Exhibit 99.5
LICENSE AGREEMENT
(HUMAN IVD SERVICES AND ANIMAL DIAGNOSTIC SERVICES)
This LICENSE AGREEMENT (Human IVD Services and Animal Diagnostic
Services) (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 00000 Xxxxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxx 00000 ("IGEN"),
X. XXXXXXXX-XX XXXXX LTD, a Swiss limited liability company with its principal
place of business at Xxxxxxxxxxxxxxxxx 000, XX-0000 Xxxxx, Xxxxxxxxxxx
("ROCHE/BASLE"), ROCHE DIAGNOSTICS GMBH, a German company with its principal
place of business at Xxxxxxxxx Xxxxxxx 000, X-00000 Xxxxxxxx, Xxxxxxx
("ROCHE/GERMANY") and ROCHE MOLECULAR SYSTEMS, INC., a Delaware corporation with
its principal place of business at 0000 Xxxxxxxx Xxxxx, Xxxxxxxxxx, Xxxxxxxxxx
00000 XXX ("ROCHE/USA" or "RMS") (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
performing PCR-based in vitro human and animal diagnostic testing procedures;
WHEREAS, Roche is willing to grant such license to IGEN upon the
following terms and conditions.
-1-
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., 0 XXX
Xxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000-0000, XXX, nor Chugai
Pharmaceutical Co., Ltd, 1-9 Kyobashi 2-chome, Xxxx-xx, Xxxxx,
000-0000, Xxxxx, shall be deemed an Affiliate of ROCHE for purposes of
this Agreement. Meso Scale Diagnostics, LLC. ("MSD"), 0000 Xxxxxxx
Xxxx, Xxxxxxxxxxxx, Xxxxxxxx, XXX 00000, 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. ("MST"), 0000 Xxxxxxx Xxxx,
Xxxxxxxxxxxx, Xxxxxxxx, XXX 00000, 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.
-2-
Animal Breeding Applications specifically exclude testing for
disease-related traits for the purpose of treating the test Animal
for that disease.
1.4 "Animal Diagnostic Services Field" means use of 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 of 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 "Combination Service" shall mean a Licensed Service or Licensed Animal
Service offered in combination with another non-PCR diagnostic assay(s)
or together with a non-testing service(s) such as a specialized
interpretive service or a consultative service (e.g., genetic
counseling) as part of a package, where the Licensed Service or
Licensed Animal Service is not separately billed.
1.7 [Reserved for future use]
1.8 "Diagnostic Services Field" means the field of human in vitro
diagnostics for the detection, quantitation, monitoring, genotyping, or
phenotyping, of genetic and infectious diseases, disease
susceptibility, genetic pre-disposition to disease or cancer; analyzing
specimens taken from a human being for the purpose of testing, with
respect to that human being, 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 a
human being, including, without limitation, clinical laboratory
services, whether or not a fee is charged for such services; tissue
transplant typing, including testing performed on animal tissue
intended for use in xenotransplantation; Parentage Determination;
diagnosis, disease management; and clinical trials, whether or not a
patient result is provided directly or indirectly to a patient.
Licensed Field shall specifically exclude any services performed for
screening of blood and/or blood products.
-3-
1.9 "Diagnostic Product" shall mean an assemblage of reagents, including
but not limited to reagents packaged in the form of a kit, useful in
performing in vitro diagnostic procedure.
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 [Reserved for future use].
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 "Homogeneous PCR Technology" shall mean 5' Nuclease Technology and
Valid Claims of United States Patent Nos. 5,491,063, 5,571,673, and
6,171,785 B1, and any reissue or reexamination patents thereof, and
only the processes defined by the method claims (if they are Valid
Claims of) United States Patent No. 5,994,056, and any reissue or
reexamination patents thereof, and only the method and primer claims
(if they are Valid Claims) of United States Patent No. 5,573,906, and
any reissue or reexamination patents thereof; and any Valid Claims of
the foreign counterparts of the foregoing listed patents or claims.
1.14 [Reserved for future use].
