Exhibit 99.4
LICENSE AGREEMENT
(HUMAN IVD, VETERINARY IVD, HLA TYPING, PATERNITY, DNA MANUFACTURING
AND PLASMA TESTING)
This LICENSE AGREEMENT (Human IVD, Veterinary IVD, HLA Typing,
Paternity, DNA Manufacturing and Plasma Testing) (the "AGREEMENT") is dated as
of the 24th day of July, 2003, by and among IGEN INTEGRATED HEALTHCARE, LLC, a
Delaware limited liability company having offices at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("IGEN"), ▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ LTD, a Swiss limited
liability company with its principal place of business at ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇,
▇▇-▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ ("ROCHE/BASLE"), ROCHE DIAGNOSTICS GMBH, a German
company with its principal place of business at ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇, ▇-▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ("ROCHE/GERMANY") and ROCHE MOLECULAR SYSTEMS, INC., a
Delaware corporation with its principal place of business at ▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇ ("ROCHE/USA") (Roche/Basle,
Roche/Germany and Roche/USA shall hereinafter be referred to collectively (or
separately as the context requires) as either "ROCHE" or "ROCHE") (hereinafter
IGEN and Roche may separately be referred to as a "PARTY" or collectively
referred to as "THE PARTIES").
W I T N E S S E T H:
WHEREAS, Roche/Basle owns or controls all right, title and interest in
and to certain patents and patent applications outside of the United States the
claims of which are directed to aspects of PCR technology, and Roche/USA owns or
controls all right, title and interest in and to corresponding patents and
patent applications in the United States;
WHEREAS, Roche/Germany owns or controls all right, title and interest
in and to certain patents and patent applications both in the United States and
outside of the United States the claims of which are directed to aspects of PCR
technology;
WHEREAS, IGEN is interested in, among other things, acquiring a
worldwide license from Roche under certain of Roche's patents for the purpose of
developing and commercializing PCR-based in vitro human diagnostic products for
use in clinical diagnostic testing;
WHEREAS, IGEN is also interested in acquiring a worldwide license from
Roche under certain of Roche's patents for the purpose of developing and
commercializing PCR-based paternity testing products for use in parentage
determination;
-1-
WHEREAS, IGEN is also interested in acquiring a worldwide license from
Roche under certain of Roche's patents for the purpose of developing and
commercializing PCR-based in vitro animal diagnostic products for use in animal
testing; and
WHEREAS, IGEN is also interested in acquiring licenses from Roche under
certain of Roche's patents for other purposes described herein;
WHEREAS, Roche is willing to grant such license to IGEN upon the
following terms and conditions.
AGREEMENT:
NOW THEREFORE, for and in consideration of the covenants and
undertakings hereinafter set forth, and in consideration for the granting of
intellectual property rights to Roche and its Affiliates from IGEN pursuant to
agreements between Roche and IGEN and their respective Affiliates, IGEN and
Roche hereby agree as follows:
ARTICLE 1
DEFINITIONS
In addition to other terms defined elsewhere herein, the following
terms shall have the following meanings when used herein (any term
defined in the singular shall have the same meaning when used in the
plural and vice versa, unless stated otherwise):
1.1 "Affiliate" of any person means another person that directly or
indirectly, through one or more intermediaries, controls, is controlled
by, or is under common control with, such first person. The term
"person" means any individual, firm, corporation, partnership, company,
limited liability company, trust, joint venture, association,
Governmental Entity or other entity. The term "Government Entity" means
any domestic or foreign (whether a national, Federal, state,
provincial, local or otherwise) government or any court of competent
jurisdiction, agency or commission or other governmental authority or
instrumentality, domestic or foreign. Neither Genentech Inc., ▇ ▇▇▇
▇▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇, ▇▇▇, nor Chugai
Pharmaceutical Co., Ltd, 1-9 Kyobashi 2-chome, ▇▇▇▇-▇▇, ▇▇▇▇▇,
▇▇▇-▇▇▇▇, ▇▇▇▇▇, shall be deemed an Affiliate of ROCHE for purposes of
this Agreement. Meso Scale Diagnostics, LLC. ("MSD"), ▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇, shall, at all times and
notwithstanding any change in circumstance, be deemed an Affiliate of
IGEN for purposes of this Agreement; provided, however, that Affiliates
of MSD shall not necessarily be, and shall have to qualify
independently from (e.g., not through or under) MSD as, Affiliates of
IGEN. Meso Scale Technologies, LLC.
-2-
("MST"), ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇, shall
not be deemed an Affiliate of IGEN for purposes of this Agreement.
1.2 "Animal" means all animals, other than human, whether dead or alive or
extinct, and specifically includes animal embryos but not human
embryos.
1.3 "Animal Breeding Applications" means the analysis of biological
specimens for the determination of genetic traits in Animals for the
purpose of selective breeding of said Animals. Animal Breeding
Applications specifically exclude testing for disease-related traits
for the purpose of treating the test Animal for that disease.
1.4 "Animal Diagnostics Field" means use of products and diagnostic
processes utilizing PCR solely for analyzing specimens taken from an
Animal (excluding a Human), including without limitation, blood, bodily
fluid or tissue, for the purpose of testing, with respect to that
Animal, for a physiological or pathological state, a congenital
abnormality, or the safety and compatibility of a treatment; monitoring
therapeutic measures or for detecting: microorganisms or any other
analyte associated with infectious and/or non-infectious diseases in
Animals; Animal genetic diseases; genetic predisposition to disease in
Animals, or genetic traits in Animals, including determining the sex of
Animals, but specifically excluding Animal Identity Applications,
Animal Breeding Applications, GMO Testing Applications, and testing
performed on Animal tissue intended for use in xenotransplantation.
1.5 "Animal Identity Applications" means the analysis of biological
specimens for the identification of individual Animals whether living,
dead or extinct, or their remains, including, without limitation,
parentage determination.
1.6 "Complete Diagnostic Kit" means a product dedicated for use in
connection with the practice of PCR in the Licensed Fields as
applicable, it being understood that a product shall be deemed to be so
dedicated if it is either: (i) a product having a package insert
indicating its use primarily in connection with the practice of PCR, or
(ii) a product which by virtue of its design, operation or construction
has no other substantial practical utility, and which product is
comprised of, at a minimum, the essential active reagents for
amplification (e.g., primers, nucleotides, enzymes, etc.) and the
essential active reagents for detection (e.g., probes, labeled
nucleotides, etc.; but does not necessarily include reagents necessary
for performing electrochemiluminescence (e.g., tri-propyl amine (TPA))
of a target nucleic acid in the Licensed Fields, which reagents would
include the oligonucleotides (i.e., primers and, if required, probes),
nucleotides, enzymes, buffers and associated co-reactants essential to
perform amplification and detection of nucleic acid using PCR. For
purposes of this
-3-
Agreement IGEN shall only convey the necessary rights for End-Users to
perform PCR-based testing services in the Licensed Fields with the Sale
of a Complete Diagnostic Kit.
1.7 "Component System" means any products (e.g. kit, reagent or group of
reagents), Sold together which will provide an End-User with the
essential active reagents necessary to perform one or more of the
following processes in connection with the practice of PCR:
(a) Sample preparation, that is, the treatment of a sample in
order to render a nucleic acid therein amplifiable: such a
Component System may have as its essential active reagents,
for example, the cell lysing, stabilization and/or
precipitation reagents essential to expose and prepare DNA for
amplification;
(b) The amplification of one or more designated nucleic acid
sequences: such a Component System may have as its essential
active reagents, for example, the oligonucleotides and/or
nucleotides, enzymes, buffers and associated co-reactants
essential to perform amplification of nucleic acid using PCR;
and/or
(c) Detection, that is, the treatment or modification of an
amplified nucleic acid so as to render it detectable,
identifiable and/or quantifiable: such a Component System may
include labelled primers, probes (including binding partners
or reporter molecules), fluorescent intercalating or tagging
agents, and any device provided therewith to enable the
detection, identification or quantification of the nucleic
acid.
1.8 "Diagnostic Services" means analyzing specimens taken from a human
being or Animal, including without limitation, blood, bodily fluid or
tissue, for the purpose of testing, with respect to that human being or
Animal, for a physiological or pathological state, for a congenital
abnormality, for safety and compatibility of a treatment or to monitor
therapeutic measures or any use of PCR as a testing service to provide
to a person data, results or interpretations of any application of PCR
for purposes of therapy or diagnosis of an Animal or a human being,
including, without limitation, clinical laboratory services, and
parentage determination, whether or not a fee is charged for such
services.
1.8A "DNA Manufacturing Field" means the manufacture in the United States,
and the Sale worldwide, directly or through distributors, of DNA
Products.
1.8B "DNA Products" means specific, individual DNA molecules produced by
means of any method that practices PCR technology.
-4-
1.9 "Distributors" means the distributors performing a bona fide
distribution function to which IGEN or any of its Affiliates grants the
right to Sell Licensed Products. IGEN's Affiliates shall not be deemed
to be "Distributors" for purposes of this Agreement.
1.10 "Effective Time" shall have the meaning ascribed to that term in that
certain Merger Agreement of even date herewith by and among, inter
alia, IGEN International, Inc. and Roche Holding Ltd (the "Merger
Agreement").
1.11 "End-Users" means the customers, including doctors, hospitals, testing
and research institutions, which perform PCR (including diagnostic
testing) and/or the detection of a target nucleic acid, and clinical
and other laboratories, purchasing and using products sold pursuant to
this Agreement.
1.11A "Expanded Test Process" means the method claims (if they are Valid
Claims) of US 5,210,015 and 5,487,972, the method and reaction mixture
claims 1-12 (if they are Valid Claims) of US 5,804,375, US 5,994,056
and US 6,171,785, the foreign counterparts thereto and any reissue
and/or reexamination patent rights thereof.
1.12 "GMO Testing Applications" means the detection and/or analysis of
nucleic acid sequences of Animals, including live animals, carcasses,
meat and meat by-products, and materials derived therefrom, solely for
the purpose of determining the presence of, or derivation from,
Genetically-Modified Organisms. In this context, "Genetically-Modified
Organism" shall mean an Animal in which the genetic material has been
altered in a way that does not occur naturally by mating and/or natural
recombination.
1.13 "HLA Typing" means genotyping of specific HLA loci in order to assess
the probability of acceptance of a transplant of a human organ or
tissue or bone marrow or other human component.
1.14 "Human Identity Field" means use of, and includes products and
processes utilizing PCR for the sole purpose of determining human
identity or distinguishing among human beings, whether living or dead.
The term "Human Identity Field" shall include forensic testing for use
in, or in preparation for, death investigations or other legal
proceedings, but such term shall specifically exclude testing for
tissue typing and the parentage determination.
1.15 "IGEN Sellers" means IGEN and its Affiliates and Distributors.
1.16 "Instrument" means an electrical, mechanical or electro-mechanical
device which is intended to be used in connection with the practice of
PCR.
-5-
1.17 "In Vitro Human Diagnostics Field" means use of, and includes products
and diagnostic processes utilizing, PCR for the measurement,
observation or determination of attributes, characteristics, diseases,
traits or other conditions of human beings for diagnostic purposes,
including, without limitation:
(a) Genetic testing, including determinations of genetic
predisposition;
(b) Oncology and cancer predisposition testing;
(c) Testing for tissue typing;
(d) Infectious disease detection, confirmation and monitoring;
(e) Therapeutic drug monitoring; and
(f) Blood screening.
1.18 "Licensed Fields" means the Animal Diagnostics Field, the Paternity
Field, HLA Typing, the In Vitro Human Diagnostics Field, the Plasma
Testing Field, and the DNA Manufacturing Field.
1.19 "Licensed Patents" means the United States and foreign patents and
patent applications of Roche listed in Exhibit "1" attached to this
Agreement, as amended from time to time, including any other patents or
patent applications that claim priority to one or more of the patents
or patent applications listed in Exhibit 1 including corresponding
foreign applications or patents; and any patents or patent applications
that claim priority to one or more priority applications of one or more
of the patents and patent applications listed in Exhibit 1 and any
divisional, continuation, continuation-in-part, extensions, reissues,
renewals, and re-examinations of such patents and patent applications,
and any corresponding foreign counterparts of such patents and patent
applications. In the event that a patent application or patent owned by
Roche (with the right to license to IGEN), which includes a Valid Claim
covering a PCR Related Invention and is entitled to an earliest
priority date not later than five (5) years from the Effective Time, is
not included in Exhibit 1, such patent application or patent shall be
deemed automatically included on Exhibit 1 for the purposes of the
Agreement as of the Effective Time, without any amendment of this
Agreement or other further action required of the Parties.
Notwithstanding anything to the contrary in this definition, Licensed
Patents shall not include (a) any rights to inventions for biological
and chemical target information such as nucleic acid sequences (e.g.,
specific primer and probe sequences) which the making, selling or using
of would infringe a Valid Claim of a patent or patent application owned
by Roche and available for license to IGEN
-6-
that is not listed on the version of Exhibit 1 attached to this
Agreement as of the Effective Time; or (b) any rights (including any
Valid Claims within the Licensed Patents) to inventions for Instruments
and/or automation of PCR Related Inventions.
