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Myriad/Genetic Technologies Marketing and Patent License Agreement

Marketing Agreement

Myriad/Genetic Technologies Marketing and

Patent License Agreement | Document Parties: GENETIC TECHNOLOGIES LTD | Myriad Genetics, Inc., You are currently viewing:
This Marketing Agreement involves

GENETIC TECHNOLOGIES LTD | Myriad Genetics, Inc.,

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Title: Myriad/Genetic Technologies Marketing and Patent License Agreement
Governing Law: Delaware     Date: 8/19/2005
Industry: Biotechnology and Drugs     Law Firm: O'Melveny Myers LLP.,Faegre Benson LLP    

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Exhibit 4.6

Myriad/Genetic Technologies Marketing and

Patent License Agreement

        This Myriad/Genetic Technologies Patent License Agreement (" Agreement ") is entered into as of October     , 2002 (" Effective Date ") by and between the Parties,

        Myriad Genetics, Inc., a corporation organized under the laws of the State of Delaware, having a principal place of business at 320 Wakara Way, Salt Lake City, Utah 84108 ("Myriad"), and

        Genetic Technologies Limited, having offices at 60-66 Hanover Street, Fitzroy, Victoria 3065, Australia ("GTG"),

and the Parties agree as follows.


A R T I C L E 1

BACKGROUND

        1.1   Myriad is the owner or the exclusive licensee, with the right to sublicense, of patents relating to genetic testing with respect to the BRCA1, BRCA2, MLH1, MSH2, APC, P16 and AGT genes.

        1.2   GTG is interested in marketing and potentially performing current and future genetic testing services, including, but not limited to, COLARIS SM , COLARIS AP SM , MELARIS SM , CardiaRisk®, and other genetic testing services provided by Myriad relating to determining a specific DNA sequence or sequences of the MLH1, MSH2, APC, P16 and/or AGT gene(s).

        1.3   GTG is interested in marketing and performing certain genetic testing services and marketing genetic testing services, including, but not limited to, BRACAnalysis®, provided by Myriad relating to determining a specific DNA sequence or sequences of the BRCA1, BRCA2 gene(s).

        1.4   The Parties have concluded that the needs and interests of the Parties will be served by the grant of rights and licenses from Myriad to GTG with respect to genetic testing relating to the BRCA1, BRCA2, MLH1, MSH2, APC, P16 and/or AGT genes.


A R T I C L E 2

DEFINITIONS

        2.1    "Diagnostic Services I" means genetic testing, including, but not limited to, BRACAnalysis®, to determine a specific DNA sequence or sequences of the BRCA1 and/or BRCA2 gene(s) in a given individual including mutations or alterations thereof, when such determination is performed for the purpose of providing information to physicians, healthcare practitioners and/or patients with respect to a patient's relative risks of inherited cancer or the diagnosis or monitoring of cancer; provided, however, that Diagnostic Services I do not include: (a) Diagnostic Products (as defined in Article 2.3), and/or (b) Therapeutic Products (as defined in Article 2.13); and/or (c) activities in which the DNA sequences of one or more individuals are ascertained for purposes other than evaluating a patient's relative risks of inherited breast and ovarian cancer or diagnosing or monitoring breast and ovarian cancer (for example, developing Diagnostic Products and/or Therapeutic Products).

        2.2    "Diagnostic Services II" means current and future genetic testing developed and commercialized by Myriad, including, but not limited to, COLARIS SM , COLARIS  AP SM , MELARIS SM , CardiaRisk®, and other genetic testing to determine a specific DNA sequence or sequences of the MLH1, MSH2, APC, P16 and/or AGT gene(s) in a given individual including mutations or alterations thereof, when such determination is performed for the purpose of providing information to physicians, healthcare practitioners and/or patients with respect to a patient's relative health risks, or the diagnosis or monitoring of such health risks; provided, however, that Diagnostic Services II do not include: (a) Diagnostic Products (as defined in Article 2.3), and/or (b) Therapeutic Products (as defined in


 

Article 2.13); and/or (c) activities in which the DNA sequences of one or more individuals are ascertained for purposes other than evaluating a patient's relative health risks, or diagnosing or monitoring such health risks (for example, developing Diagnostic Products and/or Therapeutic Products).

