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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: Case Western Reserve University | Exact Sciences Corporation You are currently viewing:
This License Agreement involves

Case Western Reserve University | Exact Sciences Corporation

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Title: LICENSE AGREEMENT
Governing Law: Ohio     Date: 8/8/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AGREEMENT, Parties: case western reserve university , exact sciences corporation
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Exhibit 10.1

 

LICENSE AGREEMENT

 

Case Western Reserve University – Exact Sciences Corporation

 

This Agreement (hereinafter “this Agreement”) entered into as of this 18th day of July, 2005 (“Effective Date”) by and between Case Western Reserve University, an Ohio non-profit corporation, having a principal place of business at 10900 Euclid Avenue, Cleveland, Ohio 44106 (“CASE”) and Exact Sciences Corporation, a Delaware corporation, having a principal place of business at 100 Campus Drive, Marlborough, MA 01752 (“Licensee”).

 

WITNESSETH

 

WHEREAS, CASE has, subject to certain interests of Howard Hughes Medical Institute (“HHMI”), certain technology developed in the laboratory of Dr. Sanford Markowitz, a Howard Hughes Medical Institute Investigator at CASE, relating to HLTF and Vimentin Gene Methylation in Colon Cancer, and is interested in licensing same,

 

WHEREAS, CASE has right, by reason of its Intellectual Property Policy and assignment from HHMI, to license such technology, subject to the right of HHMI to review and approve of any such license;

 

WHEREAS, CASE’s interest in such technology is subject to certain retained rights by the United States of America and HHMI;

 

WHEREAS, Licensee desires to acquire rights in and to the technology upon the terms and conditions herein set forth;

 

NOW THEREFORE, in consideration of the mutual covenants contained herein and intending to be legally bound hereby, the parties agree as follows:

 

1.              DEFINITIONS

 

1.1            The term “Copyrights” shall mean CASE’s and/or HHMI’s copyrights in the Licensed Technology.

 

1.2            The term “Dispose” or “Disposition” shall mean the sale, lease or other transfer of Licensed Product(s).

 

1.3            The term “Dollar”, “U.S. Dollar” and “U.S. $” shall mean lawful money of the United States of America.

 

1.4            The term “Field of Use” shall mean use of the Licensed Technology in detecting human colorectal cancer and tumors, including, without limitation, adenomas, in stool-based assays, and other products for the purposes of colorectal disease screening and detection, disease staging, disease monitoring, disease prognosis, and/or pharmacogenomic testing.

 

1.5            The term “Fiscal Quarter” or “Quarter” shall refer to the normal quarterly accounting periods of Licensee; if Licensee does not have normal quarterly accounting periods,

 

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.

 



 

then “Fiscal Quarters” shall mean the calendar three months periods commencing with January of each year.

 

1.6            The term “Licensed Product” shall mean any product, service and/or process that constitutes, is based on, incorporates or uses, in whole or in part, Licensed Technology, including any mutant or altered form of the genetic material which is covered by the Patent Rights.

 

1.6.1         The term “Licensed Combination Product” shall mean a Licensed Product that includes one or more genes for which Licensee or a Product Sublicensee must pay royalties, upon Disposition, to one or more Third Party Licensors.

 

1.6.2         The term “Third Party Licensor” means an entity (other than CASE, Licensee or Sublicensee) that has entered a royalty-bearing license agreement with Licensee or a Product Sublicensee for one or more genes included in a Licensed Product.

 

1.7            The term “Licensed Technology” or “Technology” shall mean (i) the Patent Rights ; and (ii) the technology, trade secrets, know-how, improvements and other information and intellectual property of CASE identified in Attachment A.

 

1.8            The term “Licensee Net Sales” shall mean the total of [********] received by Licensee due to Dispositions of Licensed Products (other than Dispositions by Product Sublicensees), less the total of all:

 

[********]

 

No deduction shall be made for commissions paid to individuals whether they are individual sales agents or persons regularly employed by Licensee.

 

1.9            The term “Product Sublicensee Royalty Basis” shall mean the revenue or sales total used in a sublicense agreement between Licensee and a Product Sublicensee as the basis for computing royalties owed by such Product Sublicensee to Licensee due to Dispositions of Licensed Products.  Product Sublicensee Royalty Basis, however, shall be no less than the value of Licensee Net Sales that would result from considering Revenues of Product Sublicensee to be Revenues of Licensee, unless CASE has agreed in advance to accept a particular definition of “Product Sublicensee Royalty Basis” for the computation of Royalties due to Dispositions by a Product Sublicensee.