1.20 "Licensed Product" means any product (excluding in all cases stand
alone enzyme reagents and Instruments) for use in connection with the
practice of PCR and/or the detection of a target nucleic acid in the
Licensed Fields (or (a) with respect to the DNA Manufacturing Field,
shall mean DNA Products, (b) with respect to the HLA Typing Field,
shall mean a reagent kit manufactured by IGEN or its Affiliates
containing a thermostable DNA polymerase in combination with all such
other reagents, enzymes or materials, whether packaged together or
separately, as are necessary to perform a PCR-based assay for the HLA
Typing Field), the manufacture, importation, use, offer for Sale or
Sale of which would infringe a Valid Claim of Licensed Patents, made
by, on behalf of or for IGEN or any of its Affiliates. Licensed
Products include, but are not limited to, any of the following or a
combination of any of the following:
(a) a Complete Diagnostic Kit; and/or
(b) a Component System; and/or
(c) a reagent, accessory, device or system which is used or Sold
to be used by End-Users in connection with the practice of PCR
and/or the detection of a target nucleic acid, including the
steps of sample preparation, amplification and/or detection;
and/or
(d) reagents Sold to be used by End-Users as replacement
components in regards to a Component System.
Licensed Products include Not Yet Approved or Not Yet Registered In
Vitro Human Diagnostics Products.
1.20A "Licensed Test" means the performance of a Licensed PCR Test or a
Licensed Expanded PCR Test by IGEN or its Affiliates in the Plasma
Testing Field for the purpose of determining nucleic acid sequences of
any one analyte in a Test Sample. Multiple performance of a Licensed
Test for any one analyte at any one point in time in any one Test
Sample, for reproducibility, shall be considered as one Licensed Test.
Performance of a multiplex PCR test shall be treated as multiple
Licensed Tests; e.g., one Licensed Test for each analyte targeted by
the multiplex PCR test. See examples provided in Section 4.5B.
a) "Licensed PCR Test" means the performance by IGEN or its
Affiliates of an analytical procedure that uses one or more Test
Processes.
-7-
b) "Licensed Expanded PCR Test" means the performance by IGEN or
its Affiliates of an analytical procedures that uses an Expanded Test
Process in addition to one or more Test Processes.
1.21 "Net Sales" has the meaning set forth in Article 3 herein.
1.22 "Not Yet Approved or Not Yet Registered In Vitro Human Diagnostics
Products" means Complete Diagnostic Kits and/or Component Systems which
are Sold to End-Users who use them for diagnostic purposes and/or
health care of a human subject and whose use is, in countries with an
approval or registration process, not yet approved by a regulatory
agency having jurisdiction over the Sale of such products regardless of
whether the labeling and/or other written materials accompanying such
products contain recommendations and/or instructions for such use. In
countries without an approval or registration process, the labeling has
to clearly identify the intended use of the product (e.g."For In Vitro
Diagnostic Use"). The Parties agree that regulatory submissions for Not
Yet Approved or Not Yet Registered In Vitro Human Diagnostic Products
shall, in countries with an approval or registration process, if
required, be filed not more than twenty-four (24) months after the
first commercial Sale of such Not Yet Approved or Not Yet Registered In
Vitro Human Diagnostic Product.
1.23 "Patent Rights" means the Valid Claims of patents and patent
applications, including, without limitation: utility or design patents
or patent applications which are original; divisional, continuation or
continuation-in-part patents and patent applications; reexaminations,
extensions and reissues of patents; and confirmation patents,
importation patents, registration patents and patents of addition.
1.24 "Paternity Field" means analysis of human genetic material to ascertain
whether two or more individuals are biologically related, but
specifically excludes analysis of forensic evidence for a sexual
assault investigation. The Paternity Field specifically excludes the
Human Identity Field.
1.25 "PCR" means the technology involving the amplification of a nucleic
acid sequence and the complement of that sequence by repeated cycles of
oligonucleotide mediated, template directed synthesis involving the
extension of a primer oligonucleotide by incorporation of monomeric
nucleotide triphosphates whereby the sequence, its complement and
subsequent synthetic copies thereof are repeatedly separated and used
as templates for further cycles of synthesis.
-8-
1.26 "PCR Related Invention" means any process, method, test, kit, reagent
and/or group of reagents for performing or, by virtue of its design,
operation and/or construction, has no other substantial practical
utility than for performing, one or more of the following operations in
connection with the practice of PCR:
(a) Sample collection, preparation, transport and/or isolation of
nucliec acid sequences from a sample, that is, the treatment
of a sample in order to render a nucleic acid therein
amplifiable and/or detectable, which may have as its essential
active reagents, for example, the cell lysing, stabilization
and/or precipitation reagents essential to expose and prepare
DNA for amplification and/or detection; and/or
(b) The amplification of one or more designated nucleic acid
sequences using PCR, which may have as its essential active
reagents, for example, the oligonucleotides and/or
nucleotides, enzymes, buffers and associated co-reactants
essential to perform amplification of nucleic acid using PCR;
and/or
(c) Detection, that is, the treatment or modification of nucleic
acid amplified using PCR so as to render it detectable,
identifiable and/or quantifiable: which may include as its
essential active reagents labelled primers, probes (including
binding partners or reporter molecules), and fluorescent
intercalating or tagging agents; and/or
(d) The synthesis, purification, labeling, and/or immobilization
of nucleic acid probes used in PCR (i.e., one or more
compounds that is/are: (y) composed of one or more nucleotides
or analogs thereof; or (z) capable of binding with one or more
nucleotides or analogs thereof); and/or
(e) The control of contamination.
1.26A "Plasma Testing Field" means the performance of a Licensed Test solely
for screening blood or blood products and/or quality control purposes
at various stages in the production of blood products, and shall
specifically exclude any use of a test result for diagnostic or
treatment of disease in any particular individual. IGEN and its
Affiliates may notify potentially infected donors of the results of
Licensed Tests when either (a) such notifications required by law or
governmental regulation, or (b) such potentially infected person is
charged a fee by IGEN or its Affiliates for such notification. When
potentially infected donors are notified in accordance with either (a)
or (b) above, such notification shall not be considered as use of a
test result for diagnosis or treatment of disease in any particular
individual.
-9-
1.27 "Reagent Agreement Plan" or "RAP" means a program (whether known as a
Reagent Agreement Plan, Reagent Rental Plan or other successor or
similar plan) for the Sale of one or more Component Systems in
conjunction with the supply of an Instrument whereby the price for such
Royalty Product includes the acquisition cost or leasing cost of an
Instrument, the cost of servicing such Instrument, interest charged for
the financing of such Instrument, and/or other items of cost recovery
in connection with the supply of such Instrument.
1.28 "Research Collaborator" means a Third Party performing research and
development for IGEN and/or its Affiliates under a contract with IGEN
and/or any of its Affiliates, which contract:
(a) Provides that the work performed by such Third Party under the
contract (which shall include a protocol) is directed toward
the development of Licensed Products; and
(b) Provides that the reagents necessary to perform the work under
the contract are supplied free of charge by IGEN or its
Affiliates and requires that such reagents may be used only
for the development of Licensed Products and that any reagents
not consumed in performing the work under the contract either
be returned to IGEN and its Affiliates or be disposed of as
laboratory waste.
1.29 "Roche Patented Enzyme" means any enzyme the manufacture, use or Sale
of which would Infringe a Valid Claim of a Roche patent within Licensed
Patents, provided that such Valid Claim is a composition of matter
claim.
1.30 "Royalty Payment Period" means the period beginning on the Effective
Time and ending on the expiration of the current calendar quarter and
each calendar quarterly period thereafter.
1.31 "Royalty Product" means (a) any Licensed Product Sold for use in the In
Vitro Human Diagnostics, Animal Diagnostics, HLA Typing and Paternity
Testing Fields, (b) any Licensed Product made in the DNA Manufacturing
Field, (c) any Instrument, accessory, device or system made by, on
behalf of or for IGEN or any of its Affiliates and Sold (whether or not
pursuant to or in connection with a RAP) for use with Licensed
Product(s) in the Licensed Field(s) where the manufacture, importation,
use, offer for Sale or Sale of Instrument, accessory, device or system
would infringe a granted or issued Valid Claim of Licensed Patents, and
(d) the performance of Licensed Tests internally for screening of
IGEN's or its Affiliates' own blood products.
1.32 "Sale" means the act of selling, leasing or otherwise placing or
distributing (including by means of Reagent Agreement Plans).
-10-
1.33 "Sell" means to make or cause to be made a Sale.
1.34 "Sold" means to have made or caused to be made a Sale.
1.34.1 "Territory" includes all countries of the world.
1.34.2 "Test Process" means with respect to the Plasma Testing Field (a) the
polymerase chain reaction process covered by the method claims of US
4,683,195 and 4,683,202, the foreign counterparts thereof and any
reissue and/or reexamination patent rights thereof, (b) the reverse
transcription process covered by the method claims of US 5,407,800, US
5,322,770 and US 5,310,652, the foreign counterparts thereof and any
reissue and/or reexamination patent rights thereof, or (c) the method
claims of US 5,008,182, US 5,176,995 and US 5,219,727, and claims 1-4,
8, 9 and 15-18 of US 5,476,774, the foreign counterparts thereof and
any reissue and/or reexamination patent rights thereof.
1.34.3 "Test Sample" means human blood or plasma or any product derived
therefrom.
1.35 "Third Party" means any person that is neither a Party to this
Agreement nor an Affiliate of any Party to this Agreement.
1.36 "Valid Claim" shall mean in any country the claim of a patent or
pending patent application which (a) has not expired, (b) has not been
disclaimed or (c) has not been revoked, held invalid or otherwise
declared unenforceable by a tribunal of competent jurisdiction over
such claim in such country from which no further appeal has or may be
taken.
ARTICLE 2
GRANTS
2.1 Grant of License by Roche to IGEN.
(a) Subject to the terms and conditions of this Agreement, Roche
grants to IGEN and its Affiliates, a non-exclusive worldwide
right and license under the Licensed Patents as follows:
(i) to make, have made, import, use, offer to Sell and
Sell Licensed Products in the Licensed Fields in the
Territory, and authorize End-Users to perform
Diagnostic Services using such Licensed Products in
the Licensed Fields in
-11-
accordance with the label license provided with the
purchase of such Licensed Products as set forth in
Article 5 below (the "LABEL LICENSE").
(ii) to grant a limited, non-transferable, royalty free
sublicense under the Licensed Patents to Research
Collaborators of IGEN and/or its Affiliates to
practice PCR under their respective contracts with
IGEN and/or its Affiliates, in accordance with the
terms and conditions of this Agreement, solely for
purposes of doing applied research and development,
improvement, quality control and/or quality assurance
for IGEN and/or its Affiliates of Licensed Products
to be Sold or otherwise commercialized in the
Licensed Fields in accordance with the other terms
and conditions of this Agreement; and
(iii) to use PCR technology internally at IGEN or its
Affiliates for the research, development, improvement
and quality control and quality assurance of Licensed
Products for Sale in the Licensed Fields, and to
practice PCR technology solely in the United States
to make Licensed Products in the DNA Manufacturing
Field; and
(iv) to perform Licensed Tests within the Plasma Testing
Field within the Territory for internal use only.
2.2 Sublicensing. Except as provided in Section 2.1(a)(ii), neither IGEN
nor any of its Affiliates may sublicense any rights granted under this
Agreement or convey any implied license except through valid Label
Licenses.
2.3 Restrictions. Notwithstanding the foregoing, IGEN understands and
agrees that the above licenses to IGEN and its Affiliates shall not
include:
(a) the right to grant sublicenses or to convey any implied
licenses, except to the limited extent expressly provided in
Sections 2.1(a)(ii) and 2.2 and Article 5;
(b) the right to Sell Roche Patented Enzymes (stand alone) for use
with Component Systems made by or for IGEN or its Affiliates;
(c) the right to convey with the Sale of any enzyme, Instrument or
other product on a stand-alone basis, i.e. independent of the
Sale of a Component System or a Complete Diagnostic Kit which
has a Label License bearing the legends set forth in Article
5, the right to practice any process, method or test covered
by a Valid Claim of any of the Licensed Patents;
-12-
(d) the right to "have made" Roche Patented Enzymes;
(e) the right to "have made" Licensed Products (other than Roche
Patented Enzymes) by a Third Party (except as permitted by
Section 2.4 below), and provided further that:
(i) all of such products so manufactured by such
Authorized Third Party carry IGEN's or its
Affiliates' own name and those trademarks,
tradenames, brand names and/or labels that IGEN or
its Affiliates is using on such products when Sold by
IGEN or its Affiliates and, in the event that any
such products also carry the name of such Authorized
Third Party, it shall be only to the effect that such
Authorized Third Party manufactured such product, or
a part thereof, for IGEN or its Affiliates and is
otherwise consistent, including by its size and
location, with recognition of the product as an IGEN
(or its Affiliate's) product; and
(ii) all such products so manufactured by such Authorized
Third Party are purchased by or otherwise transferred
to IGEN or its Affiliates and/or otherwise sold by
IGEN or its Affiliates to End-Users; and
(iii) such Authorized Third Party manufacturing for IGEN
shall not be a seller or distributor of unlicensed
products (which products Infringe Valid Claims of the
Licensed Patents) in connection with the
manufacturing operations for IGEN;
(f) the right, under Licensed Patents, for IGEN or its Affiliates
to perform or otherwise engage in Diagnostic Services, other
than clinical trials performed by or on behalf of IGEN or its
Affiliates for purposes of clinical research and development
of Licensed Products or the registration of Licensed Products;
or
(g) the right to convey the necessary rights for End-Users to
perform PCR based Diagnostic Services under the Licensed
Patents in the Licensed Fields, except in conjunction with the
Sale of a Complete Diagnostic Kit.