1.15 "Licensed Animal Service(s)" shall mean either:
a) "Service A": the performance by IGEN or its Affiliates of an
in vitro diagnostic procedure utilizing PCR Technology, RT and RT-PCR
Technology and/or Quantitation Technology on a sample of material
obtained from an animal solely to detect the presence, absence or
quantity of a nucleic acid sequence associated with a disease or
condition within the Animal Diagnostic Services Field; or
b) "Service B": the performance by IGEN or its Affiliates of an
in vitro diagnostic procedure utilizing Homogeneous PCR Technology on a
sample of material obtained from an animal solely to detect the
presence, absence or quantity of a nucleic acid sequence associated
with a disease or condition within the Animal Diagnostic Services
Field.
-4-
Licensed Animal Services include but are not limited to, any
combination of the steps of collecting a sample for analysis, isolating
nucleic acid sequences therein, amplifying one or more desired
sequences, analyzing the amplified material, including sequence
analysis, and reporting the results.
1.16 [Reserved for future use].
1.17 [Reserved for future use]
1.18 "Licensed Fields" means the Animal Diagnostic Services Field and the
Diagnostic Services 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 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 Service(s)" shall mean either:
a) "Service A": the performance by IGEN or its
Affiliates of an in vitro diagnostic procedure
utilizing PCR Technology, Other Technology, RT and
RT-PCR Technology and/or Quantitation Technology on a
sample of material obtained from a human being solely
to detect the presence, absence or quantity of a
-5-
nucleic acid sequence associated with a human disease
or condition within the Diagnostic Services Field; or
b) "Service B": the performance by IGEN or its
Affiliates of an in vitro diagnostic procedure
utilizing Homogeneous PCR Technology on a sample of
material obtained from a human being solely to detect
the presence, absence or quantity of a nucleic acid
sequence associated with a human disease or condition
within the Diagnostic Services Field.
Licensed Services include but are not limited to, any combination of
the steps of collecting a sample for analysis, isolating nucleic acid
sequences therein, amplifying one or more desired sequences, analyzing
the amplified material, including sequence analysis, and reporting the
results.
1.21 "NET SERVICE REVENUES" shall mean gross invoice price for the Licensed
Services or Licensed Animal Services performed by IGEN or its
Affiliates (or the fair market value for any nonmonetary consideration
which IGEN or its Affiliates agrees to receive in exchange for Licensed
Services or Licensed Animal Services), less the following deductions
where they are factually applicable and are not already reflected in
the gross invoice price:
a) discounts allowed and taken, in amounts customary in
the trade (which shall include the difference between
the dollar amount charged by IGEN or its Affiliates
for a Licensed Service and the Medicare and/or
Medicaid Limits of Allowance and/or reimbursement
limitations of a Third Party insurance program); and
b) actual bad debt, up to two percent (2%) of gross
invoice price for Licensed Services or Licensed
Animal Services, which bad debt IGEN or its
Affiliates can prove and document that it was
reasonable and diligent in its efforts to collect
payment.
No allowance or deduction shall be made for commissions or collections,
by whatever name known.
1.21.1 The Net Service Revenues of those Licensed Services or
Licensed Animal Services that are performed by IGEN for any
Affiliate of IGEN shall be determined based on the average Net
Service Revenues from all Third Parties during the period on a
test by test basis.
1.21.2 The Net Service Revenues of those Licensed Animal Services
that are performed by IGEN or its Affiliates for any Third
Party, for which IGEN or its Affiliate, as the case may be,
either a) does not charge a fee, or b) charges a nominal fee,
not commensurate with the value of such Licensed Animal
Services, after consulting with IGEN or such Affiliate,
Roche/USA or its designee shall assign a flat fee as a royalty
for each such Licensed Animal Service performed. All such
Licensed Animal Services performed
-6-
shall be stated on Attachment I with a corresponding royalty
due per Licensed Animal Service. Notwithstanding any provision
contained in Section 1.21 to the contrary, no amounts shall be
deducted from any royalty due in accordance with this Section
1.21.2.
1.21.3 It is hereby understood and agreed that, to the extent
feasible, Licensed Services, Licensed Animal Services and
Combination Services shall at all times be invoiced, listed
and billed by IGEN and its Affiliates as a separate item in
IGEN's or its Affiliate's invoices, bills and reports to
customers. Net Service Revenues for determining royalties on a
Licensed Service or Licensed Animal Service which is part of a
Combination Service shall be determined by multiplying the
gross invoice price, less applicable deductions, by the
appropriate fraction in Attachment I-A or I-B, as applicable,
hereto. The fraction specified in Attachment I-A or I-B, as
applicable, for a particular Licensed Service or Licensed
Animal Service shall be set by Roche/USA or its designee after
consultation with IGEN or its Affiliate, as applicable, as
accurately reflecting the value contributed by the Licensed
Service or Licensed Animal Service to the overall value of the
Combination Service as offered by IGEN or its Affiliate, and
as set forth in Section 2.4. Attachment I-A or I-B, as
applicable, hereto shall be modified as new Combination
Services are identified and new royalty-bearing fractions set,
and as set forth in Section 2.4.
