MassARRAY(TM) Core Facility Contract Terms - Sequenom Inc. and Hitachi Ltd. Life Science Group
CONFIDENTIAL
MassARRAY(TM) Core Facility Contract Terms
SEQUENOM, Inc. ("Sequenom")
11555 Sorrento Valley Rd
San Diego, CA 92121-1331
USA
and
Hitachi, Ltd., Life Science Group ("Hitachi LS")
1-3-1, Minamidai
Kawagoe, Saitama, 350-1165, Japan
Between, Hitachi, Ltd., Life Science Group ("Hitachi LS") a corporation
duly organized and existing under the laws of Japan and having offices at 1-3-1,
Minamidai, Kawagoe, Saitama, 350-1165, Japan, and Sequenom, Inc. ("Sequenom") a
Delaware corporation having its principal place of business at 11555 Sorrento
Valley Road, San Diego, California 92121-1331, U.S.A. (collectively the
"parties");
Whereas, Sequenom is in the business of, among other things, designing,
developing, manufacturing and selling proprietary biopolymer analysis products
and related software and consumables;
Whereas, Sequenom has expertise in the development and utilization of mass
spectrometry for biopolymer analysis and has developed Sequenom's proprietary
MassARRAY(TM) products, technology, assays, assay design protocols and methods,
and related know-how for high-throughput DNA analysis;
Whereas, Hitachi LS desires to license Sequenom's MassARRAY technology and
have access to Sequenom's related know-how, including Sequenom's assay design
abilities and Sequenom desires to provide the same in exchange for certain fees,
intellectual property and revenue sharing rights; and
Whereas, Sequenom and Hitachi LS would like to set forth the general terms
and conditions of such an arrangement in this binding Letter of Intent, which
upon execution, obligates the parties as follows:
1. General Terms
1.1 Research License. Sequenom grants Hitachi LS the right to use Sequenom's
MassARRAY technology for individual sample "DNA Genotyping" (as defined
in 1.1.1) in the Territory for Hitachi LS's "Internal Research and
Development Purposes" (as defined in 1.1.2).
1.1.1 "DNA Genotyping" means performing services involving analysis of
biopolymer samples to discover, test, confirm, or validate
potential or known mutations or polymorphisms or identifying and
characterizing mutations or polymorphisms as to genotype and/or
allelotype.
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1.1.2 "Internal Research and Development Purposes" means purposes and
activities within Hitachi LS that are limited to research and
development activities involving DNA Genotyping.
1.2 Commercial License. Sequenom grants Hitachi LS the right to use MassARRAY
technology for individual sample "Commercial DNA Genotyping" (as defined
in 1.2.1) and individual sample "Commercial Diagnostics Services" (as
defined in 1.3.1) in the Territory.
1.2.1 "Commercial DNA Genotyping" means DNA Genotyping (as defined in
1.1.1) for customers or collaborators in exchange for a fee or fee
equivalent.
1.2.2 For all Commercial DNA Genotyping services using MassARRAY
technology, Hitachi LS will pay Sequenom [...***...] of the
revenues from such services.
1.2.3 Where a combination of commercial services (including Commercial
DNA Genotyping services) is provided to a customer of Hitachi LS,
the value of the MassARRAY based services component will be fairly
allocated, independently identified, and a payment applied to this
component only. Activities involving -assay design, sample
preparation, sample amplification, genotype analysis and calling
are all considered to be MassARRAY based services and will be
included in the fair allocation and payment to Sequenom.
1.2.4 The revenues associated with a Commercial DNA Genotyping service
using MassARRAY technology must fairly reflect the value of such
service in the Territory.
1.2.5 For Commercial DNA Genotyping services that include Diagnostic
Assays developed or co-developed by Sequenom, an additional
payment will be paid by Hitachi LS to Sequenom as set forth under
sections 1.3.2.1 and 1.3.3.1 below.
1.3 Diagnostic Assays: The parties recognize and acknowledge that Hitachi LS
and Sequenom will each be designing and developing assays and assay
panels useful for providing Commercial Diagnostics Services (as defined
in 1.3.1). These assays and assay panels for Commercial Diagnostics
Services will be referred to as "Diagnostic Assays." The following
outlines the parties' understanding in this regard.