2.4 Included Rights.
(a) The rights and licenses granted in Section 2.1 hereof include:
(i) the right of IGEN or its Affiliates to grant to its
distributors, contract manufacturers, toll manufacturers,
component suppliers, leasing agents and other third parties
engaged by IGEN or its Affiliates to assist IGEN or its
Affiliates in commercializing the intellectual property rights
licensed hereunder (the "Authorized Third Parties") immunity
from suit under the licensed intellectual property rights, and
(ii) the right of IGEN or its Affiliates to grant immunity
from suit under the licensed intellectual property rights to
IGEN's or
-13-
its Affiliate's customers for use or subsequent sale of the
Licensed Products, in each case only as permitted within the
limitations of this Agreement.
(b) No rights are licensed or deemed licensed to IGEN or its
Affiliates hereunder or in connection herewith, other than
those rights specifically licensed to IGEN or its Affiliates
in Section 2.1 or 2.3(e) above and as permitted in this
Section 2.4.
2.5 Grant Back Licenses/Additional Licenses. At the request of Roche, IGEN
shall enter into good faith negotiations with Roche for a worldwide,
royalty-bearing, field-limited, non-exclusive license agreement with
respect to IGEN Patent Rights claiming PCR Related Inventions. At the
request of IGEN, Roche shall enter into good faith negotiations with
IGEN with respect to a license under Licensed Patents for fields other
than the Licensed Field ("Other Field(s)") when Roche has the right to
grant such license in such Other Field(s) to IGEN and Roche makes it a
practice to license such Other Fields to Third Parties.
ARTICLE 3
NET SALES
3.1 Calculation of Net Sales. Net Sales with respect to the Sale of Royalty
Products for use in the Licensed Fields, other than the Plasma Testing
Field, by an IGEN Seller to End-Users shall mean the gross invoice
price to End-Users for such Royalty Products, less: (a) deductions for
allowances, discounts, including cash discounts, and returns all to the
extent customarily given in the trade by the IGEN Seller (except that
discounts, credits or similar allowances provided to purchasers of
Royalty Products in consideration of the purchaser's agreement to
purchase non-Royalty Products shall not be deducted), (b) sales taxes,
duties and transportation, if separately stated on the invoice, (c)
amounts repaid or credited by reason of rejection or return, (d)
outbound transportation costs prepaid or allowed and costs of insurance
in transit and handling charges (or other similar charges), and/or (e)
compulsory payments and rebates to Third Parties related to the Sale of
the Licensed Products paid or payable pursuant to agreements
(including, without limitation, managed care agreements) or
governmental regulations.
3.2 Distributor Net Sales. In the event Royalty Products are Sold to
Distributors and IGEN cannot obtain accurate and complete Net Sales for
Sales by the Distributors to the End Users of such Royalty Products,
then IGEN may use the gross invoice price for the Sale of Royalty
Products by IGEN or its Affiliates to the Distributors, less the
allowable adjustments as set forth in 3.1 above, multiplied by 1.67 as
the Net Sales for such Royalty Products.
-14-
3.3 RAP Sales. In the case of the Sale under a Reagent Agreement Plan of a
Component System, the Net Sales of such Component System shall be
reduced by a percentage ("RAP DEDUCTION") to allow for deduction of
non-manufactured service charges included in such Net Sales, including
such charges as interest for the financing of Instruments supplied and
the cost of Instrument service. The RAP Deduction (a) shall be
determined by IGEN according to generally accepted accounting
principles prior to the first commercial Sale of such Component System
and shall be subject to the reasonable acceptance of Roche, and (b)
shall be adjustable by IGEN, but not more than once per calendar year,
and subject to reasonable acceptance by Roche.
3.4 Interaffiliate Transfers. If IGEN transfers any Royalty Product to an
Affiliate which becomes the End-User, then the Net Sales of such
Royalty Product shall be determined based the average Net Sales of such
Royalty Product to all Third Party End-Users during the accounting
period or, if no average Net Sales of such Royalty Product is available
for such period, at a reasonable value based upon the average prices,
as actually sold, of products available in the marketplace similar to
such Royalty Product.
3.5 Royalty Products with Multiple Uses.
(a) Where Royalty Products are Sold for use in connection with the
practice of PCR, but are also used by End-Users for purposes
other than in connection with the practice of PCR, the Net
Sales of such Royalty Product shall be the proportion of the
Net Sales thereof equal to the proportion of such Royalty
Product's use in connection with the practice of PCR, provided
that IGEN reasonably demonstrates to Roche the proportionate
uses of such Royalty Product in accordance with generally
accepted accounting principles.
(b) Where the Royalty Product in subsection (a) above is an
Instrument which is Sold independently of a Reagent Agreement
Plan in a given Royalty Payment Period, then the royalties
payable on the Net Sales of such Instruments shall equal the
Net Sales of such Instruments multiplied by the fraction A/B
where A is the number of assays Sold for use in such
Instruments in such period involving the practice of PCR, and
B is the aggregate number of assays of all types Sold for use
in such Instruments in such period.
-15-
ARTICLE 4
CONSIDERATION AND PAYMENTS
4.1 License Fee Due to Roche. IGEN shall pay to Roche a non-refundable,
non-creditable license fee in the amount of FIFTY MILLIION DOLLARS (US
$50,000,000) as follows:
(a) IGEN shall pay to Roche/Basel a non-refundable, non-creditable
license fee of TWENTY-FIVE MILLION DOLLARS (US $25,000,000)
(the "Basel Fee") no later than two (2) Business Days
following the Effective Time; and
(b) IGEN shall pay to Roche/USA a non-refundable, non-creditable
license fee of TWENTY-FIVE MILLION DOLLARS (US $25,000,000)
(the "USA Fee") payable no later than two (2) Business Days
following the Effective Time.
"Business Day" shall mean any day other than a Saturday,
Sunday and any day on which the banks in Germany, Switzerland
or the United States or the federal courts in the United
States are permitted or required by applicable law to close.
The Basel Fee and the USA Fee shall be paid in US Dollars made
by wire transfer to the following accounts:
Basel Fee:
UBS AG, Zurich, Switzerland
To the account of: ▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ Ltd
Account No. 230-▇▇▇▇▇▇▇▇.0
SWIFT Code: ▇▇▇▇▇▇▇▇▇▇▇
With the reference: DI-PCI-9962
USA Fee:
Roche Molecular Systems, Inc.
Chase Manhattan Bank of New York
ABA No.: 02000021
Account No.: ▇▇▇▇▇▇▇▇
4.2 Royalties Due to Roche/Basel for products Sold in the In Vitro
Diagnostics Field. IGEN shall account to and pay to Roche/Basel for
each Royalty Payment Period during the term of this Agreement a royalty
equal to the percentages, listed below, of the Net Sales of Royalty
-16-
Products that are (i) in the In Vitro Human Diagnostics Field, (ii)
Sold in any of the European Union Member States, Switzerland, Norway,
Liechtenstein or Iceland ("EUROPE"), and (iii) at the time of such
Sale, covered by, or the use thereof is covered by, one or more Valid
Claims of Licensed Patents in the country of Sale:
(a) 12% until December 31, 2005; and
(b) 6% thereafter.
4.3 Royalties Due to Roche/USA for products Sold in the In Vitro Human
Diagnostics Field. IGEN shall account to and pay to Roche/USA for each
Royalty Payment Period during the term of this Agreement a royalty
equal to the percentages, listed below, of the Net Sales of Royalty
Products that are (i) in the In Vitro Human Diagnostics Field, (ii)
Sold in the United States, and (iii) at the time of such Sale, is
covered by, or the use thereof is covered by, one or more Valid Claims
of Licensed Patents in the United States:
(a) 12% until December 31, 2005;
(b) 8% from January 1, 2006 until December 31, 2010; and
(c) 7% thereafter.
4.4 Other Royalties to Roche/Basel for products Sold in the In Vitro Human
Diagnostics Field. IGEN shall account to and pay to Roche/Basel for
each Royalty Payment Period during the term of this Agreement a royalty
equal to the percentages, listed in Section 4.3 (a), (b) and (c), of
the Net Sales of Royalty Products that are (i) in the In Vitro Human
Diagnositcs Field, (ii) Sold in any country or territory of the world
excluding the United States and Europe, and (iii) at the time of such
Sale, covered by, or the use thereof is covered by, one or more Valid
Claims of Licensed Patents in the country of Sale.
4.5 Other Royalties to Roche/USA. IGEN shall account to and pay to
Roche/USA for each Royalty Payment Period during the term of this
Agreement a royalty equal to the percentages listed in Section 4.5 (a)
and (b) below, of the Net Sales of Royalty Products that are (i) in the
Animal Diagnostics Field and the Paternity Field, (ii) Sold in any
country or territory of the world, and (iii) at the time of such Sale
covered by, or the use thereof is covered by, one or more Valid Claims
of Licensed Patents in the country of sale:
(a) For Royalty Products in the Animal Diagnostics Field:
(i) 8% until December 31, 2005;
-17-
(ii) 5% from January 1, 2006 until December 31, 2010; and
(iii) 4% thereafter.
(b) For Royalty Products in the Paternity Field:
(i) 12% until December 31, 2005;
(ii) 8% from January 1, 2006 until December 31, 2010; and
(iii) 7% thereafter.
4.5A [Reserved].
4.5B Royalties Due to Roche in the Plasma Testing Field. IGEN shall account
to and pay to Roche/USA for each Royalty Payment Period during the term
of this Agreement a royalty equal to the amounts listed below for
Licensed Tests that are (i) in the Plasma Testing Field, and (ii) at
the time of such test covered by, or the use thereof is covered by, one
or more Valid Claims of Licensed Patents in the country where the
Licensed Test is performed:
a) sixteen dollars ($16) for each Licensed PCR Test
performed in any country or territory of the world
by IGEN or its Affiliates, or
b) twenty-five dollars ($25) for each Licensed
Expanded PCR Test performed in any country or
territory of the world by IGEN or its Affiliates.
The following examples are presented for clarification of the
procedure to be followed in determining the royalties due for
Licensed Tests, where Licensed PCR Tests or Licensed Expanded
PCR Tests, performed internally by IGEN or its Affiliates, for
both initial screening of pools and reflux testing necessary
to detect the positive sample(s) in a pool identified as a
true positive.
a) Licensed Tests performed for initial screening:
Number of pools multiplied by the number of
analytes tested for multiplied by the fixed
royalty rate for a Licensed Expanded PCR Test
(e.g., 700 pools x 3 (HCV, HIV, HBV) x $25 =
$52,500)
b) Licensed Tests performed for reflux testing:
Number of true positive samples multipled by the
number of reflux tests performed to identify each
positive sample. For example, in a pool size of
600 which is
-18-
subdivided in 6 pools with 100 samples each, the
following would apply: The 6 pools of 100 are each
tested (6 tests). The individual members of these
6 pools are arranged in a 10x10 matrix (10 rows
with 10 individual samples in each row and 10
columns with 10 individual samples in each
column). Each row is pooled as a pool of 10. Each
column is pooled as a pool of ten. These 20 pools
of ten are then tested to identify the positive
member by row and column (20 tests). Thus, in
order to detect a positive plasma, 26 Licensed
Test would have to be processed. In the event that
15 true positive plasmas were identified by
Licensed Expanded PCR Tests the royalty would be
calculated as 15 x 26 x $25 = $9,750).
Reference or control PCR tests carried on in connection with
testing of a Test Sample shall be royalty free. If
a new chemical or a new lot of chemical is
introduced into the testing which make control
tests necessary, such tests shall be royalty free.
4.5C Royalties Due to Roche for products Sold in the DNA Manufacturing
Field. IGEN shall account to and pay to Roche/USA for each Royalty
Payment Period during the term of this Agreement a royalty equal to the
percentages listed below, of the Net Sales of Licensed Products that
are (i) in the DNA Manufacturing Field, (ii) Sold in any country or
territory of the world, and (iii) at the time of such Sale covered by,
or the use thereof is covered by, one or more Valid Claims of Licensed
Patents in the country of sale:
(a) for direct Sales of such Licensed Products to end users, earned
royalties equal to three percent (3%) of such Net Sales; and
(b) for Sales of such Licensed Products to distributors, earned
royalties equal to five percent (5%) of such Net Sales.
4.5D Royalties Due to Roche for products Sold in the HLA Typing Field. IGEN
shall account to and pay to Roche/Basel for each Royalty Payment Period
during the term of this Agreement a royalty equal to the percentages
listed below, of the Net Sales of Licensed Products that are (i) in the
HLA Typing Field, (ii) Sold in any country or territory of the world,
and (iii) at the time of such Sale covered by, or the use thereof is
covered by, one or more Valid Claims of Licensed Patents in the country
of sale:
a) a royalty of twenty percent (20%) on Net Sales of such
Licensed Products; provided, however, that such royalty rate shall
apply only for so long as any claim of U.S. Patent Nos. 4,683,195 or
4,683,202 (if Sold in the United States), or any claim of corresponding
foreign patent rights in the country of Sale, shall be in force.
Thereafter, the Parties shall negotiate in good faith a reduced royalty
rate for such Licensed Products licensed hereunder.