1.22 "OTHER TECHNOLOGY" shall mean the processes covered by the method
claims (if they are Valid Claims) of United States Patent Nos.
5,008,182, 5,677,152, 5,773,258 and 5,176,995, and any reissue or
reexamination patents thereof, and the claims (if they are Valid
Claims) of United States Patent No. 5,110, 920, and any reissue or
reexamination patents thereof; and any Valid Claims of the foreign
counterparts of the foregoing listed patents or claims.
1.22A "Parentage Determination" 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.
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 [Reserved for future use].
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
-7-
synthetic copies thereof are repeatedly separated and used as templates
for further cycles of synthesis.
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.
1.27 "PCR TECHNOLOGY" shall mean polymerase chain reaction technology
covered by Valid Claims of United States Patent Nos. B1 4,683,195, B1
4,683,202, and 4,965,188 and any reissue or reexamination patents
thereof; and any Valid Claims of the foreign counterparts of the
foregoing listed patents or claims.
1.28 "QUANTITATION TECHNOLOGY" shall mean the method claims (if they are
Valid Claims) of United States Patent Nos. 5,389,512 and 5,219,727, and
any reissue or reexamination patents thereof, and claims 1-4, 8, 9 and
15-18 (if they are Valid Claims) of United States Patent No. 5,
476,774, and any reissue or reexamination patents thereof; and any
Valid Claims of the foreign counterparts of the foregoing listed
patents or claims.
-8-
1.29 "RT AND RT-PCR TECHNOLOGY" shall mean the reverse transcription process
covered by the method claims (if they are Valid Claims) of United
States Patent Nos. 5,407,800, 5,310,652, 5,561,058, 5,618,703 and
5,322,770, and any reissue or reexamination patents thereof, and the
claims (if they are Valid Claims) of United States Patent No.
5,693,517, and any reissue or reexamination patents thereof; and any
Valid Claims of the foreign counterparts of the foregoing listed
patents or claims.
1.30 [Reserved for future use].
1.31 [Reserved for future use].
1.32 [Reserved for future use].
1.33 [Reserved for future use].
1.34 "Territory" includes all countries of the world.
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.
1.37 "5' Nuclease Technology" shall mean only the processes defined by the
method claims (if they are Valid Claims) of United States Patent Nos.
5,210,015 and 5,487,972 and any reissue or reexamination patents
thereof and the reaction mixture claims (if they are Valid Claims) of
United States Patent No. 5,804,375 and any reissue or reexamination
patents thereof; and any Valid Claims of the foreign counterparts of
the foregoing listed patents or claims.
-9-
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 perform in vitro human and/or animal diagnostic
testing procedures on a sample of material obtained
from a human or animal, as applicable, solely to
detect the presence, absence or quantity of a nucleic
acid sequence associated with a disease or condition
in the Licensed Fields within the Territory.
2.2 The Licensed Patents hereunder may be used solely for the performance
of Licensed Services and Licensed Animal Services and for no other
purpose whatsoever, and no other right, immunity or license is granted
expressly, impliedly or by estoppel.
2.3 IGEN expressly acknowledges and agrees that the license pursuant to
this Agreement is personal to IGEN and its Affiliates alone and IGEN
and its Affiliates shall have no right to sublicense, assign or
otherwise transfer or share its rights under the foregoing license.