 

1.10          The term “Patent Rights “ shall mean and include the United States patents and/or patent applications listed in Attachment A to this Agreement; United States patents issued from the applications listed in Attachment A and from divisionals and continuations of these applications and any reissues of such United States patents; claims of continuation-in-part applications and patents directed to subject matter specifically described in the applications described above; and claims of all foreign patent applications, patents, and other intellectual property which are directed to subject matter specifically described in the United States patents and/or patent applications described above.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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1.11          The term “Prime Rate” shall mean the interest rate per annum announced from time to time by Key Bank, Cleveland, Ohio, as its prime rate.

 

1.12          The term “Product Launch” shall mean the first commercial sale of Licensed Product(s).

 

1.13          The term “Product Sublicensee” shall mean an entity to which Licensee sublicenses rights to make, sell, distribute, manufacture, or otherwise convey or Dispose of Licensed Products pursuant to a sublicense agreement.

 

1.14          The term “Revenue” shall mean the U.S. Dollar value of all consideration realized from the Disposition of Licensed Product(s).

 

1.15          The term “Royalties” shall mean royalties calculated as a percentage of Net Sales and payable by Licensee to CASE under this Agreement.

 

1.16          The term “Year” refers to contract years of the License Agreement, i.e ., a 12-month period starting with the date (or anniversary) of the Effective Date of the License Agreement.

 

2.              LICENSE GRANT

 

2.1            CASE hereby grants to Licensee, and Licensee hereby accepts, (i) an exclusive, royalty bearing, world-wide right and license under and to the Licensed Technology to make, have made, use and Dispose of Licensed Products in the Field of Use and (ii) a non-exclusive, world-wide, royalty free right and license under and to the Licensed Technology for internal research and development purposes in the Field of Use.

 

2.2            No right to sublicense the Licensed Technology is hereby granted to Licensee except that Licensee may sublicense to (i) Product Sublicensees to the extent necessary to enable Product Sublicensees to make and/or Dispose of Licensed Products within the Field of Use; (ii) customers to the extent necessary for their personal use of a Licensed Product; or (iii) other entities with the specific agreement of CASE.

 

2.2.1         Licensee understands that any sublicenses granted by Licensee to entities other than customers (even though the specific agreement by CASE to such a sublicense has been obtained) must provide that the obligations to CASE and HHMI (as a third-party beneficiary) under this Agreement, including but not limited to, Indemnification, Insurance, HHMI’s third party beneficiary status, and procedures for Dispute Resolution shall be binding upon such sublicensee as if it were a party to this Agreement and that the economic return to CASE from the Disposition of Licensed Products be not less than the economic returns would be if such Disposition had been by Licensee.  In addition, any sublicense agreement shall provide for automatic assignment to CASE in the event of termination of Licensee’s license to the Licensed Technology (prior to expiration of this Agreement).  Licensee shall be responsible for the acts or omissions of its sublicensees and shall not grant any rights which are inconsistent with the rights granted to and obligations of Licensee hereunder.  Any act or omission of a sublicensee that would be a breach of this License Agreement if performed by Licensee shall be

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

3



 

deemed to be a breach of this License Agreement by Licensee if such breach is not cured before 180 days.  Each sublicense agreement granted by Licensee shall include an audit right by CASE of the same scope as provided herein below with respect to Licensee.  No such sublicense agreement shall contain any provision which would cause it to extend beyond the Team of this Agreement.  Licensee shall give CASE prompt notification of the identity and address of each sublicensee with whom it concludes a sublicense agreement and shall supply CASE with a copy of each such sublicense agreement.

 

2.3            No provision of this Agreement shall restrict Licensee’s, CASE’s and/or HHMI’s ability to conduct further research and development in the area of Licensed Technology or other areas.

 

2.4            All Licensed Products shall be manufactured, sold and performed by Licensee in compliance with all applicable governmental laws, rules and regulations.  Licensee shall keep CASE fully informed of, and shall move expeditiously to resolve, any complaint by a governmental body relevant to Licensed Products, except for complaints subject to the Section of this Agreement entitled “Infringement.”