1.3.1 "Commercial Diagnostics Services" means, in exchange for a fee or
fee equivalent, performing DNA Genotyping in conjunction with (a)
the diagnosis or monitoring of any disease, state, or condition in
humans, or (b) the selection of treatment of any disease, state,
or condition in humans, or (c) the determination of genetic traits
in humans. Commercial Diagnostics Services includes the use of DNA
Genotyping in conjunction with a clinical diagnostic test
(regardless of whether such clinical diagnostic test has been
approved by the United State FDA or any governmental or regulatory
authority in Japan or elsewhere). Commercial Diagnostics Services
includes the provision of medical diagnostic information to a
patient/individual or to an intermediate company/provider that
transfers this information a patient/individual or their medical
fund.
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1.3.2 Hitachi LS will have the ability to license Sequenom Diagnostic
Assays (that is, assays from Sequenom that are not a standard
distribution product that would be available through Nissei Sangyo
Co., Ltd.) on a non-exclusive basis for Commercial Diagnostics
Services to be provided by Hitachi LS in the Territory. The only
exception will be for Sequenom Diagnostic Assays which, prior to
entering into this Letter of Intent, have already been exclusively
licensed to another party.
1.3.2.1 In addition to the [...***...] payment obligation under
section 1.2.2 for Commercial DNA Genotyping, Hitachi LS
shall pay Sequenom an additional payment of [...***...]
of the revenues from Commercial Diagnostics Services
using a Sequenom Diagnostic Assay. For clarity, Hitachi
LS's total payment obligation to Sequenom for Commercial
Diagnostics Services using a Sequenom Diagnostic Assay
will be [...***...].
1.3.3 For Diagnostic Assays that are co-developed by Hitachi LS and
Sequenom, Sequenom shall grant an exclusive license to Hitachi LS
to Sequenom's rights in such Diagnostic Assays, for Commercial
Diagnostics Services in the Territory for a period of [...***...]
from the date such Diagnostic Assay is available for use in
Commercial Diagnostics Services. Following the expiration of this
[...***...] period, such co-developed Diagnostic Assays may be
licensed by Sequenom to other parties.
1.3.3.1 In addition to the [...***...] payment obligation under
section 1.2.2 for Commercial DNA Genotyping, Hitachi LS
shall pay Sequenom an additional payment of [...***...]
the revenues from Commercial Diagnostics Services using
a co-developed Diagnostic Assay. For clarity, Hitachi
LS's total payment obligation to Sequenom for Commercial
Diagnostics Services using a co-developed Diagnostic
Assay will be [...***...].
1.3.4 For Diagnostic Assays designed and developed solely by Hitachi LS
that are used in Commercial Diagnostics Services, Hitachi LS will
be obligated to pay Sequenom the [...***...] payment for
Commercial DNA Genotyping as set forth under section 1.2.2. For
clarity, Hitachi LS's total payment obligation to Sequenom for
Commercial Diagnostics Services using a Hitachi LS developed
Diagnostic Assay will be [...***...].
1.4 Revenue Sharing. For the commercial license payments and diagnostic assay
payments refererenced under sections 1.2 and 1.3 payable to Sequenom that
are based upon percentages of revenues, the parties agree to [...***...]
that will be payable to Sequenom [...***...]. Hitachi LS agrees to
provide Sequenom [...***...] and the parties agree to [...***...] that
will be payable to Sequenom.
*** Confidential Treatment Requested
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1.5 Pooling Technology. At least for the present time, this licensed right
will not include the right for Hitachi LS to use Sequenom's proprietary,
quantitative, pooled sample analysis technology for determining allele
frequencies in populations for more than one biopolymer sample,
simultaneously. The sale or support of DNA Genotyping programs or
services by Hitachi LS that would make use of this pooling technology
will require completion of a separate and independent agreement between
Sequenom and Hitachi LS. Should such opportunities arise, the parties
agree to negotiate the terms of such an agreement in good faith.
1.6 Access to Distribution Products. Hitachi LS will have access (that is,
access through Nissei Sangyo as a Distributor of Sequenom products,
including assays) to Sequenom developed genotyping assay panels (subject
to the limitations and restrictions as set forth in the Letter of Intent
re Distribution between Nissei Sangyo and Sequenom) at Nissei's cost, at
Nissei's discretion.
1.7 Assay Design and Oligo QC Software. Sequenom will sell SpectroDESIGNER
Assay Design Software and SpectroCHECK Oligo QC software to Nissei Sangyo
Co., Ltd. for the use by and benefit of Hitachi Ltd., Life Science Group
in their Core Facility for Commercial Genotyping Services. The transfer
of this software is beyond the scope of the present Core Facility
Agreement and will be provided for separately in an Agreement with Nissei
Sangyo Co., Ltd.
