PATENT LICENSE AGREEMENT
PCR
PATENT
LICENSE
AGREEMENT
BY
AND BETWEEN
ROCHE
MOLECULAR
SYSTEMS,
INC.
AND
RESPONSE
GENETICS,
INC.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(HUMAN)
CONTENTS
Page
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Background
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2
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Section
1 Definitions
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3
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Section
2 Grant
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5
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Section
3 Additional Limitations &
Acknowledgment re Diagnostic Products
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6
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Section
4 Royalties, Records and Reports
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6
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Section
5 Technology Notification
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8
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Section
6 Diligence
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8
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Section
7 Term and Termination
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8
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Section
8 Confidentiality-Publicity
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10
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Section
9 Compliance
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11
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Section
10 Assignment
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11
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Section
11 Negation of Warranties and Indemnity
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12
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Section
12 General
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12
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Attachments:
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Attachment
I
List
of Licensed Technology
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15
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Attachment
II
Combination Services
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16
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Attachment
III
Summary
Royalty Report Form
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17
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Attachment
IV
Collection Rate
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18
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1
(Human)
This
Agreement is made by and between
Roche
Molecular Systems, Inc., 0000 Xxxxxxxx Xxxxx, Xxxxxxxxxx, Xxxxxxxxxx
00000
(hereafter
referred to as "RMS")
and
Response
Genetics, Inc., 0000 Xxxxxxx Xxxxxx, 0xx
Xxxxx,
Xxx Xxxxxxx, Xxxxxxxxxx 00000
(hereafter
referred to as "RGI")
hereafter
individually referred
to
as a
"Party" or collectively as "The Parties"
********
BACKGROUND
A. |
RMS
owns and has the right to grant licenses to practice under certain
United
States Patents describing and claiming, inter
alia, nucleic
acid amplification processes known as polymerase chain reaction
("PCR"),
homogeneous PCR, and RT-PCR ("reverse transcription
PCR").
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B. |
RGI
desires to obtain a non-exclusive license from RMS to use the
Licensed
Technology to perform certain PCR-based human in
vitro clinical
laboratory services, and RMS is willing to grant such a license
to RGI on
the terms and subject to the conditions provided exclusively
in this
Agreement.
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NOW,
THEREFORE, for and in consideration of the mutual covenants contained herein,
RMS and RGI
agree
as follows:
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1. |
Definitions
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For
the
purpose of this
Agreement,
and
solely for that purpose, the terms set forth hereinafter shall be
defined as follows:
1.1 |
The
term "Affiliate"
shall
mean with respect to a given Party:
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a) |
an
organization which, directly or indirectly, controls such
Party;
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b) |
an
organization which is, directly or indirectly, controlled by such
Party;
or
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c) |
an
organization which is controlled, directly or indirectly, by
the ultimate
parent company
which controls, directly or indirectly, such
Party.
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For
purposes of this paragraph, "control" shall mean the ownership of fifty percent
(50%) or more of the voting stock or equity interests of an organization
or
otherwise having the power to
govern
or direct the financial and the operating policies or to appoint the management
of such
organization.
With
respect to RMS, the term "Affiliate" shall not include Genentech, Inc., 0
XXX
Xxx, Xxxxx
Xxx
Xxxxxxxxx, Xxxxxxxxxx 00000-0000, U.S.A. ("Genentech") nor Chugai Pharmaceutical
Co., Ltd, 0-0, Xxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx, 000-0000 Xxxxx ("Chugai").
1.2 |
"Combination
Service" shall
mean a Licensed Service offered in combination with another
non-PCR
testing service 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 is not separately
billed.
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1.3 |
"Diagnostic
Product" shall
mean an assemblage of reagents, including but not limited to
reagents
packaged in the form of a kit, useful in performing a Licensed
Service.
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1.4 |
"Effective
Date" shall
mean the date on which the last signatory to this Agreement
signs
this
Agreement.
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1.5 |
"Licensed
Field" shall
mean the field of clinical laboratory services that detect
the
presence,
absence and/or quantity of a nucleic acid sequence for the
detection,
diagnosis, confirmation,
prognosis, management and/or treatment of a human disease or
condition,
including, but not limited to, such services: to identify predisposition
to disease, disease susceptibility,
confirm disease, predict therapeutic effectiveness or monitor
disease
progress; used
in the course of human clinical trials; for Parentage Determination;
and
for tissue transplant
typing, including testing performed on animal tissue intended
for use in
xenotransplantation.
Licensed Field shall specifically exclude any services performed
for
the
screening of blood and/or blood
products.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
3
1.6
|
"Licensed
Service(s)" shall
mean the performance by RGI of an in
vitro procedure
within the
Licensed Field which utilizes the Licensed Technology. Licensed Services
include, but are
not limited to, any combination of the steps of collecting a sample
for
analysis, isolating nucleic
acid sequences from the sample, amplifying one or more desired sequences,
analyzing
the amplified material, including sequence analysis, and reporting
the
results.
