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Collaborative Pronet Research & License Agreement

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Exhibit 10.9


COLLABORATIVE PRONET RESEARCH AND LICENSE AGREEMENT


dated as of November 11, 1998


by and between


MYRIAD GENETICS, INC


and


MONSANTO COMPANY


COLLABORATIVE PRONET RESEARCH AND LICENSE AGREEMENT
---------------------------------------------------


This COLLABORATIVE PRONET RESEARCH AND LICENSE AGREEMENT (this
"Agreement"), is made as of November 11, 1998 (the "Effective Date"), by and - ---------- -------------- between MONSANTO COMPANY, a Delaware corporation (hereinafter "MONSANTO"), and
-------- MYRIAD GENETICS, INC., a Delaware corporation (hereinafter "MYRIAD"). MONSANTO
------ and MYRIAD are sometimes referred to herein individually as a "Party" and
----- collectively as the "Parties."
-------


W I T N E S S E T H:


WHEREAS, MYRIAD has expertise in the discovery and characterization of genes related to major common diseases and in the development of human diagnostic products and services derived from disease genes, and has developed a proprietary ProNet Technology to identify and compile data with respect to protein-protein Interactions with potential application in the development of human diagnostic and therapeutic products; and


WHEREAS, MONSANTO has expertise in discovering, developing, manufacturing, distributing and marketing human therapeutic products; and


WHEREAS, MYRIAD and MONSANTO are interested in entering into an agreement whereby MYRIAD and MONSANTO will jointly perform research using MYRIAD's proprietary ProNet Technology to identify Genes and Interactive Proteins and whereby MONSANTO shall have the option to obtain from MYRIAD a license to use, commercialize and exploit the results of such research for the discovery, development, manufacture and marketing of Licensed Products derived from such Genes and Interactive Proteins.


NOW THEREFORE, in consideration of the premises, and the representations, covenants and agreements hereinafter set forth, and for other good and valuable consideration, the adequacy and sufficiency of which is hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:


ARTICLE 1
DEFINITIONS
-----------


As used in this Agreement, the following terms, when capitalized, shall have the meanings ascribed to them below.


1.1 "Affiliate" means any person, corporation, partnership, firm,
--------- joint venture or other entity which, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, MONSANTO or MYRIAD, as the case may be. As used in this definition, "control" means the possession of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of the outstanding voting securities or by contract or otherwise.


1.2 "Annual Research Plan" means the written plan describing the
-------------------- research in the Field to be carried out during each year of the Research Program by MYRIAD and MONSANTO pursuant to this Agreement. Each Annual Research Plan shall be approved by the Steering Committee pursuant to Section 2.1(b) below.


1.3 "Applicable Rate" has the meaning set forth in Section 4.7(b).
---------------


1.4 "Bait" means any protein or gene or fragment thereof intended to
---- be used with the ProNet Technology under the Research Program to identify and select Interactive Proteins and/or Genes that Interact therewith.


1.5 "Characterize" means, with respect to any gene, understanding the
------------ function or activity of the protein produced by such gene.


1.6 "Claims" has the meaning set forth in Section 9.1.
------


1.7 "Confidential Information" means all information (including but
------------------------ not limited to information about any element of Technology) which is disclosed by one Party to the other hereunder or under the Confidentiality Agreement referred to in Section 5.4 to the extent that such information, as of the date of its disclosure, is not demonstrably known to the Party or its Affiliates receiving such disclosure as shown by written, electronic or other


2


records (other than by virtue of a prior confidential disclosure to such Party or its Affiliates). For purposes of this definition, "Confidential Information" shall not include any information which, as of the date of disclosure or thereafter (i) is disclosed in published literature through no fault or omission of the Party receiving such disclosure; (ii) is obtained from a Third Party free from any obligation of confidentiality owed to the disclosing Party and having the lawful right to disclose it; or (iii) is known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party, as evidenced by the written, electronic or other records of the receiving Party.


1.8 "Control" or "Controlled" refers to possession of the ability to
------- ---------- grant a license or sublicense of patent rights, know-how or other intangible rights as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.


1.9 "Diagnostic Product" means all human, veterinarian and other in
------------------ vivo or in vitro diagnostic products and services derived from a Gene or Interactive Protein discovered under the Research Program, including without limitation products or services utilized to identify predisposition to disease, confirm disease, predict therapeutic effectiveness, monitor disease progression, determine prognosis or stratify patient groups.


1.10 "Discover" (and any derivation such as Discovered or Discovery
-------- with appropriate adjustments in tense as the context shall require) shall mean, with respect to any Gene, to isolate, clone, identify and sequence that Gene.


