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PATENT LICENSE AGREEMENT

Patent License Agreement

PATENT LICENSE AGREEMENT | Document Parties: GENOMIC HEALTH INC | INCYTE GENOMICS You are currently viewing:
This Patent License Agreement involves

GENOMIC HEALTH INC | INCYTE GENOMICS

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Title: PATENT LICENSE AGREEMENT
Governing Law: California     Date: 7/15/2005

PATENT LICENSE AGREEMENT, Parties: genomic health inc , incyte genomics
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Exhibit 10.6.1

*** Confidential Treatment Requested. Confidential portions of this document have been
redacted and have been separately filed with the Commission.

PATENT LICENSE AGREEMENT

THIS LICENSE AGREEMENT, dated as of March 30, 2001, is entered into between INCYTE GENOMICS, a Delaware corporation, with offices at 3160 Porter Drive, Palo Alto, California 94303 (“Incyte”), and Genomic Health, Inc., a Delaware corporation with offices at 101 University Avenue, Suite 220, Palo Alto, California 94301 (“GHI”).

BACKGROUND

     WHEREAS, Incyte has the right to grant licenses under certain patent applications and patents that have application to Diagnostic Products (as defined herein) and Personalized Research Products (as defined herein).

     WHEREAS, GHI is interested in obtaining, and Incyte has agreed to grant licenses under certain of these patents and patent applications for use in the fields described herein, subject to the terms and conditions of this Agreement.

     NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the parties hereby agree as follows:

ARTICLE
1
DEFINITIONS

In this Agreement the following words and expressions have the following meanings:

1.1  

Affiliate ”: shall mean any corporation or other entity that is directly or indirectly controlled by GHI. For the purpose of this agreement, control means ownership of one hundred percent (100%), or in the case of foreign corporations or entities the greatest percentage that may be owned by foreign interests, of the shares or other equity interests entitled to vote for the election of directors, in the case of a corporation, or equivalent governing body in the case of any other entity.

 

1.2  

Calendar Quarter ”: shall mean a period of three consecutive calendar months ending on March 31, June 30, September 30 or December 31.

 

 

 

 

1.3  

Cancer Marker Patent Rights ”: shall mean all claims listed in any of the following patents and patent applications, to the extent that they are owned by Incyte with the right to license under this Agreement, and to the extent that they claim the composition of matter or use of any nucleic acids or proteins as markers or diagnostics for cancer: (a) the patents and patent applications listed in Schedule A to this Agreement, and (b) all counterpart foreign patent applications claiming priority of the patents and patent applications described in clause (a) above, together with all continuations, continuations-in-part and divisions of such patents and patent applications, (c) all patents issuing from any patent

 

 

 

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application described in clause (a) or (b) above, and (d) all reissues and re-examinations of any of the foregoing patents.

 

1.4  

Control ” or “ Controlled ” shall mean possession of the ability to grant the right and licenses provided for herein, without violating the terms of any agreement or other arrangement with any third party, and which a party has the right to disclose or provide to the other party without a resulting obligation to pay royalties or other amounts to a third party.

 

 

 

 

1.5  

Database Patent ”: shall mean (a) the patents listed in Schedule D to this Agreement, and (b) all counterpart foreign patent applications claiming priority of the patents and patent applications described in clause (a) above, together with all continuations, continuations-in-part and divisions of such patents and patent applications, (c) all patents issuing from any patent application described in clause (a) or (b) above, and (d) all reissues and re-examinations of any of the foregoing patents.

 

 

 

 

1.6  

Diagnostic Field of Use ”: shall mean the research, development, manufacture, importation. use and/or sale of Diagnostic Product(s). The Diagnostic Field of Use excludes the Personalized Research Field of Use, the Homebrew Field of Use and the Internal Research Field of Use.

 

 

 

 

1.7  

Diagnostic Product(s) ”: shall mean an assay provided as a product or service performed on a human tissue or other human biological sample containing nucleic acids or proteins that are collectively intended to establish or identify an association between the presence or absence of such nucleic acids or proteins and:

 

 

 

 

 

(i)  

diagnosis of the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;

 

 

(ii)  

predisposition to the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;

 

 

 

 

(iii)  

response or lack of response to disease therapy(ies) in humans or preventative strategies in humans;

 

 

 

 

(iv)  

prediction of the disease course in humans, and or other changes in state(s) or condition(s) in humans over time;

 

 

 

 

(v)  

clinical traits in humans for which a medical professional should be consulted;

 

 

 

 

(vi)  

variation(s) in specific trait(s) and/or characteristics among individuals; and/or

 

 

 

 

(vii)  

predisposition to development of toxicities to disease therapies or preventative strategies in humans,

 

 

 

   

the results of which are provided to payors, providers or patients, and for which FDA approval (or comparable regulatory agency in other jurisdictions) is required. Diagnostic Products exclude Homebrew Products, Personalized Research Products and GHI Database Products.

