed Services, less the following deductions:

 

(a)                                   Trade, quantity, cash or other discounts, if any, actually allowed and taken;

 

(b)                                  Credits or allowances, not to exceed two percent of EXACT Net Revenues, made or given on account of defective services or

 

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disputed services that are specifically identifiable to Licensed Services sold to a Third Party; and

 

(c)                                   Any tax or governmental charge received by EXACT from its customer with respect to the sale, use or delivery of Licensed Services to the customer and paid by EXACT to a governmental entity.

 

1.3                                  “Field” shall mean /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ used for /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

Notwithstanding the foregoing, the “Field” shall not include:

 

the provision of /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ or the /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ for the provision of /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ that consist of /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ for the /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ of samples of /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ to produce /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

For the sake of clarity, the parties confirm that the limitation set forth in paragraph (b) of this definition in conjunction with the definition of Specialty Testing operates within the Field to:

 

(i)                                      INCLUDE within the scope of this license the ability of EXACT and its Sublicensee to provide to /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ for which the /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ does not require a /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ or a /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ (including those laboratory services performed as /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ or that are based on /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/), and

 

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(ii)                                   EXCLUDE from the scope of this license the ability of EXACT and its Sublicensee to sell products or services for which /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ requires a /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

1.4                                  “Licensed Patents” shall mean, individually and collectively, (i) the U.S. patent(s) identified on Exhibit 1, attached hereto, and any reissues, reexaminations, and extensions thereof, and all Canadian patents or applications corresponding to any of the foregoing; (ii) the U.S. patent applications identified on Exhibit 1, and all Canadian patents or applications corresponding thereto; (iii) all non-provisional, continuation, continuation-in part, divisional and Canadian applications that claim the priority, either directly or indirectly, to any Licensed Patents described in subsection (i) or (ii) above; and (iv) all United States and Canadian patents issued on the Licensed Patents described in subsection (ii) or (iii) above, and all reissues, reexaminations and extensions thereof.

 

1.5                                  “Licensed Services” shall mean services that but for this Agreement would infringe a valid and enforceable claim in the Licensed Patents.

 

1.6                                  “Intellectual Property” shall mean rights to patents, copyrights, trademarks, trade secrets, proprietary information, know-how and technical data (whether or not patentable) and all other intellectual property rights, in each case whether registered or unregistered and including applications for the grant of any of the foregoing and all rights or forms of protection having equivalent or similar effect to any of the foregoing which may subsist anywhere in the world.

 

1.7                                  “License Term” shall mean the period of time from the Effective Date of the Agreement through expiration of the last to expire of the Licensed Patents.

 

1.8                                  “Party” or “Parties” shall mean BECKMAN and/or EXACT, as the context requires.

 

1.9                                  “Sublicensee” shall mean any entity to which EXACT has granted a sublicense of some or all of the rights conveyed to EXACT under this Agreement.

 

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1.10                            “Territory” shall mean the United States and Canada.

 

1.11                            “Test” shall mean a test result per single patient derived from the provision of Licensed Services.

 

1.12                            “Third Party” means any person or entity other than EXACT or BECKMAN.

 

1.13                            /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ means that patent license agreement signed by BECKMAN and /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ on /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

1.14                            “Fluorescence Polarization” means the process by which a fluorescent sample is irradiated with plane-polarized excitation radiation and components of a resultant fluorescent signal are separately detected from the sample which are polarized respectively parallel to and perpendicular to the plane of polarization of the excitation radiation, either on a steady state or time resolved basis relative to the excitation radiation, as and to the extent claimed in any valid, maintained and enforceable U.S. or foreign patent issuing from or claiming priority from U.S. Patent Application Serial No. 09/137,826 entitled Fluorescence Polarization in Nucleic Acid Analysis, filed August 20, 1998, owned or licensed by NEN Life Science Products, Inc.