1.11 "Discontinued Product" has the meaning set forth in Section 3.8.
--------------------


1.12 "Effective Date" has the meaning specified in the Preamble to
-------------- this Agreement.


1.13 "Exclusive License" has the meaning set forth in Section 3.3.
-----------------


1.14 "Expiration Date" has the meaning set forth in Section 2.4.
---------------


1.15 "FDA" means the United States Food and Drug Administration or
--- any successor agency.


1.16 "Field" means all life science uses of products, including,
----- without limitation, products relating to human, veterinarian, agricultural, therapeutic and prophylactic uses (including Small Molecule Drugs and Non-Small Molecule Drugs and Diagnostic Products (subject to the remainder of this definition), protein replacement, antisense, ribozymes, and cell or gene therapy) for any clinical indication of the Genes and/or Interactive Proteins discovered under the Research Program through the ProNet Technology, but
--- excluding human Diagnostic Products to the extent commercialized for sale to or - --------- use by a Third Party (provided that MONSANTO shall have a right of first offer on any sales, transfers, assignments, licenses or other dispositions to a Third Party by MYRIAD of rights in and/or to any such human Diagnostic Products).


1.17 "First Commercial Sale" shall mean, with respect to any Licensed
--------------------- Product, the first sale (including to wholesalers) for end use or consumption of such Licensed Product in a country after all required approvals, including marketing and pricing approvals, have been granted by the governing health authority of such country.


1.18 "G7 Country" means Canada, England, France, Germany, Italy,
---------- Japan or the United States.


1.19 "Gene" means a DNA fragment, or portion thereof, that has been
---- identified under the Research Program through the ProNet Technology and which codes for an Interactive Protein or a portion thereof.


1.20 "IND" means an investigational new drug application required to
--- be filed with the FDA pursuant to 21 C.F.R. (S) 312, as such regulations may be amended from time to time, to test drug products in humans, or any foreign equivalent in any G7 Country.


1.21 "Interaction" or "Interact" means contact between proteins that
----------- -------- is sufficiently stable to allow the ProNet Technology to identify such proteins or portions thereof.


1.22 "Interactive Protein" means a gene or protein or portion of a
------------------- protein or gene which has been identified under the Research Program by means of the ProNet Technology as a protein which directly, or indirectly through a series of Interactions, Interacts with another protein or gene or portion of a protein or gene.


3


1.23 "Licensed Product" means any product for prophylactic or
---------------- therapeutic use in the Field as to which MONSANTO has exercised an Option pursuant to Section 2.3(b), which consists of, is comprised of, is derived from and/or related to:


(a) a Gene or Interactive Protein that is licensed by MONSANTO hereunder;


(b) any fragment or mutation of (a);


(c) an RNA or a DNA sequence corresponding, complementary to, or an antisense sequence to a Gene or fragment of a Gene in (a) or (b);


(d) an antibody to an Interactive Protein;


(e) a gene therapy or cell therapy product incorporating any of (a), (b), (c) or (d); or


(f) a molecule or compound, regardless of its function or utility, which is discovered or whose function or utility is discovered in the Research Program utilizing the ProNet Technology or other information relating to (a) through (e) above.


The entities listed in (b) through (f) are sometimes referred to herein as "derived" from the Gene or Interactive Protein in (a) above. For purposes of the payments required to be made by MONSANTO under Article IV only, the term "Licensed Product" shall not include any Interactive Protein, Gene or other specific composition of matter that (x) as of the date hereof, is already known as a product candidate to Monsanto or its Affiliates, as shown by written, electronic or other records, or their current and future licensors, or to any third party that acquires, is acquired by or merges with Monsanto or any successor entity (with the right to use), other than by receipt from MYRIAD, or that after the date hereof ceases to be proprietary and comes within the public domain or knowledge of MONSANTO or (y) at the time of disclosure to MONSANTO, or at the time of use by MONSANTO, as applicable, is part of the public domain or independently known to MONSANTO, as shown by written, electronic or other records, provided, however, that any such Interactive Protein, Gene or other specific composition of matter or use thereof shall be a "Licensed Product" for purposes of payments required to be made by MONSANTO under Article IV if it or its use is covered by a Valid Claim of a Research Program Patent.


1.24 "Losses" has the meaning set forth in Section 9.1.
------


1.25 "MONSANTO Database" has the meaning set forth in Section 2.6(a).
-----------------


1.26 "MONSANTO Indemnitees" has the meaning set forth in Section 9.2.
--------------------


1.27 "MONSANTO Information" means any information and materials,
-------------------- including DNA and other similar molecules, delivered by MONSANTO to MYRIAD for use in the Research Program, and all results, including DNA and other similar molecules produced in PCR reactions and otherwise, of research conducted using such information and materials to the extent such information and materials are proprietary and confidential to MONSANTO.