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1.8  

“Effective Date” : shall mean the date first set forth above.

 

1.9  

GHI Database Field of Use ”: shall mean the research, development, manufacture, importation, use and/or sale of GHI Database Product(s) to end users.

 

 

 

 

1.10  

GHI Database Product ”: GHI Database Product shall mean a collection of information derived from or by testing a person or persons in the Diagnostic Field of Use, Homebrew Field of Use or the Personalized Research Field of Use. GHI Database Products exclude Diagnostic Products, Homebrew Products, and Personalized Research Products.

 

 

 

 

1.11  

Homebrew Field of Use ”: shall mean the research, development, manufacture, importation, use and/or sale of Homebrew Product(s). The Homebrew Field of Use excludes the Diagnostic Field of Use, the Internal Research Field of Use and the Personalized Research Field of Use.

 

 

 

 

1.12  

Homebrew Product(s) ” shall mean a Single Analyte Assay(s) provided as a product or a service performed by a service provider that would constitute a Diagnostic Product with the sole exception that it is provided prior to receipt of approval by the FDA or comparable regulatory agency in any jurisdiction outside of the United States. Homebrew Products exclude Diagnostic Products, Personalized Research Products and GHI Database Products. For purposes of the foregoing, “Single-Analyte Assays” shall mean an assay designed for testing or measuring only a single analyte.

 

 

 

 

1.13  

Incyte Research Product ” shall have the meaning set forth in Section 2.8.

 

 

 

 

1.14  

Internal Research Field of Use ”: shall mean (a) internal research, development, manufacture, use, importation and/or sale of Internal Research Products; and (b) internal research and development purposes (including without limitation, drug discovery, development, commercialization and regulatory filings), including the development of databases and other products and tools marketed for use in internal research and development purposes, including without limitation, drug discovery, development. commercialization and regulatory filings. The Internal Research Field of Use excludes the Diagnostic Field of Use, the Homebrew Field of Use, and the Personalised Research Field of Use.

 

 

 

 

1.15  

Internal Research Product(s) ”: shall mean internal research and development purposes (including without limitation, drug discovery, development, commercialization and regulatory filings), including the development of databases and other products and tools marketed for use in internal research and development purposes, including without limitation, drug discovery, development. commercialization and regulatory filings. Internal Research

 

 

 

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*** Confidential material redacted and filed separately with the Commission.

   

Product(s) exclude Diagnostic Product(s), Homebrew Product(s) and Personalized Research Product(s).

 

1.16  

Layton Patent Rights ”: shall mean (a) U.S. Patent No. 5,716,785 , “Processes for Genetic Manipulations Using Promoters” issued February 1, 1998; U.S. Patent No. 5,891,636 , “Processes for Genetic Manipulations Using Promoters” issued April 6, 1999 (b) all counterpart foreign patent applications claiming priority of the patent described in clause (a) above, together with all continuations, continuations-in-part and divisions of such patent applications, (c) all patents issuing from any patent application described in clause (b) above and (d) all reissues and re-examinations of any of the foregoing patents.

 

 

 

 

1.17  

Montefiore Patent Rights ”: shall mean U.S. Patent No. 4,981,783 , “Method for Detecting Pathological Conditions”, issued Jan. 1, 1991.

 

 

 

 

1.18  

Net Sales ”: shall mean invoiced sales by a party or a party’s Affiliate on all sales of Products (in final form for end use) to an unaffiliated third party, and exclusive of intercompany transfers or sales, less the following deductions from such invoiced sales, which are actually incurred, to the extent that they are reasonable and customary, and to the extent that they do not exceed *** percent (***%) of invoiced sales during any Calendar Quarter:

 

 

 

(i) credits or allowances actually granted for damaged Products, returns or rejections of Product and retroactive price reductions;

(ii) freight, postage, shipping, customs duties and insurance charges;

(iii) normal and customary trade, cash and quantity discounts, allowances and credits;

(iv) uncollected amounts to the extent not exceeding *** percent (***%) of invoiced sales for a calendar quarter; and

(v) sales, value added or similar taxes measured by the billing amount, when included in billing.

1.19  

Patent Rights ”: shall mean collectively, the Cancer Marker Patent Rights, Database Patent Rights, Layton Patent Rights, the Montefiore Patent Rights, the Seilhamer/Scott Patent Rights, and the Stanford Patent Rights;

 

1.20  

Personalized Research Field of Use ”: shall mean the research, development, manufacture, importation, use and/or sale of Personalized Research Product(s). The Personalized Research Field of Use excludes the Diagnostic Field of Use, the Homebrew Field of Use, and the Internal Research Field of Use.