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1.7
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"Licensed
Technology" shall
mean, subject to the following limitations, the Valid Claims of
the United States patents listed in Attachment I to this Agreement
and any
reissue or reexamination
patents thereof. No rights under any kit claims of such patents are
included in
this definition or licensed under this Agreement. With the exception
of
the reaction mixture
claims of United States Patents Nos. 5,804,375, 5,693,517, 5,476,774
and
6,127,155,
the plasmid claims of the 5,476,774 patent, the primer claims of
United
States Patent
No. 5,573,906, and the probe claims of United States Patent No. 5,110,920,
no rights under
any apparatus, device, composition of matter, reagent or substance
claims
of such patents
are included in this definition or licensed under this
Agreement.
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1.8
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"Net
Service Revenues" shall
mean the gross invoice price for the Licensed Services performed
by RGI (or the fair market value for any nonmonetary consideration
which
RGI agrees
to receive in exchange for Licensed Services), less the following
deductions where they
are factually applicable and are not already reflected in the gross
invoice price:
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a)
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discounts
allowed and taken, in amounts customary in the trade (which shall
include
the
difference between the dollar amount charged by RGI for a Licensed
Service
and the
Medicare and/or Medicaid Limits of Allowance and/or reimbursement
limitations
of a Third Party insurance program);
and
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b)
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actual
bad debt which bad debt RGI can prove and document that it was reasonable
and
diligent in its efforts to collect
payment.
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1.8.1
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The
Net Service Revenues of those Licensed Services that are performed
by
RGI
for any person, firm or corporation controlling, controlled by or
under
common
control with RGI, or enjoying a special course of dealing with RGI,
shall
be determined based on the average selling price of such Licensed
Services
to all Third Parties during the period in
question.
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1.8.2
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It
is hereby understood and agreed that, to the extent feasible, Licensed
Services
and Combination Services shall at all times be invoiced, listed and
billed
by RGI as a separate item in RGI's invoices, bills and reports to
customers.
Net Service Revenues for determining royalties with respect to a
Licensed
Service which is part of a Combination Service shall be determined
by
multiplying the gross invoice price of the Combination Service, less
applicable
deductions, by the appropriate fraction in Attachment II hereto.
The
fraction specified in Attachment II for a particular Licensed Service
included
in a Combination Service shall be set by RMS after consultation with
RGI, as accurately reflecting the value contributed by the Licensed
Service
to the overall value of the Combination Service as offered by RGI,
and
as provided in Section 2.4. Attachment II hereto shall be modified
as
new
Combination Services are identified and new royalty-bearing fractions
set,
and as set forth in Section
2.4.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
4
1.9
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"Parentage
Determination" shall
mean 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.
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1.10
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"Territory"
shall
mean the United States and its possessions and the Commonwealth of
Puerto
Rico.
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1.11 |
"Third
Party" shall
mean an entity other than an Affiliate of either Party to this
Agreement.
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1.12
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"Valid
Claim" shall
mean a claim of a patent which has not expired or been disclaimed,
cancelled,
held invalid or held unenforceable by a decision of a court or other
governmental agency of competent jurisdiction, from which no further
appeal is possible or has been taken within the time period provided
under
applicable law for such an appeal.
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2. |
Grant
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2.1 |
Grant.
Upon the terms and subject to the conditions and restrictions
of this
Agreement, RMS
hereby grants to RGI, and RGI hereby accepts from RMS, a royalty-bearing,
non exclusive,
personal, non-transferable license under the Licensed Technology
solely to
perform
Licensed Services within the
Territory.
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2.2 |
Performance
of Licensed Services Only.
The Licensed Technology may be used solely for the
performance of Licensed Services and for no other purpose whatsoever,
and
no other right,
immunity or license is granted to RGI expressly, impliedly or
by
estoppel.
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2.3 |
Personal
License.
RGI expressly acknowledges and agrees that the license granted
hereunder
is personal to RGI alone and RGI shall have no right to sublicense,
assign
or otherwise
transfer or share its rights under the foregoing
license.
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2.4 |
Combination
Service(s).
For each Combination Service that RGI intends to offer pursuant
to
this Agreement, and at least sixty (60) days before RGI intends
to offer
any such Combination
Service, RGI shall:
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a)
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notify
RMS of such proposed Combination Service, such notice to include
a
complete
and detailed description of the proposed Combination Service;
and
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b)
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obtain
from RMS a duly authorized agreement, in the form of Attachment II
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
hereunder.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
5
For
any
Combination Service(s) for which RGI has not satisfied the criteria set forth
in
subsections
(a) and (b) above, the royalty payable on such Combination Service shall be
assessed
on 100% of the package price of such Combination Service, less applicable
deductions. As to all other Licensed Services offered by RGI which are not
part
of a Combination
Service, RGI agrees to inform RMS of the availability from RGI of each such
Licensed
Service within thirty (30) days after RGI commences offering the Licensed
Service.