-19-
4.6 Reporting and Payment.
(a) With respect to the royalties required pursuant to Section
4.2, 4.3 and 4.4 and 4.5D, IGEN shall, within sixty (60) days
after the close of each Royalty Reporting Period, provide to:
KPMG Fides Peat
▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇
▇▇-▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇
To the attention of: Licensing Trustee
Fax: ▇▇▇ ▇▇ ▇▇▇-▇▇▇▇
or another trustee as notified to IGEN by Roche, an account of
all Net Sales of such Royalty Products outside the United
States and within the United States and of the royalty due
pursuant to Section 4.2, 4.3 and 4.4 and 4.5D in respect to
the preceding Royalty Reporting Period, according to the
royalty report forms in Exhibit "2". Simultaneously, when it
delivers such account, IGEN shall make payment of the royalty
amount shown, as follows:
Credit Suisse, Basel
Switzerland
Account No. 0504/920 654/62-1
SWIFT Code: ▇▇▇▇▇▇▇▇▇▇▇
To the account of: KPMG Fides Peat
With the reference: DI-PC1-9962
Each royalty report of IGEN will be released by KPMG Fides
Peat to Roche after one (1) calendar year following the
subject Royalty Reporting Period.
(b) The royalties payable by IGEN in US Dollars to Roche on the
Net Sales outside of the United States of all Royalty Products
by the IGEN Sellers in the Licensed Fields shall be converted
by IGEN from the currency in which the Sales were made to US
Dollars converted using the method used by IGEN for internal
financial reporting purposes in accordance with United States
generally accepted accounting principles.
(c) With respect to the royalties required pursuant to Section
4.5, 4.5B or 4.5C, IGEN shall, within sixty (60) days after
the close of each Royalty Reporting Period provide to :
-20-
Roche Molecular Systems, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: Licensing Department
an account, on a U.S./ex-U.S. basis, of all Net Sales of such
Royalty Products Sold and of the royalty due pursuant to
Section 4.5, 4.5B or 4.5C in respect to the Royalty Reporting
Period, according to the royalty report forms in Exhibit "3".
Simultaneously, when it delivers such account, IGEN shall make
payment of the royalty due in US Dollars by wire transferred
to the bank account as shown below:
Roche Molecular Systems, Inc.
Chase Manhatten Bank of New York
ABA No.: 02000021
Account No.: 323839657
4.7 Withholding.
(a) Any withholding tax levied by a government, in the country
where payment originates, on payments made by IGEN to Roche
shall be borne by Roche. IGEN shall use commercially
reasonable efforts to do all things necessary to enable Roche
to claim exemption therefrom under any double taxation or
similar agreement in force and shall produce to Roche proper
evidence of payment of all withholding tax and other
certification that might be required by the respective double
taxation agreement.
(b) In case any taxing authority holds: (i) that any payment from
any Affiliate of IGEN to IGEN is in effect a royalty payment
from such Affiliate of IGEN to Roche, and (ii) such royalty
payment to Roche is subject to a withholding tax, then, at
such time, the Parties will discuss the issue and try to find
an appropriate solution satisfying the business interests of
both Parties.
(c) Except as otherwise provided in subsections (a) and (b) above,
all payments of royalties and other consideration made by IGEN
to Roche under this Agreement shall be made in full without
deduction of taxes, charges and any other duties that may be
imposed on such payments to Roche.
4.8 Books and Records.
-21-
(a) IGEN shall keep a complete and accurate set of books and
records relating to the quantity of Royalty Products shipped
by or for IGEN and its Affiliates and the Sales of Royalty
Products by IGEN and its Affiliates. Such books and records
shall contain sufficient detail to substantiate the
computation of the Net Sales of Royalty Products and the
amount of royalties payable under this Article 4 as well as
all other information in the statements of account provided
for in Section 4.7 above, and shall be maintained by IGEN for
a period of not less than three (3) years from the date of
such Sales.
(b) Roche shall be entitled, upon reasonable notice to IGEN, to
have such books and records audited by an independent
certified public accounting firm retained by Roche and
reasonably acceptable to IGEN (which acceptance shall not be
unreasonably withheld), provided that any such audit occurs
during IGEN's normal business hours not more than once in any
calendar year. Roche also shall be entitled to have copies of
the books and records of each of IGEN's Affiliates relating to
the quantity of Royalty Products shipped by or for such
Affiliate and such Affiliate's Sales of Royalty Products
audited, upon reasonable notice to such Affiliate, by an
independent certified public accounting firm retained by Roche
and reasonably acceptable to such Affiliate, provided that any
such audit occurs during such Affiliate's normal business
hours not more than once in any calendar year. Roche agrees
that all audited information shall be confidential to IGEN and
IGEN's Affiliates. Any such audit will be limited to those
records required to be maintained pursuant to Section 4.8(a)
and the Sales associated therewith.
(c) Any person conducting an audit on behalf of Roche will be
required to protect the confidentiality of such information
and shall provide to Roche a report only of the ultimate
conclusions resulting from such audit. Except where IGEN
disputes the conclusion of the audit by written notice to
Roche, IGEN shall pay promptly to Roche the amount of any
royalties determined by such an audit to be outstanding, along
with interest accrued up to and including the date of payment
as provided in Section 4.9 below. The costs of such an audit
shall be borne by Roche; provided, however, that, if such
audit determines that the royalties paid by IGEN for any
audited Royalty Payment Period were at least five percent (5%)
less than the royalties otherwise due and payable, then IGEN
shall reimburse Roche for the costs of such audit. If such
audit determines that IGEN has overpaid the amount of
royalties otherwise due and payable for the audited Royalty
Payment Period, then Roche shall credit the amount of such
overpayment, plus interest at the rate provided in Section
4.9, to IGEN against future royalties payable by IGEN.
-22-
4.9 Past Due Payments. If IGEN fails to pay any amount specified under this
Agreement after the due date thereof, the amount owed shall bear an
interest of one percent (1%) per month from the due date until paid,
provided, however, that if this interest rate is held to be
unenforceable for any reason, the interest rate shall be the maximum
rate allowed by law at the time the payment is made.
4.10 No Multiple Royalties. At no time shall more than one royalty be
payable by IGEN upon the Net Sales of any one Royalty Product,
regardless of whether the manufacture, use and/or Sale of such Royalty
Product would infringe more than one Valid Claim of one or more
Licensed Patents and regardless of whether such product qualifies as a
"Royalty Product" for purposes of this Agreement under more than one of
the criteria for designating a product to be a "Royalty Product" as
provided in Section 1.31 above.
4.11 Most Favored Licensee.
(a) If, after the Effective Time, Roche grants to any Third Party
a license in the In Vitro Human Diagnostics Field under
substantially equivalent terms and conditions as granted to
IGEN herein but under more favorable royalty rates than those
given to IGEN under this Agreement, Roche shall promptly
notify IGEN of such more favorable royalty rates, and IGEN
shall have the right and option to substitute such more
favorable royalty rates for the royalty rates contained
herein.
(b) IGEN's right to elect such more favorable royalty rates shall
extend only for so long as and shall be conditioned on IGEN's
acceptance of all the same conditions, favorable or
unfavorable, under which such more favorable royalty rates
shall be available to such Third Party including any increase
in license fees and the application of milestones payments, if
any. Upon IGEN's acceptance of all such terms of such Third
Party agreement, the more favorable royalty rates shall be
effective as to IGEN on the effective date of such Third Party
agreement.
(c) Notwithstanding the foregoing, in the event that Roche shall
receive substantial nonmonetary consideration in the form of
technology or intellectual property rights to technology, as a
part of the consideration for its granting such a license to a
Third Party, then this Section 4.11 shall not apply.
(d) It is understood by the Parties that a trustee has been
appointed by Roche, who will be managing certain of the
royalty reporting and royalty payments from IGEN to Roche
under this Agreement as described in Sections 4.2, 4.3 and
4.4. IGEN is entitled to contact the trustee should IGEN wish
to review compliance by Roche with this Section 4.11. At
present, KPMG Fides Peat, Basel, Switzerland is the said
-23-
trustee. Roche shall promptly provide written notice to IGEN
of any change in trustee.
ARTICLE 5
LABEL LICENSES
5.1 Label Licenses on Royalty Products Sold in the In Vitro Human
Diagnostics, Animal Diagnostics, HLA Typing, Paternity Testing and DNA
Manufacturing Fields.
(a) IGEN agrees that it shall ▇▇▇▇ conspicuously all Component
Systems for amplification made by or for it, and shall cause
each of its Affiliates to ▇▇▇▇ conspicuously all such
Component Systems made by or for such Affiliates, with a Label
License bearing the following legend or such alternative
legend as shall be mutually agreed to by the Parties:
THE PURCHASE OF THIS PRODUCT ALLOWS THE PURCHASER TO USE IT
FOR AMPLIFICATION OF NUCLEIC ACID SEQUENCES FOR HUMAN IN VITRO
DIAGNOSTICS [OR ANIMAL DIAGNOSTICS, OR HLA TYPING OR PATERNITY
TESTING, AS THE CASE MAY BE]. NO GENERAL PATENT OR OTHER
LICENSE OF ANY KIND OTHER THAN THIS SPECIFIC RIGHT OF USE FROM
PURCHASE IS GRANTED HEREBY.
(b) IGEN agrees that it shall ▇▇▇▇ conspicuously all Component
Systems for detection made by or for it, and shall cause each
of its Affiliates to ▇▇▇▇ conspicuously all such Component
Systems made by or for such Affiliates, with a Label License
bearing the following legend or such alternative legend as
shall be mutually agreed to by the Parties:
THE PURCHASE OF THIS PRODUCT ALLOWS THE PURCHASER TO USE IT
FOR DETECTION OF NUCLEIC ACID SEQUENCES FOR HUMAN IN VITRO
DIAGNOSTICS [OR ANIMAL DIAGNOSTICS, OR HLA TYPING OR PATERNITY
TESTING, AS THE CASE MAY BE]. NO GENERAL PATENT OR OTHER
LICENSE OF ANY KIND OTHER THAN THIS SPECIFIC RIGHT OF USE FROM
PURCHASE IS GRANTED HEREBY.
(c) IGEN agrees that it shall ▇▇▇▇ conspicuously all Component
Systems for amplification and detection made by or for it, and
shall cause each of its Affiliates to ▇▇▇▇ conspicuously all
such Component Systems made by or for such Affiliates,
-24-
with a Label License bearing the following legend or such
alternative legend as shall be mutually agreed to by the
Parties.
THE PURCHASE OF THIS PRODUCT ALLOWS THE PURCHASER TO USE IT
FOR AMPLIFICATION OF NUCLEIC ACID SEQUENCES AND FOR DETECTION
OF NUCLEIC ACID SEQUENCES FOR HUMAN IN VITRO DIAGNOSTICS [OR
ANIMAL DIAGNOSTICS, OR HLA TYPING OR PATERNITY TESTING, AS THE
CASE MAY BE]. NO GENERAL PATENT OR OTHER LICENSE OF ANY KIND
OTHER THAN THIS SPECIFIC RIGHT OF USE FROM PURCHASE IS GRANTED
HEREBY.
(d) IGEN agrees that it shall ▇▇▇▇ conspicuously all Royalty
Products other than Component Systems for amplification,
Component Systems for detection, Component Systems for
amplification and detection, and Complete Diagnostic Kits made
by or for it and Sold in the In Vitro Human Diagnostics,
Animal Diagnostics, HLA Typing, Paternity Testing and DNA
Manufacturing Fields, and shall cause each of its Affiliates
to ▇▇▇▇ conspicuously all such Royalty Products, with the
following legend or such alternative legend as shall be
mutually agreed to by the Parties:
THE PURCHASE OF THIS PRODUCT ALONE DOES NOT IMPLY ANY LICENSE
UNDER PATENTS OWNED BY ROCHE MOLECULAR SYSTEMS, INC.,
▇.▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ LTD OR ROCHE DIAGNOSTICS GMBH COVERING PCR
AMPLIFICATION OR DETECTION.
(e) IGEN agrees that it shall ▇▇▇▇ conspicuously all Royalty
Products in the DNA Manufacturing Field made by or for it and
Sold, all such Royalty Products, with the following legend or
such alternative legend as shall be mutually agreed by the
Parties:
THIS PRODUCT WAS MADE USING THE POLYMERASE CHAIN REACTION
("PCR") PROCESS WHICH IS COVERED BY PATENTS OWNED BY ROCHE
MOLECULAR SYSTEMS, INC. AND ▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ LTD. NO
LICENSE TO USE THE PCR PROCESS IS CONVEYED EXPRESSLY OR BY
IMPLICATION TO THE PURCHASER BY THE PURCHASE OF THIS PRODUCT.
INFORMATION ON PURCHASING LICENSES TO PRACTICE THE PCR PROCESS
MAY BE OBTAINED BY CONTACTING THE LICENSING DEPARTMENT, ROCHE
MOLECULAR SYSTEMS, INC., ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇.
-25-
(e) IGEN agrees that it shall ▇▇▇▇ conspicuously all Complete
Diagnostic Kits made by or for it, and shall cause each of its
Affiliates to ▇▇▇▇ conspicuously all Complete Diagnostic Kits
made by or for such Affiliates, with a Label License bearing
the following legend or such alternative legend as shall be
mutually agreed to by the Parties:
THE PURCHASE OF THIS PRODUCT ALLOWS THE PURCHASER TO USE IT
FOR AMPLIFICATION AND DETECTION OF NUCLEIC ACID SEQUENCES FOR
HUMAN IN VITRO DIAGNOSTICS [OR ANIMAL DIAGNOSTICS, OR HLA
TYPING OR PATERNITY TESTING, AS THE CASE MAY BE]. NO GENERAL
PATENT OR OTHER LICENSE OF ANY KIND OTHER THAN THIS SPECIFIC
RIGHT OF USE FROM PURCHASE IS GRANTED HEREBY
5.2 Maintenance of Label Licenses by Distributors. IGEN agrees to use its
reasonable efforts to ensure that the IGEN Distributors maintain on all
Royalty Products Sold by such Distributors the Label Licenses provided
for in this Article 5 that are to be applied by IGEN and its
Affiliates.