        2.3    "Diagnostic Products" means any reagent, article, equipment and/or apparatus that (i) is used, either alone or in combination with other reagents, articles and/or equipment, to determine the specific DNA sequence or sequences of genes in a given individual, including mutations thereof and relative risks of cancer, and (ii) is sold to a customer who actually performs a test to determine a DNA sequence or sequences of the genes in a given individual, including mutations thereof and relative risks of cancer or high blood pressure, without the provision from the maker or distributor of such products of any testing or interpretive services covering such DNA sequences.

        2.4    "Full Sequence Testing" means any analytical method of determining the sequence of a gene.

        2.5    "Improvement" means any discovery or invention made by GTG or GTG Subsidiaries relating to an improvement in, or a new use or application of, or a new method of determining a specific DNA sequence or sequences of the BRCA1, BRCA2, MLH1, MSH2, APC, P16 and/or AGT gene(s), including but not limited to the discovery of any novel mutations of the BRCA1, BRCA2, MLH1, MSH2, APC, P16 and/or AGT gene(s).

        2.6    "Licensed Patents" means patents owned, licenseable, or sub-licensable by Myriad, and claiming (i) a BRCA1, BRCA2, MLH1, MSH2, APC, P16, AGT or other gene sequence which is the coding sequence or the genomic sequence set forth in the sequence listing of a patent as specifically limited by that base discovered at each of a specific set of polymorphic sites along the coding or genomic sequence, (ii) mutations, polymorphisms, alterations and variants in, such BRCA1, BRCA2, MLH1, MSH2, APC, P16, AGT, or other sequences; or (iii) processes and methods for using (i) and (ii), and all divisions, continuations, continuations-in-part, reexaminations, and reissues of such patents.

        2.7    "Myriad Testing Services" means all genetic testing services performed by Myriad.

        2.8    "Net Revenues" means gross revenues recognized in accordance with generally accepted accounting principles for Diagnostic Services I and/or Diagnostic Service II, less governmental and healthcare rebates, and hospital, insurance company and HMO performance incentive program rebates.

        2.9    "Southeast Asia" means the region of Asia bounded by the Indian subcontinent on the west, China on the north, and the Pacific Ocean on the east, including Indochina, the Malay Peninsula, and the Malay Archipelago, including the countries of Singapore, Malaysia, Indonesia, Brunei, Burma (Myanmar), Cambodia, Laos, The Philippines, Thailand, and Vietnam.

        2.10  "Specific Mutation Testing" means site-specific detection of a predetermined, known mutation of a gene.

        2.11  "Subsidiaries" means any corporation, company or other legal entity, in which more than fifty percent (50%) of the shares entitled to vote for the election of directors or persons performing similar functions are, now or hereafter, owned or controlled, directly or indirectly by a Party hereto, or jointly by the Parties hereto; provided, however, that any corporation, company or other legal entity shall be a Subsidiary only for as long as such ownership or control exists.

        2.12  "Territory" means Australia and New Zealand.

        2.13  "Therapeutic Products" means compositions of matter, including but not limited to DNA sequences, proteins or polypeptides produced from such DNA sequences or vectors harboring such DNA sequences, intended for either preventing or treating various forms of cancer or high blood pressure.

        2.14  "Third Party" means any person or entity other than Myriad, GTG, and GTG's Subsidiaries.

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A R T I C L E 3

LICENSE GRANT

        3.1   Myriad grants GTG and GTG's Subsidiaries the exclusive (except as provided in Article 3.8) right and license under Licensed Patents issued in the Territory to market, sell, offer to sell, and import Diagnostic Services II performed by Myriad, including Full Sequence Testing and Specific Mutation Testing.

        3.2   Myriad grants GTG and GTG's Subsidiaries an exclusive (except as provided in Article 3.8), fee-bearing, non-transferable (except as provided in Article 7.1) right and license under Licensed Patents issued in the Territory to market, sell, offer to sell, perform, and import Diagnostic Services I, including Full Sequence Testing, Specific Mutation Testing, and Myriad Testing Services, in the Territory.

        3.3   Myriad grants GTG and GTG's Subsidiaries an exclusive (except as provided in Article 3.8), fee-bearing, non-transferable (except as provided in Article 7.1) right and license under Licensed Patents issued in the Territory to market, sell, offer to sell, perform, and import Diagnostic Services II, limited to Specific Mutation Testing, in the Territory.

        3.4   GTG shall pay Myriad an annual fee of One Hundred Thousand United States Dollars (US$100,000) on each anniversary date of the Effective Date as consideration for the marketing rights granted in Article 3.1 and the rights and licenses granted in Articles 3.2 and 3.3.