IGEN further agrees that Licensed Services and Licensed Animal Services
will be performed, offered, marketed and sold only by IGEN and/or its
Affiliates, except as provided in Section 2.3(a), and that IGEN shall
not authorize any other party, including its Affiliates, except those
IGEN Affiliates named in Attachment V, as may be amended from time to
time by written notice from IGEN to Roche.
a) IGEN and its Affiliates may offer, market and sell Licensed
Services or Licensed Animal Services that are performed by
other laboratories subject to the following conditions:
i) Each laboratory performing Licensed Services or
Licensed Animal Services for IGEN or its Affiliates
must be separately licensed under Roche's diagnostic
services program.
ii) IGEN's and its Affiliate's report forms must list all
Licensed Services or Licensed Animal Services
marketed and sold by IGEN or its Affiliates which are
performed by another laboratory even though IGEN and
its Affiliates will
-10-
not be obligated to pay royalties on those Licensed
Services or Licensed Animal Services.
iii) IGEN or its Affiliates must contact Roche/USA or its
designee to verify that a new laboratory to which it
seeks to send samples for performance of Licensed
Services or Licensed Animal Services is properly
licensed by Roche before sending samples to that
laboratory.
iv) Each laboratory performing Licensed Services or
Licensed Animal Services for IGEN and its Affiliates
must report and pay royalties on Licensed Services or
Licensed Animal Services performed for IGEN and its
Affiliates.
2.4 For each Combination Service that IGEN or its Affiliates intends to
offer pursuant to this Agreement, and at least sixty (60) days before
IGEN or its Affiliates intends to offer any such Combination Service,
IGEN or its Affiliates shall:
a) notify Roche/USA or its designee of such proposed Combination
Service, such notice to include a complete and detailed
description of the proposed Combination Service; and
b) obtain from Roche/USA or its designee a duly authorized
agreement, in the form of Attachment I-A or Attachment I-B, as
applicable, hereto, for such Combination Service, which
agreement shall indicate the fraction or percentage of the
package price of such Combination Service, less appropriate
deductions, on which royalties shall be paid.
For any Combination Service(s) claimed by IGEN or its Affiliates on
royalty reports for which IGEN or such Affiliate has not satisfied the
criteria set forth in subsections (a) and (b) above, the royalty
payable on such Combination Service shall be assessed at 100% of the
package price of such Combination Service, less applicable deductions.
As to all other Licensed Services offered by IGEN or its Affiliates
which are not part of a Combination Service, IGEN or such Affiliate, as
the case may be, agrees to inform RMS of the availability from IGEN or
such Affiliate of each such Licensed Service within thirty (30) days
after IGEN or such Affiliate commences offering the Licensed Service.
2.5 Roche hereby grants to IGEN and its Affiliates the right and IGEN and
its Affiliates accept and agree to credit Roche as the source of
Licensed Patents in IGEN's and its Affiliates', promotional materials
and any other materials intended for distribution to Third Parties with
respect to Licensed Services or Licensed Animal Services as follows:
-11-
"This service is performed pursuant to an agreement with Roche
Molecular Systems, Inc., X. Xxxxxxxx-Xx Xxxxx Ltd, and Roche
Diagnostics GmbH."
ARTICLE 3
ADDITIONAL LIMITATIONS AND ACKNOWLEDGMENT ON DIAGNOSTIC PRODUCTS
3.1 IGEN acknowledges and agrees that the license granted hereunder is for
the performance of Licensed Services and License Animal Services only and does
not include any right to make, have made, import, offer or sell any products,
including devices, PCR reagents, kits or Diagnostic Products.
ARTICLE 4
CONSIDERATION AND PAYMENTS
4.1 [Reserved for future use]
4.2 Royalties Due to Roche in the Diagnostic Services Field. For the rights
and privileges granted under Section 2.1 of this Agreement IGEN shall
pay the following royalties tto RMS:
a) For Licensed Services in the Diagnostic Services Field defined
as Service A: an amount equal to fifteen percent (15%) of Net
Service Revenue per each Service A performed; provided,
however, that such amount shall equal 15.5% of Net Service
Revenues for each Service A falling within the scope of U.S.
Patent No. 4,965,188; and
b) For Licensed Services in the Diagnostic Services Field defined
as Service B: an amount equal to:
i) (for infectious disease testing): twenty percent
(20%) of Net Service Revenues per each Service B
performed; and
ii) (for non-infectious disease testing): eighteen
percent (18%) of Net Service Revenues per each
Service B performed.
4.3 Royalties Due to Roche in the Animal Diagnostic Services Field. For the
rights and privileges granted under Section 2.1 of this Agreement IGEN
shall pay the following royalties to RMS:
a) For Licensed Animal Services in the Animal Diagnostic Services
Field defined as Service A: an amount equal to:
-12-
i) for detection of agents associated with infectious
disease testing: five percent (5%) of IGEN's or its
Affiliate's Net Service Revenues for each Service A
performed; provided, however, that such amount shall
equal 5.5% of Net Service Revenues for each Service A
falling within the scope of U.S. Patent No.