 

 

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1.21  

Personalized Research Product(s) ”: shall mean a Multi-Analyte Assay(s) provided as a product or a service containing nucleic acids or proteins that are collectively intended to establish or identify an association between the presence or absence of such nucleic acids or proteins and:

 

 

(i)  

diagnosis of the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;

 

 

(ii)  

predisposition to the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;

 

 

 

 

(iii)  

response or lack of response to disease therapy(ies) in humans or preventative strategies in humans;

 

 

 

 

(iv)  

prediction of the disease course in humans, and or other changes in state(s) or condition(s) in humans over time;

 

 

 

 

(v)  

clinical traits in humans for which a medical professional should be consulted;

 

 

 

 

(vi)  

variation(s) in specific trait(s) and/or characteristics among individuals; and/or

 

 

 

 

(vii)  

predisposition to development of toxicities to disease therapies or preventative strategies in humans,

 

 

 

   

Such an assay will be considered a “Personalized Research Product” only where the results are provided directly to the tested individual and/or to the tested individual’s health care provider, and where the approval by the FDA or comparable regulatory agency in any jurisdiction outside of the United States is not required. “Personalized Research Products” exclude Homebrew Products, Diagnostic Products and GHI Database Products. For purposes of the foregoing, “Multi-Analyte Assay(s)” shall mean an assay designed for testing or measuring more than a single analyte.

 

1.22  

Product(s) ”: shall mean GHI Database Products, Personalized Research Products, Homebrew Products, Incyte Research Products, Therapeutic Products and/or Diagnostic Products.

 

1.23  

Seilhamer/Scott Patent Rights ”: shall mean (a) US Patent No. 6,114,114 “Comparative Gene Transcript Analysis” issued September 5, 2000, (b) US Patent No. 5,840,484 “Comparative Gene Transcript Analysis” issued November 24, 1998 (c) all counterpart foreign patent applications claiming priority to the patents described in clauses (a)and (b) above, together with all continuations, continuations-in-part and divisions of such patents, and (d) all reissues and re-examinations of any of the foregoing patents.

 

1.24  

Stanford Patent Rights ”: shall mean (a) US Patent No. 5,807,522 “Methods for Fabricating Micro Arrays of Biological Samples” issued September 15, 1998 (b) all counterpart foreign patent applications claiming priority of the patent described in clause (a) above, together with all continuations, continuations-in-part and divisions of such patent applications, (c) all patents issuing from any patent

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application described in clause (b) above and (d) all reissues and re-examinations of any of the foregoing patents.

 

1.25  

Therapeutic Product ” shall have the meaning set forth in Section 2.8.

 

 

 

 

1.26  

Valid Claim ”: shall mean a claim of an issued and unexpired patent which has not been held unenforceable, unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, rendered unenforceable due to disclaimer or otherwise, or lost through an interference proceeding.

 

 

 

ARTICLE
2
LICENSE GRANT

2.1  

Layton and Stanford Patent Rights . Subject to the terms of this Agreement, Incyte hereby grants to GHI and its Affiliates, and GHI and its Affiliates accept from Incyte a nonexclusive, non-transferrable, limited sublicenseable (only as set forth in Sections 2.5 and 2.6 below), world-wide license under the Layton Patent Rights and the Stanford Patent Rights to practice and use the subject matter within the Layton Patent Rights and the Stanford Patent Rights in the GHI Database Field of Use, Diagnostic Field of Use, the Homebrew Field of Use and the Personalized Research Field of Use.

 

2.2  

Montefiore Patent Rights . Subject to the terms of this Agreement, Incyte hereby grants to GHI and its Affiliates, and GHI and its Affiliates accept from Incyte a non-transferrable, limited sublicenseable (only as set forth in Sections 2.5 and 2.6 below), world-wide license under the Montefiore Patent Rights to practice and use the subject matter within the Montefiore Patent Rights in the GHI Database Field of Use, the Diagnostic Field of Use, the Homebrew Field of Use and the Personalized Research Field of Use. The license under the Montefiore Patent Rights shall be exclusive in the Personalized Research Field of Use and Co-exclusive (as described in Section 2.6) in the GHI Database Field of Use, the Homebrew Field of Use and the Diagnostic Field of Use.

 

2.3  

Cancer Marker Patent Rights . Subject to the terms of this Agreement, Incyte hereby grants to GHI and its Affiliates, and GHI and its Affiliates accept from Incyte a non-transferrable, limited sublicenseable (only as set forth in Sections 2.5 and 2.6 below), world-wide license under the Cancer Marker Patent Rights to practice and use the subject matter within the Cancer Marker Patent Rights in the GHI Database Field of Use, the Diagnostic Field of Use, the Homebrew Field of Use and the Personalized Research Field of Use, only with respect to cancer. The license under the Cancer Marker Patent Rights shall be exclusive in the Personalized Research Field of Use with respect to cancer, and co-exclusive (as described in Section 2.6) in the GHI Database Field of Use, Diagnostic Field of Use and the Homebrew Field of Use with respect to cancer.