1.28 "MONSANTO Technology" has the meaning set forth in Section
------------------- 6.1(b).


1.29 "MYRIAD Indemnitees" has the meaning set forth in Section 9.1.
------------------


1.30 "MYRIAD Patent" means a Patent Controlled by MYRIAD which claims
------------- any Technology necessary or useful for the development, manufacture, use, importation, sale or offer for sale of a Licensed Product.


1.31 "MYRIAD Technology" means all Technology Controlled by MYRIAD,
----------------- including the ProNet Technology, Research Program Technology and any Technology claimed or described in a MYRIAD Patent or a Research Program Patent.


1.32 "NDA" means a new drug application required to be filed with the
--- FDA pursuant to 21 C.F.R. (S) 313, as such regulation may be amended from time to time, to market a drug, or any foreign equivalent in a G7 Country.


4
1.33 "Net Sales" means, with respect to each country in the
--------- Territory, amounts invoiced by MONSANTO, its Affiliates and sublicensees with respect to all sales of Licensed Products covered by a Valid Claim under any MYRIAD Patent or Research Program Patent or Patent resulting from use of Research Program Technology ("Patented Licensed Products") to unaffiliated Third
-------------------------- Parties (whether an end-user, a distributor or otherwise), and exclusive of intracompany transfers in the Territory, less the reasonable and customary deductions from such gross amounts including, without limitation:


(a) cash and quantity discounts, allowances and credits actually allowed and taken;


(b) credits or allowances actually granted for damaged goods, recalls, returns or rejections of Licensed Products and retroactive price reductions;


(c) sales or similar taxes (including duties or other governmental charges levied on, absorbed or otherwise imposed on the sale of Licensed Products including, without limitation, value added taxes or other governmental charges otherwise measured by the billing amount) when included in billing;


(d) freight, postage, shipping, customs duties and insurance charges paid by MONSANTO;


(e) charge back payments, discounts and rebates (whether mandated or otherwise) incurred for managed health care organizations or to federal, state and local governments, their agencies, and purchasers and reimbursers or to trade customers, including but not limited to, wholesalers and chain and pharmacy buying groups and charge back payments, discounts and rebates (whether mandated or otherwise) charged by national or local government authorities in countries other than the United States and paid or credited by MONSANTO; and


(f) commissions paid to Third Parties other than sales personnel and sale representatives or sales agents directly related to such sales.


1.34 "Non-Small Molecule Drugs" means genes, gene fragments,
------------------------ proteins, protein fragments, RNA, antibodies and any other compounds with molecular weights equal to or greater than 1,000 daltons.


1.35 "Option" has the meaning set forth in Section 2.3(b).
------


1.36 "Option Period" has the meaning set forth in Section 2.3(b).
-------------


1.37 "Patent" means United States and foreign patents, applications
------ and provisional applications for United States and foreign patents, and all reexaminations, reissues, extensions, term restorations, divisionals, continuations and continuations-in-part thereof.


1.38 "Patented Licensed Products" shall have the meaning set forth in
-------------------------- Section 1.33.


1.39 "Pathway" means a series of Genes that code for Interactive
------- Proteins that Interact with one another, including the related Interactions.


1.40 "Previously Licensed Proteins" shall mean those proteins and/or
---------------------------- genes licensed by MYRIAD to any Third Party prior to the date such proteins and/or genes are placed in the MONSANTO Database; provided that, as of the date of such license, MYRIAD had no reason to believe such proteins and/or genes could form a part of a the Research Program and/or a Monsanto Database.


1.41 "ProNet" shall mean MYRIAD's database of Interactive Proteins
------ resulting from the use of the ProNet Technology.


1.42 "ProNet Technology" means the proprietary tools (robotics,
----------------- plastics, software, etc.), proprietary methods (protocols, processes, etc.) and proprietary reagents (vectors, strains, buffers and solutions, etc.) used by MYRIAD to carry out yeast two hybrid protein-protein Interaction studies, including MYRIAD's proprietary compilation of protein-protein Interaction data for the human genome which is generally accessible to MYRIAD's ProNet collaborators, including improvements thereto.


1.43 "Related Licensed Products" shall have the meaning set forth in
------------------------- Section 4.2.


1.44 "Research Program" means the collaborative research program
---------------- specified in the applicable Annual Research Plan.