4,965,188; and
ii) for detection of genetic diseases, genetic
predisposition to disease, genetic traits, and for
sex determination, including determining the sex of
embryos: nine percent (9%) of IGEN's or its
Affiliate's Net Service Revenues per each Service A
performed; provided, however, that such amount shall
equal 9.5% of Net Service Revenues for each Service A
falling within the scope of U.S. Patent No.
4,965,188.
b) For Licensed Services defined as Service B: an amount equal
to:
i) for detection of agents associated with infectious
disease testing: eight percent (8%) of IGEN's or its
Affiliate's Net Service Revenues for each Service B
performed; provided, however, that such amount shall
equal ten percent (10%) of Net Service Revenues for
each Service B falling within the scope of U.S.
Patent No. 4,965,188; and
ii) for detection of genetic diseases, genetic
predisposition to disease, genetic traits, and for
sex determination, including determining the sex of
embryos: twelve percent (12%) of IGEN's or its
Affiliate's Net Service Revenues per each Service B
performed; provided, however, that such amount shall
equal fifteen percent (15%) of Net Service Revenues
for each Service B falling within the scope of U.S.
Patent No. 4,965,188.
4.4 Reports. IGEN and its Affiliates shall deliver to RMS, within sixty
(60) days as of the end of and for each semiannual calendar period,
i.e. the six (6) month periods that are January 1 through June 30 and
July 1 through December 31 (each a "Reporting Period"), a true and
accurate royalty report ("Royalty Report"). Each Royalty Report shall
indicate the number of Licensed Services or Licensed Animal Services
performed during the relevant Reporting Period and the detail specified
below. Each Royalty Report shall be submitted either (a) on the
"Summary Royalty Report", a copy of which is attached hereto as
Attachment III or Attachment IV, as applicable, or (b) on a form
generated by IGEN or its Affiliate which duplicates the format of the
Summary Royalty Report; and includes at least the following:
a) (i) with respect to Licensed Services: the name of each
Licensed Service and Combination Service by target or analyte
(e.g., HIV Quantitation, Cystic fibrosis/ HLA and specifying
either Service A or Service B) and the number performed or
(ii) with respect to Licensed Animal Services: the name of
each Licensed Animal Service and Combination Service by target
or analyte (e.g. FIV, Mycobacteria paratuberculosis, etc. and
specifying either Service A or Service B) and the number
performed;
-13-
b) the gross invoice price billed for each Licensed Service or
Licensed Animal Service, as applicable, and Combination
Service and any amounts deducted from that gross invoice price
in determining Net Service Revenues (e.g., amount not
reimbursed by third-party payer or Combination Service
approved must be stated and annotated);
c) Net Service Revenues and the calculation of total royalties
thereon; and
d) the calculation of the royalties payable to RMS. If no
royalties are due, it shall be so reported.
In the event IGEN or any of its Affiliates, as applicable, is unable to
calculate Net Service Revenues as prescribed in Section 1.21, IGEN or
such Affiliate shall so inform RMS, and upon RMS's written consent,
IGEN or such Affiliate shall calculate royalties as follows:
Upon receipt by RMS of satisfactory documentation verifying IGEN's
actual percentage of gross xxxxxxxx collected for IGEN's most recently
ended fisacl year (the "Collection Rate"), IGEN shall be permitted to
calculate Net Service Revenues based on the Collection Rate. In the
event that IGEN wishes to avail itself of such privilege, then IGEN
shall notify RMS thereof in writing using Attachment II and shall
represent and confirm to RMS its Collection Rate for its most-recently
completed fiscal year, whereupon such rate shall be specified in
Attachment II. Thereafter during the Term of this Agreement, IGEN shall
deliver, within ninety (90) days after the end of IGEN's fiscal year,
to RMS satisfactory documentation that verifies the Collection Rate. If
IGEN's Collection Rate varies by at least five percent (5%) of the rate
stated in Attachment II, RMS shall amend Attachment II accordingly.
Should IGEN fail to provide the required updated documentation, IGEN
shall calculate Net Service Revenues and royalties due as prescribed in
Section 1.21 for the remaining term of the Agreement.