5.3 Misuse by Purchasers of Licensed Products. In the event that Roche
becomes aware that any purchaser of any Licensed Product is misusing
the purchased Licensed Product in violation of the applicable Label
License on such Licensed Product and therein is infringing the Licensed
Patents, Roche shall provide evidence of such misuse to IGEN. Upon
receipt of such evidence, IGEN shall notify such purchaser of the
purchaser's misuse and shall use its reasonable efforts to obtain a
written assurance from such purchaser that the purchaser shall not
engage in such misuse in the future. If the purchaser refuses to
provide such written assurance, then IGEN shall cease, to the extent
permitted by any applicable law or statute, the Sale to such purchaser
of the Licensed Product which was being misused until such time as the
purchaser provides such written assurance. If, notwithstanding the
purchaser's provision of such written assurance, the purchaser persists
in misusing the Licensed Product, then IGEN, on receiving actual
knowledge of such continued misuse, shall discontinue, to the extent
permitted by any applicable law or statute, the Sale to such purchaser
of such Licensed Product.
5.4 Additional Label Licenses. In addition to the Label Licenses provided
for in Section 5.1 above, Roche may request that IGEN apply additional
Label Licenses on Licensed Products made by or for IGEN or its
Affiliates. The Parties shall negotiate in good faith concerning the
need for and/or the content of any such additional Label Licenses.
5.5 Incorrect Application of Label Licenses. In the event that Roche
notifies IGEN that IGEN or any of its Affiliates is incorrectly
applying one of the Label Licenses provided for above, then
-26-
IGEN shall consult and cooperate with Roche in taking such reasonable
steps as it or Roche may suggest to apply such Label License correctly
and comply with the provisions of this Article 5.
ARTICLE 6
THIRD PARTY CLAIMS; LIMITATION ON LIABILITY; INDEMNIFICATION
6.1 Defense of Third Party Infringement Actions. If the manufacture,
production, sale, or use of any Licensed Product results in a claim,
suit or proceeding brought by a Third Party (each, an "Action")
alleging patent infringement against ROCHE or IGEN (or any of their
respective Affiliates), such Party shall promptly notify in writing the
other Party. The Party subject to such Action (the "Controlling Party")
shall have the exclusive right and obligation to defend and control the
defense of any such Action using counsel of its own choice; provided
that the Controlling Party shall not enter into any settlement of such
Action without the written consent of the other Party, which consent
may be withheld in the unfettered discretion of the other Party if such
settlement admits the invalidity or unenforceability of any patent
rights of the other Party, and otherwise may not be unreasonably
withheld. The Controlling Party agrees to keep the other Party
reasonably informed of all material developments in connection with any
Action.
6.2 Product Liability Indemnity. IGEN expressly and unequivocally agrees to
and hereby does indemnify, release, defend and hold ROCHE (and its
Affiliates, sublicensees and licensors and their respective officers,
directors, shareholders, representatives, employees, consultants and
agents and each of the heirs, executors, successors and assigns of the
foregoing) harmless from and against all claims, damages, losses, costs
and expenses, including reasonable attorneys' fees, arising in favor of
any person, resulting from or arising out of liability in any way
relating to the Licensed Products sold, placed or otherwise
commercialized by IGEN, or its Affiliates, Distributors, or Authorized
Third Parties, including without limitation, the manufacture,
packaging, use, sale or other distribution of Licensed Products by IGEN
or its Affiliates, or any representation made or warranty given by IGEN
of any of its Affiliates with respect to any Licensed Product provided
that ROCHE (a) gives IGEN notice of such claim, (b) cooperates with
IGEN, at IGEN's expense, in the defense of such claim, and (c) gives
IGEN the right to control the defense and settlement of any such claim,
except that IGEN shall not enter into any settlement that affects
ROCHE's rights or interest without ROCHE's prior written approval.
ROCHE shall have no authority to settle any claim on behalf of IGEN.
IGEN also agrees to maintain proper product liability insurance
policies, reasonably acceptable to ROCHE everywhere it sells Licensed
Products and to furnish satisfactory evidence of same upon request by
ROCHE from time to time.
-27-
6.3 Waiver of Claims. IGEN shall not assert, and IGEN shall ensure that its
Affiliates do not assert, any claims against ROCHE for any matter for
which IGEN has provided indemnity to ROCHE under Sections 6.2 and 6.4
hereof. IGEN shall indemnify, hold harmless and defend ROCHE against
any such claims.
6.4 Breach by Affiliate, Authorized Third Party or Research Collaborator.
Failure of an Affiliate, Authorized Third Party or Research
Collaborator to adopt and satisfy a condition stated in this Agreement
applicable to IGEN, an Affiliate, Authorized Third Party or Research
Collaborator, as the case may be, shall be considered a breach of this
Agreement by IGEN. IGEN and such Affiliate shall be jointly and
severally responsible for and indemnify ROCHE and its Affiliates (and
their respective officers, directors, shareholders, representatives,
employees, consultants and agents and each of the heirs, executors,
successors and assigns of the foregoing) against any loss, cost, damage
or liability (including reasonable attorneys' fees) arising from the
breach by such Affiliate of this Agreement. IGEN shall indemnify ROCHE
and its Affiliates (and their respective officers, directors,
shareholders, representatives, employees, consultants and agents and
each of the heirs, executors, successors and assigns of the foregoing)
against any loss, cost, damage or liability (including reasonable
attorneys' fees) arising from the failure by an Authorized Third Party
or Research Collaborator to adopt and satisfy a condition stated in
this Agreement applicable to such parties.
ARTICLE 7
PATENT ENFORCEMENT
7.1 Notice of Substantial Infringement. In the event IGEN becomes aware of
an alleged Substantial Infringement of a Licensed Patent in a given
country by an unlicensed Third Party, IGEN may invoke the provisions of
this Article 7 as to enforcement and royalty abatement by providing
written notice thereof to Roche, including documentary evidence of
Infringement and market data as to the infringing Sales activity which
are in Roche's good faith judgment reasonably reliable. "SUBSTANTIAL
INFRINGEMENT" or "SUBSTANTIALLY INFRINGING" as used in this Article 7
shall mean that the alleged infringing Sales of the Third Party in the
given country are at least fifteen percent (15%) of total Sales of
Competing Products in such country. "COMPETING PRODUCTS" means all
products essentially equivalent to a Complete Diagnostic Kit and which
test for the same analytes and which directly compete with each other
for use in or in conjunction with PCR (for example, a test for the
presence of an organism would not be considered to be testing for the
same analyte as a test for a specific drug resistant subspecies of such
organism, but two PCR-based tests both of which detect the presence of
HIV1 (even if using different sequences of the genome) would
-28-
be considered to be testing for the same analyte whereas two tests, one
for HIV1 and one for HIV2, would be considered to be testing for
different analytes).
7.2 Enforcement and Royalty Abatements. If Roche fails, within sixty (60)
days of such notice of Substantial Infringement of a Licensed Patent by
a Third Party in a given country, to enter into license negotiations
with or enforcement proceedings against such Third Party in such
country, or if having timely entered into license negotiations with
such Third Party, Roche fails to obtain an executed license agreement
or enter into enforcement proceedings with such Third Party within six
(6) months of said notice, then IGEN shall be entitled to a fifty
percent (50%) reduction in royalties on IGEN's Net Sales of Royalty
Products which are Competing Products with such Substantially
Infringing Sales in such country as of such notice, continuing until
Roche provides written notice to IGEN that either a license has been
granted to such Third Party or enforcement proceedings have been
brought against such Third Party. In the event the Substantially
Infringing Sales shall exceed thirty percent (30%) of total competing
Sales in any particular Royalty Payment Period, then the royalty
reduction shall be one hundred percent (100%) for such Royalty Payment
Period. An enforcement proceeding shall mean a court action or other
legal action brought before a competent patent authority in the
relevant country. An enforcement proceeding pursued against such
infringer for Sales of such infringing product in one Major Territory
shall satisfy Roche's obligation to pursue enforcement hereunder
against such products in all countries. If no Substantial Infringement
exists in any such Major Territory, then a suit in any other country
where such Substantial Infringement exists shall satisfy Roche's
obligation hereunder. "MAJOR TERRITORY" shall mean any of the United
States, Great Britain, Germany, France, Italy, The Netherlands and
Japan.
7.3 Continuing Royalty Payment Obligations. Except to the extent provided
in Section 7.2, IGEN's obligation to pay royalties on the Net Sales of
Royalty Products Sold by the IGEN Sellers shall remain in effect to the
extent provided for in this Agreement notwithstanding any alleged
infringement by any Third Party of any of the Licensed Patents.
7.4 No IGEN Right to Enforce the Licensed Patents. It is expressly
understood that nothing contained herein shall in any way grant or be
construed to grant to IGEN the right to enforce the Licensed Patents.
Roche shall have the sole right to bring legal action to enforce the
Licensed Patents against any alleged Infringement by any Third Party.
-29-
ARTICLE 8
TERM AND TERMINATION
8.1 Term. The term of this Agreement shall commence as of the Effective
Time and shall continue in full force and effect, unless terminated
sooner in accordance with Section 8.2 below, until the expiration date
of the last to expire of the Valid Claims of the Licensed Patents.
8.2 Termination. This Agreement, and the licenses granted to IGEN and its
Affiliates herein, are perpetual and irrevocable, except to the extent
termination is permitted in this Section 8.2:
(a) IGEN may terminate this Agreement with respect to all or any
one or more of the Licensed Patents for any reason by written
notice to Roche at any time during the term of this Agreement.
(b) Roche may terminate this Agreement immediately upon written
notice to IGEN if IGEN fails to make the payments in
accordance with Section 4.1.
(c) In the event that IGEN does not make any royalty payments
which are due and payable (other than under Section 4.1),
Roche may deliver written notice thereof to IGEN. If IGEN,
within sixty (60) days after delivery of such notice to IGEN
(the "Notice Period"), makes such payment to Roche, then Roche
shall not have the right to terminate this Agreement for such
non-payment. If, at the expiration of the Notice Period, IGEN
has neither paid such royalty payment to Roche nor disputed
the payment obligation in a written notice to Roche, then
Roche may, upon written notice to IGEN following the Notice
Period, terminate this Agreement. If, during the Notice
Period, IGEN provides written notice to Roche that IGEN
disputes such payment obligation, then the Parties shall
arbitrate such dispute in accordance with Section 11.2. If the
arbitration award requires IGEN to pay all or any portion of
such royalty payments to Roche (the "Arbitrated Amount"), then
IGEN shall pay such Arbitrated Amount to Roche within thirty
(30) days after final resolution of the dispute or, if IGEN
fails to do so, Roche may, upon written notice to IGEN
following such 30-day period, terminate this Agreement. If the
arbitration award does not require IGEN to pay any portion of
such royalty payments to Roche, then Roche shall not have the
right to terminate this Agreement with respect to such claimed
non-payment.
-30-
(d) Bankruptcy. IGEN shall retain the rights granted to it as a
licensee under Section 365(n) of the United States Bankruptcy
Code in case of the bankruptcy, insolvency or winding-up of
ROCHE.
(e) Expiration or termination of this Agreement shall not affect
the ability of any Party to seek resolution of any matter
arising prior to such expiration or termination pursuant to
Article 11 herein.
(f) The Parties agree that the provisions of this Section 8.2
shall not be considered when making the determination pursuant
to Section 4.11(a), nor amended in the event of exercise of
Section 4.11(b).
(g) In the event of the termination of any license, in whole or in
part, under this Agreement, the manufacture and/or Sale by the
IGEN Sellers of products covered by such license shall cease
immediately to the extent that such manufacture and/or Sale no
longer is licensed as a result of such termination, except
that such products in inventory as of the date of such
termination may be Sold in accordance with the terms and
subject to the restrictions of this Agreement for a period of
one hundred eighty (180) days following such termination and
royalties shall be due and payable on the Net Sales of such
products in accordance with the terms of this Agreement.
8.3 Survival of Certain Rights Upon Expiration or Termination. All rights
granted to and obligations undertaken by the Parties hereunder shall
terminate immediately upon the expiration of the term of this Agreement
(as set forth in Section 8.1 above) or the termination of this
Agreement (pursuant to Section 8.2 above) except for:
(a) The obligations of IGEN to pay any and all royalties or other
consideration accrued hereunder prior to such expiration or
termination (or during the one hundred eighty (180) day period
following termination in the case of inventory as of the date
of termination);
(b) The right of Roche to have audited by an independent certified
public accounting firm the books and records of IGEN and
IGEN's Affiliates as provided in Section 4.8 above;
(c) The indemnification provisions of Section 6.2 above;
(d) The procedures set forth in Article 11 herein in respect of
any matter arising prior to such expiration or termination;
and
-31-
(e) Any and all confidentiality obligations provided for in this
Agreement; and
(f) Sections 4.9, 8.2(e), 8.2(g), 8.3, 10, 12.1, 12.3, 12.5, 12.8,
12.9, 12.10, 12.14, 12.15, 12.17, 12.18 and 12.20.
ARTICLE 9
ADDITIONAL COVENANTS AND AGREEMENTS
9.1 IGEN shall not, and shall cause each of its Affiliates not to, enter
into a joint venture or other arrangement with any Third Party that
would result in the conveyance to such Third Party of benefits
substantially equivalent to those that would be received from a
sublicense under the Licensed Patents licensed under this Agreement.