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2.4  

Database Patent Rights and Seilhamer/Scott Patent Rights . Subject to the terms of this Agreement, Incyte hereby grants to GHI and its Affiliates, and GHI and its Affiliates accept from Incyte a non-exclusive, non-transferable, non-sublicenseable , world-wide license under the Database Patent Rights and Seilhamer/Scott Patent Rights to practice and use the subject matter within the Database Patent Rights and the Seilhamer/Scott Patent Rights in the GHI Database Field of Use, the Diagnostic Field of Use, the Homebrew Field of Use, and the Personalized Research Field of Use.

 

2.5  

Sublicenses . Except as provided in Section 2.6 and this Section 2.5, the rights granted in Section 2.1 through 2.3 above shall not be sublicensable; provided, GHI shall have the right to grant sublicenses to third parties under such Patent Rights on a Product-by-Product basis to make, use, import, sell, and offer for sale Product(s) developed by GHI or its Affiliates.

 

2.6  

Co-Exclusive License(s) — Homebrew and Diagnostic Fields of Use . For the purposes of this Article 2.0, “Co-Exclusive” shall mean that (a) each Party has the right to exercise all of the rights under the Patent Rights in question in the field of use for which the parties have co-exclusive rights, without obligation to the other except to the extent provided in this Agreement, and (b) neither Party alone has the right to grant sublicenses to third parties under such Patent Rights without express written consent of the other Party with the following exceptions:

 

 

 

 

 

(v)  

GHI shall have the right to grant sublicenses as provided in Section 2.5 above;

 

 

(w)  

Incyte shall have the right to grant licenses in the Homebrew Field of Use and the Diagnostic Field of Use on a Product-by-Product basis to make, use, import, sell, and offer for sale Product(s) developed by Incyte or its Affiliates.

 

 

 

 

(x)  

Incyte shall have the right to grant sublicenses with respect to the Cancer Marker Patent Rights in the Homebrew and Diagnostic Fields of Use) with respect to individual nucleic acids or proteins in connection with Incyte licenses of nucleic acids or proteins for use as targets for the development of vaccines or therapeutic products;

 

 

 

 

(y)  

GHI shall have the right to request that Incyte grant a sublicense under the Montefiore Patent Rights in the Diagnostic Field of Use and/or the Homebrew Field of Use to one (1) third party with which GHI enters into a cross license agreement involving the Montefiore Patent Rights, and Incyte agrees to grant such a sublicense;

 

 

 

 

(z)  

Incyte shall have the right to grant a sublicense under the Montefiore Patent Rights in the Diagnostic Field of Use and/or the Homebrew Field of Use to one (1) third party with which Incyte enters into a cross license agreement involving the Montefiore Patent Rights; and

 

 

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(zz)  

Any additional licenses under the Montefiore Patent Rights granted by the Parties shall be subject to mutual written agreement of the parties, and the parties shall share all revenues received from licensees for licenses under the Montfiore Patent Rights, after deduction of all amounts owed to the owner of the Montefiore Patent Rights.

 

2.7  

No Implied Licenses . Incyte grants no licenses to GHI under any Patent Rights except as expressly granted under this Agreement. There are no other licenses granted by Incyte to GHI under this Agreement, whether by implication, estoppel or otherwise. GHI shall not use any Patent Rights for any purpose or in any field other than as described in Sections 2.1 through 2.6.

 

2.8  

Grant Back . GHI hereby grants to Incyte, and Incyte hereby accepts, an exclusive, paid up, non-transferable, sublicensable, worldwide license under GHI patent rights and trade secret rights owned and Controlled by GHI, with respect to any discoveries (to the extent such discoveries relate to the composition of matter or use of any nucleic acids or proteins claimed in the Cancer Marker Patent Rights) made by GHI in connection with GHI’s use of the Cancer Marker Patent Rights (the “Cancer Marker Improvements”) for use by Incyte and Incyte’s sublicensees in the (i) Internal Research Field of Use, (ii) in connection with the manufacture, use and sale of vaccines and therapeutic products (each therapeutic product a “Therapeutic Product”), and (iii) Diagnostic Products in connection with the exercise of rights under (ii).

 

 

 

 

   

GHI hereby grants to Incyte, and Incyte hereby accepts, a non-exclusive, royalty-bearing, non-transferable, non-sublicensable, worldwide license under GHI patent rights and trade secret rights owned and Controlled by GHI, with respect to Personalized Research Products developed by GHI and licensed under this Agreement or the LifeSeq Collaborative Agreement of even date herewith (the “GHI PRx Improvements”)


 
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