 

1.15                            “Fluorescence Resonance Energy Transfer” means the process by which a fluorescent sample containing two distinct dyes wherein the sample is irradiated with light energy optimal to excite the first of the two dyes and wherein that first dye upon excitation transfers the energy to the second dye specifically when both dyes are attached to the same primer through a process whereby a nucleic acid template-dependent primer extension reaction determines the identity of a single nucleotide base at a specific position in a nucleic acid of interest, which process is covered by U.S. Patent No. 5,888,819 and 6,004,744 and any divisionals, continuation, reissues and foreign counterparts thereof, and the fluorescence emission of the second dye is detected at second wavelength, as and to the extent claimed in U.S. Patent No. 5,945,283 entitled Methods and Kits for Nucleic Acid Analysis Using Fluorescence Resonance Energy Transfer, issued on

 

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December 17, 1996 and owned or licensed by NEN Life Science Products, Inc., and any divisionals, continuations, reissues and foreign counterparts thereof and as and to the extent such NEN patents are valid, maintained and enforceable.

 

1.16                            “Specialty Testing” means:

 

(a)                                   products and processes for the /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ of samples of human, animal or vegetable origin, and

 

(b)                                  /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ are intended for use in a diagnostic application for /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

1.17                            /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ means:

 

(a)                                   in the case of the /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ and

 

(b)                                  in the case of countries outside of the United States, /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ with similar responsibilities.

 

1.18                            “Colorectal Cancer Assay” means any /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ (including but not limited to /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ testing).

 

ARTICLE 2 - GRANT OF LICENSES; OWNERSHIP

 

2.1                                  LICENSE GRANT. Subject to the terms and conditions of this Agreement, BECKMAN grants to EXACT a non-exclusive, royalty-bearing license under the Licensed Patents in the Field in the Territory during the License Term, to make, have made, use, offer to sell, sell and import Licensed Services. This license

 

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granted hereunder shall include a limited right to sublicense as herein provided. Nothing in this Agreement will be construed to grant to EXACT any license or rights except under the Licensed Patents and within the Field.

 

2.2                                  SUBORDINATION TO /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/. This Agreement will not be construed to grant EXACT (i) any rights that are broader then the rights granted to BECKMAN under the /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ with regard to /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ (as that term is defined in the /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/; or (ii) a term of license that is longer than the term of the /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/

 

2.3                                  SUBLICENSING. EXACT shall have the right to sublicense the rights granted in Paragraph 2.1 above only to Laboratory Corporation of America Holdings (“LabCorp”), provided however, that no such sublicense shall be effective until LabCorp executes a written sublicense agreement (the “Sublicense Agreement”) with EXACT with respect to the Licensed Services and provided that the terms of the Sublicense Agreement are not inconsistent with and are subordinate to the rights afforded EXACT hereunder. The Sublicense Agreement will include the following provisions of this Agreement: Article 4 - Royalty Reports; Records; Article 7 - Indemnification and Insurance; and, Article 8 - Disclaimer of Warranties; and, Section 10.12 - References to BECKMAN; and further will provide that those provisions are for the benefit of and may be enforced by BECKMAN. EXACT will provide BECKMAN with a copy of the Sublicense Agreement within sixty (60) days after it is executed.

 

2.4                                  NO IMPLIED LICENSES. Nothing in this Agreement shall be construed as granting any Party any right or license under any Intellectual Property of the other Party by implication, estoppel or otherwise, except as expressly provided otherwise in this Agreement.

 

2.5                                  EXCLUDED FIELD. Notwithstanding anything to the contrary in this Agreement, the licenses granted therein shall not extend to /*/[CONFIDENTIAL TREATMENT

 

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REQUESTED]/*/ or to /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ provided that the foregoing limitation shall (i) only be in force during the shorter of the term of the /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ specified in the definitions thereof, or during such time as such /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ are valid, enforceable and maintained and (ii) not limit or restrict EXACT’s right to use the Licensed Patents in connection with /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ and /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ to the extent EXACT has obtained license rights to /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ and /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ from an appropriate Third Party.

 

ARTICLE 3 - ROYALTIES

 

3.1                                  ROYALTIES. During the License Term, EXACT shall pay BECKMAN a /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ percent /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ royalty on EXACT Net Revenues. EXACT shall pay royalties due with respect to each calendar quarter hereunder within forty-five (45) days after the last day of such calendar quarter.