The correctness and completeness of each Royalty Report shall be
attested to in writing by an authorized representative of IGEN.
In the event that, during any Reporting Period, IGEN and its Affiliates
performs no tests which are Licensed Services or Licensed Animal
Services, IGEN shall so indicate on the Royalty Report, by checking the
appropriate box regarding License Services or Licensed Animal Services.
4.5 [Reserved for future use]
4.6 Reporting and Payment.
(a) [Reserved for future use]
-14-
(b) The royalties payable by IGEN in US Dollars to Roche on the
Net Service Revenues generated outside of the United States on
all Licensed Services and Licensed Animal Services by IGEN or
its Affiliates in the Licensed Fields shall be converted by
IGEN from the currency in which the revenues were generated 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) Simultaneously with the delivery of each Royalty Report, IGEN
or its Affiliates shall pay to RMS the royalty due under this
Agreement for the period covered by such report. All payments
due RMS hereunder shall be payable in United States currency
and sent together (unless such payment is wire transferred as
provided below) with the Royalty Report by the due date to the
following address:
Roche Molecular Systems, Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attention: Licensing Department
IGEN may make payment of the royalty due in US Dollars by wire
transferred to the bank account as shown below simultaneously
with the delivery of the Royalty Report:
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
-15-
(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.
(a) IGEN shall keep a complete and accurate set of books and
records relating to the quantity of Licensed Services or
Licensed Animal Services performed by or for IGEN and its
Affiliates and the revenues of IGEN and its Affiliates
generated thereby. Such books and records shall contain
sufficient detail to substantiate the computation of the Net
Service Revenues of Licensed Services or Licensed Animal
Services 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 4.4 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 Licensed Services or Licensed Animal Services
performed by or for such Affiliate and such Affiliate's
revenues generated therefrom 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 revenues
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
-16-
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 ten percent (10%) 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.
4.8A Licensed Services and Licensed Animal Services performed by IGEN prior
to execution of this Agreement shall be royalty bearing and reported to
RMS together with the first Royalty Report due hereunder.
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 Service Revenues of any one Licensed
Service or Licensed Animal Service, regardless of whether the
performance, use and/or sale of such Licensed Service or Licensed
Animal Service would infringe more than one Valid Claim of one or more
Licensed Patents and regardless of whether such product qualifies as a
"Licensed Service" or "Licensed Animal Service" for purposes of this
Agreement under more than one of the criteria for designating a product
to be a "Licensed Service" or "Licensed Animal Service" as provided in
Section 1.20 or 1.15 above.
4.11 Most Favored Licensee.
(a) If, after the Effective Time, Roche grants to any Third Party
a license in the Diagnostic Services Field or the Animal
Diagnostic Services 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.
-17-
(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.
ARTICLE 5
[RESERVED FOR FUTURE USE]
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 Service or Licensed Animal
Service 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 IGEN shall assume full responsibility for its and its Affiliates'
performance, use and sale of the Licensed Services and Licensed Animal
Services and shall defend, indemnify and hold RMS (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,
-18-
damages, losses, costs and expenses (including reasonable attorneys'
fees) for death, personal injury, illness, property damage or any other
injury or damage, including any damages or expenses arising in
connection with state or federal regulatory action (collectively
"Damages"), resulting from or arising out of liability in any way
relating to the performance, use and sale by IGEN or its Affiliates,
including its officers, directors, agents and employees, of the
Licensed Services and Licensed Animal Services.
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. Failure of an Affiliate to adopt and satisfy a
condition stated in this Agreement applicable to IGEN or an Affiliate
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 .
ARTICLE 7
PATENT ENFORCEMENT
7.1 Continuing Royalty Payment Obligations. IGEN's obligation to pay
royalties on the Net Service Revenue of Licensed Services or Licensed
Animal Services performed by IGEN and its Affiliates 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.
7.2 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.
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
-19-
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) [Reserved for future use].
(c) In the event that IGEN does not make any royalty payments
which are due and payable, 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.
(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.
-20-
(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 performance by IGEN and its
Affiliates of services covered by such license shall cease
immediately to the extent that such performance no longer is
licensed as a result of such termination.
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;
(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
(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.
-21-
9.2 IGEN shall not, and shall cause each of its Affiliates not to, arrange
the performance of Licensed Services or Licensed Animal Services (or
utilize the definitions relating thereto) to reduce in bad faith the
Net Service Revenues for which royalties are payable by IGEN hereunder.