 

2.5            CASE represents and warrants that CASE has the right to license the Patent Rights to Licensee under the terms provided in this Agreement and that CASE’s obligations to HHMI do not conflict with the licenses provided hereunder.  CASE retains the right to grant either exclusive or non-exclusive licenses for the Licensed Technology in fields of use other than the Field of Use for which the license hereunder is granted.

 

2.6            If Licensed Technology was supported under a United States Government funding agreement, then (a) the United States Government has been or will be granted licensing rights solely as required under the terms of those federal agreements, (b) all rights and obligations reserved to the United States Government and others under Public Law 96-517, and Public Law 98-620 and any applicable governmental rules and regulations, including but not limited to government purpose license and march-in rights and sharing of certain research materials, shall be respected and shall in no way be diminished by this Agreement and any right granted in this Agreement regarding Licensed Technology greater than that permitted under Public Law 96-517 or Public Law 98-620, and any applicable governmental rules and regulations, shall be subject to modification as may be required to conform to the provisions of those statutes, and (c) products using Licensed Technology sold or used in the United States will be manufactured substantially in the United States of America, unless a waiver has been obtained from the federal funding agency under whose funding agreement the Licensed Technology was generated.

 

2.7            Notwithstanding the license granted in this Agreement, CASE and HHMI and any health care institutions affiliated with either of them shall have and retain all rights to use, free of charge, the Licensed Technology for their non-commercial research, clinical research treatment ( i.e. the treatment of patients as part of a clinical research effort to determine the effectiveness, safety or tolerability of Licensed Technology), educational or academic purposes, even in the Field of Use, but not for licensing to others.  There is no restriction on licensing by CASE of Licensed Technology outside the Field of Use.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

4



 

2.8            CASE and HHMI may have in the past, and shall have the right in the future, to provide Licensed Technology to academic and/or non-profit health care institutions for non-commercial research, clinical research treatment, educational, or academic purposes.  Nothing in this Agreement shall prohibit such conduct by CASE or HHMI or use for such purposes by academic or non-profit health care institutions receiving Licensed Technology from CASE or HHMI.  For the avoidance of confusion, CASE may not, during the Term of this Agreement, permit any third party to use the Licensed Technology in the Field of Use for commercial purposes.

 

3.              FIELD OF USE OPTION

 

CASE hereby grants to Licensee an option (the “Field of Use Option”) for a term of twenty-four (24) months only, commencing on the Effective Date, (the “Option Period”) to negotiate an amendment to the Agreement with CASE to expand the Field of Use for the Licensed Technology to include human blood-based assays for the purposes of colorectal disease screening and detection, disease staging, disease monitoring, disease prognosis, and/or pharmacogenomic testing.  To exercise this Field of Use Option, Licensee must (i) provide a written statement, reasonably satisfactory to CASE, demonstrating Licensee’s capability and intention to develop Licensed Products within the human blood-based assay field of use for public sale as soon as practicable, consistent with sound and reasonable business practices and judgment, and (ii) execute an amendment to this Agreement with CASE prior to expiration of the Option Period.

 

4.              TERM OF THIS AGREEMENT

 

This Agreement shall expire at the end of its term (the “Term”), which extends from the Effective Date to the expiration of the last to expire of the Patent Rights.  The Agreement may be terminated prior to expiration pursuant to other provisions of this Agreement.

 

5.              DUE DILIGENCE

 

5.1            Licensee shall use its best commercially reasonable efforts to effect introduction of Licensed Technology into the commercial market as soon as reasonably practical; thereafter, until the termination of this Agreement, Licensee shall keep Licensed Technology reasonably available to the public.  At a minimum, Licensee shall achieve Product Launch within thirty (30) months of the Effective Date.

 

5.2            Licensee’s default in performance in accordance with Subsection 5.1 shall be grounds for CASE to terminate this Agreement.

 

6.              LICENSE FEES AND ROYALTIES

 

6.1            For Dispositions of Licensed Products other than Licensed Combination Products, Licensee shall pay CASE a Royalty of [********] (hereinafter the “Royalty Rate”) of the sum of Licensee Net Sales and Product Sublicensee Royalty Basis.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

5



 

6.2            For Dispositions of Licensed Combination Products, the Royalty Rate of [********] shall be reduced by the percentage, if any, of Licensee Net Sales and/or Product Sublicensee Royalty Basis payable as a royalty to the Third Party Licensor(s) who have contributed one or more genes to such Licensed Combined Products.  Notwithstanding the foregoing, in no event shall the Royalty Rate be less than 1 percent.