1.8 Territory: Territory for the contract is Japan.
1.8.1 Hitachi LS may provide Commercial DNA Genotyping services to
companies or entities (third parties) that have an established
business office in the Territory and that are headquartered or are
principally located outside of the Territory, provided that the
provision of services to this company or entity does not conflict
with the business interests of Sequenom in dealing with the same
company or entity outside of the Territory.
1.8.2 Hitachi LS must obtain written authorization from Sequenom prior
to the provision of Commercial DNA Genotyping Services using
MassARRAY technology for any company, entity, or individual
outside the Territory.
1.9 Term: Until [...***...]; renewable on an annual basis thereafter upon
mutual agreement.
1.10 Confidentiality. This Letter of Intent and the information contained
herein, is considered the Confidential Information of Sequenom. Hitachi
LS agrees to (i) hold such Confidential Information in strict confidence;
(ii) not disclose it to any third parties or to use it in any way,
commercially or otherwise; and (iii) not allow any unauthorized person
access to such Confidential Information, without the prior written
consent of Sequenom.
1.11 Detailed Agreement. Both parties agree that a formal, detailed agreement,
that will include the terms herein, will be executed by the parties
within sixty (60) days following the execution of this binding Letter of
Intent.
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2. Sequenom Support Commitment
2.1 Sequenom will provide Hitachi LS personnel with comprehensive training
covering system installation, support and service; applications and
systems software, assay development and implementation.
3. Intellectual Property
3.1 Inventions, discoveries, products, assays, improvements, and
modifications that are conceived and developed by Hitachi LS will be
owned by Hitachi LS (or jointly owned in the case of joint conception or
development with Sequenom) except where such inventions, discoveries,
products, assays, improvements, or modifications pertain to improvements,
modifications, or revisions to the MassARRAY System, related software,
related consumables, or Sequenom assays, in which case Hitachi LS will
grant back to Sequenom an exclusive, perpetual, royalty-free license to
such improvements, modifications, or revisions, for all purposes, while
Hitachi LS will reserve the royalty free right to use such improvements,
modifications, or revisions for Hitachi LS's internal use only, without
sublicense rights. For co-developed Diagnostic Assays, as set forth in
section 1.3.3 and 1.3.3.1, ownership shall be joint, but subject to the
license rights set forth in sections 1.3.3 and 1.3.3.1.
4. Trademarks and Brand Ownership
4.1 All trademarks, trade names, trade dress and other trade rights of
Sequenom remain the property of Sequenom, however, Hitachi LS will use
such trade rights in connection with its supply of MassARRAY based DNA
Genotyping Services and Diagnostics Services to customers, provided that
such use has been approved and authorized by Sequenom, in writing, in
advance. Nothing in this section should be construed to prevent Hitachi
LS from using brand or trade names of its own, in conjunction with those
of Sequenom, for MassARRAY based assays developed solely by Hitachi LS,
co-developed with Sequenom, or those exclusively licensed to Hitachi LS
by Sequenom.
5. Payment Terms
5.1 Hitachi LS will pay Sequenom a [...***...] Core Facility fee of
[...***...]. Hitachi LS will pay [...***...] by wire transfer to an
account designated by Sequenom [...***...]. Hitachi LS will pay to
Sequenom the remaining portion [...***...] of the Core Facility fee due,
by wire transfer within thirty (30) days of [...***...].
5.2 All fees due and prices are net amounts due to Sequenom, exclusive of any
and all taxes, customs, duties, or other fees that may be governmentally
imposed or otherwise.
5.3 All payments shall be made in United States dollars and are fixed amounts
regardless of exchange rate fluctuations.
*** Confidential Treatment Requested
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In Witness Whereof, both Sequenom and Hitachi LS have executed this Letter
of Intent, in duplicate originals, by their respective employee hereunto duly
authorized, as of the date below.
Sequenom, Inc. Hitachi Ltd., Life Science Group
By: /s/ Rick Episcopo By: /s/ Idiroya Taguchi
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Name: Rick Episcopo Name: Idiroya Taguchi
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Title: Sr. V.P. Commercial Ops. Title: President & CEO
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Date: December 9, 2000 Date: 11 Dec. 2000
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