2.5 |
Credit
for Licensed Technology Rights.
RMS hereby grants to RGI the right and RGI accepts
and agrees to credit RMS as the source of its Licensed Technology
rights
in RGI's promotional
materials and any other materials intended for distribution to
Third
Parties as follows:
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"This
service is performed pursuant to an agreement with Roche Molecular Systems,
Inc."
3. |
Additional
Limitations and Acknowledgment Regarding Diagnostic
Products
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RGI
acknowledges and agrees that the license rights granted hereunder are for the
performance of Licensed
Services only and do not include any right to make, have made, import, offer
to
sell or sell any
products, including apparatuses, devices, PCR reagents, kits or Diagnostic
Products. RGI further
acknowledges and agrees that RMS and its Affiliates are in the business of
providing clinical laboratory
testing services and the commercial sale of diagnostic testing systems, kits
and
reagents and
therefore may compete directly with RGI's business.
4. |
Royalties,
Records and Reports
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4.1 |
Royalties.
For the rights and privileges granted under Section 2.1 of this
Agreement,
RGI shall
pay to RMS royalties equal to [***] percent ([***]%) of RGI's Net
Service Revenues.
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[***] royalty
is due on PCR-based assays performed solely for the purpose of evaluating a
procedure to be used as a Licensed Service after validation.
[***] royalty
is due on assays performed with Roche labeled diagnostic kits or Third Party
diagnostics
kits licensed by Roche, which convey human diagnostic label license rights
to
end
users.
4.2 |
Reports.
RGI shall deliver to RMS, within forty-five (45) days after the
end of and
for each quarterly
calendar period during the Term, i.e. the three (3) month periods
that are
January 1
through March 31, April 1 through June 30, July 1 through September
30,
and October 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 performed during the relevant Reporting Period and the
detail
specified on the "Summary Royalty
Report," a copy of which is attached hereto as Attachment III,
or on a
form generated
by RGI which duplicates the format of the Summary Royalty Report.
If no
royalties
are due for a given Royalty Period, it shall be so reported.
The
correctness and completeness
of each Royalty Report shall be attested to in writing by an
authorized
representative
of RGI.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
6
In
the
event RGI is unable to calculate Net Service Revenues as prescribed in Section
1.8, RGI
shall
so inform RMS, and upon RMS's written consent, RGI shall calculate royalties
as
follows:
Upon
receipt by RMS of satisfactory documentation verifying RGI's actual percentage
of gross
xxxxxxxx for Licensed Services and/or Combination Services collected for RGI's
most recently ended fiscal year (the "Collection Rate"), subject to the
provisions of Section 2.4 above, RGI shall be permitted to calculate Net Service
Revenues taking into account the Collection
Rate. As of the Effective Date, RGI hereby represents and confirms to RMS that
its
Collection Rate for its fiscal year ending NA
was
NA
percent
(
NA
%),
which rate is specified
in Attachment IV. During the Term of this Agreement, and within ninety (90)
days
after the end of each RGI fiscal year, RGI shall deliver to RMS satisfactory
documentation
that verifies the then Collection Rate. If RGI's Collection Rate varies by
at
least
five percent (5%) from the rate stated in Attachment IV, RMS shall amend
Attachment IV accordingly. Should RGI fail to provide the required updated
documentation, RGI shall calculate
Net Service Revenues and royalties due as prescribed in Sections 1.8 and 2.4
for
the
remaining Term of the Agreement.
Simultaneously
with the delivery of each Royalty Report, RGI 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 with the Royalty
Report
by
the due date to the following address:
Roche
Molecular Systems, Inc.
X.X.
Xxx
000000
Xxxxxxxx,
XX 00000-0000
or
to any
other address that RMS may advise in writing.
4.3
|
Inspection.
Within ten (10) days after RMS's written request to RGI, RMS or an
accounting firm
selected by RMS (including, but not limited to, RMS's normal certified
public accounting
firm), may, at RMS's own expense (except as provided below), inspect
the
records,
books of account and any other materials of RGI pertaining to the
transactions and matters
contemplated by this Agreement and/or the Royalty Reports required
in
Section 4.2 above,
provided that any accounting firm will hold such records in strict
confidence, except as
necessary to report to RMS and RGI on RGI's compliance with the terms,
conditions and restrictions
of this Agreement. If such an inspection shows an underpayment by
RGI to
RMS
by more than ten percent (10%) for any Reporting Period, RGI will
pay, in
addition to the
amount due, plus interest, the accounting firm's reasonable fees
and
expenses.