5


1.45 "Research Program Patent" means any Patent filed by either party
----------------------- covering Research Program Technology.


1.46 "Research Program Technology" has the meaning set forth in
---------------------------- Section 6.1(a).


1.47 "Research Term" has the meaning set forth in Section 2.4.
-------------


1.48 "Small Molecule Drugs" means naturally occurring or synthetic
-------------------- compounds with molecular weights of less than 1,000 daltons.


1.49 "Steering Committee" has the meaning set forth in Section 2.2.
-------------------


1.50 "Surrogate Product" has the meaning set forth in Section 3.8.
-----------------


1.51 "Technology" means and includes all proprietary information and
---------- materials related to the Field, including but not limited to nucleic acid constructs, genes, proteins, DNA fragments and primers, procedures, processes, technical information, know-how, data, expertise and trade secrets.


1.52 "Territory" means the world.
---------


1.53 "Term" refers to the term of this Agreement as provided in
---- Section 7.1.


1.54 "Third Party" means any entity other than MONSANTO, MYRIAD and
----------- their respective Affiliates.


1.55 "Valid Claim" means any claim of a pending patent application or
----------- an unexpired patent which has not been held unenforceable, unpatentable or invalid by a decision of a court of other governmental agency of competent jurisdiction, unappealed or unappealable within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue, reexamination, disclaimer or otherwise.


1.56 "Written Disclosure" has the meaning set forth in Section 5.3.
------------------


ARTICLE II
RESEARCH PROGRAM
----------------


2.1 Research Program.
----------------


(a) Objectives of Research Program. MYRIAD and MONSANTO shall engage
------------------------------ in the Research Program upon the terms and conditions set forth in this Agreement and in the applicable Annual Research Plan. As will be specified in the initial Annual Research Plan, Monsanto shall initially select for analysis in the Research Program two Pathways and several Baits related thereto. From time to time thereafter, MONSANTO may specify additional Baits to be used in the Research Program. MYRIAD will use commercially reasonable efforts using the ProNet Technology to identify all Genes and Interactive Proteins that Interact with the initial Baits provided by MONSANTO hereunder and such additional Baits as may be approved by the Steering Committee hereunder; provided, however, that MYRIAD shall not be obligated to disclose the name and/or sequence of any Previously Licensed Protein to the extent that MYRIAD is prohibited from doing so under any binding agreement with the licensee of such Previously Licensed Protein. It is hereby agreed that MONSANTO may, at anytime during the Research Term and upon not less than thirty (30) days' written notice, or as otherwise approved by the Steering Committee, and upon payment to MYRIAD of [ ], add one additional Pathway (or more with the prior approval of the Steering Committee) to the Research Program (and Baits related thereto) for analysis using the ProNet Technology.


(b) Annual Research Plans. For each year of the Research Program
--------------------- commencing with the second year, an Annual Research Plan shall be prepared and approved in preliminary form by the Steering Committee no later than one hundred eighty (180) days before the end of the prior year and approved by the Steering Committee in final form no later than ninety (90) days before the end of the prior year. The Annual Research Plan for the first year shall be approved by the Steering Committee in final form within 30 days after the Effective Date. Each Annual Research Plan shall be in writing and shall set forth with reasonable specificity research objectives and milestones for the period covered by the Annual Research Plan. The Steering Committee may make adjustments in the Annual Research Plan at its quarterly meetings or otherwise as it may determine.


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2.2 Joint Research Steering Committee. The parties hereby establish
--------------------------------- a Joint Research Steering Committee (the "Steering Committee") to facilitate the
------------------ Research Program as follows:


(a) Establishment and Functions. The Steering Committee shall
--------------------------- plan, administer and monitor the Research Program. In particular, the Steering Committee shall review progress in the Research Program and recommend necessary adjustments to the Research Program as the research takes place.


(b) Membership. MYRIAD and MONSANTO each shall appoint, in its
---------- sole discretion, three members to the Steering Committee, unless otherwise agreed to by the Parties. Substitutes or alternates may be appointed at any time by notice in writing to the other Party.


The members of the Steering Committee initially shall be:


MYRIAD Appointees:


[


]


MONSANTO Appointees:


[


]


(c) Chairs. The Steering Committee shall be chaired by two co-
------ chairpersons, one appointed by MYRIAD and the other appointed by MONSANTO from the Steering Committee members.


(d) Meetings. The Steering Committee shall meet at least
-------- quarterly, at places and on dates selected by each Party in turn, unless the Parties agree otherwise. Representatives of each Party or its Affiliates, in addition to the
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