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.
(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.
-22-
(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
customers shall be immune from any suit for infringement of
any patent rights which would constitute a failure of this
representation and warranty.
(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.
-23-
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 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."
-24-
(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 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,
-25-
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 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.
-26-
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 OF DESIGN,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO LICENSED
INTELLECTUAL PROPERTY RIGHTS OR ANY SERVICE; (b) THE COMMERCIAL SUCCESS
OF ANY LICENSED SERVICE; (c) THE EXISTENCE, VALIDITY OR SCOPE OF
LICENSED INTELLECTUAL PROPERTY RIGHTS; (d) ANY LICENSED SERVICE 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
-27-
(WHETHER PURSUANT TO JUDGMENT OR SETTLEMENT) FOR WHICH A PARTY HAS AN
OBLIGATION TO INDEMNIFY THE OTHER PARTY HEREUNDER.
12.2 [Reserved for future use].
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 performance of any Licensed Service or Licensed Animal Service, at
IGEN's expense, including, without limitation, any safety studies. IGEN
shall have sole responsibility for the quality control for any Licensed
Product.
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 subcontractors to the extent necessary to
have the services licensed hereunder performed 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
-28-
(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 Affiliate's or
subcontractor's, employees or agents with a need to have access. The
Recipient acknowledges that by virtue of this Agreement it acquires
only 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 or subcontractors 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 and/or agents) performs Licensed Services and Licensed
Animal Services, where required, and shall otherwise ensure that the
laws of all the countries where performance of its Licensed Services
and Licensed Animal Services occurs 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.
-29-
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 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
00000 Xxxxxxxxxx Xxxxx
Xxxxxxxxxxxx, Xxxxxxxx 00000
Attention: President
Telephone: 0-000-000-0000
Facsimile: 0-000-000-0000
With a copy to:
-30-
Xxxx and Xxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxx Xxxxxxx, Esq.
Telephone: 0-000-000-0000
Facsimile: 1-617-526-5000
If to Roche, to each and all of the following:
X. Xxxxxxxx-Xx Xxxxx Ltd.
Xxxxxxxxxxxxxxxxx 000
XX-0000 Xxxxx, Xxxxxxxxxxx
Attention: Legal Department
Telephone: 000-0000-000-0000
Facsimile: 011-4161-688-1396
Roche Diagnostics GmbH
Xxxxxxxxx Xxxxxxx 000
X-00000 Xxxxxxxx
Xxxxxxx
Attention: Legal Department
Telephone: 000-00-000-000-0000
Facsimile: 011-49-621-759-4461
Roche Molecular Systems, Inc.
0000 Xxxxxxxx Xxxxx
Xxxxxxxxxx, Xxxxxxxxxx 00000
Attention: President
Telephone: 000 000 0000
Facsimile: 000 000 0000
Roche Molecular Systems, Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attention: Licensing Department
Telephone: 000 000 0000
Facsimile: 000 000 0000
-31-
Roche Molecular Systems, Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attention: General Counsel
Telephone: 000 000 0000
Facsimile: 000 000 0000
Either Party may change its address for communications by a
notice to the other Party in accordance with this Section.
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:
-32-
(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 Xxx, 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, Veterinary IVD, HLA Typing,
Paternity, DNA Manufacturing and Plasma Testing), dated as of
the date hereof, by and between the Parties;
(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.
-33-
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 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 and 2.3 relating to license rights and performance by other
laboratories 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 performance of
Licensed Services or Licensed Animal Services by IGEN and its
Affiliates pursuant to this Agreement, IGEN shall pay the same and hold
Roche harmless with respect thereto.
[Remainder of Page Intentionally Left Blank]
-34-
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
By: /s/ Xxxxxxx X. Xxxxxx
-------------------------------
President and Chief
Title: Operating Officer
----------------------------
Date: 7/24/2003
-----------------------------
X. XXXXXXXX-XX XXXXX LTD
By: /s/ D. Xxxxx X. Xxxxx
------------------------------
Chairman and Chief
Title: Executive Officer
----------------------------
By: /s/ Xxxxx Xxxxxxxx
------------------------------
Title: Chief Financial Officer
----------------------------
Date: 7/24/2003
-----------------------------
-35-
ROCHE DIAGNOSTICS GMBH
/s/ X.X. Xxxxxxx
By: ______________________________
General Counsel
Title: ____________________________
/s/ Xxxxx von Prondzynski
By: ______________________________
Authorized Signatory
Title: ____________________________
7/24/2003
Date: _____________________________
ROCHE MOLECULAR SYSTEMS, INC.