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Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
7
4.4 |
Prior
Licensed Services.
Licensed Services performed by RGI prior to execution of this Agreement
shall be subject to the royalties described in this Agreement and
shall be
reported and
due to RMS with the first Royalty Report due provided under Section
4.2.
Provided, however,
that where this Agreement replaces an existing license agreement,
the
royalty obligations
of RGI under this Agreement commence the first day of the month in
which
this Agreement is executed.
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4.5 |
Past
Due Amounts Bear Interest.
If RGI shall fail to pay any amount specified under this Agreement
after the due date thereof, the amount owed shall bear interest at
the
lower of (i) the
Citibank, N.A. base lending rate (aka, the "Prime Rate"), or (ii)
the
maximum rate allowed
by applicable law, from the due date until
paid.
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4.6 |
Survival.
The provisions of this Section 4 shall survive any termination or
expiration of this Agreement.
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5. |
Technology
Notification
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5.1 |
Notification.
With respect to any invention, improvement or discovery (hereinafter
referred to
as "Discoveries" in this Section) of RGI made after entering into
this
Agreement and resulting
from work conducted under or in conjunction with this Agreement and
being
applicable
to the Licensed Technology, if RGI decides to license said Discoveries
to
Third Parties,
then RGI agrees to provide to RMS, unless not possible due to RGI's
pre-existing commitments
to Third Parties relating to said Discoveries, a reasonable opportunity
to
negotiate
a license to use said Discoveries in PCR-based Diagnostic Products
and
services. Such
Discoveries may include, but are not limited to, improvements of
the
Licensed Technology
or in the performance of Licensed Services, modifications to or new
methods of performing
the Licensed Services, including the automation of the PCR process
or of
the Licensed
Services.
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5.2 |
Agreement
re Discovery.
Any agreement reached between The Parties as a result of RGI's
notification to RMS of a Discovery pursuant to Section 5.1 hereto
shall be
upon terms and conditions
negotiated in good faith by The
Parties.
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6. |
Diligence
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RGI
shall
exercise reasonable diligence in developing, testing, validating, documenting,
promoting
and performing the Licensed Services. In the course of such diligence, RGI
shall
implement
appropriate procedures and take appropriate steps including, upon reasonable
written
request of RMS, furnishing RMS with representative copies of all promotional
material
relating to the Licensed Services.
7. |
Term
and Termination
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7.1 |
Term
of Agreement.
This Agreement shall commence on the Effective Date and, unless
terminated
earlier as provided herein, shall terminate on the date of expiration
of
the last to expire
of the patents included within the Licensed Technology, which patent
contains at least
one Valid Claim covering the performance of a Licensed
Service.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
8
7.2 |
RGI
Termination for Convenience.
Notwithstanding any other Section of this Agreement, RGI
may terminate this Agreement for any reason on thirty (30) days'
written
notice to RMS.
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7.3 |
Termination
for Change of Control Etc.
RMS shall have the right to terminate this Agreement
and the license rights granted herein immediately upon written notice
to
RGI upon
any material change in the ownership or control of RGI or of its
assets or
in the event RGI
breaches the provisions of Section 10
below.
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7.4 |
Termination
for Insolvency, Etc.
This Agreement and the license rights granted hereunder to
RGI shall automatically terminate upon: (a) an adjudication of RGI
as
bankrupt or insolvent,
or RGI's admission in writing of its inability to pay its obligations
as
they mature; or
(b) an assignment by RGI for the benefit of creditors; or (c) RGI's
applying for or consenting
to the appointment of a receiver, trustee or similar officer for
any
substantial part of
its business or property, or such a receiver, trustee or similar
officer's
appointment without
the application or consent of RGI, if such appointment shall continue
in
effect for a period
of ninety (90) days; or (d) RGI's instituting (by petition, application,
answer, consent or otherwise) any bankruptcy, insolvency arrangement
or
similar proceeding relating to RGI or
its business or property under the laws of any jurisdiction; or (e)
the
institution of any such
proceeding (by petition, application, answer, consent or otherwise)
against RGI, if such proceeding
shall remain in effect for a period of ninety (90) days; or (f) the
issuance or levy of
any judgment, writ, warrant of attachment or execution or similar
process
against a substantial
part of the property of RGI, if such judgment, writ, or similar process
shall not be released,
vacated or fully bonded within ninety (90) days after its issue or
levy;
or (g) the loss
of RGI's federal or state licenses, permits or accreditation necessary
for
the operation of RGI as a health care
institution.
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7.5 |
Termination
for Change of Status.