        3.5   The rights and licenses granted under Articles 3.1, 3.2, and 3.3 of this Agreement exclude the right to grant sublicenses.

        3.6   During the term of this Agreement GTG shall have the right to prosecute, at GTG's own expense, any infringement of Licensed Patents issued in the Territory and to collect damages for such infringement, provided that:

        3.6.1 GTG provides Myriad with written notice identifying (a) the alleged infringer, and (b) the alleged infringer's accused products, and (c) the specific claims of the Licensed Patents that GTG intends to assert against the alleged infringer's accused products, and (d) reasonable evidence of infringement; and

        3.6.2 Within ninety (90) days of the notice specified in Article 3.6.1 of this Agreement, Myriad elects not to prosecute the alleged infringer identified by GTG and notifies GTG in writing that Myriad has elected not to prosecute the alleged infringer; and

        3.6.3 GTG shall be responsible for the total cost of any infringement action brought by GTG; and

        3.6.4 GTG shall pay Myriad fifty percent (50%) of any cash amount actually received by GTG as an award in any action or in settlement of any action brought by GTG for infringement of the Licensed Patents; provided, however, that the total value of any cash paid to Myriad by GTG shall be reduced by the amount of the total out-of-pocket fees and costs incurred by GTG in the prosecution and/or defense of the Licensed Patents in any such action; and

        3.6.5 No settlement, consent judgment or other voluntary final disposition of any action for infringement of the Licensed Patents or any declaratory judgment action alleging invalidity or non-infringement of the Licensed Patents may be entered into without the consent of Myriad, which consent shall not be unreasonably withheld.

        3.7   No right or license is granted by Myriad to GTG under this Agreement, by implication or by estoppel, or otherwise to any patents, inventions, patent application, know-how, technology, trademark,

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copyright, trade secret, or other property right, other than the rights and licenses expressly granted in Articles 3.1, 3.2, 3.3, 3.6, and 5 of this Agreement.

        3.8   GTG shall use commercially reasonable and timely efforts to commercialize Diagnostic Services I and Diagnostic Services II in the Territory, and in the event that GTG or a GTG Subsidiary does not commercialize Diagnostic Services I and Diagnostic Services II in the Territory within two (2) years of the Effective Date, the rights and licenses granted in Articles 3.1, 3.2, and 3.3 of this Agreement shall convert to non-exclusive rights and licenses and the right to sue infringers provided under Article 3.6 of this Agreement shall be revoked.

        3.9   Myriad shall use reasonable efforts to maintain the Licensed Patents in the Territory, including, but not limited to, paying all maintenance and/or annuity fees.

        3.10  Improvements . GTG and/or GTG's Subsidiaries shall promptly provide Myriad with a complete disclosure of all Improvements.

        3.10.1   At the request of Myriad, GTG and/or GTG's Subsidiaries shall grant Myriad an exclusive, fully-paid, royalty-free, perpetual right and license under all applicable patent and other proprietary rights relating to such Improvement(s), to make, have made, use, sell, offer for sale, market, perform, and import Diagnostic Services I and/or Diagnostic Services II, including Full Sequence Testing and Specific Mutation Testing, in all jurisdictions other than those jurisdictions in which GTG and GTG's Subsidiaries have exclusive rights or an option to obtain exclusive rights.

        3.10.2   If GTG and/or GTG's Subsidiary elects not to obtain patent coverage for an Improvement, GTG and/or GTG's Subsidiary shall provide Myriad with the opportunity to prepare and file appropriate patent applications covering the Improvement.

        3.10.3   GTG and/or GTG's Subsidiaries shall require all employees to assign all inventions made by them in the course of developing, marketing, selling, offering for sale, performing, or importing Diagnostic Services I and Diagnostic Services II to GTG and/or GTG's Subsidiaries.


A R T I C L E 4

TESTING SERVICES AND FEES

        4.1    Subcontracting to Myriad . All Diagnostic Services I and/or Diagnostic Services II subcontracted by GTG or GTG's Subsidiaries shall be subcontracted solely to Myriad, and not to any other Third Party.

        4.1.1   All subcontracted Diagnostic Services I and/or Diagnostic Services II shall be performed by Myriad at the prices set forth in Exhibit A; provided, however, that:

        4.1.1.1   Myriad may, at Myriad's discretion, increase the prices set forth in Exhibit A, provided that such increases are consistent with increases for Myriad's other commercial partners.

        4.1.1.2   Myriad shall provide GTG with prices for Diagnostic Services I and/or Diagnostic Servi


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