Nothing in the foregoing shall restrict or limit IGEN's rights to
sublicense, assign or transfer its rights hereunder in accordance with
Sections 2.1, 2.3(e), 2.4 or 12.9.
9.2 IGEN shall not, and shall cause each of its Affiliates not to, arrange
Sales of Royalty Products (or utilize the definitions relating thereto)
to reduce in bad faith the Net Sales for which royalties are payable by
IGEN hereunder.
9.3 IGEN shall not tolerate and shall enforce the provisions of any
contract with a Research Collaborator of IGEN in the event that such
Research Collaborator of IGEN repeatedly and materially fails to adhere
to the provisions of its contract with IGEN and/or any of its
Affiliates requiring that Licensed Products necessary to perform the
work under such contract may be used only for the purposes of the
protocol and that any Licensed Products not consumed in performing the
work under such contract either be returned to IGEN and its Affiliates
or be disposed of as laboratory waste.
ARTICLE 10
REPRESENTATIONS AND WARRANTIES
10.1 Representations and Warranties of IGEN. IGEN hereby represents and
warrants to Roche as follows:
(a) The execution, delivery and performance of, and the
consummation by IGEN of the transactions contemplated by, this
Agreement have been duly authorized by all necessary action on
the part of IGEN and no further consents by IGEN are needed in
order to consummate the transactions contemplated hereby.
-32-
(b) This Agreement, when executed and delivered by Roche/Basle,
Roche/Germany and Roche/USA in accordance with the provisions
hereof, shall be a legal, valid and binding obligation of
IGEN, enforceable against IGEN in accordance with its terms,
except as such enforceability may be limited by applicable
bankruptcy, insolvency, moratorium, reorganization or similar
laws affecting the enforcement of creditors' rights generally
and by limitations on the availability of specific performance
and other equitable remedies against IGEN.
(c) IGEN's execution of this Agreement shall not constitute a
breach or default under any contract, instrument or agreement
to which IGEN or any of its Affiliates is a Party or by which
IGEN or any of its Affiliates is bound.
(d) All persons who will execute this Agreement on behalf of IGEN
have been duly authorized to do so by all necessary action on
the part of IGEN.
10.2 Representations and Warranties of Roche. Roche hereby represents and
warrants to IGEN as follows:
(a) Roche/Basle has the full power and right to grant to IGEN and
IGEN's Affiliates the license outside of the United States
under the Licensed Patents, and Roche/USA has the full power
and right to grant to IGEN and IGEN's Affiliates the license
in the United States under the Licensed Patents, set forth in
Section 2.1, 2.2. and 2.4 above.
(b) To the best of Roche's knowledge, Exhibit "1" constitutes a
complete list of all granted U.S. patents (or where a
corresponding U.S. patent is not granted as of the Effective
Time, then a representative corresponding published U.S. or
European patent application is listed) owned by Roche or its
Affiliates as of the Effective Time and available for license
to IGEN, which meet the criteria of Section 1.19 herein.
IGEN's exclusive remedy for a breach of the foregoing
representation and warranty shall be inclusion of the missing
patents in Exhibit 1 as required by Section 1.19 herein. For
the purposes of such list, where a U.S. patent application
from which priority has been claimed has been abandoned and
succeeded by one or more continuations and/or
continuations-in-part, any such granted continuations and/or
continuations-in-part, will be listed. Where no such U.S.
Licensed Patents have been issued, the granted non-U.S.
Licensed Patents or corresponding representative published
application are listed. Subject to the terms, conditions and
limitations of this Agreement, IGEN, its Affiliates and
End-Users shall be immune from any suit for infringement of
any patent rights which would constitute a failure of this
representation and warranty.
-33-
(c) The execution, delivery and performance of, and the
consummation by Roche of the transactions contemplated by,
this Agreement have been duly authorized by all necessary
action, and the execution, delivery and performance of, and no
further consents are needed in order to consummate the
transactions contemplated hereby.
(d) This Agreement, when executed and delivered by IGEN in
accordance with the provisions hereof, shall be a legal, valid
and binding obligation of Roche, enforceable against Roche in
accordance with its terms, except as such enforceability may
be limited by applicable bankruptcy, insolvency, moratorium,
reorganization or similar laws affecting the enforcement of
creditors' rights generally and by limitations on the
availability of specific performance and other equitable
remedies against Roche.
(e) Roche's execution of this Agreement shall not constitute a
breach or default under any contract, instrument or agreement
to which Roche or any of its Affiliates is a Party or by which
Roche or any of its Affiliates is bound.
(f) All persons who will execute this Agreement on behalf of
Roche/Basle have been duly authorized to do so by all
necessary action on the part of Roche/Basle, and all persons
who will execute this Agreement on behalf of Roche/Germany
have been duly authorized to do so by all necessary action on
the part of Roche/Germany, and all persons who will execute
this Agreement on behalf of Roche/USA have been duly
authorized to do so by all necessary action on the part of
Roche/USA.
10.3 No Other Representations or Warranties. Except as otherwise expressly
set forth herein, the Parties make no other representation or warranty,
express or implied, with regard to PCR or any other matter hereunder
whatsoever.
ARTICLE 11
DISPUTE RESOLUTION; VENUE AND CHOICE OF LAW
11.1 Good Faith Resolution. In the event that at any time during the term of
this Agreement a disagreement, dispute, controversy or claim should
arise out of or relating to the interpretation of this Agreement, or
performance by a Party under this Agreement, or a breach of this
Agreement by a Party, or any claim by a Party that any provision of
this Agreement is invalid (a "Dispute" or collectively "Disputes"), one
Party shall give written notice to the other Party that a dispute
exists and the Parties will then attempt in good faith to resolve their
differences before resorting to arbitration provided in Section 11.2.
If the Parties cannot resolve the disputed matter within thirty (30)
days after such notice, then
-34-
either Party shall be free to submit the disputed matter to binding
arbitration in accordance with Section 11.2 hereof. For purposes of
this Article 11, the terms "Party" and "Parties" shall include each of
the signatories to this Agreement and/or any one or more of their
respective Affiliates, whether the reference is to a Party as a
claimant or a Party against which a claim is made.
11.2 Arbitration.
(a) The Parties intend Section 11.2 hereof to be enforceable in
accordance with the Federal Arbitration Act (9 U.S.C. Section
1, et seq.), including any amendments to that Act which are
subsequently adopted, notwithstanding any other choice of law
provision set forth in this Agreement. In the event that
either Party refuses to submit to arbitration as required
herein, the other Party may request a United States District
Court to compel arbitration in accordance with the Federal
Arbitration Act.
(b) Any dispute or other matter in question between Roche and IGEN
arising out of or relating to the formation, interpretation,
performance, or breach of this Agreement, whether such dispute
or matter arises before or after termination of this
Agreement, shall be resolved solely by arbitration if the
Parties are unable to resolve the dispute through negotiation
pursuant to Section 11.1 hereof. Arbitration shall be
initiated by the delivery of a written notice of demand for
arbitration by one Party to the other. The date on which the
other Party receives such written notice shall be hereinafter
referred to as the "Arbitration Notice Date."
(c) Each Party shall appoint an individual as arbitrator and the
two so appointed shall then appoint a third arbitrator. If
either Party refuses or neglects to appoint an arbitrator
within thirty (30) days after the Arbitration Notice Date,
then the arbitration shall be conducted by a single arbitrator
appointed by the American Arbitration Association. If two
arbitrators are appointed but do not agree on the third
arbitrator within sixty (60) days after the Arbitration Notice
Date, each of the arbitrators shall nominate within
sixty-seven (67) days after the Arbitration Notice Date three
individuals. Each arbitrator shall then within seventy-two
(72) days after the Arbitration Notice Date decline two of the
nominations presented by the other arbitrator. The third
arbitrator shall then be chosen from the remaining two
nominations by drawing lots. Notwithstanding anything
contained herein to the contrary, if the third arbitrator is
not chosen with seventy-two (72) days after the Arbitration
Notice Date, then the American Arbitration Association shall
appoint the third arbitrator within seventy-seven (77) days
after the Arbitration Notice Date. The arbitrators shall not
be or have been affiliated with, or have any personal,
financial or business relationship with, either of the Parties
or any Affiliate of either Party; the
-35-
arbitrators shall not have a personal or financial interest in the
result of the arbitration.
(d) The arbitration hearings shall be held in Borough of
Manhattan, State of New York or such other place as may be
mutually agreed by the Parties, shall be conducted in the
English language and shall be conducted as confidential
proceedings (except to the extent necessary to enforce the
award resulting therefrom). Unless the Parties agree
otherwise, the arbitrators shall commence the arbitration
hearing within thirty (30) days after the selection of the
third arbitrator. The arbitrators shall issue orders to
protect the confidentiality of proprietary information, trade
secrets and other sensitive information disclosed. Pending the
arbitration hearing, at the request of a Party, the
arbitrators may issue temporary injunctive or other equitable
relief to address any violation or threatened violation of
this Agreement. All awards shall be made based on a majority
vote of the arbitrators, shall be in writing, shall not be
considered confidential information of either Party, shall be
issued within sixty (60) days after hearings before the
arbitrators are completed, and shall state the reasoning on
which the award rests unless the Parties agree otherwise. In
addition to any relief at law which may be available to an
aggrieved Party for such breach, such Party shall be entitled
to injunctive and other equitable relief as the arbitration
panel may grant. The arbitrators shall deliver a copy of the
award to each Party personally or by registered mail. Any
party may request within ten (10) days after receiving the
decision that, for good cause, the arbitrators reconsider and
modify such decision. The arbitrators shall have thirty (30)
days after such request to modify their decision, if they
consider it appropriate. Thereafter, the decision of the
arbitrators shall be final, binding and nonappealable, except
to the extent appeals are permitted by the Federal Arbitration
Act, with respect to all persons, including (without
limitation) persons who have failed or refused to participate
in the arbitration process. Judgment upon the award rendered
may be entered in any court having jurisdiction thereof.
(e) Each Party shall bear its own costs in connection with any
such arbitration including, without limitation, (i) all legal,
accounting, and any other professional fees and expenses, (ii)
the fees and expenses of its own arbitrator, and (iii) all
other costs and expenses each Party incurs to prepare for such
arbitration. Other than set forth above, each side shall pay,
(iv) one-half of the fee and expenses of the third arbitrator,
and (v) one-half of the other expenses that the Parties
jointly incur directly related to the arbitration proceeding.
(f) Except as provided above, arbitration shall be based upon the
Commercial Arbitration Rules of the American Arbitration
Association. Discovery shall be
-36-
limited at the discretion of the arbitrators, so that the
timing and extent of such discovery shall not interfere with
the normal business operations of the Parties. The arbitrators
may proceed to an award notwithstanding the failure of either
Party to participate in the proceedings.
(g) In the event of subsequent actions or proceedings to confirm
the award or to enforce the judgment entered thereon or any
other rights flowing therefrom, the prevailing Party shall be
entitled to recover its reasonable attorney's fees incurred in
such actions or proceedings.
(h) The fact that the dispute resolution procedures specified in
this Article 11 shall have been or may be invoked shall not
excuse any Party from performing its obligations under this
Agreement, and during the pendency of any such procedure the
Parties shall continue to perform their respective obligations
in good faith.
11.3 Limited Recourse to Courts. This Article 11 shall be the exclusive
dispute resolution procedure for Disputes under this Agreement and no
Party shall bring Disputes before any court, except as appeals to
arbitration awards are permitted by Section 11.2. Except as permitted
by Section 11.2, the Parties hereby waive any right to appeal an
arbitration award to any court. The provisions of Section 11.2 may be
enforced, and judgment on the award (including without limitation
equitable remedies) granted in any arbitration hereunder may be
entered, in any court of competent jurisdiction. The Parties hereby
submit to the non-exclusive in personam jurisdiction of the federal
courts in New York for such purposes. THE PARTIES HEREBY WAIVE ANY AND
ALL RIGHTS TO TRIAL BY JURY FOR MATTERS RELATED TO DISPUTES SUBMITTED
TO ANY COURT.
11.4 Governing Law. This Agreement is made in accordance with and shall be
governed and construed under the laws of the State of New York, U.S.A.,
without regard to its conflicts of laws rules.