If RGI is a government institution or a non-profit entity, this
Agreement and the license rights granted to RGI herein shall automatically
terminate within
thirty (30) days of RGI's reclassification as a non-government
institution, or as a for-profit
entity pursuant to the applicable provisions of the United States
Internal
Revenue Code,
26 U.S.C. Upon such termination, RGI may request a new license pursuant
to
the same
terms and conditions then being offered to other for-profit institutions,
although RMS is not obligated by anything contained in this Agreement
to
grant such a license.
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7.6 |
Termination
for Breach.
Upon any breach of or default by RGI of a material term under this
Agreement,
RMS may terminate this Agreement upon thirty (30) days' written notice
to
RGI. Said termination shall become effective at the end of the thirty-day
period, unless during
said period RGI fully cures such breach or
default.
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7.7 |
Effects
of Termination.
Upon termination of this Agreement as provided herein, all license
rights
and immunities granted to RGI hereunder shall terminate and revert
to or
be retained by
RMS. To the extent RMS has licensed technology or know-how of RGI
pursuant
to Section
5 hereto; those licenses shall remain in force according to their
terms.
Other provisions
of this Agreement which by their nature would reasonably be expected
to
survive termination
shall so survive. Termination of this Agreement shall not relieve
either
Party from
any duty or obligation that had accrued prior to termination. Each
Party
shall retain all of
its rights and remedies in respect of any breach or default by the
other
party of the terms, conditions and provisions of this
Agreement.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
9
7.8 |
Duty
to Report and Pay Royalties Survives.
RGI's obligations to report to and pay royalties to
RMS as to the Licensed Services performed under the Agreement
prior to
termination or expiration of the Agreement shall survive such
termination
or expiration.
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8. |
Confidentiality-Publicity
|
8.1 |
Publicity.
Except as otherwise specifically provided in Section 2.5, RGI
agrees to
obtain RMS's
written approval before distributing any written information,
such as a
press release, to
Third Parties which contains references to RMS or this Agreement.
RMS's
approval shall
not be unreasonably withheld or delayed and, in any event, RMS's
decision
shall be rendered
within three (3) weeks of receipt of the written information.
Once
approved, such materials,
or abstracts of such materials, which do not materially alter
the context
of the material
originally approved may be reprinted during the Term of the Agreement
without further
approval by RMS unless RMS has notified RGI in writing of its
decision to
withdraw
permission for such
use.
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8.2 |
Confidentiality
Obligations.
Each Party agrees that any financial, legal or business information
or any
technical information marked "Confidential" or "Proprietary"
and
disclosed
to it (the "Receiving Party") by the other (the "Disclosing Party")
in
connection with
this Agreement, shall be considered the confidential and proprietary
information of the Disclosing
Party, and the Receiving Party shall not disclose same to any
Third Party
and shall
hold it in confidence for a period of five (5) years and will
not use it
other than in the performance
of this Agreement, provided, however, that any information, know-how
or
data which
is orally disclosed to the Receiving Party shall not be considered
confidential and proprietary unless such oral disclosure is stated
to be
confidential or proprietary prior to disclosure
and is reduced to writing and given to the Receiving Party in
written form
within thirty
(30) days after the oral disclosure thereof. Such confidential
and
proprietary information
shall include, without limitation, marketing and sales information,
commercialization
plans and strategies, research and development work plans, and
technical
information
such as patent applications, inventions, trade secrets, systems,
methods,
apparatus,
designs, tangible material, organisms and products and derivatives
thereof.
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8-3 |
Exceptions.
The above obligations of confidentiality and restrictions on use
shall not
be applicable
to the extent:
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
10
a)
|
such
information is general public knowledge or, after disclosure hereunder,
becomes
general or public knowledge through no fault of the Receiving
Party;
|
b)
|
such
information can be shown by the Receiving Party by its written records
to
have been
in its possession, with no obligation of confidentiality to a Third
Party,
prior to receipt thereof hereunder;
|
c)
|
such
information is received by the Receiving Party from any Third Party
for
use or disclosure
by the Receiving Party without any obligation of confidentiality
or
restriction
on use, provided, however, that information received by the Receiving
Party
from any Third Party funded by the Disclosing Party (e.g. consultants,
subcontractors,
etc.) shall not be released from confidentiality under this
exception;
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d)
|
such
information was independently developed by the Receiving Party without
use
of
the information of the Disclosing Party;
or
|
e)
|
the
disclosure of such information is required or desirable to comply
with or
fulfill applicable
law or court process, governmental requirements, submissions to
governmental
bodies, or the securing of regulatory
approvals.
|
8.4 |
Confidentiality
of Agreement.