 

ARTICLE 4 - ROYALTY REPORTS; RECORDS

 

4.1                                  ROYALTY REPORTS. Within forty-five (45) days after March 31, June 30, September 30 and December 31 of each year during the Term, EXACT shall deliver to BECKMAN the royalty payment due pursuant to Section 3.1 hereof and a corresponding royalty report relating to the calendar quarter to which the royalty paid relates. If EXACT Net Revenue includes revenue denominated in a currency other than the currency of the United States of America, those foreign currency sales for each calendar quarter will be converted to the currency of the United States of America at the prevailing rate for the last business day of the quarter as quoted by THE WALL STREET JOURNAL (or if THE WALL STREET JOURNAL is not available

 

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then a comparable publication) or such conversion shall be accomplished by a procedure mutually agreed upon by EXACT and BECKMAN.

 

4.2                                  REPORTS. Each royalty report shall include the following:

 

(a)                                   Identification of the Licensed Services performed by EXACT during the relevant calendar quarter;

 

(b)                                  The quantity of each Licensed Services performed by EXACT during the relevant calendar quarter;

 

(c)                                   The Exact Net Revenues for each of the Licensed Services performed by EXACT during the relevant calendar quarter;

 

(d)                                  Deductions applicable to determining EXACT Net Revenues during the relevant calendar quarter;

 

(e)                                   Identification of the Licensed Services performed by Sublicensee during the relevant calendar quarter;

 

(f)                                     The quantity of each Licensed Services performed by Sublicensee during the relevant calendar quarter;

 

(g)                                  The Exact Net Revenues for each of the Licensed Services performed by Sublicensee during the relevant calendar quarter;

 

(h)                                  Total royalties due to EXACT from Sublicensee under the sublicense granted under this Agreement during the relevant calendar quarter; and

 

(i)                                      Total royalties due to BECKMAN for the calendar quarter.

 

With each report, EXACT shall pay to BECKMAN the royalties due and payable for such calendar quarter in accordance with paragraph 3.1.

 

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4.3                                  RECORD KEEPING.

 

4.3.1                         BOOKS AND RECORDS. EXACT shall keep complete and accurate records for the latest five (5) years as necessary to establish from source documents and data the EXACT Net Revenues for each Licensed Service. EXACT will maintain such records in sufficient detail and in a manner and context to enable the determination of the amount of royalties due hereunder to BECKMAN.

 

4.3.2                         INSPECTIONS. Upon thirty (30) days’ written notice, EXACT agrees to permit one or more auditors appointed by BECKMAN (except any to whom EXACT has a reasonable objection) to enter upon the premises of EXACT during usual business hours of EXACT in order to examine records pertaining to this Agreement for previous quarter(s) and to make on EXACT’s premises and retain copies of any and all parts of the records and accounts kept by EXACT pursuant to this Article 4, including invoices and Sublicense payment records and reports which are relevant to any report required to be rendered by EXACT. Said copies shall be provided to the auditor(s) at no expense to the auditor(s) or to BECKMAN. Said auditor(s) shall provide BECKMAN with the amount of the EXACT Net Revenue and the application of the appropriate royalty rate so that royalties due BECKMAN may be calculated for each Licensed Service. In the event such audit establishes that EXACT has underpaid its royalty obligations by /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ or more during any calendar quarter, any amounts found to have been owed but not paid shall be paid to BECKMAN promptly with nine percent (9%) interest per annum. In the event such audit establishes that EXACT has underpaid its royalty obligations by /*/[CONFIDENTIAL TREATMENT REQUESTED]/*/ or more during any calendar quarter, EXACT shall reimburse BECKMAN for the out-of-pocket expense of such audit. BECKMAN shall not make more than one audit request annually.

 

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4.4                                  FORM OF PAYMENTS. EXACT shall make all payments due under this Agreement by check or wire transfer in United States funds.

 

4.5                                  LATE PAYMENT. If EXACT does not make any payment under this Agreement when due, the payment will accrue


 
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