ARTICLE 12
MISCELLANEOUS
12.1 Disclaimer. EXCEPT AS OTHERWISE PROVIDED HEREIN THE INTELLECTUAL
PROPERTY RIGHTS LICENSED HEREUNDER ARE PROVIDED BY ROCHE "AS IS WHERE
IS" AND ROCHE MAKES NO, AND DISCLAIMS ALL WARRANTIES AND
REPRESENTATIONS, EXPRESS OR IMPLIED, CONCERNING: (a) LICENSED
INTELLECTUAL PROPERTY RIGHTS COVERED BY THIS AGREEMENT, INCLUDING
WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTY
-37-
OF DESIGN, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO
LICENSED INTELLECTUAL PROPERTY RIGHTS OR ANY PRODUCT; (b) THE
COMMERCIAL SUCCESS OF ANY LICENSED PRODUCT; (c) THE EXISTENCE, VALIDITY
OR SCOPE OF LICENSED INTELLECTUAL PROPERTY RIGHTS; (d) ANY LICENSED
PRODUCT BEING FREE FROM AN INFRINGEMENT ON PATENTS OR OTHER
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES; (e) WHETHER ANY THIRD
PARTIES ARE IN ANY WAY INFRINGING LICENSED INTELLECTUAL PROPERTY RIGHTS
COVERED BY THIS AGREEMENT; OR (f) THE ACCURACY, UTILITY OR SUFFICIENCY
OF ANY TECHNICAL INFORMATION TRANSFERRED TO IGEN HEREUNDER. THE PARTIES
SPECIFICALLY AGREE THAT NEITHER PARTY SHALL BE SUBJECT TO AND THAT EACH
DISCLAIMS: (A) ANY OTHER OBLIGATIONS OR LIABILITIES ARISING OUT OF
BREACH OF WARRANTY, AND (B) ALL CONSEQUENTIAL, INCIDENTAL, CONTINGENT,
PUNITIVE AND EXEMPLARY DAMAGES WHATSOEVER WITH RESPECT TO (i) ANY
DISPUTES BETWEEN THE PARTIES UNDER THIS AGREEMENT OR (ii) CLAIMS MADE
BY ONE PARTY AGAINST ANOTHER PARTY ARISING FROM THE COURSE OF CONDUCT
WITHIN THE RELATIONSHIP OF THE PARTIES UNDER THIS AGREEMENT (WHETHER
SUCH CLAIMS ARISE UNDER CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE),
EVEN THOUGH A PARTY MAY HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES. THE LIMITATION OF DAMAGES IN CLAUSE (B) ABOVE SHALL NOT APPLY
TO DAMAGES PAID TO UNRELATED THIRD PARTIES (WHETHER PURSUANT TO
JUDGMENT OR SETTLEMENT) FOR WHICH A PARTY HAS AN OBLIGATION TO
INDEMNIFY THE OTHER PARTY HEREUNDER.
12.2 Export Control. IGEN agrees, and shall cause its Affiliates to agree,
to abide by all laws and regulations of the United States Government,
or the government having jurisdiction therefor, governing the export or
re-export of any Licensed Products. IGEN shall inform itself as to the
details of such laws and regulations and their amendments.
12.3 Additional Documents. Each Party agrees to execute such further papers
or agreements as may be necessary to effect the purposes of this
Agreement.
12.4 Governmental Approvals and Marketing of Licensed Products. IGEN shall
be responsible for obtaining all necessary governmental approvals for
the development, production, distribution, sale and use of any Licensed
Product, at IGEN's expense, including, without limitation, any safety
studies. IGEN shall have sole responsibility for any warning labels,
packaging and instructions as to the use of Licensed Products and for
the quality control for any Licensed Product.
-38-
12.5 Confidentiality. ROCHE and IGEN agree for themselves and their
Affiliates, and on behalf of their respective officers, employees and
agents, that until the later of (i) 10 years from the Effective Time
hereof or (ii) 5 years after the expiration date of this Agreement,
each will treat as confidential, using the same degree of care as it
uses for its own confidential and proprietary information, but in no
event less than reasonable care, and shall not disclose to any Third
Party, and shall not use for its own benefit or the benefit of any
Third Party (except as permitted hereunder, including disclosures to
IGEN Affiliates and permitted sublicensees or subcontractors to the
extent necessary to have Licensed Products manufactured and subject to
confidentiality obligations at least as restrictive as those contained
herein) the confidential information furnished to it by the other Party
unless the furnishing party ("Discloser") otherwise agrees in writing
or unless such information clearly and convincingly falls within the
following exceptions:
(a) Such confidential information was known to the receiving party
("Recipient") prior to the time of disclosure by the Discloser
or was in the public domain at the time of disclosure by
Discloser as can be documented by written records; or
(b) Such confidential information is or becomes publicly known
after disclosure by Discloser through no fault or omission
attributable to Recipient; or
(c) Such confidential information is given to Recipient from
sources independent of Discloser who have the right to
disclose it; or
(d) Such confidential information is independently developed by
employees of Recipient that did not have access to it as can
be documented by written records; or
(e) Recipient is required to disclose such confidential
information to a court of law or to appropriate governmental
agencies to enable Recipient to carry out the evaluation of a
Product or to secure a governmental approval, or as otherwise
required by law; provided, however, that (1) Recipient gives
the Discloser prompt written notice of such required
disclosure and reasonably assists the Discloser in its efforts
to prevent or limit such disclosure; and (2) any confidential
information disclosed pursuant to this Section 12.5(e) shall
otherwise remain confidential information for the purposes of
this Agreement.
For purposes of this License, ROCHE's confidential information shall
include (subject to the exclusions in (a)-(e) above) all information
relating to the Licensed Patents. Access to such confidential
information must be restricted to the Recipient's, its Affiliates,
subcontractor's, Authorized Third Parties' or Research Collaborators'
employees or agents with a need to have access. The Recipient
acknowledges that by virtue of this Agreement it acquires only
-39-
such rights as set forth under the terms and conditions of this
Agreement and only so long as it is in effect and does not acquire any
rights of ownership or title in the Discloser's confidential
information. In addition, each of the Parties agrees to execute
appropriate confidentiality agreements with Third Party collaborators
of such Party prior to disclosing the other Party's confidential
information to such Third Party collaborator. Upon expiration of this
Agreement, each Party, its Affiliates, subcontractors, Authorized Third
Parties or Research Collaborators and their employees and agents shall
immediately discontinue use of the other's confidential information,
except as otherwise permitted under the provisions hereof. The Parties
agree that this Section 12.5 sets out in its entirety the Parties'
confidentiality obligations with respect to the subject matter of this
Agreement. Neither Party nor any of its Affiliates shall make any
public announcement of or otherwise disclose to any Third Party this
Agreement or any of its terms without the prior written consent of the
other Party.
12.6 License Registration. IGEN shall pay all costs and legal fees connected
with registration of this Agreement in those countries where it (or its
Affiliates, Distributors and/or agents) sells Licensed Products, where
required, and shall otherwise ensure that the laws of all the countries
where sales of its Licensed Products occur are fully satisfied. None of
such amounts shall be deductible against amounts payable to ROCHE
hereunder. ROCHE shall provide reasonable assistance to IGEN in
effecting such registrations if IGEN reimburses any out-of-pocket
expenses incurred in providing such assistance.
12.7 Reservation of Rights. ROCHE reserves the right to use for any purpose
(commercial or noncommercial), anywhere in the world, and the right to
allow other persons to use for any purpose, anywhere in the world, any
Licensed Patents licensed hereunder, without ROCHE or such other
persons being obligated to pay IGEN any royalties or other
compensation.
12.8 Waiver. No delay or omission on the part of either Party to this
Agreement in requiring performance by the other Party or in exercising
any right hereunder shall operate as a waiver of any provision hereof
or of any right or rights hereunder; and the waiver, omission or delay
in requiring performance or exercising any right hereunder on any one
occasion shall not be construed as a bar to or waiver of such
performance or right, or of any right or remedy under this Agreement,
on any future occasion. Any agreement on the part of either Party to
any such extension or waiver shall be valid only if set forth in an
instrument in writing signed on behalf of such Party.
12.9 Assignment. This Agreement shall be binding upon and inure to the
benefit of the Parties hereto and their permitted successors and
assigns; provided, however, that: (a) neither Party shall assign any of
its rights and obligations hereunder except as consented to by the
other Party, which consent shall not be unreasonably withheld, and (b)
such consent shall not be
-40-
required with respect to an assignment of (i) any or all of its rights
and obligations hereunder to an Affiliate of such assigning party; or
(ii) all (but not less than all) of its rights and obligations
hereunder to an acquirer of all or substantially all of the assets or
business of the assigning party related to such party's use of the
Licensed Patents, whether as incident to a merger, consolidation,
reorganization, acquisition or otherwise. Whenever there has been an
assignment or a sublicense by IGEN or ROCHE, as the case may be, as
permitted by this Agreement, the term "IGEN" or "ROCHE" as used in this
Agreement shall also include and refer to, if appropriate, such
assignee or sublicensee.
12.10 Notices. Any notice or other communication required or permitted to be
given to either Party hereto shall be in writing and shall be deemed to
have been properly given and to be effective on the date of delivery if
delivered in person or by facsimile (with electronic confirmation of
receipt and with a confirmation copy sent by internationally-recognized
air courier service), to such Party at the following address:
If to IGEN:
IGEN Integrated Healthcare, LLC
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: President
Telephone: ▇-▇▇▇-▇▇▇-▇▇▇▇
Facsimile: ▇-▇▇▇-▇▇▇-▇▇▇▇
With a copy to:
▇▇▇▇ and ▇▇▇▇ LLP
▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇ ▇▇▇▇▇▇▇, Esq.
Telephone: ▇-▇▇▇-▇▇▇-▇▇▇▇
Facsimile: ▇-▇▇▇-▇▇▇-▇▇▇▇
-41-
If to Roche, to each and all of the following:
▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ Ltd.
▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇
▇▇-▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇
Attention: Legal Department
Telephone: ▇▇▇-▇▇▇▇-▇▇▇-▇▇▇▇
Facsimile: 011-4161-688-1396
Roche Diagnostics GmbH
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇
▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
Attention: Legal Department
Telephone: ▇▇▇-▇▇-▇▇▇-▇▇▇-▇▇▇▇
Facsimile: 011-49-621-759-4461
Roche Molecular Systems, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: President
Telephone: ▇▇▇ ▇▇▇ ▇▇▇▇
Facsimile: ▇▇▇ ▇▇▇ ▇▇▇▇
Roche Molecular Systems, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: Licensing Department
Telephone: ▇▇▇ ▇▇▇ ▇▇▇▇
Facsimile: ▇▇▇ ▇▇▇ ▇▇▇▇
Roche Molecular Systems, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: General Counsel
Telephone: ▇▇▇ ▇▇▇ ▇▇▇▇
Facsimile: ▇▇▇ ▇▇▇ ▇▇▇▇
Either Party may change its address for communications by a
notice to the other Party in accordance with this Section.
-42-
12.11 Headings. The headings of the several sections are inserted for
convenience of reference only and are not intended to be a part of or
to affect the meaning or interpretation of this Agreement.
12.12 Force Majeure. Any delays in performance by any Party under this
Agreement (other than a Party's failure to make payments hereunder)
shall not be considered a breach of this Agreement if and to the extent
caused by occurrences beyond the reasonable control of the Party
affected, including but not limited to acts of God, embargoes,
governmental restrictions, strikes or other concerted acts of workers,
fire, flood, explosion, riots, wars, civil disorder, rebellion or
sabotage. The Party suffering such occurrence shall immediately notify
the other Party and any time for performance hereunder shall be
extended by the actual time of delay caused by the occurrence.
12.13 Independent Contractors. In granting, performing or exercising rights
under this Agreement, ROCHE and IGEN act and shall act at all times as
independent contractors and nothing contained in this Agreement shall
be construed or implied to create an agency, partnership or employer
and employee relationship between IGEN and ROCHE. At no time shall one
Party make commitments or incur any charges or expenses for or in the
name of the other Party.
12.14 Severability. If, under applicable law, any term, condition or
provision of this Agreement is held invalid or unenforceable, or
otherwise directly or indirectly affects the validity of any other
material provision(s) of this Agreement (the "Severed Clause"), then
this Agreement shall remain in full force and effect, except for the
Severed Clause. The Parties agree to renegotiate in good faith the
Severed Clause and be bound by the mutually agreed substitute
provision.
12.15 Interpretation. The official text of this Agreement shall be English.
For purposes of this Agreement, except as otherwise expressly provided
or unless the context otherwise requires:
(a) the terms of this Agreement do not amend or supersede, and
shall not be used to interpret, the terms of the License
Agreement, dated as of the date hereof, by and between IGEN
International, Inc. and IGEN LS LLC, the Improvements License
Agreement, dated as of the date hereof, by and between
Roche/Germany and IGEN International, Inc., the Covenants Not
to ▇▇▇, dated as of the date hereof, by and among IGEN, MSD,
MST, Roche/Germany, Roche Holding Ltd, and IGEN LS LLC, or the
License Agreement (Human IVD Services and Animal Diagnostic
Services), dated as of the date hereof, by and between the
Parties;
-43-
(b) the terms defined in this Agreement have the meanings assigned
to them in this Agreement and include the plural as well as
the singular, and the use of any gender herein shall be deemed
to include the other gender;
(c) references herein to "Sections," "Subsections," "Paragraphs,"
and other subdivisions without reference to a document are to
designated Sections, Subsections, Paragraphs and other
subdivisions of this Agreement;
(d) a reference to a Subsection without further reference to a
Section is a reference to such Subsection as contained in the
same Section in which the reference appears, and this rule
shall also apply to Paragraphs and other subdivisions;
(e) the words "herein," "hereof," "hereunder," and other words of
similar import refer to this Agreement as a whole and not to
any particular provision;
(f) the term "include" or "including" shall mean "including
without limitation";
(g) the term "to the extent" shall mean the degree to which a
subject or other thing extends, and such phrase shall not mean
simply "if";
(h) the term "or" is not exclusive; and
(i) the Exhibits, Appendices and Annexes to this Agreement are
hereby incorporated and made a part hereof and are an integral
part of this Agreement.
12.16 Cumulative Rights. The rights, powers and remedies hereunder shall be
in addition to, and not in limitation of, all rights, powers and
remedies provided at law or in equity. All of such rights, powers and
remedies shall be cumulative, and may be exercised successively or
cumulatively.