Each Party shall, to the extent reasonably practicable, maintain
the confidentiality of this Agreement and its provisions and
shall refrain
from making
any public announcement or disclosure of the terms of this Agreement
without the prior
written consent of the other Party, except to the extent a Party
concludes
in good faith that such disclosure is required under applicable
law or
regulations, in which case the other Party shall be notified
in
advance.
|
9. |
Compliance
with Law
|
In
exercising any and all rights and in performing its obligations hereunder,
RGI
shall comply fully with
any
and all applicable laws, regulations and ordinances and shall obtain and keep
in
effect all applicable
licenses, permits and other governmental approvals, whether at the federal,
state or local levels,
necessary or appropriate to perform the Licensed Services and carry on its
activities hereunder
and RGI hereby agrees to defend, indemnify and hold RMS and its Affiliates
harmless from
and
against any and all liability, demands, damages, expenses (including attorneys'
and experts'
fees) and losses suffered or incurred by RMS or its Affiliates arising from,
resulting from or
otherwise concerning any breach by RGI of its obligations under this Section
9.
RGI further agrees
to
refrain from any activities that would have an adverse effect on the business
reputation of RMS.
RMS
may advise RGI of any such activities and RGI will have thirty (30) days to
correct any
such
activity.
10. |
Assignment
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
11
This
Agreement shall not be assigned or transferred by RGI (including by merger,
operation of law or
in any
other manner including, without limitation, any purported assignment or transfer
that might
arise from a sale or transfer of RGI's business or assets) without the express
written consent of
RMS.
RMS may assign all or any part of its rights and obligations under this
Agreement at any time without the consent of RGI. RGI agrees to execute such
further acknowledgments or other instruments
as RMS may reasonably request in connection with any such
assignment.
11. |
Negation
of Warranties and
Indemnity
|
11.1 |
Nothing
in this Agreement shall be construed
as:
|
a)
|
a
warranty or representation by RMS as to the validity or scope of
any
patent included within the Licensed
Technology;
|
b)
|
a
warranty or representation that the use of the Licensed Technology
and/or
the
performance of Licensed Services are or will be free from infringement
of
patents of Third Parties;
|
c)
|
an
obligation to bring or prosecute actions or suits against Third Parties
for infringement;
or
|
d)
|
conferring
by implication, estoppel or otherwise any license, right or immunity
under any patents or patent applications of RMS other than those
patents
specified in Licensed Technology, regardless of whether such other
patents
and patent applications are dominant or subordinate to the patents
in
Licensed
Technology.
|
11.2 |
RMS
MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A
PARTICULAR PURPOSE OR
NON-INFRINGEMENT.
|
11.3 |
RGI
shall assume full responsibility for its use of the Licensed
Technology
and shall defend, indemnify
and hold RMS and its Affiliates harmless from and against all
liability,
demands, damages,
expenses (including attorneys' and experts' fees) and losses
for death,
personal injury,
illness, errors, property damage or any other injury or damage,
including
any damages
or expenses arising in connection with state or federal regulatory
action
(collectively
"Damages"), arising or resulting from or otherwise concerning
the use by
RGI, including
its officers, directors, agents and employees, of the Licensed
Technology
or the performance
of the Licensed Services except, and only to the extent, that
such Damages
are caused solely by the negligence or willful misconduct of
RMS.
|
12. |
General
|
12.1 |
Entire
Agreement.
This Agreement constitutes the entire agreement between The Parties
as
to
the subject matter hereof, and all prior negotiations, representations,
agreements and understandings
are merged into, extinguished by and completely expressed by it.
This
Agreement
may be modified or amended only by a writing executed by an authorized
officer
of each of The Parties.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
12
12.2
|
Notice.
Any notice required or permitted to be sent hereunder shall be given
by
hand delivery,
by registered, express or certified mail, return receipt requested,
postage prepaid, or
by nationally recognized private express courier or by confirmed
facsimile
to the other Party
at the address listed below, or to such other addresses of which
a Party
may so notify the other. Notices will be deemed given when hand delivered
if by hand delivery, or when received
if by any other authorized method.
|
If
to RMS:
|
Roche
Molecular Systems, Inc.
|
0000
Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx,
Xxxxxxxxxx 00000
Attn:
Licensing Department
|
|
RMS
cc:
|
Roche
Molecular Systems, Inc.
|
0000
Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx,
Xxxxxxxxxx 00000
Attn:
Sr. Vice President, General Counsel
|
|
If
to RGI:
|
Response
Genetics, Inc.
|
0000
Xxxxxxx Xxxxxx, 0xx
Xxxxx
Xxx
Xxxxxxx, XX 00000
Attn:
Xxxxx Xxxxxxxxx, CEO
|
12.3
|
Governing
Law.
This Agreement is subject to and shall be construed and enforced
in
accordance
with the law of the State of California, U.S.A., excluding its conflict
of
laws rules
and except as to any issue concerning the validity, scope or
enforceability of any patent within
the Licensed Technology, which issue shall be determined in accordance
with the applicable
patent laws of the United States.
|
12.4
|
Arbitration.