/s/ X. Xxxxxxxxx APROVED BY RMS LEGAL DEPT:
/s/ CMD
By: ______________________________ ________________________
President
Title: ______________________________
7/24/2003
Date: _____________________________
-36-
EXHIBIT 1
LICENSED PATENTS
[attached]
37
ATTACHMENT I-A
COMBINATION SERVICES
PERCENT OF NET SERVICE
REVENUES FOR COMBINATION
SERVICES WHICH IS
ATTRIBUTABLE TO LICENSED
LICENSED SERVICES SERVICES (specify Service A
or Service B)
[TO BE XXXXXXXXXX]
0
XXXXXXXXXX X-X
COMBINATION SERVICES
PERCENT OF NET SERVICE
REVENUES FOR COMBINATION
SERVICES WHICH IS
ATTRIBUTABLE TO LICENSED
LICENSED ANIMAL SERVICES NIMAL SERVICES (specify
Service A or Service B)
[TO BE DETERMINED]
2
ATTACHMENT II
COLLECTION RATE
Fiscal Year Collection Rate Percentage
NA UNLESS STATED IN SECTION 4.4
3
ATTACHMENT III SUMMARY ROYALTY REPORT
for the Period _________ to __________
Licensee: IGEN Integrated Healthcare, LLC Field of Use: Diagnostic Services
Effective Time: Royalty Rate: See Section 4.2
---------------------------------------------------------------------------------------------------------------------------
GROSS
SERVICE A INVOICE PRICE NUMBER OF COMBINATION
LICENSED SERVICE OR OF LIC. SERVICE DEDUCTIONS SERVICE % NET SERVICE EARNED
("LIC. SERVICE") SERVICE B LIC. SERVICE PERFORMED ALLOWED* (FROM ATT. I-A) REVENUE ROYALTY
---------------------------------------------------------------------------------------------------------------------------
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
ROYALTY PAYMENT DUE
=======================
* Please attach to this form documentation or supplemental data for
"Deductions Allowed".
** Combination Service %'s must be previously agreed upon. To confirm that a
Combination Service % has been established or to propose this status,
please contact RMS Licensing Dept. @ (000)000-0000.
CHECK HERE IF THERE WERE NO LICENSED SERVICES PERFORMED FOR THIS REPORT
PERIOD: _____
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 REPORT WITH ANY ROYALTY PAYMENT DUE TO: ROCHE MOLECULAR SYSTEMS,
INC., X.X. XXX 000000, XXXXXXXX, XX 00000-0000
4
ATTACHMENT IV SUMMARY ROYALTY REPORT
for the Period _________ to __________
Licensee: IGEN Integrated Healthcare, LLC Field of Use: Animal
Effective Date: Diagnostic Services
Royalty Rate: See Section 4.3
---------------------------------------------------------------------------------------------------------------------------
GROSS
SERVICE A INVOICE PRICE NUMBER OF COMBINATION
LICENSED SERVICE OR OF LIC. SERVICE DEDUCTIONS SERVICE % NET SERVICE EARNED
("LIC. SERVICE") SERVICE B LIC. SERVICE PERFORMED ALLOWED* (FROM ATT. I-A) REVENUE ROYALTY
---------------------------------------------------------------------------------------------------------------------------
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________________
ROYALTY PAYMENT DUE
=======================
* Please attach to this form documentation or supplemental data for
"Deductions Allowed".
** Combination Service %'s must be previously agreed upon. To confirm that a
Combination Service % has been established or to propose this status,
please contact RMS Licensing Dept. @ (000)000-0000.
CHECK HERE IF THERE WERE NO LICENSED SERVICES PERFORMED FOR THIS REPORT
PERIOD: _____
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 REPORT WITH ANY ROYALTY PAYMENT DUE TO: ROCHE MOLECULAR SYSTEMS,
INC., X.X. XXX 000000, XXXXXXXX, XX 00000-0000
5
ATTACHMENT V
IGEN AFFILIATES
IGEN KK
IGEN EUROPE, INC.
MESO SCALE DIAGNOSTICS, LLC.
6