12.17 Entire Agreement; Amendment. This Agreement and any and all Schedules
and Appendices referred to herein, together with the Transaction
Agreements (as defined in the Merger Agreement), embody the entire
understanding of the Parties with respect to the subject matter hereof
and shall supersede all previous communications, representations or
understandings, either oral or written, between the Parties relating to
the subject matter hereof. This Agreement shall not be amended, altered
or changed except by a written agreement signed by all of the Parties
hereto. In the event of any inconsistency between the terms of this
Agreement and the Improvements License Agreement dated as of the date
hereof, between Roche/Germany and IGEN International, Inc. (the
"Improvements License Agreement") (e.g., if a product or service is
licensed under the Improvements License
-44-
Agreement and does not require the license under this this Agreement),
then the terms of the Improvements License Agreement shall control.
12.18 No Third Party Beneficiary Rights. Except for the provisions of Section
2.1, 2.3(e), and 2.4(a) relating to immunity from suit and Article 6
relating to Indemnitees, nothing contained in this Agreement is
intended to confer upon any person other than the Parties hereto and
their respective Affiliates, successors and permitted assigns, any
benefit, right or remedy under or by reason of this Agreement.
12.19 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original but all of
which together shall constitute one and the same instrument.
12.20 Sales Tax. In the event any sales, use or similar tax (if any) is
required to be collected or paid in connection with the Sale of Royalty
Products by IGEN Sellers pursuant to this Agreement, IGEN shall pay the
same and hold Roche harmless with respect thereto.
[Remainder of Page Intentionally Left Blank]
-45-
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their duly authorized officers effective as of the Effective Time.
IGEN INTEGRATED HEALTHCARE, LLC
/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
By: ________________________________________
President and Chief Operating Officer
Title: _____________________________________
7/24/2003
Date: ______________________________________
▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ LTD
/s/ D. ▇▇▇▇▇ ▇. ▇▇▇▇▇
By: ________________________________________
President and Chairman
Title: _____________________________________
/s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
By: _______________________________
Chief Financial Officer
Title: ____________________________
7/24/2003
Date: _____________________________
-46-
ROCHE DIAGNOSTICS GMBH
/s/ ▇.▇. ▇▇▇▇▇▇▇
By: _______________________________
General Counsel
Title: ____________________________
/s/ ▇▇▇▇▇ Von Prondzynski
By: _______________________________
Authorized Signatory
Title: ____________________________
7/24/2003
Date: _____________________________
ROCHE MOLECULAR SYSTEMS, INC.
APPROVED BY RMS LEGAL DEPT:
/s/ ▇. ▇▇▇▇▇▇▇▇▇ /s/ CMD
By: ______________________________ ____________________________
President
Title: ____________________________
7/24/2003
Date: _____________________________
-47-
EXHIBIT 1
LICENSED PATENTS
[attached]
48
EXHIBIT 2 SUMMARY ROYALTY REPORT FOR THE PERIOD ___________TO__________
ROYALTIES TO ROCHE/BASEL FOR SALES IN EUROPE Royalty Rate(s): 12% to 12/31/05;
6% thereafter
Licensee: IGEN Integrated Healthcare, LLC Effective Time: _______________
-------------------------------------------------------------------------------------------------------------------
NUMBER
OF PRODUCT CUMULATIVE DEDUCTIONS
UNITS SOLD OR GROSS SALES OF ALLOWED*
ROYALTY PRODUCT TRANSFERRED ROYALTY PRODUCT (EXPLAIN) NET SALES ROYALTY DUE
===================================================================================================================
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
CHECK HERE IF THERE WERE NO SALES FOR THIS PERIOD TOTAL ROYALTY EARNED
-----------------------------------------------------
ROYALTY PAYMENT DUE
-----------------------------------------------------
I hereby certify the information set forth above is correct and complete with
respect to the amounts due under the applicable license agreement.
By: ________________________ Title:_________________ Date: ________________
(authorized signature)
Name (please print): ___________________________________
SEND REPORT TO: KPMG Fides, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇, ▇▇-▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, to the
attention of: Licensing Trustee, Fax: ▇▇▇ ▇▇ ▇▇▇-▇▇▇▇
SEND PAYMENT TO: Credit Suisse, Basel, Switzerland, Account No. ▇▇▇▇-▇▇▇▇▇▇-▇▇,
Swift Code: ▇▇▇▇▇▇▇▇▇▇▇, IBAN: ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇
Reference: DI-PC1-9962, payment period
61
EXHIBIT 2 SUMMARY ROYALTY REPORT FOR THE PERIOD ___________TO__________
ROYALTIES TO ROCHE/USA FOR SALES IN Royalty Rate(s): 12% to 12/31/05; 8%
THE UNITED STATES to 12/31/10; 7% thereafter
Licensee: IGEN Integrated Healthcare, LLC Effective Time: _________________
-------------------------------------------------------------------------------------------------------------------
NUMBER
OF PRODUCT CUMULATIVE DEDUCTIONS
UNITS SOLD OR GROSS SALES OF ALLOWED*
ROYALTY PRODUCT TRANSFERRED ROYALTY PRODUCT (EXPLAIN) NET SALES ROYALTY DUE
===================================================================================================================
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
CHECK HERE IF THERE WERE NO SALES FOR THIS PERIOD TOTAL ROYALTY EARNED
-----------------------------------------------------
ROYALTY PAYMENT DUE
----------------------------------------------------
I hereby certify the information set forth above is correct and complete with
respect to the amounts due under the applicable license agreement.
By: __________________________ Title: __________________ Date: ____________
(authorized signature)
Name (please print): ____________________________________
SEND REPORT TO: KPMG Fides, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇, ▇▇-▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, to the
attention of: Licensing Trustee, Fax: ▇▇▇ ▇▇ ▇▇▇-▇▇▇▇
SEND PAYMENT TO: Credit Suisse, Basel, Switzerland, Account No. ▇▇▇▇-▇▇▇▇▇▇-▇▇,
Swift Code: ▇▇▇▇▇▇▇▇▇▇▇, IBAN: ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇ Reference:
DI-PC1-9962, payment period
62
EXHIBIT 2 SUMMARY ROYALTY REPORT FOR THE PERIOD ___________TO__________
ROYALTIES TO ROCHE/BASEL FOR SALES IN COUNTRIES OTHER THAN EUROPE OR THE UNITED
STATES
Royalty Rate(s): 12% to 12/31/05; 8% to
12/31/10; 7% thereafter
Licensee: IGEN Integrated Healthcare, LLC Effective Time: _________________
-------------------------------------------------------------------------------------------------------------------
NUMBER
OF PRODUCT CUMULATIVE DEDUCTIONS
UNITS SOLD OR GROSS SALES OF ALLOWED*
ROYALTY PRODUCT TRANSFERRED ROYALTY PRODUCT (EXPLAIN) NET SALES ROYALTY DUE
===================================================================================================================
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
CHECK HERE IF THERE WERE NO SALES FOR THIS PERIOD TOTAL ROYALTY EARNED
-----------------------------------------------------
ROYALTY PAYMENT DUE
----------------------------------------------------
I hereby certify the information set forth above is correct and complete with
respect to the amounts due under the applicable license agreement.
By: ____________________________ Title: __________________ Date: __________
(authorized signature)
Name (please print): _____________________________
SEND REPORT TO: KPMG Fides, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇, ▇▇-▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, to the
attention of: Licensing Trustee, Fax: ▇▇▇ ▇▇ ▇▇▇-▇▇▇▇
SEND PAYMENT TO: Credit Suisse, Basel, Switzerland, Account No. ▇▇▇▇-▇▇▇▇▇▇-▇▇,
Swift Code: ▇▇▇▇▇▇▇▇▇▇▇, IBAN: ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇ Reference:
DI-PC1-9962, payment period
63
EXHIBIT 2 SUMMARY ROYALTY REPORT FOR THE PERIOD ___________TO__________
LICENSEE: IGEN Integrated FIELD OF USE: HLA Typing Products ROYALTY RATE: 20%
Healthcare, LLC EFFECTIVE TIME:
-------------------------------------------------------------------------------------------------------------------
NUMBER CUMULATIVE
OF PRODUCT GROSS SALES DEDUCTIONS
UNITS SOLD OR OF LICENSED ALLOWED*
LICENSED PRODUCT TRANSFERRED PRODUCT (EXPLAIN) NET SALES ROYALTY DUE
===================================================================================================================
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
--------------------------------------- ---------------------------------------------------------------------------
CHECK HERE IF THERE WERE NO SALES FOR THIS PERIOD [ ] TOTAL ROYALTY EARNED
--------------------------------------------------
ROYALTY PAYMENT DUE
--------------------------------------------------
I hereby certify the information set forth above is correct and complete with
respect to the amounts due under the applicable license agreement.
By: _________________________ Title: _______________________ Date: ________
(authorized signature)
Name (please print): _______________________________
MAIL COMPLETED FORM: KPMG FIDES PEAT, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇, ▇▇-▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇
ATTN: LICENSING TRUSTEE/▇▇ ▇▇ ▇▇▇-▇▇▇▇ (T)/41 61 286 9401 (F)
MAIL ROYALTY PAYMENT TO: CREDIT SUISSE, BASEL, SWITZERLAND/TO THE ACCOUNT OF
KPMG/SWIFT CODE: ▇▇▇▇▇▇▇▇▇▇▇/IBAN: ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ ▇/REFERENCE
DI-PC1-__________ AND PAYMENT PERIOD
64
EXHIBIT 3 SUMMARY ROYALTY REPORT FOR THE PERIOD ___________TO__________
ROYALTIES TO ROCHE/USA FOR FIELD: ANIMAL DIAGNOSTICS SALES:___U.S./____EX-U.S.
SALES IN ALL COUNTRIES
Royalty Rate(s): 8% to 12/31/05; 5% to 12/31/10; 4% thereafter
Licensee: IGEN Integrated Healthcare, LLC Effective Time: ________________
------------------------------------------------------------------------------------------------------------------
NUMBER
OF PRODUCT CUMULATIVE DEDUCTIONS
UNITS SOLD OR GROSS SALES OF ALLOWED*
ROYALTY PRODUCT TRANSFERRED ROYALTY PRODUCT (EXPLAIN) NET SALES ROYALTY DUE
==================================================================================================================
------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
CHECK HERE IF THERE WERE NO SALES FOR THIS PERIOD TOTAL ROYALTY EARNED
--------------------------------------------------
ROYALTY PAYMENT DUE
--------------------------------------------------
I hereby certify the information set forth above is correct and complete with
respect to the amounts due under the applicable license agreement.
By: __________________________ Title: ______________________ Date: ________
(authorized signature)
Name (please print): ___________________________
SEND REPORT TO: Roche Molecular Systems, Inc., ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, Attention: Licensing Department
SEND PAYMENT TO: Chase Manhattan Bank of NY, ABA No. ▇▇▇▇▇▇▇▇▇, Account Name:
Roche Molecular Systems, Inc., Account No. 323839657
65
EXHIBIT 3 SUMMARY ROYALTY REPORT FOR THE PERIOD ___________TO__________
ROYALTIES TO ROCHE/USA FOR FIELD: PATERNITY SALES: ____U.S. / ____EX-U.S.
SALES IN ALL COUNTRIES
Royalty Rate(s): 12% to 12/31/05; 8% to 12/31/10; 7% thereafter
Licensee: IGEN Integrated Healthcare, LLC Effective Time: _______________
------------------------------------------------------------------------------------------------------------------
NUMBER
OF PRODUCT CUMULATIVE DEDUCTIONS
UNITS SOLD OR GROSS SALES OF ALLOWED*
ROYALTY PRODUCT TRANSFERRED ROYALTY PRODUCT (EXPLAIN) NET SALES ROYALTY DUE
===================================================================================================================
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
CHECK HERE IF THERE WERE NO SALES FOR THIS PERIOD TOTAL ROYALTY EARNED
--------------------------------------------------
ROYALTY PAYMENT DUE
--------------------------------------------------
I hereby certify the information set forth above is correct and complete with
respect to the amounts due under the applicable license agreement.
By: ___________________________ Title: ____________________ Date: _________
(authorized signature)
Name (please print): ________________________________
SEND REPORT TO: Roche Molecular Systems, Inc., ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, Attention: Licensing Department
SEND PAYMENT TO: Chase Manhattan Bank of NY, ABA No. ▇▇▇▇▇▇▇▇▇, Account Name:
Roche Molecular Systems, Inc., Account No. 323839657
66
EXHIBIT 3 SUMMARY ROYALTY REPORT FOR THE PERIOD ___________TO__________
Licensee: Integrated Healthcare, LLC Field of Use: DNA Manufacturing
Agreement
U.S._______ / Ex-U.S._______
Effective Time: Royalty Rate: 3% & 5%
-------------------------------------------------------------------------------------------------------------------
NUMBER OF CUMULATIVE
PRODUCT GROSS SALES OF
UNITS SOLD OR LICENSED DEDUCTIONS
LICENSED PRODUCT TRANSFERRED PRODUCT ALLOWED NET SALES ROYALTY DUE
===================================================================================================================
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------
TOTAL ROYALTY EARNED
--------------------------------------------------
CHECK HERE IF THERE WERE NO SALES FOR THIS PERIOD _____
--------------------------------------------------
ROYALTY PAYMENT DUE
--------------------------------------------------
--------------------------------------------------
I hereby certify the information set forth above is correct and complete with
respect to the amounts due under the applicable license agreement.
By: ____________________________ Title: ___________________ Date: _________
(authorized signature)
Name (please print): ______________________________
MAIL COMPLETED FORM AND ROYALTY PAYMENT TO: ROCHE MOLECULAR SYSTEMS, INC., P. O.
▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
67