All disputes, claims or controversies arising between the Parties
concerning this Agreement
or the matters or transactions contemplated herein shall be settled
by
final and binding
arbitration conducted in San Francisco, California pursuant to the
Commercial Arbitration
Rules of the American Arbitration Association, in accordance with
the
following procedural
process:
|
a) |
The
arbitration tribunal shall consist of three arbitrators. In the request
for arbitration
and the answer thereto, each Party shall nominate one arbitrator
and the
two
arbitrators so named will then jointly appoint a third neutral arbitrator
as chairman
of the arbitration tribunal. If the two arbitrators so named are
unable to
appoint
a third neutral arbitrator, the third neutral arbitrator shall be
appointed by the American
Arbitration Association in accordance with the procedures contained
in
the
Commercial Arbitration Rules.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
13
b) |
The
decision of the arbitration tribunal shall be final and binding and
judgment upon such
decision may be entered in any court of competent jurisdiction for
judicial acceptance
of such an award and enforcement. Each Party hereby submits itself
to the
jurisdiction of the courts of the place of arbitration, but only
for the
entry of judgment
with respect to the decision of the arbitrators
hereunder.
|
12.5
|
No
Conflict with Law.
Nothing in this Agreement shall be construed so as to require the
commission
of any act contrary to law, and wherever there is any conflict between
any
provision
of this Agreement or concerning the legal right of The Parties to
enter
into this Agreement
and any statute, law, ordinance or treaty, the latter shall prevail,
but
in such event the
affected provisions of the Agreement shall be curtailed and limited
only
to the extent necessary
to bring it within the applicable legal requirements. In any event,
all
other provisions
of this Agreement shall be deemed valid and enforceable to the fullest
extent possible.
|
12.6
|
Superceding
Agreement.
Concurrent with the execution of this Agreement, and effective as
of
the Effective Date herein, any existing agreement between The Parties
which grants rights
to PCR technology to RGI to perform human diagnostic testing services,
is
hereby superceded
and replaced in its entirety by this
Agreement.
|
IN
WITNESS WHEREOF, The Parties hereto have set their hands and seals and duly
executed this Agreement
on the date(s) indicated below, to be effective as of the Effective Date as
defined herein.
ROCHE
MOLECULAR SYSTEMS,
INC.
|
RESPONSE
GENETICS, INC.
|
||
By:
|
By:
|
||
Name:
|
Name:
Xxxxx Xxxxxxxxx
|
||
Title:
SVP, General Counsel
|
Title:
Chief Executive Officer
|
||
Date:
Nov. 2, 2004
|
Date:
11/16/04
|
Apprv'd
As To Form
RMS
LAW
DEPT.
By:
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
14
ATTACHMENT
I
Licensed
Technology:
USP
Bl 4,683,195
|
Process
for Amplifying, Detecting and/or Cloning Nucleic Acid
Sequences
|
|
USP
Bl 4,683,202
|
Process
for Amplifying Nucleic Acid Sequences
|
|
USP
4,965,188
|
Process
for Amplifying, Detecting, and/or Cloning Nucleic Acid Sequences
Using a
Thermostable Enzyme
|
|
USP
5,008,182
|
Detection
of AIDS Associated Virus by PCR
|
|
USP
5,110,920
|
HLA
Typing Method and DNA Probes Used Therein
|
|
USP
5,176,995
|
Detection
of Viruses by Amplification and Hybridization
|
|
USP
5,210,015
|
Homogeneous
Assay System Using the Nuclease Activity of a Nucleic Acid Polymerase
|
|
USP
5,219,727
|
Quantitation
of Nucleic Acids Using PCR
|
|
USP
5,310,652
|
Reverse
Transcription With Thermostable DNA Polymerases -High Temperature
|
|
Reverse
Transcription
|
||
USP
5,322,770
|
Reverse
Transcription with Thermostable DNA Polymerases - High Temperature
|
|
Reverse
Transcription
|
||
USP
5,389,512
|
Method
for Determining the Relative Amount of a Viral Nucleic Acid Segment
in a Sample by the PCR
|
|
USP
5,407,800
|
Reverse
Transcription with Thermus thermophilus Polymerase
|
|
USP
5,476,774
|
Quantitation
of Nucleic Acids Using PCR (limited to claims
1-4,8,9,15-18)
|
|
USP
5,487,972
|
Nucleic
Acid Detection by the 5'-3' Exonuclease Activity of
Polymerases
Acting on Adjacently Hybridized Oligonucleotides
|
|
USP
5,491,063
|
Methods
for In-Solution Quenching of Fluorescently Labeled
Oligonucleotide Probes
|
|
USP
5,561,058
|
Methods
for Coupled High Temperatures Reverse Transcription and
PCR
|
|
USP
5,571,673
|