 

6.3            The parties acknowledge that Licensee, in partial satisfaction of its fee obligations to CASE hereunder, paid CASE [********] on March 10, 2003.  In addition to this amount, Licensee shall pay CASE non-refundable License Fees of (i) [********] due and payable [********]; (ii) [********] due and payable, if this Agreement is still in effect, upon the earlier of: (a) [********] or, (b) [********]; and (iii) [********] due and payable [********].  The License Fees described in this section 6.3 will be in addition to any other amounts due under this Agreement.

 

6.4            Licensee shall pay CASE a minimum royalty of [********] per year (“ Annual Minimum Royalty ”), commencing on the anniversary date of the Effective Date following the Product Launch, and payable on each anniversary of the Effective Date thereafter.  The Annual Minimum Royalty shall be credited against the Royalties payable in a Year.

 

6.5            Annual Minimum Royalty payments are to be adjusted by the cumulative percentage change in the CPI-W Consumer Price Index between December 2004 and the December preceding the date on which the payment in question is payable.

 

7.              PAYMENT TERMS

 

7.1            Royalties shall be paid by Licensee to CASE, as defined in the Section entitled “Royalties” for each Fiscal Quarter within sixty (60) days of the end of such Fiscal Quarter, until this Agreement expires or is terminated in accordance with this Agreement.  If this Agreement terminates before the end of a Fiscal Quarter, the payment for that terminal fractional portion of a Fiscal Quarter shall be made within ninety (90) days of the date of termination of this Agreement.

 

7.2            All Royalties hereunder shall be paid in U.S. Dollars and shall be made by wire transfer to CASE’s account No. [********] at Key Bank’s Cleveland office, or by Licensee’s check sent in accordance with the Section entitled “Notices”.

 

7.3            All Royalties payable hereunder that are overdue shall bear interest until paid at a rate equal to the Prime Rate in effect at the date such Royalties were due plus four percent (4%) per annum, but in no event to exceed the maximum rate of interest permitted by applicable law.  This provision for interest shall not be construed as a waiver of any rights CASE has as a result of Licensee’s failure to make timely payment of any amounts.

 

8.              REPORTS AND AUDITS

 

8.1            Licensee shall provide Quarterly reports of its progress in achieving Product Launch and shall notify CASE within ten (10) days of achieving Product Launch.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

 

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8.2            Licensee shall maintain accurate books and records such that the Royalties due and payable hereunder can be easily ascertained.  Such books and records shall be maintained at Licensee’s principal place of business and shall be available for inspection by CASE or its representatives during the normal business day upon not less than ten (10) days prior written notice, provided that CASE or its representatives agree to protect the confidentiality of the informational Licensee.

 

8.3            Licensee shall make available Licensee’s books and records for audit by an independent accounting firm of CASE’s selection and Licensee agrees to cooperate fully in any such audit, provided that the auditors agree to protect the confidentiality of the information of Licensee.  Any such audit shall not be more frequent than annually.  In the event that such audit determines that the amount of Royalties paid to CASE was in error by the greater of [********] or [********], Licensee shall pay the costs of the audit.

 

9.              IMPROVEMENTS

 

9.1            Discussion of technical matters with each other by the parties will not create in a party any rights to ownership of patents, copyrights, trade secrets or other intellectual property rights in solutions to the matters that are invented solely by employees or agents of the other party hereto.

 

9.2            Licensee will own all of the right, title and interest (including patents, copyrights, trade secrets and any other intellectual property rights) in and to any results developed solely by Licensee or on its behalf in connection with this Agreement, including the results of any collaboration between the parties that are invented solely by Licensee’s employees or agents.

 

9.3            CASE will own all of the right, title and interest (including patents, Patent Rights, Copyrights, mask work rights, trade secrets and any other intellectual property rights) in and to any results developed solely by CASE or on its behalf in connection with this Agreement, including the results of any collaboration between the parties that are invented solely by CASE employees or agents.

 

9.4            All intellectual property that is a direct improvement of and is dominated


 
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