Methods
for In-Solution Quenching of Fluorescently Labeled
Oligonucleotide Probes
|
|
USP
5,573,906
|
Detection
of Nucleic Acids Using a Hairpin Forming Oligonucleotide
Primer
and an Energy Transfer Detection System (claims 13-15
excluded)
|
|
USP
5,618,703
|
Unconventional
Nucleotide Substitution in Temperature Selective RT-PCR
|
|
USP
5,677,152
|
Amplification
Using a Reversibly Inactivated Thermostable Enzyme (method
claims only)
|
|
USP
5,693,517
|
Reagents
and Methods for Coupled High Temperature Reverse
Transcription and Polymerase Chain Reactions
|
|
USP
5,773,258
|
Amplification
Using a Reversibly Inactivated Thermostable Enzyme (method claims
only)
|
|
USP
5,804,375
|
Reaction
Mixtures for Detection of Target Nucleic Acids
|
|
USP
5,994,056
|
Homogeneous
Methods for Nucleic Acid Amplification and Detection
|
|
USP
6,127,155
|
Stabilized
Thermostable Nucleic Acid Polymerase Compositions Containing
Non-Ionic Polymeric Detergents
|
|
USP
6,171,785
|
Methods
and Devices for Homogeneous Nucleic Acid Amplification
and Detection
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
15
ATTACHMENT
II
COMBINATION
SERVICES
Licensed
Service(s)
|
Percent
of Net Service
Revenues
for Combination
Services
which is Attributable
to
Licensed Service(s)
|
|
Xxxxxxxxx Tumor Profile™ mRNA expression test |
[***]%
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
16
ATTACHMENT
III
SUMMARY
ROYALTY REPORT
for
the
Period __________ to __________
Licensee: Response Genetics, Inc. | Field of Use: human in vitro services |
Effective Date: | Royalty Rate: [***]% [***] |
Licensed
Service
("Lic.
Service")
|
Number
of Lic.
Services Performed
|
Gross
Invoice
Price
per Lic.
Service
|
Allowed
Deductions
|
Combination
Service % (see
Attach
II) *
|
Net
Service
Revenue
|
Earned
Royalty
|
||||||
TOTALS
|
Check
here if there were no
Licensed Services performed
for this report period: _____
*
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
at
(000) 000-0000.
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: | ||
(authorized
signature)
|
|
|
|
Name (please print): | Date: | ||
|
|
Mail
report with any royalty payment due to:
Roche
Molecular Systems, Inc., P. X. Xxx 000000, Xxxxxxxx, XX
00000-0000
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
17
ATTACHMENT
IV
COLLECTION
RATE
Fiscal Year |
Collection
Rate
Percentage
|
(Only
applicable as provided in Section 4.2)
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
18
Via
Overnight Courier
November 5, 2004
|
Direct Dial: 000-000-0000
Fax: 000-000-0000
|
Response
Genetics
0000
Xxxxxxx Xxxxxx, Xxxxx 000
Xxx
Xxxxxxx, XX 00000
Attn: |
Xxxx
Xxxxxx
|
Vice President, Finance |
Re: | PCR Patent License Agreement between Licensee ("RGI") and Roche Molecular Systems, Inc. ("RMS") (the "Agreement") |
Enclosed
are duplicate RMS-executed originals of the Agreement. Please have the Agreement
signed where
indicated, retain one fully executed original and return the other to my
attention at the below address.
If
you
previously held a PCR services agreement, please keep the following in mind:
a)
unlike most PCR licenses
previously issued, this Agreement requires
quarterly royalty reports, not
semiannual reports; and
b)
Licensed Services performed prior to the effective date of this Agreement,
are
royalty-bearing as specified under the agreement being replaced.
When
returning the executed agreement, please include any literature, if available,
that describes the Licensed Services. If such information is provided on the
internet, please provide the URL address.
RMS
occasionally receives requests (from the media, medical professionals, and
companies wishing to offer
reagents such as primers and probes for sale) to provide the names of
organizations that have rights to
use
PCR. We respond to such requests by providing a comprehensive list of those
organizations. Should
you prefer not to be included in such lists, please let us know.
We
look
forward to finalizing this Agreement within 30 days; after that time, it may
be
necessary to process
and execute new documents. Therefore, if you anticipate a delay, please let
me
know, and please call me if you have any questions.
Kind
regards,
Roche
Molecular Systems
|
|
Xxxxx
Xxxxxxx
Licensing
Manager
|
|
dd
Enclosure(s)
|
Roche
Molecular Systems,
Inc.
|
0000 Xxxxxxxx Xxxxxx |
Tel.
000-000-0000
|
Xxxxxxx, Xxxxxxxxxx 00000 |
Fax
000-000-0000
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.